Medtronic announced on 19 November 2010 the publication of data showing that use of its Reveal family of insertable cardiac monitors led to diagnosis and specific treatment for 78% (170 of 218) of patients who experienced a recurrent syncopal event during the course of the study. Of those diagnosed patients, 75% 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, multicentre clinical trial on insertable cardiac monitors to date, was published online in EP-Europace, the European Journal of Pacing, Arrhythmias and Cardiac Electrophysiology.
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, 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.”
“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, professor of medicine with University of Western Ontario in London, Ontario, Canada. “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.”
About the PICTURE trial
The PICTURE study is the largest clinical trial to date to evaluate the use and effectiveness of a Reveal insertable cardiac monitor in diagnosing patients with unexplained, recurrent syncope (and pre-syncope). Reveal-guided diagnoses led to pacemaker implants in 51% of diagnosed cases. Anti-arrhythmic drug therapy (7%), other pharmacologic treatment (5%), implantable cardioverter defibrillators (6%) and ablation (5%) were also prescribed treatments.
A total of 650 patients presenting with unexplained, recurrent (pre-) syncope and scheduled for an implant with a Reveal insertable cardiac monitor were originally enrolled in the PICTURE study from 2006 until 2008. Of these patients, follow-up visit data (with or without syncopal events) were available for 570 subjects who were included in the analysed population. Patients received the implant based on clinical indications and were followed up until the first recurrence of a syncopal event leading to a diagnosis or for at least 12 months after implant. Seventy-one study sites in 11 countries (Austria, Czech Republic, Denmark, Finland, France, Germany, Israel, The Netherlands, Slovakia, Sweden and Switzerland) participated in the trial.
About the Reveal DX and Reveal XT insertable cardiac monitors
In patients with unexplained and unpredictable symptoms such as syncope and palpitations, the Reveal DX and Reveal XT insertable cardiac monitors can be used to rule in or rule out an abnormal heart rhythm as the cause.
Placed just under the skin of the chest area in an outpatient procedure, Reveal DX and XT capture and store electrocardiogram (ECG) recordings in two ways: a patient-activated feature allows the patient to press a button and store an ECG recording during a symptomatic episode, and an auto-activation feature automatically detects and records predefined arrhythmic events. Later, a physician analyses the stored information which can be transmitted remotely via the Medtronic CareLink Network, or viewed during an in-office patient visit.
The latest generation product, Reveal XT, has added the capability to detect atrial fibrillation (AF) and provides longer-term trended diagnostic data via Reveal XT’s ICM’s Cardiac Compass Report, including daily AF burden, patient activity, and average day and night heart rates.
Medtronic Reveal devices are labeled MR-conditional for use in MRI machines, meaning patients with a device implanted may safely undergo MRI scans under certain conditions.