The top stories out of Heart Rhythm Society 2024 (2024)

Part of the Farapulse pulsed-field ablation system, the Farawave single-shot catheter is designed to create durable and circumferential lesions. [Image courtesy of Boston Scientific]

The Kardia ECG. [Image from AliveCor]

The all-in-one Sphere-9 catheter for mapping and ablation. [Image courtesy of Medtronic]

The Varipulse catheter comprises one key piece of the Varipulse platform. [image courtesy of Biosense Webster]

[Image courtesy of Philips]

[Image from Boston Scientific]

Findings from three studies shared at Heart Rhythm Society highlighted the role of mobile cardiac monitoring technology in the early detection of adverse cardiac events. Results also demonstrate how the detection enables potentially life-saving interventions and helps reduce readmissions and lower costs.

Philips’ study compared outcomes using its mobile cardiac outpatient telemetry (MCOT) wearable ECG sensor with implantable loop recorders (ILRs) in stroke patients to determine how cardiac remote monitoring technology impacts current standards of care.

“Effective cardiac monitoring starts with quality data, and with the AI-powered data platform behind MCOT, Philips is uniquely positioned to help care teams make quick, impactful, and cost-conscious decisions for their cardiac patients,” said Manish Wadhwa, chief medical officer for Philips Ambulatory Monitoring & Diagnostics.

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The Sydney, Australia-based company, which just emerged from stealth mode, designed its ElectroPulse pulsed field ablation (PFA) system to treat symptomatic AFib. The system features the ElectroPulse generator, variable loop mapping and ablation catheter with the ElectroTouch contact sensing module.

CathRx’s all-in-one design streamlines ablation and minimizes the need for additional catheters, CathRx says. It seamlessly integrates with existing hospital equipment, minimizing the need for additional capital investment. CathRx enrolled both paroxysmal and persistent AFib patients and observed a 100% success rate in isolating all four pulmonary veins, as well as the posterior wall of the left atrium.

The study presented at Heart Rhythm Society also achieved bi-directional electrical blocks in all patients. The company reported no serious adverse events in the study and no evidence of significant blood cell destruction or kidney injury. ElectroPulse delivered short procedure times with limited fluoroscopy.

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Medtronic’s investigational OmniaSecure catheter-delivered defibrillation lead met its primary safety and effectiveness endpoints and exceeded prespecified performance goals in the LEADR pivotal trial, for which the company presented results at Heart Rhythm Society .

Implantable cardioverter defibrillators (ICDs) provide life-saving cardiac interventions. However, the medtech giant aims to improve upon one area of weakness: the transvenous leads. Medtronic engineers designed the OmniaSecure defibrillation lead based on its SelectSecure Model 3830 pacing lead. The company says it’s the world’s smallest transvenous defibrillation lead at 4.7 French. That equals about the diameter of graphite in a wooden pencil.

Medtronic reported 97.5% success in defibrillation testing conducted at device implantation in 119 patients. That exceeded the prespecified efficacy goal of 88%.

Additionally, the lead demonstrated reliable performance with zero fractures through the average follow-up period. Medtronic’s in-vitro model accurately predicts lead reliability out to 10 years and applied that model within the study. It predicts a fracture-free survival of 99.9% at two years for OmniaSecure.

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AliveCor presented two studies at Heart Rhythm Society . The first evaluated the accuracy of the recordings and interpretations of the Kardia 12L device that records 12-lead ECG. It compared the accuracy of the AI-powered device to standard 12-lead ECG technology.

Kardia 12L uses a deep neural network model, expanding eight leads into a complete 12-lead ECG. In 150 participants, all measurements showed strong correlation, meaning Kardia’s evaluations are “highly similar” to standard 12-lead ECG, according to the study’s abstract. This enables the rapid acquisition of complete ECG information in clinical practice.

The second study compared six-lead Kardia ECG to the traditional Holter monitor. KardiaMobile 6L, an FDA-cleared, portable recording device enables patient-initiated recordings during symptoms, potentially enhancing diagnostic accuracy. This study looked to assess the system’s diagnostic yield compared to conventional Holter monitoring.

Both studies presented at Heart Rhythm Society highlighted the potential of AliveCor’s ECG technology.

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Johnson & Johnson MedTech’s Biosense Webster shared positive results from a clinical trial of its Varipulse pulsed field ablation (PFA) platform at Heart Rhythm Society.

The company presented results from its admIRE pivotal clinical trial and additional data from the Virtue study. Both studies evaluated Varipulse for the treatment of cardiac arrhythmias, including AFib.

The company submitted Varipulse for FDA approval at the end of March. If approved, Varipulse would become the third PFA system authorized for treating AFib, following Medtronic and Boston Scientific.

Biosense Webster submitted the results from the admIRE study to support its FDA approval bid.

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Medtronic shared data at Heart Rhythm Society demonstrating the safety and efficacy of its Affera mapping and ablation system with the Sphere-9 catheter.

The all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high-density (HD) mapping catheter treats persistent AFib. Medtronic’s SPHERE Per-AF study, an FDA IDE pivotal trial, compared it to the Biosense Webster Thermocool SmartTouch SF ablation system with Carto 3 mapping.

Dr. Elad Anter, director of the Arrythmia Institute, Shamir Medical Center, Israel, called the results “excellent” for the investigational system. Anter said the data demonstrated the ability of the Sphere-9 lattice tip to create a wide circumferential pulmonary vein isolation. This demonstrated the ability to ablate lesions in a safe, effective and efficient manner through versatile means.

According to Medtronic, patients treated with Sphere-9 experienced quality-of-life improvements in both mental and physical well-being.

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Data presented at Heart Rhythm Society supported the use of the Boston Scientific modular cardiac rhythm management (mCRM) technology.

The mCRM system features a novel leadless pacemaker (LP) with wireless communication to a subcutaneous implantable cardioverter defibrillator (S-ICD). This combination delivers anti-tachycardia pacing (ATP) and bradycardia pacing to patients while avoiding transvenous lead complications.

Boston Scientific’s mCRM offering utilizes the Emblem MRI S-ICD system and the Empower modular pacing system (MPS). The company previously touted it as the first leadless pacemaker capable of delivering both bradycardia pacing support and ATP. It kicked off the MODULAR-ATP study evaluating the technology in late 2021.

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New data from Boston Scientific presented at Heart Rhythm Society looked at the impact of post-ablation atrial arrhythmia (AA) burden outcomes.

The ADVENT trial compared Boston Scientific’s Farapulse pulsed field ablation (PFA) system to thermal ablation. In August, the company had positive 12-month results from same trial. Earlier this year, it became the second PFA system approved by the FDA to treat AFib.

ADVENT revealed no significant difference in one-year freedom from AA between thermal ablation and PFA. However, studies indicate that post-ablation AA burden better predicts clinical outcomes than a 30-second AA recurrence. As a result, Boston Scientific looked at the impact of post-ablation AA burden on outcomes and the effect of ablation modality.

According to Boston Scientific, patients treated with the Farapulse PFA system had a statistically superior reduction in arrhythmia burden relative to thermal ablation.

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Study results showed that HeartBeam AI with VCG outperformed an expert panel of heart rhythm cardiologists in detecting atrial flutter.

HeartBeam’s AI algorithm uses deep learning to detect abnormalities in the timing or pattern of heartbeats. VCG measures the magnitude and direction of the electrical forces generated by the heart using a continuous series of vectors that form curving lines around a central point.

HeartBeam AI plus VCG outperformed the panel reviewing single-lead ECGs with a statistically significant 40% improvement in atrial flutter detection. For 12-lead ECGs, the AI and VCG outperformed the panel by 6% (also statistically significant). The technology delivvered zero variability in the detection of atrial flutter compared to the EP panel.

The HeartBeam core vectorelectrocardiography (3D VECG) captures the heart’s signals in three projections, like a VCG, synthesizing a 12-lead ECG. The company plans to apply this platform to the AIMIGo credit card-sized device for patient use at home or anywhere. AIMIGo remains under review by the FDA, but the company hopes to commercialize it this year.

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The Marseille, France-based company’s findings from an FDA investigational device exemption (IDE) trial were presented at Heart Rhythm Society 2024.

Results showed that Volta’s AI decision support system, in addition to pulmonary vein isolation (PVI), was superior to a PVI-only procedure in persistent or long-standing persistent AFib patients in attaining freedom from documented AFib with or without anti-arrhythmic drugs at 12 months.

The Volta system enabled a tailored cardiac ablation procedure for patients. Volta designed it to provide cardiologists with real-time identification of specific abnormal electrograms (EGMs).

Volta’s trial evaluated 187 patients who underwent the tailored cardiac ablation guided by AI in addition to PVI. A total of 183 received conventional PVI-only treatment. The study took place across 26 centers in five countries.

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