In the Journals

Commentary: TAVR, surgical AVR should be regulated similarly

Satya Shreenivas
Satya Shreenivas

The CMS recently eliminated the requirement that patients with aortic stenosis be evaluated by two cardiac surgeons before undergoing transcatheter aortic valve replacement to help speed up and optimize the decision-making process, but other regulatory barriers to optimal care for these patients remain, according to a viewpoint published in JAMA Cardiology.

“Unfortunately, both the CMS [National Coverage Decision] proposal and the American College of Cardiology certification program perpetuate what are now arbitrary distinctions between TAVR and [surgical] AVR, and subject TAVR to greater regulatory oversight in lieu of fortifying a heart team approach for the care of all patients with [aortic stenosis],” Satya Shreenivas, MD, interventional cardiologist at The Christ Hospital Heart and Vascular Center/The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, and colleagues wrote.

As Cardiology Today’s Intervention previously reported, CMS finalized its coverage policy for TAVR procedures, now requiring evaluation by one cardiac surgeon instead of two and setting volume thresholds for hospitals.

“The [National Coverage Decision] is great for what it is trying to do, but our biggest problem is that is still ... setting up a dichotomy between two different therapies, whereas with all the data we have so far, what we really should be talking about is what is the optimal treatment for the aortic stenosis; let’s develop a treatment plan for the disease process as opposed to keeping arbitrary distinctions between two therapies that is somewhat limiting,” Shreenivas told Cardiology Today’s Intervention. “It has gotten to the point where the heart team is such a benefit to taking care of a patient that we don’t want to create artificial barriers. We should talk about how do we combine the rules and regulations for both.”

The CMS recently eliminated the requirement that patients with aortic stenosis be evaluated by two cardiac surgeons before undergoing transcatheter aortic valve replacement to help speed up and optimize the decision-making process, but other regulatory barriers to optimal care for these patients remain, according to a viewpoint published in JAMA Cardiology.
Source: Adobe Stock

The heart team should be in charge of all patients with aortic stenosis, not just those who are being considered for TAVR, which raises the question of what to do with centers that offer surgical AVR but not TAVR, he said.

“If those hospitals don’t want to do TAVR but want to continue doing [surgical] AVR, we’ve got no rules and regulations for that,” Shreenivas said in an interview. “Even this new iteration of the [National Coverage Decision] does not go far enough. We need to rethink the regulations and quality metrics around TAVR. The best measure of quality is, can you offer patients both surgical and transcatheter valve options and do a good job with both? Those institutions are the best places for patients to go, not the places where you are pigeonholed into one therapy or the other.”

Patrick T. O'Gara
Patrick T. O'Gara

The authors concluded that “all patients appropriate for [surgical] AVR or TAVR should be evaluated by a TAVR-performing interventional cardiologist and a TAVR-performing cardiac surgeon. Evaluation of all patients with [aortic stenosis] potentially appropriate for either therapy helps ensure patients get true informed consent and can participate in shared decision-making.”

The solution is not to mandate elimination of surgical AVR-only programs, but to organically increase the number of centers that offer both procedures and perform them well, which may be helped by the elimination of the two-surgeon rule and the eventual expansion of TAVR to patients at low surgical risk, Shreenivas said in an interview.

The low-risk trials are a game changer in terms of access to care for a lot of patients,” he said.

In an Editor’s Note, Patrick T. O’Gara, MD, MACC, director of strategic planning in the division of cardiovascular medicine at Brigham and Women’s Hospital, Watkins Family Distinguished Chair in Cardiology Professor at Harvard Medical School and past president of the ACC, and colleagues wrote, “Physician-specific or site-specific limitations should not be an impediment to the delivery of the right treatment for the right patient at the right time and in the right place.

“Overcoming the problem highlighted by Shreenivas et al will require fundamental changes in how patients can most easily access comprehensive valve centers,” O’Gara and colleagues concluded. “Simply increasing the number of such centers does not seem clinically or financially feasible. A dedicated system of care for patients with valve disease, similar to the systems in place for acute stroke and acute [STEMI], should be strongly considered.” – by Erik Swain

References:

CMS. Decision Memo for Transcatheter Aortic Valve Replacement (TAVR). Accessed June 25, 2019.

O’Gara PT, et al. JAMA Cardiol. 2019;doi:10.1001/jamacardio.2019.2115.

Shreenivas S, et al. JAMA Cardiol. 2019;doi:10.1001/jamacardio.2019.2017.

For more information:

Satya Shreenivas, MD, can be reached at satya.shreenivas@thechristhospital.com.

Disclosures: Shreenivas reports his institution receives research funding from Boston Scientific, Edwards Lifesciences and Medtronic. O’Gara reports he received travel and lodging reimbursement from Medtronic. Please see the editorial for the other authors’ relevant financial disclosures.

 

Satya Shreenivas
Satya Shreenivas

The CMS recently eliminated the requirement that patients with aortic stenosis be evaluated by two cardiac surgeons before undergoing transcatheter aortic valve replacement to help speed up and optimize the decision-making process, but other regulatory barriers to optimal care for these patients remain, according to a viewpoint published in JAMA Cardiology.

“Unfortunately, both the CMS [National Coverage Decision] proposal and the American College of Cardiology certification program perpetuate what are now arbitrary distinctions between TAVR and [surgical] AVR, and subject TAVR to greater regulatory oversight in lieu of fortifying a heart team approach for the care of all patients with [aortic stenosis],” Satya Shreenivas, MD, interventional cardiologist at The Christ Hospital Heart and Vascular Center/The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, and colleagues wrote.

As Cardiology Today’s Intervention previously reported, CMS finalized its coverage policy for TAVR procedures, now requiring evaluation by one cardiac surgeon instead of two and setting volume thresholds for hospitals.

“The [National Coverage Decision] is great for what it is trying to do, but our biggest problem is that is still ... setting up a dichotomy between two different therapies, whereas with all the data we have so far, what we really should be talking about is what is the optimal treatment for the aortic stenosis; let’s develop a treatment plan for the disease process as opposed to keeping arbitrary distinctions between two therapies that is somewhat limiting,” Shreenivas told Cardiology Today’s Intervention. “It has gotten to the point where the heart team is such a benefit to taking care of a patient that we don’t want to create artificial barriers. We should talk about how do we combine the rules and regulations for both.”

The CMS recently eliminated the requirement that patients with aortic stenosis be evaluated by two cardiac surgeons before undergoing transcatheter aortic valve replacement to help speed up and optimize the decision-making process, but other regulatory barriers to optimal care for these patients remain, according to a viewpoint published in JAMA Cardiology.
Source: Adobe Stock

The heart team should be in charge of all patients with aortic stenosis, not just those who are being considered for TAVR, which raises the question of what to do with centers that offer surgical AVR but not TAVR, he said.

“If those hospitals don’t want to do TAVR but want to continue doing [surgical] AVR, we’ve got no rules and regulations for that,” Shreenivas said in an interview. “Even this new iteration of the [National Coverage Decision] does not go far enough. We need to rethink the regulations and quality metrics around TAVR. The best measure of quality is, can you offer patients both surgical and transcatheter valve options and do a good job with both? Those institutions are the best places for patients to go, not the places where you are pigeonholed into one therapy or the other.”

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Patrick T. O'Gara
Patrick T. O'Gara

The authors concluded that “all patients appropriate for [surgical] AVR or TAVR should be evaluated by a TAVR-performing interventional cardiologist and a TAVR-performing cardiac surgeon. Evaluation of all patients with [aortic stenosis] potentially appropriate for either therapy helps ensure patients get true informed consent and can participate in shared decision-making.”

The solution is not to mandate elimination of surgical AVR-only programs, but to organically increase the number of centers that offer both procedures and perform them well, which may be helped by the elimination of the two-surgeon rule and the eventual expansion of TAVR to patients at low surgical risk, Shreenivas said in an interview.

The low-risk trials are a game changer in terms of access to care for a lot of patients,” he said.

In an Editor’s Note, Patrick T. O’Gara, MD, MACC, director of strategic planning in the division of cardiovascular medicine at Brigham and Women’s Hospital, Watkins Family Distinguished Chair in Cardiology Professor at Harvard Medical School and past president of the ACC, and colleagues wrote, “Physician-specific or site-specific limitations should not be an impediment to the delivery of the right treatment for the right patient at the right time and in the right place.

“Overcoming the problem highlighted by Shreenivas et al will require fundamental changes in how patients can most easily access comprehensive valve centers,” O’Gara and colleagues concluded. “Simply increasing the number of such centers does not seem clinically or financially feasible. A dedicated system of care for patients with valve disease, similar to the systems in place for acute stroke and acute [STEMI], should be strongly considered.” – by Erik Swain

References:

CMS. Decision Memo for Transcatheter Aortic Valve Replacement (TAVR). Accessed June 25, 2019.

O’Gara PT, et al. JAMA Cardiol. 2019;doi:10.1001/jamacardio.2019.2115.

Shreenivas S, et al. JAMA Cardiol. 2019;doi:10.1001/jamacardio.2019.2017.

For more information:

Satya Shreenivas, MD, can be reached at satya.shreenivas@thechristhospital.com.

Disclosures: Shreenivas reports his institution receives research funding from Boston Scientific, Edwards Lifesciences and Medtronic. O’Gara reports he received travel and lodging reimbursement from Medtronic. Please see the editorial for the other authors’ relevant financial disclosures.