Flora Floyd,  First Levacor™ VAD Recipient

Jan. 21, 2010

Fifty-nine-year-old Flora Floyd of Oklahoma City is a pioneer. Not only was she the first person in the state of Oklahoma to try the world’s smallest heart pump, known as the Impella, but now, less than a year later, she is making history again, this time on a national level.

On Jan. 13, 2010, Floyd became the first person in the United States to be implanted with an investigational device called the Levacor™ Ventricular Assist Device (“VAD” ) manufactured by World Heart Corporation. Levacor is a next generation heart pump that utilizes a magnetically levitated rotating disk to circulate blood.  It recently obtained an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA) for a Bridge to Transplant clinical trial. INTEGRIS Baptist Medical Center in Oklahoma City, Oklahoma, was chosen as the inaugural site for the U.S. clinical study. And Floyd was once again prepared to go first.

“I figured somebody has to be first,” says Floyd, shrugging off the attention. “I thought, why not me?”

Floyd suffered a heart attack in 1997. She was diagnosed with severe cardiomyopathy, or a weakened heart muscle. Despite extensive medical attention her condition only worsened. She continued to decline in activity and suffered from constant shortness of breath. Her quality of life was rapidly disappearing.

Floyd was referred to Dr. David Nelson with the Nazih Zuhdi Transplant Institute at INTEGRIS for a heart transplant evaluation. He, in turn, sent her to Dr. Douglas Horstmanshof at INTEGRIS Advanced Cardiac Care to see if anything could be done to repair her heart. Dr. Horstmanshof discovered the underlying problem, finding new severe blockages in the arteries of her heart. Two of the three main vessels supplying blood to her heart were more than 85 percent blocked, and the third was completely closed. Measurements also showed she was in severe heart failure with her heart’s squeezing power severely compromised, ejecting only 10 percent of the blood inside with each beat instead of the normal 65 percent.

It was determined that Floyd needed a high risk stent placement to open the blocked arteries. But doctors were concerned her damaged heart would never be able to tolerate the procedure. They decided the best available option was supporting her through this risky process with the newly approved Impella temporary blood pump support system. Floyd became the first person in the state of Oklahoma to have that procedure, on Jan. 22, 2009. The procedure was a success and her condition improved.

The procedure helped her feel better for most of a year, but her underlying heart failure failed to improve despite aggressive medical care. Dr. Horstmanshof determined that Floyd would indeed need a heart transplant to provide her the best chance for ongoing life. But with no donor heart immediately available and her underlying condition slowly worsening, it became necessary to support her with an implantable mechanical heart pump or VAD, a procedure available in Oklahoma only at INTEGRIS.

Dr. Horstmanshof, principal investigator at INTEGRIS for the Levacor trial, gave Floyd the option to participate in the Levacor VAD clinical trial or to receive a standard, previously FDA approved heart pump. After careful consideration and discussion with doctors, her twin daughters, and family, Floyd decided to be a pioneer again and proceed with the implantation of the Levacor.

“My family is the main reason I chose Levacor,” explains Floyd. “I want to live for them. I want to see my grandchildren and great-grandchildren grow up. So I’ll do whatever it takes to extend my life for as long as I can.”

Floyd made history and underwent open heart surgery for implantation of the Levacor VAD on January 13, 2010, by INTEGRIS cardiac surgeons Dr. James Long and Dr. Craig Elkins. Her surgery was successful and she is recovering at INTEGRIS. She has already been walking, learning how to take care of her new Levacor VAD, and will be able to go home in a few weeks to await her heart transplant. She will be carefully followed and monitored as part of the ongoing evaluation of this exciting new technology until her new heart is available.