PMID- 38095010
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231214
IS  - 2772-3747 (Electronic)
IS  - 2772-3747 (Linking)
VI  - 3
IP  - 5
DP  - 2023 Oct
TI  - Liquid Nitrogen Cryoballoon Ablation System for Paroxysmal Atrial Fibrillation: A 
      Multicenter, Prospective, Single-Arm Clinical Trial.
PG  - 805-816
LID - 10.1016/j.jacasi.2023.07.005 [doi]
AB  - BACKGROUND: Cryoballoon ablation (CBA) has emerged as an effective treatment for 
      atrial fibrillation (AF). OBJECTIVES: This study sought to assess the performance 
      of a novel liquid nitrogen-driven CBA system and evaluate its safety and efficacy 
      in the treatment of drug-resistant paroxysmal atrial fibrillation (PAF). METHODS: 
      This was a prospective multicenter single-arm clinical trial with 10 
      participating tertiary hospitals enrolling 176 patients with PAF. All 
      participants received liquid nitrogen-driven CBA developed by the Cryofocus 
      Medtech Company. Scheduled follow-up was performed before discharge and 3 months, 
      6 months, and 12 months after CBA. The primary endpoints were defined as 1) 
      treatment success (freedom from antiarrhythmic drugs and atrial tachycardia at 
      12 months after CBA); and 2) immediate success rate of pulmonary vein isolation. 
      The safety endpoint was the incidence of device- and procedure-related adverse 
      events (AEs) and all-cause mortality. RESULTS: A total of 172 participants were 
      included, with an average age of 59.22 +/- 9.25 years and 99 (57.56%) of them men. 
      Immediate success rate was 97.67% (95% CI: 94.15%-99.36%) and 12-month treatment 
      success rate was 82.56% (95% CI: 76.89%-88.23%), including a late recurrence rate 
      of 13.61%. Incidences of device- and procedure-related AEs were 2.27% and 25.00%, 
      respectively. Phrenic nerve palsy (PNP) occurred in 6 patients, of which 5 
      recovered during follow-up. Although the incidence of total severe AEs was 
      17.05%, including an all-cause mortality of 0.57%, only 1 case of permanent PNP 
      was related to the CBA procedure. CONCLUSIONS: This premarketing prospective 
      multicenter single-arm clinical trial demonstrated that the liquid nitrogen 
      cryoablation system is safe and effective in the treatment of PAF.
CI  - (c) 2023 The Authors.
FAU - Nie, Zhenning
AU  - Nie Z
AD  - Zhongshan Hospital, Fudan University, Shanghai, China.
FAU - Zhao, Dongdong
AU  - Zhao D
AD  - Heart Center, Shanghai Tenth People's Hospital, Tongji University School of 
      Medicine, Shanghai, China.
FAU - Ren, Zhongyuan
AU  - Ren Z
AD  - Heart Center, Shanghai Tenth People's Hospital, Tongji University School of 
      Medicine, Shanghai, China.
FAU - Hou, Cody R
AU  - Hou CR
AD  - Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 
      Shanghai, China.
FAU - Su, Xi
AU  - Su X
AD  - Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical 
      College, Beijing, China.
FAU - Deng, Chenggang
AU  - Deng C
AD  - Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical 
      College, Beijing, China.
FAU - Yao, Yan
AU  - Yao Y
AD  - Wuhan Asia Heart Hospital, Wuhan, China.
FAU - Tang, Kai
AU  - Tang K
AD  - Heart Center, Shanghai Tenth People's Hospital, Tongji University School of 
      Medicine, Shanghai, China.
FAU - Li, Yigang
AU  - Li Y
AD  - West China Hospital, Sichuan University, Sichuan, China.
FAU - Fu, Hua
AU  - Fu H
AD  - First Affiliated Hospital of the University of Science and Technology of China, 
      Anhui Provincial Hospital, Anhui, China.
FAU - Zeng, Rui
AU  - Zeng R
AD  - First Affiliated Hospital of the University of Science and Technology of China, 
      Anhui Provincial Hospital, Anhui, China.
FAU - Lu, Zhibing
AU  - Lu Z
AD  - Zhongnan Hospital of Wuhan University, Wuhan, China.
FAU - Li, Hongbing
AU  - Li H
AD  - First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
FAU - Su, Hao
AU  - Su H
AD  - First Affiliated Hospital of Wenzhou Medical University, First Provincial Wenzhou 
      Hospital of Zhejiang, Zhejiang, China.
FAU - Xiao, Fangyi
AU  - Xiao F
AD  - Cardiovascular Division, Department of Medicine, University of Minnesota Medical 
      School, Minneapolis, Minnesota, USA.
FAU - Xu, Yawei
AU  - Xu Y
AD  - Heart Center, Shanghai Tenth People's Hospital, Tongji University School of 
      Medicine, Shanghai, China.
FAU - Ge, Junbo
AU  - Ge J
AD  - Zhongshan Hospital, Fudan University, Shanghai, China.
LA  - eng
PT  - Journal Article
DEP - 20230926
PL  - United States
TA  - JACC Asia
JT  - JACC. Asia
JID - 9918452380106676
PMC - PMC10715880
OTO - NOTNLM
OT  - cryoballoon ablation
OT  - efficacy
OT  - liquid nitrogen
OT  - paroxysmal atrial fibrillation
OT  - premarketing trial
OT  - safety
COIS- This study was supported by Shanghai Hospital Development Center, Shanghai, China 
      (grant no. SHDC2020CR1040B). The authors have reported that they have no 
      relationships relevant to the contents of this paper to disclose.
EDAT- 2023/12/14 06:42
MHDA- 2023/12/14 06:43
PMCR- 2023/09/26
CRDT- 2023/12/14 04:26
PHST- 2023/02/22 00:00 [received]
PHST- 2023/07/17 00:00 [revised]
PHST- 2023/07/18 00:00 [accepted]
PHST- 2023/12/14 06:43 [medline]
PHST- 2023/12/14 06:42 [pubmed]
PHST- 2023/12/14 04:26 [entrez]
PHST- 2023/09/26 00:00 [pmc-release]
AID - S2772-3747(23)00215-6 [pii]
AID - 10.1016/j.jacasi.2023.07.005 [doi]
PST - epublish
SO  - JACC Asia. 2023 Sep 26;3(5):805-816. doi: 10.1016/j.jacasi.2023.07.005. 
      eCollection 2023 Oct.