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Comparison between balloon-expandable (Sapien XT or Sapien 3 valve, Edwards Lifesciences) vs self-expanding (CoreValve, Medtronic) TAVR from 2013 to 2015, Results: Lower mortality rate and other advantages with balloon-expandable valves over self-expanding valves.

Reporter: Aviva Lev-Ari, PhD, RN

The coprimary end point of at least moderate paravalvular regurgitation (PVR) at discharge and/or in-hospital mortality was more common with a self-expanding (SE) valve than with a balloon-expandable (BE) valve (19.8% vs 11.9%; relative risk [RR], 1.68). This related to nearly twofold more PVR (15.5% vs 8.3%; RR, 1.90) and a 1.4% absolute mortality difference (5.6% vs 4.2%; RR, 1.33).

Need for a permanent pacemaker (22.3% vs 11.0%; P < .0001) and a second transcatheter heart valve (3.7% vs 1.0%; P < .0001) was more frequent with SE valves.

Patients receiving an SE valve also had higher rates of myocardial infarction (0.4% vs 0.2%; P = .02) but had a lower mean transprosthetic gradient than those receiving a BE valve (7 vs 10; P < .0001).

At 2 years, use of a self-expanding valve was associated with a higher risk for all-cause mortality (29.8% vs 26.6%; hazard ratio, 1.17; 95% CI, 1.06 – 1.28) and cardiovascular death (23.3% vs 20.9%; P = .001). This is explained by a 36% excess risk for death during the first 3 months (P = .0001), with the two mortality curves remaining parallel thereafter, Van Belle said.

The findings were consistent across subgroups, although the difference in the primary composite end point was stronger for those who received transfemoral TAVR and for those treated at the end of the study in 2015.

On multivariable analysis, independent predictors of all-cause mortality were valve design and PVR severity, according to the study, simultaneously published online in Circulation.

Limitations include the use of observational data, potential unmeasured residual confounders, site-reported PVR grading and clinical events (except mortality), and a lack of newer valve designs, Van Belle said.

“The present study strongly supports conducting a randomized trial in order to compare head-to-head the most recent iterations of SE and BE THVs on all-cause mortality,” he concluded.

The study, he said, “points out, if nothing else, that perhaps there is an inherent difference between the TAVR valves. It may be incorrect to assume it is a class effect.”

A second propensity-matched analysis, also published online in Circulation but not presented at AHA, used the nationwide French administrative hospital-discharge database to compare 10,459 matched pairs who underwent TAVR with the balloon-expandable Sapien 3 or self-expanding Evolut R (Medtronic) valve from 2014 to 2018.

Over a mean follow-up of 358 days, use of the BE vs the SE valve was associated with a lower yearly incidence of all-cause death (rate ratio, 0.88; corrected P = .005), cardiovascular death (rate ratio, 0.82; corrected P = .002), and rehospitalization for heart failure (rate ratio, 0.84; corrected P < .0001).

Pacemaker implantation was also lower with the balloon-expandable valve (rate ratio, 0.72; corrected P < .0001), Pierre Deharo, MD, PhD, CHU Timone, Marseille, France, and colleagues report.

In an editorial accompanying the two analyses, Mohamed Abdel-Wahab, MD, and Holger Thiele, MD, both with the Heart Center Leipzig at the University of Leipzig, Germany, praised the authors for reporting what is currently the largest published dataset comparing the two valve designs. The limitations of registry-based analyses, however, are “obvious, and the findings should therefore be considered thought-provoking but by no means definite.”