Faculty Bibliography

INTRODUCTION: A modern ventricular assist device (VAD) system comprises an implantable rotary blood pump and external components located outside the patient's body: a wearable controller connected to the pump via a percutaneous cable, wearable rechargeable batteries, battery charger, alternating- and direct-current power supplies, and a hospital device to control and monitor the system. If the blood pump is the 'heart' of a VAD system, the controller is its 'brain.' The controller drives the pump's electrical motor; varies the pump speed or flow based on user commands or feedback signals; collects, processes, and stores data; performs self-diagnostics; transmits to and receives data from other system components, i.e., hospital monitor and batteries; and provides various types of user interface - audible, visual, and tactile. Areas covered: Here we describe the essential functions and basic design of the VAD external controller and give our views on the future of this technology. Expert commentary: Controllers for VAD systems are crucial to their successful operation. The current clinically available system comprises an external power supply and patient-friendly controller unit. Future controller solutions may enable remote hospital monitoring, more intuitive system interface, and the potential to use a single controller to automatically control a biventricular assist device configuration.

INTRODUCTION: Heart failure (HF) remains a major global burden in terms of morbidity and mortality. Despite advances in pharmacological and resynchronization device therapy, many patients worsen to end-stage HF. Although the gold-standard treatment for such patients is heart transplantation, there will always be a shortage of donor hearts. Areas covered: A left ventricular assist device (LVAD) is a valuable option for these patients as a bridge measure (to recovery, to candidacy for transplant, or to transplant itself) or as destination therapy. This review describes the current indications for and complications of the most commonly implanted LVADs. In addition, we review the potential and promising new LVADs, including the HeartMate 3, MVAD, and other LVADs. Studies investigating each were identified through a combination of online database and direct extraction of studies cited in previously identified articles. Expert commentary: The goal of LVADs has been to fill the gap between patients with end-stage HF who would likely not benefit from heart transplantation and those who could benefit from a donor heart. As of now, the use of LVADs has been limited to patients with end-stage HF, but next-generation LVAD therapy may improve both survival and quality of life in less sick patients.

The development of total artificial heart devices is a complex undertaking that includes chronic biocompatibility assessment of the device. It is considered particularly important to assess whether device design and features can be compatible long term in a biological environment. As part of the development program for the Cleveland Clinic continuous-flow total artificial heart (CFTAH), we evaluated the device for signs of thrombosis and biological material deposition in four animals that had achieved the intended 14-, 30-, or 90-day durations in each respective experiment. Explanted CFTAHs were analyzed for possible clot buildup at "susceptible" areas inside the pump, particularly the right pump impeller. Depositions of various consistency and shapes were observed. We here report our findings, along with macroscopic and microscopic analysis post explant, and provide computational fluid dynamics data with its potential implications for thrombus formation.

For patients in cardiogenic shock, several devices can serve as a "bridge," ie, provide circulatory support and allow the patient to live long enough to recover or to receive a heart transplant or a long-term device. Options include an intra-aortic balloon pump, TandemHeart, Impella, extracorporeal membrane oxygenation (ECMO), and CentriMag. Which device to use depends on individual patient needs, local expertise, and anatomic and physiologic considerations.

INTRODUCTION: The benefits and disadvantages of pulsatility in mechanical circulatory support devices have been argued since before the first use of cardiopulmonary bypass (CPB) with a nonpulsatile pump. The debate over the superiority of either pulsatile or nonpulsatile perfusion during CPB persists, but recently, the evidence in favor of pulsatile perfusion during CPB is increasing. Complications associated with chronic nonpulsatile flow in patients implanted with left ventricular assist devices have renewed interest in generating pulsatility with these devices. Areas covered: Here we review the definition of pulsatility, the outcomes of CPB using pulsatile and nonpulsatile pumps, and how best to produce and assess pulsatility. This information was identified through online databases and direct extraction of single studies cited in previously identified reports. Expert commentary: The newer generation of biocompatible pulsatile pumps that can generate physiologic pulsation may prove beneficial during temporary support for short-term use during CPB or intermediate support for cardiogenic shock.

BACKGROUND: Changes in the geometry of the HeartMate II (HMII) inflow cannula have been implicated in device thrombosis post-implant. The purpose of this in vitro study was to evaluate what effects changing the angle of the cannula in relation to the pump may have on pump flow and arterial pressure, under simulated inflow conditions. METHODS: The HMII with an inflow cannula was mounted on a mock loop consisting of a pulsatile pneumatic ventricle to simulate the native ventricle. The angles of the HMII in relation to the inflow cannula were adjusted by separate fixed gooseneck holders. A custom-made miniature steerable camera was introduced into a flexible portion of the HMII inflow cannula. Endoscopic views of various types of inflow cannula constriction (bending, squeezing, stretching and twisting) were recorded, and pump flow and systemic arterial pressure (AoP) were assessed during each simulation. RESULTS: Baseline mean pump flow (3.5 liters/min) and mean AoP (91.5 mm Hg) were unchanged by bending maximally in 2 different directions, twisting up to 30 degrees , stretching (compression or extension), or occluding the inflow graft <90%. However, mean pump flow and mean AoP decreased substantially when the inflow graft became occluded by >/=90% by sliding or squeezing. CONCLUSIONS: "Less-than-critical" obstruction (what we define here as <90%) of the HMII inflow cannula did not reveal substantial changes in pump flow or AoP. Data suggest that a major alteration to inflow cannula geometry is required to achieve clinically relevant hemodynamic changes. These data confirm that minor changes in angulation of the inflow cannula have no impact on flow through the device.

There is insufficient data on patients with small body size to determine if this should be considered a risk factor for continuous-flow left ventricular assist device (CF-LVAD) support. We sought to evaluate survival outcomes, adverse events, and functional status of CF-LVAD patients with body surface area (BSA) <1.5 m in a large national registry. Adults with BSA < 1.5 m (n = 128) implanted with a HeartMate II (HMII)-LVAD from the Interagency Registry for Mechanically Assisted Circulatory Support registry from April 2008 to December 2012 formed this cohort. Outcomes were compared with HMII bridge to transplant (BTT) and destination therapy (DT) post approval studies. The majority of patients were female (n = 106, 83%). A total of 64% (n = 82) were implanted for BTT and 36% (n = 46) for DT. The median BSA (range) was 1.44 (1.19-1.49) and 1.45 (1.25-1.49) m for BTT and DT, respectively. Overall survival 1 year post implant was 81% +/- 5% for BTT and 84% +/- 6% for DT. The most common adverse events for BTT and DT patients were bleeding (0.91, 0.88 events/patient year) and driveline infection (16%, 0.28 events/patient year). Six months post implantation, 87% of BTT and 77% of DT patients were New York Heart Association functional class I or II. Post implant survival, functional status improvement, and adverse event profile for adult BTT and DT HMII patients with BSA < 1.5 m are favorable and comparable with outcomes published in the overall patient population.