January 26, 2021
RHYTHM AI Ltd, a UK company focused on the treatment of Atrial Fibrillation (AF), today announces the publication of a clinical outcome study for its STAR (Stochastic Trajectory Analysis of Ranked signals) Mapping system, which is designed to improve outcomes in patients receiving ablation treatment for persistent AF.
The article in the peer-reviewed journal, Journal of Cardiovascular Electrophysiology is titled “Ablation guided by STAR Mapping, in addition to pulmonary vein isolation, is superior to pulmonary vein isolation alone or in combination with CFAE/linear ablation for persistent AF”.*
Patients undergoing Pulmonary Vein Isolation (PVI) plus STAR guided ablation (STAR cohort) was compared to a propensity-matched cohort undergoing PVI and Complex Fractionated Atrial Electrogram (CFAE) and/or linear ablation (conventional ablation cohort). The STAR cohort was also compared to a cohort of patients undergoing PVI only ablation (PVI alone ablation cohort).
Key highlights from the study:
- The AF termination rates were significantly higher in the STAR cohort compared to both the conventional ablation cohort and the PVI alone ablation cohort.
- During ≥20 months follow-up a lower proportion of patients had AF/AT recurrence in the STAR cohort when compared to the conventional ablation cohort or the PVI alone ablation cohort.
- The number of patients undergoing a repeat procedure during the follow-up period was significantly lower in the STAR cohort when compared to the conventional ablation cohort and the PVI alone ablation cohort.
- Performance of the PVI alone and conventional patient cohorts were in line with expectations based on other published studies.**
- 65 patients were studied in the STAR cohort.
- 65 patients were studied in the conventional ablation cohort.
- 50 patients were studied in the PVI alone ablation cohort.
- STAR vs. conventional ablation:
o Success (freedom from AF/AT) after a single procedure was 80% (52/65) in the STAR cohort, compared to 49.2% (32/65) in the conventional ablation cohort (p<0.001).
o Rates of recurrent AF (excluding Atrial tachycardia) were 4/65 (6.2%) with STAR, compared to 26/65 (40%) with conventional ablation (p<0.001).
o Follow-up period was longer in the STAR cohort (29.5±3.7 months vs. 20.5±8.1 months; p<0.001).
- STAR vs. PVI alone ablation:
- Success (freedom from AF/AT) after a single procedure was significantly higher in the STAR cohort when compared to the PVI alone ablation cohort (80% (52/65) vs 50% (25/50); p=0.001).
- Rates of recurrent AF (excluding Atrial tachycardia)4/65 (6.2%) in the STAR cohort, compared to 22/50 (44.0%) in the PVI alone ablation cohort (p<0.001).
- Follow-up period was longer in the STAR cohort (29.5±3.7 months vs. 22.6±5.8 months; p<0.001).
Simon Hubbert, Chief Executive of RHYTHM AI Ltd, commented: “We are encouraged to see additional, positive data demonstrating the superior results of STAR Mapping in the treatment of persistent AF, that has historically proved difficult to treat with conventional ablation therapy.