Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias: The NO-PARTY multicentre randomized trial

Michela Casella, Antonio Dello Russo, Gemma Pelargonio, Maurizio Del Greco, Gianluca Zingarini, Marcello Piacenti, Andrea Di Cori, Victor Casula, Massimiliano Marini, Francesca Pizzamiglio, Martina Zucchetti, Stefania Riva, Eleonora Russo, Maria Lucia Narducci, Ezio Soldati, Luca Panchetti, Umberto Startari, Gianluigi Bencardino, Francesco Perna, Pasquale SantangeliLuigi Di Biase, Fabrizio Cichocki, Giovanni Fattore, Mariagrazia Bongiorni, Eugenio Picano, Andrea Natale, Claudio Tondo

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Aims Aim of this study was to compare a minimally fluoroscopic radiofrequency catheter ablation with conventional fluoroscopy-guided ablation for supraventricular tachycardias (SVTs) in terms of ionizing radiation exposure for patient and operator and to estimate patients' lifetime attributable risks associated with such exposure. Methods and results We performed a prospective, multicentre, randomized controlled trial in six electrophysiology (EP) laboratories in Italy. A total of 262 patients undergoing EP studies for SVT were randomized to perform a minimally fluoroscopic approach (MFA) procedure with the EnSiteTMNavXTM navigation system or a conventional approach (ConvA) procedure. The MFA was associated with a significant reduction in patients' radiation dose (0 mSv, iqr 0-0.08 vs. 8.87 mSv, iqr 3.67-22.01; P < 0.00001), total fluoroscopy time (0 s, iqr 0-12 vs. 859 s, iqr 545-1346; P < 0.00001), and operator radiation dose (1.55 vs. 25.33 μS per procedure; P < 0.001). In the MFA group, X-ray was not used at all in 72% (96/134) of cases. The acute success and complication rates were not different between the two groups (P = ns). The reduction in patients' exposure shows a 96% reduction in the estimated risks of cancer incidence and mortality and an important reduction in estimated years of life lost and years of life affected. Based on economic considerations, the benefits of MFA for patients and professionals are likely to justify its additional costs. Conclusion This is the first multicentre randomized trial showing that a MFA in the ablation of SVTs dramatically reduces patients' exposure, risks of cancer incidence and mortality, and years of life affected and lost, keeping safety and efficacy. Trial registration clinicaltrials.gov Identifier: NCT01132274.

Original languageEnglish
Pages (from-to)1565-1572
Number of pages8
JournalEuropace
Volume18
Issue number10
DOIs
Publication statusPublished - Oct 1 2016

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Catheter Ablation
Multicenter Studies
Cardiac Arrhythmias
Supraventricular Tachycardia
Electrophysiology
Fluoroscopy
Radiation
Mortality
Incidence
Ionizing Radiation
Italy
Neoplasms
Randomized Controlled Trials
Economics
X-Rays
Safety
Costs and Cost Analysis

Keywords

  • Electroanatomical mapping
  • Radiation exposure
  • Radiofrequency ablation
  • Supraventricular tachycardia

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias : The NO-PARTY multicentre randomized trial. / Casella, Michela; Dello Russo, Antonio; Pelargonio, Gemma; Del Greco, Maurizio; Zingarini, Gianluca; Piacenti, Marcello; Di Cori, Andrea; Casula, Victor; Marini, Massimiliano; Pizzamiglio, Francesca; Zucchetti, Martina; Riva, Stefania; Russo, Eleonora; Narducci, Maria Lucia; Soldati, Ezio; Panchetti, Luca; Startari, Umberto; Bencardino, Gianluigi; Perna, Francesco; Santangeli, Pasquale; Di Biase, Luigi; Cichocki, Fabrizio; Fattore, Giovanni; Bongiorni, Mariagrazia; Picano, Eugenio; Natale, Andrea; Tondo, Claudio.

In: Europace, Vol. 18, No. 10, 01.10.2016, p. 1565-1572.

Research output: Contribution to journalArticle

Casella, M, Dello Russo, A, Pelargonio, G, Del Greco, M, Zingarini, G, Piacenti, M, Di Cori, A, Casula, V, Marini, M, Pizzamiglio, F, Zucchetti, M, Riva, S, Russo, E, Narducci, ML, Soldati, E, Panchetti, L, Startari, U, Bencardino, G, Perna, F, Santangeli, P, Di Biase, L, Cichocki, F, Fattore, G, Bongiorni, M, Picano, E, Natale, A & Tondo, C 2016, 'Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias: The NO-PARTY multicentre randomized trial', Europace, vol. 18, no. 10, pp. 1565-1572. https://doi.org/10.1093/europace/euv344
Casella, Michela ; Dello Russo, Antonio ; Pelargonio, Gemma ; Del Greco, Maurizio ; Zingarini, Gianluca ; Piacenti, Marcello ; Di Cori, Andrea ; Casula, Victor ; Marini, Massimiliano ; Pizzamiglio, Francesca ; Zucchetti, Martina ; Riva, Stefania ; Russo, Eleonora ; Narducci, Maria Lucia ; Soldati, Ezio ; Panchetti, Luca ; Startari, Umberto ; Bencardino, Gianluigi ; Perna, Francesco ; Santangeli, Pasquale ; Di Biase, Luigi ; Cichocki, Fabrizio ; Fattore, Giovanni ; Bongiorni, Mariagrazia ; Picano, Eugenio ; Natale, Andrea ; Tondo, Claudio. / Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias : The NO-PARTY multicentre randomized trial. In: Europace. 2016 ; Vol. 18, No. 10. pp. 1565-1572.
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abstract = "Aims Aim of this study was to compare a minimally fluoroscopic radiofrequency catheter ablation with conventional fluoroscopy-guided ablation for supraventricular tachycardias (SVTs) in terms of ionizing radiation exposure for patient and operator and to estimate patients' lifetime attributable risks associated with such exposure. Methods and results We performed a prospective, multicentre, randomized controlled trial in six electrophysiology (EP) laboratories in Italy. A total of 262 patients undergoing EP studies for SVT were randomized to perform a minimally fluoroscopic approach (MFA) procedure with the EnSiteTMNavXTM navigation system or a conventional approach (ConvA) procedure. The MFA was associated with a significant reduction in patients' radiation dose (0 mSv, iqr 0-0.08 vs. 8.87 mSv, iqr 3.67-22.01; P < 0.00001), total fluoroscopy time (0 s, iqr 0-12 vs. 859 s, iqr 545-1346; P < 0.00001), and operator radiation dose (1.55 vs. 25.33 μS per procedure; P < 0.001). In the MFA group, X-ray was not used at all in 72{\%} (96/134) of cases. The acute success and complication rates were not different between the two groups (P = ns). The reduction in patients' exposure shows a 96{\%} reduction in the estimated risks of cancer incidence and mortality and an important reduction in estimated years of life lost and years of life affected. Based on economic considerations, the benefits of MFA for patients and professionals are likely to justify its additional costs. Conclusion This is the first multicentre randomized trial showing that a MFA in the ablation of SVTs dramatically reduces patients' exposure, risks of cancer incidence and mortality, and years of life affected and lost, keeping safety and efficacy. Trial registration clinicaltrials.gov Identifier: NCT01132274.",
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author = "Michela Casella and {Dello Russo}, Antonio and Gemma Pelargonio and {Del Greco}, Maurizio and Gianluca Zingarini and Marcello Piacenti and {Di Cori}, Andrea and Victor Casula and Massimiliano Marini and Francesca Pizzamiglio and Martina Zucchetti and Stefania Riva and Eleonora Russo and Narducci, {Maria Lucia} and Ezio Soldati and Luca Panchetti and Umberto Startari and Gianluigi Bencardino and Francesco Perna and Pasquale Santangeli and {Di Biase}, Luigi and Fabrizio Cichocki and Giovanni Fattore and Mariagrazia Bongiorni and Eugenio Picano and Andrea Natale and Claudio Tondo",
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T1 - Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias

T2 - The NO-PARTY multicentre randomized trial

AU - Casella, Michela

AU - Dello Russo, Antonio

AU - Pelargonio, Gemma

AU - Del Greco, Maurizio

AU - Zingarini, Gianluca

AU - Piacenti, Marcello

AU - Di Cori, Andrea

AU - Casula, Victor

AU - Marini, Massimiliano

AU - Pizzamiglio, Francesca

AU - Zucchetti, Martina

AU - Riva, Stefania

AU - Russo, Eleonora

AU - Narducci, Maria Lucia

AU - Soldati, Ezio

AU - Panchetti, Luca

AU - Startari, Umberto

AU - Bencardino, Gianluigi

AU - Perna, Francesco

AU - Santangeli, Pasquale

AU - Di Biase, Luigi

AU - Cichocki, Fabrizio

AU - Fattore, Giovanni

AU - Bongiorni, Mariagrazia

AU - Picano, Eugenio

AU - Natale, Andrea

AU - Tondo, Claudio

PY - 2016/10/1

Y1 - 2016/10/1

N2 - Aims Aim of this study was to compare a minimally fluoroscopic radiofrequency catheter ablation with conventional fluoroscopy-guided ablation for supraventricular tachycardias (SVTs) in terms of ionizing radiation exposure for patient and operator and to estimate patients' lifetime attributable risks associated with such exposure. Methods and results We performed a prospective, multicentre, randomized controlled trial in six electrophysiology (EP) laboratories in Italy. A total of 262 patients undergoing EP studies for SVT were randomized to perform a minimally fluoroscopic approach (MFA) procedure with the EnSiteTMNavXTM navigation system or a conventional approach (ConvA) procedure. The MFA was associated with a significant reduction in patients' radiation dose (0 mSv, iqr 0-0.08 vs. 8.87 mSv, iqr 3.67-22.01; P < 0.00001), total fluoroscopy time (0 s, iqr 0-12 vs. 859 s, iqr 545-1346; P < 0.00001), and operator radiation dose (1.55 vs. 25.33 μS per procedure; P < 0.001). In the MFA group, X-ray was not used at all in 72% (96/134) of cases. The acute success and complication rates were not different between the two groups (P = ns). The reduction in patients' exposure shows a 96% reduction in the estimated risks of cancer incidence and mortality and an important reduction in estimated years of life lost and years of life affected. Based on economic considerations, the benefits of MFA for patients and professionals are likely to justify its additional costs. Conclusion This is the first multicentre randomized trial showing that a MFA in the ablation of SVTs dramatically reduces patients' exposure, risks of cancer incidence and mortality, and years of life affected and lost, keeping safety and efficacy. Trial registration clinicaltrials.gov Identifier: NCT01132274.

AB - Aims Aim of this study was to compare a minimally fluoroscopic radiofrequency catheter ablation with conventional fluoroscopy-guided ablation for supraventricular tachycardias (SVTs) in terms of ionizing radiation exposure for patient and operator and to estimate patients' lifetime attributable risks associated with such exposure. Methods and results We performed a prospective, multicentre, randomized controlled trial in six electrophysiology (EP) laboratories in Italy. A total of 262 patients undergoing EP studies for SVT were randomized to perform a minimally fluoroscopic approach (MFA) procedure with the EnSiteTMNavXTM navigation system or a conventional approach (ConvA) procedure. The MFA was associated with a significant reduction in patients' radiation dose (0 mSv, iqr 0-0.08 vs. 8.87 mSv, iqr 3.67-22.01; P < 0.00001), total fluoroscopy time (0 s, iqr 0-12 vs. 859 s, iqr 545-1346; P < 0.00001), and operator radiation dose (1.55 vs. 25.33 μS per procedure; P < 0.001). In the MFA group, X-ray was not used at all in 72% (96/134) of cases. The acute success and complication rates were not different between the two groups (P = ns). The reduction in patients' exposure shows a 96% reduction in the estimated risks of cancer incidence and mortality and an important reduction in estimated years of life lost and years of life affected. Based on economic considerations, the benefits of MFA for patients and professionals are likely to justify its additional costs. Conclusion This is the first multicentre randomized trial showing that a MFA in the ablation of SVTs dramatically reduces patients' exposure, risks of cancer incidence and mortality, and years of life affected and lost, keeping safety and efficacy. Trial registration clinicaltrials.gov Identifier: NCT01132274.

KW - Electroanatomical mapping

KW - Radiation exposure

KW - Radiofrequency ablation

KW - Supraventricular tachycardia

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