HVAD's Exit: A Cliffhanger Season Finale in the History of Left Ventricular Assist Devices
- The ideals for left ventricular assist devices are and always shall be an evolving target.
- As the field continues to advance, often fueled by competition, it is important to acknowledge if a superior technology has emerged so that patients are directed to the best contemporary therapy.
- Medtronic's decision to discontinue HeartWare Ventricular Assist Device is a success of medical device feedback and monitoring.
- The current era of durable mechanical circulatory support technologies serves many advanced heart failure patients well, however there will always be opportunities for continued innovation and advancement.
Biomedical science and technology are not about finding a solution that works and moving on. It is an iterative innovative field. Today's aircraft are nothing like the first successful models of aircraft developed by the Wright brothers, and the needs for powered air travel are diverse and changing, like the healthcare needs of society. Our current options for durable ambulatory mechanical circulatory support (MCS) are increasingly more sophisticated and compact than the early cardiopulmonary bypass machines and ventricular assist devices.
On June 3, 2021, Medtronic informed implanting centers to stop implants of the HeartWare Ventricular Assist Device (HVAD) system, citing higher frequency of neurologic events, mortality, and risk of pump restart failure.1 Medtronic's decision to discontinue HVAD is a success of medical device feedback and monitoring, ensuring patients are prospectively provided the best contemporary technology without abandoning those supported by prior best practices and devices. This is not a signal that competition is over in this space or that we have reached the pinnacle of durable advanced MCS. Instead, we are likely at a pivot point in the history of MCS in which we will see exciting innovation from emerging thinkers or established leaders in healthcare engineering and newer small companies emerging in the field.
Every iteration of technology is a building block for the next generation of innovation. Automotive technology is constantly evolving, and it is not always the same manufacturers making the newest fastest, sleekest, slimmest models. We must ensure the cycle of innovation and progress does not stop with this change in players. Instead, we continue to learn from all that HeartWare, and Medtronic have brought to the field. HeartWare should be celebrated for pushing the envelope in MCS. The ability of HeartWare monitors to allow instantaneous visualization of waveforms has provided valuable real-time clinical insight that can be applied immediately at the bedside: a true boon to the patient and clinician alike. Similarly, Medtronic should be lauded for promoting an innovative surgical approach and becoming the first commercially available left ventricular assist system (LVAS) to gain US Food and Drug Administration (FDA) approval for implant via thoracotomy.2 The progress demonstrated by the HeartMate 3™ was built upon lessons learned from its predecessors as well as its competitors. With the HeartMate 3™, Abbott moved the field forward with improved reliability of devices and decreased incidence of stroke.1,3 Abbott is actively advancing the path of less invasive implantation with the SWIFT trial, studying surgical alternatives to the traditional full median sternotomy.4 The anticipation of what will come racing to the forefront next and by whom, should give us anticipatory excitement.
The progress to date is outstanding yet there is still much work to be done. Patients and doctors are not satisfied. We call to industry and healthcare organizations to support the necessary continued innovation of established technology to further improve established standards of care and to innovate to meet those still unserved by today's technology. There are vulnerable subpopulations of cardiac patients waiting for this innovation, such as children, small-framed adults, and those with predominantly right-sided heart failure or heart failure with preserved ejection fraction. MCS technology currently has many areas for continued improvement and growth, including but certainly not limited to the technology of power transfer, power storage, and automating remote timely communication of pertinent clinical data. We eagerly await the miniaturization of fully magnetically levitated devices, automatic LVAS response to physiologic change, electrical inductance applied to replace a physical transcutaneous driveline, smaller and lighter battery technology to ease the way for patients, and automated remote monitoring and notification of LVAS parameters.
We stand on a foundation built upon decades of great products developed in part from lessons learned by numerous iterations of LVAS. Heart failure is a growing problem in the Unites States and the rest of the world. It is only logical to expect that as a giant step down from the LVAD market, this void will be filled with innovation and improvement on previous technologies that will continue to challenge contemporary durable MCS, further elevating the field of advanced heart failure therapies.
- Urgent Medical Device Communication Notification Letter Medtronic HVAD™ System (Medtronic.com). 2021. Available at: https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-urgent-medical-device-notice-june-2021.pdf. Accessed 07/02/2021.
- McGee E Jr, Danter M, Strueber M, et al. Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: the LATERAL clinical trial. J Heart Lung Transplant 2019;38:344-51.
- Mehra MR, Uriel N, Naka Y, et al. A fully magnetically levitated left ventricular assist device - final report. N Engl J Med 2019;380:1618-27.
- Abbott Medical Devices. Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy SWIFT HM3 PMS (SWIFT) (ClinicalTrials.gov). 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04548128. Accessed 07/02/2021.
Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Noninvasive Imaging, Cardiac Surgery and Heart Failure, Acute Heart Failure, Mechanical Circulatory Support, Magnetic Resonance Imaging
Keywords: Heart Failure, Heart-Assist Devices, Sternotomy, Thoracotomy, Cardiopulmonary Bypass, United States Food and Drug Administration, Reproducibility of Results, Standard of Care, Stroke Volume, Heart Ventricles, Magnetic Resonance Imaging, Delivery of Health Care, Stroke, Family Characteristics
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