Heart-failure patient Jose Fernandez was nervous as he waited to be wheeled into an operating room at the Hospital of the University of Pennsylvania for experimental surgery.
The 42-year-old husband and father of three had pinned his hopes on a soft mesh "jacket" that surgeons planned to put around his heart. The experimental device might save him from a transplant, or an early death.
By now, Fernandez had few choices. Medications had failed, leaving him short of breath and unable to work or fully participate in family life.
He was one of the 5.7 million Americans with congestive heart failure, a growing illness that kills about 300,000 a year.
"I'm strong now," Fernandez said as he underwent testing before surgery in August 2009 to implant the device. "Better now rather than wait until it's too late."
His heart had gotten so big - twice normal size - that it was not pumping blood efficiently. And his mitral valve could no longer fully close, allowing blood to flow backward inside his heart and causing the organ to compensate by growing larger.
Michael Acker, chief of cardiovascular surgery at Penn, planned to replace the damaged valve. And while Fernandez's chest was open, Acker would encase his heart in a flexible polyester mesh, known as the CorCap Cardiac Support Device.
The mesh would act like a girdle, supporting his heart's ability to pump, and stabilizing its expansion and possibly reversing it.
Acker hoped that Fernandez and others who received the experimental jacket would do well enough to persuade the U.S. Food and Drug Administration to approve the device for use in this country.
But that would not be easy. The device's maker - Acorn Cardiovascular Inc. of New Brighton, Minn. - was in as much peril as many of the patients it was trying to help.
An FDA advisory panel had rejected the device in 2005, citing problems with its first clinical trial and concerns that it had caused scarring that made subsequent surgery - common for heart-failure patients - more difficult.
In 2006, the company lost an appeal of that decision but received FDA approval for an additional trial. Fernandez was one of 50 patients slated to be in that second trial.
The FDA also approved a third trial that would test the newest version of the device, one that would not require open-heart surgery. This next-generation jacket could be inserted through a two-inch hole in the chest.
But in February, the FDA rejected the third trial's protocol and said the company would need to conduct a new, randomized study on 500 to 600 patients.
Such a trial would cost up to $60 million, far more than Acorn had, executives said.
The firm had already spent more than $110 million that investors had put into the medical start-up.
Now the question was: Would the company recover?
As a surgeon specializing in mitral-valve replacements and repairs, Acker knew that high-risk patients like Fernandez could benefit from having their leaky heart valves fixed.
But he was excited by the simple way the CorCap device worked. The mesh gave added strength to the walls of the heart, helping it pump and halting its expansion.
"This patient's heart is gigantic," Acker said after cutting through the patient's breast bone and exposing the heart cavity.
He saw that the left ventricle - the lower chamber - was so large that it was compressing the right side of his heart. "Unbelievable," said the 6-foot, 4-inch surgeon, whose surgical mask covered a bushy brown mustache.
Moving at a steady pace, Acker and his team connected Fernandez to the heart-lung machine so they could stop and deflate his heart by removing all the blood. That would let them get to the mitral valve, which helps regulate blood flow between two chambers and prevents blood from going backward.
Forty minutes after making the first incision, Acker was connecting tubes to divert blood from the heart. That done, he then had the heart-lung machine turned on.
"Empty the heart," he said.
Taking the white mesh CorCap, Acker then began to stitch it onto the bottom of the heart.
Once he got it attached, but not fully encasing the organ, Acker moved to the more complex phase - replacing the damaged valve.
He cut into the heart's upper chamber - the left atrium - to get at the damaged valve, which he would leave in place and push aside with a new valve.
He then placed sutures around the old valve. The long silk threads were left uncut. Once he had stitched around the entire valve opening, Acker put the long threads through the new valve's outer rim.
He would slide the new valve down the threads - a maneuver termed parachuting - to put it in place of the old valve. Acker then tied each of the more than 20 threads, securing the replacement valve in the right spot and ensuring there would be no leaks.
"It looks perfect," he said. "Now, the ultimate test."
Acker asked the profusionist operating the heart-lung machine to pump some blood into the heart.
There was a small bleed.
Acker pointed out the spot to a young doctor he was training. He quickly got another suture and closed the tiny tear.
"Call for the next patient, please," Acker asked a nurse.
He still needed to finish sewing the heart jacket into place, which took another hour.
Then he began removing the tubes that connected Fernandez to the heart-lung machine.
Finally, Acker began closing the patient's chest cavity and wired the breast bone back together. After 31/2 hours, he stepped away.
The surgery had gone well. After Fernandez recovered, Acker was confident he would do better, and that would be another data point for the FDA to consider when it reviews the CorCap again.
Three months after his surgery, Fernandez was in markedly better shape.
His shortness of breath had lessened, and he was again active and hoping to get well enough to return to work.
"My life has changed a lot for the better," said Fernandez, who lives in Hazleton, south of Wilkes-Barre.
Now, more than a year after his surgery, he was still taking his medications and had realized that the surgery alone would not cure him. But it had stopped his slow decline.
"It is not getting worse," he said last month. "As long as it doesn't get worse, that is good."
But as good as the news was for the patient, there was another problem. The clinical trial that Fernandez had participated in was technically still active, but Acorn can no longer afford to enroll new patients.
"The company ran out of money. . . . They are seeking buyers, other investors," Acker said. "Unless new ownership or investors are interested, CorCap . . . will never be a commercial product."
That is enormously frustrating for Acker.
"I still believe the jacket has a significant place in certain patients," he said - those with worsening heart failure but not yet in dire need of a transplant.
Acker has used the device in about 30 patients.
"It is very hard to do randomized surgical trials in heart failure," he said. That's because the FDA demands that such studies show that the devices reduce the death rate - something that takes years of following patients and is prohibitively expensive, especially for start-up companies like Acorn.
Despite treating between 500 and 600 patients, the once-promising company with 55 employees at its height has just two people left, said Acorn's chief executive, Steve Anderson. The phones have been disconnected, and the company's website is disabled to save money.
The case shows how a company - even with a promising product - can rise or fall for lack of money. Without a workable agreement with the FDA, Acorn has been unable to get more support from investors or attract new ones.
As a result, Anderson said, "we tried to significantly cut back, including moving out of our building. In the meantime, we are looking for a partner and hoping we can resurrect this thing like a phoenix."
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