Cardiac resynchronization therapy: implant rates, temporal trends and relationships with heart failure epidemiology.

BACKGROUND: Consensus guidelines define indications for cardiac resynchronization therapy (CRT), but the variability in implant rates in 'real world' clinical practice, as well as the relationship with the epidemiology of heart failure are not defined. METHODS AND RESULTS: In Emilia-Romagna, an Italian region with around 4.4 million inhabitants, a registry was instituted to collect data on implanted devices for CRT, with (CRT-D) or without defibrillation (CRT-P) capabilities. Data from all consecutive patients resident in this region who underwent a first implant of a CRT device in years 2006-2010 were collected and standardized (considering each of the nine provinces of the region). The number of CRT implants increased progressively, with a 71% increase in 2010 compared to 2006. Between 84 and 90% of implants were with CRT-D devices. The variability in standardized implant rates among the provinces was substantial and the ratio between the provinces with the highest and the lowest implant rates was always greater than 2. Considering prevalent cases of heart failure in the period 2006-2010, the proportion of patients implanted with CRT per year ranged between 0.23 and 0.30%. CONCLUSIONS: The application in 'real world' clinical practice of CRT in heart failure is quite heterogeneous, with substantial variability even among areas belonging to the same region, with the need to make the access to this treatment more equitable. Despite the increased use of CRT, its overall rate of adoption is low, if a population of prevalent heart failure patients is selected on the basis of administrative data on hospitalizations.

A simplified biventricular defibrillator with fixed long detection intervals reduces implantable cardioverter defibrillator (ICD) interventions and heart failure hospitalizations in patients with non-ischaemic cardiomyopathy implanted for primary prevention: the RELEVANT [Role of long dEtection window programming in patients with LEft VentriculAr dysfunction, Non-ischemic eTiology in primary prevention treated with a biventricular ICD] study.

AIMS: To investigate the efficacy and safety of a cardiac resynchronization therapy with cardioverter-defibrillator (CRT-D) device with simplified ventricular tachycardia management in patients with non-ischaemic heart failure (HF) and primary prevention implantable cardioverter defibrillator (ICD) indication. METHODS AND RESULTS: Prospective, controlled, parallel, multicentre, non-randomized study enrolling 324 primary prevention non-ischaemic HF patients implanted with CRT-D devices from 2004 to 2007: Protect group, 164 patients implanted with a Medtronic Insync III Protect device and Control group, 160 patients utilizing other Medtronic CRT-D devices. Efficacy was assessed by computing appropriate and inappropriate detections and therapies during follow-up; safety compared hospitalizations and syncopal events between groups. Ninety per cent of both ventricular and supraventricular tachyarrhythmias terminated within the 13-29 beat detection interval with the Protect algorithm. The Protect group showed a significantly better event-free survival to first delivered therapy for total (P = 0.0001), appropriately treated (P = 0.002), and inappropriately treated episodes (P = 0.017). The total number of delivered shocks was significantly lower in the Protect group (22 vs. 59, P < 0.0001). In the Protect group, a significantly reduced HF hospitalization (hazard ratio 0.38, 95% CI 0.15-0.98, P = 0.044) was observed without any increase of syncope or death. CONCLUSION: A simplified CRT-D device with fixed long detection reduced overall ICD therapy burden and HF hospitalizations without entailing any additional adverse events in primary prevention non-ischaemic HF patients.

Electrical storm in patients with biventricular implantable cardioverter defibrillator: incidence, predictors, and prognostic implications.

BACKGROUND: The aim of the present study was to evaluate the incidence, predictors, and related outcomes of patients with heart failure (HF) treated with cardiac resynchronization therapy with an implantable cardioverter defibrillator (CRT-D) who experienced electrical storm (ES). Electrical storm was defined as the occurrence of >or=3 episodes in 24 hours of sustained ventricular tachyarrhythmias. METHODS: A total of 631 patients with HF (90% male, mean 66+/-9 years) consecutively received a CRT-D device. At baseline, the mean left ventricular ejection fraction was 26%+/-7%, the QRS duration was 164+/-33 milliseconds, and the mean New York Heart Association class was 3.3+/-0.3. RESULTS: During a mean follow-up of 19+/-11 months, 2,419 ventricular tachyarrhythmia episodes were appropriately detected in 141 (22%) patients. Electrical storm occurred in 45 (7%) of 631 patients. Kaplan-Meier analysis and multivariable Cox regression showed that ES is more frequent in secondary prevention (hazard ratio 2.3, 95% CI 1.2-4.3, P=.015) and in nonischemic patients (hazard ratio 2.0, 95% CI 1.1-3.8, P=.028). In patients who presented ES, CRT was associated with only marginal nonsignificant improvements of New York Heart Association class and left ventricular ejection fraction. Hospitalizations and death due to HF were more frequent in patients with ES compared with those without ES, amounting to 16.8 (4.3) versus 8.6 (0.9) per 100 patient-years (P = .018) and 7.7 versus 2.7 per 100 patient-years (P=.014), respectively. CONCLUSIONS: Electrical storm affect only 7% of CRT-D recipients and occurred more frequently in nonischemic patients with HF with biventricular implantable cardioverter defibrillators implanted for secondary prevention. Electrical storm was associated with worse HF morbidity and mortality.

Clustering of ventricular tachyarrhythmias in heart failure patients implanted with a biventricular cardioverter defibrillator.

BACKGROUND: Temporal patterns of ventricular tachyarrhythmia (VT/VF) have been studied only in patients who have received implantable cardioverter defibrillators (ICD) for secondary prevention of sudden death, and mainly in ischemic patients. The aim of this study was to evaluate VT/VF recurrence patterns in heart failure (HF) patients with biventricular ICD and to stratify results according to HF etiology and ICD indication. METHODS AND RESULTS: We studied 421 patients (91% male, 66 +/- 9 years). HF etiology was ischemic in 292 patients and nonischemic in 129. ICD indication was for primary prevention in 227 patients and secondary prevention in 194. Baseline left ventricular ejection fraction (LVEF) was 26 +/- 7%, QRS duration 168 +/- 32 msec, and NYHA class 2.9 +/- 0.6. In a follow-up of 19 +/- 11 months, 1,838 VT/VF in 110 patients were appropriately detected. In 59 patients who had > or = 4 episodes, we tried to determine whether VT/VF occurred randomly or rather tended to cluster by fitting the frequency distribution of tachycardia interdetection intervals with exponential functions: VT/VF clusters were observed in 46 patients (78% of the subgroup of patients with > or = 4 episodes and 11% of the overall population). On multivariate logistic analysis, VT/VF clusters were significantly (P < 0.01) associated with ICD indication for secondary prevention (odds ratio [OR] = 3.12; confidence interval [CI] = 1.56-6.92), nonischemic HF etiology (OR = 4.34; CI = 2.02-9.32), monomorphic VT (OR = 4.96; CI = 2.28-10.8), and LVEF < 25% (OR = 3.34; CI = 1.54-7.23). Cardiovascular hospitalizations and deaths occurred more frequently in cluster (21/46 [46%]) than in noncluster patients (63/375 (17%), P < 0.0001). CONCLUSIONS: In HF patients with biventricular ICDs, VT/VF clusters may be regarded as the epiphenomenon of HF deterioration or as a marker of suboptimal response to cardiac resynchronization therapy.

A controlled study on the effect of verapamil on atrial tachycaarrhythmias in patients with brady-tachy syndrome implanted with a DDDR pacemaker.

While verapamil has been proposed as a treatment for reducing electrophysiological remodeling due to atrial fibrillation and atrial tachyarrhythmias, no previous study has tested its effects in brady-tachy patients implanted with a dual-chamber pacemaker. Fourteen patients with frequent episodes of atrial fibrillation (> or =2 episodes/month) in the setting of brady-tachy syndrome, implanted with a DDDR pacing system with extensive monitor function (Selection 900, Vitatron) were enrolled. Four months after implantation, they were randomly allocated to a 2-month period of treatment with verapamil (240 mg/day) or to no treatment, followed by a crossover. The burden of atrial tachyarrhythmias, the total number of hours spent in atrial tachyarrhythmia and the mean number of hours per day spent in atrial tachyarrhythmia were retrieved from diagnostic devices. The accuracy of atrial tachyarrhythmias detection was confirmed independently by two observers. The main results showed that treatment with verapamil was associated with a trend towards an higher percentage of atrial pacing in comparison with control (mean value+/-S.D.=63.2+/-29.9% vs. 57.3+/-30.6%, median value 53% vs. 49%, P value at Wilcoxon signed rank test=0.069), but without any significant reduction in atrial tachyarrhythmia burden (4.5+/-11.8 vs. 3.3+/-9.1%) or total hours spent in atrial tachyarrhythmia (65+/-161 vs. 48+/-131 h). Palpitation episodes were not significantly reduced by verapamil treatment in comparison with control (10.3+/-7.8 vs. 6.1+/-6.5). In conclusion, verapamil does not exert any beneficial effect on documented episodes of atrial tachyarrhythmia in patients with brady-tachy syndrome implanted with a DDDR device. Moreover, this drug was ineffective in reducing the number of palpitation episodes reported by the patient.

Cardiac resynchronization and implantable cardioverter defibrillator therapy: preliminary results from the InSync Implantable Cardioverter Defibrillator Italian Registry.

The aim of this study was to evaluate ventricular arrhythmias occurring in recipients of the InSync ICD for the primary and secondary prevention of sudden death. The InSync ICD was implanted in 142 patients (128 men; mean age 65 +/- 10 years) with heart failure (mean NYHA functional Class 3.0 +/- 0.7) and wide QRS (mean 159 +/- 33 ms). The underlying etiology was ischemic in 55%, idiopathic in 33%, and valvular or hypertensive cardiomyopathy in 12% of patients. The numbers of arrhythmic episodes/100 patient-months was computed with their 95% CI, assuming a Poisson distribution. Implants were performed in 48 (34%) patients who did not have an ACC/AHA guidelines Class I indication for ICD therapy. A total of 104 patients were compliant for follow-up visits. During a 9-month median (range 0.1-24) follow-up of 104 compliant patients, 19 experienced a total of 94 ventricular arrhythmias, all successfully interrupted or self-terminated, with a median number of two separate episodes, corresponding to a rate of 10 episodes/100 person-month (95% CI 8-12). A rate of 12 episodes/100 person-months (95% CI 10-15) was measured in the subgroup of patients with ACC/AHA class I indications, versus two episodes/100 person-months (95% CI 1-5) in the remainder of the population. Among 12 deaths, 9 were due to heart failure, 1 to a non-cardiovascular cause, and 2 to unknown causes. The implantation of ICD in heart failure patients has been prominently extended to primary prevention. Patients without standard ICD indications experienced life-threatening arrhythmic events. The impact of ICD combined with cardiac resynchronization therapy on arrhythmic profile, mortality, and costs in this subgroup of patients need to be more precisely studied, with a particular focus on the various types of underlying heart disease.