Physiologic and hematologic concerns of rotary blood pumps: what needs to be improved?

Over the past few decades, advances in ventricular assist device (VAD) technology have provided a promising therapeutic strategy to treat heart failure patients. Despite the improved performance and encouraging clinical outcomes of the new generation of VADs based on rotary blood pumps (RBPs), their physiologic and hematologic effects are controversial. Currently, clinically available RBPs run at constant speed, which results in limited control over cardiac workload and introduces blood flow with reduced pulsatility into the circulation. In this review, we first provide an update on the new challenges of mechanical circulatory support using rotary pumps including blood trauma, increased non-surgical bleeding rate, limited cardiac unloading, vascular malformations, end-organ function, and aortic valve insufficiency. Since the non-physiologic flow characteristic of these devices is one of the main subjects of scientific debate in the literature, we next emphasize the latest research regarding the development of a pulsatile RBP. Finally, we offer an outlook for future research in the field.

Power consumption of rotary blood pumps: pulsatile versus constant-speed mode.

We investigated the power consumption of a HeartMate III rotary blood pump based on in vitro experiments performed in a cardiovascular simulator. To create artificial-pulse mode, we modulated the pump speed by decreasing the mean speed by 2000 rpm for 200 ms and then increasing speed by 4000 rpm (mean speeds plus 2000 rpm) for another 200 ms, creating a square waveform shape. The HeartMate III was connected to a cardiovascular simulator consisting of a hydraulic pump system to simulate left ventricle pumping action, arterial and venous compliance chambers, and an adjustable valve for peripheral resistance to facilitate the desired aortic pressure. The simulator operated based on Suga's elastance model to mimic the Starling response of the heart, thereby reproducing physiological blood flow and pressure conditions. We measured the instantaneous total electrical current and voltage of the pump to evaluate its power consumption. The aim was to answer these fundamental questions: (i) How does pump speed modulation affect pump power consumption? (ii) How does the power consumption vary in relation to external pulsatile flow? The results indicate that speed modulation and external pulsatile flow both moderately increase the power consumption. Increasing the pump speed reduces the impact of external pulsatile flow.

ACTION-ARC Pediatric and Adult Congenital Heart Disease Ventricular Assist Device Adverse Event Definitions-2023.

Adverse events (AEs) experienced by children and adults with congenital heart disease (CHD) on ventricular assist devices (VADs) are sometimes unique to these populations. The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) and the Academic Research Consortium (ARC) aimed to harmonize definitions of pediatric and CHD AEs for use in clinical trials, registries, and regulatory evaluation. Data from the ACTION registry and adjudication committee were used to adapt general mechanical circulatory support ARC definitions. This ACTION-ARC international expert panel of trialists, clinicians, patients, families, statisticians, biomedical engineers, device developers, and regulatory agencies drafted and iterated definitions harmonized to ACTION data and existing literature during sessions conducted between December 2022 and May 2023, followed by dissemination across clinical/research audiences and professional organizations and further revision. Both email-linked, internet-based surveys and in-person discussions were used as a modified Delphi process. Nineteen AE types were identified and defined, including seven new event types and six event types that were deleted and will no longer be collected, achieving consensus. ACTION-ARC paired rigorous development with methodical stakeholder involvement and dissemination to define pediatric VAD AEs to facilitate assimilation of data across future clinical trials and evaluation of devices for VAD-supported children and adults with CHD.

Adverse Hemodynamic Consequences of Continuous Left Ventricular Mechanical Support: JACC Review Topic of the Week.

Left ventricular assist devices (LVADs) provide lifesaving therapy for patients with advanced heart failure. The recognition of pump thrombosis, stroke, and nonsurgical bleeding as hemocompatibility-related adverse events (HRAEs) led to pump design improvements and reduced adverse event rates. However, continuous flow can predispose patients to right-sided heart failure (RHF) and aortic insufficiency (AI), especially as patients live longer with their device. Given the hemodynamic contributions to AI and RHF, these comorbidities can be classified as hemodynamic-related events (HDREs). Hemodynamic-driven events are time dependent and often manifest later than HRAEs. This review examines the emerging strategies to mitigate HDREs, with a focus on defining best practices for AI and RHF. As we head into the next generation of LVAD technology, it is important to differentiate HDREs from HRAEs so that we can continue to advance the field and improve the true durability of the pump-patient continuum.

Graft Resistance Difference after HVAD to HeartMate 3 Left Ventricular Assist Device Exchange.

BACKGROUND: A likely consequence of the discontinued distribution and sale of the HVAD System (Medtronic, Minneapolis, MN) will be an increase in replacement with the HeartMate 3 (Abbott, Chicago, IL) left ventricular assist device when device exchange is necessary. If part or all of the HVAD 10-mm-diameter outflow graft is retained during replacement, the HeartMate 3 will have to run at a higher speed than it would with its 14-mm-diameter graft. METHODS: A steady-state, in vitro study was run with 250-mm-long samples of HVAD, HeartMate 3, and half-HVAD/half-HeartMate 3 grafts and additionally 125- and 375-mm-long samples of the HVAD graft. Flows of 3.0, 3.9, 4.3, 4.7, and 6.0 L/min were applied to encompass expected clinical conditions. RESULTS: At typical and high flow rates of 4.3 and 6.0 L/min, HeartMate 3 rotor speeds with the full HVAD graft had to be increased relative to those with the HeartMate 3 graft from 5350 to 5700 and 6350 to 6900 rpm, respectively, with power consumption increases from 3.7 to 4.3 W (16%) and 5.5 to 6.8 W (24%), respectively. CONCLUSIONS: The study did not elucidate a severe consequence of using a remnant HVAD graft during pump exchange, but the incremental risks of a higher rotor speed, disadvantage to the patient in battery runtime, and the general benefit of complete conversion to the HeartMate 3 graft should be balanced against other procedural considerations. Complete graft replacement during HVAD-to-HeartMate 3 conversion remains the preferred approach from an engineering point of view.

Outcomes in Smaller Body Size Adults After HeartMate 3 Left Ventricular Assist Device Implantation.

BACKGROUND: Outcomes in patients with smaller body size after HeartMate 3 left ventricular assist device (HM3) implantation are not well characterized. We sought to evaluate outcomes in smaller vs larger body surface area (BSA) patients in the MOMENTUM 3 pivotal trial and its Continued Access Protocol cohort. METHODS: The analysis cohort included 1015 HM3 patients divided into 2 groups: BSA ≤1.70 m2 (small patients, n = 82) and BSA >1.70 m2 (large patients, n = 933). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or to remove a malfunctioning device. Adverse events were compared between groups. RESULTS: Smaller patients were more frequently women (56.1% vs 17.7%; P < .001) and had lower prevalence of diabetes (28.1% vs 43.9%; P = .005) and hypertension (51.2% vs 71.9%; P < .001), larger median indexed LVEDD (normalized by BSA, 40 vs 33 mm/m2; P < .001), and lower median serum creatinine concentration (1.1 vs 1.3 mg/dL; P < .001). The proportion of patients achieving the composite end point at 2 years was 77% in both groups (adjusted hazard ratio, 1.14; 95% CI, 0.68-1.91; P = .62). Two-year adverse event rates were also similar between groups except for sepsis (6.1% vs 14.9%; P = .029) and cardiac arrhythmias (24.4% vs 35.3%; P = .005), which were higher in the larger patients. CONCLUSIONS: Outcomes after HM3 implantation were comparable between small and large patients. Smaller body size should not be used to deny HM3 implantation in patients who are otherwise suitable candidates for durable mechanical circulatory support.

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.

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.

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.