PR85057

AUSTIN, Texas, Aug. 8, 2020 /PRNewswire=KYODO JBN/ --

  -- 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