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Outcomes of transfemoral balloon expandable transcatheter aortic valve implantation: Comparison of two subsequent valve generations
Author(s) -
Schymik Gerhard,
Wendler Olaf,
Hengstenberg Christian,
Ohlmann Patrick,
Gilard Martine,
Digne Franck,
Souteyrand Geraud,
Letocart Vincent,
Belle Eric,
Bramlage Peter,
Tarantini Giuseppe
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28621
Subject(s) - medicine , cardiology , hazard ratio , stroke (engine) , balloon , proportional hazards model , aortic valve , mortality rate , propensity score matching , surgery , confidence interval , mechanical engineering , engineering
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.