Departments of Cardiology, Cardiovascular Center, Bad Neustadt 1, 97616, Bad Neustadt (Saale), Germany.
Catheter Cardiovasc Interv. 2013 Nov 1;82(5):E734-41. doi: 10.1002/ccd.25053. Epub 2013 Aug 1.
Aim of this study was to analyze feasibility, efficacy, and safety of a double-ProGlide preclose technique for access site closure after transfemoral transcatheter aortic valve implantation (TAVI).
An effective and safe transcutaneous closure device is advantageous in transfemoral TAVI to avoid surgical cut down of the large caliber sheath insertion site. The use of two ProGlide sutures has not been described in this context in a large patient cohort.
ProGlide closure was used between 2010 and 2012 in 162 patients. ProGlide sutures were deployed in a preclose technique prior to insertion of the large caliber sheath. Success of the closure technique was defined as effective hemostasis and no further access site-related vascular or bleeding complications during the index hospitalization.
Patients were 82 ± 5 years old with a logistic EuroSCORE of 16.7 ± 12.5. Edwards SAPIEN valves were used in 81.5% and Medtronic CoreValves in 18.5%. The overall success rate of the double-ProGlide technique was 93.9%. Success rate was only 40.0% under circumstances of prolonged high-dose heparinization. Success rate was 96.8% among the patients on dual-antiplatelet therapy (DAPT). All 10 ProGlide failures could effectively be managed by either percutaneous angioplasty or surgical reconstruction. The rate of VARC major vascular complications was 4.3%. Thirty-day mortality was 5.6%.
The double-ProGlide preclose technique offers a simple, highly effective, and safe method for closure of the arterial access site after transfemoral TAVI. The double-ProGlide strategy results in low rates of major vascular complications and translates into favorable early outcome.
本研究旨在分析经股动脉经导管主动脉瓣置换术（TAVI）后应用双 ProGlide 预闭技术进行血管入路封堵的可行性、疗效和安全性。
在经股 TAVI 中，使用一种有效且安全的经皮闭合装置有利于避免大口径鞘管插入部位的外科切开。在这种情况下，尚未在大样本患者队列中描述使用两个 ProGlide 缝线。
2010 年至 2012 年，在 162 例患者中使用 ProGlide 闭合。在插入大口径鞘管之前，采用预闭技术部署 ProGlide 缝线。闭合技术的成功定义为有效止血，且在住院期间无其他与血管入路相关的血管或出血并发症。
患者年龄为 82±5 岁，逻辑 EuroSCORE 为 16.7±12.5。81.5%使用 Edwards SAPIEN 瓣膜，18.5%使用 Medtronic CoreValve。双 ProGlide 技术的总体成功率为 93.9%。在持续大剂量肝素化的情况下，成功率仅为 40.0%。在双联抗血小板治疗（DAPT）的患者中，成功率为 96.8%。所有 10 例 ProGlide 失败均可以通过经皮血管成形术或手术重建有效处理。VARe 主要血管并发症的发生率为 4.3%。30 天死亡率为 5.6%。
双 ProGlide 预闭技术为经股 TAVI 后经股动脉血管入路封堵提供了一种简单、高效且安全的方法。双 ProGlide 策略可降低主要血管并发症的发生率，转化为有利的早期结果。
