Key result
RDAVR with Perceval-S yielded a 30-day all-cause mortality of 5.1% versus 1.7% for TAVI with ACURATE neo (P=0.619), while TAVI was associated with significantly higher rates of mild paravalvular leak.
Why the study?
RDAVR and TAVI have emerged as increasingly used alternatives to conventional aortic valve replacement in patients at higher surgical risk, but comparative clinical and hemodynamic outcomes between self-expanding Perceval-S and ACURATE neo/TF needed evaluation.
Does rapid deployment aortic valve replacement with Perceval-S compared to TAVI with ACURATE neo/TF improve clinical outcomes and hemodynamics in patients with symptomatic aortic valve stenosis?
Cohort (n=332)
No
Does rapid deployment aortic valve replacement with Perceval-S compared to TAVI with ACURATE neo/TF improve clinical outcomes and hemodynamics in patients with symptomatic aortic valve stenosis?
Absolute Event Rate: 5.1% vs 1.7%
p-value: p=0.619
In a propensity-matched cohort of high-risk patients with aortic stenosis, TAVI with ACURATE neo resulted in higher rates of mild paravalvular leak compared to rapid deployment surgical valve replacement with Perceval-S, though short-term mortality and pacemaker rates were comparable.
Higher mild paravalvular leak with TAVI NEO versus RDAVR PER without mortality difference should not yet change practice; leaves open need for randomized comparisons.
Background Rapid deployment aortic valve replacement (RDAVR) and transcatheter aortic valve implantation (TAVI) have emerged as increasingly used alternatives to conventional aortic valve replacement to treat patients at higher surgical risk. Therefore, in this single-center study, we retrospectively compared clinical outcomes and hemodynamic performance of two self-expanding biological prostheses, the sutureless and rapid deployment valve (RDV) Perceval-S (PER) and the transcatheter heart valve (THV) ACURATE neo/TF (NEO) in a 1:1 propensity-score-matching (PSM) patient cohort. Methods A total of 332 consecutive patients with symptomatic aortic valve stenosis underwent either singular RDAVR with PER (119) or TAVI with NEO (213) at our institutions between 2012 and 2017. To compare the unequal patient groups, a 1:1 PSM for preoperative data and comorbidities was conducted. Afterward, 59 patient pairs were compared with regard to relevant hemodynamic parameter, relevant paravalvular leak (PVL), permanent postoperative pacemaker (PPM) implantation rate, and clinical postoperative outcomes. Results Postoperative clinical short-term outcomes presented with slightly higher rates for 30-day all-cause mortality (PER = 5.1% vs. NEO = 1.7%, p = 0.619) and major adverse cardiocerebral event in PER due to cerebrovascular events (transient ischemic attack [TIA]-PER = 3.4% vs. TIA-NEO = 1.7%, p = 0.496 and Stroke-PER = 1.7% vs. Stroke-NEO = 0.0%, p = 1). Moreover, we show comparable PPM rates (PER = 10.2% vs. NEO = 8.5%, p = 0.752). However, higher numbers of PVL (mild—PER = 0.0% vs. NEO = 55.9%, p = 0.001; moderate or higher—PER = 0.0% vs. NEO = 6.8%, p = 0.119) after TAVI with NEO were observed. Conclusion Both self-expanding bioprostheses, the RDV-PER and THV-NEO provide a feasible option in elderly and patients with elevated perioperative risk. However, the discussed PER collective showed more postoperative short-term complications with regard to 30-day all-cause mortality and cerebrovascular events, whereas the NEO showed higher rates of PVL.
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Mauri et al. (2021) conducted a cohort in Symptomatic aortic valve stenosis (n=332). Rapid deployment aortic valve replacement (RDAVR) with Perceval-S vs. Transcatheter aortic valve implantation (TAVI) with ACURATE neo/TF was evaluated on 30-day all-cause mortality (p=0.619). RDAVR with Perceval-S yielded a 30-day all-cause mortality of 5.1% versus 1.7% for TAVI with ACURATE neo (P=0.619), while TAVI was associated with significantly higher rates of mild paravalvular leak.
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