Popular TAVR valves linked to comparable long-term outcomes
Cardiologists have spent a significant amount of time over the years evaluating different transcatheter aortic valve replacement (TAVR) platforms to see which one is associated with the best patient outcomes.
According to a new analysis published in Cardiovascular Revascularization Medicine, however, the three most widely used platforms—the ones developed by Medtronic, Edwards Lifesciences and Boston Scientific—are all associated with comparable long-term outcomes.[1]
“Moreover, valve-related clinical efficacy was high, with low and comparable bioprosthetic valve failure (BVF) rates among the three study devices,” wrote corresponding author Marco Barbanti, MD, a cardiologist with Umberto I Hospital in Italy, and colleagues.
Diving deep into the data
Barbanti et al. examined data from 383 transfemoral TAVR patients treated at a single facility from September 2014 to December 2018. All patients received one of three second-generation transcatheter heart valves included in this analysis—and deciding which valve to use was left entirely up to the patient’s physicians. Patients were excluded if pre-TAVR CT angiography was not performed or they received a valve from a prior generation.
The Acurate Neo TAVR valve from Boston Scientific.
While 34.9% of patients received an Evolut R or Evolut PRO valve from Medtronic, 34.2% of patients received a Sapien 3 valve from Edwards Lifesciences and 30.8% received an Acurate Neo valve from Boston Scientific.
After seven years, the study’s primary composite endpoint—all-cause mortality, disabling stroke or heart failure hospitalization—was seen in 51.6% of Evolut patients, 60.2% of Sapien 3 patients and 62.1% of Acurate Neo patients. All-cause mortality on its own, meanwhile, was seen in 49.3% of Evolut patients, 52.1% of Sapien 3 patients and 55.9% of Acurate Neo patients. And the study’s other primary endpoint, valve-related clinical efficacy according to VARC-3 definitions, was seen in 1.2% of Evolut patients, 2.2% of Sapien 3 patients and 4.2% of Acurate Neo patients.
In all three instances, the rates were close enough to one another that any differences were not seen as being statistically significant.
The authors did point to some significant differences, however. For example, echocardiography assessments showed that the Sapien 3 valves were associated with higher residual transvalvular gradients and lower rates of mild or moderate paravalvular regurgitation (PVR). In fact, mild or moderate PVR was seen in just 19.1% of Sapien 3 patients compared to 46.4% of Evolut patients and 48.2% of Acurate Neo patients.
“As the life-expectancy of TAVR recipients increases, the durability of new valves is a matter that requires a proper and in-depth investigation,” the authors wrote. “Manufacturers have revised leaflets design and production process to obtain a longer leaflet tissue integrity of new-generation devices (i.e. ad-hoc anti-calcification processes) and it is therefore expected that valve durability outperforms that of their predecessors.”
Notable limitations
The team behind this study was quick to point to some of its limitations. They focused on procedures performed at a single facility, for instance, and the final sample size was relatively small. Also, because heart teams made their own device choices, there is a risk of “selection bias” that should be avoided in future studies exploring this same topic.
The authors called for randomized clinical trials to be performed in the future that include an “independent echocardiographic laboratory assessment.” This, they noted, will help provide cardiologists and the entire cardiology community with a better understanding of how these different platforms compare with one another over time.
Click here to read the full analysis in Cardiovascular Revascularization Medicine.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.