Hemodynamic Comparison of Sutureless and Rapid-Deployment Valves with Conventional Bioprostheses

Abstract

Background Sutureless and rapid-deployment bioprostheses (RPDs) are advantageous due to shorter aortic cross-clamp times (ACCs); however, few studies have investigated hemodynamic outcomes in comparison to conventional bioprostheses (CBs). Methods All patients receiving the Perceval (LivaNova, London, United Kingdom) and Intuity (Edwards Lifesciences, Irvine, California, United States) valves from February 2016 to December 2017 were included (n = 61). For controls, patients who underwent aortic valve replacement using CB from 2015 to 2018 (n = 743) were propensity-matched (n = 108). Primary end points were mean gradient at discharge, true internal diameter (ID) after implantation, and paravalvular leakage. Secondary end points were ACCs, cardiopulmonary bypass times (CPBTs), mortality, and pacemaker implantation. Results Age was 73.2 years (standard deviation [SD]: 7.6) in the RPD group and 72.9 years (SD: 7.3) in the CB group (p = 0.827). Median logistic EuroSCORE II was 3.4% (Q1: 2; IQ3: 5.3) and 3% (Q1: 1.9; IQ3: 5.6; p = 0.599). While ACCs and CPBT were shorter in RPDs (97 [SD: 31.4] vs. 125.4 minutes [SD: 62.1], p = 0.003; and 76.1 [SD: 25.7] vs. 89.7 minutes [SD: 34.3], p = 0.022), procedural times were similar (p = 0.257). True ID was 21.97 mm (SD: 1.79) in RPDs and 20.15 mm (SD: 1.70) in CB (p < 0.001).RPDs and CB resulted in comparable mean gradients (12.8 mm Hg [SD: 6.4] vs. 13.8 mm Hg [SD: 5.6]; p = 0.387) and rate of paravalvular regurgitation. There were no differences in the rates of pacemaker implantation and mortality.In a subanalysis of RPDs, mean gradient was 15.48 mm Hg (SD: 7.51) in Perceval (n = 21) and 10.79 mm Hg (SD: 4.78) in Intuity (n = 33; p = 0.010). Conclusions RPDs provided comparable hemodynamic performance, although implanted valves were larger in true ID. Whether this provides superior hemodynamic performance during exercise and longer durability needs further investigation. Among RPDs, the Intuity valve provided lower mean gradients at rest than Perceval valve.

Sutureless valve and rapid deployment valves: a systematic review and meta-analysis of comparative studies

“…After full review, seven papers met the pre-determined inclusion criteria (4,5,8-12) ( Figure S2) Table 2). Overall, all-cause mortality was reported in 3,998 patients (2,351 SURD, 1,647 RDV) across all seven studies (4,5,(8)(9)(10)(11)(12). In the overall studied population, there were 95 deaths (2.4%) with 54 deaths (2.3%) in the SURD group and 41 deaths (2.5%) in the RDV group.…”

“…Hospital LOS was reported in 3,165 patients (2,077 SURD, 1,088 RDV) across six studies (5,(8)(9)(10)(11)(12). There was no significant difference in the in the hospital LOS for patients receiving the two valve types (P=0.33; I 2 =96%) ( Figure S15).…”

“…If this study is excluded, CPB times remain shorter for patients receiving SURD by 8.8 minutes (95% CI: 6.0-11.7; P<0.001; I 2 =23%). ICU LOS was reported in 3,165 patients (2,077 SURD, 1,088 RDV) across six studies (5,(8)(9)(10)(11)(12). There was a trend towards a shorter ICU LOS with SURD, although this did not reach statistical significance (95% CI: 2.26-0.01; P=0.05; I 2 =84%) ( Figure S14).…”

Direct comparison of rapid deployment versus sutureless aortic valve replacement: a meta-analysis

“…Because the SU valve comes in 4 sizes (small, medium, large and extralarge) and the RD valves has 5 sizes (19, 21, 23, 25 and 27 mm), AVMPG after surgery was compared between RDAVR and SUAVR with conservative matchings: a 19 mm RD valve vs. a small SU valve, 21 mm vs. medium, 23 mm vs. large and 25 mm vs. extralarge; and with liberal matchings: 21 mm vs. small, 23 mm vs. medium, 25 mm vs. large and 27 mm vs. extralarge. In one study (13) where the SD of AVMPG in each valve size was not provided, the missing SD was substituted with the overall SD in each group.…”

“…Among these articles, 1,977 publications were excluded because they clearly did not fulfill the selection criteria based on the title and abstract. Full manuscripts of the remaining 47 articles were reviewed, and 8 publications (5,11,13,(15)(16)(17)(18)(19) were included in this study (Figure 1). Because two studies (11,15) were from the same multinational registry, one study (11) was selected for baseline-data and outcome analyses.…”