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Introduction: Conventional implantable cardioverter-defibrillators (ICDs) and pacemakers carry a risk of pocket- and lead-related complications in particular. To avoid these complications, extravascular devices (EVDs) have been developed, such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP). However, data on patient or centre characteristics related to the actual adoption of EVDs are lacking., Objective: To assess real-world nationwide trends in EVD adoption in the Netherlands., Methods: Using the Netherlands Heart Registration, all consecutive patients with a de novo S‑ICD or conventional single-chamber ICD implantation between 2012-2020, or de novo LP or conventional single-chamber pacemaker implantation between 2014-2020 were included. Trends in adoption are described for various patient and centre characteristics., Result: From 2012-2020, 2190 S‑ICDs and 10,683 conventional ICDs were implanted; from 2014-2020, 712 LPs and 11,103 conventional pacemakers were implanted. The general use has increased (S-ICDs 8 to 21%; LPs 1 to 8%), but this increase seems to have reached a plateau. S‑ICD recipients were younger than conventional ICD recipients (p < 0.001) and more often female (p < 0.001); LP recipients were younger than conventional pacemaker recipients (p < 0.001) and more often male (p = 0.03). Both S‑ICDs and LPs were mainly implanted in high-volume centres with cardiothoracic surgery on-site, although over time S‑ICDs were increasingly implanted in centres without cardiothoracic surgery (p < 0.001)., Conclusion: This nationwide study demonstrated a relatively quick adoption of innovative EVDs with a plateau after approximately 4 years. S‑ICD use is especially high in younger patients. EVDs are mainly implanted in high-volume centres with cardiothoracic surgery back-up, but S‑ICD use is expanding beyond those centres., (© 2024. The Author(s).)

Importance: Patients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT., Objective: To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT., Design, Setting, and Participants: This cohort study was a propensity score-matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score-matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score., Exposure: Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group)., Main Outcomes and Measures: The primary outcome was time to first ischemic stroke., Results: Four hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy., Conclusions and Relevance: In patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.

Background: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO., Objectives: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data., Methods: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores., Results: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT., Conclusions: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT., Competing Interests: Funding Support and Author Disclosures Dr Maarse has received an educational grant from Boston Scientific. Dr Tondo serves on the advisory board of Boston Scientific; and has received lecture and tutoring fees from Boston Scientific and Abbott Medical. Dr Demkow has received proctoring fees from Boston Scientific and Abbott. Dr de Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Nielsen-Kudsk has received grants from Abbott and Boston Scientific. Dr Estevez-Loureiro is a proctor for Abbott Vascular, Boston Scientific, and Lifetech. Dr de Prado is a proctor for Boston Scientific. Dr Nombela-Franco is a proctor for Abbott Vascular, Edwards Lifesciences, and Boston Scientific. Dr Salinas is a proctor for Abbott Vascular. Dr Berti is a proctor for Edwards Lifesciences, Boston Scientific, and Abbott. Dr Millan has received consultant fees/honoraria from Abbott Laboratories and Boston Scientific. Dr Arzamendi has received consultant fees/honoraria from Abbott Laboratories and Boston Scientific. Dr Agarwal is a member of the Speaker Bureau and proctor for Medtronics, Abbott, Edwards Lifesciences, and Boston Scientific. Dr Spoon is a speaker for Medtronic, Abiomed, and Abbott. Dr El-Chami is a consultant for Medtronic and Boston Scientific. Dr Adamo has received speaker honoraria from Abbott Structural Heart. Dr van Dijk is a proctor for Boston Scientific. Dr Swaans is a proctor/lecturer for Abbott Vacular, Bioventrix Inc, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, GE Healthcare, and Philips Healthcare. Dr Vireca is an employee of Boston Scientific. Dr Bergmann has received speaker honoraria from Boston Scientific and Abbott; and has received research support from Boston Scientific and Abbott. Dr Boersma is a consultant for Boston Scientific; and is a proctor for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: In the Rate Control versus Electrical Cardioversion Trial 7-Acute Cardioversion versus Wait and See, patients with recent-onset atrial fibrillation (AF) were randomized to either early or delayed cardioversion., Aim: This prespecified sub-analysis aimed to evaluate heart rate during AF recurrences after an emergency department (ED) visit identified by an electrocardiogram (ECG)-based handheld device., Methods: After the ED visit, included patients (n = 437) were asked to use an ECG-based handheld device to monitor for recurrences during the 4-week follow-up period. 335 patients used the handheld device and were included in this analysis. Recordings from the device were collected and assessed for heart rhythm and rate. Optimal rate control was defined as a target resting heart rate of <110 beats per minute (bpm)., Results: In 99 patients (29.6%, mean age 67 ± 10 years, 39.4% female, median 6 [3-12] AF recordings) a total of 314 AF recurrences (median 2 [1-3] per patient) were identified during follow-up. The average median resting heart rate at recurrence was 100 ± 21 bpm in the delayed vs 112 ± 25 bpm in the early cardioversion group (p = .011). Optimal rate control was seen in 68.4% [21.3%-100%] and 33.3% [0%-77.5%] of recordings (p = .01), respectively. Randomization group [coefficient -12.09 (-20.55 to -3.63, p = .006) for delayed vs. early cardioversion] and heart rate on index ECG [coefficient 0.46 (0.29-0.63, p < .001) per bpm increase] were identified on multivariable analysis as factors associated with lower median heart rate during AF recurrences., Conclusion: A delayed cardioversion strategy translated into a favorable heart rate profile during AF recurrences., (© 2023 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

Background: Left atrial appendage occlusion (LAAO) may be a viable option for stroke prevention in patients with non-valvular atrial fibrillation and a contraindication for oral anticoagulation. No evidence evaluating the safety of this procedure in patients with a cardiac implantable electronic device (CIED) exists. The aim of this study was to evaluate whether CIED function is affected by LAAO and to explore LAAO procedural characteristics and complications in patients with a CIED., Methods: This single-center cohort study included consecutive patients scheduled for percutaneous LAAO. Patients with a CIED prior to LAAO were selected and compared to the patients without CIED, concerning procedural characteristics and peri-procedural complications. In the group of patients with CIEDs, essential pacemaker integrity parameters were compared before and after the procedure to detect possible micro and macro lead displacements., Results: Thirty-one patients with CIED were scheduled for LAAO (age 73.7 ± 5.4 years, 65% males, CHA 2 DS 2 -VASc 4.3 ± 1.5, and HAS-BLED 3.3 ± 1.0). The 245 patients without CIED were younger, and HAS-BLED-score was slightly lower (69.4 ± 8.2 years, p < 0.001; 2.8 ± 1.0, p = 0.022). Patients without CIED more frequently underwent LAAO combined with catheter ablation (p = 0.002). All other procedural characteristics were comparable between both groups. No visible lead displacement was observed on chest X-ray after LAAO. Additionally, no differences in impedance, threshold, or intracardiac sensing in various CIED lead locations were found prior versus post LAAO., Conclusion: This study supports the feasibility and safety of LAAO in patients with a CIED., (© 2023. The Author(s).)

Background: High-density (HD) mapping is increasingly used to characterize arrhythmic substrate for ablation of atypical atrial flutters (AAFl). However, results on clinical outcomes and factors that are associated with arrhythmia recurrence are scarce., Methods: Single-center, prospective, observational cohort study that enrolled patients with catheter ablation for AAFl using a HD mapping system and a grid-shaped mapping catheter. Procedural characteristics, rates of atrial flutter recurrence, and factors that were associated with atrial flutter recurrence were evaluated., Results: Sixty-one patients with a total of 94 AAFl were included in the cohort. HD mapping was used to successfully identify the flutter circuit of 80/94 AAFl. The circuit was not identified for 14/94 AAFl in 11 patients. Critical isthmuses were identified and ablated in 29 patients (48%). Acute procedural success was achieved in 52 patients (85%), and 37 patients (61%) remained free from atrial flutter recurrence during a follow up of 1.3 [1.0-2.1] years. Atrial flutter recurrence was univariably associated with presence of a non-identified flutter circuit (HR:2.6 95% CI [1.1-6.3], p = .04) and critical isthmus-targeted ablation (HR:0.4 [0.15-0.90], p = .03). In multivariable regression analyses, critical isthmus ablation remained significant (HR:0.4 [0.16-0.97], p = .04), whereas presence of a non-identified flutter did not (HR:2.4 [0.96-5.8], p = .06)., Conclusion: HD mapping was successfully used to identify the majority of AAFl circuits. Ablation resulted in freedom from atrial flutter recurrence in 61% of the cohort. Successful identification of all flutter circuits and critical isthmuses appears to be beneficial for long-term outcomes., (© 2023 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Background: The tissue response viewer (TRV) is a novel marker for ablation lesion quality that aims to classify lesions into transmural or nontransmural lesions (high or low dielectric response, HDR or LDR) using dielectric-based tissue assessment. The objective of this study was to gain insight in the TRV by relating its outcomes to conventional ablation parameters., Methods: Patients that had repeat ablation for atrial fibrillation with a dielectric imaging-based mapping system were enrolled. All ablation data were downloaded from the mapping system and analyzed to explore associations between TRV outcomes and other ablation parameters., Results: The cohort included 24 patients, in which 58 pulmonary veins and 8 superior vena cavas were targeted. A total of 388 energy applications were applied, resulting in 639 ablation points. The system classified 36% of ablation points as HDR and 44% as LDR. The system did not provide a dielectric response in 20%. The system's ability to provide a dielectric response was related to longer ablation duration and absence of dragging ablation. HDR (versus LDR) was multivariably associated with longer energy applications, higher mean ablation power, and lower wall thickness. Greater impedance drop was univariably associated with HDR., Conclusion: Outcomes of the TRV are associated with conventional ablation parameters (e.g., duration and power) but also local wall thickness. Catheter stability seems important for successful lesion assessment with the TRV. Further reduction of missing outcomes and validation of the tool are warranted before widespread use., Competing Interests: VvD and LB are consultants for Philips. All other authors declare they have no competing interests., (© 2023 The Authors. Journal of Arrhythmia published by John Wiley & Sons Australia, Ltd on behalf of Japanese Heart Rhythm Society.)

Background: Adequate real-world safety and efficacy of leadless pacemakers (LPs) have been demonstrated up to 3 years after implantation. Longer-term data are warranted to assess the net clinical benefit of leadless pacing., Objective: The purpose of this study was to evaluate the long-term safety and efficacy of LP therapy in a real-world cohort., Methods: In this retrospective cohort study, all consecutive patients with a first LP implantation from December 21, 2012, to December 13, 2016, in 6 Dutch high-volume centers were included. The primary safety endpoint was the rate of major procedure- or device-related complications (ie, requiring surgery) at 5-year follow-up. Analyses were performed with and without Nanostim battery advisory-related complications. The primary efficacy endpoint was the percentage of patients with a pacing capture threshold ≤2.0 V at implantation and without ≥1.5-V increase at the last follow-up visit., Results: A total of 179 patients were included (mean age 79 ± 9 years), 93 (52%) with a Nanostim and 86 (48%) with a Micra VR LP. Mean follow-up duration was 44 ± 26 months. Forty-one major complications occurred, of which 7 were not advisory related. The 5-year major complication rate was 4% without advisory-related complications and 27% including advisory-related complications. No advisory-related major complications occurred a median 10 days (range 0-88 days) postimplantation. The pacing capture threshold was low in 163 of 167 patients (98%) and stable in 157 of 160 (98%)., Conclusion: The long-term major complication rate without advisory-related complications was low with LPs. No complications occurred after the acute phase and no infections occurred, which may be a specific benefit of LPs. The performance was adequate with a stable pacing capture threshold., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Introduction: Over the past years, mapping and ablation techniques for the treatment of ventricular tachycardia (VT) have evolved rapidly. High Density (HD) substrate mapping is now routine and pre-procedural imaging is increasingly used. The additional value of these techniques for long-term VT-free survival is not clear., Methods: We compared baseline and procedural characteristics, procedural success, safety and outcome of mapping and ablation of ventricular tachycardia in patients with ischemic heart disease between two groups. (1) Low Density (LD) group: VT mapping and ablation with a 4 mm single tip catheter (2) HD group: HD substrate mapping with the Pentaray (Biosense Webster, USA) or HD Grid (Abbott, USA) catheter and ablation with a 4 mm single tip catheter., Results: VT ablation was performed in 133 patients (71 patients in LD group and 62 patients in HD group). The median follow-up was 5.0 years in LD group and 2.0 years in HD group. One-, two-, and five-year VT recurrence rates were 47%, 56%, and 65% in the LD group versus 39%, 50%, and 55% in the HD group (log-rank test for VT recurrence p = .70). One-, two-, and five-year ICD shock recurrence rates were 14%, 18%, and 24% in the LD group versus 8%, 15%, and 19% in the HD group (log-rank test for ICD-shock p = .79). All-cause mortality, cardiac (non-arrhythmic), and arrhythmic death, were similar in both groups. Severe procedural complications (tamponade, stroke, or procedural death) occurred in four patients (5%, 1 vascular, 3 tamponade) in the LD group versus two patients (3%, both tamponade) in the HD group (NS). In univariate and multivariable analysis, only a higher LVEF was significantly associated with VT-free survival. HD mapping was not significantly associated with VT-free survival. Anterior infarct location and age were significantly associated with ICD recurrent shock in both univariate and multivariable analyses., Conclusions: In patients with ischemic cardiomyopathy, a HD substrate mapping, and ablation strategy did not lead to higher VT-free survival and shock-free survival compared to a single tip mapping and ablation strategy. In this study, only LVF is an independent predictor for VT recurrence. Anterior infarct location and age predict recurrent ICD shocks., (© 2023 Wiley Periodicals LLC.)

Cardiac implantable electronic device (CIED) therapy is an essential element in treating cardiac arrhythmias. Despite their benefits, conventional transvenous CIEDs are associated with a significant risk of mainly pocket- and lead-related complications. To overcome these complications, extravascular devices (EVDs), such as the subcutaneous implantable cardioverter-defibrillator and intracardiac leadless pacemaker, have been developed. In the near future, several other innovative EVDs will become available. However, it is difficult to evaluate EVDs in large studies because of high costs, lack of long-term follow-up, imprecise data or selected patient populations. To improve evaluation of these technologies, real-world, large-scale, long-term data are of utmost importance. A Dutch registry-based study seems to be a unique possibility for this goal due to early involvement of Dutch hospitals in novel CIEDs and an existing quality control infrastructure, the Netherlands Heart Registration (NHR). Therefore, we will soon start the Netherlands-ExtraVascular Device Registry (NL-EVDR), a Dutch nationwide registry with long-term follow-up of EVDs. The NL-EVDR will be incorporated in NHR's device registry. Additional EVD-specific variables will be collected both retrospectively and prospectively. Hence, combining Dutch EVD data will provide highly relevant information on safety and efficacy. As a first step, a pilot project has started in selected centres in October 2022 to optimise data collection., (© 2023. The Author(s).)

Background: Percutaneous left atrial appendage occlusion (LAAO) is an alternative to anticoagulation in the prevention of stroke in patients with nonvalvular atrial fibrillation, especially in patients with a contraindication for oral anticoagulation therapy (OAT)., Objective: The study sought to obtain long-term patient outcomes after successful LAAO in everyday clinical practice., Methods: In this single-center registry spanning over 10 years, data of all consecutive patients that underwent percutaneous LAAO were collected. Observed thromboembolic and major bleeding event rates after successful LAAO during follow-up were compared with expected event rates based on CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) and HAS-BLED (hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores. Furthermore, anticoagulation and antiplatelet use during follow-up was evaluated., Results: Of 230 patients scheduled for LAAO (38% women, 69.5 ± 8.2 years of age, CHA 2 DS 2 -VASc score 3.9 ± 1.6, HAS-BLED score 2.9 ± 1.0), 218 patients had a successful implantation (95%) with a follow-up duration of 5.2 ± 3.1 years. The procedure was combined with catheter ablation in 52% of the patients. Fifty thromboembolic complications (24 ischemic stroke, 26 transient ischemic attack) were observed during follow-up in 40 (18%) of 218 patients. Ischemic strokes occurred with a rate of 2.1 per 100 patient-years, accounting for a 66% relative risk reduction compared with the CHA 2 DS 2 -VASc predicted event rate. Device-related thrombus was observed in 5 (2%) patients. Sixty-five nonprocedural major bleeding complications occurred in 24 (11%) of 218 patients with a rate of 5.7 per 100-patient years, which is comparable to estimated HAS-BLED-bleeding rates under OAT use. At end of follow-up 71% of all patients were on single antiplatelet or no antiplatelet or anticoagulation treatment, while 29% were on OAT., Conclusion: Thromboembolic event rates during long-term follow-up after successful LAAO remained consistently lower than expected supporting the efficacy of LAAO., (© 2023 Heart Rhythm Society. Published by Elsevier Inc.)

Objective: The Rate Control versus Electrical Cardioversion Trial 7-Acute Cardioversion versus Wait and See trial compared early to delayed cardioversion for patients with recent-onset symptomatic atrial fibrillation (AF). This study aims to evaluate the adherence to a 4-week mobile health (mHealth) prescription to detect AF recurrences after an emergency department visit., Methods: After the emergency department visit, the 437 included patients, irrespective of randomisation arm (early or delayed cardioversion), were asked to record heart rate and rhythm for 1 min three times daily and in case of symptoms by an electrocardiography-based handheld device for 4 weeks (if available). Adherence was appraised as number of performed measurements per number of recordings asked from the patient and was evaluated for longitudinal adherence consistency. All patients who used the handheld device were included in this subanalysis., Results: 335 patients (58% males; median age 67 (IQR 11) years) were included. The median overall adherence of all patients was 83.3% (IQR 29.9%). The median number of monitoring days was 27 out of 27 (IQR 5), whereas the median number of full monitoring days was 16 out of 27 (IQR 14). Higher age and a previous paroxysm of AF were identified as multivariable adjusted factors associated with adherence., Conclusions: In this randomised trial, a 4-week mHealth prescription to monitor for AF recurrences after an emergency department visit for recent-onset AF was feasible with 85.7% of patients consistently using the device with at least one measurement per day. Older patients were more adherent., Trial Registration Number: NCT02248753., Competing Interests: Competing interests: JL has a consultancy agreement with Medtronic and has received speakers fee from Bayer and Novartis, and a research grant ZonMW LEAP trial project number 852002101. MR has received consultancy fees from Medtronic, Arca Biopharma and Roche to the institution, unrestricted research grant from ZonMW and the Dutch Heart Foundation; DECISION project 848090001. Unrestricted research grants from the Netherlands Cardiovascular Research Initiative: an initiative with support of the Dutch Heart Foundation; RACE V (CVON2014-9), RED-CVD (CVON2017-11). Unrestricted research grant from Top Sector Life Sciences & Health to the Dutch Heart Foundation (PPP Allowance; CVON-AI (2018B017)). Unrestricted research grant from the European Union’s Horizon 2020 research and innovation programme under grant agreement; EHRA-PATHS (945260). IVG has received consultancy fees Institute from Medtronic, Daiichi, BMS, Bayer and Roche to the institution, unrestricted research grants from the Netherlands Cardiovascular Research Initiative: an initiative with support of the Dutch Heart Foundation; unrestricted research grant from the European Union’s Horizon 2020 research and innovation programme under grant agreement; EHRA-PATHS (945260)., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: The second-generation multi-electrode catheter, PVAC Gold, was designed to improve the safe delivery of phased radiofrequency energy using a "single shot" approach for pulmonary vein isolation (PVI), while retaining efficacy. This large registry presents long-term performance in a daily practice setting., Methods: A total of 1011 patients undergoing first time ablation for atrial fibrillation (AF) using PVAC Gold were included, 639 patients with PVI for paroxysmal AF (PAF PVI) and 372 patients with persistent or long-standing persistent AF, divided into 175 patients receiving PVI only (PersAF PVI) and 197 patients receiving PVI with additional substrate ablation (PersAF PVI +)., Results: At 24-month follow-up, single procedure freedom from atrial tachyarrhythmia (ATA) was 58% (368/639) in the PAF PVI group, 44% (77/175) in the PersAF PVI group, and 29% (57/197) in the PersAF PVI + group. Allowing one repeat procedure in 33% of patients, 76%, 65%, and 54% were free from ATA at 24 months, respectively. Pulmonary vein reconnection was observed in 98% of patients with recurrent arrhythmia after PVI., Conclusions: Although phased RF ablation with PVAC Gold is quick and safe, the efficacy outcomes are modest compared to current mainstream ablation strategies., (© 2022. The Author(s).)

Background: Image guidance to assist left ventricular (LV) lead placement may improve outcome after cardiac resynchronization therapy (CRT), but previous approaches and results varied greatly, and multicenter feasibility is lacking altogether., Objective: We sought to investigate the multicenter feasibility of image guidance for periprocedural assistance of LV lead placement for CRT., Methods: In 30 patients from 3 hospitals, cardiac magnetic resonance imaging was performed within 3 months prior to CRT to identify myocardial scar and late mechanical activation (LMA). LMA was determined using radial strain, plotted over time. Segments without scar but clear LMA were classified as optimal for LV lead placement, according to an accurate 36-segment model of the whole heart. LV leads were navigated using image overlay with periprocedural fluoroscopy. After 6 months, volumetric response and super-response were defined as ≥15% or ≥30% reduction in LV end-systolic volume, respectively., Results: Periprocedural image guidance was successfully performed in all CRT patients (age 66 ± 10 years; 59% men, 62% with nonischemic cardiomyopathy, 69% with left bundle branch block). LV leads were placed as follows: within (14%), adjacent (62%), or remote (24%) from the predefined target. According to the conventional 18-segment model, a remote position occurred only once (3%). On average, 86% of patients demonstrated a volumetric response (mean LV end-systolic volume reduction 36 ± 29%), and 66% of all patients were super-responders., Conclusion: On-screen image guidance for LV lead placement in CRT was feasible in a multicenter setting. Efficacy will be further investigated in the randomized controlled ADVISE (Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy) trial (NCT05053568)., (© 2022 Heart Rhythm Society. Published by Elsevier Inc.)

Introduction: The AcQMap High Resolution Imaging and Mapping System was recently introduced. This system provides 3D maps of electrical activation across an ultrasound-acquired atrial surface., Methods: We evaluated the feasibility and the acute and short-term efficacy and safety of this novel system for ablation of persistent atrial fibrillation (AF) and atypical atrial flutter., Results: A total of 21 consecutive patients (age (mean ± standard deviation) 62 ± 8 years, 23% female) underwent catheter ablation with the use of the AcQMap System. Fourteen patients (67%) were treated for persistent AF and 7 patients (33%) for atypical atrial flutter. Eighteen patients (86%) had undergone at least one prior ablation procedure. Acute success, defined as sinus rhythm without the ability to provoke the clinical arrhythmia, was achieved in 17 patients (81%). At 12 months, 4 patients treated for persistent AF (29%) and 4 patients treated for atypical flutter (57%) remained in sinus rhythm. Complications included hemiparesis, for which intra-arterial thrombolysis was given with subsequent good clinical outcome (n = 1), and complete atrioventricular block, for which a permanent pacemaker was implanted (n = 2). No major complications attributable to the mapping system occurred., Conclusion: The AcQMap System is able to provide fast, high-resolution activation maps of persistent AF and atypical atrial flutter. Despite a high acute success rate, the recurrence rate of persistent AF was relatively high. This may be due to the selection of the patients with therapy-resistant arrhythmias and limited experience in the optimal use of this mapping system that is still under development., (© 2021. The Author(s).)

Background: Risk stratification for sudden cardiac death (SCD) in cardiac sarcoidosis (CS) is challenging in patients without overt cardiac symptoms., Objective: The purpose of this study was to determine the incidence of ventricular arrhythmias (VAs) and mortality after long-term monitoring with a cardiovascular implantable electronic device (CIED) in CS patients identified after systematic screening of patients with extracardiac sarcoidosis (ECS)., Methods: A retrospective study was performed in 547 predominantly Caucasian patients with ECS screened for cardiac involvement. If CS was diagnosed, risk stratification (high vs low risk) for SCD was performed by a multidisciplinary team. The primary endpoint was defined as sustained VA, appropriate implantable cardioverter-defibrillator (ICD) therapy, or cardiac death., Results: In total, 105 patients were included (mean follow-up 33 ± 16 months). An ICD was implanted in 17 high-risk patients (16.2%), whereas 80 low-risk patients (76.1%) received an implantable loop recorder (ILR). Eight low-risk patients (7.6%) did not receive a device. The primary endpoint occurred in 4.8% (n = 5), with an overall annualized event rate of 1.7%. The annualized event rate was 9.8% in high-risk patients and 0.4% in low-risk patients. Nine low-risk patients received an ICD during follow-up, in 7 patients as a result of the ILR recordings. None of these patients required ICD therapy., Conclusion: In CS patients without overt cardiac symptoms at initial presentation the annualized overall event rate was 1.7%; 10% in high-risk patients, but only 0.4% in low-risk patients. In low-risk patients long-term arrhythmia monitoring with an ILR enabled early detection of clinically important arrhythmias without showing impact on prognosis., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become increasingly safe and effective with the evolution of single-tip ablation catheters aided by contact force sensing (ST-CF) and single-shot devices such as the second-generation pulmonary vein ablation catheter (PVAC) Gold multi-electrode array. The multicentre randomized GOLD FORCE trial was conducted to evaluate non-inferiority of safety and efficacy of PVAC Gold PVI compared to ST-CF ablation for paroxysmal AF., Methods and Results: The primary efficacy endpoint documented AF recurrence ≥30 s was assessed by time-to-first-event analysis after a 90-day blanking period using repeated 7-day Holters. Secondary endpoints include acute success and procedural characteristics. Safety endpoints included procedural complications, stroke/transient ischaemic attack (TIA), tamponade, bleeding, and access site complications. Two hundred and eight patients underwent randomization and PVI (103 assigned to PVAC Gold, 105 to ST-CF). Acute success rates were 95% and 97% for PVAC Gold and ST-CF, respectively. At 12 months, AF recurrence was observed in 46.6% of the PVAC Gold group and in 26.2% of the ST-CF group [absolute efficacy difference 20.4% (95% confidence interval, CI 7.5-33.2%), hazard ratio 2.05 (95% CI 1.28-3.29), P = 0.003]. PVAC Gold had significantly shorter procedure and ablation times. Complication rates were 5.7% and 4.9% for PVAC Gold and ST-CF, respectively (P = 0.782)., Conclusion: In this multicentre randomized clinical trial, ablation with ST-CF and PVAC Gold ablation catheters non-inferiority for efficacy was not met. AF recurrence was significantly more frequent in the PVAC Gold group compared to single-tip contact force group. Both groups had similarly low rates of adverse events. PVAC Gold ablation had significantly shorter procedure and ablation times., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Subcutaneous implantable cardioverter/defibrillators (S-ICDs) have been developed to offer ICD treatment to patients without venous access to the heart and to overcome complications associated with transvenous leads, particularly lead fracture/insulation defects and endocarditis. Several studies and registries have demonstrated the feasibility and safety of S‑ICD in different groups of patients. Further developments in S‑ICD technology involve the combination with devices that can provide anti-bradycardia and anti-tachycardia pacing if needed. The extravascular ICD (EV-ICD) is a new system that similarly offers ICD therapy without a transvenous lead but uses a substernal instead of a subcutaneous lead to facilitate detection of ventricular fibrillation and to provide anti-tachycardia and also temporary anti-bradycardia pacing. The first animal but also clinical data on EV-ICDs have been published. This review discusses the current state, potential advantages and limitations, and future research of both S‑ICD and EV-ICD., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Purpose: Ablation of atypical atrial flutter (AAFL) can be challenging. High-density (HD) mapping of ablation targets may potentially increase procedural success and freedom from recurrent AAFL. The objective of the present study was to explore whether employing HD mapping leads to a more favorable outcome in ablation of AAFL., Methods: We compared baseline and procedural characteristics, procedural success, safety and outcome of mapping and ablation of atypical flutter in three groups. (1) HD Grid catheter + the high-density electroanatomical mapping (EAM) system EnSite Precision; (2) standard 10-pole circular mapping catheter (CMC) + EnSite Precision; (3) CMC + the low-density EnSite Velocity EAM. Voltage and propagation maps were constructed., Results: Mapping of 142 AAFL in 82 patients was performed. Acute ablation success was 78%, 68%, and 51% in groups 1, 2, and 3 (p = 0.037 between group 1 and 3, non-significant between groups otherwise). Moreover, 8%, 27%, and 36% of flutters were unmappable in groups 1, 2, and 3, respectively (p < 0.05 between group 1 and both groups 2 and 3). AAFL recurrence at 1-year FU was 26%, 36%, and 62% in groups 1, 2, and 3 (p = 0.007 between groups 1 and 3, p = 0.05 between groups 2 and 3). AAFL-free survival was significantly higher in patients mapped with Precision than with Velocity (p = 0.011). No strokes or mortality occurred within 30 days., Conclusions: Acute procedural success of ablation of atypical atrial flutter is higher and the number of unmappable flutters is lower using the HD Grid mapping catheter in combination with the high-density EnSite Precision system, as compared to a decapolar circular mapping catheter and the low-density EnSite Velocity EAM system. This may lead to increased freedom from recurrent AAFL at 1 year. HD mapping is safe., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Achieving optimal placement of the left ventricular (LV) lead in cardiac resynchronisation therapy (CRT) is a prerequisite in order to achieve maximum clinical benefit, and is likely to help avoid non-response. Pacing outside scar tissue and targeting late activated segments may improve outcome. The present study will be the first randomised controlled trial to compare the efficacy of real-time image-guided LV lead delivery to conventional CRT implantation. In addition, to estimate the cost-effectiveness of targeted lead implantation, an early decision analytic model was developed, and described here., Methods and Analysis: A multicentre, interventional, randomised, controlled trial will be conducted in a total of 130 patients with a class I or IIa indication for CRT implantation. Patients will be stratified to ischaemic heart failure aetiology and 1:1 randomised to either empirical lead placement or live image-guided lead placement. Ultimate lead location and echocardiographic assessment will be performed by core laboratories, blinded to treatment allocation and patient information. Late gadolinium enhancement cardiac magnetic resonance imaging (CMR) and CINE-CMR with feature-tracking postprocessing software will be used to semi-automatically determine myocardial scar and late mechanical activation. The subsequent treatment file with optimal LV-lead positions will be fused with the fluoroscopy, resulting in live target-visualisation during the procedure. The primary endpoint is the difference in percentage of successfully targeted LV-lead location. Secondary endpoints are relative percentage reduction in indexed LV end-systolic volume, a hierarchical clinical endpoint, and quality of life. The early analytic model was developed using a Markov-model, consisting of seven mutually exclusive health states., Ethics and Dissemination: The protocol was approved by the Medical Research Ethics Committee Utrecht (NL73416.041.20). All participants are required to provide written informed consent. Results will be submitted to peer-reviewed journals., Trial Registration Number: NCT05053568; Trial NL8666., Competing Interests: Competing interests: FJS is cofounder, chief technical officer and shareholder of CART-Tech B.V. MM and FJS are inventors and beneficiaries of a patent license arrangement between the University Medical Centre Utrecht and CART-Tech B.V. according to the rules of the University Medical Centre Utrecht., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Electroanatomic mapping systems have become an essential tool to guide the identification and ablation of arrhythmic substrate. Recently, a novel guiding system for electrophysiology procedures was introduced that uses dielectric sensing to perform high resolution anatomical imaging. Dielectric imaging systems use electrical fields to differentiate anatomic structures based on their conductivity and permittivity. This technique enables non-fluoroscopic, noncontact mapping of anatomic structures, assessment of pulmonary vein occlusion state during cryoballoon ablation, and has the potential to assess for additional tissue characterization including tissue thickness and tissue type. This article elaborates on the functioning and potential of dielectric imaging systems and provides two cases to illustrate the clinical impact for electrophysiology procedures., (© 2021 Wiley Periodicals LLC.)

Purpose: The second-generation multi-electrode catheter, pulmonary vein ablation catheter (PVAC) GOLD, was designed to improve the delivery of phased radiofrequency energy and reduce procedure times using a 'single-shot' approach for pulmonary vein isolation (PVI), while retaining efficacy and safety. This large registry presents acute success rates and safety outcomes in a daily practice setting., Methods: A total of 1017 patients undergoing first-time ablation for atrial fibrillation (AF) using PVAC GOLD were included, 644 patients with paroxysmal AF and 373 patients with non-paroxysmal AF, divided into 175 patients receiving PVI only and 198 patients receiving PVI with additional substrate modification., Results: High and comparable percentages of successful PVI could be achieved in all groups (98%, 95% and 99%; p = 0.108). The median total procedure time for all groups was 90 min [70-100]. As expected, the total procedure, ablation and fluoroscopy time were significantly longer in the PVI + substrate modification group compared with the PVI-only cases (all p < 0.001), but not between the PVI-only groups (p = 0.306, p = 0.088, p = 0.233, respectively). A total of 44 complications were observed in 43 patients (4.2%). Major complications were seen in 19 patients (1.87%) and non-major procedure-related complications were seen in 25 patients (2.46%). Complications leaving permanent sequelae were rare and occurred in only four patients (0.39%). Complications did not differ between groups (p = 0.199, p = 0.438, p = 0.240 and p = 0.465 respectively)., Conclusion: PVAC GOLD performs successful PVI, while reducing procedure times and retaining safety for paroxysmal, persistent and long-standing persistent AF. Safety was unaffected by additional substrate modification.

Background: At a time when self-sufficiency and health are becoming increasingly important in society, the chances of intoxications with wild plants are increasing. Foxglove contains poisonous cardiac glycosides such as digoxin, digitoxin and gitoxin. The levels vary greatly and depend on the season and the location of the plants. The "non-digoxin" cardiac glycosides show a limited cross-reaction with the digoxin assay. This means that a low or therapeutic digoxin level does not rule out a severe foxglove intoxication. Due to the long half-life of the different cardiac glycosides, toxic symptoms can be persistent., Case Description: A 43-year-old woman arrived at the Emergency Department with persistent vomiting and specific ECG-abnormalities. The day before, she drunk a smoothie made from wild plants picked in the woods. Patient appeared to have mistaken foxglove for common sorrel., Conclusion: In case of persistent gastrointestinal complaints with specific ECG abnormalities after ingestion of plant material, clinicians should be aware of a foxglove intoxication.

The completely subcutaneous implantable cardioverter defibrillator (S-ICD) is rapidly evolving to become a complete alternative for the transvenous ICD (TV-ICD) leaving the heart and vasculature untouched. Newer trials and registries in cohorts that are similar to real-world ICD patient populations confirm the initial data on safety and efficacy. Technical improvements have resulted in reduced inappropriate shock rates, although more data are warranted, and new developments such as substernal lead positioning, communication between the S-ICD and a leadless cardiac pacemaker and remote monitoring options have evolved to overcome the shortcomings of S-ICD therapy. With these continuing developments, it is expected that within the next years the S-ICD will continue to evolve to a treatment option for ventricular arrhythmia as effective as the TV-ICD overcoming the shortcomings of transvenous leads as well as the drawbacks of the initial system, providing effective shock therapy, pacing capabilities, low complication and inappropriate therapy rates, and automated remote monitoring., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Atrial fibrillation (AF) is associated with an increased risk of stroke. Stroke prevention with oral anticoagulation (OAC) is recommended in AF patients at increased risk of stroke. The left atrial appendage (LAA) is the main source of thrombus formation in AF patients. The WATCHMAN percutaneous LAA closure (LAAC) device may serve as an alternative to OAC overcoming disadvantages including the risk of (major) bleeding., Areas Covered: This review will focus on LAAC with the Watchman device for stroke prevention in AF patients. Current status, available literature, clinical safety and efficacy will be summarized. Furthermore, the future perspectives of Watchman will be discussed., Expert Opinion: LAAC with Watchman appears a promising, safe, and effective alternative to OAC. Ongoing and future studies to consolidate the position of Watchman should focus on comparative safety and efficacy of different LAAC devices, patient selection, various post-procedural antithrombotic regimens, head-to-head comparisons with NOAC, better understanding of device-related thrombus, and the role of the LAA in the propagation of non-valvular AF. This research may attribute to a paradigm shift in which LAAC no longer serves as a 'last resort' treatment for AF patients ineligible for OAC but may serve as a second-line or even first-line treatment option for AF patients.

Background: In the battle against the SARS-CoV‑2 pandemic, chloroquine has emerged as a new potential therapeutic option for the treatment of infected patients. A safety consideration for the application of chloroquine is its QTc-prolonging potential. Thus far, no data are available on the QTc-prolonging potential of chloroquine in COVID-19 patients., Objective: To assess the degree of chloroquine-induced QTc prolongation in hospitalised COVID-19 patients., Methods: A baseline electrocardiogram (ECG) and ECGs recorded during chloroquine treatment were retrospectively collected in patients suspected of having COVID-19. The QTc interval was calculated by computerised and manual interpretation. Baseline and follow-up QTc intervals were compared using the paired samples t-test., Results: A total of 95 patients had a baseline ECG recording and at least one ECG recording during chloroquine therapy. Chloroquine treatment resulted in a mean QTc prolongation of 35 ms (95% CI 28-43 ms) using computerised interpretation and 34 ms (95% CI 25-43 ms) using manual interpretation. No torsade de pointes was observed during chloroquine treatment. After manual review, 22 patients (23%) had a QTc interval exceeding 500 ms during chloroquine treatment. None of these patients had a prolonged QTc interval prior to the initiation of chloroquine treatment., Conclusions: Chloroquine significantly prolongs the QTc interval in a clinically relevant matter. This highlights the need for ECG monitoring when prescribing chloroquine to COVID-19 patients.

Introduction: In patients with a prior myocardial infarction (MI) but preserved left ventricular (LV) function, sustained ventricular arrhythmias (VAs) may arise in the setting of an acute coronary syndrome (ACS). It is unknown whether an implantable cardioverter-defibrillator (ICD) is mandatory in these patients as VA might be triggered by a reversible cause. The purpose of this study is to analyze the benefit of ICD therapy in this patient population., Methods: We conducted a retrospective observational study in ICD recipients implanted from 2008 to 2011. The study group consisted of patients with sustained VA in the setting of an ACS, with a history of MI, but with left ventricular ejection fraction (LVEF) greater than 35 (group A). The two control groups consisted of patients admitted with VA with a history of MI, but without ACS at presentation, either with LVEF greater than 35% (group B) or ≤35% (group C). The primary endpoint was the number of patients with appropriate ICD therapy (antitachycardia pacing or shock)., Results: A total of 291 patients were included with a mean follow-up of 5.3 years. Appropriate ICD therapy occurred in 45.6% of the patients in group A vs 51.6% and 60.4% in groups B and C (P = .11). In group A, 31.1% received an appropriate ICD shock vs 34.7% and 44.3% in control groups B and C (P = .12)., Conclusion: On the basis of these data, ICD implantation seems warranted in patients with history of MI presenting with VA in the setting of an ACS, despite preserved LV function and adequate revascularization. Further trials, preferably randomizes, should be performed to address these findings., (© 2020 Wiley Periodicals, Inc.)

Background: Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously., Methods: In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with a wait-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than -10., Results: The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, -2.9 percentage points; 95% confidence interval [CI], -8.2 to 2.2; P = 0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the early-cardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the early-cardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively., Conclusions: In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks. (Funded by the Netherlands Organization for Health Research and Development and others; RACE 7 ACWAS ClinicalTrials.gov number, NCT02248753.)., (Copyright © 2019 Massachusetts Medical Society.)

Aims: Left atrial appendage closure (LAAC) is increasingly used as an alternative to oral anticoagulation (OAC) for stroke prevention in atrial fibrillation (AF) patients. Feasibility and safety of left atrial (LA) catheter ablation (CA) in patients with previously implanted LAAC devices have not been well studied. We report on the feasibility, safety, and efficacy of LA CA in the presence of a previously implanted LAAC device., Methods and Results: In this prospective cohort study consecutive patients that underwent LA CA with a previously implanted Watchman device were included. Periprocedural characteristics and long-term clinical follow-up were evaluated. Twenty-three LA CA procedures were performed in 19/162 AF patients with previously implanted Watchman devices [47% male, age 63.9 ± 6.2 years, CHA2DS2-VASc 4.0 (3.0-5.0); HASBLED 3.0 (2.0-4.0); 63% paroxysmal]. Left atrial CA was performed with irrigated radiofrequency (RF; n = 20, 87%) or phased RF (n = 3, 13%) in a mean of 18 months after LAAC implantation (range 4-80 months). Targets of CA consisted of pulmonary vein isolation (n = 19, 83%), superior vena cava isolation (n = 13, 57%), and additional linear lesions (n = 8, 35%). Procedures were carried out under vitamin K antagonist (VKA; n = 6, 26%), non-VKA OAC (NOAC; n = 8, 35%), or single antiplatelet therapy alone (n = 9, 39%). Left atrial CA was successful without any signs of interference from the device. Procedure-related complications were not observed. During a mean follow-up of 28 months, 11 patients (58%) had AF recurrence., Conclusion: Left atrial CA after LAAC appears to be feasible, effective, and safe in this single centre cohort. Previously implanted Watchman device should not be a reason to relinquish CA in symptomatic AF patients, even in patients on single antiplatelet therapy alone., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com.)

Introduction: Experience with the subcutaneous implantable cardioverter-defibrillator (S-ICD) is expanding rapidly. However, data on long-term performance or complications related to elective generator replacement are lacking., Methods: Follow-up (FU) data of all patients implanted between December 2008 and April 2011 were collected. Complications were defined as those requiring surgical intervention. Kaplan-Meier estimates for complication and shock rates, with corresponding 95% confidence intervals (CI), were calculated., Results: One hundred and eighteen patients were included. Median FU was 6.1 years (IQR 5.6-6.5 years). Short-term complication rate (0-30 days) was 3% (CI 0-6%). Long-term complication rate at 6 years was 19% (CI 12-26%), corresponding with an annual complication rate of 3%. One patient in this cohort developed a need for a transvenous ICD (TV-ICD) in order to provide pacing for bradycardia (1%). Six patients were implanted with a TV-ICD after experiencing an S-ICD complication for which extraction was necessary. In total, 10 S-ICDs were extracted; none resulted in a complication. Eight patients had a nonsystemic ICD-related infection and no lead failures were observed. The majority, 68 (58%) patients, received an elective generator replacement. Two patients had a complication related to generator replacement (3%). Battery longevity was 5.6 years (IQR 5.2-6.1). Appropriate and inappropriate shock rates of 6-year estimates were 17% (CI 9-25%) and 21% (CI 15-27%), respectively., Conclusions: This cohort represents the longest follow-up to date and shows a low annual complication rate without lead failures or systemic infections. Battery longevity of the first S-ICD generation results in relative early generator replacement procedures., (© 2018 Wiley Periodicals, Inc.)

Introduction: Treatment infections is challenging in pacemaker (PM) dependent patients. We proposed a novel implantation strategy for this group of patients., Methods: Patients who were PM dependent and were admitted with a PM infection received a combined procedure of left ventricular (LV) epicardial implantation of a PM lead and subsequent extraction of the infected system. No temporary pacing wire was used and the PM generator was placed in the left flank., Results: Between 2012 and 2015 we treated 16 patients who were PM dependent and with a PM infection. The majority of patients were male (81% [13/16]) and the median age was 71 years (50-91). The cause of infection was valvular endocarditis in 38% (6/16), lead infection in 25% (4/16), and isolated pocket infection in 38% (6/16). All patients underwent epicardial implantation of a LV lead (1084T bipolar lead; St. Jude Medical Myodex, St. Paul, MN, USA) and extraction of the infected device. There was no occurrence of periprocedural mortality and no postprocedural tamponades. There was one complication in the form of a hemorrhage at the infected device extraction site. In the median follow-up period of 17 months there were four of 16 deaths, none of which were attributable to epicardial LV implantation. LV-lead threshold was 1.1V (±0.7V) upon implantation that increased to 1.2V (±0.6V) at 0.4-ms pulse duration. There were no reinfections of the epicardial lead or device., Conclusion: Epicardial left ventricle PM implantation and subsequent extraction of an infected PM in PM-dependent patients is feasible and safe with good long-term outcome., (© 2018 Wiley Periodicals, Inc.)

Introduction: Optimal left ventricular (LV) lead position in patients undergoing cardiac resynchronization therapy (CRT) is crucial to achieve an optimal effect on hemodynamics. Due to various difficulties, up to 30% of transvenous LV lead placements fail, or a suboptimal position is achieved. Surgical epicardial LV lead placement could be performed at a position anticipated to be the optimal site. This could have a more favorable effect, which may be expressed by increased improvement in left ventricular ejection fraction (LVEF) and cardiac perfusion. The objective of this trial is to compare transvenous versus epicardial LV lead placement in CRT in a randomized fashion METHODS AND RESULTS: Fifty-two patients were randomized to either epicardial or transvenous approach. All patients received an ICD with CRT. Patients were followed for 6 months after device implant. Primary endpoint was the degree of change in cardiac perfusion measured by myocardial perfusion scintigraphy. LVEF equally improved in both groups, from 24% to 36% in the transvenous group versus 25% to 35% in the epicardial group (P = 0.797). Cardiac perfusion, expressed as summed stress score, improved in both groups without a significant difference as well (P = 0.727). Complication rate was similar, respectively 6 and 7 patients had any complication. Admission time was significantly longer in the epicardial group with 2 (2-7) versus 3 (2-32) days (P <0.001)., Conclusion: Epicardial LV lead placement does not result in additional improvement of LVF or myocardial perfusion compared to the conventional transvenous in CRT., (© 2017 Wiley Periodicals, Inc.)

Introduction: Modern pacemakers are designed to allow patients to undergo magnetic resonance imaging (MRI) under a set of specific conditions. Aim of this study is to provide confirmatory evidence of safety and performance of a new pacing system (ImageReady™, Boston Scientific) in patients undergoing 1.5 and 3T MRI., Methods and Results: Two prospective, nonrandomized, single-arm studies were designed to provide confirmatory data of no impact of MRI on device function, lead parameters, and patient conditions in subjects implanted with the system undergoing a clinically non-indicated 1.5T and 3T MRI, respectively. Device measurements were done within 1 hour before and after the scan and at 1 month follow-up. Thirty-two subjects underwent MRI visit (17 subjects with 1.5T MRI and 15 subjects with 3T MRI). There were no unanticipated adverse effects related to the pacemaker. Device measurements taken pre- and post-MRI scan did not show any clinical relevant change that could indicate an effect of the MRI on the device or at the lead-tissue interface (RV threshold change: 0.01 ± 0.13 V, P = 0.60; RA threshold change: 0.01 ± 0.11 V, P = 0.53; R wave change: -0.44 ± 1.73 mV, P = 0.36; R wave change: 0.12 ± 1.67 mV, P = 0.73), with data confirmed at 1-month follow-up visit., Conclusion: The study documented safety of the pacing system in the 1.5T and 3T MRI environment by showing no adverse events related to device or MRI scan. Additional data are required to cover the more complex scenarios involving different diagnostic needs, conditions of use, clinical conditions, and new emerging technologies., (© 2017 Wiley Periodicals, Inc.)

Aims: Transcatheter aortic valve implantation (TAVI) is frequently associated with cardiac conduction defects (CCD) requiring permanent pacemaker implantation (PPI). Although new-onset left bundle branch block (LBBB) is often seen, the rate of progression to severe CCD is unclear. We aimed to find clinical and electrocardiographic (ECG) parameters associated with severe CCD requiring PPI in patients with a new-onset LBBB after TAVI and assess its effect on clinical outcome., Methods and Results: All consecutive patients undergoing TAVI who developed a new-onset LBBB were retrospectively analysed. We excluded patients with pre-existing bundle branch block or pacemaker. Patients were divided into two groups: with or without PPI after TAVI. We included 155 patients (50% female, 80 ± 7 years), of which 37 (24%) developed CCD requiring PPI, mainly due to a total atrioventricular block (n = 17; 46%). Cardiac conduction defects requiring PPI were associated with the following pre-existing parameters: atrial fibrillation (AF), the use of digoxin, CoreValve implantation, and left heart axis. Furthermore, it was associated with the following post-procedural parameters: left heart axis, lower mean heart rate, and prolonged PQ and QRS times. During follow-up, patients with PPI showed a lower mortality rate (11 vs. 29%, P = 0.03). In patients without PPI, mortality was lower in those with narrower QRS complex and transient LBBB., Conclusion: The severity and persistence of a new-onset LBBB after TAVI is associated with mortality. Cardiac conduction defects requiring PPI are associated with prior AF, the use of digoxin, CoreValve implantation, and a left heart axis. In these patients, PPI portends a better prognosis than no PPI., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions please email: journals.permissions@oup.com.)

Introduction: The latest European Society of Cardiology Guidelines recommend consideration of a wearable cardioverter-defibrillator (WCD) for patients with a poor left ventricular ejection fraction (LVEF) who are at risk of sudden arrhythmic death but are not eligible for an implantable defibrillator. For these patients a WCD can be an alternative to long-term hospitalisation., Purpose: To evaluate the use of WCD therapy in these patient groups in two Dutch centres., Methods: All consecutive patients treated with the WCD between 2009 and 2016 were included from two centres in the Netherlands. Data on events and compliance were collected retrospectively through home monitoring systems and adjudicated by the investigators., Results: A total of 79 patients were treated with a WCD. Common indications were newly diagnosed cardiomyopathy without optimal medical treatment in 46 patients (58.2%) and bridge to implantable cardioverter-defibrillator (ICD) implant in 33 patients (41.8%). Bridge to implant indications consisted of contraindications for immediate implantation such as infections (e. g. previous device-related infections) and radiotherapy. Compliance was over 97% per day (median 23.3 h, 22.6-23.7), during a median of 79 days (50.0-109.8.0). Two patients (2.6%) received an appropriate shock (annual rate 13.6%), there was 1 (1.3%) inappropriate shock (annual rate 6.7%). In 24 patients (52.2%) without optimal medical treatment, the LVEF was sufficiently improved and ICD implant was avoided. Eight (10.1%) patients did not receive an ICD. In 45 patients an ICD was implanted (57.0%)., Conclusion: WCD therapy provides a safe and effective treatment in outpatient setting for patients at high risk for sudden cardiac death and reduces the number of ICDs implanted.

A 53-year-old female patient with hypertrophic obstructive cardiomyopathy (HOCM) was admitted for alcohol septal ablation (ASA). A subcutaneous internal cardioverter defibrillator (S-ICD) was implanted for primary prevention. After ASA, the patient developed a right bundle branch block, and the S-ICD delivered a total of five inappropriate shocks due to T-wave oversensing (TWOS). TWOS is a relatively frequent cause of inappropriate shocks in S-ICD patients. After invasive treatment for HOCM, there is a risk of developing intraventricular conduction delay and subsequent changes in QRS and T-wave morphology. This should be taken into consideration when ICD indication is evaluated in HOCM patients., (©2015 Wiley Periodicals, Inc.)

Objectives: The study sought to determine long-term clinical effects of combining catheter ablation (CA) and left atrial appendage (LAA) occlusion (LAAO) in a single procedure., Background: CA relieves symptoms in atrial fibrillation (AF), but freedom from AF is not assured. Thus, oral anticoagulation (OAC) remains necessary in high stroke risk patients. LAAO has proved a viable alternative for preventing thromboembolic complications., Methods: Symptomatic patients with drug-refractory AF (CHADS 2  ≥1) and indications for LAAO were included. Transesophageal echocardiography was performed to assess LAA size/anatomy/thrombus. After CA, LAAO was performed using the Watchman device (Atritech, Inc., Plymouth, Minnesota, Minnesota). At 3 months, OAC was switched to aspirin/clopidogrel if LAAO criteria were met., Results: From September 2009 to October 2013, 62 patients (22 female, 64 ± 8 years of age, CHADS 2 2.5) underwent combined procedures. Indications for LAAO included history of stroke despite OAC (29.0%), contraindications for OAC (24.2%), high stroke risk (24.2%), and miscellaneous reasons (22.6%). LAAO resulted in complete acute closure in all, with a median number of 1 device. After a median follow-up of 38 (range: 25 to 45) months, 95% of the patients met the criteria for successful sealing and 78% could discontinue OAC, while recurrence of AF was documented in 42%. During long-term follow-up, 3 ischemic strokes were observed with an annual stroke risk of 1.7%, which is lower than the expected annual risk of 6.5%., Conclusions: LAAO combined with CA for AF can be performed successfully and safely in a single procedure, with a lower than expected stroke rate. Further studies are necessary to determine which patients benefit most from the combined therapy., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The purpose of this study was to assess the feasibility of real-time 3D echocardiography (RT-3DE) data acquisition in adult patients after atrioventricular septal defect (AVSD) repair and to evaluate whether RT-3DE has additional value over 2D echocardiography, regarding morphology and function of the left-sided AV valve (LAVV)., Methods: Twenty consecutive patients with surgically corrected partial or complete AVSD were enrolled in this study. The 3DE data sets were acquired with the Hewlett-Packard Sonos 7500 echo system (Philips Medical Systems, Andover, MA, USA). Images were reviewed off-line with assistance of TomTec Echoview 5.2 software (TomTec Inc., Munich, Germany) by experienced observers. En face reconstructions, from, respectively, the ventricular and atrial view, were made to evaluate the LAVV morphology and motion., Results: 3DE reconstruction of the LAVV was feasible in 17 of 20 patients (85%). Mean time of 3DE acquisition was 9+/-6 min. The quality of the 3DE images was optimal in 35%, good in 30%, sufficient in 20% and insufficient in 15%. Identification of the LAVV structures was importantly better facilitated from a ventricular view. Accurate identification of LAVV morphology was possible in all 17 patients (85%). Relationship of the LAVV and the abnormal position of the LVOT was easier to evaluate from the 3DE reconstructions than from 2D echo., Conclusion: This study demonstrate that RT-3DE is feasible in daily practice and provides new insight into the dynamic morphology of the left-sided AV valve and LVOT anatomy after AVSD repair.