Immediate outcome after sutureless versus transcatheter aortic valve replacement

Abstract

The aim of this study was to compare the immediate outcome of patients undergoing transcatheter (TAVI) versus surgical aortic valve replacement with the sutureless Perceval bioprosthesis (SU-AVR). This is a retrospective multicenter analysis of 773 patients who underwent either TAVI (394 patients, mean age, 80.8 ± 5.5 years, mean EuroSCORE II 5.6 ± 4.9 %) or SU-AVR (379 patients, 77.4 ± 5.4 years, mean EuroSCORE II 4.0 ± 3.9 %) with or without concomitant myocardial revascularization. Data on SU-AVRs were provided by six European institutions (Belgium, Finland, Germany, Italy and Sweden) and data on TAVIs were provided by a single institution (Catania, Italy). In-hospital mortality was 2.6 % after SU-AVR and 5.3 % after TAVI (p = 0.057). TAVI was associated with a significantly high rate of mild (44.0 vs. 2.1 %) and moderate-severe paravalvular regurgitation (14.1 vs. 0.3 %, p < 0.0001) as well as the need for permanent pacemaker implantation (17.3 vs. 9.8 %, p = 0.003) compared with SU-AVR. The analysis of patients within the 25th and 75th percentiles interval of EuroSCORE II, i.e., 2.1-5.8 %, confirmed the findings of the overall series. One-to-one propensity score-matched analysis resulted in 144 pairs with similar baseline characteristics and operative risk. Among these matched pairs, in-hospital mortality (6.9 vs. 1.4 %, p = 0.035) was significantly higher after TAVI. SU-AVR with the Perceval prosthesis in intermediate-risk patients is associated with excellent immediate survival and is a valid alternative to TAVI in these patients.

Clinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis

“…This cannot prevent to notice that costs associated to patients treated with Perceval are significantly lower compared with patients treated with TAVI, and in the meanwhile, longer term clinical outcomes showed lower mortality for patients treated with Perceval compared with patients in TAVI group presenting paravalvular leak. This outcome agrees with other studies such as that by Biancari et al, 10 which reported a mortality rate for the matched analysis equal to 6.9% for TAVI and 1.4% for Perceval: this outcome is probably driven by a significantly different rate of mild-to-severe paravalvular leak for TAVI compared with Perceval, 14.1% for TAVI group versus 0.3% for Perceval cohort. 10 Even if not in the condition to fullfledged cost-effectiveness analysis, for the reasons laid previously around different time horizons for costs and effectiveness, a beneficial cost-effectiveness profile in favor of Perceval could be reasonably expected: this may be one of the outcomes of future studies that we are being planning in our institution.…”

“…A mean cost of the device was calculated from the observations included in this data set, starting from 2009 to 2013. TAVI mean cost is threefold compared with Perceval mean cost, and this is in line with the figures reported by Biancari et al 10 where the device cost difference between TAVI and Perceval was even higher.…”

Decellularized aortic conduits: could their cryopreservation affect post-implantation outcomes? A morpho-functional study on porcine homografts

“…Valve replacement surgery is the leading therapeutic option, with approximately 300,000 valve prostheses required per year, worldwide [1]. The European Homograft Bank has recently reported a total of 4516 allograft valve implantations during the last 20 years for the repair or reconstruction of diseased ventricular outflow and inflow tracts (1391 aortic, 2620 pulmonary, and 48 mitral) [2].…”

It’s not fair to compare transcatheter aortic valve implantation with surgical replacement

“…2 Nonetheless, constitutional complications of TAVR have been surfacing and limiting its use such as embolization of calcified debris and consequent cerebral infarction; complete AV block and need of pacemaker insertion; paravalvular leakage and its effect on longterm survival; coronary ostium closure and even aortic rupture. 3,4 Up to 42.5% complete AV block, 15% moderate-to-severe paravalvular leak, and 84% new cerebral infarction have been reported after TAVR. 5 Despite higher complication rates in terms of major adverse cardiac and cerebrovascular events (MACCE) among TAVR patients; early studies those compared SAVR and TAVR revealed that TAVR is not inferior to surgical AVR in mortality rates.…”

“…Comparative reports between sutureless valves and TAVR in intermediate and high risk patients have shown lower rate of perioperative complications in terms of MACCE and enhanced survival at 24-month follow-up with sutureless valves. 3,13 We can easily assume that the results would be even better if we can add mini CBP techniques into these technology. Consequently, sutureless aortic bioprostheses has been situated as an alternative to conventional surgical AVR or TAVR in elderly and high-risk patients.…”