The use of CF sensing catheters did not improve procedural outcome or safety profile in comparison to non-CF sensing ablation in this observational study of ventricular arrhythmia ablations.
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.
IntroductionStroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures.Methods and ResultsThe REDUCE‐TE Pilot was a prospective multicenter, single‐arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold‐tip, externally irrigated ablation catheter. After ablation, cerebral diffusion‐weighted MRI and a postablation follow‐up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA2DS 2‐VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3‐16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow‐up.ConclusionsAblation of AF using a novel gold‐tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.
BackgroundThe role of epicardial substrate ablation of ventricular tachycardia (VT) as a first-line approach in patients with ischemic heart disease is not clearly defined. Epicardial ablation as a first-line option is standard for patients with nonischemic dilated cardiomyopathy and arrhythmogenic right ventricular cardiomyopathy. Several nonrandomized studies, including studies on patients with ischemic heart disease, have shown that epicardial VT ablation improves outcome but this approach was often used after a failed endocardial approach. The aim of this study is to determine whether a combined endo-epicardial scar homogenization as a first-line approach will improve the outcome of VT ablation.Methods/DesignThe EPILOGUE study is a multicenter, two-armed, nonblinded, randomized controlled trial. Patients with ischemic heart disease who are referred for VT ablation will be randomly assigned to combined endo-epicardial scar homogenization or endocardial scar homogenization only (control group). The primary outcome is recurrence of sustained VT during a 2-year follow-up. Secondary outcomes include procedural success and safety.DiscussionThis study is the first randomized trial that evaluates the role of a combined endo-epicardial scar homogenization versus endocardial scar homogenization for the treatment of ischemic scar-related VT.Trial registrationNL4816807814v02
Introduction: Remote magnetic navigation (RMN)-guided catheter ablation (CA) is a feasible treatment option for patients presenting with ischemic ventricular tachycardia (VT). Catheter-tissue contact feedback, enhances lesion formation and may consequently improve CA outcomes. Until recently, contact feedback was unavailable for RMN-guided CA. The novel e-Contact Module (ECM) was developed to continuously monitor and ensure catheter-tissue contact during RMN-guided CA.Objective: The present study aims to evaluate the effect of ECM implementation on acute and long-term outcomes in RMN-guided ischemic VT ablation. Method: This retrospective, two-center study included consecutive ischemic VT patients undergoing RMNguided CA from 2010 to 2017. Baseline clinical data, procedural data, including radiation times, and acute success rates were compared between CA procedures performed with ECM (ECM+) and without ECM (ECM−). Oneyear VT-free survival was analyzed using Cox-proportional hazards models, adjusting for potential confounders: age, left ventricular function, VT inducibility at baseline and substrate based ablation strategy. Results: The current study included 145 patients (ECM+ N = 25, ECM− N = 120). Significantly lower fluoroscopy times were observed in the ECM+ group (9.5 (IQR 5.3-13.5) versus 12.5 min (IQR 8.0-18.0), P = 0.025). Non-inducibility of the clinical VT at the end of procedure was observed in 92% ECM+ versus 72% ECM− patients (P = 0.19). ECM guidance was associated with significantly lower VT-recurrence rates during 1-year follow-up (16% ECM+ versus 40% ECM−; multivariable HR 0.29, 95%-CI 0.10-0.69, P = 0.021, reference group: ECM−). Conclusion: Contact feedback by the ECM further decreases fluoroscopy exposure and improves VT-free survival in RMN-guided ischemic VT ablation.
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