Groups Outline Key Issues for Dissemination of Transcatheter Mitral Valve Therapies
Four cardiovascular professional societies have laid out the key issues facing the evolving field of transcatheter therapies for mitral valve regurgitation. The document, published online November 25, 2013, ahead of print in the Journal of the American College of Cardiology, provides a framework for discussion by the various stakeholders and future development of guidelines aimed at appropriate integration of the procedures into patient care.
Written by a committee co-chaired by Patrick T. O’Gara, MD, of Brigham and Women’s Hospital (Boston, MA), and John H. Calhoon, MD, of the University of Texas Health Science Center at San Antonio (San Antonio, TX), the statement represents the views of the leadership of the American College of Cardiology (ACC), the American Association for Thoracic Surgery, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons (STS).
“Both TAVR and transcatheter [mitral regurgitation] therapies represent transformative technologies that can extend care to select populations of patients considered [to be at] prohibitive risk for open surgery,” Dr. O’Gara said in a press release. “The lessons learned from the dissemination of TAVR will help guide a similar process for the integration of these transcatheter therapies for severe [mitral regurgitation] into clinical practice.”
Moreover, the authors say, “It is imperative that professional societies, industry, payers, and regulatory agencies work collaboratively to promote needed research and ensure that the technology is disseminated rationally and responsibly in the best interests of patients.”
Setting the Agenda
The authors identify a number of key issues to be considered in preparation for future practice guidelines, expert consensus statements, and requirements for training, operator credentialing, and institutional policies.
The document makes the following broad recommendations:
- Regional heart valve referral centers of excellence should be established, defined in part by the competence and experience of the individual members of a dedicated multidisciplinary heart team. In addition, the availability of new devices and reimbursement for their application should be limited to centers that meet national criteria.
- All patients referred for consideration for transcatheter therapy should follow the same evaluation and treatment pathways in order to promote consistency, reduce variability, and allow for more uniform reporting of results. Specific protocols for pre-, intra, and post-procedural patient assessment and care should be in place along with clear delineation of the roles of the individual heart team members. Moreover, a collaborative process for shared decision-making with patients should be established.
- All referral centers should be required to participate in the ongoing ACC/STS TVT registry to benchmark quality and enable outcomes and cost analysis, as well as comparative effectiveness research.
- Operator training and credentialing criteria should be established by professional societies rather than commercial sponsors. The authors acknowledge a number of challenges to this goal, including gaining the required minimum number of cases, appropriate balance between simulation and/or large animal laboratory experience, the limited number of centers at which mitral procedures have been performed, and the limited number of senior mentors available.
- Guidelines for transcatheter mitral valve interventions should be substantiated and developed.
Aortic Paradigm, with a Few Differences
In a telephone interview with TCTMD, Ted Feldman, MD, of Evanston Hospital (Evanston, IL), characterized the societies’ statement as very general. “Of course, the details are what we’re all looking forward to,” he said, adding that “the next important document will be the credentialing paper, which is in process.”
Overall, the approach to dissemination of mitral procedures is deliberately based on the paradigm of the aortic experience in the United States, Dr. Feldman observed, although there will be some important differences in detail. Perhaps the biggest of these, he said, is that surgery for the type of patients targeted by MitraClip (Abbott Vascular, Santa Clara, CA) is far less common than is surgery for aortic stenosis.
“So while 50 surgical aortic valve replacements [in the previous] year are required to define a TAVR center [without prior TAVR experience], the number for mitral centers will have to be very different,” Dr. Feldman commented, adding that he hoped the requirements will still allow for an adequate number of centers. “It seems to have worked out very well so far with [TAVR] . . . and hopefully we’ll be on target as well with the mitral [centers] when we see the specifics of the [credentialing] document,” he said.
Dr. Feldman added that the role of the heart team may be even more important in the mitral field than in the aortic field. Although patient management is equally complicated for both interventions, he said, aortic disease often is amenable to more straightforward decision making regarding treatment. “With mitral regurgitation, there are many more ‘gray zone’ patients and consensus decisions rather than fairly straightforward, protocol-driven decisions,” he noted.
It remains to be seen whether hammering out specific criteria for centers and operators will lead to disagreements, Dr. Feldman said. “When [TAVR] started to roll out, there was a lot more concern about the requirements being either too inclusive or too restrictive, depending on who you talked to. . . . I’m sure we’ll have discussion around these [with mitral procedures], and we’ll see whether it is persistent contention or growing consensus as time passes.”
O’Gara, PT, Calhoon JH, Moon MR, Tommaso CL. Transcatheter therapies for mitral regurgitation: A professional society overview from the American College of Cardiology, American Association for Thoracic Surgery, Society for Cardiovascular Angiography and Interventions Foundation, and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2013;Epub ahead of print.
- Drs. O’Gara and Calhoon report no relevant conflicts of interest.
- Dr. Feldman reports serving as an investigator and consultant for Abbott Vascular, Boston Scientific, and Edwards Lifesciences.