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Medtronic, Inc. (NYSE: MDT) today announced the results of a double-blind, randomized study, ISSUE-3, which found that patients who suffered from fainting due to neurocardiogenic syncope had fewer fainting occurrences when treated with a Medtronic pacemaker. The results, which found a statistically and clinically significant 57 percent relative reduction of fainting recurrence in patients at two years, were presented today in a late-breaking clinical trial session at the American College of Cardiology’s (ACC's) 61st Annual Scientific Session in Chicago.
In the study, patients at high risk for syncope recurrence (known as asystolic neurally-mediated syncope or NMS) were identified through the use of Medtronic’s Reveal® family of Insertable Cardiac Monitors (ICM), thereby allowing physicians to determine which patients could benefit from a pacemaker implant.
“This study adds to the strength of clinical evidence affirming the effectiveness of pacemakers in reducing the recurrence of asystolic syncope, allowing us to determine which patients may benefit best from pacing,” said Michele Brignole, M.D., Ospedali del Tigullio in Lavagna, Italy and the principal investigator of ISSUE-3 (
Etiology 3). “Based on these compelling results, the ISSUE investigators are hopeful that the clinical implications of this study will be taken into account when drafting updates to the current guidelines for these patients.”
While a previous observational study, ISSUE-2 (
Etiology-2), showed that the use of an ICM effectively diagnosed asystolic syncope, thereby leading to effective treatment outcomes, the ISSUE-3 study was needed to confirm these results through a more rigorous, randomized controlled trial.
The ISSUE-3 study was conducted in 51 centers in Western Europe and Canada in two phases: a screening phase, followed by a treatment phase. From September 2006 to November 2011, 511 patients met the inclusion criteria and received a Reveal device to assist with the diagnosis of each patient’s syncope. Results of the ISSUE-3 include:
Fainting reoccurred in 185 of the 511 study patients (36 percent).
Fainting was documented by the ICM in 141 (76 percent) of these patients.
The Reveal ICM diagnosed about half (51 percent) of patients with reoccurring fainting as an asystolic event, indicating them for a pacemaker and making them eligible for the treatment phase of the study. These patients received a dual-chamber Medtronic pacemaker and were randomized 1:1 (pacemaker on and pacemaker off).
The treatment phase of the study demonstrated significant reduction in recurrence of fainting in patients who received Medtronic pacemaker therapy. For patients receiving pacemaker implants, the fainting recurrence rate was 25 percent when the pacemaker was turned on and the fainting recurrence rate was 57 percent when the pacemaker was turned off (this condition is associated with a drop in blood pressure separate from the asystole).