Feature | March 29, 2012

Pacemakers Reduce Occurrence of Fainting

ACC.12 late-breaker shows promise of pacemakers in diminishing fainting in syncope patients

March 29, 2012   Results of the double-blind, randomized study ISSUE-3 found patients suffering from fainting due to a neurocardiogenic syncope had fewer fainting occurrences when treated with a pacemaker. The results, which found a statistically and clinically significant 57 percent relative reduction of fainting recurrence in patients at two years, were presented this week in a late-breaking clinical trial session at the American College of Cardiology (ACC) 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 implantable cardiac monitors (ICM), 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 (International Study onSyncope of Uncertain 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, 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).

“This study shows that a difficult-to-diagnose patient population can be identified early in the patient care pathway through the use of implantable cardiac monitors, and that effective treatment is available and effective for patients with asystolic syncope,” said Elizabeth Hoff, vice president and general manager of cardiac connected care at Medtronic.

Medtronic 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.

For more information: www.medtronic.com

Related Content

blood pressure, gray zone, hypertension, personalized treatment, Circulation journal study, CT calcium scores
News | Hypertension| January 23, 2017
Using data from a national study, Johns Hopkins researchers determined that using heart computed tomography (CT) scans...
NCDR, ACC, JACC, American College of Cardiology, national trends, heart disease treatments, trends in cardiovascular care
News | Cath Lab| January 23, 2017
January 23, 2017 — Over 93 percent of heart attack patients are receiving stents within the guideline-recommended thr
Stereotaxis, Niobe remote magnetic navigation system, Philips Allura Xper FD10 cardiovascular X-ray, interface, integration
News | Robotic Systems| January 20, 2017
Stereotaxis Inc. announced the release of an interface between its remote magnetic navigation system for...
Biotronik, BioMonitor 2 implantable cardiac monitor, BioInsight clinical study, first patients enrolled
News | Implantable Cardiac Monitor (ICM)| January 20, 2017
Biotronik has enrolled the first patients in the BioInsight clinical study evaluating the safety and feasibility of...
ICDs, non-ischemic cardiomyopathy, University of Alabama at Birmingham study, Circulation
News | Implantable Cardioverter Defibrillators (ICD)| January 18, 2017
A new study published in Circulation has found there is a 23 percent risk in reduction of all-cause mortality in non-...
LindaCare, expansion, remote patient monitoring, CIEDs, cardiac implantable electronic devices, United States
News | Remote Monitoring| January 18, 2017
LindaCare announced that it will open a new customer support facility in Connecticut to support growing interest in...
stress, brain activity, cardiovascular risk, PET-CT, MGH, ISSMS, The Lancet study
News | Cardiac Diagnostics| January 18, 2017
A study led by Massachusetts General Hospital (MGH) and Icahn School of Medicine at Mount Sinai (ISSMS) investigators...
ICDs, implantable cardioverter defibrillators, survival rate, elderly patients, JACC study
News | Implantable Cardioverter Defibrillators (ICD)| January 17, 2017
Of patients over age 65 who received an implantable cardioverter-defibrillator (ICD) after surviving sudden cardiac...
University of Utah, Frank Sachse, heart failure, LVAD implantation, left ventricular assist device, biomarker, t-system

Two patients may seem equally sick based upon clinical measures, but differences in their heart physiology could predict who has the potential to recover from heart failure. A study carried out by scientists at the University of Utah finds that patients whose hearts have flattened t-tubules have a decreased chance of showing signs of recovery after implanting a mechanical heart pump. Ordinarily, t-tubules in the heart are long, thin, and rounded. Image courtesy of Frank Sachse.

News | Cardiac Diagnostics| January 17, 2017
Investigators at the University of Utah have identified distinct differences in the hearts of advanced heart failure...
Synergy stent, abluminal polymer DES, bioresorbable polymer DES, bioresorbable polymer metallic stent

The Synergy stent is the first FDA cleared drug-eluting stent to use a bioresorbable polymer drug carrier. When the polymer dissolves after about four months, the devices become a bare metal stent. The technology is supposed to reduce the rate of late stent thrombosis due to vessel inflammation caused by durable polymers.

Feature | Stents Bioresorbable| January 17, 2017 | Dave Fornell
One of the big advancements in drug-eluting stent (DES) technology has been the development of bioresorbable polymers
Overlay Init