Szumowski Łukasz, Przybylski Andrzej, Maciag Aleksander, Derejko Paweł, Bodalski Robert, Zakrzewska Joanna, Orczykowski Michał, Szufladowicz Ewa, Szwed Hanna, Walczak Franciszek
Instytut Kardiologii, ul. Alpejska 42, 04-628 Warszawa.
Kardiol Pol. 2009 Feb;67(2):123-7; discussion 128-9.
Reduction of ICD interventions improves the quality of life and possibly reduces mortality. Ablation reduces ICD interventions in patients with ablatable arrhythmia, but its effectiveness needs to be proven for patients with coronary artery disease (CAD) regardless of the type of arrhythmia. Our study was designed to address this issue, but it had to be terminated due to recruitment problems. The reasons for early termination are described in this paper.
Patients with CAD and implanted ICD, who within the past three months survived an episode of VT/VF, were selected for this study. Patients were to be randomised for ablation or pharmacotherapy. A group of 209 patients was screened between June and December of 2007.
Out of 209 patients, 39 (18.7%) had appropriate ICD therapy during the last three months and were potentially eligible for the trial. Out of 39 patients, 34 could not be randomised, due to the presence of exclusion criteria (n-25) or consent refusal (n-9). Previous ablation (n-10), left ventricular thrombus (n-3) or presence of mitral or aortic artificial valve (n-3) were the most frequent exclusion criteria. During follow-up of 12 months one patient required ablation due to frequent ICD discharges. From the five randomised patients, two were randomised to ablation and three to the pharmacotherapy arm.
减少植入式心律转复除颤器（ICD）干预可改善生活质量，并可能降低死亡率。消融术可减少可消融性心律失常患者的ICD干预，但对于冠心病（CAD）患者，无论心律失常类型如何，其有效性仍需证实。我们的研究旨在解决这一问题，但由于招募问题不得不终止。本文描述了提前终止的原因。
选取过去三个月内心室性心动过速/心室颤动（VT/VF）发作后存活的CAD且植入ICD的患者进行本研究。患者将被随机分为消融组或药物治疗组。2007年6月至12月期间筛选了一组209例患者。
209例患者中，39例（18.7%）在过去三个月内接受了适当的ICD治疗，有资格参加试验。39例患者中，34例因存在排除标准（n = 25）或拒绝同意（n = 9）而无法随机分组。既往消融术（n = 10）、左心室血栓（n = 3）或存在二尖瓣或主动脉人工瓣膜（n = 3）是最常见的排除标准。在12个月的随访期间，1例患者因ICD频繁放电而需要进行消融术。在5例随机分组的患者中，2例被随机分配到消融组，3例被分配到药物治疗组。
