Objective: To investigate the safety and feasibility of sheathless transfemoral aortic valve replacement (TAVR). Methods: In this prospective study, we enrolled 23 patients with severe aortic stenosis (AS) who were inoperable or at high-risk for surgical aortic valve replacement operation in Fuwai hospital From September 2012 to June 2015. Multislice spiral CT and angiography of femoral artery showed that all patients had minimal femoral artery diameters (<6.5 mm) and severe calcification which was not suitable for transfemoral TAVR through sheath. We attempted to apply the sheathless transfemoral TAVR using Venus-A prosthesis without sheath insertion, and procedure related complication during the procedure and hospital stay were observed. Results: The 6 mm×30 mm balloon was used for femoral artery predilation in 1 patient with iliofemoral artery stenosis before delivery system was transported. In the other 22 patients, the delivery system was transported directly. A total of 21 patients finished TAVR with transfemoral sheathless technique. In 2 patients, prosthesis was unable to fully expand after release due to severe valve calcification, and patients received urgent surgical aortic valve replacement. One patient had valve dislocation into the ascending aorta that was not related to the sheathless replacement technique, and delivery system and Venus-A valve were removed after femoral artery was opened surgically, and repeated sheathless TAVR implantation was performed and was successful. Moderate aortic regurgitation occurred in 2 patients immediately after procedure, and trace or mild aortic regurgitation was detected in rest of the patients. One patient had puncture site rupture and bleeding after procedure, and was successfully treated by balloon compression without blood transfusion. Complete atrioventricular block occurred in 3 patients within 24 hours after procedure and lasted after 48-72 hours, permanent pacemakers were implanted in these patients. Conclusion: The sheathless transfemoral technique in TAVR is safe and feasible in severe aortic stenosis patients with small access vessel diameter.
目的： 探讨经股动脉无鞘技术在经导管主动脉瓣置入术(TAVR)中应用的安全性和可行性。 方法： 采用前瞻性研究方法，纳入2012年9月至2015年6月在阜外医院住院的不宜行外科手术或外科手术风险为高危的重度主动脉瓣狭窄患者23例。多排螺旋CT或股动脉造影检查显示，患者的股动脉最小内径均<6.5 mm，且合并严重钙化，不宜经鞘管行经导管主动脉瓣置入术。尝试经股动脉采用不置入动脉鞘管的无鞘技术置入国产Venu－A瓣膜完成TAVR，并观察术中和住院期间的手术相关并发症。 结果： 1例患者因股动脉及髂外动脉狭窄，术中使用6 mm×30 mm球囊行预扩张后送入输送系统；其余22例患者均直接经股动脉途径送入输送系统。其中21例患者采用无鞘技术完成TAVR；其余2例患者由于自身瓣膜严重钙化，人工瓣膜释放后未能充分扩张，急转外科完成主动脉瓣置换术。1例患者术中发生与鞘管无关的瓣膜移位，脱入升主动脉，通过外科手术切开股动脉后取出输送系统和Venus－A瓣膜，再次经股动脉置入Venus－A瓣膜。2例患者术后即刻出现中度主动脉瓣反流，其余患者为微量至轻度主动脉瓣反流。1例患者术后股动脉穿刺点撕裂出血，经球囊压迫后止血，无需输血。3例患者在术后24 h内发生完全性房室传导阻滞，观察48～72 h后病情无好转，置入永久性起搏器。 结论： 在股动脉内径较小的重度主动脉瓣狭窄患者中采用无鞘技术实施TAVR安全、可行。.
Keywords: Aortic valve stenosis; Postoperative complications; Transcatheter aortic valve replacement.