As ubiquitous as pacemakers have become, a massive study involving next-generation Medtronic ($MDT) devices shows their evolving capacity to do more than just regulate heartbeats. With certain enhancements, they may also help slow the advance of permanent atrial fibrillation and reduce hospitalization rates, researchers believe.
The MINERVA study, which involved 1,166 patients with bradycardia (slow heartbeat) in Europe, the Middle East and Asia, found that the extra features helped delay progression to permanent atrial fibrillation by 61% at 2 years, and also drastically reduced atrial fibrillation-related hospitalizations and emergency room visits. Pacers used in the study carried advancements such as atrial intervention features, reactive pacing--which kicks in only when an irregular heart rhythm is detected--and managed ventricular pacing, which helps to promote regular heart rhythms. The company's EnRhythm pacer was used in the study, but the technology is also in other Medtronic devices such as its Advisa and Revo MRI SureScan pacers.
"Our study is the first to demonstrate that pacemakers with enhanced pacing features can significantly reduce the progression of this dangerous condition," Luigi Padeletti, a cardiology professor at the University of Florence in Italy and principal investigator, said in a statement. "We know that [atrial fibrillation] 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."
Padeletti and others presented the results at the American Heart Association's Scientific Sessions 2013 meeting in Dallas.
Pacemakers are commonplace and not exactly the focus of soaring sales these days. So data showing that next-generation pacers can lead to long-term health benefits by delaying worsening cardiac conditions such as atrial fibrillation could provide a jolt for Medtronic as well as its rivals as they develop and promote competing products. Echoing this theme, lead author Giuseppe Boriani of the Institute of Cardiology at the University of Bologna in Italy said in a statement that the results were promising enough to warrant "an update of society guidelines"--referring to American Heart Association guidelines as to when pacemakers should be used.
More studies are needed, of course. Delaying the advance of atrial fibrillation doesn't mean it won't arrive, and device companies are also devoting their resources to treating health problems created by the condition. Boston Scientific ($BSX), for example, will have an FDA advisory panel hearing in December to consider its Watchman device, which is designed to prevent strokes in atrial fibrillation patients. St. Jude Medical ($STJ) is in the middle of a pivotal trial for its similarly targeted Amplatzer Cardiac plug.
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