Efficacy and safety of novel temperature-controlled
radiofrequency ablation system during pulmonary vein isolation
in patients with paroxysmal atrial fibrillation: TRAC-AF study

J 2022

Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study

STÁREK, Zdeněk, František LEHAR, Jiří JEŽ, Martin PEŠL, Petr NEUZIL et. al.

Basic information

Original name

Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study

Authors

STÁREK, Zdeněk (203 Czech Republic, guarantor, belonging to the institution), František LEHAR (203 Czech Republic, belonging to the institution), Jiří JEŽ (203 Czech Republic, belonging to the institution), Martin PEŠL (203 Czech Republic, belonging to the institution), Petr NEUZIL (203 Czech Republic), Lucie SEDIVA (203 Czech Republic), Jan PETRU (203 Czech Republic), Libor DUJKA (203 Czech Republic), Moritoshi FUNASAKO, Josef KAUTZNER (203 Czech Republic), Petr PEICHL (203 Czech Republic), Bashar ALDHOON, Jean-Paul ALBENQUE, Stephane COMBES, Serge BOVEDA, Srinivas R. DUKKIPATI and Vivek Y. REDDY

Edition

Journal of interventional cardiac electrophysiology, Dordrecht, Springer, 2022, 1383-875X

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

Netherlands

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 1.800

RIV identification code

RIV/00216224:14110/22:00124969

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1007/s10840-021-00986-0

UT WoS

000658058700001

Keywords in English

Catheter radiofrequency ablation; Atrial fibrillation; Diamond tip irrigated catheter; Temperature contol ablation; High-resolution electrograms; Safety and efficacy

Abstract

V originále

Background and purpose Saline-irrigated radiofrequency ablation (RFA) for atrial fibrillation (AF) is limited by the absence of reliable thermal feedback limiting the utility of temperature monitoring for power titration. The DiamondTemp (DT) ablation catheter was designed to allow efficient temperature-controlled irrigated ablation. We sought to assess the 1-year clinical safety and efficacy of the DT catheter in treating drug-refractory paroxysmal AF. Methods The TRAC-AF trial (NCT02821351) is a prospective, multi-center (n = 4), single-arm study which enrolled patients with symptomatic, drug-refractory, paroxysmal AF. Using the DT catheter, point-by-point ablation was performed around all pulmonary veins (PVs) to achieve PV isolation (PVI). Ablation was performed in a temperature-controlled mode (60 degrees C, max 50 W). Acute and chronic efficacy and safety was evaluated. Results Seventy-one patients (age 69.9 +/- 11.0 years; 60.6% male) were ablated using the DT catheter. The mean fluoroscopy and RF ablation times were 9.3 +/- 6.1 min and 20.6 +/- 8.9 min, respectively. Acute isolation of all PVs was achieved in 100% of patients, and freedom from AF after 1 year was 70.6%. There were no steam pops, char, or coagulum on the catheter tip after ablation. There were few serious procedure/device-related adverse events including a single case of cardiac tamponade (1.4%) and transient ischemic attack (1.4). Conclusion This first inman series demonstrates that temperature-controlled irrigated RFA with the DT catheter is efficient, safe, and effective in the treatment of paroxysmal AF. Randomized controlled trials are ongoing and will evaluate better the role of this catheter in relation to standard RFA.

Citovat

STÁREK, Zdeněk, František LEHAR, Jiří JEŽ, Martin PEŠL, Petr NEUZIL, Lucie SEDIVA, Jan PETRU, Libor DUJKA, Moritoshi FUNASAKO, Josef KAUTZNER, Petr PEICHL, Bashar ALDHOON, Jean-Paul ALBENQUE, Stephane COMBES, Serge BOVEDA, Srinivas R. DUKKIPATI and Vivek Y. REDDY. Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study. Journal of interventional cardiac electrophysiology. Dordrecht: Springer, 2022, vol. 64, No 2, p. 375-381. ISSN 1383-875X. Available from: https://dx.doi.org/10.1007/s10840-021-00986-0.

@article{1786838,
   author = {Stárek, Zdeněk and Lehar, František and Jež, Jiří and Pešl, Martin and Neuzil, Petr and Sediva, Lucie and Petru, Jan and Dujka, Libor and Funasako, Moritoshi and Kautzner, Josef and Peichl, Petr and Aldhoon, Bashar and Albenque, JeanandPaul and Combes, Stephane and Boveda, Serge and Dukkipati, Srinivas R. and Reddy, Vivek Y.},
   article_location = {Dordrecht},
   article_number = {2},
   doi = {http://dx.doi.org/10.1007/s10840-021-00986-0},
   keywords = {Catheter radiofrequency ablation; Atrial fibrillation; Diamond tip irrigated catheter; Temperature contol ablation; High-resolution electrograms; Safety and efficacy},
   language = {eng},
   issn = {1383-875X},
   journal = {Journal of interventional cardiac electrophysiology},
   title = {Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study},
   url = {https://link.springer.com/article/10.1007%2Fs10840-021-00986-0},
   volume = {64},
   year = {2022}
}

TY  - JOUR
ID  - 1786838
AU  - Stárek, Zdeněk - Lehar, František - Jež, Jiří - Pešl, Martin - Neuzil, Petr - Sediva, Lucie - Petru, Jan - Dujka, Libor - Funasako, Moritoshi - Kautzner, Josef - Peichl, Petr - Aldhoon, Bashar - Albenque, Jean-Paul - Combes, Stephane - Boveda, Serge - Dukkipati, Srinivas R. - Reddy, Vivek Y.
PY  - 2022
TI  - Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study
JF  - Journal of interventional cardiac electrophysiology
VL  - 64
IS  - 2
SP  - 375-381
EP  - 375-381
PB  - Springer
SN  - 1383875X
KW  - Catheter radiofrequency ablation
KW  - Atrial fibrillation
KW  - Diamond tip irrigated catheter
KW  - Temperature contol ablation
KW  - High-resolution electrograms
KW  - Safety and efficacy
UR  - https://link.springer.com/article/10.1007%2Fs10840-021-00986-0
N2  - Background and purpose Saline-irrigated radiofrequency ablation (RFA) for atrial fibrillation (AF) is limited by the absence of reliable thermal feedback limiting the utility of temperature monitoring for power titration. The DiamondTemp (DT) ablation catheter was designed to allow efficient temperature-controlled irrigated ablation. We sought to assess the 1-year clinical safety and efficacy of the DT catheter in treating drug-refractory paroxysmal AF. Methods The TRAC-AF trial (NCT02821351) is a prospective, multi-center (n = 4), single-arm study which enrolled patients with symptomatic, drug-refractory, paroxysmal AF. Using the DT catheter, point-by-point ablation was performed around all pulmonary veins (PVs) to achieve PV isolation (PVI). Ablation was performed in a temperature-controlled mode (60 degrees C, max 50 W). Acute and chronic efficacy and safety was evaluated. Results Seventy-one patients (age 69.9 +/- 11.0 years; 60.6% male) were ablated using the DT catheter. The mean fluoroscopy and RF ablation times were 9.3 +/- 6.1 min and 20.6 +/- 8.9 min, respectively. Acute isolation of all PVs was achieved in 100% of patients, and freedom from AF after 1 year was 70.6%. There were no steam pops, char, or coagulum on the catheter tip after ablation. There were few serious procedure/device-related adverse events including a single case of cardiac tamponade (1.4%) and transient ischemic attack (1.4). Conclusion This first inman series demonstrates that temperature-controlled irrigated RFA with the DT catheter is efficient, safe, and effective in the treatment of paroxysmal AF. Randomized controlled trials are ongoing and will evaluate better the role of this catheter in relation to standard RFA.
ER  -

STÁREK, Zdeněk, František LEHAR, Jiří JEŽ, Martin PEŠL, Petr NEUZIL, Lucie SEDIVA, Jan PETRU, Libor DUJKA, Moritoshi FUNASAKO, Josef KAUTZNER, Petr PEICHL, Bashar ALDHOON, Jean-Paul ALBENQUE, Stephane COMBES, Serge BOVEDA, Srinivas R. DUKKIPATI and Vivek Y. REDDY. Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study. \textit{Journal of interventional cardiac electrophysiology}. Dordrecht: Springer, 2022, vol.~64, No~2, p.~375-381. ISSN~1383-875X. Available from: https://dx.doi.org/10.1007/s10840-021-00986-0.

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