Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.

MedStar author(s):
Citation: New England Journal of Medicine. 382(9), 2020 02 27.PMID: 31995682Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Research Support, Non-U.S. Gov'tSubject headings: *Aortic Valve Stenosis/su [Surgery] | *Heart Valve Prosthesis | *Heart Valve Prosthesis Implantation/mt [Methods] | *Transcatheter Aortic Valve Replacement | Aged | Aged, 80 and over | Aortic Valve Insufficiency/et [Etiology] | Aortic Valve Insufficiency/pp [Physiopathology] | Aortic Valve Stenosis/co [Complications] | Aortic Valve Stenosis/dg [Diagnostic Imaging] | Aortic Valve Stenosis/mo [Mortality] | Aortic Valve/dg [Diagnostic Imaging] | Aortic Valve/su [Surgery] | Cohort Studies | Echocardiography | Female | Health Status | Humans | Incidence | Intention to Treat Analysis | Kaplan-Meier Estimate | Male | Multivariate Analysis | Postoperative Complications/mo [Mortality] | Risk Factors | Stroke/ep [Epidemiology] | Stroke/et [Etiology] | Treatment OutcomeYear: 2020Local holdings: Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - presentISSN:
  • 0028-4793
Name of journal: The New England journal of medicineAbstract: BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.). Copyright (c) 2020 Massachusetts Medical Society.METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke.RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery.All authors: Alu MC, Babaliaros V, Brown DL, Cohen DJ, Dewey TM, Fearon WF, Greason KL, Hahn RT, Herrmann HC, Hodson RW, Jaber WA, Kapadia S, Kereiakes DJ, Kodali SK, Leon MB, Mack MJ, Makkar RR, Miller DC, PARTNER 2 Investigators, Pibarot P, Rogers E, Russo MJ, Satler L, Smith CR, Svensson LG, Szeto WY, Thourani VH, Trento A, Webb JG, Wheeler J, Whisenant BK, Williams MR, Xu K, Yoon SH, Zajarias AFiscal year: FY2020Digital Object Identifier: Date added to catalog: 2020-02-10
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 31995682 Available 31995682

Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - present

BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.

CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.). Copyright (c) 2020 Massachusetts Medical Society.

METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke.

RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery.

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