SynCardia total artificial heart opportunities and challenges moving forward

Arabía, Francisco A.

doi:10.1111/aor.13546

Cited by 10 publications

(7 citation statements)

References 7 publications

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“…In contrast, the previous allocation system was the 3-tier system (Status 1A, 1B and 2) which has evolved to a 7-tier system (Status 1-6) as of September 2018. Status 2 patients now include those who cannot be discharged from the hospital such as TAH patients, those with surgically placed CF-LVADs or BiVADs and those on intra-aortic balloon pumps (5). The more refined system also allows for greater distinctions between the different types of MCS devices, such as the differentiation between temporary or durable devices (27).…”

Section: Discussionmentioning

confidence: 99%

“…Among these, SynCardia's total artificial heart (TAH) has been the mainstay of mechanical support to replace both ventricles and all four heart valves as a bridge-to-transplant, with current destination therapy trials underway (4). With a proven record of effectiveness, the SynCardia TAH has been functioning as a biventricular failure option for over 20 years (5), and for now represents the only FDAapproved long-term biventricular replacement option. Despite this, there are many drawbacks to the device with respect to portability and ease of use at home.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of SynCardia total artificial heart and HeartWare HVAD biventricular support for management of biventricular heart failure: a systematic review and meta-analysis

Maynes¹,

O’Malley²,

Luc³

et al. 2020

Ann Cardiothorac Surg

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Background: The aim of this study was to compare the outcomes of patients undergoing SynCardia total artificial heart (TAH) and biventricular HeartWare ventricular assist device (Bi-HVAD) support for biventricular heart failure (HF). Methods: Electronic search was performed to identify all relevant studies detailing patients who underwent biventricular assist device implantation using Bi-HVAD devices and those who underwent TAH placement for biventricular HF. Twelve studies including 512 patients in the TAH group versus 38 patients in the Bi-HVAD group were pooled for meta-analysis. Results: Ischemic cardiac etiology was present in 32% (95% CI, 24-47) of TAH vs. 15% (95% CI, 4-44) of Bi-HVAD patients (P=0.21). There was a comparable incidence of stroke [TAH 11% (95% CI, 7-16) vs. Bi-HVAD 13% (95% CI, 2-51), P=0.86] and acute kidney injury [TAH 28% (95% CI, 2-89) vs. Bi-HVAD 27% (95% CI, 9-59), P=0.98]. Overall infection rate was 67% (95% CI, 47-82) in TAH and 36% (95% CI, 10-74) in Bi-HVAD (P=0.16). Driveline infections were comparable between the two groups [TAH 11% (95% CI, 6-19) vs. Bi-HVAD 8% (95% CI, 1-39), P=0.73] and although a higher incidence of mediastinitis was found in the Bi-HVAD group [TAH 4% (95% CI, 2-7) vs. Bi-HVAD 15% (95% CI, 4-45), P=0.07] there was no statistically significant difference between the groups. Postoperative bleeding was present in 42% (95% CI, 28-58) of TAH vs. 23% (95% CI, 8-52) of Bi-HVAD (P=0.22). Patients in the TAH group had shorter duration of support [TAH 71 days (95% CI, 15-127) vs. Bi-HVAD 167 days (95% CI, 116-217), P=0.01]. At the mean follow-up time of 120 days, (95% CI, 83-157) patients in both groups had similar overall mortality [TAH 36% (95% CI, 22-49) vs. Bi-HVAD 26% (95% CI, 6-46), P=0.44] including mortality on device support [TAH 26% (95% CI, 17-36) vs. Bi-HVAD 21% (95% CI, 4-37), P=0.55]. Discharge home on support was achieved in 6% (95% CI, 4-17%) of TAH patients vs. 73% (95% CI, 48-89%) of Bi-HVAD (P<0.01), and 68% (95% CI, 52-84) of TAH patients were transplanted vs. 61% (95% CI, 47-75) in the Bi-HVAD group (P=0.14). Conclusions: Patients on Bi-HVAD support were more likely to be able to be discharged home on support and had similar overall mortality to TAH, albeit with much longer duration of support.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comparison of SynCardia total artificial heart and HeartWare HVAD biventricular support for management of biventricular heart failure: a systematic review and meta-analysis

Maynes¹,

O’Malley²,

Luc³

et al. 2020

Ann Cardiothorac Surg

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“…The SynCardia device has two blood chambers equipped with diaphragms pneumatically driven to pump blood into the systemic and pulmonary circulation. The SynCardia has FDA and CE approval for use as a bridge to transplantation and about 1800 devices have been implanted to date 1 . The device is undergoing clinical trials for use as destination therapy.…”

Section: Introductionmentioning

confidence: 99%

Hemodynamic characterization of the Realheart® total artificial heart with a hybrid cardiovascular simulator

Fresiello

Najar²,

Ignell³

et al. 2022

Artificial Organs

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Background: Heart failure is a growing health problem worldwide. Due to the lack of donor hearts there is a need for alternative therapies, such as total artificial hearts (TAHs). The aim of this study is to evaluate the hemodynamic performance of the Realheart® TAH, a new 4-chamber cardiac prosthesis device. Methods:The Realheart® TAH was connected to a hybrid cardiovascular simulator with inflow connections at the left/right atrium, and outflow connections at the ascending aorta/pulmonary artery. The Realheart® TAH was tested at different pumping rates and stroke volumes. Different systemic resistances (20.0-16.7-13.3-10.0 Wood units), pulmonary resistances (6.7-3.3-1.7 Wood units), and pulmonary/systemic arterial compliances (1.4-0.6 ml/mm Hg) were simulated. Tests were also conducted in static conditions, by imposing predefined values of preload-afterload across the artificial ventricle. Results:The Realheart® TAH allows the operator to finely tune the delivered flow by regulating the pumping rate and stroke volume of the artificial ventricles. For a systemic resistance of 16.7 Wood units, the TAH flow ranges from 2.7 ± 0.1 to 6.9 ± 0.1 L/min. For a pulmonary resistance of 3.3 Wood units, the TAH flow ranges from 3.1 ± 0.0 to 8.2 ± 0.3 L/min. The Realheart® TAH delivered a pulse pressure ranging between ~25 mm Hg and ~50 mm Hg for the tested conditions. Conclusions:The Realheart® TAH offers great flexibility to adjust the output flow and delivers good pressure pulsatility in the vessels. Low sensitivity of device flow to the pressure drop across it was identified and a new version is under development to counteract this.

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“…4 The only FDAapproved TAH-Syncardia has been implanted almost 1800 times in the United States, Canada, and Europe. 5 No matter which type of MAC, blood is constantly exposed to non-physiological shear stress (NPSS) due to mechanical pumping action and non-biological, artificial surfaces of the circuit components, such as blood pump, hollow fiber membrane oxygenator, filters, arterial and venous cannulas, tubing and connectors. These 2 factors have been shown to cause blood cell damage and protein activation, leading to activation of the contact system, coagulation cascade, fibrinolytic system, complement system and possibly weakened immune defense system.…”

Section: Introductionmentioning

confidence: 99%

“…4 The only FDA-approved TAH—Syncardia has been implanted almost 1800 times in the United States, Canada, and Europe. 5…”

Section: Introductionmentioning

confidence: 99%

Device-Induced Hemostatic Disorders in Mechanically Assisted Circulation

Wang

Griffith

2021

Clin Appl Thromb Hemost

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Mechanically assisted circulation (MAC) sustains the blood circulation in the body of a patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) or on ventricular assistance with a ventricular assist device (VAD) or on extracorporeal membrane oxygenation (ECMO) with a pump-oxygenator system. While MAC provides short-term (days to weeks) support and long-term (months to years) for the heart and/or lungs, the blood is inevitably exposed to non-physiological shear stress (NPSS) due to mechanical pumping action and in contact with artificial surfaces. NPSS is well known to cause blood damage and functional alterations of blood cells. In this review, we discussed shear-induced platelet adhesion, platelet aggregation, platelet receptor shedding, and platelet apoptosis, shear-induced acquired von Willebrand syndrome (AVWS), shear-induced hemolysis and microparticle formation during MAC. These alterations are associated with perioperative bleeding and thrombotic events, morbidity and mortality, and quality of life in MCS patients. Understanding the mechanism of shear-induce hemostatic disorders will help us develop low-shear-stress devices and select more effective treatments for better clinical outcomes.

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SynCardia total artificial heart opportunities and challenges moving forward

Cited by 10 publications

References 7 publications

Comparison of SynCardia total artificial heart and HeartWare HVAD biventricular support for management of biventricular heart failure: a systematic review and meta-analysis

Comparison of SynCardia total artificial heart and HeartWare HVAD biventricular support for management of biventricular heart failure: a systematic review and meta-analysis

Hemodynamic characterization of the Realheart® total artificial heart with a hybrid cardiovascular simulator

Device-Induced Hemostatic Disorders in Mechanically Assisted Circulation

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