TY - JOUR
T1 - Pulsed Field Ablation in Patients With Persistent Atrial Fibrillation
AU - Reddy, Vivek Y.
AU - Anic, Ante
AU - Koruth, Jacob
AU - Petru, Jan
AU - Funasako, Moritoshi
AU - Minami, Kentaro
AU - Breskovic, Toni
AU - Sikiric, Ivan
AU - Dukkipati, Srinivas R.
AU - Kawamura, Iwanari
AU - Neuzil, Petr
N1 - Funding Information:
The trials were supported by the manufacturer of the ablation system, Farapulse Inc. Dr. Reddy holds stock in Farapulse; has served as a consultant for Biosense Webster and Boston Scientific; has served as a consultant for Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Axon, Backbeat, BioSig, Biotronik, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co., Ltd., East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Impulse Dynamics, Javelin, Kardium, Keystone Heart, LuxCath, Medlumics, Medtronic, Middlepeak, Nuvera, Philips, Sirona Medical, Stimda, Thermedical, and Valcare (not related to this manuscript); and has equity in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co., Ltd., East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Javelin, Kardium, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Middlepeak, Newpace, Nuvera, Sirona Medical, Surecor, Valcare, and Vizaramed (not related to this manuscript). Dr. Anic has received grant support from and served as a consultant for Farapulse. Dr. Koruth has received grant support from and served as a consultant for Farapulse; has served as a consultant for Medtronic, Vytronus, Abbott, and Cardiofocus (not related to this manuscript); and has received grant support from Vytronus, Cardiofocus, Luxcath, Affera, LuxCath, and Medlumics (not related to this manuscript). Dr. Petru has received grant support from Farapulse. Dr. Dukkipati holds stock in Farapulse; and has received grant support from Biosense Webster. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Funding Information:
The trials were supported by the manufacturer of the ablation system, Farapulse Inc. Dr. Reddy holds stock in Farapulse; has served as a consultant for Biosense Webster and Boston Scientific; has served as a consultant for Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Axon, Backbeat, BioSig, Biotronik, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co., Ltd., East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Impulse Dynamics, Javelin, Kardium, Keystone Heart, LuxCath, Medlumics, Medtronic, Middlepeak, Nuvera, Philips, Sirona Medical, Stimda, Thermedical, and Valcare (not related to this manuscript); and has equity in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co., Ltd., East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Javelin, Kardium, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Middlepeak, Newpace, Nuvera, Sirona Medical, Surecor, Valcare, and Vizaramed (not related to this manuscript). Dr. Anic has received grant support from and served as a consultant for Farapulse. Dr. Koruth has received grant support from and served as a consultant for Farapulse; has served as a consultant for Medtronic, Vytronus, Abbott, and Cardiofocus (not related to this manuscript); and has received grant support from Vytronus, Cardiofocus, Luxcath, Affera, LuxCath, and Medlumics (not related to this manuscript). Dr. Petru has received grant support from Farapulse. Dr. Dukkipati holds stock in Farapulse; and has received grant support from Biosense Webster. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Funding Information:
The PersAFOne (Pulsed Fields for Persistent Atrial Fibrillation) clinical trial ( NCT04170621 ) is a single arm, multicenter feasibility study conducted at Homolka Hospital, Prague, Czech Republic and Clinical Hospital Center Split, Split, Croatia. An independent clinical events committee adjudicated endpoint events. The study was funded and conducted by Farapulse Inc. All data have been entered in a study database, and monitoring performed by a clinical research organization (MedPass International, Paris, France) was complete, except for the most recent follow-up visits. The trials were approved by local ethics committees and national regulatory agencies.
Publisher Copyright:
© 2020 The Authors
PY - 2020/9/1
Y1 - 2020/9/1
N2 - Background: Unlike for paroxysmal atrial fibrillation (AF), pulmonary vein isolation (PVI) alone is considered insufficient for many patients with persistent AF. Adjunctive ablation of the left atrial posterior wall (LAPW) may improve outcomes, but is limited by both the difficulty of achieving lesion durability and concerns of damage to the esophagus—situated behind the LAPW. Objectives: This study sought to assess the safety and lesion durability of pulsed field ablation (PFA) for both PVI and LAPW ablation in persistent AF. Methods: PersAFOne is a single-arm study evaluating biphasic, bipolar PFA using a multispline catheter for PVI and LAPW ablation under intracardiac echocardiographic guidance. A focal PFA catheter was used for cavotricuspid isthmus ablation. No esophageal protection strategy was used. Invasive remapping was mandated at 2 to 3 months to assess lesion durability. Results: In 25 patients, acute PVI (96 of 96 pulmonary veins [PVs]; mean ablation time: 22 min; interquartile range [IQR]: 15 to 29 min) and LAPW ablation (24 of 24 patients; median ablation time: 10 min; IQR: 6 to 13 min) were 100% acutely successful with the multispline PFA catheter alone. Using the focal PFA catheter, acute cavotricuspid isthmus block was achieved in 13 of 13 patients (median: 9 min; IQR: 6 to 12 min). The median total procedure time was 125 min (IQR: 108 to 166 min) (including a median of 28 min [IQR: 25 to 33 min] for voltage mapping), with a median of 16 min (IQR: 12 to 23 min) fluoroscopy. Post-procedure esophagogastroduodenoscopy and repeat cardiac computed tomography revealed no mucosal lesions or PV narrowing, respectively. Invasive remapping demonstrated durable isolation (defined by entrance block) in 82 of 85 PVs (96%) and 21 of 21 LAPWs (100%) treated with the pentaspline catheter. In 3 patients, there was localized scar regression of the LAPW ablation, albeit without conduction breakthrough. Conclusions: The unique safety profile of PFA potentiated efficient, safe, and durable PVI and LAPW ablation. This extends the potential role of PFA beyond paroxysmal to persistent forms of AF.
AB - Background: Unlike for paroxysmal atrial fibrillation (AF), pulmonary vein isolation (PVI) alone is considered insufficient for many patients with persistent AF. Adjunctive ablation of the left atrial posterior wall (LAPW) may improve outcomes, but is limited by both the difficulty of achieving lesion durability and concerns of damage to the esophagus—situated behind the LAPW. Objectives: This study sought to assess the safety and lesion durability of pulsed field ablation (PFA) for both PVI and LAPW ablation in persistent AF. Methods: PersAFOne is a single-arm study evaluating biphasic, bipolar PFA using a multispline catheter for PVI and LAPW ablation under intracardiac echocardiographic guidance. A focal PFA catheter was used for cavotricuspid isthmus ablation. No esophageal protection strategy was used. Invasive remapping was mandated at 2 to 3 months to assess lesion durability. Results: In 25 patients, acute PVI (96 of 96 pulmonary veins [PVs]; mean ablation time: 22 min; interquartile range [IQR]: 15 to 29 min) and LAPW ablation (24 of 24 patients; median ablation time: 10 min; IQR: 6 to 13 min) were 100% acutely successful with the multispline PFA catheter alone. Using the focal PFA catheter, acute cavotricuspid isthmus block was achieved in 13 of 13 patients (median: 9 min; IQR: 6 to 12 min). The median total procedure time was 125 min (IQR: 108 to 166 min) (including a median of 28 min [IQR: 25 to 33 min] for voltage mapping), with a median of 16 min (IQR: 12 to 23 min) fluoroscopy. Post-procedure esophagogastroduodenoscopy and repeat cardiac computed tomography revealed no mucosal lesions or PV narrowing, respectively. Invasive remapping demonstrated durable isolation (defined by entrance block) in 82 of 85 PVs (96%) and 21 of 21 LAPWs (100%) treated with the pentaspline catheter. In 3 patients, there was localized scar regression of the LAPW ablation, albeit without conduction breakthrough. Conclusions: The unique safety profile of PFA potentiated efficient, safe, and durable PVI and LAPW ablation. This extends the potential role of PFA beyond paroxysmal to persistent forms of AF.
KW - catheter ablation
KW - esophagus
KW - persistent atrial fibrillation
KW - posterior wall
KW - pulmonary vein isolation
KW - pulsed field ablation
UR - http://www.scopus.com/inward/record.url?scp=85089426299&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2020.07.007
DO - 10.1016/j.jacc.2020.07.007
M3 - Article
C2 - 32854842
AN - SCOPUS:85089426299
SN - 0735-1097
VL - 76
SP - 1068
EP - 1080
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 9
ER -