Rapid Deployment (Sutureless) vs. Conventional SAVR
How does the use of rapid deployment (RD) surgical aortic valve replacement (SAVR) compare with conventional bioprosthetic SAVR?
A total of 22,062 patients who underwent isolated SAVR using conventional or RD bioprostheses between 2011 and 2015 were enrolled in the German Aortic Valve Registry (GARY), a prospective, collaborative, multicenter all-comers registry that was initiated to analyze contemporary outcomes after invasive treatment of aortic valve stenosis. Baseline, procedural, and in-hospital outcomes were analyzed for conventional and RD procedures before and after using 1:1 propensity-score matching (1,021 matched pairs). In addition, three commercially available RD valves (3f Enable [Medtronic], Intuity [Edwards], and Perceval [Sorin/LivaNova]) were compared with each other.
A total of 20,937 patients underwent isolated SAVR using a conventional bioprosthesis, and 1,125 patients underwent isolated SAVR with an RD valve. Using 1,021 propensity-matched pairs, patients treated with an RD valve had significantly lower procedural time (161 [138-195] vs. 150 [126-177] minutes, p < 0.001), cardiopulmonary bypass time (85 [71-105] vs. 69 [56-87] minutes, p < 0.001), and aortic cross clamp time (62 [56-76] vs. 44 [34-56] minutes, p < 0.001); had significantly higher rates of pacemaker implantation (4.1 vs. 9.1%, p < 0.001) and disabling stroke (1.2 vs. 2.4%, p = 0.04); and similar rates of in-hospital mortality (1.8 vs. 2.2%, p = 0.52). Comparison of the three RD valves revealed statistically nonsignificant differences in pacemaker rates (11.8% [3f Enable] vs. 8.1% [Intuity] vs. 13.7% [Perceval], p not reported), but statistically significantly differences in postoperative transvalvular gradients (mean gradient ≥20 mm Hg 8.9% [3f Enable] vs. 1.7% [Intuity] vs. 21.1% [Perceval], p < 0.001).
Data from this large all-comers database suggest that the incidence of pacemaker implantation and disabling stroke was higher with RD valves compared to conventional bioprosthetic SAVR, with no demonstrated beneficial impact on in-hospital mortality. The three RD valves had nonsignificant trends toward different rates of pacemaker implantation, and statistically significant differences in the rates of high postoperative gradients.
Rapid deployment (or so-called ‘sutureless’) AVR is, in a way, a hybrid between SAVR and TAVR, allowing for a relatively rapid deployment of an aortic bioprosthesis at the time of SAVR. If there is a net reduction in perioperative risk, it was not demonstrated in this large registry. Although it is possible that a subset of patients might benefit from the technology, higher rates of pacemaker implantation and disabling stroke raise concern about use of these devices in a broader cardiac surgical population.
Keywords: Aortic Valve Stenosis, Bioprosthesis, Cardiac Surgical Procedures, Cardiopulmonary Bypass, Heart Valve Diseases, Heart Valve Prosthesis, Hospital Mortality, Pacemaker, Artificial, Stroke, Transcatheter Aortic Valve Replacement
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