Schaefer Andreas, Dickow Jannis, Schoen Gerhard, Westhofen Sumi, Kloss Lisa, Al-Saydali Tarik, Reichenspurner Hermann, Philipp Sebastian A, Detter Christian
Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
PLoS One. 2018 Jan 16;13(1):e0191171. doi: 10.1371/journal.pone.0191171. eCollection 2018.
Current retrospective evidence suggests similar clinical and superior hemodynamic outcomes of the Sorin Freedom Solo stentless aortic valve (SFS) (LivaNova PLC, London, UK) compared to the Carpentier Edwards Perimount stented aortic valve (CEP) (Edwards Lifesciences Inc., Irvine, California, USA). To date, no reports exist describing case-matched long-term outcomes and analysis for treatment of native valve endocarditis (NVE).
From 2004 through 2014, 77 consecutive patients (study group, 59.7% male, 68.9 ± 12.5 years, logEuroSCORE II 7.6 ± 12.3%) received surgical aortic valve replacement (SAVR) with the SFS. A control group of patients after SAVR with the CEP was retrieved from our database and matched to the study group regarding 15 parameters including preoperative endocarditis. Acute perioperative outcomes and follow-up data (mean follow-up time 48.7±29.8 months, 95% complete) were retrospectively analyzed.
No differences in early mortality occurred during 30-day follow up (3/77; 3.9% vs. 4/77; 5.2%; p = 0.699). Echocardiographic findings revealed lower postprocedural transvalvular pressure gradients (max. 17.0 ± 8.2 vs. 24.5 ± 9.2 mmHg, p< 0.001/ mean pressure of 8.4 ± 4.1 vs. 13.1 ± 5.9 mmHg, p< 0.001) in the SFS group. Structural valve degeneration (SVD) (5.2% vs. 0%; p = 0.04) and valve explantation due to SVD or prosthetic valve endocarditis (PVE) (9.1% vs. 1.3%; p = 0.04) was more frequent in the SFS group. All-cause mortality during follow-up was 20.8% vs. 14.3% (p = 0.397). When patients were divided into subgroups of NVE and respective utilized bioprosthesis, the SFS presented impaired outcomes regarding mortality in NVE cases (p = 0.031).
The hemodynamic superiority of the SFS was confirmed in this comparison. However, clinical outcomes in terms of SVD and PVE rates, as well as survival after NVE, were inferior in this study. Therefore, we are reluctant to recommend utilization of the SFS for treatment of NVE.
目前的回顾性证据表明,与卡朋蒂埃爱德华兹Perimount带支架主动脉瓣(CEP)(美国加利福尼亚州尔湾市爱德华兹生命科学公司)相比,索林Freedom Solo无支架主动脉瓣(SFS)(英国伦敦LivaNova PLC公司)具有相似的临床效果和更优的血流动力学结果。迄今为止,尚无关于匹配病例的长期结果及天然瓣膜心内膜炎(NVE)治疗分析的报告。
2004年至2014年期间,77例连续患者(研究组,男性占59.7%,年龄68.9±12.5岁,欧洲心脏手术风险评估系统II评分7.6±12.3%)接受了SFS主动脉瓣置换术(SAVR)。从我们的数据库中检索出接受CEP SAVR的对照组患者,并根据包括术前心内膜炎在内的15项参数与研究组进行匹配。对围手术期急性结果和随访数据(平均随访时间48.7±29.8个月,完成率95%)进行回顾性分析。
30天随访期间早期死亡率无差异(3/77;3.9%对4/77;5.2%;p = 0.699)。超声心动图结果显示,SFS组术后跨瓣压差较低(最大值17.0±8.2对24.5±9.2 mmHg,p<0.001/平均压差8.4±4.1对13.1±5.9 mmHg,p<0.001)。SFS组结构性瓣膜退变(SVD)(5.2%对0%;p = 0.04)以及因SVD或人工瓣膜心内膜炎(PVE)导致的瓣膜取出术(9.1%对1.3%;p = 0.04)更为常见。随访期间全因死亡率为20.8%对14.3%(p = 0.397)。当将患者分为NVE亚组及相应使用的生物瓣膜时,SFS在NVE病例的死亡率方面表现较差(p = 0.031)。
在本次比较中证实了SFS的血流动力学优势。然而,本研究中SVD和PVE发生率以及NVE后的生存率等临床结果较差。因此,我们不建议使用SFS治疗NVE。