MedStar Authors catalog › Details for: Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy.
Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy. Journal: Circulation.ISSN: 0009-7322.UI/PMID: 25205802.Subject(s): Aged | Aged, 80 and over | Aortic Valve Insufficiency/mo [Mortality] | Aortic Valve Insufficiency/th [Therapy] | *Aortic Valve Stenosis/mo [Mortality] | *Aortic Valve Stenosis/th [Therapy] | Cardiac Catheterization | Female | Follow-Up Studies | Hemodynamics | Hemorrhage/et [Etiology] | Hemorrhage/mo [Mortality] | Humans | Kaplan-Meier Estimate | Male | Outcome Assessment (Health Care) | Patient Readmission/sn [Statistics & Numerical Data] | Proportional Hazards Models | Stroke/et [Etiology] | Stroke/mo [Mortality] | Transcatheter Aortic Valve Replacement/ae [Adverse Effects] | *Transcatheter Aortic Valve Replacement/mt [Methods] | *Transcatheter Aortic Valve Replacement/mo [Mortality] | Treatment OutcomeInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Comparative Study | Journal Article | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tOnline resources: Click here to access online Digital Object Identifier: http://dx.doi.org/10.1161/CIRCULATIONAHA.114.009834 (Click here) Abbreviated citation: Circulation. 130(17):1483-92, 2014 Oct 21.Local Holdings: Available online from MWHC library: 1950 - present, Available in print through MWHC library: 1999 - 2006.Abstract: BACKGROUND: The long-term outcomes of transcatheter aortic valve replacement (TAVR) in inoperable patients with severe aortic stenosis remain unknown.Abstract: METHODS AND RESULTS: In the Placement of Aortic Transcatheter Valves (PARTNER) study, 358 patients were randomly assigned to TAVR or standard therapy. We report the 3-year outcomes on these patients, and the pooled outcomes for all randomly assigned inoperable patients (n=449) in PARTNER, as well, including the randomized portion of the continued access study (n=91). The 3-year mortality rate in the TAVR and standard therapy groups was 54.1% and 80.9%, respectively (P<0.001; hazard ratio, 0.53; 95% confidence interval, 0.41-0.68; P<0.001). In survivors, there was significant improvement in New York Heart Association functional class sustained at 3 years. The cumulative incidence of strokes at 3-year follow-up was 15.7% in TAVR patients versus 5.5% in patients undergoing standard therapy (hazard ratio, 2.81; 95% confidence interval, 1.26-6.26; P=0.012); however, the composite of death or strokes was significantly lower after TAVR versus standard therapy (57.4% versus 80.9%, P<0.001; hazard ratio, 0.60; 95% confidence interval, 0.46-0.77; P<0.001). Echocardiography showed a sustained increase in aortic valve area and decrease in transvalvular gradient after TAVR. Analysis of the 449 pooled randomly assigned patients (TAVR, n=220; standard therapy, n=229) demonstrated significant improvement in all-cause mortality and functional status during early and 3-year follow-up. The results of the pooled cohort were similar to the results obtained from the pivotal PARTNER trial.Abstract: CONCLUSIONS: TAVR resulted in better survival and functional status in inoperable patients with severe aortic stenosis with durable hemodynamic benefit on long-term follow-up. However, high residual mortality, even in successfully treated TAVR patients, highlights the need for more strategic patient selection.Abstract: CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.Copyright � 2014 American Heart Association, Inc.