Tom De Potter1, Massimo Grimaldi2, Henrik Kjaerulf Jensen3, Josef Kautzner4, Petr Neuzil5, Johan Vijgen6, Andrea Natale7,8, Steen Buus Kristiansen3, Peter Lukac3, Petr Peichl4, Vivek Y Reddy5,9. 1. OLV Hospital, Cardiology Department, Moorselbaan 164, 9300 Aalst, Belgium. 2. Ospedale Generale Regionale "F. Miulli" Strada Prov. 127, 70021 Acquaviva delle Fonti BA, Italy. 3. Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark. 4. Institute for Clinical and Experimental Medicine, Vídeňská 1958/9, 140 21 Prague, Czech Republic. 5. Na Homolce Hospital, Roentgenova 2, 150 30 Prague 5, Czech Republic. 6. Jessa Ziekenhuis, Virga Jesse, Stadsomvaart 11, 3500 Hasselt, Belgium. 7. Texas Cardiac Arrhythmia Institute, St. David's Medical Center 3000 N. IH-35, Suite 720 Austin, TX, 78705, USA. 8. Interventional Electrophysiology, SCRIPPS Green Hospital, San Diego, CA, 92037, USA. 9. Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA.
Abstract
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.
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.
Authors: Andrea Natale; Vivek Y Reddy; George Monir; David J Wilber; Bruce D Lindsay; H Thomas McElderry; Charan Kantipudi; Moussa C Mansour; Daniel P Melby; Douglas L Packer; Hiroshi Nakagawa; Baohui Zhang; Robert B Stagg; Lee Ming Boo; Francis E Marchlinski Journal: J Am Coll Cardiol Date: 2014-08-19 Impact factor: 24.094
Authors: Jin Iwasawa; Jacob S Koruth; Jan Petru; Libor Dujka; Stepan Kralovec; Katerina Mzourkova; Srinivas R Dukkipati; Petr Neuzil; Vivek Y Reddy Journal: J Am Coll Cardiol Date: 2017-08-01 Impact factor: 24.094
Authors: Hugh Calkins; Gerhard Hindricks; Riccardo Cappato; Young-Hoon Kim; Eduardo B Saad; Luis Aguinaga; Joseph G Akar; Vinay Badhwar; Josep Brugada; John Camm; Peng-Sheng Chen; Shih-Ann Chen; Mina K Chung; Jens Cosedis Nielsen; Anne B Curtis; D Wyn Davies; John D Day; André d'Avila; N M S Natasja de Groot; Luigi Di Biase; Mattias Duytschaever; James R Edgerton; Kenneth A Ellenbogen; Patrick T Ellinor; Sabine Ernst; Guilherme Fenelon; Edward P Gerstenfeld; David E Haines; Michel Haissaguerre; Robert H Helm; Elaine Hylek; Warren M Jackman; Jose Jalife; Jonathan M Kalman; Josef Kautzner; Hans Kottkamp; Karl Heinz Kuck; Koichiro Kumagai; Richard Lee; Thorsten Lewalter; Bruce D Lindsay; Laurent Macle; Moussa Mansour; Francis E Marchlinski; Gregory F Michaud; Hiroshi Nakagawa; Andrea Natale; Stanley Nattel; Ken Okumura; Douglas Packer; Evgeny Pokushalov; Matthew R Reynolds; Prashanthan Sanders; Mauricio Scanavacca; Richard Schilling; Claudio Tondo; Hsuan-Ming Tsao; Atul Verma; David J Wilber; Teiichi Yamane Journal: J Arrhythm Date: 2017-09-15
Authors: Vivek Y Reddy; Massimo Grimaldi; Tom De Potter; Johan M Vijgen; Alan Bulava; Mattias Francis Duytschaever; Martin Martinek; Andrea Natale; Sebastien Knecht; Petr Neuzil; Helmut Pürerfellner Journal: JACC Clin Electrophysiol Date: 2019-05-08
Authors: Vivek Y Reddy; Scott Pollak; Bruce D Lindsay; H Thomas McElderry; Andrea Natale; Charan Kantipudi; Moussa Mansour; Daniel P Melby; Dhanunjaya Lakkireddy; Tzachi Levy; David Izraeli; Chithra Sangli; David Wilber Journal: JACC Clin Electrophysiol Date: 2016-11-21
Authors: Jens Cosedis Nielsen; Arne Johannessen; Pekka Raatikainen; Gerhard Hindricks; Håkan Walfridsson; Steen Michael Pehrson; Anders Englund; Juha Hartikainen; Leif Spange Mortensen; Peter Steen Hansen Journal: Heart Date: 2016-08-26 Impact factor: 5.994
Authors: Saumil R Oza; Tina D Hunter; Angelo B Biviano; Gopi Dandamudi; Bengt Herweg; Anshul M Patel; Scott J Pollak; Huijian Wang; Robert S Fishel Journal: J Cardiovasc Electrophysiol Date: 2014-04-09