Nistal J F, Hurlé A, Gutiérrez J A, Mazorra F, Revuelta J M
Department of Cardiovascular Surgery, Hospital Universitario Marqués de Valdecilla, University of Cantabria, Santander, Spain.
J Thorac Cardiovasc Surg. 1995 Sep;110(3):688-95; discussion 695-6. doi: 10.1016/S0022-5223(95)70100-1.
Manufacturing factors have seldom been implicated as a direct cause of structural deterioration of valvular bioprostheses; this phenomenon has generally been considered to be of a host-dependent origin. We analyzed the clinical and pathologic data from 12 Carpentier-Edwards mitral bioprostheses removed from 12 patients because of severe dysfunction and showing detachment of the porcine aortic wall from the stent in one commissure or more. These 12 prostheses were part of a group of 92 such valves that were explanted and displayed structural deterioration. They belong to a population of 405 Carpentier-Edwards bioprostheses implanted in the mitral position in our institution between May 1978 and November 1988. The patients included three men and nine women with a mean age of 54 +/- 13 years. One patient had a history of chronic renal failure, and two had systemic hypertension. Prosthesis sizes were 29, 31, and 33 mm (n = 4 for each size). The models of the valves were 6625 (n = 8) and 6650 (n = 4). Mean duration of implantation of the prostheses was 99 +/- 27 months (52 to 136 months) and did not differ depending on the model. There was no significant clustering of commissural detachments depending on valve size, year of implantation, or gender of the patient. No similar phenomenon was observed among 76 explanted aortic Carpentier-Edwards bioprostheses with structural deterioration from a population of 441 valves implanted during the same time frame. Native porcine aortic roots (n = 5) and aortic Carpentier-Edwards bioprostheses explanted because of structural deterioration (n = 4) were used as controls for comparison. Macroscopic examination showed single commissural dehiscence in 10 patients and double in two. Radiology disclosed no or mild mineralization in eight valves and no calcium in the area of aortic wall dehiscence, except for heavily calcified valves. Light microscopy evidenced a significant thinning of the aortic wall at the paracommissural level of mitral bioprostheses (351 +/- 68 microns) compared with either aortic bioprostheses (526 +/- 59 microns; p < 0.01) or control native porcine aortic roots (419 +/- 50 microns; p < 0.01). No difference was found in terms of aortic wall thickness between detached (322 +/- 42 microns) and intact (366 +/- 74 microns) commissures in mitral bioprostheses.(ABSTRACT TRUNCATED AT 400 WORDS)
制造因素很少被认为是生物瓣膜结构退化的直接原因；这种现象通常被认为源于宿主相关因素。我们分析了12例因严重功能障碍而取出的Carpentier-Edwards二尖瓣生物瓣膜的临床和病理数据，这些瓣膜在一个或多个瓣叶连接处出现猪主动脉壁与支架分离。这12个瓣膜是92个因结构退化而被取出的此类瓣膜中的一部分。它们属于1978年5月至1988年11月间在我院二尖瓣位置植入的405个Carpentier-Edwards生物瓣膜。患者包括3名男性和9名女性，平均年龄为54±13岁。1例患者有慢性肾衰竭病史，2例有系统性高血压。瓣膜尺寸为29、31和33毫米（每种尺寸4个）。瓣膜型号为6625（8个）和6650（4个）。瓣膜植入的平均时长为99±27个月（52至136个月），且不同型号之间无差异。瓣叶连接处分离情况在瓣膜尺寸、植入年份或患者性别方面无明显聚集现象。在同期植入的441个主动脉Carpentier-Edwards生物瓣膜中，76个因结构退化而被取出的瓣膜未观察到类似现象。取自天然猪主动脉根部（5个）和因结构退化而取出的主动脉Carpentier-Edwards生物瓣膜（4个）用作对照比较。宏观检查显示，10例患者为单个瓣叶连接处裂开，2例为两个瓣叶连接处裂开。放射学检查显示，8个瓣膜无矿化或仅有轻度矿化，除严重钙化瓣膜外，主动脉壁裂开区域无钙化。光学显微镜检查表明，二尖瓣生物瓣膜瓣叶旁水平的主动脉壁显著变薄（351±68微米），与主动脉生物瓣膜（526±59微米；p<0.01）或对照天然猪主动脉根部（419±50微米；p<0.01）相比。二尖瓣生物瓣膜中，裂开（322±42微米）和未裂开（366±74微米）的瓣叶连接处的主动脉壁厚度无差异。（摘要截选至400字）
