Implantable Cardioverter-defibrillator Implantation Research Articles

Enhancing patient acceptance of ICD implantation through structured shared decision making: conversation is key.

Implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) are lifesaving treatments for patients at risk for sudden cardiac death. Effective physician-patient communication during the shared decision-making process is essential. Electrophysiologist-patient conversations were targeted to obtain objective data on the interaction, understand the conversation framework, and uncover opportunities for improved communication. Individuals previously identified as requiring an ICD/CRT-D but declined implantation were recruited for this four-stage interview and survey-based study. Quantitative analysis of surveys and AI analysis of conversation videos was conducted to evaluate patient participant expectations, analyze feedback about the conversations with study physicians, and gauge willingness for device implantation. The study included 27 patients (mean age 51years, 51.9% female) and 9 study physicians. Patients were significantly more willing to undergo ICD/CRT-D implantation after conversing with study physicians compared to their own physicians and pre-conversation surveys (mean scores: 5.0, 3.1, and 4.4 out of 7, respectively; p < 0.001). Patient participants had higher satisfaction with the study conversation, rating study physicians higher in effectiveness of explanations, responsiveness to questions, and overall quality of the conversation compared to their own physicians (all p < 0.001). In a cohort of patients who previously declined ICD/CRT-D implantation, patient satisfaction and willingness to undergo implantation of a guideline-directed device therapy increased significantly following a structured conversation with study physicians. Identified key elements could be integrated into user-friendly tools and educational materials to facilitate these conversations, improving patient engagement with the decision-making process and enhancing informed acceptance of indicated device therapies.

Anxiety and depression in a patient with an implantable cardioverter defibrillator for early repolarization syndrome: A case report and clinical discussion

Early repolarization syndrome (ERS) was initially thought to be a good prognostic manifestation detectable by electrocardiogram. In recent years, with the gradual deepening of research and understanding, ERS is considered to possess malignant tendency and related to ventricular fibrillation (VF) and sudden cardiac death (SCD). Implantable cardioverter defibrillator (ICD) is currently the first choice of treatment used to reduce the risk of potentially life-threatening arrhythmias and SCD in patients at high risk for ERS. The stress of living with an implanted device and receiving ICD shock has been noted to exert a psychological toll on patients, especially those who have previously experienced VF and syncope. The current case report describes symptoms and signs of a patient with ERS, and discusses the changes of psychological condition after ICD implantation. Moreover, we explored a targeted treatment approach for anxiety and depression in an individual with an ICD for ERS, which combined medication, cognitive behavioral therapy, and physical exercise. We believe that the psychological experience of ICD recipients, which is a critical component in designing the biopsychosocial therapeutic approach for this growing patient population, is worthy of more attention.

Disparities in the implantation of secondary prevention implantable cardioverter defibrillator in the United States.

The annual incidence of sudden cardiac death is over 300,000 in the United States (US). Historically, inpatient implantation of secondary prevention implantable cardioverter defibrillator (ICD) has been variable and subject to healthcare disparities. To evaluate contemporary practice trends of inpatient secondary prevention ICD implants within the US on the basis of race, sex, and socioeconomic status (SES). The study is a retrospective analysis of the National Inpatient Sample from 2016 to 2020 of adult discharges with a primary diagnosis of ventricular tachycardia (VT), ventricular flutter, and fibrillation (VF). Adjusted ICD implantation rates based on race, sex, and SES and associated temporal trends were calculated using multivariate regression. A total of 193,600 primary VT/VF discharges in the NIS were included in the cohort, of which 57,895 (29.9%) had ICD placement. There was a significant racial and ethnic disparity in ICD placement for Black, Hispanic, Asian, and Native American patients as compared to White patients; adjusted odds ratio (aOR): 0.86 [p<.01], 0.90 [p = .03], 0.81[p<.01], 0.45 [p<.01], respectively. Female patients were also less likely to receive an ICD compared to male patients (aOR: 0.75, p<.01). Disparities in ICD placement remained stable over the study period (ptrend ≥.05 in all races, both sexes and income categories). Racial, sex, and SES disparities persisted for secondary prevention ICD implants in the US. An investigation into contributing factors and subsequent approaches are needed to address the modifiable causes of disparities in ICD implantation as these trends have not improved compared to historic data.

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.

Multimodal explainable artificial intelligence identifies patients with non-ischaemic cardiomyopathy at risk of lethal ventricular arrhythmias

The efficacy of an implantable cardioverter-defibrillator (ICD) in patients with a non-ischaemic cardiomyopathy for primary prevention of sudden cardiac death is increasingly debated. We developed a multimodal deep learning model for arrhythmic risk prediction that integrated late gadolinium enhanced (LGE) cardiac magnetic resonance imaging (MRI), electrocardiography (ECG) and clinical data. Short-axis LGE-MRI scans and 12-lead ECGs were retrospectively collected from a cohort of 289 patients prior to ICD implantation, across two tertiary hospitals. A residual variational autoencoder was developed to extract physiological features from LGE-MRI and ECG, and used as inputs for a machine learning model (DEEP RISK) to predict malignant ventricular arrhythmia onset. In the validation cohort, the multimodal DEEP RISK model predicted malignant ventricular arrhythmias with an area under the receiver operating characteristic curve (AUROC) of 0.84 (95% confidence interval (CI) 0.71–0.96), a sensitivity of 0.98 (95% CI 0.75–1.00) and a specificity of 0.73 (95% CI 0.58–0.97). The models trained on individual modalities exhibited lower AUROC values compared to DEEP RISK [MRI branch: 0.80 (95% CI 0.65–0.94), ECG branch: 0.54 (95% CI 0.26–0.82), Clinical branch: 0.64 (95% CI 0.39–0.87)]. These results suggest that a multimodal model achieves high prognostic accuracy in predicting ventricular arrhythmias in a cohort of patients with non-ischaemic systolic heart failure, using data collected prior to ICD implantation.

Psychological factors associated with exercise self-efficacy in the recipients of an implantable cardioverter defibrillator.

Insufficient exercise affects the health of patients who have implantable cardioverter defibrillators (ICD). The purpose of this study was to investigate the correlations between exercise self-efficacy (ESE) and its associated psychological factors in ICD recipients. This cross-sectional study included individuals who had undergone ICD implantation at the cardiology department of a medical centre in Taiwan. A face-to-face survey was conducted. The survey questionnaire included questions regarding the participants' demographics, perceived health (PH), ICD shock-related anxiety (ICD-SRA), self-care self-efficacy (SSE), perceived exercise benefit (PE-benefit), perceived exercise barrier (PE-barrier), and ESE. Data were analysed using SPSS 20.0 Software. Stepwise multiple regression analyses were also performed to evaluate the predictive effects of the aforementioned factors on ESE. A total of 52 ICD recipients were enrolled. ESE was negatively correlated with ICD-SRA (r = -0.511; p < 0.01) and PE-barrier (r = -0.563; p < 0.01), but positively correlated with SSE (r = 0.339; p < 0.05) and PE-benefit (r = 0.464; p < 0.01). The stepwise multiple regression analysis revealed that PE-barrier, PE-benefit, and ICD-SRA effectively predicted ESE in the participants. ESE may be improved by overcoming PE-barrier, ICD-SRA and enhancing PE-benefit. Consequently, improving ESE may enhance the health benefits of exercise.

Two-Year Outcomes of Primary Prophylactic Use of Defibrillators for Ischemic and Non-Ischemic Cardiomyopathy - Propensity Score-Matched Analysis From the Nippon Storm Study.

In 2016, the DANISH study reported negative results regarding the efficacy of implantable cardioverter-defibrillators (ICDs) in patients with non-ischemic cardiomyopathy (NICM) and reduced left ventricular ejection fraction (LVEF). In this study we determined the efficacy of using ICDs for primary prophylaxis in patients with NICM.Methods and Results: We selected 1,274 patients with underlying cardiac disease who were enrolled in the Nippon Storm Study. We analyzed the data of 451 patients with LVEF ≤35% due to NICM or ischemic cardiomyopathy (ICM) who underwent ICD implantation for primary prophylaxis (men, 78%; age, 65±12 years; LVEF, 25±6.4%; cardiac resynchronization therapy, 73%; ICM, 33%). After propensity score matching, we compared the baseline covariates between groups: NICM (132 patients) and ICM (132 patients). The 2-year appropriate ICD therapy risks were 27.7% and 12.2% in the NICM and ICM groups, respectively (hazard ratio, 0.390 [95% confidence interval, 0.218-0.701]; P=0.002). This subanalysis of propensity score-matched patients from the Nippon Storm Study revealed that the risk of appropriate ICD therapy was significantly higher in patients with NICM than in those with ICM.

Assisting Black Patients With Decision-Making for Implantable Cardioverter Defibrillator Therapy: Qualitative Findings From the Videos to Reduce Racial Disparities in ICD Therapy via Innovative Designs (VIVID) Trial.

The VIVID (Videos for Addressing Racial Disparities in Implantable Cardioverter Defibrillator Therapy via Innovative Designs) study was a multicenter, randomized controlled trial aimed at evaluating the effectiveness of a video-based decision support tool in enhancing informed consent for implantable cardioverter defibrillator (ICD) implantation among Black patients who met guideline criteria for primary prevention ICDs. Within the broader VIVID randomized trial, a qualitative investigation was conducted to elucidate the decisional factors among Black individuals considering ICD implantation for the primary prevention of sudden cardiac arrest. Between October 2016 and July 2019, in-depth interviews were conducted at 2 time points from randomization, ≈7 days (time interval for the decision) and at 90 days; the time interval for determining ICD implantation. Interview findings were categorized by randomized groups, those assigned to 1 of the 2 encounter-based video decision support tools or standard care (without video). Interview participants were purposefully selected to ensure diversity across gender, age, educational background, research site, and randomization group; participants were sampled from 14 academic and community-based electrophysiology clinics in the United States. Data analysis employed applied thematic analysis techniques. A diverse sample of Black individuals were interviewed at 1 week (n=59; female, 37.3%) and 90 days (n=48; female, 39.6%). The primary factors influencing the decisions of Black individuals considering a primary prevention ICD implantation were (1) their clinicians' recommendations for ICD implantation; (2) their perception of their cardiac health status; and (3) a desire to prolong their lives for the sake of their families. These findings offer valuable insights that may guide clinicians in their communication with Black patients during shared decision-making encounters related to ICD implantation.

Risk factors for mortality in post-myocardial infarction patients: insights from the improve SCA bridge study

BackgroundUnderutilization of implantable cardioverter defibrillators (ICD) to prevent sudden cardiac death (SCD) in post-myocardial infarction (MI) patients remains an issue across several geographies. A better understanding of risk factors for SCD in post-MI patients from regions with low ICD adoption rates will help identify those who will benefit from an ICD. This analysis assessed risk factors for all-cause and cardiovascular-related mortality in post-MI patients from the Improve Sudden Cardiac Arrest (SCA) Bridge Trial.ResultsFor the entire cohort, the overall 1-year mortality rate was 5.9% (88/1491) and 3.4% (51/1491) for all-cause and cardiovascular mortality, respectively, with 76.5% of all cardiac deaths being from SCD. A multivariate model determined increased age, reduced left ventricular ejection fraction (LVEF), increased time from myocardial infarction to hospital admission, being female, being from Southeast Asia (SEA), and having coronary artery disease to be significant risk factors for all-cause mortality. The risk factors for cardiovascular-related mortality revealed increased age, reduced LVEF, and being from SEA as significant risk factors.ConclusionsWe show several characteristics as being predictors of cardiovascular-related mortality in post-MI patients from the Improve SCA Bridge study. Patients who experience an MI and present with these characteristics would benefit from a referral to an electrophysiologist for further SCD risk stratification and management and possible subsequent ICD implantation to reduce unnecessary death.

Sex Disparities in the Use and Outcomes of Septal Reduction Therapies for Obstructive Hypertrophic Cardiomyopathy

BackgroundData are limited that examine potential sex-based disparities in the utilization and complications of septal reduction therapy (SRT) in patients with obstructive hypertrophic cardiomyopathy. Our aim was to assess the use and in-hospital outcomes of SRT, according to sex. We performed a retrospective cohort study using the 2017-2019 National Inpatient Sample database. Adult patients with obstructive hypertrophic cardiomyopathy were identified. MethodsWe assessed the use of SRT (surgical septal myectomy and alcohol septal ablation), according to sex. In those who underwent SRT, rates of in-hospital mortality, pacemaker implantation, implantable cardioverter defibrillator (ICD) implantation, ischemic stroke, major bleeding, and pericardial complication were assessed. All outcomes were compared between groups using inverse probability of treatment weighting (IPTW), adjusting for demographics, comorbidity burden, and hospital characteristics. ResultsIn total, 72,680 weighted hospitalizations (median age: 67 years [range: 57-77]; 61% female patients) were included, and only 5.9% of patients underwent SRT. After IPTW adjustment, female patients were more likely to undergo SRT (adjusted risk ratio [aRR] 1.18, 95% confidence interval [95% CI] 1.03-1.36) and alcohol septal ablation (aRR 1.38, 95% CI 1.04-1.83). Likewise, female patients received pacemaker implantation more often (aRR 1.96, 95% CI 1.10-3.50) and ICD implantation (aRR 0.58, 95% CI 0.34-0.99) less frequently, compared with male patients. No differences were present in rates of surgical septal myectomy, in-hospital mortality, ischemic stroke, major bleeding, and pericardial complication between groups. ConclusionsOur results suggest that female patients were slightly more likely to undergo SRT, especially alcohol septal ablation. In-hospital mortality and postprocedural complications were similar between the sexes, but women received more pacemaker implantation and less ICD implantation.

Right Bundle Branch Block Predicts Appropriate Implantable Cardioverter Defibrillator Therapies in Patients with Non-Ischemic Dilated Cardiomyopathy and a Prophylactic Implantable Cardioverter Defibrillator.

Background: The benefit of prophylactic implantable cardioverter defibrillators (ICDs) in patients with severe systolic dysfunction of non-ischemic origin is still unclear, and the identification of patients at risk for sudden cardiac death remains a major challenge. Aims/Methods: We retrospectively reviewed all consecutive patients with non-ischemic dilated cardiomyopathy (NICM) who underwent prophylactic ICD implantation between 2008 and 2020 in two tertiary centers. Our main goal was to identify the predictors of appropriate ICD therapies (anti-tachycardia pacing [ATP] and/or shocks) in this cohort of patients. Results: A total of 224 patients were included. After a median follow-up of 51 months, 61 patients (27.2%) required appropriate ICD therapies. Patients with appropriate ICD therapies were more frequently men (87% vs. 69%, p = 0.006), of younger age (59 years, (53-65) vs. 64 years, (57-70); p = 0.02), showed more right bundle branch blocks (RBBBs) (15% vs. 4%, p = 0.007) and less left bundle branch blocks (LBBBs) (26% vs. 47%, p = 0.005) in the ECG, and had higher left ventricular end-diastolic (100 mL/m2, (90-117) vs. 86, (71-110); p = 0.011) and systolic volumes (72 mL/m2, (59-87) vs. 61, (47-81), p = 0.05). In a multivariate competing-risks regression analysis, RBBB (HR 2.26, CI 95% 1.02-4.98, p = 0.043) was identified as an independent predictor of appropriate ICD therapies. Conclusion: RBBBs may help to identify patients with NICM at high risk of ventricular arrhythmias and requiring ICD intervention.

Seattle proportional risk model in GISSI-HF: Estimated benefit of ICD in patients with EF less than 50%

BackgroundThe Seattle Proportional Risk Model (SPRM) estimates the proportion of sudden cardiac death (SCD) in heart failure (HF) patients, identifying those most likely to benefit from implantable cardioverter-defibrillator (ICD) therapy (those with ≥50% estimated proportion of SCD). The GISSI-HF trial tested fish oil and rosuvastatin in HF patients. We used the SPRM to evaluate its accuracy in this cohort in predicting potential ICD benefit in patients with EF ≤50% and an SPRM-predicted proportion of SCD either ≥50% or <50%. MethodsThe SPRM was estimated in patients with EF ≤50% and in a logistic regression model comparing SCD with non-SCD. ResultsWe evaluated 6,750 patients with EF ≤50%. There were 1,892 all-cause deaths, including 610 SCDs. Fifty percent of EF ≤35% patients and 43% with EF 36% to 50% had an SPRM of ≥50%. The SPRM (OR: 1.92, P < 0.0001) accurately predicted the risk of SCD vs non-SCD with an estimated proportion of SCD of 44% vs the observed proportion of 41% at 1 year.By traditional criteria for ICD implantation (EF ≤35%, NYHA class II or III), 64.5% of GISSI-HF patients would be eligible, with an estimated ICD benefit of 0.81. By SPRM >50%, 47.8% may be eligible, including 30.2% with EF >35%. GISSI-HF participants with EF ≤35% with SPRM ≥50% had an estimated ICD HR of 0.64, comparable to patients with EF 36% to 50% with SPRM ≥50% (HR: 0.65). ConclusionsThe SPRM discriminated SCD vs non-SCD in GISSI-HF, both in patients with EF ≤35% and with EF 36% to 50%. The comparable estimated ICD benefit in patients with EF ≤35% and EF 36% to 50% supports the use of a proportional risk model for shared decision making with patients being considered for primary prevention ICD therapy.

Mindfulness Is Associated with Lower Depression, Anxiety, and Post-Traumatic Stress Disorder Symptoms and Higher Quality of Life in Patients with an Implantable Cardioverter-Defibrillator-A Cross-Sectional Study.

Several studies suggested the efficacy of dispositional mindfulness and mindfulness-based interventions in reducing anxiety and depression in cardiovascular diseases. However, data on the impact of mindfulness on the psychological well-being of patients with an implantable cardioverter-defibrillator (ICD) are scarce. In this study, 422 patients with an ICD were prospectively recruited. Logistic regression was applied to determine associations between dispositional mindfulness (Freiburg Mindfulness Inventory), depression (Patient Health Questionnaire-8), anxiety (Generalized Anxiety Disorder-7 scale), and post-traumatic stress disorder (PTSD) symptoms (Post-Traumatic Stress Diagnostic Scale), adjusting for age, sex, educational status, number of ICD shocks after ICD implantation, and physical activity. The PROCESS regression path analysis modelling tool was used to identify indirect mediating effects of dispositional mindfulness on depression, anxiety, and PTSD symptoms and quality of life (QoL; EuroQol group 5-dimension questionnaire). Participants presented high baseline QoL (mean 1.06 to 1.72) and medium-high mindfulness scores (mean 40.85 points). Higher mindfulness scores were associated with lower levels of anxiety (OR 0.90, 95% CI 0.86 to 0.95, 0.001), depression (OR 0.93, 95% CI 0.88 to 0.98, p = 0.006), and PTSD symptoms (OR 0.94, 95% CI 0.89 to 0.98, p = 0.011). Furthermore, greater mindfulness partially mediated the relationship between anxiety (indirect effect 0.10, 95% CI 0.02 to 0.21), depression (indirect effect 0.08, 95% CI 0.01 to 0.17), or PTSD (indirect effect 0.04, 95% CI 0.01 to 0.17) as independent variables and the QoL as the dependent variable. This study suggests that greater dispositional mindfulness is associated with less anxiety, depression, and PTSD symptoms. Mindfulness might also increase the QoL in ICD patients by mitigating the impact of those with psychological distress.

Prognostic value of delayed gadolinium enhancement on cardiac magnetic resonance imaging in patients with ischemic cardiomyopathy and an implanted cardioverter-defibrillator

Aim. To examine the impact of late gadolinium enhancement (LGE) in the left ventricular myocardium on magnetic resonance imaging (MRI) on overall mortality and the phases of arrhythmic events in patients with ischemic cardiomyopathy and implantable cardioverter defibrillator (ICD).Methods. This was a single-center retrospective study. A total of 382 medical records of patients from the period between 2019 and 2022, who underwent ICD implantation as part of primary prevention of sudden cardiac death at National Centre of Cardiovascular Surgery, were analyzed. Seventy-four patients were selected for the study. Observation was conducted through in-person examinations and remote monitoring. Endpoints evaluated included overall mortality and arrhythmic events. The cause of death was determined based on the “Promed” medical database. Patients who reached a specific endpoint constituted the case group, while those who did not reach any endpoint formed the control group.Results. During the observation period, arrhythmic events were registered in 26 patients (35.1%), with a total of 27.1±13.2 events. Twenty-one patients (28.4%) deceased. In univariate regression analysis, the presence of LGE, the extent of LGE (%), and the number of segments with LGE served as predictors of ICD activation and overall mortality. Two multivariate logistic regression models were constructed. ROC curves were used to determine the quality of the regression model, with an area under the curve of 0.807 for ICD activation and 0.789 for mortality. The highest sensitivity and specificity of the method were observed with a LGE value equal to or greater than 14% for ICD activation (sensitivity 81%, specificity 75%) and 26% for overall mortality (sensitivity 89%, specificity 64%).Conclusion. Substantiated ICD activations (shock/antitachycardia pacing) were observed in 35.1% of cases, and the overall mortality rate was 28.4%. The association between ICD activation and the extent of LGE occurred when LGE was &gt;14%. The association between overall mortality and the extent of LGE occurred when LGE was &gt;26%.

Lack of Prognostic Value of T-Wave Alternans for Implantable Cardioverter-Defibrillator Benefit in Primary Prevention.

New methods to identify patients who benefit from a primary prophylactic implantable cardioverter-defibrillator (ICD) are needed. T-wave alternans (TWA) has been shown to associate with arrhythmogenesis of the heart and sudden cardiac death. We hypothesized that TWA might be associated with benefit from ICD implantation in primary prevention. In the EU-CERT-ICD (European Comparative Effectiveness Research to Assess the Use of Primary Prophylactic Implantable Cardioverter-Defibrillators) study, we prospectively enrolled 2327 candidates for primary prophylactic ICD. A 24-hour Holter monitor reading was taken from all recruited patients at enrollment. TWA was assessed from Holter monitoring using the modified moving average method. Study outcomes were all-cause death, appropriate shock, and survival benefit. TWA was assessed both as a contiguous variable and as a dichotomized variable with cutoff points <47 μV and <60 μV. The final cohort included 1734 valid T-wave alternans samples, 1211 patients with ICD, and 523 control patients with conservative treatment, with a mean follow-up time of 2.3 years. TWA ≥60 μV was a predicter for a higher all-cause death in patients with an ICD on the basis of a univariate Cox regression model (hazard ratio, 1.484 [95% CI, 1.024-2.151]; P=0.0374; concordance statistic, 0.51). In multivariable models, TWA was not prognostic of death or appropriate shocks in patients with an ICD. In addition, TWA was not prognostic of death in control patients. In a propensity score-adjusted Cox regression model, TWA was not a predictor of ICD benefit. T-wave alternans is poorly prognostic in patients with a primary prophylactic ICD. Although it may be prognostic of life-threatening arrhythmias and sudden cardiac death in several patient populations, it does not seem to be useful in assessing benefit from ICD therapy in primary prevention among patients with an ejection fraction of ≤35%.

Impact of gender on the utilisation implantable cardioverter defibrillators and outcome: results from the German DEVICE registry

Abstract 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.

Sex differences in hospitalization for ventricular arrhythmia after a first myocardial infarction in patients without indication for implantable cardioverter-defibrillator implantation

Abstract Background Ventricular arrhythmias (VAs) represent a serious complication of myocardial infarction (MI). Incidence rate of VAs and sudden cardiac death is commonly reported to be lower in women than in men after MI (1,2). While data regarding SCD and VAs after MI in patients with implantable cardioverter defibrillator (ICD) are well described, data regarding the incidence of readmissions for VA in patients without ICD implantation criteria after a first MI are scarce, as well as the impact of sex on their occurrence. Objective This study aims to investigate the impact of sex on VA occurrences in post-MI patients without ICD implantation criteria. Methods This study was conducted using the French national health data system using electronic codes for procedures (CCAM) and hospitalizations data (PMSI). The study population consisted of patients discharged after a first MI and without criteria for ICD implantation. Results Between January 2014 and January 2015, 137,736 patients were hospitalized in France with a diagnosis of first MI and were followed using CCAM and PMSI codes. Among the 112,465 alive at discharge, 6838 patients were excluded due to criteria for the implantation of an ICD for primary or secondary prevention. Of the remaining 105,629 patients, 1600 (1.51%) were rehospitalized for VA with a median delay of 505 days (IQR 110-1208). Men had almost twice the risk of VA than women after initial discharge for MI (OR 1.88, 95% CI 1.65-2.14; p&amp;lt;0.0001). Among the 72,103 men included, 1240 (1.72%) were rehospitalized for VA with a median delay of 514 days (IQR 107-1212). Factors independently associated with VA in men were previous atrial fibrillation (OR 1.91, 95% CI 1.66 - 2.21, p&amp;lt;0.0001), previous vascular disease (OR 1.28, 95% CI 1.10 - 1.50, p=0.002), absence of coronary angioplasty (OR 1.28, 95% CI 1.10 - 1.50, p=0.002), previous diabetes (OR 1.19, 95% CI 1.04 - 1.36, p=0.012), previous hypertension (OR 1.19, 95% CI 1.05 - 1.34, p=0.007), previous or in-hospital congestive heart failure (OR 1.47, 95% CI 1.03-2.08, p=0.032 and OR 1.65, 95% CI 1.32-2.07, p&amp;lt;0.0001), and age (patients between 60 and 79 yo being at the higher risk of VA compared to &amp;lt;60 and &amp;gt;80yo patients, p=0.002 and &amp;lt;0.0001 respectively). Among the 33,526 women included, 360 (1.07%) were rehospitalized for VA with a median (IQR) delay of 461 days (116-1159) after MI. Factors independently associated with VA were previous atrial fibrillation (OR 1.68, 95% CI 1.30 - 2.18, p&amp;lt;0.0001), previous vascular disease (OR 1.37, 95% CI 1.01 - 1.84, p=0.041), and age (patients between 60 and 79 yo being at the higher risk of VA compared to &amp;gt;80yo patients, p=0.001). Conclusion The risk of readmission for VAs after a first MI is significantly lower in women compared to men, with distinct predictive factors. These findings suggest that sex-specific VA risk stratification and management strategies may be warranted after an initial MI.Sexe influence on post-MI VAs occurence

Cardiac implantable electronic devices following orthotopic heart transplantation: insights on indications and outcomes from a single centre experience

Abstract Background Need for cardiac implantable electronic devices (CIED) after orthotopic heart transplantation (OHT) ranges from 7 to 24% of cases depending on several patient and procedural related factors. Purpose The aims of this study were to investigate the frequency, indications and the predictors of CIED implantation (especially permanent pacemaker [PPM]) following biatrial anastomosis OHT. Methods A retrospective, single centre, observational study was conducted, including all the patients who underwent OHT between May 1990 and October 2023 at our Institution. For each patient clinical and procedural information were collected and a long-term active follow-up was performed. The primary endpoint of the study was PPM or implantable cardioverter defibrillator (ICD) implantation while all-cause mortality or de novo OHT was a secondary endpoint. Uni- and multivariable logistic regression analyses were performed to identify factors associated with PPM implantation. Results Overall, 546 patients were included and followed-up for a median of 8 years [IQR 1.2-14.3]. During this time frame, 89 (16.3%) patients required PPM implantation (only one patient [0.2%] underwent ICD implantation) at median time of 110 days [IQR 25-2230] after OHT. The main indication for PPM implantation was the development of sinus node dysfunction in 60 patients (67.4%) whereas 29 (32.6%) patients with atrioventricular block required PPM implantation. During follow-up, 265 deaths (48.5%) occurred but no significant differences in long-term prognosis were observed between patients requiring CIED implantation and those who did not (45.5% vs. 49.1%, p-value=0.53, figure). At multivariable analysis, impaired renal function (i.e. low eGFR), cardiac allograft vasculopathy, the occurrence of severe heart transplant rejection and a higher BMI were factors associated with PPM implantation (table). Conclusions Among patients undergoing OHT with biatrial anastomosis technique, PPM implantation is not uncommon but it does not negatively impact on prognosis. Several factors, especially severe heart transplant rejection, cardiac allograft vasculopathy and impaired renal function can help identifying patients at higher risk of PPM.TableFigure

Factors influencing inappropriate device therapy in implantable cardioverter defibrillators: a predictive analysis

Abstract Background Implantable cardioverter defibrillator (ICD) implantation and subsequent ICD therapy have shown to be efficacious in the prevention of sudden cardiac death. However, patients with an ICD are at risk of inappropriate device therapy (IDT), which is associated with worse outcomes, reduced quality of life (QoL), and may influence psychosocial and mental wellbeing. Purpose This study aimed to predict which patients are at risk of IDT by investigating the influence of pre-implant clinical parameters on occurrence of IDT. Methods From January 2010 to December 2019, patients who received an ICD in our medical center, were included in a prospective registry. Only patients with ICD (including ICDs used for cardiac resynchronization therapy, i.e. CRT-D) with an atrial lead were included in the current analysis, to better distinguish between appropriate and inappropriate device therapy. After implant, the device was interrogated at least every 6 months and clinical symptoms related to the device, recorded events, and relevant technical setting changes were recorded. IDT was defined as antitachycardia pacing (ATP) or shock delivered for any reason other than ventricular arrhythmia. Follow-up ended after IDT, death, or loss-to-follow-up. Results 428 patients underwent an implantation of a dual chamber ICD or CRT-D of various manufacturers. 14 patients were lost to follow-up within the first year and one patient was excluded because of a dislocated atrial lead, leaving 413 patients (76% male, mean age 67±9.7 years, 39% CRT-D) with a minimum of 1-year follow-up. During a mean of 5.3 (±3.0) years, 136 (32.9%) patients received appropriate therapy and 36 (8.7%) patients received IDT. Of those 36 patients, 18 patients received only ATP, 12 received ATP followed by a shock, and 6 patients received a shock without prior ATP. The median time from implantation to IDT was 2.8 [0.3-5.8] years. Univariate logistic regression on 40 clinical parameters followed by a forward multivariate logistic regression was performed. The area under the ROC curve of the resulting multivariate model was 0.724 (95%CI 0.622-0.826). Cox regression analysis resulted in device type (CRT-D) (HR=0.533, 95%CI 0.234-1.211, p=0.133), use of mineralocorticoid receptor-antagonists (MRA) (HR=0.280, 95%CI 0.104-0.754, p=0.012), use of diuretics (HR=3.378, 95%CI 1.479-7.714, p=0.004), and eGFR (HR=1.217, 95%CI 0.972-1.523, p=0.087) as predictors of IDT. A history of atrial fibrillation was not a significant predictor of IDT. Conclusion This study identified CRT-D and use of MRAs to be protective against IDT, and use of diuretics and lower eGFR as risk factors of IDT. To inform patients optimally, pre-implant assessment of those factors could help identify patients at higher risk of IDT. Furthermore, it could dictate more cautious device programming and consequently reduce rates of IDT, reducing the negative influence of IDT on QoL and wellbeing in the ICD population.

Effects of tele-yoga on physical and psychological outcomes in patients living with ICD, a randomised controlled trial

Abstract Background Patients with long-term illness, including those living with an implantable cardioverter defibrillator (ICD), often suffer from symptoms of anxiety and depression, decreased health-related quality-of-life (HRQOL), and impaired functional capacity. Yoga, being a mind-body intervention, may improve all these outcomes. Purpose To determine effects of tele-yoga on exercise capacity and patient-reported outcome measures. Methods A single-blind (evaluator blinded) parallel two-arm RCT with 1:1 distribution. Participants were recruited from four hospitals in Sweden. Inclusion criteria: &amp;gt;18 years, admitted to a cardiology or intensive care units &amp;gt;48 hours during the last 36 months due to ICD implantation or ventricular arrhythmias, heart failure, or conditions in need of intensive care and now clinically stable. The participants were randomised to a control group receiving individual exercise advice or to the intervention group (tele-yoga). The intervention included performing live-streamed group-yoga for 60 min twice/week for 3 months and practicing yoga individually for a minimum of 10 min/day using an app. The group-sessions with approximately 10 participants were led by certified Mediyoga-instructors via the virtual video-platform ZOOM. The yoga form was Kundalini adapted to individuals with health conditions (Mediyoga). Two standardised yoga-programmes including different postures, breathing exercises and meditations were rotated. The primary endpoint of the study after 3 months was a combined endpoint consisting of change in functional capacity measured by 6-min walk test (6MWT), HRQOL (EQ-5D index/VAS) and symptoms of anxiety and depression (HADS). The used cut offs for change were 30 meters for 6MWT, a score &amp;gt;11 for EQ-5D VAS and ≥8 for anxiety/depression in HADS. Secondary endpoints included separate analysis of functional capacity, HRQOL and symptoms of anxiety/depression. Results In total, 311 participants were randomized to tele-yoga (n=156) and control (n=155), mean age 65.8 years, 30% women, 38% living with an ICD (whereof 62% had a primary preventive indication). Median attendance to yoga-sessions was 20 sessions for 12 weeks and 74% of the study participants were adherent to &amp;gt;16 tele-yoga sessions. There were no adverse events reported during yoga sessions or app usage. In this sub-group analysis involving the ICD cohort (n=118), there was a significant improvement in favour of the tele-yoga group in the combined primary endpoint (p=.011). When analysing them separately, there was a significant improvement in 6MWT (p=.002), but not in HRQOL in EQ-5D VAS or symptoms of anxiety and depression. No adverse events were reported during yoga sessions or app usage. Conclusion Digitally delivered mind-body training such as tele-yoga showed a significant improvement in the combined endpoint consisting of physical function, HRQOL and mental health. Tele-yoga may be a promising new form of rehabilitation for patients living with ICD.