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One of the Greatest Medtech Innovations of Our Time, 40 Years Later

In honor of the 40th anniversary of the first human implant of an implantable cardioverter-defibrillator (ICD), we look back at the key moments in ICD history.

  • Mieczyslaw "Michel" Mirowski (pictured above on the right) and Morton Mower begin work in July 1969 on what would ultimately become the first ICD. Although they successfully tested their first crude prototype of the device (made from a broken external defibrillator paddle) on a dog just one month after their work began, the first human implant of the ICD occured nearly 11 years later, on Feb. 4, 1980.

    All this week, MD+DI will pay tribute to Mirowski, Mower, and others who pioneered the ICD field, as well as the researchers and companies that continue to advance ICD therapy today. To kick things off, here is a look back at the key moments in ICD history.

  • Shown above is an example of an abdominal implanted ICD system in a 15-year-old female, courtesy of the U.S. National Library of Medicine.

    Although the first ICD model implanted in a human was considered a success in 1980, the device was bulky, required a thoracotomy for implantation of the electrode patches, and was only capable of defibrillation. In the years that followed, however, numerous advances in ICD design were made and Mirowski and Mower were both involved in many of those early refinements, including the additional capacity of synchronized cardioversion for ventricular tachycardia. True to Mirowski's original vision, a catheter-electrode-based model developed in the late 1980s could be implanted without a thoracotomy, in a similar manner to the way a pacemaker is implanted.

    FDA approved the world's first ICD in 1985 under the tradename Automatic Implantable-Cardioverter Defibrillator (AICD). The general term implantable-cardioverter defibrillators was introduced in the late 1980s as other manufacturers came out with their own versions of the technology. The ACID was manufactured by Intec Systems, a subsidiary of Medrad. Eli Lilly acquired Intec in 1985 and later spun it out as Guidant, which was acquired in 2006 by Boston Scientific.

  • In 2005, serious malfunction issues concerning ICDs from major manufacturers were brought to light, and bad press continued into 2006. The scandal spurred increased scrutiny from FDA, motivated a response from CMS, and prompted a panel discussion from the Heart Rhythm Society. In 2007, a study in the Journal of the American Medical Association found significant complication rates -- 5.8% of 3,000 patients -- in procedures to remove certain ICD models after they were recalled.

    In August 2006, Medtronic initiated a nearly $100 million marketing and public relations campaign to rebuild the ICD market, "Candidly, we were surprised by the extent to which the U.S. ICD market softened during the quarter and particularly at quarter end, and we are doing everything we can to ensure it doesn't happen again," Art Collins, Medtronic's CEO at that time, said during an earnings call. The company reported a 6% revenue drop during its first quarter of fiscal 2007, compared to the first quarter of fiscal 2006.

    Image by Gerd Altmann on Pixabay
  • As ICDs became more mainstream, scientists looked for ways to improve the devices. In January 2005, MD+DI reported on research out of Johns Hopkins University suggesting that reprogramming ICDs may help prevent a rare episode in patients suffering from an abnormally rapid heartbeat.

    The device usually jolts the heart back to a normal rhythm. However, in rare instances, the pulse has an adverse effect and sets off a faster, more hazardous rhythm, the researchers explained. The rapid pumping of the heart can become indistinguishable from ventricular fibrillation, a condition that can cause death in minutes if medical attention isn't provided. When this happens, the ICD delivers a painful shock in an attempt to reestablish a normal heartbeat.

    Biomedical engineers at Johns Hopkins performed a study on heart cell cultures and found that the cause of these dangerous arrhythmias may be a result of multiarm spirals. The spirals are waves of electrical activity that form when the pulse from an ICD is applied. Upon electrical stimulation, the single wave, or arm, can multiply.

    "Multiarm spirals could be a mechanism by which ICDs sometimes accelerate the ventricular tachycardia, making it more dangerous and more likely to turn into fibrillation, rather than stopping it," said Nenad Bursac, assistant professor in the biomedical engineering department at Duke University who performed the research and data analysis at Johns Hopkins.

    Bursac explained that the regular jolt of an ICD can cause harm by trying to alleviate all the spirals at once. "ICDs could be programmed to try to first annihilate one of the spiral arms and slow down the tachycardia, making it safer, before attempting to finally terminate it," he said.

    Based on the experiments, it may be possible to program a pacing rate slower than that of accelerated tachycardia in ICDs, Bursac proposed.

  • Biotronik has been a significant contributor to the advancement of ICD therapy since the development of the first FDA-approved single-lead ICD capable of performing both pacing and atrial sensing.

    The technology provides the benefits of the single and dual-chamber in a single-lead device. This was important because single-chamber ICDS were designed to only sense changes in ventricular rhythm and were unable to sense atrial arrhythmias, such as atrial fibrillation, which increased the patient's risk of an inappropriate shock or potentially even a stroke. Because there is only one lead to implant, Biotronik's device also represented an opportunity for less complex and less costly procedures, along with fewer lead-related complications.

    Image Courtesy of Biotronik
  • Boston Scientific's Emblem S-ICD represented a significant advancement in the space as it removed what many believe is the weakest link in ICDs - the leads in the heart. The device that came to Boston Scientific through the Cameron Health acquisition in 2012 is inserted just under the skin near the chest.

    In 2015 the European Society of Cardiology updated its guidelines to allow physicians to use the S-ICD in a certain group of patients. Then, in 2016, the company launched an MR-conditional version of the device, first in Europe and then in the United States. The MR conditional labeling also covered Embelm S-ICDs that had already been implanted in patients.

    In addition, the Emblem MRI S-ICD added on two more new capabilities--the SMART Pass technology to ensure defibrillation therapy is administered only when needed, and the AF Monitor element to inform clinicians about episodes of atrial fibrillation. The SMART Pass technology also became available to alread-implanted devices via a software update.

    Image Credit: Boston Scientific
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