News | August 23, 2009

Mount Sinai First in U.S. to Perform Percutaneous Sealing of the Left Atrial Appendage

LARIAT Suture Delivery Device

August 24, 2009 – Physicians at The Mount Sinai Medical Center were the first in the country to perform a nonsurgical procedure using sutures to tie off a left atrial appendage (LAA), which is the source of blood clots leading to stroke in patients with atrial fibrillation (AFib). AFib is the most common sustained heart-rhythm disorder in the United States.

The procedure was performed Wednesday by Vivek Y. Reddy, M.D., professor of medicine and director of the cardiac arrhythmia service at Mount Sinai Heart, and his colleague, Srinivas R. Dukkipati, M.D., director of Mount Sinai’s experimental electrophysiology laboratory. With the patient under general anesthesia, the physicians guided two catheters into the patient’s heart to seal the LAA with a pretied suture loop. The technique is a safe alternative to drug therapies such as the blood thinner warfarin (Coumadin) that can have serious side effects, as well as open-heart surgery, and more invasive implant surgery.

“People who take Coumadin because of atrial fibrillation include active and otherwise healthy people, as well as elderly people for whom the drug may be contraindicated,” said Valentin Fuster, M.D., Ph.D., director of Mount Sinai Heart and chair of the American/European Guidelines of Atrial Fibrillation.

Drs. Reddy and Dukkipati joined Mount Sinai this month to focus on building the institution’s services for heart-rhythm disorders. They had been performing preclinical testing of the nonsurgical LAA device, and this procedure represents its first application in people in the United States.

“Compared to a lifetime of medication therapy, or other surgical modalities, a one-time, non-surgical procedure to relieve the complications of AFib offers a whole new paradigm,” said Dennis S. Charney, M.D., Anne and Joel Ehrenkranz Dean Mount Sinai School of Medicine, and executive vice president for academic affairs, The Mount Sinai Medical Center. “Drs. Reddy and Dukkipati have ushered in a new standard of care for people with this serious cardiac condition.”

Approximately 6 million U.S. adults have been diagnosed with AFib, a condition characterized by a rapid and irregular heartbeat that can cause serious complications, including stroke and early death. The majority of these patients take warfarin because left untreated, AFib can cause life-threatening blood clots. Approximately 25-30 percent of patients with AFib have contraindications to the drug, such as concerns of falling or imbalance in elderly patients and, even for the remainder, only about 55-60 percent receive warfarin.

AFib-related deaths have increased over the past two decades and now account for one-quarter of all strokes in the elderly. Those who do take warfarin must rigorously manage the drug’s level in their blood. High levels can cause excessive or internal bleeding, even after minor falls, bruises, or cuts. For some, this management regime can mean monthly tests over the course of many years. In eliminating the need to take warfarin, the LAA procedure can reduce the need for frequent medical visits.

“This nonsurgical procedure could lead to a permanent means of protecting against stroke in patients with AFib who are ineligible for long-term warfarin anticoagulation therapy,” said Dr. Reddy. “The suture delivery system allows us to place a pretied suture loop on the outside of the LAA using a pericardial approach, similar to what is used in surgery. But instead of surgery, which can involve spreading the ribcage or cutting through bone to access the LAA, this procedure does not require surgical incisions and is instead performed percutaneously; that is, using needle punctures to introduce catheters to the heart.”

In addition to open-heart surgery, which is rarely performed as a stand-alone surgical procedure because of the associated morbidity, nonpharmaceutical treatment options involve occlusion of the LAA via an implant, a technique that is not yet approved by the FDA, said Samin K. Sharma, M.D., director of Mount Sinai’s Cardiac catheterization laboratory.

The patient, a 78-year-old woman from Miami, presented with a history of stroke and a fall. Her physicians prescribed Coumadin but had difficulty titrating the medication for her. She initially sought an implant, but traveled to Mount Sinai for the nonsurgical, catheter-based suture delivery system. Following the procedure, the patient is recovering safely and no longer needs to take the drug for stroke prevention. Patients receiving noninvasive procedures usually return to normal activities in about a week.

The procedure, aided by the LARIAT Suture Delivery Device developed by SentreHEART, Inc. and approved by the FDA in May, was performed in a cardiac catheterization laboratory and did not require cardiopulmonary bypass.

For more information: www.mountsinai.org

Related Content

SanBio Receives $20 Million Grant for Stroke Clinical Trial
News | Stroke| July 12, 2017
July 12, 2017 — SanBio Inc.
German Workshop Highlights Possibilities of Perfusion MRI
News | Stroke| July 03, 2017
When diagnosing strokes and heart diseases or looking at tumors, perfusion magnetic resonance imaging (MRI) offers a...
Stroke History Higher in Asymptomatic Versus Symptomatic Atrial Fibrillation Patients
News | Stroke| June 28, 2017
Newly diagnosed asymptomatic atrial fibrillation patients have a higher rate of previous stroke than those with...
Data was positive from the Watchman Left Atrial Appendage Closure (LAAC) Device from the EWOLUTION registry
News | Atrial Fibrillation| May 30, 2017
May 30, 2017 — Data was positive for safety and efficacy rates of the Watchman Left Atrial Appendage Closure (LAAC) D
Analysis Shows Increased Risk of Early Stroke with New-Onset Atrial Fibrillation Post-TAVR, SCAI 2017 late-breaking clinical trial
News | Stroke| May 12, 2017
More than one-third of patients undergoing transcatheter aortic valve replacement (TAVR) were observed to have atrial...
AtriCure's AtriClip System Surpasses 100,000 Units Sold Worldwide
News | Left Atrial Appendage (LAA) Occluders| April 25, 2017
AtriCure Inc. announced it has sold more than 100,000 AtriClip Left Atrial Appendage Exclusion System devices worldwide...
3-D-printed Model of Stenotic Intracranial Artery Enables Vessel-Wall MRI Standardization
News | 3-D Printing| April 18, 2017
A collaboration between stroke neurologists at the Medical University of South Carolina (MUSC) and bioengineers at the...
PinnacleHealth Initiates Clinical Study of TriGuard Embolic Protection Device
News | Embolic Protection Devices| April 11, 2017
Through a new clinical trial, patients at Harrisburg, Pa.-based PinnacleHealth have access to an investigational device...
hyperbaric oxygen treatment, HBOT, stroke, David Steenblock D.O.

Image courtesy of David Steenblock, D.O.

News | Stroke| April 06, 2017
David Steenblock, D.O., an osteopathic physician based in San Clemente, Calif., recently discussed his use of...
atricure atriclip, LAA occlusion, acc17

The AtriCure Atriclip surgical LAA occlusion device. It loops over the LAA on the outside of the heart and clips it off from the rest of the heart to prevent the formation of clots.

Feature | Left Atrial Appendage (LAA) Occluders| March 29, 2017
March 29, 2017 — For patients with...
Overlay Init