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).
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).
Authors: Leon Iden; Sonia Busch; Daniel Steven; Roland R Tilz; Dong-In Shin; K R Julian Chun; Heidi Estner; Felix Bourier; David Duncker; Philipp Sommer; Andreas Metzner; Tilman Maurer; Nils-Christian Ewertsen; Henning Jansen; Andreas Rillig; Victoria Johnson; Till Althoff Journal: Herzschrittmacherther Elektrophysiol Date: 2021-07-26
Authors: Luigi Pannone; Ivan Eltsov; Robbert Ramak; David Cabrita; Marc Verherstraeten; Anaïs Gauthey; Antonio Sorgente; Cinzia Monaco; Ingrid Overeinder; Gezim Bala; Alexandre Almorad; Erwin Ströker; Juan Sieira; Pedro Brugada; Mark La Meir; Gian-Battista Chierchia; Carlo de Asmundis Journal: Front Cardiovasc Med Date: 2022-06-28
Authors: Tom De Potter; Massimo Grimaldi; Henrik Kjaerulf Jensen; Josef Kautzner; Petr Neuzil; Johan Vijgen; Andrea Natale; Steen Buus Kristiansen; Peter Lukac; Petr Peichl; Vivek Y Reddy Journal: J Atr Fibrillation Date: 2021-04-30