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Introduction: In patients with atrial arrhythmias originating from the superior vena cava (SVC), the use of radiofrequency energy to isolate the SVC is associated with a significant risk of injury both to the phrenic nerve and the sinus node. Pulsed field ablation (PFA) may overcome the disadvantages of thermal energy and improve both ablation efficacy and safety., Objective: We report the feasibility, safety, and clinical efficacy of focal monopolar PFA in patients with the origin of their atrial arrhythmia in the SVC., Methods: Nine patients (7 men, age 66 ± 8 years) with SVC-induced paroxysmal AF (n = 3), persistent AF (n = 5), or frequent premature atrial beats (n = 1) underwent SVC isolation using focal monopolar PFA., Results: Acute circumferential SVC isolation was achieved in all cases, using 22 Ampere (A) or 25 A in areas with or without phrenic capture, respectively. The safety profile was excellent: two patients had transient sinus arrest and two had transient phrenic nerve stunning. Sinus node and phrenic nerve function recovered during the procedure, and no permanent damage was observed at follow-up. Coronary vasospasm occurred (and quickly resolved after injection of nitroglycerin) in one patient during additional ablation of a focal atrial tachycardia at the coronary sinus ostium. Kidney function remained stable before and after ablation in all patients., Conclusions: In this patient cohort with SVC-triggered atrial arrhythmia, isolation using focal monopolar PFA was feasible, effective, and safe. No permanent injury to the phrenic nerve or sinus node was observed., (© 2024 Wiley Periodicals LLC.)

Background: Pulsed field ablation (PFA) is a novel technology for catheter-based atrial arrhythmia treatment. Evidence of its application for ventricular arrhythmia ablation is still limited. In this study, we describe the feasibility and efficacy of focal PFA for premature ventricular contraction (PVC) ablation., Methods: A prospective cohort of 20 patients referred for PVC ablation at 2 centers was enrolled, regardless of the presence of structural heart disease, PVC morphology, or previous ablation attempts. All procedures were performed using the CENTAURI System in combination with contact force sensing catheters and 3-dimensional electroanatomical mapping systems. Energy output and the number of applications were left to the operator's discretion., Results: Eleven (55%) procedures were conducted under general anesthesia, 6 (30%) under deep sedation, and 3 (15%) under light sedation. Muscular contraction was observed in one case (5%). Median procedural and fluoroscopy times were 95.5 and 6.55 minutes, respectively. The median number of PFA applications was 8 with a median contact force of 10 g . A statistically significant (76%) reduction was observed in mean peak-to-peak bipolar electrogram voltage before and after ablation (0.707 versus 0.098 mV; P =0.008). Ventricular irritative firing was observed in 11 (55%) patients after PFA. The median follow-up was 120 days. Acute procedural success was achieved in 17 of 20 (85% [95% CI, 0.70-1]) patients. Two of the patients with procedural failure had late success with >80% clinical PVC burden suppression during follow-up, and 2 of 17 patients with acute success had late PVC recurrence, which accounts for a total of 17 of 20 (85% [95% CI, 0.70-1]) patients with chronic success. Transient ST-segment depression occurred in 1 patient, and the right bundle branch block was induced in 2 others (permanently only in one case)., Conclusions: PVC ablation using a focal PFA is feasible, effective, and safe, with promising acute and long-term results in several ventricular locations. Irritative firing is frequently observed. Coronary evaluation should be considered when targeting the outflow tract., Competing Interests: Dr La Meir is a consultant for AtriCure. Dr Chierchia received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, and Acutus Medical. Dr Chierchia received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, and Acutus Medical. Dr de Asmundis received research grants on behalf of the center from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, and Acutus and compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, LivaNova, Boston Scientific, AtriCure, Acutus Medical, and Daiichi Sankyo. Dr Sorgente is a consultant for Biosense Webster and Abbott and received compensation for teaching purposes from Medtronic, Biotronik, and Microport. The other authors report no conflicts.

Introduction: Esophageal injury is one of the most serious complications of pulmonary vein isolation (PVI) with thermic energy sources. Better tissue selectivity of primarily non-thermic pulsed field ablation (PFA) may eliminate collateral injury, particularly the risk of atrio-esophageal fistula (AEF)., Objective: To compare the incidence of any (peri)-esophageal injury following PVI using PFA to thermic energy sources., Methods: Using endoscopy, endoscopic ultrasound, and electrogastrography before and after PVI, esophageal and periesophageal injury (mucosal lesions, food retention, periesophageal edema, or vagal nerve injury) were assessed following PFA and radiofrequency (RF)- or cryoballoon (CB)-PVI., Results: Between December 2022 and February 2023, 20 patients (67 ± 10 years, 53% male) undergoing PFA (Farapulse, Boston Scientific) for atrial fibrillation (AF) were studied and compared with a previous cohort of 57 patients who underwent thermic PVI (CB: n = 33; RF: n = 24). Following PFA-PVI, none of the patients had mucosal lesions, food retention, or ablation-induced vagal nerve injury; four patients showed periesophageal edema. Following thermic ablation, 33/57 patients (58%) showed esophageal and/or periesophageal injury (CB: 21/33 [64%], RF: 12/24 [50%]), in detail 4/57 mucosal lesions, 18/57 food retention, 17/57 vagal nerve injury, and 20/52 edema. Midterm success rates were similar for all energy sources., Conclusion: In contrast to thermic ablation tools, PFA is not associated with relevant esophageal and periesophageal injury, and might, therefore, reduce or eliminate the risk of potentially lethal AEF in interventional treatment of AF. The etiology of ablation-induced periesophageal edema is unknown but has not been shown to be related to lesion progression., (© 2023 Wiley Periodicals LLC.)

Aims: Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist and share an increased risk of thrombo-embolism (TE). CKD concomitantly predisposes towards a pro-haemorrhagic state. Our aim was to evaluate the prognostic value of CKD in patients undergoing percutaneous left atrial appendage occlusion (LAAO)., Methods and Results: A total of 2124 consecutive AF patients undergoing LAAO were categorized into CKD stage 1+2 (n = 1089), CKD stage 3 (n = 796), CKD stage 4 (n = 170), and CKD stage 5 (n = 69) based on the estimated glomerular filtration rate at baseline. The primary endpoint included cardiovascular (CV) mortality, TE, and major bleeding. The expected annual TE and major bleeding risks were estimated based on the CHA2DS2-VASc and HAS-BLED scores. A non-significant higher incidence of major peri-procedural adverse events (1.7 vs. 2.3 vs. 4.1 vs. 4.3) was observed with worsening CKD (P = 0.14). The mean follow-up period was 13 ± 7 months (2226 patient-years). In comparison to CKD stage 1+2 as a reference, the incidence of the primary endpoint was significantly higher in CKD stage 3 (log-rank P-value = 0.04), CKD stage 4 (log-rank P-value = 0.01), and CKD stage 5 (log-rank P-value = 0.001). Left atrial appendage occlusion led to a TE risk reduction (RR) of 72, 66, 62, and 41% in each group. The relative RR of major bleeding was 58, 44, 51, and 52%, respectively., Conclusion: Patients with moderate-to-severe CKD had a higher incidence of the primary composite endpoint. The relative RR in the incidence of TE and major bleeding was consistent across CKD groups., Competing Interests: Conflict of interest: G.B.C. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, and Acutus Medical. C.dA. received research grants on behalf of the centre from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, and Acutus and compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Livanova, Boston Scientific, Atricure, Acutus Medical, and Daiichi Sankyo. J.C.G. is a consultant and has received speaker fees from Boston Scientific, Abbott, Medtronic, Biotronik, Pfizer, Bayer, Novartis, Daiichi Sankyo, and Boehringer Ingelheim. M.M. serves as a consultant for Boston Scientific and Abbott. L.D.B. is a consultant for Stereotaxis, Biosense Webster, Boston Scientific, Rhythm Management, and Abbott Medical. J.S. is a consultant for Boston Scientific, Abbott, Baylis, Gore, and FEops, and a proctor for Boston Scientific and Abbott. D.G. is a consultant for Boston Scientific, Abbot, Acutus, and Biosense Webster. A.N. is as a consultant for Abbott, Biosense Webster, Inc., Biotronik, Boston Scientific, Baylis, and Medtronic. The remaining authors have nothing to disclose., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: To allow timely initiation of anticoagulation therapy for the prevention of stroke, the European guidelines on atrial fibrillation (AF) recommend remote monitoring (RM) of device-detected atrial high-rate episodes (AHREs) and progression of arrhythmia duration along pre-specified strata (6 min…<1 h, 1 h…<24 h, ≥ 24 h). We used the MATRIX registry data to assess the capability of a single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (DX ICD system) to follow this recommendation in patients with standard indication for single-chamber ICD., Methods and Results: In 1841 DX ICD patients with daily automatic RM transmissions, electrograms of first device-detected AHREs per patient in each duration stratum were adjudicated, and the corresponding positive predictive values (PPVs) for the detections to be true atrial arrhythmia were calculated. Moreover, the incidence and progression of new-onset AF was assessed in 1451 patients with no AF history. A total of 610 AHREs ≥6 min were adjudicated. The PPV was 95.1% (271 of 285) for episodes 6min…<1 h, 99.6% (253/254) for episodes 1 h…<24 h, 100% (71/71) for episodes ≥24 h, or 97.5% for all episodes (595/610). The incidence of new-onset AF was 8.2% (119/1451), and in 31.1% of them (37/119), new-onset AF progressed to a higher duration stratum. Nearly 80% of new-onset AF patients had high CHA2DS2-VASc stroke risk, and 70% were not on anticoagulation therapy. Age was the only significant predictor of new-onset AF., Conclusion: A 99.7% detection accuracy for AHRE ≥1 h in patients with DX ICD systems in combination with daily RM allows a reliable guideline-recommended screening for subclinical AF and monitoring of AF-duration progression., Competing Interests: Conflict of interest: D.T. is a consultant of Boston Scientific and has received research grants from Biotronik and Boston Scientific. M.A. has received speaker fees and conducts research sponsored by Biotronik. J.M. is an investigator in the Bio|Stream.HF study sponsored by Biotronik. I.D. has received speaker fees from Biotronik and Boston Scientific and conducts research sponsored by Abbott, Biotronik, Boston Scientific, and Medtronic. T.T. is an employee of Biotronik. The other authors declare no competing interests., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Introduction: Safety of pulmonary vein isolation (PVI) has been established in clinical studies. However, despite prevention efforts the incidence of damage to (peri)-esophageal tissue has not decreased, and the pathophysiology is incompletely understood. Damage to vagal nerve branches may be involved in lesion progression to atrio-esophageal fistula. Using electrogastrography, we assessed the incidence of periesophageal vagal nerve injury (VNI) following atrial fibrillation ablation and its association with procedural parameters and endoscopic results., Methods: Patients were studied using electrogastrography, endoscopy, and endoscopic ultrasound before and after cryoballoon (CB) or radiofrequency (RF) PVI. The incidence of ablation-induced neuropathic pattern (indicating VNI) in pre- and postprocedural electrogastrography was assessed and correlated with endoscopic results and ablation data., Results: Between February 2021 und January 2022, 85 patients (67 ± 10 years, 53% male) were included, 33 were treated with CB and 52 with RF (38 with moderate power moderate duration [25-30 W] and 14 with high power short duration [50 W]). Ablation-induced VNI was detected in 27/85 patients independent of the energy form. Patients with VNI more frequently had postprocedural endoscopically detected pathology (8% mucosal esophageal lesions, 36% periesophageal edema, 33% food retention) but there was incomplete overlap. Pre-existing esophagitis increased the likelihood of VNI. Ablation data and esophageal temperature data did not predict VNI., Conclusion: PVI-induced VNI is quite common and independent of ablation energy source. VNI is part of (peri)-esophageal damage and only partially overlaps with endoscopic findings. VNI-associated acidic reflux may be involved in the complex pathophysiology of esophageal lesion progression to fistula., (© 2023 Wiley Periodicals LLC.)

Background: Reflux-induced esophagitis might facilitate ablation-induced esophageal lesions (ELs) following pulmonary vein isolation (PVI), and these may progress to atrio-esophageal fistula (AEF). In contrast, preexisting ELs are not prone to progression but may affect procedure planning., Objective: To study the incidence of preexisting esophageal and upper gastrointestinal (UGI) pathology in patients undergoing PVI, and the relation to ablation-induced ELs., Methods: From 08/2018 to 09/2021, consecutive patients undergoing (radiofrequency [RF] or cryoballoon [CB]) PVI were examined by esophagogastroscopy (EGD) before and following ablation. Postprocedural endoscopic ultrasound (EUS) was added in 2021., Results: 412 patients (median age 67.5 [IQR 61.3-75.0] years, 56.1% male) were studied. Preprocedural EGD showed abnormalities in 226/399 patients, 15% in the lower third of the esophagus. Half (99/226) were relevant for PVI, 13 procedures were postponed, 6 due to pathological EGD results. A third of the patients with new esophageal injury following ablation had preexisting esophagitis which was associated with a trend for a higher incidence of ELs after RF ablation (12.5 vs. 6.9%, p = 0.232), and a six- and two-fold higher rate of food retention after CB-PVI (28.6 vs. 4.5%, p = 0.008) and RF ablation (8.3 vs. 4.4%, p = 0.279), respectively., Conclusion: (1) EGD before PVI showed UGI abnormalities in > 50% of patients, one-fourth of these relevant for PVI. (2) Esophageal inflammation was associated with a higher incidence of post-ablation (peri)-esophageal injury. Whether having this information before ablation is able to reduce ELs or AEF remains to be shown., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Purpose: Inappropriate implantable cardioverter-defibrillator (ICD) shocks are associated with greater healthcare resource utilization, poorer quality-of-life, and higher mortality. We aimed to investigate the performance of enhanced supraventricular tachycardia (SVT) discrimination algorithms (morphology discrimination, rate stability, and sudden or chamber onset) for reducing inappropriate ICD therapies in patients with ICD/cardiac resynchronization therapy devices., Methods: This prospective, non-randomized, multicenter study (ReduceIT) study took place at 56 sites across Germany and Estonia. Adults at risk of sudden cardiac death undergoing St. Jude Medical™ ICD or CRT-D implantation were included. The primary endpoint was freedom from inappropriate ICD shock at 12 months and was analyzed in the intention to treat (ITT) and per-protocol population., Results: Overall, 733 patients (65.9 ± 11.4 years) were included, of which 40.9% and 59.1% received a single- and dual-chamber detection device, respectively. During follow-up (median 11.9 [0-21.6] months), 96.3% of patients experienced no inappropriate therapy (ITT). The sensitivity, specificity, and accuracy for VT/VF were 91.9%, 95.5%, and 94.7%, respectively. In the per-protocol population (n = 620), the proportion of patients free from inappropriate shock at 12 months was 98.4% (n = 610; 95% CI 97.1-99.2%) and exceeded the expected value of 93% (p < 0.0001) which was derived from the rates in the SPICE, ATPonFastVT, and DECREASE studies. A total of 44 patients (6.0%) died during follow-up, 19 deaths were cardiac-related which is consistent with a meta-analysis of EMPIRIC, MADIT-RIT, ADVANCE III, and PROVIDE. Serious device and procedure-related adverse effects occurred in 9.8% of patients., Conclusions: In ICD/CRT-D devices with advanced SVT discriminators, device programming according to clinical setting and detection chamber significantly reduces the rate of inappropriate ICD shocks without compromising patient safety. The algorithms and settings described herein have particular clinical importance and their employment may be of benefit to ICD recipients., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Endoscopically detected esophageal lesions (EDELs) are common following pulmonary vein isolation (PVI) and may progress to atrioesophageal fistula (AEF)., Objective: The purpose of this study was to study (1) the benefit of luminal esophageal temperature (LET) monitoring and (2) the impact of esophagogastroduodenoscopy (EGD) in detecting EDEL and defining pre-existing lesions. The primary endpoint was the number of ablation-induced lesions., Methods: Patients with atrial fibrillation were randomized to PVI with LET monitoring (LET[+]) or without LET monitoring (LET[-]). All patients underwent EGD before and after PVI. Ablation power at the left atrial (LA) posterior wall was limited to 25 W in all patients and was titrated to a minimum of 10 W guided by esophageal temperature in the LET[+] group., Results: Eighty-six patients (age 67 ± 10 years; 57% male) were included (44 LET[+], 42 LET[-]). PVI was achieved in all, and additional linear LA lesions were done in 50%. Eight patients developed EDEL (6 LET[+], 2 LET[-]; P = NS). Whereas LET <41°C did not differentiate with regard to EDEL formation, temperature overshooting ≥42°C was associated with a higher risk for new EDEL. Two-thirds of patients showed incidental findings (esophagitis, gastric ulcer) on preprocedural EGD; 8 esophageal lesions were pre-existing. Four patients in the LET[+] group developed epistaxis following insertion of the probe., Conclusion: Monitoring of LET does not prevent ablation-induced esophageal lesions. Patients without temperature surveillance were not at higher risk, but temperatures ≥42°C were associated with increased likelihood of mucosal lesions., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Purpose: To limit the ever-increasing healthcare costs, strategies to minimize hospitalization length are warranted. In this perspective, early discharge (the same day or after < 24 h) post-cardiac implantable electronic device (CIED) implantation might represent a useful strategy; nevertheless, it is imperative first to understand the timing of (potentially lethal) complications and evaluate whether this is not only an effective but also a safe clinical decision., Methods: A retrospective cohort analysis of all patients undergoing new CIED implantation from Jan 2008 to Dec 2014 was conducted. Patient demographics, comorbidities, and timing of complications post CIED implantation were evaluated, and the timing of complications was divided into intra-operative, 0-6 h (h), 6 to 24 h, and > 24 h post-implant. One-year post-implant follow-up (FU) was performed in our CIED clinic., Results: A total of 1868 patients (68% men, average age 70 years, 85% hypertension, 39% diabetes, 57% coronary artery disease, and average left ventricular ejection fraction (LVEF) 41%) received 703 (38%) pacemaker, 448 (24%) implantable cardioverter-defibrillator (ICD), 639 (34%) cardiac resynchronization therapy (CRT) devices, and 78 (4.2%) cardiac contractility modulation. A total of 199 (11%) patients experienced 214 complications. Most (75%) occurred > 24 h post-implantation (with a median of 7 days). At univariate analysis, complications occurred more often in patients with a lower LVEF, on anticoagulation/antiplatelet therapy, and undergoing ICD/CRT-D implantation (p < 0.05 for all)., Conclusion: Most complications occur > 24 h after first time CIED implantation. Therefore, it might not be optimal to discharge patients in ≤ 24 h, unless extensive ambulatory monitoring for complications is available.

Background: The prospective WEARIT-II-EUROPE registry aimed to assess the value of the wearable cardioverter-defibrillator (WCD) prior to potential ICD implantation in patients with heart failure and reduced ejection fraction considered at risk of sudden arrhythmic death., Methods and Results: 781 patients (77% men; mean age 59.3 ± 13.4 years) with heart failure and reduced left ventricular ejection fraction (LVEF) were consecutively enrolled. All patients received a WCD. Follow-up time for all patients was 12 months. Mean baseline LVEF was 26.9%. Mean WCD wearing time was 75 ± 47.7 days, mean daily WCD use 20.3 ± 4.6 h. WCD shocks terminated 13 VT/VF events in ten patients (1.3%). Two patients died during WCD prescription of non-arrhythmic cause. Mean LVEF increased from 26.9 to 36.3% at the end of WCD prescription (p < 0.01). After WCD use, ICDs were implanted in only 289 patients (37%). Forty patients (5.1%) died during follow-up. Five patients (1.7%) died with ICDs implanted, 33 patients (7%) had no ICD (no information on ICD in two patients). The majority of patients (75%) with the follow-up of 12 months after WCD prescription died from heart failure (15 patients) and non-cardiac death (15 patients). Only three patients (7%) died suddenly. In seven patients, the cause of death remained unknown., Conclusions: Mortality after WCD prescription was mainly driven by heart failure and non-cardiovascular death. In patients with HFrEF and a potential risk of sudden arrhythmic death, WCD protected observation of LVEF progression and appraisal of competing risks of potential non-arrhythmic death may enable improved selection for beneficial ICD implantation.

Background: Tachycardia-induced cardiomyopathy (TCM) has been known for decades as a reversible form of non-ischemic cardiomyopathy. However, its mechanism and characteristics remain poorly understood., Objectives: This retrospective study investigated endomyocardial biopsy (EMB) samples from consecutive patients with TCM and compared them with samples from patients with dilated cardiomyopathy (DCM) and inflammatory cardiomyopathy (InCM)., Materials and Methods: A total of 684 patients (18 TCM, 170 DCM, 496 InCM) with recent-onset heart failure and reduced ejection fraction unrelated to valvular or ischemic heart disease were analyzed., Results: In the TCM group, 81% were male, the mean age was 60 ± 13 years, and 94% had heart failure symptoms ≥2 New York Heart Association (NYHA) class. At baseline (BL), 78% had atrial fibrillation/flutter and 12% other forms of tachycardia or frequent extrasystole. The ventricular rate was higher compared to DCM and InCM patients (122 ± 25 versus 78 ± 21; p < 0.001). Mean ejection fraction at BL was lower compared to DCM and InCM (27 ± 12% versus 39.0 ± 14.6%; p = 0.001), but improved to a significantly greater extent during follow-up (FU) (20% versus 6%; p < 0.001). At FU, heart rate and presence of sinus rhythm were similar in all groups; 69% of TCM patients underwent cardioversion or ablation. Compared with DCM patients, TCM patients had stronger myocardial expression of major histocompatibility complex (MHC) class II and an equal amount of infiltration with T‑cells/macrophages. Compared with InCM patients, the presence of T‑cells/macrophages was significantly lower in TCM. The marker of apoptosis (caspase 3) was comparably elevated in TCM/InCM patients., Conclusion: Tachycardia-induced cardiomyopathy is characterized by immunohistological changes comparable to DCM except for caspase 3 levels, which were similar to those in InCM.

Background: Pulmonary vein isolation is the cornerstone of catheter ablation in patients with atrial fibrillation (AF). However, with advanced left atrial (LA) structural changes, additional targeted catheter ablation of low-voltage zones (LVZs) has produced favorable results. Therefore, with the advent of single-shot techniques, it would be helpful to predict the presence of LVZs before an ablation procedure., Objective: We hypothesized that computed tomography (CT)-derived left atrial volume index (LAVI), in combination with other objective parameters, could be used to develop a score able to predict the presence of LVZs., Methods: In a large cohort of patients undergoing their first AF ablations, comprehensive echocardiographic evaluations and cardiac CT were performed. During the electrophysiological studies, LA geometry and electroanatomic voltage maps were created. LVZs were defined as areas ≥1 cm 2 with bipolar peak-to-peak voltage amplitudes ≤0.5 mV., Results: In a derivation cohort of 374 patients, predictors of LVZs were identified by regression analysis and used to build the Zentralklinik Bad Berka and University of L'Aquila (ZAQ) score (age ≥65 years; female sex; and CT-LAVI ≥57 mL/m 2 ). The ZAQ score of 2 points accurately identified the presence and the extent of LVZs (area under the curve [AUC], 0.809; 95% confidence interval [CI], 0.758-0.861; P < .001 and 3 [interquartile range, IQR, 1.5-4.5] vs 7 cm 2 [IQR 4-9]; P = .001). In a validation cohort of 103 patients, the predictive value of the score was confirmed (AUC, 0.793; 95% CI, 0.709-0.878; P < .001 and 4 [IQR, 2-7] vs 11.5 cm 2 [IQR, 8-16.5]; P = .001)., Conclusions: The ZAQ score identifies LVZs and may be useful for planning the ablation strategy ahead of time., (© 2020 Wiley Periodicals, Inc.)

Background: Implantable cardioverter-defibrillators (ICDs) are designed to deliver therapy in the event of malignant ventricular arrhythmias. Despite their benefits, some ICD recipients regret their decision on device implantation., Objectives: The aim of this study was to evaluate the incidence, predictors, and consequences of recipients that regretted their decision after implantation., Methods: A questionnaire-based cross-sectional survey of consecutive ICD recipients examined during a routine outpatient follow-up visit was conducted. Their level of depression and anxiety was assessed with the hospital anxiety and depression scale (HADS). Quality of life (QOL) was assessed using the Minnesota living with heart failure questionnaire., Results: Of 434 ICD recipients invited to the study, 423 (97.5%) agreed and completed the survey, 349 (83%) had a primary prevention indication, and 339 (80%) ischemic cardiomyopathy. A total of 41 recipients (9.7%) regretted their decision to undergo ICD implantation. These patients were: (1) younger (63 versus 69 years), (2) more frequently in New York Heart Association (NYHA) ≥2 functional class (63% versus 22%), (3) had higher education levels (more than high-school: 76% versus 60%), (4) felt that preoperative information was lacking (22% versus 4%), (5) had more complications in the perioperative period (15% versus 3%), (6) felt less safe after ICD implantation (54% versus 5%), and (7) considered more frequently ICD deactivation during near end-of-life situations (54% versus 29%). Mean QOL and HADS scores were significantly worse in these patients (36 versus 30 and 12 versus 8.8 points, respectively; p < 0.01 for all)., Conclusion: Almost 10% of ICD recipients regretted their decision after implantation. Predictors included younger age, higher education levels, complicated perioperative period, and lack of preoperative information.

Aims: To define the clinical characteristics and long-term clinical outcomes of a large cohort of patients with idiopathic ventricular fibrillation (IVF) and normal 12-lead electrocardiograms (ECGs)., Methods and Results: Patients with ventricular fibrillation as the presenting rhythm, normal baseline, and follow-up ECGs with no signs of cardiac channelopathy including early repolarization or atrioventricular conduction abnormalities, and without structural heart disease were included in a registry. A total of 245 patients (median age: 38 years; males 59%) were recruited from 25 centres. An implantable cardioverter-defibrillator (ICD) was implanted in 226 patients (92%), while 18 patients (8%) were treated with drug therapy only. Over a median follow-up of 63 months (interquartile range: 25-110 months), 12 patients died (5%); in four of them (1.6%) the lethal event was of cardiac origin. Patients treated with antiarrhythmic drugs only had a higher rate of cardiovascular death compared to patients who received an ICD (16% vs. 0.4%, P = 0.001). Fifty-two patients (21%) experienced an arrhythmic recurrence. Age ≤16 years at the time of the first ventricular arrhythmia was the only predictor of arrhythmic recurrence on multivariable analysis [hazard ratio (HR) 0.41, 95% confidence interval (CI) 0.18-0.92; P = 0.03]., Conclusion: Patients with IVF and persistently normal ECGs frequently have arrhythmic recurrences, but a good prognosis when treated with an ICD. Children are a category of IVF patients at higher risk of arrhythmic recurrences., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: In the IN-TIME trial, automatic daily implant-based multiparameter telemonitoring significantly improved clinical outcomes in patients with chronic systolic heart failure and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). We compared IN-TIME results for ICD and CRT-D subgroups., Methods: Patients with LVEF ≤ 35%, NYHA class II/III, optimized drug treatment, no permanent atrial fibrillation, and a dual-chamber ICD (n = 274) or CRT-D (n = 390) were randomized 1:1 to telemonitoring or no telemonitoring for 12 months. Primary outcome measure was a composite clinical score, classified as worsened if the patient died or had heart failure-related hospitalization, worse NYHA class, or a worse self-reported overall condition., Results: The prevalence of worsened score at study end was higher in CRT-D than ICD patients (26.4% vs. 18.2%; P = 0.014), as was mortality (7.4% vs. 4.1%; P = 0.069). With telemonitoring, odds ratios (OR) for worsened score and hazard ratios (HR) for mortality were similar in the ICD [OR = 0.55 (P = 0.058), HR = 0.39 (P = 0.17)] and CRT-D [OR = 0.68 (P = 0.10), HR = 0.35 (P = 0.018)] subgroups (insignificant interaction, P = 0.58-0.91)., Conclusion: Daily multiparameter telemonitoring has a potential to reduce clinical endpoints in patients with chronic systolic heart failure both in ICD and CRT-D subgroups. The absolute benefit seems to be higher in higher-risk populations with worse prognosis.

Background: Implantable cardioverter defibrillators (ICDs) are designed to deliver shocks in the event of ventricular arrhythmias. Some ICD recipients experience the sensation of ICD discharge in the absence of an actual discharge (phantom shock, PS)., Objectives: The aim of this study was to evaluate the incidence, predictors, and consequences of PS in ICD recipients., Materials and Methods: Consecutive ICD recipients were examined during a routine outpatient follow-up (FU) visit. Subjects completed a written survey; their level of depression and anxiety was assessed with the hospital anxiety and depression scale (HADS). Quality of life (QOL) was assessed using the Minnesota living with heart failure questionnaire., Results: Of 434 patients invited to the study, 423 (97.5%) ICD recipients agreed to and completed the survey; 349 (83%) had a primary prevention indication and 339 (80%) ischemic cardiomyopathy. A total of 27 patients (6.4%) reported a PS during a mean FU of 64 ± 44 months (5.4% in the primary prevention group and 10.8% in the secondary prevention group; p = 0.11). PS were related to higher education (≥bachelor's degree 41% versus 20%; p = 0.03), and more frequent in patients receiving adequate shocks during FU (34% versus 0.5%; p < 0.001). HADS score levels were higher following PS (15 ± 6 versus 8.8 ± 7.4; p < 0.001). The majority of patients reporting PS felt that the information provided to them prior to ICD placement was insufficient (22.2% versus 5.0%), that they needed psychological support after ICD implantation (26% versus 3%), and considered ICD deactivation in near end-of-life situations (59% versus 29%; p < 0.001 for all)., Conclusions: PS occur in 6.4% of all ICD recipients and are related to higher education and to patients that experienced adequate shocks during FU.

Purpose: We sought to assess the safety and effectiveness of three different devices: (1) vacuum drainage system, (2) hemostatic gelatin sponge (Stypro®), and (3) compression device (Premofix®) compared to standard of care (control) in patients undergoing cardiac implantable electronic device (CIED) implantation receiving anticoagulation and/or dual antiplatelet therapy (DAPT)., Methods: We enrolled all consecutive patients admitted for first permanent CIED implantation receiving anticoagulation and/or DAPT into a prospective registry. The primary endpoint (1°EP) was a composite of hematoma grade > 1 and pocket infection., Results: We included 406 patients (median age 73 years, 71% male) of whom 103 (25%) received a vacuum drainage system, 99 (24%) received Stypro®, 103 (25%) received Premofix®, and 101 (25%) were in the control group. One hundred eighty patients (44%) were treated with anticoagulation (median INR 2.0), 176 (43%) received DAPT, and 50 (12%) both. The occurrence of the 1°EP was reduced by Stypro® (hazard ratio (HR) 0.38 (95% confidence interval (CI) 0.16-0.94) and Premofix® (HR: 0.37 (95% CI 0.15-0.90)) compared to controls (p < 0.05 for both). The incidence of hematoma grade 2 or 3 was exclusively lowered by Premofix® compared to control (6% versus 15%; p < 0.05) and was not affected by the type of CIED, INR (≥ 2.5 versus < 2.5), body mass index (≥ 30 versus < 30), or CIED implantation under anticoagulation plus DAPT. The vacuum drainage system did not affect the 1°EP or the incidence of hematoma., Conclusions: In patients receiving anticoagulation and/or DAPT undergoing CIED implantation, the use of Premofix® and Stypro® significantly lowered the 1°EP occurrence compared to control. Premofix® additionally lowered the frequency of pocket hematomas >grade 1.

Left atrial appendage (LAA) may be the source for initiation and maintenance of atrial fibrillation (AF). This report shows restoration of sinus rhythm in the atria during radiofrequency wide-area LAA electrical isolation, whereas AF persists in the LAA., (© 2018 Wiley Periodicals, Inc.)

Aims: The aim of this study was to analyze whether local application of 3% hydrogen peroxide (H2O2) additionally to standard antibiotic prophylaxis following implantation of cardiac implantable electronic devices (CIED) reduces the incidence of pocket infections (PI)., Methods: In this observational case-control study every patient from the group additionally treated with H2O2 was matched with two patients out of the control group for age, male-gender, body-mass-index and operation time. The incidence of PI within 365 days after device implantation was compared., Results: During the 5-year study period, 429 consecutive patients were additionally treated with H2O2 and matched with 858 patients undergoing standard treatment (mean age 69 ± 12 years, 876 males (67.4%), body-mass-index 28 ± 4.0 kg/m 2 and operation time 45 ± 23 min). Except for a more frequent use of dual-platelet-inhibition in the H2O2-group, clinical characteristics were otherwise similar. A total of 23 (1.78%) PIs occurred, most of them (14/23; 61%) during the first 45 days after implantation procedure. The use of H2O2 was associated with a significant reduction (3/429 = 0.69% versus 20/858 = 2.33%; p = 0.04), although patients of the H2O2 treated group received more complex procedures increasing the risk of PI., Conclusion: Intraoperative local application of 3% H2O2 seems to be associated with a significant reduced incidence of PI following implantation of CIED. Because of its non-randomized character this trial should be considered as a hypothesis generating study., (Copyright © 2018 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.)

Aim: To test of the implantable-cardioverter-defibrillator is done at the time of implantation. We investigate if any testing should be performed., Methods: All consecutive patients between January 2006 and December 2008 undergoing implantable cardioverter-defibrillator (ICD) implantation/replacement (a total of 634 patients) were included in the retrospective study., Results: Sixteen patients (2.5%) were not tested (9 with LA/LV-thrombus, 7 due to operator's decision). Analyzed were 618 patients [76% men, 66.4 + 11 years, 24% secondary prevention (SP), 46% with left ventricular ejection fraction (LVEF) < 20%, 56% had coronary artery disease (CAD)] undergoing defibrillation safety testing (SMT) with an energy of 21 + 2.3 J. In 22/618 patients (3.6%) induced ventricular fibrillation (VF) could not be terminated with maximum energy of the ICD. Six of those (27%) had successful SMT after system modification or shock lead repositioning, 14 patients (64%) received a subcutaneous electrode array. Younger age ( P = 0.0003), non-CAD ( P = 0.007) and VF as index event for SP ( P = 0.05) were associated with a higher incidence of ineffective SMT. LVEF < 20% and incomplete revascularisation in patients with CAD had no impact on SMT., Conclusion: Defibrillation testing is well-tolerated. An ineffective SMT occurred in 4% and two third of those needed implantation of a subcutaneous electrode array to pass a SMT > 10 J., Competing Interests: Conflict-of-interest statement: No conflicts of interests of any of the authors have to be declared.

Catheter ablation of para-Hisian premature ventricular contractions (PVCs) still represents a challenge and is a compromise between success and inadvertent AV block. We describe a possible strategy to address PVCs from this location with high-amplitude His-bundle potentials at the site of earliest activation.

With the introduction of edoxaban last year in Germany, four nonvitamin K antagonist oral anticoagulants are now available for stroke prevention in patients with nonvalvular atrial fibrillation. These novel oral anticoagulants (NOAC) represent an attractive new option compared to vitamin K antagonists (e.g., warfarin or phenprocoumon) due to simple use and fewer interactions with other drugs or food. Therefore, no INR monitoring and dosage adjustments are required for NOAC. The compelling clinical advantage of NOAC is the dramatic risk reduction of hemorhagic stroke and intracranial bleeding compared to current standard. In addition, total mortality is significantly reduced by 10 %. These effects are demonstrated for all four NOAC (dabigatran, rivaroxaban, apixaban and edoxaban). Therefore, current national and international guidelines recommend NOAC as the preferred option or at least as an attractive alternative compared to the former standard of vitamin K antagonists. The economic impact and reimbursement by Statutory Health Insurance (GKV) is of major importance for treatment in an outpatient setting. For apixaban and edoxaban, an additional benefit was granted by the institution of G‑BA and IQWiG in this clinical setting, whereas dabigatran and rivaroxaban were not assessed due to market entrance prior to 2011 before the AMNOG procedure was initiated. The members of this consensus paper recommend NOAC as the preferred option for patients with nonvalvular atrial fibrillation who are currently not treated with anticoagulant drugs in spite of clear indication for anticoagulation. For new patients with nonvalvular fibrillation, it should be decided on an individual basis which treatment option is adequate for the patient with their respective comorbidities.

A 70-year-old woman with persistent atrial fibrillation underwent pulmonary vein isolation and linear ablation with a contact sensor catheter. During cavotricuspid isthmus ablation, a steam pop resulted in cardiac tamponade, and the patient developed severe hypotension despite successful pericardial puncture and minimal residual pericardial effusion. Right coronary artery angiography revealed extravasal contrast medium accumulation posterior of the Crux Cordis. Emergent cardiac surgery confirmed isolated disruption of the artery in the absence of additional heart perforation. Although contact sensor catheters may reduce complications, steam pops can still occur and result in dramatic complications., (© 2016 Wiley Periodicals, Inc.)

Aims: Inadvertent lead malposition (ILM) in the left heart is a potential cause of thromboembolism and, therefore, a complication of heart rhythm device implantation [HRDI: pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT)]. The aim of the study was to report the incidence and clinical outcome of ILM., Methods and Results: Postoperative lateral and posterior-anterior chest X-rays of all consecutive patients undergoing HRDI from 2007 through 2012 were retrospectively analysed. During the study period, 2579 patients underwent HRDI at our institution. ILM was present in six patients (0.34%, 50% male, mean age 71.5 ± 9.4 years). In one and four patients, malposition was in the left atrium and ventricle, respectively. In one case, the RV-lead was placed in a coronary sinus branch. In four patients, ILM was detected intra-operatively or in the early postoperative period. In the remaining two patients, malposition was not recognized and they suffered cerebral embolism 4 months and 1 year after implantation. ILM was corrected during the same hospital stay (four cases), or during follow-up by percutaneous extraction (two cases). Patients with ILM had significantly more scoliosis (16.7 vs. 0.17%; P = 0.01), congenital heart disease (CHD: 33.3 vs. 0.4%; P = 0.003), or prior surgery for CHD (16.7 vs. 0.5%; P = 0.03). The likelihood of ILM was also increased when HRDI was performed by an inexperienced operator (<100 HRDI; P < 0.01)., Conclusion: The incidence of ILM was 0.34% in our series. Scoliosis, CHD, prior correction of CHD, and limited operator experience were identified as risk factors., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Aims: This prospective, multicentre study (PRECISION GOLD) evaluated the incidence of asymptomatic cerebral embolism (ACE) after pulmonary vein isolation (PVI) using a new gold multi-electrode radiofrequency (RF) ablation catheter, pulmonary vein ablation catheter (PVAC) GOLD. Also, procedural efficiency of PVAC GOLD was compared with ERACE. The ERACE study demonstrated that a low incidence of ACE can be achieved with a platinum multi-electrode RF catheter (PVAC) combined with procedural manoeuvres to reduce emboli., Methods and Results: A total of 51 patients with paroxysmal atrial fibrillation (AF) (age 57 ± 9 years, CHA2DS2-VASc score 1.4 ± 1.4) underwent AF ablation with PVAC GOLD. Continuous oral anticoagulation using vitamin K antagonists, submerged catheter introduction, and heparinization (ACT ≥ 350 s prior to ablation) were applied. Cerebral magnetic resonance imaging (MRI) scans were performed within 48 h before and 16-72 h post-ablation. Cognitive function assessed by the Mini-Mental State Exam at baseline and 30 days post-ablation. New post-procedural ACE occurred in only 1 of 48 patients (2.1%) and was not detectable on MRI after 30 days. The average number of RF applications per patient to achieve PVI was lower in PRECISION GOLD (20.3 ± 10.0) than in ERACE (28.8 ± 16.1; P = 0.001). Further, PVAC GOLD ablations resulted in significantly fewer low-power (<3 W) ablations (15 vs. 23%, 5 vs. 10% and 2 vs. 7% in 4:1, 2:1, and 1:1 bipolar:unipolar energy modes, respectively). Mini-Mental State Exam was unchanged in all patients., Conclusion: Atrial fibrillation ablation with PVAC GOLD in combination with established embolic lowering manoeuvres results in a low incidence of ACE. Pulmonary vein ablation catheter GOLD demonstrates improved biophysical efficiency compared with platinum PVAC., Trial Registration: ClinicalTrials.gov NCT01767558., (© The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.)

The purpose of this study was to assess (1) the incidence of safety margin testing <10 J (SMT) and (2) the efficacy/safety of routinely adding a subcutaneous array (SQA) (Medtronic 6996SQ) for these patients. Patients with SMT smaller than a 10-J safety margin from maximum output were considered to have very high readings and underwent SQA insertion. These patients were compared with the rest of the patients who had acceptable SMT (≥10 J). A total of 616 patients underwent ICD implantation during the analysis period. Of those, 16 (2.6%) had SMT <10 J. By univariate analysis, younger age, and non-ischemic cardiomyopathy, were all significant predictors of SMT <10 J (p < 0.05). In all 16 cases, other methods to improve SMT prior to array insertion were attempted but failed for all patients: reversing shock polarity (n = 15), removing the superior vena cava coil (n = 14), reprogramming shock waveform (n = 9), and repositioning right ventricular lead (n = 9). Addition of the SQA successfully increased SMT to within safety margin for all patients (32 ± 2 versus 21 ± 3 J; p < 0.001). Follow-up (mean 48.1 ± 21 months) was available for all patients with SQA, only 2 cases with inappropriate shocks due to atrial fibrillation had to be noted. None of the patients experienced complications due to SQA implantation. SMT <10 J occur in about 2.6% of patients undergoing ICD implantation. SQA insertion corrects this problem without procedural/mid-term complications., (Copyright © 2016 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.)

Introduction: Radiofrequency (RF) ablation of atrial tachycardia (AT) with earliest activation at the His-bundle may be associated with the risk of AV block, and detection of this AT origin using the electrocardiogram (ECG) would be helpful in planning ablation. Aim of this study was to characterize the P-wave morphology and intracardiac electrograms at the successful ablation site for this group of ATs., Methods: All consecutive patients undergoing ablation for AT with earliest activation at the His-bundle were included. Twelve-lead ECG and intracardiac electrograms were analyzed., Results: A total of 33 patients underwent successful ablation. The P-wave and the PR interval during AT (cycle length 460 ± 88, range 360-670 milliseconds) were significantly shorter compared to sinus rhythm 87 ± 18 vs. 117 ± 23 and 131 ± 37 vs. 170 ± 47 milliseconds, respectively, P < 0.01. In 28 patients (85%), the P-wave was biphasic (-/+) or triphasic (+/-/+) in the precordial leads, especially V4 -V6 , and in 25 patients (76%) it was biphasic (-/+) or triphasic (+/-/+) in the inferior leads. RF was delivered at the following locations: noncoronary aortic cusp (NCC) in 24 patients, antero-septal left atrium in 4, supero-septal right atrium in 3, left coronary cusp in 1, and between the right coronary cusp and the NCC in 1. Atrial bipolar electrograms at the successful ablation site preceded the P-wave by 38 ± 11 (range 10-60) milliseconds, and AT termination was obtained after a mean RF energy time of 10 ± 8 (range 2-31) seconds., Conclusion: A characteristic narrow and biphasic (-/+) or triphasic (+/-/+) P-wave in the inferior and precordial leads reliably identifies the group of AT arising from the para-Hisian region., (© 2015 Wiley Periodicals, Inc.)

Premature ventricular contractions (PVC) are a common cause for complaints. As a rule PVCs are not life-threatening if no structural heart disease is present; however, due to the symptoms treatment is often required using either antiarrhythmic drugs or more commonly catheter ablation. The surface electrocardiogram (ECG) is very helpful in localizing the origin of the arrhythmia, in particular for differentiating right from left ventricular sources.

Background: Pocket hematoma is a common complication after heart rhythm device implantation (HRD) in patients receiving anticoagulation and/or dual antiplatelet therapy (DAPT)., Methods: We conducted a prospective case-control study and enrolled all patients admitted for HRD receiving anticoagulation or DAPT. Participants received D-Stat (a mixture of collagen and thrombin) into the pectoral pocket and were compared with an age- and gender-matched group receiving a vacuum drainage system. The primary endpoint was a composite of hematoma needing evacuation and pocket infection., Results: We included a total of 164 patients (mean age 73 ± 10.7 years; 118 [72 %] men). In all, 82 patients (50 %) received D-stat and 82 (50 %) vacuum drainage. There were 83 (51 %) patients who were treated with anticoagulation, 69 (42 %) patients received DAPT, and 11 (7 %) patients both. The primary endpoint occurred in 14.5 % (12/82) of patients in the D-Stat group and 0 % (0/82) of patients in the drainage group (p < 0.01). The use of D-Stat solution was associated with an increased incidence of pocket hematoma requiring evacuation (8.5 % versus 0 %; p = 0.01), and tended to an increased rate of pocket infections (6.1 % versus 0 %; p = 0.06). Postoperative immunoglobulin E levels (106 ± 219 IU/ml [D-Stat] versus 117 ± 189 IU/ml [drainage]) and increase of C-reactive protein (D-Stat: ∆19 mg/l versus drainage: ∆21 mg/l) were similar in both groups (p = 0.7 and p = 0.5, respectively)., Conclusions: Administration of D-Stat solution is associated with a higher rate of pocket hematoma requiring reoperation in a high risk population receiving anticoagulation and/or DAPT. The observed rate of pocket infections in the D-Stat group is a matter of concern.