Cardiac Resynchronization Therapy With Defibrillator Research Articles

Comparative Analysis of Response to Cardiac Resynchronisation Therapy Upgrades in Patients with Implantable Cardioverter-Defibrillators and Pacemakers

Introduction: The efficacy of de novo cardiac resynchronisation therapy (CRT) in patients with heart failure (HF), left ventricular systolic dysfunction (LVSD), and a broad QRS morphology is well established. However, the optimal stage for upgrading patients with existing pacemakers (PPMs) or implantable cardioverter-defibrillators (ICDs) and HF with high-burden right ventricular (RV) pacing remains uncertain. Thus, this multicentre retrospective analysis compared patients with pre-existing PPMs or ICDs who underwent CRT upgrades to investigate the appropriate stage for CRT implantation in these patients and to assess the validity of treating both PPM and ICD recipients under the same recommendation level in the current guidelines. Materials and Methods: A total of 151 participants underwent analysis in this study, comprising 93 upgrades to cardiac resynchronisation therapy with pacemaker (CRT-P) and 58 upgrades to cardiac resynchronisation therapy with defibrillator (CRT-D) across three centres in the UK. The aim of the study was to investigate the safety and efficacy of upgrading to CRT from an existing conventional pacemaker or an ICD in the context of high-burden RV pacing. The analysis was conducted separately for each group, assessing changes in echocardiographic parameters, functional New York Heart Association (NYHA) class, and procedure-related complications. Results: The PPM group had a higher percentage RVP burden compared to the ICD group. Post-upgrade, NYHA functional class and EF and LV volumes improved in both groups; however, the response to an upgrade from a pacemaker was greater compared to an upgrade from an ICD. Post-procedural complication risks were similar across the two subgroups but significantly higher compared to de novo implantation. Conclusions: Within the CRT-P subgroup, participants exhibited better responses than their CRT-D counterparts, evident both in echocardiographic improvements and clinical outcomes. Furthermore, patients with non-ischemic cardiomyopathy (NICM) were better responders than those with ischaemic cardiomyopathy. These findings suggest that international guidelines should consider approaching each subgroup separately in the future.

Impact of Chronotropic Incompetence and Correlation with Exercise Tolerance in Patients with Implantable Cardiac Devices Undergoing a Phase II Cardiac Rehabilitation Program Article Sidebar

Objective: Since patients with implantable cardiac devices tend to develop chronotropic incompetence (CI) associated with the effect of the device itself or the pharmacological effect of the underlying disease, CI could act as a limiting factor in improving exercise tolerance in patients undergoing cardiac rehabilitation program, since an increase in HR is a crucial part in improving cardiac output as a central component of oxygen consumption (VO2). However, it has been observed that there could be other factors contributing to the improvement in exercise tolerance in these patients regardless of the presence of CI. The aim of this research is to clarify the effect of chronotropic incompetence on the improvement in exercise capacity in patients with implantable cardiac devices after a phase II cardiac rehabilitation program (CRP). Methods: Quasi-experimental study applied to patients with implantable cardiac devices (ICDs, CRT, pacemakers) undergoing a supervised concurrent CRP, lasting 4-6 weeks, at an intensity between 65-80% of heart rate reserve (HRR), associated with kinesiotherapy sessions (with strength and endurance training and other biomotor qualities) and interdisciplinary intervention, education, and counseling. CI was calculated using the chronotropic response index, and METs-load measurement was performed at the beginning and at the end of the intervention. Results: Forty patients with a mean age of 61.4 years were included, mostly male (29) 72.5%, (23) 57.5% diagnosed with heart failure, and regarding the type of device, pacemakers (20) 50%, implantable cardioverter-defibrillator (ICD) (12) 30%, and cardiac resynchronization therapy with defibrillator (CRT-D) (20) 8%, of the total patients (35) 87.5% presented chronotropic incompetence and only (5) 12.5% with normal chronotropic response at the end of the intervention. A significant decrease in the chronotropic response index from 0.70 to 0.47 (p <0.001) and a significant increase in METs-load from 5.47 to 9.35 (p <0.001) were found. The value of the differential between initial and final METs (delta-METs) was obtained for both groups, observing a significant increase between initial and final METs in favor of patients with CI (3.8 Vs 3.5, p<0.012) at the end of the intervention. A significant moderate negative correlation (r=-0.395, Spearman, p<0.012) was determined between the degree of CI and final METs-load. Conclusions: It was observed that patients with implantable cardiac devices undergoing a CRP show an increase in exercise tolerance measured in METs, with an inversely proportional correlation to chronotropic incompetence.

Impact of atrial fibrillation on 1-year outcome in patients with implantable cardioverter defibrillator or cardiac resynchronization therapy with defibrillator: results from the German DEVICE Registry.

Atrial fibrillation (AF) is a cardiac arrhythmia frequently documented in patients requiring implantable cardioverter defibrillators (ICDs) and/or cardiac resynchronization therapy with defibrillator (CRT-D). Patients with diagnosed AF at the point of ICD or CRT-D implantation may have an impaired follow-up outcome. The German DEVICE I-II registry is a nationwide prospective multicentre database of patients implanted with ICD and CRT-D with clinical follow-up data. We analysed a 1-year follow up of implanted patients with AF and with sinus rhythm (SR). A total of 4,929 ICD/CRT patients are included in the present analysis: 946 (19.2%) were in AF and 3,983 (80.8%) were SR at time of device implantation. AF patients had a significantly more comorbid profile including older age {72 [interquartile range (IQR), 66-77] vs. 66 (IQR, 56-73) years; P<0.001}, and higher rate of patients with left ventricular ejection fraction <30% (68.2% vs. 61.0%; P<0.001), peripheral artery disease (4.5% vs. 2.7%; P=0.002), diabetes (33.6% vs. 25.5%; P<0.001), hypertension (58.4% vs. 51.1%; P<0.001) and renal failure (22.6% vs. 15.3%; P<0.001). The intra-hospital complication rate was 4.3% in the AF and 3.6% in the SR group (P=0.38). In 1-year follow-up AF patients experienced a significantly higher rate of defibrillator shocks (25% vs. 15.3%; P<0.001). One-year estimated mortality was 10.8% in the AF and 5.9% in the SR group (P<0.001), while estimated 1-year major adverse cardiac and cerebrovascular events (MACCE) rate was 11.2% vs. 7.0% (P<0.001). The effects of AF on electrical shocks and mortality persisted after adjusting for age, sex, advanced New York Heart Association (NYHA) class, severely impaired left ventricular ejection fraction (LVEF), coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), chronic renal failure (CRF), QRS duration, and type of indication for electronic device implantation. Our clinical data on an extended cohort of contemporary patients confirm the significant impact of AF, and its associated comorbidities, upon mortality and major adverse events after implantation of ICD/CRT.

Cardiac Device Therapy in Patients with Chronic Kidney Disease: An Update.

Cardiovascular diseases (CVDs) and chronic kidney disease (CKD) are frequently interconnected and their association leads to an exponential increase in the risk of both fatal and non-fatal events. In addition, the burden of arrhythmias in CKD patients is increased. On the other hand, the presence of CKD is an important factor that influences the decision to pursue cardiac device therapy. Data on CKD patients with device therapy are scarce and mostly derives from observational studies and case reports. Cardiac resynchronization therapy (CRT) is associated with decreased mortality, reduced heart failure symptoms, and improved renal function in early stages of CKD. Implantable cardioverter defibrillators (ICDs) are associated with a significant reduction in the mortality of CKD patients only for the secondary prevention of sudden cardiac death. Cardiac resynchronization therapy with defibrillator (CRT-D) is preferred in patients who meet the established criteria. The need for cardiac pacing is increased three-fold in dialysis patients. CKD is an independent risk factor for infections associated with cardiac devices.

Factors associated with early and late Staphylococcus aureus bacteraemia after first cardiac implantable electronic device implantation a Danish nationwide cohort study

Abstract Background Staphylococcus aureus bacteraemia (SAB) is a serious condition with high morbidity and mortality. Patients with a cardiac implantable electronic device (CIED) and SAB carries a risk of up to 50 % for device related infection. Yet, little is known about risk factors for early and late SAB in CIED patients in real-world clinical practice. Purpose We aimed to identify risk factors associated with first-time early and late SAB following de novo CIED implantation among adult Danish patients. Methods Using the Danish Pacemaker and ICD Register, we identified all Danish patients aged 18 to 99 years with a first CIED implantation between 2000 and 2020. The primary outcome of first-time post-CIED implantation SAB was identified from The National Danish Staphylococcus Aureus Bacteriemia Database. Early SAB was defined as SAB ≤ 6 months from CIED implantation. Late SAB was defined as first-time SAB after CIED, occurring &amp;gt; 6 months from CIED implantation. Multivariable Cox regression with backward elimination was used to identify factors associated with increased risk of developing early and late SAB. Age, sex, device type, implantation year, preexisting co-morbidity, procedure related factors and prior surgery (thoracic, abdominal, orthopedic, gynecologic, or urologic) was evaluated. Statistically significant variables were fitted to the final models to obtain hazard ratios with 95% confidence intervals. Results We identified 87,216 patients with first-time CIED implantation within the study period: PM n = 66,151 (75.8%); Implantable Cardioverter Defibrillator (ICD) n = 13,498 (15.5%); Cardiac resynchronization therapy PM (CRT-P) n = 3,491 (4.0 %); Cardiac resynchronization therapy with defibrillator (CRT-D) n = 4,076 (4.7 %). Median age across the population was 75 years (IQR 66-82) and 62.6% were males. Median time to SAB in the early SAB group was 46 days (IQR 18-105) and 2,9 years (IQR 1.5-5.1) in the late SAB group. Post implantation SAB was observed in 1,399 (1.6%) patients; with 363 (25.9%) early SAB events and 1,036 (74.1%) late SAB events. Factors associated with early SAB included previous SAB, renal dialysis, COPD, surgery 1 year prior to CIED implantation, liver disease, diabetes, and congestive heart failure (Figure 1). Male sex, increasing age, previous SAB, congestive heart failure, aortic valve disease, diabetes, renal dialysis, COPD, cancer, liver disease and the use of systemic corticosteroids were associated with an increased risk of late SAB. Conclusions Renal dialysis, previous SAB, diabetes, congestive heart failure, COPD and liver disease were associated with an increased risk of both early and late SAB. Increasing age, male sex, aortic valve disease and cancer were associated with an increased risk of late SAB, while surgery within 1 year prior to CIED implantation was associated with early SAB. Most of the identified factors were non-modifiable and comparable to known risk factors for SAB in non-CIED patients.Figure 1

Abstract 17896: Implantable Cardioverter Defibrillator in Cardiac Resynchronization Therapy Recipients With Advanced Chronic Kidney Disease

Introduction: The effectiveness of the implantable cardioverter defibrillator (ICD) in preventing sudden cardiac death (SCD) is well-established in heart failure patients with reduced ejection fraction (HFrEF). However, the benefit of the ICD in advanced chronic kidney disease (CKD) patients remains elusive, particularly in those who are cardiac resynchronization therapy (CRT) recipients. Hypothesis: In CRT recipients with CKD, the benefit of the ICD may be attenuated due to the competing risk of mortality before experiencing an arrhythmia. Methods: A total of 1015 patients receiving CRT with defibrillator (CRT-D) for primary prevention of SCD were included from the MADIT-CRT and RAID trials. Patients were categorized into two groups based on kidney disease (KD) stage: Stage 1-3a (S1-S3a) CKD and Stage 3b-5 (S3b-S5) CKD. The primary endpoint was the occurrence of ventricular tachycardia (VT) or ventricular fibrillation (VF). Results: The cumulative incidence of any VT/VF was 23.5% in patients with (S1-S3a)KD and 12.6% in those with (S3b-S5)KD (p&lt;0.001 [Figure left panel]). Death without VT/VF occurred in 6.6% of patients with (S1-S3a)KD and 21.6% of patients with( S3b-S5)KD (p&lt;0.001 [Figure right panel]). A multivariate competing risk regression model revealed that patients with (S3b-S5)KD had a 43% lower risk of experiencing any VT/VF compared to those with (S1-S3a)KD (HR=0.56, 95% CI [0.33-0.94], p=0.03). Over two years of follow-up, patients with (S3b-S5)KD had nearly a five-fold increased risk of death without VT/VF compared to those with (S1-S3a)KD (HR=4.63, 95% CI [2.46-8.72], p for interaction with time=0.012). Conclusions: The benefit of the ICD may be attenuated in CRT recipients with advanced CKD due to a lower incidence of arrhythmias and a higher risk of non-arrhythmic death. Future prospective trials should investigate whether CRT without a defibrillator is more suitable for these patients.

Tachycardia Therapy Outcomes of Ischemic Versus Nonischemic Cardiomyopathy on Cardiac Resynchronization Therapy: A Propensity Score-matched Analysis.

This investigation aimed to investigate differences between dilated cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) patients treated with cardiac resynchronization therapy with defibrillator (CRT-D) for tachycardia therapy-related outcomes as well as mortality during follow-up of at least 1 year. Seventy-eight patients with DCM (n = 42) and ICM (n = 36) with implantation or upgradation to CRT-D were included in this study and analyzed for incidence of non-sustained ventricular tachycardia (NSVT), non-sustained ventricular fibrillation (NSVF), defibrillator therapies, anti-tachycardia pacing (ATP), and mortality. DCM was the underlying etiology in 42 (53.84%) and ICM in 36 (46.15%). Time to first therapy was numerically longer in DCM than in ICM (9.5 ± 2.4 vs. 7.1 ± 3.2; P-value = 0.088). DCM patients had significantly higher therapy-free survival and mortality compared with ICM patients (OR (95%CI): 0.238 (0.155-0.424); log-rank P = 0.017) and (OR (95% CI): 0.612 (0.254-0.924); log-rank P = 0.029). ICM (HR (95%CI): 0.529 (0.243-0.925); P-value = 0.014) CAD (HR (95%CI): 0.326 (0.122-0.691): P-value = 0.003), and NSVT (HR (95%CI): 0.703 (0.513-0.849): P-value = 0.005) were demonstrated as independent predictors of the primary endpoint of appropriate therapy in CRT-D and ICM (HR (95%CI): 0.421 (0.321-0.524); P-value = 0.037), chronic kidney disease (CKD; HR (95%CI): 0.289 (0.198-0.380); P-value = 0.013), and CAD (HR (95%CI): 0.786 (0.531-0.967); P-value = 0.003) were predictors of mortality. The clinical course of ICM and DCM cohorts who were treated with CRT-D differs significantly during follow-up, with increased tachycardia therapy and increased incidence of mortality in ICM patients.

Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial.

De novo implanted cardiac resynchronization therapy with defibrillator (CRT-D) reduces the risk of morbidity and mortality in patients with left bundle branch block, heart failure and reduced ejection fraction (HFrEF). However, among HFrEF patients with right ventricular pacing (RVP), the efficacy of CRT-D upgrade is uncertain. In this multicentre, randomized, controlled trial, 360 symptomatic (New York Heart Association Classes II-IVa) HFrEF patients with a pacemaker or implantable cardioverter defibrillator (ICD), high RVP burden ≥ 20%, and a wide paced QRS complex duration ≥ 150 ms were randomly assigned to receive CRT-D upgrade (n = 215) or ICD (n = 145) in a 3:2 ratio. The primary outcome was the composite of all-cause mortality, heart failure hospitalization, or <15% reduction of left ventricular end-systolic volume assessed at 12 months. Secondary outcomes included all-cause mortality or heart failure hospitalization. Over a median follow-up of 12.4 months, the primary outcome occurred in 58/179 (32.4%) in the CRT-D arm vs. 101/128 (78.9%) in the ICD arm (odds ratio 0.11; 95% confidence interval 0.06-0.19; P < .001). All-cause mortality or heart failure hospitalization occurred in 22/215 (10%) in the CRT-D arm vs. 46/145 (32%) in the ICD arm (hazard ratio 0.27; 95% confidence interval 0.16-0.47; P < .001). The incidence of procedure- or device-related complications was similar between the two arms [CRT-D group 25/211 (12.3%) vs. ICD group 11/142 (7.8%)]. In pacemaker or ICD patients with significant RVP burden and reduced ejection fraction, upgrade to CRT-D compared with ICD therapy reduced the combined risk of all-cause mortality, heart failure hospitalization, or absence of reverse remodelling.

Primary prevention implantable cardioverter defibrillator in cardiac resynchronization therapy recipients with advanced chronic kidney disease.

The implantable cardioverter defibrillator (ICD) is effective for the prevention of sudden cardiac death (SCD) in patients with heart failure and a reduced ejection fraction (HFrEF). The benefit of the ICD in patients with advanced CKD, remains elusive. Moreover, the benefit of the ICD in patients with advanced chronic kidney disease (CKD) and HFrEF who are cardiac resynchronization therapy (CRT) recipients may be attenuated. We hypothesized that patients with CKD who are CRT recipients may derive less benefit from the ICD due to the competing risk of dying prior to experiencing an arrhythmia. The study population included 1,015 patients receiving CRT with defibrillator (CRT-D) device for primary prevention of SCD who were enrolled in either (Multicenter Automated Defibrillator Implantation Trial) MADIT-CRT trial or the Ranolazine in High-Risk Patients with Implanted Cardioverter Defibrillator (RAID) trial. The cohort was divided into two groups based on the stage of CKD: those with Stage 1 to 3a KD, labeled as (S1-S3a)KD. The second group included patients with Stage 3b to stage 5 kidney disease, labeled as (S3b-S5)KD. The primary endpoint was any ventricular tachycardia (VT) or ventricular fibrillation (VF) (Any VT/VF). The cumulative incidence of Any VT/VF was 23.5% in patients with (S1-S3a)KD and 12.6% in those with (S3b-S5)KD (p < 0.001) The incidence of Death without Any VT/VF was 6.6% in patients with (S1-S3a)KD and 21.6% in patients with (S3b-S5)KD (p < 0.001). A Fine and Gray multivariate competing risk regression model showed that Patients with (S3b-S5)KD had a 43% less risk of experiencing Any VT/VF when compared to those with (S1-S3a)KD (HR = 0.56, 95% CI [0.33-0.94] p = 0.03. After two years of follow up, there was almost a 5-fold increased risk of Death without Any VT/VF among patients with (S3b-S5)KD when compared to those with (S1-S3a)KD [HR = 4.63, 95% CI (2.46-8.72), p for interaction with time = 0.012]. Due to their lower incidence of arrhythmias and higher risk of dying prior to experiencing an arrhythmia, the benefit of the ICD may be attenuated in CRT recipients with advanced CKD. Future prospective trials should evaluate whether CRT without a defibrillator may be more appropriate for these patients.

Effectiveness of adding a defibrillator with cardiac resynchronization therapy in heart failure according to the modified Model for End-stage Liver Disease-Albumin score.

Current guidelines lack clear recommendations between the implantation of cardiac resynchronization therapy (CRT) with defibrillator (CRT-D) and CRT with pacemaker (CRT-P). We hypothesized that modified model for end-stage liver disease score including albumin (MELD-Albumin score), could be used to select patients who may not benefit from CRT-D. We consecutively included patients with CRT-P or CRT-D implantation between 2010 and 2022. The primary endpoint was the composite of all-cause mortality or worsening heart failure. We performed multivariable-adjusted Cox proportional hazard regression. We assessed the interaction between the MELD-Albumin score and the effect of adding a defibrillator with CRT.A total of 752 patients were included in this study, with 291 implanted CRT-P. During a median follow-up of 880 days, 205 patients reached the primary endpoint. MELD-Albumin score was significantly associated with the primary endpoint in the CRT-D group [HR 1.16 (1.09-1.24); P < 0.001] but not in the CRT-P group [HR 1.03 (0.95-1.12); P = 0.49]. There was a significant interaction between the MELD-Albumin score and the effect of CRTD (P = 0.013). The optimal cut-off value of the MELD-Albumin score was 12. For patients with MELD-Albumin ≥ 12, CRT-D was associated with a higher occurrence of the primary endpoint [HR 1.99 (1.10-3.58); P = 0.02], whereas not in patients with MELD-Albumin < 12 [HR 1.19 (0.83-1.70); P = 0.35). Our findings suggest that CRT-D is associated with an excess risk of composite clinical endpoints in HF patients with higher MELD-Albumin score.

Substernal Extravascular Implantable Cardioverter-Defibrillator System Infections in Large Animals.

The extravascular implantable cardioverter-defibrillator (EV ICD) with lead implantation in the substernal space may provide clinical advantages over transvenous and subcutaneous systems. This is the first reported examination of substernal infection in large animals implanted with the EV ICD system.The system was implanted in 13 large animals (canine, porcine, and ovine). The porcine were co-implanted with a transvenous cardiac resynchronization therapy with defibrillator (CRT-D) system. Infection was promoted through a cadence of immunosuppressive monitors and study interventions. The animals were monitored for clinical presentation of infection over 12-18 weeks, and cultures were collected to confirm infection. Treatment was bifurcated: 1) some infections were treated only with antibiotics ( "antibiotics only" ), whereas 2) some infections were treated with system removal and antibiotics ( "antibiotics + explant" ). Histopathology was conducted at the study closure.Five infections were confirmed over the course of the study, four of which involved infection of the EV ICD system and one infection of only the concomitantly implanted transvenous CRT-D system without EV ICD-related infection. Among the four EV ICD infections, two of two infections treated with antibiotics only did not resolve whereas two of two infections treated with antibiotics + explant resolved, as shown by histology. The transvenous CRT-D system infection progressed to septicemia and endocarditis, requiring early study discontinuation. No EV ICD-related infection progressed to blood stream infection, and the sternal bone did not become infected when infection was present in the substernal tissues.The study findings suggest that EV ICD-related infections are treatable with system removal and antibiotic therapy.

Left bundle branch pacing-optimized implantable cardioverter-defibrillator (LOT-ICD) for cardiac resynchronization therapy: A pilot study.

Left bundle branch pacing (LBBP) involves direct capture of left bundle fibers by placing the lead deep inside the interventricular septum. Several studies have shown the feasibility and efficacy of LBBP as an alternative modality for cardiac resynchronization therapy (CRT). This paper describes approach for providing cost effective CRT with defibrillator (CRT-D) by LBBP and dual chamber implantable cardioverter defibrillator (ICD) which we label as LBBP optimized ICD (LOT-ICD). LBBP was performed using C315 sheath and 3830 Selectsecure lead in all patients by premature ventricular complex guided approach. In patients with complete correction of conduction system disease, IS-1 connector plug of the IS-1/DF-1 lead was capped and 3830 lead connected to the dual chamber ICD pulse-generator at RV-P/S port. LOT-ICD provided stable R-wave sensing for arrhythmia monitoring and resulted in cost-effective resynchronization therapy at reduced fluoroscopy duration and radiation dose.

Abstract 10739: Impact of Cardiac Device Implantation in Elderly Japanese Patients With Heart Failure as Primary Prevention-A Post Hoc Analysis of the HINODE Trial

Introduction: Despite increase in the incidence of chronic heart failure (HF) and sudden cardia death (SCD), the current use of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) in Japan is much lower than in Western countries. The HF Indication and SCD Prevention Trial Japan (HINODE) was designed to prospectively assess the rate of mortality, appropriately treated ventricular arrhythmias (VA) and heart failure (HF) for comparison with references from historical landmark trial MADIT-RIT in Japanese patients. Hypothesis: This sub analysis of HINODE evaluates the impact of ICD or CRT implantation in elderly Japanese patients concomitant with higher risk of heart failure. Methods: After treatment decisions following contemporary practice in Japan, patients were prospectively enrolled into four cohorts: (1) ICD (2) CRT with defibrillator (CRT-D) (3) standard medical therapy (‘non-device’) (4) pacing (indicated for CRT; received pacemaker or CRT pacing). We compared the all-cause mortality between elderly and non-elderly patients with elderly defined as age&gt;70 at the time of study enrollment. Results: The HINODE study enrolled 354 patients (191 elderly) followed for 19.6 ± 6.5 months with a minimum of 12 months and an absolute death rate of 11.0%. The estimated survival rate for device recipients (n=239) through 24 months was 86.1% (97.5% LCL: 79.8%) with no significant difference for elderly vs non-elderly patients (HR 1.97, 95%CI: 0.86-4.54). Analysis within cohorts showed increased risk of all-cause mortality for elderly with an ICD compared to non-elderly with an ICD (HR 5.09 95% CI: 1.1-23.6). However, ICD cohort excluding those with CRT-D indication showed no significant difference (HR 3.70, 95% CI: 0.75-18.35). No significant difference showed in other cohorts: CRT-D (HR 1.53 95% CI: 0.34-6.84) or pacing (HR 0.84, 95%CI: 0.2-3.5). Ventricular event free rate in ICD and CRT-D patients also had no difference (HR 0.84 95% CI: 0.31-2.25) Conclusions: Although elderly patients might be associated with higher risk of mortality in general, benefit of device therapy is comparable to non-elderly patients. We might consider device therapy despite age as a standalone risk in contemporary Japanese clinical practice.

Angiotensin receptor/Neprilysin inhibitor effects in CRTd non-responders: From epigenetic to clinical beside

ObjectivesWe evaluated whether Angiotensin receptor/Neprilysin inhibitors (ARNI) reduce heart failure (HF) hospitalizations and deaths in cardiac resynchronization therapy with defibrillator (CRTd) non-responders patients at 12 months of follow-up, modulating microRNAs (miRs) implied in adverse cardiac remodeling. Backgroundadverse cardiac remodeling characterized by left ventricle ejection fraction (LVEF) reduction, left ventricular end-systolic volume (LVESv) increase, and the 6-minute walking test (6MWT) reduction are relevant pathological mechanisms in CRTd non-responders and could be linked to changes in miRNAs (miRs), regulating cardiac fibrosis, apoptosis, and hypertrophy. MethodsmiRs levels and clinical outcomes (LVEF, cardiac deaths, and 6MWT) were evaluated at baseline and one year of follow-up in CRTd non-responders divided into ARNI-users and Non-ARNI users. ResultsAt baseline, there were no differences in levels of inflammatory markers, miR-18, miR-145, and miR-181 (p > 0.05) between Non-ARNI users (n 106) and ARNI-users (n 312). At one year of follow-up, ARNI-users vs. Non-ARNI users showed lowest inflammatory markers (p < 0.01) and miR-181 levels (p < 0.01) and higher values of miR-18 (p < 0.01)and miR-145 (p < 0.01). At one year of follow-up, ARNI-users had a higher increase of LVEF (p < 0.01) and 6MWT (p < 0.01) along with a more significant reduction of LVESv (p < 0.01) compared to Non-ARNI users. Cox regression analysis evidenced that ARNI-based therapies increase the probability of anti-remodeling effects of CRTd. Based on symptomatic improvements, echocardiographic and functional classification improvements, 37 (34.9%) patients among ARNI-users became responders, while only twenty (6.4%) patients became responders among Non-ARNi-users. ConclusionsARNI might influence epigenetic mechanisms modulating miRs implicated in the adverse cardiac remodeling responses to CRTd.

Population-Level Impact of the Guidelines Update on Patient Selection and Outcomes After Cardiac Resynchronization Therapy

This study sought to analyze the impact of the American College of Cardiology, American Heart Association, and Heart Rhythm Society (ACC/AHA/HRS) guidelines for cardiac resynchronization therapy with defibrillator (CRT-D) update on utilization and efficacy of CRT-D. In September 2012, the ACC/AHA/HRS guidelines for CRT-D were modified to include left bundle branch block (LBBB) as a Class I indication. The IBM Watson MarketScan Database was queried between January 1, 2003, and December 31, 2018, for CRT-D implants or upgrades. The primary outcome was heart failure (HF) hospitalization following left ventricular lead implant. Secondary outcomes included all-cause mortality and device-related lead revision. A total of 27,238 patients were analyzed: 18,384 pre-update and 8,854 post-update. Mean age was 69 ± 11 years, 73% men, and 98% with history of HF hospitalization. The proportion of patients with LBBB increased from 29% to 55% (P< 0.001) after the update. Patients receiving CRT-D post-update demonstrated a greater prevalence of comorbidities, including atrial fibrillation (47% vs 40%; P< 0.001), diabetes mellitus (45% vs 39%; P< 0.001), chronic kidney disease (24% vs 15%; P< 0.001), and HF hospitalization in the year before CRT-D (40% vs 37%; P< 0.001). Despite greater baseline comorbidities, HF hospitalization significantly declined post-update (HR: 0.89; P< 0.001). Multivariate predictors of reduced HF hospitalization included angiotensin receptor neprilysin inhibitor prescription (HR: 0.48; P< 0.001) and presence of LBBB (HR: 0.71; P< 0.001). All-cause mortality was not significantly different between the 2 groups, and fewer lead revisions were noted post-update (0.6% vs 1.7%; P< 0.001). The revised 2012 guidelines led to an increased proportion of LBBB patients receiving CRT-D at the population-level. This change was associated with reduced HF hospitalization, despite broadening therapy to patients with more comorbid conditions.

Temporal trends and long-term outcomes among recipients of cardiac resynchronization therapy with defibrillator in the United States, 2011-2015: Insights from the National Cardiovascular Data Registry.

BackgroundContemporary data on national trends and outcomes in cardiac resynchronization therapy with defibrillator (CRT-D) recipients following the 2012 updated guidelines has not been studied.ObjectivesThis study assessed the trends in long-term outcomes among CRT-D Medicare-aged recipients implanted in 2011–2015.MethodsPatients aged ≥65 years undergoing de novo CRT-D implantation in the National Cardiovascular Data Implantable Cardiac Defibrillator Registry from 2011–2015 with follow-up through 2017 using Medicare data were included and stratified by year of implant. Patient characteristics, in-hospital outcomes, and outcomes up to 2 years following implant were evaluated.ResultsAmong 53,174 patients (aged 75.6–6.4 years, 29.7% women) implanted with CRT-D from 2011 to 2015, there was an increase in implantations based on guideline-concordant recommendations (81.0% to 84.7%, P < .001). Compared to 2011, in-hospital procedural complications decreased in 2015 (3.9% vs 2.9%; adjusted odds ratio, 0.76, 95% confidence interval, 0.66–0.88, P < .001), driven in part by decreased lead dislodgement (1.4% vs 1.0%). After multivariable adjustment, there was a lower risk of all-cause hospitalization, cardiovascular hospitalization, and mortality at 2-year follow-up in 2015 as compared to 2011, while there were no differences in heart failure hospitalizations at follow-up.ConclusionAmong Medicare beneficiaries receiving CRT-D from 2011 to 2015, there was an increase in implantations based on guideline-concordant recommendations. Furthermore, there has been a reduction in in-hospital complications and long-term outcomes, including cardiovascular hospitalization, all-cause hospitalization, and mortality; however, there has been no difference in the risk of heart failure hospitalization after adjustment.

Guideline-directed device therapies in heart failure: A clinical practice-based analysis using electronic health record data

BackgroundGuideline-directed device therapies (GDDT) improve outcomes for eligible patients with heart failure (HF) with reduced ejection fraction (HFrEF). Utilization rates of device therapies in HFrEF after the 2012 ACCF/AHA/HRS Focused Update for Device-based Therapies of Cardiac Rhythm Abnormalities have not been well studied. ObjectiveCharacterize the use of GDDT in newly indicated HFrEF patients from 2012 to 2019 using aggregated electronic health record (EHR) data. MethodsComputable phenotyping algorithms for implantable cardioverter defibrillator/cardiac resynchronization therapy-defibrillator (ICD/CRT-D) indications from the GuideLine Indications Detected in EHR for Heart Failure program (GLIDE-HF) used diagnoses, procedures, measures, prescriptions, and the output of natural language processed provider notes from de-identified Optum® EHR data. Patients had a diagnosis of HF, dilated cardiomyopathy, or prior infarct, and were included if they had HFrEF with >1 year of records prior to a new Class 1 or Class 2a indication for an ICD or cardiac resynchronization therapy with defibrillator (CRT-D) from 2012 to 2019. ResultsRecords showed 137,476 HFrEF patients were newly indicated for an ICD or CRT-D. GDDT was used in 14,892 of 36,358 (41.0%) CRT-D indicated patients and in 14,904 of 101,118 (14.7%) ICD-indicated patients. While GDDT use was low, 95.7% had echocardiography and 92.1% had prescriptions for beta-blockers or angiotensin-converting enzyme/angiotensin-receptor blockers medications. ConclusionsIn this modern cohort of HF patients, a large proportion of eligible patients did not receive ICDs or CRT-Ds, while frequently receiving other indicated cardiovascular interventions and treatments.

Complications and Mortality Following CRT-D Versus ICD Implants in Older Medicare Beneficiaries With Heart Failure

ObjectivesThis study sought to assess the comparative effectiveness of cardiac resynchronization therapy with defibrillator (CRT-D) over implantable cardioverter-defibrillator (ICD) alone in older Medicare patients with heart failure with reduced ejection fraction (HFrEF). BackgroundDespite growing numbers of older patients with HFrEF, the benefits of cardiac resynchronization therapy (CRT) in this group are largely unknown. MethodsA cohort of fee-for-service Medicare beneficiaries ≥65 years of age with HFrEF and enrolled in Medicare Part D who underwent CRT-D or ICD implantation from January 2008 to August 2015 was identified. Beneficiaries were divided by age (65-74, 75-84, and 85+ years), and outcomes were compared between the CRT-D and ICD groups after inverse probability weighting. ResultsCompared with the ICD group, the CRT-D group was older and more likely to be White, be female, and have left bundle branch block. After weighting, overall complications were high across age and device groups (14%-20%). The 1-year mortality was high across all groups. In the 2 oldest age strata, the hazard of death was lower in the CRT-D group (HR: 0.90; 95% CI: 0.86-0.95 and HR: 0.81; 95% CI: 0.72-0.90, respectively; P < 0.001); the hazard of heart failure hospitalization was lower for CRT-D vs ICD in the 85+ years age group (HR: 0.82; 95% CI: 0.74-0.92; P < 0.001). ConclusionsIn older Medicare beneficiaries undergoing ICD with or without CRT, complications and 1-year mortality were high. Compared with ICD alone, CRT-D was associated with a lower hazard of mortality in patients ≥74 years of age and lower hazard of HF hospitalization in those ≥85 years of age. These findings support the use of CRT in eligible older patients undergoing ICD implantation.

Association of Night-Time Heart Rate With Ventricular Tachyarrhythmias, Appropriate and Inappropriate Implantable Cardioverter-Defibrillator Shocks.

Background: Night-time heart rate (HR) is expected to reflect more accurately the cardiac autonomic function of modulating cardiovascular activity. Few studies have been conducted on the predictive values of night-time HR in relation to cardioverter-defibrillator therapies.Aims: To explore the associations of night-time HR with the ventricular tachyarrhythmias (VTAs), appropriate and inappropriate implantable cardioverter-defibrillator (ICD) shocks.Methods: Patients from the SUMMIT registry receiving ICD or cardiac resynchronization therapy with defibrillator (CRT-D) implantation were retrospectively analyzed using archived home monitoring data. Night-time HR was recorded from 2:00 am to 6:00 am during the first 30 to 60 days after implantation. VTA events and ICD shocks were identified using the intracardiac electrograms by two independent physicians. Restricted cubic splines and smooth curve fitting were conducted to address the non-linear associations between night-time HR and adjusted hazards for clinical outcomes.Results: Over a mean follow-up duration of 55.8 ± 22.7 months, 187 deaths were observed among 730 patients. VTAs, appropriate and inappropriate ICD shocks were observed in 422 (57.8%), 293 (40.1%), and 72 (10.0%) patients, respectively. Apparent U-shaped non-linear associations of night-time HR with VTAs (P for non-linearity = 0.007), appropriate ICD shocks (P for non-linearity = 0.003) and inappropriate ICD shocks (P for non-linearity = 0.014) were detected. When night-time HR was beyond 60 bpm, every 1 bpm increase in night-time HR could result in 3.2, 3.3, and 4.9% higher risks of VTAs and appropriate and inappropriate ICD shocks, respectively; when night-time HR was lower than 60 bpm, every 1 bpm increase in night-time HR could result in 6.0 and 10.7% lower risks of appropriate and inappropriate ICD shocks. Compared to night-time HR of ≤ 50 or ≥70 bpm, night-time HR of 50–70 bpm was associated with 24.9, 30.2, 63.5, and 31.5% reduced incidences of VTA events, appropriate ICD shocks, inappropriate ICD shocks, and all-cause mortality, respectively.Conclusion: Apparent non-linear associations of night-time HR with VTAs and ICD shocks were detected. An increasing incidence of VTAs and ICD shocks was observed at both low and high levels of night-time HR. Night-time HR of 50–70 bpm might be the optimal therapeutics target for the management of ICD/CRT-D recipients.

Artificial intelligence: an attempt to automate remote device follow-up

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Artificial intelligence (AI) through machine learning (ML) refers to the simulation of human intelligence with the capacity for achieving goals within computers. In electrophysiology, ML has many applications in electrocardiography, intracardiac mapping and cardiac implantable electronic devices (CIEDs). Remote monitoring (RM) of patients equipped with CIEDs associates the analysis of event reports and calendar-based remote follow-ups (FU). ML applications have allowed for risk stratification, improved arrhythmia localisation and streamlined remote monitoring which may significantly reduce the workload faced by electrophysiologists. Aim To develop a system that automates cardiac implantable electronic devices remote follow-up. Methods and Results We created a Java software application, that uses the latest optical character recognition techniques combined with artificial intelligence and natural language processing to extract information from PDF reports of RM of CIEDs from different manufacturers. The current version is HIPAA (Health Insurance Portability and Accountability Act) complaint and runs on local computers only. Using the current system, we were able to run and extract data from 30 remote follow-up PDF reports of Cardiac Implantable Defibrillators (ICDs) and Cardiac Resynchronization Therapy with Defibrillator (CRT-Ds). Time taken from data extraction to conversion of all 30 device PDFs was under 5 minutes. Process and data extracted are presented in the figure below. (Figure 1) Conclusion This machine learning algorithm proved that it is possible to facilitate and automate remote follow-up of cardiac implantable electronic devices. In a near future this will allow to us to efficiently increase productivity, by speeding and facilitating interpretation of remote device follow-ups, leading to improvements in patientcare and precision cardiovascular medicine. Furthermore, in the current and future pandemics it may help prevent unnecessary in-person medical visits, avoiding additional, unnecessary strain on an already overburdened and overwhelmed healthcare system, and saving costs. Abstract Figure 1