Selection and outcome of implantable cardioverter-defibrillator patients with and without cardiac resynchronization therapy: Comparison of 4384 patients from the German Device Registry to randomized controlled trials.

BACKGROUND: Registry data add important information to randomized controlled trials (RCT) on real-life aspects of implantable cardioverter-defibrillator (ICD) patients with and without cardiac resynchronization therapy (CRT-D). This analysis of the prospectively conducted German Device Registry aims at comparing mortality rates, comorbidities, complication rates to results from RCT. METHODS: The German Device registry (DEVICE) prospectively collected data on ICD and CRT-D first implantations from 50 German centres. Demographic data, details on cardiac disease, electrocardiogram (ECG), medication, and data about procedure, complications, and hospital stay were stored in electronic case report forms. One year after device implantation patients were contacted for follow-up. RESULTS: DEVICE included n = 4384 first ICD/CRT-D implantations (29.3% CRT-D devices). We found a strong adherence to guidelines with over 90% of patients being on ß-blocker and ACE-inhibitor medication and adequate QRS width in the majority of CRT-D patients. Patients receiving a CRT-D were older (67.6 ± 11.0 years vs. 63.9 ± 13.4 years, p < .001) and had lower ejection fractions (mean 25% vs. 30%, p < .001) compared to ICD patients. Dilated cardiomyopathy was the predominant underlying heart disease in CRT-D (53.3%), coronary artery disease in ICD patients (64.7%). Compared to RCT our DEVICE patients had more comorbidities (17.9% chronic kidney disease [CKD]) and higher 1-year mortality rates (10.7% ICD group, 12.3% CRT group). In multivariate analysis, CKD patients had an almost 2-fold higher risk of 1-year mortality. CONCLUSION: Despite relevant limitations of registry data, DEVICE highlights important differences between RCT and real-world registry data and the impact of comorbidities on mortality of ICD and CRT-D recipients.

Impact of atrial fibrillation on 1-year outcome in patients with implantable cardioverter defibrillator or cardiac resynchronization therapy with defibrillator: results from the German DEVICE Registry.

Background: Atrial fibrillation (AF) is a cardiac arrhythmia frequently documented in patients requiring implantable cardioverter defibrillators (ICDs) and/or cardiac resynchronization therapy with defibrillator (CRT-D). Patients with diagnosed AF at the point of ICD or CRT-D implantation may have an impaired follow-up outcome. Methods: The German DEVICE I-II registry is a nationwide prospective multicentre database of patients implanted with ICD and CRT-D with clinical follow-up data. We analysed a 1-year follow up of implanted patients with AF and with sinus rhythm (SR). Results: A total of 4,929 ICD/CRT patients are included in the present analysis: 946 (19.2%) were in AF and 3,983 (80.8%) were SR at time of device implantation. AF patients had a significantly more comorbid profile including older age {72 [interquartile range (IQR), 66-77] vs. 66 (IQR, 56-73) years; P<0.001}, and higher rate of patients with left ventricular ejection fraction <30% (68.2% vs. 61.0%; P<0.001), peripheral artery disease (4.5% vs. 2.7%; P=0.002), diabetes (33.6% vs. 25.5%; P<0.001), hypertension (58.4% vs. 51.1%; P<0.001) and renal failure (22.6% vs. 15.3%; P<0.001). The intra-hospital complication rate was 4.3% in the AF and 3.6% in the SR group (P=0.38). In 1-year follow-up AF patients experienced a significantly higher rate of defibrillator shocks (25% vs. 15.3%; P<0.001). One-year estimated mortality was 10.8% in the AF and 5.9% in the SR group (P<0.001), while estimated 1-year major adverse cardiac and cerebrovascular events (MACCE) rate was 11.2% vs. 7.0% (P<0.001). The effects of AF on electrical shocks and mortality persisted after adjusting for age, sex, advanced New York Heart Association (NYHA) class, severely impaired left ventricular ejection fraction (LVEF), coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), chronic renal failure (CRF), QRS duration, and type of indication for electronic device implantation. Conclusions: Our clinical data on an extended cohort of contemporary patients confirm the significant impact of AF, and its associated comorbidities, upon mortality and major adverse events after implantation of ICD/CRT.

Implantable cardioverter defibrillators in patients with electrical heart disease and hypertrophic cardiomyopathy: data from the German device registry.

BACKGROUND: Implantable cardioverter- defibrillator (ICD) therapy is established for the prevention of sudden cardiac death (SCD) in different entities. However, data from large patient cohorts with electrical heart disease are rare. Therefore, we investigated these patients as well as patients with hypertrophic cardiomyopathy by analyzing registry data from a multi-center 'real-life' registry. METHODS: The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5450 patients receiving device implantations in 50 German centers. The present analysis of DEVICE focussed on patients with electrical heart disease or HCM who received an ICD for primary or secondary prevention. RESULTS: 174 patients with HCM and 112 patients with electrical heart disease (long-QT syndrome, Brugada syndrome and arrhythmogenic right ventricular cardiomyopathy) were compared with 5164 other ICD patients. Median follow-up was 17.0 months. Patients in the control group were significantly older. Of note, overall mortality after 1 year was 1.8% in HCM patients, 6.6% in patients with electrical heart disease and 7.3% in the control group. Patients in the control group presented significantly more severe comorbidities. In contrast to HCM patients and the control group where primary prevention was the major indication for ICD implantation, 77.5% of patients with electrical heart disease received an ICD for secondary prevention. The number of surgical revisions was higher in patients with electrical heart disease. CONCLUSION: Data from the present registry display a surprisingly high mortality in patients with electrical heart disease equivalent to the control group. A high proportion of patients who received an ICD for secondary prevention may be regarded as a major determinant for these results, while severe comorbidities such as diabetes, hypertension, and renal failure are major determinants for mortality in the control cohort.

Impact of atrial fibrillation on early complications and one year-survival after cardioverter defibrillator implantation: results from the German DEVICE registry.

AIMS AND OBJECTIVE: Outcome data of patients with implantable cardioverter defibrillators (ICD) and atrial fibrillation (AF) are conflicting. The German DEVICE registry aims to add further information on this particular cohort. METHODS AND RESULTS: The German DEVICE registry is a nationwide prospective multicenter database of ICD implantations. 3261 patients are included (81% males, 2701 (82.8%) first ICD implantations, 560 (17.2%) ICD replacements). Cardiac resynchronization therapy (CRT-D) was performed in 882 patients (27.0%). Sinus rhythm (SR) was present in 2654 (81.4%) and atrial fibrillation (AF) in 607 (18.6%). Left ventricular ejection fraction (LVEF) did not differ between groups (SR 32.3%, AF 30.4%; p = 0.09). AF patients were older (AF 70.9 versus SR 63.9 years; p < 0.0001), presented with more co-morbidities (diabetes, hypertension, chronic kidney disease; all p < 0.001). In-hospital complications were not significantly different between groups (p = 0.58). Follow-up information after one year was available in 2967 patients (91%). One-year overall mortality after first ICD implantation was 4.9% for SR and 11.2% for AF patients (p < 0.0001); mortality one year after ICD replacement was 8.4% for SR and 12.0% for AF (p = 0.34). No statistically significant difference between SR and AF patients receiving a CRT device was observed (SR 6.9%, AF 10.7%, p = 0.16) in terms of one-year mortality. CONCLUSION: The German DEVICE registry demonstrates that patients with AF who receive ICD devices are older, have more co-morbidity and more severe heart failure. AF carries an independent 1.39 fold risk (95% CI 1.02-1.89) of death after one year in patients only with first ICD implantation.

Comparing outcome of patients with coronary artery disease and dilated cardiomyopathy in ICD and CRT recipients: data from the German DEVICE-registry.

AIMS: The purpose of this study was to evaluate whether there are differences in use and outcome of implantable cardioverter defibrillator (ICD) therapy with or without cardiac resynchronization therapy (CRT) between patients with underlying coronary artery disease (CAD) and non-ischemic dilated cardiomyopathy (DCM). METHODS: A total of 2,263 consecutive patients from 44 German centers who underwent new ICD or CRT implantation between March 2007 and April 2010 were enrolled in the German DEVICE registry. Patients were followed for at least 1 year. RESULTS: Of 1,621 patients who received an ICD, 1,202 (74.2%) had CAD and 419 (25.8%) suffered from DCM. Patients who received CRT (n = 642) had CAD in 52.2% and DCM in 47.8%. The vast majority received CRT with ICD backup (CRT-D, 95%). In both ICD and CRT groups, CAD patients were older and more often male. LV ejection fraction in ICD patients with CAD was significantly higher than in DCM patients. Heart failure classification and history of atrial fibrillation were similar in CAD and DCM in CRT patients. There was no significant difference in mortality and first ICD shock delivery between CAD and DCM after 1 year of follow-up. Heart failure symptoms showed significant improvement in CRT patients irrespective of the underlying disease. CONCLUSION: ICD and CRT patients in the DEVICE registry showed similar short-term outcome irrespective of their underlying disease etiology. Except older age and preponderance of males, clinical characteristics, device selection and outcome of ICD or CRT patients in the German DEVICE registry are comparable with patients from randomized trials.