Implantable Cardioverter Defibrillator 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.

Novel electric predictors of lethal arrhythmic event in patients with hypertrophic cardiomyopathy

Abstract Background Little is known regarding the association between electrical markers and lethal arrhythmic events (LAE) in patients with hypertrophic cardiomyopathy (HCM). This study aimed to identify the electrical predictors of LAE in adult patients with HCM. Methods This study was a retrospective analysis of patients with HCM at a single center from 1998 to 2021. LAE was defined as a composite outcome of (1) sustained ventricular arrhythmia, (2) aborted sudden cardiac death (SCD), (3) implantable cardioverter defibrillator (ICD) implantation, and (4) appropriate ICD shock. A 12-lead electrocardiography was performed at the time of diagnosis. Results A total of 611 patients with HCM were analyzed, and 48 (7.8%) experienced LAE. Patients who experienced LAE were diagnosed at a younger age and more frequently had history of ventricular arrhythmia, new-onset atrial fibrillation (AF) or non-sustained ventricular tachycardia. New-onset AF, an increase in the QTc interval, and the absence of massive LVH were associated with LAE risk. In addition to conventional markers of HCM Risk-SCD, consideration of the QTc interval and massive LVH on electrocardiography improved the prediction of LAE (area under curve 0.682 to 0.740). Further inclusion of new-onset AF, history of ventricular arrhythmia, HCM type, and left ventricular mass index improved the predictability to 0.867. Conclusion An increase in the QTc interval, the absence of a massive LVH pattern on electrocardiography (ECG), and new-onset AF were independently associated with an increased risk of LAE. Comprehensive stratification using electrical markers improves the prediction of LAE when combined with conventional markers.

Role of common variants and new genes associated with arrhythmogenic cardiomyopathy

Abstract Introduction Arrhythmogenic Cardiomyopathy (ACM) is an inherited cardiac disease, predominantly affecting males, characterized by fibro-fatty myocardial replacement mainly in the right ventricle. It leads to 5% sudden cardiac death in affected young adults (<25 yo) without an implantable cardioverter defibrillator. Early diagnosis is crucial for appropriate clinical management to reduce mortality and prevent disease progression. Rare variants in desmosomal genes (PKP2,DSC2,DSG2,DSP and JUP) are found in 50% of cases. However, challenges persist since we observe a low penetrance in relatives (28-58%) and a high variability in expressivity and severity annihilating any preventive strategy. Objective We aim to decipher the genetic architecture of ACM by investigating the role of common variants in disease susceptibility/severity and to idendify new genes associated to ACM. Method A Genome Wide Association Study (GWAS) was performed on 1079 ACM index patients and 7305 controls, followed by conditional analysis. New candidate genes were knocked out (KO) in Zebrafish and/or hiPSC using CRISPR/Cas9. Impedance and external field potential measurements were performed on hiPSC derived cardiomyocytes (CM-hiPSC). Results The GWAS identified 5 significant loci (Figure 1, P<5.10-8), including 2 desmosomal genes (PKP2 a n d DSG2) and 3 new candidates (KLF12, CTNNA3, and ARL17B/WNT3). Conditional analysis revealed 3 additional loci with suggestive p-values (P<1.10-6), highlighting 3 new susceptible loci. Among them, we uncovered key non-coding regulatory regions near desmosomal genes (DSC2 and DSG2). Initial findings in PKP2-KO zebrafish present hearts with structural defects, while CM-hiPS KLF12-KO(-/-) exhibited altered interbeat interval and relaxation time compared to isogenic controls. Conclusion Our findings reveal ACM's complex genetic architecture, implicating common variants in disease susceptibility. A polygenic risk score will be implemented to improve patient risk stratification. Three novel loci/genes for ACM as well as specific regulatory regions of desmosomal genes have been highlighted. Their functional studies in isogenic hiPSC and Zebrafish models will offer new insights in ACM underlying molecular mechanism and potential therapeutic targets.

Navigating the Uncommon: Case Report of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) Successfully Managed with Implantable Cardioverter Defibrillator (ICD)

With a high risk of sudden cardiac mortality, arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare inherited cardiomyopathy characterized by right ventricular dysfunction and ventricular arrhythmias (VA). In this case study, a 35-year-old presented with palpitations and revealed epsilon waves on the right precordial electrocardiogram (ECG) leads which led to the suspicion of ARVC. A 24-hour Holter monitoring revealed frequent ventricular extrasystoles (>500 per 24 hours), a CMRI revealed RV dyskinesia and transmural LGE in the apical RV, and an electrophysiologic study detected spontaneous polymorphic ventricular tachycardia (VT) despite the presence of induction ventricle fibrillation (VF). These results validated the diagnosis of ARVC and indicated that an implantable cardioverter defibrillator was necessary treatment. The ability to identify potential ARVC’s ECG abnormalities, the timing to pursue further studies, and determining necessary treatment execution are critical. The evaluation of cardiac, electrophysiological, and clinical imaging parameters is essential for the risk stratification, diagnosis, and management of patients with ARVC.

Cardiovascular etiologies and risk factors of survival outcomes after resuscitation for out-of-hospital cardiac arrest: data from the KoCARC registry

Abstract Background The outcomes and characteristics of out-of-hospital cardiac arrest (OHCA) vary across geographic regions. The etiologies and prognoses of OHCA in Asian populations remain less established. This study aimed to investigate the etiologies and clinical characteristics of patients successfully resuscitated after OHCA and identify predictors of survival outcomes. Methods Data were extracted from a South Korean multicenter prospective registry of OHCA that included 64 tertiary hospitals from 2015 to 2018 (n=7577). The primary outcome was in-hospital mortality, and secondary outcome was the grade-1 cerebral performance category (CPC) score at discharge. Results Of the 7577 patients, 2066 achieved return of spontaneous circulation (ROSC) and were hospitalized and 915 (44·2%) presented with ventricular arrhythmia (VA) as their initial rhythm or on admission. The leading cause was obstructive coronary artery disease (n=413; 20·0%). Sudden unexplained death syndrome (SUDS) accounted for 67·5% of survivors, which were significantly lower with VA (82·7% vs. 48·3%, p<0.001). VA was an independent predictor of in-hospital mortality (adjusted hazard ratio [aHR] 0·72, 95% confidence interval 0·60–0·87) and the grade-1 CPC score at discharge (aHR 3·63, 95% CI 2·56–5·15). Other predictors of the primary outcome included age, ROSC on arrival, total arrest time, alertness on admission, extracorporeal membrane oxygenation use, targeted temperature management, implantable cardioverter defibrillator use, and coronary vasospasm. Conclusions SUDS was common in patients with ROSC after OHCA and thus needs to be evaluated comprehensively. VA was independently associated with favorable survival outcomes at discharge. Further management may improve clinical outcomes in patients with OHCA, particularly those with VA.

Infection management in the extravascular implantable cardioverter defibrillator: experience from the EV ICD Pivotal study

Abstract Background The extravascular implantable cardioverter defibrillator (EV ICD) has recently emerged as an option for guideline indicated ICD patients. Results from the EV ICD Pilot and Pivotal studies demonstrated that the device can provide safe and effective therapy through chronic follow up. Lead placement outside the vasculature has the potential to reduce systemic infections. Infection occurrence and management details from the Pivotal are reported. Purpose To report on details of infection occurrence and management from the EV ICD Pivotal study. Methods The EV ICD Pivotal study was an international, prospective, single-arm, premarket clinical study. Patients with a class I or IIa indication for a single-chamber ICD per ESC or ACC/AHA/HRS guidelines were enrolled. Results In the EV ICD Pivotal study, 316 patients had an implant attempt, (74.7% male, age 53.8±13.1 years, 82% primary prevention, LVEF of 38.9%±15.4%, and NYHA Class I [23.7%] or II/III [65.5%]), of which 15 had a system or procedure-related infection (4.7%, 9 - 737 days post-implant) through an average 16.2 months follow-up. Of these infections, 8 were classified as major complications, 3 as minor, and 4 as observations. Most (n=9) infections were addressed through medication with or without wound care (2.8% of patients) while 6 (1.9% of patients) resulted in system removal. There was a single lead-related infection addressed through system explant. However, there were no reports of mediastinitis, sepsis, or endocarditis. No system removal resulted in sequelae. Conclusions Infection rates observed in the EV ICD Pivotal study were similar to those reported in the subcutaneous implantable cardioverter defibrillator. The results from this study support that EV ICD related infections are treatable with antibiotic therapy or system removal. No system or procedure-related systemic infections such as mediastinitis, sepsis, or endocarditis have been reported in the Pivotal study.

Mortality and patient stratification 30 days after Staphylococcus aureus bacteraemia in patients with cardiac implantable electronic devices - a Danish nationwide cohort study

Abstract Background Staphylococcus aureus bacteraemia (SAB) is a high-risk condition with a reported 30-day mortality of up to 25% even with timely and correct treatment. Patients with cardiac implantable electronic devices (CIEDs) are at increased risk of a complicated course of disease due to the risk of device infection. Purpose We aimed to estimate the 30-day mortality rate following SAB among adult Danish patients with a de novo CIED. Furthermore, we aimed to identify patients with low, intermediate, and high mortality risk following SAB. Methods Using The National Danish Staphylococcus Aureus Bacteriemia Database and The Danish Pacemaker and ICD Register, we identified all Danish patients aged 18 to 99 years with a de novo CIED implantation between 2000 and 2020, and subsequently positive Staphylococcus aureus blood culture. The primary outcome was 30-day all-cause mortality from date of SAB. Clinical variables significantly associated with increased 30-day mortality following SAB were identified (p<0.05 and 95% CI not including 1) using adjusted multivariable Cox regression modelling. We tested variables related to age, sex, calendar year of SAB, device type, timing of infection, previous SAB, concomitant medication, and clinically relevant pre-existing co-morbidities including valvular replacement, recent surgery, and renal dialysis. Patients were awarded 1 point for each of the significant variables present, and the sum was used to stratify into low-, intermediate-, and high-risk groups. The cut-offs between the groups were set at 0 and 2 points (0 points = low risk, 1-2 points = intermediate risk, ≥3 = high risk). Results We identified 1,393 patients with de novo CIED (pacemaker: n=983, implantable cardioverter defibrillator: n=230, cardiac resynchronization therapy w/wo defibrillator capacity: n=180) and subsequent SAB (median time to SAB from CIED implantation: 679 days [IQR 168-1,525]). Median age at the time of SAB diagnosis was 77 years [IQR 68-84] with 72.4% being males. In total, 469 patients died within the first 30 days from SAB, equivalent to an overall 30-day mortality rate of 33.7% (95% CI 31.2-36.2). We identified high age, left sided valvular disease, use of systemic corticosteroids, and SAB occurring >6 months from CIED implantation to be associated with an increased hazard of 30-day mortality following the SAB diagnosis (Fig. 1). The median total sum obtained from the stratification model was 2 points [IQR 1-2]. 30-day all-cause mortality was estimated to 16.2%, 31.6% and 54.9% for the low-, intermediate- and high-risk groups, respectively (Fig. 2). Conclusions In patients with a de novo cardiac implantable electronic device and subsequent Staphylococcus aureus bacteraemia the overall 30-day mortality from date of SAB was 33.7%. Patients with high age, recent surgery, left sided valvular disease, and use of systemic corticosteroids were particularly at risk.Fig. 1.Simplified stratification modelFig. 2.30-day mortality following SAB

Preexisting pulmonary hypertension impact on in-hospital outcomes of cardiac implantable electrical device implantation

Abstract Background Preexisting pulmonary hypertension (PH) is associated with unfavorable in-hospital outcomes in cardiac as well as non-cardiac surgeries and procedures. However, its impact on cardiac implantable electronic device (CIED) implantations is not established. We investigated the extent of preexisting PH among patients undergoing CIED implantations and evaluated its effect on in-hospital outcomes. Methods Using the National Inpatient Sample (NIS) database, we identified patients who were hospitalized in the US between 2016-2019 and underwent CIED implantation with a preexisting diagnosis of PH. Patients with any CIED in-situ were excluded. Sociodemographic, clinical data, in-hospital procedures and outcomes as well as in-hospital mortality were collected. Multivariable logistic regression models were used to identify predictors of in-hospital complications. Results An estimated total of 718,980 patients underwent CIED implantation during the study period. Of them, 74,150 patients (10.3%) had preexisting PH diagnosis. Compared with non-PH patients, PH patients were older, had higher Charlson Comorbidity Index, and more often implanted with implantable cardioverter defibrillators and cardiac resynchronization therapy devices. Higher rate of total complications was observed in PH patients (14.5% versus 9.9%; P<0.001) driven mainly by respiratory complications as well as in-hospital mortality (2.3% versus 1.2%; P<0.001). Multivariable analyses confirmed PH as an independent predictor for respiratory complications, total complications and in-hospital mortality. Conclusion Preexisting PH in patients undergoing CIED implantation was associated with increased risk for respiratory complications as well as in-hospital mortality in a US nationwide, all-comer registry.

Left ventricular apical aneurysms and outcomes in hypertrophic cardiomyopathy

Abstract Background/Introduction The presence of left ventricular apical aneurysm (LVAA) has been shown to be associated with increased risk of adverse events in patients with hypertrophic cardiomyopathy (HCM). However, the between LVAA size and outcomes is uncertain. Purpose To explore associations between baseline LVAA diameter and progressive changes in LVAA size over time and poor outcomes in HCM patients. Methods Our HCM multimodality imaging database (transthoracic echocardiography (TTE) or cardiac magnetic resonance (CMR)) was retrospectively assessed for studies reporting LVAA, defined as one or more akinetic or dyskinetic apical segments. LVAA size (widest systolic diameter in millimetres in the transverse plane) was recorded at two time points: earliest identification and most recent imaging, with LVAA size progression (mm/year) calculated. Patients’ electronic records were reviewed for composite outcome including stroke, apical thrombus, death, and appropriate therapy from implantable cardioverter defibrillator (ICD). Continuous variables are presented as mean ± standard deviation (SD), categorical data numerically or as percentages. Comparisons between groups were made using Wilcoxon ranks sum and Fischer exact test for continuous and binary variables, respectively. Cox regression was used to assess independent associations with composite outcomes. A p value of <0.05 was considered statistically significant. Results A total of 106 patients were identified with LVAA and clinical follow-up (mean age 64.7±11.4 years, 70% male). Mean follow-up duration was 6.5±3.0 years. Baseline LVAA was confirmed by CMR and TTE in 70 and 30% of cases respectively. Mean LVAA size at baseline was 16.2±7.6 mm (range 6-56 mm). During multivariate Cox analysis, baseline LVAA size in mm was independently associated with the composite outcome (HR 1.04, 95% CIs 1.0 to 1.08, p=0.04). Mean duration between baseline and maximal LVAA size scan was 5.4±3.0 years. Median progression in LVAA size was 1.0 (IQR 0.6 to 1.8) mm per annum (range 0.0 to 8.1 mm). During multivariate analysis, LVAA progression rate in mm per year was independently associated with the composite outcome (HR 1.4 95% CIs 1.11 to 1.7, p=0.002). Conclusion(s) These data support the association between LVAA size and poor outcomes in HCM patients. We also demonstrate the progressive nature of LVAAs and indicate those more rapidly increasing in size are at highest risk of adverse events, with potential implications for management strategies.

High-intensity exercise-related sudden cardiac death in hypertrophy cardiomyopathy

Abstract Background Whether exercise provokes sudden cardiac death (SCD) in patients with hypertrophic cardiomyopathy (HCM) is uncertain. Current European guidelines recommend against high-intensity exercise in individuals with high SCD risk or obstructive physiology. Purpose We investigated the factors associated with exercise-related SCD in HCM. Methods We retrospectively analyzed of 2,844 consecutive patients with HCM who underwent evaluation between 2005 and 2023 at a high-volume tertiary center. SCD events were defined as a composite of aborted SCD, appropriate implantable cardioverter-defibrillator (ICD) shock, and SCD. Among 80 first SCD events (2.8%), 75 events had a description of the physical activity at the time of the event. Patients were classified into two groups according to physical activity level at the time of the SCD event. Group 1 included patients with high-intensity exercise-related SCD events, defined as happening during or immediately after high-intensity exercise or physical activity, while Group 2 included patients with SCD events happening at rest or during light or moderate physical activity. Results The 75 first SCD events included 44 aborted SCD, 22 appropriate ICD shocks, and 9 SCD. Median age at SCD event was 54 (IQR 39.5–62.5) years and 60 (80%) were men. Patients in Group 1 (n=14) were younger than patients in Group 2 (n=61) (23.5 [IQR 16–48] vs. 55 [IQR 44–64] years, p<0.001), and most patients in group 1 (92.9%) were under the age of 60 years. Patients in Group 1 had slightly smaller left ventricular (LV) end-diastolic dimension and had higher ESC SCD risk scores (3.6 [IQR 2.5–6.7] vs. 2.4 [IQR 1.7–4.8], p=0.044) than patients in Group 2; however, there were no significant differences in the proportion of high-risk patients (28.6% vs. 14.8%, p=0.396) or patients with AHA major SCD risk factors (57.1% vs. 55.7%, p=0.999). Otherwise, there were no significant differences in the presence of obstructive physiology, apical HCM, and apical aneurysm, LV systolic and diastolic function, and comorbidities between the two groups. Furthermore, of the 29 patients who underwent genetic testing, there was no difference in the proportion of patients with pathogenic sarcomeric variants according to exercise-related SCD (50.0% vs. 65.2%, p=0.683). To note, there was a non-significant tendency towards higher proportion of thin filament variants in Group 1 than Group 2 among those with pathogenic sarcomeric variants (100% [3/3] vs 26.7% [4/15], p=0.084). Conclusions Most high-intensity exercise-related SCD events happened under the age of 60. The ESC SCD risk score was higher in patients with high-intensity exercise-related SCD events, although the SCD risk categories or AHA risk factors could not discriminate patients at higher risk of events. These results suggest that exercise recommendations should not be based on SCD risk category, presence of obstruction, or degree of LV hypertrophy.

Outcomes of implantable cardioverter-defibrillators in patients with a left ventricular assist device: a systematic review and meta-analysis

Abstract Introduction Implantable Cardioverter-Defibrillators (ICDs) improve survival in advanced heart failure with reduced ejection fraction (HFrEF) and prevent sudden cardiac death. However, the prognostic benefits of ICDs among patients with a Left Ventricular Assist Device (LVAD) remain uncertain and controversial. Therefore, we conducted a systematic review and meta-analysis to assess the effectiveness and safety of ICD implantation among LVAD recipients. Methods We performed a systematic review and meta-analysis following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched PubMed and EMBASE for the peer-reviewed articles published in English assessing the impact of ICD implantation among LVAD recipients, till 10/01/2024. ICD implantation was defined as implantation before LVAD, simultaneous implantation with LVAD, or within 30 days of LVAD insertion. Two independent review authors assessed the quality and risk of bias of the included studies. A random-effect model was used to combine data in forest plots. The primary outcome was all-cause mortality associated with ICD implantation compared to no ICD implantation, and the secondary outcomes included ventricular arrhythmia (VT), and hemorrhagic stroke. Heterogeneity was assessed using Q test and I2, with I2 > 50% indicating marked heterogeneity. Results A total of 13 observational studies comprising 54571 recipients of LVAD were included in the analysis of the primary outcome. All-cause mortality was similar among patients with ICD versus no ICD (Odds Ratio [OR]= 0.77; 95% CI, 0.57-1.04, I2= 89%, P=0.09), as shown in Figure 1. Likewise, ICD implantation was associated with similar rates of VT and hemorrhagic stroke (VT: OR= 1.81, 95% Cl, 0.82-4.01, I2= 90%, P=0.14; hemorrhagic stroke: OR= 1.01, 95% Cl, 0.81-1.25, I2= 0%, P= 0.95). Conclusion Among patients with HFrEF and LVAD as advanced heart failure therapy, ICD implantation didn’t provide additional prognostic survival benefit, suggesting possible use of LVAD without ICD implantation.Figure 1.Forest plot of mortality

Conduction-System pacing Italian Network Group (C-SING): insights from a Nationwide Multicenter Observational Study

Abstract Background/Introduction Conduction system pacing (CSP), encompassing His bundle pacing (HBP) and left bundle branch area pacing (LBBAP), has gained prominence in treating bradycardia and heart failure in recent years. Despite its increasing utilization, data on real-world adoption of CSP are limited. Purpose The C-SING study aimed at assessing patient characteristics, implant success, procedural details, and safety of CSP when performed in routine clinical practice. Methods Periprocedural data from 27 experienced CSP centers across Italy were collected on patients undergoing CSP implantation for various indications between January 2021 and January 2024. Results The study comprised 1,317 patients (median age 78 years [interquartile range, 71-83], male 66.2%). Leading indications included atrioventricular (AV) block (40.8%), sinus node dysfunction (12.1%), atrial fibrillation with bradycardia (9.7%), AV node ablation (9.5%), and heart failure (12.5%). Pacemakers were implanted in 77.3% of patients, cardiac resynchronization devices in 21.7%, and implantable cardioverter-defibrillators in 1.0%. Stylet-driven and lumenless CSP leads were utilized in 64.7% and 35.3% of procedures, respectively. Final 12-lead ECG assessment revealed LBBAP capture in 88.7% patients, HBP in 8.4% (selective 4.2%, non-selective 4.2%), and no CSP capture in 3.0%, resulting in a 97.0% CSP lead implantation success rate. In patients with LBBAP, predominant capture types were left bundle branch pacing (19.6%), left posterior fascicular pacing (19.2%), and left septal fascicular pacing (14.8%). Comparing HBP to LBBAP, the latter showed shorter procedural time (60 minutes [45-80] vs. 70 minutes [60-95], p=0.003), but similar fluoroscopy time (6.0 minutes [3.3-10.8] vs. 6.1 minutes [4-10], p=0.735). Paced QRS duration was longer in LBBAP (118 ms [105-130]) compared to HBP (110 ms [101-122], p<0.001). LBBAP showed lower capture thresholds (0.6 V [0.5-0.9] @0.4 ms vs. 0.8 V [0.5-1.5] @1.0 ms, p<0.001) and higher R-wave sensing (10.7 mV [8-16] vs. 4.5 mV [2.4-9.9], p<0.001). The rate of periprocedural complications was higher in patients with LBBAP than HBP (7.3% vs. 1.8%, p=0.03), with the most frequent events being intraprocedural perforation into the left ventricular cavity during lead screwing (2.6%) and CSP lead dislodgment before hospital discharge (1.4%). These occurrences necessitated lead repositioning without additional complications. Conclusion CSP demonstrated feasibility as a primary pacing strategy for various indications in a real-world, multicenter setting. LBBAP, more frequently used than HBP, exhibited shorter procedural time and superior acute electrical parameters. LBBAP revealed a higher rate of minor procedural complications than HBP. Further investigations, supported by additional long-term outcome data, are essential to comprehensively assess CSP performance.

Elderly patients with decompensated heart failure: prospective analysis from the LECRA-HF registry

Abstract Background/Introduction Heart failure (HF) presents as a clinical syndrome associated with an adverse prognosis, increased mortality risk, and recurrent hospitalizations for HF (HHF). In Poland, there has been a persistent increase in the overall prevalence and hospitalizations of HF among patients. Each subsequent HHF is associated with progressively worsening prognosis. In Europe, HF is most prevalent in elderly individuals, rendering this patient group particularly susceptible to HF exacerbations. Purpose The aim of this study was to conduct a comprehensive analysis of the oldest patients (≥80 years) hospitalized due to HF decompensation, compared to the rest of the evaluated cohort, including overall mortality after median 46 months of observation. Methods The prospective registry of patients with HF decompensation (LECRA-HF) is an ongoing registry conducted at a tertiary cardiology center specializing in HF treatment. Patients enrolled in the registry (n=1394) were evaluated for the presence of cardiovascular risk factors, HF phenotype, laboratory, and echocardiographic findings, as well as overall mortality. Due to the frequent occurrence of HF in elderly patients, we arbitrarily chose to compare two cohorts of patients: those above (n=306) vs. below 80 years of age (n=1088). Results Median age of elderly patients was 84 [82-86] years, of which only 7.8% were >90 years of age. HFrEF was the most common HF phenotype, which, occurred less frequently in the elderly (54.4 vs 74.4%, P<0.001). In turn, HFpEF was more prevalent in elderly group (39.2 vs 17.7%, P<0.001). Elderly patients were more often female (45.1 vs 30.2%, P<0.001) and had more comorbidities: arterial hypertension (85.6 vs 78.6%, P=0.007), atrial fibrillation (61.1 vs 45.7%, P<0.001), renal failure (49.7 vs 28.5%, P<0.001) as well as peripheral arterial disease (17 vs 9.8%, P=0.005). Those patients had more frequently implanted cardiac pacemakers (28.6 vs 12.6%, P<0.001), but less often implantable cardioverter-defibrillators (7.9 vs 14.3%, P=0.003). During HHF they were less often qualified to elective coronary angiography (24.2 vs 31.5%, P=0.039). At discharge mineralocorticoid receptor antagonist were less often prescribed in that group (42.4 vs 50.3%, P=0.010). During long-term observation patients ≥80 years had a higher all-cause mortality (81 vs 67.4%, P<0.001, Panel A). Moreover, it was also higher elderly with NT-proBNP>4497 pg/mL (P<0.001) and LVEF<41% (P=0.014) (Panel B). Conclusion(s) Patients aged ≥80 years were characterized by a higher burden of comorbidities. They were more often qualified to cardiac pacemakers, but less often to implantable cardioverter-defibrillators and invasive coronary procedures. The most common HF phenotype was HFrEF, however with a significant increase in HFpEF. They exhibited significantly higher overall mortality compared to those <80 years old, which was associated with both LVEF and NT-proBNP levels.

Role of ventricular tachycardia cycle length in the outcomes after catheter ablation or antiarrhythmic drugs in the SURVIVE-VT trial

Abstract Background It has been suggested that antiarrhythmic drugs (AAD) are less effective and safe in slow ventricular tachycardia (VT) due to their effect on conduction velocity, which could stabilize reentry. Conversely, catheter ablation aims to disrupt the VT circuit. Because of the distinct mechanisms of action of AAD and catheter ablation on the VT circuit, VT cycle length (VT-CL) may play a crucial role in determining their therapeutic efficacy. Therefore, VT-CL could be important in selecting VT treatment. Purpose The aim of this study was to assess the impact of VT-CL on outcomes following catheter ablation or antiarrhythmic drugs in AAD-naïve patients with ischemic cardiomyopathy presenting with VT. Methods This is a post hoc analysis of the previously published Substrate Ablation vs Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia (SURVIVE-VT) trial. In summary, 144 patients with ischemic cardiomyopathy and symptomatic VT were randomized to receive either catheter ablation (N=71) or AAD (N=73) as first-line therapy. We analyzed VT recurrence, implantable cardioverter-defibrillator (ICD) therapies, and the incidence of slow/incessant VT/VT storm using Cox proportional hazard models, with treatment and VT-CL interaction terms, adjusted for age. Missing VT-CL data for five patients were imputed using the median value. Results In patients with chronic ischemic heart disease and VT treated with either AAD or catheter ablation, a significant interaction was observed between clinical VT-CL and treatment effect on VT recurrence (p=0.016 for the interaction). Specifically, slower VT cycle lengths were associated with higher rates of VT recurrence (hazard ratio per 10 ms [HR] 1.094, 95% confidence interval [CI] 1.015, 1.179; p=0.037) in patients treated with AAD, while no significant effect was observed in those undergoing catheter ablation (see Figure 1). Survival freedom from VT recurrence in patients with VT-CL ≥300ms was significantly higher in patients treated with catheter ablation (78.8% vs 58.1%, log-rank p=0.044, see Figure 2). As expected, VT-CL was significantly associated with a higher risk of slow/incessant VT/VT storm (HR per 10 ms 1.115, 95% CI 1.017-1.222, p=0.047) but was not associated with ICD therapies (HR per 10 ms 1.082, 95% CI 0.994-1.178, p=0.102). Conclusion VT-CL significantly influences treatment outcomes, with slower VT cycles associated with an increased risk of VT recurrence in patients treated with AAD, but not in those undergoing catheter ablation. Therefore, VT-CL should be taken into consideration when selecting the optimal therapy for patients with ischemic cardiomyopathy and VT.Figure 1Figure 2

Risk factors for fatal ventricular arrhythmias in heart failure with preserved ejection fraction: a report from the CHART-2 Study

Abstract Background Fatal ventricular arrhythmia events (FAE), such as sustained ventricular tachycardia (VT) and ventricular fibrillation (VF), along with sudden cardiac death (SCD), represent serious complications in patients with heart failure (HF). While individuals with severely reduced left ventricular ejection fraction (LVEF), particularly below 35%, are deemed at high risk for lethal arrhythmic events and are considered for implantable cardioverter-defibrillator (ICD) therapy, recent studies have highlighted the occurrence of FAE or SCD in heart failure with preserved ejection fraction (HFpEF) as well. However, the specific risk factors for FAE or SCD in patients with HFpEF remain inadequately elucidated. Purpose This study aimed to investigate the incidence of FAE or SCD and identify their associated risk factors in patients with HFpEF. Methods We retrospectively analyzed the data from our multicenter observational study, the CHART-2 Study, where a total of 10,219 patients were enrolled between 2006 and 2010. Among them, we included patients with HF and LVEF≥50% (n=2,423) with available LVEF data at one year (Figure 1A). They were categorized into two groups based on LVEF status; 198 with decreased LVEF (35-50%; D-group) and 2,225 with preserved LVEF (≥50%; P-group). The primary endpoint was the composite event of FAE or SCD, and all statistical analyses were adjusted for competing risks due to all-cause mortality. Results Among the 2,423 patients with HFpEF (mean age: 69±12 years, 35% female), 120 patients (5.0%) experienced the composite event of FAE or SCD during a median follow-up of 9.1 years (interquartile range: 4.5-11.2 years), with a cumulative incidence of 5.1% at 10 years. Gray’s test revealed a significantly higher incidence of the primary endpoint in the D-group compared with the P-group (10.6% vs. 4.5% at 10 years, p<0.001, Figure 2A). Multivariable analysis identified mild decline of LVEF (Hazard Ratio [HR] 2.20, 95% confidence interval [CI] 1.34-1.60; p=0.002) and non-sustained VT (HR 2.33, 95% CI 1.37-3.97; p=0.002) as independent risk factors for composite event. Landmark analysis demonstrated a consistent trend in the composite event of FAE or SCD in both groups (Figure 2B). Conclusion In patients with HFpEF, even a mild decline in LVEF, which typically does not prompt ICD consideration, was significantly associated with a heightened risk of FAE or SCD. Therefore, a chronological clinical assessment, encompassing changes in LVEF, is essential for patients with HFpEF.

Associated factors and percentage of cardiac recovery among patients using LVAD: a meta-analysis of 31 studies

Abstract Introduction Patients with advanced heart failure use left ventricular assist devices (LVAD) to improve their outcomes and enhance the reverse remodeling of the heart. There has been no previous meta-analysis on the percentage of cardiac recovery after LVAD. This study aims to find the pooled percentage of cardiac recovery after LVAD. Methods A systematic search was done in PubMed, Scopus, Web of Science, Embase, and Cochrane from inception to December 2023. We used the relevant keywords to include studies that reported the percentage of people who achieved cardiac recovery after LVAD. The percentage of participants using LVAD and achieving cardiac recovery was extracted from the studies. RevMan 5.4 was used for meta-analysis. Results Thirty-two studies totaling 39215 patients were included. Different types of LVAD were used among participants. Across studies, different definitions for cardiac recovery were used, and the most used one is device explant following cardiac recovery and achieving left ventricular ejection fraction (LVEF) ≥ 40% after using LVAD. The pooled percentage of people who achieved cardiac recovery was 5.06%, 95% CI [4.17, 5.95], and the result was heterogeneous (I2 = 94%, p < 0.00001). Shorter duration of heart failure, female gender, younger age, presence of Implantable cardioverter-defibrillator (ICD) and low left ventricular end-diastolic diameter (LVEDD) were the most common mentioned factors associated with cardiac recovery. Conclusion Low cardiac recovery was found in patients using LVAD, and several factors were associated with cardiac recovery. Further action could be taken to improve the recovery among this population.

Temporal trends in sudden cardiac death after acute decompensation in HFrEF patients: a 13-year Japanese multicentre registry study

Abstract Background The implementation of guideline-based medical therapy (GBMT) for heart failure with reduced ejection fraction (HFrEF) has significantly contributed to reducing mortality risks. Yet, detailed analyses on temporal trends of sudden cardiac death (SCD) among these patients, especially post-discharge following acute decompensation, remain scarce. Purpose This study aimed to explore changes in the incidence of SCD over the last 13 years in patients with HFrEF discharged after acute decompensation treatment, and to identify clinical factors associated with SCD risk. Methods We analyzed 2,604 consecutive HFrEF (left ventricular ejection fraction [LVEF] ≤40%) patients enrolled in a Japanese multicentre acute heart failure (HF) registry from 2009 to 2021. SCD was defined as an unexpected and otherwise unexplained death in a previously stable patient or death due to documented or presumed cardiac arrhythmia without a clear non-cardiovascular cause. The determination of death cause (SCD, pump failure death, or other) was made by a central adjudicating committee. The Fine and Gray method was employed to analyze factors associated with SCD. The variables submitted to the model included age (≥70 years), gender, LVEF (<30%), ischaemic aetiology and prescription of GBMT (use of renin-angiotensin system inhibitors, β-blockers and mineralocorticoid receptor antagonist) at discharge. Results The mean age of studied patients was 70.9±14.2 years, and 70.0% were male. During the 1-year follow-up period, 262 deaths (10.1%) occurred, including 51 SCDs (2.0%). Older age was associated with an increased risk of SCD (adjusted hazard ratio [HR] 2.81, 95% confidence interval [CI] 1.40-5.64, P=0.004). Further, patients with an ischaemic aetiology had a higher risk of SCD (HR 1.84, 95% CI 1.06-3.22, P=0.032). During the study period, mean age remained constant (71.0 years to 70.7 years, P for trend =0.884). The proportion of ischaemic aetiology also remained constant (from 37.2% to 38.2%, P for trend =0.972). Overall, there were significant decreases in the incidence of all cause death and SCD (from 13.7% to 8.4%, P for trend =0.002; and from 3.5% to 1.0%, P for trend <0.001; Figure A). Notably, there was an increase in the prescription rate of three classes of GBMT at discharge (from 30.9% to 45.6%, P for trend <0.001; Figure B), and the rate of implantable cardioverter-defibrillator (ICD) use in eligible patients (New York Heart Association functional class II-III with LVEF ≤35%) remained constant (from 9.6% to 11.6%, P for trend =0.157; Figure B). Conclusions With the increasing use of GBMT, the incidence of SCD decreased in real-world patients with HFrEF registered in a Japanese acute HF registry over the past decade.

Equal performance of the subcutaneous and transvenous implantable cardioverter defibrillator across all age groups in the PRAETORIAN trial

Abstract Introduction The subcutaneous ICD (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. In the PRAETORIAN trial the S-ICD proved to be non-inferior to the TV-ICD with regard to inappropriate shocks (IAS) and complications. However, the S-ICD is still mainly the preferred choice in young patients with a long life expectancy and therefore higher risk for lead-related complications. We aimed to evaluate the impact of age on complications and IAS between the S-ICD and TV-ICD. Methods The PRAETORIAN trial is an investigator-initiated, international, multicenter, randomized, two-arm noninferiority trial that was conducted in the United States and Europe. In total 849 patients with a class I or IIa indication for ICD therapy and no pacing indication were randomized to receive an S-ICD (N=426) or TV-ICD (N=423) and followed for a median of 49 months. We compare the occurrence of complications and IAS between increasing quartiles of age. Results Quartile 1 (Q1) consisted of 203 patients aged <55 (109 S-ICD, 94 TV-ICD), Q2 of 199 patients aged 55-62 (100 S-ICD, 99 TV-ICD), Q3 of 232 patients aged 63-69 (111 S-ICD, 121 TV-ICD) and Q4 of 215 patients aged ≥70 (106 S-ICD, 109 TV-ICD). Between the quartiles, there were no significant differences in occurrence of device-related complications (P = 0.32) or IAS (P = 0.66). In Q1, there were 15 (7.4%) complications (5 S-ICD, 10 TV-ICD) and 13 (6.4%) IAS (7 S-ICD, 6 TV-ICD), compared to 20 (10.1%) complications (7 S-ICD, 13 TV-ICD) and 17 (8.5%) IAS (9 S-ICD, 8 TV-ICD) in Q2, 22 (9.5%) complications (12 S-ICD, 10 TV-ICD) and 19 (8.2%) IAS (11 S-ICD, 8 TV-ICD) in Q3 and 18 (8.4%) complications (7 S-ICD, 11 TV-ICD) and 21 (9.8%) IAS (14 S-ICD, 7 TV-ICD) in Q4 (Figure 1.). Figure 2. shows forest plots of the hazard ratios per quartile. Conclusions The S-ICD performed equal to the TV-ICD with regard to IAS and complications between quartiles of age, making the S-ICD a good alternative across all age groups.

Predictor of wasted implantable cardioverter defibrillator for secondary prevention

Abstract Background ICD is the first line treatment to prevent sudden cardiac death from recurrence of VT/VF. However, patients with organic heart disease have many comorbidities, and some patients die without history of appropriate ICD therapy in lifetime. Purpose The aim of this study is to examine the predictors of death without appropriate ICD therapy in lifetime, among ICD patients for secondary prevention with organic heart disease. Methods We enrolled consecutive patients implanted with ICD/CRT-D for secondary prevention between 2000 and 2022. We excluded patients without organic heart disease, and alive patients without history of appropriate ICD therapy. Inappropriate candidate (Wasted-group) for defibrillator was defined as the patient who died without history of appropriate ICD therapy or died within one year from appropriate ICD therapy. Appropriate candidate (Appropriate-group) was defined as the patient who had been alive over one year from appropriate ICD therapy (Wasted-group:36, Appropriate-group:131). Results During a follow-up of 8.3 ± 5.3 years, a total of 93 (56%) patients died, including 6 (4%) patients died within one year from ICD/CRT-D implantation. Among the 36 patients of Wasted-group, 28 patients died without history of appropriate ICD therapy. Higher age, ischemic cardiomyopathy, non-ARVC, a past history of VF, diabetes mellitus, and higher serum creatinine was the predictor of Wasted-group (P<0.05). Wasted ICD risk score was constructed with the summation of these predictors for predicting candidates of Wasted-group. When the Wasted ICD risk score was ≥3, positive predictive value and negative predictive value were 39.7% and 89.4%, respectively (AUC=0.77, P<0.001). Conclusion Patients with a Wasted ICD risk score <3 is likely to receive appropriate ICD therapy in lifetime. Therefore, Wasted ICD risk score might be useful to decide to need for ICD therapy, regarding elderly patients who would be hesitant to have ICD implanted.Wasted ICD risk score

Long-term prognostic value of multiple circulating biomarkers for ventricular arrhythmias in patients with left ventricular hypertrabeculation

Abstract Background Left ventricular hypertrabeculation (LVHT) is a rare morphologic phenotype of the heart with heterogeneous manifestations and variable prognosis [1,2]. Ventricular arrhythmia (VA) has been recognized as an independent risk factor that significantly impacts the mortality of LVHT patients [1,3]. However, knowledge regarding the prognosis and risk stratification of VAs in LVHT is currently limited. Purpose To explore the long-term predictive value of multiple circulating biomarkers reflecting cardiac function, endothelial function, inflammation, and oxidative stress for the development of VAs in LVHT patients. Methods This longitudinal cohort study consecutively enrolled morphologically diagnosed LVHT patients between January 2012 and December 2020 at a national-level medical center. All participants possessed thorough profiles of multiple biomarkers [N-terminal pro-brain natriuretic peptide, big endothelin-1 (big ET-1), high-sensitivity C-reactive protein, uric acid and free fatty acid] and had no previously documented ventricular arrhythmic events. The cohort were followed annually until October 2022. VA was defined as a composite of non-sustained ventricular tachycardia, sustained ventricular tachycardia, ventricular fibrillation, and appropriate therapy of implantable cardioverter defibrillator. Potential predictors for VAs in the LVHT cohort were evaluated by multivariable Cox regression. Restricted cubic spline (RCS) analysis was employed to explore the nonlinear association between plasma big ET-1 and clinical outcomes. Differences in the cumulative incidence of VAs according to big ET-1 levels and/or the extent of hypertrabeculation were analyzed by Kaplan-Meier curves. Results A total of 265 morphologically diagnosed LVHT patients (44.2 ± 17.0 years, 65.7% male) were included in this study. Over a median follow-up of 4.34 years, 82 (30.9%) patients experienced ventricular arrhythmic events. Multivariable Cox regression analysis identified that baseline levels of big ET-1 (hazard ratio 1.513, 95% confidence interval 1.136-2.013) and isolated hypertrabeculation in left ventricular lateral wall (LVLW) (hazard ratio 1.810, 95% confidence interval 1.023-3.202) were independently associated with the occurrence of VAs. RCS analysis illustrated that the susceptibility to VAs was remarkably raised with the increase of big ET-1 levels. LVHT patients with higher plasma big ET-1 suffered from more severe cardiac dysfunction and remodeling. Individuals who displayed elevated concentrations of big ET-1 and isolated LVLW hypertrabeculation were at a significantly greater risk of developing VAs. Conclusions Introducing routine assessments for plasma big ET-1 and the extent of hypertrabeculation at baseline can offer valuable support in the risk stratification and clinical management of ventricular arrhythmic events in patients with LVHT.Prognositc value of big ET-1 for VAsbig ET-1/LVLW hypertrabeculation & VAs