Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.
Chin Med J (Engl). 2012 Aug;125(16):2807-10.
Transcatheter aortic valve implantation (TAVI) is a rapidly evolving strategy for therapy of aortic stenosis. We presented the procedural results and analyzed the death causes of 30-day mortality and clinical events in patients who underwent TAVI with Edwards prosthetic valves in University Hospital of Caen, France.
The patients with severe aortic stenosis but at high surgical risk or inoperable were considered as candidates for TAVI. Forty-eight patients undergoing TAVI from July 2010 to September 2011 were enrolled in this registry. The Edwards prosthetic valves were solely used in this clinical trial.
Overall 48 patients underwent TAVI, 28 of which accepted TAVI by trans-femoral (TF) approaches, 20 by trans-apical approaches (TA). The aortic valve area (AVA) was (0.70 ± 0.23) cm(2), left ventricular ejection fraction (LVEF) was (57.4 ± 17.6)%, Log EuroSCORE was (19.2 ± 15.8)%, mean gradient was (47.0 ± 16.6) mmHg. There were no significant differences between TF and TA groups in all these baseline parameters. Device success rate was 95.8%, and procedural success rate was 93.7% in total. Procedural mortality was 6.7% (3/48): two deaths in TA group (10%), and one death in TF group (3.6%). Forty-six Edwards valves were implanted: 10 Edwards Sapien and 36 Edwards XT. Procedure-related complications included cardiac tamponade in 2 cases (4.2%), acute myocardial infarction (AMI) in 1 case (2.1%), permanent pacemaker implantation in 1 case (2.1%), life-threatening and major bleeding in 3 cases; access site related major complication in 1 case, AKI stage 3 in 3 cases (6.3%), minor stroke in 1 case (2.1%). Thirty-day survival rate was 89.6%. There were 5 deaths in total (10.4%): 4 in TA group (20%) and 1 in TF group (3.6%).
The procedural success rate and 30-day mortality were acceptable in these high risk patients with Edwards prosthetic valves in the first 48 TAVI.
经导管主动脉瓣植入术（TAVI）是治疗主动脉瓣狭窄的一种快速发展的策略。我们报告了在法国卡昂大学医院接受 Edwards 人工瓣膜 TAVI 的患者的手术结果，并分析了 30 天死亡率和临床事件的死亡原因。
严重主动脉瓣狭窄但手术风险高或无法手术的患者被认为是 TAVI 的候选者。该注册研究纳入了 2010 年 7 月至 2011 年 9 月期间接受 TAVI 的 48 例患者。该临床试验仅使用 Edwards 人工瓣膜。
总共 48 例患者接受了 TAVI，其中 28 例经股动脉（TF）入路，20 例经心尖入路（TA）。主动脉瓣面积（AVA）为（0.70±0.23）cm2，左心室射血分数（LVEF）为（57.4±17.6）%，Log EuroSCORE 为（19.2±15.8）%，平均梯度为（47.0±16.6）mmHg。TF 组和 TA 组在所有这些基线参数方面无显著差异。器械成功率为 95.8%，总手术成功率为 93.7%。手术死亡率为 6.7%（3/48）：TA 组 2 例（10%），TF 组 1 例（3.6%）。共植入 46 枚 Edwards 瓣膜：10 枚 Edwards Sapien 和 36 枚 Edwards XT。手术相关并发症包括 2 例（4.2%）心脏压塞，1 例（2.1%）急性心肌梗死（AMI），1 例（2.1%）永久性起搏器植入，3 例（6.3%）危及生命和大出血，1 例（2.1%）经股动脉相关严重并发症，3 例（6.3%）急性肾损伤（AKI）3 期，1 例（2.1%）小卒中。30 天生存率为 89.6%。共有 5 例死亡（10.4%）：TA 组 4 例（20%），TF 组 1 例（3.6%）。
在接受 Edwards 人工瓣膜的高危患者中，前 48 例 TAVI 的手术成功率和 30 天死亡率可接受。
