Cardiothoracic Surgery

The second patient to be transplanted with a genetically modified pig heart at the University of Maryland Medical Center (UMMC), Baltimore, is said to be stable and doing well after the Sept. 22 operation. The organ passed an early test by avoiding hyperacute rejection.

Physicians for the patient, a 58-year-old former lab tech repeatedly turned down for standard allograft transplantation, say they are making good use of lessons from last year’s case of David Bennett, who survived in hospital with difficulty for 2 months after receiving the first such heart at the center in January 2022.

Mr. Bennett’s clinical course had been promising at first but grew turbulent with repeated bouts of infection followed by adjustments to his aggressive immunosuppressant regimen and other complications.

It was also learned weeks after the xenotransplant operation that the heart from the genetically modified donor pig had carried a porcine cytomegalovirus to Mr. Bennett’s body, although there was never evidence that the virus infected other organs or played a major role in his death.

The new xenotransplant recipient, Lawrence Faucette of Frederick, Md., is benefiting from that experience, which was documented in journal reports.

Mr. Faucette had been turned down by UMMC “and several other leading transplant hospitals due to his pre-existing peripheral vascular disease and complications with internal bleeding,” notes a UMMC press release describing his procedure.

The patient “is currently breathing on his own, and his heart is functioning well without any assistance from supportive devices,” says the statement.

Despite a few setbacks, Mr. Faucette is “on the right track,” said Muhammad M. Mohiuddin, MBBS, surgeon and xenotransplantation program director at the University of Maryland, Baltimore, in an interview.

“We’re taking one day at a time. His immune system is still intact, despite the heavy immune suppression,” he told this news organization. His heart didn’t carry a virus and “has not shown any signs of rejection so far.”

The University of Maryland team, Dr. Mohiuddin said, “is very hopeful that we will be able to at least mobilize the patient, and he can be discharged. But it’s a little too early to call.”

Mr. Faucette, as part of his immunosuppressant regimen, is receiving tegoprubart (Eledon Pharmaceuticals), an investigational antibody that blocks CD40 ligand. His predecessor Mr. Bennett, in contrast, had received a blocker of the CD40 receptor (Kiniksa Pharmaceuticals) along with other more familiar immunosuppressants.

The new anti–CD40-ligand blocker, Eledon said, is in phase 1 studies looking at efficacy in patients with conventional kidney transplants.

A version of this article appeared on Medscape.com.

The second patient to be transplanted with a genetically modified pig heart at the University of Maryland Medical Center (UMMC), Baltimore, is said to be stable and doing well after the Sept. 22 operation. The organ passed an early test by avoiding hyperacute rejection.

Physicians for the patient, a 58-year-old former lab tech repeatedly turned down for standard allograft transplantation, say they are making good use of lessons from last year’s case of David Bennett, who survived in hospital with difficulty for 2 months after receiving the first such heart at the center in January 2022.

Mr. Bennett’s clinical course had been promising at first but grew turbulent with repeated bouts of infection followed by adjustments to his aggressive immunosuppressant regimen and other complications.

It was also learned weeks after the xenotransplant operation that the heart from the genetically modified donor pig had carried a porcine cytomegalovirus to Mr. Bennett’s body, although there was never evidence that the virus infected other organs or played a major role in his death.

The new xenotransplant recipient, Lawrence Faucette of Frederick, Md., is benefiting from that experience, which was documented in journal reports.

Mr. Faucette had been turned down by UMMC “and several other leading transplant hospitals due to his pre-existing peripheral vascular disease and complications with internal bleeding,” notes a UMMC press release describing his procedure.

The patient “is currently breathing on his own, and his heart is functioning well without any assistance from supportive devices,” says the statement.

Despite a few setbacks, Mr. Faucette is “on the right track,” said Muhammad M. Mohiuddin, MBBS, surgeon and xenotransplantation program director at the University of Maryland, Baltimore, in an interview.

“We’re taking one day at a time. His immune system is still intact, despite the heavy immune suppression,” he told this news organization. His heart didn’t carry a virus and “has not shown any signs of rejection so far.”

The University of Maryland team, Dr. Mohiuddin said, “is very hopeful that we will be able to at least mobilize the patient, and he can be discharged. But it’s a little too early to call.”

Mr. Faucette, as part of his immunosuppressant regimen, is receiving tegoprubart (Eledon Pharmaceuticals), an investigational antibody that blocks CD40 ligand. His predecessor Mr. Bennett, in contrast, had received a blocker of the CD40 receptor (Kiniksa Pharmaceuticals) along with other more familiar immunosuppressants.

The new anti–CD40-ligand blocker, Eledon said, is in phase 1 studies looking at efficacy in patients with conventional kidney transplants.

A version of this article appeared on Medscape.com.

The second patient to be transplanted with a genetically modified pig heart at the University of Maryland Medical Center (UMMC), Baltimore, is said to be stable and doing well after the Sept. 22 operation. The organ passed an early test by avoiding hyperacute rejection.

Physicians for the patient, a 58-year-old former lab tech repeatedly turned down for standard allograft transplantation, say they are making good use of lessons from last year’s case of David Bennett, who survived in hospital with difficulty for 2 months after receiving the first such heart at the center in January 2022.

Mr. Bennett’s clinical course had been promising at first but grew turbulent with repeated bouts of infection followed by adjustments to his aggressive immunosuppressant regimen and other complications.

It was also learned weeks after the xenotransplant operation that the heart from the genetically modified donor pig had carried a porcine cytomegalovirus to Mr. Bennett’s body, although there was never evidence that the virus infected other organs or played a major role in his death.

The new xenotransplant recipient, Lawrence Faucette of Frederick, Md., is benefiting from that experience, which was documented in journal reports.

Mr. Faucette had been turned down by UMMC “and several other leading transplant hospitals due to his pre-existing peripheral vascular disease and complications with internal bleeding,” notes a UMMC press release describing his procedure.

The patient “is currently breathing on his own, and his heart is functioning well without any assistance from supportive devices,” says the statement.

Despite a few setbacks, Mr. Faucette is “on the right track,” said Muhammad M. Mohiuddin, MBBS, surgeon and xenotransplantation program director at the University of Maryland, Baltimore, in an interview.

“We’re taking one day at a time. His immune system is still intact, despite the heavy immune suppression,” he told this news organization. His heart didn’t carry a virus and “has not shown any signs of rejection so far.”

The University of Maryland team, Dr. Mohiuddin said, “is very hopeful that we will be able to at least mobilize the patient, and he can be discharged. But it’s a little too early to call.”

Mr. Faucette, as part of his immunosuppressant regimen, is receiving tegoprubart (Eledon Pharmaceuticals), an investigational antibody that blocks CD40 ligand. His predecessor Mr. Bennett, in contrast, had received a blocker of the CD40 receptor (Kiniksa Pharmaceuticals) along with other more familiar immunosuppressants.

The new anti–CD40-ligand blocker, Eledon said, is in phase 1 studies looking at efficacy in patients with conventional kidney transplants.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Michelle L. O’Donoghue, MD, MPH: Hi. This is Dr. Michelle O’Donoghue reporting for Medscape. Joining me today is Dr. Sahil Parikh, who’s a cardiologist and an interventionalist at Columbia University. He’s an associate professor of medicine.

We’ll be discussing two interesting trials that were presented at the ESC Congress here in Amsterdam. They do have the potential to be very practice-changing, so I think it’s worth talking about.
 

The FIRE trial

The first trial we’ll be talking about is the FIRE trial. Perhaps setting the stage, Sahil, I’d love to get your thoughts. We’ve had data in this space to suggest that, for patients with STEMI [ST-segment elevation myocardial infarction], a strategy of complete revascularization – and not only treating the culprit lesion but also treating additional lesions – may be of benefit. Where does that lead us in terms of what we didn’t know?

Sahil A. Parikh, MD: I think that the practice has moved, at least in the United States, over the past two decades, from staging percutaneous coronary interventions over 30 days from index to intervention to now trying to do patients in the same hospitalization whenever possible to achieve complete revascularization.

I think these data support not only that complete revascularization is compulsory now in these patients, but also doing it sooner rather than later, and that the benefit applies to most of the patients that we see in clinical practice. In the earlier data, the patients were relatively youthful – under Medicare age, less than 65 – and now this dataset has a median age of 80. This is more like the real-world clinical practice that most of us are encountering, and it extends the benefit, perhaps, greater than we’ve ever seen before.

O’Donoghue: The FIRE trial is interesting. As you say, it enrolled patients who were over the age of 75, where I think that some proceduralists are probably a little bit hesitant to think about complete revascularization due to concerns about any additional contrast load on their kidneys and other types of comorbidities. Of course, for any trial, there’s going to be some patient selection.

I think it’s very reassuring that even in this older patient group, a strategy of treating all the lesions – and not only in STEMI but also in non-STEMI patients – reduced cardiovascular events and mortality. I was really quite impressed by the mortality benefit.

Parikh: The mortality curve is almost surprising to me. On the other hand, it emboldens us now that we can treat these patients more completely and earlier in their clinical presentation. Certainly, we worried about contrast exposure and the duration of procedures in this older population, but it seems that the benefit that’s derived, which we saw in younger patients where we had a natural inclination to be more aggressive, extends also to this older population.
 

MULTISTARS AMI

O’Donoghue: To the question of timing, as you mentioned, prior to this, we had a study presented earlier this year, the BIOVASC trial, which also was suggestive that maybe earlier complete revascularization was better. But it wasn’t a significant difference, at least for the primary outcome. Now we have MULTISTARS AMI, which is very supportive of what we saw earlier this year, suggesting that complete revascularization really at the time that you’re treating the culprit may be the way to go.

Parikh: All of us, as interventionalists, are circumspect about what we might do in the middle of the night versus what we would do in the light of day. Certainly it seems clear, particularly if it’s straightforward anatomy, that taking care of it in the index procedure is not only saving contrast and fluoroscopy time, but it’s also providing a clinical benefit to the patients. That’s something that will also impact how clinicians interpret these data. Previously, there was always a question about whether we should just do it in the same hospitalization or do it at the same time. I think now, increasingly, we’re emboldened to do more in the index procedure.

O’Donoghue: When you’re thinking about nonculprit lesions and which ones to treat, do you always make that determination based on physiologic guidance of some kind? Are you using instantaneous wave-free ratio? What’s your practice?

Parikh: In the acute setting, imaging is superior for at least the assessment of which is a culprit. If you see a ruptured atherothrombotic situation on optical coherence tomography, for example, that’s fairly convincing and definitive. In the absence of that physiology, we are taught to avoid in the infarct-related artery because of potential spuriously false-negative findings.

In this situation, certainly, an imaging subgroup probably would be helpful because some of the benefit is almost certainly derived from identifying the infarct-related artery by accident – in other words, doing what you thought was the nonculprit artery, which is, in fact, the culprit. I think that probably is part of this. As somebody who uses imaging in the overwhelming number of my cases, I think that imaging would be an important surrogate to this.
 

Index procedure versus staged

O’Donoghue: For the operator who is coming in to do their STEMI case at 2:00 in the morning, would these data now push you toward doing complete revascularization at that time of night, or do you think that there is wiggle room in terms of interpreting these results regarding timing, where as long as you were doing it before hospital discharge and not, let’s say, 30 days out, that you may be able to derive the same benefit? What are some of the pros and cons?

Parikh: There’s definitely a fatigue factor in the middle of the night if it’s a particularly arduous intervention for the index infarct-related artery. I think there’s a human element where it may make sense just to stop and then bring the patient back in the same hospitalization. It’s clear, though, that doing complete revascularization is better and doing it sooner is better. How soon one actually does it is a judgment call, as ever.

In our practice, we’ve been pushing ourselves to get most of the patients done in their index hospitalization. If you have a left-sided culprit, the left anterior descending artery, for example, and there’s a high-grade stenosis in the circumflex, it may make sense to take care of that in the same index procedure. If, on the other hand, it’s in the right coronary artery where you have to put a new guide in and spend more time, that may be a patient whom you stage. I think those nuances will come up as interventionalists look at the subgroup analysis data more carefully.

O’Donoghue: Those are great points, and I think they also underscore that we always need to think about what type of patient was enrolled in these studies. Certainly, if you have somebody with renal dysfunction, there might be more concern about giving them a large contrast load all in one sitting, albeit hard to know whether they do or not. But spacing that out by just a couple of days would really have a big impact.

Parikh: Very often in the STEMI patient, you don’t have the benefit of knowing the creatinine. The patient will come in immediately, if not directly from the ambulance to the cath lab, and there are no laboratories at all to work with. If the patient has never been seen in the system before, you won’t know. Again, in those situations, one may have pause, particularly if it’s an older patient. I think what’s reassuring, though, is that the data are supportive of being more aggressive earlier, and certainly this is the dataset that we were looking for.

O’Donoghue: To summarize, the two key takeaways are that, one, we now have more data to support a complete revascularization strategy and even extending that now to non-STEMI patients. Two, sooner appears to be better, so ideally, all done at the time of the index procedure. I think this is very interesting science and we’ll see how it changes practice.

Thanks for joining me today. Signing off for Medscape, this is Dr. Michelle O’Donoghue.

Michelle O’Donoghue is a cardiologist at Brigham and Women’s Hospital and senior investigator with the TIMI Study Group.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Michelle L. O’Donoghue, MD, MPH: Hi. This is Dr. Michelle O’Donoghue reporting for Medscape. Joining me today is Dr. Sahil Parikh, who’s a cardiologist and an interventionalist at Columbia University. He’s an associate professor of medicine.

We’ll be discussing two interesting trials that were presented at the ESC Congress here in Amsterdam. They do have the potential to be very practice-changing, so I think it’s worth talking about.
 

The FIRE trial

The first trial we’ll be talking about is the FIRE trial. Perhaps setting the stage, Sahil, I’d love to get your thoughts. We’ve had data in this space to suggest that, for patients with STEMI [ST-segment elevation myocardial infarction], a strategy of complete revascularization – and not only treating the culprit lesion but also treating additional lesions – may be of benefit. Where does that lead us in terms of what we didn’t know?

Sahil A. Parikh, MD: I think that the practice has moved, at least in the United States, over the past two decades, from staging percutaneous coronary interventions over 30 days from index to intervention to now trying to do patients in the same hospitalization whenever possible to achieve complete revascularization.

I think these data support not only that complete revascularization is compulsory now in these patients, but also doing it sooner rather than later, and that the benefit applies to most of the patients that we see in clinical practice. In the earlier data, the patients were relatively youthful – under Medicare age, less than 65 – and now this dataset has a median age of 80. This is more like the real-world clinical practice that most of us are encountering, and it extends the benefit, perhaps, greater than we’ve ever seen before.

O’Donoghue: The FIRE trial is interesting. As you say, it enrolled patients who were over the age of 75, where I think that some proceduralists are probably a little bit hesitant to think about complete revascularization due to concerns about any additional contrast load on their kidneys and other types of comorbidities. Of course, for any trial, there’s going to be some patient selection.

I think it’s very reassuring that even in this older patient group, a strategy of treating all the lesions – and not only in STEMI but also in non-STEMI patients – reduced cardiovascular events and mortality. I was really quite impressed by the mortality benefit.

Parikh: The mortality curve is almost surprising to me. On the other hand, it emboldens us now that we can treat these patients more completely and earlier in their clinical presentation. Certainly, we worried about contrast exposure and the duration of procedures in this older population, but it seems that the benefit that’s derived, which we saw in younger patients where we had a natural inclination to be more aggressive, extends also to this older population.
 

MULTISTARS AMI

O’Donoghue: To the question of timing, as you mentioned, prior to this, we had a study presented earlier this year, the BIOVASC trial, which also was suggestive that maybe earlier complete revascularization was better. But it wasn’t a significant difference, at least for the primary outcome. Now we have MULTISTARS AMI, which is very supportive of what we saw earlier this year, suggesting that complete revascularization really at the time that you’re treating the culprit may be the way to go.

Parikh: All of us, as interventionalists, are circumspect about what we might do in the middle of the night versus what we would do in the light of day. Certainly it seems clear, particularly if it’s straightforward anatomy, that taking care of it in the index procedure is not only saving contrast and fluoroscopy time, but it’s also providing a clinical benefit to the patients. That’s something that will also impact how clinicians interpret these data. Previously, there was always a question about whether we should just do it in the same hospitalization or do it at the same time. I think now, increasingly, we’re emboldened to do more in the index procedure.

O’Donoghue: When you’re thinking about nonculprit lesions and which ones to treat, do you always make that determination based on physiologic guidance of some kind? Are you using instantaneous wave-free ratio? What’s your practice?

Parikh: In the acute setting, imaging is superior for at least the assessment of which is a culprit. If you see a ruptured atherothrombotic situation on optical coherence tomography, for example, that’s fairly convincing and definitive. In the absence of that physiology, we are taught to avoid in the infarct-related artery because of potential spuriously false-negative findings.

In this situation, certainly, an imaging subgroup probably would be helpful because some of the benefit is almost certainly derived from identifying the infarct-related artery by accident – in other words, doing what you thought was the nonculprit artery, which is, in fact, the culprit. I think that probably is part of this. As somebody who uses imaging in the overwhelming number of my cases, I think that imaging would be an important surrogate to this.
 

Index procedure versus staged

O’Donoghue: For the operator who is coming in to do their STEMI case at 2:00 in the morning, would these data now push you toward doing complete revascularization at that time of night, or do you think that there is wiggle room in terms of interpreting these results regarding timing, where as long as you were doing it before hospital discharge and not, let’s say, 30 days out, that you may be able to derive the same benefit? What are some of the pros and cons?

Parikh: There’s definitely a fatigue factor in the middle of the night if it’s a particularly arduous intervention for the index infarct-related artery. I think there’s a human element where it may make sense just to stop and then bring the patient back in the same hospitalization. It’s clear, though, that doing complete revascularization is better and doing it sooner is better. How soon one actually does it is a judgment call, as ever.

In our practice, we’ve been pushing ourselves to get most of the patients done in their index hospitalization. If you have a left-sided culprit, the left anterior descending artery, for example, and there’s a high-grade stenosis in the circumflex, it may make sense to take care of that in the same index procedure. If, on the other hand, it’s in the right coronary artery where you have to put a new guide in and spend more time, that may be a patient whom you stage. I think those nuances will come up as interventionalists look at the subgroup analysis data more carefully.

O’Donoghue: Those are great points, and I think they also underscore that we always need to think about what type of patient was enrolled in these studies. Certainly, if you have somebody with renal dysfunction, there might be more concern about giving them a large contrast load all in one sitting, albeit hard to know whether they do or not. But spacing that out by just a couple of days would really have a big impact.

Parikh: Very often in the STEMI patient, you don’t have the benefit of knowing the creatinine. The patient will come in immediately, if not directly from the ambulance to the cath lab, and there are no laboratories at all to work with. If the patient has never been seen in the system before, you won’t know. Again, in those situations, one may have pause, particularly if it’s an older patient. I think what’s reassuring, though, is that the data are supportive of being more aggressive earlier, and certainly this is the dataset that we were looking for.

O’Donoghue: To summarize, the two key takeaways are that, one, we now have more data to support a complete revascularization strategy and even extending that now to non-STEMI patients. Two, sooner appears to be better, so ideally, all done at the time of the index procedure. I think this is very interesting science and we’ll see how it changes practice.

Thanks for joining me today. Signing off for Medscape, this is Dr. Michelle O’Donoghue.

Michelle O’Donoghue is a cardiologist at Brigham and Women’s Hospital and senior investigator with the TIMI Study Group.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Michelle L. O’Donoghue, MD, MPH: Hi. This is Dr. Michelle O’Donoghue reporting for Medscape. Joining me today is Dr. Sahil Parikh, who’s a cardiologist and an interventionalist at Columbia University. He’s an associate professor of medicine.

We’ll be discussing two interesting trials that were presented at the ESC Congress here in Amsterdam. They do have the potential to be very practice-changing, so I think it’s worth talking about.
 

The FIRE trial

The first trial we’ll be talking about is the FIRE trial. Perhaps setting the stage, Sahil, I’d love to get your thoughts. We’ve had data in this space to suggest that, for patients with STEMI [ST-segment elevation myocardial infarction], a strategy of complete revascularization – and not only treating the culprit lesion but also treating additional lesions – may be of benefit. Where does that lead us in terms of what we didn’t know?

Sahil A. Parikh, MD: I think that the practice has moved, at least in the United States, over the past two decades, from staging percutaneous coronary interventions over 30 days from index to intervention to now trying to do patients in the same hospitalization whenever possible to achieve complete revascularization.

I think these data support not only that complete revascularization is compulsory now in these patients, but also doing it sooner rather than later, and that the benefit applies to most of the patients that we see in clinical practice. In the earlier data, the patients were relatively youthful – under Medicare age, less than 65 – and now this dataset has a median age of 80. This is more like the real-world clinical practice that most of us are encountering, and it extends the benefit, perhaps, greater than we’ve ever seen before.

O’Donoghue: The FIRE trial is interesting. As you say, it enrolled patients who were over the age of 75, where I think that some proceduralists are probably a little bit hesitant to think about complete revascularization due to concerns about any additional contrast load on their kidneys and other types of comorbidities. Of course, for any trial, there’s going to be some patient selection.

I think it’s very reassuring that even in this older patient group, a strategy of treating all the lesions – and not only in STEMI but also in non-STEMI patients – reduced cardiovascular events and mortality. I was really quite impressed by the mortality benefit.

Parikh: The mortality curve is almost surprising to me. On the other hand, it emboldens us now that we can treat these patients more completely and earlier in their clinical presentation. Certainly, we worried about contrast exposure and the duration of procedures in this older population, but it seems that the benefit that’s derived, which we saw in younger patients where we had a natural inclination to be more aggressive, extends also to this older population.
 

MULTISTARS AMI

O’Donoghue: To the question of timing, as you mentioned, prior to this, we had a study presented earlier this year, the BIOVASC trial, which also was suggestive that maybe earlier complete revascularization was better. But it wasn’t a significant difference, at least for the primary outcome. Now we have MULTISTARS AMI, which is very supportive of what we saw earlier this year, suggesting that complete revascularization really at the time that you’re treating the culprit may be the way to go.

Parikh: All of us, as interventionalists, are circumspect about what we might do in the middle of the night versus what we would do in the light of day. Certainly it seems clear, particularly if it’s straightforward anatomy, that taking care of it in the index procedure is not only saving contrast and fluoroscopy time, but it’s also providing a clinical benefit to the patients. That’s something that will also impact how clinicians interpret these data. Previously, there was always a question about whether we should just do it in the same hospitalization or do it at the same time. I think now, increasingly, we’re emboldened to do more in the index procedure.

O’Donoghue: When you’re thinking about nonculprit lesions and which ones to treat, do you always make that determination based on physiologic guidance of some kind? Are you using instantaneous wave-free ratio? What’s your practice?

Parikh: In the acute setting, imaging is superior for at least the assessment of which is a culprit. If you see a ruptured atherothrombotic situation on optical coherence tomography, for example, that’s fairly convincing and definitive. In the absence of that physiology, we are taught to avoid in the infarct-related artery because of potential spuriously false-negative findings.

In this situation, certainly, an imaging subgroup probably would be helpful because some of the benefit is almost certainly derived from identifying the infarct-related artery by accident – in other words, doing what you thought was the nonculprit artery, which is, in fact, the culprit. I think that probably is part of this. As somebody who uses imaging in the overwhelming number of my cases, I think that imaging would be an important surrogate to this.
 

Index procedure versus staged

O’Donoghue: For the operator who is coming in to do their STEMI case at 2:00 in the morning, would these data now push you toward doing complete revascularization at that time of night, or do you think that there is wiggle room in terms of interpreting these results regarding timing, where as long as you were doing it before hospital discharge and not, let’s say, 30 days out, that you may be able to derive the same benefit? What are some of the pros and cons?

Parikh: There’s definitely a fatigue factor in the middle of the night if it’s a particularly arduous intervention for the index infarct-related artery. I think there’s a human element where it may make sense just to stop and then bring the patient back in the same hospitalization. It’s clear, though, that doing complete revascularization is better and doing it sooner is better. How soon one actually does it is a judgment call, as ever.

In our practice, we’ve been pushing ourselves to get most of the patients done in their index hospitalization. If you have a left-sided culprit, the left anterior descending artery, for example, and there’s a high-grade stenosis in the circumflex, it may make sense to take care of that in the same index procedure. If, on the other hand, it’s in the right coronary artery where you have to put a new guide in and spend more time, that may be a patient whom you stage. I think those nuances will come up as interventionalists look at the subgroup analysis data more carefully.

O’Donoghue: Those are great points, and I think they also underscore that we always need to think about what type of patient was enrolled in these studies. Certainly, if you have somebody with renal dysfunction, there might be more concern about giving them a large contrast load all in one sitting, albeit hard to know whether they do or not. But spacing that out by just a couple of days would really have a big impact.

Parikh: Very often in the STEMI patient, you don’t have the benefit of knowing the creatinine. The patient will come in immediately, if not directly from the ambulance to the cath lab, and there are no laboratories at all to work with. If the patient has never been seen in the system before, you won’t know. Again, in those situations, one may have pause, particularly if it’s an older patient. I think what’s reassuring, though, is that the data are supportive of being more aggressive earlier, and certainly this is the dataset that we were looking for.

O’Donoghue: To summarize, the two key takeaways are that, one, we now have more data to support a complete revascularization strategy and even extending that now to non-STEMI patients. Two, sooner appears to be better, so ideally, all done at the time of the index procedure. I think this is very interesting science and we’ll see how it changes practice.

Thanks for joining me today. Signing off for Medscape, this is Dr. Michelle O’Donoghue.

Michelle O’Donoghue is a cardiologist at Brigham and Women’s Hospital and senior investigator with the TIMI Study Group.

A version of this article first appeared on Medscape.com.

Diffuse Lung Disease & Transplant Network

Lung Transplant Section

Frailty, a concept that originated in the geriatric population, is a state of vulnerability resulting from a decline in reserve and function across physiological systems. While it is more commonly observed in older adults, some aging-associated syndromes, such as sarcopenia, impaired cognition, inflammation, and malnutrition, may be present in younger patients with end-stage organ disease. These syndromes can be associated with biological age, as opposed to chronological age, which explains why younger patients with end-stage organ disease can develop frailty (Schaenman JM, et al. Am J Transplant. 2021 Jun;21[6]:2018-24). Frailty in the lung transplant population is associated with increased morbidity and mortality while on the waitlist and post-transplant (Montgomery E, et al. J Transplant. 2020 Aug 7:3239495). In 2021, the International Society of Heart and Lung Transplantation recommended including a frailty assessment to complete a patient’s transplant evaluation. The committee cautioned using current assessment tools, as they are not yet accepted as the standard of care (Leard, et al. J Heart Lung Transplant. 2021 Nov;40[11]:1349-79). Existing tools being used evolved from studies of community-dwelling older adults with no predilection for distinct organ disease, which include the Fried Physical Frailty Phenotype (FPFP) and the Short Physical Performance Battery (SPPB). Along with physical limitations, frail patients tend to have abnormal biomarkers including higher inflammatory cytokines, such as plasma IL-6 and tumor necrosis factor receptor 1, and lower insulin-like growth factor I and leptin (Singer JP, et al. Am J Respir Crit Care Med. 2015;192[11]1325-34). The concept of a lung-focused approach to frailty, which considers biomarkers and body composition, is currently being researched (Singer JP, et al. J Heart Lung Transplant. 2023;S1053-S2498[23]00049-9). This disease-specific frailty scale would identify lung transplant candidates who may benefit from targeted interventions, and such frailty would also be expected to improve after transplant.

Erin Meier, MD
Section Fellow-in-Training

Anupam Kumar, MD, FCCP
Section Member-at-Large

Diffuse Lung Disease & Transplant Network

Lung Transplant Section

Frailty, a concept that originated in the geriatric population, is a state of vulnerability resulting from a decline in reserve and function across physiological systems. While it is more commonly observed in older adults, some aging-associated syndromes, such as sarcopenia, impaired cognition, inflammation, and malnutrition, may be present in younger patients with end-stage organ disease. These syndromes can be associated with biological age, as opposed to chronological age, which explains why younger patients with end-stage organ disease can develop frailty (Schaenman JM, et al. Am J Transplant. 2021 Jun;21[6]:2018-24). Frailty in the lung transplant population is associated with increased morbidity and mortality while on the waitlist and post-transplant (Montgomery E, et al. J Transplant. 2020 Aug 7:3239495). In 2021, the International Society of Heart and Lung Transplantation recommended including a frailty assessment to complete a patient’s transplant evaluation. The committee cautioned using current assessment tools, as they are not yet accepted as the standard of care (Leard, et al. J Heart Lung Transplant. 2021 Nov;40[11]:1349-79). Existing tools being used evolved from studies of community-dwelling older adults with no predilection for distinct organ disease, which include the Fried Physical Frailty Phenotype (FPFP) and the Short Physical Performance Battery (SPPB). Along with physical limitations, frail patients tend to have abnormal biomarkers including higher inflammatory cytokines, such as plasma IL-6 and tumor necrosis factor receptor 1, and lower insulin-like growth factor I and leptin (Singer JP, et al. Am J Respir Crit Care Med. 2015;192[11]1325-34). The concept of a lung-focused approach to frailty, which considers biomarkers and body composition, is currently being researched (Singer JP, et al. J Heart Lung Transplant. 2023;S1053-S2498[23]00049-9). This disease-specific frailty scale would identify lung transplant candidates who may benefit from targeted interventions, and such frailty would also be expected to improve after transplant.

Erin Meier, MD
Section Fellow-in-Training

Anupam Kumar, MD, FCCP
Section Member-at-Large

Diffuse Lung Disease & Transplant Network

Lung Transplant Section

Frailty, a concept that originated in the geriatric population, is a state of vulnerability resulting from a decline in reserve and function across physiological systems. While it is more commonly observed in older adults, some aging-associated syndromes, such as sarcopenia, impaired cognition, inflammation, and malnutrition, may be present in younger patients with end-stage organ disease. These syndromes can be associated with biological age, as opposed to chronological age, which explains why younger patients with end-stage organ disease can develop frailty (Schaenman JM, et al. Am J Transplant. 2021 Jun;21[6]:2018-24). Frailty in the lung transplant population is associated with increased morbidity and mortality while on the waitlist and post-transplant (Montgomery E, et al. J Transplant. 2020 Aug 7:3239495). In 2021, the International Society of Heart and Lung Transplantation recommended including a frailty assessment to complete a patient’s transplant evaluation. The committee cautioned using current assessment tools, as they are not yet accepted as the standard of care (Leard, et al. J Heart Lung Transplant. 2021 Nov;40[11]:1349-79). Existing tools being used evolved from studies of community-dwelling older adults with no predilection for distinct organ disease, which include the Fried Physical Frailty Phenotype (FPFP) and the Short Physical Performance Battery (SPPB). Along with physical limitations, frail patients tend to have abnormal biomarkers including higher inflammatory cytokines, such as plasma IL-6 and tumor necrosis factor receptor 1, and lower insulin-like growth factor I and leptin (Singer JP, et al. Am J Respir Crit Care Med. 2015;192[11]1325-34). The concept of a lung-focused approach to frailty, which considers biomarkers and body composition, is currently being researched (Singer JP, et al. J Heart Lung Transplant. 2023;S1053-S2498[23]00049-9). This disease-specific frailty scale would identify lung transplant candidates who may benefit from targeted interventions, and such frailty would also be expected to improve after transplant.

Erin Meier, MD
Section Fellow-in-Training

Anupam Kumar, MD, FCCP
Section Member-at-Large

Two Boston doctors associated with Salem Hospital, a clinical affiliate of Massachusetts General Hospital, must pay nearly $29 million to the family of a man whose aortic aneurysm and dissection went undiagnosed and untreated, according to a story posted on Boston.com, among other news sites.

On the morning of Jan. 13, 2018, Joseph Brown awoke with shortness of breath and upper abdominal pain, which eventually spread to his chest and back. Taken to Salem Hospital’s emergency department, Mr. Brown was seen by Steven D. Browell, MD, an emergency medicine specialist.

Dr. Browell ordered tests that ruled out both a heart attack and a pulmonary embolism. He called for a blood test, which indicated that the patient’s white blood count was elevated. Suspecting an infection, Dr. Browell ordered that Mr. Brown be admitted to the hospital.

Accepting Mr. Brown’s admission was William D. Kenyon, MD, a hospitalist, who also examined the patient and concurred with Dr. Browell’s probable diagnosis. The patient was then sent to the medical floor.

There he underwent additional testing, including a chest x-ray, which proved negative except for one finding: a “mild hazy interstitial opacity that could represent a small airway inflammation or developing/early pneumonia.” Because Mr. Brown had reported that he had punctured his foot several days earlier, he also underwent a foot x-ray, which showed a possible foreign body. It was thought that might be the source of his infection.

Neither Dr. Browell nor Dr. Kenyon had completely ruled out a possible aortic aneurysm and dissection. Mr. Brown’s symptoms, after all, were in some ways suggestive of those conditions. Then again, he was very young – only 43 at the time – and his pain, while severe, didn’t correspond to the “searing” pain that, at trial, Dr. Kenyon described as typical of an aneurysm and dissection. As the hospitalist testified at trial, Mr. Brown had “a constellation of nonspecific symptoms” and an “unusual presentation of a rare condition,” typically seen in patients aged 65 and older.

Given these factors – and the results of Mr. Brown’s tests, lab studies, and physical exam – Dr. Kenyon didn’t think that the case warranted a CT scan to rule out an aortic aneurysm or aortic dissection.

By early the next morning, though, Mr. Brown’s shortness of breath and pain had intensified significantly. The on-duty doctor ordered a CT scan, which showed “a massive aneurysm at the beginning of [the patient’s] aorta and a dissection extending through most of his aorta.”

Mr. Brown was flown to Boston to undergo emergency surgery. En route to the helicopter, his aorta ruptured, stopping his heart and causing his death.

During the 8-day trial, each side introduced expert witnesses. Speaking for the plaintiffs, experts in cardiothoracic surgery and emergency medicine testified that the treating physicians were negligent in failing to order a CT scan on Jan. 13. Had they done so, the patient would have almost certainly undergone surgery earlier, which would have prevented his death.

Experts for the defense saw things differently. They testified that, given the evidence, it was reasonable and appropriate for Dr. Browell and Dr. Kenyon to have treated their patient for an infection rather than an aneurysm or dissection.

The jury found the defense’s arguments unconvincing, however. After deliberating 3 hours, it awarded the plaintiffs $20,000,000, to be paid out over time largely to Mr. Brown’s two daughters, who were aged 12 and 18 when he died. Including interest, the total award is close to $29 million.

In a statement following the verdict, lead plaintiff’s attorney Robert M. Higgins, of Lubin & Meyer, Boston, said the takeaway from the case was: “If you just treat people based on what the likelihood is, statistically, you’re going to miss a lot of life-threatening conditions. And that’s what happened in this case.”
 

Urologists typically prevail in BPH suits

Malpractice claims following surgery for benign prostatic hyperplasia (BPH) tend to be limited in scope and are typically resolved in favor of the surgeon-defendant, as a study in The Cureus Journal of Medical Science makes clear.

The study – conducted by a team of researchers that included Joao G. Porto, MD, of the Desai Sethi Urology Institute, University of Miami – investigated whether such surgeries pose a significant malpractice risk for urologists.

With information gleaned from two well-known legal databases, the team used a variety of key terms to identify BPH-related claims from January 2000 to December 2021.

Within this universe of claims, researchers identified several significant trends:

• Among BPH-related procedures, transurethral resection of the prostate was the most frequently identified (37%);
• Among the most-often cited reasons cited for a claim, allegations of inadequate postoperative care were the most common (33%);
• Of possible postsurgical complications, those that led to the greatest number of suits were urinary incontinence (23%), erectile dysfunction (13%), and urinary retention (13%); and,
• Not unexpectedly, the specialist most frequently named in a suit was a urologist (57%).

Interestingly, in all but two of the claims, the verdict favored the doctor-defendant. In the two cases in which the plaintiff prevailed, each involved unexpected and serious postsurgical complications.

A version of this article originally appeared on Medscape.com.

Two Boston doctors associated with Salem Hospital, a clinical affiliate of Massachusetts General Hospital, must pay nearly $29 million to the family of a man whose aortic aneurysm and dissection went undiagnosed and untreated, according to a story posted on Boston.com, among other news sites.

On the morning of Jan. 13, 2018, Joseph Brown awoke with shortness of breath and upper abdominal pain, which eventually spread to his chest and back. Taken to Salem Hospital’s emergency department, Mr. Brown was seen by Steven D. Browell, MD, an emergency medicine specialist.

Dr. Browell ordered tests that ruled out both a heart attack and a pulmonary embolism. He called for a blood test, which indicated that the patient’s white blood count was elevated. Suspecting an infection, Dr. Browell ordered that Mr. Brown be admitted to the hospital.

Accepting Mr. Brown’s admission was William D. Kenyon, MD, a hospitalist, who also examined the patient and concurred with Dr. Browell’s probable diagnosis. The patient was then sent to the medical floor.

There he underwent additional testing, including a chest x-ray, which proved negative except for one finding: a “mild hazy interstitial opacity that could represent a small airway inflammation or developing/early pneumonia.” Because Mr. Brown had reported that he had punctured his foot several days earlier, he also underwent a foot x-ray, which showed a possible foreign body. It was thought that might be the source of his infection.

Neither Dr. Browell nor Dr. Kenyon had completely ruled out a possible aortic aneurysm and dissection. Mr. Brown’s symptoms, after all, were in some ways suggestive of those conditions. Then again, he was very young – only 43 at the time – and his pain, while severe, didn’t correspond to the “searing” pain that, at trial, Dr. Kenyon described as typical of an aneurysm and dissection. As the hospitalist testified at trial, Mr. Brown had “a constellation of nonspecific symptoms” and an “unusual presentation of a rare condition,” typically seen in patients aged 65 and older.

Given these factors – and the results of Mr. Brown’s tests, lab studies, and physical exam – Dr. Kenyon didn’t think that the case warranted a CT scan to rule out an aortic aneurysm or aortic dissection.

By early the next morning, though, Mr. Brown’s shortness of breath and pain had intensified significantly. The on-duty doctor ordered a CT scan, which showed “a massive aneurysm at the beginning of [the patient’s] aorta and a dissection extending through most of his aorta.”

Mr. Brown was flown to Boston to undergo emergency surgery. En route to the helicopter, his aorta ruptured, stopping his heart and causing his death.

During the 8-day trial, each side introduced expert witnesses. Speaking for the plaintiffs, experts in cardiothoracic surgery and emergency medicine testified that the treating physicians were negligent in failing to order a CT scan on Jan. 13. Had they done so, the patient would have almost certainly undergone surgery earlier, which would have prevented his death.

Experts for the defense saw things differently. They testified that, given the evidence, it was reasonable and appropriate for Dr. Browell and Dr. Kenyon to have treated their patient for an infection rather than an aneurysm or dissection.

The jury found the defense’s arguments unconvincing, however. After deliberating 3 hours, it awarded the plaintiffs $20,000,000, to be paid out over time largely to Mr. Brown’s two daughters, who were aged 12 and 18 when he died. Including interest, the total award is close to $29 million.

In a statement following the verdict, lead plaintiff’s attorney Robert M. Higgins, of Lubin & Meyer, Boston, said the takeaway from the case was: “If you just treat people based on what the likelihood is, statistically, you’re going to miss a lot of life-threatening conditions. And that’s what happened in this case.”
 

Urologists typically prevail in BPH suits

Malpractice claims following surgery for benign prostatic hyperplasia (BPH) tend to be limited in scope and are typically resolved in favor of the surgeon-defendant, as a study in The Cureus Journal of Medical Science makes clear.

The study – conducted by a team of researchers that included Joao G. Porto, MD, of the Desai Sethi Urology Institute, University of Miami – investigated whether such surgeries pose a significant malpractice risk for urologists.

With information gleaned from two well-known legal databases, the team used a variety of key terms to identify BPH-related claims from January 2000 to December 2021.

Within this universe of claims, researchers identified several significant trends:

• Among BPH-related procedures, transurethral resection of the prostate was the most frequently identified (37%);
• Among the most-often cited reasons cited for a claim, allegations of inadequate postoperative care were the most common (33%);
• Of possible postsurgical complications, those that led to the greatest number of suits were urinary incontinence (23%), erectile dysfunction (13%), and urinary retention (13%); and,
• Not unexpectedly, the specialist most frequently named in a suit was a urologist (57%).

Interestingly, in all but two of the claims, the verdict favored the doctor-defendant. In the two cases in which the plaintiff prevailed, each involved unexpected and serious postsurgical complications.

A version of this article originally appeared on Medscape.com.

Two Boston doctors associated with Salem Hospital, a clinical affiliate of Massachusetts General Hospital, must pay nearly $29 million to the family of a man whose aortic aneurysm and dissection went undiagnosed and untreated, according to a story posted on Boston.com, among other news sites.

On the morning of Jan. 13, 2018, Joseph Brown awoke with shortness of breath and upper abdominal pain, which eventually spread to his chest and back. Taken to Salem Hospital’s emergency department, Mr. Brown was seen by Steven D. Browell, MD, an emergency medicine specialist.

Dr. Browell ordered tests that ruled out both a heart attack and a pulmonary embolism. He called for a blood test, which indicated that the patient’s white blood count was elevated. Suspecting an infection, Dr. Browell ordered that Mr. Brown be admitted to the hospital.

Accepting Mr. Brown’s admission was William D. Kenyon, MD, a hospitalist, who also examined the patient and concurred with Dr. Browell’s probable diagnosis. The patient was then sent to the medical floor.

There he underwent additional testing, including a chest x-ray, which proved negative except for one finding: a “mild hazy interstitial opacity that could represent a small airway inflammation or developing/early pneumonia.” Because Mr. Brown had reported that he had punctured his foot several days earlier, he also underwent a foot x-ray, which showed a possible foreign body. It was thought that might be the source of his infection.

Neither Dr. Browell nor Dr. Kenyon had completely ruled out a possible aortic aneurysm and dissection. Mr. Brown’s symptoms, after all, were in some ways suggestive of those conditions. Then again, he was very young – only 43 at the time – and his pain, while severe, didn’t correspond to the “searing” pain that, at trial, Dr. Kenyon described as typical of an aneurysm and dissection. As the hospitalist testified at trial, Mr. Brown had “a constellation of nonspecific symptoms” and an “unusual presentation of a rare condition,” typically seen in patients aged 65 and older.

Given these factors – and the results of Mr. Brown’s tests, lab studies, and physical exam – Dr. Kenyon didn’t think that the case warranted a CT scan to rule out an aortic aneurysm or aortic dissection.

By early the next morning, though, Mr. Brown’s shortness of breath and pain had intensified significantly. The on-duty doctor ordered a CT scan, which showed “a massive aneurysm at the beginning of [the patient’s] aorta and a dissection extending through most of his aorta.”

Mr. Brown was flown to Boston to undergo emergency surgery. En route to the helicopter, his aorta ruptured, stopping his heart and causing his death.

During the 8-day trial, each side introduced expert witnesses. Speaking for the plaintiffs, experts in cardiothoracic surgery and emergency medicine testified that the treating physicians were negligent in failing to order a CT scan on Jan. 13. Had they done so, the patient would have almost certainly undergone surgery earlier, which would have prevented his death.

Experts for the defense saw things differently. They testified that, given the evidence, it was reasonable and appropriate for Dr. Browell and Dr. Kenyon to have treated their patient for an infection rather than an aneurysm or dissection.

The jury found the defense’s arguments unconvincing, however. After deliberating 3 hours, it awarded the plaintiffs $20,000,000, to be paid out over time largely to Mr. Brown’s two daughters, who were aged 12 and 18 when he died. Including interest, the total award is close to $29 million.

In a statement following the verdict, lead plaintiff’s attorney Robert M. Higgins, of Lubin & Meyer, Boston, said the takeaway from the case was: “If you just treat people based on what the likelihood is, statistically, you’re going to miss a lot of life-threatening conditions. And that’s what happened in this case.”
 

Urologists typically prevail in BPH suits

Malpractice claims following surgery for benign prostatic hyperplasia (BPH) tend to be limited in scope and are typically resolved in favor of the surgeon-defendant, as a study in The Cureus Journal of Medical Science makes clear.

The study – conducted by a team of researchers that included Joao G. Porto, MD, of the Desai Sethi Urology Institute, University of Miami – investigated whether such surgeries pose a significant malpractice risk for urologists.

With information gleaned from two well-known legal databases, the team used a variety of key terms to identify BPH-related claims from January 2000 to December 2021.

Within this universe of claims, researchers identified several significant trends:

• Among BPH-related procedures, transurethral resection of the prostate was the most frequently identified (37%);
• Among the most-often cited reasons cited for a claim, allegations of inadequate postoperative care were the most common (33%);
• Of possible postsurgical complications, those that led to the greatest number of suits were urinary incontinence (23%), erectile dysfunction (13%), and urinary retention (13%); and,
• Not unexpectedly, the specialist most frequently named in a suit was a urologist (57%).

Interestingly, in all but two of the claims, the verdict favored the doctor-defendant. In the two cases in which the plaintiff prevailed, each involved unexpected and serious postsurgical complications.

A version of this article originally appeared on Medscape.com.

The U.K. Mini Mitral trial, showing that mitral valve repair with the less invasive minithoracotomy approach achieved similar outcomes, compared with sternotomy, has now been published.

The trial, which was first presented earlier this year at the American College of Cardiology meeting, showed that minimally invasive mitral valve repair does not improve physical function at 12 weeks, compared with sternotomy, but outcomes at 1 year show minimally invasive repair is as safe and effective as sternotomy for degenerative mitral regurgitation.

The full results are now published online in JAMA.

The authors, led by Enoch Akowuah, MD, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom, explain that mitral valve repair surgery is the preferred treatment for patients with degenerative mitral regurgitation and is routinely performed via full sternotomy, enabling easy access to the heart, flexibility in myocardial protection strategies, and multiple ways of accessing the mitral valve and easing de-airing to prevent air emboli, which cause cerebrovascular accidents. 

However, the invasiveness of sternotomy is associated with delayed return to presurgery physical function levels and an increase in postoperative complications.

An alternative new video-guided minimally invasive approach involving a 4- to 7-cm lateral thoracotomy, completely avoiding sternotomy, has been developed, with the hope that it should speed physical recovery function after surgery and reduce postoperative complications and costs by reducing hospital stay.

Dr. Akowuah et al. note that uptake of minithoracotomy is variable, with low rates in the United States and the United Kingdom but high rates in Germany. They say that this variation is attributable to the absence of high-quality evidence from randomized trials demonstrating equivalent or superior benefits, compared with sternotomy, and there are also concerns that the increased technical complexity of minithoracotomy may impair the ability to repair complex valve lesions or increase perioperative complications, particularly vascular injuries and stroke.

The U.K. Mini Mitral trial was therefore conducted to compare the effectiveness and safety of minithoracotomy versus sternotomy mitral valve repair.

For the trial, 330 patients with degenerative mitral regurgitation were randomized to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon.

The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) physical functioning scale 12 weeks after the surgery.  

This failed to show superiority of minithoracotomy, with a mean difference of 0.68 (95% confidence interval, −1.89 to 3.26) between the two groups.

Analysis of secondary outcomes demonstrated that time spent undertaking moderate to vigorous physical activity was higher among participants receiving minithoracotomy at 6 weeks, although the treatment effect was small at an average of 9 minutes and was not different at 12 weeks.  

Postoperative length of hospital stay was reduced after minithoracotomy by 1 day, with a median of 5 days, compared with 6 days after sternotomy.

Although repair techniques were at the discretion of the surgeons and differed between the two procedures, high rates of valve repair and low rates of recurrent mitral regurgitation were observed in both groups. Cardiopulmonary bypass times were longer with minithoracotomy, but postoperative complications and adverse events were similar.

There was no difference between the two groups with respect to the prespecified safety outcome of death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year, which occurred in 5.4% of patients undergoing minithoracotomy and 6.1% of those undergoing sternotomy.

“These findings can inform shared decision-making and treatment guidelines,” the authors conclude.
 

Approach ‘may appeal to patients’

In an editorial accompanying the publication of the study in JAMA, Maurice Enriquez-Sarano, MD, Minneapolis Heart Institute, Minnesota, says the results should be integrated into patient management.

“Mini-thoracotomy mitral repair carried low risk and was highly effective compared with sternotomy. It can thus be applied successfully by surgeons who achieve the necessary expertise,” he notes.

“Mini-thoracotomy may appeal to patients because the procedure is less disfiguring than sternotomy. The early (6-week) benefit, albeit small and transient, is important to patients,” he adds.

The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reports no relevant financial relationships with industry. Dr. Enriquez-Sarano reports receiving consulting fees from Edwards Lifesciences, Artivion, ChemImage, HighLife, and Corcym.

A version of this article first appeared on Medscape.com.

The U.K. Mini Mitral trial, showing that mitral valve repair with the less invasive minithoracotomy approach achieved similar outcomes, compared with sternotomy, has now been published.

The trial, which was first presented earlier this year at the American College of Cardiology meeting, showed that minimally invasive mitral valve repair does not improve physical function at 12 weeks, compared with sternotomy, but outcomes at 1 year show minimally invasive repair is as safe and effective as sternotomy for degenerative mitral regurgitation.

The full results are now published online in JAMA.

The authors, led by Enoch Akowuah, MD, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom, explain that mitral valve repair surgery is the preferred treatment for patients with degenerative mitral regurgitation and is routinely performed via full sternotomy, enabling easy access to the heart, flexibility in myocardial protection strategies, and multiple ways of accessing the mitral valve and easing de-airing to prevent air emboli, which cause cerebrovascular accidents. 

However, the invasiveness of sternotomy is associated with delayed return to presurgery physical function levels and an increase in postoperative complications.

An alternative new video-guided minimally invasive approach involving a 4- to 7-cm lateral thoracotomy, completely avoiding sternotomy, has been developed, with the hope that it should speed physical recovery function after surgery and reduce postoperative complications and costs by reducing hospital stay.

Dr. Akowuah et al. note that uptake of minithoracotomy is variable, with low rates in the United States and the United Kingdom but high rates in Germany. They say that this variation is attributable to the absence of high-quality evidence from randomized trials demonstrating equivalent or superior benefits, compared with sternotomy, and there are also concerns that the increased technical complexity of minithoracotomy may impair the ability to repair complex valve lesions or increase perioperative complications, particularly vascular injuries and stroke.

The U.K. Mini Mitral trial was therefore conducted to compare the effectiveness and safety of minithoracotomy versus sternotomy mitral valve repair.

For the trial, 330 patients with degenerative mitral regurgitation were randomized to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon.

The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) physical functioning scale 12 weeks after the surgery.  

This failed to show superiority of minithoracotomy, with a mean difference of 0.68 (95% confidence interval, −1.89 to 3.26) between the two groups.

Analysis of secondary outcomes demonstrated that time spent undertaking moderate to vigorous physical activity was higher among participants receiving minithoracotomy at 6 weeks, although the treatment effect was small at an average of 9 minutes and was not different at 12 weeks.  

Postoperative length of hospital stay was reduced after minithoracotomy by 1 day, with a median of 5 days, compared with 6 days after sternotomy.

Although repair techniques were at the discretion of the surgeons and differed between the two procedures, high rates of valve repair and low rates of recurrent mitral regurgitation were observed in both groups. Cardiopulmonary bypass times were longer with minithoracotomy, but postoperative complications and adverse events were similar.

There was no difference between the two groups with respect to the prespecified safety outcome of death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year, which occurred in 5.4% of patients undergoing minithoracotomy and 6.1% of those undergoing sternotomy.

“These findings can inform shared decision-making and treatment guidelines,” the authors conclude.
 

Approach ‘may appeal to patients’

In an editorial accompanying the publication of the study in JAMA, Maurice Enriquez-Sarano, MD, Minneapolis Heart Institute, Minnesota, says the results should be integrated into patient management.

“Mini-thoracotomy mitral repair carried low risk and was highly effective compared with sternotomy. It can thus be applied successfully by surgeons who achieve the necessary expertise,” he notes.

“Mini-thoracotomy may appeal to patients because the procedure is less disfiguring than sternotomy. The early (6-week) benefit, albeit small and transient, is important to patients,” he adds.

The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reports no relevant financial relationships with industry. Dr. Enriquez-Sarano reports receiving consulting fees from Edwards Lifesciences, Artivion, ChemImage, HighLife, and Corcym.

A version of this article first appeared on Medscape.com.

The U.K. Mini Mitral trial, showing that mitral valve repair with the less invasive minithoracotomy approach achieved similar outcomes, compared with sternotomy, has now been published.

The trial, which was first presented earlier this year at the American College of Cardiology meeting, showed that minimally invasive mitral valve repair does not improve physical function at 12 weeks, compared with sternotomy, but outcomes at 1 year show minimally invasive repair is as safe and effective as sternotomy for degenerative mitral regurgitation.

The full results are now published online in JAMA.

The authors, led by Enoch Akowuah, MD, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom, explain that mitral valve repair surgery is the preferred treatment for patients with degenerative mitral regurgitation and is routinely performed via full sternotomy, enabling easy access to the heart, flexibility in myocardial protection strategies, and multiple ways of accessing the mitral valve and easing de-airing to prevent air emboli, which cause cerebrovascular accidents. 

However, the invasiveness of sternotomy is associated with delayed return to presurgery physical function levels and an increase in postoperative complications.

An alternative new video-guided minimally invasive approach involving a 4- to 7-cm lateral thoracotomy, completely avoiding sternotomy, has been developed, with the hope that it should speed physical recovery function after surgery and reduce postoperative complications and costs by reducing hospital stay.

Dr. Akowuah et al. note that uptake of minithoracotomy is variable, with low rates in the United States and the United Kingdom but high rates in Germany. They say that this variation is attributable to the absence of high-quality evidence from randomized trials demonstrating equivalent or superior benefits, compared with sternotomy, and there are also concerns that the increased technical complexity of minithoracotomy may impair the ability to repair complex valve lesions or increase perioperative complications, particularly vascular injuries and stroke.

The U.K. Mini Mitral trial was therefore conducted to compare the effectiveness and safety of minithoracotomy versus sternotomy mitral valve repair.

For the trial, 330 patients with degenerative mitral regurgitation were randomized to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon.

The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) physical functioning scale 12 weeks after the surgery.  

This failed to show superiority of minithoracotomy, with a mean difference of 0.68 (95% confidence interval, −1.89 to 3.26) between the two groups.

Analysis of secondary outcomes demonstrated that time spent undertaking moderate to vigorous physical activity was higher among participants receiving minithoracotomy at 6 weeks, although the treatment effect was small at an average of 9 minutes and was not different at 12 weeks.  

Postoperative length of hospital stay was reduced after minithoracotomy by 1 day, with a median of 5 days, compared with 6 days after sternotomy.

Although repair techniques were at the discretion of the surgeons and differed between the two procedures, high rates of valve repair and low rates of recurrent mitral regurgitation were observed in both groups. Cardiopulmonary bypass times were longer with minithoracotomy, but postoperative complications and adverse events were similar.

There was no difference between the two groups with respect to the prespecified safety outcome of death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year, which occurred in 5.4% of patients undergoing minithoracotomy and 6.1% of those undergoing sternotomy.

“These findings can inform shared decision-making and treatment guidelines,” the authors conclude.
 

Approach ‘may appeal to patients’

In an editorial accompanying the publication of the study in JAMA, Maurice Enriquez-Sarano, MD, Minneapolis Heart Institute, Minnesota, says the results should be integrated into patient management.

“Mini-thoracotomy mitral repair carried low risk and was highly effective compared with sternotomy. It can thus be applied successfully by surgeons who achieve the necessary expertise,” he notes.

“Mini-thoracotomy may appeal to patients because the procedure is less disfiguring than sternotomy. The early (6-week) benefit, albeit small and transient, is important to patients,” he adds.

The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reports no relevant financial relationships with industry. Dr. Enriquez-Sarano reports receiving consulting fees from Edwards Lifesciences, Artivion, ChemImage, HighLife, and Corcym.

A version of this article first appeared on Medscape.com.

WASHINGTON – Patients with emphysema treated with one-way endobronchial values showed consistent improvement in lung function after 5 years compared with controls, based on data from 174 individuals.

One-way endobronchial valves demonstrated benefits for patients with severe emphysema over a 12-month period in the EMPROVE trial, according to Gerard J. Criner, MD, of Temple University, Philadelphia, and colleagues.

Five-year results from the EMPROVE study were presented in a poster session at the American Thoracic Society’s international conference.

The initial EMPROVE trial demonstrated safety and efficacy of the Spiration Valve System (SVS) over 12 months. However, data on the long-term benefits of one-way endobronchial values are limited, the researchers wrote.

The valve was designed for use in selected areas of the bronchial airways and features a flexible umbrella that allows air and mucus to clear from treated airways while blocking inspired air flow to areas of the lungs affected by disease, the researchers explained in the poster.

Dr. Criner and colleagues assessed 172 patients who were randomly assigned to treatment with a one-way valve system (113 patients) or a control group (59 patients).

Participants were evaluated at 1, 3, 6, and 12 months, then annually for 5 years.

The primary efficacy outcome was lung function, measured by forced expiratory volume per second (FEV₁). At five years, the FEV₁ values improved by 0.1098 liters in the treatment group (P < .001). Treated patients and controls experienced decreased FEV₁ at a rate of 0.0440 liters per year from baseline, a significant difference (P < .001). Assuming a steady rate of disease progression, “the treatment group gained approximately 2.5 years of FEV₁ improvement immediately following SVS treatment, which was maintained, compared to controls,” the researchers noted in their abstract.

Serious adverse events were assessed from 6 months to 5 years (352.7 patient-years) for treated patients and from 6 months to 2 years (72.9 patient-years) for controls.

Overall, 210 SAEs occurred in the treatment group and 35 occurred in controls, for rates of 0.60 and 0.48, respectively (P = .201). The most common SAEs in the treatment and control groups were COPD exacerbations, pneumothorax, and death.

The results suggest that the FEV₁ improvements seen in patients with severe emphysema after one-way endobronchial value placement compared with usual care are enduring after 5 years, with no significant changes in safety, the researchers concluded.

The original EMPROVE study was supported by Olympus Respiratory America, a part of Olympus Corporation and the developer of the Spiration Valve System. Results of the original study were published in the American Journal of Respiratory and Critical Care Medicine. Dr. Criner is associate editor of the American Journal of Respiratory and Critical Care Medicine. His participation complies with American Thoracic Society requirements for recusal from review and decisions for authored works.
 

A version of this article first appeared on Medscape.com.

WASHINGTON – Patients with emphysema treated with one-way endobronchial values showed consistent improvement in lung function after 5 years compared with controls, based on data from 174 individuals.

One-way endobronchial valves demonstrated benefits for patients with severe emphysema over a 12-month period in the EMPROVE trial, according to Gerard J. Criner, MD, of Temple University, Philadelphia, and colleagues.

Five-year results from the EMPROVE study were presented in a poster session at the American Thoracic Society’s international conference.

The initial EMPROVE trial demonstrated safety and efficacy of the Spiration Valve System (SVS) over 12 months. However, data on the long-term benefits of one-way endobronchial values are limited, the researchers wrote.

The valve was designed for use in selected areas of the bronchial airways and features a flexible umbrella that allows air and mucus to clear from treated airways while blocking inspired air flow to areas of the lungs affected by disease, the researchers explained in the poster.

Dr. Criner and colleagues assessed 172 patients who were randomly assigned to treatment with a one-way valve system (113 patients) or a control group (59 patients).

Participants were evaluated at 1, 3, 6, and 12 months, then annually for 5 years.

The primary efficacy outcome was lung function, measured by forced expiratory volume per second (FEV₁). At five years, the FEV₁ values improved by 0.1098 liters in the treatment group (P < .001). Treated patients and controls experienced decreased FEV₁ at a rate of 0.0440 liters per year from baseline, a significant difference (P < .001). Assuming a steady rate of disease progression, “the treatment group gained approximately 2.5 years of FEV₁ improvement immediately following SVS treatment, which was maintained, compared to controls,” the researchers noted in their abstract.

Serious adverse events were assessed from 6 months to 5 years (352.7 patient-years) for treated patients and from 6 months to 2 years (72.9 patient-years) for controls.

Overall, 210 SAEs occurred in the treatment group and 35 occurred in controls, for rates of 0.60 and 0.48, respectively (P = .201). The most common SAEs in the treatment and control groups were COPD exacerbations, pneumothorax, and death.

The results suggest that the FEV₁ improvements seen in patients with severe emphysema after one-way endobronchial value placement compared with usual care are enduring after 5 years, with no significant changes in safety, the researchers concluded.

The original EMPROVE study was supported by Olympus Respiratory America, a part of Olympus Corporation and the developer of the Spiration Valve System. Results of the original study were published in the American Journal of Respiratory and Critical Care Medicine. Dr. Criner is associate editor of the American Journal of Respiratory and Critical Care Medicine. His participation complies with American Thoracic Society requirements for recusal from review and decisions for authored works.
 

A version of this article first appeared on Medscape.com.

WASHINGTON – Patients with emphysema treated with one-way endobronchial values showed consistent improvement in lung function after 5 years compared with controls, based on data from 174 individuals.

One-way endobronchial valves demonstrated benefits for patients with severe emphysema over a 12-month period in the EMPROVE trial, according to Gerard J. Criner, MD, of Temple University, Philadelphia, and colleagues.

Five-year results from the EMPROVE study were presented in a poster session at the American Thoracic Society’s international conference.

The initial EMPROVE trial demonstrated safety and efficacy of the Spiration Valve System (SVS) over 12 months. However, data on the long-term benefits of one-way endobronchial values are limited, the researchers wrote.

The valve was designed for use in selected areas of the bronchial airways and features a flexible umbrella that allows air and mucus to clear from treated airways while blocking inspired air flow to areas of the lungs affected by disease, the researchers explained in the poster.

Dr. Criner and colleagues assessed 172 patients who were randomly assigned to treatment with a one-way valve system (113 patients) or a control group (59 patients).

Participants were evaluated at 1, 3, 6, and 12 months, then annually for 5 years.

The primary efficacy outcome was lung function, measured by forced expiratory volume per second (FEV₁). At five years, the FEV₁ values improved by 0.1098 liters in the treatment group (P < .001). Treated patients and controls experienced decreased FEV₁ at a rate of 0.0440 liters per year from baseline, a significant difference (P < .001). Assuming a steady rate of disease progression, “the treatment group gained approximately 2.5 years of FEV₁ improvement immediately following SVS treatment, which was maintained, compared to controls,” the researchers noted in their abstract.

Serious adverse events were assessed from 6 months to 5 years (352.7 patient-years) for treated patients and from 6 months to 2 years (72.9 patient-years) for controls.

Overall, 210 SAEs occurred in the treatment group and 35 occurred in controls, for rates of 0.60 and 0.48, respectively (P = .201). The most common SAEs in the treatment and control groups were COPD exacerbations, pneumothorax, and death.

The results suggest that the FEV₁ improvements seen in patients with severe emphysema after one-way endobronchial value placement compared with usual care are enduring after 5 years, with no significant changes in safety, the researchers concluded.

The original EMPROVE study was supported by Olympus Respiratory America, a part of Olympus Corporation and the developer of the Spiration Valve System. Results of the original study were published in the American Journal of Respiratory and Critical Care Medicine. Dr. Criner is associate editor of the American Journal of Respiratory and Critical Care Medicine. His participation complies with American Thoracic Society requirements for recusal from review and decisions for authored works.
 

A version of this article first appeared on Medscape.com.

A new analysis suggests that the initial target of therapy – lung or brain – doesn’t affect overall survival rates in patients with non–small cell lung cancer that has spread to the brain.

“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

The study was released at European Lung Cancer Congress 2023.

According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.

“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”

However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”

For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.

There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)

“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.

He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”

Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”

He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”

No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.

A new analysis suggests that the initial target of therapy – lung or brain – doesn’t affect overall survival rates in patients with non–small cell lung cancer that has spread to the brain.

“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

The study was released at European Lung Cancer Congress 2023.

According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.

“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”

However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”

For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.

There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)

“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.

He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”

Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”

He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”

No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.

A new analysis suggests that the initial target of therapy – lung or brain – doesn’t affect overall survival rates in patients with non–small cell lung cancer that has spread to the brain.

“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

The study was released at European Lung Cancer Congress 2023.

According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.

“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”

However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”

For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.

There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)

“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.

He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”

Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”

He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”

No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.

Nearly 2 years after a whistleblower alleged that the University of Pittsburgh Medical Center (UPMC) and its head of cardiothoracic surgery participated in billing fraud and dangerous operating room practices, the case has ended in an $8.5 million settlement, the Department of Justice (DOJ) announced.

The lawsuit alleges that James L. Luketich, MD, the longtime chair of the school’s cardiothoracic surgery department, regularly performed up to three complex surgical procedures simultaneously, moving among multiple operating rooms and attending to matters other than patient care. The investigation began after Jonathan D’Cunha, MD, a former UPMC surgeon, raised concerns about his colleague’s surgical scheduling and billing practices.

Dr. Luketich’s overbooking of procedures led to patients enduring hours of medically unnecessary anesthesia time and risking surgical complications, according to court documents.

In addition, the complaint states that these practices violated the False Claims Act, which prohibits “teaching physicians” like Dr. Luketich from billing Medicare and other government health plans for “concurrent surgeries” – regulations federal authorities say UPMC leadership were aware of and the University of Pittsburgh Physicians (UPP), also named in the suit, permitted Dr. Luketich to skirt.

The whistleblower provision of the False Claims Act allows private parties to file an action on behalf of the United States and receive a portion of the recovery to help deter health care fraud, says the DOJ.

The defendants previously asked the court to dismiss the case, but a judge denied the request in June 2022.

Paul Wood, vice president and chief communications officer for UPMC, told this news organization that the lawsuit pertained to Dr. Luketich’s “most complicated, team-based surgical procedures.”

“At issue was compliance with the Centers for Medicare & Medicaid Services’ (CMS’s) Teaching Physician Regulation and related billing guidance as well as with UPMC’s internal surgical policies,” he said.

“While UPMC continues to believe Dr. Luketich’s surgical practice complies with CMS requirements, it has agreed to [the settlement] to avoid the distraction and expense of further litigation,” said Mr. Wood, adding that all parties agree that UPMC can seek clarity from CMS regarding future billing of these surgeries.

Efrem Grail, JD, Dr. Luketich’s attorney, said in an interview that he and Dr. Luketich are pleased that the settlement puts an end to the case and that he hopes the United States will issue “authoritative guidance” on billing regulations for teaching physicians, something medical schools and hospitals have sought for years.

Dr. Luketich, UPMC, and UPP face more legal challenges from a separate medical malpractice lawsuit. In March 2018, Bernadette Fedorka underwent a lung transplant at UPMC. Although Dr. Luketich did not perform the surgery, Ms. Fedorka alleges that his poor leadership caused understaffing of the lung transplant program and contributed to surgical complications, including a 4-inch piece of wire left in her neck.

Ms. Fedorka claims that suboxone impaired Dr. Luketich’s decision-making. He began taking the drug in 2008 to manage the pain from a slipped disc injury after a history of prescription drug abuse. Both UPMC and Dr. Luketich have denied the validity of Ms. Fedorka’s claims.

The malpractice suit centers on a recording of a conversation between Dr. Luketich and David Wilson, MD, who prescribed the suboxone and treated the surgeon’s opioid use disorder for several years. Dr. Luketich has accused former colleagues, Dr. D’Cunha and Lara Schaheen, MD, of illegally recording the private conversation that discussed Dr. Luketich’s suboxone prescription – something both physicians deny.

For the billing fraud case, Dr. Luketich has agreed to complete a corrective action plan and submit to a third-party audit of his Medicare billings for 1 year.

“This is an important settlement and a just conclusion to the United States’ investigation into Dr. Luketich’s surgical and billing practices and UPMC and UPP’s acceptance of those practices,” Acting U.S. Attorney Troy Rivetti said in a statement that, “no medical provider – however renowned – is excepted from scrutiny or above the law.”

A version of this article first appeared on Medscape.com.

Nearly 2 years after a whistleblower alleged that the University of Pittsburgh Medical Center (UPMC) and its head of cardiothoracic surgery participated in billing fraud and dangerous operating room practices, the case has ended in an $8.5 million settlement, the Department of Justice (DOJ) announced.

The lawsuit alleges that James L. Luketich, MD, the longtime chair of the school’s cardiothoracic surgery department, regularly performed up to three complex surgical procedures simultaneously, moving among multiple operating rooms and attending to matters other than patient care. The investigation began after Jonathan D’Cunha, MD, a former UPMC surgeon, raised concerns about his colleague’s surgical scheduling and billing practices.

Dr. Luketich’s overbooking of procedures led to patients enduring hours of medically unnecessary anesthesia time and risking surgical complications, according to court documents.

In addition, the complaint states that these practices violated the False Claims Act, which prohibits “teaching physicians” like Dr. Luketich from billing Medicare and other government health plans for “concurrent surgeries” – regulations federal authorities say UPMC leadership were aware of and the University of Pittsburgh Physicians (UPP), also named in the suit, permitted Dr. Luketich to skirt.

The whistleblower provision of the False Claims Act allows private parties to file an action on behalf of the United States and receive a portion of the recovery to help deter health care fraud, says the DOJ.

The defendants previously asked the court to dismiss the case, but a judge denied the request in June 2022.

Paul Wood, vice president and chief communications officer for UPMC, told this news organization that the lawsuit pertained to Dr. Luketich’s “most complicated, team-based surgical procedures.”

“At issue was compliance with the Centers for Medicare & Medicaid Services’ (CMS’s) Teaching Physician Regulation and related billing guidance as well as with UPMC’s internal surgical policies,” he said.

“While UPMC continues to believe Dr. Luketich’s surgical practice complies with CMS requirements, it has agreed to [the settlement] to avoid the distraction and expense of further litigation,” said Mr. Wood, adding that all parties agree that UPMC can seek clarity from CMS regarding future billing of these surgeries.

Efrem Grail, JD, Dr. Luketich’s attorney, said in an interview that he and Dr. Luketich are pleased that the settlement puts an end to the case and that he hopes the United States will issue “authoritative guidance” on billing regulations for teaching physicians, something medical schools and hospitals have sought for years.

Dr. Luketich, UPMC, and UPP face more legal challenges from a separate medical malpractice lawsuit. In March 2018, Bernadette Fedorka underwent a lung transplant at UPMC. Although Dr. Luketich did not perform the surgery, Ms. Fedorka alleges that his poor leadership caused understaffing of the lung transplant program and contributed to surgical complications, including a 4-inch piece of wire left in her neck.

Ms. Fedorka claims that suboxone impaired Dr. Luketich’s decision-making. He began taking the drug in 2008 to manage the pain from a slipped disc injury after a history of prescription drug abuse. Both UPMC and Dr. Luketich have denied the validity of Ms. Fedorka’s claims.

The malpractice suit centers on a recording of a conversation between Dr. Luketich and David Wilson, MD, who prescribed the suboxone and treated the surgeon’s opioid use disorder for several years. Dr. Luketich has accused former colleagues, Dr. D’Cunha and Lara Schaheen, MD, of illegally recording the private conversation that discussed Dr. Luketich’s suboxone prescription – something both physicians deny.

For the billing fraud case, Dr. Luketich has agreed to complete a corrective action plan and submit to a third-party audit of his Medicare billings for 1 year.

“This is an important settlement and a just conclusion to the United States’ investigation into Dr. Luketich’s surgical and billing practices and UPMC and UPP’s acceptance of those practices,” Acting U.S. Attorney Troy Rivetti said in a statement that, “no medical provider – however renowned – is excepted from scrutiny or above the law.”

A version of this article first appeared on Medscape.com.

Nearly 2 years after a whistleblower alleged that the University of Pittsburgh Medical Center (UPMC) and its head of cardiothoracic surgery participated in billing fraud and dangerous operating room practices, the case has ended in an $8.5 million settlement, the Department of Justice (DOJ) announced.

The lawsuit alleges that James L. Luketich, MD, the longtime chair of the school’s cardiothoracic surgery department, regularly performed up to three complex surgical procedures simultaneously, moving among multiple operating rooms and attending to matters other than patient care. The investigation began after Jonathan D’Cunha, MD, a former UPMC surgeon, raised concerns about his colleague’s surgical scheduling and billing practices.

Dr. Luketich’s overbooking of procedures led to patients enduring hours of medically unnecessary anesthesia time and risking surgical complications, according to court documents.

In addition, the complaint states that these practices violated the False Claims Act, which prohibits “teaching physicians” like Dr. Luketich from billing Medicare and other government health plans for “concurrent surgeries” – regulations federal authorities say UPMC leadership were aware of and the University of Pittsburgh Physicians (UPP), also named in the suit, permitted Dr. Luketich to skirt.

The whistleblower provision of the False Claims Act allows private parties to file an action on behalf of the United States and receive a portion of the recovery to help deter health care fraud, says the DOJ.

The defendants previously asked the court to dismiss the case, but a judge denied the request in June 2022.

Paul Wood, vice president and chief communications officer for UPMC, told this news organization that the lawsuit pertained to Dr. Luketich’s “most complicated, team-based surgical procedures.”

“At issue was compliance with the Centers for Medicare & Medicaid Services’ (CMS’s) Teaching Physician Regulation and related billing guidance as well as with UPMC’s internal surgical policies,” he said.

“While UPMC continues to believe Dr. Luketich’s surgical practice complies with CMS requirements, it has agreed to [the settlement] to avoid the distraction and expense of further litigation,” said Mr. Wood, adding that all parties agree that UPMC can seek clarity from CMS regarding future billing of these surgeries.

Efrem Grail, JD, Dr. Luketich’s attorney, said in an interview that he and Dr. Luketich are pleased that the settlement puts an end to the case and that he hopes the United States will issue “authoritative guidance” on billing regulations for teaching physicians, something medical schools and hospitals have sought for years.

Dr. Luketich, UPMC, and UPP face more legal challenges from a separate medical malpractice lawsuit. In March 2018, Bernadette Fedorka underwent a lung transplant at UPMC. Although Dr. Luketich did not perform the surgery, Ms. Fedorka alleges that his poor leadership caused understaffing of the lung transplant program and contributed to surgical complications, including a 4-inch piece of wire left in her neck.

Ms. Fedorka claims that suboxone impaired Dr. Luketich’s decision-making. He began taking the drug in 2008 to manage the pain from a slipped disc injury after a history of prescription drug abuse. Both UPMC and Dr. Luketich have denied the validity of Ms. Fedorka’s claims.

The malpractice suit centers on a recording of a conversation between Dr. Luketich and David Wilson, MD, who prescribed the suboxone and treated the surgeon’s opioid use disorder for several years. Dr. Luketich has accused former colleagues, Dr. D’Cunha and Lara Schaheen, MD, of illegally recording the private conversation that discussed Dr. Luketich’s suboxone prescription – something both physicians deny.

For the billing fraud case, Dr. Luketich has agreed to complete a corrective action plan and submit to a third-party audit of his Medicare billings for 1 year.

“This is an important settlement and a just conclusion to the United States’ investigation into Dr. Luketich’s surgical and billing practices and UPMC and UPP’s acceptance of those practices,” Acting U.S. Attorney Troy Rivetti said in a statement that, “no medical provider – however renowned – is excepted from scrutiny or above the law.”

A version of this article first appeared on Medscape.com.

Some time ago I was invited to join a bipartisan congressional task force on valley fever, also known as coccidioidomycosis. A large and diverse crowd attended the task force’s first meeting in Bakersfield, Calif. – a meeting for everyone: the medical profession, the public, it even included veterinarians.

The whole thing was a resounding success. Francis Collins was there, the just-retired director of the NIH. Tom Frieden, then-director of the Centers for Disease Control and Prevention was there, as were several congresspeople and also my college roommate, a retired Navy medical corps captain. I was enjoying it.

Afterward, we had a banquet dinner at a restaurant in downtown Bakersfield. One of the people there was a woman I knew well – her husband was a physician friend. The restaurant served steak and salmon, and this woman made the mistake of ordering the steak.

Not long after the entrees were served, I heard a commotion at the table just behind me. I turned around and saw that woman in distress. A piece of steak had wedged in her trachea and she couldn’t breathe.

Almost immediately, the chef showed up. I don’t know how he got there. The chef at this restaurant was a big guy. I mean, probably 6 feet, 5 inches tall and 275 pounds. He tried the Heimlich maneuver. It didn’t work.

At that point, I jumped up. I thought, “Well, maybe I know how to do this better than him.” Probably not, actually. I tried and couldn’t make it work either. So I knew we were going to have to do something.

Paul Krogstad, my friend and research partner who is a pediatric infectious disease physician, stepped up and tried to put his finger in her throat and dig it out. He couldn’t get it. The patient had lost consciousness.

So, I’m thinking, okay, there’s really only one choice. You have to get an airway surgically.

I said, “We have to put her down on the floor.” And then I said, “Knife!”

I was looking at the steak knives on the table and they weren’t to my liking for doing a procedure. My college roommate – the retired Navy man – whipped out this very good pocketknife.

So, there we were, I had Paul Krogstad holding her head, and CDC Director Tom Frieden taking her pulse, which she still had. I took the knife and did a cricothyroidotomy. I had never done this in my life.

While I was making the incision, somebody gave Paul a ballpoint pen and he broke it into pieces to make a tracheostomy tube. Once I’d made the little incision, I put the tube in. She wasn’t breathing, but she still had a pulse.

I leaned forward and blew into the tube and inflated her lungs. I could see her lungs balloon up. It was a nice feeling, because I knew I was clearly in the right place.

I can’t quite explain it, but while I was doing this, I was enormously calm and totally focused. I knew there was a crowd of people around me, all looking at me, but I wasn’t conscious of that.

It was really just the four of us: Paul and Tom and me and our patient. Those were the only people that I was really cognizant of. Paul and Tom were not panic stricken at all. I remember somebody shouting, “We have to start CPR!” and Frieden said, “No. We don’t.”

Moments later, she woke up, sat up, coughed, and shot the piece of steak across the room.

She was breathing on her own, but we still taped that tube into place. Somebody had already summoned an ambulance; they were there not very long after we completed this procedure. I got in the ambulance with her and we rode over to the emergency room at Mercy Truxtun.

She was stable and doing okay. I sat with her until a thoracic surgeon showed up. He checked out the situation and decided we didn’t need that tube and took it out. I didn’t want to take that out until I had a surgeon there who could do a formal tracheostomy.

They kept her in the hospital for 3 or 4 days. Now, this woman had always had difficulties swallowing, so steak may not have been the best choice. She still had trouble swallowing afterward but recovered.

I’ve known her and her husband a long time, so it was certainly rewarding to be able to provide this service. Years later, though, when her husband died, I spoke at his funeral. When she was speaking to the gathering, she said, “And oh, by the way, Royce, thanks for saving my life.”

That surprised me. I didn’t think we were going to go there.

I’d never tried to practice medicine “at the roadside” before. But that’s part of the career.

Royce Johnson, MD, is the chief of the division of infectious disease among other leadership positions at Kern Medical in Bakersfield, Calif., and the medical director of the Valley Fever Institute.

A version of this article first appeared on Medscape.com.

Some time ago I was invited to join a bipartisan congressional task force on valley fever, also known as coccidioidomycosis. A large and diverse crowd attended the task force’s first meeting in Bakersfield, Calif. – a meeting for everyone: the medical profession, the public, it even included veterinarians.

The whole thing was a resounding success. Francis Collins was there, the just-retired director of the NIH. Tom Frieden, then-director of the Centers for Disease Control and Prevention was there, as were several congresspeople and also my college roommate, a retired Navy medical corps captain. I was enjoying it.

Afterward, we had a banquet dinner at a restaurant in downtown Bakersfield. One of the people there was a woman I knew well – her husband was a physician friend. The restaurant served steak and salmon, and this woman made the mistake of ordering the steak.

Not long after the entrees were served, I heard a commotion at the table just behind me. I turned around and saw that woman in distress. A piece of steak had wedged in her trachea and she couldn’t breathe.

Almost immediately, the chef showed up. I don’t know how he got there. The chef at this restaurant was a big guy. I mean, probably 6 feet, 5 inches tall and 275 pounds. He tried the Heimlich maneuver. It didn’t work.

At that point, I jumped up. I thought, “Well, maybe I know how to do this better than him.” Probably not, actually. I tried and couldn’t make it work either. So I knew we were going to have to do something.

Paul Krogstad, my friend and research partner who is a pediatric infectious disease physician, stepped up and tried to put his finger in her throat and dig it out. He couldn’t get it. The patient had lost consciousness.

So, I’m thinking, okay, there’s really only one choice. You have to get an airway surgically.

I said, “We have to put her down on the floor.” And then I said, “Knife!”

I was looking at the steak knives on the table and they weren’t to my liking for doing a procedure. My college roommate – the retired Navy man – whipped out this very good pocketknife.

So, there we were, I had Paul Krogstad holding her head, and CDC Director Tom Frieden taking her pulse, which she still had. I took the knife and did a cricothyroidotomy. I had never done this in my life.

While I was making the incision, somebody gave Paul a ballpoint pen and he broke it into pieces to make a tracheostomy tube. Once I’d made the little incision, I put the tube in. She wasn’t breathing, but she still had a pulse.

I leaned forward and blew into the tube and inflated her lungs. I could see her lungs balloon up. It was a nice feeling, because I knew I was clearly in the right place.

I can’t quite explain it, but while I was doing this, I was enormously calm and totally focused. I knew there was a crowd of people around me, all looking at me, but I wasn’t conscious of that.

It was really just the four of us: Paul and Tom and me and our patient. Those were the only people that I was really cognizant of. Paul and Tom were not panic stricken at all. I remember somebody shouting, “We have to start CPR!” and Frieden said, “No. We don’t.”

Moments later, she woke up, sat up, coughed, and shot the piece of steak across the room.

She was breathing on her own, but we still taped that tube into place. Somebody had already summoned an ambulance; they were there not very long after we completed this procedure. I got in the ambulance with her and we rode over to the emergency room at Mercy Truxtun.

She was stable and doing okay. I sat with her until a thoracic surgeon showed up. He checked out the situation and decided we didn’t need that tube and took it out. I didn’t want to take that out until I had a surgeon there who could do a formal tracheostomy.

They kept her in the hospital for 3 or 4 days. Now, this woman had always had difficulties swallowing, so steak may not have been the best choice. She still had trouble swallowing afterward but recovered.

I’ve known her and her husband a long time, so it was certainly rewarding to be able to provide this service. Years later, though, when her husband died, I spoke at his funeral. When she was speaking to the gathering, she said, “And oh, by the way, Royce, thanks for saving my life.”

That surprised me. I didn’t think we were going to go there.

I’d never tried to practice medicine “at the roadside” before. But that’s part of the career.

Royce Johnson, MD, is the chief of the division of infectious disease among other leadership positions at Kern Medical in Bakersfield, Calif., and the medical director of the Valley Fever Institute.

A version of this article first appeared on Medscape.com.

Some time ago I was invited to join a bipartisan congressional task force on valley fever, also known as coccidioidomycosis. A large and diverse crowd attended the task force’s first meeting in Bakersfield, Calif. – a meeting for everyone: the medical profession, the public, it even included veterinarians.

The whole thing was a resounding success. Francis Collins was there, the just-retired director of the NIH. Tom Frieden, then-director of the Centers for Disease Control and Prevention was there, as were several congresspeople and also my college roommate, a retired Navy medical corps captain. I was enjoying it.

Afterward, we had a banquet dinner at a restaurant in downtown Bakersfield. One of the people there was a woman I knew well – her husband was a physician friend. The restaurant served steak and salmon, and this woman made the mistake of ordering the steak.

Not long after the entrees were served, I heard a commotion at the table just behind me. I turned around and saw that woman in distress. A piece of steak had wedged in her trachea and she couldn’t breathe.

Almost immediately, the chef showed up. I don’t know how he got there. The chef at this restaurant was a big guy. I mean, probably 6 feet, 5 inches tall and 275 pounds. He tried the Heimlich maneuver. It didn’t work.

At that point, I jumped up. I thought, “Well, maybe I know how to do this better than him.” Probably not, actually. I tried and couldn’t make it work either. So I knew we were going to have to do something.

Paul Krogstad, my friend and research partner who is a pediatric infectious disease physician, stepped up and tried to put his finger in her throat and dig it out. He couldn’t get it. The patient had lost consciousness.

So, I’m thinking, okay, there’s really only one choice. You have to get an airway surgically.

I said, “We have to put her down on the floor.” And then I said, “Knife!”

I was looking at the steak knives on the table and they weren’t to my liking for doing a procedure. My college roommate – the retired Navy man – whipped out this very good pocketknife.

So, there we were, I had Paul Krogstad holding her head, and CDC Director Tom Frieden taking her pulse, which she still had. I took the knife and did a cricothyroidotomy. I had never done this in my life.

While I was making the incision, somebody gave Paul a ballpoint pen and he broke it into pieces to make a tracheostomy tube. Once I’d made the little incision, I put the tube in. She wasn’t breathing, but she still had a pulse.

I leaned forward and blew into the tube and inflated her lungs. I could see her lungs balloon up. It was a nice feeling, because I knew I was clearly in the right place.

I can’t quite explain it, but while I was doing this, I was enormously calm and totally focused. I knew there was a crowd of people around me, all looking at me, but I wasn’t conscious of that.

It was really just the four of us: Paul and Tom and me and our patient. Those were the only people that I was really cognizant of. Paul and Tom were not panic stricken at all. I remember somebody shouting, “We have to start CPR!” and Frieden said, “No. We don’t.”

Moments later, she woke up, sat up, coughed, and shot the piece of steak across the room.

She was breathing on her own, but we still taped that tube into place. Somebody had already summoned an ambulance; they were there not very long after we completed this procedure. I got in the ambulance with her and we rode over to the emergency room at Mercy Truxtun.

She was stable and doing okay. I sat with her until a thoracic surgeon showed up. He checked out the situation and decided we didn’t need that tube and took it out. I didn’t want to take that out until I had a surgeon there who could do a formal tracheostomy.

They kept her in the hospital for 3 or 4 days. Now, this woman had always had difficulties swallowing, so steak may not have been the best choice. She still had trouble swallowing afterward but recovered.

I’ve known her and her husband a long time, so it was certainly rewarding to be able to provide this service. Years later, though, when her husband died, I spoke at his funeral. When she was speaking to the gathering, she said, “And oh, by the way, Royce, thanks for saving my life.”

That surprised me. I didn’t think we were going to go there.

I’d never tried to practice medicine “at the roadside” before. But that’s part of the career.

Royce Johnson, MD, is the chief of the division of infectious disease among other leadership positions at Kern Medical in Bakersfield, Calif., and the medical director of the Valley Fever Institute.

A version of this article first appeared on Medscape.com.

For patients with early stage non–small cell lung cancer (NSCLC), the survival outcomes can be just as good with sublobar resection as with the more invasive lobar resection, suggest results from the CALGB 140503 trial, although strict patient selection remains key.

These new results contrast with those from a previous study from 1995, which found that local recurrence was three times higher and cancer mortality was twice as high with the less invasive procedure.

Those results from nearly 30 years ago established lobectomy as the standard of surgical care in this patient population, but since then advances in imaging and staging have allowed the detection of smaller and earlier tumors, which has “rekindled interest in sublobar resection,” the authors comment.

Hence, they conducted the new trial, which involved almost 700 U.S. patients with clinical T1aN0 NSCLC and a tumor size up to 2 cm, who were randomly assigned to lobar or sublobar tumor resection, and followed for 7 years.

The rates of both disease-free and overall survival were similar between the two groups, with no significant differences observed. There were also no substantial differences in rates of distant and locoregional recurrence.

In addition, there was a suggestion of less reduction in pulmonary function following the less invasive procedure.

“These findings affirm that sublobar resection ... is an effective management approach for this subgroup of patients with NSCLC,” says lead author Nasser Altorki, MD, Weill Cornell Medicine, NewYork–Presbyterian Hospital, New York.

“It is important that these results are interpreted strictly within the constraints of the eligibility criteria mandated by the trial, he emphasizes. “Specifically, the results are applicable only to a highly selected group of patients ... in whom the absence of metastases to hilar and mediastinal lymph nodes is pathologically confirmed.”

Nevertheless, Dr. Altorki said that “these results will become increasingly relevant as the proportion of patients with early-stage lung cancer increases with expanded implementation of lung cancer screening, and as the number of older persons with early-stage disease in whom sublobar resection may be the preferred surgical option increases.”

The study was published online in the New England Journal of Medicine.

In an accompanying editorial, Valerie W. Rusch, MD, Thoracic Service, Memorial Sloan Kettering Cancer Center, New York, agrees. “As CT screening becomes more widespread, this patient population will increase in clinical practice,” she explains.

However, Dr. Rusch also urges caution around patient selection, underlining that the results do not “provide a license for suboptimal surgical care.”

She says that “safeguards” such as the meticulous and strict patient criteria used in the trial “must be preserved in routine practice.”

“Thoracic surgeons will need to expand their expertise in sublobar resections, especially complex segmentectomies, and will need to collaborate closely with pathologists in assessing margins of resection, adequacy of lymph-node staging, and tumor characteristics that may predict recurrence.”

While emphasizing that lobectomy should still be performed when appropriate, Dr. Rusch nevertheless says: “The era of ‘precision’ surgery for NSCLC has arrived.”


 

Consistent with Japanese results

The investigators also point out that their findings are “consistent” with those of a recent Japanese study that compared lobectomy with anatomical segmentectomy, which found that the 5-year overall survival was 91.1% for lobectomy and 94.3% for segmentectomy.

The authors suggest that the difference in overall survival rates between the two trials might be due to anatomical segmentectomy being “considered by most surgeons to be more oncologically sound than wedge resection.”

In the current trial, wedge resection was allowed, however, “because it is the most frequently practiced method of sublobar resection in North America and Europe; thus, its inclusion would make the trial more representative of a ‘real world’ setting.”

Another important difference could be that more than 90% of the patients in the Japanese trial had adenocarcinoma, 45% with an associated ground-glass component, which is associated with better survival than a completely solid adenocarcinoma.

Dr. Rusch agrees that there are likely to be various factors related to the survival differences between the two trials, including patient selection, intraoperative management, and tumor characteristics.

“However, these two landmark trials are practice-changing because they establish sublobar resection as the standard of care for a select group of patients with NSCLC,” Dr. Rusch concluded.
 

Study details

Dr. Altorki and colleagues conducted the multicenter, international, randomized, noninferiority, phase 3 trial in patients with clinically staged T1aN0 NSCLC from 83 academic and community-based institutions in the United States, Canada, and Australia.

Patients were required to have a peripheral lung nodule with a solid component of up to 2 cm on preoperative CT, a tumor center in the outer third of the lung, and a tumor location amenable to sublobar resection, whether wedge or segment, or lobar resection, among other criteria.

In all, 697 patients were randomly assigned to undergo either lobar resection or sublobar resection, of whom 59.1% had wedge resection and 37.9% anatomical segmental resection. The median age was 67.9 years, and 57.4% were female. The vast majority (90%) were White.

After a median follow-up of 7 years, the 5-year disease-free survival was 63.6% with sublobar resection and 64.1% following lobar resection.

The team found that sublobar resection was not inferior to lobectomy for disease-free survival, at a hazard ratio for disease recurrence or death of 1.01 (90% confidence interval, 0.83-1.24), which adjusted to 0.99 after taking into account the site where the patient was treated.

The 5-year overall survival rate was 80.3% after sublobar resection, and 78.9% following lobar resection, at a hazard ratio for death of 0.95 (95% CI, 0.72-1.26).

The results were “generally consistent” when accounting for factors such as age group, sex, tumor location, histologic type, smoking history, tumor size, and ECOG performance status, the team says.

Turning to recurrence, they showed that, among 687 patients eligible for assessment, 30.4% of those in the sublobar resection group and 29.3% of those assigned to lobar resection experienced disease recurrence, with 13.4% and 10%, respectively, having locoregional recurrence.

An exploratory analysis indicated that 5-year recurrence-free survival was similar in the two groups, at 70.2% vs. 71.2% or a hazard ratio for recurrence of 1.05 (95% CI, 0.80-1.39). The cumulative incidence of death was also similar.

It was also notable that reduction in predictive forced expiratory volume in 1 second from baseline was lower with sublobar than lobar resection, at –4.0 vs. –6.0, as was the reduction in predicted forced vital capacity, at –3.0 vs. –5.0.

“Although this difference is arguably not clinically meaningful in this patient population with normal baseline pulmonary functions,” the team writes, “it may be more clinically relevant in patients with compromised pulmonary functions, or in those with lower-lobe disease in whom lobar resection may be associated with greater impairment of pulmonary function.”

Dr. Rusch suggests that “more sensitive or functional assessments” of pulmonary function might include “diffusion capacity and 6-minute walk tests,” although she noted that even short-term differences in pulmonary function “may affect perioperative and functional outcomes, especially for tumors in the lower lobe.”

The study was supported by the National Cancer Institute of the National Institutes of Health, including via grants to the Alliance for Clinical Trials in Oncology and the Canadian Cancer Trials Group, and supported in part by Covidien and Ethicon.

Dr. Altorki reports relationships with AstraZeneca, Genentech, Johnson & Johnson, and Regeneron. Dr. Rusch reports relationships with Cancer Research UK, Genentech, and the National Cancer Institute.

A version of this article first appeared on Medscape.com.

For patients with early stage non–small cell lung cancer (NSCLC), the survival outcomes can be just as good with sublobar resection as with the more invasive lobar resection, suggest results from the CALGB 140503 trial, although strict patient selection remains key.

These new results contrast with those from a previous study from 1995, which found that local recurrence was three times higher and cancer mortality was twice as high with the less invasive procedure.

Those results from nearly 30 years ago established lobectomy as the standard of surgical care in this patient population, but since then advances in imaging and staging have allowed the detection of smaller and earlier tumors, which has “rekindled interest in sublobar resection,” the authors comment.

Hence, they conducted the new trial, which involved almost 700 U.S. patients with clinical T1aN0 NSCLC and a tumor size up to 2 cm, who were randomly assigned to lobar or sublobar tumor resection, and followed for 7 years.

The rates of both disease-free and overall survival were similar between the two groups, with no significant differences observed. There were also no substantial differences in rates of distant and locoregional recurrence.

In addition, there was a suggestion of less reduction in pulmonary function following the less invasive procedure.

“These findings affirm that sublobar resection ... is an effective management approach for this subgroup of patients with NSCLC,” says lead author Nasser Altorki, MD, Weill Cornell Medicine, NewYork–Presbyterian Hospital, New York.

“It is important that these results are interpreted strictly within the constraints of the eligibility criteria mandated by the trial, he emphasizes. “Specifically, the results are applicable only to a highly selected group of patients ... in whom the absence of metastases to hilar and mediastinal lymph nodes is pathologically confirmed.”

Nevertheless, Dr. Altorki said that “these results will become increasingly relevant as the proportion of patients with early-stage lung cancer increases with expanded implementation of lung cancer screening, and as the number of older persons with early-stage disease in whom sublobar resection may be the preferred surgical option increases.”

The study was published online in the New England Journal of Medicine.

In an accompanying editorial, Valerie W. Rusch, MD, Thoracic Service, Memorial Sloan Kettering Cancer Center, New York, agrees. “As CT screening becomes more widespread, this patient population will increase in clinical practice,” she explains.

However, Dr. Rusch also urges caution around patient selection, underlining that the results do not “provide a license for suboptimal surgical care.”

She says that “safeguards” such as the meticulous and strict patient criteria used in the trial “must be preserved in routine practice.”

“Thoracic surgeons will need to expand their expertise in sublobar resections, especially complex segmentectomies, and will need to collaborate closely with pathologists in assessing margins of resection, adequacy of lymph-node staging, and tumor characteristics that may predict recurrence.”

While emphasizing that lobectomy should still be performed when appropriate, Dr. Rusch nevertheless says: “The era of ‘precision’ surgery for NSCLC has arrived.”


 

Consistent with Japanese results

The investigators also point out that their findings are “consistent” with those of a recent Japanese study that compared lobectomy with anatomical segmentectomy, which found that the 5-year overall survival was 91.1% for lobectomy and 94.3% for segmentectomy.

The authors suggest that the difference in overall survival rates between the two trials might be due to anatomical segmentectomy being “considered by most surgeons to be more oncologically sound than wedge resection.”

In the current trial, wedge resection was allowed, however, “because it is the most frequently practiced method of sublobar resection in North America and Europe; thus, its inclusion would make the trial more representative of a ‘real world’ setting.”

Another important difference could be that more than 90% of the patients in the Japanese trial had adenocarcinoma, 45% with an associated ground-glass component, which is associated with better survival than a completely solid adenocarcinoma.

Dr. Rusch agrees that there are likely to be various factors related to the survival differences between the two trials, including patient selection, intraoperative management, and tumor characteristics.

“However, these two landmark trials are practice-changing because they establish sublobar resection as the standard of care for a select group of patients with NSCLC,” Dr. Rusch concluded.
 

Study details

Dr. Altorki and colleagues conducted the multicenter, international, randomized, noninferiority, phase 3 trial in patients with clinically staged T1aN0 NSCLC from 83 academic and community-based institutions in the United States, Canada, and Australia.

Patients were required to have a peripheral lung nodule with a solid component of up to 2 cm on preoperative CT, a tumor center in the outer third of the lung, and a tumor location amenable to sublobar resection, whether wedge or segment, or lobar resection, among other criteria.

In all, 697 patients were randomly assigned to undergo either lobar resection or sublobar resection, of whom 59.1% had wedge resection and 37.9% anatomical segmental resection. The median age was 67.9 years, and 57.4% were female. The vast majority (90%) were White.

After a median follow-up of 7 years, the 5-year disease-free survival was 63.6% with sublobar resection and 64.1% following lobar resection.

The team found that sublobar resection was not inferior to lobectomy for disease-free survival, at a hazard ratio for disease recurrence or death of 1.01 (90% confidence interval, 0.83-1.24), which adjusted to 0.99 after taking into account the site where the patient was treated.

The 5-year overall survival rate was 80.3% after sublobar resection, and 78.9% following lobar resection, at a hazard ratio for death of 0.95 (95% CI, 0.72-1.26).

The results were “generally consistent” when accounting for factors such as age group, sex, tumor location, histologic type, smoking history, tumor size, and ECOG performance status, the team says.

Turning to recurrence, they showed that, among 687 patients eligible for assessment, 30.4% of those in the sublobar resection group and 29.3% of those assigned to lobar resection experienced disease recurrence, with 13.4% and 10%, respectively, having locoregional recurrence.

An exploratory analysis indicated that 5-year recurrence-free survival was similar in the two groups, at 70.2% vs. 71.2% or a hazard ratio for recurrence of 1.05 (95% CI, 0.80-1.39). The cumulative incidence of death was also similar.

It was also notable that reduction in predictive forced expiratory volume in 1 second from baseline was lower with sublobar than lobar resection, at –4.0 vs. –6.0, as was the reduction in predicted forced vital capacity, at –3.0 vs. –5.0.

“Although this difference is arguably not clinically meaningful in this patient population with normal baseline pulmonary functions,” the team writes, “it may be more clinically relevant in patients with compromised pulmonary functions, or in those with lower-lobe disease in whom lobar resection may be associated with greater impairment of pulmonary function.”

Dr. Rusch suggests that “more sensitive or functional assessments” of pulmonary function might include “diffusion capacity and 6-minute walk tests,” although she noted that even short-term differences in pulmonary function “may affect perioperative and functional outcomes, especially for tumors in the lower lobe.”

The study was supported by the National Cancer Institute of the National Institutes of Health, including via grants to the Alliance for Clinical Trials in Oncology and the Canadian Cancer Trials Group, and supported in part by Covidien and Ethicon.

Dr. Altorki reports relationships with AstraZeneca, Genentech, Johnson & Johnson, and Regeneron. Dr. Rusch reports relationships with Cancer Research UK, Genentech, and the National Cancer Institute.

A version of this article first appeared on Medscape.com.

For patients with early stage non–small cell lung cancer (NSCLC), the survival outcomes can be just as good with sublobar resection as with the more invasive lobar resection, suggest results from the CALGB 140503 trial, although strict patient selection remains key.

These new results contrast with those from a previous study from 1995, which found that local recurrence was three times higher and cancer mortality was twice as high with the less invasive procedure.

Those results from nearly 30 years ago established lobectomy as the standard of surgical care in this patient population, but since then advances in imaging and staging have allowed the detection of smaller and earlier tumors, which has “rekindled interest in sublobar resection,” the authors comment.

Hence, they conducted the new trial, which involved almost 700 U.S. patients with clinical T1aN0 NSCLC and a tumor size up to 2 cm, who were randomly assigned to lobar or sublobar tumor resection, and followed for 7 years.

The rates of both disease-free and overall survival were similar between the two groups, with no significant differences observed. There were also no substantial differences in rates of distant and locoregional recurrence.

In addition, there was a suggestion of less reduction in pulmonary function following the less invasive procedure.

“These findings affirm that sublobar resection ... is an effective management approach for this subgroup of patients with NSCLC,” says lead author Nasser Altorki, MD, Weill Cornell Medicine, NewYork–Presbyterian Hospital, New York.

“It is important that these results are interpreted strictly within the constraints of the eligibility criteria mandated by the trial, he emphasizes. “Specifically, the results are applicable only to a highly selected group of patients ... in whom the absence of metastases to hilar and mediastinal lymph nodes is pathologically confirmed.”

Nevertheless, Dr. Altorki said that “these results will become increasingly relevant as the proportion of patients with early-stage lung cancer increases with expanded implementation of lung cancer screening, and as the number of older persons with early-stage disease in whom sublobar resection may be the preferred surgical option increases.”

The study was published online in the New England Journal of Medicine.

In an accompanying editorial, Valerie W. Rusch, MD, Thoracic Service, Memorial Sloan Kettering Cancer Center, New York, agrees. “As CT screening becomes more widespread, this patient population will increase in clinical practice,” she explains.

However, Dr. Rusch also urges caution around patient selection, underlining that the results do not “provide a license for suboptimal surgical care.”

She says that “safeguards” such as the meticulous and strict patient criteria used in the trial “must be preserved in routine practice.”

“Thoracic surgeons will need to expand their expertise in sublobar resections, especially complex segmentectomies, and will need to collaborate closely with pathologists in assessing margins of resection, adequacy of lymph-node staging, and tumor characteristics that may predict recurrence.”

While emphasizing that lobectomy should still be performed when appropriate, Dr. Rusch nevertheless says: “The era of ‘precision’ surgery for NSCLC has arrived.”


 

Consistent with Japanese results

The investigators also point out that their findings are “consistent” with those of a recent Japanese study that compared lobectomy with anatomical segmentectomy, which found that the 5-year overall survival was 91.1% for lobectomy and 94.3% for segmentectomy.

The authors suggest that the difference in overall survival rates between the two trials might be due to anatomical segmentectomy being “considered by most surgeons to be more oncologically sound than wedge resection.”

In the current trial, wedge resection was allowed, however, “because it is the most frequently practiced method of sublobar resection in North America and Europe; thus, its inclusion would make the trial more representative of a ‘real world’ setting.”

Another important difference could be that more than 90% of the patients in the Japanese trial had adenocarcinoma, 45% with an associated ground-glass component, which is associated with better survival than a completely solid adenocarcinoma.

Dr. Rusch agrees that there are likely to be various factors related to the survival differences between the two trials, including patient selection, intraoperative management, and tumor characteristics.

“However, these two landmark trials are practice-changing because they establish sublobar resection as the standard of care for a select group of patients with NSCLC,” Dr. Rusch concluded.
 

Study details

Dr. Altorki and colleagues conducted the multicenter, international, randomized, noninferiority, phase 3 trial in patients with clinically staged T1aN0 NSCLC from 83 academic and community-based institutions in the United States, Canada, and Australia.

Patients were required to have a peripheral lung nodule with a solid component of up to 2 cm on preoperative CT, a tumor center in the outer third of the lung, and a tumor location amenable to sublobar resection, whether wedge or segment, or lobar resection, among other criteria.

In all, 697 patients were randomly assigned to undergo either lobar resection or sublobar resection, of whom 59.1% had wedge resection and 37.9% anatomical segmental resection. The median age was 67.9 years, and 57.4% were female. The vast majority (90%) were White.

After a median follow-up of 7 years, the 5-year disease-free survival was 63.6% with sublobar resection and 64.1% following lobar resection.

The team found that sublobar resection was not inferior to lobectomy for disease-free survival, at a hazard ratio for disease recurrence or death of 1.01 (90% confidence interval, 0.83-1.24), which adjusted to 0.99 after taking into account the site where the patient was treated.

The 5-year overall survival rate was 80.3% after sublobar resection, and 78.9% following lobar resection, at a hazard ratio for death of 0.95 (95% CI, 0.72-1.26).

The results were “generally consistent” when accounting for factors such as age group, sex, tumor location, histologic type, smoking history, tumor size, and ECOG performance status, the team says.

Turning to recurrence, they showed that, among 687 patients eligible for assessment, 30.4% of those in the sublobar resection group and 29.3% of those assigned to lobar resection experienced disease recurrence, with 13.4% and 10%, respectively, having locoregional recurrence.

An exploratory analysis indicated that 5-year recurrence-free survival was similar in the two groups, at 70.2% vs. 71.2% or a hazard ratio for recurrence of 1.05 (95% CI, 0.80-1.39). The cumulative incidence of death was also similar.

It was also notable that reduction in predictive forced expiratory volume in 1 second from baseline was lower with sublobar than lobar resection, at –4.0 vs. –6.0, as was the reduction in predicted forced vital capacity, at –3.0 vs. –5.0.

“Although this difference is arguably not clinically meaningful in this patient population with normal baseline pulmonary functions,” the team writes, “it may be more clinically relevant in patients with compromised pulmonary functions, or in those with lower-lobe disease in whom lobar resection may be associated with greater impairment of pulmonary function.”

Dr. Rusch suggests that “more sensitive or functional assessments” of pulmonary function might include “diffusion capacity and 6-minute walk tests,” although she noted that even short-term differences in pulmonary function “may affect perioperative and functional outcomes, especially for tumors in the lower lobe.”

The study was supported by the National Cancer Institute of the National Institutes of Health, including via grants to the Alliance for Clinical Trials in Oncology and the Canadian Cancer Trials Group, and supported in part by Covidien and Ethicon.

Dr. Altorki reports relationships with AstraZeneca, Genentech, Johnson & Johnson, and Regeneron. Dr. Rusch reports relationships with Cancer Research UK, Genentech, and the National Cancer Institute.

A version of this article first appeared on Medscape.com.