Improved procedural workflow for catheter ablation of paroxysmal AF with high-density mapping system and advanced technology: Rationale and study design of a multicenter international study

The antral region of pulmonary veins (PV)s seems to play a key role in a strategy aimed at preventing atrial fibrillation (AF) recurrence. Particularly, low-voltage activity in tissue such as the PV antra and residual potential within the antral scar likely represent vulnerabilities in antral lesion sets, and ablation of these targets seems to improve freedom from AF. The aim of this study is to validate a structured application of an approach that includes the complete abolition of any antral potential achieving electrical quiescence in antral regions.The improveD procEdural workfLow for cathETEr ablation of paroxysmal AF with high density mapping system and advanced technology (DELETE AF) study is a prospective, single-arm, international post-market cohort study designed to demonstrate a low rate of clinical atrial arrhythmias recurrence with an improved procedural workflow for catheter ablation of paroxysmal AF, using the most advanced point-by-point RF ablation technology in a multicenter setting. About 300 consecutive patients with standard indications for AF ablation will be enrolled in this study. Post-ablation, all patients will be monitored with ambulatory event monitoring, starting within 30 days post-ablation to proactively detect and manage any recurrences within the 90-day blanking period, as well as Holter monitoring at 3, 6, 9, and 12 months post-ablation. Healthcare resource utilization, clinical data, complications, patients' medical complaints related to the ablation procedure and patient's reported outcome measures will be prospectively traced and evaluated.The DELETE AF trial will provide additional knowledge on long-term outcome following a structured ablation workflow, with high density mapping, advanced algorithms and local impedance technology, in an international multicentric fashion. DELETE AF is registered at ClinicalTrials.gov (NCT05005143).© 2022 The Authors. Clinical Cardiology published by Wiley Periodicals LLC

Minimal fluoroscopic approaches and factors associated with radiation dose when high-definition mapping is used for supraventricular tachycardia ablation: insight from the CHARISMA registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Limited data exist on factors associated with radiation exposure during ablation procedures when a high definition mapping technology is used. Purpose To report factors associated with radiation exposure and data on feasibility and safety of a minimal fluoroscopic approach using the Rhythmia mapping system in supraventricular tachycardia (SVT) ablation procedures. Methods Consecutive patients indicated for arrhythmia ablation were enrolled in the CHARISMA study at 12 centers. We included in this analysis consecutive right-side procedures performed through a minimal fluoroscopy approach with the Rhythmia mapping system were analyzed. A 3D geometry of chambers of interest was reconstructed on the basis of the electroanatomic information taken from the mapping system. Fluoroscopy was used only if deemed necessary. The effective dose (ED) was calculated using accepted formula. For our purpose high dose exposure was defined as an ED greater than the median value of ED of the population exposed to radiation. Results This analysis included 325 patients (mean age = 56 ± 17 years, 57% male) undergoing SVT procedures (152 AVNRT, 116 AFL, 41 AP and 16 AT). During the study, 27481 seconds of fluoroscopy was used (84.6 ± 224 seconds per procedure), resulting in a mean equivalent ED of 1.1 ± 3.7 mSv per patient. The mean reconstructed RA volume was 99 ± 54 ml in a mean mapping time of 12.2 ± 7 min. The mean number of radiofrequency ablations (RFC) to terminate each arrhythmia was 9.4 ± 9 (mean RFC delivery time equal to 6.7 ± 6 min). 192 procedures (59.1%) were completed without any use of fluoroscopy; during the remaining 133 procedures (39.9%), 206.6 ± 313.4 seconds of fluoroscopy was used (median ED = 1.2 mSv). In a minority of the cases (n = 25, 7.7%) the fluoroscopy time was higher than 5 minutes (median ED = 6.5 mSv), whereas radiologic exposure time greater than 1 minute occurred in ninety cases (27.7%, median ED = 2.1 mSv). On multivariate logistic analysis adjusted for baseline confounders the RFC application time (OR = 1.0014, 95%CI: 1.0007 to 1.0022; p = 0.0001) was independently associated to an ED greater than 1.2 mSv, whereas female gender had an inverse association (0.54, 0.29 to 0.98; p = 0.0435). Acute success was reached in 97.8% of the cases. During a mean of 290.7 ± 169.6 days follow-up, no major adverse events related to the procedure were reported. Overall, the recurrence rate of the primary arrhythmia during follow-up was 2.5%. Conclusions In our experience, arrhythmias ablation through minimal fluoroscopy approach with the use of a novel ablation technology is safe, feasible, and effective in common right atrial arrhythmias. High-dose exposure occurred in a very limited number of cases, without any reduction of the safety and acute and long-term effectiveness profile

Chronotropic Incompetence and Functional Capacity in Chronic Heart Failure: No Role of beta-Blockers and beta-Blocker Dose.

Aim: To assess the effect of chronotropic incompetence on functional capacity in chronic heart failure (CHF) patients, as evaluated as NYHA and peak oxygen consumption (pVO 2), focusing on the presence and dose of β-blocker treatment. Methods: Nine hundred and sixty-seven consecutive CHF patients were evaluated, 328 of whom were discarded because they failed to meet the study criteria. Of the 639 analyzed, 90 were not treated with β-blockers whereas the other 549 were. The latter were further subdivided in high (n = 184) and low (n = 365) β-blockers daily dose group in accordance with an arbitrary cut-off of 25 mg for carvedilol and of 5 mg for bisoprolol. Failure to achieve 80% of the percentage of maximum age predicted peak heart rate (%Max PHR) or of HR reserve (%HRR) constituted chronotropic incompetence. Results: No differences were found in NYHA or pVO2 between patients with and without β-blockers and, similarly, between high and low β-blocker dose groups. Twenty and sixty-nine percent of not β-blocked patients showed chronotropic incompetence according to %Max PHR and %HRR, respectively, whereas this prevalence rose to 61% and 84% in those on β-blocker therapy. Patients taking β-blockers without chronotropic incompetence, as inferable from both %Max PHR and %HRR, showed higher NYHA and pVO2 regardless of drug dose, whereas, in not β-blocked patients, only %HRR revealed a difference in functional capacity. At multivariable analysis, HR increase during exercise (ΔHR) was the variable most strongly associated to pVO2 (β: 0.572; SE: 0.008; P < 0.0001) and NYHA class (β: -0.499; SE: 0.001; P < 0.0001). Conclusions: ΔHR is a powerful predictor of CHF severity regardless of the presence of β-blocker therapy and of β-blocker daily dose