MedStar Authors catalog › Details for: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.
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Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.

by Thourani, Vinod H.
Citation: New England Journal of Medicine. 380(18):1695-1705, 2019 05 02..Journal: The New England journal of medicine.Published: ; 2019ISSN: 0028-4793.Full author list: Mack MJ; Leon MB; Thourani VH; Makkar R; Kodali SK; Russo M; Kapadia SR; Malaisrie SC; Cohen DJ; Pibarot P; Leipsic J; Hahn RT; Blanke P; Williams MR; McCabe JM; Brown DL; Babaliaros V; Goldman S; Szeto WY; Genereux P; Pershad A; Pocock SJ; Alu MC; Webb JG; Smith CR; PARTNER 3 Investigators; the PARTNER 3 Investigators.UI/PMID: 30883058.Subject(s): Aged | *Aortic Valve/su [Surgery] | Aortic Valve Stenosis/co [Complications] | Aortic Valve Stenosis/mo [Mortality] | *Aortic Valve Stenosis/su [Surgery] | Atrial Fibrillation/et [Etiology] | Female | *Heart Valve Prosthesis | Heart Valve Prosthesis Implantation/ae [Adverse Effects] | *Heart Valve Prosthesis Implantation/mt [Methods] | Humans | Kaplan-Meier Estimate | Length of Stay | Male | *Patient Readmission/sn [Statistics & Numerical Data] | *Postoperative Complications/ep [Epidemiology] | Prosthesis Design | Risk Factors | Stroke/ep [Epidemiology] | Stroke/et [Etiology] | Transcatheter Aortic Valve Replacement/ae [Adverse Effects] | *Transcatheter Aortic Valve Replacement/is [Instrumentation]Institution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal Article | Research Support, Non-U.S. Gov'tOnline resources: Click here to access online Digital Object Identifier: https://dx.doi.org/10.1056/NEJMoa1814052 (Click here) Abbreviated citation: N Engl J Med. 380(18):1695-1705, 2019 05 02.Local Holdings: Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - present.Abstract: BACKGROUND: Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk.Abstract: METHODS: We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population.Abstract: RESULTS: At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation.Abstract: CONCLUSIONS: Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).Abstract: Copyright (c) 2019 Massachusetts Medical Society.

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