Rizzoli G, Guglielmi C, Toscano G, Pistorio V, Vendramin I, Bottio T, Thiene G, Casarotto D
Istituto Chirurgia Cardiovascolare, University of Padova, Padua, Italy.
Eur J Cardiothorac Surg. 1999 Jul;16(1):74-80. doi: 10.1016/s1010-7940(99)00124-4.
Mechanical valvular prostheses have the advantage of longevity but carry a risk of thrombosis which is dependant on valve design, materials and host-related interface. While pannus is common to both biologic and mechanical valves, acute prosthetic thrombosis is mostly a complication of mechanical valves; therefore we investigated to find rates and risk of these obstructive complications.
Between 1/1/70 and 31/12/97, 2680 patients received at least one mechanical prosthesis in the aortic or mitral or tricuspid position and a total of 3014 operations were performed. Follow-up included 18523 years and was 98% complete. Incidence rates, Kaplan-Meier estimates, modeling of the hazard and multivariate analysis in the hazard domain were used in the analysis.
Overall survival was 76%, 64%, 51%, 38.5% and 29% at 5, 10, 15, 20 and 25 years, respectively. It was significantly better in aortic than in mitral than in double prosthesis. 290 patients received a single reoperation, 37 a second, six a third and one a fourth reoperation. Two-hundred and fifty-one of these reoperations were exclusively due to malfunction of mechanical prosthesis, nine to malfunction of both mechanic and biologic prostheses. Most frequent reoperative indications was dehiscence (133), pannus (48) and thrombosis (29). The linearized rate of reoperations for pannus was 0.24%/patient per year, for valvular thrombosis 0.15%/patient per year. The shape of the thrombotic hazard was constant (at random) and the relative risk 12 times higher for tricuspid prosthesis, seven times higher for mitral prosthesis. Multivariate analysis controlling for prosthetic position, age, sex and prosthetic size, showed a 67% risk reduction with larger prosthesis (>27 mm), a 69% risk reduction with the Sorin tilting disk prosthesis and an 83% risk reduction with the bileaflet prosthesis. Pannus hazard shows a delayed exponential rise and was two times higher in tricuspid and three times higher in mitral position. Multivariate analysis showed a 50% risk reduction with larger prosthesis, an 11 times higher hazard of old (caged-disk, caged ball) prosthesis and a three times higher hazard of Lillehei-Kaster prosthesis. Reoperation for thrombosis has a 62% perioperative (30 days) survival compared to 92% survival of pannus reoperation.
Mechanical valves have a low incidence of reoperation, mostly for prosthetic dehiscence. Pannus development is the next frequent complication increasing with time since implant, therefore in this series it was related to old valvular models and tilting disk prosthesis, with longer follow-up. Acute thrombosis occurs significantly earlier than pannus formation. Despite shorter follow-up we are therefore confident that bileaflet prostheses are less prone to this complication and pannus is a rare early etiologic factor. Thrombosis has very high operative risk as compared to pannus, justifying the present trend to thrombolysate selected cases.
机械瓣膜假体具有使用寿命长的优点,但存在血栓形成风险,这取决于瓣膜设计、材料和宿主相关界面。虽然生物瓣膜和机械瓣膜都会出现血管翳,但急性人工瓣膜血栓形成主要是机械瓣膜的并发症;因此,我们进行研究以找出这些阻塞性并发症的发生率和风险。
在1970年1月1日至1997年12月31日期间,2680例患者在主动脉、二尖瓣或三尖瓣位置接受了至少一个机械瓣膜假体,共进行了3014次手术。随访时间共计18523年,随访完整性为98%。分析中使用了发病率、Kaplan-Meier估计值、风险建模以及风险领域的多变量分析。
5年、10年、15年、20年和25年的总体生存率分别为76%、64%、51%、38.5%和29%。主动脉瓣置换患者的生存率显著高于二尖瓣置换患者,双瓣膜置换患者的生存率最低。290例患者接受了一次再次手术,37例接受了二次再次手术,6例接受了三次再次手术,1例接受了四次再次手术。其中251次再次手术完全是由于机械瓣膜假体故障,9次是由于机械瓣膜和生物瓣膜假体均出现故障。最常见的再次手术指征是瓣膜裂开(133例)、血管翳(48例)和血栓形成(29例)。血管翳再次手术的线性化发生率为每年0.24%/患者,瓣膜血栓形成的发生率为每年0.15%/患者。血栓形成风险的形状是恒定的(随机),三尖瓣假体的相对风险高12倍,二尖瓣假体的相对风险高7倍。在控制假体位置、年龄、性别和假体尺寸的多变量分析中,较大尺寸(>27mm)的假体风险降低67%,Sorin倾斜盘式假体风险降低69%,双叶瓣膜假体风险降低83%。血管翳风险呈延迟指数上升,在三尖瓣位置高2倍,在二尖瓣位置高3倍。多变量分析显示,较大尺寸的假体风险降低50%,老式(笼球瓣、笼碟瓣)假体的风险高11倍,Lillehei-Kaster假体的风险高3倍。与血管翳再次手术92%的生存率相比,血栓形成再次手术的围手术期(30天)生存率为62%。
机械瓣膜再次手术的发生率较低,主要原因是人工瓣膜裂开。血管翳形成是第二常见的并发症,自植入后随时间增加,因此在本系列研究中,它与老式瓣膜模型和倾斜盘式假体有关,随访时间更长。急性血栓形成比血管翳形成明显更早出现。因此,尽管随访时间较短,但我们确信双叶瓣膜假体较少发生这种并发症,血管翳是一种罕见的早期病因。与血管翳相比,血栓形成的手术风险非常高,这证明了目前对选定病例进行溶栓治疗的趋势是合理的。