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Lattice-Tip Focal Ablation Catheter That Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: A First-in-Human Trial.
Circ Arrhythm Electrophysiol. 2020 06; 13(6):e008718.CA

Abstract

BACKGROUND

The tissue selectivity of pulsed field ablation (PFA) provides safety advantages over radiofrequency ablation in treating atrial fibrillation. One-shot PFA catheters have been shown capable of performing pulmonary vein isolation, but not flexible lesion sets such as linear lesions. A novel lattice-tip ablation catheter with a compressible 9-mm nitinol tip is able to deliver either focal radiofrequency ablation or PFA lesions, each in 2 to 5 s.

METHODS

In a 3-center, single-arm, first-in-human trial, the 7.5F lattice catheter was used with a custom mapping system to treat paroxysmal or persistent atrial fibrillation. Toggling between energy sources, point-by-point pulmonary vein encirclement was performed using biphasic PFA posteriorly and either temperature-controlled irrigated radiofrequency ablation or PFA anteriorly (RF/PF or PF/PF, respectively). Linear lesions were created using either PFA or radiofrequency ablation.

RESULTS

The 76-patient cohort included 55 paroxysmal and 21 persistent atrial fibrillation patients undergoing either RF/PF (40 patients) or PF/PF (36 patients) ablation. The pulmonary vein isolation therapy duration time (transpiring from first to last lesion) was 22.6±8.3 min/patient, with a mean of 50.1 RF/PF lesions/patient. Linear lesions included 14 mitral (4 RF/2 RF+PF/8 PF), 34 left atrium roof (12 RF/22 PF), and 44 cavotricuspid isthmus (36 RF/8 PF) lines, with therapy duration times of 5.1±3.5, 1.8±2.3, and 2.4±2.1 min/patient, respectively. All lesion sets were acutely successful, using 4.7±3.5 minutes of fluoroscopy. There were no device-related complications, including no strokes. Postprocedure esophagogastroduodenoscopy revealed minor mucosal thermal injury in 2 of 36 RF/PF and 0 of 24 PF/PF patients. Postprocedure brain magnetic resonance imaging revealed diffusion-weighted imaging+/fluid-attenuated inversion recovery- and diffusion-weighted imaging+/fluid-attenuated inversion recovery+ asymptomatic lesions in 5 and 3 of 51 patients, respectively.

CONCLUSIONS

A novel lattice-tip catheter could safely and rapidly ablate atrial fibrillation using either a combined RF/PF approach (capitalizing on the safety of PFA and the years of experience with radiofrequency energy) or an entirely PF approach. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT04141007 and NCT04194307.

Authors+Show Affiliations

Department of Cardiology, Homolka Hospital, Prague, Czech Republic (V.Y.R., M.F., K.M., P.N.). Helmsley Electrophysiology Center, Department of Cardiology, Icahn School of Medicine at Mount Sinai, New York, NY (V.Y.R., J.S.K.).Cardiac Electrophysiology Section, Department of Cardiovascular Medicine, Cleveland Clinic, OH (E.A., H.N.).Centre for Cardiology and Angiology, Department of Cardiovascular Diseases, Vilnius University, Lithuania (G.R., G.M., A.A.).Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic (P.P., J.K.).Helmsley Electrophysiology Center, Department of Cardiology, Icahn School of Medicine at Mount Sinai, New York, NY (V.Y.R., J.S.K.).No affiliation info availableDepartment of Cardiology, Homolka Hospital, Prague, Czech Republic (V.Y.R., M.F., K.M., P.N.).Department of Cardiology, Homolka Hospital, Prague, Czech Republic (V.Y.R., M.F., K.M., P.N.).Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin (A.N.).University of Bordeaux, CHU Bordeaux, IHU LIRYC ANR-10-IAHU-04, France (P.J.).Cardiac Electrophysiology Section, Department of Cardiovascular Medicine, Cleveland Clinic, OH (E.A., H.N.).Centre for Cardiology and Angiology, Department of Cardiovascular Diseases, Vilnius University, Lithuania (G.R., G.M., A.A.).Centre for Cardiology and Angiology, Department of Cardiovascular Diseases, Vilnius University, Lithuania (G.R., G.M., A.A.).Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic (P.P., J.K.).Department of Cardiology, Homolka Hospital, Prague, Czech Republic (V.Y.R., M.F., K.M., P.N.).

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Video-Audio Media

Language

eng

PubMed ID

32383391

Citation

Reddy, Vivek Y., et al. "Lattice-Tip Focal Ablation Catheter That Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: a First-in-Human Trial." Circulation. Arrhythmia and Electrophysiology, vol. 13, no. 6, 2020, pp. e008718.
Reddy VY, Anter E, Rackauskas G, et al. Lattice-Tip Focal Ablation Catheter That Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: A First-in-Human Trial. Circ Arrhythm Electrophysiol. 2020;13(6):e008718.
Reddy, V. Y., Anter, E., Rackauskas, G., Peichl, P., Koruth, J. S., Petru, J., Funasako, M., Minami, K., Natale, A., Jais, P., Nakagawa, H., Marinskis, G., Aidietis, A., Kautzner, J., & Neuzil, P. (2020). Lattice-Tip Focal Ablation Catheter That Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: A First-in-Human Trial. Circulation. Arrhythmia and Electrophysiology, 13(6), e008718. https://doi.org/10.1161/CIRCEP.120.008718
Reddy VY, et al. Lattice-Tip Focal Ablation Catheter That Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: a First-in-Human Trial. Circ Arrhythm Electrophysiol. 2020;13(6):e008718. PubMed PMID: 32383391.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lattice-Tip Focal Ablation Catheter That Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: A First-in-Human Trial. AU - Reddy,Vivek Y, AU - Anter,Elad, AU - Rackauskas,Gediminas, AU - Peichl,Petr, AU - Koruth,Jacob S, AU - Petru,Jan, AU - Funasako,Moritoshi, AU - Minami,Kentaro, AU - Natale,Andrea, AU - Jais,Pierre, AU - Nakagawa,Hiroshi, AU - Marinskis,Germanas, AU - Aidietis,Audrius, AU - Kautzner,Josef, AU - Neuzil,Petr, Y1 - 2020/05/08/ PY - 2020/5/10/pubmed PY - 2020/11/11/medline PY - 2020/5/9/entrez KW - atrial fibrillation KW - catheter ablation KW - coronary sinus KW - electroporation KW - magnetic resonance imaging KW - pulmonary vein SP - e008718 EP - e008718 JF - Circulation. Arrhythmia and electrophysiology JO - Circ Arrhythm Electrophysiol VL - 13 IS - 6 N2 - BACKGROUND: The tissue selectivity of pulsed field ablation (PFA) provides safety advantages over radiofrequency ablation in treating atrial fibrillation. One-shot PFA catheters have been shown capable of performing pulmonary vein isolation, but not flexible lesion sets such as linear lesions. A novel lattice-tip ablation catheter with a compressible 9-mm nitinol tip is able to deliver either focal radiofrequency ablation or PFA lesions, each in 2 to 5 s. METHODS: In a 3-center, single-arm, first-in-human trial, the 7.5F lattice catheter was used with a custom mapping system to treat paroxysmal or persistent atrial fibrillation. Toggling between energy sources, point-by-point pulmonary vein encirclement was performed using biphasic PFA posteriorly and either temperature-controlled irrigated radiofrequency ablation or PFA anteriorly (RF/PF or PF/PF, respectively). Linear lesions were created using either PFA or radiofrequency ablation. RESULTS: The 76-patient cohort included 55 paroxysmal and 21 persistent atrial fibrillation patients undergoing either RF/PF (40 patients) or PF/PF (36 patients) ablation. The pulmonary vein isolation therapy duration time (transpiring from first to last lesion) was 22.6±8.3 min/patient, with a mean of 50.1 RF/PF lesions/patient. Linear lesions included 14 mitral (4 RF/2 RF+PF/8 PF), 34 left atrium roof (12 RF/22 PF), and 44 cavotricuspid isthmus (36 RF/8 PF) lines, with therapy duration times of 5.1±3.5, 1.8±2.3, and 2.4±2.1 min/patient, respectively. All lesion sets were acutely successful, using 4.7±3.5 minutes of fluoroscopy. There were no device-related complications, including no strokes. Postprocedure esophagogastroduodenoscopy revealed minor mucosal thermal injury in 2 of 36 RF/PF and 0 of 24 PF/PF patients. Postprocedure brain magnetic resonance imaging revealed diffusion-weighted imaging+/fluid-attenuated inversion recovery- and diffusion-weighted imaging+/fluid-attenuated inversion recovery+ asymptomatic lesions in 5 and 3 of 51 patients, respectively. CONCLUSIONS: A novel lattice-tip catheter could safely and rapidly ablate atrial fibrillation using either a combined RF/PF approach (capitalizing on the safety of PFA and the years of experience with radiofrequency energy) or an entirely PF approach. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT04141007 and NCT04194307. SN - 1941-3084 UR - https://www.unboundmedicine.com/medline/citation/32383391/Lattice_Tip_Focal_Ablation_Catheter_That_Toggles_Between_Radiofrequency_and_Pulsed_Field_Energy_to_Treat_Atrial_Fibrillation:_A_First_in_Human_Trial_ DB - PRIME DP - Unbound Medicine ER -