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Nov 20th, 2024

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LBS 07: NEW APPROACHES TO MANAGING AFIB

Combined linear ablation, radiofrequency ablation, metformin and aggressive risk
factor management.



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Investigators in four trials revealed surprising findings on novel approaches to
atrial fibrillation (AFib) ablation during their Late-Breaking Science session
on Monday. They found:

 * Combined linear ablation strategy provides rhythm control in patients with
   persistent atrial fibrillation.
 * Radiofrequency ablation did not offer a superior advantage to cryoballoon
   ablation.
 * Metformin did not improve Afib burden or progression.
 * Aggressive risk factor management may provide long-term relief from atrial
   fibrillation symptoms.

Combined linear ablation strategy for patients with persistent AFib may be
considered

The disease burden of AFib is increasing globally. In the U.S. alone, the
incidence is projected to double from 6 million to 12.1 million people by 2030.
Rhythm control has shown potential to improve outcomes, but success rates of
pulmonary vein isolation (PVI) alone have been modest for persistent AFib. Could
linear ablation combined with ethanol infusion vein of Marshall (EIVOM), a
treatment that involves injecting ethanol into the VOM (vein of Marshall) to
eliminate AFib triggers, be superior to pulmonary vein isolation (PVI) alone?

That was the question asked in “Comparison of Linear Ablation Plus Pulmonary
Vein Isolation Versus Pulmonary Vein Isolation Alone for Persistent Atrial
Fibrillation: Results From the PROMPT-AF Randomized Trial.” In the
investigator-initiated, multicenter, open label trial, 498 patients with
persistent AFib over three months undergoing first-time AFib ablation were
randomized 1:1 to pulmonary vein isolation alone or pulmonary vein isolation
with linear ablation and EIVOM. EIVOM was performed first, followed by PVI and
linear ablation of the left atrial roof, mitral isthmus and cavo tricuspid
isthmus. Arrhythmia recurrence was monitored using wearable single-lead
electrocardiogram (ECG) patches for 24 hours per week, along with any additional
symptom-triggered ECGs and Holter monitoring. Among randomized patients, 495
were included in the primary analysis.

The primary endpoint, freedom from any documented atrial arrhythmias lasting >30
seconds without anti-arrhythmic drugs at 12 months post-procedure, was met in
174 patients (70.7%) in the PVI + lines + EIVOM group and 153 patients (61.5%)
in the PVI alone group (HR 0.73, 95% CI: 0.54 to 0.99, p = 0.045).   

“Our study demonstrates that linear ablation combined with ethanol infusion vein
of Marshall in addition to pulmonary vein isolation can be an effective rhythm
control strategy for patients with persistent atrial fibrillation,” said Cheyang
Jiang, MD, a cardiologist with Sir Run Run Shaw Hospital and Zhejiang University
School of Medicine in Hangzhou, China, the study’s co-principal investigator.
 Jiang noted that PROMPT-AF is the first randomized trial to investigate the
benefit of linear ablation combined with EIVOM beyond PVI alone.

“Previous trials have failed to demonstrate a significant incremental benefit of
linear ablation when added to PVI alone, primarily due to difficulties in
achieving durable lesions,” Jiang said. “But our study provides direct evidence
that ethanol EIVOM facilitating ablation at the mitral isthmus is an optimized
linear ablation strategy.” The study was simultaneously published online in the
Journal of the American Medical Association.Kengo Kusano, MD (left) and Cheyang
Jiang, MD

CRRF-PeAF shows cryoballoon ablation comparable to radiofrequency ablation in
patients with persistent AFib

In catheter ablation of AFib, cryoballoon ablation demonstrated noninferiority
to radiofrequency ablation, according to Cryoballoon Ablation Versus
Radiofrequency Ablation in Patients With Persistent Atrial Fibrillation
(CRRF-PeAF): A Prospective, Multicenter, Randomized, Noninferiority Clinical
Trial.  

The prospective, multicenter, randomized, parallel-group, open-label study
randomized 500 patients with PeAF 1:1 to cryoballoon ablation or radiofrequency
ablation across 12 sites in Japan between April 2021 and June 2023. Pulmonary
vein isolation therapy was mandatory for all patients undergoing catheter
ablation. Adjunctive ablation lesion sets targeting sites outside the pulmonary
veins were performed at the physician’s direction.

One-channel electrocardiograms were recorded twice daily for one year after
catheter ablation using an ambulatory electrogram recorder in addition to other
scheduled examinations, including 12-lead ECGs and 24-hour Holter recordings at
three and 12 months. All documented atrial tachyarrhythmias lasting ≥30 seconds
occurring outside the 90-day blanking period were considered recurrences. The
final analysis included 499 patients.

The primary endpoint, defined as the occurrence of atrial tachyarrhythmias at
one year after the 90-day blanking period was observed in 22.5% of patients in
the cryoballoon ablation group and 23.2% in the radiofrequency ablation group.
Overall, cryoballoon ablation demonstrated non-inferiority to radiofrequency
ablation for the occurrence of atrial tachyarrhythmias at one year after the
90-day blanking period in patients with persistent atrial fibrillation (PeAF),
which met the primary endpoint (HR 0.99, 95% CI, 0.69-1.43; P=0.96). Cryoballoon
ablation demonstrated less atrial structural change compared with radiofrequency
ablation despite the similar recurrence rate and atrial fibrillation burden
after ablation between the two groups.

 “Until now, there hasn’t been a prospective randomized study conducted with
sufficient sample size comparing the outcome of catheter ablation between
cryoballoon ablation and radiofrequency ablation in patients with persistent
atrial fibrillation,” said Kengo Kusano, MD, director of the division of
arrhythmia and electrophysiology at the National Cerebral and Cardiovascular
Center in Osaka, Japan. “Our study shows that in catheter ablation of persistent
atrial fibrillation, cryoballoon ablation, which is a safer and shorter
treatment compared to radiofrequency ablation, is something you may want to
select for patients more often.”

Metformin and lifestyle changes did not reduce AFib burden compared to standard
of care

Treatment with metformin, lifestyle changes, or a combination of both did not
improve AFib burden or progression, with compared with the standard of care,
according to Randomized Controlled Trial of Metformin and Lifestyle/Risk Factor
Modification for Upstream Prevention of Atrial Fibrillation Progression: The
Targeting Risk Interventions and Metformin for Atrial Fibrillation, the TRIM-AF
Trial.

In the prospective, open-label, blinded endpoint, 2x2 factorial trial, 149
adults with paroxysmal AFib or persistent Afib with plans for conversion, with a
permanent pacemaker or ICD (with or without cardiac resynchronization
therapy) with an implanted atrial lead or electrode capable of providing AFib
diagnostics and remote monitoring. With at least one device-recorded ³5 minute
episode of AFib over 3-month pre-enrollment period) were randomized to one of
four treatment groups: standard of care (educational pamphlets on healthy diet
and exercise without individual counseling); metformin up to 750 mg BID;
lifestyle/risk factor modification (LRFM), including referral to a preventive
cardiology team for diet and nutrition counseling as well as exercise
prescription and to address other CV risk factors; or both metformin and LRFM.  

Patients’ implantable devices were capable of recording daily AFib burden and
activity. Patients were not on diabetes medications, with no contraindications
to metformin use. The mean age of patients was 73.7 years; 38.9% were female,
3.4% were non-White, 79.2% had hypertension, 8.7% had diabetes, 38.3% had
coronary artery disease, 68.5% had a pacemaker, and 31.5% had an ICD. Mean LVEF
was 55.0±11.2%; left atrial size 4.3±0.79 cm, and baseline AF average daily
burden 16.7±27.4%. The primary endpoint was a composite change in AFib burden or
death after one year of follow-up by intention-to-treat analysis. Participants
were followed for up to two years.Mina K. Chung, MD, FAHA

After the one-year follow-up, AFib burden decreased over time in the standard of
care group, the lifestyle/risk factor modification group, and the lifestyle/risk
factor modification and metformin group, but there were no significant
differences in AFib burden change between the four groups.  At 9-12 months,
median AFib burden was 0.67% (relative change -73.5%) in the standard of care
group, 0.62% (relative change -48.9%) in the metformin group, 0.13% (relative
change -85.9%) in the lifestyle/risk factor modification group and 0.90%
(relative change -72.4%) in the combined lifestyle/risk factor modification and
metformin group.  

All three intervention groups experienced weight loss, an average of 2.4% of
their starting body weight in the metformin group, 2.1% in the lifestyle/risk
factor modification group and 4.4% (9.1 pounds) -in the combined lifestyle/risk
factor modification and metformin group.

“Interventions, including weight loss, exercise and metformin act on AMP kinase,
the master regulator of metabolic stress in cells, but metformin alone should
not be recommended as an upstream therapy for AFib,” said Mina K. Chung, MD,
FAHA, a cardiologist and professor of medicine at the Cleveland Clinic in Ohio,
the lead study author. Still, don’t underestimate the motivational power of
discussing lifestyle and risk factor modification with patients with AFib. “We
were surprised by the decrease in AFib burden in the standard of care group,”
Chung said. “It’s possible that the written literature on diet and exercise we
distributed to the standard of care group could have had a greater effect on
reducing AFib burden than we thought.”  

Aggressive risk factor management improved outcomes in patients after AFib
ablation

The rising incidence of AFib coincides with an increase of cardiac risk factors
in the general population, including obesity, hypertension, diabetes and sleep
apnea. Catheter ablation of AFib is an effective treatment strategy, but it
shows attrition of success over time. Cardiac risk factors are associated with
increased risk of recurrence post-ablation. Could aggressive risk factor
management improve outcomes in patients after AFib ablation treatment? That was
the question asked in Aggressive Risk factor REduction STudy for Atrial
Fibrillation (ARREST-AF) implications for ablation outcomes: A Randomized
Clinical Trial.  

The study randomized 122 patients in Australia with BMI >27 and one additional
cardiac risk factor, such as hypertension, obesity, diabetes or sleep apnea 1:1
to intensive risk factor modification (RFM) or usual care after de novo catheter
ablation for paroxysmal or persistent AFib. Patients in the RFM group attended a
physician-led clinic to reduce modifiable risk factors in accordance with
American Heart Association guidelines every three months for one year. Both
groups received guideline-directed care for management of AFib. Pulmonary vein
isolation was undertaken in each patient with additional ablation considered at
the discretion of the electrophysiologist.  Rajeev Pathak, MBBS, PhD, FHRS

The primary endpoint, the percentage of patients free from AFib beginning at 12
months after ablation, which included a three-month blanking period, was 61.3%
in the RFM group and 40% in the usual care group (HR 0.53, 95% CI 0.32-0.89, 
p=0.03). An arrhythmia was defined as a 30-second episode. Secondary endpoints
included atrial symptom severity, risk factor profile, exercise capacity and the
need for additional ablation. The risk factor management group had a median
weight loss of approximately 20 pounds and showed superior blood pressure
control, fasting glucose, lipid profile and exercise capacity, compared to the
usual care group.

“This is the first in human randomized control trial showing that risk factor
management after catheter ablation for AFib is associated with a significant
reduction in AFib recurrence, as seen on an implantable loop recorder and
improvement in self-reported symptoms and cardiac metabolic risk factors,
compared with the usual care,” said Rajeev Pathak, MBBS, PhD, FHRS, the study’s
principal investigator and clinical academic and director of cardiac
electrophysiology at The Australian National University and Canberra Heart
Rhythm.

Pathak noted the RFM group participated in a highly structured program tailored
to each patient’s particular risk profile. “This was not one size fits all. For
aggressive risk factor medication to work, it’s important to identify exactly
which cardiac risk factors patients have and come up with a lifestyle
modification plan that also addresses each patient’s limitations and
challenges,” he said. 


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