Department of Medicine II, University Hospital Bonn, Bonn, Germany.
JACC Cardiovasc Interv. 2011 Jul;4(7):751-7. doi: 10.1016/j.jcin.2011.03.015.
The purpose of this pilot study was to evaluate the feasibility and safety of transcatheter aortic valve implantation (TAVI) without balloon pre-dilation.
Balloon pre-dilation of the stenosed aortic valve is currently believed to be a necessary step for valve preparation before device placement in patients undergoing TAVI and, therefore, is considered an obligatory part of the procedure. However, clear evidence supporting this policy is lacking. In contrast, pre-dilation might be responsible in part for distal embolizations as well as atrioventricular conduction disturbances seen during TAVI procedures.
A total of 60 consecutive patients (mean age 80.1 ± 6.4 years, 53% female, mean logistic EuroScore 23.3 ± 15.2%) undergoing TAVI using the self-expanding Medtronic CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) have been prospectively enrolled at 13 international centers.
Pre-procedural mean transaortic valve gradient was 47.8 ± 15.5 mm Hg, mean effective orifice area was 0.67 ± 0.15 cm(2). Technical success rate was 96.7% (58 of 60) of patients. Post-dilation was performed in 16.7% (10 of 60) of patients. Post-procedural mean valve gradient was 4.4 ± 2.0 mm Hg. Circular and noncircular valve configuration was present in 41 and 19 cases (68.3% vs. 31.7%), respectively, with similar effective orifice areas (1.74 ± 0.10 cm(2) vs. 1.71 ± 0.22 cm(2), p = NS). In-hospital mortality, myocardial infarction, stroke, and major vascular complications occurred in 6.7% (4 of 60), 0%, 5%, and 10% of patients. There was no valve embolization. New permanent pacing was needed in 11.7% (7 of 60) of patients.
Transcatheter aortic valve implantation without balloon pre-dilation is feasible and safe, resulting in similar acute safety and efficacy as the current standard approach of TAVI with pre-dilation.
本研究旨在评估不经球囊预扩张行经导管主动脉瓣植入术（TAVI）的可行性和安全性。
目前认为，在接受 TAVI 的患者中，球囊预扩张狭窄的主动脉瓣是瓣膜准备的必要步骤，因此被认为是该手术的一个必要环节。然而，目前缺乏支持这一策略的明确证据。相反，预扩张可能部分导致 TAVI 过程中出现的远端栓塞以及房室传导障碍。
共前瞻性纳入了 13 个国际中心的 60 例连续患者（平均年龄 80.1 ± 6.4 岁，53%为女性，平均 logistic EuroScore 23.3 ± 15.2%），这些患者均使用自膨式美敦力 CoreValve 瓣膜（美敦力，明尼苏达州明尼阿波利斯）行 TAVI。
术前平均跨主动脉瓣梯度为 47.8 ± 15.5mmHg，平均有效瓣口面积为 0.67 ± 0.15cm2。60 例患者中，技术成功率为 96.7%（58 例）。16.7%（10 例）的患者进行了后扩张。术后平均瓣口梯度为 4.4 ± 2.0mmHg。瓣膜形态为圆形和非圆形的患者分别为 41 例（68.3%）和 19 例（31.7%），有效瓣口面积相似（1.74 ± 0.10cm2比 1.71 ± 0.22cm2，p = NS）。院内死亡率、心肌梗死、卒中和主要血管并发症的发生率分别为 6.7%（4 例）、0%、5%和 10%。无瓣膜栓塞。11.7%（7 例）的患者需要新的永久性起搏。
不经球囊预扩张行 TAVI 是可行且安全的，其急性安全性和疗效与目前的 TAVI 标准预扩张方法相似。
