Medical Societies Issue Position Paper in Anticipation of Transcatheter Valve Availability

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With just weeks to go before a US Food and Drug Administration (FDA) panel meets to discuss the fate of a transcatheter aortic valve—poised to be the first to be approved in the United States—2 medical societies have issued a consensus document outlining issues that must be addressed before the technology is widely introduced. The paper was jointly published June 27, 2011, by the Journal of the American College of Cardiology and the Annals of Thoracic Surgery.

The FDA is set to meet July 20, 2011, to review the premarket approval (PMA) application for the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA).

Co-authors David R. Holmes Jr, MD, of the Mayo Clinic (Rochester, MN), president of the American College of Cardiology (ACC) Foundation, and Michael J. Mack, MD, of Baylor Health Care System (Dallas, TX) and president of the Society of Thoracic Surgeons (STS), say the paper is the first of several joint endeavors aimed at addressing the many issues that clinicians and hospitals will face if and when the valve is approved.

To date, the only randomized clinical trial of the valve, the PARTNER (Placement of AoRTic traNscatheterER valves) study, has shown a significant advantage in inoperable patients for transcatheter aortic valve implantation (TAVI) over traditional medical management at 1 year for the co-primary endpoints of all-cause mortality and the composite of death and repeat hospitalization. On the downside, TAVI was associated with higher rates of major vascular complications and bleeding episodes as well as a trend toward increased stroke at 30 days.

More recently, the PARTNER trial’s Cohort A, which focused on high-risk patients with severe aortic stenosis, found TAVI to be noninferior to traditional aortic valve surgery in those eligible for either treatment. However, periprocedural risks varied greatly between the 2 therapies: stroke and vascular complications were more common with TAVI, while bleeding and new-onset atrial fibrillation occurred more frequently with surgery.

Advocating for a Multidisciplinary Team

In a telephone interview with TCTMD, Dr. Mack said the cardiology community is on the verge of a “disruptive—in a positive sense—new technology that promises to change the treatment of patients with aortic stenosis.”

He added that both the ACC and STS support the multidisciplinary heart team approach used in the PARTNER trial and believe it is important for clinicians and centers hoping to adopt TAVI to embrace the same approach.

“[In coronary revascularization] we’ve seen what can happen when you have competitive therapeutic strategies practiced by 2 difference specialties in the same arena,” he said. “We’ve seen many issues arise from that competitiveness of CABG vs. PCI, and we think we have learned from that and can go forward . . . in a collaborative situation between the 2 specialties.”

Specifically, the document provides guidance on:

  • The basics of the heart team principle and the key players (including primary cardiologists, interventional cardiologists, cardiac surgeons, noninvasive and heart failure cardiologists, cardiac imaging specialists, and others)
  • The importance of regional heart centers, which will require development of facilities and personnel experience, pre- and post-procedural care protocols, and complication management strategies
  • The concept of new-generation ‘hybrid’ suites, including the necessary elements as well as possible locations, training, and team-structuring suggestions

Additionally, Dr. Mack said the ACC and STS are committed to careful long-term documentation and assessment of patient outcomes after transcatheter valve therapy. To that end, they are collaborating on a project known as ASCERT (ACCF/STS Collaboration on the Comparative Effectiveness of Revascularization Strategies), which links both societies’ large clinical databases to administrative databases including the Social Security Death Master File and the Centers for Medicare and Medicaid Services Medicare Provider and Analysis Review data.

“Now we truly can have universal capture of all patients and long-term follow-up,” Dr. Mack said. “The problem with the clinical databases is that there is only 30-day follow-up, but by marrying our databases to the Social Security death file, we will have a picture of true long-term survival.”

Disappointment Looms for Some?

Despite considerable anticipation over the upcoming FDA decision, some clinicians fear that approval of the device will be a letdown in a sense because they believe far more patients could benefit than will meet the inclusion criteria or that some will not have access to a center eligible to perform the procedure.

“There will be some [clinicians] disappointed that they will not be included in the initial centers as this rolls out,” Dr. Mack agreed. “The STS and ACC [are working] to begin to prepare centers for this. But some have said they had no idea what was necessary and that they don’t think they want to invest in the infrastructure necessary to do this. So, those that feel that there will be limitations . . . withholding lifesaving therapy from [patients] that need it, in my opinion, don’t understand everything involved in terms of personnel and programmatic infrastructure.”

As for patients who do not meet inclusion criteria, Dr. Mack said that, despite criticism that initial use of the device in the United States will be limited to a small number of inoperable patients, he believes the FDA is “trying to strike the right balance between allowing devices that are safe into the US population, yet not withholding lifesaving therapy from a population that has no alternative.”

Ultimately, though, Dr. Mack believes the future of TAVI will come down to cost-effectiveness and quality-of-life issues.

“PARTNER Cohort B was overwhelmingly positive [in inoperable patients], but still you look at this trial and 30% who got this very expensive therapy are not alive at 1 year. This isn’t going to be cost-effective therapy long-term,” he said. “I think we’re smart enough now to realize that although someone is inoperable they may not be a candidate for [TAVI] because they are too old, too frail, and too debilitated. We are going to have to determine a ceiling because 70% survival is not going to be a sustainable endpoint for cost-effectiveness and quality of life long-term.”


Holmes DR, Mack MJ. Transcatheter valve therapy: A professional society overview from the American College of Cardiology Foundation and the Society of Thoracic Surgeons. Ann Thorac Surg. 2011;92:380-389.



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  • Dr. Holmes reports no relevant conflicts of interest.
  • Dr. Mack reports receiving research support from Edwards Lifesciences.