Feature | Left Atrial Appendage (LAA) Occluders | September 07, 2017

Closure of Left Atrial Appendage During Heart Surgery Protects the Brain

LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

September 7, 2017 — Closure of the left atrial appendage (LAA) during heart surgery protects the brain, according to late-breaking research presented today in a Hot Line Late-breaking Clinical Trial session at he European Society of Cardiology (ESC) Congress. The results of the The Left Atrial Appendage Closure by Surgery (LAACS) study suggest that LAA closure should be routinely added to open heart surgery.

“This is the first randomized study to show that closure of the left atrial appendage during open heart surgery effectively protects against brain infarctions and stroke,” said Associate Prof. Helena Domínguez, the cardiologist who designed the study.

“A stroke following open heart surgery can have devastating consequences for patients and their families,” said principal investigator Dr. Park-Hansen, from the Department of Cardiology at Bispebjerg/Frederiksberg University Hospital, Copenhagen, Denmark. “Expectations of returning to work and having improved quality of life after surgery can suddenly turn into early retirement, hospitalizations and prolonged rehabilitation.”

It is well known that atrial fibrillation often occurs after heart surgery and increases the risk for subsequent stroke. Patients may have no symptoms and therefore be unaware that they have atrial fibrillation. Without prophylactic oral anticoagulation treatment, patients remain at risk of blood clotting which can provoke embolic injuries such as strokes.

Blood clots predominantly form in the left atrial appendage, a small sac in the wall of the left atrium of the heart. Some heart surgeons close the left atrial appendage to protect against stroke, particularly in patients with a history of atrial fibrillation, yet there is little evidence to support the efficacy and safety of this practice. No randomized study to date has shown whether left atrial appendage closure can prevent ischemic brain damage.

The LAACS study tested the hypothesis that left atrial appendage closure during open heart surgery would minimize long term ischaemic brain damage. The study prospectively enrolled 187 patients referred for open heart surgery (coronary artery bypass grafting, valve surgery, or both). Patients were randomized to surgical closure of the left atrial appendage (101 patients) or no closure (86 patients).

The primary endpoint was the occurrence of stroke/transient ischemic attack (TIA) or silent cerebral infarction demonstrated on magnetic resonance imaging (MRI) or clinical follow-up. Patients underwent brain MRI before surgery, shortly after discharge, and six months or longer after surgery.

Out of the total randomized cohort, 19 patients reached the combined endpoint during an average follow-up of 3.65 years. The cumulative probability of an ischemic event in the brain was consistently lower in the closed, compared to the not-closed, group (figure 1).

In the intention-to-treat analysis, the proportion of patients meeting the combined endpoint was 16.3% (14 of 86) in the control group and 5% (5 of 101) in the left atrial appendage closure group (hazard ratio [HR] 0.3; 95% confidence interval [CI] 0.1–0.8; p = 0.0197).

Of 187 patients randomized, 141 followed their assigned protocol. Deviations from the protocol were primarily decided by the surgeon, for example refraining from extra procedures in technically complicated operations. In the per protocol analysis, the proportion of patients who met the combined endpoint was 18.2% (14 of 77) in the control group, and 6.3% (4 of 64) in the closure group (HR 0.3; 95% CI 0.1–1.0; p = 0.0465). All but one of the patients in the control group with ischemic events had recurrent atrial fibrillation during follow-up.

“More than three years after open heart surgery, patients who also had left atrial appendage closure were significantly less likely to have strokes or symptomless signs of blood clots in the brain, so-called silent strokes, than the control group,” Park-Hansen said.

He concluded: “Based on the LAACS study, it would be advisable to systematically add surgical closure of the left atrial appendage to planned open heart surgery. Our results need to be replicated in larger cohorts that can also confirm the safety of the procedure.”

Read the related article "Update for LAA Occluder Technology News and Trends."
 

Read about other late-breakers in the article “Late-breaking Trial Presentations at ESC 2017.”

Related Content

The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evaluated the detection of silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using the FDA-cleared Zio by iRhythm ambulatory monitoring patch. The results support the clinical value of early screening and targeted detection in moderate-risk populations. #AHA #AHA20 #AHA2020

The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evaluated the detection of silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using the FDA-cleared Zio by iRhythm ambulatory monitoring patch. The results support the clinical value of early screening and targeted detection in moderate-risk populations.

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 — The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evalu
The Medtronic SEEQ mobile cardiac telemetry system, pictured here, and the Icentia CardioSTAT cardiac rhythm monitoring device both found in reased rates of post-operative atrial fibrillation in the SEARCH-AF trial presented at the American Heart Association annual meeting. #AHA #AHA20 #AHA2020

The Medtronic SEEQ mobile cardiac telemetry system, pictured here, and the Icentia CardioSTAT cardiac rhythm monitoring device both found in reased rates of post-operative atrial fibrillation in the SEARCH-AF trial presented at the American Heart Association annual meeting.

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 — Atrial fibrill...
The Medtronic Arctic Front cryoballoon balloon was used a a front-line treatment of AF in the EARLY-AF trial. It was found to be better than anti-arrhythmic drugs in preventing the recurrence of abnormal heart rhythm (atrial tachyarrhythmia, atrial fibrillation), and improve patient well-being.  #AHA #AHA2020 #AHA20

The Medtronic Arctic Front cryoballoon balloon was used a a front-line treatment of AF in the EARLY-AF trial. It was found to be better than anti-arrhythmic drugs in preventing the recurrence of abnormal heart rhythm (atrial tachyarrhythmia, atrial fibrillation), and improve patient well-being.  

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 – Doctors from the Mo...

The study used cadaver hearts that were images with contrast enhanced MRI and the images used to create a 3-D computation model of the electrical activation in the heart and how it was influenced by adenosine and ablation. Find more images in the original article

News | Atrial Fibrillation | October 08, 2020
October 8, 2020 – People who suffer from persistent atrial fibrillation in the heart may find relief from a new treat
The TactiFlex PAF investigational device exemption (IDE) study will evaluate he investigational TactiFlex Ablation Catheter, Sensor Enabled (SE) to treat people suffering from paroxysmal atrial fibrillation (PAF). 

The TactiFlex PAF investigational device exemption (IDE) study will evaluate he investigational TactiFlex Ablation Catheter, Sensor Enabled (SE) to treat people suffering from paroxysmal atrial fibrillation (PAF). 

News | Atrial Fibrillation | August 04, 2020
August 4, 2020 — Abbott announced the first enrollments in the TactiFlex PAF  investigational device exemption (IDE)
PREDICT-AF trial showed first time there is extensive extracellular matrix remodeling. #HRS2020 #Heartrhythm2020. Marilyn Fornell
News | Atrial Fibrillation | May 19, 2020
May 19, 2020 — Structural changes of the atrium may occur long before the onset of atrial fibrillation (AF), and the
Results of the Atrial Fibrosis Predicts Recurrent Stroke Or New Atrial Fibrillation In Patients With Embolic Stroke Of Undetermined Source - A Multi-Center Study at HRS 2020. #HRS2020 #Heartrhythm2020,
News | Atrial Fibrillation | May 19, 2020
May 19, 2020 — Atrial disease has been implicated in embolic stroke of undetermined source (ESUS) and a late-breaking