• #17 - Deep Inside the Heart • MedicalExpo e-Magazine

    The Smart Magazine About Medical Technology Innovations

    Deep in the Heart




    Three-D printed models of newborns’ hearts, biodegradable stents, cardiac MRI showing the heart in seven dimensions and innovative wearable cardiac devices—this new edition of MedicalExpo e-magazine goes deep inside the human heart to unveil the latest trends in cardiology

     

    We also interviewed an expert from the U.S. Food and Drug Administration to understand how they regulate 3D printed devices, and we offer you a taste of new healthcare IT products showcased at the conhIT Conference this month in Berlin.

    Smart People
    The most striking thing about the 3D models, when you have them in your hands, is how small and complex a newborn baby’s heart can be
    Babies' Hearts 3D Models (Courtesy of 3D Print Lab)

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    The Phoenix Children’s Heart Center created a couple of years ago its own in-house Cardiac 3D Print Lab. Dr. Justin Ryan, lead research scientist at the lab, and Dr. Stephen Pophal, interventional cardiologist, explained to MedicalExpo how 3D printed models of babies’ hearts represent a tremendous aid in surgical...

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    Hot Topic
    Developers hope bioresorbable scaffolds will avoid some of the long-term problems with permanent stents
    Bioresorbable Scaffold (Courtesy of Abbott Vascular)

    A medical breakthrough, bioresorbable scaffolds are designed to repair and restore diseased coronary vessels. They are intended to deliver results similar to drug-eluting stents before being completely resorbed by the body. Despite some limitations, they usher in a new era for interventional cardiology.

     

    A couple of square millimeters is all the space oxygen-rich blood has to push its way through the lumen of a coronary artery.

    Plaque lesions along the way do not exactly facilitate the journey and may lead to Coronary Artery Disease (CAD), with its typical symptoms and complications, including angina and myocardial infarction. So ever since researchers and cardiologists have learned about the pathogenesis of CAD, they have been working on materials and techniques to open up lesions and restore blood flow and arterial function.

    Following angioplasty-balloons, bare-metal stents (BMS) and drug-eluting stents (DES), the latest addition to the interventional cardiologist’s toolbox is the bioresorbable scaffold, aka bioabsorbable or biodegradable stent, such as Abbott Vascular’s Absorb, or Elixir’s DESolve.

    Dissolving Several Months After Implantation

    Instead of remaining permanently inside the body, these devices aim at propping up diseased vessels by providing radial strength just as long as it is really necessary, before beginning to gradually degrade several months after implantation. Developers hope this will avoid some of the long-term problems with permanent stents, particularly important for younger patients. 

    Dr. Petra Guhr, Manager Marketing Communication DACH, at Abbott Vascular, Germany told MedicalExpo:

    Dr. Petra Guhr (Courtesy of Abbott Vascular)

    Dr. Petra Guhr (Courtesy of Abbott Vascular)

    The dream has always been to find a temporary solution for a temporary problem, giving blood vessels a chance to bounce back to their natural state.

    “This is comparable to putting a cast on a broken leg and removing it after the bone is fully healed,” she said. Abbott Vascular has been developing the Absorb Bioresorbable Vascular Scaffold System (BVS) since the early 2000s, winning CE certification in 2010 and a positive review by the U.S. Food and Drug Administration Advisory Committee in 2016.

    Absorb BVS consists of bioresorbable scaffold and coating elements, both made of polylactide acids (PLA). Such materials are also used in absorbable surgical sutures and other medical applications, and are the key constituents of Elixir’s DESolve and the ancestor of all bioresorbable scaffolds, the Igaki-Tamai stent, as well. “However, one PLA is not necessarily identical to another. Only the exact composition of the PLA and the design of the scaffold determine its essential properties, such as the speed at which the scaffold dissolves.”

    Raising Questions

    Furthermore, just like Abbott’s industry standard drug-eluting stent, Xience, Absorb BVS releases Everolimus to prevent restenosis, and has an enhanced delivery system to facilitate use. According to Guhr, to date about 125,000 patients have been treated with Absorb worldwide, 13,000 of them in the context of clinical studies.

    The Absorb BVS passed the recent ABSORB III non-inferiority trial, using an Xience DES control group. However, although not considered statistically significant, slightly more patients in the Absorb group (7.8%) experienced target lesion failure than in the Xience group (6.1%). This raises the question of whether the new bioresorbable technology might be inferior to established stents after all.

    Dr. Sharma (Courtesy of Dr. Samin K. Sharma)

    Dr. Sharma (Courtesy of Dr. Samin K. Sharma)

    Dr. Samin K. Sharma, Professor of Cardiology at the Mount Sinai Hospital, New York City, has worked in interventional cardiology since the 1980ies and has treated patients as part of the ABSORB III trial. He explained in an interview with MedicalExpo:

    I think that this is just work in process. In my opinion, interventionalists have to understand this as a proof of concept – that this is a great technology, it is here to stay, and we need to make it better.

    Learning More About This Technology

    “I know that a lot of people are sitting on the fence and that there is a borderline enthusiasm on this issue, but I am very enthusiastic. I have used it and I think that will be good for us,” explained Sharma. His current clinical experience with bioresorbable scaffolds includes about 75 patients in the U.S. and India.

    We cannot get them in complex lesions yet, because we need to learn how this technology is going to behave in complex lesions. So until we have that, I would say, that we should reserve it for the non-complex, noncalcified lesions.

    Might bioresorbable scaffolds replace DES as the gold standard for treating Acute Coronary Syndrome (ACS) in the future? Sharma thinks it will be used as “a specialty item”, particularly because of some limitations, such as when treating lesions around coronary artery bifurcations or in very large vessels.

    “Once we improve techniques and maybe get second generations of biodegradable stents, at the peak time my prediction is, that it could take up to 40 percent of the DES-market.”

     


    Doctor 2 0 MedicalExpo Partnership
    Innovation Focus
    ViosWorks offers a way of encoding all of the diagnostic information at once
    Screen capture of a 4D flow acquisition of a full chest (Courtesy of Arterys)

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    Accelerated visualization, depicting 3D cardiac anatomy, function, and flow analysis, with cloud-based image processing, are key advances of ViosWorks, a major innovation for cardiac MRI. Although ViosWorks is not yet commercially available, GE Healthcare and the San Francisco start-up Arterys showcased it at the...

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    CONTRIBUTORS



    Guy Ramsay

    Guy Ramsay is a South African medical writer.


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    Celia Sampol

    Celia Sampol is a journalist with 13 years of experience in Paris, Brussels and Washington. She’s now the editor-in-chief of MedicalExpo e-magazine.


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    Laura Newman

    Laura Newman is a New York-based medical writer who writes frequently about medical technological advances and health policy.


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    Kristina Müller

    Kristina Müller is a freelance journalist writing mainly about nautical and medical issues.


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    Kerry Sheridan

    Kerry Sheridan is an authors and health journalist based in Miami, Florida.


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    Christina Kuhrcke

    Christina Kuhrcke is a Berlin-based freelance journalist, doctor and digital storyteller.


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