-
Something wrong with this record ?
Targeted ablation of epicardial ganglionated plexi during cardiac surgery with pulsed field electroporation (NEURAL AF)
DR. Musikantow, VY. Reddy, I. Skalsky, T. Shaburishvili, M. van Zyl, B. O'Brien, K. Coffey, J. Reilly, P. Neuzil, S. Asirvatham, JR. de Groot
Language English
Document type Clinical Study, Journal Article
Grant support
879499
Horizon 2020
- MeSH
- Electrocardiography, Ambulatory MeSH
- Electroporation * methods MeSH
- Atrial Fibrillation * surgery MeSH
- Ganglia, Autonomic * surgery MeSH
- Catheter Ablation * methods MeSH
- Coronary Artery Bypass * methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Pericardium * surgery innervation MeSH
- Prospective Studies MeSH
- Aged MeSH
- Feasibility Studies MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Study MeSH
BACKGROUND: Modulation of the cardiac autonomic nervous system (ANS) is a promising adjuvant therapy in the treatment of atrial fibrillation (AF). In pre-clinical models, pulsed field (PF) energy has the advantage of selectively ablating the epicardial ganglionated plexi (GP) that govern the ANS. This study aims to demonstrate the feasibility and safety of epicardial ablation of the GPs with PF during cardiac surgery with a primary efficacy outcome of prolongation of the atrial effective refractory period (AERP). METHODS: In a single-arm, prospective analysis, patients with or without a history of AF underwent epicardial GP ablation with PF during coronary artery bypass grafting (CABG). AERP was determined immediately pre- and post- GP ablation to assess cardiac ANS function. Holter monitors were performed to determine rhythm status and heart rate variability (HRV) at baseline and at 1-month post-procedure. RESULTS: Of 24 patients, 23 (96%) received the full ablation protocol. No device-related adverse effects were noted. GP ablation resulted in a 20.7 ± 19.9% extension in AERP (P < 0.001). Post-operative AF was observed in 7 (29%) patients. Holter monitoring demonstrated an increase in mean heart rate (74.0 ± 8.7 vs. 80.6 ± 12.3, P = 0.01). There were no significant changes in HRV. There were no study-related complications. CONCLUSIONS: This study demonstrates the safety and feasibility of epicardial ablation of the GP using PF to modulate the ANS during cardiac surgery. Large, randomized analyses are necessary to determine whether epicardial PF ablation can offer a meaningful impact on the cardiac ANS and reduce AF. TRIAL REGISTRATION: Clinical trial registration: NCT04775264.
Homolka Hospital Prague Czech Republic
Royal Jubilee Hospital Victoria BC Canada
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc25016381
- 003
- CZ-PrNML
- 005
- 20250731092853.0
- 007
- ta
- 008
- 250708s2025 ne f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1007/s10840-023-01615-8 $2 doi
- 035 __
- $a (PubMed)37561246
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a x
- 100 1_
- $a Musikantow, Daniel R $u Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, Box 1030, One Gustave L. Levy Place, New York, NY, 10029, USA
- 245 10
- $a Targeted ablation of epicardial ganglionated plexi during cardiac surgery with pulsed field electroporation (NEURAL AF) / $c DR. Musikantow, VY. Reddy, I. Skalsky, T. Shaburishvili, M. van Zyl, B. O'Brien, K. Coffey, J. Reilly, P. Neuzil, S. Asirvatham, JR. de Groot
- 520 9_
- $a BACKGROUND: Modulation of the cardiac autonomic nervous system (ANS) is a promising adjuvant therapy in the treatment of atrial fibrillation (AF). In pre-clinical models, pulsed field (PF) energy has the advantage of selectively ablating the epicardial ganglionated plexi (GP) that govern the ANS. This study aims to demonstrate the feasibility and safety of epicardial ablation of the GPs with PF during cardiac surgery with a primary efficacy outcome of prolongation of the atrial effective refractory period (AERP). METHODS: In a single-arm, prospective analysis, patients with or without a history of AF underwent epicardial GP ablation with PF during coronary artery bypass grafting (CABG). AERP was determined immediately pre- and post- GP ablation to assess cardiac ANS function. Holter monitors were performed to determine rhythm status and heart rate variability (HRV) at baseline and at 1-month post-procedure. RESULTS: Of 24 patients, 23 (96%) received the full ablation protocol. No device-related adverse effects were noted. GP ablation resulted in a 20.7 ± 19.9% extension in AERP (P < 0.001). Post-operative AF was observed in 7 (29%) patients. Holter monitoring demonstrated an increase in mean heart rate (74.0 ± 8.7 vs. 80.6 ± 12.3, P = 0.01). There were no significant changes in HRV. There were no study-related complications. CONCLUSIONS: This study demonstrates the safety and feasibility of epicardial ablation of the GP using PF to modulate the ANS during cardiac surgery. Large, randomized analyses are necessary to determine whether epicardial PF ablation can offer a meaningful impact on the cardiac ANS and reduce AF. TRIAL REGISTRATION: Clinical trial registration: NCT04775264.
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 12
- $a fibrilace síní $x chirurgie $7 D001281
- 650 12
- $a katetrizační ablace $x metody $7 D017115
- 650 12
- $a koronární bypass $x metody $7 D001026
- 650 _2
- $a elektrokardiografie ambulantní $7 D015716
- 650 12
- $a elektroporace $x metody $7 D018274
- 650 _2
- $a studie proveditelnosti $7 D005240
- 650 12
- $a ganglia autonomní $x chirurgie $7 D005725
- 650 12
- $a perikard $x chirurgie $x inervace $7 D010496
- 650 _2
- $a prospektivní studie $7 D011446
- 650 _2
- $a výsledek terapie $7 D016896
- 655 _2
- $a klinická studie $7 D000068397
- 655 _2
- $a časopisecké články $7 D016428
- 700 1_
- $a Reddy, Vivek Y $u Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, Box 1030, One Gustave L. Levy Place, New York, NY, 10029, USA. vivek.reddy@mountsinai.org $u Homolka Hospital, Prague, Czech Republic. vivek.reddy@mountsinai.org
- 700 1_
- $a Skalsky, Ivo $u Homolka Hospital, Prague, Czech Republic
- 700 1_
- $a Shaburishvili, Tamaz $u Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia
- 700 1_
- $a van Zyl, Martin $u Royal Jubilee Hospital, Victoria, BC, Canada
- 700 1_
- $a O'Brien, Barry $u AtriAN Medical, Galway, Ireland
- 700 1_
- $a Coffey, Ken $u AtriAN Medical, Galway, Ireland
- 700 1_
- $a Reilly, John $u AtriAN Medical, Galway, Ireland
- 700 1_
- $a Neuzil, Petr $u Homolka Hospital, Prague, Czech Republic
- 700 1_
- $a Asirvatham, Samuel $u Mayo Clinic, Rochester, MN, USA
- 700 1_
- $a de Groot, Joris R $u University Medical Center, Amsterdam, The Netherlands
- 773 0_
- $w MED00008134 $t Journal of interventional cardiac electrophysiology $x 1572-8595 $g Roč. 68, č. 2 (2025), s. 467-474
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/37561246 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20250708 $b ABA008
- 991 __
- $a 20250731092847 $b ABA008
- 999 __
- $a ok $b bmc $g 2366913 $s 1253506
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2025 $b 68 $c 2 $d 467-474 $e 20230810 $i 1572-8595 $m Journal of interventional cardiac electrophysiology $n J Interv Card Electrophysiol $x MED00008134
- GRA __
- $a 879499 $p Horizon 2020
- LZP __
- $a Pubmed-20250708
