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Lesion Size and Safety Comparison Between the Novel Flex Tip on the FlexAbility Ablation Catheter and the Solid Tips on the ThermoCool and ThermoCool SF Ablation Catheters.
J Cardiovasc Electrophysiol. 2016 Jan; 27(1):102-9.JC

Abstract

INTRODUCTION

Next-generation catheters have been developed to reduce irrigation volume and preserve power delivery. A novel design uses a flexible tip (FlexAbility™ catheter) that directs flow to the contact surface. Because of recent safety issues with new catheters, we undertook a study in a canine heart with 3 irrigated catheters to compare efficacy and safety.

METHODS

Endocardial ablation was performed by 2 independent operators in 12 anesthetized canines with the FlexAbility (St. Jude Medical), ThermoCool™ (Biosense Webster), and ThermoCool™ SF (Biosense Webster) catheters. Endocardial RF lesions were delivered with each catheter in all 4 chambers of each animal for 52 ± 16 seconds. Each chamber was randomized to receive ablation from one catheter with recording of safety events. Cardiac pathology was performed with triphenyl tetrazolium chloride stain.

RESULTS

Average lesion dimensions were not significantly different between the 3 catheters. FlexAbility™ demonstrated a lower risk of steam pops relative to ThermoCool SF (P-value = 0.013) despite equal mean power and radiofrequency time. High-temperature generator shutdowns were observed with FlexAbility™ but not with either ThermoCool catheter. High-temperature shutdowns were associated with larger average impedance drops (28.5 ohms vs. 19 ohms) without compromising lesion size.

CONCLUSIONS

The FlexAbility™ tip is safe and effective with no significant difference in lesion sizes compared to both standard ThermoCool and ThermoCool SF. FlexAbility™ has a significantly lower risk of steam pops compared to ThermoCool SF in a beating heart as defined predominantly by an abrupt rise of impedance.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Winterfield JR
Loyola University Medical Center, Maywood, Illinois.
Jensen J
St. Jude Medical, St. Paul, Minnesota.
Gilbert T
St. Jude Medical, St. Paul, Minnesota.
Marchlinski F
University of Pennsylvania, Philadelphia, Pennsylvania.
Natale A
Texas Cardiac Arrhythmia Institute, Austin, Texas.
Packer D
Mayo Clinic, Rochester, Minnesota.
Reddy V
Mount Sinai Medical Center, New York, New York, USA.
Mahapatra S
St. Jude Medical, St. Paul, Minnesota.
Wilber DJ
Loyola University Medical Center, Maywood, Illinois.

MeSH

AnimalsCardiac CatheterizationCardiac CathetersCatheter AblationDogsElectric ImpedanceEndocardiumEquipment DesignHot TemperatureMaterials TestingModels, AnimalTherapeutic Irrigation

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26359632

Citation

Winterfield, Jeffrey R., et al. "Lesion Size and Safety Comparison Between the Novel Flex Tip On the FlexAbility Ablation Catheter and the Solid Tips On the ThermoCool and ThermoCool SF Ablation Catheters." Journal of Cardiovascular Electrophysiology, vol. 27, no. 1, 2016, pp. 102-9.
Winterfield JR, Jensen J, Gilbert T, et al. Lesion Size and Safety Comparison Between the Novel Flex Tip on the FlexAbility Ablation Catheter and the Solid Tips on the ThermoCool and ThermoCool SF Ablation Catheters. J Cardiovasc Electrophysiol. 2016;27(1):102-9.
Winterfield, J. R., Jensen, J., Gilbert, T., Marchlinski, F., Natale, A., Packer, D., Reddy, V., Mahapatra, S., & Wilber, D. J. (2016). Lesion Size and Safety Comparison Between the Novel Flex Tip on the FlexAbility Ablation Catheter and the Solid Tips on the ThermoCool and ThermoCool SF Ablation Catheters. Journal of Cardiovascular Electrophysiology, 27(1), 102-9. https://doi.org/10.1111/jce.12835
Winterfield JR, et al. Lesion Size and Safety Comparison Between the Novel Flex Tip On the FlexAbility Ablation Catheter and the Solid Tips On the ThermoCool and ThermoCool SF Ablation Catheters. J Cardiovasc Electrophysiol. 2016;27(1):102-9. PubMed PMID: 26359632.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lesion Size and Safety Comparison Between the Novel Flex Tip on the FlexAbility Ablation Catheter and the Solid Tips on the ThermoCool and ThermoCool SF Ablation Catheters. AU - Winterfield,Jeffrey R, AU - Jensen,James, AU - Gilbert,Therese, AU - Marchlinski,Francis, AU - Natale,Andrea, AU - Packer,Douglas, AU - Reddy,Vivek, AU - Mahapatra,Srijoy, AU - Wilber,David J, Y1 - 2015/11/18/ PY - 2015/07/01/received PY - 2015/08/28/revised PY - 2015/09/01/accepted PY - 2015/9/12/entrez PY - 2015/9/12/pubmed PY - 2016/12/15/medline KW - catheter ablation KW - flexibility catheter KW - lesion KW - radiofrequency KW - steam pop SP - 102 EP - 9 JF - Journal of cardiovascular electrophysiology JO - J Cardiovasc Electrophysiol VL - 27 IS - 1 N2 - INTRODUCTION: Next-generation catheters have been developed to reduce irrigation volume and preserve power delivery. A novel design uses a flexible tip (FlexAbility™ catheter) that directs flow to the contact surface. Because of recent safety issues with new catheters, we undertook a study in a canine heart with 3 irrigated catheters to compare efficacy and safety. METHODS: Endocardial ablation was performed by 2 independent operators in 12 anesthetized canines with the FlexAbility (St. Jude Medical), ThermoCool™ (Biosense Webster), and ThermoCool™ SF (Biosense Webster) catheters. Endocardial RF lesions were delivered with each catheter in all 4 chambers of each animal for 52 ± 16 seconds. Each chamber was randomized to receive ablation from one catheter with recording of safety events. Cardiac pathology was performed with triphenyl tetrazolium chloride stain. RESULTS: Average lesion dimensions were not significantly different between the 3 catheters. FlexAbility™ demonstrated a lower risk of steam pops relative to ThermoCool SF (P-value = 0.013) despite equal mean power and radiofrequency time. High-temperature generator shutdowns were observed with FlexAbility™ but not with either ThermoCool catheter. High-temperature shutdowns were associated with larger average impedance drops (28.5 ohms vs. 19 ohms) without compromising lesion size. CONCLUSIONS: The FlexAbility™ tip is safe and effective with no significant difference in lesion sizes compared to both standard ThermoCool and ThermoCool SF. FlexAbility™ has a significantly lower risk of steam pops compared to ThermoCool SF in a beating heart as defined predominantly by an abrupt rise of impedance. SN - 1540-8167 UR - https://www.unboundmedicine.com/medline/citation/26359632/Lesion_Size_and_Safety_Comparison_Between_the_Novel_Flex_Tip_on_the_FlexAbility_Ablation_Catheter_and_the_Solid_Tips_on_the_ThermoCool_and_ThermoCool_SF_Ablation_Catheters_ DB - PRIME DP - Unbound Medicine ER -