Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial.
Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial.
- 2015
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.
English
0022-5223
*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 States
MedStar Heart & Vascular Institute
Journal Article
Multicenter Study
Randomized Controlled Trial
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.
English
0022-5223
*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 States
MedStar Heart & Vascular Institute
Journal Article
Multicenter Study
Randomized Controlled Trial