First patient fitted with Carmat artificial heart dies

The first patient fitted with an artificial heart made by the French company Carmat has died, the hospital that had performed the transplant in December said on Monday.

The 76-year-old man died on Sunday, 75 days after the operation, the Georges Pompidou European Hospital in Paris said in a statement, adding that the cause of his death could not be known for sure at this stage.

When he was fitted with the device, the man was suffering from terminal heart failure, when the sick heart can no longer pump enough blood to sustain the body, and was said to have only a few weeks, or even days, to live.

Carmat’s bioprosthetic device is designed to replace the real heart for as much as five years, mimicking nature’s work using biological materials and sensors. It aims to help the thousands of patients who die each year while awaiting a donor, and reducing the side-effects associated with transplants.

“Carmat wishes to pay tribute to the courage and the pioneering role of this patient and his family, as well as the medical team’s dedication,” a company spokeswoman said.

She stressed that it was premature to draw any conclusions on Carmat’s artificial heart at this stage.

Three more patients in France with terminal heart failure are due to be fitted with the device. The clinical trial will be considered a success if the patients survive with the implant for at least a month.

If it passes the test, Carmat has said it would fit the device into about 20 patients with less severe heart failure.

EXTENDING LIFE

“The doctors directly involved in the post-surgical care wish to highlight the value of the lessons learned from this first clinical trial, with regard to the selection of the patient, his surveillance, the prevention and treatment of difficulties encountered,” the hospital said in its statement.

An in-depth analysis of the medical and technical data gathered since the patient’s operation will be needed to establish the cause of his death, the hospital added.

Carmat estimates around 100,000 patients in the United States and Europe could benefit from its artificial heart, a market worth more than 16 billion euros ($22 billion).

Among Carmat’s competitors for artificial heart implants are privately-held SynCardia Systems and Abiomed, both of the United States.

SynCardia’s artificial heart is the only one approved both in the United States and the European Union and has been implanted in more than 1,200 patients to keep them waiting for a heart from a matching donor. The longest a patient has lived with the device is just under four years prior to a transplant.

Carmat’s heart is designed to serve not as a bridge to transplant but as a permanent implant, extending life for terminally ill patients who cannot hope for a real organ, generally because they are too old and donors too scarce.

Source: Reuters


3D-printed heart aids life-saving surgery on US baby

3d-printed-splint-family-13

A newly developed 3D-printed heart has helped doctors perform a life-saving heart surgery on a 14-month old infant in the US.

Researchers from the University of Louisville and Kosair Children’s Hospital created a 3D printed model of the organ 1.5 times its actual size that helped the surgeons to prepare for the surgery.

Built in three pieces using a flexible filament, the printing reportedly took around 20 hours and cost USD 600.

Roland Lian Cung Bawi of Owensboro, Kentucky, was born with four congenital heart defects and his doctors were looking for greater insights into his condition prior to a February 10 operation.

Philip Dydynski, chief of radiology at Kosair Children’s Hospital wondered if a 3D model of the child’s heart could be constructed using a template created by images from a CT scan to allow doctors to better plan and prepare for his surgery.

The result was a model heart 1.5 times the size of the child’s.

Once the model was built, Erle Austin III, cardiothoracic surgeon at Louisville, was able to develop a surgical plan and complete the heart repair with only one operation.

“I found the model to be a game changer in planning to do surgery on a complex congenital heart defect,” he said.

Roland was released from Kosair Children’s Hospital on February 14. His prognosis is good, doctors said.

Source: zee news


Carmat artificial heart patient in satisfactory condition

A patient with terminal heart failure is in “satisfactory condition” two months after becoming the first person to be fitted with Carmat’s artificial heart which is designed to beat for several years, his hospital said.

The 76-year-old man is eating normally, no longer needs constant respiratory assistance and is able to walk a little further every day thanks to physical therapy, the Georges Pompidou European Hospital in Paris said in a statement on Tuesday.

“The Carmat bioprosthesis continues to function satisfactorily, without any anti-clotting treatment since January 10,” said the hospital, where the implant surgery was performed on December 18 and where the patient is being treated.

It praised the patient’s “exemplary courage, sense of humour and family support” for playing a role in his recovery.

Heart-assistance devices have been used for decades as a temporary solution for patients awaiting transplants, but Carmat’s product is designed to replace the real heart over the long term, mimicking nature using biological materials and sensors.

It aims to extend life for thousands of patients who die each year while awaiting a donor, while reducing the side-effects that can be associated with transplants, such as blood clots and rejection.

Three more patients in France are due to be fitted with Carmat’s device. The people selected in this first series of clinical studies suffer from terminal heart failure – when the sick heart can no longer pump enough blood to sustain the body – and would otherwise have only a few days or weeks to live.

Success will be judged on whether the patients survive with the implant for at least a month. If deemed safe, the device will then be fitted into about 20 lower-risk patients.

A spokeswoman for Carmat declined to say when the other three patients in the first round of tests would be fitted with its artificial heart.

The company estimates around 100,000 patients in the United States and Europe could benefit from its artificial heart, a market worth more than 16 billion euros ($22 billion)

Chief Executive Marcello Conviti told Reuters in November that Carmat hoped to finish human trials of the heart by the end of 2014 and to obtain approval to market them in the European Union by early 2015.

Among its competitors for artificial heart implants are privately-held SynCardia Systems and Abiomed, both of the United States.

Source: Diabetes Support


Patient doing well with French company’s artificial heart: report

A 75-year-old Frenchman was feeding himself and chatting to his family, more than a week after becoming the first person to be fitted with an artificial heart made by French biomedical company Carmat, one of his surgeons said.

“He is awake, feeding himself and talking with his family. We are thinking of getting him up on his feet soon, probably as early as this weekend,” Professor Daniel Duveau, who saw the patient on Thursday, told Le Journal du Dimanche newspaper.

A more detailed account of the patient’s health would be made public on Monday, the paper wrote.

Heart-assistance devices have been used for decades as a temporary solution for patients awaiting transplants, but Carmat’s bioprosthetic product is designed to replace the real heart over the long run, mimicking nature using biological materials and sensors.

It aims to extend life for patients suffering from terminal heart failure who cannot hope for a heart transplant, often because they are too old and donors too scarce.

 

The artificial heart, which can beat up to five years, has been successfully tested on animals but the December 18 implant in a Paris hospital was the first in a human patient.

Three more patients in France are due to be fitted with the device. The next operation is scheduled for the first weeks of January, the newspaper reported.

In this first range of clinical trials, the success of the device will be judged on whether patients survive with the implant for at least a month.

The patients selected suffer from terminal heart failure – when the sick heart can no longer pump enough blood to sustain the body – and would otherwise have only a few days or weeks to live.

Artificial hearts thus fuel huge hope amongst patients, their families, and investors. Shares in Carmat have risen more than five-fold since floating on the Paris exchange in 2010.

Duveau told the JDD that Carmat’s first patient was very combative and confident with his new prosthetic heart.

“When his wife and his daughter leave him, he tells them: ‘See you tomorrow!’ All he wants is to enjoy life. He can’t wait to get out of the intensive care unit, out of his room, and out of uncertainty.”

Source: Fresh News


New Artificial hearts won’t beat

The human heart beats 60 to 100 times a minute, more than 86,000 times a day, 35 million times a year. A single beat pushes about 6 tablespoons of blood through the body.

An organ that works that hard is bound to fail, says Dr. Billy Cohn, a heart surgeon at the Texas Heart Institute. And he’s right. Heart failure is the leading cause of death in men and women, killing more than 600,000 Americans every year.

For a lucky few, a heart transplant will add an average of 10 years to their lives. For others, technology that assists a failing heart — called “bridge-to-transplant” devices — will keep them alive as they wait for a donor heart.

Unfortunately, more often than not, the new heart doesn’t arrive in time.

That’s why Cohn and his mentor — veteran heart surgeon Dr. O.H “Bud” Frazier — are working to develop a long-term, artificial replacement for the failing human heart. Unlike existing short-term devices that emulate the beating organ, the new machine would propel blood through the body at a steady pace so that its recipients will have no heartbeat at all.

The concept of a pulseless heart is difficult to fathom. Cohn often compares it to the development of the airplane propeller. When people started to develop flying machines, he says, they first tried to emulate the way birds fly — by flapping the wings aggressively.

“It wasn’t until they decided, ‘We can’t do this the way Mother Nature did,’ and came up with the rapidly spinning propeller that the Wright Brothers were able to fly,” Cohn says.
The idea of an artificial heart goes back decades.

Frazier began medical school in what he describes as “the Kennedy Era.”

“We were going to the moon; we were going to achieve world peace,” and Frazier wanted to develop the first artificial heart. In 1968, he left for Vietnam as a flight surgeon. Thirteen months later, his helicopter was shot down, and he nearly died.

“That experience convinced me I should stick to something more meaningful for the rest of my life.”
That he did. The veteran surgeon, inventor and researcher has devoted the last half century to developing technologies to fix or replace the human heart, the most notable of which is the newest generation of continuous flow Left Ventricular Assist Devices, known as LVADs.

Modeled after an Archimedes Screw, a machine that raises water to fill irrigation ditches, the continuous flow LVAD is a pump that helps failing hearts push additional blood through the body with a rapidly spinning impeller.

Today, the continuous flow LVAD has been implanted in 20,000 people worldwide, including former Vice President Dick Cheney before he received a heart transplant nearly two years later.

In some cases, the LVAD’s turbine has essentially taken over the pumping process entirely from the biological heart. In these instances, the implant recipient barely has any pulse at all.

Observing what happened in these patients led Frazier to one compelling question: If the LVAD can take
over for a weakened heart, could it replace the organ entirely?

In 2004, Frazier asked Cohn to collaborate on a new research project. Cohn’s interest in heart surgery dates back to when he was a young boy reading articles about world-renowned heart surgeons Dr. Michael E. Debakey and Dr. Denton Cooley, who developed and played a role in the transplant of the first artificial heart in a human in 1969.

Now the holder of some 70-odd U.S. patents, Cohn says his work with Frazier to build an artificial heart is the most ambitious project of his career.

The surgeons set out to combine two LVADs to replicate the functions of the heart’s right and left ventricles. Using two commercially available LVAD turbines, Frazier and Cohn combined the devices with plastics and other material used for implants: hernia mesh, Dacron cardiovascular patches and medical silicone. Everything met FDA standards, but Cohn describes the final product as “rather kludged together.”

The surgeons tested their invention by installing it in around 70 calves. All of the cows produced a flat line on an EKG, which measures heart electrical activity, yet they stood, ate and walked around, paying seemingly no notice to a small technicality: They had no heartbeat.

In order for the FDA to approve the device for clinical trials, the calves needed to live for at least one month. Cohn and Frazier’s device trumped these standards, with many calves living healthily for full 90-day studies.

Cohn and Frazier were encouraged, and in March 2011, put their artificial heart into a human patient.
Craig Lewis, 55, was admitted to the Texas Heart Institute with amyloidosis, a rare autoimmune disease that fills internal organs with a viscous protein that causes rapid heart, kidney and liver failure. Without some intervention, Lewis would have been dead in days. Frazier and Cohn decided it was the right moment to test their device and the surgeons undertook the lengthy procedure.

Less than 48 hours later, Lewis was sitting up, talking and using his laptop. When doctors put the stethoscope to Lewis’s heart, all they heard was a steady whir of what sounded like a boat propeller. Lewis survived for six weeks until his failing kidneys and liver got the best of him and his family asked doctors to unplug the device.

Source: CNN