The role of trigger factors in the occurrence of appropriate ICD shocks and their clinical and prognostic implications.

BACKGROUND: The role of triggers in the occurrence of appropriate implantable cardioverter-defibrillator (ICD) shocks due to ventricular tachyarrhythmias is not well known. The aim of the study was to assess the prevalence of trigger factors in appropriate ICD shocks and to analyze their prognostic impact on clinical outcome. METHODS: A total of 710 consecutive patients of a prospective single-center ICD-registry who received a first appropriate ICD shock between 2000 and 9/2021 were analyzed. RESULTS: In 35% of ICD patients with first ICD shock, at least one of the following triggers was found: Ischemia (22%), Compliance (9%), Decompensation (38%), Stress (12%), Technical (5%), Electrolyte/endocrinological disorder (22%) and Medication side effects (4%). The trigger factors can be summarized under the acronym ICD-STEMi. The prospective application of the ICD-STEMi scheme increased the rate of identified triggers from 32% to 56% (p < .001). Patients with triggered first ICD shock had an increased 5-year mortality rate (50% vs. 38%, p < .001). Patients with triggers did not show different mortality outcomes or recurrent ICD shocks whether they received arrhythmia therapy or not. CONCLUSIONS: The evaluation of trigger factors after the occurrence of ICD shocks is mandatory and can be systematically evaluated using the acronym ICD-STEMi. Systematic evaluation of triggers using the ICD-STEMi scheme can identify triggers in about half of ICD patients with first appropriate ICD shock. Patients with triggered ICD shock have a 12% higher 5-year mortality rate.

[Supraventricular tachycardia]. / Supraventrikuläre Tachykardien.

Supraventricular tachycardia is a common occurrence in routine clinical practice. As a physician, one can encounter them everywhere, whether as a general practitioner or as an emergency doctor in a hospital. Some tachycardias might have robbed an on-call doctor the night or the last nerve; however, supraventricular tachycardia is usually a benign condition that is easily treatable and, in many cases, even curable. This article covers the differential diagnoses of supraventricular tachycardia and its treatment options. Atrial fibrillation, also a supraventricular tachycardia, is not discussed in this article.

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.

Long-term performance and lead failure analysis of the Durata defibrillation lead compared to its previous model, the recalled Riata defibrillation lead.

INTRODUCTION: Data on long-term durability of St Jude Medical Durata defibrillation leads compared to its previous model, the St Jude Medical Riata leads in clinical practice are missing. Aim of the study was to analyze the long-term performance of the Durata defibrillation leads compared to the Riata leads in clinical practice. METHODS AND RESULTS: A total of 1407 consecutive patients of a prospective single-centre implantable cardioverter defibrillator (ICD)-registry were analyzed who underwent ICD implantation with a Durata (n = 913) or Riata (n = 494) ICD lead between 2002 and 2017. Most of the leads were implanted via a subclavian vein access. The estimated lead defect rates after 5 and 10 years were not different between the Durata (11% and 36%) and Riata leads (13% and 38%). Among Durata leads single coil and DF-4 connector ICD leads had a lower incidence of lead failure. Major causes of lead failure were compression of the lead in the clavicular region, generator to lead friction and distal fatigue fracture whereas lead defect due to externalization was a rare cause of lead defect in Riata leads (3%). CONCLUSION: Among ICD leads implanted via the subclavian vein access the lead defect rate of Durata leads after 10 years is similar to that of Riata leads. Single coil and DF-4 ICD leads are associated with a lower lead failure rate. Mechanical stress represents a major cause of lead failure mechanism whereas externalization might only play a minor role in clinical practice.

Can we rely on Danish? Real-world data on patients with nonischemic cardiomyopathy from the German Device Registry.

According to current guidelines prophylactic implantable cardioverter-defibrillator (ICD) therapy is recommended in patients with significantly impaired left ventricular systolic function. However, the recently published DANISH trial did not find a significantly lower long-term rate of death from any cause compared with usual clinical care in patients with non-ischemic cardiomyopathy. We investigated whether registry data from a multi-center 'real-life' registry on patients with non-ischemic cardiomyopathy are similar to this trial. The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5451 patients receiving device implantations in 50 German centers. The present analysis of DEVICE focused on patients with non-ischemic cardiomyopathy and a left ventricular ejection fraction ≤35% who received a prophylactic ICD. Out of 779 patients with symptomatic heart failure and nonischemic cardiomyopathy, 33.1% received a single chamber ICD (VVI), while 11.0% were implanted with a dual-chamber ICD (DDD), and 55.8% received a defibrillator system for cardiac resynchronization therapy. Median follow-up was 16.1 months. 90.7% were alive at follow-up, 9.3% had died during this period. Overall mortality after one year was 5.4%. Overall mortality one year after implantation was significantly increased in patients 68 years and older(7.9%) as compared to younger patients (59-68 years: 2.5%; < 59 years: 3.8%; p < 0.015). Data from the present registry support the recently published results of the DANISH trial. In particular the influence of an increased age as proven in the DANISH trial might also play a role in the present collective. This limits the potential beneficial effect of ICD therapy in particular in the elderly population.

Clinical course and prognostic relevance of antitachycardia pacing-terminated ventricular tachyarrhythmias in implantable cardioverter-defibrillator patients.

AIMS: In patients with an implantable cardioverter-defibrillator (ICD), ICD shocks due to ventricular tachycardia (VT) or ventricular fibrillation (VF) have been associated with an increased mortality. It is not known whether patients with antitachycardia pacing (ATP)-terminated VT/VF episodes have a similar worse outcome. The aim of this study was to evaluate the clinical course and prognostic impact of ATP-terminated episodes on mortality in ICD patients. METHODS AND RESULTS: A total of 1398 consecutive patients of the prospective single-centre ICD-registry Ludwigshafen who underwent an ICD implantation between 1992 and 2008 for primary or secondary prevention of sudden cardiac death were analysed. Patients treated with ATP were compared with patients with appropriate ICD shocks or patients without any appropriate ATP or ICD shock. During the median follow-up time of 6 years, 749 (54%) patients experienced 17 827 episodes of VT or VF which were terminated by ATP in 74% and by shock in 26% of patients. In approximately half (n = 321/749) of those patients with VT/VF, the first episode was terminated by ATP. In a multivariate analysis adjusted for different baseline confounding parameters, the occurrence of first ATP therapy was associated with a higher mortality rate [hazard ratio (HR) 2.60, 95% confidence interval (CI) 2.02-3.35]. When excluding all patients with appropriate ICD shocks first ATP therapy remained associated with a worse prognosis (HR 1.92, 95% CI 1.38-2.67). CONCLUSIONS: In ICD patients, about three-fourths of ventricular arrhythmias are terminated by ATP. The occurrence of ATP-terminated episode is associated with an increased mortality rate.

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.

Generalized anxiety is a predictor of impaired quality of life in patients with atrial fibrillation: Findings from the prospective observational ARENA study.

OBJECTIVE: Atrial fibrillation (AF) is associated with impaired health-related quality of life (HRQoL), an increased risk of morbidity, and mortality. Traditional AF-related outcomes (e.g., AF recurrence) primarily demonstrate the physiological benefits of AF management but do not focus on the benefits experienced subjectively by the patient (i.e., patient-reported outcomes), which have been suggested as optimal endpoints in AF intervention studies. The aim of this study is to identify medical and psychological factors associated with impaired HRQoL at 1-year follow-up. METHODS: Using data from the prospective observational multicenter ARENA study in patients with AF, we analyzed associations between medical factors, anxiety, and HRQoL at 1-year follow-up assessed using 5-level EuroQoL-5D. RESULTS: In 1353 AF patients (mean age 71.4 ± 10.3 years, 33.8% female), none of the medical predictors (e.g., heart disease) or history of cardioversion were associated with HRQoL at the 1-year follow-up. Higher generalized anxiety (ß = -0.114, p < .001) but not cardiac anxiety (ß = -0.006, p = .809) at baseline predicted decreased HRQoL, independent of confounding variables and patients' medical status. Furthermore, the worsening of patients' generalized anxiety was associated with decreased HRQoL (ß = -0.091, p < .001). In contrast, the improvement of generalized anxiety over time predicted higher HRQoL (ß = 0.097, p < .001). Finally, the worsening of patients' cardiac anxiety over time was associated with decreased HRQoL (ß = -0.081, p < .001). CONCLUSION: Our results highlight the importance of anxiety as a predictor of future HRQoL in patients with AF. Additional studies to examine the impact of anxiety treatment on HRQoL in this population are needed. CLINICAL TRIAL REGISTRATION: The investigators registered on ClinicalTrials.gov (NCT02978248) on November 30, 2016 https://clinicaltrials.gov/ct2/show/NCT02978248.

Single beta-blocker or combined amiodarone therapy in implantable cardioverter-defibrillator and cardiac resynchronization therapy-defibrillator patients: Insights from the German DEVICE registry.

BACKGROUND: Because of its antiarrhythmic potency and due to the lack of alternatives, amiodarone is often used for antiarrhythmic therapy in patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator systems. To date, robust data on the safety and clinical benefit of amiodarone therapy in these patients are missing. OBJECTIVE: The purpose of this study was to assess the periprocedural and postprocedural outcomes of combined therapy with beta-blockers plus amiodarone compared to treatment with single beta-blockers in the "real-life" cohort of ICD recipients of the German DEVICE registry. METHODS: A total of 4499 patients who underwent ICD implantation, revision, or upgrade in 49 centers participating in the German DEVICE registry were enrolled from March 2007 to February 2014. RESULTS: Amiodarone had no significant effect on the success of defibrillation testing. Early implantation-associated complications were similar between the groups. However, 1-year overall mortality was significantly higher in the beta-blocker plus amiodarone cohort (adjusted hazard ratio 2.09; P <.001). Interestingly, among the surviving patients, amiodarone was not associated with a significantly reduced risk of ICD discharges or syncopal events. Furthermore, the occurrence of ventricular tachycardia (VT) storm or incessant VTs and the number of patients scheduled for intracardiac ablation did not differ among both groups, whereas the rate of rehospitalization was lower in the cohort with only beta-blockers. CONCLUSIONS: Although amiodarone has no adverse effect on the success of defibrillation testing, our data suggest an increased all-cause mortality under amiodarone therapy, especially in the subgroups of patients with sinus rhythm or severely reduced left ventricular function. In surviving patients, rates of arrhythmic events were comparable.

Prevention of cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation: the ODIn-AF trial.

BACKGROUND AND OBJECTIVES: Long-term oral anticoagulation (OAC) following successful catheter ablation of atrial fibrillation (AF) remains controversial. Prospective data are missing. The ODIn-AF study aimed to evaluate the effect of OAC on the incidence of silent cerebral embolic events and clinically relevant cardioembolic events in patients at intermediate to high risk for embolic events, free from AF after pulmonary vein isolation (PVI). METHODS: This prospective, randomized, multicenter, open-label, blinded endpoint interventional trial enrolled patients who were scheduled for PVI to treat paroxysmal or persistent AF. Six months after PVI, AF-free patients were randomized to receive either continued OAC with dabigatran or no OAC. The primary endpoint was the incidence of new silent micro- and macro-embolic lesions detected on brain MRI at 12 months of follow-up compared to baseline. Safety analysis included bleedings, clinically evident cardioembolic, and serious adverse events (SAE). RESULTS: Between 2015 and 2021, 200 patients were randomized into 2 study arms (on OAC: n = 99, off OAC: n = 101). There was no significant difference in the occurrence of new cerebral microlesions between the on OAC and off OAC arm [2 (2%) versus 0 (0%); P = 0.1517] after 12 months. MRI showed no new macro-embolic lesion, no clinical apparent strokes were present in both groups. SAE were more frequent in the OAC arm [on OAC n = 34 (31.8%), off OAC n = 18 (19.4%); P = 0.0460]; bleedings did not differ. CONCLUSION: Discontinuation of OAC after successful PVI was not found to be associated with an elevated risk of cerebral embolic events compared with continued OAC after a follow-up of 12 months.

Comparison between atrial fibrillation-triggered implantable cardioverter-defibrillator (ICD) shocks and inappropriate shocks caused by lead failure: different impact on prognosis in clinical practice.

INTRODUCTION: Recent studies suggest a worse impact of inappropriate shock therapies on the outcome of patients with an implantable cardioverter-defibrillator (ICD). However, it is not known whether the worse impact is attributed to the ICD shock itself or due to the underlying heart disease. The aim of the study was to evaluate the impact of inappropriate ICD shocks on clinical outcome by comparing ICD shocks triggered by atrial fibrillation (AF) with shocks caused by lead failure. METHODS AND RESULTS: A total of 1,411 consecutive patients of the prospective single-center ICD-registry Ludwigshafen who underwent an ICD implantation between 1992 and 2008 for primary or secondary prevention of sudden cardiac death were analyzed. During the median follow-up of 3 years, 297 (21%) patients experienced inappropriate ICD shocks. Sixty percent of patients had inappropriate shocks due to AF and 24% due to lead defect or T-wave oversensing. Multiple ICD shocks (≥2) triggered by AF were associated with a worse prognosis, whereas a single shock due to AF or 1 or multiple shocks resulting from lead failure were not. ICD shocks caused by AF occurred more often in tandem with a serious adverse event than in patients with a lead failure (15% vs 6%, P < 0.05). CONCLUSION: Multiple ICD shocks triggered by AF are associated with a worse prognosis in ICD patients, whereas a single shock due to AF or shocks resulting from lead failure are not. These data support that the ICD shock itself has no worse impact on the outcome of ICD patients.

[Recurrent torsades and asystole without structural heart disease]. / Rezidivierende Torsaden und Asystolie ohne strukturelle Herzerkrankung.

We report on a 67-year-old female patient with recurrent syncope induced by asystole and polymorphic ventricular tachycardia without relevant structural heart disease. After secondary prophylactic ICD implantation, beta-blocker and flecainide therapy, the patient suffered from recurrent syncope and ICD shocks due to ventricular fibrillation. A rare cause of polymorphic ventricular tachycardia in patients without structural heart disease was found and successfully treated.

Reduction of inappropriate implantable cardioverter-defibrillator therapies using enhanced supraventricular tachycardia discriminators: the ReduceIT study.

PURPOSE: Inappropriate implantable cardioverter-defibrillator (ICD) shocks are associated with greater healthcare resource utilization, poorer quality-of-life, and higher mortality. We aimed to investigate the performance of enhanced supraventricular tachycardia (SVT) discrimination algorithms (morphology discrimination, rate stability, and sudden or chamber onset) for reducing inappropriate ICD therapies in patients with ICD/cardiac resynchronization therapy devices. METHODS: This prospective, non-randomized, multicenter study (ReduceIT) study took place at 56 sites across Germany and Estonia. Adults at risk of sudden cardiac death undergoing St. Jude Medical™ ICD or CRT-D implantation were included. The primary endpoint was freedom from inappropriate ICD shock at 12 months and was analyzed in the intention to treat (ITT) and per-protocol population. RESULTS: Overall, 733 patients (65.9 ± 11.4 years) were included, of which 40.9% and 59.1% received a single- and dual-chamber detection device, respectively. During follow-up (median 11.9 [0-21.6] months), 96.3% of patients experienced no inappropriate therapy (ITT). The sensitivity, specificity, and accuracy for VT/VF were 91.9%, 95.5%, and 94.7%, respectively. In the per-protocol population (n = 620), the proportion of patients free from inappropriate shock at 12 months was 98.4% (n = 610; 95% CI 97.1-99.2%) and exceeded the expected value of 93% (p < 0.0001) which was derived from the rates in the SPICE, ATPonFastVT, and DECREASE studies. A total of 44 patients (6.0%) died during follow-up, 19 deaths were cardiac-related which is consistent with a meta-analysis of EMPIRIC, MADIT-RIT, ADVANCE III, and PROVIDE. Serious device and procedure-related adverse effects occurred in 9.8% of patients. CONCLUSIONS: In ICD/CRT-D devices with advanced SVT discriminators, device programming according to clinical setting and detection chamber significantly reduces the rate of inappropriate ICD shocks without compromising patient safety. The algorithms and settings described herein have particular clinical importance and their employment may be of benefit to ICD recipients.

Distribution and impact of age in patients with implantable cardioverter-defibrillators regarding early complications and 1-year clinical outcome: results from the German Device Registry.

BACKGROUND: Patients receiving implantable-cardioverter-defibrillators (ICD) in clinical practice are often older or younger than in clinical trials. Whether older patients benefit from ICD-therapy in a similar way as younger patients is under debate. The objective of this study was to provide real-world data regarding outcomes with respect to age in a large cohort in the German Device Registry. METHODS: Within the registry data from 50 German centers were collected between January 2007 and February 2014. RESULTS: Our analysis included 3239 ICD patients representing a group of young (28%; group I: < 58 years), intermediate aged (50%; group II: 58-74 years), and elderly patients (22%; group III: 75-92 years). Intergroup comparison of all groups was performed followed by individual comparison vs. group II serving as age-reference group. Procedure-related complications did not differ between all groups. Analysis of the primary endpoint, 1-year all-cause mortality, revealed an increased mortality in the elderly and a decreased mortality in the young cohort vs. the reference group II (group I 2.1%, group II 6.2%, group III 13.2%; p < 0.001). While all-cause rehospitalizations did not differ, we observed a difference in reported device revisions showing more device revisions required in younger patients (group I 8.9%, group II 6.8%, group III 4.0%; p = 0.001). CONCLUSIONS: One-year mortality was doubled in elderly ICD patients probably due to non-cardiac causes. These results further underpin the need for re-evaluating the primary prevention ICD indication in octo- and nonagenarians. Young patients show lower mortality rates but seem to bear higher risk of device-related complications, which highlights the need for improved measures to reduce device-related complications in the young.

Endocarditis at a large community hospital with on-site cardiac surgery.

OBJECTIVE: Infective endocarditis (IE) is still a serious disease. The currently published EURO-ENDO registry showed a rate of surgery of 51.2% and a lower mortality in operated IE patients. We hypothesized differences between our data and the registry. METHODS: Retrospective single centre registry on the hospital course of patients with IE. RESULTS: In four years, 171 IE patients were treated at our hospital. Mean age of patients was 66.5 ± 13.8 years and 62.6% of patients were transferred from other hospitals. There were 85 (49.7%) patients with native valve IE (NVE), 53 (31%) with prosthetic valve IE (PVE) and 33 (19.3%) with either intra-cardiac device related IE (n = 29) or IE associated with central access lines (n = 4) (DRE). A total of 81.3% (n = 139) of patients were sent to cardiac surgery. Using a logistic regression model to analyse predictors of conservative instead of surgical therapy the only independent variables were: presence of large vegetation or abscesses (OR: 0.36, 95%CI 0.15-0.83; p = 0.016) and age (for each ten years) (OR: 1.61, 95%CI 1.11-2.32, p = 0.01). Hospital mortality was 21.6% (n = 37/171), with no difference (p = 0.97) between those who were operated (21.6%, n = 30/139) and those treated conservatively (21.9%, n = 7/32). Comparing those treated conservatively without an indication for surgery with those with an indication, mortality was 9.5% versus 45.5%, p = 0.02. CONCLUSIONS: In this registry from a hospital with on-site cardiac surgery more than half of patients were referred. The rate of patients treated surgically was 81.3%. Hospital mortality was 21.6%, with no difference between operated and conservatively treated patients.

Prevalence of bacterial colonization of generator pockets in implantable cardioverter defibrillator patients without signs of infection undergoing generator replacement or lead revision.

AIMS: This study was designed to evaluate the prevalence of bacterial colonization of generator pockets in implantable cardioverter defibrillator (ICD) patients without signs of infection and to analyse the impact of bacterial colonization on the incidence of device infection during follow-up. METHODS AND RESULTS: In 122 ICD patients undergoing generator replacement or surgical lead revision between January 2006 and July 2008, microbiological cultures of generator pockets and extracted leads were consecutively obtained. Patients with clinical evidence of a device infection were excluded. Positive cultures from the generator pocket and leads were found in 40 (33%) patients. The most common bacteria isolated were coagulase negative staphylococci (68%). During a median follow-up time of 203 days after the revision device infection occurred in three [7.5%, confidence interval (CI) 1.6-20.4%] patients with a positive culture vs. two (2.4%, CI 0.3-8.5%) patients with a negative culture (P = 0.33). Time from revision to infection was 108 +/- 73 days in patients with positive culture vs. 60 +/- 39 days in patients with negative culture (P = 0.50). CONCLUSION: A third of ICD patients undergoing generator replacement or lead revision have an asymptomatic bacterial colonization of generator pockets. After revision 7.5% of these patients develop a device infection with the same species of microorganism.

Prognostic relevance of new onset arrhythmia and ICD shocks in primary prophylactic ICD patients.

BACKGROUND: The prognostic relevance of new onset arrhythmias compared to ICD shocks in ICD patients is not well known. OBJECTIVES: Aim of the study was to evaluate the prognostic relevance of new onset atrial fibrillation (AF) or ventricular arrhythmias (VT/VF) compared to ICD shocks in primary prophylactic ICD-patients. METHODS: A total of 622 of 1955 (32%) patients of the prospective single-centre ICD-registry Ludwigshafen with primary prophylactic ICD indication and sinus rhythm (SR) at baseline without history of AF were analyzed. All patients underwent an ICD implantation between 1992 and 2012. RESULTS: During the median follow-up time of 6 years, 200 (32%) ICD patients developed new AF and 249 (40%) patients new VT/VF. There was an approximately 10% increase of 5-year mortality rate depending on the type of new onset arrhythmia (no arrhythmia 19%, new AF 28%, new VT 36% and new VF 55% 5-year mortality). In a multivariate analysis, new onset of AF or VT/VF was an independent predictor for increased mortality whereas VT shocks and inappropriate ICD shocks were not. CONCLUSION: More than half of primary prophylactic ICD patients with SR at baseline develop new AF or VT/VF after 6 years. New onset arrhythmias of AF and VT/VF are independent prognostic factors for increased mortality in primary prophylactic ICD patients. ICD shocks itself, inappropriate or appropriate, are not additionally associated with a worse outcome. These results support the hypothesis that in clinical practice rather the arrhythmia than the ICD shock itself is responsible for a deteriorated prognosis.

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.

Single chamber implantable cardioverter defibrillator compared to dual chamber implantable cardioverter defibrillator: less is more! Data from the German Device Registry.

BACKGROUND: In patients with high risk for sudden cardiac death the implantation of a defibrillator is an established treatment. However the benefits and risks for patients in accordance to the number of the leads are not clear. Even in the current guidelines a recommendation to this question is missing. We analyzed advantage and disadvantages of single-chamber implantable cardioverter defibrillators (VVI-ICD) versus dual-chamber implantable cardioverter defibrillators (DDD-ICD) in the prospective German Device Registry. METHODS: The data of 2240 patients who underwent ICD implantation in 45 German Centers between January 2007 and March 2011 were included in a prospective device registry (VVI: n = 1629, male = 1358, EF = 34% ± 13%; DDD: n = 611, male = 491, EF = 35% ± 14%). RESULTS: The in-hospital complications were significantly higher in the DDD-ICD group with higher revision/device complication rates (3.0% vs. 1.2%; p = 0.003) but also higher mortality rate (1.0% vs. 0.1%; p < 0.001). Regarding the adjusted data at 1-year follow-up DDD-ICD caused more device revisions, but no difference in rehospitalization and mortality. CONCLUSION: It is still unclear whether DDD-ICD may be beneficial for patients with preserved sinus and atrioventricular nodal function. Our data show that the decision of the operator to choose a DDD-ICD in these patients must be taken very carefully. By choosing a DDD-ICD the patient is exposed to a significantly higher periprocedural complication rate and higher in-hospital mortality. In absence of relevant bradycardias implantation of a DDD-ICD is not justified.

Impact of diabetes on clinical outcome of patients with heart failure undergoing ICD and CRT procedures: results from the German Device Registry.

AIMS: Diabetes mellitus (DM) has a negative impact on prognosis in patients with heart failure (HF). The role impact of DM in HF patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices might differ and remains unclear. The aim of our study was to investigate the impact of DM on periprocedural complications and clinical outcome in HF patients undergoing ICD or CRT implantation. METHODS AND RESULTS: Within the German Device Registry, data from 50 German centres were collected between January 2007 and February 2014. A retrospective analysis of n = 5329 patients undergoing ICD implantation was conducted. Patients' characteristics, procedural data, periprocedural complications, and post-procedural clinical outcome, including a composite clinical endpoint of all-cause mortality, stroke, and myocardial infarction (MACCE), were analysed. Subgroup analysis were performed for ICD and CRT implantations. Median follow-up was 15.7 (12.9; 20.0) and 16.2 (12.8; 21.2) months in DM and non-DM patients. Of 5329 patients enrolled, n = 1448 (27.2%) had a diagnosis of DM. Within the cohort, 94% of DM and 90% of non-DM patients had a diagnosis of HF. Patients with DM were older, had higher body mass index, and higher rate of cardiovascular comorbidities compared with non-DM patients. Unadjusted and adjusted analyses revealed similar all-over intrahospital periprocedural complication rates in both groups (4.1% vs 3.9%). Unadjusted Kaplan-Meier survival analysis showed higher all-cause mortality after 1 year (9.0% vs 6.3%; log-rank P = 0.001) with higher MACCE rates (10.0% vs 7.3%; P < 0.001) in the DM group versus non-DM patients. After multivariable adjustment for relevant covariates, the association of DM to MACCE disappeared [HR 1.11 (0.89-1.38)]. Because chronic kidney disease (CKD) was clearly associated with increased 1 year MACCE after multivariate adjustment [odds ratio (OR) 2.11 (1.68-2.64)], a subgroup analysis was performed showing a strong trend towards more perioperative complications in DM patients with CKD [OR 2.16 (0.9-5.21)], while no effect of DM was observed in patients without CKD [OR 0.73 (0.42-1.28)]. CONCLUSIONS: The overall risk of periprocedural complications and short-term (1 year) clinical outcome in patients with DM and HF undergoing ICD or CRT defibrillator (CRT-D) implantation was not increased. In contrast, CKD was associated with an increased risk of 1 year MACCE in HF patients undergoing ICD/CRT-D implantation.