Factors Associated With Non-Uptake of Implantable Cardioverter-Defibrillator (ICD) Among Eligible Patients at a Tertiary Hospital in Kenya.

Background: Efficacy of Implantable Cardioverter-Defibrillator (ICD) implantation in both primary and secondary prevention of Sudden Cardiac Death (SCD) in at-risk population is well established. ICD implantation rates remain low particularly in Africa with a paucity of data regarding factors associated with non-uptake. Objectives: The primary study objective was to determine the factors associated with non-uptake of ICD among heart failure (HF) patients with reduced ejection fraction (EF<35%). Reasons for ICD refusal among eligible patients were reviewed as a secondary objective. Methods: This was a retrospective study among HF patients eligible for ICD implantation evaluated between 2018 to 2020. Comparison between ICD recipient and non-recipient categories was made to establish determinants of non-uptake. Results: Of 206 eligible patients, only 69 (33.5%) had an ICD. Factors independently associated with non-uptake were lack of private insurance (42.3% vs 63.8%; p = 0.005), non-cardiology physician (16.1% vs 5.8%; p = 0.045) and non-ischemic cardiomyopathy (54.7% vs 36.4% p = 0.014). The most common (75%) reason for ICD refusal was inability to pay for the device. Conclusion: ICDs are underutilized among eligible HF with reduced EF patients in Kenya. The majority of patients without ICD had no private insurance, had non-ischemic cardiomyopathy and non-cardiology primary physician. Early referral of HF with reduced EF patients to HF specialists to optimize guideline-directed medical therapy and make ICD recommendation is needed.

Percutaneous Extraction of Transvenous Permanent Pacemaker/Defibrillator Leads-A Single-Center Experience.

Background and Objectives: The number of cardiac pacemakers being used has increased in recent decades, and this increase has led to a rise in device-related complications, requiring percutaneous device extraction. Our aim was to present our single-center clinical experience in percutaneous lead extractions. Materials and Methods: We analyzed an observational retrospective cohort study of 93 patients for the transvenous removal of a total of 163 endocardial leads. We evaluated the device details, indications, lead characteristics, extraction methods, complications, reimplantation procedure, follow-up data, effectiveness, and safety. Results: Patients' mean age was 68.6 ± 11.6 years. Lead extraction indications were pocket infection in 33 (35.5%), lead dysfunction in 33 (35.5%), and system upgrade in 21 (23%) cases, and lead endocarditis in 6 (6%) cases. The duration from implantation to extraction time was a detected median of 43 (24-87) months. The most common retracted lead type was the RV defibrillator lead (62%), and the lead fixation type was active for one hundred (61%) patients. A new device was inserted in 74 (80%) patients, and the device type was most commonly a CRT-D (61%). Patients were followed up at a median of 17 (8-36) months, and 18 patients (19%) died at follow-up. Complete procedural success was obtained in 78 (84%) patients, and clinical procedural success was obtained in 83 (89%) patients. Procedural failure was detected in 15 (16%) patients. Major and minor complications were detected in 10 (11%) and 6 (6.5%) patients, respectively. The most common minor complication was pocket hematoma. Conclusions: Our experience suggests that transvenous lead extraction has a high success rate with an acceptable risk of procedural complications. The simple manual traction method has a high rate of procedural success, despite a high dwell time of the lead.

Association Between Adherence to a 3-Month Cardiac Rehabilitation Program and Long-Term Clinical Outcomes in Japanese Patients With Cardiac Implantable Electronic Devices.

PURPOSE: The objective of this study was to evaluate the association between comprehensive cardiac rehabilitation (CCR) completion and long-term clinical outcomes in patients with cardiac implantable electronic devices (CIED). METHODS: This retrospective cohort study included 834 patients with CIED who participated in CCR, which included a cardiopulmonary exercise test or 6-min walk test. Patients with a left ventricular ejection fraction ≤40%, predicted peak oxygen uptake ≤80%, or B-type natriuretic peptide level ≥80 pg/mL were eligible. The primary outcome was all-cause mortality. RESULTS: After excluding 241 patients with duplicate records and 69 who underwent CCR in the outpatient department, the data of 524 patients were analyzed. Mean age was 64 ± 15 yr, 389 (74%) patients were men, left ventricular ejection fraction was 31 ± 15%, and 282 (54%) patients had a history of hospitalization for worsening heart failure. Of the patients referred for CCR, 294 (56%) completed the program, and an additional 230 patients started but did not complete CCR. Over a 3.7-yr median follow-up period, all-cause mortality occurred in 156 (30%) patients. Completers had lower all-cause mortality rates than non-completers (log-rank 15.77, P < .001). After adjusting for prognostic baseline characteristics, completers had 58% lower all-cause mortality risks than non-completers (HR = 0.42; 95% CI, 0.27-0.64, P < .001). CONCLUSIONS: Three-mo CCR program completion was associated with lower mortality risks in patients with CIED. New programs or management methods are needed to decrease mortality risks, especially for those who cannot complete CCR programs.

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

BACKGROUND: The 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%. METHODS: The SPRM was estimated in patients with EF ≤50% and in a logistic regression model comparing SCD with non-SCD. RESULTS: We 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). CONCLUSIONS: The 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.

Factors associated with cardiac implantable electronic device-related infections, New South Wales, 2016-21: a retrospective cohort study.

OBJECTIVES: To quantify the rate of cardiac implantable electronic device (CIED)-related infections and to identify risk factors for such infections. DESIGN: Retrospective cohort study; analysis of linked hospital admissions and mortality data. SETTING, PARTICIPANTS: All adults who underwent CIED procedures in New South Wales between 1 January 2016 and 30 June 2021 (public hospitals) or 30 June 2020 (private hospitals). MAIN OUTCOME MEASURES: Proportions of patients hospitalised with CIED-related infections (identified by hospital record diagnosis codes); risk of CIED-related infection by patient, device, and procedural factors. RESULTS: Of 37 675 CIED procedures (23 194 men, 63.5%), 500 were followed by CIED-related infections (median follow-up, 24.9 months; interquartile range, 11.2-40.8 months), including 397 people (1.1%) within twelve months of their procedures, and 186 of 10 540 people (2.5%) at high risk of such infections (replacement or upgrade procedures; new cardiac resynchronisation therapy with defibrillator, CRT-D). The overall infection rate was 0.50 (95% confidence interval [CI], 0.45-0.54) per 1000 person-months; it was highest during the first month after the procedure (5.60 [95% CI, 4.89-6.42] per 1000 person-months). The risk of CIED-related infection was greater for people under 65 years of age than for those aged 65-74 years (adjusted hazard ratio [aHR], 1.71; 95% CI, 1.32-2.23), for people with CRT-D devices than for those with permanent pacemakers (aHR, 1.46; 95% CI, 1.02-2.08), for people who had previously undergone CIED procedures (two or more v none: aHR, 1.51; 95% CI, 1.02-2.25) or had CIED-related infections (aHR, 11.4; 95% CI, 8.34-15.7), or had undergone concomitant cardiac surgery (aHR, 1.62; 95% CI, 1.10-2.39), and for people with atrial fibrillation (aHR, 1.33; 95% CI, 1.11-1.60), chronic kidney disease (aHR, 1.54; 95% CI, 1.27-1.87), chronic obstructive pulmonary disease (aHR, 1.37; 95% CI, 1.10-1.69), or cardiomyopathy (aHR 1.60; 95% CI, 1.25-2.05). CONCLUSIONS: Knowledge of risk factors for CIED-related infections can help clinicians discuss them with their patients, identify people at particular risk, and inform decisions about device type, upgrades and replacements, and prophylactic interventions.

The Average Age of Atrioventricular Block Onset in Middle Eastern Patients with Cardiac Rhythm Devices Adjusted for the Overall Young Population: Insights from a Multicenter International Registry.

Background: Previous registries have shown a younger average age at presentation with cardiovascular diseases in the Middle East (ME), but no study has examined atrioventricular block (AVB). Moreover, these comparisons are confounded by younger populations in the ME. We sought to describe the average age at presentation with AVB in ME and quantify the effect of being from ME, adjusted for the overall younger population. Methodology: This was a retrospective analysis of PANORAMA registries, which collected data on patients who underwent cardiac rhythm device placement worldwide. Countries with a median population age of ≤30 were considered 'young countries'. Multivariate linear regression was performed to assess the effect of being from ME, adjusted for being from a 'young country', on age at presentation with AVB. Results: The study included 5,259 AVB patients, with 640 (8.2%) from the ME. Mean age at presentation was seven years younger in ME than in other regions (62.9 ± 17.8 vs. 70 ± 14.1, P < 0.001). Being from a 'young country' was associated with 5.6 years younger age at presentation (95%CI -6.5--4.6), whereas being from ME was associated with 3.1 years younger age at presentation (95%CI -4.5--1.8), (P < 0.001 for both). Conclusion: The average age at presentation with AVB in the ME is seven years younger than in other regions. While this is mostly driven by the overall younger population, being from the ME appears to be independently associated with younger age. Determinants of the earlier presentation in ME need to be assessed, and care should be taken when applying international recommendations.

Mortality Benefit Among Primary Prevention Implantable Cardioverter-Defibrillator Recipients on Contemporary Heart Failure Treatment.

BACKGROUND: Past clinical trials have shown the benefit of implantable cardioverter-defibrillators (ICDs) for reducing sudden cardiac death in at-risk patients. However, heart failure management and ICD technology have changed since these trials were first published. An updated assessment of ICD mortality benefit is needed. OBJECTIVES: The purpose of this study was to compare mortality rates between patients with a primary prevention (PP) indication for an ICD who did or did not receive an ICD using a contemporary, real-world data set. METHODS: Data was obtained from a large electronic health record data set covering patients in the United States from 2012 through 2020 who had a PP indication for an ICD and survived at least 1-year postindication. RESULTS: A total of 25,296 patients were identified as having a PP indication for ICD implantation, of which 2,118 (8.4%) were treated with an ICD within a year. Treated patients were younger than nontreated patients (age 63.4 years vs 66.1 years) with a smaller proportion of women (25.0% vs 36.7%). After 4-to-1 propensity matching, treated patients had similar clinical characteristics to nontreated patients. A Cox proportional hazard model estimated a 24.3% lower risk of all-cause mortality in patients when treated vs not treated with an ICD (HR: 0.757; 95% CI: 0.678-0.835; P <0.001). There was no detectable difference in ICD benefit between patients with ischemic and nonischemic heart disease (P = 0.50). CONCLUSIONS: ICD treatment of patients with a PP indication is associated with improved mortality even in the context of evolving adjunctive HF treatment, consistent with earlier landmark trials.

Impact of Atrial Fibrillation Burden on Health Care Costs and Utilization.

BACKGROUND: Integrating patient-specific cardiac implantable electronic device (CIED)-detected atrial fibrillation (AF) burden with measures of health care cost and utilization allows for an accurate assessment of the AF-related impact on health care use. OBJECTIVES: The goal of this study was to assess the incremental cost of device-recognized AF vs no AF; compare relative costs of paroxysmal atrial fibrillation (pAF), persistent atrial fibrillation (PeAF), and permanent atrial fibrillation (PermAF) AF; and evaluate rates and sources of health care utilization between cohorts. METHODS: Using the de-identified Optum Clinformatics U.S. claims database (2015-2020) linked with the Medtronic CareLink database, CIED patients were identified who transmitted data ≥6 months postimplantation. Annualized per-patient costs in follow-up were analyzed from insurance claims and adjusted to 2020 U.S. dollars. Costs and rates of health care utilization were compared between patients with no AF and those with device-recognized pAF, PeAF, and PermAF. Analyses were adjusted for geographical region, insurance type, CHA2DS2-VASc score, and implantation year. RESULTS: Of 21,391 patients (mean age 72.9 ± 10.9 years; 56.3% male) analyzed, 7,798 (36.5%) had device-recognized AF. The incremental annualized increased cost in those with AF was $12,789 ± $161,749 per patient, driven by increased rates of health care encounters, adverse clinical events associated with AF, and AF-specific interventions. Among those with AF, PeAF was associated with the highest cost, driven by increased rates of inpatient and outpatient hospitalization encounters, heart failure hospitalizations, and AF-specific interventions. CONCLUSIONS: Presence of device-recognized AF was associated with increased health care cost. Among those with AF, patients with PeAF had the highest health care costs. Mechanisms for cost differentials include both disease-specific consequences and physician-directed interventions.

Ventricular Arrhythmias and Sudden Cardiac Death in Left Ventricular Assist Device Patients Without Implantable Cardioverter Defibrillators.

Patients with left ventricular assist devices (LVAD) can develop sustained ventricular arrhythmias (VA). The history and presentation of VA in implantable cardioverter defibrillator (ICD)-naive patients with LVAD is not well described in the literature and the risks/benefits of ICD implantation are unknown. This single-center retrospective cohort study included patients >18 years old who did not have an ICD during LVAD implantation from 2010 to 2022. The primary outcome was VA event rate per 100 patient-years. Two hundred thirty-seven patients underwent LVAD implantation and we identified 46 (19.4%) ICD naive patients. The etiology of heart failure in most patients was nonischemic cardiomyopathy (67.4%). Of all patients, only five were found to have documented VA. Only two episodes of VA occurred in the ambulatory setting. The estimated index VA rate was 5.89 events per 100 patient-years in our entire ICD-naive LVAD population. In the ambulatory ICD-naive population, the estimated VA rate was 2.42 events per 100 patient-years with no associated mortality. The rate of index VA in ICD-naive patients was below thresholds associated with benefits from ICD insertion. No ambulatory mortality from VA was seen and VA was well tolerated by the LVAD population. Perioperative VA in this population is associated with high mortality.

Registro español de desfibrilador automático implantable. XIX informe oficial de la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (2022) / Spanish implantable cardioverter-defibrillator registry. 19th official report of Heart Rhythm Association of the Spanish Society of Cardiology (2022)

Introducción y objetivos: Se presentan los datos de implantes de desfibrilador automático implantable en España en el año 2022.Métodos: Los datos provienen de los centros implantadores, que cumplimentaron voluntariamente una hoja de recogida de datos durante el implante, a mano o a través de una página web.Resultados: Durante 2022, han participado en el registro 170 hospitales. Se han recibido 7.693 formularios, frente a los 7.970 comunicados por la European Confederation of Medical Suppliers Associations (Eucomed), lo que representa un 96,5% de los dispositivos. La tasa total de implantes registrados fue 162/millón de habitantes (168 según Eucomed), un ligero incremento respecto a años anteriores. Las diferencias entre las comunidades autónomas persisten, así como nuestra última posición respecto a los países europeos que participan en la Eucomed.Conclusiones: Los datos del registro de 2022 reflejan la recuperación completa de la actividad tras el impacto de la pandemia de la COVID-19 en 2020. Pese a la leve mejora, se mantiene nuestra posición en Europa y también las grandes diferencias entre nuestras comunidades autónomas.(AU)

Introduction and objectives: This article presents data on implantable cardioverter-defibrillator implants in Spain in 2022.Methods: The data were collected from implantation centers, which voluntarily completed a data collection sheet during the implantation process, either manually or through a web page.Results: In 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.Conclusions: The 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.(AU)

Registro español de desfibrilador automático implantable. XVIII informe oficial de la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (2021) / Spanish implantable cardioverter-defibrillator registry. 18th official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2021)

Introducción y objetivos Se presentan los datos correspondientes a los implantes de desfibrilador automático implantable (DAI) en España en el año 2021. Métodos Los datos provienen de los centros implantadores, que cumplimentaron voluntariamente una hoja de recogida de datos durante el implante. Resultados En 2021 se recibieron 7.496 formularios de implante, frente a los 7.743 comunicadas por Eucomed (European Confederation of Medical Suppliers Associations), lo que implica que se han recogido datos del 96,8% de los dispositivos implantados en España. El cumplimiento osciló entre el 99,9% en el campo «nombre del hospital implantador» y el 8,9% en la variable «hospital de referencia». En 2021, 199 hospitales han participado en el registro, lo cual supera las cifras de los años previos en que el número de participantes osciló alrededor de 170 hospitales. La tasa total de implantes registrados fue 158/millón de habitantes (163 según Eucomed), lo que la sitúa como el año con mayor actividad. Sin embargo, el registro sigue mostrando diferencias importantes entre las comunidades autónomas y la tasa de implante más baja de todos los países europeos participantes en Eucomed. Conclusione El Registro español de desfibrilador automático implantable del año 2021 recoge un incremento en el número de implantes de DAI y refleja la recuperación de la actividad hospitalaria tras el impacto inicial de la pandemia por COVID-19 durante 2020. A pesar del incremento en el número total de implantes en España, este sigue siendo muy inferior a la media de la Unión Europea y persisten las diferencias entre las comunidades autónomas españolas (AU)

Introduction and objectives This article presents the data corresponding to implantable cardioverter-defibrillator (ICD) implantations in Spain in 2021. Methods The data were drawn from implanting centers, which voluntarily completed a data collection sheet during the procedure. Results In 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. Conclusions The 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 (AU)

Hospital Characteristics and Early Enrollment Trends in the American College of Cardiology Voluntary Public Reporting Program.

Importance: Limited data exist regarding the characteristics of hospitals that do and do not participate in voluntary public reporting programs. Objective: To describe hospital characteristics and trends associated with early participation in the American College of Cardiology (ACC) voluntary reporting program for cardiac catheterization-percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries. Design, Setting, and Participants: This cross-sectional study analyzed enrollment trends and characteristics of hospitals that did and did not participate in the ACC voluntary public reporting program. All hospitals reporting procedure data to the National Cardiovascular Data Registry (NCDR) CathPCI or ICD registries that were eligible for the public reporting program from July 2014 (ie, program launch date) to May 2017 were included. Stepwise logistic regression was used to identify hospital characteristics associated with voluntary participation. Enrollment trends were evaluated considering the date US News & World Report (USNWR) announced that it would credit participating hospitals. Data analysis was performed from March 2017 to January 2018. Main Outcomes and Measures: Hospital characteristics and participation in the public reporting program. Results: By May 2017, 561 of 1747 eligible hospitals (32.1%) had opted to participate in the program. Enrollment increased from 240 to 376 hospitals (56.7%) 1 month after the USNWR announcement that program participation would be considered as a component of national hospital rankings. Compared with hospitals that did not enroll, program participants had increased median (IQR) procedural volumes for PCI (481 [280-764] procedures vs 332 [186-569] procedures; P < .001) and ICD (114 [56-220] procedures vs 62 [25-124] procedures; P < .001). Compared with nonparticipating hospitals, an increased mean (SD) proportion of participating hospitals adhered to composite discharge medications after PCI (0.96 [0.03] vs 0.92 [0.07]; P < .001) and ICD (0.88 [0.10] vs 0.81 [0.12]; P < .001). Hospital factors associated with enrollment included participation in 5 or more NCDR registries (odds ratio [OR],1.98; 95% CI, 1.24-3.19; P = .005), membership in a larger hospital system (ie, 3-20 hospitals vs ≤2 hospitals in the system: OR, 2.29; 95% CI, 1.65-3.17; P = .001), participation in an NCDR pilot public reporting program of PCI 30-day readmissions (OR, 2.93; 95% CI, 2.19-3.91; P < .001), university affiliation (vs government affiliation: OR, 3.85, 95% CI, 1.03-14.29; P = .045; vs private affiliation: OR, 2.22; 95% CI, 1.35-3.57; P < .001), Midwest location (vs South: OR, 1.47; 95% CI, 1.06-2.08; P = .02), and increased comprehensive quality ranking (4 vs 1-2 performance stars in CathPCI: OR, 8.08; 95% CI, 5.07-12.87; P < .001; 4 vs 1 performance star in ICD: OR, 2.26; 95% CI, 1.48-3.44; P < .001) (C statistic = 0.829). Conclusions and Relevance: This study found that one-third of eligible hospitals participated in the ACC voluntary public reporting program and that enrollment increased after the announcement that program participation would be considered by USNWR for hospital rankings. Several hospital characteristics, experience with public reporting, and quality of care were associated with increased odds of participation.

Variation in regional implantation patterns of cardiac implantable electronic device in Switzerland.

INTRODUCTION: There is a substantial geographical variation in the rates of pacemaker (PM), implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) device implantation across European countries. We assessed the extent of regional variation and potential determinants of such variation. METHODS: We conducted a population-based analysis using discharge data for PM/ICD/CRT implantations from all Swiss acute care hospitals during 2013-2016. We derived hospital service areas (HSA) by analyzing patient flows. We calculated age- and sex-standardized rates and quantified variation using the extremal quotient (EQ) and the systemic component of variation (SCV). We estimated the reduction in variance of crude implantation rates across HSAs using multilevel regression models, with incremental adjustment for age and sex, language, socioeconomic factors, population health, diabetes mellitus, and the density of cardiologists on the HSA level. RESULTS: We analyzed implantations of 8129 PM, 1461 ICD, and 1411 CRT from 25 Swiss HSAs. The mean age- and sex-standardized implantation rate was 29 (range 8-57) per 100,000 persons for PM, 5 (1-9) for ICD, and 5 (2-8) for CRT. There was a very high variation in PM (EQ 7.0; SCV 12.6) and ICD (EQ 7.2; SCV 11.3) and a high variation in CRT implantation rates (EQ 3.9; SCV 7.1) across HSAs. Adjustments for age and sex, language, socioeconomic factors, population health, diabetes mellitus, and density of cardiologists explained 94% of the variance in ICD and 87.5% of the variance in CRT implantation rates, but only 36.3% of the variance in PM implantation rates. Women had substantially lower PM/ICD/CRT implantation rates than men. CONCLUSION: Switzerland has a very high regional variation in PM/ICD implantation and a high variation in CRT implantation rates. Women had substantially lower implantation rates than men. A large share of the variation in PM procedure rates remained unexplained which might reflect variations in physicians' preferences and practices.

Cardiac resynchronization therapy with or without defibrillator in patients with heart failure.

AIMS: Randomized data on the efficacy/safety of cardiac resynchronization therapy with vs. without defibrillator (CRT-D,-P) in heart failure with reduced ejection fraction (HFrEF) are scarce. We aimed to evaluate survival associated with use of CRT-D vs. CRT-P in a contemporary cohort with HFrEF. METHODS AND RESULTS: Patients from Swedish HF Registry treated with CRT-D/CRT-P and fulfilling criteria for primary prevention defibrillator use were included. Logistic regression was used to evaluate predictors of CRT-D non-use. All-cause mortality was compared in CRT-D vs. CRT-P by Cox regression in a 1 : 1 propensity-score-matched cohort. Of 1988 patients with CRT, 1108 (56%) had CRT-D and 880 (44%) CRT-P. Older age, higher ejection fraction (EF), female sex, and the lack of referral to HF nurse-led outpatient clinic were major determinants of CRT-D non-use. After matching, 645 CRT-D patients were compared with 645 with CRT-P. The CRT-D use was associated with lower 1- and 3-year all-cause mortality [hazard ratio (HR):0.76, 95% confidence interval (CI):0.58-0.98; HR: 0.82, 95% CI: 0.68-0.99, respectively]. Results were consistent in all pre-specified subgroups except for CRT-D use being associated with lower 3-year mortality in patients with an EF < 30% but not in those with an EF ≥ 30% (HR: 0.73, 95% CI: 0.59-0.89 and HR: 1.24, 95% CI: 0.83-1.85, respectively; P-interaction = 0.02). CONCLUSION: In a contemporary HFrEF cohort, CRT-D was associated with lower mortality compared with CRT-P. The CRT-D use was less likely in older patients, females, and in patients not referred to HF nurse-led outpatient clinic. Our findings support the use of CRT-D vs. CRT-P in HFrEF, in particular with severely reduced EF.

Implantation of cardiac electronic devices in active COVID-19 patients: Results from an international survey.

BACKGROUND: Cardiac implantable electronic device (CIED) implantation rates as well as the clinical and procedural characteristics and outcomes in patients with known active coronavirus disease 2019 (COVID-19) are unknown. OBJECTIVE: The purpose of this study was to gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey. METHODS: Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure. RESULTS: The CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (P <.001). Most devices were implanted due to high-degree/complete atrioventricular block (112 [67.5%]) or sick sinus syndrome (31 [18.7%]). Of the 166 patients in the study survey, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a fatal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs 66 years; P <.001) with a nonsignificant higher complication rate (16.5% vs 7.7%; P = .2) was observed in Europe vs North America, whereas higher rates of critically ill patients (33.3% vs 3.3%; P <.001) and mortality (26.9% vs 5%; P = .002) were observed in North America vs Europe. CONCLUSION: CIED procedure rates during known active COVID-19 disease varied greatly, from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take these risks into consideration before proceeding with CIED implantation in active COVID-19 patients.

The Impact of Charlson Comorbidity Index on De Novo Cardiac Implantable Electronic Device Procedural Outcomes in the United States.

OBJECTIVE: To investigate the utility of Charlson comorbidity index (CCI) as a measure of comorbidity burden to predict procedural outcomes after de novo cardiac implantable electronic device (CIED) implantation. METHODS: All de novo CIED implantations in the United States National Inpatient Sample between 2015 and 2018 were retrospectively analyzed, stratified by CCI score (0=no comorbidity burden, 1=mild, 2=moderate, ≥3=severe). Multivariable logistic regression models were performed to examine the association between unit CCI score (scale) and in-hospital outcomes (major adverse cerebrovascular and cardiovascular events [MACCE]: composite of all-cause mortality, acute ischemic stroke, thoracic and cardiac complications, and device-related complications; and MACCE individual components). RESULTS: Of 474,475 CIED procedures, the distribution of CCI score was as follows: CCI=0 (17.7%), CCI=1 (21.8%), CCI=2 (18.7%), and CCI=3+ (41.8%). Charlson comorbidity index score was associated with increased odds ratios of MACCE (1.10; 95% CI, 1.09 to 1.11), all-cause mortality (1.23; 95% CI, 1.21 to 1.25), and acute stroke (1.45; 95% CI, 1.44 to 1.46). This finding was consistent across all CIED groups except the cardiac resynchronization therapy groups in which CCI was not associated with increased risk of mortality. A higher CCI score was not associated with increased odds of procedural (thoracic and cardiac) and device-related complications. CONCLUSION: In a nationwide cohort of CIED procedures, higher comorbidity burden as measured by CCI score was associated with an increased risk of in-hospital mortality and acute ischemic stroke, but not procedure-related (thoracic and cardiac) or device-related complications. Objective assessment of comorbidity burden is important to risk-stratify patients undergoing CIED implantation for better prognostication of their in-hospital survival.

Periprocedural complications of cardiac implantable electronic device implantation in very elderly patients with cognitive impairment: A prospective study.

ABSTRACT: Very elderly people (over 80 years) with cardiac implantable electronic devices (CIEDs) indications often have a higher prevalence of aging comorbidity, among which cognitive impairment is not uncommon. This study aimed to investigate periprocedural complications of CIED implantation among very elderly patients with and without cognitive impairment. One hundred eighty patients ≥80 years of age indicated for CIED implantation were included in our study. During hospitalization, the cognitive evaluation was performed according to the Diagnostic and Statistical Manual of Mental Disorders (fifth edition). According to the cognitive test results, patients were divided into 2 groups (90 patients with normal cognitive function and 90 patients with cognitive impairment). Meanwhile, their physical parameters and laboratory measurements were completed. The procedural data and periprocedural complications were collected from both groups. The association between cognitive impairment and periprocedural complications was analyzed using univariate and multiple logistic regression analyses. During a one-month follow-up, the most frequent periprocedural complications in very elderly patients were pocket hematoma and thrombosis events. Cognitively impaired patients had a higher incidence of complications than normal cognitive patients. Multivariate regression analysis showed that cognitive impairment was positively correlated with periprocedural complications in very elderly patients. Cognitive impairment is associated with increased periprocedural complications of CIED implantation in very elderly patients.

Long-term Outcomes Associated With Permanent Pacemaker Implantation After Surgical Aortic Valve Replacement.

Importance: Prior studies investigating the long-term clinical outcomes of patients who have undergone permanent pacemaker implantation after aortic valve replacement reported conflicting results. Objective: To investigate long-term outcomes after primary surgical aortic valve replacement among patients who underwent postoperative permanent pacemaker implantation. Design, Setting, and Participants: This cohort study included all patients who underwent surgical aortic valve replacement in Sweden from 1997 to 2018. All patients who underwent primary surgical aortic valve replacement in Sweden and survived the first 30 days after surgical treatment were included. Patients who underwent preoperative permanent pacemaker implantation, concomitant surgical treatment for another valve, or emergency surgical treatment were excluded. Patients who underwent concomitant coronary artery bypass grafting or surgical treatment of the ascending aorta were included. Follow-up data were complete for all patients. Data were analyzed from October through December 2020. Exposures: Patients underwent implantation of a permanent pacemaker or implantable cardioverter defibrillator within 30 days after aortic valve replacement. Main Outcomes and Measures: The primary outcome was all-cause mortality. Results: Among 24 983 patients who underwent surgical aortic valve replacement, 849 patients (3.4%) underwent permanent pacemaker implantation within 30 days after surgical treatment and 24 134 patients (96.6%) did not receive pacemakers in that time. The mean (SD) age of the total study population was 69.7 (10.8) years, and 9209 patients were women (36.9%). The mean (SD) and maximum follow-up periods were 7.3 (5.0) years and 22.0 years, respectively. At 10 years and 20 years after surgical treatment, the Kaplan-Meier estimated survival rates were 52.8% and 18.0% in the pacemaker group, respectively, and 57.5% and 19.6% in the nonpacemaker group, respectively. All-cause mortality was statistically significantly increased in the pacemaker group compared with the nonpacemaker group (hazard ratio [HR], 1.14; 95% CI, 1.01-1.29; P = .03), and so was risk of heart failure hospitalization (HR, 1.58; 95% CI, 1.31-1.89; P < .001). No statistically significant increase was found in the risk of endocarditis in the pacemaker group. Conclusions and Relevance: This study found that there were increased risks of all-cause mortality and heart failure hospitalization among patients who underwent permanent pacemaker implantation after surgical aortic valve replacement, suggesting that these risks are important considerations, especially in an era when transcatheter aortic valve replacement is used in younger patients at lower risk of adverse surgical outcomes. These findings further suggest that future research should investigate how to avoid permanent pacemaker dependency after surgical and transcatheter aortic valve replacement.

Subcutaneous implantable cardioverter-defibrillator and defibrillation testing: A propensity-matched pilot study.

BACKGROUND: To date, only a few comparisons between subcutaneous implantable cardioverter-defibrillator (S-ICD) patients undergoing and those not undergoing defibrillation testing (DT) at implantation (DT+ vs DT-) have been reported. OBJECTIVE: The purpose of this study was to compare long-term clinical outcomes of 2 propensity-matched cohorts of DT+ and DT- patients. METHODS: Among consecutive S-ICD patients implanted across 17 centers from January 2015 to October 2020, DT- patients were 1:1 propensity-matched for baseline characteristics with DT+ patients. The primary outcome was a composite of ineffective shocks and cardiovascular mortality. Appropriate and inappropriate shock rates were deemed secondary outcomes. RESULTS: Among 1290 patients, a total of 566 propensity-matched patients (283 DT+; 283 DT-) served as study population. Over median follow-up of 25.3 months, no significant differences in primary outcome event rates were found (10 DT+ vs 14 DT-; P = .404) as well as for ineffective shocks (5 DT- vs 3 DT+; P = .725). At multivariable Cox regression analysis, DT performance was associated with a reduction of neither the primary combined outcome nor ineffective shocks at follow-up. A high PRAETORIAN score was positively associated with both the primary outcome (hazard ratio 3.976; confidence interval 1.339-11.802; P = .013) and ineffective shocks alone at follow-up (hazard ratio 19.030; confidence interval 4.752-76.203; P = .003). CONCLUSION: In 2 cohorts of strictly propensity-matched patients, DT performance was not associated with significant differences in cardiovascular mortality and ineffective shocks. The PRAETORIAN score is capable of correctly identifying a large percentage of patients at risk for ineffective shock conversion in both cohorts.

CMR-Based Risk Stratification of Sudden Cardiac Death and Use of Implantable Cardioverter-Defibrillator in Non-Ischemic Cardiomyopathy.

Non-ischemic cardiomyopathy (NICM) is one of the most important entities for arrhythmias and sudden cardiac death (SCD). Previous studies suggest a lower benefit of implantable cardioverter-defibrillator (ICD) therapy in patients with NICM as compared to ischemic cardiomyopathy (ICM). Nevertheless, current guidelines do not differentiate between the two subgroups in recommending ICD implantation. Hence, risk stratification is required to determine the subgroup of patients with NICM who will likely benefit from ICD therapy. Various predictors have been proposed, among others genetic mutations, left-ventricular ejection fraction (LVEF), left-ventricular end-diastolic volume (LVEDD), and T-wave alternans (TWA). In addition to these parameters, cardiovascular magnetic resonance imaging (CMR) has the potential to further improve risk stratification. CMR allows the comprehensive analysis of cardiac function and myocardial tissue composition. A range of CMR parameters have been associated with SCD. Applicable examples include late gadolinium enhancement (LGE), T1 relaxation times, and myocardial strain. This review evaluates the epidemiological aspects of SCD in NICM, the role of CMR for risk stratification, and resulting indications for ICD implantation.