TY - JOUR
T1 - Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias: 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 - Riva, Silvia
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
Y1 - 2016
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 - Adult
KW - Body Surface Potential Mapping
KW - Catheter Ablation
KW - Electroanatomical mapping
KW - Female
KW - Fluoroscopy
KW - Humans
KW - Italy
KW - Male
KW - Middle Aged
KW - Minimally Invasive Surgical Procedures
KW - Prospective Studies
KW - Radiation Exposure
KW - Radiation exposure
KW - Radiofrequency ablation
KW - Supraventricular tachycardia
KW - Tachycardia, Supraventricular
KW - Treatment Outcome
KW - Adult
KW - Body Surface Potential Mapping
KW - Catheter Ablation
KW - Electroanatomical mapping
KW - Female
KW - Fluoroscopy
KW - Humans
KW - Italy
KW - Male
KW - Middle Aged
KW - Minimally Invasive Surgical Procedures
KW - Prospective Studies
KW - Radiation Exposure
KW - Radiation exposure
KW - Radiofrequency ablation
KW - Supraventricular tachycardia
KW - Tachycardia, Supraventricular
KW - Treatment Outcome
UR - http://hdl.handle.net/10807/172376
U2 - 10.1093/europace/euv344
DO - 10.1093/europace/euv344
M3 - Article
SN - 1099-5129
VL - 18
SP - 1565
EP - 1572
JO - Europace
JF - Europace
ER -