左心耳封堵.pptVIP

背 景 左心耳封堵器械研发现状 左心耳封堵器械临床试验 左心耳封堵存在的问题 Block PC et al.JACC: Cardiovascular Interventions. 2009;2(7):594-600 Percutaneous Left Atrial Appendage Occlusion for Patients in Atrial Fibrillation Suboptimal for Warfarin Therapy 5-Year Results of the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) Study 61/64 patients 9 sites in the U.S. And 1 Canadian site. November 18, 2003.. 死亡7例 ，重症中风5例 ，小中风3例 ，可能的脑出血1例 ，心梗1例，心包压塞1例 Initial Worldwide Experience With the WATCHMAN Left Atrial Appendage System for Stroke Prevention in Atrial Fibrillation Peter B. Sick et al.J Am Coll Cardiol 2007;49:1490–5 open-label nonrandomized pilot study Conclusions LAA occlusion with the WATCHMAN device appears to be safe with preliminary results consistent with low stroke risk despite discontinuation of anticoagulation. …in whom anticoagulation carries a high risk or is contraindicated, these devices may offer an attractive solution to the AF-related emboli problem … 2例发生心脏压塞，1例发生空气栓塞，1例发生输送导丝断裂需外科手术取出。6个月，4例出现装置表面血栓，97.1％的患者在6个月内可停用华法林，随访2年时仅2例发生一过性脑缺血 David R Holmes.et al. Lancet 2009; 374: 534–42 PROTECT AF Thus, our strategy for closing the LAA was non-inferior to warfarin therapy in terms of the primary efficacy endpoint of all stroke, cardiovascular death, and systemic embolism. Although there is a higher initial safety event rate for device implantation, adverse events were without long-term sequelae for most patients. Closure of the LAA might provide an alternative strategy to chronic warfarin therapy for stroke prophylaxis in patients with nonvalvular atrial fibrillation. Interpretation Circulation. 2011;123:417-424 As shown in Table 2, on a per-patient basis, the 手术后7天，手术或装置相关安全事件发生率显著降低：①在2项研究中，分别有7.7%和3.7%的患者发生安全性终点事件（P=0.007）；②在PROTECT?AF的2组人群（第1年600例及随后900例）及CAP研究人群中，分别有10.0%、5.5%和3.7%的患者发生安全性终点事件（P=0.006）。置入7天内，PROTECT?AF研究人群严重心包积液发生率为5.0%，占该组安全性事件的50%以上，而CAP注册研究人群严重心包积液发生率较低（2.2%），P=0.019。PROTECT?AF研究人群与CAP注册研究人群手术相关卒中的经验相关改善率基本相似（分别为0.9%对0%，P=0.039）。最终，在PR