Medtronic, Inc. (NYSE:MDT) today announced the publication of data showing that use of its Reveal® family of Insertable Cardiac Monitors led to diagnosis and specific treatment for 78 percent (170 of 218) of patients who experienced a recurrent syncopal (fainting) event during the course of the study. Of those diagnosed patients, 75 percent were shown to have had a cardiac cause of their syncopal event. PICTURE (Place of Reveal In the Care Pathway And Treatment of patients with Unexplained Recurrent SyncopE), the largest international, multi-center clinical trial on Insertable Cardiac Monitors to date, was published online today in EP-Europace, the European Journal of Pacing, Arrhythmias and Cardiac Electrophysiology.
“The results of the PICTURE trial suggest that insertable cardiac monitors may more quickly diagnose the patient's underlying cause of syncope and may provide physicians the information they need to effectively treat their patients.”
In the course of the study, it was found that patients were evaluated by an average of three different specialists for management of their syncope and underwent a median of 13 tests (range 9-20) without providing a conclusive diagnosis. Patients were followed up until the first recurrence of a syncopal event for at least one year. These findings support current guidelines suggesting that an Implantable Loop Recorder, also known as an Insertable Cardiac Monitor, be implanted earlier rather than later in the evaluation of unexplained syncope.
"Getting to the root of what causes a patient's symptoms can be costly and time-consuming, but is the first step in recommending an effective treatment," said Nils Edvardsson, M.D., Ph.D., the lead investigator of the PICTURE trial, with Sahlgrenska University Hospital in Göteborg, Sweden. "The results of the PICTURE trial suggest that insertable cardiac monitors may more quickly diagnose the patient's underlying cause of syncope and may provide physicians the information they need to effectively treat their patients."
Syncope, also known as fainting, is a sudden loss of consciousness that usually occurs when the blood pressure drops and not enough oxygen reaches the brain. Syncope accounts for one to six percent of hospital admissions and approximately one percent of visits to the emergency department per year. While some causes of unexplained fainting are harmless, others may be life threatening. Heart-related causes, including abnormal heart rhythms, are among the most serious causes of syncope. In addition, fainting may lead to further injury, as 70 percent of patients in the PICTURE trial had been hospitalized at least once for syncope and more than one-third had experienced significant physical trauma in association with a syncopal episode.
"These findings provide important, real-world insights into the diagnosis of unexplained syncope and validate the current treatment guidelines set forth by the European Society of Cardiology," said Andrew Krahn, M.D., professor of medicine with University of Western Ontario in London, Ontario. "The results suggest that the large number of tests often performed prior to arriving at a definitive diagnosis may delay effective treatment and increase overall healthcare costs."
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