Faculty Bibliography
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385
Risk factors, mortality, and timing of ischemic and hemorrhagic stroke with left ventricular assist devices
BACKGROUND: Stroke is a major cause of mortality after left ventricular assist device (LVAD) placement. METHODS: Prospectively collected data of patients with HeartMate II (n = 332) and HeartWare (n = 70) LVADs from October 21, 2004, to May 19, 2015, were reviewed. Predictors of early (during index hospitalization) and late (post-discharge) ischemic and hemorrhagic stroke and association of stroke subtypes with mortality were assessed. RESULTS: Of 402 patients, 83 strokes occurred in 69 patients (17%; 0.14 events per patient-year [EPPY]): early ischemic stroke in 18/402 (4%; 0.03 EPPY), early hemorrhagic stroke in 11/402 (3%; 0.02 EPPY), late ischemic stroke in 25/402 (6%; 0.04 EPPY) and late hemorrhagic stroke in 29/402 (7%; 0.05 EPPY). Risk of stroke and death among patients with stroke was bimodal with highest risks immediately post-implant and increasing again 9-12 months later. Risk of death declined over time in patients without stroke. Modifiable stroke risk factors varied according to timing and stroke type, including tobacco use, bacteremia, pump thrombosis, pump infection, and hypertension (all p < 0.05). In multivariable analysis, early hemorrhagic stroke (adjusted odds ratio [aOR] 4.3, 95% confidence interval [CI] 1.0-17.8, p = 0.04), late ischemic stroke (aOR 3.2, 95% CI 1.1-9.0, p = 0.03), and late hemorrhagic stroke (aOR 3.7, 95% CI 1.5-9.2, p = 0.005) predicted death, whereas early ischemic stroke did not. CONCLUSIONS: Stroke is a leading cause and predictor of death in patients with LVADs. Risk of stroke and death among patients with stroke is bimodal, with highest risk at time of implant and increasing risk again after 9-12 months. Management of modifiable risk factors may reduce stroke and mortality rates.
PMID: 28110971
ISSN: 1557-3117
CID: 2465252
Mechanism of Self-Regulation and In Vivo Performance of the Cleveland Clinic Continuous-Flow Total Artificial Heart
Cleveland Clinic's continuous-flow total artificial heart (CFTAH) provides systemic and pulmonary circulations using one assembly (one motor, two impellers). The right pump hydraulic output to the pulmonary circulation is self-regulated by the rotating assembly's passive axial movement in response to atrial differential pressure to balance itself to the left pump output. This combination of features integrates a biocompatible, pressure-balancing regulator with a double-ended pump. The CFTAH requires no flow or pressure sensors. The only control parameter is pump speed, modulated at programmable rates (60-120 beats/min) and amplitudes (0 to +/-25%) to provide flow pulses. In bench studies, passive self-regulation (range: -5 mm Hg
PMID: 27401215
ISSN: 1525-1594
CID: 2465322
Is a pulse absolutely necessary during cardiopulmonary bypass?
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.
PMID: 27892719
ISSN: 1745-2422
CID: 2465242
The axial continuous-flow blood pump: Bench evaluation of changes in flow associated with changes of inflow cannula angle
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.
PMID: 28029574
ISSN: 1557-3117
CID: 2465232
Moderate hypothermia technique for chronic implantation of a total artificial heart in calves
The benefit of whole-body hypothermia in preventing ischemic injury during cardiac surgical operations is well documented. However, application of hypothermia during in vivo total artificial heart implantation has not become widespread because of limited understanding of the proper techniques and restrictions implied by constitutional and physiological characteristics specific to each animal model. Similarly, the literature on hypothermic set-up in total artificial heart implantation has also been limited. Herein we present our experience using hypothermia in bovine models implanted with the Cleveland Clinic continuous-flow total artificial heart.
PMID: 28238150
ISSN: 1619-0904
CID: 2465222
Thrombotic Depositions on Right Impeller of Double-Ended Centrifugal Total Artificial Heart In Vivo
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.
PMID: 27878837
ISSN: 1525-1594
CID: 2465272
Deairing Techniques for Double-Ended Centrifugal Total Artificial Heart Implantation
The unique device architecture of the Cleveland Clinic continuous-flow total artificial heart (CFTAH) requires dedicated and specific air-removal techniques during device implantation in vivo. These procedures comprise special surgical techniques and intraoperative manipulations, as well as engineering design changes and optimizations to the device itself. The current study evaluated the optimal air-removal techniques during the Cleveland Clinic double-ended centrifugal CFTAH in vivo implants (n = 17). Techniques and pump design iterations consisted of developing a priming method for the device and the use of built-in deairing ports in the early cases (n = 5). In the remaining cases (n = 12), deairing ports were not used. Dedicated air-removal ports were not considered an essential design requirement, and such ports may represent an additional risk for pump thrombosis. Careful passive deairing was found to be an effective measure with a centrifugal pump of this design. In this report, the techniques and design changes that were made during this CFTAH development program to enable effective residual air removal and prevention of air embolism during in vivo device implantation are explained.
PMID: 27654489
ISSN: 1525-1594
CID: 2465302
Stroke. 2016:47.DOI:
Mortality Due to Hemorrhagic and Ischemic Stroke Following Left Ventricular Assist Device. [Meeting Abstract]
ISI:000399956100039
ISSN: 1524-4628
CID: 2689582
The Contribution to Hemodynamics Even at Very Low Pump Speeds in the HVAD
BACKGROUND: We recently reported using bench testing that the Thoratec HeartMate II at 6,000 rpm contributed to hemodynamics when the heart had not recovered well, making weaning assessment questionable. In this bench study, we characterized hemodynamics and pump flow of the HeartWare HVAD at 1,800 rpm, the lowest speed commonly used to assess clinical recovery. METHODS: The HVAD was operated in a mock loop at 1,800, 2,400, and 3,000 rpm. We acquired pressure-flow curves in each steady state. In pulsatile mode with the pneumatic ventricle (heart simulator) activated, pump flow, total flow, and aortic pressure (AoP) data were obtained under conditions simulating normal heart function or heart failure. RESULTS: A large regurgitant flow during diastole was confirmed during normal heart function at 1,800 rpm support; however, the net flow was zero, and there was no difference in mean AoP between 1,800 rpm support and no HVAD support. In contrast, in the heart failure condition, HVAD flow at 1,800 rpm significantly contributed to mean AoP and total flow, because there was less regurgitant flow. CONCLUSIONS: Similar to the results for the HeartMate II at 6,000 rpm, we found that the net pump flow generated by the HeartWare HVAD at 1,800 rpm depends on the degree of residual left ventricular (LV) function. In the setting of improved LV function, at 1,800 rpm we noted a large regurgitant flow. Although this "marker" can serve as a useful indicator for recovery, assessing recovery at this speed is flawed unless measures are taken to prevent regurgitant flow.
PMID: 26912300
ISSN: 1552-6259
CID: 2465332
Mechanical circulatory support in pediatrics
End-stage heart failure affects thousands of children yearly and mechanical circulatory support is used at many points in their care. Extracorporeal membrane oxygenation supports both the failing heart and lungs, which has led to its use as an adjunct to cardiopulmonary resuscitation as well as in post-operative cardiogenic shock. Continuous-flow ventricular assist devices (VAD) have replaced pulsatile-flow devices in adults and early studies have shown promising results in children. The Berlin paracorporeal pulsatile VAD recently gained U.S. Food and Drug Administration approval and remains the only VAD approved in pediatrics. Failing univentricular hearts and other congenitally corrected lesions are new areas for mechanical support. Finding novel uses, improving durability, and minimizing complications are areas of growth in pediatric mechanical circulatory support.
PMID: 26950799
ISSN: 1745-2422
CID: 2465342
