Hostname: page-component-848d4c4894-p2v8j Total loading time: 0.001 Render date: 2024-05-29T05:52:33.125Z Has data issue: false hasContentIssue false

Rationale and design of the NO-PARTY trial: near-zero fluoroscopic exposure during catheter ablation of supraventricular arrhythmias in young patients

Published online by Cambridge University Press:  13 February 2012

Michela Casella*
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy
Antonio Dello Russo
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy
Gemma Pelargonio
Affiliation:
Department of Cardiovascular Medicine, Catholic University of the Sacred Heart, Rome, Italy
Maria Grazia Bongiorni
Affiliation:
Department of Cardiovascular Disease 2, Santa Chiara Hospital, Hospital University of Pisa, Italy
Maurizio Del Greco
Affiliation:
Department of Cardiology, Santa Chiara Hospital, Trento, Italy
Marcello Piacenti
Affiliation:
CNR, Institute of Clinical Physiology, Fondazione G. Monasterio, Pisa, Italy
Maria Grazia Andreassi
Affiliation:
CNR, Institute of Clinical Physiology, Fondazione G. Monasterio, Pisa, Italy
Pasquale Santangeli
Affiliation:
Department of Cardiovascular Medicine, Catholic University of the Sacred Heart, Rome, Italy
Stefano Bartoletti
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy Department of Cardiovascular Sciences, University of Milan, Milan, Italy
Massimo Moltrasio
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy
Gaetano Fassini
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy
Massimiliano Marini
Affiliation:
Department of Cardiology, Santa Chiara Hospital, Trento, Italy
Andrea Di Cori
Affiliation:
Department of Cardiovascular Disease 2, Santa Chiara Hospital, Hospital University of Pisa, Italy
Luigi Di Biase
Affiliation:
Texas Cardiac Arrhythmia Institute, St. Davis Medical Center, Austin, Texas, United States of America
Cesare Fiorentini
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy Department of Cardiovascular Sciences, University of Milan, Milan, Italy
Paolo Zecchi
Affiliation:
Department of Cardiovascular Medicine, Catholic University of the Sacred Heart, Rome, Italy
Andrea Natale
Affiliation:
Texas Cardiac Arrhythmia Institute, St. Davis Medical Center, Austin, Texas, United States of America
Eugenio Picano
Affiliation:
CNR, Institute of Clinical Physiology, Fondazione G. Monasterio, Pisa, Italy
Claudio Tondo
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy
*
Correspondence to: Dr M. Casella, MD, PhD, Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Via Parea 4, 20138 Milan, Italy. Tel: +39 02 58002340; Fax: +39 02 58002398; E-mail: michela.casella@ccfm.it

Abstract

Introduction

Radiofrequency catheter ablation is the mainstay of therapy for supraventricular tachyarrhythmias. Conventional radiofrequency catheter ablation requires the use of fluoroscopy, thus exposing patients to ionising radiation. The feasibility and safety of non-fluoroscopic radiofrequency catheter ablation has been recently reported in a wide range of supraventricular tachyarrhythmias using the EnSite NavX™ mapping system. The NO-PARTY is a multi-centre, randomised controlled trial designed to test the hypothesis that catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system results in a clinically significant reduction in exposure to ionising radiation compared with conventional catheter ablation.

Methods

The study will randomise 210 patients undergoing catheter ablation of supraventricular tachyarrhythmias to either a conventional ablation technique or one guided by the EnSite NavX™ mapping system. The primary end-point is the reduction of the radiation dose to the patient. Secondary end-points include procedural success, reduction of the radiation dose to the operator, and a cost-effectiveness analysis. In a subgroup of patients, we will also evaluate the radiobiological effectiveness of dose reduction by assessing acute chromosomal DNA damage in peripheral blood lymphocytes.

Conclusions

NO-PARTY will determine whether radiofrequency catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system is a suitable and cost-effective approach to achieve a clinically significant reduction in ionising radiation exposure for both patient and operator.

Type
Original Article
Copyright
Copyright © Cambridge University Press 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1.Orejarena, LA, Vidaillet, H Jr, DeStefano, F, et al. . Paroxysmal supraventricular tachycardia in the general population. J Am Coll Cardiol 1998; 31: 150157.CrossRefGoogle ScholarPubMed
2.Waldo, AL, Wit, AL. Mechanisms of cardiac arrhythmias. Lancet 1993; 341: 11891193.CrossRefGoogle ScholarPubMed
3.Rodriguez, LM, de Chillou, C, Schläpfer, J, et al. . Age at onset and gender of patients with different types of supraventricular tachycardias. Am J Cardiol 1992; 70: 12131215.CrossRefGoogle ScholarPubMed
4.Goyal, R, Zivin, A, Souza, J, et al. . Comparison of the ages of tachycardia onset in patients with atrioventricular nodal reentrant tachycardia and accessory pathway-mediated tachycardia. Am Heart J 1996; 132: 765767.CrossRefGoogle ScholarPubMed
5.Blomström-Lundqvist, C, Scheinman, MM, Aliot, EM, et al. . ACC/AHA/ESC guidelines for the management of patients with supraventricular arrhythmias-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines. Circulation 2003; 108: 18711909.Google Scholar
6.Spector, P, Reynolds, MR, Calkins, H, et al. . Meta-analysis of ablation of atrial flutter and supraventricular tachycardia. Am J Cardiol 2009; 104: 671677.CrossRefGoogle ScholarPubMed
7.Hirshfeld, JW Jr, Balter, S, Brinker, JA, et al. . ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training. Circulation 2005; 111: 511532.Google Scholar
8. United Nations Scientific Committee on the sources and effects of Ionizing radiation. Report on the effects of atomic radiation to the general Assembly, 2000. United Nations, New York, 2001.Google Scholar
9. International Commission on Radiation Protection: radiation and your patient: a guide for medical practitioners. A web module produced by Committee 3 of the International Commission on Radiological Protection. Available at: www.icrp.org/docs/Rad_for_GP_for_web.pdf. 2001.Google Scholar
10.Committee to Assess Health Risks from Exposure to Low Levels of Ionizing Radiation; Nuclear and Radiation Studies Board, Division on Earth and Life Studies, National Research Council of the National Academies. Health risks from exposure to low levels of ionizing radiation: BEIR VII phase 2. The National Academies Press, Washington, DC, 2006.Google Scholar
11.Kleinerman, RA. Cancer risks following diagnostic and therapeutic radiation exposure in children. Pediatr Radiol 2006; 36: 121125.CrossRefGoogle ScholarPubMed
12.Estner, HL, Deisenhofer, I, Luik, A, et al. . Electrical isolation of pulmonary veins in patients with atrial fibrillation: reduction of fluoroscopy exposure and procedure duration by the use of a non-fluoroscopic navigation system (NavX). Europace 2006; 8: 583587.CrossRefGoogle ScholarPubMed
13.Rotter, M, Takahashi, Y, Sanders, P, et al. . Reduction of fluoroscopy exposure and procedure duration during ablation of atrial fibrillation using a novel anatomical navigation system. Eur Heart J 2005; 26: 14151421.CrossRefGoogle ScholarPubMed
14.Sporton, SC, Earley, MJ, Nathan, AW, Schilling, RJ. Electroanatomic versus fluoroscopic mapping for catheter ablation procedures: a prospective randomized study. J Cardiovasc Electrophysiol 2004; 15: 310315.CrossRefGoogle ScholarPubMed
15.Alvarez, M, Tercedor, L, Almansa, I, et al. . Safety and feasibility of catheter ablation for atrioventricular nodal re-entrant tachycardia without fluoroscopic guidance. Heart Rhythm 2009; 6: 17141720.CrossRefGoogle ScholarPubMed
16.Ferguson, JD, Helms, A, Mangrum, JM, et al. . Catheter ablation of atrial fibrillation without fluoroscopy using intracardiac echocardiography and electroanatomic mapping. Circ Arrhythm Electrophysiol 2009; 2: 611619.CrossRefGoogle ScholarPubMed
17.Casella, M, Pelargonio, G, Dello Russo, A, et al. . “Near-zero” fluoroscopic exposure in supraventricular arrhythmia ablation using the EnSite NavX™ mapping system: personal experience and review of the literature. J Interv Card Electrophysiol 2011; 31: 109118.CrossRefGoogle ScholarPubMed
18.Andreassi, MG, Ait-Ali, L, Botto, N, Manfredi, S, Mottola, G, Picano, E. Cardiac catheterization and long-term chromosomal damage in children with congenital heart disease. Eur Heart J 2006; 27: 27032708.CrossRefGoogle ScholarPubMed
19.Andreassi, MG, Cioppa, A, Manfredi, S, Palmieri, C, Botto, N, Picano, E. Acute chromosomal DNA damage in human lymphocytes after radiation exposure in invasive cardiovascular procedures. Eur Heart J 2007; 28: 21952199.CrossRefGoogle ScholarPubMed
20.Ait-Ali, L, Andreassi, MG, Foffa, I, Spadoni, I, Vano, E, Picano, E. Cumulative patient effective dose and acute radiation-induced chromosomal DNA damage in children with congenital heart disease. Heart 2010; 96: 269274.CrossRefGoogle ScholarPubMed
21.Bedetti, G, Botto, N, Andreassi, MG, Traino, C, Vano, E, Picano, E. Cumulative patient effective dose in cardiology. Br J Radiol 2008; 81: 699705.CrossRefGoogle ScholarPubMed
22.Beels, L, Bacher, K, De Wolf, D, Werbrouck, J, Thierens, H. Gamma-H2AX foci as a biomarker for patient X-ray exposure in pediatric cardiac catheterization: are we underestimating radiation risks? Circulation 2009; 120: 19031909.CrossRefGoogle ScholarPubMed
23.Cappato, R, Kuck, KH. Catheter ablation in the year 2000. Curr Opin Cardiol 2000; 15: 2940.CrossRefGoogle ScholarPubMed
24.Venneri, L, Rossi, F, Botto, N, et al. . Cancer risk from professional exposure in staff working in cardiac catheterization laboratory: insights from the National Research Council's Biological Effects of Ionizing Radiation VII Report. Am Heart J 2009; 157: 118124.CrossRefGoogle ScholarPubMed
25.Germano, JJ, Day, G, Gregorious, D, et al. . A novel radiation protection drape reduces radiation exposure during fluoroscopy guided electrophysiology procedures. J Invasive Cardiol 2005; 17: 469472.Google ScholarPubMed
26.Rossi, PL, Mariselli, M, Corazza, I, et al. . Decrease in patient radiation exposure by a tantalum filter during electrophysiological procedures. Pacing Clin Electrophysiol 2009; 32 (Suppl. 1) S109S112.CrossRefGoogle ScholarPubMed
27.Rogers, DP, England, F, Lozhkin, K, et al. . Improving safety in the electrophysiology laboratory using a simple radiation dose reduction strategy: a study of 1007 radiofrequency ablation procedures. Heart 2011; 97: 366370.CrossRefGoogle Scholar
28.Picano, E, Santoro, G, Vano, E. Sustainability in the cardiac cath lab. Int J Cardiovasc Imaging 2007; 23: 143147.CrossRefGoogle ScholarPubMed
29.Earley, MJ, Showkathali, R, Alzetani, M, et al. . Radiofrequency ablation of arrhythmias guided by non-fluoroscopic catheter location: a prospective randomized trial. Eur Heart J 2006; 27: 12231229.CrossRefGoogle ScholarPubMed