Study: Medtronic's PulseSelect Improves Quality of Life for Afib Patients

Medtronic, a leading medical technology company, has recently completed a groundbreaking trial assessing the effectiveness of their Medtronic PulseSelect Pulsed Field Ablation (PFA) System in reducing atrial arrhythmia (AA) burden. This study, known as PULSED AF, achieved remarkable results, with 87% of paroxysmal (PAF) and 82% of persistent (PsAF) AF patients experiencing less than 10% of AA burden.

The PULSED AF trial is particularly significant as it is the first and only global, multi-center study conducted under the U.S. Food and Drug Administration's Investigational Device Exemption (IDE) program, specifically focusing on a PFA system. The primary objective was to evaluate the safety and effectiveness of the PulseSelect system for AF ablation. The results surpassed the predetermined safety and efficacy performance goals, demonstrating the system's potential as an advanced treatment option.

Dr. Atul Verma, the study's principal investigator from McGill University Health Centre, Montreal, highlighted the groundbreaking nature of these results. He emphasised that the study's focus on AA burden provides a more comprehensive understanding of patients' arrhythmia experience, allowing for significant improvements in quality of life, which is a crucial consideration for clinicians and patients when choosing a treatment option.

The study analysed the impact of PFA treatment on AF burden, considering episodes lasting at least 30 seconds and monitored rigorously using trans-telephonic monitors (TTMs) and Holter monitoring. The findings revealed that post-ablation, 87% of PAF and 82% of PsAF patients experienced a burden of less than 10%. Impressively, 69% of PAF and 62% of PsAF patients demonstrated zero burden.

Additionally, the study assessed the relationship between AA burden and improvements in patients' quality of life, measured through the AF Effect On Quality-Of-Life Questionnaire (AFEQT). The analysis showed that a reduction in AA burden to less than 10% was associated with significant improvements in quality of life for PAF patients who underwent PFA. For PsAF patients, regardless of burden level, PFA treatment resulted in a positive impact on their quality of life.

The trial also considered healthcare utilisation following PFA treatment, examining the correlation between AA burden and AF-related healthcare use, such as repeat ablations, cardioversions, and emergency room visits or hospitalizations. The results indicated that as AA burden increased, so did the need for repeat ablations and cardioversions, highlighting the significance of effective AF treatments.

The PULSED AF trial was conducted on 300 patients with either paroxysmal or persistent AF, enrolled across 41 sites in nine countries. The study used the PulseSelect PFA System to perform pulmonary vein isolation, with rigorous monitoring at three, six, and 12 months, along with weekly symptomatic trans-telephonic monitoring. A significant number of patients, 96%, completed the 12-month follow-up.

The PulseSelect PFA System is an innovative ablation technology that employs pulsed electric fields to isolate the pulmonary veins and treat PAF or PsAF. Unlike traditional methods that use thermal approaches, the PulseSelect System's non-thermal approach preferentially targets the irregular electrical pathways in the heart, minimising the risk of injury to surrounding structures. It is worth noting that the PulseSelect System is still under investigation and not approved for sale or distribution worldwide. However, the results of the PULSED AF trial signify a promising advancement in AF treatments and their potential impact on patients' quality of life.

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