Medtronic has reported results from a double-blind randomised study which demonstrated that patients who suffered from fainting due to neurocardiogenic syncope had fewer occurrences when treated with a Medtronic pacemaker.
The International Study on Syncope of Uncertain Etiology 3 (ISSUE-3) was conducted at 51 centres in Western Europe and Canada in two phases: a screening phase, followed by a treatment phase.
In the study, patients at high risk for syncope recurrence were identified through the use of Medtronic's Reveal family of insertable cardiac monitors (ICM), thereby enabling physicians to determine which patients could benefit from a pacemaker implant.
The treatment phase of the study demonstrated that for patients receiving pacemaker implants, the fainting recurrence rate was 25% when the pacemaker was turned on, and the fainting recurrence rate was 57% when the pacemaker was turned off.
Ospedali del Tigullio in Lavagna, Italy, professor and principal investigator of the study Michele Brignole said the study adds to clinical evidence affirming the effectiveness of pacemakers in reducing recurrence of asystolic syncope, allowing them to determine which patients may benefit from pacing.
"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," Brignole added.
Medtronic Cardiac Connected Care vice president and general manager Elizabeth Hoff said the study showed that a difficult-to-diagnose patient population can be identified early in the patient care pathway through use of insertable cardiac monitors, and that treatment is available and effective for patients with asystolic syncope.
The previous observational study, International Study on Syncope of Uncertain Etiology-2 (ISSUE-2), also showed that use of an ICM effectively diagnosed asystolic syncope, leading to effective treatment outcomes.
The company's pacemakers are currently indicated for use in patients who have experienced one or more of the following conditions: symptomatic paroxysmal or permanent second or third-degree AV block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders, and bradycardia-tachycardia syndrome.
Image: Medtronic World Headquarters located in Fridley, Minnesota, US. Photo: Bobak Ha'Eri.