St. Johannes Hospital, Dortmund, Germany.
Herzzentrum Leipzig, Leipzig, Germany.
JACC Cardiovasc Interv. 2017 Aug 14;10(15):1538-1547. doi: 10.1016/j.jcin.2017.05.021.
The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system.
The Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances.
Patients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study. Patients were implanted with the full range of Portico heart valves (23, 25, 27, and 29 mm) using the transfemoral approach. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included valve performance, improvement in functional class, and procedural outcomes as defined by Valve Academic Research Consortium criteria.
A total of 220 patients (mean age 83.0 ± 4.6 years, 74.3% women, mean Society of Thoracic Surgeons score 5.8%) had valves implanted. All resheathing and repositioning attempts (n = 72) were successful. At 30 days, all-cause mortality was 3.6%. Procedural outcomes included disabling (major) stroke (3.2%), major vascular complications (7.2%), and permanent pacemaker implantation (13.5%). Compared with baseline, 75.8% of patients improved by ≥1 New York Heart Association functional class at 30 days. The rate of moderate paravalvular leak was 5.7%, with no severe paravalvular leak reported. No differences in paravalvular leak incidence and severity were observed among valve sizes (p = 0.24).
Across all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients.
本研究旨在评估 Portico 经导管主动脉瓣置换系统提供的全系列瓣膜尺寸的短期安全性和性能。
Portico 经导管主动脉心脏瓣膜是一种完全可重新护套、可重新定位和自扩张的生物假体，旨在实现最佳瓣膜位置和血液动力学性能，并限制传导干扰。
2011 年 12 月至 2015 年 9 月，多学科心脏团队认为具有高手术风险的有症状（纽约心脏协会功能分级≥II 级）严重主动脉瓣狭窄的患者（n=222）参与了这项前瞻性、非随机、多中心研究。使用经股动脉入路为患者植入全系列 Portico 心脏瓣膜（23、25、27 和 29mm）。主要终点是 30 天的全因死亡率。次要终点包括瓣膜性能、功能分级改善和 Valve Academic Research Consortium 标准定义的程序结果。
共植入 220 例患者（平均年龄 83.0±4.6 岁，74.3%为女性，平均胸外科医生协会评分 5.8%）。所有重新护套和重新定位尝试（n=72）均成功。30 天时，全因死亡率为 3.6%。程序结果包括致残性（主要）中风（3.2%）、大血管并发症（7.2%）和永久性起搏器植入（13.5%）。与基线相比，75.8%的患者在 30 天内改善了≥1 个纽约心脏协会功能分级。中度瓣周漏的发生率为 5.7%，无严重瓣周漏报告。瓣膜尺寸之间未见瓣周漏发生率和严重程度的差异（p=0.24）。
在所有瓣膜尺寸中，使用可重新定位的 Portico 经导管主动脉瓣置换系统为高危患者的主动脉瓣狭窄提供了安全有效的治疗。
