Danik Stephan B, Mansour Moussa, Heist E Kevin, Ellinor Patrick, Milan David, Singh Jagmeet, Das Saumya, Reddy Vivek, D'Avila Andre, Ruskin Jeremy N, Mela Theofanie
Cardiac Arrhythmia Service, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, USA.
Heart Rhythm. 2008 Dec;5(12):1667-72. doi: 10.1016/j.hrthm.2008.09.017. Epub 2008 Sep 16.
Recent studies have reported a possible increased risk of delayed perforation with the St. Jude Riata defibrillator lead.
The purpose of this study was to determine the incidence and time of occurrence of this complication in a large number of patients who underwent implantationm at a single center.
We reviewed the data and clinical course on all patients who underwent implantation of the St. Jude Riata (1580/1581, 1590/1591, and the 7000/7001 ST series) right ventricular defibrillator lead at the Massachusetts General Hospital between June 2001 and October 2007. Data were compared with all Medtronic Sprint Fidelis leads implanted during the same time period.
Of a total of 416 implanted Riata leads, follow-up data at 6 weeks and 3 months was available for 87% and 75% of patients, respectively. There were 6 cases of lead perforation (6 of 233, 2.6%) with the 1580/1581 series, no cases of lead perforation (0 of 92) with the 1590/1591 series, and 2 cases of perforation (2 of 92, 2.2%) with the 7000/7001 ST series. Interrogation the day after implantation did not reveal any abnormalities. Patients with perforation developed symptoms of chest pain or shortness of breath within 3 weeks post-implantation; interrogation revealed pacing thresholds of >5 V at 0.5 ms within the first follow-up period of 6 weeks.
All cases of perforation with the St. Jude Riata lead occurred within 6 weeks post-implantation and showed pacing thresholds >5 V at 0.5 ms. There were no cases of delayed perforation after 6 weeks in 307 patients with at least 3 months of follow-up.
近期研究报告称，圣犹达Riata除颤器导线可能会增加迟发性穿孔的风险。
本研究旨在确定在单一中心接受植入手术的大量患者中，这种并发症的发生率及发生时间。
我们回顾了2001年6月至2007年10月在马萨诸塞州总医院接受圣犹达Riata（1580/1581、1590/1591和7000/7001 ST系列）右心室除颤器导线植入的所有患者的数据及临床病程。将数据与同期植入的所有美敦力Sprint Fidelis导线进行比较。
在总共416根植入的Riata导线中，分别有87%和75%的患者可获得6周和3个月的随访数据。1580/1581系列中有6例导线穿孔（233例中的6例，2.6%），1590/1591系列中无导线穿孔病例（92例中的0例），7000/7001 ST系列中有2例穿孔（92例中的2例，2.2%）。植入后第二天进行的问询未发现任何异常。穿孔患者在植入后3周内出现胸痛或呼吸急促症状；问询显示，在6周的首次随访期内，起搏阈值在0.5毫秒时>5伏。
圣犹达Riata导线的所有穿孔病例均发生在植入后6周内，且在0.5毫秒时起搏阈值>5伏。在307例至少随访3个月的患者中，6周后未出现迟发性穿孔病例。
