Abstract
BackgroundThere is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis.MethodsIn a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality.ResultsA total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Four-year rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts.ConclusionsThe Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome.Trial registrationClinicalTrials.gov Identifier: NCT03385915.
Highlights
There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR)
A meta-analysis of randomized controlled trials recently showed that TAVR is associated with significant reduction of all-cause mortality, a lower risk for stroke, atrial fibrillation and bleeding, but a higher risk for permanent pacemaker implantation and major vascular complications at 2 years compared to SAVR [8]
The main findings of our study are the following: 1) patients treated for severe aortic stenosis (AS) with the transfemoral TAVR with the Sapien 3 bioprosthesis had similar mid-term mortality compared to patients who underwent SAVR with the Perimount Magna Ease bioprosthesis; 2) the risk for coronary revascularization, repeat aortic valve intervention and prosthetic valve endocarditis at 4 years was low and similar with both bioprostheses; 3) the Sapien 3 was associated with a higher cumulative rate of permanent pacemaker implantation than the Perimount Magna Ease bioprosthesis; 4) procedural safety in terms of stroke, atrial fibrillation, kidney injury and bleeding favoured TAVR, whilst lower rate of major vascular complications was observed with SAVR
Summary
There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). Transcatheter aortic valve replacement (TAVR) with balloon-expandable [1,2,3] and self-expanding [4,5,6,7] bioprosthesis has proven its efficacy and safety compared to surgical aortic valve replacement (SAVR) in the treatment of aortic stenosis (AS) regardless of the operative risk. The indications for TAVR are expanding, but it is controversial whether TAVR should be performed on a larger scale because of limited data on the long-term outcome and valve durability of TAVR prostheses compared to SAVR prostheses. It is important to compare the outcomes of each TAVR prosthesis separately against SAVR prostheses with proven long-term durability [17, 18]
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