Medtronic’s (NYSE:MDT) next-generation pacemaker may be able to keep patients out of hospitals and delay the onset of a potentially deadly heart rhythm disorder, according to a late-breaking study released during the American Heart Assn.’s Scientific Sessions 2013, taking place this week in Texas.
Pacemakers with features that prevent unnecessary shocks and promote healthy heart rhythms were associated with fewer deaths, fewer heart-related hospitalizations and a major reduction in the risk of developing permanent atrial fibrillation, according to a randomized, prospective study of nearly 1,200 patients across 63 centers in Europe, the Middle East and Asia
"This is the 1st study to show that using these enhanced pacing features in combination not only delays the AF disease progression, but also has an impact on health care utilization," lead author and study presenter Dr. Giuseppe Boriani said in prepared remarks on behalf of Medtronic. "Based on this compelling evidence, an update of society guidelines should be considered."
The MINERVA study (MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure) examined the effects of 3 pacing modalities, according to a Medtronic statement:
- MVP, which promotes physiologic heart rhythms, thereby reducing the risks associated with unnecessary pacing in the right ventricle.
- Atrial Intervention Pacing, atrial overdrive pacing designed to counteract potential atrial tachyarrhythmia initiating events.
- Reactive ATP, which paces during atrial tachyarrhythmia intending to restore sinus rhythm.
The MVP and Reactive ATP modalities are exclusive to Medtronic technologies and are features of the company’s Advisa and Revo MRI SureScan pacing systems, the company noted.
Participating patients had no permanent atrial fibrillation and no complete heart blockages at the time of enrollment. The trial was designed to evaluate whether the pacing programs could lower mortality and hospitalizations and delay or prevent atrial fibrillation, a heart rhythm disorder associated with death, stroke and heart failure.
Patients treated with the Medtronic pacemakers experienced a 26% reduction in adverse events, driven primarily by a 61% reduction in atrial fibrillation risk, according to a press release. Researchers further noted a 52% relative reduction in atrial-fibrillation-related hospitalizations and ER visits.
"By addressing atrial fibrillation, which is the most common cardiac arrhythmia encountered in clinical practice, our study is the 1st to demonstrate that pacemakers with enhanced pacing features can significantly reduce the progression of this dangerous condition," principal investigator Luigi Padeletti said in prepared remarks. "We know that AF has been associated with a higher risk of heart failure, stroke and death, so slowing down the progression of this disease may help reduce a patient’s risk of suffering these life-threatening conditions."
The findings are good news for Minnesota-based Medtronic, which has gotten some bad press recently over a recall of its coronary surgery guidewires, which got the FDA’s highest-risk Class I label after the device was implicated in the injury of at least 1 patient.
MDT shares were flat in early afternoon trading, with shares at $58.52 as of about 1:15 p.m., down 0.05% on the day.