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Biomedical Innovation with Colin Stewart ~ Biomedical news and comment from Orange County, Calif., and beyond

To the brink of death and back

September 24th, 2008, 1:41 pm by Colin Stewart

Photos: At top of post: Karen Kozawa sits up on Sept. 9, eight days after emerging from a coma. (Courtesy of Sue Mordin) Lower photo, Susan Davis chats with Karen Kozawa on Sept. 18 (Photo by Mindy Schauer, The Orange County Register)    Slide show: Karen Kozawa’s recovery.

Aneurysm patient’s journey takes her to Mission Hospital and the cutting edge of medical technology

Karen Kozawa’s life was hanging in the balance, but she didn’t know it.

At 7:10 a.m. July 28, she complained that she was nauseous, felt tingling in her arms and had a headache worse than any before in her life.

Those symptoms sounded distressingly familiar to her roommate, Susan Davis, so Davis told Kozawa they needed to go to the hospital.

Immediately.

That decision launched Kozawa on a journey that so far has lasted eight weeks, taking her to the brink of death, along the cutting edge of modern medical technology, and slowly back to something approaching normal life

Kozawa, 55, was a manager at the Rays Group clothing company in Irvine. On that July morning, she had an aneurysm — a weak spot in the wall of a blood vessel — that was threatening to burst, potentially causing a fatal stroke by flooding her brain with blood.

Davis, 50, an English teacher at Macarthur Fundamental Intermediate School in Santa Ana, had heard of the same symptoms from a school colleague whose daughter-in-law had an aneurysm last year.

“I knew it was an aneurysm or a stroke,” Davis said, recalling her split-second decision.

She had Kozawa lie down in the back seat of her car and drove her south from their home in Irvine.

They passed Irvine Regional Hospital. They passed the new Kaiser Permanente hospital in Irvine. They passed Saddleback Memorial Medical Center in Laguna Hills

With Kozawa’s consent, Davis planned to take her to Mission Hospital in Mission Viejo. That was a life-saving choice, but not for the reason that Davis had in mind.

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Posted in: Surgery • • • | 1 Comment »

UCI anesthesia computer targets messy handwriting, messy reputation

September 17th, 2008, 4:31 pm by Colin Stewart


Photos: At right, detail of anesthesia computer screen. Next, on left, Dr. Zeev Kain, chairman of the UCI Department of Anesthesiology. Next, Dr. Scott Engwall, the department’s medical director of perioperative services. Bottom, Dr. Shermeen B. Vakharia, the department’s patient safety officer. (Photos by Mark Martinez, The Orange County Register, except Dr. Kain’s photo, which is courtesy of UCI.)

NEW TECHNOLOGY FOR THE O.R.

Screen of anesthesia computer system

UCI just spent $3 million on a computer system that eliminates the problem of doctors’ messy handwriting.

It’s also aimed at removing a messy stain on the reputation of the UCI Medical Center anesthesiology department, which has suffered from several years of internal turmoil.

The $3 million investment is part of UCI’s response to those past problems, which included investigations and a lawsuit about patient safety and equipment quality.

To put those problems behind it, in March UCI hired anesthesiologist Dr. Zeev Kain from the Yale University School of Medicine as the new department chairman.

The purchase of the new Anesthesiology Information Management System, or AIMS, was part of the package that convinced Kain to make the move.

“It was in the letter of understanding,” he said. “My mission is to transform the department into one that’s recognized worldwide for its quality of patient care and research.”

That’s a far cry from 2003, when regulators cited the UCI anesthesiology department as too weak to support the hospital’s now-closed liver-transplant program.

The national group that coordinates organ transplants said UCI anesthesiologists had no specific training for the transplant surgeries and relied on unsophisticated monitoring equipment.

In 2005, a former UCI anesthesiologist said in a lawsuit that he lost his job because he complained about safety problems, including cutting costs by rushing patients into surgery without proper medical documentation.

Documentation is a prime focus of the new AIMS computers, which create a database from a stream of information about the vital signs, medications and brain activity of each patient during operations at UC

Considering the high-tech achievements of modern medicine, you might expect that computers like AIMS had been whirring away in operating rooms since the 1980s, but you’d be wrong.

Kain estimates that fewer than five percent of hospitals nationwide have such systems.

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EV3 — starting from scratch to design an aneurysm fighter

September 10th, 2008, 6:54 pm by Colin Stewart

Model aneurysm

Photos: Above, model of an aneurym filled with Axium coil. Below: Clean room at EV3, where Axium coils and other products are made. Bottom: EV3 employee shows the thinness of the coil, which varies in width from .0115 to .0145 inch. (Register photos by H. Lorren Au)

REVERSAL OF FORTUNES

EV3 is like an inventor who crashes his car, peers out from the wreck and declares that he’s happy to have found a good opportunity to design a totally new vehicle.

That approach is bearing fruit for the company, especially at its offices and manufacturing plant in Irvine.

But EV3 didn’t have that strategy in mind in 2002. Then, EV3 – more specifically, an affiliated company that later became part of EV3 – purchased the German firm Dendron GmbH in a $40 million deal to gain a quick entrée into the market for devices that treat brain aneurysms.

Instead the deal gave EV3 a quick entrée into patent litigation.
In 2003, a Dutch court decision barred EV3 from selling Dendron’s key product, called Sapphire – a catheter-based system for filling aneurysms with filaments so they won’t rupture and cause a stroke.

The underlying technology had been developed at UCLA, and the court ruled that EV3’s device infringed on the University of California’s patent, which it had licensed to Boston Scientific of Natick, Mass.

EV3 decided to set aside the old technology and make a fresh start, recalled Pascal Girin, president of the Irvine-based neurovascular division.

ASK THE CUSTOMER

“What do the customers want? What do they expect?” were the first questions EV3 asked as it wiped the slate clean. To get answers, the company interviewed neurosurgeons and interventional neuroradiologists worldwide, Girin said.

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Posted in: Surgery • • | 1 Comment »

FDA okays Edwards implant to fix defective mitral heart valves

September 3rd, 2008, 6:30 am by Colin Stewart

FIGHTING HEART DISEASE

Edwards logoHeart-valve maker Edwards Lifesciences of Irvine has won approval from the Food and Drug Administration for a new type of replacement mitral valve made of cow tissue.

The Carpentier-Edwards Perimount Magna mitral valve has been available in Europe since 2005. In the United States, it will compete with mechanical heart valves and pig-tissue valves as treatment for patients with mitral valve disease.

The mitral valve separates two chambers of the heart, the atrium and the ventricle, on the left side of the organ. It closes during contraction of the left ventricle so blood won’t flow back into the atrium.

The new Edwards device is based on an existing Edwards mitral valve, but redesigned to match the asymmetric shape of the human mitral valve, the company said in its announcement.

It’s based on the same technology as the Edwards Perimount Magna replacement for the aortic valve, which is the valve that lets blood flow from the left ventricle out into the aorta.

Mitral valve disease, one of the most common types of heart valve problems, will require an estimated 35,000 to 40,000 surgical mitral valve replacements this year in the United States, Edwards said.

Cardiac surgeon Dr. A. Marc Gillinov at the Cleveland Clinic Heart and Vascular Institute, a consultant to Edwards, said, “This valve provides patients and surgeons with an important option for mitral valve replacement” and is “designed to provide ease of implantation in a difficult valve position.”

Posted in: Heart • • • • | Post a Comment »

Play-by-play account of joystick heart repair

August 13th, 2008, 2:54 pm by Colin Stewart

Dr. Doshi at Sensei work station

Photo: Above, Dr. Rahul Doshi at the controls of Sensei robotic catheter system. (Register photo by Leonard Ortiz)

Craig Link to slide showSchumacher’s heart operation was nothing to be taken lightly, yet the mood in the operating room was upbeat.

  • “Look at that!” Zap. “Amazing!”
  • “What the hell is this?” Zap.
  • “Come on, come on, come on!” Zap.

Those were some of the sounds and actions in the O.R. on the first day doctors at St. Jude Medical Center in Fullerton used a new Sensei robotic catheter system. Schumacher was one of the first patients operated on with it.

Cardiac electrophysiologist Dr. Rahul Doshi had no trouble dissipating tension that day, because the Sensei system required him to sit in front of three computer monitors and use a joystick, as if he were playing a video game.

For a description of Schumacher’s condition and what the new Sensei system means for cardiac patients, see the related story “Robotics turns heart repair into serious game.” For a play-by-play account of the operation itself, see below.

ROCK STAR

Doshi downed a can of Rock Star energy drink, then began the operation shortly after 2 p.m. First he inserted the catheter deep inside the Schumacher’s body, extending it from the groin to the heart.

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Posted in: Heart • Surgery | Post a Comment »

Robotics turns heart repair into serious game

August 13th, 2008, 2:16 pm by Colin Stewart

See also: Blow-by-blow account of robotic heart operation, “Joystick plays central role in new heart repair.”

New robotically controlled catheter tracks down heart abnormalities

Link to slide showCraig Schumacher’s heart operation was routine at first, but then it began to resemble a video game.

In the catheter lab at St. Jude Medical Center in Fullerton, Calif., the 56-year-old heart patient was stretched out on the operating table, draped, medicated, and anesthetized.

Cardiac electrophysiologist Dr. Rahul Doshi oversaw the placement of a slender cardiac catheter, which entered through Schumacher’s groin and snaked upward through his veins to the heart. It’s a procedure that Doshi has performed hundreds of times in operations to correct patients’ irregular heartbeats.

But this time the doctor stepped away from the operating table to sit at a bank of computer monitors. From there, he controlled the catheter with a joystick.

“This is pretty darn cool,” Doshi exclaimed after his first operation using St. Jude’s new Sensei robotic catheter system, made by Hansen Medical Inc. of Mountain View.

Schumacher’s procedure was two weeks ago, on July 31, the first day of operation for the $750,000 system. The device at St. Jude’s is the first of its kind in southern California and one of 21 installed nationwide. Read the rest of this entry »

Posted in: Heart • Surgery | 1 Comment »

‘Cool’ technology helps patients but red ink flows

August 6th, 2008, 4:03 pm by Colin Stewart

Cardiac and stroke patients can benefit from controlled cooling, which is the specialty of Alsius Corp. in Irvine.

William Worthen and posterA “cool” new technology from Alsius Corp. in Irvine helped former Buffalo Bills player Kevin Everett recover from a paralyzing spinal injury he suffered during a midfield collision last fall.

It also helped a teenage basketball player in Minnesota who was struck down by a midgame heart seizure, a Seattle engineer whose heart stopped on the job, and about 20,000 other patients in 330 hospitals worldwide in the past eight years.

Alsius makes computer-regulated catheters that can cool or warm a patient’s body from the inside. By circulating temperature-controlled water in a closed loop that’s inserted inside a patient’s veins, the devices let doctors adjust blood and body temperature quickly and smoothly.

The growing use of Alsius devices such as the Thermogard XP controller and Cool Line catheter mirrors the medical community’s growing awareness of the therapeutic value of regulating body temperature, especially in heart-attack and stroke victims.

“It’s a huge market,” said William Worthen, the president and chief executive of Alsius. “We’ve just scratched the surface.”

But the company’s ability to make a profit in that huge market remains unproven.

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