Two-year outcomes after transcatheter or surgical aortic-valve replacement.

MedStar author(s):
Citation: New England Journal of Medicine. 366(18):1686-95, 2012 May 3.PMID: 22443479Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Aortic Valve Stenosis/su [Surgery] | *Aortic Valve/su [Surgery] | *Cardiac Catheterization | *Heart Valve Prosthesis Implantation/mt [Methods] | Anticoagulants/ae [Adverse Effects] | Anticoagulants/tu [Therapeutic Use] | Aortic Valve Insufficiency/cl [Classification] | Aortic Valve Insufficiency/et [Etiology] | Aortic Valve Stenosis/co [Complications] | Aortic Valve Stenosis/mo [Mortality] | Aortic Valve Stenosis/th [Therapy] | Aortic Valve/us [Ultrasonography] | Cardiac Catheterization/ae [Adverse Effects] | Female | Follow-Up Studies | Heart Valve Prosthesis Implantation/ae [Adverse Effects] | Heart Valve Prosthesis | Hemorrhage/et [Etiology] | Heparin/ae [Adverse Effects] | Heparin/tu [Therapeutic Use] | Humans | Kaplan-Meier Estimate | Male | Platelet Aggregation Inhibitors/ae [Adverse Effects] | Platelet Aggregation Inhibitors/tu [Therapeutic Use] | Postoperative Complications | Prosthesis Failure | Stroke/et [Etiology] | Survival Rate | Treatment OutcomeLocal 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: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits.CONCLUSIONS: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation.RESULTS: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001).All authors: Akin JJ, Anderson WN, Dewey TM, Douglas PS, Fischbein M, Fontana GP, Greason KL, Hahn RT, Kodali SK, Leon MB, Lim S, Makkar RR, Malaisrie SC, PARTNER Trial Investigators, Pichard AD, Smith CR, Svensson LG, Szeto WY, Teirstein PS, Thourani VH, Wang D, Webb JG, Whisenant B, Williams MR, Zajarias ADigital Object Identifier: Date added to catalog: 2013-09-17
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article Available 22443479

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

BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits.

CONCLUSIONS: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation.

RESULTS: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001).

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