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

Wilson Y Szeto; Lars G Svensson; Jeevanantham Rajeswaran; John Ehrlinger; Rakesh M Suri; Craig R Smith; Michael Mack; D Craig Miller; Patrick M McCarthy; Joseph E Bavaria; Lawrence H Cohn; Paul J Corso; Robert A Guyton; Vinod H Thourani; Bruce W Lytle; Mathew R Williams; John G Webb; Samir Kapadia; E Murat Tuzcu; David J Cohen; Hartzell V Schaff; Martin B Leon; Eugene H Blackstone; Placement of Aortic Transcatheter Valves Trial Investigators

doi:10.1016/j.jtcvs.2015.05.073

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

J Thorac Cardiovasc Surg. 2015 Sep;150(3):557-68.e11. doi: 10.1016/j.jtcvs.2015.05.073. Epub 2015 Jun 30.

Authors

Wilson Y Szeto¹, Lars G Svensson², Jeevanantham Rajeswaran³, John Ehrlinger⁴, Rakesh M Suri⁵, Craig R Smith⁶, Michael Mack⁷, D Craig Miller⁸, Patrick M McCarthy⁹, Joseph E Bavaria¹⁰, Lawrence H Cohn¹¹, Paul J Corso¹², Robert A Guyton¹³, Vinod H Thourani¹³, Bruce W Lytle⁵, Mathew R Williams¹⁴, John G Webb¹⁵, Samir Kapadia¹⁶, E Murat Tuzcu¹⁶, David J Cohen¹⁷, Hartzell V Schaff¹⁸, Martin B Leon¹⁹, Eugene H Blackstone²⁰; Placement of Aortic Transcatheter Valves Trial Investigators

Affiliations

¹ Division of Cardiovascular Surgery, University of Pennsylvania Health System, Philadelphia, Pa.
² Placement of Aortic Transcatheter Valves Publications Office, Cleveland, Ohio; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.
³ Placement of Aortic Transcatheter Valves Publications Office, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
⁴ Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
⁵ Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.
⁶ Department of Surgery, Columbia University Medical Center/New York Presbyterian Hospital, New York, NY.
⁷ Cardiovascular Surgery, Baylor Scott & White Health, Plano, Tex.
⁸ Department of Cardiovascular Surgery, Falk Cardiovascular Research Center, Stanford University School of Medicine, Stanford, Calif.
⁹ Cardiac Surgery, Northwestern Memorial Hospital, Chicago, Ill.
¹⁰ Division of Thoracic Surgery, University of Pennsylvania Health System, Philadelphia, Pa.
¹¹ Department of Surgery, Brigham and Women's Hospital, Boston, Mass.
¹² Department of Cardiac Surgery, Medstar Washington Hospital Center, Washington, DC.
¹³ Department of Surgery, Division of Cardiothoracic Surgery, Emory University Hospital, Atlanta, Ga.
¹⁴ Department of Cardiothoracic Surgery & Department of Medicine, New York University, Langone Medical Center, New York, NY.
¹⁵ Division of Cardiology, Department of Medicine, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
¹⁶ Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
¹⁷ Division of Cardiology, St. Luke's Mid-America Heart Institute, Kansas City, Mo.
¹⁸ Cardiac Surgery, Mayo Clinic, Rochester, Minn.
¹⁹ Placement of Aortic Transcatheter Valves Publications Office, Cleveland, Ohio; Center for Interventional Vascular Therapy, Division of Cardiology, Department of Medicine, Columbia University Medical Center/New York Presbyterian Hospital, New York, NY.
²⁰ Placement of Aortic Transcatheter Valves Publications Office, Cleveland, Ohio; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address: [email protected].

PMID: 26238287
DOI: 10.1016/j.jtcvs.2015.05.073

Abstract

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.

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.

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.

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.

Trial registration: ClinicalTrials.gov NCT00530894.

Keywords: Society of Thoracic Surgeons; aortic stenosis; aortic valve replacement.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Aged
Aged, 80 and over
Aortic Valve / surgery*
Aortic Valve Stenosis / diagnosis
Aortic Valve Stenosis / mortality
Aortic Valve Stenosis / surgery*
Benchmarking
Female
Health Care Rationing* / standards
Heart Valve Prosthesis Implantation* / adverse effects
Heart Valve Prosthesis Implantation* / mortality
Heart Valve Prosthesis Implantation* / standards
Hospital Mortality
Humans
Kaplan-Meier Estimate
Male
Medical Futility
Patient Selection*
Postoperative Complications / mortality
Process Assessment, Health Care* / standards
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
United States

Associated data

ClinicalTrials.gov/NCT00530894