PMID- 34950350
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220429
IS  - 1941-6911 (Print)
IS  - 1941-6911 (Electronic)
IS  - 1941-6911 (Linking)
VI  - 13
IP  - 6
DP  - 2021 Apr-May
TI  - Temperature-Controlled Catheter Ablation for Paroxysmal Atrial Fibrillation: the 
      QDOT-MICRO Workflow Sttudy.
PG  - 20200460
LID - 10.4022/jafib.20200460 [doi]
LID - 20200460
AB  - 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 degrees C+/-1.6 degrees 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.
FAU - Potter, Tom De
AU  - Potter T
AD  - OLV Hospital, Cardiology Department, Moorselbaan 164, 9300 Aalst, Belgium.
FAU - Grimaldi, Massimo
AU  - Grimaldi M
AD  - Ospedale Generale Regionale "F. Miulli" Strada Prov. 127, 70021 Acquaviva delle 
      Fonti BA, Italy.
FAU - Jensen, Henrik Kjaerulf
AU  - Jensen HK
AD  - Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens 
      Boulevard 99, DK-8200 Aarhus N, Denmark.
FAU - Kautzner, Josef
AU  - Kautzner J
AD  - Institute for Clinical and Experimental Medicine, Videnska 1958/9, 140 21 Prague, 
      Czech Republic.
FAU - Neuzil, Petr
AU  - Neuzil P
AD  - Na Homolce Hospital, Roentgenova 2, 150 30 Prague 5, Czech Republic.
FAU - Vijgen, Johan
AU  - Vijgen J
AD  - Jessa Ziekenhuis, Virga Jesse, Stadsomvaart 11, 3500 Hasselt, Belgium.
FAU - Natale, Andrea
AU  - Natale A
AD  - Texas Cardiac Arrhythmia Institute, St. David's Medical Center 3000 N. IH-35, 
      Suite 720 Austin, TX, 78705, USA.
AD  - Interventional Electrophysiology, SCRIPPS Green Hospital, San Diego, CA, 92037, 
      USA.
FAU - Kristiansen, Steen Buus
AU  - Kristiansen SB
AD  - Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens 
      Boulevard 99, DK-8200 Aarhus N, Denmark.
FAU - Lukac, Peter
AU  - Lukac P
AD  - Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens 
      Boulevard 99, DK-8200 Aarhus N, Denmark.
FAU - Peichl, Petr
AU  - Peichl P
AD  - Institute for Clinical and Experimental Medicine, Videnska 1958/9, 140 21 Prague, 
      Czech Republic.
FAU - Y Reddy, Vivek
AU  - Y Reddy V
AD  - Na Homolce Hospital, Roentgenova 2, 150 30 Prague 5, Czech Republic.
AD  - Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 
      10029, USA.
LA  - eng
PT  - Journal Article
DEP - 20210430
PL  - United States
TA  - J Atr Fibrillation
JT  - Journal of atrial fibrillation
JID - 101514767
PMC - PMC8691282
OTO - NOTNLM
OT  - Arrhythmia
OT  - Atrial fibrillation
OT  - Catheter ablation
OT  - Pulmonary vein isolation
OT  - Workflow
EDAT- 2021/12/25 06:00
MHDA- 2021/12/25 06:01
PMCR- 2021/04/30
CRDT- 2021/12/24 05:49
PHST- 2020/05/11 00:00 [received]
PHST- 2020/05/16 00:00 [revised]
PHST- 2020/06/26 00:00 [accepted]
PHST- 2021/12/24 05:49 [entrez]
PHST- 2021/12/25 06:00 [pubmed]
PHST- 2021/12/25 06:01 [medline]
PHST- 2021/04/30 00:00 [pmc-release]
AID - 10.4022/jafib.20200460 [doi]
PST - epublish
SO  - J Atr Fibrillation. 2021 Apr 30;13(6):20200460. doi: 10.4022/jafib.20200460. 
      eCollection 2021 Apr-May.