Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust, London, United Kingdom.
Department of Cardiology, Leeds General Infirmary, Leeds, United Kingdom.
Catheter Cardiovasc Interv. 2019 Mar 1;93(4):751-757. doi: 10.1002/ccd.27934. Epub 2018 Nov 5.
The UK & Ireland Implanters' registry is a multicenter registry which reports on real-world experience with novel transcatheter heart valves.
The 34 mm Evolut R transcatheter aortic valve is a self-expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus.
Between January 2017 and April 2018, clinical, procedural and 30-day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2(VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days.
A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm . Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all-cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%.
Real-world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.
英国和爱尔兰植入者登记处是一个多中心登记处，报告了新型经导管心脏瓣膜的真实世界经验。
34mm Evolut R 经导管主动脉瓣是一种自扩张和完全可回收的经导管主动脉瓣，旨在治疗主动脉瓣环较大的患者。
2017 年 1 月至 2018 年 4 月，从英国和爱尔兰的 17 个参与中心的所有接受 34mm Evolut R 瓣膜的患者中前瞻性地收集了临床、手术和 30 天结局数据。主要疗效终点是 Valve Academic Research Consortium-2（VARC-2）定义的器械成功。主要安全性终点是 VARC-2 定义的 30 天早期安全性复合终点。
共 217 例患者尝试植入。平均年龄为 79.5±8.8 岁，胸外科医师协会预测死亡率 5.2%±3.4%。91.2%的患者采用了髂股动脉入路。器械成功率为 79.7%。平均梯度为 7.0±4.6mmHg，有效瓣口面积为 2.0±0.6cm 。瓣周漏大于轻度的为 7.2%。植入了 15.7%的新永久性起搏器。早期安全性为 91.2%。30 天全因死亡率为 3.2%，卒中 3.7%，大血管并发症 2.3%。
34mm Evolut R 经导管主动脉瓣的真实世界经验显示出可接受的手术成功率、安全性、瓣膜功能和新永久性起搏器植入的发生率。
