2015 Mitral Valve Conclave

NEW YORK – Combined transcatheter mitral valve interventions with the potential to have results as good as cardiac surgery are beginning to emerge in Europe, where cardiac surgeons are also getting early experience with newer transcatheter systems that offer alternatives to existing mitral valve treatments, said Dr. Francesco Maisano.

Surgeons in Europe are investigating for mitral valve repair, as alternatives to the MitraClip (Abbott Vascular) percutaneous mitral valve system, and developers of these devices have met their share of challenges, Dr. Maisano of the University Hospital Zurich (Switzerland) said at the 2015 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.

“This list was much longer in the past, but some of the companies have lost their way in the past few years,” he said. “This is because it is difficult to pursue such a tremendous effort of doing a transcatheter repair that is competing with a device that has been commercially available.”

The NeoChord system (NeoChord) has been approved in Europe and has been implanted in about 200 patients so far. It is implanted through a small (2-3–inch) left thoracotomy and deploys implantation of multiple neochordae. “This is slowly getting into practice,” Dr. Maisano said. “The main problem with this technology is that it still is a hybrid procedure; it requires general anesthesia. It’s still doubtful what the role will be for this procedure in the spectrum of mitral interventions.”

The Carillon Mitral Contour System (Cardiac Dimension Inc.) is “the only coronary sinus annuloplasty technology that survived in these years,” he said. The device is in clinical trials in Europe and Australia. However, he noted, efficacy with the device “doesn’t happen at the implant, but it happens over time.” Group outcomes data is pending. “Enthusiasm around coronary sinus annuloplasty never took, so a lot of physicians are still reluctant to embrace this technology,” he said. Nonetheless, in some patients the device has show results ”as good as other procedures.”

Meanwhile, three other percutaneous systems that aim to reproduce surgical annuloplasty are in development: the Mitralign (Mitralign), a percutaneous system that selectively plicates the annulus using pledget sutures; the Accucinch (Guided Delivery Systems) which completes a full-seal annuloplasty using suture-connected mitral anchors; and Cardioband (ValtechCardio), which can perform surgery-like annuloplasty without sutures. Dr. Maisano said Mitralign is hopeful to get CE-mark approval possibly as early as this year, and the Cardioband has been implanted in 42 patients in Europe with an average 22% reduction in septal dimensions – “good outcomes in terms of reduction of mitral regurgitation and improvement of symptoms,” he said.

Helping to advance the development of percutaneous procedures and the promise of combining those procedures to replicate surgery is the integration of multimodal imaging in the cardiac suite, Dr. Maisano said.

“There are many problems to be solved” in pursuing combined percutaneous procedures to replicate surgical results, he said. “It’s not easy from a regulatory standpoint or from an economical standpoint, but there is the potential to simulate what is done today in surgery-associated procedures. This is something that is happening in Europe, which is land of freedom in terms of utilizing devices.”

He related the story of a patient in whom he implanted two mitral valve clips and then, to stop leakage, used a vascular plug to fill the gap in the subcommissure. European cardiac surgeons have pondered or attempted transcatheter aortic implantation (TAVI) in combination with other procedures, including left atrial appendage closure (LAAC) and mitral clip insertion in varied combinations. “This is still feasible and something that is getting done more in Europe in experienced centers,” Dr. Maisano said. Although feasibility, safety, and efficacy of such approaches need to be proved in larger series, combination therapy will evolve in the future, in an attempt to reproduce surgical standards, he said.

Findings were presented on behalf of the European Society of Cardiology. Dr. Maisano is a consultant for Abbott Vascular and ValtechCardio, among other companies. He receives royalties from Edwards Lifesciences.

NEW YORK – Combined transcatheter mitral valve interventions with the potential to have results as good as cardiac surgery are beginning to emerge in Europe, where cardiac surgeons are also getting early experience with newer transcatheter systems that offer alternatives to existing mitral valve treatments, said Dr. Francesco Maisano.

Surgeons in Europe are investigating for mitral valve repair, as alternatives to the MitraClip (Abbott Vascular) percutaneous mitral valve system, and developers of these devices have met their share of challenges, Dr. Maisano of the University Hospital Zurich (Switzerland) said at the 2015 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.

“This list was much longer in the past, but some of the companies have lost their way in the past few years,” he said. “This is because it is difficult to pursue such a tremendous effort of doing a transcatheter repair that is competing with a device that has been commercially available.”

The NeoChord system (NeoChord) has been approved in Europe and has been implanted in about 200 patients so far. It is implanted through a small (2-3–inch) left thoracotomy and deploys implantation of multiple neochordae. “This is slowly getting into practice,” Dr. Maisano said. “The main problem with this technology is that it still is a hybrid procedure; it requires general anesthesia. It’s still doubtful what the role will be for this procedure in the spectrum of mitral interventions.”

The Carillon Mitral Contour System (Cardiac Dimension Inc.) is “the only coronary sinus annuloplasty technology that survived in these years,” he said. The device is in clinical trials in Europe and Australia. However, he noted, efficacy with the device “doesn’t happen at the implant, but it happens over time.” Group outcomes data is pending. “Enthusiasm around coronary sinus annuloplasty never took, so a lot of physicians are still reluctant to embrace this technology,” he said. Nonetheless, in some patients the device has show results ”as good as other procedures.”

Meanwhile, three other percutaneous systems that aim to reproduce surgical annuloplasty are in development: the Mitralign (Mitralign), a percutaneous system that selectively plicates the annulus using pledget sutures; the Accucinch (Guided Delivery Systems) which completes a full-seal annuloplasty using suture-connected mitral anchors; and Cardioband (ValtechCardio), which can perform surgery-like annuloplasty without sutures. Dr. Maisano said Mitralign is hopeful to get CE-mark approval possibly as early as this year, and the Cardioband has been implanted in 42 patients in Europe with an average 22% reduction in septal dimensions – “good outcomes in terms of reduction of mitral regurgitation and improvement of symptoms,” he said.

Helping to advance the development of percutaneous procedures and the promise of combining those procedures to replicate surgery is the integration of multimodal imaging in the cardiac suite, Dr. Maisano said.

“There are many problems to be solved” in pursuing combined percutaneous procedures to replicate surgical results, he said. “It’s not easy from a regulatory standpoint or from an economical standpoint, but there is the potential to simulate what is done today in surgery-associated procedures. This is something that is happening in Europe, which is land of freedom in terms of utilizing devices.”

He related the story of a patient in whom he implanted two mitral valve clips and then, to stop leakage, used a vascular plug to fill the gap in the subcommissure. European cardiac surgeons have pondered or attempted transcatheter aortic implantation (TAVI) in combination with other procedures, including left atrial appendage closure (LAAC) and mitral clip insertion in varied combinations. “This is still feasible and something that is getting done more in Europe in experienced centers,” Dr. Maisano said. Although feasibility, safety, and efficacy of such approaches need to be proved in larger series, combination therapy will evolve in the future, in an attempt to reproduce surgical standards, he said.

Findings were presented on behalf of the European Society of Cardiology. Dr. Maisano is a consultant for Abbott Vascular and ValtechCardio, among other companies. He receives royalties from Edwards Lifesciences.

NEW YORK – Combined transcatheter mitral valve interventions with the potential to have results as good as cardiac surgery are beginning to emerge in Europe, where cardiac surgeons are also getting early experience with newer transcatheter systems that offer alternatives to existing mitral valve treatments, said Dr. Francesco Maisano.

Surgeons in Europe are investigating for mitral valve repair, as alternatives to the MitraClip (Abbott Vascular) percutaneous mitral valve system, and developers of these devices have met their share of challenges, Dr. Maisano of the University Hospital Zurich (Switzerland) said at the 2015 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.

“This list was much longer in the past, but some of the companies have lost their way in the past few years,” he said. “This is because it is difficult to pursue such a tremendous effort of doing a transcatheter repair that is competing with a device that has been commercially available.”

The NeoChord system (NeoChord) has been approved in Europe and has been implanted in about 200 patients so far. It is implanted through a small (2-3–inch) left thoracotomy and deploys implantation of multiple neochordae. “This is slowly getting into practice,” Dr. Maisano said. “The main problem with this technology is that it still is a hybrid procedure; it requires general anesthesia. It’s still doubtful what the role will be for this procedure in the spectrum of mitral interventions.”

The Carillon Mitral Contour System (Cardiac Dimension Inc.) is “the only coronary sinus annuloplasty technology that survived in these years,” he said. The device is in clinical trials in Europe and Australia. However, he noted, efficacy with the device “doesn’t happen at the implant, but it happens over time.” Group outcomes data is pending. “Enthusiasm around coronary sinus annuloplasty never took, so a lot of physicians are still reluctant to embrace this technology,” he said. Nonetheless, in some patients the device has show results ”as good as other procedures.”

Meanwhile, three other percutaneous systems that aim to reproduce surgical annuloplasty are in development: the Mitralign (Mitralign), a percutaneous system that selectively plicates the annulus using pledget sutures; the Accucinch (Guided Delivery Systems) which completes a full-seal annuloplasty using suture-connected mitral anchors; and Cardioband (ValtechCardio), which can perform surgery-like annuloplasty without sutures. Dr. Maisano said Mitralign is hopeful to get CE-mark approval possibly as early as this year, and the Cardioband has been implanted in 42 patients in Europe with an average 22% reduction in septal dimensions – “good outcomes in terms of reduction of mitral regurgitation and improvement of symptoms,” he said.

Helping to advance the development of percutaneous procedures and the promise of combining those procedures to replicate surgery is the integration of multimodal imaging in the cardiac suite, Dr. Maisano said.

“There are many problems to be solved” in pursuing combined percutaneous procedures to replicate surgical results, he said. “It’s not easy from a regulatory standpoint or from an economical standpoint, but there is the potential to simulate what is done today in surgery-associated procedures. This is something that is happening in Europe, which is land of freedom in terms of utilizing devices.”

He related the story of a patient in whom he implanted two mitral valve clips and then, to stop leakage, used a vascular plug to fill the gap in the subcommissure. European cardiac surgeons have pondered or attempted transcatheter aortic implantation (TAVI) in combination with other procedures, including left atrial appendage closure (LAAC) and mitral clip insertion in varied combinations. “This is still feasible and something that is getting done more in Europe in experienced centers,” Dr. Maisano said. Although feasibility, safety, and efficacy of such approaches need to be proved in larger series, combination therapy will evolve in the future, in an attempt to reproduce surgical standards, he said.

Findings were presented on behalf of the European Society of Cardiology. Dr. Maisano is a consultant for Abbott Vascular and ValtechCardio, among other companies. He receives royalties from Edwards Lifesciences.

Mechanical valve is the best choice

BY THORALF M. SUNDT III, M.D.

It’s not very sexy to talk about mechanical valves, but the reasons for placing a mechanical valve in a 50-year-old patient with rheumatic disease are obvious: Mechanical valves provide outstanding hemodynamics, they are beautifully engineered devices, their durability is beyond question, and, importantly, there’s no survival advantage to a biological prosthesis although one incurs the penalty of reoperation, which in a 50-year-old is going to be inevitable.

While this patient will have to continue on anticoagulation therapy with a mechanical valve, many patients who receive a biological valve, especially those with rheumatic disease, need anticoagulation for atrial fibrillation anyway. One can argue that a maze procedure might convert them to sinus rhythm, but this is least reproducible in the subset of patients with rheumatic disease. What’s more, the American Heart Association/American College of Cardiology Guideline for the Management of Patients With Valvular Heart Disease states that a mechanical prosthesis is reasonable for aortic or mitral valve replacement in patients aged 60 and younger with no contraindication to anticoagulation.

The fact that you have to use Coumadin (warfarin, Bristol-Myers Squibb), is not a condemnation of the mechanical valve; it just means we need to get smarter and better about how we manage anticoagulation in people with these prostheses.

While neither option is desirable, surprisingly morbidity with mechanical and biological valves is not demonstrably different. Stroke, embolic events, and bleeding complications have been found to be similar in numerous studies including a recent one authored by Dr. Vinay Badhwar and colleagues. Among 469 patients aged 65 years or younger who received a bileaflet mechanical prostheses or tissue valves, researchers found nearly identical rates of bleeding and thromboembolic complications when the anticoagulation was closely monitored (Ann. Thorac. Surg. 2012;93:748-53) Indeed, they even identified a mortality benefit among those with mechanical valves.

It’s also worth noting that the risk of anticoagulation-related complications is higher when the patient’s INR (international normalized ratio) is poorly controlled; up to 60% of INR values are outside the therapeutic range when thromboembolic complications occur. One can anticipate home INR testing and home management as ways to help patients stay within therapeutic range and reduce these risks. If the issue is anticoagulation, let’s improve it.

In summary, if you implant a biological valve in a 50-year-old patient, I guarantee that patient is going to be back for a reoperation and the prosthesis is going to deteriorate. For the surgeon, a biological valve can be an annuity of sorts. The mechanical valve has a clear advantage in durability, especially in younger patients.

Neither one is perfect, but there is no difference in morbidity between the two. A tissue prosthesis just buys you a reoperation – maybe valve-in-valve transcatheter valve. Maybe.

Dr. Sundt is chief of the division of cardiac surgery, Massachusetts General Hospital, Harvard Medical School, Boston. He is an adviser to Thrasos Innovation, but has no relevant relationships to disclose.

Why biological valve is the better choice

BY ANELECHI C. ANYANWU, M.D.

The reality is that whether you implant a mechanical or biological valve for mitral regurgitation, neither is good. The survival is poor. The half-life or median survival of a patient after either valve is about 15-20 years. The death rates are about 3% per year. The morbidity is high whether you have mechanical or biological valve, and none of them are good mitral substitutes.

Yet the biological valve is often a reasonable choice for a 50-year-old patient, despite studies that have shown a higher reoperation rate and decreased survival rate after biological mitral valve repair when compared to mechanical valve implantation in patients aged 65 and younger. But those study results may be skewed.

Dr. Tsuyoshi Kaneko and colleagues at Brigham and Women’s Hospital, Boston, showed that survival at about 20 years was much better with the mechanical valve. (J. Thorac. Cardiovasc. Surg. 2014;147:117-26). However, the difference in survival is greatest immediately after surgery. By 1 year the survival difference between mechanical valve and a tissue valve was more than 10%.

Why is this? I would argue this is a function of patient selection. We know in the United States that a patient with no insurance or low socioeconomic status does poorly compared to one who does have insurance. With a mechanical valve, they can thrombose; but with a biological valve, if they don’t take care of their health, of course they can die early. The reality is surgeons tend to use biological valves in patients of lower socioeconomic status and those with questionable compliance. None of these factors were considered in the propensity matching used in this study.

Dr. Joanna Chikwe and colleagues at Mount Sinai recently compared outcomes in several thousand patients who underwent biological or mechanical mitral valve replacement in New York State (JAMA 2015:323:1435-42). They found no survival difference in the first 30 or 90 days after surgery, or even at 15 years among patients aged 50-69 years. Indeed, a critical review of any study that has shown a survival advantage of the mechanical valve would find that the advantage occurred within the first few months after surgery, making it likely that such differences are due to patient selection, or other systematic bias, rather than a prostheses effect.

Mayo Clinic investigators, including Dr. Thoralf M. Sundt III, reported that among a cohort that received a mechanical valve, with an average age of 65 years, 16% had had a stroke at 5 years, compared with 8% of the biological valve group (J. Am. Coll. Cardiol. 2008;51:1203-11). You can only imagine what would happen at 10 or 20 years. They followed the data out to 10 years for thromboembolic events; that rate was 30% in the mechanical valve group. They concluded, “the mechanical valve is the least desirable correction of mitral regurgitation.”

As for managing anticoagulation, the literature provides no evidence that self-testing is superior to clinic testing. A trial published in the New England Journal of Medicine involving more than 2,000 patients, 700 of whom had a mechanical valve, showed a higher rate of stroke in patients who were randomized to home-INR monitoring compared with INR in the clinic. (N. Engl. J. Med. 2010;363:1608-20). Self-testing did not delay the time to first stroke, bleeding, or death.

Anticoagulation can be problematic if the patient needs to undergo another operation or medical procedure later, especially on an emergent basis. If the patient with a mechanical valve stops anticoagulation for even a short period of time, the risk of valve thrombosis is great. A patient with a biological valve can stop anticoagulation for a week or more without any consequence.

Finally, I relate the story of a man who could not bear the clicking sound of his mechanical valve. He asked for a new valve, but the surgeon would not take his request seriously. The man was taking drugs and started treatment for posttraumatic stress disorder. After 3 years, he killed himself. How many times have we sat down and talked to patients about what the clicking sound can do to them? Why don’t we make more of this? The patient should be given more choice.

Dr. Anyanwu is with the department of cardiac surgery, Mount Sinai Medical Center, New York. He has no relationships to disclose.

Mechanical valve is the best choice

BY THORALF M. SUNDT III, M.D.

It’s not very sexy to talk about mechanical valves, but the reasons for placing a mechanical valve in a 50-year-old patient with rheumatic disease are obvious: Mechanical valves provide outstanding hemodynamics, they are beautifully engineered devices, their durability is beyond question, and, importantly, there’s no survival advantage to a biological prosthesis although one incurs the penalty of reoperation, which in a 50-year-old is going to be inevitable.

While this patient will have to continue on anticoagulation therapy with a mechanical valve, many patients who receive a biological valve, especially those with rheumatic disease, need anticoagulation for atrial fibrillation anyway. One can argue that a maze procedure might convert them to sinus rhythm, but this is least reproducible in the subset of patients with rheumatic disease. What’s more, the American Heart Association/American College of Cardiology Guideline for the Management of Patients With Valvular Heart Disease states that a mechanical prosthesis is reasonable for aortic or mitral valve replacement in patients aged 60 and younger with no contraindication to anticoagulation.

The fact that you have to use Coumadin (warfarin, Bristol-Myers Squibb), is not a condemnation of the mechanical valve; it just means we need to get smarter and better about how we manage anticoagulation in people with these prostheses.

While neither option is desirable, surprisingly morbidity with mechanical and biological valves is not demonstrably different. Stroke, embolic events, and bleeding complications have been found to be similar in numerous studies including a recent one authored by Dr. Vinay Badhwar and colleagues. Among 469 patients aged 65 years or younger who received a bileaflet mechanical prostheses or tissue valves, researchers found nearly identical rates of bleeding and thromboembolic complications when the anticoagulation was closely monitored (Ann. Thorac. Surg. 2012;93:748-53) Indeed, they even identified a mortality benefit among those with mechanical valves.

It’s also worth noting that the risk of anticoagulation-related complications is higher when the patient’s INR (international normalized ratio) is poorly controlled; up to 60% of INR values are outside the therapeutic range when thromboembolic complications occur. One can anticipate home INR testing and home management as ways to help patients stay within therapeutic range and reduce these risks. If the issue is anticoagulation, let’s improve it.

In summary, if you implant a biological valve in a 50-year-old patient, I guarantee that patient is going to be back for a reoperation and the prosthesis is going to deteriorate. For the surgeon, a biological valve can be an annuity of sorts. The mechanical valve has a clear advantage in durability, especially in younger patients.

Neither one is perfect, but there is no difference in morbidity between the two. A tissue prosthesis just buys you a reoperation – maybe valve-in-valve transcatheter valve. Maybe.

Dr. Sundt is chief of the division of cardiac surgery, Massachusetts General Hospital, Harvard Medical School, Boston. He is an adviser to Thrasos Innovation, but has no relevant relationships to disclose.

Why biological valve is the better choice

BY ANELECHI C. ANYANWU, M.D.

The reality is that whether you implant a mechanical or biological valve for mitral regurgitation, neither is good. The survival is poor. The half-life or median survival of a patient after either valve is about 15-20 years. The death rates are about 3% per year. The morbidity is high whether you have mechanical or biological valve, and none of them are good mitral substitutes.

Yet the biological valve is often a reasonable choice for a 50-year-old patient, despite studies that have shown a higher reoperation rate and decreased survival rate after biological mitral valve repair when compared to mechanical valve implantation in patients aged 65 and younger. But those study results may be skewed.

Dr. Tsuyoshi Kaneko and colleagues at Brigham and Women’s Hospital, Boston, showed that survival at about 20 years was much better with the mechanical valve. (J. Thorac. Cardiovasc. Surg. 2014;147:117-26). However, the difference in survival is greatest immediately after surgery. By 1 year the survival difference between mechanical valve and a tissue valve was more than 10%.

Why is this? I would argue this is a function of patient selection. We know in the United States that a patient with no insurance or low socioeconomic status does poorly compared to one who does have insurance. With a mechanical valve, they can thrombose; but with a biological valve, if they don’t take care of their health, of course they can die early. The reality is surgeons tend to use biological valves in patients of lower socioeconomic status and those with questionable compliance. None of these factors were considered in the propensity matching used in this study.

Dr. Joanna Chikwe and colleagues at Mount Sinai recently compared outcomes in several thousand patients who underwent biological or mechanical mitral valve replacement in New York State (JAMA 2015:323:1435-42). They found no survival difference in the first 30 or 90 days after surgery, or even at 15 years among patients aged 50-69 years. Indeed, a critical review of any study that has shown a survival advantage of the mechanical valve would find that the advantage occurred within the first few months after surgery, making it likely that such differences are due to patient selection, or other systematic bias, rather than a prostheses effect.

Mayo Clinic investigators, including Dr. Thoralf M. Sundt III, reported that among a cohort that received a mechanical valve, with an average age of 65 years, 16% had had a stroke at 5 years, compared with 8% of the biological valve group (J. Am. Coll. Cardiol. 2008;51:1203-11). You can only imagine what would happen at 10 or 20 years. They followed the data out to 10 years for thromboembolic events; that rate was 30% in the mechanical valve group. They concluded, “the mechanical valve is the least desirable correction of mitral regurgitation.”

As for managing anticoagulation, the literature provides no evidence that self-testing is superior to clinic testing. A trial published in the New England Journal of Medicine involving more than 2,000 patients, 700 of whom had a mechanical valve, showed a higher rate of stroke in patients who were randomized to home-INR monitoring compared with INR in the clinic. (N. Engl. J. Med. 2010;363:1608-20). Self-testing did not delay the time to first stroke, bleeding, or death.

Anticoagulation can be problematic if the patient needs to undergo another operation or medical procedure later, especially on an emergent basis. If the patient with a mechanical valve stops anticoagulation for even a short period of time, the risk of valve thrombosis is great. A patient with a biological valve can stop anticoagulation for a week or more without any consequence.

Finally, I relate the story of a man who could not bear the clicking sound of his mechanical valve. He asked for a new valve, but the surgeon would not take his request seriously. The man was taking drugs and started treatment for posttraumatic stress disorder. After 3 years, he killed himself. How many times have we sat down and talked to patients about what the clicking sound can do to them? Why don’t we make more of this? The patient should be given more choice.

Dr. Anyanwu is with the department of cardiac surgery, Mount Sinai Medical Center, New York. He has no relationships to disclose.

Mechanical valve is the best choice

BY THORALF M. SUNDT III, M.D.

It’s not very sexy to talk about mechanical valves, but the reasons for placing a mechanical valve in a 50-year-old patient with rheumatic disease are obvious: Mechanical valves provide outstanding hemodynamics, they are beautifully engineered devices, their durability is beyond question, and, importantly, there’s no survival advantage to a biological prosthesis although one incurs the penalty of reoperation, which in a 50-year-old is going to be inevitable.

While this patient will have to continue on anticoagulation therapy with a mechanical valve, many patients who receive a biological valve, especially those with rheumatic disease, need anticoagulation for atrial fibrillation anyway. One can argue that a maze procedure might convert them to sinus rhythm, but this is least reproducible in the subset of patients with rheumatic disease. What’s more, the American Heart Association/American College of Cardiology Guideline for the Management of Patients With Valvular Heart Disease states that a mechanical prosthesis is reasonable for aortic or mitral valve replacement in patients aged 60 and younger with no contraindication to anticoagulation.

The fact that you have to use Coumadin (warfarin, Bristol-Myers Squibb), is not a condemnation of the mechanical valve; it just means we need to get smarter and better about how we manage anticoagulation in people with these prostheses.

While neither option is desirable, surprisingly morbidity with mechanical and biological valves is not demonstrably different. Stroke, embolic events, and bleeding complications have been found to be similar in numerous studies including a recent one authored by Dr. Vinay Badhwar and colleagues. Among 469 patients aged 65 years or younger who received a bileaflet mechanical prostheses or tissue valves, researchers found nearly identical rates of bleeding and thromboembolic complications when the anticoagulation was closely monitored (Ann. Thorac. Surg. 2012;93:748-53) Indeed, they even identified a mortality benefit among those with mechanical valves.

It’s also worth noting that the risk of anticoagulation-related complications is higher when the patient’s INR (international normalized ratio) is poorly controlled; up to 60% of INR values are outside the therapeutic range when thromboembolic complications occur. One can anticipate home INR testing and home management as ways to help patients stay within therapeutic range and reduce these risks. If the issue is anticoagulation, let’s improve it.

In summary, if you implant a biological valve in a 50-year-old patient, I guarantee that patient is going to be back for a reoperation and the prosthesis is going to deteriorate. For the surgeon, a biological valve can be an annuity of sorts. The mechanical valve has a clear advantage in durability, especially in younger patients.

Neither one is perfect, but there is no difference in morbidity between the two. A tissue prosthesis just buys you a reoperation – maybe valve-in-valve transcatheter valve. Maybe.

Dr. Sundt is chief of the division of cardiac surgery, Massachusetts General Hospital, Harvard Medical School, Boston. He is an adviser to Thrasos Innovation, but has no relevant relationships to disclose.

Why biological valve is the better choice

BY ANELECHI C. ANYANWU, M.D.

The reality is that whether you implant a mechanical or biological valve for mitral regurgitation, neither is good. The survival is poor. The half-life or median survival of a patient after either valve is about 15-20 years. The death rates are about 3% per year. The morbidity is high whether you have mechanical or biological valve, and none of them are good mitral substitutes.

Yet the biological valve is often a reasonable choice for a 50-year-old patient, despite studies that have shown a higher reoperation rate and decreased survival rate after biological mitral valve repair when compared to mechanical valve implantation in patients aged 65 and younger. But those study results may be skewed.

Dr. Tsuyoshi Kaneko and colleagues at Brigham and Women’s Hospital, Boston, showed that survival at about 20 years was much better with the mechanical valve. (J. Thorac. Cardiovasc. Surg. 2014;147:117-26). However, the difference in survival is greatest immediately after surgery. By 1 year the survival difference between mechanical valve and a tissue valve was more than 10%.

Why is this? I would argue this is a function of patient selection. We know in the United States that a patient with no insurance or low socioeconomic status does poorly compared to one who does have insurance. With a mechanical valve, they can thrombose; but with a biological valve, if they don’t take care of their health, of course they can die early. The reality is surgeons tend to use biological valves in patients of lower socioeconomic status and those with questionable compliance. None of these factors were considered in the propensity matching used in this study.

Dr. Joanna Chikwe and colleagues at Mount Sinai recently compared outcomes in several thousand patients who underwent biological or mechanical mitral valve replacement in New York State (JAMA 2015:323:1435-42). They found no survival difference in the first 30 or 90 days after surgery, or even at 15 years among patients aged 50-69 years. Indeed, a critical review of any study that has shown a survival advantage of the mechanical valve would find that the advantage occurred within the first few months after surgery, making it likely that such differences are due to patient selection, or other systematic bias, rather than a prostheses effect.

Mayo Clinic investigators, including Dr. Thoralf M. Sundt III, reported that among a cohort that received a mechanical valve, with an average age of 65 years, 16% had had a stroke at 5 years, compared with 8% of the biological valve group (J. Am. Coll. Cardiol. 2008;51:1203-11). You can only imagine what would happen at 10 or 20 years. They followed the data out to 10 years for thromboembolic events; that rate was 30% in the mechanical valve group. They concluded, “the mechanical valve is the least desirable correction of mitral regurgitation.”

As for managing anticoagulation, the literature provides no evidence that self-testing is superior to clinic testing. A trial published in the New England Journal of Medicine involving more than 2,000 patients, 700 of whom had a mechanical valve, showed a higher rate of stroke in patients who were randomized to home-INR monitoring compared with INR in the clinic. (N. Engl. J. Med. 2010;363:1608-20). Self-testing did not delay the time to first stroke, bleeding, or death.

Anticoagulation can be problematic if the patient needs to undergo another operation or medical procedure later, especially on an emergent basis. If the patient with a mechanical valve stops anticoagulation for even a short period of time, the risk of valve thrombosis is great. A patient with a biological valve can stop anticoagulation for a week or more without any consequence.

Finally, I relate the story of a man who could not bear the clicking sound of his mechanical valve. He asked for a new valve, but the surgeon would not take his request seriously. The man was taking drugs and started treatment for posttraumatic stress disorder. After 3 years, he killed himself. How many times have we sat down and talked to patients about what the clicking sound can do to them? Why don’t we make more of this? The patient should be given more choice.

Dr. Anyanwu is with the department of cardiac surgery, Mount Sinai Medical Center, New York. He has no relationships to disclose.

NEW YORK – What if correcting secondary mitral regurgitation doesn’t improve patients’ lives or helps them live longer? What if results of the COAPT trial of the MitraClip (Abbott Vascular) repair for mitral regurgitation are negative or inconclusive? What if transcatheter mitral valve repair works too well?

The answers to these questions could determine the future landscape of transcatheter mitral valve replacement (TMVR) for mitral regurgitation (MR) and the prosthetics in various stages of clinical and preclinical investigation, Dr. Michael Mack of Baylor University said at the 2015 Mitral Valve Conclave, which was sponsored by the American Association for Thoracic Surgery.

Dr. Mack reviewed the first four transcatheter mitral valve replacement devices approved for early feasibility studies in the United States, noting that “it has become a very crowded field very quickly,” especially when one considers that only between 20 and 50 TMVR procedures have been done worldwide up until now.

For the makers of the devices, it is becoming a potentially perilous field as well. Replacement, Dr. Mack said, does meet a “large clinical unmet need” in that it can completely correct mitral regurgitation better than valve repair.

“But what are the challenges for transcatheter mitral valve replacement and why isn’t this going to be the same as TAVR (transcatheter aortic valve replacement) all over again?” he said. “Unlike aortic stenosis, there is not a single cause of mitral regurgitation. In addition, it has never even been definitively proven that correcting MR helps prolong survival and improve quality of life.”

Another obstacle for TMVR is that delivery of the device into the mitral valve is more complex than doing so in the aortic valve. “The seating and the anchoring of the valve is more complex,” Dr. Mack said. “Based on the profile of the device, left ventricular outflow tract obstruction can be an issue, and perivalvular leak may carry more import here because mitral perivalvular leaks have the potential to cause hemololysis.”

He reviewed the four systems cleared for early feasibility studies.

CardiAQ (CardiAQ Valve Technologies), a porcine pericardial valve, has been implanted in eight patients worldwide and last month received Food and Drug Administration (FDA) approval for early feasibility study in 20 U.S. patients: 10 by a transfemoral approach and 10 by a transapical approach.

Tendyne Bioprosthetic Mitral Valve (Tendyne Holdings), a trileaflet porcine pericardium, also has been implanted in eight patients worldwide and was used for the first time in the United States last month by Dr. Wes Pederson and colleagues at the Minneapolis Heart Institute.

FORTIS (Edwards Lifesciences), a bovine pericardium valve, has been implanted in early feasibility trials in Europe and has been approved for an early feasibility trial of 15 patients in the United States.

Tiara (Neovasc), a D-shaped bovine pericardium valve, received FDA approval last year for the TIARA-I early feasibility trial in the United States (NCT02276547). The trial will enroll up to 30 patients worldwide.

At least five other TMVR devices are in preclinical studies, Dr. Mack said. These emerging devices face “threats and obstacles” as they move through the pipeline – a number of “what ifs,” Dr. Mack said.

“What if you can’t prove that correcting secondary mitral regurgitation makes a difference? What are the repercussions of the COAPT Trial (NCT01626079) of the MitraClip if it is positive and shows that correcting mitral regurgitation does make a difference? Does completely correcting mitral regurgitation then really make a difference? What if transcatheter mitral valve repair works too well?” (COAPT stands for Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation). “With the excellent safety profile of MitraClip, it may be hard to justify TMVR,” he said.

Dr. Mack noted that MitraClip for mitral valve repair has “a superb safety profile.” He added, “How do you choose what patients should be treated by a mitral valve replacement vs. a MitraClip by a transfemoral venous approach that enables them to go home the next day?”

The early feasibility trials of TMVR devices may point a way to answers.

Dr. Mack has received research grants from Edwards Lifesciences. He is a principal investigator in the ongoing COAPT Trial, which is sponsored by EVALVE with the collaboration of Abbott Vascular.

NEW YORK – What if correcting secondary mitral regurgitation doesn’t improve patients’ lives or helps them live longer? What if results of the COAPT trial of the MitraClip (Abbott Vascular) repair for mitral regurgitation are negative or inconclusive? What if transcatheter mitral valve repair works too well?

The answers to these questions could determine the future landscape of transcatheter mitral valve replacement (TMVR) for mitral regurgitation (MR) and the prosthetics in various stages of clinical and preclinical investigation, Dr. Michael Mack of Baylor University said at the 2015 Mitral Valve Conclave, which was sponsored by the American Association for Thoracic Surgery.

Dr. Mack reviewed the first four transcatheter mitral valve replacement devices approved for early feasibility studies in the United States, noting that “it has become a very crowded field very quickly,” especially when one considers that only between 20 and 50 TMVR procedures have been done worldwide up until now.

For the makers of the devices, it is becoming a potentially perilous field as well. Replacement, Dr. Mack said, does meet a “large clinical unmet need” in that it can completely correct mitral regurgitation better than valve repair.

“But what are the challenges for transcatheter mitral valve replacement and why isn’t this going to be the same as TAVR (transcatheter aortic valve replacement) all over again?” he said. “Unlike aortic stenosis, there is not a single cause of mitral regurgitation. In addition, it has never even been definitively proven that correcting MR helps prolong survival and improve quality of life.”

Another obstacle for TMVR is that delivery of the device into the mitral valve is more complex than doing so in the aortic valve. “The seating and the anchoring of the valve is more complex,” Dr. Mack said. “Based on the profile of the device, left ventricular outflow tract obstruction can be an issue, and perivalvular leak may carry more import here because mitral perivalvular leaks have the potential to cause hemololysis.”

He reviewed the four systems cleared for early feasibility studies.

CardiAQ (CardiAQ Valve Technologies), a porcine pericardial valve, has been implanted in eight patients worldwide and last month received Food and Drug Administration (FDA) approval for early feasibility study in 20 U.S. patients: 10 by a transfemoral approach and 10 by a transapical approach.

Tendyne Bioprosthetic Mitral Valve (Tendyne Holdings), a trileaflet porcine pericardium, also has been implanted in eight patients worldwide and was used for the first time in the United States last month by Dr. Wes Pederson and colleagues at the Minneapolis Heart Institute.

FORTIS (Edwards Lifesciences), a bovine pericardium valve, has been implanted in early feasibility trials in Europe and has been approved for an early feasibility trial of 15 patients in the United States.

Tiara (Neovasc), a D-shaped bovine pericardium valve, received FDA approval last year for the TIARA-I early feasibility trial in the United States (NCT02276547). The trial will enroll up to 30 patients worldwide.

At least five other TMVR devices are in preclinical studies, Dr. Mack said. These emerging devices face “threats and obstacles” as they move through the pipeline – a number of “what ifs,” Dr. Mack said.

“What if you can’t prove that correcting secondary mitral regurgitation makes a difference? What are the repercussions of the COAPT Trial (NCT01626079) of the MitraClip if it is positive and shows that correcting mitral regurgitation does make a difference? Does completely correcting mitral regurgitation then really make a difference? What if transcatheter mitral valve repair works too well?” (COAPT stands for Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation). “With the excellent safety profile of MitraClip, it may be hard to justify TMVR,” he said.

Dr. Mack noted that MitraClip for mitral valve repair has “a superb safety profile.” He added, “How do you choose what patients should be treated by a mitral valve replacement vs. a MitraClip by a transfemoral venous approach that enables them to go home the next day?”

The early feasibility trials of TMVR devices may point a way to answers.

Dr. Mack has received research grants from Edwards Lifesciences. He is a principal investigator in the ongoing COAPT Trial, which is sponsored by EVALVE with the collaboration of Abbott Vascular.

NEW YORK – What if correcting secondary mitral regurgitation doesn’t improve patients’ lives or helps them live longer? What if results of the COAPT trial of the MitraClip (Abbott Vascular) repair for mitral regurgitation are negative or inconclusive? What if transcatheter mitral valve repair works too well?

The answers to these questions could determine the future landscape of transcatheter mitral valve replacement (TMVR) for mitral regurgitation (MR) and the prosthetics in various stages of clinical and preclinical investigation, Dr. Michael Mack of Baylor University said at the 2015 Mitral Valve Conclave, which was sponsored by the American Association for Thoracic Surgery.

Dr. Mack reviewed the first four transcatheter mitral valve replacement devices approved for early feasibility studies in the United States, noting that “it has become a very crowded field very quickly,” especially when one considers that only between 20 and 50 TMVR procedures have been done worldwide up until now.

For the makers of the devices, it is becoming a potentially perilous field as well. Replacement, Dr. Mack said, does meet a “large clinical unmet need” in that it can completely correct mitral regurgitation better than valve repair.

“But what are the challenges for transcatheter mitral valve replacement and why isn’t this going to be the same as TAVR (transcatheter aortic valve replacement) all over again?” he said. “Unlike aortic stenosis, there is not a single cause of mitral regurgitation. In addition, it has never even been definitively proven that correcting MR helps prolong survival and improve quality of life.”

Another obstacle for TMVR is that delivery of the device into the mitral valve is more complex than doing so in the aortic valve. “The seating and the anchoring of the valve is more complex,” Dr. Mack said. “Based on the profile of the device, left ventricular outflow tract obstruction can be an issue, and perivalvular leak may carry more import here because mitral perivalvular leaks have the potential to cause hemololysis.”

He reviewed the four systems cleared for early feasibility studies.

CardiAQ (CardiAQ Valve Technologies), a porcine pericardial valve, has been implanted in eight patients worldwide and last month received Food and Drug Administration (FDA) approval for early feasibility study in 20 U.S. patients: 10 by a transfemoral approach and 10 by a transapical approach.

Tendyne Bioprosthetic Mitral Valve (Tendyne Holdings), a trileaflet porcine pericardium, also has been implanted in eight patients worldwide and was used for the first time in the United States last month by Dr. Wes Pederson and colleagues at the Minneapolis Heart Institute.

FORTIS (Edwards Lifesciences), a bovine pericardium valve, has been implanted in early feasibility trials in Europe and has been approved for an early feasibility trial of 15 patients in the United States.

Tiara (Neovasc), a D-shaped bovine pericardium valve, received FDA approval last year for the TIARA-I early feasibility trial in the United States (NCT02276547). The trial will enroll up to 30 patients worldwide.

At least five other TMVR devices are in preclinical studies, Dr. Mack said. These emerging devices face “threats and obstacles” as they move through the pipeline – a number of “what ifs,” Dr. Mack said.

“What if you can’t prove that correcting secondary mitral regurgitation makes a difference? What are the repercussions of the COAPT Trial (NCT01626079) of the MitraClip if it is positive and shows that correcting mitral regurgitation does make a difference? Does completely correcting mitral regurgitation then really make a difference? What if transcatheter mitral valve repair works too well?” (COAPT stands for Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation). “With the excellent safety profile of MitraClip, it may be hard to justify TMVR,” he said.

Dr. Mack noted that MitraClip for mitral valve repair has “a superb safety profile.” He added, “How do you choose what patients should be treated by a mitral valve replacement vs. a MitraClip by a transfemoral venous approach that enables them to go home the next day?”

The early feasibility trials of TMVR devices may point a way to answers.

Dr. Mack has received research grants from Edwards Lifesciences. He is a principal investigator in the ongoing COAPT Trial, which is sponsored by EVALVE with the collaboration of Abbott Vascular.

NEW YORK – A simplified surgical approach that uses an adult-sized, basic ring annuloplasty with a complete edge-to-edge leaflet repair has been found to yield good outcomes in a group of children with connective tissue disorders like Marfan syndrome and Loeys-Dietz syndrome and mitral regurgitation, based on an evaluation of the technique at four centers.

Cardiac surgeons employed the simplified operation in 18 patients under age 18 (median age 8.2 years) and found that after 2.4 years of follow-up, no patients required another operation for mitral regurgitation, reported Dr. Luca Vricella, pediatrics director, pediatric cardiac surgery and heart transplantation, John Hopkins University, Baltimore.

The patients underwent the simplified mitral valve repair at Johns Hopkins Pediatric Cardiac Surgery in Baltimore and Orlando; Duke University School of Medicine in Durham, N.C.; and University of Pavia Medical School in Italy.

These young patients can be challenging to operate on because of skeletal abnormalities and marginal pulmonary reserve, Dr. Vricella said at the meeting sponsored by the American Association for Thoracic Surgery. Of the 18 children in the study, 15 had Marfan syndrome, a genetic disorder that commonly affects the heart valves and aorta. “The most common mode of early presentation of mitral valve pathology, from a morphological standpoint, is that mitral regurgitation is often characterized as severe bileaflet prolapse and annular and left ventricular dilation,” Dr. Vricella said.

The simplified technique involves an approach through an atriotomy and placing an adult-sized annuloplasty ring in the valve. The next step is to place an Alfieri stitch, named for the Italian cardiac surgeon Dr. Ottavio Alfieri, with a braided suture in the middle of the valve, which opposes the leaflet “very effectively,” Dr. Vricella said.

In the study group, all 18 patients had severe bileaflet prolapse and severe mitral regurgitation of grade 4 or higher, but all patients also had normal ejection fraction, Dr. Vricella said. One infant was being considered for a heart transplant.

The operation was achieved in isolation in less than an hour. Five patients underwent simultaneous valve-sparing aortic root replacement, one of whom died (one of two deaths in a larger 300-plus group of both adults and children who had valve-sparing aortic root repair). No other complications were reported among the 18-patient group. Median length of stay in the hospital was 9 days.

After the operation, all patients had significant reductions in mitral regurgitation. After 2.4 years, 94% of survivors maintained mild regurgitation or better without stenosis. Entering the study, the median left ventricular end-diastolic diameter (LVEDD) score of all patients was 4.9 (range 2.1-11.9), but at 2.4 years after the operation the median LVEDD score had regressed to 1.3 (range –0.51-4.3).

“In pediatric patients with severe mitral regurgitation and connective tissue disorders, a simplified repair can result in intermediate-term competency without systolic anterior motion and with no mitral stenosis,” Dr. Vricella said. “We’ve been pleasantly surprised in seeing this reduction in left ventricular enlargement, and particularly in this group of patients in which you may need to have a longer plant time, simplifying things so you don’t have to intervene on the subvalvular annuloplasty.”

NEW YORK – A simplified surgical approach that uses an adult-sized, basic ring annuloplasty with a complete edge-to-edge leaflet repair has been found to yield good outcomes in a group of children with connective tissue disorders like Marfan syndrome and Loeys-Dietz syndrome and mitral regurgitation, based on an evaluation of the technique at four centers.

Cardiac surgeons employed the simplified operation in 18 patients under age 18 (median age 8.2 years) and found that after 2.4 years of follow-up, no patients required another operation for mitral regurgitation, reported Dr. Luca Vricella, pediatrics director, pediatric cardiac surgery and heart transplantation, John Hopkins University, Baltimore.

The patients underwent the simplified mitral valve repair at Johns Hopkins Pediatric Cardiac Surgery in Baltimore and Orlando; Duke University School of Medicine in Durham, N.C.; and University of Pavia Medical School in Italy.

These young patients can be challenging to operate on because of skeletal abnormalities and marginal pulmonary reserve, Dr. Vricella said at the meeting sponsored by the American Association for Thoracic Surgery. Of the 18 children in the study, 15 had Marfan syndrome, a genetic disorder that commonly affects the heart valves and aorta. “The most common mode of early presentation of mitral valve pathology, from a morphological standpoint, is that mitral regurgitation is often characterized as severe bileaflet prolapse and annular and left ventricular dilation,” Dr. Vricella said.

The simplified technique involves an approach through an atriotomy and placing an adult-sized annuloplasty ring in the valve. The next step is to place an Alfieri stitch, named for the Italian cardiac surgeon Dr. Ottavio Alfieri, with a braided suture in the middle of the valve, which opposes the leaflet “very effectively,” Dr. Vricella said.

In the study group, all 18 patients had severe bileaflet prolapse and severe mitral regurgitation of grade 4 or higher, but all patients also had normal ejection fraction, Dr. Vricella said. One infant was being considered for a heart transplant.

The operation was achieved in isolation in less than an hour. Five patients underwent simultaneous valve-sparing aortic root replacement, one of whom died (one of two deaths in a larger 300-plus group of both adults and children who had valve-sparing aortic root repair). No other complications were reported among the 18-patient group. Median length of stay in the hospital was 9 days.

After the operation, all patients had significant reductions in mitral regurgitation. After 2.4 years, 94% of survivors maintained mild regurgitation or better without stenosis. Entering the study, the median left ventricular end-diastolic diameter (LVEDD) score of all patients was 4.9 (range 2.1-11.9), but at 2.4 years after the operation the median LVEDD score had regressed to 1.3 (range –0.51-4.3).

“In pediatric patients with severe mitral regurgitation and connective tissue disorders, a simplified repair can result in intermediate-term competency without systolic anterior motion and with no mitral stenosis,” Dr. Vricella said. “We’ve been pleasantly surprised in seeing this reduction in left ventricular enlargement, and particularly in this group of patients in which you may need to have a longer plant time, simplifying things so you don’t have to intervene on the subvalvular annuloplasty.”

NEW YORK – A simplified surgical approach that uses an adult-sized, basic ring annuloplasty with a complete edge-to-edge leaflet repair has been found to yield good outcomes in a group of children with connective tissue disorders like Marfan syndrome and Loeys-Dietz syndrome and mitral regurgitation, based on an evaluation of the technique at four centers.

Cardiac surgeons employed the simplified operation in 18 patients under age 18 (median age 8.2 years) and found that after 2.4 years of follow-up, no patients required another operation for mitral regurgitation, reported Dr. Luca Vricella, pediatrics director, pediatric cardiac surgery and heart transplantation, John Hopkins University, Baltimore.

The patients underwent the simplified mitral valve repair at Johns Hopkins Pediatric Cardiac Surgery in Baltimore and Orlando; Duke University School of Medicine in Durham, N.C.; and University of Pavia Medical School in Italy.

These young patients can be challenging to operate on because of skeletal abnormalities and marginal pulmonary reserve, Dr. Vricella said at the meeting sponsored by the American Association for Thoracic Surgery. Of the 18 children in the study, 15 had Marfan syndrome, a genetic disorder that commonly affects the heart valves and aorta. “The most common mode of early presentation of mitral valve pathology, from a morphological standpoint, is that mitral regurgitation is often characterized as severe bileaflet prolapse and annular and left ventricular dilation,” Dr. Vricella said.

The simplified technique involves an approach through an atriotomy and placing an adult-sized annuloplasty ring in the valve. The next step is to place an Alfieri stitch, named for the Italian cardiac surgeon Dr. Ottavio Alfieri, with a braided suture in the middle of the valve, which opposes the leaflet “very effectively,” Dr. Vricella said.

In the study group, all 18 patients had severe bileaflet prolapse and severe mitral regurgitation of grade 4 or higher, but all patients also had normal ejection fraction, Dr. Vricella said. One infant was being considered for a heart transplant.

The operation was achieved in isolation in less than an hour. Five patients underwent simultaneous valve-sparing aortic root replacement, one of whom died (one of two deaths in a larger 300-plus group of both adults and children who had valve-sparing aortic root repair). No other complications were reported among the 18-patient group. Median length of stay in the hospital was 9 days.

After the operation, all patients had significant reductions in mitral regurgitation. After 2.4 years, 94% of survivors maintained mild regurgitation or better without stenosis. Entering the study, the median left ventricular end-diastolic diameter (LVEDD) score of all patients was 4.9 (range 2.1-11.9), but at 2.4 years after the operation the median LVEDD score had regressed to 1.3 (range –0.51-4.3).

“In pediatric patients with severe mitral regurgitation and connective tissue disorders, a simplified repair can result in intermediate-term competency without systolic anterior motion and with no mitral stenosis,” Dr. Vricella said. “We’ve been pleasantly surprised in seeing this reduction in left ventricular enlargement, and particularly in this group of patients in which you may need to have a longer plant time, simplifying things so you don’t have to intervene on the subvalvular annuloplasty.”