Costa Roberto, Da Silva Kátia Regina, Rached Roberto, Martinelli Filho Martino, Carnevale Francisco César, Moreira Luiz Felipe Pinho, Stolf Noedir Antonio Groppo
Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.
Pacing Clin Electrophysiol. 2009 Mar;32 Suppl 1:S247-51. doi: 10.1111/j.1540-8159.2008.02295.x.
The incidence of venous lesions following transvenous cardiac device implantation is high. Previous implantation of temporary leads ipsilateral to the permanent devices, and a depressed left ventricular ejection fraction have been associated with an increased risk of venous lesions, though the effects of preventive strategies remain controversial. This randomized trial examined the effects of warfarin in the prevention of these complications in high-risk patients.
Between February 2004 and September 2007, we studied 101 adults who underwent a first cardiac device implantation, and who had a left ventricular ejection fraction < or =0.40, or a temporary pacing system ipsilateral to the permanent implant, or both. After device implantation, the patients were randomly assigned to warfarin to a target international normalized ratio of 2.0-3.5, or to placebo. Clinical and laboratory evaluations were performed regularly up to 6 months postimplant. Venous lesions were detected at 6 months by digital subtraction venography.
Venous obstructions of various degrees were observed in 46 of the 92 patients (50.0%) who underwent venography. The frequency of venous obstructions was 60.4% in the placebo, versus 38.6% in the warfarin group (P = 0.018), corresponding to an absolute risk reduction of 22% (relative risk = 0.63; 95% confidence interval = 0.013-0.42).
Warfarin prophylaxis lowered the frequency of venous lesions after transvenous devices implantation in high-risk patients.
经静脉心脏设备植入术后静脉病变的发生率很高。先前在与永久性设备同侧植入临时导线以及左心室射血分数降低与静脉病变风险增加有关，尽管预防策略的效果仍存在争议。这项随机试验研究了华法林在预防高危患者这些并发症方面的效果。
在2004年2月至2007年9月期间，我们研究了101名首次接受心脏设备植入的成年人，他们的左心室射血分数≤0.40，或在与永久性植入物同侧有临时起搏系统，或两者皆有。设备植入后，患者被随机分配接受华法林治疗，目标国际标准化比值为2.0 - 3.5，或接受安慰剂治疗。在植入后长达6个月的时间内定期进行临床和实验室评估。在6个月时通过数字减影静脉造影检测静脉病变。
在接受静脉造影的92名患者中，有46名（50.0%）观察到不同程度的静脉阻塞。安慰剂组静脉阻塞的发生率为60.4%，而华法林组为38.6%（P = 0.018），绝对风险降低22%（相对风险 = 0.63；95%置信区间 = 0.013 - 0.42）。
在高危患者中，华法林预防可降低经静脉设备植入术后静脉病变的发生率。
