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 (2015-11-10)
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 Santangeli, Luigi Di Biase, Fabrizio Cichocki, Giovanni Fattore, Mariagrazia Bongiorni, Eugenio Picano, Andrea Natale, Claudio Tondo; Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias: the NO-PARTY multicentre randomized trial, EP Europace, Volume 18, Issue 10, 1 October 2016, Pages 1565–1572, https://doi.org/10.1093/europace/euv344
© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
https://creativecommons.org/licenses/by-nc/4.0/
https://urn.fi/URN:NBN:fi-fe2017121155587
Tiivistelmä
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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