Abstract
Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with earlier-generation devices. Current meta-analysis compared outcomes of TAVR with next-generation devices: ACURATE neo and SAPIEN 3. In random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed. One randomized controlled trial and five observational studies including 2818 patients (ACURATE neo n = 1256 vs. SAPIEN 3 n = 1562) met inclusion criteria. ACURATE neo was associated with a 3.7-fold increase of moderate-to-severe PVL (RR (risk ratio): 3.70 (2.04–6.70); P < 0.0001), which was indirectly related to higher observed 30-day mortality with ACURATE valve (RR: 1.77 (1.03–3.04); P = 0.04). Major vascular complications, acute kidney injury, periprocedural myocardial infarction, stroke and serious bleeding events were similar between devices. ACURATE neo demonstrated lower transvalvular pressure gradients both at discharge (P < 0.00001) and at 30 days (P < 0.00001), along with lower risk of patient–prosthesis mismatch (RR: 0.29 (0.10–0.87); P = 0.03) and pacemaker implantation (RR: 0.64 (0.50–0.81); P = 0.0002), but no differences were observed regarding composite endpoints early safety and device success. In conclusion, ACURATE neo, as compared with SAPIEN 3, was associated with higher rates of moderate-to-severe PVL, which were indirectly linked with increased observed 30-day all-cause mortality.
Highlights
Since first its mention by Cribier in 2002 [1], transcatheter aortic valve replacement (TAVR) has been complementary method to surgical aortic valve replacement (SAVR) in inoperable or high-risk patients with severe symptomatic aortic stenosis
Studies were included if having met all of the following criteria: (1) human study; (2) study or study arms comparing directly strategy of transcatheter aortic valve replacement with ACURATE neo and SAPIEN 3; (3) randomized controlled trial (RCT) or propensity score matched observational study
61 (2.2%) patients died within the first 30 days, with respective rates of 2.9% and 1.6% in ACURATE neo and SAPIEN 3 groups; ACURATE neo was associated with 77% higher 30-day mortality risk (RR 1.77, 95% confidence intervals (95% CI), (1.03, 3.04); P = 0.04; I2 = 0% (Figure 5a and Appendix Figure A12)
Summary
Since first its mention by Cribier in 2002 [1], transcatheter aortic valve replacement (TAVR) has been complementary method to surgical aortic valve replacement (SAVR) in inoperable or high-risk patients with severe symptomatic aortic stenosis. Though, higher incidence of paravalvular leak (PVL), in turn associated with increased late mortality and higher rate of other adverse clinical incidents, as compared to SAVR [11,12,13], often outweigh the benefits of transcatheter approach. To minimize these shortcomings, technological innovations were developed in next-generation valves including the following: balloon-expandable SAPIEN 3 (Edwards Lifesciences, Irvine, CA, USA) and self-expandable ACURATE neo (Boston Scientific Corporation, Marlborough, MA, USA). The objective of the present investigation was to evaluate and compare short-term results of TAVR with ACURATE neo and SAPIEN 3 in patients presenting with symptomatic severe native aortic valve stenosis
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