Key result
SAPIEN 3 and Evolut R show similar device success and long-term survival in TAVR.
Why the study?
Comparative data on periprocedural and long-term outcomes between new generation TAVR prostheses SAPIEN 3 and Evolut R were lacking.
Does TAVR with the SAPIEN 3 prosthesis compared to the Evolut R prosthesis improve periprocedural and long-term outcomes in patients with severe aortic stenosis?
Cohort (n=359)
No
Does TAVR with the SAPIEN 3 prosthesis compared to the Evolut R prosthesis improve periprocedural and long-term outcomes in patients with severe aortic stenosis?
Absolute Event Rate: 93% vs 92.4%
p-value: p=0.812
New generation TAVR valves (SAPIEN 3 and Evolut R) offer excellent implant success and comparable long-term survival, with mortality primarily driven by baseline comorbidities rather than prosthesis choice.
Should not yet drive prosthesis selection; leaves open whether randomized trials would detect subgroup differences.
The aim of this study was to compare patients with transcatheter aortic valve replacement (TAVR) receiving new generation prostheses SAPIEN 3 (S3, Edwards Lifesc.) and Evolut R (ER, Medtronic Inc.) in terms of periprocedural and long-term outcome. Our retrospective, single-center analysis included 359 consecutive patients with severe aortic stenosis who underwent TAVR with S3 or ER from 2014–2016 (mean age 82 ± 7 years, 47% male, mean EuroSCORE II 8.0 ± 8%, mean follow-up 3.8 years). Device Success was equal (S3 93.0% vs. ER 92.4%, p = 0.812). We report a 30-day mortality of 2.8% in the S3 group, and 2.1% in the ER group (p = 0.674). There was no difference in stroke, conversion to open surgery, vascular and bleeding complications or myocardial infarction. While prosthesis mean gradients were higher with S3 (12.0 mmHg vs. 8.2 mmHg, p < 0.001), there was a trend to less paravalvular regurgitation (PVR moderate or severe: 1% vs. 3.6%, p = 0.088). All-cause mortality up to 5 years did not show a difference (mean survival S3 3.5 ± 0.24 years, ER 3.3 ± 0.29 years, p = 0.895). Independent predictors of long-term mortality were impaired LVEF, chronic kidney injury, peripheral artery disease, malignant tumor and periprocedural stroke. New generation TAVR valves offer an excellent implant and outcome success rate. Long-term survival was independent of prostheses choice and mainly attributed to comorbidities and complications.
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Tamm et al. (2021) conducted a cohort in Severe aortic stenosis (n=359). SAPIEN 3 (S3) vs. Evolut R (ER) was evaluated on Device success (p=0.812). In patients with severe aortic stenosis undergoing TAVR, SAPIEN 3 and Evolut R prostheses showed similar device success (93.0% vs. 92.4%, p=0.812) and long-term survival.
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