Blood Volume Analysis of Total Artificial Heart Recipients: A Case Series.

Blood volume analysis provides a quantitative volume assessment in patients with equivocal or discordant clinical findings. Reports on its use in mechanical circulatory support are limited and it has never been described in patients with a total artificial heart. Our series demonstrates that patients supported with total artificial heart as a bridge to transplant have significant reductions in red blood cell volume and heterogeneous adaptations in their total blood volume and plasma volume. Pathologic derangements in our patient's total blood volume were targeted to restore euvolemia.

In Search of the Holy Grail of Artificial Hearts: Are We There Yet?

The total artificial heart (TAH) has a long and rich history, being the product of decades of innovation, hard work, and dedication. This review examines the history of the TAH, a device that has revolutionized the treatment of end-stage biventricular heart failure. It reviews the development of the device from early concepts to the current state-of-the-art device, the SynCardia TAH, which has been implanted in over 2,000 patients worldwide. The article also discusses the challenges and successes experienced by researchers, clinicians, and patients throughout the development of TAH devices. Our focus will also be on discussing the hemostatic alterations in patients implanted with TAH and anticoagulation strategies to decrease associated thromboembolic risks. The article concludes with a look at other novel TAH devices and the future of TAH as an increasingly viable treatment for end-stage heart failure.

Next Generation Development of Hybrid Continuous Flow Pediatric Total Artificial Heart Technology: Design-Build-Test.

To address the unmet clinical need for pediatric circulatory support, we are developing an operationally versatile, hybrid, continuous-flow, total artificial heart ("Dragon Heart"). This device integrates a magnetically levitated axial and centrifugal blood pump. Here, we utilized a validated axial flow pump, and we focused on the development of the centrifugal pump. A motor was integrated to drive the centrifugal pump, achieving 50% size reduction. The motor design was simulated by finite element analysis, and pump design improvement was attained by computational fluid dynamics. A prototype centrifugal pump was constructed from biocompatible 3D printed parts for the housing and machined metal parts for the drive system. Centrifugal prototype testing was conducted using water and then bovine blood. The fully combined device ( i.e. , axial pump nested inside of the centrifugal pump) was tested to ensure proper operation. We demonstrated the hydraulic performance of the two pumps operating in tandem, and we found that the centrifugal blood pump performance was not adversely impacted by the simultaneous operation of the axial blood pump. The current iteration of this design achieved a range of operation overlapping our target range. Future design iterations will further reduce size and incorporate complete and active magnetic levitation.

The total artificial heart: where have we been, where are we now, where are we going?

The incidence and prevalence of end-stage heart failure continue to rise; however, the number of donor hearts available for transplantation continues to be limited. Therefore, alternatives to transplantation, such as the use of total artificial hearts (TAH), are necessary. The long and winding road to the development and implantation of the ideal TAH remains under construction. Although efforts have been ongoing for almost a century, researchers and clinicians continue to improve currently available TAHs and design and construct new models. With mortality and morbidity rates decreasing, particularly at high-volume centers with a dedicated team and carefully selected patients, the use of TAHs as a bridge to transplantation, and even destination therapy in clinical trials, the future of TAHs is bright.

Heart Transplant Outcomes After Total Artificial Heart.

BACKGROUND: We sought to compare heart transplant (HTX) outcomes from patients with a total artificial heart (TAH), biventricular assist device (BiVAD), or left ventricular assist device (LVAD) as a bridge to transplant (BTT). Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)-Scientific Registry of Transplant Recipients (SRTR) created a dataset with TAH or durable mechanical circulatory support (MCS) who reached HTX between 2006 and 2015. METHODS: The retrospective analysis compared TAH outcomes with those with a BiVAD or LVAD before HTX. The primary outcome was posttransplant survival at 1, 36, and 60 months. Secondary outcomes included simultaneous heart-kidney transplants, donor characteristics, and mortality risk factors. INTERMACS-SRTR cohort had, at the time of HTX, 2762 patients with LVAD; 205 BiVAD (139 durable and 66 temporary RVAD); 176 TAH (6 prior HeartMate II). RESULTS: Sixty months after HTX, mortality rates were 16.5% in the total group: LVAD 15.2%, BiVAD 22.4%, and TAH 29%. Survival differed between the LVAD, the TAH, and BiVAD but not between the BiVAD and TAH groups. One-year survival and complication rates were similar across groups-there was no difference in survival by donor age in the overall cohort. There was a difference in TTD based on recipient age in the LVAD group but not in BiVAD or TAH groups. Occurrence of HTX-kidney and post-transplant dialysis were higher in the TAH versus LVAD and BiVAD groups. CONCLUSIONS: The TAH is an efficacious BTT. Refinements in technology and patient selection may improve outcomes.

Feasibility of Outpatient Hemodialysis for Patients With Total Artificial Heart: A Case Series.

Total artificial hearts (TAH) are used in patients with end-stage heart failure as a bridge-to-transplant. AKI is a common postoperative complication associated with TAH implant. Patients requiring temporary dialysis are denied implantation of TAH due to the inability to provide outpatient (OP) dialysis in the long term. Here we discuss four cases of TAH patients from a single center who were successfully maintained on OP hemodialysis (HD). All four patients were implanted with a 70cc Syncardia TM TAH for NICM. Two patients were implanted as bridge-to-transplant (BTT); one received a heart/kidney transplant and the other received a heart transplant. Two patients were implanted as destination therapy; one was maintained on OP HD until end-of-life, and the other received a heart transplant after becoming transplant eligible. These cases confirm that OP HD is a feasible option for TAH patients with post-implant chronic renal dysfunction provided that the dialysis centers are trained and supported by the implanting program.

Experience With SynCardia Total Artificial Heart as a Bridge to Transplantation in 100 Patients.

BACKGROUND: The SynCardia temporary total artificial heart (TAH-t) is an effective bridge to transplantation for patients with severe biventricular failure. However, granular single-center data from high-volume centers are lacking. We report our experience with the first 100 TAH-t recipients. METHODS: A prospective institutional database was used to identify 100 patients who underwent 101 TAH-t implantations between 2012 and 2022. Patients were stratified and compared according to Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 vs 2 or greater. Median follow-up on device support was 94 days (interquartile range, 33-276), and median follow-up after transplantation was 4.6 years (interquartile range, 2.1-6.0). RESULTS: Overall, 61 patients (61%) were successfully bridged to transplantation and 39 (39%) died on TAH-t support. Successful bridge rates between INTERMACS profile 1 and INTERMACS profile 2 or greater patients were similar (55.6% [95% CI, 40.4%-68.3%] vs 67.4% [95% CI, 50.5%-79.6%], respectively; P = .50). The most common adverse events (rates per 100 patient-months) on TAH-t support included infection (15.8), ischemic stroke (4.6), reoperation for mediastinal bleeding (3.5), and gastrointestinal bleeding requiring intervention (4.3). The most common cause of death on TAH-t support was multisystem organ failure (n = 20, 52.6%). Thirty-day survival after transplantation was 96.7%; survival at 6 months, 1 year, and 5 years after transplantation was 95.1% (95% CI, 85.4%-98.4%), 86.6% (95% CI, 74.9%-93.0%), and 77.5% (95% CI, 64.2%-86.3%), respectively. CONCLUSIONS: Acceptable outcomes can be achieved in the highest acuity patients using the TAH-t as a bridge to heart transplantation.

Extended systemic antibiotic prophylaxis in ventricular assist device recipients, an infectious disease perspective.

OBJECTIVES: To evaluate whether mediastinitis/deep sternal wound infection (Med/DSWI) is more common in ventricular assist device (VAD) with delayed sternal closure (DSC) compared to VAD with primary sternal closure (PSC). METHODS: A literature search was done over the last four decades for studies that addressed this comparison. RESULTS: Two studies met our inclusion criteria, and their results are contradictory. The first study compared 184 VAD recipients with PSC to 180 VAD recipients with DSC. There was no difference in VAD-related infections between DSC and PSC (15% vs. 16%, respectively; odds ratio = 0.965, 95% confidence interval [CI] = 0.525-1.635). The second study compared 464 VAD recipients with PSC to 94 VAD recipients with DSC. The rate of surgical site infection was higher in the DSC patients (12.5% vs. 1.4%, respectively; odds ratio = 10.1; 95% CI = 3.8-27.0). DSC was identified as an independent risk factor for postoperative mortality, but no detailed infection information was given. CONCLUSIONS: There is no clear evidence of the association between DSC, compared to PSC, and Med/DSWI. Therefore, DSC is not an absolute indication for extended systemic antibiotic prophylaxis. The decision to extend the duration of systemic antibiotic prophylaxis should be made on a case-by-case basis, in collaboration with an infectious disease specialist.

Total Artificial Heart Update.

The SynCardia Total Artificial Heart (TAH, SynCardia Systems, Tucson, AZ) is the only biventricular cardiac replacement approved for bridge to transplantation by the U.S. Food and Drug Administration (FDA) and which carries the European Union CE mark. It has been implanted in about 2000 patients. In experienced centers, 60 to 80 % of implanted patients have been transplanted and over 80 % of those transplanted have lived for over 1 year. The SynCardia TAH has supported potential cardiac recipients with irreversible biventricular failure for up to 6 years, providing physiologic pulsatile flows of 6 to 8 L/min at filling pressures of less than 10 mmHg allowing for optimal perfusion and recovery of organs such as the kidneys and liver. It is a tested device that provides a method for recovering potential transplant candidates who rapidly decompensate from biventricular failure or who have chronic cardiac failure from a variety of etiologies. This article covers the history, mechanical function and monitoring, implantation, patient selection and management, and outpatient use. It also reviews outcome data from the original FDA study as well as contemporary data from experienced centers.

The Total Artificial Heart: Where Are We?

The total artificial heart (TAH) is a device that replaces the failing ventricles. There have been numerous TAHs designed over the last few decades, but the one with the largest patient experience is the SynCardia temporary TAH. The 50-mL and 70-mL sizes have been approved in the United States, Europe, and Canada as a bridge to transplantation. It is indicated in patients with severe biventricular failure or structural heart issues that preclude the use of a left ventricular assist device. The majority of the patients implanted are Interagency Registry for Mechanically Assisted Circulatory Support profile 1 or 2. The 1-year survival in experienced centers that have implanted over 10 TAHs is 73%. The risk factors for death include older age, need for preimplantation dialysis, and malnutrition. The most common causes of death are multiple organ failure, usually the result of physiologic deterioration before implantation, and neurologic dysfunction. The device allows the patient to be discharged home and managed as an outpatient. Proper patient selection, the timing of intervention, patient care, and device management are essential for a suitable outcome. In addition, the CARMAT TAH is another device that will soon be studied in a clinical trial in the United States. The BiVACOR TAH is a revolutionary design utilizing electromagnetic levitation that is expected to enter a clinical trial in the next few years.

Platelet Mapping by Thromboelastography and Whole Blood Aggregometry in Adult Patients Supported by Mechanical Circulatory Support Device on Aspirin Therapy.

Patients on mechanical circulatory support (MCS) devices are placed on aspirin and may require platelet function testing (PFT) to monitor the adequacy of therapy. Routine laboratory PFT is performed using whole blood aggregation (WBA) which typically has a long turnaround time (4-5 hours) and may not be readily available. By contrast, platelet mapping by thromboelastography (TPM) can provide results within 45 minutes. The objective of this study was to compare the results of TPM with WBA. We compared platelet mapping maximal amplitude (MA) by TPM with that of arachidonic acid (AA) to WBA with AA by impedance. We analyzed paired samples where both TPM and WBA were available. Of 45 paired samples, 34 were from 29 MCS patients and 11 were from non-MCS patients. When applying institutional interpretation guidelines with an MAActivator cutoff of ≤40 mm, WBAAA vs TPM MAAA in non-MCS and MCS patients correlated well with an accuracy of 100 and 94.4%, respectively. MAActivator >40 had poor correlation with an accuracy of 37.5%. Irrespective of MAActivator value, TPM AA inhibition expressed in percent of inhibition had poor accuracy. When used with proper guidelines for interpretation, specifically when MAActivator ≤ 40 mm, TPM is a suitable and reliable test to use for MCS patients on aspirin.

Total artificial heart: surgical technique in the patient with normal cardiac anatomy.

Heart failure is a complex, growing problem with significant morbidity and mortality. Though heart transplantation remains the gold standard treatment for end-stage heart failure, there remains a national shortage of donor hearts. Mechanical circulatory support has provided an additional option for clinicians to support patients for the purposes of bridging patients to transplantation or to be used for destination therapy purposes. Despite generally favorable outcomes with univentricular support, in a subset of patients with biventricular heart failure, an isolated left ventricular assist device is not sufficient. Right ventricular failure has a negative impact on patient survival if not identified and treated promptly. The Total Artificial Heart (TAH) is the only Food and Drug Administration (FDA) approved artificial heart used for bridging patients to transplantation. Outcomes in patients who undergo implantation of the TAH at experienced centers have been good and reproducible.

Assessing Cerebrovascular Hemodynamics Using Transcranial Doppler in Patients with Mechanical Circulatory Support Devices.

BACKGROUND AND PURPOSE: Mechanical circulatory support (MCS) devices are commonly used in heart failure patients. These devices carry risk for presumably embolic and additionally hemorrhagic stroke. Alterations in blood flow play a key role in stroke pathophysiology, and we aimed to learn more about hemodynamic compromise. In this study, we used transcranial Doppler (TCD) ultrasound to define hemodynamics of commonly used nonpulsatile MCS devices, as well as pulsatile devices, with special attention to the total artificial heart (TAH). METHODS: From 2/2013 through 12/2016, we prospectively enrolled patients with MCS who underwent TCD imaging. We analyzed TCD parameters, including peak systolic velocity, end-diastolic velocity, pulsatility indices (PIs), and number of high-intensity transient signals. Waveform morphologies were compared between various MCS devices. RESULTS: We performed 132 TCD studies in 86 MCS patients. Waveforms in patients supported by venoarterial-extracorporeal membrane oxygenation demonstrated continuous flow without clear systolic peaks with an average (±SD) PI of .43 (±.2). PIs were low in patients with continuous-flow left ventricular assist devices with a mean PI of .32 (±.13). Impella patients had morphologically distinct pulsatile waveforms and a higher mean PI of .65 (±.24). In intra-arterial balloon pump patients, mean PI was 1.01 (±.16) and diastolic upstrokes were pronounced. In TAH patients, mean middle cerebral artery velocity of 79.69 (±32.33) cm/seconds and PI of .74 (±.14) approached normal values. CONCLUSION: TCD can detect characteristic waveforms in patients supported by various MCS devices. These device-specific TCD patterns are recognizable and reproducible.