Kermen Stéphane, Aupart Arthur, Bonal Myriam, Strella Juliette, Aupart Michel, Espitalier Fabien, Morisseau Marlène, Bernard Anne, Bourguignon Thierry
Department of Cardiac Surgery, Tours University Hospital, Tours, France.
Department of Cardiac Surgery, Tours University Hospital, Tours, France.
J Thorac Cardiovasc Surg. 2025 Jan;169(1):92-102.e1. doi: 10.1016/j.jtcvs.2023.11.021. Epub 2023 Nov 21.
This study evaluated the very long-term results of the Carpentier-Edwards pericardial bioprosthesis in the mitral position, with particular attention to structural valve deterioration based on echocardiographic criteria.
From 1984 to 2016, 648 patients (mean age 68.8 years; 53.9% female) underwent mitral valve replacement using the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. Multiple valve replacements were excluded. Clinical, operative, and follow-up data were prospectively recorded. The mean follow-up was 7.8 ± 5.4 years, for a total of 5043 valve-years. The follow-up data were 98.3% complete (11 patients lost). Structural valve deterioration was determined by strict echocardiographic assessment based on Heart Valve Collaboratory criteria.
Operative mortality was 4%. A total of 322 late deaths occurred, for a linearized rate of 6.4%/valve-year. The actuarial survival rate at 15 years was 31.4 ± 2.6%. Age at implantation, male sex, and preoperative New York Heart Association class III or IV were significant risk factors affecting late survival. Actuarial freedoms from complications at 15 years were thromboembolism, 92.5 ± 1.9%; major bleeding, 93.8 ± 1.7%; endocarditis, 93.2 ± 1.3%; and explantation due to structural valve deterioration, 69.3 ± 3.5%. The median survival time for explantation due to structural valve deterioration was 21.7 years for the entire cohort (16.1 years for patients <65 years old). Based on echocardiographic data, actuarial freedom from severe and moderate/severe structural valve deterioration at 15 years were 64.0 ± 3.6% and 52.1 ± 3.6%, respectively.
With low 15-year rates of valve-related events and structural valve deterioration based on Heart Valve Collaboratory echocardiographic criteria, the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis remains a reliable choice for a mitral tissue valve.
本研究评估了Carpentier-Edwards心包生物瓣置换二尖瓣的长期结果，尤其关注基于超声心动图标准的瓣膜结构退化情况。
1984年至2016年期间，648例患者（平均年龄68.8岁；53.9%为女性）接受了使用Carpentier-Edwards PERIMOUNT心包生物瓣的二尖瓣置换术。排除多次瓣膜置换病例。前瞻性记录临床、手术及随访数据。平均随访时间为7.8±5.4年，总计5043个瓣膜年。随访数据完整率为98.3%（11例患者失访）。根据心脏瓣膜协作组标准，通过严格的超声心动图评估确定瓣膜结构退化情况。
手术死亡率为4%。共发生322例晚期死亡，线性化死亡率为6.4%/瓣膜年。15年时的精算生存率为31.4±2.6%。植入时年龄、男性性别以及术前纽约心脏协会心功能分级III或IV级是影响晚期生存的显著危险因素。15年时血栓栓塞的精算无并发症发生率为92.5±1.9%；大出血为93.8±1.7%；心内膜炎为93.2±1.3%；因瓣膜结构退化而进行瓣膜置换的发生率为69.3±3.5%。整个队列因瓣膜结构退化而进行瓣膜置换的中位生存时间为21.7年（<65岁患者为16.1年）。根据超声心动图数据，15年时无严重及中/重度瓣膜结构退化的精算发生率分别为64.0±3.6%和52.1±3.6%。
根据心脏瓣膜协作组超声心动图标准，Carpentier-Edwards PERIMOUNT心包生物瓣15年瓣膜相关事件及瓣膜结构退化发生率较低，仍是二尖瓣组织瓣的可靠选择。
