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Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Balloon-Expandable Transcatheter Heart Valve: A Single-Center Experience.
- Source :
-
JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2015 Dec 21; Vol. 8 (14), pp. 1809-16. - Publication Year :
- 2015
-
Abstract
- Objectives: Evaluation of 30-day outcomes after transcatheter aortic valve replacement (TAVR) with the novel balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) emphasizing the updated Valve Academic Research Consortium (VARC-2) criteria.<br />Background: Preliminary data on clinical performance with the S3 THV are promising. However, information regarding 30-day outcome is limited.<br />Methods: A total of 250 consecutive patients undergoing transfemoral TAVR with the S3 THV at our center were enrolled, and outcomes according to VARC-2 criteria were analyzed at 30 days.<br />Results: The mean age was 81.0 ± 6.2 years, median logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) and Society of Thoracic Surgeons score were 12.1% and 4.4%, respectively. VARC-2-defined device success was achieved in 244 patients (97.6%); moderate paravalvular leakage developed in 5 patients (2.0%). One patient (0.4%) died of a noncardiac cause and 8 patients (3.2%) had a stroke. Life-threatening bleeding and major vascular complications occurred in 12 (4.8%) and 9 (3.6%) of the patients, respectively. From discharge to 30 days, 5 patients (2.0%) were hospitalized due to valve-related symptoms or worsening of heart failure. The VARC-2 composite early safety endpoint was observed in 25 patients (10.0%). Permanent pacemaker implantation rate at 30 days was 15.2%. Myocardial infarction, coronary obstruction requiring intervention, valve-related dysfunction, and endocarditis were not observed.<br />Conclusions: We found very good 30-day results using the novel S3 THV with a low rate of clinical events according to VARC-2 criteria. The S3 THV is associated with high procedural success and favorable early safety profile. The need for pacemaker implantations appears to be more frequent than with its predecessor.<br /> (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged, 80 and over
Aortic Valve Stenosis diagnosis
Echocardiography
Female
Femoral Artery
Follow-Up Studies
Germany epidemiology
Humans
Incidence
Male
Multidetector Computed Tomography
Prosthesis Design
Retrospective Studies
Survival Rate trends
Time Factors
Treatment Outcome
Aortic Valve Stenosis surgery
Catheterization, Peripheral methods
Heart Valve Prosthesis
Postoperative Complications epidemiology
Transcatheter Aortic Valve Replacement methods
Subjects
Details
- Language :
- English
- ISSN :
- 1876-7605
- Volume :
- 8
- Issue :
- 14
- Database :
- MEDLINE
- Journal :
- JACC. Cardiovascular interventions
- Publication Type :
- Academic Journal
- Accession number :
- 26718512
- Full Text :
- https://doi.org/10.1016/j.jcin.2015.08.014