Author + information
- Vivek Y. Reddy, MD1,2,∗ (, )
- Massimo Grimaldi, MD3,
- Tom De Potter, MD4,
- Johan M. Vijgen, MD, FHRS5,
- Alan Bulava, MD, PhD6,
- Mattias Francis Duytschaever, MD7,
- Martin Martinek, MD8,
- Andrea Natale, MD, FHRS9,
- Sebastien Knecht, MD, PhD7,
- Petr Neuzil, MD, PhD2 and
- Helmut Pürerfellner, MD8
- 1Icahn School of Medicine at Mount Sinai, New York, NY, USA
- 2Na Homolce Hospital, Prague, Czech Republic
- 3Ospedale General Regionale F. Muilli, Acquaviva delle Fonti, Italy
- 4OLV Hospital, Aalst, Belgium
- 5Jessa Hospital, Hasselt, Belgium
- 6Ceske Budejovice Hospital and Faculty of Health and Social Sciences, University of South Bohemia in Ceske Budejovice, Czech Republic
- 7AZ Sint Jan, Bruges, Belgium
- 8Ordensklinikum Linz Elisabethinen, Linz, Austria
- 9Texas Cardiac Arrhythmia Institute, Austin, TX, USA
- ↵∗Address for Correspondence Vivek Y. Reddy, MD Helmsley Electrophysiology Center Icahn School of Medicine at Mount Sinai One Gustave L. Levy Place, PO Box 1030 New York, NY 10029 Tel: +1-212-241-7114; Fax: +1-646-537-9691.
Objectives To evaluate the safety and acute performance of a novel catheter for very high power–short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation (PAF).
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 90W/4s lesions.
Methods QDOT-FAST is a prospective, multicenter, single-arm study enrolling patients with symptomatic PAF indicated for catheter-based pulmonary vein isolation (PVI). Primary endpoints were acute effectiveness (confirmation of entrance block in all targeted pulmonary veins [PVs] after adenosine/isoproterenol challenge) and acute safety (primary adverse events [PAEs]). Participants were screened for silent cerebral lesions (SCLs) by MRI. Patients were followed for 3 months post-ablation.
Results A total of 52 patients underwent ablation and completed follow-up. PVI was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 and 6.6 ± 8.2 minutes, respectively. Most patients (n=49; 94.2%) were in sinus rhythm at 3 months. Two PAEs were reported: one pseudoaneurysm and one asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, PV stenosis, or unanticipated adverse device effects. Six patients had identified SCLs—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.
- Atrial fibrillation
- Catheter ablation
- Pulmonary vein ablation
- Contact force
- Irrigation rate
Disclosure information: This study was funded by Biosense Webster. Dr. Reddy reports receiving consulting fees from Biosense Webster. He also has conflicts of interest with other companies not related to this manuscript; a comprehensive list is included as a Supplemental Appendix. Dr. Grimaldi reports a patent agreement with Johnson & Johnson not related to the submitted work. Dr. De Potter reports nonfinancial support from Johnson & Johnson during the conduct of the study. Dr. Martinek reports personal fees from Biosense Webster (Johnson & Johnson), personal fees from Abbott Medical, personal fees from Medtronic, and personal fees from Boston Scientific outside the submitted work. Dr. Knecht reports grants and personal fees from Biosense Webster outside the submitted work. Dr. Pürerfellner reports other support from Biosense Webster during the conduct of the study and outside the submitted work. Dr. Vijgen, Dr. Bulava, Dr. Duytschaever, Dr. Natale, and Dr. Neuzil have nothing to disclose.
ClinicalTrials.gov Identifier: NCT03459196
- Received March 30, 2019.
- Revision received April 24, 2019.
- Accepted April 25, 2019.
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.