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

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.

Atrial fibrillation in recipients of cardiac resynchronization therapy device: 1-year results of the randomized MASCOT trial.

BACKGROUND: Atrial fibrillation (AF) is associated with increased morbidity and mortality in patients suffering from heart failure (HF). Patients in New York Heart Association HF classes III or IV, with systolic dysfunction and a wide QRS, are candidates for cardiac resynchronization therapy (CRT), and might benefit from atrial overdrive pacing (AOP). METHODS: The Management of Atrial fibrillation Suppression in AF-HF COmorbidity Therapy (MASCOT) trial enrolled 409 CRT device recipients (79% men), who were randomly assigned to AOP ON (n = 197), versus AOP OFF (n = 197) and followed up for 1 year. Their mean age was 68 +/- 10 years, left ventricular ejection fraction 25 +/- 6%, QRS duration 163 +/- 29 milliseconds. New York Heart Association class III was present in 86% of patients and 19% had a history of paroxysmal AF. The primary study end point was incidence of permanent AF at 1 year. RESULTS: Atrial overdrive pacing increased the percentage of atrial pacing from 30% to 80% (P < .0001), was well tolerated, and did not interfere with (a) delivery of CRT (95% mean ventricular pacing in both groups), (b) response to CRT (70% responders in the control vs 67% in the treatment group), or (c) cardiac function (left ventricular ejection fraction increased from 24.5% +/- 6.2% to 32.7% +/- 10.9% in the control and from 25.8% +/- 6.8% to 33.1% +/- 12.6% in the treatment group). The incidence of permanent AF was 3.3% in both groups. By logistic regression analysis, a history of AF (P < .001) and absence of antiarrhythmic drugs (P = .002) were associated with permanent AF. CONCLUSIONS: In this first trial of a specific AF prevention algorithm in CRT recipients, AOP was safe and did not worsen HF. The prevention algorithm did not lower the 1-year incidence of AF.