With increasing numbers of patients undergoing transcatheter aortic valve replacement (TAVR), data on management of failed TAVR, including repeat TAVR procedure, are needed. The aim of this study was to assess the safety and efficacy of redo-TAVR in a national registry. This study included all consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from Nov 9, 2011, to Dec 30, 2022 who underwent TAVR with balloon-expandable valves in failed transcatheter heart valves (redo-TAVR) or native aortic valves (native-TAVR). Procedural, echocardiographic, and clinical outcomes were compared between redo-TAVR and native-TAVR cohorts using propensity score matching. Among 350 591 patients (1320 redo-TAVR; 349 271 native-TAVR), 1320 propensity-matched pairs of patients undergoing redo-TAVR and native-TAVR were analysed (redo-TAVR cohort: mean age 78 years [SD 9]; 559 [42·3%] of 1320 female, 761 [57·7%] male; mean predicted surgical risk of 30-day mortality 8·1%). The rates of procedural complications of redo-TAVR were low (coronary compression or obstruction: four [0·3%] of 1320; intraprocedural death: eight [0·6%] of 1320; conversion to open heart surgery: six [0·5%] of 1319) and similar to native-TAVR. There was no significant difference between redo-TAVR and native-TAVR populations in death at 30 days (4·7% 4·0%, p=0·36) or 1 year (17·5% 19·0%, p=0·57), and stroke at 30 days (2·0% 1·9%, p=0·84) or 1 year (3·2% 3·5%, p=0·80). Redo-TAVR reduced aortic valve gradients at 1 year, although they were higher in the redo-TAVR group compared with the native-TAVR group (15 mm Hg 12 mm Hg; p<0·0001). Moderate or severe aortic regurgitation rates were similar between redo-TAVR and native-TAVR groups at 1 year (1·8% 3·3%, p=0·18). Death or stroke after redo-TAVR were not significantly affected by the timing of redo-TAVR (before or after 1 year of index TAVR), or by index transcatheter valve type (balloon-expandable or non-balloon-expandable). Redo-TAVR with balloon-expandable valves effectively treated dysfunction of the index TAVR procedure with low procedural complication rates, and death and stroke rates similar to those in patients with a similar clinical profile and predicted risk undergoing TAVR for native aortic valve stenosis. Redo-TAVR with balloon-expandable valves might be a reasonable treatment for failed TAVR in selected patients. Edwards Lifesciences.

中文翻译：

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使用球囊扩张瓣膜重复经导管主动脉瓣置换术的结果：一项登记研究

随着接受经导管主动脉瓣置换术 (TAVR) 的患者数量不断增加，需要有关 TAVR 失败处理（包括重复 TAVR 手术）的数据。本研究的目的是在国家登记处评估重做 TAVR 的安全性和有效性。本研究纳入了胸外科医生协会/美国心脏病学会经导管瓣膜治疗登记处从 2011 年 11 月 9 日至 2022 年 12 月 30 日期间对失败的经导管心脏瓣膜进行球囊扩张瓣膜 TAVR 治疗 (redo-TAVR) 的所有连续患者或天然主动脉瓣（天然 TAVR）。使用倾向评分匹配比较重做 TAVR 和原生 TAVR 队列的手术、超声心动图和临床结果。在 350 591 例患者（1320 例重做 TAVR；349 271 例原生 TAVR）中，分析了 1320 例倾向匹配的接受重做 TAVR 和原生 TAVR 的患者（重做 TAVR 队列：平均年龄 78 岁 [SD 9]；559 1320 名女性中 [42·3%]，761 名男性 [57·7%]；30 天死亡率的平均预测手术风险为 8·1%）。重做 TAVR 的手术并发症发生率较低（冠状动脉受压或阻塞：1320 人中有 4 人 [0·3%]；术中死亡：1320 人中有 8 人 [0·6%]；转为心脏直视手术：6 人 [0·6%] 5%] of 1319) 与原生 TAVR 类似。重做 TAVR 和原生 TAVR 人群在 30 天 (4·7% 4·0%, p=0·36) 或 1 年 (17·5% 19·0%, p= 0·57)，以及30天时中风(2·0% 1·9%，p=0·84)或1年时(3·2% 3·5%，p=0·80)。重做 TAVR 在 1 年时降低了主动脉瓣梯度，尽管重做 TAVR 组的主动脉瓣梯度高于天然 TAVR 组（15 mm Hg 12 mm Hg；p<0·0001）。1 年时，重做 TAVR 组和自然 TAVR 组中度或重度主动脉瓣反流率相似 (1·8% 3·3%，p=0·18)。重做 TAVR 后的死亡或中风不受重做 TAVR 时间（索引 TAVR 1 年之前或之后）或索引经导管瓣膜类型（球囊扩张或非球囊扩张）的显着影响。采用球囊扩张瓣膜的 Redo-TAVR 可以有效治疗 TAVR 手术的功能障碍，手术并发症发生率低，死亡率和中风率与具有相似临床特征和因自体主动脉瓣狭窄接受 TAVR 的预测风险的患者相似。使用球囊扩张瓣膜的重做 TAVR 可能是特定患者 TAVR 失败的合理治疗方法。爱德华兹生命科学。