Molina J E, Benditt D G, Adler S
Department of Surgery, University of Minnesota, Minneapolis 55455, USA.
J Thorac Cardiovasc Surg. 1995 Jul;110(1):258-64. doi: 10.1016/S0022-5223(05)80032-7.
The durability and reliability of the implantable cardioverter-defibrillator epicardial patch systems have not been reported. In 128 consecutive patients such systems manufactured by Cardiac Pacemakers, Inc. (St. Paul, Minn.) or Medtronic, Inc. (Minneapolis, Minn.) were implanted with 100% follow-up to investigate the rate of patch crinkling and its consequences. A total of 122 patients survived the operation (operative mortality, 6 patients: 4.7%). Ninety-four patients received Cardiac Pacemakers, Inc. AICD patches and 28 received Medtronic PCD patches. Patients had chest x-ray studies every 3 to 6 months and function of the defibrillator was checked every 3 months. Late mortality occurred in 17 patients (13%) leaving a total of 105 long-term survivors (82%) to the present. Among 122 survivors, severe crinkling of the patches occurred in 48 patients--33 in the Cardiac Pacemakers, Inc. AICD group (36%) and 15 in the PCD group (54%)--within 2 years of the implant. Crinkling of patches caused not only malfunction of the system, but also cardiac pain in three patients. Crinkling occurred as early as 2 months after implant and progressed throughout the period of observation. Fourteen patients later required implant of an additional transvenous defibrillator because of failure of the epicardial system. The percentage of transvenous implantable cardioverter-defibrillator systems needed was higher for the Medtronic group (28%) than for the Cardiac Pacemakers, Inc. AICD group (6.3%). Both systems have shown an unacceptably high rate of patch crinkling that occurs in a relatively short time. There is no difference whether a thoracotomy or midline sternotomy is used or whether the patches are implanted intrapericardially or extrapericardially. The quest should continue for a better patch system design.
植入式心脏复律除颤器心外膜贴片系统的耐用性和可靠性尚未见报道。在128例连续患者中，植入了由心脏起搏器公司（明尼苏达州圣保罗）或美敦力公司（明尼苏达州明尼阿波利斯）生产的此类系统，并进行了100%的随访，以调查贴片起皱率及其后果。共有122例患者术后存活（手术死亡率为6例：4.7%）。94例患者接受了心脏起搏器公司的自动植入式心脏复律除颤器（AICD）贴片，28例接受了美敦力公司的植入式心脏复律除颤器（PCD）贴片。患者每3至6个月进行胸部X光检查，每3个月检查除颤器功能。截至目前，17例患者发生晚期死亡（13%），共有105例长期存活者（82%）。在122例存活者中，48例患者的贴片出现严重起皱——心脏起搏器公司AICD组33例（36%），PCD组15例（54%）——在植入后2年内出现。贴片起皱不仅导致系统故障，还使3例患者出现心前区疼痛。起皱最早在植入后2个月出现，并在整个观察期内进展。14例患者后来因心外膜系统故障需要植入额外的经静脉除颤器。美敦力组（28%）比心脏起搏器公司AICD组（6.3%）需要经静脉植入式心脏复律除颤器系统的比例更高。两种系统均显示出在相对较短时间内出现的贴片起皱率高得令人无法接受。无论采用开胸手术还是正中胸骨切开术，也无论贴片是在心包内还是心包外植入，情况均无差异。应继续寻求更好的贴片系统设计。
