Implantable Cardioverter Defibrillator Population Research Articles

Cost impact of the use of a universal cardiac implantable electronic devices remote monitoring solution: results of the Evidence RM study

Abstract Background Remote monitoring (RM) is considered the standard of care for patients with cardiac implantable electronic devices (CIED). In 2023 the HRS/EHRA/APHPRS/LAHRS expert consensus highlighted the potential interest of alert-based monitoring and the use of a third-party platform for RM management. By lightening the RM workload for clinical staff, valuable time and resources can be redirected towards patient care. Purpose This study aims to assess the impact on healthcare expenditures of the adoption of a Universal, vendor-neutral, and alert-focused remote monitoring (RM) platform for CIED in France, as opposed to the Conventional RM conducted via device specific manufacturers' platforms. Methods This study utilizes the French National Health Database (SNDS) to evaluate the effectiveness of RM solutions among patients with implantable cardioverter defibrillators (ICD), including cardiac resynchronization therapy defibrillators (CRT-D). All patients under RM were categorized based on the type of monitoring, either the Universal RM or the Conventional RM. The analysis was conducted on year 2019 and included only patients maintaining consistent RM solutions and device types throughout the entirety of the study period. To mitigate potential biases, costs were adjusted according to age, gender, device type, year of first implantation, year of RM initiation, medical center experience with RM, and Elixhauser score for comorbidities. Results Study cohort consisted of 36,401 patients (age 67.3 ± 13.0 years / male 78.4% / CRT-D 40.1%), 1,482 patients followed using the Universal RM platform and 34,419 patients monitored with the Conventional RM solutions. The study findings revealed a 4% decrease in corrected total costs and a notable 17.8% reduction in hospital costs among patients utilizing the Universal RM. Analysis further identified that this decrease in hospital expenses was primarily influenced by a reduction of the costs associated with cardiovascular diseases. Conversely, the group utilizing the Universal RM experienced a 7.9% increase in total outpatient costs compared to Conventional RM, while ambulatory visit costs remained unchanged. As costs incurred by patients were not included, total costs may however be underestimated. Patients under the Universal RM solution may benefit of more proactive preventive measures delivered through outpatient care. By addressing issues preemptively, critical conditions may be averted, enhancing overall patient management, and diminishing hospital costs. The adoption of a third-party Universal platform may thus yield to cost savings, exemplified by a negative Incremental Cost-Effectiveness Ratio (ICER) of -103€ per Day Alive and Out of Hospital (DAOH) as observed in this study. Conclusions The use of a third-party Universal RM platform showed a positive impact in terms of costs reduction for the French healthcare system on this ICD population.

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.

Temporal trends in baseline characteristics of implantable cardioverter defibrillator recipients for primary prevention of sudden cardiac death- The DAIPP program

Abstract Introduction Since expanding the indication for implantable cardioverter defibrillators (ICD) to primary prevention, the patient population of ICD carriers continues to evolve over time. In pursuit of progressively decreasing the burden of sudden cardiac death, improved patient selection and risk-benefit assessment demand, among others, awareness of these temporal changes in clinical baseline characteristics of the ICD population. Purpose The aim was to explore the temporal differences in baseline characteristics of ICD recipients implanted for primary prevention of sudden cardiac death (SCD), and perioperative complications, to improve understanding of ICD population selection over the last two decades in a real-world setting. Methods The Primary Prevention ICD French Registry (DAI-PP program) was initiated in 2002 with an overall aim to assess the risk-benefit ratio of the introduction of ICD for primary prevention over a 20-year period, including a pilot evaluation that finished in 2012. The pilot study laid ground for the ongoing prospective DAIPP Consortium that started in 2018 and is aiming to follow 10000 patients under remote monitoring, using a specific integrational research platform. The two cohorts are in this study compared with regards to baseline characteristics as well as perioperative outcomes, i.e., early mortality and procedural complications. Results This study included 8432 participants, 5521 from the pilot study and 2211 from the prospective trial, with a median follow up of 2.36 (IQR 1.25-3.75) years. Median age was 64 (IQR 56-71) years, 17% female and 61% had ischemic heart disease. Baseline characteristics that remained stable over time were age, cancer burden. Compared to the 2002-2012 period, recent findings found a significant increase in the proportion of females (15 vs 20%, p <0.001), pauci-symptomatic patients (New York Heart Association Functional class-NYHA II, 41 vs. 57%, p <0.001), narrow QRS patients (31 vs. 43%, p<0.001), use of subcutaneous ICD (0 vs. 14%, P<0.001) and more comorbidities including an increase in diabetes, and slight increase in stroke. Regarding pharmacological treatment, there was an increase in use of 2 or 3 medications (2: 6.5% to 16% p<0.001; 3: 20% to 33%, p<0.001) where more received beta blockers and amiodarone in the contemporary study. Perioperative complications decreased over time (13% to 7.9% p<0.001) with a decrease in early reinterventions (1.3% to 0.1% p<0.001) and discrete fall in number of infections (0.7% to 0.1%, p<0.001) and pocket hematoma (4.4% to 3.0% p<0.001). A slight upward trend in number of lead dislodgements was seen over time (1.3% to 1.7% p<0.001). See Table 1 for perioperative complications. Conclusion The primary prevention ICD population has significantly changed over time. An increase in women, comorbidities, and use of 2-3 medications was seen, coupled with more participants receiving a subcutaneous ICD. Perioperative complications decreased over time.

Abstract 15458: Incidence of Ventricular Arrhythmias Related to Covid Infection and Vaccination in Patients With Brugada Syndrome: Insights From a Large Italian Multicenter Study

Introduction: Brugada syndrome (BrS) is an inherited channelopathy leading to an increased risk of life-threatening arrhythmias. BrS patients have a dynamic ECG pattern that might be revealed by certain conditions such as fever. Covid infection/vaccination is associated with fever. Therefore, prompt treatment with antipyretic drugs is recommended. Hypothesis: We evaluated the incidence and management of fever-related arrhythmias from Covid infection/vaccination among BrS patients previously implanted with an implantable loop recorder (ILR) or an implantable cardioverter-defibrillator (ICD) and followed by remote monitoring. Methods: 326 patients were retrospectively analyzed in 9 Italian Centers with a dedicated inherited disease ambulatory. All patients had a previously implanted device (ICD/ILR) and remote monitoring. We recorded ventricular arrhythmias (non-sustained VT, VT, FVT, VF) 6-month before Covid infection/vaccination, during Covid infection, at each vaccination, and up to 6-month post-Covid healing or 1-month after the last dose of vaccine. In ICD patients, we documented any device intervention (ATP/shock). Results: Mean age was 48.02±14.08, 240 patients were males (73.6%). 235 patients had an ICD (72.1%), and 91 had an ILR (27.9%). 175 patients had a spontaneous type 1 ECG pattern (53.7%). Fever occurred in 18.4% of all patients. The mean temperature was 38.2±0.6 degrees, 2.76% were hospitalized due to Covid. All patients developing fever received paracetamol, only a minority ibuprofen, antibiotics, and hydroxychloroquine. After Covid, we recorded 2 VT episodes in the same patient treated with paracetamol and hydroxychloroquine. After the 1st, 2nd, and 3rd vaccine doses we recorded: 10 NSVT; 16 NSVT and 2 VT; and 7 NSVT, respectively. After 1-month from the last dose, only 1 patient had an episode of FVT. The overall incidence of sustained VT is 1.2%. No ICD interventions, ATP and shocks, were recorded in the ICD population. Patients with an ILR had no ventricular arrhythmias. Conclusions: From this large multicenter study, fever treatment in patients with BrS is widely performed with paracetamol. The overall incidence of sustained ventricular arrhythmias after Covid infection/vaccination is relatively low.

Clinical phenotyping of implantable cardioverter defibrillator patients to identify the association of remote device monitoring on survival benefit: a cluster analysis

Abstract Background/Introduction Over the past decade, various studies have demonstrated an association between remote device monitoring (RM) in implantable cardioverter-defibrillator (ICD) patients and all-cause mortality. However, it is unclear which clinical phenotypes account for this survival benefit. Purpose We aimed to identify clinical phenotypes within an ICD population on RM and conventional follow-up (NRM), and evaluate differences in long-term survival per clinical phenotype. Methods This is a single-center, retrospective, observational study of de novo ICD implantations (single- and dual chamber, biventricular and subcutaneous) between 2010 and 2021 in patients ≥18 years old. Data was extracted from electronic health records. Unsupervised two-step cluster analysis (TSC) was performed to identify distinct clinical phenotypes in the RM and NRM cohorts. Multinomial logistic regression analysis was performed to identify cluster characteristics, differences among the different clusters were analysed by Chi-squared test. Variable importance was evaluated for each of the 18 included clinical variables. Survival analysis was performed using the Kaplan-Meier method, log-rank was used to compare survival between groups. Results A total of 1872 ICD patients were analysed using TCS, comprising 1265 RM and 607 NRM patients, respectively. TCS for a mean follow-up duration of 5.4±3.1 years partitioned the RM and NRM groups into six clusters (Table 1). Clusters RM1 (n=444) and NRM3 (n=220) represented a predominantly primary prevention and DCM phenotype. Clusters RM2 (n=300) and NRM2 (n=173) indicated young and secondary prevention phenotypes. Clusters RM3 (n=220) and NRM1 (n=214) comprised an older, male and ischaemic cardiomyopathy (ICM) phenotype. In survival analysis 5-year cumulative incidence of mortality for the subsequent clusters was 7.4%, 4.5%, 11.6%, 41.4%, 29.8%, and 25.1%, respectively (log rank p-value <0.001, Figure 1). Thus, younger and DCM phenotypes (often with genetic aetiologies) experienced superior survival and high rates on RM, whereas older, male and ICM phenotypes with low rates on RM were associated with worse survival. In addition, between-group cluster-comparison of patients on RM only demonstrated important differences in long-term survival, where RM3 (comprising older, male with predominantly ICM) had poorer survival compared to young patients with a high prevalence of DCM, primary arrhythmia syndrome and low proportions of comorbidities (i.e. atrial arrhythmias, cerebral vascular accidents, diabetes mellitus). Conclusion We identify novel clinical phenotypes (clusters) of ICD patients on RM and having conventional follow-up with large differences in long-term survival. Future studies should further explore if these differences reflect benefit from RM, or the underlying natural history of each phenotype. These results may accordingly guide monitoring strategies tailored to specific ICD patient profiles. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Public funding

Adherence to wearables in implantable cardioverter-defibrillator patients: Preliminary results from the prospective, multicenter SafeHeart-study

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – EU funding. Main funding source(s): Horizon2020 Introduction Wearable devices are gaining interest in the clinical assessment of physical behavior as a marker of disease severity. With the increased use, patient willingness and adherence will be increasingly important. As part of the SafeHeart study, examining the potential of physical behavior as an identifier of clinical deterioration in patients with an implantable cardioverter defibrillator (ICD), we present preliminary results on adherence to a wrist-worn wearable used for physical behavior assessment. Purpose Define the willingness to participate and long-term adherence to wearables in an ICD population. Methods This is a preliminary analysis of the ongoing multicenter, prospective, observational SafeHeart study. SafeHeart is aimed to construct a personalized prediction engine for ICD therapy using wearable-assessed physical behavior, remote ICD monitoring, electronic health records, and patient-reported data. The study will enroll 400 participants with an ICD with or without cardiac resynchronization therapy (CRT-D). In this preliminary analysis, wearable data was analyzed for the first 50 participants, where inclusion required a minimum of 1 month of follow up data. No data from the wearables were provided to the participants. The wrist-worn wearables were used continuously (day and night) for up to 12 months of follow-up. Adherence to the wearable was measured through patient-reported (subjective) adherence and wearable-measured (objective) adherence. Data were extracted from the wearables and non-wear time was detected via open source algorithms. A valid day was set to 22 hours of available wear time with 24-hour periods assessed from 3pm to 3pm for sleep metric capture. The willingness to participate and dropout rates were calculated for the same first 50 patients of the study. Results A total of 50 ICD participants were included in this study. The mean age was 65.1 years, 82 % male, with a mean follow up of 7 weeks, generating 326 patient weeks of data. Regarding patient-reported adherence, participants reported 81.4% full adherence and 18.6 % of participants reported very brief non-wear due to e.g. sauna or surgery. Of those reporting non-wear, 62.5% described one episode only of non-wear lasting 15-75 minutes. Regarding objectively measured adherence from wearable data, full adherence was shown in 91.7% of days. The mean number of valid days per participant was 41.3. Recruitment rates showed a willingness to participate of 50% (50/100) out of eligible subjects invited. No participants were lost to follow Conclusion Results show high adherence and reasonable willingness to participate without wearable adherence dropping over time. Comparison of objectively measured and patient-reported adherence showed similar values.

Implantable cardioverter-defibrillator therapy in the very young - Patient characteristics procedural outcome and one-year follow-up - A subgroup analysis of the german DEVICE registry

Abstract Funding Acknowledgements Type of funding sources: None. Background The implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) are well-established and essential therapeutic pillars for patients with heart failure and survivors of sudden cardiac death. The number of young patients receiving ICD or CRT-D has been increasing in the last decades. Understanding the key differences between the typically older ICD population and younger patients is paramount to optimized patient care. Methods The DEVICE registry prospectively enrolled patients undergoing ICD/CRT implantation or revision from 50 German centers between 2007–2014. Data on patient characteristics, procedural outcome, adverse events and mortality during the initial stay and follow-up was collected. All patients under the age of 45 years were identified and included into a comparative analysis with the remaining population. Results A total number of 4181 patients were enrolled into the registry, of which 236 patients (5.6%) were under the age of 45 years. Median age was 38.0 [31.0; 42.0] vs. 69.0 [60.0; 75.0] years, p<0.001), compared to older patients. Young patients were more likely to receive an ICD (91.5 vs. 69.4%, p<0.001), than CRT device and were less likely to suffer from non-cardiac comorbidities (20.3 vs. 67.4%, p<0.001). Coronary artery disease was less common in young patients (15.7 vs. 63.6%, p<0.001), whereas hypertrophic cardiomyopathy (11.0 vs. 2.5%, p<0.001) and primary cardiac electrical diseases (14.0 vs. 1.6%, p< 0.001) were encountered more often. Mean left-ventricular ejection fractions were 42.4±18.5 vs. 31.5±11.8%, respectively (p<0.001) with less young patients in NYHA functional class III/IV (19.5 vs. 45.3%, p<0.001). Primary symptom at presentation was chronic heart failure for older patients (19.5 vs. 34.8%, p<0.001) and survived sudden cardiac death (30.9 vs. 15.6%, p<0.001) for young patients. Thus, ICD for secondary prevention was more common in young patients (53.8 vs. 43.2%, p<0.001). There were no detectable differences in postoperative complications (3.0 vs. 4.1%, p=0.500) or in-hospital mortality (0.0 vs. 0.3%, p=1.000). Median follow-up time was 514 [398; 669] vs. 458 [391; 563] days (p=0.006). Device-associated complications requiring revision were more common in young patients (16.3 vs. 8.2%, p<0.001) and all-cause 1-year-mortality after implantation was lower (3.1 vs. 7.3%, p=0.029; HR 0.42, 95%CI: 0.19-0.94). Even though there was no difference in rates of rehospitalization between groups (32.1 vs. 32.4%, p=0.93), young patients were re-admitted more often for "cardiac" reasons (82.7 vs. 58.9%, p<0.001). Conclusion Rates for procedural complications and in-hospital mortality were very low and without differences between both age groups. However younger patients experienced a higher rate of postoperative complications requiring revision and had higher readmission rates for cardiac reasons, potentially due to a more active lifestyle.

Accelerometry-assessed physical behaviour and the association with clinical outcomes in implantable cardioverter-defibrillator recipients: a systematic review

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – EU funding. Main funding source(s): Eurostars Introduction Patients at a high risk of sudden cardiac death (SCD) benefit from an implantable cardioverter defibrillator (ICD). However, they remain at a high risk of (inappropriate) shocks, heart failure, mortality and psychological distress. Consumer-level wearable accelerometry as method for recording physical behaviour (PB) has gained popularity over the past years, but so far the clinical potential is largely underinvestigated. The identification of patterns in PB and the association with clinical outcomes may provide a means to improve ICD therapy. Purpose This review addresses the evidence concerning PB in ICD patients and aims to characterise PB patterns associated with clinical outcomes. Methods A systematic review of studies focussing on accelerometer-assessed PB in patients older than 18 years equipped with an ICD, or patients at a high risk of SCD (e.g. advanced heart failure) was performed. PB could be assessed using a wearable accelerometer or an embedded accelerometer in the ICD (i.e. device-measured physical activity (D-PA)). Papers presenting quantitative data in English language peer reviewed journals published between January 2000 and September 2020 were identified via the OVID MEDLINE and OVID EMBASE databases. A study protocol describing study selection, data charting and summarisation of results was developed apriori. Study selection was conducted by two independent reviewers and a third reviewer in case of disagreement. Results A total of 4219 studies were identified, of which 51 were deemed appropriate for this review. Of these studies, 29 examined D-PA (n = 169.742 patients), 19 examined wearable accelerometery (n = 1.601) and 3 validated wearable accelerometry against D-PA (n = 106). The main findings were that (i) a low level of physical activity (PA) after implantation of the ICD and (ii) a decline in physical activity were both associated with an increased risk of ICD shocks, hospitalization and mortality. Second, PB was affected by cardiac factors (e.g. onset of atrial arrhythmias, ICD shocks) and non-cardiac factors (e.g. seasonal differences, pandemic lockdown). Third, PB was related to left ventricular ejection fraction, physical and cognitive function and quality of life. The evidence regarding wearable accelerometry compared to D-PA was scarce and heterogeneous. Conclusion This review demonstrated the potential of PB as an identifier of clinical deterioration in an ICD population. Accelerometer-assessed PB data could improve early warning systems and facilitate preventive and pro-active strategies, especially considering the nature of PB as modifiable risk factor. We suggest two directions for future research: (i) prospective collection of wearable accelerometry data in an ICD population to identify the most clinically relevant behavioural metrics (ii) investigation of preventive measures that can be undertaken once changes in PB are observed. Abstract Figure. Accelerometry-derived physical behaviour

Prognostic value of cardiovascular magnetic resonance left ventricular volumetry and geometry in patients receiving an implantable cardioverter defibrillator

BackgroundCurrent indications for implantable cardioverter defibrillator (ICD) implantation for sudden cardiac death prevention rely primarily on left ventricular (LV) ejection fraction (LVEF). Currently, two different contouring methods by cardiovascular magnetic resonance (CMR) are used for LVEF calculation. We evaluated the comparative prognostic value of these two methods in the ICD population, and if measures of LV geometry added predictive value.MethodsIn this retrospective, 2-center observational cohort study, patients underwent CMR prior to ICD implantation for primary or secondary prevention from January 2005 to December 2018. Two readers, blinded to all clinical and outcome data assessed CMR studies by: (a) including the LV trabeculae and papillary muscles (TPM) (trabeculated endocardial contours), and (b) excluding LV TPM (rounded endocardial contours) from the total LV mass for calculation of LVEF, LV volumes and mass. LV sphericity and sphere-volume indices were also calculated. The primary outcome was a composite of appropriate ICD shocks or death.ResultsOf the 372 consecutive eligible patients, 129 patients (34.7%) had appropriate ICD shock, and 65 (17.5%) died over a median duration follow-up of 61 months (IQR 38–103). LVEF was higher when including TPM versus excluding TPM (36% vs. 31%, p < 0.001). The rate of appropriate ICD shock or all-cause death was higher among patients with lower LVEF both including and excluding TPM (p for trend = 0.019 and 0.004, respectively). In multivariable models adjusting for age, primary prevention, ischemic heart disease and late gadolinium enhancement, both LVEF (HR per 10% including TPM 0.814 [95%CI 0.688–0.962] p = 0.016, vs. HR per 10% excluding TPM 0.780 [95%CI 0.639–0.951] p = 0.014) and LV mass index (HR per 10 g/m2 including TPM 1.099 [95%CI 1.027–1.175] p = 0.006; HR per 10 g/m2 excluding TPM 1.126 [95%CI 1.032–1.228] p = 0.008) had independent prognostic value. Higher LV end-systolic volumes and LV sphericity were significantly associated with increased mortality but showed no added prognostic value.ConclusionBoth CMR post-processing methods showed similar prognostic value and can be used for LVEF assessment. LVEF and indexed LV mass are independent predictors for appropriate ICD shocks and all-cause mortality in the ICD population.

Long-term follow-up of paediatric patients with a subcutaneous implantable cardioverter-defibrillator

Abstract Background Inherited channelopathies, cardiomyopathies and structural heart diseases are known to increase the risk of sudden cardiac death in children and are occasionally treated with an implantable cardioverter-defibrillator (ICD). Due to their physical growth and higher level of activity, children experience more adverse events than adults, such as lead fractures, vascular problems and infections. The subcutaneous ICD (S-ICD) was introduced to avoid these lead-related complications and is expected to be especially beneficial for children who require ICD therapy. However, long-term follow-up data of this population are lacking. Purpose To evaluate long-term clinical outcomes of the S-ICD in the paediatric population. Methods Follow-up data were prospectively collected of all paediatric patients (age &amp;lt;18 years) who received their S-ICD in our tertiary centre between November 2009 and June 2019. Clinical outcomes that were assessed were appropriate or inappropriate shocks and complications that required surgical intervention. Results A total of 21 paediatric patients received an S-ICD, with a median age of 15 years (ranged 8–17) and a median body mass index of 18.8 kg/m2 (ranged 15.5–28.8, lowest weight 30kg). The indication for ICD implantation was mostly idiopathic ventricular fibrillation (38.1%) or genetic arrhythmic disease (28.6%). The subcutaneous lead was implanted in an S-shape to accommodate for growth in small patients, and straightening of the lead could be observed on successive chest X-rays (see figure). There was no need for lead or device revisions in this cohort. After a median follow-up of 4.3 years (IQR 2.7–6.5), five patients (23.8%) received an appropriate shock for ventricular arrhythmias and six patients (28.6%) received an inappropriate shock for supraventricular tachycardia (n=4) or double-counting (n=2). Complications that required device extraction occurred in three patients after 0.8±1.1 years and was the result of inappropriate shocks (n=1) and pocket infection (n=2). In two patients the S-ICD was extracted due to progression of their cardiac disease, of whom one needed biventricular pacing and one underwent heart transplantation. Conclusions The S-ICD appears efficacious in this heterogeneous paediatric population. Although higher than reported in adults, the long-term complication rate in paediatric S-ICD recipients is similar to the paediatric transvenous ICD population. Funding Acknowledgement Type of funding source: None

Seventeen-year trend (2001–2017) in pacemaker and implantable cardioverter-defibrillator utilization based on hospital discharge database data: An analysis by age groups

AimsTo analyze temporal trends (2001 -2017) of Pacemakers (PM) and Implantable Cardioverter-Defibrillators (ICD) procedures in Italy, according to the national Hospital Discharge Database (HDD). MethodsFrequency and implant rate (IR) in the Italian population were analyzed by age groups (<50, 50–79, ≥80 years). ResultsFrom 2001 (2009 for Cardiac Resynchronization Therapy-Defibrillator – CRT-D) to 2017, first PM implants (1stPM) increased from 36,823 (637/million inhabitants) to 49,716 (820/million), ICD implants from 3,141 (54/million) to 24,255 (400/million) and CRT-D from 2,915 (49/million, 16.5% of ICD) to 8,595 (142/million, 35.4% of ICD).ICD implants due to ventricular tachycardia or ventricular fibrillation decreased from 55.6% to 13.5% and from 15.9% to 4.5% respectively, while the proportion increased among patients with heart failure (from 22.9% to 46.8%), hypertension (from 11.1% to 15.0%), diabetes (from 6.5% to 10.9%), and renal insufficiency (from 4.4% to 7.6%). Both PM and ICD procedures markedly increased in patients ≥80 years old. However, while IR for ICDs increased from 82/million to 1,038/million inhabitants, IR of 1stPM only changed from 6,111/million to 6,212/million as the population in this age group nearly doubled in Italy. ConclusionSince 2001, the increase of 1stPM in Italy was mainly due to the ultra-octogenarian population growth. No differences were observed for IR in each PM age group, while the absolute number and IR increased in all groups (especially ≥80 years old) for ICDs and CRT-Ds. An increase in comorbidities and a reduction in implants for secondary prevention were observed in the ICD population.

Defibrillators in adult congenital heart disease: Long-term risk of appropriate shocks, inappropriate shocks, and complications.

Sudden cardiac death (SCD) accounts for up to 25% of deaths in the adult congenital heart disease (ACHD) population. Current guidelines for defibrillator implantation are either extrapolated from acquired cardiac disease or are based upon single lesion studies, predominantly Tetralogy of Fallot (TOF). Defibrillator-related morbidity appears to be substantially higher in ACHD patients. We retrospectively evaluated all patients in our ACHD database who received an implantable cardioverter-defibrillator (ICD) between 2000 and 2019, and who were ≥16 years old at time of implant. Patients were followed for appropriate shocks, inappropriate shocks, and complications. Of 4748 patients in our database, 59 patients (1.2%) underwent ICD implantation. ICDs were for primary prevention in 63% and secondary prevention in 37%. Over a median follow-up of 6.6 years, 24% received an appropriate shock, 27% an inappropriate shock, and 42% suffered a device-related complication (annualized risks of 3.2%, 3.6%, and 5.7%, respectively). There were no significant predictors of appropriate shocks or inappropriate shocks. All appropriate shocks in primary prevention patients occurred in TOF or transposition of the great arteries (TGA) with atrial switch, typically in the presence of multiple SCD risk factors. The majority of inappropriate shocks were due to supraventricular arrhythmias. Device-related mortality was 1.7% (0.3% per annum). Appropriate shocks were relatively common in an ACHD ICD population followed in the long term. Device-related morbidity was significant. Although risk factors have been established for TOF, and to a lesser extent TGA, risk stratification for ICD implantation in ACHD remains challenging.

Comparison of left ventricular lead upgrade vs continued medical care among patients eligible for cardiac resynchronization therapy at the time of defibrillator generator replacement: Predictors of left ventricular lead upgrade and associations with long-term outcomes

Randomized trials evaluating cardiac resynchronization therapy (CRT) have excluded patients with a pre-existing implantable cardioverter-defibrillator (ICD). The association of CRT upgrade with clinical outcomes in patients with a pre-existing ICD is unclear. The purpose of this study was to examine a CRT-eligible population to evaluate clinical outcomes associated with CRT upgrade compared to patients who did not undergo CRT. Using the National Cardiovascular Data Registry (NCDR) ICD Registry between April 2010 and December 2014, we created a hierarchical logistic regression model to identify predictors of CRT upgrade in a CRT-eligible ICD population. In the subpopulation of patients with Medicare-linked claims data, differential outcomes were determined with censoring at 3 years. The primary endpoint of this study was all-cause mortality, with secondary endpoints of rates of hospitalization and procedural complications. CRT upgrade was performed in 75.5% of CRT-eligible patients with pre-existing ICD (n = 15,803). Presence of left bundle branch block conduction was the strongest predictor of CRT upgrade (odds ratio [OR] 4.56; 95% confidence interval [CI] 4.08-5.11; P<.0001). In both unadjusted and adjusted analyses, CRT upgrade was associated with a reduction in mortality at 3 years (unadjusted hazard ratio [HR] 0.80; 95% CI 0.70-0.92; P = .001; adjusted HR 0.84; 95% CI 0.72-0.98; P = .02, respectively). Compared to patients with ICD generator replacement only, patients who underwent CRT upgrade experienced no different 3-year rates of hospitalization (adjusted HR 1.01; 95% CI 0.91-1.12; P = .81) or 1-year periprocedural complication rates (adjusted HR 1.07; 95% CI 0.79-1.45; P = .66). In a national registry of CRT-eligible patients with pre-existing ICD, upgrade to CRT was associated with lower rates of mortality than continued medical management.

Anger and long-term mortality and ventricular arrhythmias in patients with a first-time implantable cardioverter-defibrillator: data from the MIDAS study.

Psychosocial factors increase risk for incident heart disease and poor prognosis. In patients with an implantable cardioverter-defibrillator (ICD), negative emotions have been associated with increased mortality risk, although the association with ventricular arrhythmias (VAs) is less consistent. Anger has been linked to incident ICD shocks, but no prospective study has examined the association of anger (state and trait) with mortality or VAs in the ICD population. In a consecutively recruited cohort of first-time ICD patients, we examined the association of state and trait anger with 7-year mortality risk and time to first VA. A consecutive cohort of patients implanted with a first-time ICD (n = 388; 80% men) between 2003 and 2010 completed the State-Trait Anger Scale and were followed for 7 years. Outcomes were mortality and time to first appropriate ICD therapy. State anger at the time of implant was associated with increased mortality risk in adjusted analyses, with a 1-point increase in score on the state anger measures associated with a 5% [hazard ratio 1.05; 95% confidence interval 1.01-1.09; P = 0.015] increased 7-year mortality risk. We found no statistically significant differences in mortality risk for trait anger, nor an effect for state or trait anger on time to first treated VA (all ps > 0.05). This is the first study to examine the association of state and trait anger with long-term clinical outcomes in ICD patients. Evaluating anger reduction strategies in newly implanted ICD patients, such as self-regulation or mindfulness techniques, may be warranted for reducing mortality risk.

Predictive value of gamma-glutamyltransferase for ventricular arrhythmias and cardiovascular mortality in implantable cardioverter-defibrillator patients

BackgroundGamma-glutamyltransferase (GGT) is a new predictor of cardiovascular diseases. In this study, we aimed to determine its association with ventricular arrhythmias (VAs) in implantable cardioverter-defibrillator (ICD) patients.MethodsOne hundred and forty patients implanted with ICD or cardiac resynchronization therapy defibrillator with home monitoring were studied retrospectively. The primary endpoint was appropriate ICD treatment of VAs, secondary endpoint was cardiac death.ResultsDuring a mean follow-up period of 44 ± 17 months, 78 patients (55.7%) experienced VAs, 50 patients (35.7%) were treated with appropriate ICD shocks and 16 patients (11.4%) died due to cardiovascular diseases. GGT was positively correlated with high sensitivity C reactive protein (r = 0.482, P < 0.001), left ventricular end-diastolic dimension (r = 0.175, P = 0.039), New York Heart Association class (r = 0.199, P = 0.018), fasting blood glucose (r = 0.233, P = 0.006) and negatively with left ventricular ejection fraction (r = − 0.181, P = 0.032) and high-density lipoprotein (r = − 0.313, P < 0.001). Based on receiver operating characteristics curve, the cut-off value of GGT = 56 U/L was identified to predict VAs. In Kaplan-Meier survival analysis, GGT ≥56 U/L was associated with increased VAs (P<0.001), ICD shock events (P = 0.006) and cardiovascular mortality (P = 0.003). In multivariate COX regression models, GGT ≥56 U/L was an independent risk factor for VAs (HR 2.253, 95%CI:1.383–3.671, P = 0.001), ICD shocks (HR 2.256, 95%CI:1.219–4.176, P = 0.010) and cardiac death (HR 3.555, 95%CI:1.215–10.404, P = 0.021).ConclusionsIn this ICD population, GGT ≥56 U/L was independently associated with VAs and cardiac death.

Predictors of rate-adaptive pacing in patients implanted with implantable cardioverter-defibrillator and subsequent differential clinical outcomes.

Patients with severe cardiomyopathy often have chronotropic incompetence, which is predominantly managed by activating rate-adaptive pacing in patients implanted with an implantable cardioverter-defibrillator (ICD) capable of atrial pacing. The purpose of this study was to determine predictors of rate-adaptive pacing activation, the cumulative incidence of activation, and the association of rate-adaptive pacing activation with subsequent clinical outcomes in an ICD population. The authors evaluated 228 patients implanted with an ICD between 2011 and 2015. Multivariable logistic regression was used to evaluate predictors of rate-adaptive pacing activation. Cox proportional-hazards regression was used to examine associations of rate-adaptive pacing activation and clinical outcomes. Rate-adaptive pacing was turned on in 38.5% (n = 88) of patients during follow-up. Several statistically significant predictors of rate-adaptive pacing activation were found, particularly previous atrial fibrillation (odds ratio [OR] = 8.27, 95% confidence interval [CI] = 2.96-23.06, p < 0.001), previous myocardial infarction (OR = 4.17, 95% CI = 1.38-12.58, p = 0.01), and non-ischemic cardiomyopathy (OR = 3.83, 95% CI = 1.22-12.00, p = 0.02). In multivariable adjusted analyses, rate-adaptive pacing activation within 30days of implantation was not associated with the risk of device therapy for tachyarrhythmias (hazard ratio [HR] = 1.52, 95% CI = 0.71-3.28, p = 0.29), atrial fibrillation (HR = 1.42, 95% CI = 0.71-2.87, p = 0.32), HF re-admission (HR = 1.39, 95% CI = 0.80-2.43, p = 0.25), nor all-cause mortality (HR = 2.34, 95% CI = 0.80-6.84, p = 0.12). During follow-up, more than one in three HF patients implanted with an ICD developed the need for rate-adaptive pacing. Atrial fibrillation, prior myocardial infarction, and non-ischemic cardiomyopathy were statistically significant baseline clinical predictors of rate-adaptive pacing activation. Rate-adaptive pacing activation was not associated with subsequent adverse clinical outcomes.

Use of Administrative Data to Monitor Cardiac Implantable Electronic Device Complications

Cardiac implantable electronic devices (CIEDs) are increasingly used in the Canadian population, because of expanding indications and an aging population. Device-related complications are a source of morbidity and mortality. There is currently no comprehensive monitoring strategy of CIED-related complications in Canada. The objective of this study was to determine the utility of administrative data in tracking CIED complications. This was a retrospective observational study in patients with newly implanted pacemakers, pacemaker system revisions, and implantable cardioverter defibrillators (ICDs) from 2011 to 2014. The study was performed at a single academic centre in Nova Scotia. A comprehensive chart review was used as the gold standard for device-related complications. This was compared with the reporting of complications identified in the Canadian Institute for Health Information Discharge Abstract Database and the National Ambulatory Care Reporting System Database (NACRS). Sensitivity and specificity of Canadian Institute for Health Information/NACRS was reported. There were 1327 patients included in the study (742 pacemakers, 585 ICDs). The rate of complications in the pacemaker population was 8.0%; the sensitivity of Discharge Abstract Database/NACRS for detection of these was 83.1%, and specificity 100%. The rate of complications in the ICD population was 12.0%, with a sensitivity of 92.1%, and specificity 100%. Thirty-day mortality was 1.8% in the pacemaker population, and 0.3% in the ICD population. This study provides feasibility for use of administrative data for detection of device-related complications, showing reasonable sensitivity and excellent specificity. Further work to determine generalizability of these data across Canada is required to ensure accurate monitoring of device-related complications.

Body image concerns in patients with an implantable cardioverter defibrillator: A scoping review.

Patients with an implantable cardioverter defibrillator (ICD) retain a scar and a bump at the site of implant. This may lead to body image concerns (BICs) that influence patients' quality of life. Few studies have examined the prevalence and impact of BICs postimplant, prompting us to conduct a scoping review of the field. We searched the Medline, Embase, PsycINFO, and Cinahl databases in August 2016 and repeated in May 2017. Included were studies reporting on patients ≥ 18 years, an ICD implant (transvenous, subcutaneous, or ICD with cardiac resynchronization therapy [CRT-D]), reporting on BICs, and published in peer-reviewed English-language journals. We excluded nonsystematic reviews, opinion pieces/letters, case studies, conference abstracts, PhD dissertations, protocol papers, studies of ICD shock treatment of atrial fibrillation, and of abdominally or submammary implanted ICDs. A total of 40 articles were included: 16 qualitative and 24 quantitative. None of the included studies had BICs as their primary endpoint. Results showed that BICs are present in various degrees in the ICD population and can be attributed to the visibility of the ICD (the scar and bump). Women and younger patients had greater problems with BICs, although men also had concerns. Two items of the "Florida Patient Acceptance Survey" were the most frequently used to assess BICs. BICs were present among ICD patients, but the degree of impact on their lives varied. There is a need for developing a BICs questionnaire to examine the prevalence of BICs and the potential impact on patients' lives in longitudinal studies.

Men with implantable cardioverter defibrillators: A qualitative study of gender and age

The purpose of this study was to examine men's adjustment to living with an implantable cardioverter defibrillator (ICD) as influenced by gender and age. Living with an ICD requires psychological and social adjustments throughout the lifespan. Approximately 60-70% of the ICD population are men, yet little is known about men's gender-specific issues related to living with ICDs. Ethnographic methods were used with 12 men, 26-85 years of age. Data were analyzed using constructs of gender, chronic illness, and Life Course theory. Themes were identified: Maintaining a masculine image, Sudden cardiac death and social implications through time, and Self-image influenced by chronic illness. Gender and location in the life-course may influence adjustment to living with an ICD. Understanding where an individual is within place and time, as well as where they are at the present may account for many aspects of their acceptance, adjustment, and recovery.

Implantable cardioverter-defibrillator in Chagas heart disease: A systematic review and meta-analysis of observational studies

BackgroundIn patients with Chagas cardiomyopathy (ChCM), sudden cardiac death (SCD) is the leading cause of mortality. Implantable cardioverter-defibrillator (ICD) is a well-established therapy for secondary prevention in patients with structural heart disease, but there are conflicting opinions regarding its efficacy and safety in patients with ChCM. The aim of this meta-analysis was to assess the efficacy of the ICD for secondary prevention in patients with ChCM, comparing mortality as the primary outcome of patients treated with ICD with those treated with amiodarone. MethodsWe systematically searched five databases for studies assessing mortality outcomes in patients with ChCM and sustained ventricular tachycardia (VT) treated with ICD implantation or with amiodarone. The results of studies were pooled using random-effects modeling. ResultsThere was no randomized clinical trial comparing efficacy of ICD versus medical treatment in patients with ChCM. Six observational studies were included, totalizing 115 patients in amiodarone group and 483 patients in ICD group. The mortality outcome in the ICD population was 9.7 per 100 patient-years of follow-up (95%CI 5.7–13.7) and 9.6 per 100 patient-years in the amiodarone group (95%CI 6.7–12.4) (p = 0.95). Meta-regression did not show any association with LV ejection fraction (p = 0.32), age (p = 0.44), beta-blocker (p = 0.33) or angiotensin-converting enzyme inhibitors (p = 0.096) usage. ConclusionThe best available evidence derived from small observational studies suggests that ICD therapy in secondary prevention of sudden death (VT or resuscitated SCD) is not associated with lower rate of all-cause mortality in patients with ChCM. Randomized controlled trials are needed to answer this question.