Clinician-to-Clinician Update Clinician-to-Clinician Update

New Devices in the Treatment of Heart Failure

November 2017

Heart failure affects about 5.7 million adults in the United States. About 50 percent of all patients with heart failure will die within 5 years of diagnosis.1 Although mild-to-moderate heart failure can be managed medically, the approach has limited efficacy for patients with advanced stages of the condition.2 Patients whose symptoms progress on optimal medical management may be treated with surgically implantable devices, including mechanical circulatory support devices. For severe heart failure, cardiac transplantation remains the gold standard; however, the limited availability of donor organs and other factors can limit access to this treatment.

In recent years, left ventricular assist devices (LVADs) have become a viable treatment option for patients not eligible for transplantation as well as a bridge to transplant for others with advanced heart disease. An electromechanical device, LVADs assist cardiac circulation. In studies of second-generation, continuous-flow LVADs, the survival rate at 2 years for patients who received LVADs as a destination therapy was 62%.3 The 18-month survival rate for those who received LVADs as a bridge to transplant was 72%.4

Heart-Care-Consult-November-2017-Feature-Article-Main-Image-HM3 Pump MR
— The HeartMate 3(TM) Left Ventricular Assist System recently received FDA approval for short-term use. (System LVAD pictured.) Image provided courtesy of St. Jude Medical, Inc., ©2017 St. Jude Medical, Inc.

In August 2017, the FDA approved the latest generation LVAD, the HeartMate 3TM Left Ventricular Assist System (St. Jude Medical), for use in providing short-term mechanical circulatory support, either to support the heart during recovery from acute heart failure or as a bridge to a heart transplant.5 This LVAD employs a magnetically levitated pump without mechanical bearings that generates centrifugal force and an artificial pulse to move blood more efficiently out of the left ventricle and into the aorta.6 The new technology is designed to reduce the risk of pump thrombosis, which occurs when there is stasis of blood within the pump leading to clots and, in turn, to adverse neurological events or surgical replacement of pumps. The new technology may have a favorable effect on hemocompatibility when compared to previous devices.6

In early results from the Momentum 3 clinical trial of the device, out of a total of 294 patients, no pump thrombosis was observed in those who received the HeartMate 3, while 18 instances of suspected or confirmed pump thrombosis were observed in 14 patients who received the HeartMate II.6 University of Minnesota serves as a site for the Momentum 3 clinical trial and is one of the largest enrollers in the country in this clinical trial.

Heart failure is a complex disease whose effective management requires a care team of clinicians from multiple specialties to achieve good outcomes.7 The University of Minnesota Health heart failure program provides a comprehensive care team for the condition. Its physicians include cardiothoracic surgeons with extensive experience in implanting LVADs in patients with advanced heart failure.

References

  1. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics. Circulation. 2016;133(4):e38-e360.
  2. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013;128:e240-e327.
  3. Jorde UP, Kushwaha SS, Tatooles AJ, et al. Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol. 2014;63:1751-1757.
  4. Pagani FD, Miller LW, Russell SD, et al. Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device. J Am Coll Cardiol. 2009;54:312-321.
  5. Food and Drug Administration. August 2017 PMA Approval List. https://www.fda.gov/MedicalDevices/ProductsandMedi...
  6. Mehra MR, Naka Y, Uriel N, et al. A fully magnetically levitated circulatory pump for advanced heart failure. N Engl J Med. 2017;376:440-450.
  7. Chen-Scarabelli C, Saravolatz L, Hirsh B, et al. Dilemmas in end-stage heart failure. J Geriatr Cardiol. 2015;12(1):57-65.

When to refer

University of Minnesota Health Heart Care physicians treat all cases of heart failure, from congenital conditions in infants to severe heart failure in older adults. Our program provides a comprehensive, teambased approach to advanced heart care, and our University of Minnesota Heart Health cardiovascular and cardiothoracic surgeons are experienced in performing heart transplants and implanting ventricular assist devices, including the HeartMate II and HeartMate 3 left ventricular assist devices (LVAD) as well as the HeartWare LVAD. Our clinicians regularly enroll patients in trials of new transplant technologies that aim to provide patients a bridge to transplantation or improved transplant outcomes. Our program also provides access to the organ preservation systems OCS Heart and OCS Lung, currently approved for use in Europe and in clinical trial in the United States.

Multidisciplinary, Collaborative Care

No two cases of heart failure are alike. Diagnosing and treating heart failure is an art that requires close communication within teams and between heart care specialists and the referring physician. Because heart failure often occurs alongside other health conditions, our teams include cardiologists, cardiovascular surgeons, transplant surgeons, pulmonologists, cardiac rehabilitation specialists, endocrinologists and diabetes specialists, as well as immunologists skilled in managing patients with newly grafted hearts, nephrologists with experience treating chronic kidney conditions, and oncologists with knowledge of the effects of cancer treatment on the heart. Our goal is to treat the whole patient while maintaining a close collaboration with the referring physician. This approach gives referring physicians and their patients the best treatment and tools to maintain their heart health.

To request a free copy of the 2017 University of Minnesota Health Adult Specialty Directory, visit mhealth.org/for-medical-professionals/adult-specialty-directory.

To find current clinical trials available through University of Minnesota Health providers: studyfinder.umn.edu

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