PMID- 33883380
OWN - NLM
STAT- MEDLINE
DCOM- 20220215
LR  - 20220215
IS  - 1347-4820 (Electronic)
IS  - 1346-9843 (Linking)
VI  - 85
IP  - 8
DP  - 2021 Jul 21
TI  - Efficacy and Safety of SATAKE HotBalloon((R)) Catheter for Treatment of Paroxysmal 
      Atrial Fibrillation　- A Post-Marketing Surveillance Study.
PG  - 1314-1320
LID - 10.1253/circj.CJ-20-0883 [doi]
AB  - BACKGROUND: SATAKE HotBalloon((R))catheter (HBC) is a radiofrequency balloon 
      catheter for the treatment of atrial fibrillation (AF), and was approved for use 
      in Japan to treat drug-resistant paroxysmal AF in 2015. Post-marketing 
      surveillance study was conducted by Toray Industries, Inc. to evaluate the 
      efficacy and safety of HBC treatment in patients with paroxysmal AF in a 
      real-world setting. This study is the first nation-wide survey of HBC treatment 
      for paroxysmal AF in clinical practice in Japan.Methods and Results:This was a 
      single-arm, multicenter observational study with an observation period of 48 
      weeks after ablation. Pulmonary vein isolation and AF non-recurrence rates were 
      evaluated and adverse events (AEs) were observed at 46 sites in Japan. An AF 
      event was defined as recurrence of AF or re-ablation from 12 to 48 weeks after 
      ablation. The success rate of pulmonary vein isolation was 99.0% (486/491) for 
      patients with AF. The cumulative AF non-recurrence rate was 94.1% at 24 weeks and 
      87.8% at 48 weeks. AEs were found to occur 21.5% (114/530), and ablation-related 
      AEs were found to occur 2.6% (14/530) during the study period, with the most 
      common being pericardial effusion (0.8%, 4/530). CONCLUSIONS: This study 
      demonstrates the efficacy and safety of HBC ablation in Japanese patients with 
      recurrent symptomatic paroxysmal AF refractory to antiarrhythmic therapy.
FAU - Yoshida, Yukihiko
AU  - Yoshida Y
AD  - Japanese Red Cross Nagoya Dai-ni Hospital.
FAU - Yamane, Teiichi
AU  - Yamane T
AD  - Jikei University School of Medicine.
FAU - Nakahara, Shiro
AU  - Nakahara S
AD  - Dokkyo Medical University Saitama Medical Center.
FAU - Kobori, Atsushi
AU  - Kobori A
AD  - Kobe City Medical Center General Hospital.
FAU - Sohara, Hiroshi
AU  - Sohara H
AD  - Shonantobu General Hospital.
FAU - Aonuma, Kazutaka
AU  - Aonuma K
AD  - University of Tsukuba.
FAU - Satake, Shutaro
AU  - Satake S
AD  - Hayama Heart Center.
CN  - HotBalloon PMS Study Investigators
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210421
PL  - Japan
TA  - Circ J
JT  - Circulation journal : official journal of the Japanese Circulation Society
JID - 101137683
SB  - IM
MH  - *Atrial Fibrillation/surgery
MH  - *Catheter Ablation
MH  - Catheters
MH  - Humans
MH  - Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - *Pulmonary Veins/surgery
MH  - Recurrence
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Atrial fibrillation
OT  - Catheter ablation
OT  - HotBalloon(R)
OT  - Pulmonary vein isolation
EDAT- 2021/04/23 06:00
MHDA- 2022/02/16 06:00
CRDT- 2021/04/22 06:06
PHST- 2021/04/23 06:00 [pubmed]
PHST- 2022/02/16 06:00 [medline]
PHST- 2021/04/22 06:06 [entrez]
AID - 10.1253/circj.CJ-20-0883 [doi]
PST - ppublish
SO  - Circ J. 2021 Jul 21;85(8):1314-1320. doi: 10.1253/circj.CJ-20-0883. Epub 2021 Apr 
      21.