A study by researchers from the Texas Cardiac Arrhythmia Institute revealed a 20% rate of atrial leak development after 1 year in patients treated with SentreHeart’s Lariat ligation device.
The 99-patient study found that, among subjects whose left atrial appendage was closed off using the Lariat device, 3 of the patients who developed leaks had major neurological events: 2 strokes and 1 transient ischemic attack.
The data, presented yesterday at the Heart Rhythm Society’s annual meeting in Boston, came from researchers at the Texas Cardiac Arrhythmia Institute.
Although only 5% of patients developed large leaks, qualified as greater than 5mm, the neurological events occurred in individuals with small leaks of less than 5mm.
In 3 patients, 2D transesophageal echocardiogram ultrasound imaging was unable to detect the leaks. The researchers concluded that 3D TEE ultrasound should be used for treating and monitoring individuals treated with the Lariat.
Redwood City, Calif.-based SentreHeart’s Lariat was indicated for soft-tissue approximation, but has been used with some frequency for the exclusion of the left atrial appendage in patients with atrial fibrillation.
"The Lariat device didn’t undergo the full pre-market approval process where it was tested for that [left atrial appendage closure] indication," University of Pennsylvania Dr. Jay Giri told heartwire. "It was cleared for soft-tissue approximation, which is what you’d do to clear a suture device. Now one could argue that you’re suturing the left atrial appendage shut and that’s soft tissue, but it’s a little bit of a stretch from an indication standpoint."