Cardioverter Defibrillator Patients Research Articles

All-cause mortality and incidence of appropriate therapy from a primary preventive implantable cardioverter defibrillator in patients with non-ischemic dilated cardiomyopathy

Abstract Background The DANISH study published in 2016 indicated limited benefit of primary prevention implantable cardioverter-defibrillator (ICD) in patients with non-ischemic dilated cardiomyopathy (niDCM). We aimed to investigate the long-term outcome and incidence of ICD therapy in patients with niDCM implanted on primary prevention indication during 2014-2022. Methods A total of 116 patients with niDCM were prospectively included for primary prevention ICD implantation between 2014 and 2022 in the multicenter IMPROVE study (clinical trials NCT02286908). All patients were examined with electrocardiogram, echocardiography and blood sampling at inclusion. The primary outcome was all-cause mortality, and the secondary outcome was appropriate ICD therapy. Outcomes were compared in patients included from 2014 to end of 2016 (DCM2014-16, n=49) and from 2017-2022 (DCM2017-22, n=67). Results At inclusion, patients in DCM2017-22 were younger (54 years [interquartile range (IQR) 44-68] vs. 64 years [IQR 55-70], p=0.001), had higher left ventricular ejection fraction (LVEF) (33% [IQR 25-38] vs. 24% [IQR 21-31], p<0.001) and less frequently received cardiac-resynchronization therapy defibrillator (6% vs. 29%, p=0.001) compared to DCM2014-16. Over a median 4.4-year follow-up, the all-cause mortality was 14%, of which 10% occurred in the DCM2017-22 patients (2.6 events/100 person-years), and 18% in the DCM2014-16 patients (4.0 events/100 person-years), p=0.38. There was no difference in appropriate ICD therapy between the two groups (p=0.90). Conclusion Patients receiving primary prevention ICD for niDCM after publication of the DANISH study were younger with higher LVEF, indicating a change in clinical practice after the publication. Despite this, there was no significant reduction in all-cause mortality or difference in appropriate ICD therapies. Unchanged mortality and event-rates may indicate the correct identification of high-risk patients.

Outcomes of implantable cardioverter-defibrillators in patients with a left ventricular assist device: a systematic review and meta-analysis

Abstract Introduction Implantable Cardioverter-Defibrillators (ICDs) improve survival in advanced heart failure with reduced ejection fraction (HFrEF) and prevent sudden cardiac death. However, the prognostic benefits of ICDs among patients with a Left Ventricular Assist Device (LVAD) remain uncertain and controversial. Therefore, we conducted a systematic review and meta-analysis to assess the effectiveness and safety of ICD implantation among LVAD recipients. Methods We performed a systematic review and meta-analysis following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched PubMed and EMBASE for the peer-reviewed articles published in English assessing the impact of ICD implantation among LVAD recipients, till 10/01/2024. ICD implantation was defined as implantation before LVAD, simultaneous implantation with LVAD, or within 30 days of LVAD insertion. Two independent review authors assessed the quality and risk of bias of the included studies. A random-effect model was used to combine data in forest plots. The primary outcome was all-cause mortality associated with ICD implantation compared to no ICD implantation, and the secondary outcomes included ventricular arrhythmia (VT), and hemorrhagic stroke. Heterogeneity was assessed using Q test and I2, with I2 > 50% indicating marked heterogeneity. Results A total of 13 observational studies comprising 54571 recipients of LVAD were included in the analysis of the primary outcome. All-cause mortality was similar among patients with ICD versus no ICD (Odds Ratio [OR]= 0.77; 95% CI, 0.57-1.04, I2= 89%, P=0.09), as shown in Figure 1. Likewise, ICD implantation was associated with similar rates of VT and hemorrhagic stroke (VT: OR= 1.81, 95% Cl, 0.82-4.01, I2= 90%, P=0.14; hemorrhagic stroke: OR= 1.01, 95% Cl, 0.81-1.25, I2= 0%, P= 0.95). Conclusion Among patients with HFrEF and LVAD as advanced heart failure therapy, ICD implantation didn’t provide additional prognostic survival benefit, suggesting possible use of LVAD without ICD implantation.Figure 1.Forest plot of mortality

Frequency of and outcomes associated with nonadherence to guideline-based recommendations for an implantable cardioverter-defibrillator in patients with congenital long QT syndrome

BackgroundGuideline-directed device therapy for long QT syndrome (LQTS) has evolved during the years, and indications for an implantable cardioverter-defibrillator (ICD) vary between professional cardiac societies. ObjectiveWe aimed to identify the subset of patients with LQTS who satisfied a class I or class II 2022 European Society of Cardiology guideline-based recommendation for an ICD and to determine the outcomes of those patients who received an ICD compared with those treated without an ICD. MethodsRetrospective analysis was conducted of 2861 patients with LQT1, LQT2, or LQT3 to identify patients meeting contemporary recommendations for guideline-directed device therapy. Basic demographics, clinical characteristics, and frequency/type of breakthrough cardiac events (BCEs) were extracted, and outcomes/complications were compared between patients treated with an ICD and those treated without one. ResultsOf the 290 patients (approximately 10%) who met a guideline-based recommendation, 53 (18%) satisfied a class I/level B indication for an ICD; 56 (19%), a class I/level C indication; 19 (7%), a class IIa/level C indication; and 162 (56%), a class IIb/level B indication. However, most patients (156/290 [54%]) did not receive an ICD. Of those who received an ICD, 55 of 134 (41%) experienced ≥1 appropriate ventricular fibrillation–terminating ICD therapy, whereas ICD-related complications occurred in 13 patients (10%). Of those who were treated without an ICD, only 6 of 154 patients (4%) had nonlethal BCEs, which was significantly lower compared with the ICD group (P < .001). ConclusionWith >1200 years of combined follow-up, the experience and evidence from our 2 LQTS specialty centers suggest that many patients who satisfy a recommendation for an ICD based on the latest 2022 European Society of Cardiology guidelines may not need one. This is particularly true when the indication stemmed from a BCE while receiving beta blocker therapy or in asymptomatic patients with an increased 1-2-3-LQTS-Risk score.

Evaluation of cardiac implantable electronic device lead parameters before and after radiotherapy.

Radiotherapy in cancer patients with a pacemaker or an implantable cardioverter defibrillator might damage the device and possibly result in malfunction of the device. We aimed to examine device malfunction and change in lead parameters in this group. The medical records of pacemaker/implantable cardioverter defibrillator patients who underwent radiotherapy at Aalborg University Hospital between July 1, 2016, and June 30, 2021, were reviewed. Treatment was planned according to risk of device malfunction, assessed using local guidelines. Bootstrap linear regression was used to identify possible differences in lead parameters depending on beam energy and anatomical location. One hundred nine patients with a pacemaker/implantable cardioverter defibrillator who received a total of 122 radiotherapy courses in the study period were identified. No device malfunctions or significant changes in lead parameters during radiotherapy were observed. Only the left ventricle lead threshold and impedance were found to be significantly different when compared by beam energy; however, these changes were relatively small and unlikely to be of clinical relevance. No device malfunction or clinically relevant changes in lead parameters were identified in this study, suggesting that radiotherapy of pacemaker/implantable cardioverter defibrillator patients can be regarded as safe when following relevant safety precautions.

No beneficial use of the wearable cardioverter defibrillator among patients suffering from inherited and congenital heart disease: data from a European multicenter registry.

Data on the use of the wearable cardioverter defibrillator in patients suffering from inherited and congenital heart disease are limited. Consequently, evidence for guideline recommendations in this patient population is lacking. In total 1,675 patients were included in a multicenter registry of eight European centers. In the present cohort, we included 18 patients suffering from congenital and inherited heart disease. Nine patients (50%) were male with a mean age of 41.3 ± 16.4 years. Four patients suffered from hypertrophic cardiomyopathy (HCM), four patients suffered from non-compaction cardiomyopathy (NCCM), two patients were diagnosed with arrhythmogenic right ventricular cardiomyopathy (ARVC) and one patient suffered from muscular dystrophy of the limb-girdle type with cardiac involvement, secondary cardiomyopathy. Three patients presented with Brugada syndrome (BrS). One patient suffered from long-QT syndrome type 1 (LQTS1). Furthermore, two patients had congenital heart defects and one patient suffered from cardiac sarcoidosis (CS). There were no appropriate/inappropriate shocks with the WCD in this cohort. One patient had recurrent self-limiting sustained ventricular tachycardia during the wear time, but actively inhibited a shock and was hospitalized. The compliance rate in this cohort was 77.8% with a mean wear time of 45.3 ± 26.9 days with a mean follow-up time of 570 ± 734 days. 55.6% (10/18) of the patients received an ICD after WCD wear time. This retrospective study of patients with inherited and congenital heart disease shows that WCD use is not beneficial in the majority of patients with inherited and congenital heart disease.

Predictors of appropriate therapies delivered by the implantable cardioverter-defibrillator in patients with coronary artery disease during long-term period.

This prospective study aimed to investigate the ability of cardiac autonomic nervous system (CANS) activity assessment to predict appropriate implantable cardioverter-defibrillator (ICD) therapy in patients with coronary artery disease (CAD) during long-term follow-up period. We enrolled patients with CAD and ICD implantation indications that included both secondary and primary prevention of sudden cardiac death. Before ICD implantation CANS was assessed by using heart rate variability (HRV), myocardium scintigraphy with 123I-meta-iodobenzylguanidine (123I-MIBG) and erythrocyte membranes β-adrenoreactivity (EMA). The study's primary endpoint was the documentation of appropriate ICD therapy. Of 45 (100.0%) patients, 15 (33.3%) had appropriate ICD therapy during 36 months follow-up period. Patients with appropriate ICD therapy were likely to have a higher summed 123I-MIBG score delayed (p < 0.001) and lower 123I-MIBG washout rate (p = 0.008) indicators. These parameters were independently associated with endpoint in univariable and multivariable logistic regression. We created a logistic equation and calculated a cut-off value. The resulting ROC curve revealed a discriminative ability with AUC of 0.933 (95% confidence interval 0.817-0.986; sensitivity 100.00%; specificity 93.33%). Combined CANS activity assessment is useful in prediction of appropriate ICD therapy in patients with CAD during long-term follow-up period after device implantation.

Efficacy and safety of the subcutaneous implantable cardioverter-defibrillator in patients with and without obesity: A meta-analysis

BackgroundThe subcutaneous implantable cardioverter-defibrillator (S-ICD) has emerged as an alternative to transvenous systems for prevention of sudden cardiac death. However, concerns have been raised regarding its efficacy and safety in obese individuals. ObjectiveThe purpose of this study was to perform a meta-analysis to evaluate the efficacy and safety of the S-ICD in patients with obesity by assessing the relationship between body mass index (BMI) and clinical outcomes. MethodsA comprehensive search of multiple databases was conducted for English-language peer-reviewed studies reporting clinical outcomes in S-ICD recipients with (BMI ≥30 kg/m2) and without obesity (BMI <30 kg/m2). Data on preimplantation screening failure, defibrillation testing, complications, appropriate and inappropriate shocks, and survival were analyzed using standard, random-effects, meta-analytical techniques. ResultsTwenty-nine studies involving 20,486 patients were included. There was no statistically significant difference in mean BMI values of patients with failed or successful preimplantation screening (mean difference –0.60 kg/m2; 95% confidence interval [CI] –2.06 to 0.86). Obesity was associated with higher rates of failed defibrillation testing at ≤65 J (odds ratio [OR] 2.16; 95% CI 1.39–3.35), and malpositioning/suboptimal positioning occurred more frequently in obese compared to nonobese patients (OR 3.37; 95% CI 1.76–6.44). Increased BMI as a continuous variable (per increase in 1 kg/m2 BMI) was associated with elevated defibrillation thresholds (OR 1.05; 95% CI 1.03–1.08); higher risk of complications (hazard ratio [HR] 1.04; 95% CI 1.02–1.05); a trend toward an increased number of appropriate shocks (HR 1.02; 95% CI 1.00–1.04); and no significant increase in the risk of inappropriate shocks (HR 1.01; 95% CI 0.99–1.03). ConclusionThis meta-analysis underscores the importance of considering obesity in S-ICD implantation decisions. Although S-ICD remains effective in obese patients, attention to potential technical challenges and higher complication rates is warranted.

Systematic review and meta-analysis comparing cardiac resynchronization therapy with versus without defibrillation in patients with non-ischemic cardiomyopathy

Abstract Background Cardiac resynchronization therapy (CRT) stands as a notable medical breakthrough for individuals with heart failure and electrical desynchrony. This intervention aims to alleviate symptoms, diminish hospitalization rates, and enhance overall survival, both in conjunction with and without implantable cardioverter-defibrillator (ICD) therapy. Despite these advancements, the role of defibrillator therapy in addition with CRT for patients with non-ischemic cardiomyopathy (NICM) remains a topic of debate. Objective To assess and compare the outcomes of individuals diagnosed with NICM who have underwent CRT with implantable cardioverter-defibrillator (CRT-D) against those who received CRT with a pacemaker only (CRT-P). Methods We conducted a systematic search of PubMed, Embase and Cochrane database during August 2023 for studies comparing CRT-P and CRT-D in patients with nonischemic cardiomyopathy. Results Thirteen studies, including two randomized clinical trials, were incorporated, with a total of 61,326 patients providing 16,446 pooled death events (9,108 in CRT-D and 7,338 in CRT-P). The meta-analysis revealed that CRT-D was associated with a significantly lower risk of all-cause mortality compared to CRT-P (pooled HR 0.74; 95% CI: 0.62-0.88; I2=84%). Subgroup analysis focusing on propensity score-matched studies yielded consistent findings (pooled HR 0.82; 95% CI: 0.77-0.87; I² = 0%, P&amp;lt;0.001). However, subgroup analysis for patients older than 75 years suggested no statistically significant difference in mortality risk within this specific age group (pooled HR 0.96; 95% CI: 0.811-1.15; I² = 39%, P&amp;lt;0.001). Regarding the secondary endpoint of cardiovascular mortality, no significant risk reduction with CRT-D was observed (pooled HR 0.70; 95% CI: 0.49-1.01; I² = 92%), albeit with high heterogeneity. Conclusion Our study suggests that the addition of defibrillator therapy significantly reduces all-cause mortality in CRT-eligible patients with NICM, although results were not observed for patients older than 75 years.All-cause MortalityPatients older 75 years old

Long-term outcomes associated with subcutaneous implantable cardioverter-defibrillators in patients with hypertrophic cardiomyopathy

Abstract Background In patients with Hypertrophic Cardiomyopathy (HCM) S-ICD is usually the preferred option as pacing is generally not indicated. However, limited data are available on its current practice adoption and long term follow-up. Purpose The present study was designed to examine in a multicenter, open-label, long-term study, the patient’s selection process for S-ICD implantation, the short and long term complications, the appropriate shock (AS) rates, shock efficacy and outcome. Methods Consecutive HCM patients with an S-ICD implanted between 2013 and 2021 in 3 international centers were enrolled in this prospective observational study. Baseline, procedural and follow-up data together with clinical evaluation, ECG, echocardiography, and telemetry checks of the S-ICD were regularly collected. Results Seventy patients (64% males) were enrolled, implanted at 41±15 years, 62 (89%) in primary prevention with a mean ESC SCD risk score of 4,5±1.9%: 25 (40%) at low risk, 17 (27%) at intermediate and 20 (33%) at high risk. Patients were followed-up for 5.1±2.3 years (327 person-years). Notably, 25 (36%) were followed for more than 6 years up to 10 years. Two patients (3%) received an appropriate shock on ventricular fibrillation and 17 (24%) were diagnosed with a de-novo atrial fibrillation, sub-clinical in 6 (9%). One TIA and 2 strokes were reported. Inappropriate shocks occurred in 4 patients (6%), all before Smart-Pass algorithm implementation. Eight patients experienced device related adverse events (11%). Conclusions S-ICDs in HCM patients followed for over 5 years showed to be effective in the conversion of VF in 2 ESC SCD high risk patients (3%) and useful in the detection of sub-clinical AF in 6 (9%). S-ICDs are implanted in patients with an overall low-intermediate ESC SCD risk, probably reflecting both the inclusion of additional risk markers (i.e extensive LGE, reduced EF and apical aneurism) and the physician perception of low device-related complications S-ICD is generally safe, but greater scrutiny may be required to avoid overtreatment in HCM patients with milder risk profiles.Real world use and candidacy of S-ICDAppropriate and inappropriate shocks

Peri-Operative Outcomes Associated With the Placement of Implantable Cardioverter-Defibrillators in Patients With Sarcoidosis: A Nationwide Database Analysis.

Rationale Sarcoidosis with cardiac involvement can be associated with serious life-threatening arrhythmias and an increased risk of sudden cardiac death. Implantable cardiac defibrillators (ICDs) have been used for primary and secondary prevention of sudden death in patients with cardiac sarcoidosis (CS).Post-ICD placement complications have been shown to be higher in patients with CS. However, data comparing postoperative ICD complications among sarcoidosis patients with the general population is limited. Here, we evaluated the association of postoperative complications with implantable cardioverter-defibrillators in sarcoidosis. Methods Using the NIS database, we identified cases of adults aged ≥ 18 years undergoing surgical placement of implantable cardioverter-defibrillators between 2010 and 2019. Using ICD-9 and ICD-10 codes, we identified patients with sarcoidosis. In all statistical analyses, we applied weights provided by HCUP to produce results representative of national estimates. We compared categorical and continuous covariates in the baseline characteristics using the chi-square test and analysis of variance, respectively. We employed multivariable logistic and linear regression to compare binomial and continuous outcomes to assess differences in mortality rates. Results We analyzed 114073 patients during the study period. Of these, 1012 (0.9%) had sarcoidosis and were found to be significantly younger and female compared to patients without sarcoidosis (56.4 ±11.5 years vs. 65.6 ± 13.9 years, p <0.001) and (39.4% vs. 28.3%, p<0.001) respectively. Further, patients with sarcoidosis were more likely to be African American (45% vs. 16.3%), have private insurance (45.4% vs. 23.8%), and less likely to have Medicare (34.9% vs. 60.9%). Overall, post-ICD placement complications such as lead complications (4.2% vs. 6.9%, p = 0.03), post-procedure hemorrhage (4.1% vs. 5.5%, p=0.048), and requirement for transfusion (2.3% vs. 4.4%) were less likely in patients with sarcoidosis. Regarding post-ICD placement inpatient mortality, sarcoidosis was not associated with any difference(OR: 0.71, 95% CI 0.18-2.88 p=0.634). Conclusions Placement of implantable cardioverter-defibrillators in patients with sarcoidosis is a safe procedure and is associated with significantly lower rates of lead complications, post-procedure hemorrhage, and requirement for transfusion. This is of great importance as it is known that patients with underlying sarcoidosis are predisposed to developing more cardiac complications.

Efficacy of implantable cardioverter-defibrillator in non-ischemic systolic heart failure in patients with and without chronic kidney disease: an extended follow-up analysis of the DANISH trial

Abstract Background Patients with heart failure (HF) and chronic kidney disease (CKD) may have an increased risk of death from causes competing with arrhythmic death, which could have implications for the efficacy of implantable cardioverter defibrillators (ICDs). Purpose In this extended follow-up study of the Danish Study to Assess the Efficacy of primary prevention of Implantable Cardioverter Defibrillators in Patients with Non-ischemic Systolic Heart failure on Mortality (DANISH), adding four years of additional follow-up, we examined the long-term effects of primary-prevention ICD implantation, compared with usual medical care, according to baseline CKD status. Methods In the DANISH trial, 1,116 patients with non-ischemic systolic HF were randomized to receive an ICD (N=556) or usual care (N=550). Outcomes were analyzed according to CKD status (eGFR ≥/&amp;lt; 60 mL/min/1.73 m2) at baseline. The primary outcome was death from any cause. Secondary outcomes were cardiovascular death and sudden cardiovascular death. Results In total, 1,113 patients had an available eGFR measurement at baseline (median eGFR 73 ml/min/1.73 m2), and 316 (28%) had CKD. During a median follow-up of 9.5 years, ICD implantation, compared with usual medical care, did not reduce the rate of death from any cause (no CKD, HR 0.81 [95% CI, 0.64-1.03]; CKD, HR 0.92 [0.68-1.26]; P for interaction=0.31) or cardiovascular death (no CKD, HR 0.76 [0.57-1.02]; CKD, HR 0.95 [0.66-1.36]; P for interaction=0.21), irrespective of baseline CKD status. Similarly, baseline CKD status did not modify the beneficial effects of ICD implantation on sudden cardiovascular death (no CKD, HR 0.57 [0.32-1.00]; CKD, HR 0.60 [0.31-1.14]; P for interaction=0.70). Conclusions Primary-prevention ICD implantation did not provide an overall survival benefit regardless of baseline kidney function in patients with non-ischemic systolic heart failure.Figure

Abstract 14772: Subcutaneous Implantable Cardioverter Defibrillator Extractions: A Single-Healthcare System Analysis of Incidence and Indications

Introduction: The subcutaneous implantable cardioverter defibrillator (SICD) serves as an alternative to traditional transvenous implantable cardioverter defibrillators in patients who meet criteria for ICD implantation without concurrent need for cardiac pacing. Data on SICD extraction is limited. This study examines the rates of SICD extraction. Methods: A retrospective study of all patients who underwent SICD implantation between 2010 and 2022 at a single healthcare system was performed. The primary endpoint was rate of SICD extraction. Results: A total of 402 patients (67.4% male; 48.5 ± 14.4 years old) underwent SICD implantation. Of these, 158 (39.3%) were for primary prevention in patients with heart failure with reduced ejection fraction, 125 (31.1%) for secondary prevention of ventricular tachyarrhythmias, and 69 (17.2%) for primary prevention in patients with hypertrophic cardiomyopathy with high-risk features. 29 (7.2%) patients (86.2% male; 51.5 ±12.9 years old) underwent SICD extraction during a mean follow up of 4.5 years. The median length of time between implant and explant was 49.1 [26.7-64.9] months. The most common indications for SICD extraction were need for pacing (17.2%), infection (17.2%), inappropriate shocks due to oversensing (13.8%), and lead failure (10.3%). There were no significant differences in average age, sex, or comorbidity profile between those who did and did not necessitate SICD extraction (extraction: 51.5 ± 12.9 years; no extraction: 48.4 ± 14.5 years; p=0.26) (Table). Conclusions: In appropriately selected patients undergoing implantation of the SICD, the likelihood of needing the device extracted was low at only 7.2% over 4.5 years, with the most common indications for extraction being need for pacing and infection. Further work must be done to determine whether these results regarding rates of, and indications for, SICD extractions are transferrable to other health systems.

Syncope and loss of consciousness after implantation of a cardioverter-defibrillator in patients with Brugada syndrome: Prevalence and characteristics in long-term follow-up.

Syncope is a significant prognostic factor in patients with Brugada syndrome (BrS). However, the risk of ventricular arrhythmia in patients with nonarrhythmic loss of consciousness (LOC) is similar to that in asymptomatic patients. LOC events after implantable cardioverter-defibrillator (ICD) implantation may provide insights into underlying causes of the initial LOC episode. The purpose of this study was to examine LOC characteristics following ICD implantation. We retrospectively analyzed 112 patients with BrS (mean age 47 years; 111 men) who were treated with an ICD. The patients were classified into 3 groups based on symptoms at implantation: asymptomatic (35 patients); LOC (46 patients); and ventricular tachyarrhythmia (VTA) (31 patients). We evaluated the incidence and cause of LOC during long-term follow-up after ICD implantation. During mean follow-up of 12.2 years, 41 patients (37%) experienced LOC after ICD implantation. Arrhythmic LOC occurred in 5 asymptomatic patients, 14 LOC patients, and 16 patients with VTA. Nonarrhythmic LOC, similar to the initial episode, occurred after ICD implantation in 6 patients with prior LOC (2 with neurally mediated syncope and 4 with epilepsy). Most epileptic patients experienced LOC during rest or sleeping, and did not show an abnormal encephalogram during initial evaluation of the LOC episodes. After ICD implantation, 13% of patients had nonarrhythmic LOC similar to the initial episode. Accurate classification of LOC based on a detailed medical history is important for risk stratification, although distinguishing arrhythmic LOC from epilepsy-related LOC episodes can be challenging depending on the circumstances and characteristics of the LOC event.

Rationale and study protocol for the BRITISH randomized trial (Using cardiovascular magnetic resonance identified scar as the benchmark risk indication tool for implantable cardioverter defibrillators in patients with nonischemic cardiomyopathy and severe systolic heart failure)

BackgroundFor patients with nonischemic cardiomyopathy (NICM), current guidelines recommend implantable cardioverter defibrillators (ICD) when left ventricular ejection fraction (LVEF) is ≤35%, but the DANISH trial failed to confirm that ICDs reduced all-cause mortality for such patients. Circumstantial evidence suggests that scar on CMR is predictive of sudden and arrhythmic death in this population. The presence of myocardial scar identified by cardiac magnetic resonance imaging (CMR) in patients with NICM and an LVEF ≤35% might identify patients at higher risk of sudden arrhythmic death, for whom an ICD is more likely to reduce all-cause mortality. Methods/DesignThe BRITISH trial is a prospective, multicenter, randomized controlled trial aiming to enrol 1,252 patients with NICM and an LVEF ≤35%. Patients with a nonischemic scar on CMR will be randomized to either: (1) ICD, with or without cardiac resynchronization (CRT-D), or (2) implantable loop recorder (ILR) or cardiac resynchronization (CRT-P). Patients who are screened for the trial but are found not to be eligible, predominantly due to an absence of scar or those who decline to be randomized will be enrolled in an observational registry. The primary endpoint is all-cause mortality, which we plan to assess at 3 years after the last participant is randomized. Secondary endpoints include clinical outcomes, appropriate and inappropriate device therapies, symptom severity and well-being, device-related complications, and analysis of the primary endpoint by subgroups with other risk markers. ConclusionThe BRITISH trial will assess whether the use of CMR-defined scar to direct ICD implantation in patients with NICM and an LVEF ≤35% is associated with a reduction in mortality.

Utilization and Outcomes of Primary Prevention Implantable Cardioverter-Defibrillators in Patients With Hypertrophic Cardiomyopathy.

Background There is uncertainty about the appropriate use of primary prevention implantable cardioverter-defibrillators (ICDs) among older patients with hypertrophic cardiomyopathy. Methods and Results Patients with hypertrophic cardiomyopathy who received a primary prevention ICD between 2010 and 2016 were identified using the National Cardiovascular Data Registry ICD Registry. Trends in ICD utilization and patient characteristics were assessed over time. Using linked Centers for Medicare and Medicaid Service claims data, Cox proportional hazard models assessed factors associated with mortality and postdischarge hospitalization for cardiac arrest/ventricular arrhythmia. Of 5571 patients with hypertrophic cardiomyopathy, 1511 (27.1%) were ≥65 years old. ICD utilization increased over time in all age groups. There were no changes in the prevalence of risk factors for sudden cardiac death over time. The variables most strongly associated with postdischarge mortality were older age (adjusted hazard ratio (aHR) 1.80 [95% CI, 1.47-2.21]), New York Heart Association class (III/IV versus I/II aHR 2.17 [95% CI, 1.57-2.98]), and left ventricular ejection fraction (left ventricular ejection fraction ≤35% versus >50% aHR 2.34 [95% CI, 1.58-3.48]; left ventricular ejection fraction 36%-50% versus >50% aHR 2.98 [95% CI, 2.02-4.40]), while history of nonsustained ventricular tachycardia (aHR 2.38 [95% CI, 1.62-3.51]) and New York Heart Association class (III/IV versus I/II aHR 1.84 [95% CI, 1.22-2.78]) were strongly associated with hospitalization for ventricular arrhythmia/cardiac arrest. Conclusions Primary prevention ICD utilization in patients with hypertrophic cardiomyopathy increased over time, including among those ≥65 years old. Among older patients, the strongest risk factors for hospitalization for ventricular arrhythmia/cardiac arrest following ICD implantation were history of nonsustained ventricular tachycardia and New York Heart Association class.

Assessing physical activity with the wearable cardioverter defibrillator in patients with newly diagnosed heart failure.

The wearable cardioverter defibrillator (WCD), (LifeVest, ZOLL, Pittsburgh, PA, USA) is a medical device designed for the temporary detection and treatment of malignant ventricular tachyarrhythmias. WCD telemonitoring features enable the evaluation of the physical activity (PhA) of the patients. We sought to assess with the WCD the PhA of patients with newly diagnosed heart failure. We collected and analyzed the data of all patients treated with the WCD in our clinic. Patients with newly diagnosed ischemic, or non-ischemic cardiomyopathy and severely reduced ejection fraction, who were treated with the WCD for at least 28 consecutive days and had a compliance of at least 18 h the day were included. Seventy-seven patients were eligible for analysis. Thirty-seven patients suffered from ischemic and 40 from non-ischemic heart disease. The average days the WCD was carried was 77.3 ± 44.6 days and the mean wearing time was 22.8 ± 2.1 h. The patients showed significantly increased PhA measured by daily steps between the first two and the last two weeks (Mean steps in the first 2 weeks: 4,952.6 ± 3,052.7 vs. mean steps in the last 2 weeks: 6,119.6 ± 3,776.2, p-value: < 0.001). In the end of the surveillance period an increase of the ejection fraction was observed (LVEF-before: 25.8 ± 6.6% vs. LVEF-after: 37.5 ± 10.6%, p < 0.001). Improvement of the EF did not correlate with the improvement of PhA. The WCD provides useful information regarding patient PhA and may be additionally utilized for early heart failure treatment adjustment.

Subcutaneous versus transvenous cardioverter-defibrillators: 6-month follow-up

Objective: To evaluate the effectiveness and safety of subcutaneous implantable cardioverter-defibrillators versus transvenous implantable cardioverter-defibrillators during 6-month follow-up.Methods: The prospective research successively included 95 patients with indications for primary prevention of sudden cardiac death. The patients were divided into 2 groups: group 1 — 52 patients with subcutaneous implantable cardioverter-defibrillators, group 2 — 43 patients with transvenous implantable cardioverter-defibrillators. The patients were followed up for 6 months. All episodes of applied shock therapy, complications, patients changes in the condition and quality of life were analyzed.Results: The groups were initially comparable in terms of gender, age, etiology of the disease, and severity of the condition. Male patients prevailed (subcutaneous implantable cardioverter-defibrillators — 90.3%, transvenous implantable cardioverter-defibrillators — 93.0%), the mean age for subcutaneous devices was 56 [49;62] years and 60 [54;65] years for transvenous implantable cardioverter-defibrillators. All patients had chronic heart failure. The median LV EF for subcutaneous implantable cardioverter-defibrillator and transvenous implantable cardioverter-defibrillator was 29% [26;32] and 30% [27;32], respectively, EDV — 220 mL [187;278] and 202 mL [186;248], ESV — 151 mL [126;188] and 145 mL [122;184]. The number of complications recorded during the 6-month follow-up was slightly higher in patients who were implanted with subcutaneous implantable cardioverter-defibrillator (subcutaneous implantable cardioverter-defibrillators — 7.6%, transvenous implantable cardioverter-defibrillators — 2.3%, p = 0.249). The incidence of inadequate shocks in the groups was comparable (7.7% for subcutaneous implantable cardioverter-defibrillators, 6.9% for transvenous implantable cardioverter-defibrillators, p = 0.882). The percentage of using adequate shock therapy was higher in the transvenous implantable cardioverter-defibrillator group, 18.6% versus 5.7% in the subcutaneous implantable cardioverter-defibrillator group (p = 0.051). Implantation of the devices (both subcutaneous and transvenous) improved quality of life according to the results of questionnaires (Minnesota and EQ-5D questionnaires) before implantation and after 6 months of follow-up (p &lt; 0.001 in both groups).Conclusion: This research demonstrates comparable results for the effectiveness and safety of subcutaneous implantable cardioverter-defibrillators compared with transvenous implantable cardioverter-defibrillators in patients with the need for primary prevention of sudden cardiac death within 6 months. Received 6 October 2022. Revised 28 February 2023. Accepted 1 March 2023. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: A.V. Vereshchagina, T.M. Uskach, O.V. SapelnikovData collection and analysis: A.V. Vereshchagina, V.A. Amanatova, I.R. GrishinStatistical analysis: A.V. Vereshchagina, V.A. AmanatovaDrafting the article: A.V. Vereshchagina, T.M. UskachCritical revision of the article: A.V. Vereshchagina, T.M. Uskach, O.V. SapelnikovFinal approval of the version to be published: A.V. Vereshchagina, T.M. Uskach, O.V. Sapelnikov, V.A. Amanatova, I.R. Grishin

Inappropriate Shock Rates and Long-Term Complications due to Subcutaneous Implantable Cardioverter Defibrillators in Patients With and Without Heart Failure: Results From a Multicenter, International Registry

HomeCirculation: Arrhythmia and ElectrophysiologyVol. 16, No. 1Inappropriate Shock Rates and Long-Term Complications due to Subcutaneous Implantable Cardioverter Defibrillators in Patients With and Without Heart Failure: Results From a Multicenter, International Registry No AccessLetterRequest AccessFull TextAboutView Full TextView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toNo AccessLetterRequest AccessFull TextInappropriate Shock Rates and Long-Term Complications due to Subcutaneous Implantable Cardioverter Defibrillators in Patients With and Without Heart Failure: Results From a Multicenter, International Registry Marco Schiavone, MD, Alessio Gasperetti, MD, Mikael Laredo, MD, Alexander Breitenstein, MD, Julia Vogler, MD, Pietro Palmisano, MD, Simone Gulletta, MD, Carlo Pignalberi, MD, Carlo Lavalle, MD-PhD, Ennio Pisanò, MD, Danilo Ricciardi, MD, Antonio Curnis, MD, Antonio Dello Russo, MD-PhD, Claudio Tondo, MD-PhD, Nicolas Badenco, MD, Luigi Di Biase, MD-PhD, Jürgen Kuschyk, MD, Mauro Biffi, MD, Roland Tilz, MD and Giovanni Battista Forleo, MD-PhD Marco SchiavoneMarco Schiavone https://orcid.org/0000-0003-0720-3380 Luigi Sacco University Hospital, Milan (M.S., A.G., G.B.F.). Department of Systems Medicine, University of Rome Tor Vergata, Italy (M.S.). *M. Schiavone and A. Gasperetti contributed equally. Search for more papers by this author , Alessio GasperettiAlessio Gasperetti Correspondence to: Alessio Gasperetti, MD, Department of Cardiology, Johns Hopkins University, Baltimore, MD 21218. E-mail E-mail Address: [email protected] https://orcid.org/0000-0003-3432-070X Luigi Sacco University Hospital, Milan (M.S., A.G., G.B.F.). Department of Cardiology, Johns Hopkins University, Baltimore, MD (A.G., N.B.). *M. Schiavone and A. Gasperetti contributed equally. Search for more papers by this author , Mikael LaredoMikael Laredo https://orcid.org/0000-0002-7326-2656 APHP, Hôpital Pitié Salpêtrière, Paris, France (M.L.). Search for more papers by this author , Alexander BreitensteinAlexander Breitenstein Cardiology, University Hospital Zurich, Switzerland (A.B.). Search for more papers by this author , Julia VoglerJulia Vogler https://orcid.org/0000-0002-8386-9750 Department of Elctrophysiology, Herzzentrum Lubeck, Germany (J.V., R.T.). Search for more papers by this author , Pietro PalmisanoPietro Palmisano Cardiology Unit, “Card. G. Panico” Hospital, Tricase, Italy (P.P.). Search for more papers by this author , Simone GullettaSimone Gulletta Arrhythmology & Electrophysiology Unit, San Raffaele Hospital, IRCCS, Milan (S.G.). Search for more papers by this author , Carlo PignalberiCarlo Pignalberi Cardiology Unit, Ospedale San Filippo Neri (C.P.). Search for more papers by this author , Carlo LavalleCarlo Lavalle Cardiology Unit, Policlinico Umberto I, Rome (C.L.). Search for more papers by this author , Ennio PisanòEnnio Pisanò https://orcid.org/0000-0002-0187-0492 U.O.S.V.D. Cardiac Electrophysiology – “V. Fazzi” Hospital, Lecce (E.P.). Search for more papers by this author , Danilo RicciardiDanilo Ricciardi Cardiology Unit, Campus Biomedico University, Rome (D.R.). Search for more papers by this author , Antonio CurnisAntonio Curnis Cardiology Unit, Spedali Civili Brescia, Brescia (A.C.). Search for more papers by this author , Antonio Dello RussoAntonio Dello Russo Cardiology and Arrhythmology Clinic, University Hospital “Umberto I-Salesi-Lancisi,” Ancona (A.D.R.). Search for more papers by this author , Claudio TondoClaudio Tondo https://orcid.org/0000-0002-8500-8313 Heart Rhythm Centre, Monzino Cardiology Centre, IRCCS, Milan, Italy (C.T.). Search for more papers by this author , Nicolas BadencoNicolas Badenco https://orcid.org/0000-0002-0623-0988 Department of Cardiology, Johns Hopkins University, Baltimore, MD (A.G., N.B.). Search for more papers by this author , Luigi Di BiaseLuigi Di Biase https://orcid.org/0000-0001-6508-4047 Cardiac Arrhythmia Center, Division of Cardiology at Montefiore-Einstein Center, Bronx, NY (L.D.B.). Search for more papers by this author , Jürgen KuschykJürgen Kuschyk Cardiology Unit, University Medical Center Mannheim, Germany (J.K.). Search for more papers by this author , Mauro BiffiMauro Biffi https://orcid.org/0000-0003-4590-8584 Cardiology, IRCCS, Department of Experimental, Diagnostic & Specialty Medicine, Sant’Orsola Hospital, University of Bologna, Bologna, Italy (M.B.). Search for more papers by this author , Roland TilzRoland Tilz https://orcid.org/0000-0002-0122-7130 Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany (R.T.). Search for more papers by this author and Giovanni Battista ForleoGiovanni Battista Forleo https://orcid.org/0000-0001-8895-8915 Luigi Sacco University Hospital, Milan (M.S., A.G., G.B.F.). Search for more papers by this author and iSUSI Investigators Originally published3 Jan 2023https://doi.org/10.1161/CIRCEP.122.011404Circulation: Arrhythmia and Electrophysiology. 2023;16Footnotes*M. Schiavone and A. Gasperetti contributed equally.†A list of iSUSI Investigators is given in the Appendix.For Sources of Funding and Disclosures, see page 59.Correspondence to: Alessio Gasperetti, MD, Department of Cardiology, Johns Hopkins University, Baltimore, MD 21218. E-mail alessio.[email protected]com

Diabetes may modify the efficacy of primary prevention implantable cardioverter-defibrillators in non-ischemic systolic heart failure: an extended follow-up of the DANISH trial

Abstract Background Since patients with both diabetes and heart failure (HF) have a substantially worse prognosis than those with each of these alone, the efficacy of implantable cardioverter defibrillator (ICD) implantation in patients with systolic HF may be modified by diabetes status. Purpose In this extended follow-up analysis of the Danish Study to Assess the Efficacy of primary prevention of Implantable Cardioverter Defibrillators in Patients with Non-ischemic Systolic Heart failure on Mortality (DANISH), adding four years of additional follow-up, we examined the long-term effects of primary prophylactic ICD implantation, compared with usual clinical care, in patients with non-ischemic systolic HF according to diabetes status. Methods In DANISH, 1,116 patients with non-ischemic systolic HF were randomized to receive an ICD (N=556) or usual clinical care (N=550). Outcomes were analyzed according to diabetes status at baseline. The primary outcome was death from any cause. Secondary outcomes were cardiovascular death and sudden cardiovascular death. Results Of the 1,116 patients randomized in DANISH, 211 (18.9%) had diabetes at baseline (median age 64 year-old, 159 males, median left ventricular ejection fraction 25%). There was a statistically significant interaction between diabetes and the effect of ICD implantation on death from any cause and cardiovascular death. There was a trend toward a reduction in both outcomes with ICD implantation, compared with usual clinical care; in patients without diabetes (death from any cause, HR 0.81 [95% CI, 0.65–1.01]; cardiovascular death, HR 0.77 [0.59–1.01]), but not in those with diabetes (death from any cause, HR 1.19 [0.81–1.74]; cardiovascular death, HR 1.20 [0.79–1.82]) (P for interaction = 0.04 and 0.04 for death from any cause and cardiovascular death, respectively). Although there was no statistically significant interaction between diabetes and the effect of ICD implantation on sudden cardiovascular death, ICD implantation significantly reduced the rate of sudden cardiovascular death in patients without diabetes (HR 0.51 [0.31–0.85]), but not in those with diabetes (HR 0.91 [0.41–1.99]) (P for interaction = 0.15). Conclusions In patients with non-ischemic systolic HF, there was a significant interaction between diabetes and the effect of ICD implantation on death from any cause and cardiovascular death, suggesting that individuals without diabetes may derive greater benefit from ICD implantation. Funding Acknowledgement Type of funding sources: None.

Prevalence of One-Year Mortality after Implantable Cardioverter Defibrillator Placement: An Opportunity for Palliative Care?

Background: Current guidelines recommend against placement of implantable cardioverter defibrillators in patients with a life expectancy less than one year. These patients may benefit from early palliative care services; however, identifying this population is challenging. Objective: Determine whether a validated prognostic tool, based on patient factors and health care utilization from electronic medical records, accurately predicts one-year mortality at the time of implantable cardioverter defibrillator placement. Design: We used the United States (U.S.) Veterans Administration's "Care Assessment Needs" one-Year Mortality Score to identify patients at high risk of mortality (score ≥95) before their procedure. Data were extracted from the Corporate Data Warehouse. Logistic regression was used to assess the odds of mortality at different score levels. Setting/Subjects: Patients undergoing a new implantable cardioverter defibrillator procedure between October 1, 2015 and September 30, 2017 in the U.S. Veterans Administration. Results: Of 3194 patients with a new implantable cardioverter defibrillator placed, 657 (21.8%) had a score ≥95. The mortality rate among these patients was 151/657 (22.9%) compared with 281/3194 (8.8%) for all patients undergoing a new implantable cardioverter defibrillator procedure. Patients with a score ≥95 had 14.0 (95% confidence interval 8.0-24.4) higher odds of death within one year of the procedure compared with those with a score ≤60. Conclusions: The "Care Assessment Needs" Score is a valid predictor of one-year mortality following implantable cardioverter defibrillator procedures. Integrating its use into the management of Veterans Administration (VA) patients considering implantable cardioverter defibrillators may improve shared decision making and engagement with palliative care.