RHYTHM AI announces publication of clinical outcome study…

…demonstrating superior results using STAR Mapping™ in the ablation
treatment of persistent atrial fibrillation (AF)

Pulmonary vein isolation (PVI) plus STAR-guided ablation demonstrates superiority to either PVI alone or when PVI was combined with other ablation techniques.  This publication adds to the growing body of peer reviewed data using STAR Mapping.

London, 26th January 2021: RHYTHM AI Ltd, a UK company focused on the treatment of Atrial Fibrillation (AF), today announces 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:

    • 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).
    • 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).
    • 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).

“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.”

CHIEF EXECUTIVE, RHYTHM AI, SIMON HUBBERT

* Honarbakhsh S, Schilling RJ, et al; 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. J Cardivasc Electrophysiol 2020. doi: 10.1111/jce.14856. An abstract of the paper is available at https://pubmed.ncbi.nlm.nih.gov/33368766/

**Atul Verma et al; Approaches to catheter ablation for persistent Atrial Fibrillation. N Engl J Med 2015; 372:1812-1822
DOI: 10.1056/NEJMoa1408288

RHYTHM AI announces publication of successful STAR Mapping™ clinical outcome trial that…

…identified Atrial Fibrillation (AF) drivers in all study patients

Trial Patients

30 patients with persistent AF were included in the trial.  Three patients had AF terminated during the Pulmonary Vein Isolation (PVI) procedure

Equipment

Commercially available multipolar catheters and equipment were used to gather sequential data for STAR Mapping in the remaining 27 patients

Result Highlights

AF drivers were identified in 100% of patients using STAR Mapping

A positive response (AF termination or Cycle Lengths slowing of ≥30ms) was achieved with STAR Mapping guided ablation in all 27 patients

81.5% of patients (22 of 27) undergoing STAR guided ablation were free from AF at an average follow up time of 17.3 months without the need for antiarrhythmic drug

Conclusion

STAR-guided AFD ablation through sequential mapping with a multipolar catheter effectively achieved an ablation response in all patients. AF terminated in a majority of patients, with a high freedom from AF/atrial tachycardia off antiarrhythmic drugs at long-term follow-up. isolation.

Honarbakhsh S, Schilling RJ, et al; Circ Arrhythm Electrophysiol, 2020

The full clinical paper can be found by following the link below.

View White Paper

STAR Mapping™ in Proof of Concept Studies Suggest that…

STAR Mapping™ has shown improvement in long term outcomes of persistent AF ablation in patients.

35 persistent AF patients were evaluated:

Followed up for >1 year (mean 18.5 months)

Extended ECG recordings and detailed clinical assessments were performed.

80% of patients were free of any abnormal rhythm

Free from abnormal rhythm with no need for any antiarrhythmic medication.

A large multi-centre study using current mapping technology published in 2015 demonstrated 48% of patients were free from documented atrial fibrillation at 18 months without antiarrhythmic medication.

The remaining 20% of patients

Of the remaining 20% only a single patient had a recurrence of AF.

The remaining 6 had recurrence of a regular rhythm that was unable to disorganise into AF.

Conclusion

This proof of concept study indicates that catheter ablation using a 3D mapping system with STAR Mapping™ may lead to significantly better procedural outcomes than when using 3D mapping in isolation.

35 Patients with Persistent AF 14 Months

Clinical Evidence Chart

Honarbakhsh et al JACC EP 2019

The full clinical paper can be found by following the link below.

View White Paper

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