经股动脉入路行 SAPIEN XT 主动脉瓣置换术治疗中危主动脉瓣狭窄患者的疗效和安全性：SOLACE-AU 试验。
Performance and Safety of Transfemoral TAVI With SAPIEN XT in Australian Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: SOLACE-AU Trial.
机构信息
Fiona Stanley Hospital, Perth, WA, Australia.
Alfred Health, Melbourne, Vic, Australia.
出版信息
Heart Lung Circ. 2020 Dec;29(12):1839-1846. doi: 10.1016/j.hlc.2020.04.010. Epub 2020 Jun 11.
BACKGROUND
To determine the safety and performance of the SAPIEN XT transcatheter heart valve (THV) in Australian patients with severe aortic stenosis (AS) and intermediate surgical risk.
METHODS
Eligible patients in this multi-centre, prospective, consecutively enrolled, non-randomised, clinical trial, received transcatheter aortic valve replacement via femoral artery access. Follow-up visits were at discharge, 30 days, and 6, 12, and 24 months. The primary endpoint was Valve Academic Research Consortium-2 composite safety at 30 days: all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury-Stage 3, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring repeat procedure. Other endpoints were device success (successful vascular access, delivery, and deployment; correct position; intended performance mean aortic valve gradient <20 mmHg, mild or less paravalvular aortic regurgitation [PAR]; and only one valve implanted) and New York Heart Association functional class (NYHA). Kaplan-Meier (KM) estimates were calculated for the primary endpoint.
RESULTS
At baseline, mean patient (N=199) age was 85.5 years, mean Society of Thoracic Surgeon score was 5.9, and 78.4% were in NYHA class III/IV. The primary composite endpoint KM estimate was 12.1%. Device success was 88.8%. SAPIEN XT was implanted in the proper location in 98.5% (n=2: valve-in-valve procedures, n=1: no implant due to left main coronary artery occlusion). No device malfunctions were reported. The post procedure PAR was mild or less in 93.8% of patients. Mean aortic gradient decreased from baseline (50.0 mmHg) to 2 years (10.3 mmHg). Most patients (90.9%) were in NYHA class I/II at 30 days. New permanent pacemaker rate was 8.1%. Stroke at 30 days was 3.5% (1.5% disabling).
CONCLUSION
SAPIEN XT was safe and improved heart failure symptoms and valve haemodynamics in this cohort of Australian patients.
背景
为了确定经导管主动脉瓣置换术（TAVR）在澳大利亚患有严重主动脉瓣狭窄（AS）和中等手术风险的患者中的安全性和性能。
方法
这项多中心、前瞻性、连续入组、非随机的临床试验中，符合条件的患者经股动脉入路接受了 TAVR。随访时间为出院时、30 天、6 个月、12 个月和 24 个月。主要终点是 30 天的 Valve Academic Research Consortium-2 复合安全性：全因死亡率、全脑卒、有生命危险的出血、急性肾损伤 3 期、需要介入治疗的冠状动脉阻塞、主要血管并发症和需要再次手术的瓣膜相关功能障碍。其他终点包括器械成功率（成功的血管入路、输送和部署；正确的位置；预期性能平均主动脉瓣梯度<20mmHg，轻度或更少的瓣周漏；仅植入一个瓣膜）和纽约心脏协会功能分级（NYHA）。主要终点的 Kaplan-Meier（KM）估计值。
结果
在基线时，平均患者（N=199）年龄为 85.5 岁，平均胸外科医师协会评分（STS）为 5.9，78.4%为 NYHA 分级 III/IV 级。主要复合终点的 KM 估计值为 12.1%。器械成功率为 88.8%。SAPIEN XT 正确植入位置，98.5%（n=2：瓣中瓣术，n=1：因左主干冠状动脉闭塞未植入）。无器械功能障碍报告。术后 PAR 为轻度或更少，93.8%的患者。平均主动脉梯度从基线（50.0mmHg）下降至 2 年（10.3mmHg）。大多数患者（90.9%）在 30 天内 NYHA 分级为 I/II。新的永久性起搏器植入率为 8.1%。30 天内卒中发生率为 3.5%（1.5%为致残性）。
结论
在这组澳大利亚患者中，SAPIEN XT 是安全的，并改善了心力衰竭症状和瓣膜血流动力学。
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