Prognostic significance of nonsustained ventricular tachycardia in patients receiving cardiac resynchronization therapy for primary prevention: Analysis of the Japan cardiac device treatment registry database

BackgroundWhether nonsustained ventricular tachycardia (NSVT) is a marker of increased risk of sustained ventricular tachyarrhythmias (VTAs) remains to be established in patients receiving cardiac resynchronization therapy with a defibrillator (CRT‐D) for primary prevention.MethodsAmong the follow‐up data of the Japan cardiac device treatment registry (JCDTR) with an implantation date between January 2011 and August 2015, information regarding a history of NSVT before the CRT‐D implantation for primary prevention had been registered in 269 patients. Outcomes were compared between two groups with and without NSVT: NSVT group (n = 179) and No NSVT group (n = 90).ResultsThere was no significant difference with regard to age, gender, and NYHA class between the two groups. Left ventricular ejection fraction (LVEF) was 25.6% in the NSVT group and 28.0% in the No NSVT group (P = .046). The rate of appropriate therapy at 24 months was 26.0% and 18.4% in the NSVT and No NSVT groups (P = .22), respectively. Survival free from heart failure death was reduced in the NSVT group, as compared with the No NSVT group, with the rate of 90.2% vs 97.2% at 24 months (P = .030). A multivariate analysis identified a history of NSVT, anemia, and no use of angiotensin‐converting enzyme inhibitor (ACEI) or angiotensin‐receptor blocker (ARB) as predictors of heart failure death.ConclusionsNSVT appears to be a surrogate marker of severe heart failure rather than a substrate for subsequent sustained VTAs in patients with CRT‐D for primary prevention

Inappropriate implantable cardioverter defibrillator shocks—incidence, effect, and implications for driver licensing

PurposePatients with implantable cardioverter defibrillators (ICDs) have an ongoing risk of sudden incapacitation that may cause traffic accidents. However, there are limited data on the magnitude of this risk after inappropriate ICD therapies. We studied the rate of syncope associated with inappropriate ICD therapies to provide a scientific basis for formulating driving restrictions.MethodsInappropriate ICD therapy event data between 1997 and 2014 from 50 Japanese institutions were analyzed retrospectively. The annual risk of harm (RH) to others posed by a driver with an ICD was calculated for private driving habits. We used a commonly employed annual RH to others of 5 in 100,000 (0.005%) as an acceptable risk threshold.ResultsOf the 4089 patients, 772 inappropriate ICD therapies occurred in 417 patients (age 61 ± 15 years, 74% male, and 65% secondary prevention). Patients experiencing inappropriate therapies had a mean number of 1.8 ± 1.5 therapy episodes during a median follow-up period of 3.9 years. No significant differences were found in the age, sex, or number of inappropriate therapies between patients receiving ICDs for primary or secondary prevention. Only three patients (0.7%) experienced syncope associated with inappropriate therapies. The maximum annual RH to others after the first therapy in primary and secondary prevention patients was calculated to be 0.11 in 100,000 and 0.12 in 100,000, respectively.ConclusionsWe found that the annual RH from driving was far below the commonly cited acceptable risk threshold. Our data provide useful information to supplement current recommendations on driving restrictions in ICD patients with private driving habits

Trends and determinant factors in the use of cardiac resynchronization therapy devices in Japan : Analysis of the Japan cardiac device treatment registry database

Background: The choice of cardiac resynchronization therapy device, with (CRT-D) or without (CRT-P) a defibrillator, in patients with heart failure largely depends on the physician's discretion, because it has not been established which subjects benefit most from a defibrillator. Methods: We examined the annual trend of CRT device implantations between 2006 and 2014, and evaluated the factors related to the device selection (CRT-D or CRT-P) for primary prevention of sudden cardiac death in patients with heart failure by analyzing the Japan Cardiac Device Treatment Registry (JCDTR) database from January 2011 and August 2015 (CRT-D, n=2714; CRT-P, n=555). Results: The proportion of CRT-D implantations for primary prevention among all the CRT-D recipients was more than 70% during the study period. The number of CRT-D implantations for primary prevention reached a maximum in 2011 and decreased gradually between 2011 and 2014, whereas CRT-P implantations increased year by year until 2011 and remained unchanged in recent years. Multivariate analysis identified age (odds ratio [OR] 0.92, 95% confidence interval [CI] 0.90-0.95, P < 0.0001), male sex (OR 1.99, 95% CI 1.28-3.11, P < 0.005), reduced left ventricular ejection fraction (LVEF) (OR 0.96, 95% CI 0.94-0.98, P < 0.0001), and non-sustained ventricular tachycardia (NSVT) (OR 2.85, 95% CI 1.87-4.35, P < 0.0001) as independent factors favoring the choice of CRT-D. Conclusions: Younger age, male sex, reduced LVEF, and a history of NSVT were independently associated with the choice of CRT-D for primary prevention of sudden cardiac death in patients with heart failure in Japan

Current status of cardiac resynchronization therapy with defibrillators and factors influencing its prognosis in Japan

AbstractPurposeThe purpose of this study was to clarify the prognosis of cardiac resynchronization therapy with defibrillators (CRT-Ds) in Japan.MethodsWe selected 384 patients implanted with a CRT-D device from the observation database (n=1482) of the Japanese Cardiac Device Therapy Registry. We investigated the CRT criteria, including the presence of New York Heart Association (NYHA) class III/IV symptoms, left ventricular ejection fraction (LVEF) ≤35%, and QRS duration ≥120ms. The patients were divided into 2 groups: the group fulfilling all of the 3 criteria (Group A, n=229) and the group not fulfilling the criteria (Group B, n=155). We compared mortality and appropriate shock rates between the 2 groups.ResultsThere was no significant difference in mortality (17.9% vs. 13.5%) or appropriate shock rates (32.5% vs. 31.6%) during the observation period of 29.0±15.7 months between the 2 groups. A logistic multivariate analysis showed that appropriate shocks (hazard ratio [HR]=1.85) and class III antiarrhythmic agents (HR=2.33) were independently associated with all-cause death, and that age ≥70 years (HR=0.55), male gender (HR=2.07), and presence of a single-chamber device (HR=1.78) were associated with appropriate shocks. The prognosis of Group A was better than that of the COMPANION trial.ConclusionsJapanese patients with CRT-D devices had a better prognosis than did those in the COMPANION trial, but no significant differences were observed between patients fulfilling and those not fulfilling the above mentioned criteria