In Vitro Study of a Medical Device to Enhance Arteriovenous Fistula Eligibility and Maturation.

The arteriovenous fistula eligibility (AFE) system (Flow Forward Medical, Olathe, KS) is a small, temporary, wearable rotary blood pump system designed to rapidly dilate peripheral veins in hemodialysis patients and improve outcomes after arteriovenous fistula (AVF) creation. A benchtop pulsatile mock circulatory loop was developed to model forearm circulation and to compare the hemodynamics of the AFE system with those of a conventional radiocephalic AVF. The AFE system maintained a mean wall shear stress (mWSS) within the 2.5-7.5 Pa target range for cephalic outflow veins of 2-6 mm diameter, which when applied clinically will provide better control of mWSS during the outflow vein maturation process when compared with a conventional AVF. These results support further study to determine whether or not vein preconditioning with the AFE system under controlled levels of mWSS will promote improved AVF outcomes.

Pediatric Mechanical Support with an External Cardiac Compression Device.

The PediBooster external cardiac compression device is a minimally invasive, non-blood contacting Biventricular Assist Device (BiVAD) intended for pediatric use. It is being developed as a palliative therapy for acute Postcardiotomy Shock (PCS). The PediBooster extracardiac wrap is pneumatically actuated to circumferentially compress the heart, providing co-pulsation support. Attachment is via a novel hydrogel coating. Early versions of the wrap were tested in vivo using a single ventricle congenital heart disease model with postcardiotomy shock, which proved unstable and demonstrated high peri-operative mortality. The final wrap design was tested in 4 acute studies with piglets (5.1 ± 0.3 kg), where the combination of ASD and PA banding induced acute right ventricular dysfunction. Data collected included routine hemodynamic values, TEE, video of the exposed heart, and cardiac histology. The model proved stable for support durations ranging from 2 to 16 hours. The wrap restricted the heart in 3 of the 4 animals, as evidenced by increased diastolic LVP during support compared to the baseline failure condition. TEE and video data showed good attachment and function of the wrap, particularly during the final 16 hr study. This model of congenital heart disease shows promise for chronic (24-72 hr) studies. Ventricular filling during support may be improved by adjusting wrap dimensions to eliminate end diastolic restriction.

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.

Incorporation of electronics within a compact, fully implanted left ventricular assist device.

The promise of expanded indications for left ventricular assist devices in the future for very long-term applications (10+ years) prompts sealed (i.e. fully implanted) systems and less-obtrusive and more reliable implanted components than their external counterparts in percutaneous configurations. Furthermore, sealed systems increase the fraction of total power losses dissipated intracorporeally, a disadvantage that must be carefully managed. We set out to incorporate the motor drive and levitation control electronics within the HeartMate III blood pump without substantially increasing the pump's size. Electronics based on a rigid-flex satellite printed circuit board (PCB) arrangement that could be folded into a very compact, dense package were designed, fabricated, and tested. The pump's lower housing was redesigned to accommodate these PCBs without increasing any dimension of the pump except the height, and that by only 5 mm. The interconnect cable was reduced from 22 wires to 10 (two fully redundant sets of 5). An ongoing test of the assembled pump in vitro has demonstrated no problems in 5 months. In addition, a 20-day in vivo test showed only 1 degrees C temperature rises, equivalent to pumps without incorporated electronics at similar operating conditions.