University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Heart Valve Center, Cardio-Thoracic-Vascular Department, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA; Cardiovascular Research Foundation, NY, New York, USA.
Int J Cardiol. 2023 Nov 1;390:131139. doi: 10.1016/j.ijcard.2023.131139. Epub 2023 Jun 23.
In the first report from the MitraBridge registry, MitraClip as a bridge to heart transplantation (HTx) proved to be at 1-year an effective treatment strategy for 119 patients with advanced heart failure (HF) who were potential candidates for HTx. We aimed to determine if benefits of MitraClip procedure as a bridge-to-transplant persist up to 2-years.
By the end of the enrollment period, a total of 153 advanced HF patients (median age 59 years, left ventricular ejection fraction 26.9 ± 7.7%) with significant secondary mitral regurgitation, who were potential candidates for HTx and were treated with MitraClip as a bridge-to-transplant strategy, were included in the MitraBridge registry. The primary endpoint was the 2-year composite adverse events rate of all-cause death, first hospitalization for HF, urgent HTx or LVAD implantation.
Procedural success was achieved in 89.5% of cases. Thirty-day mortality was 0%. At 2-year, Kaplan-Meier estimates of freedom from primary endpoint was 47%. Through 24 months, the annualized rate of HF rehospitalization per patient-year was 44%. After an overall median follow-up time of 26 (9-52) months, elective HTx was successfully performed in 30 cases (21%), 19 patients (13.5%) maintained or obtained the eligibility for transplant, and 32 patients (22.5%) no longer had an indication for HTx because of significant clinical improvement.
After 2-years of follow-up, the use of MitraClip as a bridge-to-transplant was confirmed as an effective strategy, allowing elective HTx or eligibility for transplant in one third of patients, and no more need for transplantation in 22.5% of cases.
在 MitraBridge 注册研究的第一份报告中,MitraClip 作为心脏移植(HTx)的桥梁,为 119 例晚期心力衰竭(HF)患者提供了为期 1 年的有效治疗策略,这些患者有 HTx 的潜在适应证。我们旨在确定 MitraClip 作为移植桥接的益处是否持续到 2 年。
在登记期结束时,共有 153 例晚期 HF 患者(中位年龄 59 岁,左心室射血分数 26.9±7.7%),有明显的继发性二尖瓣反流,有 HTx 的潜在适应证,接受 MitraClip 作为移植桥接策略,被纳入 MitraBridge 注册研究。主要终点是全因死亡、HF 首次住院、紧急 HTx 或 LVAD 植入的 2 年复合不良事件发生率。
手术成功率为 89.5%。30 天死亡率为 0%。2 年时,Kaplan-Meier 估计无主要终点事件的生存率为 47%。24 个月时,每位患者每年 HF 再住院的年化率为 44%。在中位数为 26(9-52)个月的总随访时间后,30 例(21%)患者成功进行了选择性 HTx,19 例(13.5%)患者保持或获得了移植的适应证,32 例(22.5%)患者不再需要 HTx,因为他们的临床状况显著改善。
在 2 年的随访后,MitraClip 作为移植桥接的应用被证实是一种有效的策略,使三分之一的患者能够进行选择性 HTx 或获得移植的适应证,22.5%的患者不再需要移植。