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

Sean D. Pokorney, Daniel J. Friedman, Hugh Calkins, David J. Callans, Emile G. Daoud, Paolo Della-Bella, Kevin P. Jackson, Kalyanam Shivkumar, Samir Saba, John Sapp, William G. Stevenson, Sana M. Al-Khatib

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalHeart Rhythm
DOIs
StateAccepted/In press - 2016

Fingerprint

Catheter Ablation
Ventricular Tachycardia
Clinical Trials
Refusal to Participate
Randomized Controlled Trials
Ablation Techniques
Myocardial Ischemia
Consensus
Catheters
Quality of Life
Prospective Studies
Technology
Equipment and Supplies
Control Groups

Keywords

  • Antitachycardia pacing
  • Appropriate shock
  • Catheter ablation
  • Clinical trials
  • Implantable cardioverter-defibrillator
  • Mortality
  • Ventricular tachycardia

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Catheter ablation of ventricular tachycardia : Lessons learned from past clinical trials and implications for future clinical trials. / Pokorney, Sean D.; Friedman, Daniel J.; Calkins, Hugh; Callans, David J.; Daoud, Emile G.; Della-Bella, Paolo; Jackson, Kevin P.; Shivkumar, Kalyanam; Saba, Samir; Sapp, John; Stevenson, William G.; Al-Khatib, Sana M.

In: Heart Rhythm, 2016.

Research output: Contribution to journalArticle

Pokorney, SD, Friedman, DJ, Calkins, H, Callans, DJ, Daoud, EG, Della-Bella, P, Jackson, KP, Shivkumar, K, Saba, S, Sapp, J, Stevenson, WG & Al-Khatib, SM 2016, 'Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials', Heart Rhythm. https://doi.org/10.1016/j.hrthm.2016.04.001
Pokorney, Sean D. ; Friedman, Daniel J. ; Calkins, Hugh ; Callans, David J. ; Daoud, Emile G. ; Della-Bella, Paolo ; Jackson, Kevin P. ; Shivkumar, Kalyanam ; Saba, Samir ; Sapp, John ; Stevenson, William G. ; Al-Khatib, Sana M. / Catheter ablation of ventricular tachycardia : Lessons learned from past clinical trials and implications for future clinical trials. In: Heart Rhythm. 2016.
@article{dc44c9c1bafc4153afb1fecd46132e6f,
title = "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.",
keywords = "Antitachycardia pacing, Appropriate shock, Catheter ablation, Clinical trials, Implantable cardioverter-defibrillator, Mortality, Ventricular tachycardia",
author = "Pokorney, {Sean D.} and Friedman, {Daniel J.} and Hugh Calkins and Callans, {David J.} and Daoud, {Emile G.} and Paolo Della-Bella and Jackson, {Kevin P.} and Kalyanam Shivkumar and Samir Saba and John Sapp and Stevenson, {William G.} and Al-Khatib, {Sana M.}",
year = "2016",
doi = "10.1016/j.hrthm.2016.04.001",
language = "English (US)",
journal = "Heart Rhythm",
issn = "1547-5271",
publisher = "Elsevier",

}

TY - JOUR

T1 - Catheter ablation of ventricular tachycardia

T2 - 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

Y1 - 2016

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

UR - http://www.scopus.com/inward/citedby.url?scp=84965080908&partnerID=8YFLogxK

U2 - 10.1016/j.hrthm.2016.04.001

DO - 10.1016/j.hrthm.2016.04.001

M3 - Article

C2 - 27050910

AN - SCOPUS:84965080908

JO - Heart Rhythm

JF - Heart Rhythm

SN - 1547-5271

ER -