Cardiac Resynchronization Therapy Defibrillator Research Articles

Smartphone-based cardiac implantable electronic device remote monitoring: improved compliance and connectivity.

Remote monitoring (RM) is the standard of care for follow up of patients with cardiac implantable electronic devices. The aim of this study was to compare smartphone-based RM (SM-RM) using patient applications (myMerlinPulse™ app) with traditional bedside monitor RM (BM-RM). The retrospective study included de-identified US patients who received either SM-RM or BM-RM capable of implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators (Abbott, USA). Patients in SM-RM and BM-RM groups were propensity-score matched on age and gender, device type, implant year, and month. Compliance with RM was quantified as the proportion of patients enrolling in the RM system (Merlin.net™) and transmitting data at least once. Connectivity was measured by the median number of days between consecutive transmissions per patient. Of the initial 9714 patients with SM-RM and 26 679 patients with BM-RM, 9397 patients from each group were matched. Remote monitoring compliance was higher in SM-RM; significantly more patients with SM-RM were enrolled in RM compared with BM-RM (94.4 vs. 85.0%, P < 0.001), similar number of patients in the SM-RM group paired their device (95.1 vs. 95.0%, P = 0.77), but more SM-RM patients transmitted at least once (98.1 vs. 94.3%, P < 0.001). Connectivity was significantly higher in the SM-RM, with patients transmitting data every 1.2 (1.1, 1.7) vs. every 1.7 (1.5, 2.0) days with BM-RM (P < 0.001) and remained better over time. Significantly more SM-RM patients utilized patient-initiated transmissions compared with BM-RM (55.6 vs. 28.1%, P < 0.001). In this large real-world study, patients with SM-RM demonstrated improved compliance and connectivity compared with BM-RM.

Abstract 13692: Gender, Process of Care and Mortality in Heart Failure Patients in India: Findings From the National Heart Failure Registry India

Introduction: HF mortality rate vary by gender in high income countries. Process of care is often associated with differences in HF mortality. Hypothesis: We hypothesized that, HF process of care is associated with differential mortality in men and women. Methods: National Heart Failure Registry is a nationwide registry . Data from 10851 consecutive acute decompensated heart failure patients (ESC2016) criteria was analysed. At baseline we examined sociodemographic characteristics, clinical features , disease etiology and co-morbid conditions of patients. We assessed both in-hospital and 90-day mortality. Results: The mean age of study population was 59.9 (SD=13.5). More than two third (69%) participants were men. Sixty-five percent (Women = 58.6%, Men =68.2%, p value = p&lt;0.001) and 13%( Women = 19.5%, Men =9.6%, p value = p&lt;0.001) of patients had HF with reduced ejection fraction and HF with preserved ejection fraction, respectively. In this study, 71.2%(Women =74.2 %, Men = 69.8%, p value = p&lt;0.001) of patients had New York Heart Association (NYHA) Class III or Class IV. In-hospital and 90-day mortality rate were 6.7%(Women = 7.6%, Men = 6.3%, p value = 0.010) and 14.2%(Women = 14.9%, Men = 13.9%, p value =0.160), respectively(Fig:1). Beta blockers (BB), angiotensin converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB), and mineralocorticoid receptor antagonists (MRA) were prescribed in 75.7% (Women=74.2%, Men=76.4%, p value = 0.015), 61.2% (Women=60.6%, Men=61.4%, p value = 0.405) and 64.7% (Women=66.4%, Men=64.0%, p value = 0.016), respectively. The study population had very low usage of devices like the automatic implantable cardioverter-defibrillator 0.9% (Women=0.4%, Men=1.1%, p value =p&lt;0.001), cardiac resynchronization therapy defibrillator 1.0% (Women=1.1%, Men=1.0%, p value =0.75). Conclusion: The HF process of care differences may partially explains the differences in mortality in men and women.

Abstract 14627: Angiotensin-Neprilysin Inhibition in Cardiac Sarcoidosis

Introduction: Sacubitril/Valsartan is an established treatment for heart failure patients with reduced ejection fraction (HFrEF). However, there is a paucity of data on its use in patients with cardiac sarcoidosis (CS). Hypothesis To establish the beneficial role of Sacubitril/Valsartan in cardiac sarcoidosis. Methods All consecutive CS patients taking Sacubitril/Valsartan were identified from our database from 2016 to 2022. They were followed up for at least 6 months with serial echocardiography. Data regarding symptoms and echocardiographic parameters were compared using Wilcoxon signed rank test. Results A total of 30 CS patients taking Sacubitril/Valsartan were identified (mean age: 56.73±11.63 years old). The diagnosis of CS was determined in all patients by a multi-disciplinary team. Patients were male predominant (73.3%). The prevalence of smoking, diabetes, hypertension and ischaemic heart disease was 20%, 10%, 10% and 3.3% respectively. Beta-blockers, mineralocorticoid receptor antagonists, prednisolone, implantable cardioverter defibrillator and cardiac resynchronisation therapy (defibrillator) were present in 93.3%, 96.7%, 53.3%, 16.7% and 56.7% patients respectively. At the time of diagnosis, 24 (80%) patients were found to have active cardiac sarcoidosis on cardiac PET. At 6-months following the commencement of Sacubitril/Valsartan, there was a significant improvement in LV ejection fraction (38.77±10.26% vs 32.87±9.30%, p&lt;0.001), LV end-systolic diameter (4.89±1.06cm vs 5.14±1.07cm, p=0.013) and New York Heart Association class (1.6±0.55 vs 2.0±0.52, p=0.001). During the median follow up of 24.9 months, the composite end-point of death and cardiac transplantation was reached in 3 (10%) patients (3 deaths and 0 cardiac transplantation). The patients experiencing at least one sustained ventricular arrhythmia (or aborted sudden cardiac death) decreased from 9 to 7 (p=0.21), the mean prednisolone dose was also comparable (11.56±4.42 vs 10.28±3.71, p=0.50) and none of the patients stopped Sacubitril/Valsartan. Conclusions Sacubitril/Valsartan in cardiac sarcoidosis patients with HFrEF is associated with at least short-term improvements in LV remodelling and functional status.

Abstract 14398: Novel Cardiac Electrical Activation Parameter Associated With CRT Response

Introduction: Simultaneous assessment of cardiac electrical activation and left ventricular (LV) function could identify optimal cardiac resynchronization therapy (CRT) pacing strategies, leading to improved CRT response and outcomes. Hypothesis: Changes in three-dimensional (3D) cardiac electrical activation timing correlate with LV function. Methods: 3D cardiac electrical activation maps from the CardioInsight 252-electrode mapping vest (Medtronic) and cardiac ultrasound images were acquired during and 6 months after CRT defibrillator implantation. Maps were acquired for intrinsic electrical activation and three CRT pacing configurations: synchronized LV pacing, right ventricular (RV) pacing, and biventricular (BIV) pacing. Three novel electrical activation parameters were calculated: LV80, RV80, and BIV80, defined as the time at which 80% of the LV, RV, or both ventricles, respectively, were electrically activated. Results: In 30 CRT patients (65.6 ± 11.3 years old, 36.7% female, 43.3% with LV scar, 57% with left bundle branch block [LBBB], and 43% with right bundle branch block [RBBB]), simultaneous measurements of electrical activation and LV function were obtained. Figure panels A and B show representative plots of the proportion of the LV and RV activated versus time within the QRS for a patient with LBBB. In this patient, BIV pacing improved the LV80 but worsened the RV80 compared with the intrinsic rhythm, consistent with a discordant effect on ventricular function. Panel C shows that synchronized LV pacing has a more unfavorable effect on RV activation than BIV pacing in this patient. In the entire cohort, the BIV80 was significantly associated with the change in LVESVI six months after CRT (p&lt;0.05) (panel D). Conclusion: A novel measurement of 3D cardiac electrical activation demonstrates the effects of different CRT pacing strategies on LV and RV function and predicts LV functional improvement after CRT.

Defining the gap in heart failure treatment in patients with cardiac implantable electronic devices.

The use of guideline-directed medical therapy (GDMT) is poorly described in patients with heart failure and reduced ejection fraction (HFrEF) with cardiac resynchronization therapy (CRT) and/or implantable cardioverter defibrillators (ICDs). To define the eligibility, uptake, dose, contraindications, and barriers to uptake of contemporary medical therapy in this population. Retrospective analysis of consecutive adults with ICD and/or CRT attending two Canadian tertiary centre device clinics between 1 March and 31 May 2021. From 1005 device clinic consultations, 227 (22.6%) patients with HFrEF and CRT and/or ICD were included. GDMT eligibility was high: beta-blockers (99.6%), mineralocorticoid receptor antagonists (MRA) (89.0%), angiotensin receptor-neprilysin inhibitors (ARNI) (84.6%), and sodium-glucose cotransporter-2 inhibitors (SGLT2I) (87.7%). Contraindications were rare: beta-blockers (0.4%), MRA (11.0%), ARNI (15.4%), and SGLT2I (12.3%). Uptake of GDMT was high for beta-blockers (97.4%) but low for other medications: MRA (63.0%), ARNI (46.7%), SGLT2I (22.9%). Except for SGLT2I (84.6%) and beta-blockers (57.9%), less than one-half of patients were prescribed target-doses of MRA (10.5%), and ARNI (47.7%). Of the visits, GDMT was already optimal in 16%, electrophysiologists acted in 33% (21% prescribed, 7% ordered investigations, 5% referred to heart function services), and in the remaining visits, optimization was either deferred to another cardiologist (20%) or no plan was mentioned (25%), besides other reasons (4%). Despite broad eligibility for GDMT in patients with HFrEF and ICD/CRT, significant gaps in prescription and titration exist. Our results highlight the need to embed quality assurance initiatives in cardiac device clinics to improve HFrEF care.

Prognostic significance of remotely monitored nocturnal heart rate in heart failure patients with reduced ejection fraction

Elevated resting heart rate is a risk factor for cardiovascular events. The purpose of this study was to investigate the clinical significance of nocturnal heart rate (nHR) and 24-hour mean heart rate (24h-HR) obtained by continuous remote monitoring (RM) of implantable devices. We analyzed daily-sampled trends of nHR, 24h-HR, and physical activity in patients on β-blocker therapy for chronic heart failure and with implantable cardioverter-defibrillators or cardiac resynchronization therapy defibrillators (CRT-Ds). Patients were grouped by average nHR and 24h-HR quartile during follow-up to estimate the respective incidence of nonarrhythmic death and device-treated ventricular tachycardia/fibrillation (VT/VF). The study cohort included 1330 patients (median age 69 years [interquartile range 61-77 years]; 41% [n = 550] with CRT-D; median follow-up 25 months [interquartile range 13-42 months]). Compared with patients in the lowest nHR quartile (≤57 beats/min) group, patients in the highest quartile group (>65 beats/min) had an increased risk of nonarrhythmic death (adjusted hazard ratio [AHR] 2.25; 95% confidence interval [CI] 1.13-4.50; P= .021) and VT/VF (AHR 1.98; 95% CI 1.40-2.79; P < .001) and were characterized by the lowest level of physical activity (P≤.0004 vs every other nHR quartiles). The highest 24h-HR quartile group (>75 beats/min) showed an increased risk of VT/VF (AHR 2.13; 95% CI 1.52-2.99; P< .001) and a weaker though significant association with nonarrhythmic mortality (AHR 1.80; 95% CI 1.00-3.22; P= .05) as compared with the lowest 24h-HR quartile group (≤65 beats/min). In remotely monitored patients with implantable cardioverter-defibrillator/CRT-D on β-blocker therapy for heart failure, elevated heart rates (nHR >65 beats/min and 24h-HR >75 beats/min) were associated with increased mortality and VT/VF risk. nHR showed a stronger association than 24h-HR with worst prognosis and lowest physical activity.

Incidence and Predictors of Cardiac Implantable Electronic Devices Malfunction with Radiotherapy Treatment.

To investigate the incidence of cardiac implantable electronic devices (CIED) malfunction with radiotherapy (RT) treatment and assess predictors of CIED malfunction. A 6-year retrospective analysis of patients who underwent RT with CIED identified through the radiation oncology electronic database. Clinical, RT (cumulative dose, dose per fraction, beam energy, beam energy dose, and anatomical area of RT) and CIED details (type, manufacturer, and device malfunction) were collected from electronic medical records. We identified 441 patients with CIED who underwent RT. CIED encountered a permanent pacemaker (PPM) (78%), cardiac resynchronization therapy-pacing (CRT-P) (2%), an implantable cardioverter defibrillator (ICD) (10%), and a CRT-defibrillator (CRT-D) (10%). The mean cumulative dose of RT was 36 gray (Gy) (IQR 1.8-80 Gy) and the most common beam energy used was photon ≥10 megavolt (MV) with a median dose of 7 MV (IQR 5-18 MV). We further identified 17 patients who had CIED malfunction with RT. This group had a higher cumulative RT dose of 42.5 Gy (20-77 Gy) and a photon dose of 14 MV (12-18 MV). None of the malfunctions resulted in clinical symptoms. Using logistic regression, the predictors of CIED malfunction were photon beam energy use ≥10 MV (OR 5.73; 95% CI, 1.58-10.76), anatomical location of RT above the diaphragm (OR 5.2, 95% CI, 1.82-15.2), and having a CIED from the ICD group (OR 4.6, 95% CI, 0.75-10.2). Clinicians should be aware of predictors of CIED malfunction with RT to ensure the safety of patients.

Efficacy of ICD/CRT-D Remote Monitoring in Patients With HFrEF: a Bayesian Meta-analysis of Randomized Controlled Trials.

To evaluate remote monitoring using implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) devices as an adjunctive tool to the traditional care of patients with heart failure (HF). We included 11 trials encompassing 5965 patients. Absolute risk difference (ARD) with 95% credible interval (CrI) was estimated. Pooled (posterior) risk difference was computed using Bayesian hierarchical methods. The ARD for mortality was centered at - 0.01 (95% CrI: - 0.03; 0.01, Tau: 0.02), with an 82% probability of ARD of ICD/CRT-D remote monitoring with respect to control being less than 0. The ARD for cardiovascular mortality was centered at - 0.03 (95% CrI: - 0.11; 0.05, Tau: 0.10), with an 84% probability of ARD of ICD/CRT-D remote monitoring with respect to control being less than 0. ICD/CRT-D remote monitoring in patients with HF is associated with a higher probability of reduced all-cause and cardiovascular mortality compared with standard care alone.

Physical activity and heart failure: a forgotten indicator

Abstract Introduction Low physical activity may be associated with comorbidities, sedentary lifestyle or clinical worsening in heart failure (HF) patients. Cardiovascular implantable electronic devices (CIEDs) detect and analyse physical activity data that is often integrated in multifactorial algorithms for predicting HF decompensations, but its potential is probably underestimated. Purpose We hypothesized that low physical-activity levels, obtained from remote monitoring of CIEDs, help predict clinical outcomes in HF patients, independently from multifactorial algorithms. Methods We retrospectively evaluated consecutive patients with HF and CIEDs through clinical assessments and remote monitoring (two monitoring systems were used). Low activity was defined as &amp;lt;1 hour/day of physical activity and two groups of patients were defined: patients with low activity alerts (group 1) and patients without low activity alerts (group 2). Primary outcome was defined as death by all causes and secondary outcome as HF hospitalizations and sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes. Results From 121 patients with RPM, physical activity data was obtained in 104 (85,9%). Mean age was 63,98±12,44 years, 70,2% were males and follow-up was 59,19±38,491 months. Fifty-four (51,9%) had implantable cardiac resynchronization therapy (CRT) defibrillator (CRT-D), 46 (44,2%) transvenous implantable cardioverter defibrillator (ICD), and 4 (3,8%) CRT pacemaker (CRT-P). The aetiology was idiopathic in 42,5% and ischemic in 40,2%. Mean left ventricular ejection fraction was 34,08±11,40% and mean physical activity duration was 2,25±1,84 hours/day. Forty-eight (53,7%) had low activity alerts (group 1) and 56 (46,3%) had no low activity alerts (group 2). In group 1 mean period of low activity was 52,978±15,75 days/year. Patients from group 1 were older (p=0,001), had more oncological disease (p=0,041) and peripheral artery disease (p=0,028). Three deaths occurred in total, all in group 1 (p=0,039) and HF hospitalizations were more frequent in group 1 (1,68±2,59 vs 0,69±1,32, p=0,005). Low activity burden was also associated with atrial fibrillation burden (r=0,473, p&amp;lt;0,05) and number of episodes of VT or VF (r=0,267, p=0,007). A decrease of 50% or more in mean duration of physical activity, but above 1 hour/day, was associated with increase HF hospitalizations (1,83±2,13 vs 1,05±1,95, p=0,006). Conclusion Low physical activity data obtained from CIEDs was associated with HF hospitalizations, arrhythmic events and death by all causes, independently of multifactorial algorithms. A decrease in basal activity even above alert threshold, was associated with HF hospitalizations and may be an even earlier sign of HF decompensations. Funding Acknowledgement Type of funding sources: None.

Biventricular or left univentricular pacing in heart failure patients: is there a better strategy

Abstract Background Cardiac resynchronization therapy (CRT) is a cornerstone in treatment of heart failure (HF) with reduced left ventricular ejection fraction (LVEF) and ventricular dyssynchrony. Biventricular (BiV) pacing is often the preferred method and corrects electrical and mechanical dyssynchrony but Left ventricular (LV) preferential pacing is may preserve conduction via the right bundle branch, preventing deleterious effects from right ventricular. The evidence is sparse and there is doubts whether which programming strategy is better. Purpose We hypothesized that BiV is non-inferior to preferential LV pacing in HF patients with reduced LVEF and CRT devices in cardiovascular death and HF hospitalizations. Methods We retrospectively evaluated 147 patients with HF patients with reduced LVEF and CRT devices. Two groups were defined: LV pacing (group 1) and BiV pacing (group 2). Primary outcome was defined as cardiovascular death and secondary outcome as HF hospitalizations and NYHA class after CRT. Results Mean age was 70,26±10,6 years, 68,1% were males and follow-up was 52,22±44,51 months. One hundred and twenty six (85,7%) patients had implantable cardiac resynchronization therapy (CRT) defibrillator (CRT-D) and 21 (14,3%) CRT pacemaker (CRT-P). Mean LVEF was 31,1±8,5% and mean QRS duration before CRT implantation was 149,5±48,6 ms. Thirty-nine (36,4%) patients were in NYHA III–IV. HF aetiology was idiopathic in 51 (47,2%), ischemic in 36 (33,3%) and alcoholic cardiomyopathy in 9 (8,3%). Forty-five (40,5%) patients had atrial fibrillation and 37 (35,6%) coronary disease. Patients in group 2 were more frequently males than group 1 patients (46 (78,0%) vs 32 (56,1%) respectively, p=0,012). There were no differences in regard to age, LVEF, HF aetiology or other comorbidities between groups. In 57 (49,1%) CRT was programming in preferential LV pacing and 50 (50,9%) in BiV pacing. There were 2 deaths in group 1 and 3 in group 2 (OR 0.80, 95% CI 0.27–2.40). There were 0,98±3,17 hospitalizations per patient and there were no differences in HF hospitalizations between groups (OR 1.01, 95% CI 0.92–1.18) or NYHA after 6 months of CRT (p=0,364). Conclusion BiV pacing was not inferior to LV-only pacing in regard to cardiovascular death, HF hospitalizations and NYHA class improvement. There was no clear advantage for one pacing strategy over the other but more studies are still required. Funding Acknowledgement Type of funding sources: None.

Lower rate limit in cardiac resynchronization therapy defibrillators

Abstract Background There is few data about programmed lower rate limit (LRL) in real world heart failure (HF) patients with cardiac resynchronization therapy–defibrillators (CRT-Ds) and its influence in clinical outcomes. Heart rate score (HRS) is the percentage of all atrial-paced and sensed events in the single tallest 10 beats/min device histogram bin and may indicate impaired heart rate variability. Purpose We hypothesized that higher LRL programming is associated with worse clinical outcomes as arrhythmic events and HF decompensations in chronic HF patients with CRT-Ds. Methods LRL was evaluated and HRS was calculated from remote monitoring in 126 HF patients with CRT-D. Primary outcome was defined as HF hospitalizations and related admissions to the emergency department and secondary outcome as number of device therapies, sustained ventricular tachycardia (VT) and ventricular fibrillation (VF). Results Mean age was 69,03±10,39 years, 81 (64,3%) were males and mean follow-up was 53,72±46,13 months. Mean left ventricular ejection fraction was 30,31±8,33% and 29 (23,0%) were in NYHA III–IV. HF aetiology was idiopathic in 39 (43,3%), ischemic in 32 (25,4%) and alcoholic cardiomyopathy in 8 (6,3%). Thirty-seven (29,4%) patients had atrial fibrillation and 33 (26,2%) coronary disease. LRL ranged from to 40 to 80 bpm and mean LRL was 52,64±9,64 and mean HRS 49,60±23,17%. Programmed LRL was higher in women (p=0,014), patients with atrial fibrillation (AF) (p=0,012) and coronary disease (p=0,015). Higher LRL correlated with HF hospitalizations and related admissions to the emergency department (ED) (r=0,541, p=0,001), VT or VF episodes (r=0,337, p=0,005) and CRT-D number of therapies (r=0,342, p=0,004) and higher HRS (r=0,547, p&amp;lt;0,05). Conclusion Higher LRL programming was associated with higher HRS, HF decompensations with hospitalization or admission to the emergency department, VT or VF episodes and CRT-D therapies in a real world population. More studies are required but lower LRL may be preferred in HF patients. Funding Acknowledgement Type of funding sources: None.

Implantable defibrillator-detected heart failure status predicts ventricular tachyarrhythmias

Abstract Background The occurrence of ventricular tachyarrhythmias is associated with increased mortality and hospitalizations for heart failure in implantable cardioverter defibrillator (ICD) patients. Nonetheless, the temporal relationship between heart failure worsening and ventricular tachyarrhythmias has been scarcely explored so far. Purpose We hypothesized that in patients with heart failure and reduced ejection fraction with ICDs, physiological sensor-based heart failure status, as reflected in the HeartLogic index, would predict appropriate device therapies for ventricular tachyarrhythmias (shocks and antitachycardia pacing). Methods and results 568 patients implanted with ICDs (n=410, 72%) or cardiac resynchronization therapy-defibrillators (CRT-D, n=158, 28%) endowed with the HeartLogic algorithm were included in this prospective observational multicenter analysis. Over a follow-up of 25 [25th-75th percentile: 15–35] months, 122 (21%) patients received an appropriate device therapy (shock, n=74, 13%), while the HeartLogic index crossed the threshold value 1200 times (0.71 alerts/patient-year) in 370 subjects (65%). The occurrence of at least one HeartLogic alert was significantly associated with both appropriate shocks (HR: 2.44, 95% CI: 1.49–3.97, p=0.003) and any ICD therapies (HR: 1.95, 95% CI: 1.37–2.85, p=0.003). Using a time-dependent Cox model, the weekly IN-alert state was the strongest predictor of ICD shocks (HR: 2.94, 95% CI: 1.73–5.01, p&amp;lt;0.001), after correction for age, secondary prevention, and use of CRT. As compared to clinically stable subjects with no therapies, patients experiencing shocks had significantly higher baseline values of the HeartLogic index, third heart sound amplitude, and respiratory rate. Beginning about one month prior to the arrhythmic event, we noticed further increase of the combined index and the third heart sound amplitude, a decrease of thoracic impedance, and higher resting heart rate (Figure 1). Conclusions The HeartLogic index is an independent predictor of appropriate defibrillator therapies. The combined index and its individual physiological components change well before the arrhythmic event, suggesting the existence of a window of opportunity to prevent shocks. Funding Acknowledgement Type of funding sources: None.

CRT-D non-responders have worse cardiovascular outcome than patients after primary ICD implantation with similar baseline left ventricular ejection fraction

Abstract Background Cardiac resynchronisation therapy (CRT) fails to improve echocardiographic parameters and outcome in 20–40% of heart failure (HF) patients with reduced ejection fraction (EF) referred to as CRT non-responders (CRT-NR). The aim of this study was to compare the outcomes of CRT-NR patients who received a CRT defibrillator (CRT-D) device with patients after primary implantable cardioverter-defibrillator (ICD) implantation for impaired left ventricular (LV) function. Methods CRT-NR status was defined as no or less than 10% improvement in LV EF 12 months post implantation. CRT-NR patients and those after primary ICD implantation for LV EF&amp;lt;35% were identified in our database between 2010 and 2019. CRT-NR patients were further categorized as progressors (decrease in LV EF ≥5%) or non-progressors (LV EF change between +9 to −5%). Primary endpoint was all-cause mortality or the need for heart transplantation during follow-up. Statistical significance was assessed by Log-rank test of Kaplan-Meier survival analysis. Results 151 CRT-NR patients and 219 patients after primary ICD implantation were identified with a mean ± SEM follow-up of 43.7±2.5 and 47.3±2.2 months, respectively. Baseline (preoperative) LV EFs were higher (p&amp;lt;0.05) for the overall CRT-NR group (EF = 27.4±0.4%) than for the ICD group (EF = 25.2±0.3%) Further, both CRT-NR subgroups of progressors (n=49; EF = 28.6±0.7%) and non-progressors (n=102; EF = 26.9±0.5%) had also significantly higher baseline LV EF as compared to ICD patients (p&amp;lt;0.05). No statistical significance was found between the two CRT-NR subgroups. Event free median survival for the overall CRT-NR group (55.6 months) was significantly worse than for the ICD group (79.6; p&amp;lt;0.05). This difference was driven by progressor patients who had a significantly worse event free survival (37.8 months, p&amp;lt;0.05) than ICD patients, while vent free survival in non-progressors (60.8 months) was comparable to ICD patients (p=0.18). Conclusion Progressor subgroup of CRT-NR have worse outcome as compared to non-progressors and also to those after primary prevention ICD implantation. The poor prognosis of these patients should have implications for timely decision regarding all therapeutic measures currently available for the management of heart failure. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Project no. TKP2021-EGA-18 has been implemented with the support provided from the National Research, Developement and Innovation Fund of Hungary, financed under the TKP2021-EGA funding scheme

Geographic variation in heart failure with reduced ejection fraction: insights from the VICTORIA trial

Abstract Background Geographic differences and background therapy have not been explored in the global VICTORIA trial, which enrolled high-risk patients with recent worsening heart failure with reduced ejection fraction (HFrEF). Methods and results Among 5050 patients enrolled in 5 pre-specified geographic regions, 34% were from Eastern Europe, 18% Western Europe, 23% Asia Pacific, 14% Latin and South America, and 11% North America (Table 1). Patients from Western Europe were older, had more atrial fibrillation, and lower glomerular filtration rates. Patients from Eastern Europe had more coronary artery disease and exhibited more advanced symptoms (∼50% New York Heart Association [NYHA] class III), whereas those from Latin and South America were less symptomatic (∼70% NYHA class II). North American patients had the largest body mass index as well as more diabetes and hypertension. Levels of NT-proBNP at randomization and MAGGIC risk scores were highest in Western European patients. Evidence-based triple medication therapy was used most frequently in Latin and South America and less frequently in North America; conversely, cardiac resynchronization therapy and implantable cardioverter defibrillators were most frequently used in North America and least frequently in Latin and South America. The overall primary composite event rate (cardiovascular death or HF hospitalization) in the placebo arm was 36.6/100 person-years over a median of 10.8 months and after adjusting for the MAGGIC score. When examined by region, these event rates were nominally highest in North America and lowest in Western Europe. Conclusion Substantial regional differences exist in characteristics and treatments among patients in this global trial of patients with HFrEF and a recent worsening event. These findings demonstrate the continuing unmet needs and opportunities for enhancing care in HFrEF. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): VICTORIA was funded by Merck Sharp &amp; Dohme Corp., a subsidiary of Merck &amp; Co., Inc., Kenilworth, NJ, USA and Bayer AG, Wuppertal, Germany.

Clinical impact of nocturnal ventricular tachyarrythmias in electrical storm.

The incidence of electrical storm (ES) is significantly higher during the daytime. However, the association between nocturnal ventricular tachyarrythmias during ES and prognosis remains unclear. Therefore, this study aimed to investigate the clinical characteristics and outcomes of ES with midnight ventricular tachyarrythmias. We included 48 consecutive patients who had an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implanted between 2010 and 2020 and those who had experienced the onset of an out-of-hospital ES episode. According to the midnight (0:00 a.m.-6:00 a.m.) occurrence of ventricular arrythmia events consisting of ventricular tachycardia (VT) and ventricular fibrillation (VF), we divided them into two groups (with-midnight group: n=27, without-midnight group: n=21). The clinical characteristics and outcomes of the two groups were compared. The patients in the with-midnight group were mostly males, had longer QRS duration, and longer corrected QT-interval than those in the without-midnight group (p&lt;.05). The incidence of all-cause death, especially heart failure death, was higher in the with-midnight group than in the without-midnight group (p&lt;.01). Multivariate analysis showed that the presence of midnight VT/VF during ES was the only independent risk factors for heart failure death (HR=18.9, 95%CI=1.98-181, p=.011). The presence of midnight VT/VF during ES might be associated with the poor prognosis. The loss of a sympathetic circadian pattern of VT/VF distribution during ES might suggest advanced stages of the cardiac disease.

The Interplay of PR Interval and AV Pacing Delays Used for Cardiac Resynchronization Therapy in Heart Failure Patients: Association with Clinical Response in a Retrospective Analysis of a Large Observational Study.

Background. Cardiac resynchronization therapy (CRT) is a treatment for heart failure (HF) patients with prolonged QRS and impaired left ventricular (LV) systolic function. We aim to evaluate how the baseline PR interval is associated with outcomes (all-cause death or HF hospitalizations) and LV reverse remodeling (>15% relative reduction in LV end-systolic volume). Methods. Among 2224 patients with CRT defibrillators, 1718 (77.2%) had a device programmed at out-of-the-box settings (sensed AV delay: 100 ms and paced AV delay: 130 ms). Results. In this cohort of 1718 patients (78.7% men, mean age 66 years, 71.6% in NYHA class III/IV, LVEF = 27 ± 6%), echocardiographic assessment at 6-month follow-up showed that LV reverse remodeling was not constant as a function of the PR interval; in detail, it occurred in 56.4% of all patients but was more frequent (76.6%) in patients with a PR interval of 160 ms. In a median follow-up of 20 months, the endpoint of death or HF hospitalizations occurred in 304/1718 (17.7%) patients; in the multivariable regression analysis it was significantly less frequent when the PR interval was between 150 and 170 ms (hazard ratio = 0.79, 95% confidence interval (CI): 0.63–0.99, p = 0.046). The same PR range was associated with higher probability of CRT response (odds ratio = 2.51, 95% CI: 1.41–4.47, p = 0.002). Conclusions. In a large population of CRT patients, with fixed AV pacing delays, specific PR intervals are associated with significant benefits in terms of LV reverse remodeling and lower morbidity. These observational data suggest the importance of optimizing pacing programming as a function of the PR interval to maximize CRT response and patient outcome.

A second chance to make a first impression-ParyleneC residuals staining the surface of cardiac implantable electronic devices.

Cardiac implantable electronic device (CIED) malfunctions are rare but concerning.1 We report a series of 3 devices, where new cardiac resynchronization therapy defibrillators (CRT-Ds) appeared stained. As per Swiss law, analysis of these devices did not require ethical approval.

Follow-up and characteristics of recipients of cardiac resynchronization therapy with and without a defibrillator.

Cardiac resynchronization therapy defibrillator (CRT-D) and pacemaker (CRT-P) are treatment options for patients with advanced heart failure and electrical dyssynchrony. Current guidelines provide only factors favoring, not specific recommendations as to implant CRT-D or CRT-P. This analysis aimed to compare and contrast populations of CRT-D and CRT-P recipients. Retrospective data were collected from medical records, including 231 patients treated with either CRT-D or CRT-P between 2015 and 2019. Following data were analyzed demographics, co-morbidities, pharmacotherapy, laboratory tests, and data related to the procedure of implantation. The primary endpoint of the study was all-cause mortality. A total of 231 patients were included (mean age [standard deviation, SD], 64.1 [12.3] years, 76% male), of these, 13.6% (n = 32) with CRT-P and 86.4% (n = 199) with CRT-D. Mean New York Heart Association (NYHA) class did not differ between the groups: 2.23 (0.9) in CRT-P and 2.35 (0.6) in CRT-D group (P = 0.42). Mean left ventricular ejection fraction was lower in patients eligible for CRT-D: 27.1% vs. 38% (P < 0.001). Patients were followed for a median (interquartile range [IQR]) of 29 (13-44) months and survival in the CRT-P group was 84%, in CRT-D - 82% (P = 0.74). Patients in the CRT-P group were older, and more often after atrioventricular node ablation. The CRT-P group had tendency towards higher Charlton Comorbidity Index, reaching a mean of 4.66 (1.5) points vs. 3.96 (1.5) points in CRT-D (P = 0.06). Populations with CRT-P and CRT-D differ in terms of comorbidities; however, they have similar survival. Further studies are required to identify a group of patients, who derive a benefit from adding a defibrillator.

Effect of Li's catheter in the cardiac resynchronization therapy implantation

Objective: To evaluate the effect of Li's catheter in cardiac resynchronization therapy (CRT) implantation. Methods: This study was a retrospective cohort study. Patients with indications for CRT implantation who visited the Department of Cardiology, Peking University People's Hospital from January 1, 2016 to January 1, 2022 were enrolled. Patients were divided into Li's catheter group (CRT implantation with Li's catheter) and control group (CRT implantation with the traditional method). The general clinical data of the patients were obtained through the electronic medical record system. Li's catheter is a new type of coronary sinus angiography balloon catheter independently developed by Dr. Li Xuebin (patent number: 201320413174.1). The primary outcome was the success rate of CRT device implantation, and the secondary outcomes included efficacy and safety parameters. Efficacy indicators included operation time, coronary sinus angiography time, left ventricular lead implantation time, X-ray exposure time, left ventricular lead threshold, and diaphragm stimulation. Safety outcomes included incidence of coronary sinus dissection, cardiac tamponade, and pericardial effusion. Results: A total of 170 patients were enrolled in this study, including 90 in Li's catheter group and 80 in control group. Age, male proportion of patients, proportion of patients with ischemic cardiomyopathy, hypertension, diabetes mellitus, chronic renal insufficiency, New York Heart Association (NYHA) functional classification, left ventricular ejection fraction, left ventricular end-diastolic diameter, proportion of left bundle branch block, and preoperative QRS wave width were similar between the two groups (all P>0.05). In Li's catheter group, 34 cases (37.8%) implanted with CRT defibrillators, and 28 cases (35.0%) implanted with CRT defibrillators in control group, the difference was not statistically significant (P=0.710). The success rate of CRT device implantation in Li's catheter group was 100% (90/90), which was significantly higher than that in control group (93.8%, 75/80, P=0.023).The operation time was 57.0 (52.0, 62.3) minutes, the time to complete coronary sinus angiography was 8.0 (6.0, 9.0) minutes, and the time of left ventricular electrode implantation was 8.0 (7.0, 9.0) minutes in Li's catheter group, and was 91.3 (86.3, 97.0), 18.0 (16.0, 20.0), 25.0 (22.0, 27.7) minutes respectively in control group, all significantly shorter in Li's catheter group (all P<0.05). The exposure time of X-ray was 15.0 (14.0, 17.0) minutes in Li's catheter group, which was also significantly shorter than that in control group (32.5 (29.0, 36.0) minutes, P<0.001). There was no coronary sinus dissection and cardiac tamponade in Li's catheter group, and 1 patient (1.1%) had diaphragmatic stimulation in Li's catheter group. In control group, 6 patients (6.7%) had coronary sinus dissection, and 1 patient (1.1%) developed pericardial effusion, and 3 patients (3.3%) had diaphragmatic stimulation. The incidence of coronary sinus dissection in Li's catheter group was significantly lower than that in control group (P=0.011). The postoperative left ventricular thresholds in Li's catheter group and control group were similar (1.80 (1.60, 2.38) V/0.5 ms vs. 1.80 (1.60, 2.40) V/0.5 ms, P=0.120). Conclusions: Use of Li's catheter is associated with higher success rate of CRT implantation, short time of coronary sinus angiography and left ventricular electrode implantation, reduction of intraoperative X-ray exposure, and lower incidence of coronary vein dissection in this patient cohort.

Differences in mode of death between men and women receiving implantable cardioverter-defibrillators or cardiac resynchronization therapy in the MADIT trials

Studies have reported sex differences in outcomes following implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) implantation. However, little is known about sex differences with regard to mode of death or device efficacy following ICD or CRT-D implantation. The purpose of this study was to investigate whether sex influenced mode of death or device efficacy in ICD and CRT-D subjects enrolled in the MADIT (Multicenter Automatic Defibrillator Implantation Trial) studies (MADIT-II, MADIT-CRT, and MADIT-RIT). The combined MADIT cohort consisted of 3038 men and 1000 women with ischemic cardiomyopathy (ICM) or nonischemic cardiomyopathy (NICM), left ventricular ejection fraction ≤30%; New York Heart Association functional class I-III heart failure who received ICD or CRT-D. Mode of death was divided into cardiac and noncardiac causes, reviewed by independent adjudication committees. A total of 295 men and 66 women died (9.7% vs 6.6%; P =.003) during 26 months. The most common cause of death was nonarrhythmic cardiac death in men (n = 121 [41%]) and noncardiac death in women (n = 22 [33%]). All-cause mortality and cardiac deaths were 1.5- to 2.0-fold higher in men vs women with ICM but similar for those with NICM after adjustment for covariates. ICD efficacy was similar in men and women, resulting in a 50% reduction in all-cause mortality. CRT-D was more effective at reducing all-cause and cardiac death in women than men. Mode of death differs between sex and is dependent on the underlying cardiac substrate. Compared to women, cardiac death is higher in men with ICM but similar in those with NICM. ICDs are equally effective at reducing mortality in both men and women. However, CRT-D may be more effective at reducing mortality in women.