Cardiac Resynchronization Therapy Defibrillator Research Articles

Cardioverter-defibrillator reduces mortality risk in eligible ischemic and non-ischemic cardiomyopathy patients: Sub-analysis of the multi-center Improve SCA study

Background & ObjectiveDespite the burden of sudden cardiac arrest (SCA) worldwide, implantable cardioverter-defibrillators (ICDs) are underutilized, particularly in Asia, Latin America, Eastern Europe, the Middle East, and Africa. The Improve SCA trial demonstrated that primary prevention (PP) patients in these regions benefit from an ICD or a cardiac resynchronization therapy defibrillator (CRT-D). We aimed to compare the rate of device therapy and mortality among ischemic and non-ischemic cardiomyopathy (ICM and NICM) PP patients who met guideline indications for ICD therapy and had an ICD/CRT-D implanted. MethodsImprove SCA was a prospective, non-randomized, non-blinded multicenter trial that enrolled patients from the above-mentioned regions. All-cause mortality and device therapy were examined by cardiomyopathy (ICM vs NICM) and implantation status. Cox proportional hazards methods were used, adjusting for factors affecting mortality risk. ResultsOf 1848 PP NICM patients, 1007 (54.5%) received ICD/CRT-D, while 303 of 581 (52.1%) PP ICM patients received an ICD/CRT-D. The all-cause mortality rate at 3 years for NICM patients with and without an ICD/CRT-D was 13.1% and 18.3%, respectively (HR 0.51, 95% CI 0.38–0.68, p < 0.001). Similarly, all-cause mortality at 3 years in ICM patients was 13.8% in those with a device and 19.9% in those without an ICD/CRT-D (HR 0.54, 95% CI 0.33–.0.88, p = 0.011). The time to first device therapy, time to first shock, and time to first antitachycardia pacing (ATP) therapy were not significantly different between groups (p ≥ 0.263). ConclusionsIn this large data set of patients with a guideline-based PP ICD indication, defibrillator device implantation conferred a significant mortality benefit in both NICM and ICM patients. The rate of appropriate device therapy was also similar in both groups. Clinical trial registrationClinicalTrials.gov ID: NCT02099721.

Trends in the Use and Complications of Cardiac Resynchronization Therapy Device Implantation in Chronic Kidney Disease Patients.

Large-scale multi-hospital data on cardiac resynchronization therapy (CRT) device implantation in patients with chronic kidney disease (CKD) are currently lacking. The purpose of this study was to examine the incidence of CRT device implantation in patients hospitalized with CKD and the impact of CRT device implantation on hospital complications and outcomes. We analyzed the Nationwide Inpatient Sample from 2008-2014 to identify yearly trends in CRT device implantation during CKD hospitalizations. We compared CRT biventricular pacemakers (CRT-Ps) and CRT defibrillators (CRT-Ds). We also obtained rates of comorbidities and complications associated with CRT device implantations. From 2008-2014, the proportion of hospitalized patients with a concurrent diagnosis of CKD receiving CRT-P devices consistently went up from 2008 to 2014 (from 12.3% to 23.8%, P < .0001) compared to the number of hospitalized patients with a concurrent diagnosis of CKD receiving CRT-D devices, which showed a consistent downward trend (from 87.7% to 76.2%, P < .0001). During CKD hospitalizations, most CRT device implantations were performed in patients aged 65-84 years (68.6%) and in men (74.3%). The most common complication of CRT device implantation during hospitalizations involving CKD was hemorrhage or hematoma (2.7%). Patients hospitalized with CKD who developed any complication associated with CRT device implantation had 3.35-fold increased odds of mortality compared to those without complications (odds ratio, 3.35; 95% confidence interval, 2.18-5.16; P < .0001). In summary, this study shows that CRT-P implantations became more common in CKD patients, while the rate of CRT-D implantations decreased over time. Hemorrhage or hematoma was the most common complication (2.7%), and the mortality risk was increased by 3.35 times in patients who developed periprocedural complications.

Cost-effectiveness analysis of cardiac implantable electronic devices with reactive atrial-based antitachycardia pacing.

Reactive atrial-based anti-tachycardia pacing (rATP) in pacemakers (PMs) and cardiac resynchronization therapy defibrillators (CRT-Ds) has been reported to prevent progression of atrial fibrillation, and this reduced progression is expected to decrease the risk of complications such as stroke and heart failure (HF). This study aimed to assess the cost-effectiveness of rATP in PMs and CRT-Ds in the Japanese public health insurance system. We developed a Markov model comprising five states: bradycardia, post-stroke, mild HF, severe HF, and death. For devices with rATP and control devices without rATP, we compared the incremental cost-effectiveness ratio (ICER) from the payer's perspective. Costs were estimated from healthcare resource utilisation data in a Japanese claims database. We evaluated model uncertainty by analysing two scenarios for each device. The ICER was 763 729 JPY/QALY (5616 EUR/QALY) for PMs and 1,393 280 JPY/QALY (10 245 EUR/QALY) for CRT-Ds. In all scenarios, ICERs were below 5 million JPY/QALY (36 765 EUR/QALY), supporting robustness of the results. According to a willingness to pay threshold of 5 million JPY/QALY, the devices with rATP were cost-effective compared with control devices without rATP, showing that the higher reimbursement price of the functional categories with rATP is justified from a healthcare economic perspective.

MRI conditional safety of mixed systems: Study of the impact of active implant medical device impedance on the radiofrequency-induced lead heating.

The aim of this paper is to study the impact of pulse generator small impedance variations on the overall radiofrequency (RF)-induced heating of a cardiac rhythm management (CRM) lead in a 1.5 T MR system. An analysis was conducted on two CRM pacing leads with different structural designs. The leads were connected to three CRM devices belonging to different technological platforms: two pacemakers and a cardiac resynchronization therapy defibrillator (CRT-D). All pulse generators had a small (< ) RF input impedance compared to the overall system (pulse generator and lead) impedance. In addition, two Dummy load devices with an input impedance that is not negligible compared to the lead impedance were also studied. The implantable systems were studied in terms of RF deposited power at the lead electrodes, which is proportional to the RF-induced heating. Results show that both leads behave very similarly in terms of RF deposited power for the same in-vivo tangential E-field excitation when mounting any of the pulse generators; reported differences are well below the combined uncertainty . On the other hand, both Dummy load devices resulted in a RF deposited power which differs from the other pulse generators by values larger than the combined uncertainty. The results of our experimental analysis show that different pulse generators would not change the RF-induced heating behavior of a given lead, provided that the pulse generator impedances are small (in our study less than 5%) compared to the overall system impedance.

Right ventricular cardiac resynchronization therapy in patients with right ventricular conduction delay and heart failure

Right ventricular cardiac resynchronization therapy in patients with right ventricular conduction delay and heart failure

Early Smartphone App-Based Remote Diagnosis of Silent Atrial Fibrillation and Ventricular Fibrillation in a Patient with Cardiac Resynchronization Therapy Defibrillator

Due to distressing statistics concerning cardiovascular diseases, remote monitoring of cardiac implantable electronic devices (CIED) has received a priority recommendation in daily patient care. However, most bedside systems available so far are not optimal due to limited patient adherence. We report that smartphone app technology communicating with CIED improved the patient's engagement and adherence, as well as the accuracy of atrial and ventricular arrhythmias diagnosis, thus offering more efficient treatment and, consequently, better patient clinical outcomes. Our findings are in concordance with previously published results for implantable loop recorders and pacemakers, and provide new insight for heart failure patients with an implanted cardiac resynchronization therapy defibrillator.

Temporal Characteristics of Device-Based Individual and Integrated Risk Metrics in Patients With Chronic Heart Failure

BackgroundTemporal characteristics of a multimetric risk score and its individual parameters before, during, and after a heart failure (HF) event have not been defined. ObjectivesA large real-world patient cohort with implantable cardioverter-defibrillators and cardiac resynchronization therapy (CRT) defibrillators was used to define these temporal characteristics. MethodsDeidentified health records were linked to manufacturer’s device database in 17,886 patients. Multimetric risk score combined daily measures of impedance, heart rate, activity, heart rate variability, and atrial fibrillation (AF) burden, AF ventricular rate, CRT pacing, and ventricular tachycardia episodes and shocks. HF event was defined as an inpatient, emergency department, or observation unit stay with primary diagnosis of HF and intravenous diuretic agents administration. Changes in risk parameters during 60 days before, during, and after an HF event were compared in patients with no HF readmissions vs patients with HF readmission. ResultsA total of 1,174 patients had HF events with no HF readmission, and 282 patients had HF events with HF readmission. Diagnostic risk score was higher on all 60 days before and after a HF event in patients with HF readmission compared with patients with no readmission (P < 0.001). Change in risk score from admission to discharge was similar in patients with and without HF readmission, but the risk score fell more significantly 7 after discharge and 30 days after admission in patients without HF readmission (P < 0.001). ConclusionsTemporal characteristics of risk metrics were significantly different in patients with no HF readmissions vs patients with HF readmission; patients without HF recurrence had larger recovery of risk metrics values toward normal.

Predicting the survival benefit of cardiac resynchronization therapy with defibrillator function for non-ischemic heart failure-Role of the Goldenberg risk score.

Primary prevention of sudden cardiac death (SCD) in non-ischemic heart failure (HF) patients remains a topic of debate at cardiac resynchronization therapy (CRT) implantation requiring individual risk assessment. Using the Goldenberg SCD risk score, we aimed to predict, which non-ischemic HF patients will benefit from the addition of an implantable cardioverter defibrillator (ICD) to CRT at long-term. Between 2000 and 2018 non-ischemic HF patients undergoing CRT implantation were collected into our retrospective registry. The Goldenberg risk score (GRS) was calculated by the presence of atrial fibrillation, New York Heat Association (NYHA) class > 2, age > 70 years, blood urea nitrogen > 26 mg/dl and QRS > 120 ms. The primary endpoint was all-cause mortality, heart transplantation or left ventricular assist device implantation. From 667 patients, 347 (52%) underwent cardiac resynchronization therapy-pacemaker (CRT-P), 320 (48%) cardiac resynchronization therapy-defibrillator (CRT-D) implantations. During the median follow up time of 4.3 years, 306 (46%) patients reached the primary endpoint (CRT-D 37% vs. CRT-P 63%; p < 0.001). CRT-D patients were younger (64 vs. 69 years; p < 0.001), infrequently females (26 vs. 39%; p < 0.001), and had a lower ejection fraction (27 vs. 29%; p < 0.01) compared to CRT-P patients. After GRS calculation, patients were dichotomized by low (< 3) and high (≥ 3) scores. CRT-D patients with low GRS showed a mortality benefit compared to CRT-P (HR 0.68; 95% CI 0.48-0.96; p = 0.03), high-risk patients did not (HR 0.84; 95% CI 0.62-1.13; p = 0.26). In our non-ischemic cohort, patients with low GRS showed a clear long-term mortality benefit by adding ICD to CRT, however, in high-risk patients no further benefit could be observed.

Implantable Cardioverter Defibrillator for the Primary Prevention of Sudden Cardiac Death among Patients With Cancer

Data are limited regarding the characteristics and outcomes of patients with cancer who are found eligible for primary defibrillator therapy. We performed a single-center retrospective analysis of patients with preexisting cancer diagnoses who become eligible for a primary prevention implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) defibrillator. Multicenter Automatic Defibrillator Implantation Trial-ICD (MADIT-ICD) benefit scores were calculated. The study included 75 cancer patients at a median age of 73 (interquartile range 64, 81) years at heart failure diagnosis. Active cancer was present in 51%. Overall, 55% of the cohort had coronary artery disease and 37% were CRT eligible. We found that 48%, 49%, and 3% of cohorts had low, intermediate, and high MADIT-ICD Benefit scores, respectively. Only 27% of patients underwent primary defibrillator implantation. Using multivariate analysis, indication for CRT and intermediate/high MADIT-ICD Benefit categories were found as independent predictors for implantation (odds ratio 8.42 p <0.001 and odds ratio 3.74 p=0.040, respectively). During a median follow-up of 5.3 (interquartile range 4.5, 7.2) years, one patient (5%) with a defibrillator had appropriate shock therapy and 2 patients (10%) had bacteremia. Of 13 patients with CRT defibrillator-implants, one patient was admitted for heart failure exacerbation (8%). Using a time-varying covariate model, we did not observe statistically significant differences in the survival of patients with cancer implanted versus those not implanted with primary defibrillators (hazard ratio 0.521, p=0.127). In conclusion, although primary defibrillator therapy is underutilized in patients with cancer, its relative benefit is limited because of competing risk of nonarrhythmic mortality. These findings highlight the need for personalized cardiologic and oncologic coevaluation.

Avcs-Sonr Pilot Study: N-Terminal Pro-Brain Natriuretic Peptide Inversely Correlates with Sonr Signal in Patients with Dilated Cardiomyopathy and Reduced Left Ventricular Ejection Fraction

Background. Chronic heart failure is a very important public health problem, and brain natriuretic peptide monitoring may help in its management but faces important logistical problems. A readily available surrogate of brain natriuretic peptide would be of value in this field. We hypothesized that SonR measurements might be this brain natriuretic peptide surrogate. Methods. Patients with chronic heart failure, left ventricular ejection fraction ≤ 30% and implanted with a cardiac resynchronization therapy defibrillator able to provide SonR values underwent monthly assessment of brain natriuretic peptide levels for 1 year. The relationship between brain natriuretic peptide levels and paired SonR values was evaluated. Results. An inverse and highly significant relationship between brain natriuretic peptide levels and paired SonR values was obtained. Conclusions. We found an inverse and significant relationship between SonR values and brain natriuretic peptide levels. This finding might lead to the use of SonR values to monitor treatment and preclude hospital admissions in patients with chronic heart failure.

Efficacy of intrinsic antitachycardia pacing for ventricular tachycardia refractory to conventional burst pacing: A case series.

Intrinsic antitachycardia pacing (iATP) is a novel automated ventricular ATP algorithm that designs ATP sequences based on the analysis of prior failed ATP. Real-world data on the efficacy and safety of iATP are lacking. Among 124 ventricular tachycardia (VT) episodes in 130 consecutive patients (mean age at implantation: 63.8 ± 14.9 years; sex, 95 male and 35 female) for whom implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator equipped with iATP algorithm was implanted, we investigated the efficacy and safety of iATP for VT refractory to conventional burst pacing.Eight patients had a total of 17 episodes of iATP therapy after failed conventional burst pacing within 11.2 ± 6.6 months of follow-up. Eleven VT episodes (64.7%) in seven patients (87.5%) were successfully terminated by iATP, and only one patient (12.5%) experienced VT acceleration.iATP might be useful for VTs refractory to conventional burst pacing with a low risk of VT acceleration.

336 TEMPORAL CONNECTION BETWEEN HOME MONITORING TRENDS OF THORACIC IMPEDANCE AND SUSTAINED VENTRICULAR ARRHYTHMIAS

Abstract Introduction Implantable cardioverter defibrillators (ICDs) provide daily values of thoracic impedance (TI) that are inversely correlated with fluid accumulation in the lungs. Since sustained ventricular arrhythmias (SVA) are known to have a short-term relationship with heart failure exacerbations, our objective was to assess TI trends temporally related to SVA episodes. Methods This study analyzed data daily transmitted from patients with ICD or cardiac resynchronization therapy defibrillator (CRT-D) of the nationwide Home Monitoring Expert Alliance network. Device-detected SVAs were adjudicated for appropriateness. Patients were randomly split into a derivation and validation cohort. To identify the most significant TI trend (TI-index), several numerical TI transformations were tested in a cross-sectional analysis of the derivation cohort modelling the odds of first SVA with univariate logistic regressions. In the same cohort, the threshold of the selected transformation was identified to maximize the projected specificity. The relative risk of SVA for TI-index above threshold was estimated in the validation cohort by applying Cox proportional hazard models stratified by individual patients to 60-day duration windows. Analyses were performed separately in the ICD and CRT-D groups. Results The study cohort included 2,384 patients with 69 years of age (interquartile range: 60, 77); 19% were women, 42% had coronary artery disease, and 43% had a CRT-D. After a median follow-up of 2.0 (1.0, 3.4) years, there were 3,298 appropriate SVA episodes in 727 patients (30%). The derived IT-index consisted of the percentage of 6-day intervals of the rolling average of TI values showing monotone decrease in the last 82 days. The increase in the risk of SVA was 3% (p&amp;lt;0.0001) per unit of percentage. The threshold of 60% of intervals with monotone decrease was associated with 99.9% projected specificity and 70.3% accuracy. In the validation cohort, the TI-Index was associated with a 42% increased risk of SVA episodes in the ICD group (hazard ratio [HR] 1.42, 95% confidence interval [CI] 1.05-1.92, p=0.023). The TI-index exceeded the 60% threshold before the episode in 38% of the detected episodes. The association was not significant in the CRT-D group (HR 0.96, 95% CI 0.62-1.47, p=0.84). Conclusions In our analysis of remote monitoring data, a specific monotonic decreasing trend of TI was temporally associated with SVA in patients with ICD. Careful monitoring of TI can identify a period of susceptibility to ventricular arrhythmias that deserves more intensive attention.

1033 A STRANGE CASE OF PULMONARY EMBOLISM IN A YOUNG PATIENT WITH CARDIAC RESYNCHRONIZATION THERAPY

Abstract Introduction Clinically relevant pulmonary embolism (PE) related to pacemaker leads is reported in up to 3.5% of cases of implantations. We reported a particular case of acute massive PE in a patient bearer of a Cardiac Resynchronization Therapy-Defibrillator (CRT-D). Case presentation A 49-year-old man presented to our ER reporting dyspnea and localized pain to the left hemithorax. Past medical history included HFrEF due to idiopathic dilated cardiomyopathy complicated by apical thrombosis, CRT-D, Charcot-Marie-Tooth syndrome, dyslipidemia, and a hepatic nodule undergoing diagnosis. Recently, he reported COVID-19 and successive pleuropneumonia requiring hospitalization. At home, he was taking Acenocoumarin, Sacubitril/Valsartan 97/103mg bid, Carvedilol 6.25mg bid, Digoxin 0.0625mg, and Canrenon 50mg with questionable adherence. On physical examination, he was pyretic, mildly hypotensive and hypoxemic. An ECG showed atrio-guided biventricular stimulation at 110 bpm. A transthoracic echocardiogram (TTE) revealed biventricular disfunction and dilation, mitral and tricuspid regurgitation, PAPs 60 mmHg, and a thrombotic formation in the left ventricle apex. Blood tests found elevated D-Dimer and infection markers, INR 1.1. A CT angiography confirmed a bilateral acute massive PE associated with lung consolidations and left pleural effusion. We excluded deep vein thrombosis in the lower limbs. Patient was admitted to CCU and treated with intravenous heparin, antibiotics, and support therapy. After one week, we performed a transesophageal echocardiogram that confirmed the previous TTE except for a minor PAPs and unknown thrombotic formations on the atrial side of the tricuspid valve, adhering to CRT-D leads, pedunculated, highly mobile, the largest with an area of 1.9cm2. Cardiac surgery wasn't indicated; we excluded thrombophilia and thoracic cancer. Patient is still hospitalized, asymptomatic and with a precarious cardiovascular status. Discussion The incidence of asymptomatic clot adhering to cardiac device's leads found by echocardiography is 1.4%, and thromboembolic complications are even rarer, especially after years from the implant. In our patient, the right atrium thrombosis is probably the cause of PE, and possible precipitating factors were pneumonia or unknown hepatic neoplasm. In the diagnostic workup, TTE probably wasn't sensitive enough to detect those thrombi. Conclusions We presented a particular case of PE in a relatively young patient affected with HFrEF. Even if thrombosis related to pacemaker leads is rare, it should be considered as a possible cause of PE in a patient bearer of a cardiac stimulating device.

432 SACUBITRIL/VALSARTAN AND RISK OF SUPRAVENTRICULAR ARRHYTHMIAS AS DETECTED BY REMOTE MONITORING IN HEART FAILURE PATIENTS

Abstract Introduction Sacubitril/valsartan (ARNI) has demonstrated a significant benefit compared to angiotensin inhibitor (enalapril) in decreasing both morbidity and mortality in patients with heart failure with reduced ejection fraction (HFrEF). While. recent studies demonstrated that in HFrEF patients, ARNI decreased ventricular arrhythmias no data is available with regards to the supraventricular arrhythmic burden in HFrEF patients with an implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy-defibrillator (CRT-D) and remote monitoring. The aim of out study was to assess if ARNI therapy was able to significantly reduce supraventricular arrhythmias. More specifically the primary endpoint was the incidence of AT/AF episodes, as detected by the device. Secondary endpoints included the total burden of AT/AF, the mean number of premature ventricular contractions (PVC) per hour and the percentage of biventricular pacing per day (in patients with CRT-D). Methods We conducted a multicentre, observational, prospective registry : the SAVE THE RHYTHM (SAacubitril Valsartan rEal-world registry evaluating THE arRHYTHMia burden in HFrEF patients with implantable cardioverter defibrillator). We enrolled all patients with HFrEF, ICD or CRT-D actively followed through remote monitoring and starting treatment with sacubitril/valsartan. All patients were followed-up for at least one year. Results At the end of enrollment, 265 patients from 5 centres had at least one sacubitril/valsartan prescription (88% males, age 68±10 years). The annual incidence of AT/AF episodes decreased from 16.6% before sacubitril/valsartan to 12.8%, 6.7% and 0.7% according to the maximum tolerated dose (24/26 mg, 49/51 mg and 97/103 mg, respectively; p=0.026). After treatment with sacubitril/valsartan, patients with at least one episode of AT/AF decreased from 32.6% to 26.5% (24/26 mg), 24.3% (49/51 mg) and 6.9% (97/103 mg); p=.041. A significant decrease in the number of PVC (-28 per hour) and in the rate of appropriate shock (-0.8% per year) were seen in patients with a previous diagnosis of paroxysmal or persistent AF. Patients with permanent AF (n=7) experienced no benefits from sacubitril/valsartan therapy in terms of arrhythmic burden reduction. Patients with a CRT device (41%) experienced a significant increase in biventricular pacing time (+3% per day). Discussion Therapy with sacubitril/valsartan could decrease arrhythmic burden in patients with non-permanent AF and HFrEF and reduce subclinical supraventricular arrhythmias in patients with no history of AF.

136 A SHOCKING CASE OF MYOCARDITIS?

Abstract Background Cardiac involvement is common in systemic sclerosis (SSc), being a poor prognostic factor and the leading cause of mortality. Cardiac involvement ranges from a serendipitous diagnosis to relevant cardiac manifestations such as arrhythmias, pericardial effusion, myocardial dysfunction, and valvular diseases. Case report A 39-year-old female without remarkable medical history, on estroprogestinic therapy was admitted to our hospital in June 2020 after an out-of-hospital cardiovascular arrest due to ventricular fibrillation (VF). A coronary angiography ruled out coronary artery disease. Magnetic resonance imaging (MRI) showed a picture of acute myopericarditis characterized by late linear and nodular intramyocardial and subepicardial gadolinium enhancement of the septal and inferior segments of the left ventricle, with trivial oedema in the same location in turbo inversion recovery magnitude (TIRM) sequences. A subcutaneous-implantable cardiac defibrillator (S-ICD) was positioned for secondary prevention. At the 5 months ICD interrogation, 3 episodes of VF detected and treated by the device were documented. In December 2020 two more appropriate device interventions on polymorphic VT/VF occurred. A septal myocardial biopsy was then performed showing diffused replacement fibrosis in the absence of signs of acute inflammation or virus on the molecular investigation. In March 2021 the patient was referred to our institution after experiencing several ventricular arrhythmia episodes successfully treated by the ICD. A myocardial positron emission tomography (PET) scan documented the uptake of 18-fluorodeoxyglucose at middle and basal septum. A 'targeted' myocardial biopsy showed a substitutive fibroadiposis with sporadic inflammatory cells, in absence of cardiotropic viruses on the molecular investigation. We then initiated Anakinra, an anti-IL1 agent with an anti-inflammatory effect to prevent further development of "inflammation-driven fibrosis". Given the Raynaud's phenomenon reported by the patient, a capillaroscopy was performed, confirming isolated megacapillaries and apical haemorrhages, compatible with early pattern scleroderma. Immunologic examinations found homogeneous ANA 1:320 and anti-RNA polymerase III, while other autoantibodies, viral serologies and tubercular analysis were negative. In October 2021, the patient was readmitted to our hospital for recurrence of arrhythmic storm. A radiofrequency catheter-based ablation was performed. After a new episode of VT properly treated by the S-ICD in May 2022, the device was explanted, and a cardiac resynchronization therapy defibrillator was implanted. The genetic analysis identified a heterozygous deletion (c1262_1263del) of Lamin A (LMNA) classified as probably pathogenic in left ventricular arrhythmogenic cardiomyopathy or dilated cardiomyopathy. Conclusion A diagnosis of borderline myocarditis in anti-RNA-polymerase III+ systemic sclerosis with heterozygous deletion of LMNA was finally formulated, after having excluded pulmonary (PET, forced vital capacity, and CO lung diffusion in normal range), cutaneous, musculoskeletal and gastro-oesophageal involvement as well as a paraneoplastic nature (by total body PET) given the positivity for antiRNA-polymerase III.

161 ABLATION OF EPICARDIAL VENTRICULAR TACHYCARDIA ORIGINATING IN THE AREA OF PERICARDIAL ADHESIONS INDUCED BY STEREOTACTIC RADIOABLATION IN A PATIENT WITH ISCHEMIC CARDIOMYOPATHY

Abstract This is the case of a 64-year-old male patient with prior inferior wall myocardial infarction, wearing a cardiac resynchronization therapy defibrillator and suffering from recurrent ventricular tachycardia (VT). The patient had undergone a transitory successful endocardial radiofrequency catheter ablation (RFCA) in 2013 and a stereotactic ablative body radiotherapy (SABR) in 2021, targeting the VT originating in the inferior wall myocardial scar. The patient was referred to our institution due to recurrent highly symptomatic slow-VT. A coronary angiography ruled out coronary artery disease (CAD) progression and a RFCA was rescheduled. Given the suspected epicardial origin of VT based on a 12-lead ECG, the decision was made to perform a combined epi-endocardial ablation. SABR-induced pericardial adhesions prevented posterior pericardial access, thus requiring an anterior access approach (Figure 1, Panel A, yellow star). Following epicardial and endocardial electroanatomic mapping (EAM), VT ablation relied on a substrate-based approach. Local abnormal ventricular activities (LAVAs), detected both in the accessible epicardial inferior wall of the left ventricle and at the opposite endocardial site, were eliminated by radiofrequency (RF) current. Upon completion of endocardial ablation, ventricular pacing induced hemodynamically unstable VT, exiting from the epicardial region corresponding to the SABR-induced pericardial adhesions. Mechanical adhesiolysis, using the elbow of the open-irrigated ablation catheter, was performed to disrupt SABR-induced pericardial adhesions in the inferior wall. The epicardial EAM performed with the open-irrigated catheter recorded LAVAs in the infero-posterior wall of the left ventricle, corresponding to the SABR-disrupted pericardial adhesions. A RF current was delivered, targeting LAVAs at this site (Figure 1, Panel B: the central green dot corresponds to the area of disrupted pericardial adhesions). At the end of the procedure, no sustained VT was induced by programmed ventricular stimulation. Conclusion SABR constitutes a novel and promising non-invasive radioablative treatment of VT, potentially associated with cardiac toxicity. To our knowledge, this is the first reported case of combined epicardial and endocardial RFCA of recurrent VT after SABR. Based on the first RFCA report and exclusion of CAD progression, we hypothesized that SABR might have favoured progression of the inferior low voltage area. With this case report, we would like to demonstrate that even if pericardial adhesions could be a consequence of SABR, gentle catheter-driven manoeuvres can be enough to disrupt the adhesions and to achieve full EAM. Further research is mandatory to shed light on SABR's long-term arrhythmogenic role.

Single beta-blocker or combined amiodarone therapy in implantable cardioverter-defibrillator and cardiac resynchronization therapy—defibrillator patients: Insights from the German DEVICE registry

Because of its antiarrhythmic potency and due to the lack of alternatives, amiodarone is often used for antiarrhythmic therapy in patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator systems. To date, robust data on the safety and clinical benefit of amiodarone therapy in these patients are missing. The purpose of this study was to assess the periprocedural and postprocedural outcomes of combined therapy with beta-blockers plus amiodarone compared to treatment with single beta-blockers in the "real-life" cohort of ICD recipients of the German DEVICE registry. A total of 4499 patients who underwent ICD implantation, revision, or upgrade in 49 centers participating in the German DEVICE registry were enrolled from March 2007 to February2014. Amiodarone had no significant effect on the success of defibrillation testing. Early implantation-associated complications were similar between the groups. However, 1-year overall mortality was significantly higher in the beta-blocker plus amiodarone cohort (adjusted hazard ratio 2.09; P <.001). Interestingly, among the surviving patients, amiodarone was not associated with a significantly reduced risk of ICD discharges or syncopal events. Furthermore, the occurrence of ventricular tachycardia (VT) storm or incessant VTs and the number of patients scheduled for intracardiac ablation did not differ among both groups, whereas the rate of rehospitalization was lower in the cohort with only beta-blockers. Although amiodarone has no adverse effect on the success of defibrillation testing, our data suggest an increased all-cause mortality under amiodarone therapy, especially in the subgroups of patients with sinus rhythm or severely reduced left ventricular function. In surviving patients, rates of arrhythmic events were comparable.

Fluorescence in situ hybridization and polymerase chain reaction to detect infections of cardiac implantable electronic devices.

In patients with infections of cardiac implantable electronic devices (CIEDs), the identification of causative pathogens is complicated by biofilm formations and previous antibiotic therapy. In this work, the impact of an additional fluorescence in situ hybridization (FISH), in combination with polymerase chain reaction and sequencing (FISHseq) was investigated. In 36 patients with CIED infections, FISHseq of explanted devices was performed and compared with standard microbiological cultivation of preoperative and intraoperative samples. The mean age was 61.9 (±16.2) years; 25 (69.4%) were males. Most patients (62.9%) had heart failure with reduced ejection fraction. Infections occurred as endoplastits (n = 26), isolated local generator pocket infection (n = 8), or both (n = 2); CIED included cardiac resynchronization therapy defibrillator (n = 17), implantable cardioverter defibrillator (n = 11), and pacemaker (n = 8) devices. The overall positive FISHseq detection rate was 97%. Intraoperatively, pathogens were isolated in 42 vs. 53% in standard cultivation vs. FISHseq, respectively. In 16 of 17 FISHseq-negative patients, the nucleic acid strain DAPI (4',6-diamidino-2-phenylindole) indicated inactive microorganisms, which were partially organized in biofilms (n = 4) or microcolonies (n = 2). In 13 patients in whom no pathogen was identified preoperatively, standard cultivation and FISHseq identified pathogens in 3 (23%) vs. 8 (62%), respectively. For the confirmation of preoperatively known bacteria, a combined approach was most efficient. Fluorescence in situ hybridization sequencing is a valuable tool to detect causative microorganisms in CIED infections. The combination of FISHseq with preoperative cultivation showed the highest efficacy in detecting pathogens. Additional cultivation of intraoperative tissue samples or swabs yielded more confirmation of pathogens known from preoperative culture.

CRT-D replacement strategy: results of the BioCONTINUE study.

In patients with cardiac resynchronization therapy defibrillators (CRT-Ds), the need for implantable cardioverter-defibrillator (ICD) back-up may be questionable at time of CRT-D replacement (REP) if ICD implant criteria are no longer met due to an improved left ventricular ejection fraction (LVEF) and if no major ventricular arrhythmic event (VAE) occurred during the CRT-D lifetime. The aim of our study was to assess the relevance of ICD back-up and predictors of VAE after REP in primary prevention CRT-D patients. The prospective, observational, international BioCONTINUE study investigated the rate of patients with at least 1 sustained VAE (sVAE) post-REP and searched for predictive factors of sVAE. Two hundred seventy-six patients (70 ± 10years, 77% men, mean LVEF 40.6 ± 12.6%) were followed for 28.4 ± 10.2months. The rate of patients with sVAE was 8.3%, 10.3%, and 21.2% at 1, 2, and 4years post-REP. Patients without persistent ICD indication at REP still had a sVAE rate of 5.7% (95% CI 2.3-11.5%) at 2years. In multivariate analysis, predictive factors of subsequent sVAE were (i) persistent ICD indication (hazard ratio (HR) 3.6; 95% CI 1.6-8.3; p = 0.003); (ii) 64-72years of age as compared to ≥ 79years (HR 3.7; 95% CI 1.4-9.7; p = 0.008); and (iii) ischemic heart disease (HR 4.4; 95% CI 2.1-9.3; p < 0.0001). The risk of sVAE (21.2% at 4years post-REP) depends on age, ischemic heart disease, and ICD indication at the time of REP. A non-trivial risk of sVAE remains in patients without persistent ICD indication. NCT02323503.

Ventricular Arrhythmias and Implantable Cardioverter-Defibrillator Therapy inWomen: A Propensity Score-Matched Analysis.

Causes of sex differences in incidence of sustained ventricular arrhythmias (SVAs) are poorly understood. This study aims to investigate sex-specific risk of SVAs and device therapies by balancing sex groups in relation to several baseline characteristics with the propensity score (PS). We used a large remote monitoring dataset from implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Study endpoints were time to the first appropriate SVA, time to the first device therapy for SVA, and time to the first ICD shock. Results were compared between females and a PS-matched male subgroup. In a cohort of 2,532 patients with an ICD or CRT-D (median age, 70 years), 488 patients (19.3%) were women. After selecting 488 men PS-matched for 19 variables relative to baseline demographics, implant indications, principal comorbidities, and concomitant therapy, yet the SVA rate at the 2.1-year median follow-up was significantly lower in women than in man (adjusted HR: 0.65; 95%CI: 0.51-0.81; P< 0.001). Women also showed a reduced risk of any device therapy (HR: 0.59; 95%CI: 0.45-0.76; P< 0.001) and shocks (HR: 0.66; 95%CI: 0.47-0.94; P=0.021). Differences in sex-specific SVA risk profile were not confirmed in CRT-D patients (HR: 0.78; 95%CI: 0.55-1.09; P=0.14) nor in those with an ejection fraction<30% (HR: 0.80; 95%CI: 0.52-1.23; P=0.31). After matching demographics, indications, principal comorbidities, and concomitant therapy, women still exhibited a lower SVA risk profile than men, except in the subgroups of CRT-D or/and ejection fraction<30%.