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.

She was heading to Mission because her brother works on the computers there. A more relevant reason would have been that Mission is one of Orange County’s two primary stroke centers, along with UCI Medical Center.

“Because of that, we try to stay on the cutting edge of stroke management,” said interventional neuroradiologist Dr. Todd Lempert, who leads the stroke team.

Minutes after Kozawa arrived at Mission’s emergency room at 7:45 a.m., the public address system signaled to the team to assemble: “Code Stroke, Room 2.”

The team included neurosurgeon Dr. K. Anthony Kim, neuro-critical care nurse specialist Mary Kay Bader and critical care physician Dr. Rudy Marquez.

“Within 15 minutes of when I drove up, she was off for a CT scan,” Davis said. “The quickness was incredible.”

The CT scan was the most familiar of three modern medical technologies that saved Kozawa’s life. Orange County medical-device companies compete in all three of those technological markets, although none of the O.C. companies’ products was used to treat Kozawa.

CT SCANNERS

First introduced in the 1970s, CT scanners use a computer to convert X-ray data into images of cross-sections, or slices, of a patient’s body. Mission Hospital uses a powerful 64-slice CT scanner from the German company Siemens. Irvine-based Toshiba America Medical Systemsalso makes 64-slice scanners, plus a new 320-slice CT scanner, which is powerful enough to create short videos of blood pulsing through the brain.

Mission’s 64-slice CT scanner created a 3D model of Kozawa’s brain, which showed doctors where the aneurysm was — and that it was already leaking blood into the brain.

ANEURYSM COILS

Next, Kozawa was taken to the cath lab, where vascular surgeon Dr. Ched Nwagwu inserted a catheter into an artery in her groin. He threaded it upward through the blood vessels past the heart to the balloon-like aneurysm.

Using the catheter, he and Lempert filled the aneurysm with soft, curled metal filaments, called coils, which stop the blood from flowing there. Normal blood flow can then resume past the aneurysm, while the remaining blood in the aneurysm clots, sealing it off.

They used coils from Boston Scientificof Natick, Mass., the market leader, although Lempert said he remains interested in newer models of coils made by a division of EV3in Irvine and coils from Aliso Viejo-based MicroVention, which was recently purchased by Japan-based Terumo.

Kozawa’s aneurysm burst in the middle of the coil procedure.

“It was a tense situation,” Lempert said. The doctors worked quickly to finish filling the aneurysm to staunch the blood flow. They succeeded, but her brain was already affected by the excess blood, which causes vessels in the brain to contract.

It was 12:15 p.m. Kozawa, in a coma, was moved to the Intensive Care Unit to be treated for the potentially fatal constriction of the brain’s blood supply.

HYPOTHERMIA INDUCTION

The team decided to treat Kozawa with another cutting-edge technology — cooling the patient dramatically to slow bodily processes and allow gradual healing to take place.

“Dr. Kim said, ‘I want to cool her to 33 degrees,’” nurse specialist Bader recalled. That’s 33 degrees Celsius, or 91.4 degrees Fahrenheit.

This technique, called cryotherapy or controlled mild hypothermia, is relatively common as a method for protecting the brain after a heart attack. But it is less widely known as a treatment for stoke or brain injury, Mission stoke team members said.

“We’re one of the few hospitals that use it in the United States,” Bader said. The nearest hospitals that also use it are at UC-San Diego and Stanford, she said.

The team used a system called Arctic Sun, made by Medivance Inc.of Louisville, Colo., which lowered Kozawa’s temperature through cooling pads attached to her legs and torso. Alsius Corp.of Irvine makes a competing system that cools patients through a catheter that’s inserted through the groin and into the torso’s central vein.

Under the care of ICU nurses, Kozawa’s temperature was held at 33 degrees Celsius for five days. When the danger seemed to be past, she was warmed back to normal over a three-day period. But then the tightening of arteries in the brain occurred again, so Kim had her cooled again — for a week.

“We were pushing the limits,” Bader said.

ICU nurse Laurie Roberts recalled being pessimistic. “I used to see her and think she’d say, ‘Just let me go.’”

But the tightness of her arteries eased, and Kozawa was slowly returned to normal temperature again.

Gradually, she was taken off medications. She was taken off a ventilator.

Even while she was in the coma, Davis visited her daily, chatted with her, exercised her arms and legs, and sang “The Beverly Hillbillies” theme song to her.

On Sept. 1, Kozawa emerged from the coma, and has been making slow progress since.

Now she can speak a bit, move her arms and legs, and sit in a chair for two hours.

Roberts says every patient is different, but a typical scenario would have Kozawa in a rehabilitation unit for a month. Then she can go home to continue her recovery — perhaps to nearly 100 percent of her abilities before her aneurysm burst.

The hospital’s stroke team now predicts a long and happy life for her.

“She’s remembering names, holding her head up and writing,” Davis said. “It’s going to be a journey, but I’m expecting 98 to 100 percent total rehabilitation.”

Related links:

• Mission Viejo woman’s ‘miraculous’ recovery from aneurysm
• EV3 — starting from scratch to design an aneurysm fighter
• ‘Cool’ technology helps patients but red ink flows

Post from: Biomedical Innovation with Colin Stewart

NEW TECHNOLOGY FOR THE O.R.

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.

True, computerized sensors have long been used in O.R.s to measure patients’ heart rate, blood pressure, blood oxygen levels, etc. Those readings are displayed on computer monitors at the anesthesiologist’s station next to the patient’s head.

But it has been left to the anesthesiologist to jot down in a patient’s chart whatever seemed noteworthy during and after the operation.

“We had 21st-century monitors, but 100-year-old technology for anesthesiology charts. At the end of the day, it was just pen and paper,” Kain said, referring to the standard of care at most hospitals.
“Handwriting of physicians is not the best, so medical records were not optimal,” he said.

PATIENTS’ DATA

The newly installed anesthesiology computers change that.

From each operating room, they feed into a permanent database that stores each patient’s vital signs moment-by-moment:

• Blood oxygen levels calculated by pulse oximeters from Irvine-based Masimo Corp.
• Blood pressure, heart rate, cardiac electrical signals, and anesthetic gas levels measured by monitoring systems from the Datex Ohmeda division of General Electric in Madison, Wisc.
• Brain waves recorded and processed by BIS machines from Aspect Medical Systems of Norwood, Mass.

The system was manufactured by Surgical Information Systems of Alpharetta, Ga., customized by UCI medical and computer experts, and installed last month.

Last week, UCI anesthesiologists concluded that the system had passed its start-up tests, so they stopped making handwritten reports.

In addition to the centralized database, AIMS also creates a real-time display of the patient’s constantly changing status during the operation. That information appears on a computer monitor in front of the doctors.

Freed from the task of recording data, anesthesiologists say they will be able to provide more hands-on help during an operation. For example, they can deploy an ultra-sound device from Acuson Corp. of Mountain View that uses a probe in the patient’s esophagus to capture a real-time image of the heart.

DATA MINING

In addition, medical administrators and researchers soon will be able to use the accumulated AIMS database to identify doctors or specific procedures that perform better or worse than average.

“We can start data mining that will impact patient care,” said Dr. Scott Engwall, the department’s medical director of perioperative services. One goal will be to determine “best practices” – the best way to handle specific medical problems – based on tens of thousands of recorded examples.

“For example, patients hate nausea – vomiting is their second-least-liked symptom, next to pain,” Engwall said. “We will be able to determine what methods cause or reduce nausea.”

If most patients of Doctor X throw up, AIMS could reveal what he’s doing wrong. If patients of Dr. Y almost never throw up, AIMS could suggest what she’s doing right.

That data will be at medical researchers’ fingertips.

“If I have a question to research, I don’t have to assemble 2,000 charts, 10,000 charts,” Engwall said.

LEGAL ISSUES

Computer systems such as AIMS were proposed about a decade ago, but were slow to catch on, Kain said.

“When this first came out, there were legal questions,” he said. Doctors worried, “Now lawyers will have access to the records.”

In practice, having objective data about an operation proved to be an advantage to doctors in malpractice cases, UCI anesthesiologists said.

“Anesthesiology is the safest medical discipline,” Kain said. It has a safety record approaching the corporate “Six Sigma” level, which is typically defined as no more than 3.4 defects per one million products, or one defect per 294,000.

By some measures, anesthesiology is at or close to that level.

In 2003, for example, the American Society of Anesthesiologists newsletter cited studies that found one anesthesia-related death per 200,000 to 300,000 relatively healthy patients, but one death per 13,000 patients if you include those who entered the O.R. with severe illnesses.

“Anesthesiology is very safe, but if we can identify patterns of complications, we can make it safer,” said Dr. Shermeen B. Vakharia, whom Kain recently named as patient safety officer.

“Safety is power,” she said.

Post from: Biomedical Innovation with Colin Stewart

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.

The focus of the conversations was on devices known as detachable coils, which are made by five medical-device companies in the United States – EV3 and Boston Scientific, plus Micrus Endovascular of San Jose; Microvention of Aliso Viejo; and Cordis of Warren, N.J.

Coils are one of three prominent methods for treating aneurysms, which are areas where the weakened wall of a blood vessel bulges outward into a balloon-like shape. In the United States, the dominant tactic is for a brain surgeon to clip off the aneurysm, but in Europe and less so in the United States, interventional neurocardiologists fill them with tiny coils of wire filaments or inject them full of a spongy polymer.

Packing an aneurysm with soft, curved stands of wire creates a tangle of filaments that impedes blood flow there. An injection of polymer can produce the same result. In each case, the filler allows the remaining blood in the aneurysm to clot so the aneurysm cannot burst.

“It’s like a pothole. You fill it with stuff,” which allows smooth passage of traffic to resume, said Earl Slee, EV3’s vice president for research and development.

Requests to EV3 during its conversations with customers and potential customers in hospitals, Slee said, included these three changes:

Finding a new way to detach the coils. The coils reach the aneurysm via a microcatheter, which the doctor threads through blood vessels from the groin, upwards past the heart, through the carotid artery in the neck and finally to the aneurysm site in the brain. The doctor then uses a wire inside the catheter to push the coil out and position it in the aneurysm. But the doctor can’t then reach in with a pair of scissors and snip off the coil from the catheter.

To solve that problem, most coils are manufactured with a short weak section that works as an electrical fuse. The doctor sends an electrical current up the wire until that weak section at the base of the coil eventually melts, detaching it.
EV3 found a quicker way. The base of the coil is a tiny ball that is blocked from detaching prematurely from the catheter tip because the catheter’s guide wire partially blocks the exit opening. With the new EV3 system, when the coil is in place the doctor simply retracts the guide wire from the opening, releasing the ball and detaching the coil.

That’s a feature of the new Axium coil system, which EV3 launched late last year  as a successor to the jinxed Sapphire and its earlier substitutes, the Nexus and NXT coil systems.

Simplicity. Doctors said they wanted a less confusing array of options. Coils are roughly the width of a human hair, but they come in a dazzling variety of widths and lengths. Five companies offer them in a total of more than 600 varieties.

In response, EV3 limited its line of coils to about 55, ranging from long, thick ones that are laid down first, around the edges of an aneurysm, to short, thin ones that fill in the middle of the aneurysm.

Safety. A wire could cause a rupture by poking a hole in an aneurysm. To avoid that, EV3 makes its Axium coils of a relatively soft platinum-tungsten alloy, as most coil makers do. It also molds them like a spring, so the coil curves in on itself instead of sticking out straight.

WE’RE NO. 2

EV3 estimates that worldwide it’s the No. 2 maker of neurovascular devices, including its Solitaire stents and its market-leading Onyx aneurysm-filling polymer. Boston Scientific is No. 1. But EV3 is only No. 4 or No. 5 in coil sales, a market totaling an estimated $330 million a year.

The company’s new leader plans to change that. Bob Palmisano, who took over as chief executive in the spring, is already putting into effect the management techniques he learned at the head of other medical-device companies.

Most recently, he led the optical-laser company IntraLase of Irvine until it was purchased last year by Advanced Medical Optics of Santa Ana.

“Moving from ophthalmology to neurovascular, there’s a learning curve,” he said, “but the management issues are the same.”
Palmisano started work at EV3 in April and promptly led a corporate retreat in May that identified new corporate goals, with project teams assigned to pursue each one.

The Axium team is preparing for the launch of coils made of nylon and, once again, focusing on customer relations.

In the past year, “Axium had a very successful launch internationally – we blew the door off – but we weren’t nearly as successful in the United States,” Palmisano said. American doctors still prefer to clip off aneurysms rather than filling them, and EV3 hopes Axium can help to change that.

“We want a dominant market share in coils,” Palmisano said.

(This post was revised Sept. 18 to correct the indirect quote from Pascal Girin, who said the company contacted neurosurgeons and interventional neuroradiologists for advice.)

Post from: Biomedical Innovation with Colin Stewart

Heart-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.”

Post from: Biomedical Innovation with Colin Stewart

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

Craig Schumacher’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.

In the past, for the duration of the operation Doshi would have held onto a manual catheter at the end where its movement controls were located.

This time, though, the new Hansen catheter was attached to a computerized movement-control device that looked like a small vacuum cleaner suspended from a mechanical arm.

ALICE IN CHAINS

At 2:30 p.m., Doshi stepped away from the operating table and sat at the new system’s work station, holding onto the Sensei catheter’s joystick. From an iPod in the corner came low-volume rock music, including Rolling Stones and Alice in Chains songs.

As Doshi tracked down and eliminated electrical abnormalities in Schumacher’s heart, his exclamations made him sound a bit like a computer gaming enthusiast. That kept spirits up in the operating room as he tackled a complex procedure that would determine Schumacher’s health for years to come.

On one screen Doshi could see the location of the catheter inside the heart, recorded by a five-foot C-shaped fluoroscope that encircled Schumacher’s upper body. Everyone in the operating room wore lead-lined garments as protection against the X-rays the fluoroscope used to create its moving image of the patient’s heart.

A second screen showed the patterns of electrical signals inside the heart.

NORAD

“It’s like we’re at NORAD,” Doshi said, comparing the Sensei video panel to a North American Aerospace Defense Command control center.

One screen showed a 3D computer simulation of the left atrial chamber of the heart, based on Schumacher’s recent CT scan. (Similar to the Hansen Medical graphic below.) Another screen (pictured at right) showed a real-time 2D image of the chest from the fluoroscope, which a computer simulation of the catheter superimposed on it.

Doshi moved the catheter methodically through the upper heart, again and again touching the atrial wall with the tip of the catheter and checking the screen for signs of the electrical activity there.

BAD ACTOR

“Look at that. There’s a potential bad actor,” he said, spotting a pattern of electrical activity that could leave the heart fluttering.

Depending on the type of electrical irregularity, the heart could be thrown into an irregular pattern, or arrhythmia. Irregularities can include incidents when the pulse rate exceeds 100 per minute, called tachycardias, and abnormal, disorganized rhythms called fibrillation.

When Doshi identified a suspect location, he pressed a control lever with his foot. In response, the tip of the catheter emitted a blast of radio waves to deaden that spot. Zap. A white oval appeared on the 3D image at the zapped location.

CLEAN-UP

“His arrhythmia just changed,” Doshi said. “What does it take to stop it?” Zap.

“There’s a lot of scarring. That doesn’t bode well,” he said. “Let’s clean up there.” Zap. Zap.

“That area has been blitzkrieged. That’s what you get with three ablations.”

It was 3:40 p.m.

“Mark that. And that. And that,” he told clinical engineer Simon Pranaitis, who worked on his own screen at Doshi’s side, controlling the heart monitoring and imaging system. The marks on the 3D image helped Doshi navigate through the heart and return to locations that might need further work.

“Come on, come on, come on. Here we are!” Zap.

“We’ve seen four different flutters. That’s surprising.”

GARBAGE FLUTTER

“What the hell is this? Garbage flutter. You just can’t win.” Zap.

“God, it’s taking forever,” Doshi said. “I’ll be worn out for playing Guitar Hero. My daughters are already beating my behind on it.”

At 4:45 p.m., Doshi decided that he should move the catheter tip into the right atrium of the heart, because he had discovered that Schumacher’s electrical irregularities weren’t limited to the left atrium.

There Doshi spotted more problems and briefly broke into song about a type of rapid heartbeat that he saw.
“Come on, come on, come on!”

BIZARRE

“I can’t get rid of it. It’s bizarre.” Zap. The irregular signal vanished.

At 5:25 p.m., he moved the catheter back to the left atrium, where more irregularities had popped up.

“What does it take? There’s no end to this guy’s tachycardias.” Zap. Zap.

“Look at that! That’s where we need to be.” Zap.

“It’s so diseased! The garbage is back. Amazing.” Zap.

Doshi moved the catheter to the roof of the left atrium.

FINAL TOUCH

“There’s something right there that we’re missing,” he said. Then he spotted one final irregularity. “That makes no sense at all, in the middle of the bloody roof!” Zap.

“Now we’ve done everything,” he said. “There’s nothing left to burn.”

The 3D image of the heart was dotted with dozens of white ovals that marked Schumacher’s newest ablation sites.

“It’s Miller time, kids,” Doshi said. “We’re done.” The time was 6:07 p.m.

Above: Hansen Medical photo of Sensei system’s controls

Post from: Biomedical Innovation with Colin Stewart

New robotically controlled catheter tracks down heart abnormalities

Craig 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.

“We now have hope again,” Schumacher’s wife, Ruby Cook, said after the operation. “We feel very blessed.”

That contrasts with their predicament three months ago, before Blue Shield and St. Jude worked through insurance problems and medical issues to clear the way for Schumacher’s latest high-tech treatment.

“It’s been a rough three years,” said Schumacher’s wife, Ruby Cook. Her husband has suffered from irregular heartbeats since surgery for cancer of the esophagus three years ago. He has repeatedly collapsed and been hospitalized.

Three times he has undergone a cardiac treatment called ablation, which is used to deaden portions of the heart where irregular electrical signals are causing irregular heartbeats.

Last year, during a trip to Yosemite National Park, he was evacuated by medical helicopter at a cost of $20,000. He has been hospitalized for seven months out of the past 12, including stays at hospitals near Yosemite, in Fresno and in Modesto, at USC Medical Center in Los Angeles, Placentia Linda Community Hospital in Placentia, Western Medical Center in Santa Ana, and UCI Medical Center in Orange, Cook said.

Schumacher is a carpenter, but he hasn’t been able to work and he couldn’t walk more than a few feet.

For a while, he had no prospects of further treatment because three ablations is typically the limit that doctors and health insurers set, she said.

But Doshi uses a different, sophisticated method of tracking electrical signals in the heart, so he and St. Jude, with support from Blue Cross, were willing to take on Schumacher for a fourth ablation procedure despite his prior history. That operation might have been done with a traditional catheter, but timing was such that Schumacher had the benefit of the new Sensei system.

FOUR-HOUR OPERATION

Doshi downed a can of Rock Star energy drink, then began the operation shortly after 2 p.m., starting by inserting the catheter deep inside the patient.

In the past, for the duration of the operation Doshi would have held the catheter at the end where its movement controls were located. Now the new Hansen catheter was attached to a computerized movement-control device that looked like a small vacuum cleaner suspended from a mechanical arm. (Pictured at right)

By 2:30 p.m., Doshi was seated at the new system’s work station (above left), holding the Sensei catheter’s joystick.

There, as he tracked down and eliminated electrical abnormalities in Schumacher’s heart, he sounded a bit like a computer gamer. It was his way of keeping spirits up in the operating room as he tackled a complex procedure that would determine Schumacher’s health for years to come.

On one screen Doshi could see the location of the catheter inside the chest, recorded by a five-foot C-shaped fluoroscope that encircled Schumacher’s upper body.

Everyone in the operating room wore lead-lined garments as protection against the X-rays the fluoroscope used to create its moving image of the patient’s heart.

A second screen showed the patterns of electrical signals inside the heart.

For nearly four hours, Doshi seemed glued to the screen as he hunted for abnormalities. Whenever he found one, he pressed a control lever with his foot. In response, the tip of the catheter emitted a blast of radio waves to deaden that spot.

The 3D image of Schumacher’s heart became dotted with dozens of white ovals that marked his newest ablation sites.Finally Doshi said, “We’re done.” The time was 6:07 p.m.

For a full account of the operation, see the post “Joystick plays central role in new heart repair” on Biomedication Innovation blog at innovation.freedomblogging.com.

THREE VIEWPOINTS

From Doshi’s viewpoint, the new robotic catheter is better for doctors and for patients.

By replacing manual control with computerized control, it will allow more accurate placement, he said.

“We can tackle more difficult situations and harder-to-reach places,” he said.

That should also help doctors cut down on errors, he said. Doctors will also be exposed to less radiation, because they will be working in front of the video screens instead of beside the X-ray-emitting fluoroscope.

From the viewpoint of some of the first medical researchers to test the Hansen device, the robotic catheter promises to be as good as manually controlled catheters. In medical journals, they gave it good grades, though not as high as Doshi did.
They also said some practical problems still need to be worked out, including occasional damage to the heart – at a rate that’s equivalent to the complications that occur with manual catheters.

Dr. Prapa Kanagaratnam of London and his co-authors wrote that they would have preferred to be able to feel in their hands how much force the catheter was applying to the heart, instead of just seeing its position on a monitor.

So far, the robotic system has proved to be “safe, feasible and effective,” although its long-term safety and effectiveness remains to be seen, they said.

The system might cut the length of ablation operations, which would reduce patients’ exposure to X-rays, Kanagaratnam said.

Dr. Walid Saliba of the Cleveland Clinic in Ohio and his co-authors reached a preliminary conclusion that the Sensei system does as well as conventional catheters, based on their experience operating on 40 heart patients.

Dr. Sabine Ernst, also of London, compared the Sensei system to a competing technology, the Niobe system from Stereotaxis Inc. of St. Louis, which uses powerful magnets to control the movement of the catheter. (Pictured at left) The Sensei system’s control mechanism consists of wires located inside the catheter sheath.

Both technologies are promising, Ernst said, but more data is needed to determine their relative strengths and weaknesses.
From the viewpoint of the patient, the surgery was a success.

Schumacher’s heart rate is more regular, he said, though it isn’t back to normal yet.

He was looking forward to returning home soon, after he recovers from a lung infection that he contracted after the surgery.
Then he hopes he can resume a more normal life.

“The obstacles I faced used to be the size of city blocks,” he said. “Now they’re just like cutting a hole in barbed wire.”

Post from: Biomedical Innovation with Colin Stewart

A “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.

Despite the growing acceptance of its cooling systems, Alsius is still a so-called “pre-profit” company. In the process of developing and marketing its technology, Alsius has recorded losses of more than $67 million in the past five years.
At the end of last year, the company had $24.4 million of cash on hand, which had dropped to $18.5 million by March 31.

That means the company needs new investments, even though getting out of the red remains a distant hope.
In its most recent annual report, Alsius said it expected “operating losses and negative cash flows to continue for the foreseeable future” because of the cost of expanding its sales force, developing new products, and seeking further approvals from the Food and Drug Administration and regulators abroad.

PROS AND CONS

The American Heart Association has endorsed medically induced hypothermia – deliberately cooling the body to about 91 degrees Fahrenheit – as a technique for preventing brain damage after a cardiac arrest. Exactly how that therapy works isn’t known, but many doctors believe that cooling temporarily reduces the brain’s need for oxygen.

Only about one hospital in four has adopted that strategy because of some contradictory research, uncertainty about how cooling works, which patients it can help, and which cooling devices work best.

In addition to Alsius catheters, which are inserted through the groin or neck and extend deep into the patient’s torso, competing technologies include ice packs, water-filled cooling blankets, Set Point catheters from Radiant Medical of Redwood City, Celsius Control System catheters from Innercool Therapies of San Diego, and Arctic Sun cooling pads from Medivance of Louisville, Colo.

The FDA, which has been an obstacle for Alsius, has not approved Cool Line catheters for use with cardiac-arrest patients. The doctors who used Alsius devices as part of successful treatments for Kevin Everett’s spinal injury, teenager Adam Thielen’s heart seizure, and engineer Dean Cowles’s cardiac arrest were using “off label” therapies, which physicians are allowed to do.

More conservative doctors stick to FDA-approved uses of medical devices, which in the case of Alsius are limited to fever control for brain patients in intensive care units and temperature management during heart and brain surgery.

CLINICAL TRIAL

A challenge facing Alsius is that only two of four sub-groups in a 298-patient clinical trial did better with the Cool Line catheter than with more conventional temperature-control treatments. As a result, the FDA approved use of the Cool Line for treating:

• Stroke patients. In the clinical trial, their death rate was 19 percent with Alsius devices vs. 21 percent in the control group.
• Patients with brain hemorrhages. Their death rate was 24 percent with Alsius systems vs. 26 percent in the control group.

But patients with traumatic brain injuries and bleeding in membranes around the brain had a higher death rate with Alsius devices, so the FDA required the company to put a warning label about that problem on its Cool Line catheters. That warning covers:

• Patients with traumatic brain injuries. Their death rate was 23 percent with Alsius systems vs. 11 percent in the control group.
• Patients with ruptured aneurysms in brain membranes. Their death rate was 21 percent with Alsius systems vs. 11 percent in the control group.

The warning label hasn’t posed a problem for most doctors, Worthen said, because they know that the sub-groups in the clinical trial were too small to be statistically significant. The typical death rate for brain injuries and ruptured aneurysms is 25 to 27 percent, he said, so Alsius devices matched the typical outcome from standard therapies.

Overall, Alsius systems have been approved by the FDA for one of three types of recognized temperature-control therapies:

• Cooling overheated patients to normal levels, reversing a temperature spike caused by bleeding in the brain or a stroke triggered by a blood clot. In the clinical trial, Alsius devices cut by 64 percent the average amount of time patients’ temperatures were dangerously high despite use of traditional cooling methods, Worthen said.

Alsius systems have not yet been approved for:

• Cooling patients to below-normal temperatures after a cardiac arrest to limit brain damage; or
• A new technique – warming burn victims whose loss of skin hampers their body’s ability to regulate temperature. This is the therapy that Brooke Army Medical Center in San Antonio, Texas, is planning to use with four Alsius systems that it recently purchased, Worthen said. The treatment is designed for soldiers who were injured in Iraq, he said.

In Europe, Alsius is allowed to market its devices as a treatment for cardiac-arrest patients. The company is still exploring ways to win similar approval from the FDA.

CHANGING STRATEGY

The company has been around since 1991, but it started out in a different direction. The first plan was to use catheter technology developed at UCLA to limit brain damage that stoke patients suffer, Worthen recalled.

At the time, the company’s name was Neuroperfusion because its system was designed to use catheters to supply oxygen-infused blood to the brain after a clot blocked normal circulation.

But a member of the company’s scientific advisory board proposed a more profitable use of the catheters, Worthen said. Stroke specialist Dr. Camilo Gomez of the University of Alabama suggested that, with a modest design change, the catheters could create medically-induced hypothermia.

Worthen checked to see what medical researchers had discovered about hypothermia.

“The potential benefits appeared to be huge – off the chart,” he said.

Several recent studies of cardiac-arrest, stroke and head-trauma patients showed that cooling the body could reduce brain damage. For example, a European study of 273 cardiac-arrest patients found that more than half of those treated with controlled cooling were living on their own six months later, but less than 40 percent of the other patients were.

But cooling technologies were rudimentary. Dr. Mary Ann Peberdy of Virginia Commonwealth University told an FDA advisory panel that medical staff used crude, time-consuming methods for controlling patients’ temperature, including large plastic garbage bags with ice.

Worthen and his colleagues saw that as an opportunity, so in 1998 the company was reorganized in pursuit of the new goal. It was also renamed “Alsius,” which means “cold” in Latin.

“We put our old technology on the shelf and gave the licenses back to UCLA,” Worthen said.

The company’s engineers redesigned the catheter and developed the computerized control system.

The first patient, a trauma victim, was treated in 2000 in Innsbruck, Austria. “It went beautifully,” Worthen said.

Since then, about 20,000 patients have been treated with Alsius devices, and some investors are betting that Alsius technology will eventually be a financial success as well as a medical one.

In June 2007, Alsius was purchased by Ithaka Acquisition Corp., an investment company that had raised money to purchase promising technology. The deal provided Alsius with about $40 million for boost its sales and marketing efforts, Worthen said.

In the past year, Alsius shares have dropped 52 percent, to $2.50 at Wednesday’s market close. But Isaac Ro of Leerink Swann & Co., the one stock analyst who tracks the company, rates it “outperform.”

He predicts that Alsius stock will soon rebound to $4.

Related links:

• Alsius Corp. company profile
• William Worthen personal profile
• FDA advisory panel in 2005 discusses Alsius catheter
• The big chill: Improving the odds after cardiac arrest (RNweb)
• Therapeutic hypothermia (American College of Emergency Physicians)
• Buffalo Bills’ Everett May Walk Again: Football Player Kevin Everett May Have Better Prognosis Due to Swift Hypothermia Treatment
  

(This post was revised Aug. 7 to add the reference to catheter systems from Innercool Therapies.)

Post from: Biomedical Innovation with Colin Stewart

ALSIUS CORP.

Business: Develops, manufactures and sells computerized systems to regulate critically ill or surgical patients’ body temperature through catheters containing temperature-controlled saline solution.

Headquarters: 15770 Laguna Canyon Road, Irvine

Employees: 100

Ownership: publicly traded company.

Stock exchange: Nasdaq

Ticker: ALUS

Recent share price: $2.50 on Aug. 6

Revenue (2007): $9.1 million

Loss (2007): $22.2 million

Top-selling products: Thermogard XP, CoolGard 3000 and a family of one-time-use catheters (Cool Line, Icy and Quattro) that go with those systems. More than 600 systems have been installed in 330 hospitals worldwide.

History: Founded 1998

More info: 949-453-0150, www.alsius.com

Post from: Biomedical Innovation with Colin Stewart

Age: 47
Born: Glendale, Calif.
Lives: Ladera Ranch, Calif.
Education: B.S., San Diego State University
Experience: President and CEO of Alsius since 1997. Prior to that, he served as president, CEO and director of Neuro Navigational Corp., a medical device company focused on minimally invasive neurosurgery. He has 24 years of experience in the medical device industry, including positions at Intertherapy, Trimedyne and Baxter’s Edwards Laboratories Division.
Family: Daughter, 17; son, 14
Favorite work-related book: “Standing Tall, The Kevin Everett Story” (“An amazing story of life, perseverance and overcoming incredible odds in combination with advances in medical technology that helped make it possible “)
Favorite pleasure reading: Everything by Clive Cussler. (“A great combination of adventure and history all wrapped up into one.”)
Favorite movie: “Caddyshack” (“I am a serious golfer and this is the ultimate spoof on golf.”)
Hero/role model: “My father, since he taught me a strong work ethic and gave me his sense of humor.”
Favorite quote: “Luck is where hard work and preparation meet opportunity.”
Tips for innovators:
– Never stop asking how something can be done better.
– Don’t be afraid to take risks
Tips for companies that want to be innovative:
— Have clearly defined goals and objectives.
– Be nimble.
– Make sure everyone in the organization understands and shares the vision

Post from: Biomedical Innovation with Colin Stewart

Photo: Dr. John Hovanesian of Laguna Hills checks Tom Rankin’s close vision after cataract removal and implant surgery. (Register photo by Ken Steinhardt)

FROM ‘SCARY’ TO ‘BEST SIGHT EVER’

Tom Rankin realized something was wrong.

He had worn thick glasses since third grade, but at age 56 he started having difficulty reading road signs. Before long he couldn’t quite see pedestrians crossing the street.

“It was scary,” said Rankin, a Mission Viejo resident who is general manager of a welding equipment company in Irvine.

“My vision was always pretty bad,” he said. “I thought I was just getting old and deteriorating.”

Ophthalmologist and eye surgeon Dr. John Hovanesian of Laguna Hills had a different message for him: At age 57, Rankin had cataracts, a clouding of the lens that affects an average of one out of every two people over age 65.

If it were 25 years ago, an eye surgeon would have removed Rankin’s clouded lenses and fitted him for a new set of thick glasses.

But modern technology has created new alternatives. Now, doctors routinely extract clouded lenses and replace them with new synthetic ones called intraocular lenses, or IOLs.

Top-of-the-lineup IOLs are all made by Orange County companies or a large Swiss-based competitor, Alcon.

The latest IOLs, approved by the Food and Drug Administration just last month, are nearly as good as a healthy natural lens.

The earliest IOLs, first approved by the Food and Drug Administration in 1981, let patients see clearly at a distance, but leave them needing glasses for reading and mid-range vision.

Since then, optical engineers have followed two main strategies for bringing IOLs’ performance closer to what a healthy natural lens can do.

One strategy was to design a multifocal synthetic lens that would focus at more than one distance, typically both near and far. Following this course, Advanced Medical Optics in Santa Ana created the ReZoom lens, while Alcon produced the ReStor. Both types of multifocal IOLs won FDA approval in 2005.

A second strategy was to create a synthetic lens called an accommodating lens, which would bend much like a natural lens. That was the route taken by Eyeonics of Aliso Viejo, which developed the Crystalens and won FDA approval for it in 2003.

The design of early Crystalens models couldn’t match a natural lens, so patients could see only distant and mid-range objects clearly.

CHOOSING A LENS

Dr. Lawrence Chao, medical director of the Chao Vision Institute in Irvine, said cataract patients choose among IOLs on the basis of their lifestyles – how much they use computers, read, drive and watch TV – and their finances.

The terms of the financial decision are set by Medicare, which pays for a basic monofocal IOL, but not for a multifocal or accommodating one. Patients typically must pay an additional $2,500 to $3,500 per eye if they choose one of those so-called premium IOLs, Chao said. That includes the cost of extra measurements and tests.

Both multifocal and accommodating lenses provide sharp vision at a distance, so the decision between those two types of premium lens comes down to a trade-off, Chao said:

• Sharp close-range focus for reading (ReZoom or ReStor); or
• Sharp mid-range focus for looking at a computer screen or car dashboard (Crystalens, which is increasingly able to provide near focus too).

“None can give you everything,” he said. “You can choose two out of three [focal ranges]. You’ll get distant vision with either type. Do you want intermediate or near vision?”

Multifocal ReZoom and ReStor lenses, with their combination of near and distant focus, are especially good for “little old ladies who don’t drive at night,” Hovanesian said. “They read the Bible and they watch Alex Trebek on TV.”

His patients who are elderly often don’t use a computer and they don’t need to focus at intermediate range, he said.

A further factor in the decision, Hovanesian said, is that 10 percent of patients with multifocal lenses are bothered by glare or halos around lights while driving at night.

LATEST MODEL

Eye-care giant Bausch & Lomb of Rochester, N.Y., had no premium IOL products until February of this year, when it purchased Eyeonics for an undisclosed price and turned it into the Bausch & Lomb Surgical division, still in Aliso Viejo.

This month that division introduced the latest advance in IOL technology, the Crystalens HD, which was approved last month by the FDA.

Hovanesian was principal investigator in the new lens’s 125-patient clinical trials.

He found that the fourth-generation Crystalens lets patients focus on anything from a distant object to a book that’s 16 inches or less from the eyes, Hovanesian said.

That’s “closer than ever” to achieving “truly good near vision,” said Michael Judy, the division’s chief marketing officer.

With the third generation of the Crystalens, 70 percent of patients could read print in a telephone book at 16 inches. In the latest, the Crystalens HD, 90 percent could, Hovanesian said.

For patients such as Rankin, Hovanesian said the HD model means “we can fix the cataract and make the patient’s vision better than before the cataract.”

IN GROWTH MODE

Monofocal IOLs, which are covered by Medicare, remain the most popular type of IOL.
AMO, for example, reported selling $263 million worth of monofocal IOLs last year, plus $54 million in multifocal IOLs.

Premium IOLs accounted for about one-tenth of total worldwide IOL sales of about $1.5 billion in 2006, according to the MarketScope market research firm, and their popularity is growing fast.

Eyeonics had about $34 million in Crystalens sales last year, about double its figure for 2006.
Crystalens accounted for about 34 percent of the premium IOL market in the first quarter of this year, Bausch and Lomb says, citing its own unreleased sale figures and MarketScope’s.

ReStor is the market leader, with 46 percent, while ReZoom has 20 percent.

In the United States, sales of IOLs have grown roughly fivefold since 2003, according to the market research firm MedMarket Diligence in Foothill Ranch.

Reasons for the increases include population growth in the over-60 age group, technological innovations, and price hikes on IOLs, said Patrick Driscoll, head of MedMarket Diligence.

But for cataract patients such as Rankin, what matters is the change in their lives that an artificial lens can create.

A third-generation Crystalens was implanted in one eye in February, followed by the second one in March, he said.

He still needs glasses when he reads the newspaper, he said, but otherwise he’s delighted with the results.

Six hours after he got the first Crystalens, he said, “I could see really well with just that one lens.
“I’d forgotten how clear the world is, how clear blue is, and how clear green is.”

“I looked at the hillside across from me. It was just beautiful. This is the best sight I’ve ever had.”

COMPANY PROFILES

Harvard Eye Associates
Offices: 24401 Calle De La Louisa, Laguna Hills; 665 Camino De Los Mares, San Clemente.
Specialties: diagnosis and treatment (both surgical and non-surgical) of all types of eye disease. Specialists in cataract surgery, Lasik, cornea, glaucoma, ocular plastic surgery, retina, contact lenses, eyeglasses.
Physician partners: Roger V. Ohanesian, M.D.;.Edward W. Kim, M.D.; Diana H. Kersten, M.D.; John A. Hovanesian, M.D.
Employees: 70
History: Founded 1975. The reference to Harvard is because the founding partners took their residency training at the Massachusetts Eye and Ear Infirmary, Harvard’s eye hospital.
More info: 949-951-2020 or www.harvardeye.com

Chao Vision Institute
Office: 2500 Alton Parkway, Irvine
Specialties: refractive, cornea and cataract surgeries.
Physician: Lawrence Chao, M.D.
Employees: 10
History: Established June 2006, when Chao left a full-time position at UCI as associate professor of ophthalmology.
More info: 949-679-2426 or www.chaovision.com.

Market data in this post includes information and estimates from “Products, Technologies, Markets and Opportunities in Ophthalmology Surgical, Device and Drug Markets Worldwide, 2007,” report #G125, published November 2006, by MedMarket Diligence LLC of Foothill Ranch.

Post from: Biomedical Innovation with Colin Stewart