Back to Search
Start Over
3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement
- Source :
- Journal of the American College of Cardiology. 67:2565-2574
- Publication Year :
- 2016
- Publisher :
- Elsevier BV, 2016.
-
Abstract
- In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery.This study sought to determine whether this clinical benefit was sustained over time.Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure.A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p0.001). There was no clinical evidence of valve thrombosis in either group.Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (Safety and Efficacy Study of the Medtronic CoreValve(®) System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
- Subjects :
- Male
Reoperation
Aortic valve
Pacemaker, Artificial
medicine.medical_specialty
medicine.medical_treatment
Aortic Valve Insufficiency
Hemodynamics
030204 cardiovascular system & hematology
Transcatheter Aortic Valve Replacement
03 medical and health sciences
0302 clinical medicine
Valve replacement
Aortic valve replacement
Internal medicine
medicine
Humans
Prospective Studies
030212 general & internal medicine
Prospective cohort study
Stroke
Aged, 80 and over
Endocarditis
business.industry
Aortic Valve Stenosis
Acute Kidney Injury
medicine.disease
United States
Surgery
Hospitalization
Stenosis
medicine.anatomical_structure
Echocardiography
Aortic Valve
Aortic valve stenosis
Cardiology
Female
Stents
Cardiology and Cardiovascular Medicine
business
Follow-Up Studies
Subjects
Details
- ISSN :
- 07351097
- Volume :
- 67
- Database :
- OpenAIRE
- Journal :
- Journal of the American College of Cardiology
- Accession number :
- edsair.doi.dedup.....a5f9cd2a7e773f703647d1389b0ce64f