-- Texas Cardiac Arrhythmia Institute at St. David's Medical Center, 
     Los Robles Health System perform near simultaneous implantation of 
     WATCHMAN FLX(TM) Left Atrial Appendage Closure (LAAC)

On Aug. 5, 2020, physicians at the Texas Cardiac Arrhythmia Institute (TCAI) at 
St. David's Medical Center ( https://tcainstitute.com/ ) in Austin, Texas, and 
Los Robles Health System ( 
https://c212.net/c/link/?t=0&l=en&o=2879434-1&h=74536050&u=https%3A%2F%2Flosrobleshospital.com%2F&a=Los+Robles+Health+System 
) in Thousand Oaks, California, became the first in the nation to implant the 
only FDA-approved device for the reduction of stroke risk in patients with 
non-valvular atrial fibrillation (A Fib). The physicians at these hospitals, 
both HCA Healthcare facilities, performed near simultaneous implantation of the 
WATCHMAN ( 
https://c212.net/c/link/?t=0&l=en&o=2879434-1&h=3010487936&u=https%3A%2F%2Fwww.watchman.com%2Fen-us%2Fhome.html&a=WATCHMAN 
) FLX(TM) Left Atrial Appendage Closure (LAAC).

Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., cardiac electrophysiologist 
and executive medical director of TCAI, and Saibal Kar, M.D., interventional 
cardiologist at Los Robles Health System, performed the first procedure in 
Thousand Oaks, California, while Rodney Horton, M.D., cardiac 
electrophysiologist at TCAI, performed the first case in Austin, Texas. 
Additionally, Dr. Kar was the principal investigator for the preclinical 
PINNACLE FLX trial prior to FDA approval, which evaluated the performance of 
the WATCHMAN FLX device as an alternative to long-term, non-vitamin K 
antagonist oral anticoagulants (NOACs) and other oral anticoagulant 
medications. 

"The new device is built upon the most studied and implanted LAAC device in the 
world as a treatment option for people with A Fib not caused by a heart valve 
problem, also known as non-valvular A Fib," Dr. Kar said. "It allows us to help 
treat more patients safely and effectively to ensure the best outcomes."

Up to six million Americans are estimated to be affected by A Fib, an irregular 
heartbeat that feels like a quivering heart. People with A Fib have a five 
times greater risk of stroke than those with normal heart rhythms.

"This device serves as a safe and effective alternative to reduce the risk of 
stroke for patients with non-valvular A Fib, especially those with a compelling 
reason not to be on blood thinners," Dr. Horton said. 

This technology is designed to reduce the risk of stroke by permanently closing 
off an area of the heart called the left atrial appendage (LAA) to keep harmful 
blood clots that can form in the LAA from entering the bloodstream and 
potentially causing a stroke. By closing off the LAA, the risk of stroke may be 
reduced and, over time, patients may be able to stop taking blood thinners, 
such as warfarin. 

"The rounded design allows us to safely enter, and maneuver within, the LAA, 
resulting in optimal placement and long-term stability," Dr. Natale said. "It 
is also available in broader size options than the previous generation device, 
which allows us to treat a wider range of patients."

The procedure is done under general anesthesia and takes about an hour. 
Patients commonly stay in the hospital overnight and leave the next day.

Media Contacts:
Erin Ochoa
St. David's HealthCare
EOchoa@EChristianPR.com
512-788-1616

Daphne Yousem
Los Robles Health System
805-390-7111
Daphne.Yousem@HCAHealthcare.com

Source - Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center