• Opinion: TAVR Rules Hurt the Heart Team

    Operators highlight 'arbitrary' distinctions between TAVR, SAVR regulation

    If the heart team is so important for the treatment of aortic stenosis, why should centers be held to stringent requirements for transcatheter but not surgical aortic valve replacement (SAVR)?

    That was the question posed by Satya Shreenivas, MD, of The Christ Hospital Heart and Vascular Center in Cincinnati, and colleagues in a viewpoint article published online in JAMA Cardiology.

    "Rules directed solely at TAVR [transcatheter aortic valve replacement] without inclusion or accompanying revision of SAVR practices will fall short of intended improvements in overall patient care and will do little to unify the heart team, which has been acknowledged as one of health care's operational successes of the 21st century," they said.

    The recently-finalized National Coverage Determination (NCD) for reimbursement by the Centers for Medicare & Medicaid Services (CMS) requires a cardiac surgeon to independently evaluate every patient prior to TAVR.

    However, "no similar recommendation is made for a cardiologist to independently evaluate every patient prior to SAVR," Shreenivas and colleagues pointed out. "Insisting that a cardiac surgeon but not an interventional cardiologist be the gatekeeper for candidacy for TAVR is counter to the concept of a heart team approach."

    The NCD also requires that every TAVR facility employ at least two cardiac surgeons. "To our knowledge, data in support of this premise are lacking," according to the authors.

    Besides the NCD, there is also now the American College of Cardiology certification for TAVR centers. No such certification is in place for hospitals performing SAVR.

    "Unfortunately, both the CMS NCD proposal and the American College of Cardiology certification program perpetuate what are now arbitrary distinctions between TAVR and SAVR and subject TAVR to greater regulatory oversight in lieu of fortifying a heart team approach for the care of all patients with aortic stenosis," the writers emphasized.

    Ultimately, they said that if the goal is to ensure comprehensive, high-quality care for all patients with aortic stenosis, anything less than a corresponding CMS NCD and a Society of Thoracic Surgeons certification program for SAVR "may not be in the best interest of care" for these patients.

    Whether new standards for surgery are warranted could be part of a greater debatearound how to make both TAVR and surgery accessible to more people without compromising patient safety.

    After all, SAVR is still the sole treatment available at hundreds of U.S. hospitals, an accompanying editor's note said.

    "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," according to the note from Patrick O'Gara, MD, of Brigham and Women's Hospital in Boston, and colleagues.

    "Overcoming the problem highlighted by Shreenivas, et al. will require fundamental changes in how patients can most easily access comprehensive valve centers. Simply increasing the number of such centers does not seem clinically or financially feasible," the editors wrote.

    Their suggestion: a tiered system for valvular heart disease, akin to existing systems for acute stroke and acute ST-elevation myocardial infarction.

     

    Shreenivas declared no conflicts of interest.

    O'Gara reported travel and lodging reimbursement from Medtronic.

    A fellow editor disclosed institutional grant support from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical.

    Source:

    JAMA Cardiology

    Source Reference: Shreenivas S, et al "Reimbursement rates and quality metrics for the care of patients with aortic stenosis -- are we missing the goal?" JAMA Cardiol 2019; DOI: 10.1001/jamacardio.2019.2017.

    JAMA Cardiology

    Source Reference: O'Gara PT, et al "Improving quality for all patients with aortic stenosis" JAMA Cardiol 2019; DOI: 10.1001/jamacardio.2019.2115.

     

    Read the original article on Medpage Today: Opinion: TAVR Rules Hurt the Heart Team

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