Sapp John L, Parkash Ratika, Wells George A, Yetisir Elizabeth, Gardner Martin J, Healey Jeffrey S, Thibault Bernard, Sterns Laurence D, Birnie David, Nery Pablo B, Sivakumaran Soori, Essebag Vidal, Dorian Paul, Tang Anthony S L
From the Department of Medicine, Division of Cardiology, Dalhousie University, Halifax, NS, Canada (J.L.S., R.P., M.J.G.); Department of Medicine (G.A.W.), Cardiovascular Research Methods Centre (E.Y.), and Department of Medicine, Division of Cardiology (D.B., P.B.N.), University of Ottawa Heart Institute, ON, Canada; Department of Medicine, Division of Cardiology, Population Health Research Institute, Hamilton, ON, Canada (J.S.H.); Department of Medicine, Montreal Heart Institute, QC, Canada (B.T.); Department of Medicine, Division of Cardiology, Royal Jubilee Hospital, Victoria, BC, Canada (L.D.S.); Department of Medicine, Division of Cardiology, University of Alberta, Edmonton, Canada (S.S.); Department of Medicine, Division of Cardiology, McGill University Health Centre and Hopital Sacre Coeur de Montreal, Quebec, Canada (V.E.); Department of Medicine, Division of Cardiology, University of Toronto, ON, Canada (P.D.); and Division of Cardiology, Department of Medicine, Western University, London, Canada (A.S.L.T.).
Circ Arrhythm Electrophysiol. 2017 Mar;10(3). doi: 10.1161/CIRCEP.116.004875.
The RAFT (Resynchronization in Ambulatory Heart Failure Trial) demonstrated that cardiac resynchronization therapy (CRT) reduced both mortality and heart failure hospitalizations in patients with functional class II or III heart failure and widened QRS. We examined the influence of CRT on ventricular arrhythmias in patients with primary versus secondary prophylaxis defibrillator indications.
All ventricular arrhythmias among RAFT study participants were downloaded and adjudicated by 2 blinded reviewers with an overreader for disagreements and committee review for remaining discrepancies. Incidence of ventricular arrhythmias among patients randomized to CRT-D versus implantable cardioverter defibrillator (ICD) were compared within the groups of patients treated for primary prophylaxis and for secondary prophylaxis. Of 1798 enrolled patients, 1764 had data available for adjudication and were included. Of these, 1531 patients were implanted for primary prophylaxis, while 233 patients were implanted for secondary prophylaxis; 884 patients were randomized to ICD and 880 to CRT-D. During 5953.6 patient-years of follow-up, there were 11 278 appropriate ICD detections of ventricular arrhythmias. In the primary prophylaxis group, CRT-D significantly reduced incidence ventricular arrhythmias in comparison to ICD (hazard ratio, 0.86; 95% confidence interval, 0.74-0.99; =0.044). This effect was not seen in the secondary prophylaxis group (hazard ratio, 1.14; 95% confidence interval, 0.82-1.58; =0.45). CRT-D was not associated with significant differences in overall ventricular arrhythmia burden in either group.
CRT reduced the rate of onset of new ventricular arrhythmias detected by ICDs in patients without a history of prior ventricular arrhythmias. This effect was not observed among patients who had prior ventricular arrhythmias.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251251.
RAFT（门诊心力衰竭再同步化试验）表明，心脏再同步化治疗（CRT）可降低功能分级为II或III级且QRS增宽的心力衰竭患者的死亡率和心力衰竭住院率。我们研究了CRT对有一级预防和二级预防植入式心律转复除颤器指征患者室性心律失常的影响。
RAFT研究参与者的所有室性心律失常事件均被下载，并由2名盲法评审员进行判定，意见不一致时由一名上级评审员评审，其余分歧由委员会评审。在接受一级预防和二级预防治疗的患者组中，比较随机接受CRT-D与植入式心律转复除颤器（ICD）治疗患者的室性心律失常发生率。在1798名登记患者中，1764名有可供判定的数据并被纳入研究。其中，1531名患者接受植入以进行一级预防，233名患者接受植入以进行二级预防；884名患者被随机分配至ICD组，880名患者被随机分配至CRT-D组。在5953.6患者-年的随访期间，ICD有11278次适当的室性心律失常检测。在一级预防组中，与ICD相比，CRT-D显著降低了室性心律失常的发生率（风险比，0.86；95%置信区间，0.74-0.99；P=0.044）。在二级预防组中未观察到这种效果（风险比，1.14；95%置信区间，0.82-1.58；P=0.45）。CRT-D在两组中与总体室性心律失常负担的显著差异均无关。
CRT降低了既往无室性心律失常病史患者中由ICD检测到的新发室性心律失常的发生率。在既往有室性心律失常病史的患者中未观察到这种效果。
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