Stefanelli Guglielmo, Pirro Fabrizio, Danniballe Giuseppe, Olaru Alina, Meli Marco, Weltert Luca
Hesperia Hospital, Modena, Italy. Electronic correspondence:
Hesperia Hospital, Modena, Italy.
J Heart Valve Dis. 2017 Sep;26(5):518-527.
The study aim was to investigate the hemodynamic behavior over time and ease of implant and durability of the Sorin Pericarbon Freedom (SPF)® stentless pericardial aortic xenograft.
Between March 2003 and April 2010, a total of 251 consecutive, non-selected patients (mean age 70.1 years; range: 17-89 years; 17.1% aged >80 years) received a SPF bioprosthesis as an aortic valve substitute at the authors' institution. All implantations were performed by a single surgeon using a classical, double-line, subcoronary implant technique. Of these patients. 108 (43%) underwent a concomitant procedure. The mean logistic EuroSCORE was 8.3. Patients were followed for complications and hemodynamic evaluation. Echocardiographic controls and clinical data were obtained at discharge, and at six months' and eight years' follow up.
The in-hospital/30-day mortality was 1.2% for the entire group, but 0% for patients with isolated valve replacement. A total of 27 deaths had occurred at the time of the last follow up (22 were due to non-cardiac causes). At follow up (mean 3.7 years; range: 0-7.8 years), 91.1% of survivors were in NYHA classes I or II. Freedom from reoperation and from structural valve deterioration was 96.0% and 96.8%, respectively, at 7.8 years. The mean pressure gradient of the series (measured using echocardiography) was 10.3 ± 4.5 mmHg at discharge, and 8.3 ± 4.5mmHg at the time of the last follow up. The mean effective orifice area was 1.85 ± 0.70 cm2 for the entire series, and there was an absence of prosthesis-patient mismatch in 90% of patients.
The study results confirmed the favourable hemodynamic behavior, low risk of implantation and acceptable durability of the pericardial stentless SPF aortic prosthesis. The data also endorsed use of the SPF as an aortic valve substitute, even in a young and active population, and particularly in the presence of a small aortic annulus. The accuracy of implantation remains a crucial factor for durability and subsequent satisfactory hemodynamic performance. A longer follow up would provide further information with regards to complications and durability of the SPF prosthesis.
本研究旨在调查索林Pericarbon Freedom（SPF）®无支架心包主动脉异种移植物随时间的血流动力学表现、植入的难易程度和耐用性。
2003年3月至2010年4月期间，共有251例连续入选的患者（平均年龄70.1岁；范围：17 - 89岁；17.1%年龄>80岁）在作者所在机构接受了SPF生物假体作为主动脉瓣置换物。所有植入手术均由一名外科医生采用经典的双线、冠状动脉下植入技术进行。在这些患者中，108例（43%）接受了同期手术。平均逻辑欧洲心脏手术风险评估系统（EuroSCORE）为8.3。对患者进行并发症和血流动力学评估随访。在出院时、术后6个月和8年随访时获取超声心动图检查结果和临床数据。
整个组的住院/30天死亡率为1.2%，但单纯瓣膜置换患者的死亡率为0%。在最后一次随访时共发生27例死亡（22例死于非心脏原因）。在随访时（平均3.7年；范围：0 - 7.8年），91.1%的幸存者心功能分级为纽约心脏协会（NYHA）I级或II级。在7.8年时，再次手术和结构性瓣膜退变的免发生率分别为96.0%和96.8%。该系列患者出院时（采用超声心动图测量）的平均压力阶差为10.3±4.5 mmHg，最后一次随访时为8.3±4.5 mmHg。整个系列的平均有效瓣口面积为1.85±0.70 cm²，90%的患者不存在人工瓣膜 - 患者不匹配情况。
研究结果证实了心包无支架SPF主动脉假体良好的血流动力学表现、低植入风险和可接受的耐用性。这些数据也支持将SPF用作主动脉瓣置换物，即使是在年轻且活动量较大的人群中，尤其是在主动脉瓣环较小的情况下。植入的准确性仍然是耐用性和随后令人满意的血流动力学性能的关键因素。更长时间的随访将提供关于SPF假体并发症和耐用性的更多信息。
