Pulsed Field Ablation Advances in Atrial Fibrillation Treatment at HRS Annual Meeting.

At the annual meeting of the Heart Rhythm Society (HRS) in San Diego this weekend, the next generation of pulsed field ablation (PFA) technology took center stage, marking a pivotal moment in the treatment of atrial fibrillation (AFib). With industry giants such as Abbott, Johnson & Johnson, Boston Scientific, and Kardium showcasing their latest developments, PFA is quickly establishing itself as a safer and more effective alternative to traditional thermal ablation methods.

Atrial fibrillation, the most common form of irregular heartbeat, affects millions globally and has long been treated using ablation techniques that employ heat or cold to disrupt abnormal electrical signals in the heart. However, these methods can inadvertently harm surrounding tissues and organs. Pulsed field ablation, which uses rapid bursts of electric fields to target heart muscle cells, is gaining recognition for its precision and lower risk of unintended damage.

Abbott's Volt System: A Breakthrough in PFA Technology:

One of the standout presentations came from Abbott, which shared 12-month clinical trial data supporting the European approval of its Volt pulsed field ablation system. The study involved patients with both persistent and paroxysmal AFib. Remarkably, 58.1% of those with persistent AFib and 83.5% of those with paroxysmal AFib were free of arrhythmia symptoms after one year. Furthermore, the Volt system demonstrated an impressive safety profile, with no serious complications such as hemolysis, coronary artery spasm, or phrenic nerve injury reported in the trial. Only 2.7% of patients experienced minor side effects, underscoring the system's promising efficacy and safety.

Notably, the Volt system showed similar safety and effectiveness whether the procedure was performed under conscious sedation, deep sedation, or general anesthesia, offering flexibility in patient care.

Christopher Piorkowski, Chief Medical Officer of Abbott’s Electrophysiology business, commented, “The latest data from the Volt CE Mark Study confirms that the Volt PFA System will make a significant positive impact on patient care for those dealing with atrial arrhythmias."

Johnson & Johnson’s Omnypulse: Minimizing Radiation Exposure:

Meanwhile, Johnson & Johnson presented groundbreaking results from its Omnypulse platform, a device that employs a large-tip catheter for focal pulsed field ablation. The Omny-IRE study, which involved 136 patients with paroxysmal AFib, showed a perfect 100% success rate in isolating the pulmonary veins using only five minutes of fluoroscopy, a dramatic reduction in radiation exposure compared to traditional procedures. After three months, about 84% of these isolations remained intact, indicating long-term effectiveness.

The FDA had previously approved J&J's Varipulse system in late 2023, although its U.S. rollout was briefly paused due to four reported strokes. After careful reevaluation and modifications, the commercial efforts resumed earlier this year. The company now advises clinicians to avoid multiple ablations in the same tissue area, ensuring patient safety while maintaining the benefits of the technology.

Boston Scientific’s Farapulse: Setting New Standards for AFib Treatment:

Boston Scientific also unveiled impressive new data from its Farapulse system, which was presented alongside upcoming catheters, Farawave and Farapoint, aimed at treating persistent AFib and atrial flutter. The Advantage-AF trial demonstrated that 73.4% of patients were free from AFib, flutter, and atrial tachycardia after 12 months. Additionally, 81% of patients did not experience any recurrence of AFib, and 96.4% had no recurrence of atrial flutter. This trial emphasized the potential for Farapulse to offer long-term freedom from arrhythmias without the need for additional anti-arrhythmic medications.

Farapulse is currently FDA-approved for treating paroxysmal AFib, and Boston Scientific anticipates regulatory approval for persistent AFib and the Farapoint catheter later this year.

Kardium's Globe System: A Novel Approach to AFib Ablation:

Kardium also made waves with its Globe system, a unique spherical catheter designed to deliver a single shot of ablation using 122 gold electrodes. The Globe system, which combines radiofrequency-powered thermal ablation with pulsed field capabilities, was presented with 12-month clinical data showing that 78% of patients treated for intermittent AFib had no symptoms after a year. The study highlighted the Globe system's ability to deliver highly effective treatments in a single procedure, taking just about 95 minutes on average.

Field Medical’s Emerging Role in Ventricular Tachycardia:

In addition to advancements in AFib treatment, Field Medical showcased its FieldForce platform, aimed at treating ventricular tachycardia (V-Tach), a dangerous arrhythmia often linked to heart damage following surgery or heart attacks. The early data from its first-in-human study showed that 78% of patients experienced freedom from symptoms after treatment, although two patients experienced worsening heart failure. The company has raised $40 million in funding to further develop its PFA technologies and prepare for pivotal trials in V-Tach.

Shifting to Same-Day Discharge for Ablation Procedures:

Finally, both the HRS and the American College of Cardiology (ACC) endorsed a shift toward protocols allowing patients to be discharged the same day after cardiac ablation procedures. This strategy, particularly important for treating the aging population with AFib, aims to reduce healthcare costs associated with overnight hospital stays and improve patient access to care. Evidence from the COVID-19 pandemic suggests that same-day discharges can be safely implemented, especially when procedures are performed in ambulatory surgery centers (ASCs).

However, experts caution that implementing such protocols will require close collaboration between patients, caregivers, and healthcare providers to ensure patient safety and comfort.

Conclusion:

With the growing prevalence of AFib and the increasing demand for effective, safe treatment options, the innovations in pulsed field ablation presented at the HRS meeting represent a promising future for patients. Technologies like Abbott’s Volt system, J&J’s Omnypulse, Boston Scientific’s Farapulse, and Kardium’s Globe system are setting new standards in the treatment of arrhythmias, providing patients with improved outcomes and reduced risks. As these systems evolve and gain broader approval, the landscape of AFib treatment is poised for a major transformation.

Source:https://www.fiercebiotech.com/medtech/next-generation-pulsed-field-ablation-takes-stage-hrs-annual-meeting

This is non-financial/medical advice and made using AI so could be wrong.