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

Abstract

AimsAim 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 resultsWe 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.ConclusionThis 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 registrationclinicaltrials.gov Identifier: NCT01132274.

Prediction of very late arrhythmia recurrence after radiofrequency catheter ablation of atrial fibrillation: The MB-LATER clinical score

“…Classification of AF recurrences to the LRAF (3–12 months) and the VLRAF (>1 year) was arbitrary, but in concordance with current reports123456789171820252627. An intermittent rhythm monitoring after ablation by only 24-hour Holter-recording may underestimate the AF recurrence rate, especially in asymptomatic cases, and undetected AF recurrence within the first postoperative year may lead to its misinterpretation as VLRAF in some patients1.…”

“…Longer procedure times may reflect a more complex anatomy and substrate, but also they can be affected by technology and experience of the operator. Recently, it has been reported that the current trend towards the use of “near zero” approach is adopted in different electrophysiological procedures, in order to protect the patients and staff from the harmful effects of ionizing radiation2021.…”

First experience with zero-fluoroscopic ablation for supraventricular tachycardias using a novel impedance and magnetic-field-based mapping system

“…Authors of the randomized NO-PARTY trial assessed lifetime attributable risks of cancer incidence and mortality from equivalent organ doses calculated with Monte Carlo code, according to the Biological Effects of Ionizing Radiation empirical risk models [23]. According to their results, the lifetime attributable cancer incidence ranged between 7.3 (95% confidence interval: 3.4–12.8)–11.0 (6.0–18.6) for males and 8.2 (5.0–12.8)–15.4 (9.9–25.3) for females for minimal fluoroscopy approach and 195 (111–315)–321 (198–512) and 241 (165–350)–486 (333–773) for females for the conventional approach, per 100 000 individuals (depending on age).…”

Maximum voltage gradient technique for optimization of ablation for typical atrial flutter with zero-fluoroscopy approach

“…[3–12,15] First, it is a nonrandomized study performed by medical staff that are already trained in NXR. [11] The success of the ablation procedure was confirmed acutely and within the observation period.…”