“You may want to come and say goodbye to him”: these are the words that hammered through Mary’s phone on March 31, 2014. Her 53-year-old husband, Steve Williams, was in hospital getting treated for the nth time for left ventricular hypertrophy and he had slipped into a coma. But what started as a traumatizing phase for the couple ended with the light shining at the end of the tunnel. This manager with Motorola Solutions in California now lives with a total artificial heart implant, while waiting for a suitable heart donor.
Steve is just one among the thousands who have received artificial working hearts in the last few years – all waiting for a suitable donor heart – yet living quite unrestricted lives with this bridge.
The U.S. Department of Health and Human Services states that on any given day the country has at least 4,000 people waiting and hoping for a suitable donor heart to come their way. However, the annual supply of donor hearts is 2,300 on an average. Same is the story with the European Union. Data with the European Commission’s Department of Health and Consumers shows that while 2,004 heart transplants were performed in 2012, by the end of the year at least 3,400 patients were still waiting for a donor heart.
What comes as a ray of hope for such patients is that perfect bridge called the artificial heart implant.
Beat to the heart
From 1969 to 2014, there have been 1,458 implants of 13 different models of artificial heart designs. The SynCardia Total Artificial Heart and its predecessors account for 96% of all implants, with more than 550 SynCardia Hearts implanted since January 2010.
Till date, the FDA has approved of only two heart designs – the SynCardia Total Artificial Heart and the AbioCor replacement heart. The AbioCor replacement heart has been implanted a total of 15 times, with the first 14 implants as part of its clinical FDA Humanitarian Use Device (HUD) Study. Following the FDA approval in September 2006, only one AbioCor heart was implanted in 2009.
So what makes SynCardia popular? The most obvious factor is its weight and size that is nearly that of a human heart. The human heart weights about 250 to 350 grams. While AbioCor’s artificial heart weighs 1,090 grams, that of SynCardia weighs just 160 grams, which is much lesser than even the human heart and makes it more eligible for implantation in the absence of an immediate donor.
Brain behind the heart
Dr. Robert Jarvik is widely known as the inventor of the first successful permanent artificial heart – the Jarvik 7 –
which was implanted in a patient for the first time in 1982. In 1988, he developed a tiny ventricular assist device called the Jarvik 2000. While these artificial hearts were then developed by Symbion Inc., over a period of time and after changing several hands, the bettered designs of Dr. Jarvik’s invention is now manufactured by SynCardia Inc.
Dr. Jarvik had 18 U.S. patents to protect his invention. Surprisingly, SynCardia Inc. does not have a significant patent portfolio. It has only two U.S patents and five pending applications. Its patent US 8021422 lays claim to the present day Syncardia CardioWest total artificial heart.
Early attempts to mimic the human heart can be witnessed in patents filed in the 1940s. A total of 2,285 patent applications have been filed with the USPTO since 1980. Patent filing trends in this field , including related accessories and monitoring, showed a sudden rise since 2000.
Thoratec Corp, Abiomed (developer of the AbioCor artificial heart), Edwards Lifesciences and National Institutes of Health are the major patent owners in the U.S. in this space.
Heart beats around the world
The Carmat bioprosthetic heart, which has been developed in France and is similar in design to the AbioCor, was implanted in two patients last year. While the first receiver of the implant died in 75 days due to malfunction of the artificial heart, the second donor is reported to be healthy. The Carmat artificial heart is estimated to cost €140,000 to €180,000 ($191,000 to $246,000).
Research and development of on artificial heart have been in progress in Asian countries like Japan and Korea.
And so while thousands of people wait for a suitable heart donor, these artificial hearts are forming the perfect temporary bridge, beating to the song of life.
(Featured image source: https://pixabay.com/en/heart-care-medical-care-heart-1040227/)