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Background: Chronic total coronary occlusions (CTO) substantially increase the risk for sudden cardiac death. Among patients with chronic ischemic heart disease at risk for sudden cardiac death, an implantable cardioverter defibrillator (ICD) is the favored therapy for primary prevention of sudden cardiac death. This study sought to investigate the impact of CTOs on the risk for appropriate ICD shocks and mortality within a nationwide prospective cohort., Methods and Results: This is a subanalysis of the nationwide Dutch-Outcome in ICD Therapy (DO-IT) registry of primary prevention ICD recipients in The Netherlands between September 2014 and June 2016 (n=1442). We identified patients with chronic ischemic heart disease (n=663) and assessed available coronary angiograms for CTO presence (n=415). Patients with revascularized CTOs were excluded (n=79). The primary end point was the composite of all-cause mortality and appropriate ICD shocks. Clinical follow-up was conducted for at least 2 years. A total of 336 patients were included, with an average age of 67±9 years, and 20.5% was female (n=69). An unrevascularized CTO was identified in 110 patients (32.7%). During a median follow-up period of 27 months (interquartile range, 24-32), the primary end point occurred in 21.1% of patients with CTO (n=23) compared with 11.9% in patients without CTO (n=27; P =0.034). Corrected for baseline characteristics including left ventricular ejection fraction, and the presence of a CTO was an independent predictor for the primary end point (hazard ratio, 1.82 [95% CI, 1.03-3.22]; P =0.038)., Conclusions: Within this nationwide prospective registry of primary prevention ICD recipients, the presence of an unrevascularized CTO was an independent predictor for the composite outcome of all-cause mortality and appropriate ICD shocks.

Background: Untreated atrial fibrillation (AF) often results in increased morbidity and mortality. Opportunistic AF screening in persons aged ≥ 65 years is recommended to identify patients with AF in order to prevent AF-related complications., Objective: The aim of this study was to assess the feasibility of screening persons for AF with the Kardia mobile electrocardiogram device (MED) and to determine the percentage of newly detected AF cases by selective population screening in the Netherlands., Methods: Persons aged ≥ 65 years, without a medical history of AF, in nursing homes, at public events or visiting the general practitioner (GP) were approached to participate. A Kardia MED smartphone ECG (sECG) was recorded and the CHA 2 DS 2 -VASc score was calculated. An automated AF algorithm classified the sECGs as 'sinus rhythm', 'AF' or 'unclassified'. In the case of AF, participants were referred to their GP. All sECGs were assessed by blinded experts., Results: A total of 2168 participants were screened for AF. According to the expert's interpretation, 2.5% had newly detected AF, of whom 76.4% never experienced palpitations and 89.1% had a CHA 2 DS 2 -VASc score ≥ 2. The algorithm result was unclassified in 12.2% of cases, of which 95.5% were interpretable by experts. With expert opinion as the gold standard and excluding unclassified sECGs, the Kardia MED's negative and positive predictive value for detecting AF was 99.8% and 60.0%, respectively., Conclusion: Screening for AF using the Kardia MED is feasible and results in 2.5% newly detected AF cases. Expert interpretation of algorithm outcomes AF and unclassified is recommended., (© 2023. The Author(s).)

Aims: Left bundle branch area pacing (LBBAP) is a novel physiological pacing modality and is regarded as a viable alternative to His bundle pacing. LBBAP has mostly been performed with the lumen-less permanent pacing lead (SelectSecure™ Model 3830, Medtronic, Inc.) with a fixed helix. The aim of this study was to compare the non-stylet driven lumen-less lead (LLL) (Medtronic 3830) with a standard stylet-driven active fixation lead (SDL) (Tendril™ STS Model 2088TC-38, Abbott Laboratories) in terms of lead parameters, procedural success and complication rates., Methods: Patients receiving a LBBA pacemaker in the Isala Hospital, The Netherlands, were prospectively enrolled. The majority received a standard right ventricular (RV) lead as backup, the implanter chose between LLL and SDL for the LBBAP lead., Results: The study included 94 patients with a mean follow-up of 30 weeks. 30/31 LLL procedures were successful, compared with 62/63 in the SDL group. Including the participants that lost LBBAP during follow-up resulted in success rates of 90.3% for LLL versus 96.8% for SDL, P = 0.199. Mean number of deployments was significantly lower in the SDL group compared with the LLL group (2 ± 2.3 versus 4 ± 3.4, P = 0.005), implantation and procedural times were comparable. Pacing thresholds were low and remained low in both groups (at last follow-up 0.8 ± 0.30 V for LLL versus 0.6 ± 0.20 V for SDL). Complication rates did not differ significantly between both groups, P = 0.805., Conclusion: LBBAP using SDL is feasible and has comparable success rates with lower number of deployments of the active fixation screw., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Introduction: Implantation of an implantable cardioverter defibrillator (ICD) is standard care for primary prevention of sudden cardiac death. However, ICD-related complications are increasing as the population of ICD recipients grows., Methods: ICD-related complications in a national DO-IT Registry cohort of 1442 primary prevention ICD patients were assessed in terms of additional use of hospital care resources and costs., Results: During a median follow-up of 28.7 months (IQR 25.2-33.7) one or more complications occurred in 13.5% of patients. A complication resulted in a surgical intervention in 53% of cases and required on average 3.65 additional hospital days. The additional hospital costs were €6,876 per complication or €8,110 per patient, to which clinical re-interventions and additional hospital days contributed most. Per category of complications, infections required most hospital utilisation and were most expensive at an average of €22,892. The mean costs were €5,800 for lead-related complications, €2,291 for pocket-related complications and €5,619 for complications due to other causes. We estimate that the total yearly incidence-based costs in the Netherlands for hospital management of ICD-related complications following ICD implantation for primary prevention are €2.7 million., Conclusion: Complications following ICD implantation are related to a substantial additional need for hospital resources. When performing cost-effectiveness analyses of ICD implantation, including the costs associated with complications, one should be aware that real-world complication rates may deviate from trial data. Considering the economic implications, strategies to reduce the incidence of complications are encouraged., (© 2022. The Author(s).)

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial., Methods and Results: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047)., Conclusion: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice., Competing Interests: Conflict of interest: R.E.K reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cairdac and has stock options from AtaCor Medical Inc. S.M. reports consultancy fees from Boston Scientific. K.V. reports consultancy fees from Medtronic and Abbott. M.C.B. is a consultant and receives honoraria, as well as research grants from Boston Scientific and has equity in and is chief medical officer for AtaCor Medical, Inc. D.J.W. has consultancy arrangements with Boston Scientific and Medtronic and a research grant from Boston Scientific. P.N. reports modest speaker honoraria from Biotronik, Boston Scientific, and Medtronic. M.A.M. reports consultancy fees from Boston Scientific. Z.I.W. is an advisor for Boston Scientific and on the advisory board for Medtronic and Abbot and reports speaker fees from Medtronic. The other authors report no conflicts., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.)

Background: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks., Methods: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population., Results: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P =0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P =0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group ( P =0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group ( P =0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group ( P =0.05)., Conclusions: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

Aims: This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation., Methods and Results: We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively. Between 2014 and 2018, we included 1441 consecutive patients in the development and 1450 patients in the validation cohort. During a median follow-up of 2.4 (IQR 2.1-2.8) years, 109 (7.6%) patients received appropriate ICD shock and 193 (13.4%) died in the development cohort. During a median follow-up of 2.7 (IQR 2.0-3.4) years, 105 (7.2%) received appropriate ICD shock and 223 (15.4%) died in the validation cohort. Selected predictors of appropriate ICD shock were gender, NSVT, ACE/ARB use, atrial fibrillation history, Aldosterone-antagonist use, Digoxin use, eGFR, (N)OAC use, and peripheral vascular disease. Selected predictors of all-cause mortality were age, diuretic use, sodium, NT-pro-BNP, and ACE/ARB use. C-statistic was 0.61 and 0.60 at respectively internal and external validation for appropriate ICD shock and 0.74 at both internal and external validation for mortality., Conclusion: Although this cohort study was specifically designed to develop prediction models, risk stratification still remains challenging and no large group with insufficient benefit of ICD implantation was found. However, the prediction models have some clinical utility as we present several scenarios where ICD implantation might be postponed., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.

Background: The randomized DAPA trial (Defibrillator After Primary Angioplasty) aimed to evaluate the survival benefit of prophylactic implantable cardioverter defibrillator (ICD) implantation in early selected high-risk patients after primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction., Methods: A randomized, multicenter, controlled trial compared ICD versus conventional medical therapy in high-risk patients with primary percutaneous coronary intervention, based on one of the following factors: left ventricular ejection fraction <30% within 4 days after ST-segment-elevation myocardial infarction, primary ventricular fibrillation, Killip class ≥2 or TIMI (Thrombolysis in Myocardial Infarction) flow <3 after percutaneous coronary intervention. ICD was implanted 30 to 60 days after MI. Primary end point was all-cause mortality at 3 years follow-up. The trial prematurely ended after inclusion of 266 patients (38% of the calculated sample size). Additional survival assessment was performed in February 2019 for the primary end point., Results: A total of 266 patients, 78.2% males, with a mean age of 60.8±11.3 years, were enrolled. One hundred thirty-one patients were randomized to the ICD arm and 135 patients to the control arm. All-cause mortality was significant lower in the ICD group (5% versus 13%, hazard ratio, 0.37 [95% CI, 0.15-0.95]) after 3 years follow-up. Appropriate ICD therapy occurred in 9 patients at 3 years follow-up (5 within the first 8 months after implantation). After a median long-term follow-up of 9 years (interquartile range, 3-11), total mortality (18% versus 38%; hazard ratio, 0.58 [95% CI, 0.37-0.91]), and cardiac mortality (hazard ratio, 0.52 [95% CI, 0.28-0.99]) was significant lower in the ICD group. Noncardiac death was not significantly different between groups. Left ventricular ejection fraction increased ≥10% in 46.5% of the patients during follow-up, and the extent of improvement was similar in both study groups., Conclusions: In this prematurely terminated and thus underpowered randomized trial, early prophylactic ICD implantation demonstrated lower total and cardiac mortality in patients with high-risk ST-segment-elevation myocardial infarction treated with primary percutaneous coronary intervention. Registration: URL: https://www.trialregister.nl; Unique identifier: Trial NL74 (NTR105).

Background: Endocardial pacing may be beneficial in patients who fail to improve following conventional epicardial cardiac resynchronization therapy (CRT). The potential to pace anywhere inside the left ventricle thus avoiding myocardial scar and targeting the latest activating segments may be particularly important. The WiSE-CRT system (EBR systems, Sunnyvale, CA) reliably produces wireless, endocardial left ventricular (LV) pacing. The purpose of this analysis was to determine whether this system improved symptoms or led to LV remodeling in patients who were nonresponders to conventional CRT., Method: An international, multicenter registry of patients who were nonresponders to conventional CRT and underwent implantation with the WiSE-CRT system was collected., Results: Twenty-two patients were included; 20 patients underwent successful implantation with confirmation of endocardial biventricular pacing and in 2 patients, there was a failure of electrode capture. Eighteen patients proceeded to 6-month follow-up; endocardial pacing resulted in a significant reduction in QRS duration compared with intrinsic QRS duration (26.6 ± 24.4 ms; P = .002) and improvement in left ventricular ejection fraction (LVEF) (4.7 ± 7.9%; P = .021). The mean reduction in left ventricular end-diastolic volume was 8.3 ± 42.3 cm 3 (P = .458) and left ventricular end-systolic volume (LVESV) was 13.1 ± 44.3 cm 3 (P = .271), which were statistically nonsignificant. Overall, 55.6% of patients had improvement in their clinical composite score and 66.7% had a reduction in LVESV ≥15% and/or absolute improvement in LVEF ≥5%., Conclusion: Nonresponders to conventional CRT have few remaining treatment options. We have shown in this high-risk patient group that the WiSE-CRT system results in improvement in their clinical composite scores and leads to LV remodeling., (© 2020 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Aims: In the past few years, promising results were described in targeting the arrhythmogenic substrate of the epicardial right ventricular outflow tract (RVOT) region in patients with Brugada syndrome (BrS). In this report, we describe our experience with endo- and epicardial substrate mapping and ablation in a series of highly symptomatic BrS patients., Methods: This case series consists of seven patients with clinical BrS diagnosis who underwent catheter ablation in two Dutch hospitals (Isala hospital Zwolle; and Amsterdam University Medical Centre, location AMC, Amsterdam) and Hamad Heart Hospital in Qatar between 2013 and 2017. All patients had an ICD and recurrent ventricular arrhythmia (VA) episodes. All patients underwent endo-and epicardial mapping of the RVOT region. Elimination of all abnormal potentials and disappearance of BrS ECG pattern during the ablation procedure was the aimed endpoint., Results: The study group consisted of seven patients with mean age 45.6 ± 16.9 years. Five patients had SCN5A mutations. One patient was excluded from analysis, since ablation could not be performed due to a very large low-voltage area and was later diagnosed with arrhythmogenic right ventricular cardiomyopathy, associated with an SCN5A mutation. One patient underwent both endo- and epicardial ablation to eliminate VA. During a mean follow-up of 3.6 ± 1.5 years, 5/6 patients remained VA free with two patients continuing quinidine., Conclusion: In patients with BrS and drug-refractory VA, ablation of the arrhythmogenic substrate in the RVOT region was associated with excellent long-term VA-free survival. The majority of these highly symptomatic BrS patients had an SCN5A mutation and also low-voltage areas epicardially.

Aims: In the SCALAF trial, catheter-based pulmonary vein isolation (PVI) was as effective in long-term prevention of atrial fibrillation (AF) as minimally invasive thoracoscopic PVI and left atrial appendage ligation (MIPI). Catheter ablation (CA) resulted in significantly less major complications as compare to MIPI. We report quality of life (QOL) outcome in these patients., Methods: In this study, 52 patients with symptomatic paroxysmal or early persistent AF were randomized to either MIPI or CA. QOL was assessed at baseline, 3, 6, and 12 months follow-up using the SF-36 Health Survey Questionnaire. AF-related symptoms were quantified at each follow-up visit using the European Heart Rhythm Association (EHRA) score., Results: Median age was 57 years and 78% was male. Paroxysmal AF was present in 74%. At 3 months follow-up, physical role limitations (88.2 ± 29.5; versus 40.9 ± 44.0; P = 0.001, respectively) and bodily pain scores (95.5 ± 8.7; versus 76.0 ± 27.8; P = 0.021, respectively) were significantly higher after CA compared to MIPI, indicating less limitation in daily activity caused by physical problems and less pain after CA than after MIPI. AF symptoms assessed by the EHRA scores improved significantly at 3, 6, 12, and 24 months compared to baseline in both treatment groups (P < 0.001), with no significant differences between treatment groups., Conclusions: CA and MIPI ablation of AF both resulted in an improvement in several QOL measurements, although CA resulted in significantly less physical problems and bodily pain 3 months after treatment compared to MIPI., Clinical Trial Number: ClinicalTrials.gov identifier: NCT00703157.

Introduction: Recurrent ventricular tachycardia (VT) after percutaneous ablation is associated with a high morbidity and mortality. We assessed the feasibility of open chest extracorporeal circulation (ECC)-supported 3D multielectrode mapping and targeted VT substrate ablation in patients with previously failed percutaneous endocardial and epicardial VT ablations., Methods: In patients with previously failed percutaneous endocardial and epicardial VT ablations and a high risk of hemodynamic collapse during the procedure, open chest ECC-supported mapping and ablation were performed in a hybrid EP lab setting. Electro-anatomic maps (3D) were acquired during sinus rhythm and VT using a multielectrode mapping catheter (HD grid; Abbott or Pentaray, Biosense Webster). Irrigated radiofrequency ablations of all inducible VT were performed with a contact force ablation catheter., Results: Hybrid VT ablation was performed in 5 patients with structural heart disease (i.e., 3 with previous old myocardial infarction and 2 with nonischemic cardiomy-opathy) and recurrent VT. Acute procedural success was achieved in all patients. Four patients were successfully weaned off the ECC. In 1 patient with a severely reduced LVEF (16%), damage to the venous graft occurred after sternotomy and that patient died after 1 month. Four patients (80%) remained VT free after a median follow-up of 6 (IQR 4-10) months., Conclusion: In high-risk patients with previously failed percutaneous endocardial and epicardial VT ablations, open chest ECC-supported multielectrode epicardial mapping revealed a VT substrate in all of the patients, and targeted epicardial ablation abolished VT substrate in these patients., (© 2019 S. Karger AG, Basel.)

Background: Symptomatic idiopathic ventricular arrhythmias (VA), including premature beats (VPB) and nonsustained ventricular tachycardia (VT) are commonly encountered arrhythmias. Although these VA are usually benign, their treatment can be a challenge to primary and secondary health care providers. Mainstay treatment is comprised of antiarrhythmic drugs (AAD) and, in case of drug intolerance or failure, patients are referred for catheter ablation to tertiary health care centers. These patients require extensive medical attention and drug regimens usually have disappointing results. A direct comparison between the efficacy of the most potent AAD and primary catheter ablation in these patients is lacking. The ECTOPIA trial will evaluate the efficacy of 2 pharmacological strategies and 1 interventional approach to: suppress the VA burden, improve the quality of life (QoL), and safety., Hypothesis: We hypothesize that flecainide/verapamil combination and catheter ablation are both superior to sotalol in suppressing VA in patients with symptomatic idiopathic VA., Study Design: The Elimination of Ventricular Premature Beats with Catheter Ablation versus Optimal Antiarrhythmic Drug Treatment (ECTOPIA) trial is a randomized, multicenter, prospective clinical trial to compare the efficacy of catheter ablation versus optimal AAD treatment with sotalol or flecainide/verapamil. One hundred eighty patients with frequent symptomatic VA in the absence of structural heart disease or underlying cardiac ischemia who are eligible for catheter ablation with an identifiable monomorphic VA origin with a burden ≥5% on 24-h ambulatory rhythm monitoring will be included. Patients will be randomized in a 1:1:1 fashion. The primary endpoint is defined as >80% reduction of the VA burden on 24-h ambulatory Holter monitoring. After reaching the primary endpoint, patients randomized to one of the 2 AAD arms will undergo a cross-over to the other AAD treatment arm to explore differences in drug efficacy and QoL in individual patients. Due to the use of different AAD (with and without β-blocking characteristics) we will be able to explore the influence of alterations in sympathetic tone on VA burden reduction in different subgroups. Finally, this study will assess the safety of treatment with 2 different AAD and ablation of VA., (© 2020 S. Karger AG, Basel.)

In transvenous implantable cardioverter-defibrillator (TV-ICD) implants, routine defibrillation testing (DFT) does not improve shock efficacy or reduce arrhythmic death but patients are exposed to the risk of complications related to DFT. The conversion rate of DFT in subcutaneous ICD (S-ICD) is high and first shock efficacy is similar to TV-ICD efficacy rates. STUDY DESIGN: The PRAETORIAN-DFT trial is an investigator-initiated, randomized, controlled, multicenter, prospective two-arm trial designed to demonstrate non-inferiority of omitting DFT in patients undergoing S-ICD implantation in which the S-ICD system components are optimally positioned. Positioning of the S-ICD will be assessed with the PRAETORIAN score. The PRAETORIAN score is developed to systematically evaluate implant position of the S-ICD system components which determine the defibrillation threshold on post-operative chest X-ray. A total of 965 patients, scheduled to undergo a de novo S-ICD implantation without contra-indications for either DFT strategy, will be randomized to either standard of care S-ICD implantation with DFT, or S-ICD implantation without DFT but with evaluation of the implant position using the PRAETORIAN score. The study is powered to claim non-inferiority of S-ICD implantation without DFT in de novo S-ICD patients in respect to the primary endpoint of first shock efficacy in spontaneous arrhythmia episodes. Patients with a high PRAETORIAN score (≥90) in the interventional arm of this study will undergo DFT according to the same DFT protocol as in the control arm. CONCLUSION: The PRAETORIAN-DFT trial is a randomized trial that aims to gain scientific evidence to safely omit a routine DFT after S-ICD implantation in patients with correct device positioning., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Renal nerve stimulation (RNS) is used to localize sympathetic nerve tissue for selective renal nerve sympathetic denervation (RDN). Examination of heart rate variability (HRV) provides a way to assess the state of the autonomic nervous system. The current study aimed to examine the acute changes in HRV caused by RNS before and after RDN., Methods and Results: 30 patients with hypertension referred for RDN were included. RNS was performed under general anesthesia before and after RDN. Heart rate (HR) and blood pressure (BP) were continuously monitored. HRV characteristics were assessed 1 min before and after RNS and RDN. RNS before RDN elicited a maximum increase in systolic BP of 45 (± 22) mmHg which was attenuated to 13 (± 12) mmHg (p < 0.001) after RDN. RNS before RDN decreased the sinus cycle length from 1210 (± 201) ms to 1170 (± 203) ms (p = 0.03), after RDN this effect was blunted (p = 0.59). The LF/HF ratio in response to RNS changed from ∆ + 0.448 (± 0.550) before RDN to ∆ - 0.656 (± 0.252) after RDN (p = 0.02). Selecting patients off beta-blockade (n = 11), the RNS-induced changes in HRV components before versus after RDN were more pronounced (LF/HF ratio ∆ + 0.900 ± 1.171 versus ∆ - 0.828 ± 0.519, p = 0.01), whereas changes in HRV parameters in patients on beta-blockade (n = 19) were no longer significant. In patients with diabetes mellitus (n = 7), RNS induced no changes in HRV parameters (LF/HF ratio ∆ - 0.039 ± 0.103 versus ∆ - 0.460 ± 0.491, p = 0.92)., Conclusion: RNS induces changes in HRV suggesting increased sympathetic activity. Conversely, after RDN, the RNS-induced changes in HRV suggesting a lower sympathetic autonomic balance. These changes were most pronounced in beta-blocker naïve patients and not present in patients with diabetes mellitus. These findings could support RNS-guided RDN to optimize results.

Background: Renal nerve denervation (RDN) is developed as a potential treatment for hypertension. Recently, we reported the use of renal nerve stimulation (RNS) to localize sympathetic nerve tissue for subsequent selective RDN. The effects of RNS on arterial pressure dynamics remain unknown. The current study aimed to describe the acute changes in arterial pressure dynamics response to RNS before and after RDN., Methods and Results: Twenty six patients with drug-resistant hypertension referred for RDN were included. RNS was performed under general anesthesia before and after RDN. We continuously monitored heart rate (HR) and invasive femoral blood pressure (BP). Augmentation pressure (AP) and index (Aix), pulse pressure (PP), time to reflected wave, maximum systolic BP and dicrotic notch were calculated. Systolic and diastolic BP at site of maximum response significantly increased in response to RNS (120 ± 16/62 ± 9 to 150 ± 22/75 ± 15 mmHg) (p < 0.001/< 0.001), whereas after RDN no RNS-induced BP change was observed (p > 0.10). RNS increased Aix (29 ± 11 to 32 ± 13%, p = 0.005), PP (59 ± 14 to 75 ± 17 mmHg, p < 0.001), time to reflected wave (63 ± 18 to 71 ± 25 ms, p = 0.004) and time to maximum systolic pressure (167 ± 36 to 181 ± 46 ms, p = 0.004) before RDN, whereas no changes were observed after RDN (p > 0.18). All changes were BP dependent. RNS had no influence on HR or the time to dicrotic notch (p > 0.12).   CONCLUSION: RNS induces temporary rises in Aix, PP, time to maximum systolic pressure and time to reflected wave. These changes are BP dependent and were completely blunted after RDN.

Background: Current guidelines recommend both percutaneous catheter ablation (CA) and surgical ablation in the treatment of atrial fibrillation, with different levels of evidence. No direct comparison has been made between minimally invasive thoracoscopic pulmonary vein isolation with left atrial appendage ligation (surgical MIPI) versus percutaneous CA comprising of pulmonary vein isolation as primary treatment of atrial fibrillation. We, therefore, conducted a randomized controlled trial comparing the safety and efficacy of these 2 treatment modalities., Methods: Eighty patients were enrolled in the study and underwent implantable loop recorder implantation. Twenty-eight patients did not reach randomization criteria. A total of 52 patients with symptomatic paroxysmal or early persistent atrial fibrillation were randomized, 26 to CA and 26 to surgical MIPI. The primary end point was defined as freedom of atrial tachyarrhythmias, without the use of antiarrhythmic drugs. The safety end point was freedom of complications., Results: Median age was 57 years (range, 37-75), and 78% were men. Paroxysmal atrial fibrillation was present in 74%. Follow-up duration was ≥2 years in all patients. CA was noninferior to MIPI in terms of single-procedure arrhythmia-free survival after 2 years of follow-up (56.0% versus 29.2%; HR, 0.56; 95% CI, 0.26-1.20; log-rank P=0.059). Procedure-related major adverse events occurred significantly more often in MIPI than CA (20.8% versus 0%; P=0.029)., Conclusions: Percutaneous pulmonary vein isolation was noninferior to MIPI in terms of efficacy and resulted in less complications., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00703157.

Introduction: Chronic venous occlusion hampers lead revisions and upgrades in patients with a cardiac implantable electronic devices (CIEDs). This can make cardiothoracic surgery, venoplasty, or contra-lateral implantation of leads with tunneling necessary. A technique using venous recanalization may be a preferred alternative. We assessed the efficacy and safety of this new technique., Methods and Results: From 2009 to 2016, all consecutive patients planned for lead revision or upgrade with known chronic venous occlusion were studied. All patients underwent extraction of an existing malfunctional or functional CIED lead with the Cook Evolution mechanical power sheath. By using the lumen of the sheath, endovascular access to the heart was obtained for new leads. Forty-two patients (107 leads, 2.6 ± 1.1) were included. The indication for this procedure was replacement of malfunctional leads (n = 35, 83%) or device upgrade (n = 7, 17%). In total, 77 leads were extracted (30 leads stayed in situ) with a mean age at time of extraction of 8.4 years. Because of damage to bystander leads during extraction, two additional leads (one RA lead, one LV lead) were extracted. Clinical success was achieved in 41 patients (97%) and complete success in 39 patients (93%). There were two minor complications (two pocket hematomas, managed conservatively) and one major complication (tamponade, needing thoracotomy). Mean procedure time was 3.0 hours (median, 2.0; range, 1:28-5:35 hours) with a mean fluoroscopy time of 14.9 ± 12.5 minutes., Conclusions: The technique of Evolution-mediated recanalization in case of lead revisions or upgrades is feasible with an acceptable safety profile and high efficacy., (© 2017 Wiley Periodicals, Inc.)

Aims: The Evolution sheath (Cook Medical, USA) is a power sheath frequently used for chronic lead extraction. In 2013, a novel type (bidirectional) of Evolution sheath (the RL type) was introduced. We evaluated differences in success and complication rates of the two types., Methods and Results: From 2009 to 2015, all lead extractions requiring the use of an Evolution sheath were prospectively examined. According to the current guidelines, complete procedural success was defined as the removal of all targeted lead materials. Clinical success was the retention of a small portion of the lead, and failure was the inability to achieve either complete procedural or clinical success or the development of any permanently disabling complication. The Evolution sheath was used to extract 149 leads in 103 patients. The first 56 leads were extracted with the original unidirectional sheath, and 93 leads were extracted with the novel bidirectional R/L type. The median age of the lead at the time of extraction was 6.8 vs. 9.1 years (P = 0.007). Complete procedural success was higher for the Evolution R/L (80.0 vs. 98%, P = 0.0004). Clinical success rate was 98 vs. 99%. There were no major complications and 6 (12.0%) vs. 2 (3.8%) minor complications (P = 0.153). We did not observe changes in success rates or complications over time, meaning that the difference cannot be explained by learning curve., Conclusion: Use of the novel Evolution R/L sheath vs. the original Evolution sheath was associated with significant higher complete success rates, without major complications and with a trend towards the reduction of minor complications., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Background: Implantable cardioverter-defibrillators (ICDs) are widely used for the prevention of sudden cardiac death. At present, both clinical benefit and cost-effectiveness of ICD therapy in primary prevention patients are topics of discussion, as only a minority of these patients will eventually receive appropriate ICD therapy., Methods/design: The DO-IT Registry is a nationwide prospective cohort with a target enrolment of 1,500 primary prevention ICD patients with reduced left ventricular function in a setting of structural heart disease. The primary outcome measures are death and appropriate ICD therapy for ventricular tachyarrhythmias. Secondary outcome measures are inappropriate ICD therapy, death of any cause, hospitalisation for ICD related complications and for cardiovascular reasons. As of December 2016, data on demographic, clinical, and ICD characteristics of 1,468 patients have been collected. Follow-up will continue up to 24 months after inclusion of the last patient. During follow-up, clinical and ICD data are collected based on the normal follow-up of these patients, assuming ICD interrogations take place every six months and clinical follow-up is once a year. At baseline, the mean age was 66 (standard deviation [SD] 10) years and 27% were women., Conclusion: The DO-IT Registry represents a real-world nationwide cohort of patients receiving ICDs for primary prevention of sudden cardiac death with reduced left ventricular function in a setting of structural heart disease. The registry investigates the efficacy of the current practice and aims to develop prediction rules to identify subgroups who will not (sufficiently) benefit from ICD implantation and to provide results regarding costs and budget impact of targeted supply of primary preventions ICDs.

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.)

Background: The level of improvement in left ventricular ejection fraction (LVEF) in super-responders to cardiac resynchronization therapy (CRT) is exceptional. However, the long-term prognosis remains unknown in a large population., Hypothesis: Whether super-responders haven good long-term outcomes., Methods: We registered 347 patients with primary CRT-D indication. Super-response was defined by LVEF >50% at follow-up echocardiogram. Best-subset regression analysis identified predictors of super-response. Endpoints were major adverse cardiac events (MACE; eg, all-cause mortality or heart failure hospitalization, cardiac death, and appropriate ICD therapy)., Results: Fifty-six (16%) patients with LVEF >50% were classified as super-responders. Female sex (OR: 3.06, 95% CI: 1.54-6.05), nonischemic etiology (OR: 2.70, 95% CI: 1.29-5.68), higher LVEF at baseline (OR: 1.07, 95% CI: 1.02-1.13), and wider QRS duration (OR: 1.17, 95% CI: 1.04-1.32) were predictors of super-response. Cumulative incidence of MACE at a median of 5.3 years was 18% in super-responders, 22% in responders, and 51% in nonresponders (P < 0.001). None of super responders died from cardiac death, compared to 9% of responders and 25% of non-responders (P < 0.001). None of super-responders experienced appropriate ICD therapy, compared with 10% of responders and 21% of non-responders (P < 0.001). In super-responders, the adjusted hazard ratio was 0.37 (95% CI: 0.19-0.73) for MACE and 0.44 (95% CI: 0.20-0.95) for total mortality, compared with non-responders., Conclusions: Female sex, non-ischemic etiology, higher baseline LVEF, and wider QRS duration were independently associated with super-response. Super-response was associated with persistent excellent prognosis regarding survival and appropriate ICD therapy during long-term follow-up., (© 2017 Wiley Periodicals, Inc.)

Renal sympathetic nerve denervation (RDN) is accepted as a treatment option for patients with resistant hypertension. However, results on decline in ambulatory blood pressure (BP) measurement (ABPM) are conflicting. The high rate of nonresponders may be related to increased systemic vascular stiffness rather than sympathetic overdrive. A single center, prospective registry including 26 patients with treatment resistant hypertension who underwent RDN at the Isala Hospital in the Netherlands. Renal perivascular calcium scores were obtained from noncontrast computed tomography scans. Patients were divided into 3 groups based on their calcium scores (group I: low 0-50, group II: intermediate 50-1000, and group III: high >1000). The primary end point was change in 24-hour ABPM at 6 months follow-up post-RDN compared to baseline. Seven patients had low calcium scores (group I), 13 patients intermediate (group II), and 6 patients had high calcium scores (group III). The groups differed significantly at baseline in age and baseline diastolic 24-hour ABPM. At 6-month follow-up, no difference in 24-hour systolic ABPM response was observed between the 3 groups; a systolic ABPM decline of respectively -9 ± 12, -6 ± 12, -12 ± 10 mm Hg was found. Also the decline in diastolic ambulatory and office systolic and diastolic BP was not significantly different between the 3 groups at follow-up. Our preliminary data showed that the extent of renal perivascular calcification is not associated with the ABPM response to RDN in patients with resistant hypertension.

Background: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) is performed with the endoscopically assisted laser balloon ablation system (EAS). We hypothesized that placement of a circular mapping catheter (CMC) in the pulmonary vein (PV) distal to the laser balloon during ablation is feasible and safe., Methods: Out of 58 included patients, 37 underwent mapping-guided EAS PVI, with the CMC inside the PV during laser ablation, and 21 patients underwent standard EAS PVI, with the CMC outside the PV during laser ablation., Results: Mean age was 56 years and 81% had paroxysmal AF. In the mapping-guided ablation group, 91% of PVs were isolated with the CMC in the PV during EAS ablation, isolation was completed in 9% of PVs after the CMC was removed from the PV. After passing a learning curve in 18 patients, a significant drop in unsuccessfully isolated PVs was observed in the mapping guided EAS PVI group (15% to 4%, P  = 0.020). No major complications were seen in the mapping-guided EAS PVI group. However, in the standard EAS PVI group, laser ablation was complicated by a temporary phrenic nerve palsy in 1 patient. After a median follow-up of 16.7 months, there was no statistical difference in AF free survival among treatment groups (mapping-guided: 56% vs. 52%, P  = 0.875)., Conclusion: Mapping guided EAS PVI with a distal CMC in the PV during laser ablation is feasible and seems safe as the standard EAS PVI approach.

Purpose: We hypothesized that pulmonary vein (PV) orientation influences tissue contact of the contact force (CF) sensing radiofrequency ablation catheter (CFC) and therefore atrial fibrillation (AF) free survival after pulmonary vein isolation (PVI). The aim of this study was to determine the association between PV orientation, CF and AF free survival in patients undergoing CFC PVI., Methods: Sixty consecutive patients undergoing CFC PVI were included. ECG-triggered cardiac CT scans were obtained in all patients before PVI, and the PV orientation was measured at the insertion in the LA for all PVs in both the transverse and frontal plane. PVs were assigned to 1 of 4 orientation groups: ventral-caudal, dorsal-caudal, ventral-cranial and dorsal-cranial., Results: Mean age was 59 years, 88% had paroxysmal AF. AF free survival off anti-arrhythmic drugs after a median follow-up of 12 months was 58% after a single PVI procedure. No association was found between PV orientation and CF. Furthermore, no association was found between PV orientation and AF free survival. In univariate analysis, the number of lesions with a mean CF of 10 g was associated with AF free survival. However, in multivariate analysis, only the AF duration was significantly associated with AF free survival., Conclusions: This study shows that in patients undergoing PVI with the CFC ablation system, PV orientation does not affect CF and is not associated with AF free survival. PV orientation assessment does not appear to be necessary in patients undergoing CFC PVI.

Aim: Septal rebound stretch (SRSsept) reflects an inefficient deformation of the septum during systole and is a potential new echocardiographic tool to predict response to Cardiac Resynchronization Therapy (CRT). However, there are only limited data on the potential predictive value of SRSsept on echocardiographic response. We evaluated the predictive value of SRSsept on echocardiographic response to CRT in a large population., Methods and Results: A total of 138 consecutive patients with functional class II-IV heart failure who underwent CRT were studied. Echocardiography was performed at baseline and after a mean follow-up period of 22 ± 8 months. Echocardiographic response to CRT was defined as a reduction in LV end-systolic volume ≥ 15%. Receiver operating characteristic curve analysis was performed to define the optimal cut-off value for SRSsept. Multivariable analyses were performed to adjust for potential confounders. Mean age was 68 ± 8 years (30% female). Mean baseline LV ejection fraction was 26 ± 7%, 51% had ischemic etiology. LBBB or LBBB like morphology was present in 95% of patients. Mean SRSsept was 4.4 ± 3.2%, 56% of patients had SRSsept ≥ 4%. Ninety six patients (70%) were echocardiographic responders. Baseline SRSsept was significantly higher in responders compared to non-responders (5.1 ± 3.2 vs 3.0 ± 2.7, P < 0.001). The optimal cut-off value for SRSsept to predict response to CRT was 4.0%. After both univariate (OR 3.74, 95% CI 1.72-8.10) and multivariate analyses (OR 3.71, 95% CI 1.49-9.2), baseline SRSsept > 4% independently predicted the response to CRT., Conclusions: Baseline septal rebound stretch is independently associated with echocardiographic response to CRT.