Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial.
Citation: Journal of Thoracic & Cardiovascular Surgery. 150(3):557-68.e11, 2015 Sep.PMID: 26238287Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Randomized Controlled TrialSubject headings: *Aortic Valve Stenosis/su [Surgery] | *Aortic Valve/su [Surgery] | *Health Care Rationing | *Heart Valve Prosthesis Implantation | *Patient Selection | *Process Assessment (Health Care) | Aged | Aged, 80 and over | Aortic Valve Stenosis/di [Diagnosis] | Aortic Valve Stenosis/mo [Mortality] | Benchmarking | Female | Health Care Rationing/st [Standards] | Heart Valve Prosthesis Implantation/ae [Adverse Effects] | Heart Valve Prosthesis Implantation/mo [Mortality] | Heart Valve Prosthesis Implantation/st [Standards] | Hospital Mortality | Humans | Kaplan-Meier Estimate | Male | Medical Futility | Postoperative Complications/mo [Mortality] | Process Assessment (Health Care)/st [Standards] | Risk Assessment | Risk Factors | Time Factors | Treatment Outcome | United StatesYear: 2015Local holdings: Available online from MWHC library: 1994 - present, Available in print through MWHC library: 1999 - 2006ISSN:- 0022-5223
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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Journal Article | MedStar Authors Catalog | Article | 26238287 | Available | 26238287 |
Available online from MWHC library: 1994 - present, Available in print through MWHC library: 1999 - 2006
CONCLUSIONS: PARTNER selection criteria for surgical aortic valve replacement, with a few caveats, may be more appropriate, realistic indications for surgery than those of the past, reflecting contemporary surgical management of severe aortic stenosis in high-risk patients at experienced sites.Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
METHODS: From May 2007 to October 2009, 699 patients with high surgical risk, aged 84 +/- 6.3 years, were randomized in PARTNER-IA; 313 patients underwent surgical aortic valve replacement. Median follow-up was 2.8 years. Survival for therapy without aortic valve replacement used 181 PARTNER-IB patients.
OBJECTIVES: The study objectives were to (1) compare the safety of high-risk surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves (PARTNER) I trial with Society of Thoracic Surgeons national benchmarks; (2) reference intermediate-term survival to that of the US population; and (3) identify subsets of patients for whom aortic valve replacement may be futile, with no survival benefit compared with therapy without aortic valve replacement.
RESULTS: Operative mortality was 10.5% (expected 9.3%), stroke 2.6% (expected 3.5%), renal failure 5.8% (expected 12%), sternal wound infection 0.64% (expected 0.33%), and prolonged length of stay 26% (expected 18%). However, calibration of observed events in this relatively small sample was poor. Survival at 1, 2, 3, and 4 years was 75%, 68%, 57%, and 44%, respectively, lower than 90%, 81%, 73%, and 65%, respectively, in the US population, but higher than 53%, 32%, 21%, and 14%, respectively, in patients without aortic valve replacement. Risk factors for death included smaller body mass index, lower albumin, history of cancer, and prosthesis-patient mismatch. Within this high-risk aortic valve replacement group, only the 8% of patients with the poorest risk profiles had estimated 1-year survival less than that of similar patients treated without aortic valve replacement.
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