TY - JOUR
T1 - Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials
AU - Pokorney, Sean D.
AU - Friedman, Daniel J.
AU - Calkins, Hugh
AU - Callans, David J.
AU - Daoud, Emile G
AU - Della-Bella, Paolo
AU - Jackson, Kevin P.
AU - Shivkumar, Kalyanam
AU - Saba, Samir
AU - Sapp, John
AU - Stevenson, William G.
AU - Al-Khatib, Sana M.
PY - 2016/8/1
Y1 - 2016/8/1
N2 - 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.
AB - 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.
KW - Antitachycardia pacing
KW - Appropriate shock
KW - Catheter ablation
KW - Clinical trials
KW - Implantable cardioverter-defibrillator
KW - Mortality
KW - Ventricular tachycardia
UR - http://www.scopus.com/inward/record.url?scp=84965080908&partnerID=8YFLogxK
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U2 - 10.1016/j.hrthm.2016.04.001
DO - 10.1016/j.hrthm.2016.04.001
M3 - Article
SN - 1547-5271
VL - 13
SP - 1748
EP - 1754
JO - Heart Rhythm
JF - Heart Rhythm
IS - 8
ER -