Dataset Information

Pulsed Field Ablation Using a Lattice Electrode for Focal Energy Delivery: Biophysical Characterization, Lesion Durability, and Safety Evaluation.

ABSTRACT: BACKGROUND:Pulsed field ablation (PFA) is a nonthermal energy that may provide safety advantages over radiofrequency ablation (RFA). One-shot PFA catheters have been developed for pulmonary vein isolation, but they do not permit flexible lesion sets. This study investigated a novel lattice-tip catheter designed for focal RFA or PFA ablation. METHODS:The effects of PFA (biphasic, 24 amperes) were investigated in 25 swine using a lattice-tip catheter and system (Affera Inc). Step 1 (n=14) examined the feasibility to create atrial line of block and described its acute effects on the phrenic nerve and esophagus. Step 2 (n=7) examined the subacute effects of PFA on block durability, phrenic nerve, and esophagus ?2 weeks. Step 3 compared the effects of PFA and RFA on the esophagus using a mechanical deviation model approximating the esophagus to the right atrium (n=4) and by direct ablation within its lumen (n=4). The effects of endocardial PFA and RFA on the phrenic nerve were also compared (n=10). Histological analysis was performed. RESULTS:PFA produced acute block in 100% of lines, achieved with 2.1 (1.3-3.2) applications/cm line. Histological analysis following (35 [18-37]) days showed 100% transmurality (thickness range 0.4-3.4 mm) with a lesion width of 19.4 (10.9-27.4 mm). PFA selectively affected cardiomyocytes but spared blood vessels and nervous tissue. PFA applied from the posterior atria (23 [21-25] applications) to the approximated esophagus (6 [4.5-14] mm) produced transmural lesions without esophageal injury. PFA (16.5 [15-18] applications) applied inside the esophageal lumen produced mild edema compared with RFA (13 [12-14] applications) which produced epithelial ulcerations. PFA resulted in no or transient stunning of the phrenic nerve (<5 minutes) without histological changes while RFA produced paralysis. CONCLUSIONS:PFA using a lattice-tip ablation catheter for focal ablation produced durable atrial lesions and showed lower vulnerability to esophageal or phrenic nerve damage compared with RFA.

SUBMITTER: Yavin H

PROVIDER: S-EPMC7338046 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Pulsed Field Ablation Using a Lattice Electrode for Focal Energy Delivery: Biophysical Characterization, Lesion Durability, and Safety Evaluation.

Yavin Hagai H Shapira-Daniels Ayelet A Barkagan Michael M Sroubek Jakub J Shim David D Melidone Raffaele R Anter Elad E

Circulation. Arrhythmia and electrophysiology 20200506 6

<h4>Background</h4>Pulsed field ablation (PFA) is a nonthermal energy that may provide safety advantages over radiofrequency ablation (RFA). One-shot PFA catheters have been developed for pulmonary vein isolation, but they do not permit flexible lesion sets. This study investigated a novel lattice-tip catheter designed for focal RFA or PFA ablation.<h4>Methods</h4>The effects of PFA (biphasic, 24 amperes) were investigated in 25 swine using a lattice-tip catheter and system (Affera Inc). Step 1 ...[more]

PMID: 32372696

Similar Datasets

Project description:BackgroundPulsed field ablation (PFA) is a nonthermal energy with potential safety advantages over radiofrequency ablation. This study investigated a novel PFA system-a circular multielectrode catheter (PFA lasso) and a multichannel generator designed to work with Carto 3 mapping system.MethodsA 7.5F bidirectional circular catheter with 10 electrodes and variable expansion was designed for PFA (biphasic, 1800 Volts). This study included a total of 16 swine used to investigate the following 3 experimental aims: Aim 1 examined the feasibility to create a right atrial ablation line of block from the superior vena cava to the inferior vena cava. Aim 2 examined the effect of PFA on lesion maturation including durability after a 30-day survival period. Aim 3 examined the effect of high-intensity PFA (10 applications) on esophageal and phrenic nerve tissue in comparison to normal intensity radiofrequency ablation (1-2 applications). Histopathologic analysis of all cardiac, esophageal, and phrenic nerve tissue was performed.ResultsAcute line of block was achieved in 12/12 swine (100%) and required a total PFA time of 14 seconds (interquartile range [IQR], 9-24.5) per line. Ablation line durability after 28±3 days was maintained in 11/12 (91.7%) swine. PFA resulted in transmural lesions in 179/183 (97.8%) sections and a median lesion width of 14.2 mm. High-intensity PFA (9 [IQR, 8-14] application) had no effect on the esophagus while standard intensity radiofrequency ablation (1.5 [IQR, 1-2] applications) resulted in deep esophageal tissue injury involving the muscularis propria and adventitia layers. High-intensity PFA (16 [IQR, 10-28] applications) has no effect on phrenic nerve function and structure while standard dose radiofrequency ablation (1.5 [IQR, 1-2] applications) resulted in acute phrenic nerve paralysis.ConclusionsIn this preclinical model, a multielectrode circular catheter and multichannel generator produced durable atrial lesions with lower vulnerability to esophageal or phrenic nerve damage.

Project description:BACKGROUND:Ventricular tachycardia ablation is often limited by insufficient lesion creation. A novel radiofrequency catheter with an expandable lattice electrode has a larger surface area capable of delivering higher currents at a lower density to potentially increase lesion dimensions without overheating. METHODS:This 8F bidirectional irrigated catheter (Sphere-9, Affera Inc) has a 9 mm spherical lattice tip ("lattice") with an effective surface area 10-fold larger than standard linear catheters. Nine surface thermocouples provide temperature feedback to a proprietary high-current generator operating in a temperature-controlled mode. Ex vivo phase: in 11 bovine hearts, unipolar ablation at 30, 60, and 120 seconds was compared between the lattice (Tmax60°C) and a standard linear irrigated-tip catheter (40 W) at contact force of 10 g. In 5 porcine hearts, bipolar ablation was compared between the catheters (Tmax60°C versus 40 W; 60 seconds). In vivo phase: in 9 swine, ventricular ablation at Tmax60°C versus 40 W was performed for 60 seconds. In addition, direct tissue temperature at 3- and 7-mm tissue depth was measured in a thigh muscle preparation. RESULTS:Ex vivo: lattice produced deeper lesions at 30, 60, and 120 seconds application duration (6.7±1.3 versus 4.8±1.2 mm; 8.3±1.4 versus 5.4±0.8 mm; 10.0±1.6 versus 6.1±1.6 mm, respectively, P?0.001 for all). Bipolar lesions were deeper (15.8±4.1 versus 10.5±1.4 mm, P<0.001) and more likely to be transmural (80% versus 0%, P=0.002). In vivo: lattice produced deeper lesions (10.5±1.4 versus 6.5±0.8 mm, P?0.001). Tissue temperature at 7 mm was higher with the lattice (+15.1±2.4°C; P<0.001). The steam-pop occurrence was lower with the lattice (total: 4% versus 18%, P=0.02; in vivo 0% versus 14.2%, P=0.13). CONCLUSIONS:This novel radiofrequency system produces larger ventricular lesions compared with standard irrigated catheters and at a lower risk of tissue overheating. This may improve the efficacy of ventricular tachycardia ablation procedures while reducing the number of applications and procedural duration.

Project description:IntroductionPulsed field ablation (PFA) was recently introduced for the treatment of symptomatic atrial fibrillation (AF) with the claim of selectively ablating the myocardium while sparing surrounding tissues. We present our initial experience with a PFA catheter for pulmonary vein isolation (PVI) and describe procedural findings and peri-procedural safety of the first 100 patients.Materials and methodsWe investigated 100 patients treated for symptomatic AF using the FARAWAVE PFA catheter (Farapulse, Menlo Park, CA, USA) between July 2021 and March 2022. Procedure workflow and electrophysiological findings at the time of ablation, peri-procedural complications, and operator learning curves are described.ResultsThe mean age of patients was 62.9 ± 9.4 years, 62% were male subjects and 80% had paroxysmal AF. The median CHA2DS2-VASc score was 1.5 (IQR: 1.0-2.0) and the mean left atrial volume index was 35.7 ± 9.6 ml/m2. In 88 (88%) patients, PVI alone was performed and in 12 (12%) patients additional ablation of the posterior wall was performed. 3D-electroanatomic mapping was performed in 18 (18%) patients. Procedures without mapping lasted for 52.3 ± 16.6 min. The mean number of applications per pulmonary vein (PV) was 8.1 ± 0.6. In all patients (100%), all PVs were confirmed to be isolated. The learning curves of the two operators who performed > 20 procedures showed a negligible variation of performance over time and practice did not significantly predict procedure time [Operator 1 (senior): R 2 = 0.034, p = 0.35; Operator 2 (junior): R 2 = 0.004, p = 0.73]. There was no difference between the procedure times between senior and junior operators (Operator 1: 46.9 ± 9.7 min vs. Operator 2: 45.9 ± 9.9 min; p = 0.73). The only complications observed were two cases of bleeding at the site of percutaneous access.ConclusionOur initial experience shows that use of the PFA catheter for pulmonary vein isolation (PVI) is safe, fast, and easy to learn.

Dataset Information

Pulsed Field Ablation Using a Lattice Electrode for Focal Energy Delivery: Biophysical Characterization, Lesion Durability, and Safety Evaluation.

Publications

Pulsed Field Ablation Using a Lattice Electrode for Focal Energy Delivery: Biophysical Characterization, Lesion Durability, and Safety Evaluation.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets