Steger Volker, Bail Dorothee H, Graf Daniela, Walker Tobias, Rittig Kilian, Ziemer Gerhard
Department of Thoracic Surgery, Schillerhöhe Hospital, Gerlingen, Germany.
J Heart Valve Dis. 2008 May;17(3):335-42.
Following mechanical heart valve replacement, patients may require a form of 'bridging' anticoagulation to prevent valve-associated thromboembolism until oral vitamin K antagonists take effect. In 2000, the present authors changed their bridging protocol to a fixed dose of 40 mg enoxaparin twice daily (b.i.d., subcutaneous), regardless of the patient's body weight and renal function. The study aim was to evaluate the feasibility of this protocol with regards to thromboembolism, hemorrhage and other valve-associated adverse effects.
Between April 2000 and December 2004, a total of 256 consecutive patients who had undergone mechanical heart valve replacement were enrolled into this retrospective study. All patients received 40 mg enoxaparin b.i.d., subcutaneously, as bridging anticoagulation for a mean of 6.7 days, commencing at a mean of 3.8 days (range: 2-42 days) after surgery. This was approximately 55% (range: 32-95%) of the recommended dose considered to be safe in this setting.
A total of 18 (7%) minor bleeding events and two (0.7%) arterial thromboses were seen to arise from previously existing high-grade (>90%) stenosis of the affected vessels. At discharge, all prosthetic valves showed regular, echocardiographically confirmed, function. The mean follow up was 38.6 days (range: 8-106 days). Mitral valve replacement (p = 0.005) was shown to be a significant risk factor for minor bleeding, but not for thromboembolism. None of the other risk factors reached significance when testing for minor bleeding or major thromboembolic events.
Within the special setting of postoperative cardiac surgery, this modified anticoagulation protocol appears feasible and safe, with efficacy equivalent to that of full-dose protocols reported elsewhere using either low-molecular-weight or unfractionated heparin. By using this protocol, the effort required to bridge patients to effective oral anticoagulation was greatly reduced as there was no requirement for repeated laboratory measurements and dose adjustments. A prospective multi-center study should be conducted to confirm the hypothesis that the first bridging period after prosthetic heart valve replacement with extracorporeal circulation is different, and permits the use of a bridging protocol with a lower anticoagulation dose.
在进行机械心脏瓣膜置换术后,患者可能需要一种“桥接”抗凝治疗,以预防瓣膜相关血栓栓塞,直至口服维生素K拮抗剂起效。2000年,本文作者将桥接方案改为固定剂量的依诺肝素40mg,每日两次(bid,皮下注射),而不考虑患者的体重和肾功能。本研究的目的是评估该方案在血栓栓塞、出血及其他瓣膜相关不良反应方面的可行性。
在2000年4月至2004年12月期间,共有256例连续接受机械心脏瓣膜置换术的患者纳入本回顾性研究。所有患者均接受依诺肝素40mg bid皮下注射作为桥接抗凝治疗,平均持续6.7天,于术后平均3.8天(范围:2 - 42天)开始。这大约是在此情况下被认为安全的推荐剂量的55%(范围:32% - 95%)。
共出现18例(7%)轻微出血事件,以及2例(0.7%)动脉血栓形成,这些血栓形成源于先前存在的受影响血管的高度(>90%)狭窄。出院时,所有人工瓣膜经超声心动图证实功能正常。平均随访时间为38.6天(范围:8 - 106天)。二尖瓣置换术(p = 0.005)被证明是轻微出血的一个显著危险因素,但不是血栓栓塞的危险因素。在检测轻微出血或重大血栓栓塞事件时,其他危险因素均未达到显著水平。
在心脏手术后的特殊情况下,这种改良的抗凝方案似乎可行且安全,其疗效与其他地方报道的使用低分子量肝素或普通肝素的全剂量方案相当。通过使用该方案,由于无需重复实验室检测和剂量调整,将患者过渡到有效的口服抗凝治疗所需的工作量大大减少。应进行一项前瞻性多中心研究,以证实人工心脏瓣膜置换术联合体外循环后的首个桥接期不同且允许使用较低抗凝剂量的桥接方案这一假设。