Cardiac Resynchronization Therapy Defibrillator Research Articles

Advanced Heart Failure Exacerbated by Discreet Left Ventricular Lead Non-Capture

This case report illustrates a challenging case of worsening heart failure in a previously well-compensated patient with unclear etiology. Further workup revealed the patient’s cardiac resynchronization therapy-defibrillator (CRT-D) left ventricle (LV) lead was losing capture during positional changes. This case demonstrates the importance of device optimization, as well as electrocardiogram (ECG) monitoring to elucidate possible causes of acute systolic heart failure.

Corynebacterium striatum Cardiac Device-Related Infective Endocarditis: The First Case Report in a Patient With a Cardiac Resynchronization Therapy Defibrillator Device and Review of the Literature

Corynebacterium striatum (C. striatum) is a skin commensal agent, rarely described as a cause of infective endocarditis. We describe a case of a 48-year-old man, with multiple comorbidities with cardiac resynchronization therapy defibrillator (CRT-D) device implanted 1 year before. A cardiac device-related infective endocarditis (CDRIE) due to C. striatum, with vegetations in the tricuspid valve adjacent to the electrode lead and concomitant lumbar spondylodiscitis were diagnosed. The patient was treated initially with a 6-week course of vancomycin with sterile blood cultures and reduction of inflammatory parameters. Surgery was refused at this stage. Six weeks later, he was readmitted due to C. striatum bacteriemia recurrence, with vegetations adhering to the electrode wire, being treated with daptomycin 10mg/kg body weight, after presenting renal toxicity to vancomycin. CRT-D device was removed with implantation of epicardial cardiac resynchronization therapy pacemaker (CRT-P). To our knowledge, this might be the first description of C. striatum CDRIE in a patient with a CRT-D. In the five cases described in the literature of CDRIE by this agent, early removal of the pacemaker was performed with good results. In this case, the device was removed only after failure of medical treatment alone.

Changes of NT-proBNP and sST2 levels for predicting isolated episodes of ventricular tachyarrhythmias and electrical storm in patients with systolic heart failure and various implanted devices

Aim . To study the changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) and growth stimulation gene-2 (sST2) to predict isolated episodes of ventricular tachyarrhythmias (VTA) and electrical storm (ES) in patients with systolic heart failure and implanted cardioverter-defibrillators, cardiac resynchronization therapy (CRT) defibrillators, as well as cardiac contractility modulation (CCM) devices. Material and methods . The study included 69 patients (mean, 59; women, 10; mean age, 59±13 years) with class I-III systolic HF and ischemic (n=36) or nonischemic (n=33) cardiomyopathy. The survey was carried out at baseline, as well as 1, 3, 6 and 12 months after device implantation. This included data collection, physical examination, determination of NT-proBNP and sST2, 6-minute walk test, electrocardiography (ECG), 24-hour Holter monitoring, echocardiography, assessment of device performance. Predictors of isolated VTA and ES were identified using ROC and multivariate analyzes. Results . According to the follow-up (median, 28 months) results, 3 groups of patients were formed: group 1 — without VTA (n=45); group 2 — isolated VTA (n=15); group 3 — ES (n=9). According to multivariate analysis, predictors of isolated VTA were as follows: 1) baseline NT-proBNP >3200 pg/ml; 2) minimum NTproBNP >1100 pg/ml during 12-month follow-up; 3) sST2 >26 ng/ml 3 months after device implantation; 4) presence of old myocardial infarction; 5) no echocardiographic signs of response to CRT or CCM therapy. There were following predictors of ES: 1) left ventricular end-systolic dimension >7,0 cm; 2) presence of VTA runs according to 24-hour Holter monitoring; 3) no echocardiographic signs of response to CRT or CCM therapy. Conclusion . The results obtained indicate that NT-proBNP and sST2 assessment in patients with systolic heart failure is promising for predicting isolated VTA, but not ES. Cardiac reverse remodeling as a result of effective CRT or CCM therapy is associated with a significant risk reduction for isolated VTA and ES.

A case report of COVID-19 with multiple comorbidities with a positive outcome in early days of COVID-19 outbreak in Bangladesh

We present a case of 68-year-old man with diabetes, heart failure, status post-coronary artery bypass grafs, cardiac resynchronization therapy defibrillator in situ, altered liver function, with corona virus disease 2019. He presented with cough and high grade fever with occasional dyspnea. He was treated at home with favipiravir, methyl prednisolone, enoxaparin and antibiotics and home oxygen therapy. He re-tested positive on 14th and 21st day and later on 31st day he was found RT-PCR negative for SARS-CoV-2. Patient came for a follow-up after 3 months in healthy state with normal D-dimer and other inflammatory markers.
 Birdem Med J 2020; 10, COVID Supplement: 131-134

Sex-Specific Ventricular Arrhythmias and Mortality in Cardiac Resynchronization Therapy Recipients.

The study goal was to examine whether there are sex-related differences in the incidence of ventricular arrhythmias and mortality in CRT-defibrillator (CRT-D) recipients. Few studies have evaluated sex-related benefits of cardiac resynchronization therapy (CRT). Moreover, data on sex-related differences in the occurrence of ventricular tachyarrhythmias in this population are limited. A multicenter retrospective study was conducted in 460 patients (355 male subjects and 105 female subjects) from the UMBRELLA (Incidence of Arrhythmia in Spanish Population With a Medtronic Implantable Cardiac Defibrillator Implant) national registry. Patients were followed up through remote monitoring after the first implantation of a CRT-D during a median follow-up of 2.2 ± 1.0 years. Sex differences were analyzed in terms of ventricular arrhythmia-treated incidence and death during the follow-up period, with a particular focus on primary prevention patients. Baseline New York Heart Association functional class was worse in women compared with that in men (67.0% of women in New York Heart Association functional class III vs. 49.7% of men; p=0.003), whereas women had less ischemic cardiac disease (20.8% vs. 41.7%; p<0.001). Female sex was an independent predictor of ventricular arrhythmias (hazard ratio: 0.40; 95% confidence interval: 0.19 to 0.86; p=0.020), as well as left ventricular ejection fraction and nonischemic cardiomyopathy. Mortality in women was one-half that of men, although events were scarce and without significant differences (2.9% vs. 5.6%; p=0.25). Women with left bundle branch block and implanted CRT have a lower rate of ventricular tachyarrhythmias than men. All-cause mortality in patients is, at least, similar between female and male subjects.

Challenges in activation of remote monitoring in patients with cardiac rhythm devices during the coronavirus (COVID-19) pandemic

BackgroundRemote monitoring (RM) technology embedded in cardiac rhythm devices permits continuous monitoring of device function, and recording of selected cardiac physiological parameters and cardiac arrhythmias and may be of utmost utility during Coronavirus (COVID-19) pandemic, when in-person office visit for regular follow-up were postponed. However, patients not alredy followed-up via RM represent a challenging group of patients to be managed during the lockdown. MethodsWe reviewed patient files scheduled for an outpatient visit between January 1, 2020 and May 11th, 2020 to assess the proportion of patients in whom RM activation was possible without office visit, and compared them to those scheduled for visit before the lockdown. ResultsDuring COVID-19 pandemic, RM activation was feasible in a minority of patients (7.8% of patients) expected at outpatient clinic for a follow-up visit and device check-up. This was possible in a good proportion of complex implantable devices such as cardiac resynchronization therapy and implantable cardioverter defibrillator but only in a minority of patients with a pacemaker the RM function could be activated during the period of restricted access to hospital. ConclusionsOur experience strongly suggest to consider the systematic activation of RM function at the time of implantation or – by default programming - in all cardiac rhythm management devices.

First Demonstration of Cardiac Resynchronization Therapy Defibrillator Service Life Exceeding Patient Survival in a Heart Failure with Reduced Ejection Fraction Cohort.

The occurrence of patient longevity exceeding implantable cardioverter-defibrillator (ICD) service life has important implications for patient outcomes and the cost of care. Battery capacity as measured in ampere-hours (Ah) is a strong predictor of survival to an elective replacement indicator (ERI) point and 2.1 Ah is the largest-capacity ICD battery in use at our facility. This was a long-term study of ICDs out of service (OOS) in patients with heart failure with reduced ejection fraction who received a 2.1-Ah cardiac resynchronization therapy defibrillator (CRT-D). All 2.1-Ah CRT-D systems implanted (n = 418) from August 1, 2008 through August 31, 2016 were included in this retrospective chart review. The primary endpoint was device OOS due to the battery reaching an ERI point, patient death, infection/erosion, advisory/recall, heart transplant, or unspecified. The maximum follow-up period was 10.3 years, with a mean follow-up length of 4.7 years. The most common reason for device OOS was patient death (65.6%), with only 5.7% of devices reaching the ERI point during the study. There was a period of OOS acceleration driven numerically by patient death in the sixth to ninth years of follow-up. Male sex, ischemic cardiomyopathy, elevated creatinine level, advanced age, and reduced ejection fraction were associated with OOS (p < 0.05). To our knowledge, this is the first study to report ICD battery life exceeding patient survival in a chronic heart failure cohort. During an accelerated time of CRT-D OOS (when it is expected that ~98% of 1.0-Ah and 1.4-Ah CRT-D systems reach an ERI point), patient death resulted in substantially more device OOS than battery replacement and avoided costs of complications and generator changes. These results help to explain the elevated risks of CRT-D generator changes in shorter-longevity devices.

Pros and Cons of Left Bundle Branch Pacing: A Single-Center Experience.

Left bundle branch pacing (LBBP) has recently emerged as a promising alternative modality for conduction system pacing. However, limited real-world data exists on the advantages and complications associated with LBBP. We analyzed the Rush conduction system pacing registry on LBBP to assess the success rates and complications associated with LBBP. All patients with an indication for permanent pacemaker or cardiac resynchronization therapy that underwent LBBP for various reasons from June 2018 to April 2020 were included in the analysis. A total of 57 of 59 patients underwent successful LBBP (success rate 97%). The average follow-up duration was 6.2±5 months. The implanted devices included 38 dual-chamber pacemakers, 17 cardiac resynchronization therapy defibrillators, and 2 cardiac resynchronization therapy pacing systems. The most common reason for performing LBBP was a high His-Bundle pacing threshold (n=23) at implant. The mean LBBP capture threshold at implant was 0.62±0.21 V at 0.4 ms which remained stable during follow-up at 0.65±0.68 V at 0.4ms. In 21 patients with cardiomyopathy, there was a significant improvement in left ventricle ejection fraction from 30±11% to 42±15%. A total of 7 lead-related complications (12.3%) were noted in the follow-up period. Three patients (5.3%) required lead revision during the follow-up period. Interventricular septal perforation occurred (as late sequela) after 2 weeks in one patient. LBBP can be achieved with a high success rate and low capture thresholds. Left ventricular dysfunction improved significantly during follow-up. Lead-related complications were relatively common occurring in 12.3% of initially successful implants. Lead revision was required in 3 (5%) of patients.

Upgrade from implantable cardioverter-defibrillator vs. de novo implantation of cardiac resynchronization therapy: long-term outcomes.

To assess and compare long-term mortality and predictors thereof in de novo cardiac resynchronization therapy defibrillators (CRT-D) vs. upgrade from an implantable cardioverter-defibrillator (ICD) to CRT-D. Study population consisted of 595 consecutive patients with CRT-D implanted between 2002 and 2015 in a tertiary care, university hospital, in a densely inhabited, urban region of Poland [480 subjects (84.3%) with CRT-D de novo implantation; 115 patients (15.7%) upgraded from ICD to CRT-D]. In a median observation of 1692 days (range 457-3067), all-cause mortality for de novo CRT-D vs. CRT-D upgrade was 35.5% vs. 43.5%, respectively (P = 0.045). On multivariable regression analysis including all CRT recipients, the previously implanted ICD was an independent predictor for death [hazard ratio (HR) 1.58, 95% confidence interval (CI) 1.10-2.29, P = 0.02]. For those, who were upgraded from ICD to CRT-D, the independent predictors for all-cause death were as follows: creatinine level (HR 1.01, 95% CI 1.00-1.02, P = 0.01), left ventricular end-systolic diameter (HR 1.07, 95% CI 1.02-1.11, P = 0.002), New York Heart Association (NYHA) IV class at baseline (HR 2.36, 95% CI 1.00-5.53, P = 0.049) and cardiac device-related infective endocarditis during follow-up (HR 2.42, 95% CI 1.02-5.75, P = 0.046). A new CRT scale (Creatinine ≥150 μmol/L; Remodelling, left ventricular end-systolic ≥59 mm; Threshold for NYHA, NYHA = IV) showed high prediction for mortality in CRT-D upgrades (AUC 0.70, 95% CI 0.59-0.80, P = 0.0007). All-cause mortality in patients upgraded from ICD is significantly higher compared with de novo CRT-D implantations and reaches almost 45% within 4.5 years. A new CRT scale (Creatinine; Remodelling; Threshold for NYHA) has been proposed to help survival prediction following CRT upgrade.

The radiofrequency interference on CRT-D functioning during AV node ablation: An educational case.

We have described some unusual findings of radiofrequency interference with ICD functioning during AV nodal ablation, guiding the reader to the possible explanation of the phenomena.

Abstract 15038: Gender Differences Amongst Caucasians and African Americans in Rates of Arrhythmias, Implantable Cardiac Devices, and In-hospital Mortality in Sarcoidosis Patients With Cardiomyopathy

Introduction: The prevalence of sarcoid cardiomyopathy (SCM) with female predominance is well known. However, gender differences amongst individual races remains poorly studied. Hypothesis: We sought to determine and compare within each gender and race, the rates of arrhythmias, implantable cardiac devices, and in-hospital mortality in patients with SCM after excluding those with a history of coronary artery disease. Methods: The Nationwide Inpatient Sample was queried from 2010 to 2014 using ICD-9 diagnosis code (135) for sarcoidosis among patients &gt;18 years old. We combined it with code (425.8) for cardiomyopathy in other diseases including sarcoid and sarcoid heart muscle disease. We excluded patients with a history of prior myocardial infarction, percutaneous coronary intervention and coronary artery bypass graft. Results: From 2010 to 2014, we identified 9,063 patients with SCM (mean age = 53.11 ± 11.28 years; men 51.8% and black 52.5%). Upon comparison of gender within races, event rates per 100 patients were (white male, white female, black male, black female; p-value): atrial fibrillation (20.7, 18.8, 18, 16.1; p=0.172), ventricular fibrillation (VF) (4.1, 1.7, 2.3, 2.1; p&lt;0.001), ventricular tachycardia (VT) (33.1, 19.3, 25.1, 21; p&lt;0.001), complete heart block (CHB) (9.1, 8.6, 3.4, 3.6; p=0.58), second degree Mobitz type II (0.3, 0.35, 0.8, 0.4; p=0.717), implantable cardioverter-defibrillator (ICD) (13.3, 9.3, 8.4, 9.2; p&lt;0.001), cardiac resynchronization therapy defibrillator (CRT-D) (5.5, 1.4, 3.4, 2.5; p&lt;0.001), permanent pacemaker (PPM) (2.2, 4.1, 1.1, 1.6; p&lt;0.001), sudden cardiac arrest (SCA) (1.3, 1.7, 1.3, 2.4; p=0.34), endomyocardial biopsy (EMB) (3.6, 2.1, 1.9, 2.3; p=0.011), cardiac MRI (CMR) (1.4, 0.3, 0.7, 1.3; p=0.002), cardiogenic shock (2.5, 1.4, 3, 3; p=0.027), orthotopic heart transplantation (OHT) (2.3, 1.4, 1.1, 0.2; p=0.05), catheter ablation (8.3, 4.5, 3.8, 1.9; p&lt;0.001), and in-hospital mortality (1.7, 3, 2.9, 2.6; p=0.008). Conclusion: White males had higher rates of VF, VT, CHB, but they also had a lower in-hospital mortality and SCA rates likely due to higher procedural rates such as EMB, ICD, CRT-D, catheter ablation and OHT as compared to others.

Delayed occurrence of an accelerated idioventricular rhythm with alternating bundle branch block after myocardial infarction as predictor of sudden cardiac arrest: a case report.

BackgroundAccelerated idioventricular rhythm (AIVR) is known as reperfusion arrhythmia in the setting of acute myocardial infarction (AMI). In healthy individuals, it is usually considered to be benign. Alternating bundle branch block (ABBB) often progresses to complete atrioventricular block requiring permanent pacemaker implantation. We report a case of delayed appearance of AIVR following myocardial infarction (MI) in combination with ABBB as precursor of sudden cardiac arrest due to ventricular fibrillation (VF).Case summaryA 62-year-old male with pre-existing left bundle branch block (LBBB) was admitted with an acute non-ST segment elevation MI. He underwent successful percutaneous coronary intervention (PCI) of a subtotal proximal left anterior descending artery (LAD) stenosis. Before and after PCI the electrocardiogram (ECG) demonstrated sinus rhythm with LBBB. The patient was discharged 5 days after PCI, left ventricular function at this time was moderately reduced (ejection fraction of 40%). After another 5 days, the patient was admitted for elective cardiac rehabilitation. At this time, the ECG demonstrated an AIVR with right bundle branch block morphology. Due to ABBB, the patient was scheduled for permanent pacemaker implantation. Before pacemaker implantation could take place, the patient developed a sudden cardiac arrest due to VF and was successfully resuscitated. A follow-up coronary angiography revealed no novel lesions. A cardiac resynchronization therapy defibrillator was implanted for secondary prevention of sudden cardiac death.DiscussionDelayed occurrence of AIVR in combination with ABBB following AMI could be a predictor of sudden cardiac death. These patients are probably at high risk for malignant ventricular arrhythmias.

Association Between Industry Payments to Physicians and Device Selection in ICD Implantation

Little is known about the association between industry payments and medical device selection. To examine the association between payments from device manufacturers to physicians and device selection for patients undergoing first-time implantation of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D). In this cross-sectional study, patients who received a first-time ICD or CRT-D device from any of the 4 major manufacturers (January 1, 2016-December 31, 2018) were identified. The data from the National Cardiovascular Data Registry ICD Registry was linked with the Open Payments Program's payment data. Patients were categorized into 4 groups (A, B, C, and D) corresponding to the manufacturer from which the physician who performed the implantation received the largest payment. For each patient group, the proportion of patients who received a device from the manufacturer that provided the largest payment to the physician who performed implantation was determined. Within each group, the absolute difference in proportional use of devices between the manufacturer that made the highest payment and the proportion of devices from the same manufacturer in the entire study cohort (expected prevalence) was calculated. Manufacturers' payments to physicians who performed an ICD or CRT-D implantation. The primary outcome of the study was the manufacturer of the device used for the implantation. Over a 3-year period, 145 900 patients (median age, 65 years; 29.6% women) received ICD or CRT-D devices from the 4 manufacturers implanted by 4435 physicians at 1763 facilities. Among these physicians, 4152 (94%) received payments from device manufacturers ranging from $2 to $323 559 with a median payment of $1211 (interquartile range, $390-$3702). Between 38.5% and 54.7% of patients received devices from the manufacturers that had provided physicians with the largest payments. Patients were substantially more likely to receive devices made by the manufacturer that provided the largest payment to the physician who performed implantation than they were from each other individual manufacturer. The absolute differences in proportional use from the expected prevalence were 22.4% (95% CI, 21.9%-22.9%) for manufacturer A; 14.5% (95% CI, 14.0%-15.0%) for manufacturer B; 18.8% (95% CI, 18.2%-19.4%) for manufacturer C; and 30.6% (95% CI, 30.0%-31.2%) for manufacturer D. In this cross-sectional study, a large proportion of ICD or CRT-D implantations were performed by physicians who received payments from device manufacturers. Patients were more likely to receive ICD or CRT-D devices from the manufacturer that provided the highest total payment to the physician who performed an ICD or CRT-D implantation than each other manufacturer individually.

Sarcoid heart disease: rates of arrhythmias, implantable cardiac devices and endomyocardial biopsy

Abstract Introduction/Background Sarcoidosis is a granulomatous disease with various cardiac manifestations such as arrhythmias, heart block, heart failure and sudden cardiac death. Objective We sought to determine and compare the rates of arrhythmias, implantable cardiac devices in patient with sarcoid heart disease (SHD) after excluding those with a history of coronary artery disease Methods The United States Nationwide Inpatient Sample was queried from 2010 to 2014 using ICD-9 diagnosis code (135) for sarcoidosis among patients &amp;gt;18 years. We combined it with code (425.8) for cardiomyopathy in others disease including sarcoid and sarcoid heart muscle disease. We excluded patients with a history of prior myocardial infarction, percutaneous coronary intervention and coronary artery bypass graft. Results From 2010 to 2014, we identified 9,063 patients with SHD (Mage = 53.11±11.28 years; men 51.8% and black 52.5%). The overall in-hospital mortality rate was 227 (2.5%). Average Length of stay (LOS) (M ± SD) was 6.15±8.964. Various arrhythmias include atrial fibrillation 1,659 (18.4%), ventricular fibrillation 223 (2.5%), ventricular tachycardia 2,248 (24.7%), complete heart block 506 (1.5%) and second degree Mobitz type II 45 (0.5%). Rates of implantable cardiac devices included implantable cardioverter-defibrillator (ICD) 881 (9.7%), Cardiac Resynchronization Therapy Defibrillator (CRT-D) 83 (3.6%), PPM 172 (1.9%). Rates of Endomyocardial biopsy were 257 (2.8%). Overall rates of sudden cardiac arrest was 161 (1.8%). On comparing the two groups, sarcoidosis without cardiac involvement and sarcoid heart disease the rates of arrhythmias, implantable cardiac devices, in-hospital mortality and sudden cardiac arrest were as follows: atrial fibrillation (9.4 vs 18.3; p&amp;lt;0.001), ventricular fibrillation (0.1 vs 2.5; p&amp;lt;0.001), ventricular tachycardia (1.3 vs 24.8; p&amp;lt;0.001), complete heart block were (0.3 vs 5.6; p&amp;lt;0.001), and second degree Mobitz type II (0.1 vs 0.5; p&amp;lt;0.001), Pacemaker (0.4 vs 1.9; p&amp;lt;0.001), ICD (0.2 vs 9.7; p&amp;lt;0.001), CRT-D (0.1 vs 3.6; p&amp;lt;0.001), in-hospital mortality (2.5 vs 2.5; p=0.8), Sudden cardiac arrest (0.6 vs 1.8; p&amp;lt;0.001). Conclusions Based on the results of our study, we conclude that SHD is associated with a variety of cardiac arrhythmias and conduction defects. Sarcoidosis with cardiac involvement is associated with increased rates of atrial fibrillation, ventricular fibrillation, ventricular tachycardia, complete heart block, and second degree Mobitz type II. They also had a higher rate of pacemaker implantation, ICD, CRT-D and had a overall higher rate of sudden cardiac arrest. Based on the results of our study we conclude that sarcoidosis with cardiac involvement has worse outcomes and hence, early diagnosis and prompt treatment can prevent the progression of the disease. Funding Acknowledgement Type of funding source: None

Gender differences, rates of arrhythmias, cardiac implantable electronic devices, diagnostic modalities among sarcoidosis patients

Abstract Introduction Sarcoidosis is a granulomatous disease with multiorgan involvement. Cardiac involvement may be asymptomatic or present clinically as heart failure, arrhythmias or even sudden cardiac death. Objective We compared gender differences in prevalence of arrhythmias and associated outcomes in patients with sarcoidosis without established coronary artery disease. Methods The United States Nationwide Inpatient Sample was queried from 2010 to 2014 to identify patients with sarcoidosis using ICD-9 diagnosis code in patients &amp;gt;18 years. We excluded patients with a prior history of myocardial infarction, percutaneous coronary intervention and coronary artery bypass graft. Chi-square test was used for statistical analysis. Results The sample consisted of 308,064 patients (Mage = 55.65±11.28 years); they were mostly women 945 (65.2%) and black 957 (46.7%). In-hospital mortality in this cohort was 1,574 (2.5%). The most common arrhythmias was atrial fibrillation 29,850 (9.7%). Prevalence of ventricular fibrillation was 669 (0.2%), ventricular tachycardia 6,184 (2%), complete heart block 1462 (0.5%) and second degree Mobitz type II 245 (0.1%). Sudden cardiac death occurred in 2,059 (0.7%). Rates of various cardiac devices implanted were: implantable cardiac defibrillator (ICD) 1,452 (0.5%), cardiac resynchronization therapy-defibrillator (CRT-D) 553 (0.2%), pacemaker 1259 (0.4%). Rates of endomyocardial biopsy (EMB), radionuclide imaging, and cardiac magnetic resonance imaging were 470 (0.2%), 879 (0.3%), and 224 (0.1%), respectively. Based on gender (male vs. female), the rates of arrhythmias, cardiac device implantation and utilization of diagnostic modalities were: atrial fibrillation (41% vs 59%; p&amp;lt;0.001), ventricular fibrillation (50% vs 50%; p=0.983), ventricular tachycardia (55% vs 45%; p&amp;lt;0.001), complete heart block (48% vs 52%; p=0.3), second degree Mobitz type II (37% vs 63%; p=0.706), sudden cardiac death (38% vs 62%; p&amp;lt;0.171), ICD (56% vs 44%; p&amp;lt;0.001), CRT-D (58% vs 42%; p&amp;lt;0.025), pacemaker (40% vs 60%; p=0.066), EMB (55% vs 45%; p&amp;lt;0.001), radionuclide imaging (32% vs 68%; p=0.403), cardiac MRI (41% vs 59%; p=0.396). In-hospital mortality was higher in females (36% vs 64%; p&amp;lt;0.001). Conclusion In our study, in-hospital death was more common in females. Females had higher rates of atrial fibrillation compared to males who were found to have a higher burden of ventricular tachycardia. Males had higher rates of ICD and CRT-D placement. Males also had EMB performed more commonly than females. Funding Acknowledgement Type of funding source: None

The incidence, clinical significance of depression and its clinical course after a cardac device implantation in patients with severe heart failure

Abstract Aim To assess the incidence, clinical significance of depression and the impact of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) implantation on psychiatric status in patients with heart failure (HF). Methods The prospective, single-center study encompassed 575 consecutive HF patients implanted with a CRT-D or ICD. Finally, the study population consisted of 494 subjects (186 ICD and 308 CRT-D patients), as 81 patients taking antidepressants were excluded from the analysis. All patients underwent psychiatric examination at the time of implantation, and the assessment of psychiatric status was repeated after 3, 6, 12 and 24 months. The study population was divided into 4 groups: Group 1 encompassed 101 (20.4%) patients with persistent depression, Group 2 constituted of 95 (19.2%) patients with depression that developed after ICD/CRT-D implantation, whereas 43 (8.7%) patients with remission of depression comprised Group 3, and Group 4 encompassed 255 (51.6%) patients with never diagnosed depression. Data on long-term follow-up (median 34.1 months) were screened to identify patients who developed a composite endpoint defined as death or hospitalization for decompensated HF. Results The cumulative incidence of depression at the baseline assessment was 39.1%. Depression developed in 95 (27.1%) patients, whereas remission of depression was observed in 43 (29.9%) subjects after ICD/CRT-D implantation. ICD intervention (HR 3.3) and increase in NYHA class by at least one class (HR 2.6) were the independent risk factors for depression development, whereas mitral regurgitation reduction (HR 1.9), as well as improvement in NYHA class by at least one class (HR 2.4) were the independent predictors for depression remission. Patients with persistent depression (Group 1) and those with newly developed depression (Group 2) were at significantly higher risk of a composite endpoint compared to patients in Group 3 and Group 4 (Table 1). Conclusions Depression is a common comorbidity associated with HF, as it affects 4 of 10 HF patients. ICD intervention and HF worsening are the strongest predictors for depression development after ICD/CRT-D implantation. Depression is a strong, independent risk factor of poor outcomes in HF population. Funding Acknowledgement Type of funding source: None

Sacubitril/valsartan reduces atrial fibrillation and supraventricular arrhythmias in patients with HFrEF and remote monitoring: preliminary data from the SAVE THE RHYTHM

Abstract Background Sacubitril/valsartan, the first combined angiotensin receptor-neprilysin inhibitor, has demonstrated a significant benefit compared to angiotensin inhibitor in decreasing ventricular arrhythmias and appropriate implantable cardioverter defibrillator (ICD) shocks in patients with heart failure with reduced ejection fraction (HFrEF). At present, there is no study which evaluates the effect of sacubitril/valsartan on the supraventricular arrhythmic burden in HFrEF patients with an ICD or cardiac resynchronisation therapy-defibrillator (CRT-D) and remote monitoring. Purpose To evaluate the effect of sacubitril/valsartan on the supraventricular arrhythmic burden in HFrEF patients with an ICD or CRTD and remote monitoring. Methods The SAVETHERHYTHM ((SAacubitril Valsartan rEal-world registry evaluating THE arRHYTHMia burden in HFrEF patients with implantable cardioverter defibrillator) is a multicentre, observational, prospective registry enrolling all patients with HFrEF, ICD or CRT-D actively followed through remote monitoring and starting treatment with sacubitril/valsartan. All patients are followed-up for at least one year after sacubitril/valsartan start. The primary endpoint is the mean number of sustained atrial tachycardia or atrial fibrillation (AT/AF) episodes per month. Secondary endpoints include the total burden of AT/AF (defined as the percentage of time in AT/AF per day), the mean number of premature ventricular contractions (PVC) per hour and the percentage of biventricular pacing per day (in patients with CRT-D). All primary and secondary endpoints are collected through remote monitoring. Results At the time of the first ad interim analysis, 60 patients (85.2% male, age 69±10 years) were consecutively enrolled. After treatment with sacubitril/valsartan, patients with at least one episode of AT/AF per month decreased from 32.8% to 21.3% (p=0.015). A significant decrease in number of AT/AF episodes (from 4.3 to 1.2 per year), in AT/AF burden (from 12% to 9%) and in number of PVC (from 83 to 74 per hour) were seen in patients with a previous diagnosis of paroxysmal or persistent AF (n=15; all p&amp;lt;0.05). Patients with permanent AF (n=7) experienced no benefits from sacubitril/valsartan therapy in terms of arrhythmic burden reduction. Patients with no previous history of AF (n=38) showed a decrease in number of AT/AF episodes (from 2.0 to 0.8 per year) and in number of PVC (from 77 to 49 per hour, all p&amp;lt;0.05). No new diagnosis of clinical AF was made after starting treatment with sacubitrl/valsartan, and patients with subclinical AT/AF episodes decreased from 8% to 3%. Conclusions Preliminary data suggest that therapy with sacubitril/valsartan could decrease arrhythmic burden in patients with non-permanent AF and reduce subclinical AT/AF episodes in patients with no history of AF. No positive effect has been noted in patients with permanent AF. Funding Acknowledgement Type of funding source: None

Real world experience with heart failure risk status generated by cardiac resynchronisation therapy defibrillators: high heart failure risk status incidence, causes and timing of remote transmissions

Abstract Background Proactive patient monitoring is of paramount importance in effective management of heart failure (HF) patients. Cardiac implantable electronic devices (CIEDs) used in HF patients are able to derive long-term trends in physiologic parameters and provide timely warning to clinicians. Little is known, however, on the real-world experience with device-generated HF risk-stratifying algorithms. Purpose Heart Failure Risk Score (HFRS) takes into account nine parameters and is calculated automatically based on long-term clinical trends. Remote transmissions provide information on the risk of HF event in next 30 days categorized as low, medium or high based on a maximum daily risk status in prior 30 days. We aimed to evaluate the ability of HFRS to alert HF specialists on the actual HF risk status. Methods The prospective registry included all patients with CIEDs featuring integrated Heart Failure Risk Score (HFRS) followed via Medtronic CareLink remote monitoring system and enabled for Co-management (CM) from May 2015 to August 2019 in a tertiary centre. High HFRS does not trigger automatic alert transmission. Study follow-up spanned between start of CM and last transmission in 2019. Inclusion criteria were CRT-D in situ, active Home Monitor, switched on OptiVol 2.0 remote alert and transmission data available on CareLink following study period completion. Transmissions were scheduled 3-monthly. Results Out of 229 consecutive patients, 132 met study criteria. Mean age was 74±10 years, 18% were female. Median follow-up duration was 2.7 years (IQR 1.3). Total number of transmissions was 2652, median per patient was 18 (IQR 13); scheduled, unscheduled and care alerts constituted 42%, 44% and 14%, respectively. One third of transmissions were automatically sent for CM review. There were 398 high HFRS episodes. OptiVol fluid index was below the threshold throughout 128 (32%) episodes. Missed episodes (not transmitted within 30 days from the final day of high HFRS) amounted to 130 (33%) and the reasons behind this included OptiVol alerting before the first day of high HFRS or persistently elevated when HFRS changed from low/medium to high (52%), low OptiVol index during the episode (38%) or other (10%). Median duration of high HFRS was 7 days (IQR 12, range, 1–187). Among timely picked-up high HFRS episodes, 38% were transmitted during the relevant episode and 62% afterwards with median delay of 10 days (IQR 15) from the last day of high HFRS; 21% of transmissions showing high HFRS were not highlighted for CM review which correlated with low OptiVol index, P&amp;lt;0.001. The factors contributing to high HFRS included: raised OptiVol (60%), patient activity (83%), AT/AF (46%), ventricular rate (VR) during AF (6%), % of VP (40%), shocks (2%), treated VT/VF (2%), night VR (72%) and HR variability (34%). Conclusions In a real-world clinical setting high HFRS was frequently under-reported. The investigation into clinical implications is warranted. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Our department has benefited from unrestricted grants from Boston Scientific and Medtronic Inc during the last 5 years.

Temporal characteristics of an integrated diagnostics risk score before and after heart failure hospitalizations in a large real-world population of patients with implantable devices

Abstract Background Diagnostic parameters measured in implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) have been shown to change before and after heart failure (HF) events with fluid overload. Purpose We investigated the temporal characteristics of an integrated diagnostic risk score before and after HF events in a large real-world cohort of patients with ICD/CRTD devices. Methods We linked a de-identified database of aggregated electronic health record (EHR) data (2007–2017) to a manufacturer's device database with continuous diagnostic monitoring data. Patients with ICD/CRTD implants with intra-thoracic impedance diagnostic feature were included for this study. The previously defined integrated diagnostic risk score was derived by combining daily diagnostic data, including intra-thoracic impedance, night-time heart rate, activity, heart rate variability, and atrial fibrillation (AF) burden, ventricular rate during AF, CRT pacing, ventricular tachycardia episodes and shocks, in a Bayesian Belief Network framework. HF event was defined as an inpatient, emergency department, or observation unit stay in a hospital with primary diagnosis of HF and intravenous diuretic administration. Temporal average of daily risk score across all patients in the 60 days pre and post HF events were compared in HF events with and without readmission within 60 days and with no HF event during pre and post follow-up days. Results A total of 17,886 patients with 1.8±1.2 years of follow-up met inclusion criteria. The average age of patients was 66.6±12.3 years, with 72% being males, and 51% with ICD devices. The average integrated diagnostics risk score in HF events with and without readmission and with no events is shown in Figure. A total of 1174 patients had 1425 HF events with no readmission for HF within 60 days and 282 patients had 295 HF events which were followed by readmission for HF within 60 days. A total of 17,839 patients had no HF events over 86,858 follow-up months. The average daily risk score across all patients was higher on all 60 days pre and post HF event with readmission compared to HF events with no readmission (p&amp;lt;0.001) and both were higher compared to follow-up period with no events (p&amp;lt;0.001). The risk score recovers less often after HF events which are followed by readmission within 60 days compared to HF events with no readmission. Conclusions In a large real-world population of patients with ICD/CRTD devices, the average integrated diagnostics risk score was higher before and after HF events with readmission compared to HF events with no readmission. Re-admissions are more likely in patients with smaller risk score recovery after HF events. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic Plc

Impact of an adaptive CRT optimization algorithm on the risk of life-threatening ventricular arrythmias of heart failure patients

Abstract Introduction Adaptive cardiac resynchronization therapy (aCRT) algorithm provides ambulatory CRT optimization and synchronized left-ventricular pacing instead of conventional biventricular pacing. Purpose To analyze the impact of aCRT on the risk of life-threatening ventricular arrythmia (VA) in patients with concomitant defibrillator therapy. Methods Symptomatic HF patients, in sinus rhythm, with LVEF ≤35% and QRS complex ≥130 ms undergoing first CRT-defibrillator (CRT-D) implant were collected from the multicentre, prospective and nationwide UMBRELLA study (2012–2017). All device information was automatically stored and collected through the remote monitoring system. An experts committee analysed in a blinded manner all electrograms. The endpoint was first appropriate therapy (AT) delivered within ventricular fibrillation zone at 12-months follow-up. Results 206 patients were collected (66.1±8.7 years; 73.3% male). Fifty nine patients composed the aCRT group and 147 composed the non-aCRT group. At implant, LBBB was present in 93% of patients, functional class III or IV in 69.9%, non-ischemic HF in 63.1% of patients and mean LVEF was 26.5±5.6%. Optimal medical treatment was achieved in a majority (B-blockers in 92%; RAASi in 89% and MRA in 72.2%). The percentage of ventricular pacing through 12 months was 96.1±9.4% in non-aCRT patients and 97.5±2.7% in aCRT patients (p=0.261). At 1-year of follow-up, 16 patients were delivered an AT (event rate: 7.8%). Most of these episodes (n=14) were due to sustained monomorphic ventricular tachycardia while the rest were caused by sustained polymorphic ventricular tachycardia/VF. A lower incidence of AT was observed in aCRT patients (3.4%) compared to non-aCRT patients (9.5%) but with no statistical differences (OR=0.33, CI 0.07–1.51, p=0.155). Conclusions In patients undergoing CRT provided by aCRT algorithm the risk of malign VA after 1-year of follow-up was low. Randomized studies are needed to clarify the impact of this dynamic algorithm on the arrhythmic risk of HF patients. Funding Acknowledgement Type of funding source: None