Author + information
- Received March 13, 2017
- Revision received May 2, 2017
- Accepted June 1, 2017
- Published online July 24, 2017.
- Jin Iwasawa, MDa,
- Jacob S. Koruth, MDa,
- Jan Petru, MDb,
- Libor Dujka, MDb,
- Stepan Kralovecb,
- Katerina Mzourkovab,
- Srinivas R. Dukkipati, MDa,
- Petr Neuzil, MD, PhDb and
- Vivek Y. Reddy, MDa,b,∗ ()
- aHelmsley Electrophysiology Center, Mount Sinai Medical Center, New York, New York
- bNa Homolce Hospital, Prague, Czech Republic
- ↵∗Address for correspondence:
Dr. Vivek Y. Reddy, Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, PO Box 1030, New York, New York 10029.
Background Saline irrigation improved the safety of radiofrequency (RF) ablation, but the thermal feedback for energy titration is absent.
Objectives To allow temperature-controlled irrigated ablation, a novel irrigated RF catheter was designed with a diamond-embedded tip (for rapid cooling) and 6 surface thermocouples to reflect tissue temperature. High-resolution electrograms (EGMs) from the split-tip electrode allowed rapid lesion assessment. The authors evaluated the preclinical and clinical performance of this catheter for pulmonary vein (PV) isolation.
Methods Using the DiamondTemp (DT) catheter, pigs (n = 6) underwent discrete atrial ablation in a temperature control mode (60°C/50 W) until there was ∼80% EGM amplitude reduction. In a single-center clinical feasibility study, 35 patients underwent PV isolation with the DT catheter (study group); patients were planned for PV remapping after 3 months, regardless of symptomatology. A control group included 35 patients who underwent PV isolation with a standard force-sensing catheter.
Results Porcine lesion histology revealed transmurality in 51 of 55 lesions (92.7%). In patients, all PVs were successfully isolated; no char or thrombus formation was observed. Compared with the control group, the study cohort had shorter mean RF application duration (26.3 ± 5.2 min vs. 89.2 ± 27.2 min; p < 0.001), shorter mean fluoroscopic time (11.2 ± 8.5 min vs. 19.5 ± 6.8 min; p < 0.001), and lower acute dormant PV reconduction (0 of 35 vs. 5 of 35; p = 0.024). At 3 months, 23 patients underwent remapping: 39 of 46 PV pairs (84.8%) remained durably isolated in 17 of these patients (73.9%).
Conclusions This first-in-human series demonstrated that temperature-controlled irrigated ablation produced rapid, efficient, and durable PV isolation. (ACT DiamondTemp Temperature-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation [TRAC-AF]; NCT02821351)
Drs. Koruth and Neuzil have received research grant support from Advanced Cardiac Therapeutics, Inc. Dr. Reddy has served as a consultant to and has received research grant support from Advanced Cardiac Therapeutics, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Andrea Natale, MD, served as Guest Editor for this paper.
- Received March 13, 2017.
- Revision received May 2, 2017.
- Accepted June 1, 2017.
- 2017 American College of Cardiology Foundation