First implantation in man of a new magnetically levitated left ventricular assist device (HeartMate III).

Outcomes of heart failure patients supported by a continuous-flow left ventricular assist device (LVAD) have steadily improved during the past decade, largely due to better patient selection and management. Nevertheless, adverse events, such as bleeding, infection, stroke, and thrombus, persist and limit the overall effectiveness of this therapy. Bleeding is the most common serious adverse event that results from the extensive surgery required for implantation and blood component damage due to shear forces in the small blood flow paths of current design axialflow and centrifugal-flow pumps. Excessive bleeding results in reoperations, intensive care time, and total hospital stay, which greatly increases a patient’s exposure for infection. The current clinically used pumps create levels of shear force that can activate platelets and damage von Willebrand factor, causing a disruption in the coagulation system that can manifest as thrombosis or gastrointestinal bleeding. The HeartMate III LVAD (Thoratec Corp, Pleasanton, CA) is a new compact intrapericardial centrifugal-flow pump with a full magnetically levitated rotor (Figure 1). The design differs from currently used devices due to actively controlled rotation and levitation of the rotor allowing gaps in the blood flow that are 10 to 20 times wider, which may minimize blood component trauma and result in more stable coagulation. The HeartMate III is now under clinical investigation, and we present here a case report of the first implantation of the device to support a patient with severe heart failure. The patient is a 55-year-old man with the diagnosis of dilated cardiomyopathy and a recent history of multiple hospital admissions due to worsening heart failure symptoms. With multiple medications, the mean arterial blood pressure was 70 mm Hg, cardiac index was 2.1 liters/min/m, and the left ventricular ejection fraction was 10% to 15%. He was classified as Interagency Registry for Mechanically Assisted Circulatory Support Profile 3. After meeting the HeartMate III Conformite Europeene Mark Study inclusion criteria, the patient gave informed consent, and the implantation was performed by Dr. Schmitto and his team at Hannover Medical School, Hanover, Germany on June 25, 2014. After a median sternotomy, the pericardium was only partially opened to help protect right heart function yet allowing access to the vena cava and aorta for cardiopulmonary bypass cannulation. Once full cardiopulmonary bypass was started, the pericardium was fully opened, the heart was elevated, and the myocardium was cored with the HeartMate coring knife approximately 1 cm medial to the left ventricular apex. The sewing cuff was attached around the apical opening with 2-0 Ethibond pledgeted sutures. The inflow conduit was inserted into the left ventricle, and the device was quickly secured to the heart with a locking mechanism. The outflow graft was trimmed for length and anastomosed to the ascending aorta. The percutaneous lead (driveline) was externalized with a doubletunnel technique and exited through the right upper quadrant of the abdominal wall. Cardiopulmonary bypass lasted 59 minutes, and the total operative time was 149 minutes.

[1]  R. John,et al.  Increase in left ventricular assist device thrombosis. , 2014, The New England journal of medicine.

[2]  M. Slaughter,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). , 2014, Journal of the American College of Cardiology.

[3]  L. Sylvia,et al.  Bridging with half-therapeutic dose enoxaparin in outpatients with left ventricular assist devices and sub-therapeutic international normalized ratios. , 2015, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[4]  M C Oz,et al.  Artificial circulatory support with textured interior surfaces. A counterintuitive approach to minimizing thromboembolism. , 1994, Circulation.

[5]  M. Mehra,et al.  The vexing problem of thrombosis in long-term mechanical circulatory support. , 2014, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[6]  F. Pagani,et al.  Gastrointestinal bleeding and subsequent risk of thromboembolic events during support with a left ventricular assist device. , 2012, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[7]  O. Frazier Increase in left ventricular assist device thrombosis. , 2014, The New England journal of medicine.

[8]  H. Antretter,et al.  Increase in left ventricular assist device thrombosis. , 2014, The New England journal of medicine.

[9]  N. Smedira,et al.  Continuous flow left ventricular assist device outcomes in commercial use compared with the prior clinical trial. , 2011, The Annals of thoracic surgery.