RECOVER AF Study Reports 91% of First Redo Patients Achieved Freedom from AF at One Year After AcQMap-guided Ablation Therapy
20 Abril 2023 - 9:00AM
Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia
management company focused on improving the way cardiac arrhythmias
are diagnosed and treated, today announced results from the RECOVER
AF study. The study, published online in EP Europace, found that
patients who received AcQMap-guided ablations for retreatment
achieved better outcomes compared to those who underwent
traditional anatomical retreatment strategies.1-3
Moreover, the study showed patients who had only undergone
pulmonary vein isolation (PVI) before enrollment achieved 91%
freedom from atrial fibrillation (AF) at one year, while the entire
study population, with varying prior procedures, reported 76%
freedom from AF at one year.1 Overall, these findings underscore
AcQMap’s differentiated offering for retreatment procedures in
delivering personalized therapy to yield improved outcomes and
fulfill a major unmet need in the market.
“These results are encouraging and add to the growing evidence
that mapping AF to guide an individualized treatment plan may be
advantageous at the earliest opportunity in patients with
persistent AF,” says principal investigator Timothy R. Betts, MD,
MBChB, FRCP (Oxford University Hospitals, UK). “Furthermore, the
particularly high success rates for persistent AF retreatment
patients with only a prior PVI, in contrast to those with prior
PVI+, suggests that ablation beyond the PVs that is empiric and not
informed by AF mapping could be detrimental.”
In the RECOVER AF study, AcQMap’s unique whole chamber
single-beat non-contact mapping was used to map AF and detect
Pathological Conduction Patterns (PCPs), which were then targeted
for therapy with a core-to-boundary ablation strategy. 76% of
patients undergoing retreatment with AcQMap-guided ablations
experienced freedom from AF at one year. Furthermore, freedom from
AF was particularly high for patients who had only PVI before
enrollment compared to those who had PVI plus additional non-PV
ablations (91% vs. 63%, p<0.05). The outcomes provide clear
evidence that advanced, patient-specific mapping with the AcQMap
system leads to superior outcomes over empirical approaches,
especially when used earlier in the patient’s treatment
pathway.
Conventional approaches to retreatment procedures for AF
consistently result in unsatisfactory outcomes, with only 60-68% of
patients being AF-free after 12 months.2-3 There are an estimated
100,000-150,000 AF retreatment procedures annually, which create a
significant burden on the healthcare system.4 Studies have shown
that a mere 1% reduction in redo ablations could save the US
healthcare system nearly $30 million annually.5 Outcomes in the
RECOVER AF study highlight the pivotal advantage of AcQMap system
and the importance of a personalized ablation strategy.
“The RECOVER AF study’s findings help advance our strategy to
become the system-of-choice for EPs treating complex arrhythmias,
including for patients undergoing treatment for persistent AF,”
said David Roman, President & CEO of Acutus Medical. “Over the
past year, we have focused the Company’s research and development,
commercial, and clinical resources to support customers tackling
the most challenging conditions in EP. Through technology
innovation and further clinical evidence generation, we believe
AcQMap has the potential to become standard-of-care across several
arrythmias, and ultimately, impact over $3 billion in addressable
procedure categories.”
Conference Call The company will host a
conference call to discuss results from RECOVER with the study’s
principal investigator Timothy R. Betts, MD, MBChB, FRCP (Oxford
University Hospitals, UK) on Friday April 21, 2023 at
12:00pm Eastern Time. Please register in advance using the
link: https://edge.media-server.com/mmc/p/cp5ykbic.
About the RECOVER AF StudyRECOVER AF was a
prospective, nonrandomized trial that enrolled patients scheduled
for their first or second ablation retreatment for recurrent AF.
PVs were assessed and re-isolated if necessary. AF maps were used
to guide the ablation of non-PV targets through the elimination of
pathologic conduction patterns (PCPs). The primary endpoint was
freedom from AF on or off antiarrhythmic drugs (AADs) at 12
months.
Patients undergoing retreatment with the AcQMap System (n=103)
were 76% AF-free at 12 months. Patients who had only received a PVI
before the study were 91% AF-free at 12 months after the treatment
of non-PV targets with the AcQMap System. No major adverse events
were reported.
The article can be viewed here on EP Europace:
https://academic.oup.com/europace/advance-article/doi/10.1093/europace/euad097/7128319
About Acutus MedicalAcutus Medical (“Acutus” or
the “Company”) is an arrhythmia management company focused on
improving the way cardiac arrhythmias are diagnosed and treated.
Acutus is committed to advancing the field of electrophysiology
with a unique portfolio of technologies and solutions designed to
enable physicians to treat more patients more effectively. Through
internal product development, acquisitions, and global
partnerships, Acutus has established a global sales presence that
delivers targeted electrophysiology solutions for the
catheter-based treatment of cardiac arrhythmias. Founded in 2011,
Acutus is based in Carlsbad, California.
Follow Acutus Medical on: Twitter, LinkedIn,
YouTube and Facebook.
Investor ContactCaroline Corner
415-202-5678caroline.corner@westwicke.com
Media ContactRhiannon
Pickus442-232-6094Rhiannon.Pickus@acutus.com
References:
- Betts et al.
Treatment of pathophysiologic propagation outside of the pulmonary
veins in retreatment of atrial fibrillation patients: Recover AF
study. Europace. 2023. doi:10.1093/europace/euad097
- Goldenberg et al. The incremental benefit of non-pulmonary vein
left atrial ablation in patients undergoing a repeat persistent
atrial fibrillation ablation procedure. J Interv Card
Electrophysiol. 2017;48:185–191. doi:
10.1007/s10840-016-0198-8
- Weng et al. Outcomes of a comprehensive strategy during repeat
atrial fibrillation ablation. J Interv Card Electrophysiol.
2022;65:391–399. doi: 10.1007/s10840-021-00970-w
- Acutus data on global AF procedure estimates. [Assumes ~450,000
AF procedures of which 43% are paroxysmal and 57% are persistent
and long-standing persistent AF (CABANA trial data). Retreatment AF
was calculated using weighted averages and composite first
procedure success rates across published trials].
- Mansour M et al. The impact of first procedure success rate on
the economics of Atrial Fibrillation Ablation. JACC Clin
Electrophysiol. 2017;3(2):129-138. doi:
10.1016/j.jacep.2016.06.002
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