Vivek Y Reddy1, Massimo Grimaldi2, Tom De Potter3, Johan M Vijgen4, Alan Bulava5, Mattias Francis Duytschaever6, Martin Martinek7, Andrea Natale8, Sebastien Knecht6, Petr Neuzil9, Helmut Pürerfellner7. 1. Cardiac Electrophysiology, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic. Electronic address: vivek.reddy@mountsinai.org. 2. Department of Cardiology, Ospedale Generale Regionale F. Muilli, Acquaviva delle Fonti, Italy. 3. Cardiovascular Center, Onze Lieve Vrouwziekenhuis, Hospital, Aalst, Belgium. 4. Hasselt Heart Center, Jessa Hospital, Hasselt, Belgium. 5. Department of Cardiology, Ceske Budejovice Hospital, Faculty of Health and Social Sciences, University of South Bohemia in Ceske Budejovice, Ceske Budejovice, Czech Republic. 6. Department of Cardiology, Algemeen Ziekenhuis Sint Jan, Bruges, Belgium. 7. Department of Cardiology, Ordensklinikum Linz Elisabethinen, Linz, Austria. 8. Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas. 9. Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.
Abstract
OBJECTIVES: This study sought to evaluate the safety and short-term performance of a novel catheter for very high power-short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation. BACKGROUND: The vHPSD catheter is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions. METHODS: QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation. RESULTS: A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions-all classified as asymptomatic without clinical or neurologic deficits. CONCLUSIONS: This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters. (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation [QDOT-FAST]; NCT03459196).
OBJECTIVES: This study sought to evaluate the safety and short-term performance of a novel catheter for very high power-short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation. BACKGROUND: The vHPSD catheter is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions. METHODS: QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation. RESULTS: A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions-all classified as asymptomatic without clinical or neurologic deficits. CONCLUSIONS: This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters. (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation [QDOT-FAST]; NCT03459196).
Authors: Leon Iden; Sonia Busch; Daniel Steven; Roland R Tilz; Dong-In Shin; K R Julian Chun; Heidi Estner; Felix Bourier; David Duncker; Philipp Sommer; Andreas Metzner; Tilman Maurer; Nils-Christian Ewertsen; Henning Jansen; Andreas Rillig; Victoria Johnson; Till Althoff Journal: Herzschrittmacherther Elektrophysiol Date: 2021-07-26
Authors: Sergio Castrejón-Castrejón; Marcel Martínez Cossiani; Marta Ortega Molina; Carlos Escobar; Consuelo Froilán Torres; Nerea Gonzalo Bada; Marta Díaz de la Torre; José Manuel Suárez Parga; José Luis López Sendón; José Luis Merino Journal: J Interv Card Electrophysiol Date: 2019-11-12 Impact factor: 1.900