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.

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, M. L., 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., Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias: The NO-PARTY multicentre randomized trial, <<EUROPACE>>, 2016; 18 (10): 1565-1572. [doi:10.1093/europace/euv344] [http://hdl.handle.net/10807/172376]

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

Casella, Michela;Dello Russo, Antonio;Pelargonio, Gemma;Riva, Silvia;Narducci, Maria Lucia;Bencardino, Gianluigi;Perna, Francesco;
2016

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.
2016
Inglese
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, M. L., 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., Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias: The NO-PARTY multicentre randomized trial, <<EUROPACE>>, 2016; 18 (10): 1565-1572. [doi:10.1093/europace/euv344] [http://hdl.handle.net/10807/172376]
File in questo prodotto:
File Dimensione Formato  
172376OA.pdf

accesso aperto

Tipologia file ?: Versione Editoriale (PDF)
Licenza: Creative commons
Dimensione 332.53 kB
Formato Unknown
332.53 kB Unknown Visualizza/Apri

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/172376
Citazioni
  • ???jsp.display-item.citation.pmc??? 37
  • Scopus 112
  • ???jsp.display-item.citation.isi??? 93
social impact