Chiariello Giovanni Alfonso, Di Mauro Michele, Villa Emmanuel, Koulouroudias Marinos, Bruno Piergiorgio, Mazza Andrea, Pasquini Annalisa, D'Avino Serena, De Angelis Gaia, Corigliano Kiara, Marcolini Alberta, Zancanaro Edoardo, Saitto Guglielmo, Meani Paolo, Massetti Massimo, Lorusso Roberto
Department of Cardiovascular Sciences, Agostino Gemelli Foundation Polyclinic IRCCS, 00136 Rome, Italy.
School of Medicine and Surgery, Catholic University of the Sacred Heart, 00168 Rome, Italy.
J Clin Med. 2024 Nov 13;13(22):6829. doi: 10.3390/jcm13226829.
In recent years, in case of aortic valve replacement (AVR), a significant increase in the use of bioprostheses has been observed. The Perceval sutureless bioprosthesis has proven to be safe and reliable in the short and mid-term, with limited but promising long-term results. An updated systematic review with the long-term results of patients who underwent a sutureless bioprosthesis implantation with a Perceval biological valve is herewith presented. Studies published between 2015 and 2024, including the long-term outcomes-with clinical as well as echocardiographic information for up to five years-of patients who underwent a Perceval implantation for AVR were selected from the published literature. The Cochrane GRADE system was used to assess the study quality, and the risk of bias in non-randomized studies (ROBINS-I) tool was used to evaluate studies. Ten studies were selected with an overall number of 5221 patients. The long-term survival ranged from 64.8 to 87.9%, freedom from structural valve degeneration (SVD) from 96.1 to 100%, freedom from significant paravalvular leak from 98.5 to 100%, freedom from prosthetic endocarditis from 90.7 to 99%, and freedom from reintervention from 94 to 100%. The long-term mortality ranged from 6.5 to 27.4%. SVD was observed in 0-4.8% patients. Significant paravalvular leak was observed in 0-3.4% patients, and infective endocarditis was observed in 0-3.4%. A bioprosthesis-related reintervention at long-term follow-up was required for 0-4.3% of patients, and 1.7-7.1% of patients required a late new pacemaker implantation. The transprosthetic mean pressure gradient ranged from 9 to 14.7 mmHg, peak pressure gradient ranged from 17.8 to 26.5 mmHg, and EOA ranged from 1.5 to 1.7 cm. This systematic review shows that there is still a paucity of data about sutureless bioprostheses. Nevertheless, the clinical results from prospective studies or retrospective series are encouraging. Medium- and long-term results seem to support the increasing use of this type of prosthesis.
近年来，在主动脉瓣置换术（AVR）中，生物瓣膜的使用显著增加。已证明Perceval无缝合生物瓣膜在短期和中期是安全可靠的，长期结果有限但很有前景。本文呈现了一项关于接受Perceval生物瓣膜无缝合植入术患者长期结果的最新系统评价。从已发表的文献中选取了2015年至2024年间发表的研究，包括接受Perceval植入术进行AVR患者的长期结局——长达五年的临床及超声心动图信息。采用Cochrane GRADE系统评估研究质量，使用非随机研究偏倚风险（ROBINS-I）工具评估研究。选取了10项研究，共5221例患者。长期生存率为64.8%至87.9%，无结构性瓣膜退变（SVD）率为96.1%至100%，无明显瓣周漏率为98.5%至100%，无人工瓣膜心内膜炎率为90.7%至99%，无需再次干预率为94%至100%。长期死亡率为6.5%至27.4%。0至4.8%的患者出现SVD。0至3.4%的患者出现明显瓣周漏，0至3.4%的患者出现感染性心内膜炎。0至4.3%的患者在长期随访中需要进行生物瓣膜相关的再次干预，1.7%至7.1%的患者需要晚期植入新的起搏器。跨瓣平均压力阶差为9至14.7 mmHg，峰值压力阶差为17.8至26.5 mmHg，有效瓣口面积为1.5至1.7 cm²。该系统评价表明，关于无缝合生物瓣膜的数据仍然匮乏。然而，前瞻性研究或回顾性系列的临床结果令人鼓舞。中长期结果似乎支持这种类型假体的使用增加。
