Outcomes of transfemoral balloon expandable transcatheter aortic valve implantation: Comparison of two subsequent valve generations. Issue 4 (3rd December 2019)

• Record Type: Journal Article
• Authors: Schymik, Gerhard; Wendler, Olaf; Hengstenberg, Christian; Ohlmann, Patrick; Gilard, Martine; Digne, Franck; Souteyrand, Geraud; Letocart, Vincent; van Belle, Eric; Bramlage, Peter; Tarantini, Giuseppe
• Is Part Of: Catheterization and cardiovascular interventions. Volume 96:Issue 4(2020)
• Page Start: 930
• Page End: 939
• Publication Date: 2019-12-03
• Subjects: pacemaker implantation -- paravalvular leakage (PVL) -- SAPIEN 3 -- SAPIEN XT -- transcatheter aortic valve implantation (TAVI); Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.28621
• Languages: English
• ISSNs: 1522-1946

Abstract

Abstract: Background: The SAPIEN 3 (S3) addresses several limitations of the SAPIEN XT (SXT) for the performance of transfemoral (TF‐) balloon expandable transcatheter aortic valve implantation (TAVI). Objectives: We aimed to determine whether their altered features translate into improved outcomes in a real‐world TF‐TAVI patient population. Methods: Data for 3, 314 patients were extracted from the European registries SOURCE‐XT and SOURCE‐3. Patients were propensity‐score (PS) matched ( n = 1, 169/group). Results: In the PS matched comparison, device success was higher in the S3 (99.2%) compared to the SXT group (98.2%; p = .04). S3 patients experienced a lower rate of procedural death (0.7 vs. 2.6%; p = .0004), moderate/severe paravalvular leakage (PVL; 1.4 vs. 5.5%; p < .0001), and procedure‐related stroke (1.2 vs. 2.4%; p = .04) while higher rates of mean aortic valve gradients ≥20 mmHg, and new permanent pacemaker implantations were seen. At 30 days a lower rate of all‐cause mortality was seen (2.1% vs. 4.3%; p = .003), which was preserved after 1 year (10.7% vs. 14.9%; p = .002). A Cox regression predicting 1‐year mortality resulted in a hazard ratio of 0.684 in favor of S3 ( p = .0026). The same was true of stroke (2.8% vs. 5.7%; p = .0007), and moderate/severe PVL (2.7 vs. 7.3%; p = .0002) at 1 year. The rate of new pacemaker implantations (13.6% vs. 9.5%; p = .001) and NYHA III/IV (12.8 vs. 8.6%; p = .004) was higher with the S3. Conclusions: The improved features of the S3 appear to translate into improved survival and reduced rates of adverse complications, with the exception of a higher rate of new pacemaker implantations.