Implantable Cardioverter Defibrillator Patients Research Articles

Comparison of outcomes and required tools between transvenous extraction of pacemaker and implantable cardioverter defibrillator leads: Insight from single high-volume center experience.

Reports of comparison with procedural outcomes for implantable cardioverter defibrillator (ICD) and pacemaker (PM) transvenous lead extraction (TLE) are old and limited. We sought to compare the safety, efficacy, and procedural properties of ICD and PM TLE and assess the impact of lead age. The study cohort included all consecutive patients with ICD and PM TLE in the Cleveland Clinic Prospective TLE Registry between 2013 and 2022. Extraction success, complications, and failure employed the definitions described in the HRS 2017 TLE guidelines. A total of 885 ICD leads, a median implant duration of 8 (5-11) years in 810 patients, and 1352 PM leads of 7 (3-13) years in 807 patients were included. Procedural success rates in ICD patients were superior to those of PM in >20 years leads but similar in ≤20 years leads. In the PM group, the complete success rate of TLE decreased significantly according to the increase of lead age, but not in the ICD group. ICD TLE required more extraction tools compared with PM TLE but cases with older leads required non-laser sheath extraction tools in both groups. The most common injury site in major complication cases differed between ICD and PM TLE, although major complication rates showed no difference in both groups (2.7% vs. 1.6%, p = .12). The procedural success rate by TLE is greater for ICD patients than PM patients with leads >20 years old but requires more extraction tools. Common vascular complication sites and the impact of lead age on procedural outcomes and required tools differed between ICD and PM TLE.

Patient characteristics, predictors and outcome of pacemaker patients upgraded to an implantable cardioverter defibrillator.

Pacemaker (PM) patients may require a subsequent upgrade to an implantable cardioverter defibrillator (ICD). Limited data exists on this patient population. We sought to characterize this population, to assess predictors for ICD upgrade, and to report the outcome. From our prospective PM and ICD implantation registry, all patients who underwent PM and/or ICD implantations at our center were analyzed. Patient characteristics and outcomes of PM patients with subsequent ICD upgrade were compared to age- and sex-matched patients with de novo ICD implantation, and to PM patients without subsequent upgrade. Of 1'301 ICD implantations, 60 (5%) were upgraded from PMs. Median time from PM implantation to ICD upgrade was 2.6 years (IQR 1.3-5.4). Of 2'195 PM patients, 28 patients underwent subsequent ICD upgrades, corresponding to an estimated annual incidence of an ICD upgrade of at least 0.33%. Lower LVEF (p=.05) and male sex (p=.038) were independent predictors for ICD upgrade. Survival without death, transplant and LVAD implantation were worse both for upgraded ICD patients compared to matched patients with de novo ICD implantation (p=.05), as well as for PM patients with subsequent upgrade compared to matched PM patients not requiring an upgrade (p=.036). One of 20 ICD implantations are upgrade of patients with a PM. At least one of 30 PM patients will require an ICD upgrade in the following 10 years. Predictors for ICD upgrade are male sex and lower LVEF at PM implantation. Upgraded patients have worse outcomes.

Impact of High-Voltage Device Implantation in Elderly Japanese Patients With Heart Failure as Primary Prevention　- Post Hoc Analysis of HINODE.

Despite an increased incidence of chronic heart failure (HF) and sudden cardiac death (SCD), the use of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) is much lower in Japan than in Western countries. The HF Indication and SCD Prevention Trial Japan (HINODE) prospectively assessed the mortality rate, appropriately treated ventricular arrhythmias (VA), and HF in Japanese patients with a higher risk of HF.Methods and Results: HINODE consisted of ICD, CRT-defibrillator (CRT-D), pacing, and non-device treatment cohorts. This subanalysis evaluated the impact of the implantation of high-voltage devices (HVD; ICD and CRT-D) in 171 Japanese patients. We compared all-cause mortality, VA, and HF events between elderly (age >70 years at study enrollment) and non-elderly HVD recipients. The estimated survival rate through 24 months in the HVD cohort was 85.8% (97.5% lower control limit 77.6%). The risk of all-cause mortality was increased for the elderly vs. non-elderly (hazard ratio [HR] 2.82; 95% confidence interval [CI] 1.01-7.91; P=0.039), but did not differ after excluding ICD patients with CRT-D indication (HR 2.32; 95% CI 0.79-6.78; P=0.11). There were no differences in VA and HF event-free rates between elderly and non-elderly HVD recipients (P=0.73 and P=0.55, respectively). Although elderly patients may have a higher risk of mortality in general, the benefit of HVD therapy in this group is comparable to that in non-elderly patients.

Selection of social comparison standards in cardiac patients with and without experienced defibrillator shock

Patients with an implantable cardioverter-defibrillator (ICD) often report psychological distress. Literature suggests that patients with physical disease often compare their well-being and coping to fellow patients. However, we lack knowledge on social comparison among patients with ICD. In this study, we examined psychological distress and social comparison selection in patients with (ICD+) and without experienced ICD shocks (ICD−). We theorized that relative to ICD− patients, those with ICD+ display higher levels of psychological distress and thereby compare more frequently with fellow patients with more severe disease, but better disease coping and try to identify more strongly with these standards to improve their own coping. We recruited 92 patients with (ICD+, n = 38) and without an experienced ICD shock (ICD−, n = 54), who selected one of four comparison standards varying in disease severity and coping capacity. Relative to ICD−, ICD+ patients reported higher levels of device-related distress, but there were no significant differences in anxiety, depression, or quality of life. ICD+ patients selected more often comparison standards with poor coping and, irrespective of standard choice, displayed more negative mood following comparison. Our results show that ICD+ patients tend to perform unfavorable comparisons to fellow patients, which might explain higher psychological distress and worse coping. These findings warrant further research into social comparison as a relevant coping mechanism in ICD patients.

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.

Left ventricular ejection fraction: clinical, pathophysiological, and technical limitations.

Risk stratification of cardiovascular death and treatment strategies in patients with heart failure (HF), the optimal timing for valve replacement, and the selection of patients for implantable cardioverter defibrillators are based on an echocardiographic calculation of left ventricular ejection fraction (LVEF) in most guidelines. As a marker of systolic function, LVEF has important limitations being affected by loading conditions and cavity geometry, as well as image quality, thus impacting inter- and intra-observer measurement variability. LVEF is a product of shortening of the three components of myocardial fibres: longitudinal, circumferential, and oblique. It is therefore a marker of global ejection performance based on cavity volume changes, rather than directly reflecting myocardial contractile function, hence may be normal even when myofibril's systolic function is impaired. Sub-endocardial longitudinal fibers are the most sensitive layers to ischemia, so when dysfunctional, the circumferential fibers may compensate for it and maintain the overall LVEF. Likewise, in patients with HF, LVEF is used to stratify subgroups, an approach that has prognostic implications but without a direct relationship. HF is a dynamic disease that may worsen or improve over time according to the underlying pathology. Such dynamicity impacts LVEF and its use to guide treatment. The same applies to changes in LVEF following interventional procedures. In this review, we analyze the clinical, pathophysiological, and technical limitations of LVEF across a wide range of cardiovascular pathologies.

Evaluation of patients with implantable cardioverter-defibrillator in a Latin American tertiary center.

Despite advancements in implantable cardioverter-defibrillator (ICD) technology, sudden cardiac death (SCD) remains a persistent public health concern. Chagas disease (ChD), prevalent in Brazil, is associated with increased ventricular tachycardia (VT) and ventricular fibrillation (VF) events and SCD compared to other cardiomyopathies. This retrospective observational study included patients who received ICDs between October 2007 and December 2018. The study aims to assess whether mortality and VT/VF events decreased in patients who received ICDs during different time periods (2007-2010, 2011-2014, and 2015-2018). Additionally, it seeks to compare the prognosis of ChD patients with non-ChD patients. Time periods were chosen based on the establishment of the Arrhythmia Service in 2011. The primary outcome was overall mortality, assessed across the entire sample and the three periods. Secondary outcomes included VT/VF events and the combined outcome of death or VT/VF. Of the 885 patients included, 31% had ChD. Among them, 28% died, 14% had VT/VF events, and 37% experienced death and/or VT/VF. Analysis revealed that period 3 (2015-2018) was associated with better death-free survival (p = .007). ChD was the only variable associated with a higher rate of VT/VF events (p < .001) and the combined outcome (p = .009). Mortality and combined outcome rates decreased gradually for ICD patients during the periods 2011-2014 and 2015-2018 compared to the initial period (2007-2010). ChD was associated with higher VT/VF events in ICD patients, only in the first two periods.

The effect of virtual interactive nurse-led support group intervention on fatigue, shock anxiety, and acceptance of implantable cardioverter defibrillator patients: a randomized trial

BackgroundImplantable cardioverter defibrillators (ICD), as a gold and standard treatment for fatal cardiac arrhythmia, may lead to some physical and psychological problems for the patients. Therefore, performing some interventions to reduce or eliminate these issues is crucial. This study aimed to determine the effect of virtual interactive nurse-led support group intervention on fatigue, shock anxiety, and acceptance of ICD patients.MethodsThis is a clinical trial study on 72 patients with ICD. They were randomly allocated to the intervention (n = 36) and control (n = 36) groups. A virtual interactive nurse-led support group intervention through WhasApp was performed for one month. Multidimensional fatigue inventory, Florida Shock Anxiety Scale, and Florida Patient Acceptance Scale were used. Data were analyzed to perform the analysis of data through SPSS, using independent and paired-t test, Mann-Whitney U test, Wilcoxon test, and ANCOVA.ResultsBefore the intervention, no significant difference was observed between the two groups with regard to fatigue, shock anxiety, and ICD acceptance. However, after the intervention, a significant difference was found between the two groups with regard to fatigue, shock anxiety, and ICD acceptance (P < 0.05).ConclusionThis study showed that virtual interactive nurse-led support group intervention reduced fatigue and shock anxiety and improved the ICD acceptance.Practice implicationsThis flexible, accessible, and interactive nurse-led support group intervention is suggested to be used for ICD patients.Trial registrationThis trial was registered and approved by Iranian Registry of Clinical Trials (Trial Id: 60,738, date: (24/02/2022). (https://www.irct.ir/trial/60738).

The Effect of Education, Telephone Monitoring on Self-Efficacy and Shock Anxiety of Implantable Cardioverter Defibrillator Patients

Objective: Implantable cardioverter defibrillators (ICDs), which are used in the treatment of fatal ventricular arrhythmias, have many life-saving benefits. On the other hand, it has negative effects in terms of physical, social and psychological aspects by commonly causing anxiety and depression. The aim of this study is to examine the effects of education and telephone monitoring on self-efficacy and shock anxiety in patients with implantable cardioverter defibrillator implantation.&#x0D; Methods: 65 patients hospitalized for ICD insertion were randomly divided into intervention (n=33) and control (n=32) groups. The intervention group was given a training booklet prepared by one-on-one training about ICD. Telephone monitoring was performed once every two weeks for three months and then once a month. No intervention was applied to the control group. Self-Efficacy and Outcome Expectation Scales, Florida Shock Anxiety Scale were applied in the third and sixth months after ICD implantation in both groups.&#x0D; Results: The self-efficacy scores at the sixth month were higher in the intervention group than in the control group (p=.03). There was no difference between the shock anxiety scores at 3 months (p=.58) and 6 months (p=.64) between the groups. Shock anxiety mean scores of both groups in the 6th month are lower than the mean scores in the 3rd month (p

Outcomes of permanent pacemakers and implantable cardioverter-defibrillators in an adult congenital heart disease population

BackgroundBrady- and tachyarrhythmias commonly complicate adult congenital heart disease (ACHD). Permanent pacemakers (PPMs) or implantable cardioverter–defibrillators (ICDs) are often utilised to prevent morbidity or mortality related to arrhythmia, but can also be associated with significant morbidity themselves. MethodsWe analysed outcomes from patients in our comprehensive ACHD database who were seen at least twice since 2000 and once since 2018. Of 1953 ACHD patients, 134 had a PPM and 78 had an ICD (47 for primary and 31 for secondary prevention). ResultsFor PPM patients, 41% had a pacing percentage below 33%, 13% had 33–66%, and 46% had above 66%. One fifth required PPM upgrade, most to cardiac resynchronisation therapy, the rest to ICD. There were 33 appropriate ICD shocks in 15 patients (19%) and 34 inappropriate shocks in 13 patients (17%) over a median follow up of 4.6 years (IQR 0.9–8.3 years). Anti-tachycardia pacing was delivered appropriately for 28% of patients and inappropriately for 9%.Apart from inappropriate therapy, one third of PPM and ICD patients had other device-related complications. Acute PPM complications included lead dysfunction requiring revision (2%), pneumothorax (2%), pleural effusion (2%) and pocket infection (2%). ICDs were also acutely complicated by lead dysfunction (4%) as well as pocket hematoma (3%). The most common long-term complication overall was lead dysfunction, affecting one sixth of both PPM and ICD patients. Finally, the rate of device insertion increased significantly with disease severity. ConclusionsAnti-arrhythmic devices can be lifesaving in ACHD patients, but inappropriate therapy and device-related complications are very common.

Development and validation of a nomogram predicting all-cause mortality for patients with an implantable cardioverter-defibrillator

Abstract Background For patients with high risk of sudden cardiac death, despite the benefits of an implantable cardioverter defibrillator (ICD), some patients are still at a high risk of death. Death risk assessment of ICD patients is beneficial to the clinical management of such patients. Purpose The purpose of this study was to develop and validate a nomogram predicting all-cause mortality for patients with an ICD. Methods We retrospectively analyzed the data of multicenter ICD registration study (SUMMIT study) from 2010 to 2014 in China. A total of 617 ICD patients from regions where the enrollment ranked top five formed a development cohort. The physical activity monitored by ICD and clinical data were collected. Univariate and multivariate COX regression analyses were used to screen mortality predictors and construct the nomogram. The performance of nomogram was evaluated by the C index and the calibration curve. A total of 196 ICD patients from other regions formed a validation cohort, and the nomogram constructed by the development cohort was further evaluated in the verification cohort. Results In the development cohort, physical activity, diabetes and left ventricular end-diastolic diameter were selected as mortality predictors by univariate and multivariate proportional hazard model analysis. The nomogram was constructed by these three factors. The C index of the nomogram was 0.80 (95% confidence interval, 0.75-0.84). The calibration curve showed that the predicted survival probability of the nomogram was in good agreement with the actual survival probability. In the validation cohort, the C index of the nomogram was 0.74 (95% confidence interval, 0.64-0.84), and the calibration curve still maintained good consistency. Conclusion Our study develops and validates a nomogram predicting all-cause mortality for patients with an ICD by integrating the physical activity monitored by ICD and clinical data. The nomogram performs well and can provide personalized death risk assessment for ICD patients.Figure 1Figure 2

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

Prognostic value of modified ADMIIRE-HF risk score in patients with implantable cardioverter defibrillator: a prospective comparative study with 6-minute walk distance

Abstract Background ADIMIRE-HF risk score is a novel risk score that combines clinical characteristics and MIBG imaging variables to predict serious arrhythmic risk in patients with chronic heart failure (CHF) and recent studies showed that highest occurrence of severe arrhythmic events (SAE) was seen in patients with an intermediate decrease in MIBG uptake rather than the lowest values. Six-minute walk distance (6MWD) has also been shown to detect high risk patients with CHF. However, there is no information available on the long-term prognostic value of these indices for the prediction of ventricular tachyarrhythmias in patients with implantable cardioverter defibrillator (ICD). Methods and Results We prospectively enrolled 231 consecutive outpatients with ICD (age: 65±14 years, male: 81%, NYHA class: 1.7±0.7, LVEF: 47±17%). At entry, cardiac MIBG imaging, echocardiography and 6-minute walk test were performed. Modified ADMIRE-HF risk score was derived from the sum of the point values of the following parameters: LVEF (&amp;lt;25%:5 points), MIBG heart-to-mediastinum ratio on delayed planar image (HMR 1.4-1.9: 12 points) and systolic blood pressure (&amp;lt;120: 3 points, 120-139: 0 point, &amp;gt;140: -3 points). During a follow-up period of 4.4±2.8 years, 72 patients had appropriate ICD therapy (ATx). At multivariate Cox analysis, modified ADMIRE-HF risk score and 6MWD were significantly and independently associated with ATx after adjustment of age, sex, non-sustained ventricular tachycardia and NYHA functional class. ATx was significantly more frequently observed in patients with both higher modified ADMIRE HF risk score (&amp;gt;9: median value) and shorter 6MWD (&amp;lt;300m) and with either, than with none of them (54% vs 34% vs 18%, respectively p&amp;lt;0.0001). Conclusion Combination of modified ADMIRE-HF risk score and 6MWD would be strongly associated with an increased risk for ventricular tachyarrhythmias in ICD patients.

Performance of a multisensor implantable defibrillator algorithm for HF monitoring in the presence of atrial fibrillation

Abstract Background Some implantable cardioverter defibrillators (ICD) are equipped with diagnostic algorithms that combine data from multiple sensors. The HeartLogic Index was shown to accurately stratify patients at risk of heart failure (HF) events. However, there are no data on its performance in the presence of atrial fibrillation (AF). We evaluated and compared the performance of the algorithm during sinus rhythm and during long-lasting AF episodes. Methods The feature was activated in 568 ICD patients from 26 centers. We analyzed stored data to identify periods of ≥30 consecutive days with atrial high-rate episode (AHRE) burden &amp;lt;1hour/day, and periods with AHRE burden ≥20hours/day. Then, we identified patients who met both conditions during their follow-up (AHRE group, N=53), to allow pairwise comparison of periods. For control purposes, we identified patients with AHRE burden &amp;lt;1h during the entire follow-up and we implemented a 2:1 propensity score matching versus the AHRE group (Matched non-AHRE group, N=106). Results In the AHRE group, the rate of HeartLogic alerts was 1.2 (95%CI:1.0-1.5) /patient-year during periods with AHRE burden &amp;lt;1hour/day and 2.0 (95%CI:1.5-2.6) /patient-year during AHRE burden ≥20hours/day periods (p=0.004). Significantly higher values of the combined index were recorded during periods with AHRE burden ≥20 hours/day (in Figure the average combined index – Day 0: alert day). The rate of HF hospitalizations was 0.34 (95%CI:0.15-0.69) /patient-year during IN-alert periods and 0.06 (95%CI:0.02-0.14) /patient-year during OUT-of-alert periods (p&amp;lt;0.001). The IN/OUT-of-alert state incidence rate ratio of HF hospitalizations was 8.59 (95%CI:1.67-55.31) during periods with AHRE burden &amp;lt;1hour/day and 2.70 (95%CI:1.01-28.33) during AHRE burden ≥20hours/day periods. In the Matched non-AHRE group, the rate of HF hospitalizations was 0.29 (95%CI:0.12-0.60) /patient-year during IN-alert periods, and 0.04 (95%CI:0.02-0.08) /patient-year during OUT-of-alert periods (p&amp;lt;0.001). The incidence rate ratio was 7.11 (95% CI: 2.19-22.44). Conclusions Patients seemed more exposed to alerts during periods of AF. The ability of the algorithm to identify increased risk of HF events was confirmed during AF, despite a lower IN/OUT-of-alert incidence rate ratio when compared to non-AF periods and non-AF patients.

Abstract 18146: Deactivation Status of Defibrillation at the End of Life in Patients With Implantable Cardioverter Defibrillators

Background: Implantable cardioverter-defibrillators (ICDs) are effective in preventing sudden cardiac death due to fatal arrhythmias. However, defibrillation is also known to cause physical and emotional distress to the patients. When patients with an ICD are approaching the end of life, the guidelines on palliative care in cardiovascular diseases recommend that the benefits and burdens of ICDs are fully explained to the patients and that a policy regarding the deactivation of defibrillation function is discussed. However, there are few reports on the therapy status of ICD patients in the end-stage of life.Aim: To investigate the deactivation status of defibrillation in patients with an ICD. Methods: We retrospectively analyzed ICD database at our hospital and studied 143 ICD patients who died from 2006 to June 2023. The frequency of ICD therapy delivered before death and information about the discussion of deactivation and do not attempt resuscitation (DNAR) decisions were reviewed using medical charts. Results: Of 143 patients, 45 (31%) patients in the end-stage of life were assigned to DNAR and 24 (17%) patients was explained deactivation of ICD therapies at the time of DNAR order. Fifteen (10%) patients, including 11 patients in the end-stage heart failure, underwent deactivation and 2 patients received ICD therapies after DNAR order. Nine (6.2%) patients did not undergo deactivation. Of those, 4 patients received ICD shock therapies. Twenty-one patients (15%) were not given the explanation for the deactivation after DNAR order. Of those, 4 patients received ICD shock therapies. Conclusion: Our study shows that only 10% of Japanese ICD patients in the end-stage of life underwent deactivation of ICD therapies. Discussions regarding ICD deactivation in palliative care are necessary to reduce the risk of painful shocks and distress during the end of life.

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.

Abstract 16616: Automatic Measurement of Short-Term Variability of Repolarization Captures Modulation by Pacing on Human Intracardiac Electrograms

Introduction: Short-term variability of repolarization (STV) increases prior to ventricular arrhythmias (VA) both in humans and in animal models of VA, and is therefore a promising tool for real-time monitoring of arrhythmic risk. To integrate this concept in cardiac devices, a method to automatically determine STV on intracardiac electrograms (EGM) was developed. This STV algorithm demonstrated high efficacy in predicting life-threatening VA in animal studies, but still needs to be evaluated on human signals. Objective: To assess the performance of the novel automatic method of STV measurement on human EGMs during sinus rhythm (SR) and pacing. Methods: ECG and EGM signals with a 1 kHz sampling frequency were recorded in 14 dual chamber implantable cardioverter-defibrillator (ICD) patients during implantation (n=4) or replacement (n=10) procedures. Recordings were obtained in SR, atrial pacing at 80 beats per minute (AAI80) and atrioventricular pacing at the same frequency (DDD80). STV was calculated over 31 consecutive beats as Σ

Abstract 13922: Reducing Health Care Disparities by Improving ICD Knowledge in a Diverse Population, a Quality Improvement Initiative to Align ICD Settings With Goals of Care

Background: Patients with implantable cardioverter defibrillators (ICDs) often lack understanding of ICD functioning, most dramatically in at-risk populations. Patient knowledge gaps preclude adequate communication regarding goals of care and informed decision-making with the potential for unwanted shocks at end of life (EOL). Both ICD studies and ICD patient education tools historically lack both diversity and accessibility. Ways to improve patient ICD comprehension in populations with barriers to care have not been well established. Research Questions: Does a patient-centered educational video improve ICD knowledge and/or affect patients’ ICD preferences in hypothetical EOL scenarios? Methods: We surveyed 30 admitted heart failure patients with ICDs using 10 validated true-false ICD knowledge questions, 4 preference questions in hypothetical EOL scenarios, and multiple qualitative questions at a diverse urban, safety-net hospital. A novel 7-minute ICD educational video narrated by real patients with ICDs, using 3 rd grade or below language was then shown either in English or Spanish. Post viewing, the same questions were repeated to assess knowledge and preferences. (Link to video: https://youtu.be/8n_M--33Ia w ) Results: The mean age was 58 years, and 38% identified as female. Of the 30 patients, 63% were Black, 37% were White, and 17% were Hispanic. Patients had a mean ejection fraction of 31%, and 50% of participants had prior ICD shocks (1 to 14 times). The mean pre-test knowledge score was 50% (SD 22.8) and mean post-test score significantly improved to 82% (SD 15.1) correct (W=346, p&lt;0.00001). Scores did not significantly vary by age, sex, race, or prior shock status. After watching the video, 66% of patients changed their EOL ICD preferences in at least 1 scenario. All participants rated the video as either very helpful or helpful. Conclusion: In a diverse group of admitted heart failure patients with ICDs, intervention with an educational video on ICDs and shocks at EOL significantly improved patient knowledge. Educational materials designed for diverse patient populations can reduce healthcare disparities, by expanding patient knowledge and therefore empowering patients to make informed decisions on ICDs at EOL.

Fear of COVID-19 Predicts Depression, Anxiety and Post-Traumatic Stress Disorders in Patients with Implantable Cardioverter Defibrillators and Is Mediated by Positive and Negative Affects-A Cross-Sectional Study.

The COVID-19 pandemic affected both the physical and mental health of the general population. People with cardiac diseases seem to be particularly vulnerable to the implications of the pandemic. However, studies on the mental health impact of the COVID-19 pandemic on people with implantable cardioverter defibrillator (ICDs) are lacking. Thus, we aimed to explore the level of fear of COVID-19 and the prevalence of anxiety, depression and post-traumatic stress disorder (PTSD) in ICD patients. Furthermore, we aimed to identify novel predictors for anxiety, depression and PTSD, including COVID-19-related variables, and to assess whether positive affects (PAs) and negative affects (NAs) mediate the relationship between the level of fear of COVID-19 and anxiety, depression and PTSD, respectively. The data of 363 patients with ICDS who had been prospectively included in this study between 2020 and 2023, were analyzed. Potential predictors for anxiety, depression, and PTSD were identified using logistic regression. To identify indirect mediating effects of PAs and NAs, we applied the PROCESS regression path analysis modeling tool. The prevalence of anxiety was 9.19%, of depression 10.85%, and of PTSD 12.99%. Being unemployed was the strongest predictor for anxiety (OR = 10.39) and depression (OR = 6.54). Younger age predicted anxiety (OR = 0.95) and PTSD (OR = 0.92). Receiving low social support was associated with anxiety (OR = 0.91), depression (OR = 0.88) and PTSD (OR = 0.91). Patients with a history of COVID-19 (OR = 3.58) and those who did not feel well-informed about COVID-19 (OR = 0.29) were more likely to be depressed. Higher levels of fear of COVID-19 predicted anxiety (OR = 1.10), depression (OR = 1.12) and PTSD (OR = 1.14). The relationship between fear of COVID-19 and anxiety or depression was fully mediated by PAs and NAs, while NAs partially mediated the relationship between fear of COVID-19 and PTSD. Vulnerable subgroups of ICD patients may need additional psychological and educational interventions due to fear of COVID-19, anxiety, depression and PTSD during the pandemic.

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.