Safety verification of a novel irrigation catheter with flexible tip of laser-cut kerfs and contact force sensor.
TactiFlex SE
catheter ablation
lesion size
steam-pop
temperature control
Journal
Pacing and clinical electrophysiology : PACE
ISSN: 1540-8159
Titre abrégé: Pacing Clin Electrophysiol
Pays: United States
ID NLM: 7803944
Informations de publication
Date de publication:
12 2023
12 2023
Historique:
revised:
27
10
2023
received:
01
08
2023
accepted:
29
10
2023
medline:
17
12
2023
pubmed:
14
11
2023
entrez:
14
11
2023
Statut:
ppublish
Résumé
The safety evaluation of TactiFlex, a novel contact-force sensing catheter with a flexible 4-mm tip irrigated through laser-cut kerfs, has been ongoing. This study aimed to verify the safety of this type of catheter. Study 1: Radiofrequency (RF) applications at a range of powers (30-50 W), contact forces (10-20 g), and durations (10-60 s) using perpendicular/parallel catheter orientation with half-normal (HNS) or normal saline irrigation were compared between TactiFlex (4-mm tip) and TactiCath (3.5-mm tip) with temperature-controlled mode in excised porcine hearts. Study 2: The relation between RF applications using TactiFlex and the incidence of steam-pops in the real clinical cases were examined. Study-1: 576 RF lesions were examined. TactiFlex demonstrated a significantly lower risk of steam-pops (5[1.7%] vs. 59[20.5%], p < .0001). Compared to 3.5-mm-tip catheter (TactiCath), 4-mm-tip catheter (TactiFlex) produced smaller lesion volume at perpendicular (193[98-554]mm TactiFlex reduced the risk of steam-pops than TactiCath. %impedance-drop ≤ 20% may be reasonable for safely use with a sufficient safety margin. For 4-mm-tip catheter, parallel-contact may be recommended for larger lesion creation.
Sections du résumé
BACKGROUND AND AIMS
The safety evaluation of TactiFlex, a novel contact-force sensing catheter with a flexible 4-mm tip irrigated through laser-cut kerfs, has been ongoing. This study aimed to verify the safety of this type of catheter.
METHODS
Study 1: Radiofrequency (RF) applications at a range of powers (30-50 W), contact forces (10-20 g), and durations (10-60 s) using perpendicular/parallel catheter orientation with half-normal (HNS) or normal saline irrigation were compared between TactiFlex (4-mm tip) and TactiCath (3.5-mm tip) with temperature-controlled mode in excised porcine hearts. Study 2: The relation between RF applications using TactiFlex and the incidence of steam-pops in the real clinical cases were examined.
RESULTS
Study-1: 576 RF lesions were examined. TactiFlex demonstrated a significantly lower risk of steam-pops (5[1.7%] vs. 59[20.5%], p < .0001). Compared to 3.5-mm-tip catheter (TactiCath), 4-mm-tip catheter (TactiFlex) produced smaller lesion volume at perpendicular (193[98-554]mm
CONCLUSION
TactiFlex reduced the risk of steam-pops than TactiCath. %impedance-drop ≤ 20% may be reasonable for safely use with a sufficient safety margin. For 4-mm-tip catheter, parallel-contact may be recommended for larger lesion creation.
Substances chimiques
Steam
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1536-1545Subventions
Organisme : JSPS KAKENHI
ID : 22K16068
Informations de copyright
© 2023 Wiley Periodicals LLC.
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