Highly skilled "heart teams" from high-volume centers are part of the requirements for Medicare reimbursement for transcatheter aortic valve implantation (TAVI) proposed by the Centers for Medicare & Medicaid Services (CMS).
The proposed decision memo from CMS recommends that TAVI, also known as transcatheter aortic valve replacement (TAVR), be approved for coverage only when the following six conditions are met:
- TAVI is being performed for an FDA-approved indication, with a complete valve and implantation system that has received FDA premarket approval for this indication
- Two cardiac surgeons have evaluated the patient's suitability for open valve replacement surgery
- TAVI is being performed by a heart team that includes joint pre-operative decision-making and intra-operative co-management of the technical aspects of the TAVI procedure
- TAVI is being performed in a facility that meets surgical or interventional program volume requirements and is committed to the heart team concept
- TAVI is being performed by physicians who meet strict interventionalist or surgeon requirements, including board certification and eligibility
- The TAVI patient and the treating physician team are enrolled in a prospective national registry to track outcomes for at least five years
CMS recommends the following outcomes be tracked: major stroke, all-cause mortality, minor stroke/transient ischemic attack, major vascular event, acute kidney injury, repeat aortic valve procedures, and quality-of-life measures.
To help track outcomes of TAVI procedures and ensure patient safety and operator efficiency, the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) in December launched the TVT Registry. The registry will capture and report patient demographics, procedure details, and facility and physician information.
The proposed national coverage determination is in response to a formal request from the ACC and STS. The document is open for public comment until March 3, after which a final determination will be made.
In a statement, David R. Holmes Jr., MD, president of ACC, said the organization is pleased with the balance CMS struck between ensuring the procedure is performed by "skilled heart care teams in qualified facilities" and "the need to collect data on experience with the device and procedure in the real world."
The FDA approved the Sapien valve (Edwards Lifesciences) in November for use in patients with severe aortic stenosis for transfemoral delivery in patients with severe symptomatic aortic valve stenosis. Patients must be determined inoperable by a cardiac surgeon. The valve is currently considered an investigational device in the U.S. for the treatment of high-risk patients.
The FDA based its approval on the pivotal PARTNER trial cohort B, which compared high-risk patients undergoing TAVI with inoperable patients receiving optimal medical therapy. Results showed a highly significant 20% decrease in mortality at one year. However, at 30 days, stroke and major bleeding rates in the TAVI arm (12 and 30, respectively) were significantly higher compared with the control group (three versus two, respectively). But by one year, the difference in the stroke rate was just 5%.
PARTNER cohort A randomized high-risk patients to the Sapien valve or surgical repair. There was no significant survival difference at one year between the two arms. Some differences existed at 30 days including more major vascular complications in the TAVI arm, and more major bleeding and new onset atrial fibrillation in the surgical arm. Again, there was concern about the higher amount of strokes in the TAVI arm at both 30 days and one year, but only the year-long rate was statistically significant.
In its analysis, CMS noted the high stroke risk in both cohorts, but it also noted the positive aspects related to mortality and symptom release associated with TAVI.
The analysis also pointed out a "rather high risk of bias" mainly in cohort B that favored TAVI. CMS had asked PARTNER investigators for more information regarding randomization but the "study sponsor did not provide additional clarity."
In addition, CMS wrote, "The fact that the main author of the study had significant financial interests in demonstrating the efficacy of TAVI raises eyebrows."
The agency expressed concern about the continued access population (n=90) in cohort B because of an absolute 12.7% higher mortality at one year for the TAVI arm as compared with standard therapy.
However, at the recent STS annual meeting in Ft. Lauderdale, results from the continued access program of cohort A (n=822) showed improvements in outcomes regarding transapical delivery both at 30 days and one year for all-cause death, stroke, and death or stroke, when compared with those who underwent transapical delivery in the original trial (n=104).
Regarding high-risk operable patients, CMS stated that there is a lack of evidence to clearly distinguish "patients who will experience an improved outcome from those who will derive harm such as a stroke or death, especially beyond one year post TAVI."
CMS said that open surgical valve replacement offers an effective treatment for these patients and that further evidence needs to be developed "to better inform treatment decisions and for fully informed discussions of risk and benefit of TAVI in operable patients with severe symptomatic aortic stenosis."
However, high-risk patients (or unlabeled uses of TAVI) will be covered if they meet a bevy of requirements, including that the clinical research study be registered on the www.ClinicalTrials.gov before the first patient is enrolled.
Medtronic's CoreValve system for TAVI is not FDA-approved and is currently undergoing a clinical trial in the U.S.