Conte John V, Hermiller James, Resar Jon R, Deeb G Michael, Gleason Thomas G, Adams David H, Popma Jeffrey J, Yakubov Steven J, Watson Daniel, Guo Jia, Zorn George L, Reardon Michael J
Departments of Surgery and Medicine, Johns Hopkins University, Baltimore, Maryland.
St. Vincent's Heart Center of Indiana, Indianapolis, Indiana.
Semin Thorac Cardiovasc Surg. 2017;29(3):321-330. doi: 10.1053/j.semtcvs.2017.06.001. Epub 2017 Jun 19.
Procedural complications following transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are usually reported as retrospective analyses. We report the first comparison of complications following SAVR or self-expanding TAVR from a prospectively randomized study of high-risk SAVR patients. Three hundred ninety-five TAVR and 402 SAVR patients were prospectively enrolled and randomized 1:1 to TAVR with a CoreValve bioprosthesis or a surgical bioprosthetic valve. The rates of major procedural and vascular complications occurring (periprocedurally (0-3 days) and early (4-30 days)) were compared for TAVR vs SAVR patients. All-cause mortality, stroke, myocardial infarction, and major infection were similar in both periods post procedure. Within 0-3 days, the major vascular complication rate was significantly higher with TAVR (P = 0.003). Life-threatening or disabling bleeding (P < 0.001), encephalopathy (P = 0.02), atrial fibrillation (P < 0.001), and acute kidney injury (P < 0.001) were significantly higher with SAVR. Non-iliofemoral TAVR approaches had a higher incidence of major or life-threatening or disabling bleeding at 0-3days (P < 0.05). Procedural complications unique to TAVR included coronary occlusion 0.5% (2) and TAVR pop outs 2.8% (11) with no valve embolizations. Pop outs were similar between iliofemoral 2.8% (9/324) and non-iliofemoral approaches 3.0% (2/66). Procedural complications unique to SAVR included aortic dissection 0.8% (3/357) and injury to other heart structures 2.0% (7/357). The procedural complication profiles of TAVR and SAVR are unique. Intraoperative deaths were seen in TAVR only. Mortality at 3 and 30 days was similar. The higher incidence of some complications likely reflects the greater invasiveness of SAVR in this aged high-risk population.
经导管主动脉瓣置换术（TAVR）或外科主动脉瓣置换术（SAVR）后的手术并发症通常作为回顾性分析进行报告。我们报告了一项对高危SAVR患者进行的前瞻性随机研究中SAVR或自膨胀TAVR后并发症的首次比较。395例TAVR患者和402例SAVR患者被前瞻性纳入并按1:1随机分组，分别接受CoreValve生物假体的TAVR或外科生物假体瓣膜置换。比较了TAVR组和SAVR组患者发生的主要手术和血管并发症发生率（围手术期（0 - 3天）和早期（4 - 30天））。术后两个时期的全因死亡率、中风、心肌梗死和主要感染情况相似。在0 - 3天内，TAVR的主要血管并发症发生率显著更高（P = 0.003）。SAVR的危及生命或致残性出血（P < 0.001）、脑病（P = 0.02）、心房颤动（P < 0.001）和急性肾损伤（P < 0.001）发生率显著更高。非髂股动脉TAVR途径在0 - 3天时发生主要或危及生命或致残性出血的发生率更高（P < 0.05）。TAVR特有的手术并发症包括0.5%（2例）的冠状动脉闭塞和2.8%（11例）的TAVR瓣膜弹出，无瓣膜栓塞。髂股动脉途径的瓣膜弹出率为2.8%（9/324），与非髂股动脉途径的3.0%（2/66）相似。SAVR特有的手术并发症包括0.8%（3/357）的主动脉夹层和2.0%（7/357）的其他心脏结构损伤。TAVR和SAVR的手术并发症情况各不相同。仅在TAVR中出现术中死亡。3天和30天的死亡率相似。某些并发症的较高发生率可能反映了在这个老年高危人群中SAVR的侵袭性更强。
