近日，美国洛杉矶Cedars-Sinai医疗中心Raj R Makkar团队研究了重复经导管主动脉瓣置换术的患者预后。这一研究成果于2023年8月31日发表在《柳叶刀》杂志上。

随着越来越多的患者接受经导管主动脉瓣置换术（TAVR），亟需有关失败的TAVR管理的数据，包括重复的TAVR手术。该研究旨在在国家注册中心评估重做TAVR的安全性和有效性。

该研究纳入了2011年11月9日至2022年12月30日在胸外科医生协会/美国心脏病学院经导管瓣膜治疗注册中心接受TAVR的所有连续患者，这些患者在失败的经导管心脏瓣膜（重做TAVR）或初次主动脉瓣（初次TAVR）中使用球囊可扩张瓣膜进行了TAVR。使用倾向评分匹配比较重做TAVR和初次TAVR队列的手术、超声心动图和临床预后。

在350591名患者中（1320名重做TAVR；349271名初次TAVR患者）、1320对接受重做TAVR和初次TAVR的倾向匹配患者进行了分析（重做TAVR队列：平均年龄78岁；1320名中559名[42.3%]女性，761名[57.7%]男性；30天死亡率的平均预测手术风险8.1%）。重做TAVR的手术并发症发生率较低（冠状动脉压迫或阻塞：1320例中有4例[0.3%]；术中死亡：1320名中有8例[0.6%]；转为心脏直视手术：1319例中有6例[0.5%]），与初次TAVR相似。

在30天（4.7% vs 4.0%，p=0.36）或1年（17.5% vs 19.0%，p=0.57）的死亡率以及30天（2.0% vs 1.9%，p=0.84）或1周（3.2% vs 3.5%，p=0.80）的中风中，重做TAVR人群与初次TAVR人群之间没有显著差异。重做TAVR在1年时降低了主动脉瓣梯度，尽管与天然TAVR组相比，重做TAVR组的主动脉瓣梯度更高（15 mm Hg vs 12 mm Hg；p<0.0001）。

在1年时，重做TAVR组和初次TAVR组的中度或重度主动脉瓣反流率相似（1.8% vs 3.3%，p=0.018）。再次TAVR后的死亡或中风不受再次TAVR的时间（在指数TAVR 1年之前或之后）或经导管瓣膜类型（球囊扩张或非球囊扩张）指数的显著影响。

研究结果表明，使用球囊可扩张瓣膜重做TAVR有效地治疗了指数TAVR手术的功能障碍，手术并发症发生率较低，死亡率和中风率与具有相似临床特征，和预测接受TAVR治疗原发性主动脉瓣狭窄风险的患者相似。对于选定患者中失败的TAVR，使用球囊扩张瓣膜恢复TAVR可能是一种合理的治疗方法。

附：英文原文

Title: Outcomes of repeat transcatheter aortic valve replacement with balloon-expandable valves: a registry study

Author: Raj R Makkar, Samir Kapadia, Tarun Chakravarty, Robert J Cubeddu, Tsuyoshi Kaneko, Paul Mahoney, Dhairya Patel, Aakriti Gupta, Wen Cheng, Susheel Kodali, Deepak L Bhatt, Michael J Mack, Martin B Leon, Vinod H Thourani

Issue&Volume: 2023-08-31

Abstract:

Background

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.

Methods

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.

Findings

Among 350591 patients (1320 redo-TAVR; 349271 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% vs 4·0%, p=0·36) or 1 year (17·5% vs 19·0%, p=0·57), and stroke at 30 days (2·0% vs 1·9%, p=0·84) or 1 year (3·2% vs 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 vs 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% vs 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).

Interpretation

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.

DOI: 10.1016/S0140-6736(23)01636-7

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01636-7/fulltext