From first-time clinical data to major industry debuts, here are Cardiac Rhythm News’ 10 most popular stories of 2024.
1. Abbott joins the pulsed field ablation party
Early on in the year, Abbott announced the first global procedures had been conducted using the company’s new Volt pulsed field ablation (PFA) system to treat patients with arrhythmias like atrial fibrillation (AF).
2. Omny-IRE clinical trial completes enrolment
Biosense Webster, now consolidated under the Johnson & Johnson (J&J) MedTech brand, announced in August 2024 that enrolment had been completed in the Omny-IRE clinical trial—a prospective, multicentre, non-randomised trial evaluating the safety and effectiveness of the Omnypulse platform for the mapping and treatment of symptomatic paroxysmal AF during standard ablation procedures.
3. “Structural heart leader” joins Cardiac Dimensions as chief medical officer
Cardiac Dimensions, a developer of invasive treatment modalities to address patients suffering from heart failure with functional mitral regurgitation (FMR), announced in the first weeks of 2024 that interventional cardiologist Satya Shreenivas had joined the company as chief medical officer.
4. Varipulse PFA system receives CE mark
In February, Biosense Webster (J&J MedTech) announced the receipt of European CE-mark approval of the Varipulse platform for the treatment of symptomatic drug-refractory recurrent paroxysmal AF using PFA.
5. AF symposium hears late-breaking data on Varipulse PFA system
February also saw 12-month results from the inspIRE study investigating predictors of success for pulmonary vein isolation (PVI) with PFA using a variable loop catheter with 3D mapping integration delivered as a late-breaking presentation at the 2024 AF symposium (1–3 February, Boston, USA).
6. Posterior wall ablation does not benefit patients with persistent AF
Posterior wall ablation—a commonly used adjunct to PVI—does not add any benefits for patients undergoing catheter ablation for persistent AF, late-breaking research also presented in February at the 2024 AF symposium showed.
7. EHRA 2024: Closed loop stimulation rate-adaptive pacing may delay sub-clinical AF in sinus node disease
Clinical findings of the B3 study, assessing the impact of closed loop stimulation on the incidence of sub-clinical AF in sinus node disease patients, were presented during a late-breaking trial session at the 2024 European Heart Rhythm Association (EHRA) congress (7–9 April, Berlin, Germany).
8. Boston Scientific’s Farapulse PFA system gains US FDA approval
In late January, Boston Scientific received US Food and Drug Administration (FDA) approval for the Farapulse PFA system. Previously, positive 12-month data from the pivotal ADVENT clinical trial found that therapy with the device was as safe and effective as conventional thermal ablation, with statistically shorter ablation times and a quick learning curve for physicians.
9. EHRA 2024: Sphere-360 study reports first-in-man results of Medtronic PFA catheter
Interim first-in-human clinical safety and efficacy results for Medtronic’s Sphere-360 investigational single-shot mapping and ablation catheter using pulsed field energy for treatment of patients with paroxysmal AF were also presented as a late-breaking clinical trial in April at the 2024 EHRA congress.
10. High-power, short-duration ablation protocol “reduces procedure times”
High-power, short-duration ablation results in significantly shorter procedure times without affecting procedural efficacy and safety among patients undergoing ablation for AF, as per the findings of a single-centre study investigating the impact of high-density mapping alongside high-power, short-duration ablation protocols on the timing, efficacy and safety of the procedures, in which the investigators assessed three standardised setups.
