Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial.
Publication/Presentation Date
9-1-2015
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.
Volume
150
Issue
3
First Page
557
Last Page
568
ISSN
1097-685X
Published In/Presented At
Szeto, W. Y., Svensson, L. G., Rajeswaran, J., Ehrlinger, J., Suri, R. M., Smith, C. R., Mack, M., Miller, D. C., McCarthy, P. M., Bavaria, J. E., Cohn, L. H., Corso, P. J., Guyton, R. A., Thourani, V. H., Lytle, B. W., Williams, M. R., Webb, J. G., Kapadia, S., Tuzcu, E. M., Cohen, D. J., … Placement of Aortic Transcatheter Valves Trial Investigators (2015). Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial. The Journal of thoracic and cardiovascular surgery, 150(3), 557–68.e11. https://doi.org/10.1016/j.jtcvs.2015.05.073
Disciplines
Medicine and Health Sciences
PubMedID
26238287
Department(s)
Department of Surgery
Document Type
Article