Author + information
- Received March 30, 2019
- Revision received April 24, 2019
- Accepted April 25, 2019
- Published online July 15, 2019.
- Vivek Y. Reddy, MDa,b,∗ (, )
- Massimo Grimaldi, MDc,
- Tom De Potter, MDd,
- Johan M. Vijgen, MDe,
- Alan Bulava, MD, PhDf,
- Mattias Francis Duytschaever, MDg,
- Martin Martinek, MDh,
- Andrea Natale, MDi,
- Sebastien Knecht, MD, PhDg,
- Petr Neuzil, MD, PhDb and
- Helmut Pürerfellner, MDh
- aCardiac Electrophysiology, Icahn School of Medicine at Mount Sinai, New York, New York
- bDepartment of Cardiology, Na Homolce Hospital, Prague, Czech Republic
- cDepartment of Cardiology, Ospedale Generale Regionale F. Muilli, Acquaviva delle Fonti, Italy
- dCardiovascular Center, Onze Lieve Vrouwziekenhuis, Hospital, Aalst, Belgium
- eHasselt Heart Center, Jessa Hospital, Hasselt, Belgium
- fDepartment of Cardiology, Ceske Budejovice Hospital, Faculty of Health and Social Sciences, University of South Bohemia in Ceske Budejovice, Ceske Budejovice, Czech Republic
- gDepartment of Cardiology, Algemeen Ziekenhuis Sint Jan, Bruges, Belgium
- hDepartment of Cardiology, Ordensklinikum Linz Elisabethinen, Linz, Austria
- iTexas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas
- ↵∗Address for correspondence:
Dr. Vivek Y. Reddy, Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, PO Box 1030, New York, New York 10029.
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)
- atrial fibrillation
- catheter ablation
- contact force
- irrigation rate
- pulmonary vein ablation
This study was funded by Biosense Webster. Dr. Reddy has received consulting fees from Biosense Webster; and has conflicts of interest with other companies not related to this manuscript (see the comprehensive list in the Online Appendix). Dr. Grimaldi has a patent agreement with Biosense Webster (Johnson and Johnson) that is not related to the submitted work. Dr. De Potter reports nonfinancial support from Johnson and Johnson during the conduct of the study. Dr. Martinek has received personal fees unrelated to the submitted work from Biosense Webster (Johnson and Johnson), Abbott Medical, Medtronic, and Boston Scientific; has served as a speaker, advisory board member, and proctor for Biosense Webster (Johnson and Johnson), Abbott Medical, and Boston Scientific; and has served as a speaker and proctor for Medtronic. Dr. Knecht has received grants and personal fees unrelated to the submitted work from Biosense Webster (Johnson and Johnson), Medtronic, Abbott Medical, and Boston Scientific. Dr. Pürerfellner has received honoraria for consulting and speaking during the conduct of the study and unrelated to the submitted work from Biosense Webster (Johnson and Johnson). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received March 30, 2019.
- Revision received April 24, 2019.
- Accepted April 25, 2019.
- 2019 The Authors