Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial.

MedStar author(s):
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
Name of journal: The Journal of thoracic and cardiovascular surgeryAbstract: 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.All authors: Bavaria JE, Blackstone EH, Cohen DJ, Cohn LH, Corso PJ, Ehrlinger J, Guyton RA, Kapadia S, Leon MB, Lytle BW, Mack M, McCarthy PM, Miller DC, Placement of Aortic Transcatheter Valves Trial Investigators, Rajeswaran J, Schaff HV, Smith CR, Suri RM, Svensson LG, Szeto WY, Thourani VH, Tuzcu EM, Webb JG, Williams MRFiscal year: FY2016Digital Object Identifier: Date added to catalog: 2016-05-24
Holdings
Item type Current library Collection Call number Status Date due Barcode
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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