Temperature-controlled catheter ablation for paroxysmal atrial fibrillation: The qdot-micro workflow study

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  • Tom De Potter, OLV Hospital Aalst
  • ,
  • Massimo Grimaldi, Ospedale Generale Regionale "F. Miulli"
  • ,
  • Henrik Kjaerulf Jensen
  • Josef Kautzner, Institute for Clinical and Experimental Medicine
  • ,
  • Petr Neuzil, Na Homolce Hospital
  • ,
  • Johan Vijgen, Jessa Ziekenhuis. Virga Jesse
  • ,
  • Andrea Natale, St. David's Medical Center, Dell Medical School, Case Western Reserve University, Stanford University, University of Texas at Austin, Scripps Green Hospital
  • ,
  • Steen Buus Kristiansen
  • Peter Lukac
  • Petr Peichl, Institute for Clinical and Experimental Medicine
  • ,
  • Vivek Y. Reddy, Na Homolce Hospital, Icahn School of Medicine at Mount Sinai

Background: A novel QDOT MICRO (Biosense Webster, Inc., Irvine, CA) catheter with optimized temperature control and microelectrodes was designed to incorporate real-time temperature sensing with contact force detection and microelectrodes to streamline ablation workflow. The QDOT-MICRO feasibility study evaluated the workflow, performance, and safety of temperature-controlled catheter ablation in patients with symptomatic paroxysmal atrial fibrillation with conventional ablation setting. Methods: This was a non-randomized, single-arm, first-in-human study. The primary outcome was pulmonary vein isolation (PVI), confirmed by entrance block after adenosine and/or isoproterenol challenge. Safety outcomes included incidences of early-onset primary adverse events (AEs) and serious adverse device effects (SADEs). Device performance was evaluated via physician survey. Results: All evaluated patients (n = 42) displayed 100% PVI. Two primary AEs (4.8%) were reported: 1 pericarditis and 1 vascular pseudoaneurysm. An additional SADE of localized infection was reported in 1 patient. No stroke, patient deaths, or other unanticipated AEs were reported. Average power delivered was 32.1±4.1 W, with a mean temperature of 40.8°C±1.6°C. Mean procedure (including 20-minute wait), fluoroscopy, and radiofrequency application times were 129.8, 6.7, and 34.0 minutes, respectively. On device performance, physicians reported overall satisfactory performance with the new catheter, with highest scores for satisfaction and usefulness of the temperature indicator. Conclusions: Initial clinical experience with the novel catheter showed 100% acute PVI success and acceptable safety and device performance in temperature-controlled ablation mode. There were no deaths, stroke, or unanticipated AEs. Fluoroscopy and procedural times were short and similar or better than reported for prior generation catheters.

TidsskriftJournal of Atrial Fibrillation
StatusUdgivet - apr. 2021

Bibliografisk note

Funding Information:
T.D.P. received non-financial support from J&J during the conduct of the study. M.G. has a licensed patent agreement with J&J, unrelated to the current data. H.K.J. received grants from Biosense Webster during the conduct of the study; grants from Novo Nordisk Foundation (NNF18OC0031258); and personal fees from Biosense Webster and Abbott, outside the submitted work. J.K. received personal fees and/ or other from Biosense Webster, Boston Scientific, EPIX, MicroPort, Medtronic, and Abbott (SJM) outside the submitted work. P.N. has nothing to disclose. J.V. has nothing to disclose. A.N. has nothing to disclose. S.B.K. has nothing to disclose. P.L. received grants and personal fees from Biosense Webster. P.P. has nothing to disclose. V.Y.R. 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.

Funding Information:
The authors wish to express their appreciation to all of the QDOT-MICRO trial investigators.The QDOT-MICRO study (ClinicalTrials. gov Identifier: NCT02944968) was sponsored by Biosense Webster, Inc. The authors wish to thank the following individuals for their efforts in execution of the trial, statistical analysis, medical writing, and providing valuable input/contribution to the development of the manuscript: Carmen Rousseeuw,Lee Ming Boo,Shelley Wells,Bharat Kumar Janapala, and Baohui Zhang. Medical writing support was provided by Megan Knagge,of MedErgy,and was funded by Biosense Webster, Inc. The authors retained full control of the manuscript content development, including revisions, as well as the decision to submit the manuscript.The authors had full access to sponsor-provided data that were collected during execution of the study protocol.

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