Hopkins R A, Reyes A, Imperato D A, Carpenter G A, Myers J L, Murphy K A
Division of Cardiac Surgery, Georgetown University Medical Center, Washington, District of Columbia 20007, USA.
Ann Surg. 1996 May;223(5):544-53; discussion 553-4. doi: 10.1097/00000658-199605000-00010.
From January 1, 1985 through December 31, 1994, one surgeon implanted cryopreserved valved homografts into 149 patients--65 since December 1988. This latter series (II) was accomplished in a single hospital, facilitating patient follow-up with biannual echocardiograms. Analysis of these 65 patients is the primary focus of this report; the indications and early surgical results for the two parts of the series (I and II) are compared to assess the evolution of a single surgeon's use of homografts in a mixed pediatric and adult practice.
Fifty-one variables for each patient (series II) were entered into a computerized database and analyzed (multivariate and univariate) using SPSS 6.1 software (Statistical Products and Service Solutions, Chicago, IL). Cox proportional hazard model was used to identify the independent contribution of each variable for patient mortality and homograft failure. Cumulative survival estimates were made using Kaplan-Meier analysis. Homograft failure was defined as requirement for replacement or death. In series I, there were 41 left ventricular outflow tract (LVOT) reconstructions (31 adult) and 43 right ventricular outflow tract (RVOT) reconstructions (42 pediatric). In series II, there were 55 RVOT reconstructions (52 pediatric) and 10 LVOT reconstructions (7 adult).
There were no technical surgical failures. Total surgical mortality rate was 6% (5/84) in series I (3 LVOT, 2 RVOT) and 15% (10/65) in series II (2 LVOT, 8 RVOT) (I vs. II NS; p = 0.11, two-tailed Fisher exact test). By the Cox analysis, only age < 2 years (p < 0.03) and cross-clamp time > 120 minutes (p < 0.05) were significant predictors for death. Age-based survival curves were compared in a sequential bivariate analyses (log rank test) and age < 2 years again was a significant predictor of decreased patient survival (p < 0.006). Actuarial freedom from patient death or reoperation for homograft failure was 82% +/- 7% at 1000 days and 77% +/- 10% at 2000 days. Three patients required re-replacement for homograft failure (5.4%); one of these patients died. The only significant predictor of homograft failure was postoperative endocarditis (p < 0.05). Homograft performance was evaluated by an extensive echocardiography protocol: in surviving patients and homografts, three valved conduits were judged to have severely impaired performance (stenosis or regurgitation), awaiting surgical replacement for a putative total homograft-related structural failures rate of 11% at 5 1/2 years.
Comparisons of series I and II shows, in one surgeon's practice, an evolution away from use of cryopreserved homografts for LVOT reconstructions except when needed for destructive bacterial endocarditis or complex congenital anatomy. Homograft efficacy and durability were similar in RVOT and LVOT positions, with 78.5% of patients surviving at 5 1/2 years; in surviving patients, 89% of homografts have continued to function well. Homografts are not immune to prosthetic bacterial endocarditis, and its occurrence is associated with accelerated deterioration. Cryopreserved homograft valves are an imperfect but satisfactory biological material for specific ventricular outflow reconstructions.
从1985年1月1日至1994年12月31日,一名外科医生为149例患者植入了冷冻保存的带瓣同种异体移植物,自1988年12月起为65例患者植入。后一组(第二组)在一家医院完成,便于每半年通过超声心动图对患者进行随访。本报告主要分析这65例患者;比较该系列两组(第一组和第二组)的适应证和早期手术结果,以评估一名外科医生在儿科和成人混合病例中使用同种异体移植物的演变情况。
将每名患者(第二组)的51个变量录入计算机数据库,并使用SPSS 6.1软件(统计产品与服务解决方案,伊利诺伊州芝加哥)进行分析(多变量和单变量分析)。采用Cox比例风险模型确定每个变量对患者死亡率和同种异体移植物失败的独立影响。使用Kaplan-Meier分析进行累积生存估计。同种异体移植物失败定义为需要更换或死亡。在第一组中,有41例左心室流出道(LVOT)重建(31例成人)和43例右心室流出道(RVOT)重建(42例儿科)。在第二组中,有55例RVOT重建(52例儿科)和10例LVOT重建(7例成人)。
无手术技术失败。第一组的总手术死亡率为6%(5/84)(3例LVOT,2例RVOT),第二组为15%(10/65)(2例LVOT,8例RVOT)(第一组与第二组无显著性差异;p = 0.11,双侧Fisher精确检验)。通过Cox分析,只有年龄<2岁(p < 0.03)和阻断时间>120分钟(p < 0.05)是死亡的显著预测因素。在序贯双变量分析(对数秩检验)中比较基于年龄的生存曲线,年龄<2岁再次是患者生存率降低的显著预测因素(p < 0.006)。在1000天时,患者免于死亡或因同种异体移植物失败再次手术的精算生存率为82%±7%,在2000天时为77%±10%。3例患者因同种异体移植物失败需要再次更换(5.4%);其中1例患者死亡。同种异体移植物失败的唯一显著预测因素是术后心内膜炎(p < 0.05)。通过广泛的超声心动图方案评估同种异体移植物的性能:在存活的患者和同种异体移植物中,3个带瓣管道被判定性能严重受损(狭窄或反流),预计在5年半时因同种异体移植物相关结构失败的总发生率为11%,有待手术更换。
第一组和第二组的比较表明,在一名外科医生的实践中,除了因破坏性细菌性心内膜炎或复杂先天性解剖结构需要外,已不再使用冷冻保存的同种异体移植物进行LVOT重建。RVOT和LVOT位置的同种异体移植物疗效和耐久性相似,5年半时78.5%的患者存活;在存活患者中,89%的同种异体移植物仍功能良好。同种异体移植物不能免于人工瓣膜性细菌性心内膜炎,其发生与加速恶化有关。冷冻保存的同种异体瓣膜是用于特定心室流出道重建的一种不完美但令人满意的生物材料。