Department of Medicine, Duke University Medical Center, Durham, North Carolina.
Duke Clinical Research Institute, Durham, North Carolina.
JACC Cardiovasc Interv. 2019 Sep 23;12(18):1768-1777. doi: 10.1016/j.jcin.2019.05.017. Epub 2019 Aug 28.
This study sought to evaluate the outcomes and factors associated with aborted procedures among patients undergoing elective transcatheter aortic valve replacement (TAVR).
Elective TAVR procedures can be aborted because of device limitations or aborted for other reasons, including patient and procedural factors. Little is known about 30-day outcomes and factors associated with aborted procedures and procedures aborted because of device limitations (ADs).
Patients undergoing elective TAVR procedures from 2011 to 2017 in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were examined. The incidence of aborted procedures, both ADs and procedures aborted for other reasons (AOs), was examined. Rates of 30-day all-cause death or stroke and a composite of vascular complications and bleeding events were compared between patients with and those without aborted procedures and between patients with ADs and those with AOs. Multivariate modeling identified factors associated with aborted procedures and ADs.
Among 106,169 patients who underwent TAVR between 2011 and 2017, procedures were aborted in 1,150 (1.1%) (581 ADs and 569 AOs). Patients with aborted procedures were more likely female with peripheral artery disease and more often treated at lower volume centers compared with those with nonaborted procedures (p < 0.01 for all). The incidence of aborted procedures and ADs decreased over the study period (p < 0.01). The adjusted rates of 30-day death and stroke were greater for aborted versus nonaborted procedures (odds ratio: 5.02; 95% confidence interval: 4.13 to 6.11). Peripheral artery disease, alternative access, and low institutional TAVR volume were factors associated with aborted procedures and ADs (p < 0.05 for all).
The incidence of aborted procedures is declining, but peripheral artery disease and low institutional TAVR volume remain associated with aborted procedures. A thorough pre-procedural assessment and referral of challenging cases to high-volume centers may be strategies to minimize aborted procedures.
本研究旨在评估择期经导管主动脉瓣置换术（TAVR）患者中因程序中断和器械相关原因而中断的程序的结局和相关因素。
择期 TAVR 程序可能因器械限制而中断，也可能因其他原因而中断，包括患者和程序因素。对于 30 天结局和与因程序中断和因器械限制而中断的程序相关的因素知之甚少。
研究人员检查了 2011 年至 2017 年期间在胸外科医师学会/美国心脏病学会 TVT（经导管瓣膜治疗）注册中心接受择期 TAVR 手术的患者。检查了因程序中断和因器械限制而中断的程序的发生率。比较了有和无因程序中断的患者以及因器械限制和其他原因而中断的患者之间 30 天全因死亡或卒中和血管并发症及出血事件复合终点的发生率。多变量建模确定了与因程序中断和因器械限制而中断相关的因素。
在 2011 年至 2017 年间接受 TAVR 的 106169 例患者中，有 1150 例（1.1%）的手术被中断（581 例因器械限制，569 例因其他原因）。与无因程序中断的患者相比，有因程序中断的患者更可能为女性，患有外周动脉疾病，并且更常在低容量中心接受治疗（p<0.01）。在研究期间，因程序中断和因器械限制而中断的发生率均有所下降（p<0.01）。与无因程序中断的患者相比，因程序中断的患者 30 天死亡和卒中的调整发生率更高（比值比：5.02；95%置信区间：4.13 至 6.11）。外周动脉疾病、替代入路和低机构 TAVR 量是与因程序中断和因器械限制相关的因素（p<0.05）。
因程序中断的发生率正在下降，但外周动脉疾病和低机构 TAVR 量仍与因程序中断相关。术前全面评估和将具有挑战性的病例转介到高容量中心可能是减少因程序中断的策略。
