Tarantini Giuseppe, Purita Paola A M, D'Onofrio Augusto, Fraccaro Chiara, Frigo Anna Chiara, D'Amico Gianpiero, Fovino Luca Nai, Martin Marta, Cardaioli Francesco, Badawy Mostafa R A, Napodano Massimo, Gerosa Gino, Iliceto Sabino
Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy.
Faculty of Medicine, Minia University, Minya, Egypt.
Ann Cardiothorac Surg. 2017 Sep;6(5):473-483. doi: 10.21037/acs.2017.08.02.
Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic performance of the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, California, USA) transcatheter heart valves (THV) are limited. Therefore, this study aimed to compare long-term clinical outcome data and hemodynamic performance of TAVR with either CV or ES.
We reviewed prospectively collected data of 171 patients treated with TAVR for severe aortic stenosis (AS) at our center between June 2007 and December 2010, with last follow-up contact in 2016.
Out of 171 patients treated with TAVR at our Institution, 87 received a CV and 84 an ES THV. Mean age was 81 [78-85] years, and mean Society of Thoracic Surgeons (STS) score was 7.5% (4.5-13.9%). Hemodynamic success by Valve Academic Research Consortium (VARC) definition was 97.1%. Mean trans-prosthetic gradient remained low and stable during follow-up in both groups (at 5-year 9.2±6.4 versus 12.7±5.1 mmHg, P=0.10). Late prosthesis failure occurred in 4 cases (2.4%). Thirty-day mortality was 4.7%, and estimated survival rates by Kaplan-Meyer after 1, 5 and 8 years were 87.6%, 44.9%, and 24.5%, respectively, without difference between THV groups. Rates of cardiovascular death, stroke, myocardial infarction (MI) and congestive heart failure (CHF) were also similar with CV and ES at long-term follow-up. History of CHF, pre-existent severe mitral regurgitation, paravalvular leak grade ≥2+, and chronic obstructive pulmonary disease were independent predictors of late mortality at multivariable analysis.
Clinical and hemodynamic outcomes of patients treated by self-expandable CV or balloon-expandable ES THV were favorable and similar throughout long-term follow-up, with a rate of prosthesis failure of less than 3%.
关于经导管主动脉瓣置换术(TAVR)中自膨胀式CoreValve(CV)和球囊扩张式Edwards SAPIEN XT(ES)(美国加利福尼亚州尔湾市爱德华兹生命科学公司)经导管心脏瓣膜(THV)的长期临床结局和血流动力学表现的数据有限。因此,本研究旨在比较使用CV或ES进行TAVR的长期临床结局数据和血流动力学表现。
我们回顾了2007年6月至2010年12月在我们中心接受TAVR治疗重度主动脉瓣狭窄(AS)的171例患者的前瞻性收集数据,最后一次随访时间为2016年。
在我们机构接受TAVR治疗的171例患者中,87例接受了CV THV,84例接受了ES THV。平均年龄为81[78 - 85]岁,平均胸外科医师协会(STS)评分为7.5%(4.5 - 13.9%)。根据瓣膜学术研究联盟(VARC)定义的血流动力学成功率为97.1%。两组随访期间平均跨瓣压差均保持较低且稳定(5年时分别为9.2±�.4与12.7±5.1 mmHg,P = 0.10)。晚期瓣膜功能障碍发生4例(2.4%)。30天死亡率为4.7%,Kaplan - Meyer法估计1年、5年和8年后的生存率分别为87.6%、44.9%和24.5%,THV组间无差异。长期随访时,CV和ES的心血管死亡、卒中、心肌梗死(MI)和充血性心力衰竭(CHF)发生率也相似。多变量分析显示,CHF病史、术前存在严重二尖瓣反流、瓣周漏≥2+级和慢性阻塞性肺疾病是晚期死亡的独立预测因素。
自膨胀式CV或球囊扩张式ES THV治疗患者的临床和血流动力学结局良好且在长期随访中相似,瓣膜功能障碍发生率低于3%。