Implantable Cardioverter-defibrillator Registry Research Articles

Long-Term Outcomes of Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Use Among Patients on Maintenance Dialysis

Despite an elevated risk of sudden cardiac death among dialysis patients, implantable cardioverter defibrillators (ICDs) have not been shown to improve mortality and are associated with high complication rates. Subcutaneous (S-)ICDs may reduce the risk of complications for eligible dialysis patients, but safety and benefits versus transvenous (TV-)ICDs are unknown. To compare long-term outcomes between dialysis patients receiving S-ICD versus TV-ICDs. We performed a retrospective analysis of ICD implants among Fee-For-Service Medicare beneficiary dialysis patients in the National Cardiovascular Data Registry ICD Registry. Outcomes were ascertained from Medicare claims data. We compared survival outcomes, hospital admissions, and ICD- associated and dialysis vascular access-associated complications, between eligible S-ICD and single chamber TV-ICD recipients using stabilized inverse probability of treatment weighting. We identified 529 dialysis patients receiving S-ICDs and 842 receiving single chamber TV-ICDs who met the inclusion criteria. S-ICD recipients were younger, more often Black, and had a higher burden of cardiac disease and prior dialysis access interventions. After propensity weighting, there was no difference in the risk of death (HR 1.12, 95% CI 0.96-1.30), hospital admission (HR 1.01, 95% CI 0.88-1.16), bacteremia/sepsis (HR 1.01, 95% CI 0.80-1.26), device reoperation (HR 1.06, 95%CI 0.59-1.89) and subsequent dialysis access interventions (HR 1.12, 95% CI 0.86-1.46). In this representative longitudinal cohort study of dialysis patients, compared with TV-ICD, S-ICD was not associated with decreased risks of death, hospitalization, device complications, and dialysis access interventions.

Similar incidence of ICD-shocks in diabetic compared to non-diabetic patients receiving implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)

Abstract Background and aims Recent studies have suggested that diabetes patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) may experience a reduced incidence of appropriate ICD-shocks and an increased mortality rate. This study aims to assess whether there is parity in ATP-treatment and ICD-shocks between patients with and without type 2 diabetes mellitus (T2DM), and to analyze associated mortality rates. Methods Using the Danish pacemaker and ICD registry we included patients who received a first-time ICD or CRT-D implantation with a primary or secondary prophylactic indication, between January 1st 2000 to December 31st 2018. Outcomes were analyzed individually for each outcome. Cause specific Cox was used for i) appropriate ATP therapy or ICD-shock, ii) inappropriate ATP therapy or ICD-shock, and a standard Cox regression model was used for iii) all-cause mortality, iv) mortality rate following an ATP-therapy or ICD-shock. Cumulative incidence curves, generated using the Aalen Johansen estimator, were utilized to compare the incidence rates for ATP therapy and ICD-shock while accounting for competing risk of death, while Kaplan-Meier methodology was utilized for survival curves. Analyses were conducted in the total population and in subgroups divided on indication and device type. Results Out of 14 747 patients who received an ICD or CRT-D, 4377 (30%) had T2DM, 4593 (31%) patients received first-time appropriate ATP therapy or ICD-shock, and 1244 (8,4%) experienced first-time inappropriate treatments, 5 112 (35%) experienced death during the follow-up time (mean 3.9 years (SD 2.7)). T2DM patients were more likely to be male (85% vs 80%), slightly older (66 vs 65 years) and burdened with more comorbidities. No significant differences were seen between T2DM and non-T2DM patients for appropriate ATP therapy (HR 0.96[0.88:1.04] p=0.31), appropriate ICD-shock (HR 0.95[0.86:1.05] p=0.32), inappropriate ATP therapy (HR 0.92 [0.77;1.09] p=0.32) and inappropriate ICD-shock (HR 0.96 [0.78;1.18] p=0.71). In the subgroup analyses, no difference was seen in the primary prophylactic subgroups (Figure 1.), only significant difference was observed in the secondary prophylactic ICD group who received less ATP-therapy at 5-year follow-up (HR0.83[0.70;0.99] p=0.04), and in the secondary prophylactic CRT-D group, were T2DM patients seemed to experience more appropriate ICD-shock treatments (HR 2.07[1.23;3.48] p=0.006). Further, we found a higher mortality rate in T2DM with primary prophylactic ICD (HR 1.46[1.31;1.62] p<0.001) and secondary prophylactic ICD (HR 1.30[1.13;1.51] p<0.001), (Figure 2.) this mortality rate remained largely unchanged post appropriate ATP or ICD-shock in the ICD subgroups. Conclusions Despite similar incidence of ATP-therapy and ICD-shocks, T2DM patients with ICD-device experienced a significantly higher post-treatment mortality and all-cause mortality rate.

Microbial specturm and antibiotic sensitivity of pocket swabs in ICD patients undergoing device replacement or lead revision surgery- findings from a ICD registry observational study

Abstract Introduction Infection is a serious complication of implantable cardioverter defibrillator (ICD) therapy, necessitating effective preventive measures during implantation or revision surgery. The intraoperative use of antibacterial envelopes containing rifampicin and minocycline has shown promising results in reducing infection, yet, it is expensive and not cost-effective. Gentamicin sponges might be an alternative to the antibacterial envelope, however its efficacy on targeting the specific microbial spectrum found in device infection must be further investigated. Aim of the study was to identify the bacterial species obtained from pocket swabs of ICD patients undergoing revision surgery, and assess their sensitivity to gentamicin, rifampicin and minocycline. Methods A total of 459 intraoperative pocket swabs were collected from consecutive ICD patients who underwent elective device replacement, system upgrade or lead revision between 2017 and 6/2023. The baseline characteristics were similar in both groups (Table 1). Results Out of the 459 swabs analysed: 416 (90.6%) were negative for microbial growth. The remaining 43 swabs (9.4%) were tested positive for microbial growth (Table 2). Coagulase-negative- staphylococci (CoNS) were the most commonly isolated bacteria, accounting for 56% of cases. Bacteria with available antibiograms exhibited a sensitivity of 92% to gentamicin, 96% to rifampicin and 96% to Minocycline (Table 2). Conclusion The antibiotic sensitivity of the bacteria obtained from the pocket swabs to gentamycin, rifampicin and minocycline was similar. Thus, gentamicin sponges might be an alternative to the antibacterial envelope in patients with ICD undergoing generator replacement or revision surgery.

Spanish implantable cardioverter-defibrillator registry. 20th official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2023)

IntroductionThis article presents data on implantable cardioverter-defibrillator implants in Spain in 2023. MethodsThe registry is based on information provided by centers following device implantation, which is submitted to the Heart Rhythm Association of the Spanish Society of Cardiology via the national online registry platform (Cardiodispositivos). Additional information sources include: a) data transfer from the manufacturing and marketing industry; and b) local databases sent from the implanting centers. Population data from the National Institute of Statistics for the first quarter of 2024 was used to calculate implant rates. ResultsIn 2023, 180 hospitals participated in the registry. Data were reported for 8219 units, compared with 8523 reported by Eucomed (European Confederation of Medical Suppliers Associations). The total implant rate was 172 implants per million inhabitants (177 according to Eucomed), representing an increase compared with previous years. However, differences among autonomous communities persisted, and Spain continues to have the lowest implant rate among the European countries participating in Eucomed. ConclusionsThe data from the 2023 registry reflects 96.4% of the implants performed in Spain. Despite the improvement observed in the implantation rate, Spain's position in Europe remains unchanged, with wide disparities among autonomous communities.

Efficacy of a gentamycin-collagen sponge to prevent infection in implantable cardioverter defibrillator patients undergoing revision surgery - results of a monocentric ICD registry observational study

Abstract Introduction Despite the obvious benefits, the use of implantable cardioverter defibrillators (ICDs) is associated with serious complications, including infections. In particular, device replacement or revision procedures are associated with an increased risk of infection. Aim of the study was to compare the cardiac device infection rate with and without the use of the gentamycin-collagen sponge (GCS) in patients undergoing device replacement or revision procedures of implanted ICDs. Methods A total of 491 consecutive ICD patients from a prospective single-centre ICD-registry who underwent elective device replacement, system upgrade or lead revision between 2017 and 6/2023 were analyzed. From September 2020 onwards, a GCS was inserted into the device pocket (GCS group, n = 256). These patients were compared to the patients implanted/ revised between 2017 and 8/2020 (control group, n = 235). Results The baseline characteristics and the PADIT score were similar in both groups (Table 1). The GCS was well tolerated and there were no complications associated with the GCS. The mean follow-time was 15 + 10 months in the GCS group and 30 + 11 months in the control group. The Kaplan-Meier estimated infection rate after one year was 1.0% in the GCS group and 3.5% in the control group (p = 0.03, Figure 1). Time from revision to infection was 144 + 134 days in the GCS group vs. 362 + 297 days in the control group. Conclusion Adjunctive use of a GCS was associated with a lower incidence of device infections than standard-of-care infection-prevention strategies alone.

Differences in underlying cardiac substrate among S-ICD recipients and its impact on long-term device-related outcomes: Real-world insights from the iSUSI registry

BackgroundOutcome comparisons among subcutaneous implantable cardioverter-defibrillator (S-ICD) recipients with nonischemic cardiomyopathies are scarce. ObjectiveThe aim of this study was to evaluate differences in device-related outcomes among S-ICD recipients with different structural substrates. MethodsPatients enrolled in the i-SUSI (International SUbcutaneouS Implantable cardioverter defibrillator registry) project were grouped according to the underlying substrate (ischemic vs nonischemic) and subgrouped into dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome (BrS), arrhythmogenic right ventricular cardiomyopathy (ARVC). The main outcome of our study was to compare the rates of appropriate and inappropriate shocks and device-related complications. ResultsAmong 1698 patients, the most common underlying substrate was ischemic (31.7%), followed by dilated cardiomyopathy (20.5%), BrS (10.8%), hypertrophic cardiomyopathy (8.5%), and ARVC (4.4%). S-ICD for primary prevention was more common in the nonischemic cohort (70.9% vs 65.4%; P = .037). Over a median (interquartile range) follow-up of 26.5 (12.6–42.8) months, no differences were observed in appropriate shocks between ischemic and nonischemic patients (4.8%/y vs 3.9%/y; log-rank, P = .282). ARVC (9.0%/y; hazard ratio [HR] 2.492; P = .001) and BrS (1.8%/y; HR 0.396; P = .008) constituted the groups with the highest and lowest rates of appropriate shocks, respectively. Device-related complications did not differ between groups (ischemic: 6.4%/y vs nonischemic: 6.1%/y; log-rank, P = .666), nor among underlying substrates (log-rank, P = .089). Nonischemic patients experienced higher rates of inappropriate shocks than did ischemic S-ICD recipients (4.4%/y vs 3.0%/y; log-rank, P = .043), with patients with ARVC (9.9%/y; P = .001) having the highest risk, even after controlling for confounders (adjusted HR 2.243; confidence interval 1.338–4.267; P = .002). ConclusionMost S-ICD recipients were primary prevention nonischemic cardiomyopathy patients. Among those, patients with ARVC tend to receive the most frequent appropriate and inappropriate shocks and patients with BrS the least frequent appropriate shocks.

Implantable-cardioverter-defibrillator after ST-elevation myocardial infarction: when and how frequently is it implanted and what is the rate of appropriate interventions? Insight from Trieste registry.

There are limited data on implantable-cardioverter-defibrillator (ICD) implantation after ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI). Therefore, we evaluated when and how frequently an ICD is implanted after pPCI, the rate of appropriate ICD interventions, and predictors of ICD implantation. We analyzed STEMI patients treated with pPCI at the University Hospital of Trieste, Italy, between January 2010 and December 2019. We cross-matched patients' data with those present in the Trieste ICD registry. Among 1805 consecutive patients treated with pPCI, 3.6% underwent ICD implantation during a median follow-up of 6.7 [interquartile range (IQR) 4.3-9.2] years. At 12 months, the mean number of ICD implantations was 2.3/100 patients [95% confidence interval (95% CI) 1.7-3.1] and remained stable over time (at 24 months: 2.5/100 patients, 95% CI 2.0-3.5 and at 36 months: 2.6/100 patients, 95% CI 2.3-3.8); 83.1% of ICDs were implanted for primary prevention, and more than half (55%) were implanted in patients with ejection fraction more than 35% at the moment of STEMI discharge. The rate of appropriate ICD interventions was 16.9% at a median follow-up of 5.7 years (IQR 3.3-8.3 years) after ICD implantation. At 12 months, the mean number of appropriate ICD interventions was 5/100 patients and 7/100 patients after 24 months. In patients with ejection fraction more than 35% at STEMI discharge (median ejection fraction 43%; IQR 40-48), independent predictors of ICD implantation were male sex, anterior STEMI and troponin peak more than 100 000 ng/dl. The rate of ICD implantations after pPCI is low; however, the rate of appropriate ICD interventions is high. A relevant subgroup of patients received ICD implantations at follow-up despite a nonsevere ejection fraction at discharge after STEMI. Among these patients, those with high troponin release deserve strict follow-up and full optimal medical treatment.

The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Report 2022

The Pacemaker (PM) and Implantable Cardioverter-Defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the voluntary Italian collaborating centers. For the year 2022 main data about national PM and ICD implantation activity were obtained on the basis of European Cards and subsequently analyzed to create a standard report. PM Registry: data about 17 800 PM implantations were collected (14 191 first implants and 3609 replacements). The number of collaborating centers was 152. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). Main ECG indications included atrioventricular conduction disorders in 46.0% of first PM implants, sick sinus syndrome in 17.7%, atrial fibrillation plus bradycardia in 7.7%, other unspecified ECG and electrophysiological abnormalities in 43.0%. For first PM implants, pacing in DDDR mode was reported in 42.2%, followed by DDD mode (20.6%), VVIR mode (25.1%), VVI mode (11.1%) and finally VDD-VDDR (5.1%). Median value of longevity of explanted PMs was 8.3 years. ICD Registry: data about 5210 ICD implantations were obtained (3656 first implants and 1554 replacements). The number of collaborating centers was 301. Median age of treated patients was 72 years (63 quartile I; 79 quartile III). Primary prevention indication was reported in 72.4% of first implants, secondary prevention in 27.6% (cardiac arrest in 4.6% of records). A single-chamber ICD was used in 30.3% of first implants, dual-chamber ICD in 30.0% and biventricular ICD in 39.7%. Median value of longevity of explanted ICDs was 7.0 years. In the calendar year 2022, the Italian PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The ICD Registry documented a large use of prophylactic and biventricular ICDs, reflecting a favorable adherence in clinical practice to trials and guidelines. The ICD longevity and the number of recalls demonstrated a favorable trend.

Spanish implantable cardioverter-defibrillator registry. 19th official report of Heart Rhythm Association of the Spanish Society of Cardiology (2022)

Introduction and objectivesThis article presents data on implantable cardioverter-defibrillator implants in Spain in 2022. MethodsThe data were collected from implantation centers, which voluntarily completed a data collection sheet during the implantation process, either manually or through a web page. ResultsIn 2022, 170 hospitals participated in the registry. A total of 7693 forms were received compared with the 7970 reported by Eucomed (European Confederation of Medical Suppliers Associations), representing 96.5% of the devices. The total rate of registered implants was 162/million inhabitants (168 according to Eucomed), showing a slight increase compared with previous years. Disparities persisted among autonomous communities and Spain continued to have the lowest implantation rate among countries participating in Eucomed. ConclusionsThe data from the registry for 2022 reflect the complete recovery of activity after the impact of the COVID-19 pandemic in 2020. Despite a slight improvement, there was no significant change in our position in Europe or in the substantial differences among autonomous communities.

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

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

Deactivation of implantable defibrillators at the end of life - A register-based study of ICD-deactivation at home and the impact of palliative care

BackgroundThe Implantable Cardioverter-Defibrillator (ICD) is a well-established life-saving therapy for heart failure patients, but due to the risk for unnecessary shocks, deactivation of ICD:s is recommended at the end of life.We aimed to identify i) how many people with HF and an ICD who died in Sweden in 2018 received Specialized Palliative Care (SPC), ii) of those dying outside of hospital, the proportion with deactivated ICDs prior to death for the group as a whole and by SPC access. Methods and resultsWe analyzed data from i) the Swedish ICD and Pacemaker Registry to find all who died with an ICD in Sweden in 2018, ii) the Swedish Register of Palliative Care and, iii) the Swedish Causes of Death Certificate Register to find those who died outside of hospital. Clinical records were obtained to assess if ICDs were deactivated before death. Descriptive statistics, t-tests and chi-squared tests were applied.46/406 (11%) of those who died with an ICD in Sweden in 2018 had SPC access, of whom 50% also had cancer. 86/164 (52%) ICDs were deactivated prior to death in people dying outside of hospital; higher in those accessing SPC (36/46, (78%) SPC access versus 151/360, (42%) no SPC access; p < 0.05). ConclusionsHalf of those with HF and an ICD dying outside of hospital had ICD deactivation prior to death. Those accessing SPC were more likely to have their ICD deactivated but few received SPC, without a comorbid cancer diagnosis.

Long-term mortality in cardiac resynchronization therapy upgrade procedures compared with de novo implantations - a nationwide cohort study

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Danish Cardiovascular Academy Background Patients with an implanted pacemaker (PM) or implantable cardioverter-defibrillator (ICD) who develop heart failure (HF) and have frequent right ventricular (RV) pacing, may be upgraded to a Cardiac Resynchronization Therapy (CRT) device. Such upgrades constitute approximately one fourth of CRT implantations. Limited research has been devoted to long-term outcomes after upgrade implantations and diverging results have been reported. Purpose We aimed to investigate long-term mortality in patients undergoing upgrade to CRT after previous PM or ICD implantation and patients undergoing CRT de novo implantation. Methods This was a nationwide register-based cohort study. The patient cohort was identified via the Danish Pacemaker and ICD Registry and consisted of consecutive Danish patients undergoing a CRT de novo implantation or an upgrade to CRT, from 01.01.2000 to 31.08.2018. Upgrade from a CRT pacemaker to a CRT defibrillator, and simple device replacement procedures were not included. Data were cross-linked with the Danish Patient Registry via the unique central person registration number. The endpoint was total mortality. Unadjusted- and adjusted Cox proportional hazard regression was used to assess the association between the procedure type (upgrade or de novo), baseline characteristics and total mortality. Results We identified 8,880 patients of whom 6,685 (75.3%) underwent de novo CRT implantation and 2,195 (24.7%) underwent upgrade to CRT from a previous PM or ICD. The median (IQR) follow-up time was 3.9 years (5.3) and 4.6 years (4.3) for upgrade and de novo implantations respectively. At baseline, patients who underwent upgrade to CRT were older (median 71.9 vs. 69.3 years) and more likely to have ischemic heart disease (66.8% vs. 57.1%), atrial fibrillation or atrial flutter (57.5% vs. 33.4%) and chronic kidney disease (10.3% vs. 7.2%) compared to patients who had de novo implantation. The proportion of males was larger among patients who underwent upgrade to CRT compared to de novo implantation (84.1% vs. 74.9%). Upgrade implantations were associated with higher minimally adjusted (age and sex) total mortality (HR 1.13, [95% CI 1.05;1.21], p&amp;lt;0.001) compared to de novo implantations. There was no difference in total mortality between upgrade and de novo implantations after adjusting for age, sex, diabetes, hypertension, chronic ischemic heart disease, atrial fibrillation or atrial flutter, chronic obstructive pulmonary disease, and chronic kidney disease (HR 1.03, [95% CI 0.96;1.10], p=0.46). Conclusion There are major differences in co-morbidities among patients undergoing upgrade to CRT and patients undergoing CRT de novo implantation. When adjusting for these differences, there was no difference in total mortality between the two populations. This suggests that CRT is equally beneficial in both de novo and upgrade implantations.

The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Report 2021

The Pacemaker (PM) and Implantable Cardioverter-Defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the voluntary Italian collaborating centers. For the year 2021 main data about national PM and ICD implantation activity were obtained on the basis of European Cards and subsequently analyzed to create a standard report. PM Registry: data about 18 631 PM implantations were collected (15879 first implants and 2752 replacements). The number of collaborating centers was 121. Median age of treated patients was 82 years (76 quartile I; 87 quartile III). Main ECG indications included atrioventricular conduction disorders in 26.8% of first PM implants, sick sinus syndrome in 12.2%, atrial fibrillation plus bradycardia in 9.6%, other unspecified ECG and electrophysiological abnormalities in 43.0%. For first PM implants, pacing in DDDR mode was reported in 46.5%, followed by DDD mode (20.6%), VVIR mode (15.0%), VVI mode (9.0%) and finally VDD-VDDR (5.8%). Median value of longevity of explanted PMs was 8.9 years. ICD Registry: data about 6878 ICD implantations were obtained (4708 first implants and 2170 replacements). The number of collaborating centers was 345. Median age of treated patients was 72 years (70 quartile I; 75 quartile III). Primary prevention indication was reported in 86.3% of first implants, secondary prevention in 13.7% (cardiac arrest in 4.4% of records). A single-chamber ICD was used in 32.1% of first implants, dual-chamber ICD in 30.3% and biventricular ICD in 37.6%. Median value of longevity of explanted ICDs was 6.9 years. In the calendar year 2021, the Italian PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The ICD Registry documented a large use of prophylactic and biventricular ICDs, reflecting a favorable adherence in the clinical practice to trials and guidelines. The ICD longevity and the number of recalls demonstrated a favorable trend. In order to increase and optimize the cooperation of Italian PM and ICD implanting centers, the online data entry (https://www.aiac.it/riprid) should be adopted at large scale.

ICD harm and benefit: risk scores applied to the Swedish ICD-treated LQTS population

Objectives. The use of implantable cardioverter defibrillators (ICDs) in long QT syndrome (LQTS) patients is essential in high-risk patients. However, it is sometimes used in patients without high-risk profiles for whom the expected benefit may be lower than the risk of ICD harm. Here, we evaluated ICD benefit and harm by assessing risk according to risk scores and pre-ICD clinical characteristics. Design. We studied 109 Swedish LQTS patients drawn from the Swedish ICD and Pacemaker Registry with data collected from medical records. In addition to clinical characteristics, we used two risk scores to assess pre-ICD risk, and evaluated ICD benefit and harm. Results. Twenty percent of all patients received ≥1 appropriate shock with a first appropriate shock incidence rate of 4.3 per 100 person-years. A long QTc (≥550 ms) and double mutations were significantly associated with appropriate shock. Low risk scores among patients without pre-ICD aborted cardiac arrest were not significantly associated with low risk of first appropriate shock. The incidence rates of a first inappropriate shock and first complication were 3.0 and 7.6 per 100 person-years, respectively. Conclusion. Our findings on ICD harm emphasize the importance of careful individual pre-ICD consideration. When we applied two risk scores to patients without pre-ICD aborted cardiac arrest, we could not validate their ability to identify patients with low risk of appropriate shocks and patients who were assessed as having a low risk still received appropriate shocks. This further supports the complexity of risk stratification and the difficulty of using risk scores.

480 ICD AFTER STEMI: WHEN AND HOW FREQUENTLY IS IMPLANTED AND WHICH IS THE RATE OF APPROPRIATE INTERVENTIONS

Abstract Background there are limited data of implantable-cardioverter-defibrillator (ICD) implantation after STEMI treated with primary percutaneous coronary intervention (pPCI). This study sought to evaluate when and how frequently is ICD implanted after STEMI, the rate of appropriate ICD-interventions, and the independent predictors of ICD implantation. Methods We analyzed STEMI patients treated with pPCI at the University Hospital of Trieste, Italy, between January 2010 and December 2019. We cross-matched patients data with those present in the Trieste ICD registry. Results 1805 consecutive patients treated with pPCI were analyzed. During a median follow-up of 6.7 (IQR 4.3-9.2) years, the probability of ICD implantation at 12 months was 2.3% (95%CI: 1.7-3.1) and it remained stable overtime (at 24 months: 2.5%, 95%CI 2.0-3.5 and at 36 months: 2.6%, 95%CI 2.3-3.8). Mean time before ICD implantation was 35.5 months (95%CI: 34.8-36) . 83.1% of implanted ICD were for primary prevention, and more than half (55%) were implanted in patients with ejection fraction (EF)&amp;gt;35% at the moment of STEMI discharge. During a median follow-up of 5.7 (IQR 3.3-8.3) years after ICD implantation, the probability of appropriate ICD intervention was 9% and 11% after 12 and 24 months respectively. In patients with EF&amp;gt;35% at STEMI discharge (median EF 43%; IQR 40-48), predictors of ICD implantation were male sex, anterior STEMI and troponin peak &amp;gt;100.000 ng/dl. Conclusions The rate of ICD implantation after pPCI is low, however the rate of appropriate ICD interventions is high. A relevant subgroup of patients received ICD implantation at follow-up despite a non-severe EF at discharge after STEMI. Among these patients those with high troponin release deserve strict follow-up and full optimal medical treatment.

Ventricular arrhythmia burden in patients with implantable cardioverter defibrillator and remote patient monitoring during different time intervals of the COVID-19 pandemic

PurposeThe current study investigated whether the changes in patient care in times of the COVID-19 pandemic, especially the reduction of in-person visits, would result in a deterioration of the arrhythmic and clinical condition of patients with an implantable cardioverter defibrillator (ICD) and remote patient monitoring.MethodsData were obtained from a local ICD registry. 140 patients who received ICD implantation at our department and had remote patient monitoring were included. The number of patients with ventricular arrhythmias, appropriate ICD therapy, the number of visits to our outpatient clinic and hospitalization due to acute coronary syndrome, stroke or heart failure were compared during three time intervals of the COVID-19 pandemic (first (LD1) and second (LD2) national lockdown in Germany and the time after the first lockdown (postLD1)) and a time interval 1 year before the pandemic began (preCOV). Each time interval was 49 days long.ResultsPatients had significantly fewer visits to our outpatient clinic during LD1 (n = 13), postLD1 (n = 22) and LD2 (n = 23) compared to the time interval before the pandemic (n = 43, each p ≤ 0.05). The number of patients with sustained ventricular arrhythmias, appropriate ICD therapy and clinical events showed no significant difference during the time intervals of the COVID-19 pandemic and the time interval 1 year prior.ConclusionsThe lockdown measures necessary to reduce the risk of infection during the COVID-19 pandemic, led to a reduction of in-person patient visits, but did not result in a deterioration of the arrhythmic and clinical condition of ICD patients with remote patient monitoring.

History of betablocker treatment breaks and risk of ventricular tachyarrhythmias among patients with heart failure and implantable cardioverter defibrillator: a nationwide cohort study

Abstract Background Beta-blockers have in randomized clinical trials been shown to reduce the risk of life-threatening arrhythmias and sudden cardiac death (SCD) in patients with heart failure (HF), and treatment is a class 1A recommendation in current guidelines. Thus, beta-blocker treatment breaks (i.e. planned break, beta-blocker related side-effects, or poor adherence) may increase risk of life-threatening arrhythmias and SCD. Whether patients with HF and a history of beta-blocker treatment breaks before implantable cardioverter defibrillator (ICD) is associated with increased risk of device related therapy and mortality is largely unknown. Aims In patients with HF and an ICD alone or combined with cardiac resynchronization therapy (CRT-D), we examined the association between a history of a beta-blocker treatment breaks prior to device implantation and the risk of appropriate and inappropriate device related therapy (i.e., anti-tachycardia pacing [ATP] or DC shock [DC]), and all-cause mortality. Methods Using the Danish Pacemaker and ICD Registry, we identified all patients with HF receiving a first-time ICD (2000–2018). Beta-blocker treatment breaks &amp;gt;60 consecutive days up to 3 years prior to device implantation were identified using the National Prescription Registry. Patients were able to switch between beta-blockers and were required to be in treatment at the time of implantation. We used multivariable Cox regressions to compare the 1-year risks of device-related therapy and all-cause mortality between patients with and without a history of a beta-blocker treatment break. Results We identified 9,239 patients with HF and an ICD (82.6% male; median age 67 years). A total of 82.5% had ischemic heart disease, 33.9% atrial fibrillation, and 33.1% of ICDs were secondary prophylaxis. During one-year follow-up, 5.7% of all patients died and appropriate DC and appropriate ATP was identified for 3.9% and 6.7% of patients, respectively. Overall, 14.6% of all HF patients had one or more beta-blocker treatment break &amp;gt;60 days. Compared with HF patients with no history of treatment breaks, a history of treatment breaks &amp;gt;60 days were associated with increased risk of appropriate DC (hazard ratio (HR)=1.33; 95% confidence interval [CI], 1.02–1.73) and appropriate ATP (HR 1.30; CI, 1.06–1.59), but also inappropriate DC and ATP therapy (Figure 1). There was no difference between groups with respect to all-cause mortality (HR=0.96; CI: 0.76–1.22). Treatment breaks of &amp;gt;30 or &amp;gt;90 days were also evaluated and yielded similar results as the main analysis. Conclusion Patients with heart failure who had a history of treatment breaks with beta-blockers prior to ICD implantation was associated with a higher 1-year risk of appropriate and inappropriate shocks and anti-tachycardia pacing, but not all-cause mortality. Funding Acknowledgement Type of funding sources: None.

Pacemaker implantation due to cardiac conduction disease in patients with subsequent cardiac sarcoidosis may be a marker of early disease and is associated with adverse 5-year clinical outcome

Abstract Background Sarcoidosis is a rare chronic granulomatous disease of unknown aetiology with potential multi-organ involvement and end-organ dysfunction. Cardiac sarcoidosis (CS) occurs in 5–10% of patients with sarcoidosis though an up to 25% prevalence has been reported by imaging and autopsy studies, suggesting undiagnosed silent disease. Progression of CS, especially if undiagnosed and untreated, may lead to heart failure, atrioventricular block (AVB), ventricular arrhythmias and sudden cardiac death. Aim We sought to determine whether signs of cardiac conduction disease (CCD) prior to the clinical diagnosis of sarcoidosis is associated with poor long-term prognosis in patients with imaging-confirmed cardiac involvement. Method All patients diagnosed with CS since January 1, 2000, at a tertiary centre (n=112) with either primary cardiac localisation (n=70) or cardiac involvement in otherwise primary non-cardiac sarcoidosis (n=42) as per imaging were included. Swedish pacemaker and ICD registry was used to identify patients who received cardiac implantable electronic device (CIED). CCD-related indications for CIED implant were defined as AVB, bi- or trifascicular block. Kaplan-Meier curve analysis and time-dependent Cox regression analysis were used for estimation of risk of death from any cause (primary endpoint), death or upgrade to cardiac resynchronization therapy (CRT, secondary endpoint) at 5 years after CS diagnosis, stratified for history of CIED implantation due to CCD. Hazard ratios were calculated in a univariate model and adjusted for age, gender and the use of implantable cardioverter-defibrillator (ICD). Results Mean age at CS diagnosis was 59±13 years (54% male). Forty-nine patients received CIED implant at a mean age of 54±13 years (14 pacemakers (29%), 14 primary prevention ICDs (29%), 13 secondary prevention ICDs (27%) and 8 CRT-D (16%)). The median time in years from CS diagnosis to CIED implant was for pacemaker −2.5 [IQR 8.5], primary ICD −0.3 [IQR 3.8], secondary ICD −4.0 [IQR 10.4] and CRT-D −0.03 [IQR 1.5]. CIED was implanted prior to CS diagnosis in 29 patients of whom 17 had CCD [MOU1] as the indication for implant. At 5-year follow-up in the CS cohort, 16 patients died and 2 underwent device upgrade to CRT (median 3.2 years [IQR 1.2]). CIED implant prior to CS diagnosis was associated with the primary (HRuni 3.5, 95% CI 1.2–10, p=0.021, Figure 1; HRadj 10.5, 95% CI 1.7–63, p=0.01) and the secondary (HR 3.5, 95% CI 1.2–10, p=0.019; HRadj 8.2, 95% CI 1.6–41.1, p=0.011) endpoints. Conclusion CIED implantation due to CCD can be an early manifestation of undiagnosed CS. It was observed in 15% of all patients with CS and was associated with adverse outcome. Identification of signs of CCD necessitating CIED implant in a middle-aged patient may motivate further diagnostic work-up aimed at timely detection of concealed CS. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Hjärt-Lung fondenAvtal om Läkarutbildning och Forskning

Spanish implantable cardioverter-defibrillator registry. 18th official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2021)

Introduction and objectivesThis article presents the data corresponding to implantable cardioverter-defibrillator (ICD) implantations in Spain in 2021. MethodsThe data were drawn from implanting centers, which voluntarily completed a data collection sheet during the procedure. ResultsIn 2021, 7496 implant data sheets were received, compared with 7743 reported by Eucomed (European Confederation of Medical Suppliers Associations), indicating that data were collected from 96.8% of the devices implanted in Spain. Data completion ranged from 99.9% for “name of implanting hospital” to 8.9% for “implanting hospital”. In 2021, 199 hospitals participated in the registry, exceeding the figures of previous years, with around 170 participating hospitals. The total rate of registered implants was 158/million inhabitants (163 according to Eucomed), making 2021 the year with the highest activity. However, the registry continues to show significant differences among the various autonomous communities and the lowest implantation rate of all the European countries participating in Eucomed. ConclusionsThe Spanish implantable cardioverter-defibrillator registry for 2021 recorded an increase in the number of ICD implantations, reflecting the recovery of hospital activity after the initial impact of the COVID-19 pandemic in 2020. Although the total number of implants has increased in Spain, figures are still much lower than the European Union average, with differences persisting among Spanish autonomous communities.

Registro español de desfibrilador automático implantable. XVIII informe oficial de la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (2021)

Introduction and objectivesThis article presents the data corresponding to implantable cardioverter-defibrillator (ICD) implantations in Spain in 2021. MethodsThe data were drawn from implanting centers, which voluntarily completed a data collection sheet during the procedure. ResultsIn 2021, 7496 implant data sheets were received, compared with 7743 reported by Eucomed (European Confederation of Medical Suppliers Associations), indicating that data were collected from 96.8% of the devices implanted in Spain. Data completion ranged from 99.9% for “name of implanting hospital” to 8.9% for “implanting hospital”. In 2021, 199 hospitals participated in the registry, exceeding the figures of previous years, with around 170 participating hospitals. The total rate of registered implants was 158/million inhabitants (163 according to Eucomed), making 2021 the year with the highest activity. However, the registry continues to show significant differences among the various autonomous communities and the lowest implantation rate of all the European countries participating in Eucomed. ConclusionsThe Spanish implantable cardioverter-defibrillator registry for 2021 recorded an increase in the number of ICD implantations, reflecting the recovery of hospital activity after the initial impact of the COVID-19 pandemic in 2020. Although the total number of implants has increased in Spain, figures are still much lower than the European Union average, with differences persisting among Spanish autonomous communities.