Starr-Edwards Heart valve and MRI safety

Lasker Awards Announcement
America’s highest medical prizes, the Lasker Awards, have been announced, and some of the winners are developers of prosthetic heart valves.
From the official announcement by the Lasker Foundation:
The Lasker Award for Basic Medical Research honors Ralph M. Steinman, 64, of the Rockefeller University, New York City, who discovered dendritic cells. These immune cells trigger other components of the immune system to thwart microbial invaders. Steinman’s work has opened up novel therapeutic avenues for combating cancer and pathogens.
The Lasker Award for Clinical Medical Research honors Alain Carpentier, 74, of Hôpital Europeen Georges Pompidou, Paris, and Albert Starr, 81, of the Providence Health System, Portland (OR), who developed prosthetic mitral and aortic valves. These devices have prolonged and enhanced the lives of millions of people with heart disease, providing treatment where none existed before.
The Mary Woodard Lasker Award for Public Service, awarded bi-annually, honors Anthony S. Fauci, 66, Director of the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health, for engineering two major U.S. governmental programs, one aimed at AIDS and the other at biodefense.
The fun part for us, of course, is about the development of artificial heart valves:The 2007 Albert Lasker Award for Clinical Medical Research honors two surgeon-scientists who revolutionized the treatment of heart disease. Albert Starr and his engineer partner, the late Lowell Edwards, invented the world’s first successful artificial heart valve. This device has transformed life for people with serious valve disease, providing a remedy where none previously existed. Alain Carpentier then circumvented the predominant limitation of mechanical valves–a propensity to clot within blood vessels and the associated need to take blood thinners–by adapting animal valves for use in humans. In the embryonic days of open-heart surgery, Starr and Carpentier opened up the entire field of valve replacement. Their work has restored health and longevity to millions of individuals with heart disease.
Starr’s and Carpentier’s contributions extend beyond these landmark innovations. In an era before the Food and Drug Administration (FDA) regulated medical devices, Starr set up the infrastructure for conducting clinical trials on his valves, including an informed-consent procedure and long-term patient tracking. This practice allowed him to evaluate valve replacement outcomes and seek solutions to clinical problems. Furthermore, his surgical patients required a new type of postoperative care. To deliver it, he assembled a multidisciplinary healthcare team, creating what corresponds to today’s cardiac intensive care unit. Carpentier, in turn, augmented his own initial discovery by formulating techniques to repair rather than replace valves–a venture that was aided by the availability of prosthetic valves as a backup. He continues to probe the suboptimal areas of heart-valve surgery,relentlessly pursuing superior strategies.
Prior to the introduction of the Starr-Edwards valve, no human with a valve replacement had survived longer than three months. As of 2004, four live patients had replacement valves that had been implanted at least 40 years earlier. Currently, more than 90,000 people in the United States and approximately 300,000 people worldwide receive new valves annually; the procedure is the second most common heart surgery in the United States, exceeded only by coronary bypass operations.
MRI Safety of Heart Valves:
Heart valve prostheses and annuloplasty rings.—Numerous heart valve prostheses and annuloplasty rings have undergone testing for MR safety. Of these, the majority showed measurable but relatively minor translational attraction and/or torque in association with exposure to the MR systems used for testing. Since the magnetic field–related forces exerted on heart valves and annuloplasty rings are deemed minimal compared with the force exerted by the beating heart (ie, approximately 7.2 N) , an MR procedure is considered to be safe for a patient with any of the heart valve prostheses or annuloplasty rings that have undergone testing to date . This includes the Starr-Edwards model Pre-6000 heart valve prosthesis, which had previously been suggested to be potentially hazardous for a patient in the MR environment. Heart valve prostheses and annuloplasty rings tested at 3 T.—Many heart valve prostheses and annuloplasty rings have now been evaluated for MR safety by using 3-T units . Findings indicate that one annuloplasty ring (Carpentier-Edwards Physio Annuloplasty Ring, Mitral model 4450; Edwards Lifesciences, Irvine, Calif) showed relatively minor magnetic field interactions. Therefore, similar to heart valve prostheses and annuloplasty rings tested at 1.5 T, because the actual attractive forces exerted on these implants are deemed minimal compared to the force exerted by the beating heart, MR procedures at 3 T are not considered to be hazardous for individuals with these implants (5,128). Additional heart valves and annuloplasty rings from the Medtronic Heart Valve Division (Minneapolis, Minn) have undergone MR safety testing at 3 T. These implants were tested for magnetic field interactions and artifacts by using a shielded 3-T MR system. According to information provided by Medtronic (Bayer KM, personal communication, 2002), these specific implants are safe for patients undergoing procedures with MR systems operating up to 3 T.
(Frank G. Shellock, PhD
John V. Crues, MD)
Here’s all 16 pages of the press release: SOURCE
Find more at the Lasker Awards’ multimedia presentation
Article at the New York Times
The Lasker Foundation press release (.pdf)
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10 thoughts on “Starr-Edwards Heart valve and MRI safety

  1. Thanks so very much for the article and all of the info. on mechanical heart valve – specifically Star Edward heart valve as my husband had one implanted at Bethesda Medical Hospital in 1991 at the age of 39 when he was diagnosed by a Navy cardiologoist with stenosis of the aortic valve (probably caused by a heart murmur and infection from an abscessed tooth) when he passed out several times during physical activity. He had been told by one of his doctors at that time that he could not have an MRI done, but other doctors told him that it would be safe. He wasn’t sure who to trust, but this information greatly relieved both of our minds! We were especially glad to read about the longevity of survivors and the mechanical valve as we were also uncertain about it. He was told that the inventor, Star, was at the hospital and observed/consulted on his surgery, but he didn’t know about it because he never had an opportunity to meet him before or after his surgery. He did have a very minor stroke in 1997, but it was determined that it was caused by the fact that his primary care doctor was not keeping his coumadin at a sufficient level to prevent blood clots. Since that time he has been problem-free regarding his valve and clotting. He just was seen by an orthopaedic specialist regarding a possible rotorcuff injury to his shoulder and the doctor wanted to do an MRI since the xray was not conclusive about the problem. Now we know that this test will be safe and he can go ahead and find out for sure why he has been in so much pain with his shoulder! Thanks again for the great information!

    I’m glad to here that. I hope your RTC surgery goes well. I am glad my little website was of some use to you all.

    chris

  2. I am happy to say that I had a Star Edwards Valve replacement in 1969, 40 years ago this April 24.

    In the beinning it was a very difficult adjustment and extremley scary experience as I was a very young 20 at the time of my surgery. I am so honored and fortunate that I had a physicain who cared enough about me to suggest the “Star Edwards” way back when.

    So here I am today to tell eveyone and anyone tht I am a 40 year surviver of this valve and plan to continue to live my life to the fullest.

    • I also had A Star Edwards Valve in February 1972 at St Vincents Hospital in Melbourne Australia when I was 19 years old .
      10 weeks before my wedding. I am currently on 5 mgs warfarin per day,
      Have a daughter 35 years old ( allthough told not to do so at the time) still enjoy life to the fullest after 39 years, we are both survivors of technology from way back then.

  3. I had a ‘Starr Edwards’ valve replaced St Thomas’ Hospital London on 5 November 1974 when I was 19 (35 years ago!). Who would believe all the medical technology way back then. Well, here I am, living proof of all the hard work the NHS puts into people’s health.

    Well done to all the researchers and surgeons etc and of course all the caring nursing staff who do all this wonderful work.

    Many thanks.

    Maggie

  4. I too had a Star Edwards aortic heart valve replacement at St Mary’s Hospital, london in 1993 when I was 49. Today I am a very fit 65yr old & have never had any trouble whatsoever. My inr range is 3.0 – 4.2 & I take 5mgs of warfarin daily & monitor my inr levels myself with a Roche ‘coaguchek’ test machine that I purchased from Ebay.

  5. I was 13 years old and had a Star Edwards valve put in to replace another mechanical valve that was not working correctly that I had put in at 7 years old. That first surgery was in 1964 at Children’s Hospital in Milwaukee. My second surgery was in 1970 at St. Luke’s Hospital in Milwaukee. That is when I had the Star Edwards put in, and it has been working fine for the last 40 years. I am 53. I pray that if it ever stops working correctly and I need it replaced that the new valve last just as long!

  6. Pingback: safety training library

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