Heart Rhythm Society (HRS) 2024 took place in Boston last week, once again bringing together a large number of top players in cardiac care.
From implantable rhythm management devices to AI-powered monitoring and diagnostic technologies, Heart Rhythm 2024 had it all. Pulsed field ablation (PFA) once again took center stage as companies continued to address the rapidly increasing prevalence of atrial fibrillation.
All of the data shared at HRS 2024 demonstrated the never-ending innovation in cardiac care and highlighted what the future holds for the field.
Last year’s HRS also brought a lot of exciting news. Here are some of the biggest news stories from Heart Rhythm Society 2024.
Click the + sign to expand it.
Philips sees strong results with AI-powered heart monitoring data
Results from three studies presented at Heart Rhythm Society highlight the role that mobile cardiac monitoring technology can play in the early detection of adverse cardiac events. Results also demonstrate that detection can enable potentially life-saving interventions, reduce hospital readmissions and save costs.
A Philips study compared outcomes using Mobile Cardiac Ambulatory Telemetry (MCOT) wearable ECG sensors with those using implantable loop recorders (ILRs) in stroke patients to determine how cardiac remote monitoring technology might impact current standards of care.
“Effective cardiac monitoring starts with quality data. With the AI-powered data platform that powers MCOT, Philips is uniquely positioned to help care teams make fast, effective and cost-conscious decisions for cardiac patients,” said Manish Wadhwa, chief medical officer, Ambulatory Monitoring and Diagnostics, Philips.
Click here for more details.>>
CathRx Supports Pulsed Field Ablation Technology with First-in-Human Data
Just emerging from stealth mode, the Sydney, Australia-based company has designed an ElectroPulse Pulsed Field Ablation (PFA) system to treat symptomatic atrial fibrillation that includes an ElectroPulse generator, variable loop mapping, and an ablation catheter with an ElectroTouch contact-sensing module.
CathRx’s all-in-one design streamlines ablation and minimizes the need for additional catheters, CathRx said. It seamlessly integrates with existing hospital equipment, minimizing the need for additional capital investment. CathRx has enrolled patients with paroxysmal and persistent atrial fibrillation and observed a 100% success rate in isolating all four pulmonary veins and the posterior wall of the left atrium.
Bidirectional electrical block was also achieved in all patients in the study published in the Heart Rhythm Society. The company reports that no serious adverse events occurred in the study and there was no evidence of significant blood cell destruction or kidney damage. The ElectroPulse enabled short procedure times while limiting fluoroscopy.
Click here for more details.>>
Medtronic Investigational Defibrillator Meets Primary Study Endpoint
Medtronic’s investigational catheter-delivered defibrillation lead, OmniaSecure, met key safety and efficacy endpoints and exceeded pre-specified performance goals in the LEADR pivotal trial, the company announced today at the Cardiac Rhythm Society meeting.
Implantable cardioverter-defibrillators (ICDs) provide life-saving cardiac interventions, but the medical technology giant is looking to improve one of their weak spots: transvenous leads. Medtronic engineers designed the OmniaSecure defibrillation lead based on the SelectSecure Model 3830 pacing lead, which the company says is the world’s smallest transvenous defibrillation lead at 4.7 French, roughly the diameter of the graphite in a wooden pencil.
Medtronic reported a 97.5% success rate in defibrillation testing conducted on 119 patients implanted with the device, exceeding its pre-established efficacy goal of 88%.
Additionally, the lead demonstrated reliable performance with zero fractures throughout the median follow-up period. Medtronic’s in vitro model accurately predicted lead reliability over 10 years and was applied in the study. The model predicted a two-year fracture-free survival rate for OmniaSecure of 99.9%.
Click here for more details.>>
AliveCor Announces Positive Study Results for Handheld AI-Powered Electrocardiogram
AliveCor presented two studies at the Heart Rhythm Society. The first evaluated the recording and interpretation accuracy of the Kardia 12L device, which records 12-lead ECGs. It compared the accuracy of the AI-enabled device to standard 12-lead ECG technology.
Kardia 12L uses a deep neural network model to expand the eight leads into a full 12-lead ECG. According to the study summary, across 150 participants, all measurements showed strong correlation, meaning Kardia assessments are “highly similar” to standard 12-lead ECGs. This allows for quicker access to complete ECG information in clinical practice.
The second study compared the 6-lead Kardia ECG with a traditional Holter ECG monitor. The KardiaMobile 6L, an FDA-cleared portable recording device, allows patients to start recording when they have symptoms, potentially improving diagnostic accuracy. The study aimed to evaluate the diagnostic yield of the system compared to a traditional Holter ECG monitor.
Two studies presented at the Heart Rhythm Society highlighted the potential of AliveCor’s ECG technology.
Click here for more details.>>
Biosense Webster Presents Data Supporting Varipulse Pulsed Field Ablation
Johnson & Johnson Medtech Biosense Webster announced positive results from a clinical trial of its Varipulse pulsed field ablation (PFA) platform at the Heart Rhythm Society Conference.
The company announced results from the admIRE pivotal clinical trial and additional data from the Virtue study, both of which evaluated Varipulse in treating arrhythmias, including atrial fibrillation.
The company submitted its Varipulse application for FDA approval at the end of March. If approved, Varipulse would become the third PFA system approved for treating atrial fibrillation, joining Medtronic and Boston Scientific.
Biosense Webster submitted results from the admIRE study in support of its FDA approval application.
Click here for more details.>>
Medtronic Data Shows Safety and Effectiveness of Affera, Sphere-9 All-in-One Ablation
Medtronic shared data at the Heart Rhythm Society demonstrating the safety and effectiveness of its Affera mapping and ablation system using the Sphere-9 catheter.
The all-in-one pulsed-field (PF) and radiofrequency (RF) ablation and high-density (HD) mapping catheter treats persistent atrial fibrillation and was compared to the Biosense Webster Thermocool SmartTouch SF Ablation System with Carto 3 Mapping in Medtronic’s SPHERE Per-AF study, an FDA IDE pivotal trial.
Dr. Elad Antar, director of the Cardiac Arrhythmia Research Institute at Shamir Medical Center in Israel, called the results of the research system “impressive.” Dr. Antar said the data demonstrated the ability of the Sphere-9 lattice chip to achieve widespread isolation of pulmonary veins, demonstrating its ability to safely, effectively and efficiently ablate lesions by a versatile means.
According to Medtronic, patients treated with Sphere-9 experienced improvements in their quality of life in both their mental and physical health.
Click here for more details.>>
Boston Scientific has good data on modular CRM
Data presented at Heart Rhythm Society supported the use of Boston Scientific’s 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), a combination that provides patients with antitachycardia pacing (ATP) and bradycardia pacing while avoiding the complications of transvenous leads.
Boston Scientific’s mCRM offering leverages the Emblem MRI S-ICD System and the Empower Modular Pacing System (MPS), which the company previously touted as the first leadless pacemaker capable of providing both bradycardia pacing support and ATP. The company launched the MODULAR-ATP study to evaluate the technology in late 2021.
Click here for more details.>>
Boston Scientific Farapulse Study Highlights Impact of Post-Ablation Arrhythmia Burden on Outcomes
New data presented by Boston Scientific at the Heart Rhythm Society Conference investigated the impact of atrial arrhythmia (AA) burden outcomes following ablation.
The ADVENT trial compared Boston Scientific’s Farapulse pulsed field ablation (PFA) system with thermal ablation. In August, the company announced positive 12-month outcomes from the same trial. Earlier this year, the system became the second PFA system approved by the FDA to treat atrial fibrillation.
ADVENT found no significant difference in the 1-year freedom from AA recurrence between thermal ablation and PFA. However, studies have shown that post-ablation AA burden is a better predictor of clinical outcomes than 30-second AA recurrence. As a result, Boston Scientific investigated 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 demonstrated a statistically superior reduction in arrhythmia burden compared to thermal ablation.
Click here for more details.>>
HeartBeam AI Combined with VCG Outperforms Cardiologists in Arrhythmia Detection
According to the study results, HeartBeam AI with VCG outperformed an expert panel of cardiac rhythm specialists in detecting atrial flutter.
HeartBeam’s AI algorithms use deep learning to detect abnormalities in heartbeat timing and patterns, while VCG measures the magnitude and direction of the electrical forces generated by the heart using a series of continuous vectors that form a curve around a central point.
The combination of HeartBeam AI and VCG showed a statistically significant 40% improvement in detecting atrial flutter, outperforming the test panel on single-lead ECGs. On 12-lead ECGs, the combination of AI and VCG outperformed the panel by 6% (also statistically significant). The technology had zero variability in detecting atrial flutter compared to the EP panel.
HeartBeam Core Vector Electrocardiogram (3D VECG) captures cardiac signals in three projections, like a VCG, and synthesizes a 12-lead ECG. The company plans to apply this platform to its AIMIGo credit card-sized device, which patients can use at home or anywhere. AIMIGo is currently under FDA review, but the company hopes to commercialize it this year.
Click here for more details.>>
Volta Medical Finds Positive Data for AI-Based Atrial Fibrillation Treatment
The Marseille, France-based company’s findings from the FDA Investigational Device Exemption (IDE) trial were presented at Heart Rhythm Society 2024.
Results showed that in patients with persistent or long-term persistent AFib, pulmonary vein isolation (PVI) plus Volta’s AI decision support system was superior to the PVI-only procedure in achieving documented freedom from AFib at 12 months with or without antiarrhythmic medications.
The Volta System enables personalized cardiac ablation procedures. Volta was designed to help cardiologists identify specific abnormal electrocardiograms (EGMs) in real time.
The Volta trial evaluated 187 patients who underwent AI-guided tailored cardiac ablation in addition to PVI. A total of 183 patients were treated with conventional PVI alone. The study was conducted at 26 centers in five countries.
Click here for more details.>>
