EaSyAs II Boosts Role for Implantable Loop Recorder

Implantable loop record speeds diagnosis

Shelley Wood

October 26, 2011

October 26, 2011 (Vancouver, British Columbia) — An implantable loop recorder (ILR) with remote monitoring is a safe and cost-effective approach to investigating recurrent unexplained syncope and diagnosing its underlying cause, results of the Eastbourne Syncope Assessment Study II (EaSyAS II) show. Presenting the results here at the Canadian Cardiovascular Congress 2011, Dr Paul Hong (Eastbourne District General Hospital, UK) said he expects the combination of an ILR and remote monitoring "to be the future" of syncope care.

In EaSyAS II, Hong and colleagues randomized 246 patients with a minimum of two syncopal episodes within two years to conventional care, conventional care plus attendance at a syncope clinic, ILR implantation, or ILR implantation plus syncope clinic attendance. All patients were followed for at least one year (range 12-28 months).

As Hong showed here, a total of 120 patients received an implantable device and, in this group, 62 patients received a diagnosis confirmed on ECG, as compared with just one patient undergoing conventional management and 20 who attended a syncope clinic on top of conventional management. Implantation of an ILR also led to a much shorter time to diagnosis (HR 35.54) and ECG-directed therapy, within a mean of 95 days postinduction. In all cases, a diagnosis was made at the first postimplant event.

Of note, there was no difference among ILR-treated patients who received a device only and those who got a device and were also urged to attend a syncope clinic.

In terms of costs, syncope clinic care was the most cost-effective strategy, followed by ILR implantation alone. During his presentation, Hong stressed that "we struggled with this — there really is no precedent" for calculating costs vs cost savings with this device. The cost of an ILR in the UK is approximately £1000, he said, "but we just don't know how much this would be offset if we added on the hidden costs of managing syncope" without an ILR.

The most common adverse events that patients experienced during syncope (prior to entering the study) were fractures and motor-vehicle accidents — things that are not easily measured in analyses of cost savings.

"If a patient dies, there is no cost to the system, but that's a terrible outcome," Dr Ratika Parkash (Capital Health, Halifax, NS), who was not involved in the study, told heartwire. "There are a lot of issues that go into cost-effectiveness analyses when you look at these kinds of devices."

Parkash also noted that ILRs will likely never be the diagnostic strategy for most patients but can play an important role.

"We certainly use them in patients when we're worried about their cause of syncope and we don't have a diagnosis, but we're not using them routinely because of cost and because they are invasive — not as invasive as implanting a pacemaker, but cost and their somewhat-invasive nature are considerations."

Hong disclosed receiving a research grant from Transoma Medical, which manufactures the Sleuth ILR studied in EaSyAs II.