MedStar Heart and Vascular Institute, Washington, DC; Georgetown University, Washington, DC.
University of Montréal, Montréal, Québec, Canada.
Ann Thorac Surg. 2018 May;105(5):1322-1329. doi: 10.1016/j.athoracsur.2017.10.062. Epub 2017 Dec 16.
The Placement of Aortic Transcatheter Valves 2A (PARTNER-2A) randomized trial compared outcomes of transfemoral transcatheter and surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis. The purpose of the present study was to perform an in-depth analysis of outcomes after SAVR in the PARTNER-2A trial.
From January 2012 to January 2014, 937 patients underwent SAVR at 57 centers. Mean age was 82 ± 6.7 years and 55% were men. Less-invasive operations were performed in 140 patients (15%) and concomitant procedures in 198 patients (21%). Major outcomes and echocardiograms were adjudicated by an independent events committee. Follow-up was 94% complete to 2 years.
Operative mortality was 4.1% (n = 38, Society of Thoracic Surgeons predicted risk of mortality: 5.2% ± 2.3%), observed to expected ratio (O/E) was 0.8, and in-hospital stroke was 5.4% (n = 51), twice expected. Aortic clamp and bypass times were 75 ± 30 minutes and 104 ± 46 minutes, respectively. Patients having severe prosthesis-patient mismatch (n = 260, 33%) had similar survival to patients without (p > 0.9), as did patients undergoing less-invasive SAVR (p = 0.3). Risk factors for death included cachexia (p = 0.004), tricuspid regurgitation (p = 0.01), coronary artery disease (p = 0.02), preoperative atrial fibrillation (p = 0.001), higher white blood cell count (p < 0.0001), and lower hemoglobin (p = 0.0002).
In this adjudicated prospective study, SAVR in intermediate-risk patients had excellent results at 2 years. However, there were more in-hospital strokes than expected, most likely attributable to mandatory neurologic assessment after the procedure. No pronounced structural valve deterioration was found during 2-year follow-up. Continued long-term surveillance remains important.
Placement of Aortic Transcatheter Valves 2A（PARTNER-2A）随机试验比较了经股动脉经导管主动脉瓣置换术（TAVR）和外科主动脉瓣置换术（SAVR）在严重主动脉瓣狭窄的中危患者中的结局。本研究的目的是对 PARTNER-2A 试验中 SAVR 的结果进行深入分析。
2012 年 1 月至 2014 年 1 月，57 个中心的 937 例患者接受了 SAVR。平均年龄为 82±6.7 岁，55%为男性。140 例（15%）患者行微创操作，198 例（21%）患者行合并手术。主要结局和超声心动图由独立事件委员会裁定。随访完成率为 94%，随访时间为 2 年。
手术死亡率为 4.1%（n=38，胸外科医师协会预测死亡率：5.2%±2.3%），观察到的与预期的比值（O/E）为 0.8，院内卒中发生率为 5.4%（n=51），是预期的两倍。主动脉夹闭和体外循环时间分别为 75±30 分钟和 104±46 分钟。有严重假体-患者不匹配（n=260，33%）的患者与无不匹配的患者（p>0.9）的生存率相似，行微创 SAVR 的患者（p=0.3）也是如此。死亡的危险因素包括恶病质（p=0.004）、三尖瓣反流（p=0.01）、冠状动脉疾病（p=0.02）、术前心房颤动（p=0.001）、白细胞计数较高（p<0.0001）和血红蛋白较低（p=0.0002）。
在这项有裁决的前瞻性研究中，中危患者的 SAVR 在 2 年内取得了优异的结果。然而，院内卒中的发生率高于预期，这很可能归因于术后强制性的神经评估。在 2 年的随访期间，未发现明显的结构性瓣膜恶化。持续的长期监测仍然很重要。
