Heart Pump Systems & Artificial Hearts; 2011 News Archives
Click on each picture to be linked to matching website.
SynCardia Named One of “America’s Most Promising Companies” by Forbes December 8, 2011
SynCardia Systems, Inc., the privately-held manufacturer of the world’s only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, has been selected by Forbes as one of “America’s Most Promising Companies.” The list features 100 privately held up-and-comers with compelling business models, strong management teams, notable customers, strategic partners and precious investment capital. Ranked No. 77, SynCardia was the only Arizona company to make the cut.
“In 2010, SynCardia doubled sales over 2009, and in 2011, we are on track to double sales again, representing a four-fold increase since 2009. We are profitable for the first time in the company’s 10-year history,” said Michael Garippa, CEO/President. “SynCardia is lean by design and many of our employees are cross-trained in multiple departments. Every Friday, we continue our six-year tradition of the entire company having lunch together and sharing project updates to ensure everyone is on the same page.”
SynCardia designed, developed, and launched the Freedom® portable driver, the world's first wearable power supply for the SynCardia temporary Total Artificial Heart. Weighing 13.5 pounds, the Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. To date, 34 patients have been enrolled in the study. Of these patients, 23 have been discharged from the hospital using the Freedom driver. The study requires that 30 patients be discharged.....read more
VAD: A Bridge to a Better Quality of Life; Dec. 5 at 5 p.m. CST.
VAD: A Bridge to a Better Quality of Life Live Webcast! December 5, 2011 at 5 pm CST/6 pm EST
UW Health's Heart, Vascular and Thoracic team will continue its series of live web broadcasts with a program on ventricular assist devices, or VADs.
UW Hospital and Clinics is one of a handful of hospitals in the region offering VADs – a heart pump that can be implanted in patients to pump blood when a patient's heart isn't able to do the work.
The device offers patients with advanced heart failure the opportunity for a better quality of life, either as an assist to the heart until the patient receives a heart transplant or as lifelong therapy.
Cardiothoracic surgeons Takushi Kohmoto, MD and Lucian Lozonschi, MD, along with Maryl Johnson, MD, director of the UW Health Transplant Program, will discuss the benefits of a VAD for patients with advanced heart failure.
The broadcast will also include video of Dr. Kohmoto taken during a VAD implant surgery. Throughout the online broadcast, viewers are invited to submit questions to the physician panel.
Join us from the comfort of your own office or home on Monday, Dec. 5 at 5 p.m. CST.
First artificial heart implant surgery saves a life in Kazakhstan November 14, 2011
The first artificial heart implant surgery, performed by the National Cardiac Surgery Centre on November 9, marked a new stage in the development of Kazakhstan's cardio surgery. This unique operation for Kazakhstan was carried out by Yuri Pya, the Chairman of the Centre, and Jan Pirk, the Head of the Cardiovascular Surgery Department in the Prague Institute for Clinical and Experimental Medicine.
The first patient to receive a left ventricular assist device (LVAD) or a so-called artificial heart was 42-year-old Marat Shymbalov, who had suffered from heart failure. The operation that has enabled Marat's heart to pump two to three times more blood than before, or the normal four to five litres of blood per minute, costing 46 million tenge, was sponsored by the Government. The only other country performing such high-tech operations in the post-Soviet space is Belarus....read more
Oklahoma Pastor With Total Artificial Heart Marks 1 Year of Life at Home With Freedom(R) Portable Driver October 27, 2011
(MARKETWIRE via COMTEX) -- SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the world's only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that Oklahoma pastor Troy Golden has surpassed one year of life at home using the Freedom(R) portable driver to power his SynCardia temporary Total Artificial Heart. Mr. Golden was discharged from INTEGRIS Baptist Medical Center in Oklahoma City on Oct. 18, 2010, to wait for a matching donor heart at home.
Before heart failure stopped him in his tracks, Mr. Golden had preached every Sunday for the last 12 years at the New Life Assembly of God in Geary, OK. A little more than a month after being discharged from the hospital, on Nov. 21, 2010, Mr. Golden gave his first sermon since receiving the Total Artificial Heart. Today, he continues to preach at his church as well as minister to other churches in his area.
Mr. Golden is participating in the FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom portable driver, the world's first wearable power supply for SynCardia's Total Artificial Heart. Weighing 13.5 pounds, the Freedom driver is designed to be carried by the patient in the Freedom Backpack or Shoulder Bag.
CAUTION -- The Freedom(R) portable driver is an investigational device, limited by United States law to investigational use. For complete story Click here
AZBio Names SynCardia "Arizona Bioscience Company of the Year" October 18, 2011
Total Artificial Heart Manufacturer Honored by Arizona BioIndustry Association for "Doing the Most to Transform the World During the Last 12 Months"
On Oct. 13, SynCardia Systems, Inc. (http://www.syncardia.com/), manufacturer of the world's only FDA, Health Canada and CE approved Total Artificial Heart, was named "Arizona Bioscience Company of the Year" by the Arizona BioIndustry Association (AZBio).
"The Arizona Bioscience Company of the Year Award recognizes the for-profit bioscience company whose Arizona-based operations did the most to transform the world during the last 12 months," said AZBio CEO Joan Koerber-Walker. "SynCardia makes it possible for patients awaiting donor hearts to not only survive the wait but also to do so with flexibility and mobility, a feat of biomedical engineering that is world-changing for these patients."
SynCardia designed, developed, and introduced the Freedom® portable driver, the world's first wearable power supply for the SynCardia temporary Total Artificial Heart. For the first time in U.S. history, stable patients without human hearts are being discharged from the hospital to wait for a matching donor heart at home using the Freedom portable driver to power their Total Artificial Hearts. Weighing 13.5 pounds, the Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S....read more
Breakthrough heart pump spares teen from transplant October 13, 2011
EDMONTON - Kolby Zanier carries her heart around in her purse. At first, it felt a little heavy on her shoulder, at just over two kilograms with a controller and batteries and spares, all connected to the human organ by cable through a hole in her belly.
But the 14-year-old is getting used to its weight, especially since it allows her to go home to Rossland, B.C., attend Grade 10, even run or play volleyball if she chooses. Swimming is out and contact sports would be iffy.
Kolby is the first pediatric patient in Canada — and likely the third in North America — to receive a HeartWare pump, a device patched into the bottom part of her severely damaged left ventricle. It pumps blood from the heart chamber through a tube directly into her aorta, which circulates blood through her body.
Until Kolby came along to try the new device, children with failed hearts like hers either needed a heart transplant — Kolby’s heart was in such bad shape she couldn’t wait any longer for a suitable donor heart — or a Berlin heart, a bulkier device created 20 years ago that often requires patients to stay in hospital up to one year because of life-threatening complications. It even makes taking showers an ordeal because of its external machinery.
Image from frenchtribune.com
The Berlin heart saves lives, but within two to four months of implantation, patients have a 20 to 30 per cent risk of strokes caused by blood clots, said Dr. Holger Buchholz, director of the pediatric artificial heart program at the Stollery Children’s Hospital which accepts complex pediatric heart patients from Western Canada.
The risk with the new HeartWare pump is far lower at three to five per cent, and kicks in far after the operation is done. The small pump has been approved in Europe for adult patients, but when Kolby came along, Buchholz said he received quick approval from Health Canada to implant the promising device into her since it was such a good fit....read more
Research and Markets: Cardiac Assist Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 September 23, 2011
Cardiac Assist Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 provides key market data on the Cardiac Assist Devices market in the BRICS countries.
The report provides value ($m) data for each segment within three market categories - Intra-Aortic Balloon Pumps, Ventricular Assist Devices and Total Artificial Heart. The report also provides company shares and distribution shares data for the overall Cardiac Assist Devices market in each of the aforementioned countries. The report is also supplemented with global corporate-level profiles of the key market participants with information on key developments, wherever available.
This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by a team of industry experts.....read more
Heart Transplant Saves Life of Young Girl Who'd Been Misdiagnosed With Pneumonia August 26, 2011
Looking at young Greer Underwood today, no one would never guess that a few months ago she was in a hospital in critical condition, on a waiting list for a new heart.
The 10-year-old Muscle Shoals, Ala., youngster might not be alive today had her parents not pushed to get a second opinion for her breathing problems that had been diagnosed as a simple sinus infection.
Now, looking back over the many medical trials Greer underwent in the past seven months -- a severe stroke, a final (correct) diagnosis of cardiomyopathy, the implantation of an experimental device, the HeartWare LVAD, to pump her heart and ultimately a full heart transplant -- her parents are thankful that the many odds stacked against their daughter turned in her favor.
Although the device by HeartWare was still considered experimental for adults, the UAB team believed Greer, who weighed 85 pounds, was large enough to support it. She was the first child in the U.S. to have ever been fitted for an LVAD......read more
The Carmat artificial heart
Building human hearts on an assembly line August 26, 2011
An artificial heart will be implanted in a patient before the end of 2011, marking a milestone in medicine. The developers are now accelerating plans to manufacture thousands of these mechanical hearts for patients worldwide, reports John Brosky.
The International Standards Organisation (ISO) gave the green light this summer to the design and quality processes for manufacturing a fully implantable mechanical human heart.
The financial world is fully behind this bold venture. In one year the share price of Carmat, the Paris-based company that is bringing the artificial heart to market, soared to 10 times its value when introduced in July 2010. The capitalisation for the company on the NYSE-Euronext is currently estimated at €712 million.
Marcello Conviti, CEO of Carmat, said the final step to bring the heart into the operating theatre is the approval of the both the French authority Agence Française de Sécurité Sanitaire des Produits Santé (AFSSAPS) and patient protection committees.
Under AFSSAPS rules, Carmat qualifies for a fast-track approval process because it is bringing forward a new technology. ‘Given the progress made in our project, we are confident we will meet the goal of a first implant of the heart before the end of 2011,’ said Carmat’s CEO. The firm is expected to receive a further €25 million in August from investors to power its accelerated drive for a commercial launch in 2013.....read more
Dr. Denton Cooley
Artificial hearts giving hope, saving lives Posted: August 21, 2011
HOUSTON (KTRK) -- What happens when you are dying of heart disease, and you won't live long enough for a transplant? One Houston hospital has a new go-to plan: the artificial heart.
In the past month, it's saved the lives of four dying people and some of them may soon go home with only a manmade pump beating in their bodies.
Ken Woychesin had a heart attack at 26, a transplant at 34 and five years later, he was dying again. "I was like I can't believe this, you know," Woychesin said. "Most people pray for things, and we pray for one more day," said his wife, Jennifer Woychesin.
In July, Texas Heart Institute surgeons said he couldn't wait for another transplant and offered him an artificial heart. "We're gonna cut your heart in half and we're gonna put these two manmade ventricles in you," Ken Woychesin recalled them saying. With no other options, he agreed. And for three weeks, he's been tethered to this giant machine that pumps for him. But he's getting stronger, taking mile walks every day.
"What's the weirdest thing about walking with a 400-pound console behind you?" we asked him. "It don't bother me, you know; as long as they can push it, I just keep walking," he replied.
"Here within the space of a 10-day period, we put in four total replacements of a human heart. It's quite an amazing accomplishment," Dr. Cooley said. "If everything goes right he will switch to a 13-pound battery that will allow him to go home....read more
From left, Ariel Quiros, chairman AnC Bio US, Governor Peter Shumlin, Senator Patrick Leahy, William Kelly, advisor to AnC Bio, and, at podium, Bill Stenger, partner with Mr. Quiros at Jay Peak Resort, and investor in AnC Bio. Photo by Joseph Gresser.
Biotech company to build $100M stem cell lab, medical device factory in Newport August 16, 2011
A South Korean biotechnology firm plans to manufacture portable dialysis machines and heart pumps in Newport. AnC Bio US is purchasing an empty 90,000 square foot building in the city that it plans to transform into a biotechnology factory.
A portion of the facility will be set aside for a research laboratory. AnC Bio would produce stem cells and vaccines, and possibly develop artificial organs, at the Newport plant.
The company hopes to produce an artificial heart for surgical procedures once it obtains approval for the device from the Food and Drug Administration. In an interview, Ariel Quiros, the founder of AnC Bio said he believes that manufacturing biotech products in the United States will ease the FDA approval process.
The heart pump, called a Twin True Pulsatile Percutaneous Life Support System, has been used with success in other countries, officials say. The small, portable dialysis system will be ready to be manufactured soon after the pump is in production.
In addition to medical device manufacture, AnC Bio is a world leader in stem cell research....read more
Local Man Receives Total Artificial Heart
Local Man Receives Total Artificial Heart August 12, 2011
Home is where the heart is. One Quad Cities area man is back home as the first person in Iowa to receive a total artificial heart.
Richard Whittington, 59, of Geneseo left University of Iowa Hospitals and Clinics Tuesday afternoon, about a month after his surgery. This also makes him the first patient in the Midwest to get this surgery and leave the hospital while waiting for a transplant.
Doctor James Davis showed a model of the artificial heart at UIHC. It has two sides and long tubes that come out the patient's abdominal to attach to a portable pump. "It basically pumps air in and out which causes the air chambers to move and push the blood around on the inside."
Davis performed the day-long surgery which marked the first for UIHC and the entire state of Iowa. Dr. Davis says, however, what's more important is that Whittington gets to leave the hospital.
Before, patients who needed total heart support while waiting for an actual transplant had to stay hospitalized, sometimes for more than six months.
Doctors say after this surgery the likelihood of getting a transplant is about 85 percent. Until then, Whittington has to return to a clinic on a weekly basis.....for complete article click here
The HeartMate II by Thoratec
Artificial Heart Device Gives Philosophy Professor Valuable Time August 5, 2011
St. Bonaventure University philosophy professor Roderick Hughes III, Ph.D., can’t wait to get back into the classroom after an almost perfect 41-year attendance record. The long-time educator missed a number of weeks of classes earlier this year due to life-threatening heart failure.
The 66-year-old is benefitting from a high-tech heart pump implanted by doctors at the University of Rochester Medical Center. The pump will keep his heart going while he waits for a heart transplant.
“I cannot say enough good things about the professionalism of the staff and the compassion extended to me. They are the main reason that I am improving every day,” said Hughes, following his April 12 procedure.
Heart surgeon H. Todd Massey, M.D., implanted a HeartMate II by Thoratec, a left ventricular assist device (LVAD) for long-term use in patients with advanced-stage heart failure, in his chest. The Medical Center is among the nation’s leaders in the use of LVADs for people with heart failure....read more
Father becomes first in Britain to get artificial heart August 3, 2011
Matthew Green has been given the first "Total Artificial Heart designed by SynCardia, in Britain that allows him to leave hospital and live a relatively normal life at home.
With the new portable heart, developed in America, Mr Green will be able to return home, walk the streets, and may even resume his nine mile cycle to work. Yesterday the father-of-one and his wife Gill, 38, said they were looking forward to resuming normal family life in London for the first time in years with their five-year-old son Dylan.....read more
FDA panel endorses HDE for Berlin Heart's Excor Pediatric VAD July 22, 2011
Gaithersburg, MD - Because it is the only hope many children with severe heart failure have of surviving until they can get a transplant, Berlin Heart's Excor Pediatric ventricular assist device (VAD) should receive an humanitarian device exemption (HDE), the FDA's Circulatory System Devices advisory committee concluded at its July 21, 2011 meeting.....read or download .pdf file
Researchers Develop Wireless Heart Pump System July 14, 2011 The development of a wireless system allows the patient to use mechanical pumps over a long period of time without worrying about infections in the stomach from cords
Joshua Smith, study leader and a University of Washington associate professor of computer science and electrical engineering, along with Dr. Pramod Bonde, a heart surgeon at the University of Pittsburgh Medical Center, and a team of researchers, have created a wireless mechanical pump that could improve a heart patient's quality of life.
Traditional mechanical pumps, used to maintain failing hearts, were originally created as a temporary fix until the patient could receive a heart transplant. But these pumps have improved over time and can be a part of a patient's body for years. The problem with this is that a power cord is routed through the patient's stomach, and 40 percent of patients get infections in this area because of the cord. These infections lead to hospitalization and can even be fatal.
But Smith and his team have relieved this problem with the development of a wireless system that allows the patient to use mechanical pumps over a long period of time without worrying about infections in the stomach.
"My primary interest is to help heart failure patients recover, and they can only recover if they are not tethered to a battery or external power supply so they can exercise and train their heart to recover," says Dr Pramod Bonde, a heart surgeon at the University of Pittsburgh Medical Center.
The wireless system works through a concept based on inductive power, where a transmitting coil sends electromagnetic waves out at a certain frequency and a receiving coil takes in the energy and uses it to charge a battery. This system is especially unique in that it doesn't require the tool to touch the charger like similar systems, such as cell phone charging pads. Also, distance from the charger doesn't affect the amount of power given to the patient's pump.
"Most people's intuition about wireless power is that as the receiver gets further away, you get less power," said Smith. "But with this technique, there's a regime where the efficiency actually doesn't change with distance."
The power stays constant over distances the same diameter as the coil. So a one-foot transmitter coil could send consistent power over the distance of one foot.
In tests, the researchers were able to power a mechanical heart pump using a small receiver coil that is 1.7 inches across. Power transmitted reliably with an efficiency of 80 percent.
The researchers are working to make the system apart of a vest, where an external transmitter coil would connect to a battery or power cord, and a small receiver coil would be implanted under the patient's skin. The receiver coil would connect to a battery that holds a two-hour charge, allowing infection-free freedom.
"The potential for wireless power in medical fields goes far beyond powering artificial hearts," said Bonde. "It can be leveraged to simplify sensor systems, to power medical implants and reduce electrical wiring in day-to-day care of the patients."
Texas Children's Hospital is First Pediatric Hospital in the Nation to Implant Artificial Heart June 29, 2011
Adolescent is 1 of only 3 congenital heart patients nationwide to receive artificial heart.
Houston/PRNewswire/ -- Texas Children's Hospital in Houston announced today that it is the first pediatric hospital in the United States to implant an artificial heart into the chest of a 17-year-old patient as the only option to save his life. The history-making patient underwent a rare 15-hour operation on May 22 and is currently recovering at Texas Children's Hospital. He is one of three congenital heart patients in the nation to get such a device. To view a video of the teen's journey Click here
Jordan Merecka, born with his heart on the wrong side of his chest (dextrocardia) and his heart vessels backwards (corrected transposition of the great arteries) underwent heart surgery at Texas Children's Heart Center, where he was implanted with the SynCardia Total Artificial Heart, a pulsatile blood pump that mimics the pumping action of the native heart. The Total Artificial Heart was implanted in Jordan as a bridge to donor-heart transplantation....read more
Pulseless Artificial Heart Never Misses a Beat June 15, 2011. source MNN
55 year old Craig Lewis lived for five weeks without a heartbeat or a pulse. If you had listened to his chest, you would have heard silence. If you had hooked him up to an electrocardiograph, you wouldn’t have heard the familiar beep, beep, beep. You would have seen a flat line.
Lewis, who was dying from amyloidosis, a disorder that caused an abnormal buildup of protein in his vital organs, became the first human trial. After being given 12 hours to live Lewis allowed the doctors to replace his heart with a pair of pulseless pumps.
Cobbled together from existing ventricular-assist implants and “a moderate amount of homemade stuff,” by Dr. Billy Cohn and Dr. Bud Frazier of the Texas Heart Institute, the artificial heart continuously pumps blood using screw-shaped propellers. Hence, constant blood flow without a beat.
Lewis survived five weeks with the machine in his chest, leaving him with no pulse and no blood pressure. His doctors say he could have kept living had it not been for his amyloidosis. By the time his family decided to turn off the device, Lewis needed liver, lung, kidney and bone marrow transplants, says Cohn. “The device never failed. It performed beautifully throughout the five-week period.”
Cohn and Frazier still have much work to do before the new heart will be available. A final design must be determined, a manufacturer must be found and they must apply for FDA approval. Results show amazing promise and may be the new future in artificial hearts.
Heart Stop Beating is the story of Billy Cohn & Bud Frazier, two visionary doctors from the Texas Heart Institute, who in March of 2011 successfully replaced a dying man's heart with a 'continuous flow' device they developed, proving that life was possible without a pulse or a heart beat.
Director Jeremiah Zagar is the Emmy-nominated director of In a Dream, Delhi House, and Coney Island, 1945.
DIRECTED BY - Jeremiah Zagar
PRODUCED BY - Jeremy Yaches
Paul Weatherbee estimates he has invested $4 million on his pump design
Abilene inventors: Doctors interested in pump as artificial heart Posted: June 12, 2011
Paul Weatherbee has been active in business for decades, starting with a home-building business at 20 and later entering oil and gas exploration.
More than 20 year ago, while looking over oil field-related pumping machinery, he said, he began trying to develop a more efficient pump. He didn't have an engineering degree, but that didn't stop him from trying.
After mulling over the problem a bit more, "I could see in my mind's eye," said Weatherbee, who went on to patent a spherical pump he says works more efficiently. It's been an ongoing project for the past 15 or so years.
As described in a 2003 article in the Reporter-News, Paul and brother Glenn first were interested in industrial applications. Then, noting the similarity in some ways to the human heart, the focus shifted to perhaps using the device in an artificial heart. The design allows for "pulses" of pumping action. "The body wants that pulse," Weatherbee said.
After calling Texas Heart Institute in Houston, he found many of the big names in the medical field were interested in the device. "It's pretty hard to build a pump to the same efficiencies of what God built," Weatherbee said.
In 2003, Bud Frazier, then the institute's chief surgeon of cardiopulmonary transplantation, told the Reporter-News the design was "ingenious."
A patent followed.
But blood can be damaged — basically sheared — by the pumping process, Weatherbee said.
For a while, he put the pump "on the shelf," he said. Calls kept coming in from the institute encouraging him to further refine the design. "I finally agreed to build them three more pumps," Weatherbee said.
Two weeks ago he was in Houston once again testing his designs, he said.....continue reading
DETROIT – The incidence of internal bleeding was higher in the most commonly implanted heart device than in an earlier model, according to two studies at Henry Ford Hospital in Detroit. The HeartMate II, a left ventricular assist device (LVAD) is a continuous-flow mechanical pump connected to the patient's heart that takes over the pumping of the weakened heart's left ventricle. "Although there were more instances of bleeding in the skull and gastrointestinal track with the HeartMate II, as opposed to the earlier model, there was no increase in mortality," says lead author Jeffrey A. Morgan, M.D., associate director of Mechanical Circulatory Support in the Edith and Benson Ford Heart &Vascular Institute at Henry Ford. Dr. Morgan will present the studies on June 11 at the annual conference of the American Society of Artificial Internal Organs in Washington, D.C.
From March 2006 through May 2010, 64 patients with chronic heart failure underwent implantation of a HeartMate II LVAD as a bridge to transplant or a permanent therapy for those ineligible for transplants. The incidence of gastrointestinal bleeding or adverse neurological events (ANE) was evaluated to determine their impact on survival and identify predictors of occurrence. The overall incidence of gastrointestinal bleeding was nearly 22 percent, and the incidence of major ANEs was eight percent. Patients with an ANE were significantly older, with a higher incidence of chronic renal insufficiency. They also had higher International Normalized Ratios (INRs), a lab test that measures the time it takes for blood to clot, and compares it to an average, at the time of the event. The higher the INR, the longer it takes blood to clot.
No complications due to blood clots occurred in those with gastrointestinal bleeding, but for patients with an ANE, there were four intracranial hemorrhages and one thromboembolic stroke. There was no significant difference in gender, race, cause of heart failure, diabetes, or body mass index (BMI) between patients who had post-operative bleeding and those who did not....read more
Heinrich Schima; technical director for mechanical cardiac support systems at Vienna Medical University
Turbocharger for sick hearts.
The first artificial heart was implanted in Vienna 25 years ago. The cardiac surgeons and researchers at Vienna General Hospital have since assumed a leading role world-wide in this field. Originally conceived as a temporary measure prior to a transplant, the artificial heart is now a permanent solution for many severely ill patients.
The human heart beats about three billion times during the course of a lifetime, pumping between five and 40 litres of blood a minute through the body as required. In a healthy body, the blood is transported from the right ventricle to the lungs, where it is enriched with oxygen before the left ventricle pumps it though the body to supply the organs with vital oxygen. In patients with cardiac insufficiency – Europe’s most common internal disease, affecting ten million people – even everyday activities like walking rapidly cause exhaustion and breathlessness. A heart transplant or implantation of an artificial heart may be necessary in severe cases of this cardiac disease.
Getting weak hearts up to speed
Today’s artificial heart systems are significantly smaller than their predecessors 25 years ago: a modern artificial heart is no larger than your thumb. “An artificial heart is like a turbocharger inserted into the left ventricle of a weak heart, taking over most of the pumping work. This enables the assisted heart and the entire organism to recover again,” explains Georg Wieselthaler, surgeon and clinical director of the artificial heart programme at Vienna Medical University. Heinrich Schima, technical director of Vienna’s artificial heart programme, adds: “To an increasing extent, we now use artificial hearts as a permanent therapeutic option.” Previously terminally ill patients are now able to lead largely normal lives, practise sports in moderation, and often even return to their jobs.
On balance, the artificial heart has brought about a tremendous improvement in the survival rate and quality of life of patients with cardiac insufficiency. Whereas a transplant was considered essential only ten years ago, as fewer than 50 per cent of patients survived for longer than two years, today the two-year survival rate in Vienna is 85 per cent – an absolute record internationally.
Vienna General Hospital currently has 35 patients fitted with artificial hearts, and a total of more than 300 implantations of this kind have been carried out, many of them revolutionary. They include the first use of the “new Vienna heart” developed here in 1986. It was modelled on a real heart, with a pulsating membrane and valves, and was implanted as a total heart replacement. The first patient fitted with a rotary pump, which produces a steady blood flow, was discharged in 1999. This was followed in 2006 by the implantation in Vienna of the world’s first rotary pump with hydromagnetic contact-free bearings.....read more
Bennet Nordstrom, 12, who recently underwent a heart transplant, high fives one of his cardiologists, Dr. Sharad Menon at St. Joseph's Hospital and Medical Center in Phoenix. David Wallace/The Arizona Republic
New heart gives Phoenix 12-year-old better chance in life April 27, 2011
On April 4, St. Joseph's Hospital and Medical Center doctors put a new heart in Bennet Nordstrom's chest.
Bennet is 12. In the past four months, he had three open-heart surgeries and lived with the help of a defibrillator and a mechanical heart. Only weeks after the surgery, he's home in north Phoenix with his parents, two sisters, two dogs and two cats.
Born with a rare heart disorder, dilated cardiomyopathy, or an enlarged heart, which becomes weakened and cannot pump blood efficiently. The low blood flow was affecting Bennet's stomach, causing extreme nausea.
Bennet became critically ill in December, in January, doctors installed a defibrillator to help Bennet's heart pump blood. Bennet, who kept a daily journal, remembers being disappointed.
"I couldn't go on roller coasters, I wouldn't be able to go water tubing or skate boarding or roller blading," Bennet said. "I wanted a heart transplant because everything I couldn't do with a defibrillator, I could do with a new heart."
Doctors prescribed synthetic medical marijuana to help Bennet's appetite. Bennet went home for three weeks, until an infection sent him back to the hospital. His condition deteriorated quickly. The defibrillator was removed and Bennet was put on the transplant list.
Until a donor heart arrived, Bennet needed an artificial heart to keep him alive. Known as the Berlin heart, the small mechanical pump sits outside the body, with attachments to the patient's heart. The device, about the size of a shampoo bottle, has been approved in Europe since 1992 and the company is now seeking Food and Drug Administration approval for use in the U.S. It was used in Bennet's case as part of a trial study.....read more
SOURCE: SynCardia Systems, Inc.
BBC's Flagship Science TV Series "Horizon" Features Patient With SynCardia's Total Artificial Heart April 26, 2011
TUCSON, AZ--(Marketwire - Apr 26, 2011) - SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, announced today that the BBC's flagship science series, "Horizon," is airing an episode that includes a segment featuring a Total Artificial Heart patient waiting at home for a matching donor heart using the Freedom® portable driver.
During the 60-minute episode titled "How To Mend A Broken Heart," the show's host Dr. Kevin Fong, visits cardiovascular surgeon James Long, MD, and heart failure cardiologist Douglas Horstmanshof, MD, at INTEGRIS Baptist Medical Center in Oklahoma City to learn more about the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Watch episode on youtube
"This thing needs to be implanted in a human being," says Dr. Fong, holding SynCardia's Total Artificial Heart. "It needs to work seamlessly and reliably for millions of beats. The valves must never stick, blood must flow over its surfaces without clotting, the pump must never leak and a person's life totally depends upon it."
Dr. Horstmanshof drives Dr. Fong to Geary, Okla. to meet 45-year-old Troy Golden, a registered nurse and pastor who has been living with the Total Artificial Heart since September 2010. A month after implant, Mr. Golden was discharged from the hospital to wait for a matching donor heart at home using the Freedom portable driver.
Mr. Golden is participating in an FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom driver.....read more
Mr Cheney is one of thousands of people around the world who have a left ventricular assist device
A wireless heart Posted: April 18, 2011
LVADs—mechanical pumps that take the stress away from a failing heart by moving blood smoothly around the body without generating a pulse—have become smaller and more reliable over the years since their introduction in the 1994.
One area in which they have not improved, though, is their power supply. The pump requires an electric cable, called a driveline, that runs through the abdominal wall to a battery pack in a harness. This device, which must be worn all the time, hampers mobility, makes it awkward for the wearer to shower (and impossible to swim) and means he cannot drive because even a minor shunt that dislodged the driveline could kill him. Most importantly, though, it is a constant source of infection. With most medical implants, such as pacemakers and hip replacements, the risk of infection decreases over time. But not only does the driveline continually collect bugs from the outside world, the LVAD then also introduces them directly into the bloodstream, allowing them to spread quickly. Because of that, the driveline must be redressed every day using sterile gloves and gauze. And even so, virtually everyone fitted with an LVAD experiences an infection every 12 to 18 months. Many such infections are serious. Some are fatal.
Joshua Smith, an engineer at the University of Washington, and Pramod Bonde, a heart surgeon at the University of Pittsburgh, hope to change that. Between them they have developed the world’s first wireless-powered, driveline-free heart pump. The device’s existence will be announced formally at the American Association for Thoracic Surgery’s annual meeting in May.......read more
Press Release: Another DuraHeart™Patient Surpasses Four Years of Support on the Device & Terumo Heart to Exhibit at ISHLT April 13, 2011
Mr. Uwe Schmidt of Germany has achieved this significant milestone and joins an exclusive group of patients that have exceeded four years of support on the DuraHeart LVAS.
Terumo Heart, Inc., a wholly owned subsidiary of Terumo Corporation, today announced that another patient implanted with the DuraHeart™ Left Ventricular Assist System (LVAS) has surpassed four years of support on the mechanical circulatory support device. Mr. Uwe Schmidt of Germany has achieved this significant milestone and joins an exclusive group of patients that have exceeded four years of support on the DuraHeart LVAS.
Mr. Schmidt received the DuraHeart LVAS as an investigational device in February 2007 at the Heart and Diabetes Center North Rhine-Westphalia. Mr. Schmidt became part of the clinical study that ultimately lead to CE Mark and commercialization of the DuraHeart LVAS in Europe. The DuraHeart LVAS is currently part of the SUSTAIN BTT clinical trial and is available as an investigational device only in the United States. “I have much confidence in the DuraHeart and don’t feel like a man with an artificial heart,” states Mr. Schmidt. “My expectations of the DuraHeart were more than fulfilled. I got my life back!”
The DuraHeart LVAS, the latest-generation rotary blood pump designed for long-term patient support, will be on display at the International Society for Heart and Lung Transplantation (ISHLT) annual meeting in San Diego this month. The pump features three position sensors and electromagnetic coils that suspend the impeller inside the pump chamber without any physical contact point. The impeller’s active magnetic levitation is designed to eliminate friction by allowing a wide gap between blood contacting surfaces, enabling blood to flow through the pump unimpeded in a smooth, non-turbulent fashion.
The SUSTAIN BTT trial is a multi-center, prospective, non-randomized study involving up to 140 patients across North America. The study is currently in the process of evaluating the safety and efficacy of the device in helping to sustain patients awaiting heart transplant who are at risk of death due to end-stage heart failure. The DuraHeart LVAS carries a CE Mark and is currently available for sale in European countries. The company has completed clinical trial enrollment for this device, and has recently received regulatory approval in Japan. For complete Press Release Click here
ACC: Heart Pump Still Promising After Missing Endpoint April 5, 2011 By Todd Neale, Staff Writer, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor University of Pennsylvania School of Medicine and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
NEW ORLEANS -- A trial comparing the Impella heart pump and an intra-aortic balloon pump for hemodynamic support during high-risk percutaneous coronary intervention failed to meet its primary endpoint -- but researchers say the device still holds some promise.
The PROTECT II trial was stopped early because an interim analysis found the primary endpoint, 30-day rates of a composite of 10 major adverse events, did not differ between the two groups -- a finding that held up in the most updated analysis of 447 patients (P=0.312), according to principal investigator William O'Neill, MD, of the University of Miami in Florida....continue reading
Heart-pump hopes boost Abiomed shares April 1, 2011
BOSTON (MarketWatch) — Shares of Abiomed Inc., which hit a 52-week high Thursday, could get another boost this weekend, when the heart-pump developer unveils more data from a key study of its flagship product, Impella 2.5, at the annual scientific meeting of the American College of Cardiology.
Abiomed’s (ABMD) stock has been on a roll since the start of the year, with shares zooming up 50%.
In a recent interview, Abiomed Chief Executive Officer Michael Minogue attributed the run-up to the company’s better-than-expected quarterly financial report, released in February, and renewed optimism about Impella sales.
“The volume of stock has not been all that high,” Minogue told MarketWatch. “It’s more that people have been buying and less have been selling,” Minogue said.....continue reading
Calon cardio heart pump
Revolutionary alternative to heart transplant wins national award March 28, 2011
The makers of a revolutionary heart pump, which could be an alternative to a transplant, have won a major award.
Calon Cardio-Technology Ltd, based at Swansea University’s Institute of Life Science, was presented with UK Trade and Investment’s best breakthrough technology award.
The company is developing new implantable pumps for the treatment of heart failure, which are cheaper than the current models available and do not require such invasive surgery to fit.
The award comes as Calon Cardio is hoping to secure £5m in funding to start acute and chronic trials of the device.
Calon Cardio was formed in 2007 and is a collaboration between Oxford artificial heart pioneer Professor Stephen Westaby and Wales-based Prof Marc Clement.
Prof Westaby, the firm’s medical director, said: “Heart failure is the commonest and most unpleasant mode of death affecting thousands of people in the UK....read more
The pump is the fifth generation of the DeBakey Heart developed by the late US cardiac surgeon Michael DeBakey in the 1990s.
Smallest Artificial Heart Pump Implanted Posted March 25, 2011
Doctors in Germany have successfully implanted the world’s smallest artificial heart pump, billed as more effective and unobtrusive than earlier devices.
The first recipient, a 50-year-old woman, received the 92-gramme (three-ounce) pump made of plastic and titanium in late July and is now leading a nearly normal life with it at home, the University Hospital of Heidelberg said in a statement.
“It can fully replace the function of the heart’s left ventricle and works particularly quietly and effectively,” said the director of the cardiac surgery division of the hospital, Matthias Karck.
The device can also help patients bridge the time until a heart donor can be found for a transplant. The pump is the fifth generation of the DeBakey Heart developed by the late US cardiac surgeon Michael DeBakey in the 1990s.
It can be worn adjacent the ailing heart and allows for external electronic monitoring and adjustment.
Drs. Bud Frazier and Billy Cohn with ventricular assist devices
New artificial heart 'a leap forward' March 22, 2011
A Houston man got a device that pulses continuously on March 12
Two Houston surgeons have successfully implanted the world's first continuous-flow artificial heart in a human patient, a significant advance that promises a smaller and much more durable alternative to existing artificial hearts.
Drs. Bud Frazier and Billy Cohn took out the dead heart of 55-year-old Craig A. Lewis on March 10 at the Texas Heart Institute. After harmful proteins built up in his heart to the point it could no longer work, Lewis lived only with the aid of external breathing, dialysis and heart support machines.
The Houston man had maybe a day to live when Frazier and Cohn were given the opportunity to test their device — a pair of turbines cobbled together to mimic the function of the heart's left and right ventricles — that had been implanted only in 37 calves.
So far Lewis is recovering well, doctors say. "It was time to take this leap forward," Frazier said. The leap is an evolution away from devices that push blood into the body in pulses, like the natural heart. Frazier was one of the earliest and probably most outspoken evangelists for a new approach, that of pumps using a tiny turbine spinning thousands of times per minute to provide a continuous flow of blood.
In 1988 he implanted the world's first left-ventricular assist device with a continuous-flow pump, and the next-generation HeartMate II pump he helped develop has now been put into 11,000 patients. Continuous flow pumps are smaller and more durable. Pulsatile pumps must beat 100,000 times a day, and 35 million times a year to match the heart. Pumps and artificial hearts with this pumping action tend to break down in months or a few years.
"This is the real beauty of continuously flowing pumps," Frazier said. "We've never spun one to failure."
The new artificial heart, in which Frazier and Cohn combined a pair of modified HeartMate II pumps, caps half a century of progress and setback in the quest to replace dying hearts with machines. Saga begins in 1963
MEDICAL TECHNOLOGY: Fully-implantable artificial heart "ReinHeart" Posted: March 20, 2011
A completely implantable artificial heart developed in Europe for the first time in more than 20 years has been successful in an animal trial. The new artificial heart called "ReinHeart" was developed at the Clinic for Thoracic and Cardiovascular Surgery under the lead responsibility of Prof. Dr. Reiner Körfer at the Heart and Diabetes Centre North Rhine-Westphalia in Bad Oeynhausen.
The Department of Applied Medical Engineering at the Helmholtz-Institute of the RWTH Aachen University also contributed to the project. The new cardiac pump is lined with a biocompatible polyurethane internal surface, 90x85 mm in size and weighing less than 1,000 gr. Based on the model of the human heart, it has a right-hand and left-hand ventricle, each with a cardiac output of 60 ml and equipped with four mechanical cardiac valves.
A fully wear-free linear drive generates 70 newtons of power for the pump's required delivery rate. The drive uses less than 20 watts. The artificial heart that was implanted into a calf in Louvain, Belgium by Dr. Michiel Morshuis and Dr. Sebastian Schulte Eistrup on 21 January 2009 performed excellently right from the start. After more than an hour, in which the artificial heart had demonstrated a regular and stable work rate with a cardiac output of up to six litres, the trial was completed successfully.
ReinHeart's development is coordinated by Dr. Sebastian Schulte Eistrup and Dr. Michiel Morshuis, Bad Oeynhausen, working in close cooperation with the research team headed by Dr. Ing. Ulrich Steinseifer and Dipl.-Ing. Thomas Finocchiaro from the RWTH Aachen University.
O.H. FRAZIER, M.D.
Renowned heart surgeon to speak at Covenant March 14, 2011
As a student at Baylor College of Medicine, Dr. O.H. Frazier was awarded the DeBakey Award for Outstanding Surgical Student, so it seems appropriate he will serve as the speaker for the upcoming installment of the Michael E. DeBakey, M.D. Distinguished Lectureship Series.
The medical school award was just the beginning for Frazier, now a world renowned heart surgeon.
He will speak on “The Development of Left Ventricle Assist Devices: The Houston Connection” at a luncheon at Covenant Health System’s Knipling Education Conference Center on March 25 from 11:45 a.m. to 1:30 p.m. Tickets cost $25.
He will also discuss his career highlights at the “Heart 2 Heart” dinner March 24 from 6:30 to 9 p.m. at the Lubbock Country Club. Ticket prices start at $275.
The proceeds from both events will help purchase new heart care technology at Covenant Health System.
The Michael E. DeBakey, M.D. Distinguished Lectureship Series was started in 2004, by Dr. Robert Salem, chief medical officer emeritus of Covenant Health System, when he asked DeBakey, his own mentor and a pioneer in the field of cardiac surgery, if he would lend his name and speak in Lubbock.
Each year, the series has welcomed a renowned medical leader to speak in Lubbock.....read more
Dr. David L.S. Morales, pediatric cardiovascular surgeon and director of mechanical circulation support at Texas Children's Hospital
Texas Children's Is First Pediatric Hospital to Begin Certification Process for SynCardia's Total Artificial Heart TUCSON, AZ--(Marketwire - March 10, 2011)
Texas Children's Hospital and SynCardia Systems, Inc. announced today that Texas Children's has become the world's first pediatric hospital to complete the first phase of certification to implant the SynCardia temporary Total Artificial Heart. The hospital intends to use the Total Artificial Heart as a bridge to transplant for their patients who received a heart transplant as children and now require mechanical support as a bridge to their second transplant.
The 15-member training team, which included cardiologists, critical care intensivists, anesthesiologists, nursing specialists and hematologists, was led by Dr. David L.S. Morales, pediatric cardiovascular surgeon and director of mechanical circulation support at Texas Children's Hospital. This first-phase of certification prepares the team for future implantation of the SynCardia temporary Total Artificial Heart into patients who meet specific body-size qualifications....read more
Japanese-Built Artificial Heart Opens Up Possibilities March 7, 2011
Terumo will soon put on the market in Japan an artificial heart that uses a world first technology. Compact, energy-saving and highly durable, it makes the most of Japan's particular strengths. It could be called a showcase for the potential of Japan's manufacturing industry in the medical care field.
Although medical technology is a field dominated by the United States with products such as pacemakers, the day when Japan could become a significant force in the global market may be drawing near. Terumo will start marketing its DuraHeart artificial heart in Japan this April.
The product, which has been on sale in Europe since 2007, was approved last December for production and sales by Japan's Ministry of Health, Labor and Welfare, based on its performance in Europe. Approval in just two and a half years since the application was submitted for production and sales is exceptionally fast. In February of this year, it was also included in coverage by the public medical insurance system. Associate Professor Shunei Kyo of the University of Tokyo Hospital says, "DuraHeart is a technology that Japan can be proud of on a global basis, as it is the first artificial heart that uses a magnetically-levitated centrifugal pump."
In the magnetically-levitated centrifugal pump, the impeller built into the pump that circulates the blood is sandwiched between magnets, and is made to rotate in a levitated state to make the blood flow. There is no need for bearings to support the impeller, eliminating contact between components, and so preventing the blocked blood vessels which were an issue in the past....read more
Surgeons Perform U of U Hospital's First Implant of Miniature Artificial Heart Device March 4, 2011
Surgeons at University of Utah Hospital have performed the hospital's first implant of a new-generation left ventricular assist device (LVAD) using the HeartWare HVAD. The tiny, partial artificial heart device is being used as part of a national research study for patients with advanced heart failure who are not candidates for heart transplantation.
"We're excited to be a part of this study," says Craig H. Selzman, M.D., surgical director of University of Utah Health Care's Cardiac Mechanical Support and Heart Transplantation Program. "This device allows us to perform a potentially lifesaving procedure for often desperately ill patients with end-stage heart disease. The HeartWare pump is smaller than many of other heart pumps and has potentially improved blood handling characteristics that fuel our enthusiasm for this technology."
The newer LVAD allows blood to be taken from a heart that is unable to pump and provide blood flow to starving organs, ultimately allowing patients to live longer and with a dramatically improved quality of life, according to Selzman, associate professor of cardiothoracic surgery at the University of Utah.
The HeartWare pump is smaller than many other heart pumps.It has only one moving part and is suspended by magnets and a hydrodynamic thrust bearing. This means the device may last longer and result in reduced risk of physical damage to blood cells as they pass through the pump.
University Hospital's first patient to receive the LVAD had the surgery late last week and is recovering well.....continue reading
Young boy’s fight for heart an inspiration February 27, 2011
Prior to receiving the Berlin Heart device, used to keep him alive until he could receive a new heart, Lane Eberhardt’s weight had dwindled to 35 pounds. At 7 years old, he was a living skeleton.
The New Philadelphia boy felt so sick he would sometimes bend forward while in his bed at Cleveland Clinic to try and alleviate the pain.
After the device’s pump was attached to his chest, the tubes pulled on Lane’s skin. But he eventually became more comfortable.
Amazingly, through his ordeal, Lane was able to keep a positive attitude and showed a will to live. His mother, Traci Reichman, shared some pictures and video from Cleveland Clinic and Lane was able to flash his infectious smile....continue reading
The temporary Total Artificial Heart by SynCardia
Plastic Heart Transplant February 21, 2011
Many people having heart diseases and waiting for a heart transplant die every year before a suitable donor can be found. This new innovation will stop the death of any more patients who are waiting for a heart donor. Doctors in the United States have successfully transplanted an artificial plastic pump into an Oklahoma pastor’s chest replacing his heart. The device, known as the temporary Total Artificial Heart by SynCardia Inc., is created from plastic and powered by a pneumatic pump. This pump is carried around in a pack by the recipient.
Pastor Troy Golden’s condition worsened in January of 2010, even after going through a serious heart surgery when he was forty one years old. Troy was born with a genetic disease which is known as MarFan’s Syndrome. The disease had affected the tissues around his heart and valves. During his previous surgery, the valves were replaced and his heart was re shaped, but that too ultimately stopped doing the job.
Dr Doug Horstmanhof, who is Troy’s cardiologist, explained that in this case a regular heart pump would not work, and it was decided to replace the entire heart with Total Artificial Heart . But after going through all this procedure Troy is still awaiting a heart donor, as the batteries in the plastic heart’s pump die often. Thus he has to keep new batteries with him at all times. The risk of clotting and infection is also continually eminent with this heart. Undoubtedly it is a big advancement in the world of technology and with the passage of time the drawbacks of this progress would be overcome hopefully.
New heart pump could reduce stroke risk February 15, 2011 MONTREAL -
In what’s being billed as a Canadian first, the McGill University Health Centre has installed a revolutionary heart pump that it says can reduce or eliminate the risk of stroke in patients who have suffered heart failure.
The C-Pulse squeezes the heart’s aorta vessel from the outside, as opposed to traditional pumps whose presence inside the heart can cause potentially deadly blood clotting.
The C-Pulse was implanted on Dec. 21, 2010 into Lauza Legere, a woman from suburban Montreal who was suffering from a weak heart. Dr. Renzo Cecere, who performed the surgery, told QMI Agency that the device is less likely to cause clotting, which is a complication in 5% to 7% of heart-pump patients. Clotting can cause obstructions that lead to strokes. “When blood comes into contact with something that isn’t naturally part of the human body, such as an artificial heart, it has a tendency to clot,” Dr. Cecere said.
“This (C-Pulse) pump actually sits on the outside of the aorta and there’s no blood-contacting surface. There’s no reason why we should ever have blood clots related to this pump.” The device is connected to two external boxes that are strapped to the patient to regulate airflow and battery power. The patient can disconnect for short periods to exercise or to take showers.
Health Canada gave Dr. Cecere permission to implant C-Pulse after it was installed in about 15 patients in the United States. The McGill University Health Centre hopes to implant about 12 of the devices into patients over the next 12 to 18 months. The patients will be monitored to see if the devices can be cleared for general use....read more
Mother who 'died' twice saved by heart pump made by Nasa February 15, 2011 From News.scotsman.com
A MOTHER-OF-THREE who "died" twice on the operating table has been saved by a revolutionary new heart pump made with parts designed by Nasa scientists.
Heather McIntyre, 27, was rushed to hospital after suffering heart failure five months after giving birth.
Her heart stopped beating after all her major organs failed and her family were told she had died "a couple of times". However, a surgeon at the Golden Jubilee National Hospital in Clydebank kept her alive by massaging her heart and inserting the CentriMag Blood Pump, a VAD device by Levitronix
It uses tiny motors designed by Nasa scientists to pump blood around the body, taking over the heart's function. Despite this, Ms McIntyre was given just a 5 per cent chance of survival, but over the following weeks her heart, and other organs, started to recover.
Unfortunately surgeons at the Golden Jubilee had to amputate her left leg, which had been severely damaged by a blood clot caused by her heart failure last July. However, Ms McIntyre, of Airdrie, Lanarkshire, is now recovering well at home and credits the VAD with saving her life.
"I don't remember much of what happened at the time, but there is no doubt that the VAD saved my life as it allowed my own heart to rest and to fully recover. My heart started to recover because it was getting that wee rest. Well that's what they think anyway."
Cardiothoracic surgeon Saleem Haj-Yahia told how he refused to give up on her.
He said: "All her organs failed: kidneys, liver, lungs and heart. She needed a very quick resuscitation which required taking her immediately to theatre. We needed to open the chest and massage the heart, while implanting the device."
Ms McIntyre is already walking on crutches and is full of optimism for the future despite the loss of her leg.....read more
Golden Jubilee National Hospital uses long term VADs, (The HeartMate II) supplied by Thoratec and short term VADs supplied by Levitronix
Young Mom Enjoys Gift of ‘Freedom’ This Valentine’s Day February 11, 2011
A Southern Arizona woman has become the first Total Artificial Heart patient in Tucson to leave the hospital while awaiting a heart transplant, thanks to a portable machine that powers her heart.
Marcela Padilla, 21, walked out of University Medical Center Jan. 20 with a backpack slung over her shoulder. Inside was the Freedom portable driver, powering the SynCardia temporary Total Artificial Heart implanted in her chest.
Padilla is the fifth person and the first woman in the nation to use the Freedom, which is undergoing a U.S. Food and Drug Administration-approved clinical study in the U.S. The driver is approved for commercial use in Europe.
"Up until now if you had biventricular failure – the failure of both sides of your heart – and your only option was the Total Artificial Heart, you knew you were stuck in the hospital until we could find you a matching donor heart,'' said Smith, who implanted Padilla's Total Artificial Heart last September.
During the wait for a donor heart, patients have been tethered to "Big Blue Hospital Driver", a 418-pound machine that powers the Total Artificial Heart. Patients can wait months for a transplant, with an average wait of 144 days in 2009. Smith hopes the Freedom driver will aid in saving more lives....continue reading
Dr. M. Cristina Smith, director of Heart Transplant and Ventricular-Assist Device Services
The 13.5 lb Freedom(tm) portable driver and the 418-lb "Big Blue" hospital driver for powering the SynCardia temporary Total Artificial Heart.
U.S. Market for Cardiac Surgery Devices 2011 February 9, 2011 From marketsmarkets
In 2010, the U.S. market for cardiac surgery devices, not including potential markets, was valued at over $2 billion a 6.3% increase over 2009. A number of new and innovative devices within this market are expected to emerge over the forecast period, particularly in the heart valve and cardiac assist segments, and as a result, growth in the overall market is expected to accelerate. Both PMVR and PAVR devices were not on the market in 2010 but are expected to be released by 2011 and grow rapidly.
The market segments covered in this report include:
World Heart Corp. (WHRT) has paused enrollment in a study of its Levacor heart pump, pending regulatory approval of refinements to the device.
The pump uses magnetic levitation to suspend the spinning impeller, its only moving part, where others use blood or mechanical bearings. The company says that's expected to provide improved blood compatibility. World Heart has been unprofitable as it is focused on development of the device.
The company said Wednesday design modifications will be "technically ready in the next two to three months," but the timeline for their implementation depends on approval by the U.S. Food and Drug Administration, the timing of which is uncertain.
Shares closed Tuesday at $1.86 and were halted premarket on the news.
Cheney's got heart February 8, 2011
Dick Cheney's heart troubles have been well-documented. Now comes the news that the former Vice President is considering a heart transplant. On Jan. 30 he turned 70, an age at which most transplant programs in the U.S. consider patients too old for the rigors of transplant surgery.
At present, the longest a patient has survived with an LVAD is six years and counting. As more high visibility patients like Cheney use the devices, their transition from temporary option to permanent solution becomes more the norm. So what are the downsides?
Patients with LVADs require anticoagulation. They have to take medicine such as warfarin to make their blood 50% thinner than normal. This requires careful monitoring: blood thinned too much can cause hemorrhage; blood that's too close to normal can lead to formation of clots which in turn can embolize and cause strokes.
The other big risk is infection; foreign material planted in the body is more susceptible to causing bacterial infestation of the blood stream which can seed other organs. Consequently, procuring a new heart would seem preferential for any patient with severe heart damage. No need for batteries. No drive line. No risk of hemorrhage and dramatically lessened chance of clots or infections.
Sign me up for transplant, right? Yet as with all things in medicine the reality is much more complicated than the sales pitch....continue reading
Recent FDA actions and approvals related to heart devices
Recent FDA actions and approvals related to heart devices Posted: February 4, 2011
Heart devices such as pacemakers and defibrillators have extended and improved the lives of millions of people worldwide. The Food and Drug Administration (FDA) helps provide access to heart devices that use the latest science and technology, through approval and oversight processes that expedite the availability—and assure the safety—of the products.
Recent FDA actions and approvals related to heart devices include:
• Approval of a new type of mechanical cardiac assist device that can be used on people of smaller size than previously possible.
• An engineering modification to homograft cardiac valves that is the first change in more than 40 years that may improve the durability of transplanted heart valves. (A homograft is a valve that has been removed from a donated human heart, preserved, and frozen under sterile conditions.)
• Approval of a protective covering for the heart that can reduce risks associated with the multiple reoperations required for infants with congenital heart ailments.
• Approval of a catheter replacement for previously placed pulmonary prostheses that have become impaired. This replacement will reduce the number of surgeries needed in children with congenital heart disease
• Approval of the first compact heart assist device. In April 2008, FDA approved the first device to support the weakened heart of a small-sized adult man or woman who is at risk of dying while awaiting a heart transplant. Previous models of these surgically implanted mechanical pumps were too large to be placed in the upper abdomen of some people.
• Comprehensive review of drug coated stents to address concerns about their safety. FDA has concluded that these stents are safe and effective when used within their labeled indication.
• Approval of the first totally implanted permanent artificial heart for humanitarian uses. The device is for patients with advanced heart failure involving both of the organ's pumping chambers, who are not eligible for a heart transplant, and who are unlikely to live more than a month without intervention.
• Approval of pacemakers that reduce severe heart failure symptoms by resynchronizing the pumping action of both heart chambers.
• Approval of new monitoring devices that allow implantable cardioverter defibrillators (ICDs) to transmit basic information about the patient and the device to physicians between office visits
Man Who's Lived Attached To Machine Finally Free Posted: February 4, 2011
PHOENIX -- A Valley man who's had to live his life attached to a machine is finally free. After his body rejected a transplant, Charles Okeke was equipped with an artificial heart. But in order for it to work, he had to be hooked up to a 400-pound pump.
He lived in the hospital for two years. Okeke was later equipped with a smaller machine that allowed him to live at home. But last week, the unimaginable happened: He received his second heart transplant as well as a kidney.
The father of three said he's grateful to the donor's family who gave him a second chance at living a normal life.
A little humor from the Brittish;
Learn about a new technology of artificial heart pumps that could help those with heart failure in the future...
Jarvik-7 artificial heart
First Total Artificial Heart implanted in California February 1, 2011
UC San Diego Medical Center performed the West Coast’s first implant of the world’s only FDA-approved total artificial heart. During the four-hour procedure, the patient’s diseased heart was completely removed and replaced by a lifesaving device that rapidly restored blood flow to his entire body. The patient, who suffered from a near-fatal heart virus in his 20s, recently underwent heart transplant surgery and is now recovering.
“The total artificial heart is a good device for people who are just beginning to lose the function of their kidneys, liver, intestines, lungs and brain. Patients may be near the point of organ failure but the damage is still reversible,” said Jack Copeland, MD, professor of surgery and director of cardiac transplantation and mechanical circulatory support at UC San Diego Health System.
In 1979, he performed Arizona’s first heart transplant and in 1985 became the first surgeon in the world to successfully use the total artificial heart as a bridge to transplant. During his career, Copeland has performed more than 850 heart transplants and 100 implants of the total artificial heart, which is manufactured by SynCardia.
Copeland helped found Syncardia in 2002 and serves on their board with no compensation. Copeland says that in the next year Americans may begin pushing for the total artificial heart as a permanent replacement and that more studies need to be done to prove the viability of this assertion.
To date, the longest anyone has ever been on the total artificial heart is more than 1,100 days.
Under the leadership of Dr. Stuart Jamieson, chief of heart surgery, the surgery team includes Jack Copeland, MD, Victor Pretorius, MD, Michael Madani, MD, David Garcia, NP, and Amanda Topik, RN.
In April 2011, UC San Diego Health System will open the doors to the Sulpizio Cardiovascular Center. This new 128,000-square-foot facility will unify UC San Diego Health System’s ambulatory, clinical, and inpatient heart and stroke care in one convenient location. For complete article Click here
Cardiothoracic surgeon Dr. Margarita Camacho.
N.J. heart-transplant surgeon Dr. Margarita Camacho is a woman in a man's world January 30, 2011
The surgeon’s hands danced carefully, but skillfully, around the patient’s beating heart, cutting and sewing arteries, while music by the Who and Queen blared in the background.
Even after bumping up against some tough scar tissue, the surgeon worked calmly and confidently, while the bright lights of the operating room at Newark Beth Israel Medical Center glinted off the scalpels, tubes, wires and the delicate string of pearls around the neck of the surgeon’s scrubs.
Four hours after Dr. Margarita Camacho cracked her patient’s chest open, a new heart pump was finally in place.
Camacho, who wears her signature pearls during every operation, is a rarity in the high-octane world of heart-lung surgery, which has one of the longest and most arduous training programs in the medical profession.
Since 1948, the American Board of Thoracic Surgeons has certified approximately 8,000 surgeons. In 1998, at the age of 43, Camacho became just the 86th woman, according to the board’s records. Today, she is one of only 200 women in the United States to become a board-certified thoracic surgeon.
She is a first-generation American, the daughter of Filipino parents, and not only grew up in Manhattan but never left the confines of New York City until she attended Vassar College and then Cornell, where she was drawn away from pharmacology by the dramatic immediacy of surgery and its life-saving solutions.
For several years she served as president of the international organization, Women in Thoracic Surgery, and Saturday addressed the Society of Thoracic Surgeons at its annual conference in San Diego.
Her talk was about her specialty: the use of left-ventricular assist devices, or LVADs — battery-operated mechanical pumps that help a diseased or damaged heart beat more efficiently and in the process provide a longer life or buy time for a critically ill patient until a suitable donor heart becomes available for transplant.
Getting A Heart Pump And Living A Tethered Life Are Better Than Death January 29, 2011 By Lacy Banks
God bless you
A year ago today, after suffering a cardio genic shock that almost killed me, I underwent open-heart surgery at the University of Chicago Medical Center, where chief cardiac surgeon, Dr. Valluvan Jeevanandam, implanted a heart pump to save my life and sustain me until I get a new heart.
It hasn't been fun living a tethered life.
By day, I'm powered by batteries whose electrical current is channeled by a system controller through a drive line that goes through my chest area into the Heartmate II, which does the pumping my diseased heart can no longer do sufficiently to keep me alive.
At night when I bed down, I change from the batteries, that are carried in a vest, to household current. To make that transition, I disconnect from the 18-inch-long cables connected to the batteries and reconnect to 15-foot-long cables drawing the power from a power console plugged into the wall to access AC current. Heaven helps me if there is a widespread, extended electrical blackout.
My batteries weigh roughly three pounds each and run for 12 hours before requiring recharged batteries. I've had to purchase huge shirts to wear over my medical machinery so that people don't mistake me for a terrorist because batteries are pretty much strapped to my sides. When you see me wearing the system controller and batteries, I can look rather armed and extremely dangerous.
I certainly have to conceal them especially when I board a plane. The batteries afford me pretty much unlimited mobility, except for things like taking baths, swimming or sitting in a sauna, as long as they are charged. But the night cables restrict me to a range of 15 feet from my bed.
Hands-off Heart Surgery at Ogden Regional January 26, 2011
OGDEN -- Ogden Regional Medical Center is the first Top of Utah hospital to perform cardiothoracic surgery with a sophisticated robot called da Vinci.
The robotic surgery, an alternative to traditional open heart surgery, is used for mitral valve repair, coronary artery bypass grafting and atrial septal defect, among other procedures.
The minimally invasive surgery uses smaller incisions without having to crack the chest open and cut through bone. The results include shorter hospital stays, faster recovery, significantly less pain and fewer complications, said Dr. Joseph Graham, a cardiothoracic surgeon at Ogden Regional Medical Center and the first in Utah to use the system for heart repairs.
"We lay the patient on their side and go in through the side, using tiny incisions," Graham said. "This allows us to get a better look at things. It's much easier to see what's wrong. The camera's magnification is 10 times that of other cameras that are used in the operating room."
Graham and his team at the hospital trained for more than 1,000 hours before performing their first procedure a little over a year ago. A cardiothoracic surgeon from Saint Joseph Hospital in Atlanta who helped teach the procedure came out to Ogden to assist in the first four surgeries. So far, Graham has operated on 22 patients with the robot....read more
Study Examines Earlier Use of Heart Pumps in Growing Group of Heart Failure Patients January 24, 2011
University of Michigan, University of Pittsburgh to lead REVIVE-IT study with $13.3 million in support from NHLBI & HeartWare.
The University of Michigan Cardiovascular Center and the University of Pittsburgh have been awarded $13.3 million to explore the potential benefits of heart devices for the large and growing group of Americans with heart failure.
In the REVIVE-IT study, researchers will compare whether non-transplant eligible patients with heart failure less advanced than that of current LVAD recipients do better with implanted devices than with current medical therapy.
Principal investigators include Keith Aaronson, M.D., M.S., medical director of the heart transplant program and Center for Circulatory Support at the U-M Cardiovascular Center, Francis A. Pagani, M.D., Ph.D., surgical director of the heart transplant program and the Center for Circulatory Support at the U-M and Robert Kormos, M.D., director of the UPMC Artificial Heart Program and co-director of the UPMC Heart Transplantation Program.
"The new study allows us to examine the use of heart devices earlier in the cascade of heart failure," says Aaronson, associate professor of medicine at the U-M Medical School....continue reading
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Dick Cheney mulls heart transplant (AFP) – 3 hours ago, January 18, 2011
WASHINGTON — Former US vice president Dick Cheney says in an interview Tuesday that he is considering a heart transplant following a series of heart attacks that prompted doctors to insert a heart pump.
Cheney, in an interview aired by NBC News, said the special pump in his heart is "a miracle of modern technology" that has kept him alive but is a "temporary measure."
Asked about the possibility of a heart transplant, Cheney said, "I haven't made a decision yet."
He said the pump, known as a Left Ventricular Assist Device, "was originally developed to provide a transition, to take somebody who's reached the point where they needed a transplant but a transplant wouldn't immediately be available, so they put this in as a temporary measure."
Cheney added that the pump technology has improved but that "I'll have to make a decision at some point whether or not I want to go for a transplant. But we haven't addressed that yet."
Cheney has had a long list of health scares, suffering his first heart attack in 1978 at the age of 37. He underwent quadruple bypass surgery in 1988 and has since had two artery-clearing angioplasties. In 2001, he was fitted with a pacemaker....read more
Baby Gets Donor Heart To Replace Pediatric Ventricular Assist Device by Berlin Heart January 14, 2011
Nashville, Tenn. - At 18 months old, Nathan Roberts has spent most of his life in a hospital. Over the past eight months, his parents said, they prayed and dreamed one day they'd get the call that would save their son's life. They almost gave up.
"After you wait so long, it seems like it's never going to happen," said Mandy Roberts, Nathan's mother.
This week, their phone rang: Vanderbilt doctors found what they call the perfect heart. "It was so exciting that it didn't really seem real," said Nathan's father, Jimmy Roberts. "I thought something is going to have to snap us back to reality."
But it's another heart that may be most impressive: the artificial one that kept Nathan alive while he waited for a donor.
Nathan was born with a hole in the left side of his heart -- a defect even surgery couldn't fix. The only hope, doctors said, was a mechanical device called a Berlin heart, which manually pumps. The Food and Drug Administration hasn't yet approved it for widespread use, and it has never been used on an infant in Tennessee.
"For him, he would not have survived if we had not had the device available," said Dr. Karla Christian of the Vanderbilt Medical Center. Nathan's parents said the risk was worth it. This week, he got a new heart. "The breathing tube is out. His heart seems to be working well," Christian said. "The medicines that we give him intravenously are being weaned appropriately."
If all continues to go well, Nathan could leave the hospital in another week and should lead a pretty normal live, according to Vanderbilt doctors. Nathan's parents said they can't wait to meet the donor's family; they said they want to personally thank them for saving their son's life.
Heart Implant Maker Convicted, Fined For Concealing Problems
Heart Implant Maker Convicted, Fined For Concealing Problems January 12, 2011
(St. Paul, MN) -- A federal judge slapped a heart-device maker with a $296 million fine and three years' probation.
Guidant, a subsidiary of Boston Scientific,(BSX) was convicted of criminal charges in U.S. District Court in St. Paul, Minnesota. The firm was accused of failing to disclose problems with certain heart implants that detect and fix abnormal heart rhythms.
Judge Donovan Frank found Guidant guilty of concealing information from the Food and Drug Administration that the implants had developed deadly defects. Three people died before Guidant finally went public about the problem in 2005.
During Guidant's three-year probation, the company must make quarterly reports to a probation officer and submit to surprise inspections. The company must also notify employees and investors of the conviction.
Heart Technology Continues to Advance, Washington University Expert Says January 11, 2011
An increase in wireless devices is among the trends in heart work, Dr. Scott Silvestry said.
Medical innovations such as the artificial heart and the Left Ventricular Assist Device (LVAD) have enabled doctors to extend patients' lives, and the continuing advancement of technology for that organ present numerous possibilities for the future, a Washington University official said.
“What a lot of the devices we have are going toward are wireless controllers, inter-connectivity and transcutaneous power so that devices that can really support the heart can be planted, set and forgot,” said Dr. Scott Silvestry, director for the university's heart transplant and mechanical circulatory support program.
These are included in what Silvestry calls the new generation of implants. Small devices such as drive lines, batteries and controllers? Those are 1990s-era technologies....continue reading
Why heart pumps could kill off the transplant Posted: January 7, 2011 From the archives of The Sunday Times
There are no rejection problems, and they cost a lot less than transplants. The new, smaller heart pumps could save thousands of lives. So why are they still treated as the poor relation?
When the South African surgeon Christiaan Barnard carried out the first heart transplant in December 1967, the world held its breath. His patient, 53-year-old Lewis Washkansky, lived for only another 18 days. The drugs he needed to stop his body rejecting the new organ compromised his immune system to such an extent he couldn’t fight off other illnesses, and he died of pneumonia. But the precedent had been set:
The most powerful and emotionally iconic of human organs could be taken from the body of a dead person to give the chance of an extended life to another. It was a transforming, era-defining moment that reinforced our faith in medical science and ensured Barnard’s place in history. But how successful would heart transplantation be in the long term?
Just over 40 years later, the very same question is still being asked. The procedure, and the drugs needed to maintain a newly donated heart, may be much more sophisticated, and heart transplants may be regarded by the public as one of the most glamorous of surgical career paths, but surgeons themselves are carrying out significantly fewer of the operations. This is partly because a range of other treatments is available to patients, and partly because of the low number of suitable donor hearts....read more
Cheney may seek heart transplant
Cheney may seek heart transplant January 5, 2011
WASHINGTON, Jan. 5 (UPI) -- Doctors say former U.S. Vice President Dick Cheney, 69, must decide within months whether to seek a heart transplant before he becomes too old to qualify. Cheney received a heart pump in July in a move doctors said saved his life, The New York Times reported Wednesday.
The mechanical pump, a partial artificial heart, leaves patients without a pulse because it pushes blood continuously instead of mimicking a heartbeat. The device poses significant risk of infection, doctors told The Times. They are implanted as a last resort either for permanent use or as a bridge until a donor heart can be found....continue reading
Simple device gives heart to those awaiting transplant January 4, 2011
Professor Frank Rosenfeldt, The Alfred hospital's head of cardiothoracic surgical research knows that keeping donor hearts viable over longer periods is vital to the success of Australia's heart transplant program.
He became aware of a machine developed overseas to pump hearts with blood to keep them alive while awaiting transplant, but the cost of the sophisticated pump-based device - about $50,000 -was prohibitive.
He wondered if there was a simple way of providing nutrients to the heart without delivering them through the bloodstream.
Last year, he set about testing the hypothesis. He created a patented solution containing oxygen and nutrients such as glucose, and introduced it into the hearts of large animals kept at 4 degrees - in a process known as perfusion - using a gravity-based set-up that could be easily transported.
The innovative system kept the animal hearts viable for up to 12 hours - three times longer than The Alfred's current safe average ischaemic time (the time from procurement to transplant) - and resulted in them pumping blood far more effectively than those kept in traditional cold storage. The result surprised even Professor Rosenfeldt. For complete story Click here
Former Vice President Dick Cheney was noticeably thinner at a groundbreaking ceremony for former President George W. Bush's presidential library in November.
Cheney Is Back, With Heart Pump and New Outlook January 4, 2011
WASHINGTON — A few days before Christmas, former Vice President Dick Cheney ended a self-imposed sabbatical from partisan politics to headline a fund-raiser for Maria Cino, a party operative and Bush administration official who is running to replace Michael Steele as head of the Republican National Committee.
The fund-raiser for Ms. Cino, held at the Alexandria, Va., home of Mr. Cheney’s former aide Mary Matalin, was his first major foray into partisan Washington political theater since receiving a mechanical heart pump in July that has, most doctors say, saved Mr. Cheney’s life by taking on the task of helping to push blood through his arteries.
Mr. Cheney, as he did at several holiday receptions in Washington, chatted about his new pump. At one cocktail party, he even opened his coat jacket to show it off. While Mr. Cheney is noticeably thinner — his trademark stiff, one-sided grin now shows up on a markedly leaner face — he is returning, associates say, to his old life, including hunting and socializing....read more
Tiny pumps can help when heart failure advances January 1, 2011
Left ventricular assist devices support the heart while waiting for — or in place of — a heart transplant.
What can be done for a failing heart when medications no longer help? A transplant is one option, but there aren't nearly enough donor hearts to meet the need. An artificial heart may someday fill the void, but one isn't yet ready for widespread use.
Small pumps the size of two D batteries offer hope and help today for thousands of people with advanced heart failure. These pumps, known as ventricular assist devices, have been around in one form or another for years. But advances in engineering and medical technology have made them small enough for almost anyone and portable enough to let their users take a walk, go shopping, and even travel. The devices don't work magic, and they come with big personal and financial costs. But they can offer months or years of extra life for people with failing hearts.
Of the dozens of left ventricular assist devices implanted in 2010, the one that former Vice President Dick Cheney received is raising the profile of this intriguing technology.
As the name implies, ventricular assist devices help the heart's lower chambers pump blood. The ones most commonly used today for heart failure support the left ventricle.
A surgeon places the pump in the abdomen, then connects its inflow tube to the bottom of the left ventricle and its outflow tube to the beginning of the aorta, blood's main pipeline from the heart to the rest of the body (see illustration). Blood from the lungs enters the left side of the heart. The ventricular assist device pulls this oxygen-rich blood into one side of the pump and propels it out of the other side, into the aorta. Although the heart continues to beat normally, the pump moves blood in a continuous fashion, eliminating the pulse we so often associate with healthy blood flow....continue reading
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