Long-term benefit of implantable cardioverter/defibrillator therapy after elective device replacement: results of the INcidence free SUrvival after ICD REplacement (INSURE) trial--a prospective multicentre study.

AIMS: Prevention of sudden cardiac death by means of the implantable cardioverter/defibrillator (ICD) is considered to be a lifelong therapy. However, it is still unresolved if patients who never experienced an appropriate ICD intervention during generator longevity really need to undergo device replacement. METHODS AND RESULTS: The INSURE trial was a multicentre prospective observational cohort study that enrolled patients at the time of their first ICD replacement. Patients with and without previous appropriate ICD therapy were enrolled prospectively and were evaluated every 3-6 months after ICD replacement. Primary endpoint of the study was the first occurrence of appropriate ICD therapy after device replacement. Five hundred and ten patients (83% males, mean age 65 ± 10 years, mean ejection fraction 39 ± 16%) were enrolled between 2002 and 2007 in the study after an average lifespan of their first ICD generator of 62 ± 18 months. Three years after elective ICD replacement, the rates of appropriate ICD therapies in patients with (n = 245) and without (n = 265) former appropriate ICD intervention were 48.1 and 21.4% (adjusted hazard ratio 3.08, CI: 2.15-4.39, P < 0.001). Notably, no predictive factors for lower need of ICD therapy could be identified in patients without prior appropriate ICD intervention. CONCLUSIONS: In this study, a significant number of ICD-indicated patients without the need for therapy by their first device received appropriate ICD intervention after generator replacement. There were no predictors for lower need of ICD therapy. Hence, ICD replacement appears still necessary in patients without prior ICD interventions.

Workload and usefulness of daily, centralized home monitoring for patients treated with CIEDs: results of the MoniC (Model Project Monitor Centre) prospective multicentre study.

AIM: Automated, daily Home Monitoring (HM) of pacemaker and implantable cardioverter-defibrillator (ICD) patients can improve patient care. Yet, HM introduction to routine clinical practice is challenged by resource allocation for regular HM data review. We tested the feasibility, safety, workload, and clinical usefulness of a centralized HM model consisting of one monitor centre and nine satellite clinics. METHODS AND RESULTS: Having no knowledge about patients' clinical data, a telemonitoring nurse (TN) and a supporting physician at the monitor centre screened and filtered HM data in 62 pacemaker and 59 ICD patients from nine satellite clinics for over 1 year. Basic screening of arrhythmic and technical events required 25.7 min (TN) and 0.7 min (physician) per working day, normalized for 100 patients monitored. Communication of relevant events to satellite clinics per email or phone required additional 4.3 min (TN) and 0.4 min (physician). Telemonitoring nurse also screened for abnormal developments in longitudinal data trends weekly for 3 months after implantation, and then monthly; one patient session lasted 4.0 ± 2.9 min. To handle transmission-gap notifications, TN needed additional 2.8 min daily. Satellite clinics received 231.3 observations from the monitor centre per 100 patients/year, which prompted 86.3 patient contacts or intensive HM screening periods by the satellite clinic itself (37.3% response rate), 51.7 extra follow-up controls (22.3%), and 30.1 clinical interventions (13.0%). CONCLUSION: Centralized HM was feasible, reliable, safe, and clinically useful. Basic screening and communication of relevant arrhythmic and technical events required a total of 30 min (TN) and 1.1 min (physician) daily per 100 patients monitored.

Myocardial scar extent evaluated by cardiac magnetic resonance imaging in ICD patients: relationship to spontaneous VT during long-term follow-up.

Patients with ischemic cardiomyopathy have an increased risk for ventricular arrhythmia, since myocardial infarction can be the substrate for re-entrant arrhythmias. Contrast-enhanced cardiac magnetic resonance imaging (CMR) has proven to reliably quantify myocardial infarction. Aim of our study was to evaluate correlations between functional and contrast-enhanced CMR findings and spontaneous ventricular tachy-arrhythmias in patients with ischemic cardiomyopathy who underwent implantable cardioverter-defibrillator (ICD) therapy. Forty-one patients with ischemic cardiomyopathy and indication for ICD therapy underwent cine and late gadolinium enhancement CMR for quantification of left ventricular volumes, function and scar tissue before subsequent implantation of ICD device. During a follow-up period of 1184 ± 442 days 68 monomorphic and 14 polymorphic types of ventricular tachycardia (VT) could be observed in 12 patients. Patients with monomorphic VT had larger scar volumes (25.3 ± 11.3 vs. 11.8 ± 7.5% of myocardial mass, P < 0.05) than patients with polymorphic VT. Moreover myocardial infarction involved more segments in the LAD perfusion territory (86 vs. 20%, P < 0.05) than in patients with polymorphic VT. Patients with spontaneous monomorphic VT during the long-term follow-up period had more infarcted tissue, which was more often present in the LAD perfusion territory than patients with polymorphic events. These data strengthen the diagnostic benefit of CMR in patients with ischemic cardiomyopathy. CMR may be used for better risk stratification in patients with ischemic cardiomyopathy undergoing ICD therapy.

Cryoablation versus radiofrequency energy for the ablation of atrioventricular nodal reentrant tachycardia (the CYRANO Study): results from a large multicenter prospective randomized trial.

BACKGROUND: Cryoablation has emerged as an alternative to radiofrequency catheter ablation (RFCA) for the treatment of atrioventricular (AV) nodal reentrant tachycardia (AVNRT). The purpose of this prospective randomized study was to test whether cryoablation is as effective as RFCA during both short-term and long-term follow-up with a lower risk of permanent AV block. METHODS AND RESULTS: A total of 509 patients underwent slow pathway cryoablation (n=251) or RFCA (n=258). The primary end point was immediate ablation failure, permanent AV block, and AVNRT recurrence during a 6-month follow-up. Secondary end points included procedural parameters, device functionality, and pain perception. Significantly more patients in the cryoablation group than the RFCA group reached the primary end point (12.6% versus 6.3%; P=0.018). Whereas immediate ablation success (96.8% versus 98.4%) and occurrence of permanent AV block (0% versus 0.4%) did not differ, AVNRT recurrence was significantly more frequent in the cryoablation group (9.4% versus 4.4%; P=0.029). In the cryoablation group, procedure duration was longer (138±54 versus 123±48 minutes; P=0.0012) and more device problems occurred (13 versus 2 patients; P=0.033). Pain perception was lower in the cryoablation group (P<0.001). CONCLUSIONS: Cryoablation for AVNRT is as effective as RFCA over the short term but is associated with a higher recurrence rate at the 6-month follow-up. The risk of permanent AV block does not differ significantly between cryoablation and RFCA. The potential benefits of cryoenergy relative to ablation safety and pain perception are counterbalanced by longer procedure times, more device problems, and a high recurrence rate. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00196222.

Implantable dual-chamber defibrillator for the selective treatment of spontaneous atrial and ventricular arrhythmias: arrhythmia incidence and device performance.

INTRODUCTION: Atrial tachyarrhythmias are a common co-morbidity in patients with an ICD indication. Recently introduced ICD's are equipped to independently detect and treat atrial and ventricular tachyarrhythmias. The purpose of this prospective study was to evaluate the incidence and termination of spontaneous atrial and ventricular tachyarrythmias in patients with a history of atrial tachyarrhythmias. METHODS AND RESULTS: Ninety patients, 70% male with an ICD indication and history of atrial tachyarrhythmia (LVEF 45 +/- 6%, [AT/AF indication 55 +/- 10, AT/VT 45 +/- 16], 46% CAD) were enrolled and 89 were implanted with a VENTAK PRIZM AVT (Guidant). Spontaneous atrial and ventricular tachyarrhythmias were printed and evaluated during an average follow-up period of 272 +/- 72 days utilizing the stored intracardial electrogram function of the device. Nineteen patients (21%) presented had only atrial tachyarrhythmias, 32 patients (36%) had both atrial and ventricular tachyarrhythmias and 18 patients (20%) had only ventricular tachyarrhythmias. Patients with only atrial tachyarrhythmias had a total of 3274 atrial episodes; 2002 terminated spontaneously, 1264 were treated with ATP and 8 with shock therapy. ATP was successful in 735 (58%) of 1264 episodes. Patients with both atrial and ventricular tachyarrhythmias had 7277 documented atrial tachyarrhythmias, 5231 terminated spontaneously, 1153 of 2009 were terminated by ATP (57.4%) and 37 by shock therapy (20 patient controlled). Atrial tachyarrhythmias identified as atrial flutter (AT) by the atrial rhythm classification (ARC) algorithm had a higher ATP conversion success rate than episodes identified as atrial fibrillation (AF); 66.7% for AT and 26.4% for AF. Patients with only ventricular tachyarrhythmias had 690 documented episodes, 401 terminated spontaneously, 248 (85.8%) were terminated by ATP and 41 by shock. CONCLUSION: Seventy-seven percent of patients with an ICD indication had spontaneous atrial and/or ventricular tachyharrhythmias within the first 6 months after ICD implantation. ATP therapy terminated 58% of all atrial tachyarrhytmias and 66.7% of the atrial flutters. The dual chamber ICD detected, classified and terminated all ventricular tacharrhythmias appropriately.

Evaluation of a dual chamber implantable cardioverter defibrillator for the treatment of atrial and ventricular arrhythmias.

Eighty-nine patients with a documented history of atrial tachyarrhythmias or fibrillation (AF) received a cardioverter defibrillator designed to selectively differentiate and treat atrial and ventricular arrhythmias. Twenty-two patients received a coronary sinus lead and, therefore, could use a separate shock vector for selective treatment of atrial tachyarrhythmias/AF. The device is designed to treat tachyarrhythmias with antitachycardia pacing (ATP) and/or shock therapy using an atrial and/or a ventricular shock vector. Patients underwent induction and shock termination of atrial or dual tachyarrhythmias (AF/VF) to verify proper device function and to measure the arrhythmia detection time with enhancements and preventive algorithms programmed On and Off, respectively. Detection time for 329 VF inductions was 2.41 +/- 0.64 seconds with enhancements On and 2.29 +/- 0.47 with enhancements Off (NS). At implant or predischarge, 283 AF and/or AF/VF (121 atrial and 162 atrial/ventricular fibrillation) were induced. Shock conversion efficacy was 89.8% with AF conversion energies ranging from 0.9 to 27 J. Thirteen of the 23 patients had atrial shock conversions using the separate shock vector with an average conversion energy of 1.9 +/- 1.4 J. (range 0.5-5 J). During follow-up the efficacy of ATP on atrial tachyarrhythmias was 59% and the efficacy of delivered shocks on AF was 85%. This new dual chamber cardioverter defibrillator appropriately detected and classified atrial arrhythmias, and shock therapy for AF was highly effective. The detection algorithm differentiated atrial tachyarrhythmia/AF and did not delay VF detection. The separate shock vector converted induced AF with energies ranging from 0.6 to 5 J.