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

Medtronic has announced promising findings from a secondary analysis of its PULSED AF study.

The trial analyzed the Medtronic PulseSelect Pulsed Field Ablation (PFA) System, specifically examining atrial arrhythmia (AA) burden reduction. In the study, 87% of paroxysmal (PAF) and 82% of persistent (PsAF) AF patients experienced less than 10% of AA burden.¹ 
 
PULSED AF is the first and only completed, global, and multi-center U.S. Food and Drug Administration IDE clinical study for a PFA system and valuated the safety and effectiveness of the PulseSelect system for AF ablation. Results of PULSED AF demonstrated the study exceeded its safety and efficacy performance goals.
 
“These are first of its kind results for PFA technology, moving us beyond the traditional binary efficacy endpoint to a more holistic picture of patients’ arrhythmia experience. Most novel is that this study shows us that treatment with the Medtronic PulseSelect PFA System results in low burden, which we know supports significant quality-of-life improvements and is something clinicians and patients consider when choosing a treatment option,” said Atul Verma, M.D., electrophysiologist and director, Division of Cardiology, McGill University Health Centre in Montreal and PULSED AF study principal investigator. 
 
AF Burden Findings
Traditionally defined as episodes of AA lasting at least 30 seconds, recurrence of known episodic AA is dependent on the monitoring strategy used. In the rigorously monitored PULSED AF study, burden was calculated for every patient utilizing recordings from trans-telephonic monitors (TTMs) and Holter monitoring. Using an endpoint of AA burden, assessed by the greater amount of burden from Holter monitoring or TTMs, findings showed that 87% of the PAF and 82% of the PsAF patients demonstrated a post-ablation burden of less than 10 percent. Further, zero burden was observed in 69% of the PAF and 62% of the PsAF cohort.
 
Quality of Life Findings
Patient improvement in quality of life was determined based on answers to the AF Effect On Quality-Of-Life Questionnaire (AFEQT) at baseline and 12 months post ablation. The analysis showed that AA burden did not have to be reduced to zero to result in quality of life (QoL) improvement. In PAF patients that underwent PFA, AA burden less than 10% was associated with meaningful improvement in QoL. PsAF patients that underwent PFA experienced QoL improvement regardless of burden level.

Healthcare Utilization Findings
The analysis evaluated the relationship between AA burden and AF-related HCU (repeat ablations, cardioversions, and ER visits/hospitalizations) that occurred following PFA treatment For both PAF and PerAF patients, repeat ablations and cardioversion significantly increased with increasing AA burden. “Catheter ablation technology has been shown to reduce AA burden, and now we’re proud to be at the forefront of the next evolution in catheter ablation by demonstrating how novel pulsed field ablation with PulseSelect can support an advancement in meaningful improvements in quality of life,” said Rebecca Seidel, president, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. 
 
The PULSED AF trial is a prospective, single arm, multi-center clinical trial that treated 300 patients (150 with paroxysmal AF and 150 with persistent AF). Patients were enrolled across 41 sites in nine countries with 67 operators throughout the United States, Canada, Europe, Australia, and Japan. Patients underwent pulmonary vein isolation using the PulseSelect PFA System and underwent rigorous arrhythmia monitoring, including assessments at three, six, and 12 months, and weekly symptomatic trans-telephonic monitoring. 96% (287) of patients completed the 12-month follow up.
 
The PulseSelect PFA system is an ablation technology that uses pulsed electric fields to efficiently isolate the pulmonary veins for the treatment of patients with PAF or PsAF. The single-shot PulseSelect System delivers pulsed electric fields through an ablation catheter designed specifically to interrupt irregular electrical pathways in the heart that trigger AF. However, unlike traditional methods of ablation that heat (radiofrequency ablation) or cool (cryoablation) the atrial tissue, the PulseSelect System uses a non-thermal approach and preferentially targets heart tissue with the goal of avoiding unwanted injury to surrounding structures, a risk of current ablation technologies. Worldwide, the PulseSelect System is investigational and not approved for sale or distribution. 
 
Headquartered in Dublin, Ireland, Medtronic is a leading global healthcare technology company that employs more than 90,000 workers in 150 countries. Its technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, and patient monitoring systems, among others. 

References
¹ Terricabras M et al. JAMA Netw Open; 2020; 3:e2025473.