Background

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).

Methods

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.

Results

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).

Conclusions

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.

中文翻译：

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无支架vs支架生物假体替代主动脉瓣膜置换术：长期随访和自然瓣膜性心内膜炎患者亚组分析的病例对照比较

背景

当前的回顾性证据表明，与Carpentier Edwards Perimount支架式主动脉瓣膜（CEP）（Edwards Lifesciences Inc.，Irvine，California）相比，Sorin Freedom Solo无支架主动脉瓣膜（SFS）（LivaNova PLC，UK，UK）具有相似的临床和优异的血液动力学结果。 ， 美国）。迄今为止，尚无报道描述病例匹配的长期预后以及对天然瓣膜性心内膜炎（NVE）进行治疗的分析。

方法

从2004年到2014年，连续77例患者（研究组，男性59.7％，68.9±12.5岁，logEuroSCORE II 7.6±12.3％）接受了SFS外科主动脉瓣置换术（SAVR）。从我们的数据库中检索出SAVR伴CEP的对照组患者，并与研究组就包括术前心内膜炎在内的15个参数进行了匹配。回顾性分析急性围手术期结局和随访数据（平均随访时间48.7±29.8个月，完成率95％）。

结果

在30天的随访期间，早期死亡率没有差异（3/77； 3.9％对4/77； 5.2％； p = 0.699）。超声心动图检查发现，SFS组的术后瓣膜后压力梯度较低（最大17.0±8.2 vs. 24.5±9.2 mmHg，p <0.001 /平均压力8.4±4.1 vs. 13.1±5.9 mmHg，p <0.001）。在SFS组中，结构性瓣膜变性（SVD）（5.2％vs.0％; p = 0.04）和因SVD或人工瓣膜心内膜炎（PVE）引起的瓣膜外植（9.1％vs. 1.3％; p = 0.04）更常见。随访期间全因死亡率为20.8％，而14.3％（p = 0.397）。将患者分为NVE亚组和各自使用的生物假体后，SFS的NVE病例死亡率降低（p = 0.031）。

结论

在该比较中证实了SFS的血液动力学优势。但是，在这项研究中，就SVD和PVE率以及NVE存活率而言，临床结果较差。因此，我们不建议使用SFS治疗NVE。