First experiences with automated annular suturing device in totally endoscopic aortic and mitral valve replacement.

0 CARDIAC & CARDIOVASCULAR SYSTEMS Interdisciplinary cardiovascular and thoracic surgery Pub Date : 2024-06-05 DOI:10.1093/icvts/ivae112
Ali El-Sayed Ahmad, Saad Salamate, Nermir Granov, Ali Bayram, Sami Sirat, Mirko Doss, Miriam Silaschi, Ömür Akhavuz, Farhad Bakhtiary
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Abstract

Objectives: To overcome some of the challenges of endoscopic minimally invasive valve surgery, an automated annular suturing device has been used in aortic and mitral valve replacement surgeries. The current study investigates early clinical outcomes of patients who received aortic or mitral valve replacement with the help of the RAM® device as first experiences in minimally invasive valve surgery.

Methods: Between September 2020 and June 2023, 66 consecutive patients (mean age 61.8 ± 11 years) underwent endoscopic minimally invasive aortic or mitral valve replacement through right anterior mini-thoracotomy at 2 cardiac surgery referral centres in Germany. The RAM® device was used in all Patients. 3.5 and 5.0 sizes were used in 16.7% and 83.3% of patients, respectively. Aortic, mitral and double valve surgery was performed in 81.8%, 15.2% and 1.5% of patients, respectively. Clinical data were prospectively entered into our institutional database.

Results: Cardiopulmonary bypass time and cross-clamping time were 97.9 ± 20.9 and 66 ± 15.7 min, respectively. Intensive care unit and hospital stays were 1 [1-2] and 9 [7-13] days, respectively. No paravalvular leak and no other intraoperative complications occurred. 30-day and in-hospital mortality were zero. Conversion to sternotomy occurred in 1 (1.5%) patient due to bleeding.

Conclusions: The usage of the RAM® device is a safe, feasible and effective approach to the endoscopic implantation of aortic or mitral valves and yield excellent early outcomes. Larger size studies are needed to evaluate the efficacy and safety of RAM® device.

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在全内窥镜主动脉瓣和二尖瓣置换术中首次使用自动瓣环缝合装置的经验。
目的:为了克服内窥镜微创瓣膜手术(MIVS)的一些难题,主动脉瓣和二尖瓣置换手术中使用了一种自动瓣环缝合装置。本研究调查了在 RAM® 设备的帮助下接受主动脉瓣或二尖瓣置换术的患者的早期临床疗效,作为 MIVS 的首次经验:方法:2020 年 9 月至 2023 年 6 月期间,66 名连续患者(平均年龄 61.8 ± 11 岁)在德国两家心脏外科转诊中心通过右前小切口接受了内镜微创主动脉瓣或二尖瓣置换术。所有患者均使用了 RAM® 设备。分别有 16.7% 和 83.3% 的患者使用了 3.5 和 5.0 尺寸。分别有 81.8%、15.2% 和 1.5% 的患者接受了主动脉瓣、二尖瓣和双瓣手术。临床数据被前瞻性地输入了我们的机构数据库:结果:心肺旁路时间和交叉钳夹时间分别为(97.9 ± 20.9)分钟和(66 ± 15.7)分钟。重症监护室和住院时间分别为 1 [1-2] 天和 9 [7-13] 天。没有发生瓣膜旁漏和其他术中并发症。30天死亡率和住院死亡率均为零。1例(1.5%)患者因出血而转为胸骨切开术:结论:使用 RAM® 装置在内窥镜下植入主动脉瓣或二尖瓣是一种安全、可行和有效的方法,并能获得良好的早期疗效。需要更大规模的研究来评估 RAM® 装置的有效性和安全性。
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