1000例连续患者的房间隔缺损和卵圆孔未闭封堵装置上血栓形成的发生率及临床过程
Incidence and clinical course of thrombus formation on atrial septal defect and patient foramen ovale closure devices in 1,000 consecutive patients.
作者信息
Krumsdorf Ulrike, Ostermayer Stefan, Billinger Kai, Trepels Thomas, Zadan Elisabeth, Horvath Kathrin, Sievert Horst
机构信息
Cardiovascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany.
出版信息
J Am Coll Cardiol. 2004 Jan 21;43(2):302-9. doi: 10.1016/j.jacc.2003.10.030.
OBJECTIVES
The purpose of this study was to investigate the incidence, morphology, and clinical course of thrombus formation after catheter closure of intra-atrial shunts.
BACKGROUND
Post-procedure detailed information about thrombotic material on different devices for transcatheter closure is missing.
METHOD
A total of 1,000 consecutive patients were investigated after patent foramen ovale (PFO) (n = 593) or atrial septal defect (ASD) (n = 407) closure. Transesophageal echocardiography (TEE) was scheduled after four weeks and six months. Additional TEEs were performed as clinically indicated.
RESULTS
Thrombus formation in the left atrium (n = 11), right atrium (n = 6), or both (n = 3) was found in 5 of the 407 (1.2%) ASD patients and in 15 of the 593 (2.5%) PFO patients (p = NS). The thrombus was diagnosed in 14 of 20 patients after four weeks and in 6 of 20 patients later on. The incidence was: 7.1% in the CardioSEAL device (NMT Medical, Boston, Massachusetts); 5.7% in the StarFLEX device (NMT Medical); 6.6% in the PFO-Star device (Applied Biometrics Inc., Burnsville, Minnesota); 3.6% in the ASDOS device (Dr. Ing, Osypka Corp., Grenzach-Wyhlen, Germany); 0.8% in the Helex device (W.L. Gore and Associates, Flagstaff, Arizona); and 0% in the Amplatzer device (AGA Medical Corp., Golden Valley, Minnesota). The difference between the Amplatzer device on one hand and the CardioSEAL device, the StarFLEX device, and the PFO-Star device on the other hand was significant (p < 0.05). A pre-thrombotic disorder as a possible cause of the thrombus was found in two PFO patients. Post-procedure atrial fibrillation (n = 4) and persistent atrial septal aneurysm (n = 4) had been found as significant predictors for thrombus formation (p < 0.05). In 17 of the 20 patients, the thrombus resolved under anticoagulation therapy with heparin or warfarin. In three patients, the thrombus was removed surgically.
CONCLUSIONS
The incidence of thrombus formation on closure devices is low. The thrombus usually resolves under anticoagulation therapy.
目的
本研究旨在调查经导管闭合心房分流术后血栓形成的发生率、形态及临床病程。
背景
目前缺少关于不同经导管闭合装置上血栓物质的术后详细信息。
方法
对总共1000例连续患者进行了研究，这些患者分别接受了卵圆孔未闭（PFO）（n = 593）或房间隔缺损（ASD）（n = 407）封堵术。四周和六个月后安排经食管超声心动图（TEE）检查。根据临床指征进行额外的TEE检查。
结果
407例ASD患者中有5例（1.2%）、593例PFO患者中有15例（2.5%）在左心房（n = 11）、右心房（n = 6）或两者（n = 3）发现血栓形成（p = 无统计学意义）。20例患者中有14例在四周后诊断出血栓，另外6例在之后诊断出。发生率分别为：CardioSEAL装置（NMT Medical，马萨诸塞州波士顿）为7.1%；StarFLEX装置（NMT Medical）为5.7%；PFO-Star装置（Applied Biometrics Inc.，明尼苏达州伯恩斯维尔）为6.6%；ASDOS装置（Dr. Ing，Osypka Corp.，德国格伦察赫 - 维伦）为3.6%；Helex装置（W.L. Gore and Associates，亚利桑那州弗拉格斯塔夫）为0.8%；Amplatzer装置（AGA Medical Corp.，明尼苏达州金谷）为0%。Amplatzer装置与CardioSEAL装置、StarFLEX装置及PFO-Star装置之间的差异具有统计学意义（p < 0.05）。在2例PFO患者中发现有血栓前状态作为血栓形成的可能原因。术后心房颤动（n = 4）和持续性房间隔瘤（n = 4）被发现是血栓形成的显著预测因素（p < 0.05）。20例患者中有17例在接受肝素或华法林抗凝治疗后血栓溶解。3例患者的血栓通过手术取出。
结论
闭合装置上血栓形成的发生率较低。血栓通常在抗凝治疗后溶解。
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