Impact of sex on the utilization of defibrillation-capable cardiac implantable devices and outcome: results from the German device registry.

Funding AcknowledgementsType of funding sources: None.BackgroundImplantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) are widely used in patients with life-threatening cardiac arrhythmias or systolic heart failure. Real world data regarding gender impact on ICD and CRT implantation and outcome is scarce.PurposeTo investigate the impact of gender-specific differences on cardiac devices implantation and outcomes.MethodsThe German DEVICE registry is a nationwide prospective multicentre database of ICD and CRT devices implantation. A total of 5451 patients were prospectively enrolled in 44 centres between March 2007 and February 2014 and were monitored for a median of 17 months.ResultsA minority of patients in this registry was female 1050 (19.3%; mean age 64.4 ± 14.6 years; median BMI 27.2) while men represented 80.7% (mean age 65.5 ± 12.4 years; median BMI 26.8). Female patients were less likely to have a LVEF <35% (70.6% vs. 77.7%; p<0.0001) and more likely to have a LVEF >55% (13.3% vs. 6.6%; p<0.0001). Moreover, women were less likely to have coronary artery disease (42.3% vs. 64.7%; p<0.0001), history of myocardial infarction, percutaneous coronary intervention, and coronary artery bypass graft (p<0.0001 for all). The rate of CRTs was significantly higher in women than in men (33.4% vs. 28.7%; p=0.0036). In terms of secondary prevention implantations, women were more likely to have history of ventricular fibrillation (VF; 50.7% vs. 37.2%; p<0.0001) but less likely to have history of ventricular tachycardia (VT; 34.5% vs. 47.5%; p<0.0001). The rates of major periprocedural complications and in-hospital complications were higher in women (3.3% vs. 1.7%; p=0.002 and 5.6% vs. 3.7%; p=0.0208). The Kaplan-Meier estimated 1-year all-cause mortality was 5.4% for women and 7.4% for men, while the overall mortality during follow-up was 10% for women and 14% for men (p=0.0004), with no gender differences in terms of death cause. Significantly less women received device shocks (14.2% vs. 17.5%; p=0.0260), while more women needed device revision during follow-up (10.9 % vs. 8.2%; p=0.0246).Similar rates of primary and secondary prevention indication were noted for female and male patients (p=0.9717). There was no difference between the groups regarding the need of postprocedural system revision (p=0.7884), as well as in-hospital death, cardiac death, or sudden cardiac death. The non-fatal complications during follow-up were comparable for men and women. Moreover, similar rates and durations of all cause and cardiac rehospitalizations were found (p=0.1644 and p= 0.1816).ConclusionIn this real-life patient cohort only a minority of female patients were enrolled. Female patients were more likely to undergo CRT implantation and had a higher risk for acute major periprocedural complications and in-hospital complications but a lower overall mortality in 1-year follow-up. However, the differences in baseline characteristics should be considered as potential confounders.Table 1. Baseline characteristicsTable 2. Procedural data and outcome

Background Implantable cardioverter defibrillators (ICD) are an established therapy for the primary and secondary prevention of sudden cardiac death. Real world data regarding the impact of gender on ICD implantation and outcome are scarce. Purpose To determine the impact of gender on the ICD implantation and outcome. Methods The German DEVICE registry is a prospective, nationwide database of ICD and CRT devices implantation and revisions. Between March 2007 and February 2014, 3794 patients undergoing a single or dual chamber ICD implantation and revisions were prospectively included in 44 centres and monitored for a median of 17 months. Herein we conducted the gender-based analysis of the ICD recipients. Results A total of 688 (18,1%) women (mean age 62.5 ± 16.0, median BMI 26.7) and 3106 men (mean age 64.6 ± 12.9, median BMI 26.8) were included in this registry. Significantly less women had coronary artery disease (p&amp;lt;0.001), while more women had hypertrophic cardiomyopathy (p=0.024) and primary electrical heart disease (p&amp;lt;0.001), mainly because of a higher incidence of long QT syndrome and arrhythmogenic right ventricular cardiomyopathy. There was a trend towards a higher rate dual chamber ICD in the female population (31.7% vs. 28.1%; p=0.061). Women were less likely to undergo ambulatory interventions (6.4% vs. 9.0%; p=0.026) and had a trend towards higher rate of ICD implantation for secondary prevention (52.3% vs. 48.7%; p=0.086). Females were more likely to have a history of ventricular fibrillation (51.7% vs. 39.4%; p&amp;lt;0.001) and resuscitation (54.7% vs. 46.3%; p=0.006), but less likely to have a history of ventricular tachycardia (33.1% vs. 45.2%; p&amp;lt;0.001). The overall rate of in-hospital complications (5.3% vs. 2.7%; p=0.005) as well as the rate of major periprocedural complications (3.1% vs. 1.3%; p=0.002) was significantly higher among females, mainly driven by a higher incidence of pneumothorax (1.0% vs. 0.1%; p=0.004) and haemothorax (0.4% vs. 0%; p=0.02). The rate of in-hospital device revision and mortality were similar between genders. The Kaplan-Meier estimated 1-year all-cause mortality was 5.2% for women and 7.1% for men (p=0.073; Fig 1), while the estimated incidence of all-cause mortality or device shocks was significantly lower in the female population (15.1% vs. 19.0%; p=0.02). Women were more likely to undergo resuscitation during follow-up (FU; 1.3% vs. 0.3%; p&amp;lt;0.001) and showed a higher fear of receiving device shocks. There was no difference in terms of ICD-shocks, VT-storm and ablation rates at FU. The all- cause, device-related, and other cardiovascular rehospitalisation rates and the incidence of non-arrhythmic adverse events during FU were similar between genders. Conclusions In this real-life patient cohort only a minority of patients were females. Female patients had a higher risk of major periprocedural complications and in-hospital complications and a trend towards a lower all-cause mortality during FU.Fig 1. Kaplan-Meier estimated survival.

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). 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. 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. 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.

Cardiac implantable electronic devices (CIEDs) are increasingly implanted in older patients with multiple comorbidities. The impact of comorbidities on procedural complications and clinical outcomes during and after defibrillator implantation remains a subject of ongoing debate. To investigate the associations of the comorbidity burden on baseline characteristics, periprocedural complications, and on outcomes in patients with implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy with defibrillator (CRT-D) implantations or revisions. Patients who underwent ICD or CRT-D implantations or revisions at 50 centers were prospectively enrolled in the German Device Registry. Data on patient characteristics, periprocedural complications, and outcomes were collected. Patients were categorized into four groups based on cardiometabolic comorbidities (stroke, chronic kidney disease (CKD), diabetes, hypertension): group I (no comorbidities), group II (one), group III (two), and group IV (three or four). Primary outcomes included 1-year all-cause mortality, major adverse cardiac and cerebrovascular events (MACCE), and arrhythmic/non-arrhythmic events. The Kaplan-Meier analysis was used to determine 1-year mortality. Overall, 5329 patients (mean age 65.2years) underwent 3794 ICD and 1535 CRT-D implantations. Median follow-up was 17months. Periprocedural complications (groupI: 2.1%, groupII: 1.5%, groupIII: 2.1%, groupIV: 2.4%; p = 0.91) and in-hospital MACCE (groupI: 0.2%, groupII: 0.4%, groupIII: 0.6%, groupIV: 0.4%; p = 0.25) were not related to comorbidity burden. Higher comorbidity burden was associated with a higher 1-year all-cause mortality (p < 0.001), but ICD shocks did not differ between groups (p = 0.97). The MADIT-ICD non-arrhythmic mortality score increased with comorbidities (p < 0.001), while the VT/VF score remained unchanged. Periprocedural complications do not appear to be affected by cardiometabolic comorbidities in patients undergoing ICD or CRT-D implantation in Germany. As expected, multimorbidity was associated with a higher risk of mortality and MACCE without detectable effects on ventricular arrhythmias.

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

Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Stiftung Institut für Herzinfarktforschung Background The number of patients receiving cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) devices has been increasing in the last decades. Both CRT and ICD play an essential role in modern heart failure therapy. However, the implantation procedure might be ensued by serious complications. Therefore, knowledge about the prevalence of complications and identification of risk factors are key to improve patient care. Methods Between 2007-2014 the German DEVICE registry enrolled patients from 50 German centers undergoing ICD or CRT implantation. Patient characteristics, data on procedural outcome, adverse events and mortality during index hospitalization and follow-up at 1 year from discharge, were recorded. Patients who suffered from perioperative complications during or shortly after device implantation were identified for comparative analysis with patients without complications. Results Out of 4170 patients enrolled, 119 (2.9%) suffered from procedure related complications. The proportion of female patients suffering from perioperative complications was higher with 29.4%, compared to 18.5% of female patients without complications (p=0.003). There were neither any differences in age (66.3±13.6 vs. 65.4±12.5 years; p=0.13), nor in cardiac or non-cardiac comorbidities and in the indications for device implantation between groups. There was a trend towards a higher rate of complications with procedures on pre-existing devices (24,8 vs. 18.1%; p=0.064), than observed with de-novo implantations (75.2 vs. 81.9%; p=0.064). CRT implantations were more frequent among patients who suffered from complications (46.2 vs. 28.9%; p&amp;lt;0.001), compared to the group without complications, in which the proportion of ICD implantations was much more frequent (53.8 vs. 71.1%; p&amp;lt;0.001). The most frequent complication overall was pocket hematoma (55.1%), followed by pneumothorax (30.3%), pericardial effusion/tamponade (12.7%) and haemothorax (4.2%). The median hospital stay was significantly longer for patients with complications (7 [5; 11] vs. 3 [2; 5] days; p&amp;lt;0.001)). There was no difference in all-cause in-hospital mortality between respective groups. Median follow-up was 455 [398; 551] vs. 462 [391; 569] days (p=0.82) with no differences in all-cause mortality (6.5 vs. 6.9%; p=0.88), device-associated complications (12.6 vs. 8.5%; p=0.18) or rehospitalizations (37.9 vs. 32.2%; p=0.26) after 1-year follow-up. Conclusion The overall procedure-related complication rate following CRT or ICD implantation is low (2.9%). Among patients with complications female gender and patients receiving CRT devices were more prevalent. Perioperative device complications neither seem to translate into increased in-hospital mortality, nor in increased rates of further device-associated complications, rehospitalizations or death after 1-year follow-up.

POSTER PRESENTATIONS

AimsDiabetes 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 resultsWithin 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)].ConclusionsThe 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.

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. 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. 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. 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.

Disorders of the cardiac muscle or cardiomyopathies are a broad, yet collectively common, group of conditions. Despite the heterogeneous etiologies, mode of death from these conditions is remarkably similar - progressive decline in cardiac function leading to intractable heart failure (HF) and sustained ventricular arrhythmias resulting in sudden cardiac death (SCD). Nearly 50% of patients die within 5 years of a HF diagnosis.1 Indeed, in the United States, HF alone is thought to cause 55,000 deaths per year2 and further contribute to 1 in 9 deaths overall.1 However, while advanced HF and the risk of SCD were once thought to be untreatable, technological advances has seen the emergence of device therapies as viable treatment options. Specifically, implantable cardioverter-defibrillator (ICD) therapy for treatment of ventricular arrhythmias, cardiac resynchronization therapy (CRT) for restoring cardiac synchrony and mechanical efficiency, and ventricular assist device (VAD) therapy to temporarily or permanently replace the function of the failing heart, have all emerged as highly efficacious therapies. The expanding use of device therapies, however, poses many challenges. First, while the indications for these devices are well summarized in clinical guidelines,3,4 considerable hurdles remain in ensuring eligible patients receive these therapies.5 By the same token, establishing the safety and effectiveness of these therapies in populations that are found in clinical practice, yet commonly excluded from trials, such as the elderly6 and uncommon forms of cardiomyopathies,7 is a high priority. Second, rapid dissemination of technologies frequently results in disparities in care. Indeed, age, gender, and racial disparities, in both receipt of these devices and outcomes following implantation, have been well documented. Whether these disparities have persisted, and the potential causative mechanisms underlying these disparities, however, are uncertain.8,9 Third, these devices are not without significant untoward effects; understanding …

More than 4000 patients have been evaluated in randomized controlled trials of cardiac resynchronization therapy (CRT). These studies have demonstrated that CRT with or without an implantable cardioverter-defibrillator (ICD) consistently improves quality of life, functional status, exercise capacity, and cardiac structure and function and reduces morbidity and mortality in heart failure patients with ventricular dyssynchrony. The magnitude of benefit seen with CRT is comparable to or exceeds that seen with evidence-based drug therapies for heart failure but occurs in patients who are already receiving such medications. Thus, CRT has been added to the list of evidence-based therapies that make heart failure patients feel better and live longer (the Table). Consequently, a strong ethical mandate exists for the use of CRT in heart failure. This mandate is reflected in our current practice guidelines for the management of chronic heart failure, which state that all eligible patients should receive CRT unless contraindicated.1,2 End of debate! CRT should be a routine part of any evidence-based treatment regimen for heart failure. View this table: Major Benefits of Evidence-Based Heart Failure Therapies Of course, things are never quite so simple, so let us take a look at the evidence supporting this clinical mandate for CRT and address patient selection, some of the limitations of CRT, and some of the unanswered questions about the use of CRT in heart failure. None of this discussion will lessen the role of CRT in the treatment of heart failure; rather, it will guide the selection of appropriate patients and speculate on the future application of CRT to an even broader group of heart failure patients. Response by Greenberg and Mehra p 2698 Approximately one third of patients with systolic heart failure exhibit ventricular dyssynchrony, defined as a QRS duration >120 ms on the surface ECG.3,4 Ventricular dyssynchrony produces suboptimal ventricular …

Managing atrial fibrillation in the CRT patient: Controversy or consensus?

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. Within the registry data from 50 German centers were collected between January 2007 and February 2014. Our analysis included 3239 ICD patients representing a group of young (28%; group I: < 58years), intermediate aged (50%; group II: 58-74years), and elderly patients (22%; group III: 75-92years). 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). 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.

Contemporary and future trends in cardiac resynchronization therapy to enhance response

Background Defibrillators with cardiac resynchronisation therapy (CRT-Ds) are widely used in patients with left ventricular (LV) systolic dysfunction and high-grade intraventricular conduction delays. Real world data regarding the impact of gender on CRT-D implantation and outcome are scarce. Purpose To determine the impact of gender on the CRT-D devices implantation and outcome. Methods The German DEVICE registry is a prospective, nationwide database of ICD and CRT devices implantations and revisions. A total of 1536 patients undergoing CRT-D implantations and revisions were included between March 2007 and February 2014 in 44 centres and monitored for a median of 17.2 months. Herein we conducted the gender-based analysis of the CRT-D recipients. Results Only a minority of the patients in this registry was females (329; 21,4%). The demographic data (age and BMI) were similar between genders. The female population was less likely to have a coronary artery disease (35.3% vs. 56.7%; p&amp;lt;0.001), but more likely to have dilated cardiomyopathy (61.1% vs. 49.5%; p&amp;lt;0.001). Significantly less women had a LVEF ≤ 35% (90.6% vs. 94.8%, p=0.005). A total of 84.2% of females and 80.2% of males received a device for the primary prevention of sudden cardiac death (SCD; p=0.10). Women were more likely to have a history of ventricular fibrillation (44.2% vs. 23.0%, p=0.002) and resuscitation (p=0.01), but less likely to have a history of ventricular tachycardia (44.2% vs. 61.9%; p=0.019). Significantly more women than men showed a left bundle branch block at implantation (89.7% vs. 80.9%, p&amp;lt;0.001). A QRS duration of at ≥ 150 ms was noted in 74.8% of women and 71.5% of men (p=0.25), while significantly more women had a QRS of ≥ 120 ms (97.0% vs. 94.2%; p=0.043). The overall incidence of major periprocedural complications and in hospital complications was similar between groups (3.6% vs 2.4%, p=0.25 and 6.0% vs. 5.8%, p=0.88 respectively), however a pneumothorax requiring intervention was more common among women (1.8% vs. 0.5%, p=0.027). The rate of device revision until discharge and the in-hospital mortality did not differ between genders. The Kaplan-Meier estimated 1-year all-cause mortality was 6.3% for women and 8.2% for men (p=0.25, Fig.1), while the estimated incidence of death or defibrillator shocks was 11.0% and 15.1%, respectively (p=0.051). The non-lethal complications and device revisions during follow-up (FU) were similar between genders. Women showed a lower non-device-dependent cardiovascular hospitalisation rate (8.2% vs. 13.1%; p=0.043) and had more fear of receiving a device shock than men (p=0.002). Conclusions In this real-life CRT-D patient cohort only a minority of patients were females. Women had a higher rate of pneumothorax requiring intervention. The 1-year mortality and the complications during FU were similar between genders. Women had a lower rate of non-device-dependent cardiovascular hospitalisation during FU.Fig.1. Kaplan-Meier estimated survival.