We appreciate the opportunity to express our views as members of the Patient, Consumer, and Public Health Coalition. Our Coalition of nonprofit organizations represents millions of patients and consumers who are concerned about the safety, effectiveness, and affordability of medical and consumer products that have the potential to benefit the health and well-being of adults and children.
We believe that a National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR) in asymptomatic severe aortic stenosis is dangerously premature because of the lack of meaningful data supporting this indication as reasonable and necessary for Medicare patients.
We disagree with those who cite the EARLY TAVR trial as sufficient evidence that the benefits outweigh the risks for Medicare patients. The trial’s finding of a benefit for asymptomatic patients was based on a composite score that combined 3 variables: death or disabling stroke as one variable, stroke, and unplanned cardiovascular hospitalization. There was no statistically significant benefit for all-cause mortality or disabling stroke (those combined were 10% and11% of the patients in the TAVR or control group, respectively) and those are the results most meaningful to patients. Stroke also did not significantly differ.
The difference that contributed to the apparent benefit based on the composite measure was unplanned cardiovascular hospitalization, but that variable was terribly flawed. As the study authors explained, one in four patients in the non-treatment control group switched to the TAVR treatment within the first 6 months of the study, and these were counted by the study authors as “unplanned cardiovascular hospitalization.” While an unplanned hospitalization would usually be considered an important negative outcome by patients and their physicians, it would not be considered a meaningful negative outcome for asymptomatic patients who merely decided that they wanted to undergo a medical procedure that was not considered medically necessary at that time.
We are also concerned that the EARLY TAVR trial patients and medical professionals are not representative of Medicare patients in the U.S. and therefore the data do not provide evidence of benefit for Medicare patients. The patients were disproportionately White and they were also low surgical risk according to their mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score. Moreover, all procedures were performed in experienced medical centers with intensive surveillance and safeguards in place, which the study authors admitted are not typical of U.S. medical facilities.
We also want to emphasize that any implanted device tends to deteriorate over time, and many need to be replaced within 5-10 years. TAVR valves have been studied for up to approximately 5 years, and longer-term durability data are not yet available. If TAVR patients are expected to survive an average of 8-10 yrs, it makes sense to delay TAVR procedures until the patient is symptomatic, to reduce the chances that the valve will need to be replaced.
We question why Medicare would want to promote a procedure that would result in asymptomatic beneficiaries relying on an implanted device earlier than necessary — given its potential complications and need for replacement — despite the lack of evidence of survival or disability benefit.
Coverage policy should be based on clear evidence, especially for an irreversible intervention for asymptomatic patients. Surgery has risks for all patients, and especially for an aging Medicare population, 40% of whom are 75 and older and 10% who are 85 and older. We are also concerned about safeguarding Medicare resources so that they are available for treatments that are proven reasonable and necessary.
We therefore recommend CMS reject a NCD at this time, but encourage additional trials and longer-term follow-up focused on all-cause mortality, disabling stroke, valve durability, and real-world patient-centered outcomes.
Sincerely,
Cancer Prevention and Treatment Fund
Jacobs Institute of Women’s Health
Medical Device Problems
Mothers Against Medical Error
National Alliance for Hispanic Health
Our Bodies Ourselves
Patient Safety Action Network
The TMJ Association
USA Patient Network
Washington Advocates for Patient Safety
Woody Matters