Institut Cardiovasculaire Paris Sud, Massy, France.
JACC Cardiovasc Interv. 2012 Feb;5(2):207-14. doi: 10.1016/j.jcin.2011.09.020.
The purpose of this study was to evaluate the incidence of vascular complications and the predictors of Prostar failure for a "true percutaneous approach" in transfemoral transcatheter aortic valve implantation (TAVI).
Safety and efficacy of a true percutaneous approach in transfemoral-TAVI has not been described in a large prospective cohort.
Among 264 patients included in our prospective TAVI database (October 2006 to December 2010), transfemoral-TAVI was performed in 170 patients. True percutaneous approach was performed in 142 consecutive patients since March 2008. Successful closure with Prostar was defined as adequate hemostasis without Prostar-related vascular complications. We compared the incidence of vascular complications in our early and late experience.
Patients were 83.0±7.2 years old and with a EuroSCORE of 24.0±11.6%. The Edwards valve (Edwards Lifesciences, Irvine, California) (18- to 24-F) was used in 109 cases and the CoreValve (Medtronic, Minneapolis, Minnesota) (18-F) in 31. The sheath outer diameter to minimal femoral diameter ratio (SFAR) was 0.96±0.14. Successful closure was achieved in 90.7%, and was significantly increased (95.7% vs. 85.7%, p=0.047) in the late experience group. Cross-over to surgery was required in 3.6%. Vascular complications occurred in 20.0%, and were significantly lower in the late experience group (11.4% vs. 28.6%, p=0.012). Major vascular complications (2.9% vs. 14.3%, p=0.018) were decreased in the late experience group. Early experience (hazard ratio [HR]: 3.66, 95% confidence interval [CI]: 1.04 to 13.89, p=0.047) and SFAR (HR: 110.80, 95% CI: 1.15 to 10,710.73, p=0.044) predicted Prostar failure by univariate analysis.
Experience reduced major vascular complications in a true percutaneous approach for transfemoral-TAVI. Further application of this less invasive strategy is feasible and may be beneficial, in this high-risk patient cohort.
本研究旨在评估经股动脉经导管主动脉瓣植入术（TAVI）中“真正经皮入路”的血管并发症发生率和 Prostar 失败的预测因素。
在大型前瞻性队列研究中，尚未描述经股动脉-TAVI 中真正经皮入路的安全性和疗效。
在我们的前瞻性 TAVI 数据库中（2006 年 10 月至 2010 年 12 月）纳入的 264 例患者中，170 例患者接受了经股动脉 TAVI。自 2008 年 3 月以来，对 142 例连续患者进行了真正的经皮入路。Prostar 成功闭合定义为无 Prostar 相关血管并发症的充分止血。我们比较了我们早期和晚期经验中的血管并发症发生率。
患者年龄为 83.0±7.2 岁，EuroSCORE 为 24.0±11.6%。109 例患者使用 Edwards 瓣膜（爱德华生命科学公司，加利福尼亚州欧文）（18-24-F），31 例患者使用 CoreValve（美敦力，明尼苏达州明尼阿波利斯）（18-F）。鞘外径与最小股动脉直径比（SFAR）为 0.96±0.14。90.7%的患者成功闭合，晚期经验组显著增加（95.7%比 85.7%，p=0.047）。需要交叉手术的比例为 3.6%。血管并发症发生率为 20.0%，晚期经验组明显降低（11.4%比 28.6%，p=0.012）。晚期经验组的主要血管并发症（2.9%比 14.3%，p=0.018）减少。单因素分析显示，早期经验（风险比[HR]：3.66，95%置信区间[CI]：1.04 至 13.89，p=0.047）和 SFAR（HR：110.80，95%CI：1.15 至 10，710.73，p=0.044）可预测 Prostar 失败。
在经股动脉 TAVI 中，经皮入路的经验减少了主要血管并发症。在这一高危患者队列中，进一步应用这种微创策略是可行的，可能是有益的。
