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Clinical outcome and paravalvular leakage of the new balloon‐expandable Edwards Sapien 3 valve in comparison to its predecessor model (Edwards Sapien XT) in patients undergoing transfemoral aortic valve replacement
Author(s) -
Bocksch Wolfgang,
Grossmann Benita,
Geisler Tobias,
Steeg Martin,
Droppa Michal,
Jorbenadze Rezo,
Haap Michael,
Gawaz Meinrad,
FatehMoghadam Suzanne
Publication year - 2016
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.26562
Subject(s) - medicine , cardiology , balloon , valve replacement , stenosis , regurgitation (circulation) , aortic valve , fluoroscopy , surgery
Objectives The aim of this study was to compare the 30‐day procedural, clinical and echocardiographic outcome of the new balloon‐expandable Edwards Sapien 3 (ES3) valve with the Edwards Sapien XT (ESXT). Background : Post‐implant paravalvular leaks (PVL) after transfemoral aortic valve replacement (TAVR) resulting in residual aortic regurgitation (AR) are a major limitation for long term outcome. New TAVR‐devices have to eliminate this problem. Methods Transfemoral TAVR was performed in 209 consecutive intermediate‐high‐risk surgical patients (pts) with symptomatic aortic stenosis (ESXT n = 102, ES3 n = 107). Transthoracic echocardiography (TTE) and 3‐dimensional computed tomography were used for valve size selection. Primary endpoint of the study was none/trace AR derived by TTE 30‐days after TAVR. Results All pts underwent successfully TAVR with a combined device success of 100/102 (99%) in ESXT and 107/107 (100%) in ES3 pts. Fluoroscopy time (ESXT 11.8 ± 0.5 min vs. ES3 10.0 ± 0.5 min, P = 0.003) and contrast (ESXT 188.9 ± 5.6 mL vs. ES3 170.4 ± 4.7 mL, P = 0.04) were significantly lower in ES3 patients. 30‐day clinical events did not differ. Transvalvular mean pressure gradients were significantly reduced to 7.4 ± 0.8 mmHg after ESXT and to 10.1± 0.4 mmHg after ES3 implantation. After 30 days none/trace AR was found in 34.3% ( n = 35) of all ESXT pts in contrast to 89.7% ( n = 96) of all ES3 patients. Moderate‐to‐severe AR was found rarely (ESXT 2.9% vs. ES3 0%, P = 0.073). Conclusions Although there was no significant difference in 30 day mortality, the newer ES3 valve reduced significantly residual paravalvular leakage. © 2016 Wiley Periodicals, Inc.