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

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

来源：The Journal of Thoracic and Cardiovascular Surgery, 2015, 150(3): 557-567.

DOI：10.1016/j.jtcvs.2015.05.073

• aortic stenosis
• aortic valve replacement
• Society of Thoracic Surgeons

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.

• 出版日期2015-9