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Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials.

ABSTRACT: Catheter ablation of ventricular tachycardia (VT) has evolved in recent years, especially in patients with ischemic heart disease. Data from prospective studies show that VT catheter ablation reduces the risk of recurrent VT; however, there is a paucity of data on the effect of VT catheter ablation on mortality and patient-centered outcomes such as quality of life. Performing randomized clinical trials of VT catheter ablation can be fraught with challenges, and, as a result, several prior trials of VT catheter ablation had to be stopped prematurely. The main challenges are inability to blind the patient to therapy to obtain a traditional control group, high crossover rates between the 2 arms of the study, patient refusal to participate in trials in which they have an equal chance of receiving a "pill" vs an invasive procedure, heterogeneity of mapping and ablation techniques as well as catheters and equipment, rapid evolution of technology that may make findings of any long trial less relevant to clinical practice, lack of consensus on what constitutes acute procedural and long-term success, and presentation of patients to electrophysiologists late in the course of their disease. In this article, a panel of experts on VT catheter ablation and/or clinical trials of VT catheter ablation review challenges faced in conducting prior trials of VT catheter ablation and offer potential solutions for those challenges. It is hoped that the proposed solutions will enhance the feasibility of randomized clinical trials of VT catheter ablation.

SUBMITTER: Pokorney SD

PROVIDER: S-EPMC5070490 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials.

Pokorney Sean D SD Friedman Daniel J DJ Calkins Hugh H Callans David J DJ Daoud Emile G EG Della-Bella Paolo P Jackson Kevin P KP Shivkumar Kalyanam K Saba Samir S Sapp John J Stevenson William G WG Al-Khatib Sana M SM

Heart rhythm 20160402 8

Catheter ablation of ventricular tachycardia (VT) has evolved in recent years, especially in patients with ischemic heart disease. Data from prospective studies show that VT catheter ablation reduces the risk of recurrent VT; however, there is a paucity of data on the effect of VT catheter ablation on mortality and patient-centered outcomes such as quality of life. Performing randomized clinical trials of VT catheter ablation can be fraught with challenges, and, as a result, several prior trials ...[more]

PMID: 27050910

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Project description:BackgroundThere is paucity of data regarding radiofrequency ablation for ventricular tachycardia (VT) in patients with cardiogenic shock and concomitant VT refractory to antiarrhythmic drugs on mechanical support.MethodsPatients undergoing VT ablation at our center were enrolled in a prospectively maintained registry and screened for the current study (2010-2017).ResultsAll 21 consecutive patients with cardiogenic shock and concomitant refractory ventricular arrhythmia undergoing bailout ablation due to inability to wean off mechanical support were included. Median age was 61 years, 86% were men, median left ventricular ejection fraction was 20%, 81% had ischemic cardiomyopathy, and PAINESD score was 18±5. The type of mechanical support in place before the procedure was intra-aortic balloon pump in 14 patients (67%), Impella CP in 2, extracorporeal membrane oxygenation in 2, extracorporeal membrane oxygenation and intra-aortic balloon pump in 2, and extracorporeal membrane oxygenation and Impella CP in 1. Endocardial voltage maps showed myocardial scar in 19 patients (90%). The clinical VTs were inducible in 13 patients (62%), whereas 6 patients had premature ventricular contraction-induced ventricular fibrillation/VT (29%), and VT could not be induced in 2 patients (9%). Activation mapping was possible in all 13 with inducible clinical VTs. Substrate modification was performed in 15 patients with scar (79%). After ablation and scar modification, the arrhythmia was noninducible in 19 patients (91%). Seventeen (81%) were eventually weaned off mechanical support successfully, but 6 (29%) died during the index admission from persistent cardiogenic shock. Patients who had ventricular arrhythmia and cardiogenic shock on presentation had a trend toward lower in-hospital mortality compared with those who presented with cardiogenic shock and later developed ventricular arrhythmia.ConclusionsBailout ablation for refractory ventricular arrhythmia in cardiogenic shock allowed successful weaning from mechanical support in a large proportion of patients. Mortality remains high, but the majority of patients were discharged home and survived beyond 1 year.

Project description:OBJECTIVES:This study sought to characterize ventricular tachycardia (VT) ablation outcomes across nonischemic cardiomyopathy (NICM) etiologies and adjust these outcomes by patient-related comorbidities that could explain differences in arrhythmia recurrence rates. BACKGROUND:Outcomes of catheter ablation of VT in patients with NICM could be related to etiology of NICM. METHODS:Data from 2,075 patients with structural heart disease referred for catheter ablation of VT from 12 international centers was retrospectively analyzed. Patient characteristics and outcomes were noted for the 6 most common NICM etiologies. Multivariable Cox proportional hazards modeling was used to adjust for potential confounders. RESULTS:Of 780 NICM patients (57 ± 14 years of age, 18% women, left ventricular ejection fraction 37 ± 13%), underlying prevalence was 66% for dilated idiopathic cardiomyopathy (DICM), 13% for arrhythmogenic right ventricular cardiomyopathy (ARVC), 6% for valvular cardiomyopathy, 6% for myocarditis, 4% for hypertrophic cardiomyopathy, and 3% for sarcoidosis. One-year freedom from VT was 69%, and freedom from VT, heart transplantation, and death was 62%. On unadjusted competing risk analysis, VT ablation in ARVC demonstrated superior VT-free survival (82%) versus DICM (p ? 0.01). Valvular cardiomyopathy had the poorest unadjusted VT-free survival, at 47% (p < 0.01). After adjusting for comorbidities, including age, heart failure severity, ejection fraction, prior ablation, and antiarrhythmic medication use, myocarditis, ARVC, and DICM demonstrated similar outcomes, whereas hypertrophic cardiomyopathy, valvular cardiomyopathy, and sarcoidosis had the highest risk of VT recurrence. CONCLUSIONS:Catheter ablation of VT in NICM is effective. Etiology of NICM is a significant predictor of outcomes, with ARVC, myocarditis, and DICM having similar but superior outcomes to hypertrophic cardiomyopathy, valvular cardiomyopathy, and sarcoidosis, after adjusting for potential covariates.

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Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials.

Publications

Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials.

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