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Medtronic publishes Carisma trial results

Medtronic has published Carisma (Cardiac Arrhythmias and Risk Stratification after Myocardial Infarction) trial results, investigating the incidence and prognostic significance of arrhythmias documented by an insertable cardiac monitor among the patient population.

Carisma is a multicenter, prospective study that showed that the Reveal Plus implantable cardiac monitor recorded arrhythmias in 46% of patients with ejection fractions less than or equal to 40% and who had previously suffered an acute myocardial infarction (AMI).

Medtronic said that pinpointing the frequency of arrhythmias in post-AMI patients has been limited due to a lack of clinically-validated measurement tools, resulting in a need for continuous long-term monitoring devices with the ability to provide insight into patients’ arrhythmic profiles.

According to the study, of the patients diagnosed with cardiac arrhythmias in the Carisma study, 27% experienced new onset atrial fibrillation, 9.8% had high-degree atrioventricular (AV) block, 6.7% had sinus bradycardia, and 13% had non-sustained ventricular tachycardia.

Additionally, 56 patients received an implantable cardioverter-defibrillator and 15 patients received a pacemaker and cox regression analysis revealed that high-degree AV block was the most powerful predictor of cardiac death.

Medtronic Cardiac Rhythm Disease Management business president and senior vice president Pat Mackin said that their Reveal family of devices can provide special monitoring information for physicians managing patients at risk for arrhythmias, providing more information to help determine the most appropriate treatment option.

“Medtronic is committed to investing in next-generation medical technologies that advance the treatment of cardiovascular disease and we look forward to furthering our offerings in this space,” Mackin said.