Better coverage near for artificial heart use
Tucson firm would benefit from federal agency's lead
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History of the artificial heart
1937: Vladimir P. Demikhov uses an assist device for 5 1/2 hours to substitute for the cardiac function of a dog.
1957: At Cleveland Clinic, Dr. Willem Kolff and Dr. Tetsuzo Akutsu design an artificial heart that sustained a dog for 90 minutes.
1963: Eight years after inventing an artificial heart, ventriloquist Paul Winchell is granted the first patent for an artificial heart. Winchell received help from Dr. Henry Heimlich, who developed the Heimlich maneuver. Winchell was also the original voice of the Winnie the Pooh character, Tigger.
1964: The National Heart and Lung Institute and the U.S. Artificial Heart Program announce plans to encourage and support further research and development of cardiac replacement devices.
1967: Dr. Christiaan Barnard performs the first heart transplant in Cape Town, South Africa. The patient lived 18 days.
1969: Dr. Denton Cooley at the Texas Heart Institute becomes the first heart surgeon to implant an artificial heart in a human. The 47-year-old male survived 64 hours on the artificial heart and 32 hours on the transplant.
1972: Winchell signs over his patent rights to Kolff at the University of Utah.
1976: The U.S. Food and Drug Administration begins regulating medical devices.
1979: The Jarvik Total Artificial Heart is designed using a flexible four-layer diaphragm and a structural design that fits in the human chest.
1982: Dr. William DeVries receives approval of an Investigational Device Exemption, from the FDA to perform the first permanent artificial heart implant using the Jarvik 7 TAH. Barney Clark lived 112 days on this device.
1983: Between 1976 and 1983, more than 200 calves are implanted with the Jarvik 5 and Jarvik 7 versions of the artificial heart.
1985: At the University of Arizona, Dr. Jack Copeland implants a prototype TAH in a patient whose body had rejected a recently transplanted heart. This device, later called the Phoenix TAH, bridges the patient to another heart transplant after 11 hours.
1985: The FDA gives approval for Hershey Medical Center to perform six Penn State University artificial heart implants as bridges to human heart transplants.
1990-92: The FDA withdraws the Investigational Device Exemption (IDE) for the Jarvik TAH from Symbion. Symbion donated the TAH technology to University Medical Center, which renamed the company CardioWest.
1993: CardioWest receives an IDE from the FDA to study the total artificial heart. Between 1993 and 2002, 81 patients received the TAH as a bridge to transplant.
2001: The TAH technology leaves UMC with private investments, and SynCardia Systems Inc. is formed by Dr. Marvin Slepian along with Richard Smith and Copeland. The IDE is transferred to SynCardia.
August 2004: The New England Journal of Medicine publishes the results of the CardioWest study. The one-year survival rate for those who received the TAH and a transplant heart was 70 percent compared to a 31 percent survival rate for those who didn't.
Oct. 2004: The CardioWest TAH becomes the world's first and only FDA approved temporary total artificial heart.
2006: The number of centers certified to use the CardioWest heart grows to 20 worldwide.
Feb. 2008: Centers for Medicaid & Medicare Services approve coverage of the total artificial heart in patients who are part of an approved FDA study.
Sources: SynCardia; Center for History and New Media, George Mason University; www.Paul Winchell.com; U.S. Food and Drug Administration
The Centers for Medicare and Medicaid are looking for public comments on the proposal to cover patients who need an artificial heart and who are involved in U.S. Food and Drug Administration studies.
To make a comment and view the proposal, go to www.cms.hhs.gov/InfoExchange/02_publiccomments.asp.
SynCardia
www.syncardia.com
University Medical Center
www.azumc.com
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Vanessa Cirillo had a heart attack when she was 20.
By the time the 28-year-old was admitted to University Medical Center on Aug. 4 last year, her deteriorating heart was shutting down.
If she had not been implanted with a total artificial heart, she would have died waiting for a heart transplant.
Cirillo was lucky. Her health insurance covered the procedure. Many insurers don't.
The door to more widespread insurance coverage opened Friday. The Centers for Medicare & Medicaid Services announced that they have made a preliminary decision to cover patients who need an artificial heart as they wait for a heart transplant. The patients would need to be part of an approved U.S. Food and Drug Administration study.
Most health insurance companies base their coverage decisions on what CMS will cover.
The announcement is good news for Tucson-based SynCardia Systems Inc., which has developed the only total artificial heart approved by the FDA as a bridge to transplant.
"We're ecstatic.This ruling in favor of us will have a major impact on a number of patients nationwide," said Richard Smith, SynCardia co-founder and technical director of the artificial heart program at University Medical Center. "This has an effect all the way across the country."
UMC does more artificial heart transplants than any other hospital in the United States, said Don Isaacs, a SynCardia spokesman.
Until recently, UMC was the only facility in Arizona certified to implant total artificial hearts. The Mayo Clinic in Scottsdale is now certified.
Smith estimated that about 25 percent of UMC's cardiac patients are on Medicare.
"People never expect to have this situation," he said. "Not having these barriers is a plus to anyone in Tucson or Arizona."
On Aug. 10, Cirillo became the 98th person to have an artificial heart implanted at UMC.
"My heart couldn't function and my organs were failing," Cirillo said.
She received her new heart Nov. 24.
Nationally, SynCardia works with 11 hospitals and Smith said he expects more will want to use the artificial heart now that CMS has proposed revising its noncoverage policy.
Two hospitals in Europe, the Heart and Diabetes Center in Bad Oeynhausen, Germany, and the Groupe Hospitalier La Pitié-Salpêtrière in Paris, implant more artificial hearts than UMC. Both hospitals use the SynCardia heart, a descendant of the Jarvik artificial heart, now called the CardioWest.
Worldwide, an estimated 700 artificial hearts have been implanted and 12 hospitals outside the U.S. use the CardioWest artificial heart.
According to the American Heart Association 20 percent to 30 percent of patients die while waiting for a heart transplant. An estimated 4,000 patients are waiting for a heart transplant at any one time, the CMS proposal states.
Don McLeod, public affairs officer for the CMS office in Washington, D.C., said that while the proposal limits who would be covered, he said this is the first time CMS has considered covering the artificial heart.
McLeod said the final decision will be made by May 1 and could be different from the proposal.
CMS is accepting public comments on the proposal on their Web site for the next 30 days.
Whatever CMS decides is effective immediately following the announcement of the final decision, he said.
SynCardia received FDA approval to conduct clinical studies on artificial hearts in 1993, three years after approval was taken away from Symbion of Tempe, which developed the Jarvik 7 artificial heart.
The artificial heart was approved in 2004 by the FDA as a temporary heart for patients awaiting a transplant. Since then SynCardia administrators have been working with CMS toward a reconsideration of their policy not to pay for total artificial heart implantations.
According to the CMS proposal, the fact that the majority of artificial heart transplants done in the U.S. were at UMC is considered a weakness, raising the question "whether the device can successfully be implanted at additional institutions at this time."
The CMS statement, however, acknowledges that the future of the artificial heart is promising.
"This device may be able to help patients that otherwise have no treatment options available to them," said CMS Acting Administrator Kerry Weems.
Up to this point, CMS policy has been to pay only for ventricular assistance devices, which help the natural heart by supporting either the left or right ventricle but don't replace the heart.
The total artificial heart completely replaces the natural heart in cases where both ventricles are failing and the patient will die before a heart transplant donor can be found.
About 50 percent of health insurers, such as Aetna and BlueCross BlueShield, have been covering the total artificial heart on a case-by-case basis. Cirillo is insured by BlueCross BlueShield.
Smith said the artificial heart device costs around $100,000.
Cirillo spent her three months waiting for a transplant in her hospital room, tethered to a washing machine-sized pump, or driver. She set up video games, a DVD player and a cot for her mother.
In 2006, hospitals in Europe began using SynCardia's smaller portable driver, which allows patients implanted with an artificial heart to wait for their heart transplant at home.
The driver would reduce the time spent in hospitals and possibly hospital, insurance company and patient costs.
While the driver would not be covered by CMS under the new proposal, Friday's announcement paves the way for SynCardia to apply to the FDA for approval to study the driver in the United States, Smith said.
According to its annual report, SynCardia hopes in 2009 to conduct clinical studies on a smaller artificial heart that would fit teens or small adults.
Whats next, A Government that helps us without running our lives??
Right.