Department of Cardiac Surgery, La Timone Hospital, Marseille, France.
J Card Surg. 2021 Aug;36(8):2826-2833. doi: 10.1111/jocs.15665. Epub 2021 May 25.
This report presents 5-year outcomes of the rapid-deployment Edwards Intuity valve in a prospective, single-center study.
All patients who underwent an aortic valve replacement (AVR) with an Edwards Intuity bioprosthesis at La Timone Hospital, Marseille, France, from July 2012 to June 2015 were assessed over a 5-year follow-up period. The primary outcome was overall mortality at 5 years. Secondary outcomes were reoperation, overall mortality and stroke, cardiovascular mortality, composite endpoints defined by the updated Valve Academic Research Consortium-2 (VARC-2), periprosthetic regurgitation, prosthesis-patient mismatch, and the need for new pacemaker implantation.
In total, 170 consecutive patients were assessed, of which 67.1% were males. The mean age was 76 years, mean EuroSCORE II was 3.5% and 5-year overall mortality was 12.4%. At 5 years, reoperation was 2.9%, overall mortality and stroke was 4.1% per patient-year, and cardiovascular mortality was 4.7%. VARC clinical efficacy and VARC time-related valve safety were achieved in 46.0% and 59.9% of patients, respectively. At one month VARC device success was 71.2% and VARC early safety was 87.1%. At one year, mild and moderate periprosthetic regurgitation were 2.4% and 0.6%, respectively, and moderate and severe prosthesis-patient mismatch were 18.8% and 4.8%, respectively. Conduction disturbances needing new PPI occurred in 3.5% patients.
The 5-year outcomes of AVR with the Edwards Intuity valve system demonstrate satisfactory midterm safety and excellent haemodynamic performance.
本报告介绍了在一项前瞻性、单中心研究中，快速部署的 Edwards Intuity 瓣膜的 5 年结果。
2012 年 7 月至 2015 年 6 月，法国马赛 La Timone 医院对所有接受 Edwards Intuity 生物瓣主动脉瓣置换术（AVR）的患者进行了 5 年随访。主要终点是 5 年总死亡率。次要终点是 5 年时的再次手术、总死亡率和卒中、心血管死亡率、根据更新的 Valve Academic Research Consortium-2（VARC-2）定义的复合终点、瓣周漏、假体-患者不匹配以及需要新植入起搏器。
共评估了 170 例连续患者，其中 67.1%为男性。平均年龄为 76 岁，平均 EuroSCORE II 为 3.5%，5 年总死亡率为 12.4%。5 年时，再次手术率为 2.9%，总死亡率和卒中为 4.1%/患者年，心血管死亡率为 4.7%。分别有 46.0%和 59.9%的患者达到了 VARC 临床疗效和 VARC 时间相关的瓣膜安全性。1 个月时 VARC 器械成功率为 71.2%，VARC 早期安全性为 87.1%。1 年时，轻度和中度瓣周漏分别为 2.4%和 0.6%，中度和重度假体-患者不匹配分别为 18.8%和 4.8%。需要新起搏器的传导障碍发生在 3.5%的患者中。
Edwards Intuity 瓣膜系统的 AVR 5 年结果显示出良好的中期安全性和出色的血液动力学性能。
