Afib treatment advances publish in prominent medical journals

Real-time feature of Acutus’ AcQMap results in improved patient outcomes

A clinical trial investigating Acutus’ AcQMap showed that this novel imaging and mapping system safely guided cardiac ablation resulting in a 12-month freedom from recurrent atrial fibrillation (AFib) in 73 percent of patients with persistent atrial fibrillation.

The results, published in the July 1, 2019 issue of the Journal Circulation: Arrhythmia and Electrophysiology were first reported earlier this year in a late-breaking trial at the 24th Annual AF Symposium in Boston.

Known as UNCOVER-AF, the trial prospectively studied the safety and efficacy of the AcQMap in 127 patients at 13 sites in Europe and Canada – 98 percent of whom achieved a normal heartbeat upon completion of the procedure.

Characterized as an irregular heartbeat, AFib is the most common type of heart arrhythmia and could greatly increase a person’s risk of developing a severe stroke. Cardiac ablation is a procedure that can reduce the risk, yet traditional ablation procedures often fail to achieve long-term absence of AFib, resulting in repeat ablation procedures.

With its precision ultrasound and high definition re-mapping capabilities, AcQMap helps inform physicians in real time who can strive to improve outcomes by checking their work after each ablation.

Adapted from Acutus’ news release: Publication of UNCOVER AF Study in Circulation Demonstrates Impact of Charge Density Mapping During AF Ablation

Acutus has been a Deerfield portfolio company since 2016.  

Farapulse PFA shown as potential alternative to existing ablation procedures

A method of non-thermal field ablation demonstrated safety and efficacy in clinical trials comparing outcomes of the modality to those seen with traditional thermal approaches in patients with paroxysmal atrial fibrillation, or episodic AFib.

The results of the first-in-human trial were reported in an online early version of the manuscript that is slated to publish in the Journal of the American College of Cardiology.

Called pulsed field ablation (PFA), the alternate modality was shown to successfully target heart tissue without damaging adjacent structures like the esophagus or phrenic nerve – a shortcoming of standard ablation therapies, including radiofrequency (via heat) and cryotherapy (by way of freezing).

In 81 patients, 100% of pulmonary veins (PV) were specifically isolated with three minutes of PFA time per patient. Furthermore, long-term remapping procedures demonstrated that the rates of durable PV isolation improved with successive waveform modifications with the most optimized PFA group demonstrating 100% durability.

The rate of primary safety events was low at 1.2%, and with no subsequent primary adverse events during follow-up.

Farapulse has been a Deerfield portfolio company since 2017.