Cardiac Resynchronization Therapy With Defibrillator Research Articles

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>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

Risk factors for the first and second inappropriate implantable cardioverter-defibrillator therapy.

IntroductionVarious risk factors for the first inappropriate implantable cardioverter-defibrillator (ICD) therapy event have been reported, including a history of atrial fibrillation/atrial flutter (AF/AFL), younger age, and multiple zones. Nonetheless, which factors are concordant with real-world data has not been clarified, and risk factors for the second inappropriate ICD therapy event have not been well examined. This study aimed to clarify the risk factors for the first and second inappropriate ICD therapy events.MethodsWe conducted a post-hoc secondary analysis of data from a multicenter, prospective observational study (the Nippon Storm Study) designed to clarify the risk factors for electrical storm.ResultsThe analysis included data from 1549 patients who received ICD or cardiac resynchronization therapy with defibrillator (CRT-D). Over a median follow-up of 28 months, 293 inappropriate ICD therapy events occurred in 153 (10.0%) patients. On multivariate Cox regression analysis, the risk factors for the first inappropriate ICD therapy event were younger age (hazard ratio [HR], 0.986; p = 0.028), AF/AFL (HR, 2.324; p = 0.002), ICD without CRT implantation (HR, 2.377; p = 0.004), and multiple zones (HR, 1.852; p = 0.010). “No-intervention” after the first inappropriate ICD therapy event was the sole risk factor for the second inappropriate ICD therapy event.ConclusionsRisk factors for the first inappropriate ICD therapy event were similar to those previously reported. Immediate intervention after the first inappropriate ICD therapy event could reduce the risk of the second inappropriate event.

A Role of Glucose Overload in Diabetic Cardiomyopathy in Nonhuman Primates.

Type 2 diabetes (T2D) plays a major role in the development of heart failure. Patients with T2D have an increased risk to develop HF than healthy subjects, and they always have very poor outcomes and survival rates. However, the underlying mechanisms for this are still unclear. To help develop new therapeutic interventions, well-characterized animal models for preclinical and translational investigations in T2D and HF are urgently needed. Although studies in rodents are more often used, the research findings in rodents have often failed to be translated into humans due to the significant metabolic differences between rodents and humans. Nonhuman primates (NHPs) serve as valuable translational models between basic studies in rodent models and clinical studies in humans. NHPs can recapitulate the natural progress of these diseases in humans and study the underlying mechanism due to their genetic similarity and comparable spontaneous T2D rates to humans. In this review, we discuss the importance of using NHPs models in understanding diabetic cardiomyopathy (DCM) in humans with aspects of correlations between hyperglycemia and cardiac dysfunction progression, glucose overload, and altered glucose metabolism promoting cardiac oxidative stress and mitochondria dysfunction, glucose, and its effect on cardiac resynchronization therapy with defibrillator (CRT-d), the currently available diabetic NHPs models and the limitations involved in the use of NHP models.

Diagnosis of atrial fibrillation in heart failure patients with implantable cardioverter defibrillator or cardiac resynchronisation therapy.

IntroductionImplantable cardioverter defibrillators register various types of arrhythmias. Thus they can be exploited to better identify patients with atrial fibrillation episodes and increase the proportion of patients who may benefit from implementation of pharmacological prophylaxis of thromboembolic events, most of which are asymptomatic. The aim of the study was to assess of the frequency, symptoms and predisposing factors for the occurrence of atrial fibrillation episodes in patients with an implanted implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy with defibrillator (CRT-D) based on the analysis of intracardiac electrocardiograms (EGM/IEGM) records.Material and methodsThe study included 174 consecutive outpatients with heart failure, sinus rhythm and an implanted cardioverter defibrillator and cardiac resynchronisation therapy with defibrillator. Follow-up visits with analysis of IEGM records occurred every 3 months. During a mean follow-up of 20 months, 901 visits were carried out. One hundred forty-seven patients had at least 1 year of follow-up.ResultsAtrial fibrillation episodes in the study group occurred in 54 (31.0%) patients and 71.4% were asymptomatic. Predisposing factors were: history of paroxysmal atrial fibrillation (37.0% vs. 13.3%, p < 0.001), atrioventricular conduction abnormalities (42.6% vs. 20.0%, p = 0.002), intraventricular conduction abnormalities (59.3% vs. 40.8%, p = 0.02) and more severe mitral regurgitation (7.4% vs. 0.8%, p = 0.04). Chronic renal disease was a risk factor for death in the study group. No stroke occurred during the study.ConclusionsEpisodes of paroxysmal atrial fibrillation in patients with systolic heart failure and implanted cardioverter-defibrillator systems are quite common. The majority of the episodes recorded in the study were asymptomatic.

Advances in cardiac resynchronization and implantable cardioverter/defibrillator therapy: Medtronic Cobalt and Crome.

Cardiovascular implantable electronic devices have revolutionized the management of heart failure with reduced ejection fraction. New device generations tend to be launched every few years, with incremental improvements in performance and safety and with an expectation that these will improve patient management and outcomes while remaining cost-effective. As a result, today's cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator devices are quite different from the pioneering but often bulky devices of the late 20th century. This review discusses new and improved features developed to target specific needs in managing heart failure patients, some of which are especially pertinent to the current worldwide healthcare situation, with focus on the latest generation of CRTs with defibrillator (CRT-Ds) and implantable cardioverter defibrillators from Medtronic.

The benefits of defibrillator in heart failure patients with cardiac resynchronization therapy: A meta-analysis.

Current guidelines did not provide recommendations on indications of an additional implantable cardioverter-defibrillator (ICD) to patients receiving cardiac resynchronization therapy (CRT), and it still remains controversial due to lack of evidence from randomized controlled trials. PubMed, Embase, and Cochrane CENTRAL from the inception to May 2020 were systematically screened for studies reporting on the comparison of cardiac resynchronization therapy with defibrillator (CRT-D) and cardiac resynchronization therapy with pacemaker (CRT-P), focusing on the adjusted hazard ratio (aHR) of all-cause mortality. We pooled the effects using a random-effect model. Twenty-one studies encompassing 69,919 patients were included in this meta-analysis. With no restriction to characteristics of including population, CRT-D was associated with a lower all-cause mortality compared with CRT-P significantly (aHR: 0.80, 95% confidence interval [CI]: 0.74-0.87, I2 =36.8%, p<.001). This mortality benefit was also observed in patients with ischemic cardiomyopathy (aHR: 0.74, 95% CI: 0.64-0.86, I2 =0%, p < .001). However, there is no significant difference in patients with nonischemic cardiomyopathy (NICM) (aHR: 0.91, 95% CI: 0.82-1.01, I2 =0%, p=.087), older age (age ≥75 years, aHR: 0.96, 95% CI: 0.83-1.12, I2 =0%, p=.610). Subgroup analysis was performed and indicated the survival benefit of CRT-D for primary prevention compared with CRT-P (aHR: 0.87, 95% CI: 0.79-0.95, I2 =0%, p=.003). After adjusted the differences in clinical characteristics, additional ICD therapy was associated with a reduced all-cause mortality in patients receiving CRT. However, our work suggested that additional ICD may not be applied to elderly (≥75 years) or patients with NICM.

Radiation therapy in patients with cardiac implantable electronic devices.

The number of patients with cardiac implantable electronic devices (CIEDs) treated with radiation therapy (RT) as an oncological treatment is expected to increase. The aim of the study was to assess whether cancer treatment with radiation therapy is associated with any device dysfunctions and device‑related threats in patients with CIEDs. The risk of all patients with CIEDs undergoing RT was assessed according to guidelines. Device interrogations were performed before the first and after the last RT session. In patients at high risk and/or with an implantable cardioverter‑defibrillator or cardiac resynchronization therapy with defibrillator (CRT‑D), all sessions were supervised by a cardiologist, and device interrogations were performed before and after every single RT session. Device parameters and events were monitored during thewhole treatment. The study included 157 patients with CIEDs who had palliative (n = 71) or radical (n = 86) RT. Pacemakers were implanted in 113 patients, implantable cardioverter‑defibrillators in 36, and CRT‑D in 8. During the 2396 RT sessions (median [interquartile range], 5 [5-28] per patient) with cumulative dose up to 78 Gy per patient for the whole RT treatment and maximum energy beam up to 20 MV, 2 events potentially related to radiation were recorded. Radiation therapy in patients with CIEDs is not associated with substantial risk to the patients assuming the patients' management follows current guidelines.

P531Cardiac resynchronization therapy in patients with permanent atrial fibrillation: insights from the HMEA database

Abstract Funding Acknowledgements This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Background/Introduction: The benefits of cardiac resynchronization therapy with defibrillator (CRT-D) in heart failure are well established. However, a gap of evidence is still present for patients with permanent atrial fibrillation (perm-AF) Purpose To investigate outcomes of CRT-D patients with perm-AF in terms of appropriate shock for ventricular arrhythmia and all-cause mortality in a long-term time horizon. Methods We used the Home Monitoring Expert Alliance (HMEA) database, a nationwide data repository of daily remote monitoring transmissions. The episodes with delivered shock were adjudicated by a board of 3 electrophysiologists. Results Among 1226 CRT-D patients (mean age 71.2 ± 10.0 years; 75.5% males), 276 (22.5%) had perm-AF at device implantation. These patients had more frequently rate responsive function (19.7% vs 64.1%) and higher basic rate (median value 60 bpm vs 70 bpm) as compared to all other patients (p &amp;lt; 0.001). The CRT pacing percentage calculated over the first 2 months was slightly lower for perm-AF patients (median value 96.0% vs 98.8%, p &amp;lt; 0.001). At 5-year appropriate shock incidence was 34.2% (95% confidence interval [CI], 25.1%-45.3%) for perm-AF and 19.9% (15.6%-25.1%) for all other patients. All-cause mortality was 27.7% (17.7%-41.8%) for perm-AF and 15.6% (12.2%-19.9%) for all other patients. The age- and sex-adjusted hazard ratio between perm-AF and all other patients was 1.81 (95% CI: 1.25-2.64, p = 0.002) for appropriate shock and 0.92 (95% CI: 0.57-1.50, p = 0.748) for all-cause mortality. Conclusion Although a higher incidence of appropriate shock, perm-AF at the time of CRT-D implantation was not associated with increased long-term mortality, Abstract Figure. Appropriate shock and mortality

854Predictors of ventricular tachyarrhythmia in patients with implantable cardioverter-defibrillator and non-ischaemic systolic heart failure

Abstract Funding Acknowledgements none OnBehalf none Background The benefit of an implantable cardioverter-defibrillator (ICD) in patients with ischaemic heart failure (HF) has been well proven but the benefit of ICD in subjects with non-ischaemic systolic HF is less well-established. Consequently, there is very limited evidence which patients with non-ischaemic HF would benefit most from receiving an ICD. Aim To determine the incidence and predictors of ventricular arrhythmia in patients with ICD and non-ischaemic systolic HF. Methods Study population consisted of 420 consecutive patients with ICD and non-ischaemic systolic HF monitored remotely (on a daily basis) between 2010 and 2017 in tertiary care university hospital, in a densely inhabited, urban region of Poland. Sixty-six percentage of patients had cardiac resynchronization therapy with defibrillator (CRT-D). Results During the median follow-up of 1645 days (range: 507-3515) sustained ventricular arrhythmia occurred in 100 patients (23.8%). Of those, ventricular fibrillation (VF), ventricular tachycardia (VT) or VT/VF (combined) occurred in 10 (10.0%), 77 (77.0%) and 13 (13.0%) patients, respectively. Patients with versus without ventricular arrhythmia did differ with respect to baseline variables such as: left ventricular end diastolic diameter (LVEDD) - median of 67 mm [49-82] vs 62 mm [46-78]; post-inflammatory HF (17 vs 9.7%, P = 0.045); atrial fibrillation/atrial flutter - AF/AFL (57 vs. 38.1%, P = 0.0009); supraventricular arrhythmia (SVT) - any supraventricular arrythmia &amp;gt;100/min other than AF/AFL (27 vs. 15.9%, P = 0.01); and left ventricular ejection fraction - EF (25 vs. 28%, P = 0.01). No differences were observed for age, sex, NYHA class, mitral regurgitation, common comorbidities (including diabetes and chronic renal disease) or concomitant medications. On multivariable regression analysis, LVEDD (HR 1.05, 95% CI 1.004-1.09, P = 0.03), AF/AFL (HR 1.81, 95% CI 1.21-2.72, P = 0.004) and SVT (HR 1.91, 95% CI 1.21-3.01, P = 0.006) were identified as independent predictors of sustained ventricular arrhythmia in patients with ICD and non-ischaemic HF. All-cause mortality in patients with VT/VF was significantly higher than in subjects without sustained ventricular arrhythmias (33% vs. 20%, P = 0.03). Conclusions Ventricular arrhythmia occurred in 23.8% of patients with systolic non-ischaemic HF during 4.5 years of observation and was associated with significantly worse prognosis compared with subjects free of VT/VF. Left ventricular dimension, atrial fibrillation/atrial flutter and supraventricular tachycardia were identified as independent predictors for ventricular arrhythmia.

Clinical impact of applying strategic programming in patients with implantable cardioverter-defibrillators beyond reducing inappropriate shocks

BackgroundThe incidence of inappropriate shocks remains high at 30% in patients with implantable cardioverter-defibrillators (ICDs). This retrospective study sought to examine the efficacy of strategic programming (ICD programming with a long detection interval and high-rate cutoff) in reducing electrical storm, inappropriate shocks, and unexpected hospital visits in patients with ICDs with/without cardiac resynchronization therapy with defibrillator (CRT-Ds).MethodsThis was a single tertiary center retrospective study, evaluating the clinical outcomes, especially regarding inappropriate therapies in patients with ICDs or CRT-Ds. Enrolled patients underwent ICD or CRT-D implantations from January 2008 to May 2016. Clinical information was attained by a thorough chart review.ResultsWe analyzed 155 defibrillator patients from January 2008 to May 2016 (124 patients had ICDs and 31 had CRT-Ds). Since we adopted this strategic programming as a default programming from 2015 implanted ICDs and CRT-Ds, we divided the patients into two groups: devices implanted before 2015 (group A, n = 94) versus implanted after 2015 (group B, n = 61). During a median of 1289 days of follow-up, electrical storms occurred in three patients (eight events) in group B versus 11 (28 events) in group A (P = 0.18); appropriate therapies were delivered in 27 patients (56 events) in group A versus 7 (15 events) in group B (P = 0.72); inappropriate therapies were delivered in 15 patients (21 events) in group A versus 1 with 1 episode in group B (P = 0.03); and 5 unexpected hospitalizations occurred in four patients in group B versus 36 in 24 patients in group A (P = 0.02).ConclusionThe clinical application of strategic programming reduced inappropriate shocks and unexpected hospitalizations in ICD and CRT-D patients.

Marital Status and Long-Term Outcomes in Mild Heart Failure Patients With an Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy With Defibrillator

Married patients have been shown to have a lower risk for adverse cardiovascular outcomes. However, the risk of heart failure (HF) or death in married versus unmarried patients with left ventricular (LV) dysfunction and an implantable cardioverter defibrillator (ICD), and the effect of cardiac resynchronization therapy with defibrillator (CRT-D) are unknown. In Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT), in patients with left bundle branch block, we evaluated long-term clinical outcomes of all-cause mortality or HF events in married (including common law status) compared with unmarried (single/divorced/widowed) patients with CRT-D versus an ICD-only. There were 937 married patients and 344 unmarried patients with left bundle branch block. Multivariate analysis showed that married patients had a 54% lower risk of all-cause mortality (hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.30 to 0.71, p <0.001) compared with the unmarried. However, the survival benefit associated with marital status was pronounced in ICD patients (HR 0.40, 95% CI 0.23 to 0.69, p <0.001) and attenuated in CRT-D patients (HR 0.74, 95% CI 0.51 to 1.06, p = 0.10), interaction (p = 0.07). Consistently, during the median follow-up of 5.6 years, in patients with ICD, married patients had a significantly lower incidence of death (24%) compared with unmarried patients (42%; p = 0.004), whereas the corresponding mortality rates in CRT-D patients were not significantly different (p = 0.814). In conclusion, during long-term follow-up of mild HF patients with LV dysfunction, married patients were at a significantly lower risk for death compared with those not married. The survival benefit associated with marital status was pronounced in patients implanted with an ICD and is attenuated in those implanted with a CRT-D device.

Predictors for early mortality and arrhythmic events in patients with cardiac resynchronization therapy with defibrillator: A two center cohort study.

Guidelines of heart failure therapy include cardiac resynchronization as standard of care in patients with severely depressed left ventricular function and wide QRS complex. It has been shown that patients benefit regarding mortality and morbidity. However, early mortality precludes longterm benefits from the device. The aim of the study was to identify predictors for early occurrence of both death and first-ever implantable cardioverter-defibrillator (ICD) therapy using a large combined database of patients with cardiac resynchronization therapy with defibrillator (CRT-D). From two registries (tertiary care centers) 904 patients were identified, no single patient was excluded. Early death was defined as death occurring within the 3 years after implantation whereas early ICD therapy as such occurring within the first year. 33 baseline parameters were compared using uni- and multivariate analysis with the Cox model and binary logistic regression. The population was predominantly male (77%), with mean age of 63 ± 11 years and primary prevention indication in 80%. Mean follow-up was 55 ± 38 months. 256 (28%) patients had ICD therapies whereof the first-ever event occurred early in 52%. 270 (30%) patients died after 41 ± ± 31 months, mostly from advancing heart failure (41%), 141 (52%) patients of them early. Independent predictors for early ICD therapy were secondary prevention and renal failure. Independent predictors for early mortality were a history of percutaneous coronary intervention and of peripheral vascular disease. Predictors for early mortality after CRT-D implantation were a history of percutaneous coronary intervention and peripheral vascular disease, present in only a minority of patients, thus limiting their use in clinical practice.

Predictive value of Tpeak-Tend interval for ventricular arrhythmia and mortality in heart failure patients with an implantable cardioverter-defibrillator: A cohort study.

Background:Tpeak-Tend interval (TpTe), a measurement of transmural dispersion of repolarization (TDR), has been shown to predict ventricular tachyarrhythmia in cardiac resynchronization therapy with defibrillator (CRT-D) patients. However, the ability of TpTe to predict ventricular tachyarrhythmia and mortality for heart failure patients with a cardioverter-defibrillator (ICD) is not clear. The purpose of this study was to assess the predictive ability of TpTe in heart failure patients with ICD.Methods and results:We enrolled 318 heart failure patients treated after ICD. Patients were divided into 3 groups according to their post-implantation TpTe values and were evaluated every 6 months. The primary endpoint was appropriate ICD therapy. The secondary endpoint was all-cause mortality. During long-term follow-up, the TpTe > 110 ms group (n = 111) experienced more VT/VF episodes (45%) and all-cause mortality (25.2%) than the TpTe 90–110 ms group (n = 109) (26.4%, 14.5%) and TpTe < 90 ms group (n = 98) (11.3%, 11.3%) (overall P < .05, respectively). In Cox regression, longer post-implantation TpTe was associated with an increased number of VT/VF episodes [HR: 1.017; 95% CI: 1.008-1.026; P < .001], all-cause mortality [HR: 1.015; 95% CI: 1.004-1.027; P = .010] and the combined endpoint [HR: 1.018; 95%CI: 1.010-1.026; P < .001].Conclusions:Post-implantation TpTe was an independent predictor of both ventricular arrhythmias and all-cause mortality in heart failure patients with an implanted ICD.