Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
Department of Cardiac Surgery, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France.
JACC Cardiovasc Interv. 2012 May;5(5):461-467. doi: 10.1016/j.jcin.2012.01.018. Epub 2012 May 9.
The authors report the feasibility and 30-day outcomes of transfemoral aortic valve replacement (TAVR), using the Edwards SAPIEN (Edwards Lifesciences, Irvine, California) and Edwards SAPIEN XT (Edwards Lifesciences) prosthesis, implanted using exclusively local anesthesia and fluoroscopic guidance.
Transfemoral TAVR is often managed with general anesthesia. However, a simplified percutaneous approach using local anesthesia has become more popular because it offers multiple advantages in an elderly and fragile population.
Between May 2006 and January 2011, the authors prospectively evaluated 151 consecutive patients (logistic EuroSCORE: 22.8 ± 11.8%) who underwent TAVR (SAPIEN: n = 78, SAPIEN XT: n = 73) using only local anesthesia and fluoroscopic guidance. The primary endpoint was a combination of all-cause mortality, major stroke, life-threatening bleeding, stage 3 acute kidney injury (AKI), periprocedural myocardial infarction (MI), major vascular complication, and repeat procedure for valve-related dysfunction at 30 days.
Transarterial femoral approach was surgical in all SAPIEN procedures and percutaneous in 97.3% of SAPIEN XT, using the ProStar vascular closure device, and was well tolerated in all cases. Conversion to general anesthesia was required in 3.3% (SAPIEN cases) and was related to complications. Vasopressors were required in 5.5%. Procedural success was 95.4%. The combined-safety endpoint was reached in 15.9%, including overall mortality (6.6%), major stroke (2.0%), life-threatening bleeding (7.9%), stage 3 AKI (0.7%), periprocedural MI (1.3%), major vascular complication (7.9%), and repeat procedure for valve-related dysfunction (2.0%) at 30 days. A permanent pacemaker was required in 5.3%.
This single-center, prospective registry demonstrated the feasibility and safety of a simplified transfemoral TAVR performed using only local anesthesia and fluoroscopic guidance in high surgical risk patients with severe aortic stenosis.
本研究报告了使用 Edwards SAPIEN（爱德华生命科学公司，加利福尼亚州欧文）和 Edwards SAPIEN XT（爱德华生命科学公司）经股主动脉瓣置换术（TAVR）的可行性和 30 天结果，该手术仅使用局部麻醉和透视引导完成。
经股 TAVR 通常采用全身麻醉进行管理。然而，一种简化的经皮入路方法，即采用局部麻醉，因其在老年和脆弱人群中具有多种优势，故越来越受欢迎。
2006 年 5 月至 2011 年 1 月，作者前瞻性评估了 151 例连续接受 TAVR（SAPIEN：n=78，SAPIEN XT：n=73）的患者，这些患者仅采用局部麻醉和透视引导。主要终点是 30 天内全因死亡率、主要卒中、威胁生命的出血、3 级急性肾损伤（AKI）、围手术期心肌梗死（MI）、主要血管并发症和瓣膜相关功能障碍的重复手术的复合终点。
所有 SAPIEN 手术均采用经动脉股入路，97.3%的 SAPIEN XT 手术采用经皮入路，使用 ProStar 血管闭合装置，所有患者均能良好耐受。3.3%（SAPIEN 病例）需要转为全身麻醉，与并发症有关。需要使用血管加压素的占 5.5%。手术成功率为 95.4%。复合安全性终点为 15.9%，包括总死亡率（6.6%）、主要卒中（2.0%）、威胁生命的出血（7.9%）、3 级 AKI（0.7%）、围手术期 MI（1.3%）、主要血管并发症（7.9%）和 30 天内瓣膜相关功能障碍的重复手术（2.0%）。需要植入永久性起搏器的占 5.3%。
这项单中心前瞻性注册研究表明，在高危外科手术患者中，仅采用局部麻醉和透视引导即可安全有效地进行简化经股 TAVR，这些患者患有严重的主动脉瓣狭窄。
