Design Rationale and Preclinical Evaluation of the HeartMate 3 Left Ventricular Assist System for Hemocompatibility.

The HeartMate 3 (HM3) left ventricular assist device (LVAD) is designed to support advanced heart failure patients. This centrifugal flow pump has a magnetically levitated rotor, artificial pulse, textured blood-contacting surfaces, optimized fluid dynamics, large blood-flow gaps, and low shear stress. Preclinical tests were conducted to assess hemocompatibility. A computational fluid dynamics (CFD) model guided design for low shear stress and sufficient washing. Hemolysis testing was conducted on six pumps. Plasma-free hemoglobin (PfHb) and modified index of hemolysis (MIH) were compared with HeartMate II (HMII). CFD showed secondary flow path residence times between 27 and 798 min, comparable with main flow residence times between 118 and 587 min; HM3 vs. HMII shear stress exposure above 150 Pa was 3.3 vs. 11 mm within the pump volume and 134 vs. 604 mm on surfaces. In in vitro hemolysis tests at 2, 5, and 10 L/min, average pfHb 6 hours after test initiation was 58, 74, and 157 mg/dl, compared with 112, 123, and 353 mg/dl for HMII. The HM3/HMII ratio of average MIH at 2, 5, and 10 L/min was 0.29, 0.36, and 0.22. Eight 60 day bovine implants were tested with average flow rates from 5.6 to 6.4 L/min with no device failures, thrombosis, or hemolysis. Results support advancing HM3 to clinical trials.

Design features, developmental status, and experimental results with the Heartmate III centrifugal left ventricular assist system with a magnetically levitated rotor.

A long-term left ventricular assist system for permanent use in advanced heart failure is being developed on the basis of a compact centrifugal pump with a magnetically levitated rotor and single-fault-tolerant electronics. Key features include its "bearingless" (magnetic levitation) design, textured surfaces similar to the HeartMate XVE left ventricular assist device (LVAD) to reduce anticoagulation requirements and thromboembolism, a sensorless flow estimator, and an induced pulse mode for achieving an increased level of pulsatility with continuous flow assistance. In vitro design verification testing is underway. Preclinical testing has been performed in calves demonstrating good in vivo performance at an average flow rate of 6 L/min (maximum: >11 L/min) and normal end-organ function and host response. Induced pulse mode demonstrated the ability to produce a physiological pulse pressure in vivo. Thirteen LVADs have achieved between 16 to 40 months of long-term in vitro reliability testing and will be continued until failure. Both percutaneous and fully implanted systems are in development, with a modular connection for upgrading without replacing the LVAD.

In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the proximal and distal aorta.

The increasing clinical use of rotary left ventricular assist devices (LVADs) suggests that chronic attenuation of arterial pulse pressure has no clinically significant detrimental effects. However, it remains possible that modulating LVAD rotor speed to produce an artificial pulse may be of temporary or occasional benefit. We sought to evaluate a pulse produced by a continuous-flow, centrifugal pump in an ovine thoracic and abdominal aorta. Both ventricles of an adult sheep were resected to eliminate all native cardiac contributions to pulsatility, each replaced by a continuous-flow Thoratec HeartMate III blood pump (Burlington, MA, USA). An LVAD-induced pulsatile flow was achieved by sharply alternating the speed of the magnetically levitated rotor of the left pump between 1,500 rpm (artificial diastole) and 5,500 rpm (artificial systole) at a rate of 60 bpm at a "systolic" interval of 30%. A catheter was advanced from the ascending aorta to the iliac bifurcation via the ventricular assist device outflow graft for pressure measurement and data acquisition. The mean LVAD-induced pulse pressures were 34, 29, 27, and 26 mm Hg in the ascending, thoracic, and abdominal aorta, and the iliac bifurcation, respectively. The maximum rate of pressure rise (deltap/deltat) was between 189 and 238 mm Hg/s, approaching that of the native pulse, although the energy equivalent pressure did not exceed the mean arterial pressure. The HeartMate III's relatively stiff speed control, low rotor mass, and robust magnetic rotor suspension result in a responsive system, enabling very rapid speed changes that can be used to simulate physiologic pulse pressure and deltap/deltat.

Computational fluid dynamics analysis of a maglev centrifugal left ventricular assist device.

The fluid dynamics of the Thoratec HeartMate III (Thoratec Corp., Pleasanton, CA, U.S.A.) left ventricular assist device are analyzed over a range of physiological operating conditions. The HeartMate III is a centrifugal flow pump with a magnetically suspended rotor. The complete pump was analyzed using computational fluid dynamics (CFD) analysis and experimental particle imaging flow visualization (PIFV). A comparison of CFD predictions to experimental imaging shows good agreement. Both CFD and experimental PIFV confirmed well-behaved flow fields in the main components of the HeartMate III pump: inlet, volute, and outlet. The HeartMate III is shown to exhibit clean flow features and good surface washing across its entire operating range.