Bottio Tomaso, Rizzoli Giulio, Caprili Luca, Testolin Luca, Thiene Gaetano, Gerosa Gino
Department of Cardiovascular Surgery, University of Padua Medical School, Padua, Italy.
J Heart Valve Dis. 2005 Jul;14(4):493-500.
The choice of aortic valve substitutes remains controversial. Malfunction and systemic valve complications affect the results of mechanical and tissue valves. Two devices--the Sorin Monocast (tilting disk) valve and the Hancock Standard valve were compared, the study aim being to determine whether the valve model is a marker or a causal influence of poor outcome after aortic valve replacement (AVR).
Between January 1970 and January 1984, patients aged < 70 years and operated on for aortic valve disease were selected. A total of 379 patients received either Sorin (group S) valves (n = 213; median age 51 years) or Hancock Standard (group HcK) valves (n = 192; median age 50 years) (p = NS). Total follow up was 2,471 patient-years (pt-yr) for group S and 2,368 pt-yr for group HcK. Follow up was 98% complete; median duration was 15 pt-yr for group S and 13.2 pt-yr for group HcK. Propensity matching for available patient intrinsic and operative risk factors was ultimately used to investigate whether biological or mechanical valve models impact upon outcome after aortic valve surgery. Patient survival was analyzed according to the 'intention to treat' principle.
The 30-day mortality was 7.5% for group S and 10.9% for group HcK (p = NS). The 19-year Kaplan-Meier freedom from valve-related mortality was 84% (group S) and 82% (group HcK) (p = NS), while overall survival was 42% (group S) and 35% (group HcK) (p = NS). Structural valve deterioration (SVD) was the major cause of reoperation in the HcK group. The 19-year freedom from all valve-related complications was 43% (group S) versus 19% (group HcK) (p = 0.0001). By propensity score, 61% of the valve replacements (247/405) were perfectly matched for available risk factors, with an equal distribution of risk covariates. When SVD and reoperation due to SVD were excluded, survival and freedom from all valve-related complications of the matched patients were identical between the prostheses under comparison.
In this relatively young population, the Sorin valve showed a significantly lower valve-related complication rate than the Hancock Standard valve. The latter valve showed a significantly increasing rate of reoperation due to SVD, and thereby a relative inadequacy for use in younger patients. When analyzed according to an 'intention to treat' principle, the 19-year survival and freedom from valve-related complications of patients with the same propensity score for selection of either valve type were similar.
主动脉瓣置换物的选择仍存在争议。机械瓣膜和组织瓣膜的功能故障及全身瓣膜并发症会影响治疗效果。对两种瓣膜——索林单铸(倾斜盘)瓣膜和汉考克标准瓣膜进行了比较,研究目的是确定瓣膜型号是主动脉瓣置换术(AVR)后不良预后的标志物还是因果影响因素。
选取1970年1月至1984年1月期间年龄小于70岁且因主动脉瓣疾病接受手术的患者。共有379例患者接受了索林瓣膜(S组)(n = 213;中位年龄51岁)或汉考克标准瓣膜(HcK组)(n = 192;中位年龄50岁)(p = 无统计学差异)。S组的总随访时间为2471患者年(pt-yr),HcK组为2368 pt-yr。随访完成率为98%;S组的中位随访时间为15 pt-yr,HcK组为13.2 pt-yr。最终采用倾向匹配法对患者的固有和手术风险因素进行匹配,以研究生物瓣膜或机械瓣膜型号对主动脉瓣置换术后结局的影响。根据“意向性治疗”原则分析患者生存率。
S组的30天死亡率为7.5%,HcK组为10.9%(p = 无统计学差异)。19年的Kaplan-Meier瓣膜相关死亡率无事件生存率在S组为84%,在HcK组为82%(p = 无统计学差异),而总生存率在S组为42%,在HcK组为35%(p = 无统计学差异)。瓣膜结构退化(SVD)是HcK组再次手术的主要原因。19年的所有瓣膜相关并发症无事件生存率在S组为43%,在HcK组为19%(p = 0.0001)。通过倾向得分,61%的瓣膜置换术(247/405)在可用风险因素方面实现了完美匹配,风险协变量分布均匀。当排除SVD及因SVD导致的再次手术时,所比较的两种人工瓣膜在匹配患者的生存率和所有瓣膜相关并发症无事件生存率方面相同。
在这个相对年轻的人群中,索林瓣膜显示出的瓣膜相关并发症发生率显著低于汉考克标准瓣膜。后者因SVD导致的再次手术率显著增加,因此相对不适合用于年轻患者。根据“意向性治疗”原则进行分析时,选择两种瓣膜类型且倾向得分相同的患者,其19年生存率和瓣膜相关并发症无事件生存率相似。