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BACKGROUND: Catheter ablation (CA) and minimally invasive surgical ablation (SA) have become accepted therapy for antiarrhythmic drug-refractory atrial fibrillation. This study describes the first randomized clinical trial comparing their efficacy and safety during a 12-month follow-up. METHODS AND RESULTS: One hundred twenty-four patients with antiarrhythmic drug-refractory atrial fibrillation with left atrial dilatation and hypertension (42 patients, 33%) or failed prior CA (82 patients, 67%) were randomized to CA (63 patients) or SA (61 patients). CA consisted of linear antral pulmonary vein isolation and optional additional lines. SA consisted of bipolar radiofrequency isolation of the bilateral pulmonary vein, ganglionated plexi ablation, and left atrial appendage excision with optional additional lines. Follow-up at 6 and 12 months was performed by ECG and 7-day Holter recording. The primary end point, freedom from left atrial arrhythmia >30 seconds without antiarrhythmic drugs after 12 months, was 36.5% for CA and 65.6% for SA (P=0.0022). There was no difference in effect for subgroups, which was consistent at both sites. The primary safety end point of significant adverse events during the 12-month follow-up was significantly higher for SA than for CA (n=21 [34.4%] versus n=10 [15.9%]; P=0.027), driven mainly by procedural complications such as pneumothorax, major bleeding, and the need for pacemaker. In the CA group, 1 patient died at 1 month of subarachnoid hemorrhage. CONCLUSION: In atrial fibrillation patients with dilated left atrium and hypertension or failed prior atrial fibrillation CA, SA is superior to CA in achieving freedom from left atrial arrhythmias after 12 months of follow-up, although the procedural adverse event rate is significantly higher for SA than for CA. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00662701. [ABSTRACT FROM AUTHOR]

Arash Alipour, Lisette I S Wintgens, Martin J Swaans, Jippe C Balt, Benno J W M Rensing, Lucas V A Boersma Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands Abstract: Atrial fibrillation (AF) remains an important clinical problem with severe complications such as stroke, which especially harms those with risk factors as calculated by the CHADS2 or CHA2DS2-VASc. Until now, no therapy has proven 100% effective against AF. Since the left atrial appendage (LAA) is the most prominent nonvalvular AF-related thromboembolic source and (novel) oral anticoagulant [(N)OAC] carries the hazard of bleeding, LAA occlusion may be an alternative, especially in patients who are ineligible for (N)OAC therapy. In this review, we discuss several LAA occlusion techniques with a focus on the Watchman device since this device is the most thoroughly studied device of all. Keywords: left atrial appendage, atrial fibrillation, ischemic stroke

Martin J Swaans, Lisette IS Wintgens, Arash Alipour, Benno JWM Rensing, Lucas VA Boersma Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands Abstract: Atrial fibrillation (AF) is the most common arrhythmia treated in the clinical practice. One of the major complications of AF is a thromboembolic cerebral ischemic event. Up to 20% of all strokes are caused by AF. Thromboembolic cerebral ischemic event in patients with AF occurs due to atrial thrombi, mainly from the left atrial appendage (LAA). Prevention of clot formation with antiplatelet agents and especially oral anticoagulants (­vitamin K antagonists or newer oral anticoagulants) has been shown to be effective in reducing the stroke risk in patients with AF but has several drawbacks with (major) bleedings as the most important disadvantage. Therefore, physical elimination of the LAA, which excludes the site of clot formation by surgical or percutaneous techniques, might be a good alternative. In this review, we discuss the safety, efficacy, and clinical utility of the Watchman™ LAA closure device. Keywords: stroke, left atrial appendage, prevention, atrial fibrillation

Background: Freedom from atrial arrhythmia (AA) recurrence ≥30 seconds after pulsed field ablation (PFA) in patients with atrial fibrillation (AF) was reported in PULSED AF (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF; ClinialTrials.gov Identifier: NCT04198701). AA burden may be a more clinically meaningful endpoint., Objective: The purpose of this study was to determine the influence of monitoring strategies on AA detection and AA burden association with quality of life (QoL) and health care utilization (HCU) after PFA., Methods: Patients underwent 24-hour Holter monitoring at 6 and 12 months and weekly, and symptomatic transtelephonic monitoring (TTM). AA burden post-blanking was calculated as the greater of (1) percentage of AA on total Holter time; or (2) percentage of weeks with ≥1 TTM with AA out of all weeks with ≥1 TTM., Results: Freedom from all AAs varied by >20% when differing monitoring strategies were used. PFA resulted in zero burden in 69.4% of paroxysmal atrial fibrillation (PAF) and 62.2% of persistent atrial fibrillation (PsAF) patients. Median burden was low (<9%). Most PAF and PsAF patients had ≤1 week of AA detection on TTM (82.6% and 75.4%) and <30 minutes of AA per day of Holter monitoring (96.5% and 89.6%), respectively. Only PAF patients with <10% AA burden averaged a clinically meaningful (>19 point) QoL improvement. PsAF patients experienced clinically meaningful QoL improvements irrespective of burden. Repeat ablations and cardioversions significantly increased with higher AA burden (P <.01)., Conclusion: The ≥30-second AA endpoint is dependent on the monitoring protocol used. PFA resulted in low AA burden for most patients, which was associated with clinically relevant improvement in QoL and reduced AA-related HCU., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications., Methods: The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points., Results: Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts., Conclusions: PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT04198701., Competing Interests: Disclosures Drs Verma, Boersma, Calkins, Haines, Hindricks, Kuck, Marchlinski, Natale, Packer, De Lurgio, and Sanders receive consultation funds from Medtronic, Inc. Dr Onal and J. Cerkvenik are employees of Medtronic, Inc. Dr Verma receives grants or consultation funds from Biosense Webster, Bayer, Medlumics, Adagio Medical, and Boston Scientific. Dr De Lurgio receives consultation or honoraria funds from Atricure and Boston Scientific. Dr Marchlinski receives grants, consultation, or honoraria funds from Biosense Webster, Abbott Medical, and Biotronik. Dr Sood receives consultation or honoraria funds from Johnson & Johnson, Boston Scientific, Atricure, Bristol Myers, and Pfizer. Dr Boersma receives consultation funds from Boston Scientific, Abbott Medical, Adagio Medical, Acutus Medical, and Philips Medical. Dr Kuck receives consultation funds from Cardiovalve. Dr Natale receives consultation funds from Abbott Medical, Baylis, Biosense Webster, Biotronik, and Boston Scientific. Dr Sanders receives grants or honoraria funds from Boston Scientific, Abbott Medical, Becton Dickenson, Pacemate, and CathRx. Dr Tada receives funds from Abbott Medical Japan LLC, Nippon Boehringer Ingelheim Co Ltd, Daiichi Sankyo Company Ltd, Alvaus Inc, Biotronik Japan Inc, Bristol Myers Squibb, and Novartis Pharma KK. Dr Calkins receives consultation or honoraria funds from Boston Scientific, Abbott Medical, Atricure, and Biosense Webster.

Competing Interests: Conflict of interest: The authors have provided declaration of interest information for all relationships that might be perceived as real or potential sources of conflicts of interest. The full disclosures can be viewed in the supplementary material for this article, available online at http://academic.oup.com/europace/article-lookup/doi/10.1093/europace/euac066#supplementary-data.

Introduction: Anticoagulation therapy is pivotal in the management of stroke prevention in atrial fibrillation (AF). Prospective registries, containing longitudinal data are lacking with detailed information on anticoagulant therapy, treatment adherence and AF-related adverse events in practice-based patient cohorts, in particular for non-vitamin K oral anticoagulants (NOAC). With the creation of DUTCH-AF, a nationwide longitudinal AF registry, we aim to provide clinical data and answer questions on the (anticoagulant) management over time and of the clinical course of patients with newly diagnosed AF in routine clinical care. Within DUTCH-AF, our current aim is to assess the effect of non-adherence and non-persistence of anticoagulation therapy on clinical adverse events (eg, bleeding and stroke), to determine predictors for such inadequate anticoagulant treatment, and to validate and refine bleeding prediction models. With DUTCH-AF, we provide the basis for a continuing nationwide AF registry, which will facilitate subsequent research, including future registry-based clinical trials., Methods and Analysis: The DUTCH-AF registry is a nationwide, prospective registry of patients with newly diagnosed 'non-valvular' AF. Patients will be enrolled from primary, secondary and tertiary care practices across the Netherlands. A target of 6000 patients for this initial cohort will be followed for at least 2 years. Data on thromboembolic and bleeding events, changes in antithrombotic therapy and hospital admissions will be registered. Pharmacy-dispensing data will be obtained to calculate parameters of adherence and persistence to anticoagulant treatment, which will be linked to AF-related outcomes such as ischaemic stroke and major bleeding. In a subset of patients, anticoagulation adherence and beliefs about drugs will be assessed by questionnaire., Ethics and Dissemination: This study protocol was approved as exempt for formal review according to Dutch law by the Medical Ethics Committee of the Leiden University Medical Centre, Leiden, the Netherlands. Results will be disseminated by publications in peer-reviewed journals and presentations at scientific congresses., Trial Registration Number: Trial NL7467, NTR7706 (https://www.trialregister.nl/trial/7464)., Competing Interests: Competing interests: GC and EMT-R are supported by a research grant of ZonMW (project numbers 848050006 and 848050007). JS is supported by a grant from the Dutch Federation of Anticoagulation Clinics (FNT), outside the submitted work. FAK has received research support from Bayer, Bristol Myers Squibb, Boehringer Ingelheim, MSD, Daiichi Sankyo, Actelion, the Dutch Thrombosis Association and the Dutch Heart foundation. JRdG reports research grants from Abbott, AtriCure, Boston Scientific, Medtronic and Bayer. He received speaker/consultancy honoraria from AtriCure, Bayer, Daiichi Sankyo, Johnson & Johnson, Servier and Novartis; all outside the scope of this work. JGM received consultancy fees from BMS/Pfizer and Daiichi Sankyo. FS received consultancy fees from Daiichi Sankyo and BMS, and restricted institutional grants from Daiichi Sankyo. RGT reports grants and personal fees from Boehringer Ingelheim, Bayer, Pfizer, Bristol Meyer Squibb and Daiichi Sankyo. FHR and GJG received unrestricted institutional grants from Bayer, BMS/Pfizer, Boehringer Ingelheim and Daiichi Sankyo. MEWH received consultancy fees from Bayer, BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo and Roche, and received a research grant from Federation of Dutch Thrombosis Services. MVH reports unrestricted grants from and personal fees from Boehringer Ingelheim, Pfizer/BMS, Bayer Health Care, Aspen and Daiichi Sankyo, outside the submitted work., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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 and Objectives: Elderly patients with atrial fibrillation are at greater risk of both cardioembolic events and major bleeding than younger patients. Left atrial appendage occlusion (LAAO) could be an attractive alternative for these patients, but there are limited data on outcomes with LAAO in patients ≥ 85 years old. The aim of the present study was to assess the safety and efficacy of LAAO in patients ≥ 85 years old., Methods: A total of 1025 patients included in the EWOLUTION registry who underwent LAAO were analyzed and 84 patients ≥ 85 years old were identified and compared with the younger cohort., Results: Patients ≥ 85 years old had higher estimated stroke and hemorrhagic risks than younger patients (CHA 2 DS 2 -VASc: 5.2±1.2 vs 4.4±1.6, P <.0001; HAS-BLED: 2.7±1.1 vs 2.3±1.2; P=.003; ≥ 85 years vs <85 years). Procedural success was high and similar in both groups (98.8% vs 98.5%; P=.99). There were no differences in 7-day device- or procedure-related adverse event rates (2.6% in ≥ 85 years vs 3.1% in <85 years; P=.80). Despite the higher baseline stroke risk, there was no difference at follow-up between the groups in the annualized stroke rate (0.8/100 patient-years in ≥ 85 years vs 1.3/100 patient-years in <85 years; P=.649)., Conclusions: LAAO in patients ≥ 85 years is safe and effective even though these patients are at high risk for embolic and hemorrhagic events. LAAO may be a reasonable alternative to oral anticoagulation in these patients., (Copyright © 2019 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has shown favorable outcomes in large registries with broad inclusion criteria. The cohorts reported had less heart disease and fewer comorbidities than standard ICD populations., Objective: The purpose of this study is to characterize acute performance for primary prevention patients with a left ventricular ejection fraction (LVEF) ≤35% (primary prevention ≤35%)., Methods: Primary prevention ≤35% patients with no prior documented sustained ventricular tachycardia (VT), pacing indication, end-stage heart failure, or advanced renal failure were prospectively enrolled. Analyses included descriptive statistics, Kaplan-Meier time to event, and multivariable linear and logistic regression., Results: In 1112 of 1116 patients, an S-ICD was successfully implanted (99.6%). Predictors for longer procedure time included 3-incision technique, higher body mass index (BMI), performing defibrillation testing (DFT), imaging, younger age, black race, and European vs North American centers. Patients undergoing DFT (82%) were successfully converted (99.2%; 93.5% converting at ≤65 J). Higher BMI was predictive of failing DFT at ≤65 J. The rate of 30-day freedom from complications was 95.8%. Most complications involved postoperative healing (45%) or interventions after DFT or impedance check (19%)., Conclusion: The procedural outcome data of UNTOUCHED reinforce that S-ICD therapy has low perioperative complication rates and high conversion efficacy of induced ventricular fibrillation, even in a higher-risk cohort with low LVEF and more comorbidities than previous S-ICD studies. Higher BMI warrants more careful attention to implant technique., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background Identification and elimination of nonpulmonary vein targets may improve clinical outcomes in patients with persistent atrial fibrillation (AF). We report on the use of a novel, noncontact imaging and mapping system that uses ultrasound to reconstruct atrial chamber anatomy and measures timing and density of dipolar, ionic activation (ie, charge density) across the myocardium to guide ablation of atrial arrhythmias. Methods The prospective, nonrandomized UNCOVER AF trial (Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation) was conducted at 13 centers across Europe and Canada. Patients with persistent AF (>7 days, <1 year) aged 18 to 80 years, scheduled for de novo catheter ablation, were eligible. Before pulmonary vein isolation, AF was mapped and then iteratively remapped to guide each subsequent ablation of charge density-identified targets. AF recurrence was evaluated at 3, 6, 9, and 12 months using continuous 24-hour ECG monitors. The primary effectiveness outcome was freedom from AF >30 seconds at 12 months for a single procedure with a secondary outcome being acute procedural efficacy. The primary safety outcome was freedom from device/procedure-related major adverse events. Results Between October 2016 and April 2017, 129 patients were enrolled, and 127 underwent mapping and catheter ablation. Acute procedural efficacy was demonstrated in 125 patients (98%). At 12 months, single procedure freedom from AF on or off antiarrhythmic drugs was 72.5% (95% CI, 63.9%-80.3%). After 1 or 2 procedures, freedom from AF was 93.2% (95% CI, 87.1%-97.0%). A total of 29 (23%) retreatments because of arrhythmia recurrence were performed with average time from index procedure to first retreatment being 7 months. The primary safety outcome was 98% with no device-related major adverse events reported. Conclusions This novel ultrasound imaging and charge density mapping system safely guided ablation of nonpulmonary vein targets in persistent AF patients with 73% single procedure and 93% second procedure freedom from AF at 12 months. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02825992 EU/NCT02462980 CN.

Background: Left atrial appendage occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. Evaluating real-life clinical outcomes in atrial fibrillation patients receiving the WATCHMAN left atrial appendage closure technology was designed to collect prospective multicenter outcomes of thromboembolic events, bleeding, and mortality for patients implanted with a WATCHMAN in routine daily practice., Methods: One thousand twenty patients with a WATCHMAN implant procedure were prospectively followed in 47 centers. Left atrial appendage occlusion indication was based on the European Society of Cardiology guidelines. Follow-up and imaging were performed per local practice up to a median follow-up of 2 years., Results: Included population was old (age 73.4±8.9 years), at high risk for stroke (311 prior ischemic stroke/transient ischemic attack and 153 prior hemorrhagic stroke) and bleeding (318 prior major bleeding), with CHA 2 DS 2 -VASc score ≥5 in 49%, hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, Labile international normalized ratio, elderly, drugs/alcohol concomitantly ≥3 in 40% and oral anticoagulation contraindication in 72%. During follow-up, 161 patients (16.4%) died, 22 strokes were observed (1.3/100 patient-years, 83% reduction versus historic data), and 47 major nonprocedural bleeding events (2.7/100 patient-years, 46% reduction versus historic data). Stroke and bleeding rates were consistently lower than historic data in those with prior ischemic (-76% and -41%) or hemorrhagic (-81% and 67%) stroke and prior bleeding (-85% and -30%). Lowest bleeding rates were seen in patients with early discontinuation of dual antiplatelet therapy. Patients with early discontinuation of antithrombotic therapy showed lower bleeding rates, while they were highest for those with prior bleeding. Device thrombus was observed in 34 patients (4.1%) and was not correlated to drug regimen during follow-up ( P=0.28)., Conclusions: During the complete 2-year follow-up of Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology, patients with a WATCHMAN left atrial appendage occlusion device had consistently low rates of stroke and nonprocedural bleeding, although most were contraindicated to oral anticoagulation and used only single antiplatelet therapy or nothing., Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT01972282.

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.)

Background: Left atrial appendage (LAA) occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials., Objective: EWOLUTION was designed to provide data in routine practice from a prospective multicenter registry., Methods: A total of 1025 patients scheduled for a WATCHMAN implant were prospectively and sequentially enrolled at 47 centers. Indication for LAA closure was based on European Society of Cardiology guidelines. Follow-up and transesophageal echocardiography (TEE) were performed per local practice., Results: The baseline CHA 2 DS 2 -VASc score was 4.5 ± 1.6; the mean age was 73.4 ± 9 years; previous transient ischemic attack/ischemic stroke was present in 312 (30.5%), 155 (15.1%) had previous hemorrhagic stroke, and 320 (31.3%) had a history of major bleeding; and 750 (73%) were deemed unsuitable for oral anticoagulation therapy. WATCHMAN implant succeeded in 1005 (98.5%) of patients, without leaks >5 mm in 1002 (99.7%) with at least 1 TEE follow-up in 875 patients (87%). Antiplatelet therapy was used in 784 (83%), while vitamin K antagonists were used in only 75 (8%). At 1 year, mortality was 98 (9.8%), reflecting the advanced age and comorbidities in this population. Device thrombus was observed in 28 patients at routine TEE (3.7%) and was not correlated with the drug regimen (P = .14). Ischemic stroke rate was 1.1% (relative risk 84% vs estimated historical data); the major bleeding rate was 2.6% and was predominantly (2.3%) nonprocedure/device related., Conclusion: LAA closure with the WATCHMAN device has a high implant and sealing success. This method of stroke risk reduction appears to be safe and effective with an ischemic stroke rate as low as 1.1%, even though 73% of patients had a contraindication to and were not using oral anticoagulation., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: This study assessed the defibrillation efficacy of the substernal-lateral electrode configuration., Background: Subcutaneous implantable cardioverter-defibrillators (ICDs) are regarded as alternatives to transvenous ICDs in certain subjects. However, substantially higher shock energy of up to 80 J may be required. Proposed is a new defibrillation method of placing the shock coil into the substernal space., Methods: This prospective, nonrandomized, feasibility study was conducted in subjects scheduled for midline sternotomy or implant of ICD. A blunted end tunneling tool was used to insert a defibrillation lead behind the sternum using a percutaneous subxiphoid approach. A skin patch electrode was placed on the left mid-axillary line at the fourth to fifth intercostal space. After ventricular fibrillation induction, a single 35-J shock was delivered between the lead and skin patch., Results: Sixteen subjects (12 males, 4 females; mean age: 61.6 ± 11.8 years) were enrolled. The mean lead placement time was 11.1 ± 6.6 min. Of the 14 subjects with successfully induced ventricular fibrillation episodes, 13 subjects (92.9%) had successful defibrillation. The 1 failure was associated with high and lateral shock coil placement. Mean ventricular fibrillation duration was 18.4 ± 5.6 s with a shock impedance of 98.1 ± 19.3 ohms. Of the 11 subjects with coil-patch electrograms, the average R-wave amplitude during sinus rhythm was 3.0 ± 1.4 mV., Conclusions: These preliminary data demonstrate that substernal defibrillation is feasible and successful defibrillation can be achieved with the shock energy available in current transvenous ICDs. This may open new alternatives to extravascular ICD therapy., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The subcutaneous implantable defibrillator (S-ICD) provides an alternative to the transvenous ICD for the prevention of sudden cardiac death, but has not been well studied in the most commonly treated transvenous ICD patient population, namely, primary prevention (PP) patients with left ventricular dysfunction., Objective: The analyses in the present study were designed to compare clinical outcomes for PP patients with and without a reduced ejection fraction (EF) and secondary prevention (SP) patients implanted with the S-ICD., Methods: All patients 18 years and older from the S-ICD IDE study and the EFFORTLESS Registry with available data as of November 18, 2013, were included (n = 856; mean follow-up duration 644 days). Outcomes were evaluated in 2 analyses: (1) comparing all PP patients (n = 603, 70.4%) with all SP patients (n = 253, 29.6%) and (2) comparing all PP patients with an EF ≤35% (n = 379) with those with an EF >35% (n = 149, 17.4%)., Results: No differences were observed in mortality, complications, inappropriate therapy, or ability to convert ventricular tachyarrhythmias between SP and PP patients. However, SP patients had a higher incidence of appropriate therapy than did PP patients (11.9% vs 5.0%; P = .0004). In the PP subanalysis, the cohort with an EF ≤35% had significantly older patients with more comorbidities and higher mortality (3.0% annually vs 0.0%). Despite these differences, device-related complications, conversion efficacy, and incidence of inappropriate shock therapies were not significantly different between PP subgroups., Conclusion: The S-ICD performs well in protecting patients with either PP or SP implant indications from sudden cardiac death. Within PP patients, device performance was independent of EF., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and the rate of ischemic stroke attributed to non-valvular AF is estimated at 5% per year. Several multi-center studies established left atrial appendage closure as a safe and effective alternative to oral anticoagulation, but there is a need for additional real world data., Methods: The purpose of this observational, prospective, single-arm, multicenter clinical study is to compile real-world clinical outcome data for WATCHMAN™ LAA (left atrial appendage) Closure Technology. One thousand subjects at up to 70 institutions in Europe, the Middle East, and Russia will be enrolled. Patients will be followed for 2 years after WATCHMAN implantation, according to standard medical practice. Primary endpoints include procedural and long-term data including stroke/embolism, bleeding, and death. This article presents the background of the LAAC device and describes the design of the study., Results: Results for peri-procedural analyses are expected toward the end of 2015; long-term follow-up data are expected in the latter half of 2017., Conclusion: The EWOLUTION study will formally expand knowledge of LAA closure into a broader real world setting. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Aims: Left atrial appendage closure is a non-pharmacological alternative for stroke prevention in high-risk patients with non-valvular atrial fibrillation. The objective of the multicentre EWOLUTION registry was to obtain clinical data on procedural success and complications, and long-term patient outcomes, including bleeding and incidence of stroke/transient ischaemic attack (TIA). Here, we report on the peri-procedural outcomes of up to 30 days., Methods and Results: Baseline/implant data are available for 1021 subjects. Subjects in the study were at high risk of stroke (average CHADS2 score: 2.8 ± 1.3, CHA2DS2-VASc: 4.5 ± 1.6) and moderate-to-high risk of bleeding (average HAS-BLED score: 2.3 ± 1.2). Almost half of the subjects (45.4%) had a history of TIA, ischaemic stroke, or haemorrhagic stroke; 62% of patients were deemed unsuitable for novel oral anticoagulant by their physician. The device was successfully deployed in 98.5% of patients with no flow or minimal residual flow achieved in 99.3% of implanted patients. Twenty-eight subjects experienced 31 serious adverse events (SAEs) within 1 day of the procedure. The overall 30-day mortality rate was 0.7%. The most common SAE occurring within 30 days of the procedure was major bleeding requiring transfusion. Incidence of SAEs within 30 days was significantly lower for subjects deemed to be ineligible for oral anticoagulation therapy (OAT) compared with those eligible for OAT (6.5 vs. 10.2%, P = 0.042)., Conclusion: Left atrial appendage closure with the WATCHMAN device has a high success rate in complete LAAC with low peri-procedural risk, even in a population with a higher risk of stroke and bleeding, and multiple co-morbidities. Improvement in implantation techniques has led to a reduction of peri-procedural complications previously limiting the net clinical benefit of the procedure., (© The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Single-shot ablation techniques may facilitate safe and simple pulmonary vein isolation to treat paroxysmal atrial fibrillation. Multielectrode pulmonary vein isolation versus single tip wide area catheter ablation-paroxysmal atrial fibrillation is the first multinational, multicenter, prospective, noninferiority randomized clinical trial comparing multielectrode-phased radiofrequency ablation (MEA) to standard focal irrigated radiofrequency ablation (STA) using 3-dimensional navigation., Methods and Results: Patients with paroxysmal atrial fibrillation were randomized to MEA (61 patients) or STA (59 patients). Preprocedure transesophageal echocardiogram and computed tomography/magnetic resonance imaging (also 6-month postprocedure) were performed. Mean age was 57 years, 25% female sex, BMI was 28, CHA2DS2-VASc score was 0 to 1 in 82%, 8% had previous right atrial ablation, whereas all had at least 1 antiarrhythmic drug failure. The MEA group had significantly shorter mean procedure time (96±36 versus 166±46 minutes, P<0.001) and fluoroscopy time (23±9 versus 27±9 minutes, P=0.023). The total radiofrequency energy duration was 22±8 minutes for MEA versus 36±13 minutes for STA (P<0.001) with confirmed pulmonary vein isolation in all patients. Hospital admission was 1 day in both groups, without major adverse events either during the procedure or during 30-day follow-up. Two patients in the STA group had 1 PV with asymptomatic narrowing >50%. Freedom of atrial fibrillation for MEA and STA was 86.4% and 89.7% at 6 months, dropping to 76.3% and 81.0% at 12 months., Conclusions: In this multicenter, randomized clinical trial, MEA and STA had similar rates of single-procedure acute pulmonary vein isolation without serious adverse events in the first 30 days. MEA had slightly lower long-term arrhythmia freedom, but showed marked and significantly shorter procedure, fluoroscopy, and radiofrequency energy times., Clinical Trial Registration: URL: www.clinicaltrials.gov; Unique identifier: NCT01696136., (© 2016 American Heart Association, Inc.)

Background: Familial idiopathic ventricular fibrillation (IVF) is a severe disease entity and is notoriously difficult to manage because there are no clinical risk indicators for premature cardiac arrest. Previously, we identified a link between familial IVF and a risk haplotype on chromosome 7q36 (involving the arrhythmia gene DPP6)., Objective: The purpose of this study was to expand our knowledge of familial IVF and to discuss its (extended) clinical characteristics., Methods: We studied 601 family members and probands: 286 DPP6 risk-haplotype positive (haplotype-positive) and 315 DPP6 risk-haplotype negative (haplotype-negative) individuals. Clinical parameters, a combination of all-cause mortality and (aborted) cardiac arrest and differences between haplotype-positives and haplotype-negatives, were evaluated., Results: There were no differences in electrocardiographic indices between haplotype-positives and haplotype-negatives, or between haplotype-positives with or without events. Cardiac magnetic resonance documented slightly larger ventricular volumes in haplotype-positives compared to controls (P <.05), but these were not clinically useful. Mortality and/or cardiac arrest occurred in 85 haplotype-positives (30%) and 18 haplotype-negatives (6%). Twenty-four haplotype-positives (8% male) were resuscitated from ventricular fibrillation (VF). Documented VF was always elicited by monomorphic short-coupled extrasystoles from the right ventricular apex/lower free wall. Median survival in risk-haplotype haplotype-positives was 70 vs. 93 years for haplotype-negatives (P < .01), with a worse phenotype in males (median survival 63 vs. 83 years in females, P < .01). Implantable cardioverter-defibrillators were implanted in 99 patients (76 [77%] for primary prevention). Two arrhythmic events occurred in the primary prevention group during follow-up (5 ± 3 years)., Conclusion: Despite our extensive analysis, the complexity in identifying asymptomatic IVF family members at risk for future arrhythmias based on clinical parameters is once more demonstrated., (Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The recent advent of subcutaneous implantable cardioverter defibrillators (S-ICDs) has provided investigators with a safe and effective new therapy in patients at risk of sudden cardiac death. At present, no data are available with regard to the longevity of these new devices. This study evaluated the longevity of the S-ICD system., Methods and Results: All patients enrolled in the European Regulatory Trial were included in the analysis. During follow-up, time and causes of device replacement or explantation were assessed and categorized. Device longevity was estimated using Kaplan-Meier analysis. Fifty-five patients were followed for a median of 5.8 years. During follow-up, 26 (47%) patients underwent device replacement and 5 (9%) underwent device explantation. Median time to replacement was 5.0 years (Q1-Q3, 4.4-5.6 years). Replacement was caused by battery depletion in 25 patients (92%), of which 5 within 1.5 years because of premature battery depletion, and by infection in 1 patient (2%). Replacement for a transvenous ICD system was required in 4 patients (7%) because of ineffective defibrillation in 1 (0.003 per patient-year), need for resynchronization therapy in 2 (0.01 per patient-year), and for antibradycardia pacing in 1 (0.003 per patient-year). At 5 years follow-up, 71% of devices were still in service., Conclusions: This study provides the first estimate of S-ICD system longevity since its introduction in clinical practice. Median longevity of the first generation S-ICD system was 5.0 years. The majority of devices were replaced because of battery depletion., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01117792., (© 2015 American Heart Association, Inc.)

Aims: Permanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker., Methods and Results: Patients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines. Prespecified objectives were >85% freedom from unanticipated serious adverse device events (safety) and <2 V 3-month mean pacing capture threshold at 0.24 ms pulse width (efficacy). Patients were implanted (n = 140) from 23 centres in 11 countries (61% male, age 77.0 ± 10.2 years) for atrioventricular block (66%) or sinus node dysfunction (29%) indications. During mean follow-up of 1.9 ± 1.8 months, the safety endpoint was met with no unanticipated serious adverse device events. Thirty adverse events related to the system or procedure occurred, mostly due to transient dysrhythmias or femoral access complications. One pericardial effusion without tamponade occurred after 18 device deployments. In 60 patients followed to 3 months, mean pacing threshold was 0.51 ± 0.22 V, and no threshold was ≥2 V, meeting the efficacy endpoint (P < 0.001). Average R-wave was 16.1 ± 5.2 mV and impedance was 650.7 ± 130 ohms., Conclusion: Early assessment shows the transcatheter pacemaker can safely and effectively be applied. Long-term safety and benefit of the pacemaker will further be evaluated in the trial., Clinical Trial Registration: ClinicalTrials.gov ID NCT02004873., (© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The entirely subcutaneous implantable cardioverter-defibrillator (S-ICD) eliminates the need for transvenous leads, and therefore has the potential to improve lead-longevity and reduce lead-related complications. The S-ICD has a morphology-based sensing algorithm of which inappropriate shocks have been reported., Methods: We analyzed the incidence, predictors and management of inappropriate shocks in the EFFORTLESS S-ICD Registry, which collects S-ICD implantation information and follow-up data from clinical centers in Europe and New Zealand., Results: During a follow-up of 21 ± 13 months, 48 out of 581 S-ICD patients (71% male, age 49 ± 18 years) experienced 101 inappropriate shocks (8.3%). The most common cause was cardiac signal oversensing (73%), such as T-wave oversensing. Eighteen shocks (18%) were due to supraventricular tachycardias (SVT), of which 15 occurred in the shock-only zone. Cox-proportional hazard modeling using time-dependent covariates demonstrated that patients with a history of atrial fibrillation (HR 2.4) and patients with hypertrophic cardiomyopathy (HR 4.6) had an increased risk for inappropriate shocks, while programming the primary vector for sensing (from xyphoid to V6) reduced the risk. Reprogramming or optimization of SVT treatment after the first clinical event of inappropriate shock was successful in preventing further inappropriate shocks for cardiac oversensing and SVT events., Conclusions: Inappropriate shocks, mainly due to cardiac oversensing, occurred in 8.3% of the S-ICD patients. Patients with hypertrophic cardiomyopathy or a history of atrial fibrillation were at increased risk, warranting specific attention for sensing and programming in this population., (Copyright © 2015. Published by Elsevier Ireland Ltd.)

Many patients with hereditary hemorrhagic telangiectasia (HHT) are unable to sustain oral anticoagulation (OAC) because of severe epistaxis, gastrointestinal (GI) bleeding and the risk of life-threatening bleeding from cerebral arteriovenous malformations (CAVMs) or pulmonary arteriovenous malformations (PAVMs). In patients with atrial fibrillation (AF), most thromboembolic complications arise from the left atrial appendage (LAA) and percutaneous transcatheter LAA closure proved to be non-inferior to OAC at mid-term follow-up. We report our experience with LAA closure in HHT with a follow-up of 12 months. Percutaneous LAA closure was performed in five patients with both HHT and high thromboembolic risk AF (CHA2DS2-VASc score ≥2) without peri-procedural complications. At 3 months no thromboembolic event occurred. After 12 months one patient had a transient ischemic attack while another patient had recurrence of stroke, this latter patient had a significant stenosis of the carotid artery and an incomplete closure of the LAA without any signs of thrombus on echocardiogram. Both patients had a non-treatable pulmonary right-to-left shunt (RLS). Percutaneous closure of the LAA may provide an alternative strategy to long-term OAC therapy in HHT patients with AF induced high stroke risk and intolerance for OAC.

Objective: The purpose of the present study was to determine the incidence of ventricular arrhythmias before and after alcohol septal ablation (ASA)., Background: In patients with hypertrophic obstructive cardiomyopathy (HOCM), gradient reduction by ASA is an alternative for surgical myectomy. However, concerns exist about whether the induction of a myocardial scar during ASA may create substrate for ventricular arrhythmias., Methods: The study group consisted of 44 patients in whom ASA was performed for symptomatic, drug-refractory hypertrophic cardiomyopathy. Continuous rhythm monitoring was obtained by implantable loop recorder (n=30) or pacemaker (n=14). Occurrence of ventricular and supraventricular arrhythmias before and after ASA was noted, retrospectively., Results: The ASA procedure was considered successful (resting gradient <30 mm Hg, and provoked gradient <50 mm Hg at 4 months in combination with NYHA Class functional status ≤2) in 30 (68%) patients. Rhythm monitoring before ASA was available in 28 patients. The median duration of rhythm monitoring after ASA was 3.0 years (IQR 1.3-4.3). Sustained VT/VF within 30 days after ASA occurred in three patients (7%), including 2 cases of procedural VF, while no VT/VF was observed before ASA (p=0.10). No sustained VT/VF was observed >30 days after ASA. No cardiac deaths occurred during follow-up., Conclusions: In a low-risk cohort of patients who underwent ASA, in which continuous rhythm monitoring was performed, sustained VT or VF within 30 days occurred in 3 patients (7%) while no VT/VF was observed before ASA. During long-term follow-up, no sustained VT or VF was observed >30 days after ASA., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Introduction: The pulmonary vein ablation catheter (PVAC) is designed for pulmonary vein isolation (PVI). Electrical reconnection of pulmonary veins is believed to result in AF recurrence. The purpose of this study was to establish the location and extent of PV reconnection after PVI with the PVAC catheter., Methods and Results: Eighty-two patients (79 % male, age 60 ± 9 years) that underwent a redo procedure for recurrent AF after PVAC ablation were assessed for prevalence and location of reconnection. The number of reconnected PV's was 0, 1, 2, 3, or 4 in 2 (2.4 %), 14 (17 %), 23 (28 %), 28 (34 %), and 15 (18 %) patients, respectively. Reconnection of left superior, left inferior, left common, right superior, and right inferior PV's was found in 66, 63, 83, 57, and 67 %, respectively (p = 0.48). In the left PV's, reconnection was located significantly more anterior than posterior; LSPV anterior 32/70 vs posterior 13/70 (p < 0.01), LIPV anterior 26/70 vs posterior 9/70 (p < 0.01). In the right PV's reconnection was distributed equally in all quadrants. Different modes of RF delivery during PVAC ablation (bipolar/unipolar 2:1 [n = 35] vs. 4:1 [n = 47]) yielded comparable rates of PV reconnection. During follow-up (median 296 days) no AF/AT was documented in 57 patients (70 %)., Conclusion: Almost all patients (98 %) with AF after PVAC ablation show reconnection of at least one PV. All PV's are equally likely to show reconnection. In the left PV's, reconnection was found more often anteriorly than posteriorly. During pulmonary vein isolation with the PVAC catheter, prevalent sites of reconnection deserve close attention to increase success.

Background: Early arrhythmia recurrences after pulmonary vein isolation (PVI) for atrial fibrillation (AF) are accepted as part of the blanking period. Their relevance for long-term efficacy is not well-known. We evaluated patients, who came to hospital with a documented recurrence of AF, or had a registered episode of AF on the 24-hour Holter 6 weeks after PVI and compared it with long-term outcome., Methods: One hundred consecutive patients with paroxysmal AF were treated with the PVAC. In the 3-month blanking period patients who came to hospital with a documented recurrence of AF on ECG were recorded. 6 weeks after procedure a 24-hour Holter was performed. After 3 months patients were asked if they felt a relapse. Follow-up was performed at 3, 6, and 12 months with ECG, 7-day Holter at 6 and/or 12 months, and event recording if needed., Results: Within the blanking period, 25/100 (25%) patients had a documented recurrence of AF while 46/100 (46%) patients felt a relapse. After the blanking period up to 12 months, 53/100 (53%) patients were free of AF without anti-arrhythmic drugs. Multivariate regression analyses revealed that absence of AF in the blanking period (OR 0.22 95%CI [0.05-0.98]) and absence of a relapse of symptoms suspect for AF during the blanking period (OR 0.21 95%CI [0.06-0.52]) were independent predictors of successful long-term outcome., Conclusions: Poor long-term outcome is strongly related to patients who experienced palpitations with ECG documented AF, AF on the 24-hour Holter at 6 weeks after PVI and a relapse in the blanking period., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting millions of individuals worldwide. The rapid, irregular, and disordered electrical activity in the atria gives rise to palpitations, fatigue, dyspnea, chest pain and dizziness with or without syncope. Patients with AF have a five-fold higher risk of stroke. Oral anticoagulation (OAC) with warfarin is commonly used for stroke prevention in patients with AF and has been shown to reduce the risk of stroke by 64%. Warfarin therapy has several major disadvantages, however, including bleeding, non-tolerance, interactions with other medications and foods, non-compliance and a narrow therapeutic range. These issues, together with poor appreciation of the risk-benefit ratio, unawareness of guidelines, or absence of an OAC monitoring outpatient clinic may explain why only 30-60% of patients with AF are prescribed this drug. The problems associated with warfarin, combined with the limited efficacy and/or serious side effects associated with other medications used for AF, highlight the need for effective non-pharmacological approaches to treatment. One such approach is catheter ablation (CA), a procedure in which a radiofrequency electrical current is applied to regions of the heart to create small ablation lesions that electrically isolate potential AF triggers. CA is a well-established treatment for AF symptoms, that may also decrease the risk of stroke. Recent data showed a significant decrease in the relative risk of stroke and transient ischemic attack events among patients who underwent ablation compared with those undergoing antiarrhythmic drug therapy. Since the left atrial appendage (LAA) is the source of thrombi in more than 90% of patients with non-valvular atrial fibrillation, another approach to stroke prevention is to physically block clots from exiting the LAA. One method for occluding the LAA is via percutaneous placement of the WATCHMAN LAA closure device. The WATCHMAN device resembles a small parachute. It consists of a nitinol frame covered by fabric polyethyl terephthalate that prevents emboli, but not blood, from exiting during the healing process. Fixation anchors around the perimeter secure the device in the LAA (Figure 1). To date, the WATCHMAN is the only implanted percutaneous device for which a randomized clinical trial has been reported. In this study, implantation of the WATCHMAN was found to be at least as effective as warfarin in preventing stroke (all-causes) and death (all-causes). This device received the Conformité Européenne (CE) mark for use in the European Union for warfarin eligible patients and in those who have a contraindication to anticoagulation therapy. Given the proven effectiveness of CA to alleviate AF symptoms and the promising data with regard to reduction of thromboembolic events with both CA and WATCHMAN implantation, combining the two procedures is hoped to further reduce the incidence of stroke in high-risk patients while simultaneously relieving symptoms. The combined procedure may eventually enable patients to undergo implantation of the WATCHMAN device without subsequent warfarin treatment, since the CA procedure itself reduces thromboembolic events. This would present an avenue of treatment previously unavailable to patients ineligible for warfarin treatment because of recurrent bleeding or other warfarin-associated problems. The combined procedure is performed under general anesthesia with biplane fluoroscopy and TEE guidance. Catheter ablation is followed by implantation of the WATCHMAN LAA closure device. Data from a non-randomized trial with 10 patients demonstrates that this procedure can be safely performed in patients with a CHADS2 score of greater than 1. Further studies to examine the effectiveness of the combined procedure in reducing symptoms from AF and associated stroke are therefore warranted.

Aims: Duty-cycled radiofrequency ablation (RFA) has been used for atrial fibrillation (AF) for around 5 years, but large-scale data are scarce. The purpose of this survey was to report the outcome of the technique., Methods and Results: A survey was conducted among 20 centres from seven European countries including 2748 patients (2128 with paroxysmal and 620 with persistent AF). In paroxysmal AF an overall success rate of 82% [median 80%, interquartile range (IQR) 74-90%], a first procedure success rate of 72% [median 74% (IQR 59-83%)], and a success of antiarrhythmic medication of 59% [median 60% (IQR 39-72%)] was reported. In persistent AF, success rates were significantly lower with 70% [median 74% (IQR 60-92%)]; P = 0.05) as well as the first procedure success rate of 58% [median 55% (IQR 47-81%)]; P = 0.001). The overall success rate was similar among higher and lower volume centres and were not dependent on the duration of experience with duty-cycled RFA (r = -0.08, P = 0.72). Complications were observed in 108 (3.9%) patients, including 31 (1.1%) with symptomatic transient ischaemic attack or stroke, which had the same incidence in paroxysmal and persistent AF (1.1 vs. 1.1%) and was unrelated to the case load (r = 0.24, P = 0.15), bridging anticoagulation to low molecular heparin, routine administration of heparin over the long sheath, whether a transoesophageal echocardiogram was performed in every patient or not and average procedure times., Conclusion: Duty-cycled RFA has a self-reported success and complication rate similar to conventional RFA. After technical modifications a prospective registry with controlled data monitoring should be conducted to assess outcome.

Objectives: The purpose of the study was to evaluate the efficacy and safety of the entirely subcutaneous implantable cardioverter-defibrillator (S-ICD)., Background: A new entirely S-ICD has been introduced, that does not require lead placement in or on the heart. The authors report the largest multicenter experience to date with the S-ICD with a minimum of 1-year follow-up in the first 118 Dutch patients who were implanted with this device., Methods: Patients were selected if they had a class I or IIa indication for primary or secondary prevention of sudden cardiac death. All consecutive patients from 4 high-volume centers in the Netherlands with an S-ICD implanted between December 2008 and April 2011 were included., Results: A total of 118 patients (75% males, mean age 50 years) received the S-ICD. After 18 months of follow-up, 8 patients experienced 45 successful appropriate shocks (98% first shock conversion efficacy). No sudden deaths occurred. Fifteen patients (13%) received inappropriate shocks, mainly due to T-wave oversensing, which was mostly solved by a software upgrade and changing the sensing vector of the S-ICD. Sixteen patients (14%) experienced complications. Adverse events were more frequent in the first 15 implantations per center compared with subsequent implantations (inappropriate shocks 19% vs. 6.7%, p = 0.03; complications 17% vs. 10%, p = 0.10)., Conclusions: This study demonstrates that the S-ICD is effective in terminating ventricular arrhythmias. There is, however, a considerable percentage of ICD related adverse events, which decreases as the therapy evolves and experience increases., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Drug-refractory atrial fibrillation (AF) increasingly is being treated with catheter ablation. However, the long-term success rate, expressed as freedom from AF, is <50%. Therefore, vitamin K antagonists, with all their complications, remain necessary. Recently, left atrial appendage (LAA) occlusion devices were introduced as an alternative to vitamin K antagonists. Here, we investigated whether AF ablation and LAA occlusion could be a feasible and safe combination in patients with symptomatic drug-refractory AF and a CHADS(2) score ≥1 or a contraindication for vitamin K antagonists., Methods and Results: Ablation was performed by using multielectrode catheters with phased radiofrequency energy. LAA was occluded with the Watchman device (Atritech, Inc, Plymouth, MN). Between February 2010 and February 2011, 30 patients were treated (21 male; age, 62.8±8.5 years). Median CHADS(2) score was 2.5 (25th to 75th percentiles: 2 to 3), median CHADS-VASc score was 3 (25th to 75th percentiles: 3 to 5), 77% had prior stroke, and 27% had a contraindication for vitamin K antagonists. Median HAS-BLED score was 2 (range, 1 to 5). Successful device implantation was achieved with a median number of 1.5 devices (median diameter 24 mm [25th to 75th percentiles: 24 to 24 mm]). Total procedure time was 97 minutes (25th to 75th percentiles: 75 to 115 minutes). At 60 days, all patients met the criteria for successful sealing. Follow-up visit at 12 months showed a 30% rate of documented recurrence of AF. A repeated pulmonary vein isolation was performed successfully in 4 patients, without interference of the LAA closure device. No thromboembolic events occurred during 1-year follow-up., Conclusion: LAA occlusion with the Watchman device and AF ablation can be combined successfully and safely in a single procedure. The Watchman does not interfere with a repeated ablation.

Background: Implantable cardioverter-defibrillators (ICDs) are widely used to prevent fatal outcomes associated with life-threatening arrhythmic episodes in a variety of cardiac diseases. These ICDs rely on transvenous leads for cardiac sensing and defibrillation. A new entirely subcutaneous ICD overcomes problems associated with transvenous leads. However, the role of the subcutaneous ICD as an adjunctive or primary therapy in patients at risk for sudden cardiac death is unclear., Study Design: The PRAETORIAN trial is an investigator-initiated, randomized, controlled, multicenter, prospective 2-arm trial that outlines the advantages and disadvantages of the subcutaneous ICD. Patients with a class I or IIa indication for ICD therapy without an indication for bradypacing or tachypacing are included. A total of 700 patients are randomized to either the subcutaneous or transvenous ICD (1:1). The study is powered to claim noninferiority of the subcutaneous ICD with respect to the composite primary endpoint of inappropriate shocks and ICD-related complications. After noninferiority is established, statistical analysis is done for potential superiority. Secondary endpoint comparisons of shock efficacy and patient mortality are also made., Conclusion: The PRAETORIAN trial is a randomized trial that aims to gain scientific evidence for the use of the subcutaneous ICD compared with the transvenous ICD in a population of patients with conventional ICD with respect to major ICD-related adverse events. This trial is registered at ClinicalTrials.gov with trial ID NCT01296022., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Background: Leads in and on the heart of the transvenous implantable cardioverter defibrillator (ICD) form the Achilles' heel of this system due to potential for peri- and postimplant complications. The S-ICD is a newer generation of the ICD that does not require leads on the heart or in the vasculature. We present the rationale and study design of the Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (EFFORTLESS S-ICD) Registry which was designed to evaluate the long-term performance of the S-ICD including patient quality of life and long-term resource utilization., Methods: The Registry is an observational, nonrandomized, standard of care evaluation to be conducted at approximately 50 investigational centers in Europe and New Zealand where the S-ICD is approved for use and distribution. Clinical Registry endpoints include perioperative (30 days postimplant) complication-free rate, 360-day complication-free rate, and percentage of inappropriate shocks for atrial fibrillation and supraventricular ventricular tachyarrhythmia. Other endpoints include patient-reported outcomes (e.g., quality of life) and hospital personnel implant and follow-up experience with the S-ICD system., Conclusions: Results from EFFORTLESS will build on and expand the initial published experience with the S-ICD, which demonstrated that the device successfully and consistently detects and treats episodes of sustained ventricular tachyarrhythmias. The Registry will also evaluate the patients' perspective of how it is to live with an S-ICD as compared to a contemporary transvenous system and track the experience of implanting physicians and personnel performing patient follow-up with a completely subcutaneous system., (©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.)

Background: Percutaneous left atrial appendage (LAA) closure can be an alternative to coumadin treatment in patients with atrial fibrillation (AF) at high risk for thromboembolic events and/or bleeding complications. We report the initial experience with this new technique., Methods: Patients were eligible if they had AF with a high stroke risk (CHADS(2) score >1), and/or contraindication for coumadin therapy. The procedure was performed under general anaesthesia, using biplane fluoroscopy and (3D) transoesophageal echocardiography (TEE) guidance. Patients were discharged on coumadin until a TEE was repeated at 45 days after closure to evaluate LAA occlusion. If LAA occlusion was achieved, oral anticoagulation was discontinued and aspirin started., Results: Percutaneous LAA closure was performed in 10 patients (50% male, age 61.6 ± 9.6 years). The median CHADS(2) score was 3 (range 2-4), median CHA(2)DS(2)-VASc score 3.5 (range 2-6) and HAS-BLED score 1.5 (range 1-4). Nine patients had a history of stroke and 2 patients had a history of major bleeding while on coumadin. Concomitant pulmonary vein isolation was performed in 9 patients. The device was successfully placed in all patients within a median of 56 min (38-137 min). Asymptomatic catheter thrombus occurred in one patient. At 45-day follow-up, no thromboembolic events occurred, TEE showed minimal residual flow in the LAA in three patients. In one patient the LAA device was dislocated, requiring successful percutaneous retrieval., Conclusion: Device closure of the LAA may provide an alternative strategy to chronic coumadin therapy in patients with AF and high risk of stroke and/or bleeding complications using coumadin.