Importance Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR.

Objective To examine the incidence, causes, and outcomes of 2V-TAVR.

Design, Setting, and Participants A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients.

Exposures Urgent implantation of a supplementary valve during TAVR.

Main Outcomes and Measures Mortality at 30 days and 1 year.

Results The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P = .02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P < .001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; P = .02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; P < .001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; P < .001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; P = .004) were associated with higher 2V-TAVR risk. In 165 patients (80%), the supplementary valve was implanted because of residual aortic regurgitation after primary valve malposition (94 [46.4%] too high and 71 [34.2%] too low). In the matched 2V-TAVR vs 1V-TAVR cohorts, the rate of device success was 147 (70.4%) vs 783 (92.2%) (P < .001), the rate of coronary obstruction was 5 (2.3%) vs 3 (0.4%) (P = .10), stroke rate was 9 (4.6%) vs 13 (1.6%) (P = .09), major bleeding rates were 25 (11.8%) vs 46 (5.5%) (P = .03) and annular rupture rate was 7 (3.3%) vs 3 (0.4%) (P = .03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45; P = .04) at 30 days, 1.45 (95% CI, 0.84-2.51; P = .18) at 1 year, and 1.20 (95% CI, 0.77-1.88; P = .42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR.

Conclusions and Relevance In this cohort study, valve malposition was the most common indication for 2V-TAVR. Incidence decreased over time and was low overall, although patients with a bicuspid or regurgitant aortic valve, nontransfemoral access, and early-generation or self-expandable valve were at higher risk. These findings suggest that compared with 1V-TAVR, 2V-TAVR is associated with high burden of complications and mortality at 30 days but not at 1 year.

重要性 经导管主动脉瓣置换术 (TAVR) 失败通常通过在手术过程中紧急植入辅助瓣膜来处理（2 瓣膜 TAVR [2V-TAVR]）。与 2V-TAVR 相关的因素或后遗症知之甚少。

目的 探讨2V-TAVR的发生率、原因和结局。

设计、设置和参与者 使用来自 2014 年 1 月 1 日至 2019 年 2 月 28 日进行的 21298 例 TAVR 手术的国际注册数据进行回顾性队列研究。在接受 TAVR 的 21298 名患者中，223 名患者 (1.0%)确定接受 2V-TAVR。所有接受 2V-TAVR 的患者和接受 1V-TAVR 的 12 052 名患者 (56.6%) 的患者水平数据均可用。在排除缺少 30 天随访或数据不一致的患者后，对 213 名 2V-TAVR 和 10 010 名 1V-TAVR 患者进行了研究。使用 1:4 17 倾向评分匹配将 2V-TAVR 患者与接受 1 瓣膜 TAVR (1V-TAVR) 的对照 TAVR 患者进行比较。最终分析包括 1065 (213:852) 名患者。

暴露 TAVR 期间紧急植入辅助瓣膜。

主要结果和测量 30 天和 1 年的死亡率。

结果 213 名接受 2V-TAVR 的患者与接受 1V-TAVR 的 10 010 名患者（平均 [SD] 年龄 81.2 岁）和性别（110 名 [51.6%] 女性）相似[0.5] 岁；110 [51.6%] 女性）。2V-TAVR 发生率从 2014 年的 2.9% 下降到 2018 年的 1.0%，并且在可复位瓣膜和不可复位瓣膜之间相似。二尖瓣主动脉瓣（优势比 [OR]，2.20；95% CI，1.17-4.15；P  = .02），中度或更严重的主动脉瓣关闭不全（OR，2.02；95% CI，1.49-2.73；P  < .001 )、心房颤动 (OR, 1.43; 95% CI, 1.07-1.93; P  = .02), 替代通路 (OR, 2.59; 95% CI, 1.72-3.89; P  < .001), 早期瓣膜 (OR , 2.32; 95% CI, 1.69-3.19; P < .001）和自扩张瓣膜（OR，1.69；95% CI，1.17-2.43；P  = .004）与较高的 2V-TAVR 风险相关。在 165 名患者 (80%) 中，由于原发性瓣膜错位后残留的主动脉瓣关闭不全而植入了辅助瓣膜（94 人 [46.4%] 过高，71 人 [34.2%] 过低）。在匹配的 2V-TAVR 与 1V-TAVR 队列中，装置成功率为 147 (70.4%) vs 783 (92.2%) ( P  < .001)，冠状动脉阻塞率为 5 (2.3%) vs 3 ( 0.4%) ( P  = .10)，卒中发生率为 9 (4.6%) vs 13 (1.6%) ( P  = .09)，大出血率分别为 25 (11.8%) vs 46 (5.5%) ( P  = . 03)，环状破裂率为 7 (3.3%) vs 3 (0.4%) ( P = .03)。死亡率的风险比在 30 天时为 2.58（95% CI，1.04-6.45；P  = .04），在 1 年时为 1.45（95% CI，0.84-2.51；P  = .18）和 1.20（95% CI , 0.77-1.88; P  = .42) 在 2 年。非经股动脉通路和某些围手术期并发症与 2V-TAVR 后 1 年的较高死亡风险独立相关。

结论和相关性 在这项队列研究中，瓣膜错位是 2V-TAVR 最常见的适应症。发病率随着时间的推移而下降，总体上较低，尽管患有二尖瓣或反流主动脉瓣、非经股动脉通路和早期代或自扩张瓣膜的患者风险较高。这些发现表明，与 1V-TAVR 相比，2V-TAVR 与 30 天的高并发症和死亡率相关，但与 1 年的死亡率无关。