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Aims Contact force (CF)–sensing radiofrequency (RF) catheters with an ablation index have shown reproducible outcomes for the treatment of atrial fibrillation (AF) in large multicentre studies. A dual-energy (DE) focal CF catheter to deliver RF and unipolar/biphasic pulsed field ablation (PFA), integrated with a three-dimensional (3D) mapping system, can provide operators with additional flexibility. The SmartfIRE study assessed the safety and efficacy of this novel technology for the treatment of drug-refractory, symptomatic paroxysmal AF. Results at 3 months post-ablation are presented here. Methods and results Pulmonary vein isolation (PVI) was performed using a DE focal, irrigated CF-sensing catheter with the recommendation of PFA at posterior/inferior and RF ablation at the anterior/ridge/carina segments. Irrespective of energy, a tag size of 3 mm; an inter-tag distance ≤6 mm; a target index of 550 for anterior, roof, ridge, and carina; and a target index of 400 for posterior and inferior were recommended. Cavotricuspid isthmus ablation was permitted in patients with documented typical atrial flutter. The primary effectiveness endpoint was acute procedural success. The primary safety endpoint was the rate of primary adverse events (PAEs) within 7 days of the procedure. A prespecified patient subset underwent oesophageal endoscopy (EE; 72 h post-procedure), neurological assessment (NA; pre-procedure and discharge), and cardiac computed tomography (CT)/magnetic resonance angiogram (MRA) imaging (pre-procedure and 3 months post-procedure) for additional safety evaluation, and a mandatory remapping procedure (Day 75 ± 15) for PVI durability assessment. Of 149 patients enrolled between February and June 2023, 140 had the study catheter inserted (safety analysis set) and 137 had ablation energy delivered (per-protocol analysis set). The median (Q1/Q3) total procedure and fluoroscopy times were 108.0 (91.0/126.0) and 4.2 (2.3/7.7) min (n = 137). The acute procedural success rate was 100%. First-pass isolation was achieved in 89.1% of patients and 96.8% of veins. Cavotricuspid isthmus ablations were successfully performed in 12 patients [pulsed field (PF) only: 6, RF only: 5, and RF/PF: 1]. The PAE rate was 4.4% [6/137 patients; 2 pulmonary vein (PV) stenoses, 2 cardiac tamponades/perforations, 1 stroke, and 1 pericarditis]. No coronary artery spasm was reported. No oesophageal lesion was seen in the EE subset (0/31, 0%). In the NA subset (n = 30), microemboli lesions were identified in 2 patients (2/30, 6.7%), both of which were resolved at follow-up; only 1 was symptomatic (silent cerebral lesion, 3.3%). In the CT/MRA subset (n = 30), severe PV narrowing (of >70%) was detected in 2 patients (2/30, 6.7%; vein level 2/128, 1.6%), of whom 1 underwent dilatation and stenting and 1 was asymptomatic; both were associated with high index values and a small inter-tag distance. In the PV durability subset (n = 30), 100/115 treated PVs (87%) were durably isolated and 18/30 patients (60.0%) had all PVs durably isolated. Conclusion A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability. Clinical trial registration ClinicalTrials.gov Identifier: NCT05752487. [ABSTRACT FROM AUTHOR]

Aims: Catheter ablation is a widely accepted intervention for atrial fibrillation (AF) management. Prior to undertaking this procedure, thorough patient education on its efficacy and potential complications is crucial. Additionally, educating patients about stroke risk management and anticoagulant therapy is imperative. At Mater Private Hospital in Dublin, we implemented a solution, integrating a customized treatment pathway and a mobile application. This patient-centred approach aims to optimize the clinical management of AF catheter ablation candidates, focusing on knowledge gaps and adherence to guideline-based care to enhance overall outcomes., Methods and Results: The application automates pre-operative assessments and post-operative support, facilitating seamless patient-clinician communication. During the observation period (September 2022-April 2023), 63 patients installed the app. Patient adherence to the pathway was strong, with 98% of patients actively engaging in the treatment pathway and with 81% completing all pre-operative tasks. The average enrolment-to-admission duration was 14 days, and post-ablation tasks were fulfilled by 62% of patients within an average of 36 days. Operators perceived the solution as user-friendly and effective in enhancing patient connectivity. Patient satisfaction was high, and knowledge about AF improved notably through the solution, particularly concerning the recognition of symptoms and anticoagulation therapy-related complications., Conclusion: Our findings demonstrate the successful implementation of the app-based Ablation Solution, showcasing widespread patient use, improved adherence, and enhanced understanding of AF and its treatments. The system effectively connects healthcare providers with patients, offering a promising approach to streamline AF catheter ablation management and improve patient outcomes., Competing Interests: Conflict of interest: N.F. reports institutional educational support from Biosense Webster and Synapse Medical as well as speakers fees from Daiichi Sankyo, unrelated to the submitted work. G.S. reports personal fees from Abbott, Bayer, Boston Scientific, Bayer, Johnson and Johnson Medical, and Luma Vision, not related to the present study, and consulting fees from Boston Scientific related to the present study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Contact force (CF)-sensing radiofrequency (RF) catheters with an ablation index have shown reproducible outcomes for the treatment of atrial fibrillation (AF) in large multicentre studies. A dual-energy (DE) focal CF catheter to deliver RF and unipolar/biphasic pulsed field ablation (PFA), integrated with a three-dimensional (3D) mapping system, can provide operators with additional flexibility. The SmartfIRE study assessed the safety and efficacy of this novel technology for the treatment of drug-refractory, symptomatic paroxysmal AF. Results at 3 months post-ablation are presented here., Methods and Results: Pulmonary vein isolation (PVI) was performed using a DE focal, irrigated CF-sensing catheter with the recommendation of PFA at posterior/inferior and RF ablation at the anterior/ridge/carina segments. Irrespective of energy, a tag size of 3 mm; an inter-tag distance ≤6 mm; a target index of 550 for anterior, roof, ridge, and carina; and a target index of 400 for posterior and inferior were recommended. Cavotricuspid isthmus ablation was permitted in patients with documented typical atrial flutter. The primary effectiveness endpoint was acute procedural success. The primary safety endpoint was the rate of primary adverse events (PAEs) within 7 days of the procedure. A prespecified patient subset underwent oesophageal endoscopy (EE; 72 h post-procedure), neurological assessment (NA; pre-procedure and discharge), and cardiac computed tomography (CT)/magnetic resonance angiogram (MRA) imaging (pre-procedure and 3 months post-procedure) for additional safety evaluation, and a mandatory remapping procedure (Day 75 ± 15) for PVI durability assessment. Of 149 patients enrolled between February and June 2023, 140 had the study catheter inserted (safety analysis set) and 137 had ablation energy delivered (per-protocol analysis set). The median (Q1/Q3) total procedure and fluoroscopy times were 108.0 (91.0/126.0) and 4.2 (2.3/7.7) min (n = 137). The acute procedural success rate was 100%. First-pass isolation was achieved in 89.1% of patients and 96.8% of veins. Cavotricuspid isthmus ablations were successfully performed in 12 patients [pulsed field (PF) only: 6, RF only: 5, and RF/PF: 1]. The PAE rate was 4.4% [6/137 patients; 2 pulmonary vein (PV) stenoses, 2 cardiac tamponades/perforations, 1 stroke, and 1 pericarditis]. No coronary artery spasm was reported. No oesophageal lesion was seen in the EE subset (0/31, 0%). In the NA subset (n = 30), microemboli lesions were identified in 2 patients (2/30, 6.7%), both of which were resolved at follow-up; only 1 was symptomatic (silent cerebral lesion, 3.3%). In the CT/MRA subset (n = 30), severe PV narrowing (of >70%) was detected in 2 patients (2/30, 6.7%; vein level 2/128, 1.6%), of whom 1 underwent dilatation and stenting and 1 was asymptomatic; both were associated with high index values and a small inter-tag distance. In the PV durability subset (n = 30), 100/115 treated PVs (87%) were durably isolated and 18/30 patients (60.0%) had all PVs durably isolated., Conclusion: A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability., Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT05752487., Competing Interests: Conflict of interest: M.D. has served on the speakers bureau and as a consultant and has received research support from Biosense Webster, Inc. T.D.P. has received consulting fees and honoraria for lectures and presentations from Biosense Webster, Inc. and Adagio Medical (all payments were directed to institution). J.H. reports speakers fees and consultant honoraria from Biosense Webster, Inc. and Boston Scientific. T.P. reports support for attending a meeting and travel from Biosense Webster, Inc. J.V. reports research grants from Abbott, Biotronik, Boston Scientific, CardioFocus, and Medtronic; speakers fees from Abbott and CardioFocus; and serving on an advisory board for Boston Scientific. G.S. reports personal fees from Abbott, Bayer, Boston Scientific, Johnson & Johnson Medical, and LUMA Vision not related to the present study and fees from Johnson & Johnson Medical in relation to the present study. M.B.K. reports speakers fees from Biosense Webster, Inc. H.P. reports consultancy and honoraria as a speaker for Abbott, Biosense Webster, Inc., Boston Scientific, and Medtronic. P.L. has received consulting fees and a travel grant from Biosense Webster, Inc. outside the presented work. All remaining authors have declared no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)