Author + information
- Received October 21, 2019
- Revision received November 18, 2019
- Accepted December 23, 2019
- Published online May 18, 2020.
- Elad Anter, MDa,
- Petr Neužil, MD, PhDb,
- Gediminas Rackauskas, MD, PhDc,
- Petr Peichl, MD, PhDd,
- Audrius Aidietis, MD, PhDc,
- Josef Kautzner, MD, PhDd,
- Hiroshi Nakagawa, MD, PhDe,
- Warren M. Jackman, MDf,
- Andrea Natale, MDg and
- Vivek Y. Reddy, MDb,h,∗ ()
- aHarvard-Thorndike Electrophysiology Institute, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
- bDepartment of Cardiology, Homolka Hospital, Prague, Czech Republic
- cCentre for Cardiology and Angiology, Department of Cardiovascular Diseases, Vilnius University, Vilnius, Lithuania
- dInstitute Klinicke a Experimentalni Mediciny, Department of Cardiology, Prague, Czech Republic
- eDepartment of Cardiovascular Medicine, Toyohashi Heart Center, Aichi, Japan
- fUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma
- gTexas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas
- hDepartment of Electrophysiology, Division of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York
- ↵∗Address for correspondence:
Dr. Vivek Y. Reddy, Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, 1190 Fifth Avenue, Guggenheim Pavilion–Suite 280, New York, New York 10029.
Objectives This study sought to evaluate the safety and acute performance of the lattice tip for the treatment of atrial flutter and fibrillation (AF).
Background A novel catheter using an expandable lattice structure with a wide thermal footprint incorporating multiple surface thermocouples/mini-electrodes has been designed for high-resolution mapping and high-current, temperature-controlled radiofrequency ablation (RFA).
Methods Patients with typical right atrial flutter or AF were prospectively enrolled in a single-arm study at 3 centers. Patients with atrial flutter underwent cavotricuspid isthmus (CTI) ablation. Patients with paroxysmal AF underwent pulmonary vein isolation (PVI) and CTI if desired, and for patients with persistent AF, mitral isthmus and left atrial roof lines were also permitted. Mapping was performed with the lattice (Sphere-9) catheter and a novel compatible electroanatomic mapping system (Prism-1). RFA was performed in a point-by-point fashion (Tmax, 73°C to 80°C; range 2 to 7 s). Patients were followed for 3 months.
Results A total of 71 patients underwent ablation: 65 PVI (38% with persistent AF) and 22 mitral isthmus, 24 roof, and 48 CTI lines. PVI was achieved in 64 of 65 (98.5%) by using the lattice alone and required a mean of 2.7 ± 0.70 RFA min. Mitral block was achieved in 100% by using 11.5 ± 10.7 applications and 1.0 ± 0.92 RFA min; only 1 patient required adjunctive epicardial coronary sinus ablation. Roof line and CTI block were achieved in 95.8% and 100% of patients, using 4.9 ± 1.9 and 5.9 ± 3.1 applications for 0.4 ± 0.16 and 0.5 ± 0.24 RFA min, respectively. At 3 months, there were no deaths, strokes, tamponade, or atrioesophageal fistula.
Conclusions This first-in-human study demonstrated clinical feasibility and safety for rapid high-current, temperature-controlled point-by-point PVI and linear ablation.
This study was partially supported by a research grant from Affera, Inc. Dr. Anter has received a research grant from and holds stock options in Affera, Inc., and reports relationships with Biosense Webster, Boston Scientific, and Itamar Medical. Dr. Neužil has received a scientific grant from Affera, Inc. Dr. Kautzner was the principal investigator for Affera, Inc., for this clinical study; has received honoraria for serving on the Advisory Board and as a proctor for Biosense Weber; has served as a speaker for Biotronik; has served on the Advisory Board of Boston Scientific; has served as a consultant and speaker for Medtronic; and has served is on the Advisory Board for and is a speaker for Abbott. Dr. Nakagawa has received research grants and served as a consultant for Affera, Inc. Dr. Jackman holds stock options in Affera, Inc., and APN Health; and has received honoraria for consulting and/or lecturing from Bioscience Weber, Boston Scientific, Biotronik, Abbott, and Spectrum Dynamics. Dr. Natale has served as a consultant/speaker for Biosense Webster, Medtronic, Biotronik, St. Jude/Abbott, and Baylis. Supplemental All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Dr. Reddy is a consultant to Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Axon, Backbeat, BioSig, Biosense-Webster, Biotronik, Boston Scientific, Cardiofocus, Cardionomic, CardioNXT / AFTx, Circa Scientific, Corvia Medical, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, Impulse Dynamics, Javelin, Keystone Heart, LuxCath, Medlumics, Medtronic, Middlepeak, Nuvera, Philips, Sirona Medical, Stimda Thermedical, Valcare, and VytronUS; and holds equity in Ablacon, Acutus Medical, Affera, Apama, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Circa Scientific, Corvia Medical, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, Javelin, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Middlespeak, Nuvera, Sirona Medical, Surecor, Valcare, Vizara, and VytronUS.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received October 21, 2019.
- Revision received November 18, 2019.
- Accepted December 23, 2019.
- 2020 The Authors