用戊二醛保存的主动脉同种异体移植物进行二尖瓣置换术。

Salles C A, Buffolo E, Andrade J C, Palma J H, Silva R R, Santiago R, Casagrande I S, Moreira M C

Hospital Felicio Rocho, Federal University of Minas Gerais, Medical School, Belo Horizonte, Brazil.

Eur J Cardiothorac Surg. 1998 Feb;13(2):135-43. doi: 10.1016/s1010-7940(97)00320-5.

OBJECTIVE

To present long-term results after mitral valve replacement with stent mounted glutaraldehyde preserved aortic allografts in patients older than 15 years. The clinical support for this study was to combine the glutaraldehyde technique of biological tissue preservation with the advantages of allografts when compared to xenografts. This was demonstrated in previous studies using other methods of tissue processing.

METHODS

Between September 1984 and November 1994, 70 patients aged 16-77 years (mean 35.4 years) underwent mitral valve replacement with this preserved and mounted allograft. Of these, 40 patients (57.2%) were aged 16-35 years and 15 (21.4%) were 20 years old or younger; 46 (65.7%) were females and 24 (34.3%) males. Single mitral valve replacement was performed in 60 patients and 10 were also subjected to other combined cardiac procedures. Human aortic valves were obtained during routine autopsy, processed in glutaraldehyde and mounted into flexible stents, using the same technique as that used for porcine bioprostheses.

RESULTS

Hospital mortality was 1.4%. Total follow-up was 543.1 patient-years, corresponding to a mean follow-up of 7.9 years per patient. Echocardiography demonstrated a hemodynamic performance similar to porcine bioprostheses. Late mortality was 0.7 +/- 0.6% per patient-year and the causes were congestive heart failure in 2, prosthetic endocarditis in 1 and acute myocardial infarction in 1. The 12-year actuarial survival was 92.4 +/- 3.2%. The incidence of late complications was 5.2 +/- 1.2% per patient-year, including congestive heart failure, prosthetic endocarditis, periprosthetic leak, thromboembolic episodes, recurrence of rheumatic disease, coronary artery disease and allograft failure. Complications related to heart disease represented 2.8 +/- 0.6% and allobioprosthesis-related 2.4 +/- 0.5% per patient-year. The 12-year actuarial freedom from primary valve failure was 81.0 +/- 15.0%. The incidence of reoperations was 1.5 +/- 0.8% per patient-year and the main indication was prosthetic endocarditis. Other causes were periprosthetic leak, aortic insufficiency in the native aortic valve and allobioprosthesis dysfunction. Functional results demonstrated a significant improvement in patients clinical condition.

CONCLUSION

This 12-year follow-up shows a very low incidence of primary allograft failure for patients older than 15 years undergoing mitral valve replacement, and much superior than our results with porcine bioprosthesis in the same age group. This supports our assumption that this investigational valve represents a new advance in cardiac valve surgery.

目的

介绍15岁以上患者采用支架式戊二醛保存主动脉同种异体移植物进行二尖瓣置换术后的长期结果。本研究的临床依据是，与异种移植物相比，将生物组织保存的戊二醛技术与同种异体移植物的优势相结合。先前使用其他组织处理方法的研究已证明了这一点。

方法

1984年9月至1994年11月，70例年龄在16 - 77岁（平均35.4岁）的患者接受了这种保存并安装的同种异体移植物二尖瓣置换术。其中，40例患者（57.2%）年龄在16 - 35岁，15例（21.4%）年龄在20岁及以下；46例（65.7%）为女性，24例（34.3%）为男性。60例患者进行了单纯二尖瓣置换术，10例还接受了其他联合心脏手术。人主动脉瓣在常规尸检时获取，用戊二醛处理并安装到柔性支架中，采用与猪生物瓣膜相同的技术。

结果

医院死亡率为1.4%。总随访时间为543.1患者年，相当于每位患者平均随访7.9年。超声心动图显示血流动力学表现与猪生物瓣膜相似。晚期死亡率为每年0.7±0.6%，病因分别为充血性心力衰竭2例、人工瓣膜心内膜炎1例和急性心肌梗死1例。12年预期生存率为92.4±3.2%。晚期并发症发生率为每年5.2±1.2%，包括充血性心力衰竭、人工瓣膜心内膜炎、人工瓣膜周漏、血栓栓塞事件、风湿性疾病复发、冠状动脉疾病和同种异体移植物失败。与心脏病相关的并发症每年发生率为2.8±0.6%，与生物人工瓣膜相关的为2.4±0.5%。12年原发性瓣膜失败的预期无事件生存率为81.0±15.0%。再次手术发生率为每年1.5±0.8%，主要指征是人工瓣膜心内膜炎。其他原因包括人工瓣膜周漏、自体主动脉瓣主动脉瓣关闭不全和生物人工瓣膜功能障碍。功能结果显示患者临床状况有显著改善。