RESUMO
ABSTRACT: Over the past 2 decades, there has been a significant increase in the utilization of long-term mechanical circulatory support (MCS) for the treatment of cardiac failure. Left ventricular assist devices (LVADs) and total artificial hearts (TAHs) have been developed in parallel to serve as bridge-to-transplant and destination therapy solutions. Despite the distinct hemodynamic characteristics introduced by LVADs and TAHs, a comparative evaluation of these devices regarding potential complications in supported patients, has not been undertaken. Such a study could provide valuable insights into the complications associated with these devices. Although MCS has shown substantial clinical benefits, significant complications related to hemocompatibility persist, including thrombosis, recurrent bleeding, and cerebrovascular accidents. This review focuses on the current understanding of hemostasis, specifically thrombotic and bleeding complications, and explores the influence of different shear stress regimens in long-term MCS. Furthermore, the role of endothelial cells in protecting against hemocompatibility-related complications of MCS is discussed. We also compared the diverse mechanisms contributing to the occurrence of hemocompatibility-related complications in currently used LVADs and TAHs. By applying the existing knowledge, we present, for the first time, a comprehensive comparison between long-term MCS options.
Assuntos
Insuficiência Cardíaca , Coração Artificial , Coração Auxiliar , Trombose , Humanos , Coração Auxiliar/efeitos adversos , Células Endoteliais , Coração Artificial/efeitos adversos , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/complicações , Hemorragia/complicações , Trombose/etiologiaRESUMO
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.
Assuntos
Insuficiência Cardíaca , Transplante de Coração , Coração Artificial , Coração Auxiliar , Humanos , Insuficiência Cardíaca/cirurgia , Insuficiência Cardíaca/etiologia , Estudos Retrospectivos , Diálise Renal , Transplante de Coração/efeitos adversos , Coração Artificial/efeitos adversos , Coração Auxiliar/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: In Germany, a total of 38 547 heart valve procedures were performed in 2022. With a growing number of patients undergoing the surgical and interventional implantation of heart valves, the incidence of prosthetic endocarditis is also rising. METHODS: We summarize the current state of the prophylaxis, diagnosis, and treatment of prosthetic endocarditis in a selective review of the literature. RESULTS: Prosthetic endocarditis accounts for 10-30% of all cases of endocarditis. As its echocardiographic and microbiologic findings are often less specific than those of native endocarditis, its diagnosis now increasingly relies on alternative imaging modalities such as F-18-FDG PET-CT. Anti-infective and surgical treatment are made more difficult by biofilm formation on the prosthetic valve and the frequent formation of perivalvular abscesses. CONCLUSION: Increased awareness of this clinical entity in the outpatient setting will promote the earlier initiation of appropriate diagnostic studies. Proper diagnostic evaluation is an essential prerequisite for the early detection and timely treatment of prosthetic endocarditis, with the goal of preventing progressive destruction and thus improving the outcome. Preventive and educative measures should be intensified, and certified, multidisciplinary endocarditis teams should be established. Antibiotic prophylaxis is now given much more restrictively than in earlier years; the risk of infection must be weighed against the potential development of both individual and collective resistance to antibiotic drugs.
Assuntos
Endocardite , Próteses Valvulares Cardíacas , Coração Artificial , Humanos , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/efeitos adversos , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Fluordesoxiglucose F18 , Próteses Valvulares Cardíacas/efeitos adversos , Endocardite/diagnóstico , Endocardite/prevenção & controle , Coração Artificial/efeitos adversosRESUMO
BACKGROUND: Total artificial heart (TAH) implantation is a rarely performed procedure. Contrarily, left ventricular assist device (VAD) implantation is rather common in many centers. As transplantation is quantitatively limited cardiac replacement with artificial hearts is a viable alternative in the treatment of severe biventricular heart failure. An alternative to TAH is the implantation of two VADs in a TAH configuration. We hereby present the first multi-center study on 3-months outcomes of patients treated by cardiectomy and placement of two HeartMate 3s in a TAH configuration. METHODS: We retrospectively investigated a cohort of 15 patients that underwent HM3-TAH-implantation at three international institutions. Follow-up was 3 months after implantation. Baseline, intra- and postoperative parameters as well as survival data and adverse events were collected. RESULTS: A total of 1089 days on HM3-TAH were observed. Thirty-day survival after HM3-TAH implantation was 53% (8/15) and three month survival was 40% (6/15). The longest duration on device was 274 days. Causes of death were multi-organ failure, sepsis, and neurological adverse events. No technical complications were documented. Two patients remained on the device. Four patients (26%) were successfully bridged to transplantation. CONCLUSIONS: The implantation of two HeartMate 3s in a TAH configuration is a last resort and off-label concept in cases of extreme biventricular heart failure. In a diligently selected patient cohort, HM3-TAH implantation is a feasible method to increase the chance of survival in a severely ill patient cohort and successfully bridge patients to heart transplantation that would otherwise have died.
Assuntos
Insuficiência Cardíaca , Transplante de Coração , Coração Artificial , Coração Auxiliar , Humanos , Coração Auxiliar/efeitos adversos , Estudos Retrospectivos , Coração Artificial/efeitos adversos , Insuficiência Cardíaca/cirurgiaRESUMO
The Syncardia total artificial heart system is the only commercially approved durable device for treating biventricular heart failure patients awaiting heart transplantation. Conventionally, the Syncardia total artificial heart system is implanted based on the distance from the anterior aspect of the 10th thoracic vertebra to the sternum and the patient's body surface area. However, this criterion does not account for chest wall musculoskeletal deformities. This case report describes a patient with a pectus excavatum who developed compression of the inferior vena cava after Syncardia total artificial heart implantation and how transesophageal echocardiography guided chest wall surgery to accommodate the total artificial heart system.
Assuntos
Tórax em Funil , Transplante de Coração , Coração Artificial , Hipotensão , Humanos , Tórax em Funil/complicações , Tórax em Funil/cirurgia , Esterno/cirurgia , Transplante de Coração/efeitos adversos , Coração Artificial/efeitos adversos , Complicações Pós-Operatórias , Hipotensão/etiologiaRESUMO
BACKGROUND: This study aims to describe the outcomes after heart transplantation using a bridge-to-bridge strategy with a sequence of extracorporeal membrane oxygenation (ECMO) support followed by temporary total artificial heart implantation (TAH-t). METHODS: A retrospective, multicenter analysis of 54 patients who underwent TAH-t implantation following an ECMO for cardiogenic shock was performed (ECMO-TAH-t group). A control group of 163 patients who underwent TAH-t implantation as a direct bridge to transplantation (TAH-t group) was used to assess this strategy's impact on outcomes. RESULTS: Fifty-four patients, averaging 47 ± 13 year old, underwent implantation of a TAH-t after 5.3 ± 3.4 days of ECMO perfusion for cardiogenic shock. In the ECMO-TAH-t group, 20 patients (20/54%; 37%) died after TAH-t implantation and 57 patients (57/163%; 35%) died in the TAH-t group (Gray test; P = .49). The top 3 causes of death of patients on TAH-t support were multisystem organ failure (40%), sepsis (20%), and neurologic events (20%). Overall, 32 patients (32/54%; 59%) underwent heart transplantation in the ECMO-TAH-t group compared with 106 patients (106/163%, 65%) in the TAH-t group (P = .44). No significant difference in survival was observed at 6 months, 1 year, and 3 years after heart transplant (ECMO-TAH-t group: 94%, 87%, and 80% vs 87%, 83%, and 76% in the TAH-t group, respectively). Deterioration of liver function (bilirubin, aspartate transaminase, and alanine aminotransferase levels on TAH-t) was associated with increased mortality before heart transplant in both groups. CONCLUSIONS: Sequential bridging from ECMO to TAH-t followed by heart transplantation is a viable option for a group of highly selected patients.
Assuntos
Oxigenação por Membrana Extracorpórea , Transplante de Coração , Coração Artificial , Coração Auxiliar , Humanos , Adulto , Pessoa de Meia-Idade , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/etiologia , Choque Cardiogênico/terapia , Oxigenação por Membrana Extracorpórea/efeitos adversos , Estudos Retrospectivos , Transplante de Coração/efeitos adversos , Coração Artificial/efeitos adversos , Resultado do TratamentoRESUMO
Total artificial heart is associated with increased incidence of thromboembolism, which can prove to be fatal. The presence of four metallic tilting discs increases the chances of thrombus formation and sudden obstruction of the valve in a closed position resulting in severe hemodynamic collapse. Such a condition is conventionally treated by a surgical approach for device change; however, this procedure is extremely high risk and associated with complications and poor outcomes. We describe two total artificial heart patients with sudden obstruction to the filling of the right side due to fixing of the atrioventricular valve in a closed position due to a thrombus. After a quick diagnosis by rescue transesophageal echocardiography, we successfully treated these patients with catheter-directed thrombolysis with minimal adverse outcomes. We propose a carefully weighed application of this approach in hemodynamically unstable patients too tenuous for a timely surgery and with low risk for bleeding.
Assuntos
Doenças das Valvas Cardíacas , Próteses Valvulares Cardíacas , Coração Artificial , Trombose , Humanos , Próteses Valvulares Cardíacas/efeitos adversos , Ecocardiografia Transesofagiana/métodos , Trombose/tratamento farmacológico , Trombose/etiologia , Trombose/diagnóstico , Catéteres/efeitos adversos , Coração Artificial/efeitos adversos , Terapia TrombolíticaRESUMO
The Aeson total artificial heart (A-TAH) has been developed for patients at risk of death from biventricular failure. We aimed to assess the inflammatory status in nine subjects implanted with the A-TAH in kinetics over one year. Laboratory assessment of leukocyte counts, inflammatory cytokines assay, and peripheral blood mononuclear cell collection before and after A-TAH implantation. Leukocyte counts were not significantly modulated according to time after A-TAH implantation (coefficient of the linear mixed effect model with 95% CI, -0.05 (-0.71 to -0.61); p = 0.44). We explored inflammatory cytokine after A-TAH and did not observe, at any time, a modified profile compared to pre-implantation values (all p -values > 0.05). Finally, we compared the distribution of circulating immune cell subpopulations identified based on sequential expression patterns for multiple clusters of differentiation. None of the population explored had significant modulation during the 12-month follow-up (all p -values > 0.05). In conclusion, using a cytokine multiplex assay combined with a flow cytometry approach, we demonstrated the absence of inflammatory signals in peripheral blood over a period of 12 months following A-TAH implantation.
Assuntos
Insuficiência Cardíaca , Transplante de Coração , Coração Artificial , Humanos , Transplante de Coração/efeitos adversos , Leucócitos Mononucleares , Coração Artificial/efeitos adversos , Insuficiência Cardíaca/cirurgia , Inflamação/etiologia , CitocinasRESUMO
BACKGROUND: Mechanical circulatory support (MCS) devices, such as ventricular assist devices (VADs) and total artificial hearts (TAHs), have become a vital therapeutic option in the treatment of end-stage heart failure for adult patients. Such therapeutic options continue to be limited for pediatric patients. Clinicians initially adapted or scaled existing adult devices for pediatric patients; however, these adult devices are not designed to support the anatomical structure and varying flow capacities required for this population and are generally operated "off-design," which risks complications such as hemolysis and thrombosis. Devices designed specifically for the pediatric population which seek to address these shortcomings are now emerging and gaining FDA approval. METHODS: To analyze the competitive landscape of pediatric MCS devices, we conducted a systematic literature review. Approximately 27 devices were studied in detail: 8 were established or previously approved designs, and 19 were under development (11 VADs, 5 Fontan assist devices, and 3 TAHs). RESULTS: Despite significant progress, there is still no pediatric pump technology that satisfies the unique and distinct design constraints and requirements to support pediatric patients, including the wide range of patient sizes, increased cardiovascular demand with growth, and anatomic and physiologic heterogeneity of congenital heart disease. CONCLUSIONS: Forward-thinking design solutions are required to overcome these challenges and to ensure the translation of new therapeutic MCS devices for pediatric patients.
Assuntos
Oxigenação por Membrana Extracorpórea , Insuficiência Cardíaca , Coração Artificial , Coração Auxiliar , Criança , Insuficiência Cardíaca/cirurgia , Coração Artificial/efeitos adversos , Coração Auxiliar/efeitos adversos , Humanos , TecnologiaRESUMO
BACKGROUND: Carmat bioprosthetic total artificial heart (Aeson; A-TAH) is a pulsatile and autoregulated device. The aim of this study is to evaluate level of hemolysis potential acquired von Willebrand syndrome after A-TAH implantation. METHODS: We examined the presence of hemolysis and acquired von Willebrand syndrome in adult patients receiving A-TAH support (n=10) during their whole clinical follow-up in comparison with control subjects and adult patients receiving Heartmate II or Heartmate III support. We also performed a fluid structure interaction model coupled with computational fluid dynamics simulation to evaluate the A-TAH resulting shear stress and its distribution in the blood volume. RESULTS: The cumulative duration of A-TAH support was 2087 days. A-TAH implantation did not affect plasma free hemoglobin over time, and there was no association between plasma free hemoglobin and cardiac output or beat rate. For VWF (von Willebrand factor) evaluation, A-TAH implantation did not modify multimers profile of VWF in contrast to Heartmate II and Heartmate III. Furthermore, fluid structure interaction coupled with computational fluid dynamics showed a gradually increase of blood damage according to increase of cardiac output (P<0.01), however, the blood volume fraction that endured significant shear stresses was always inferior to 0.03% of the volume for both ventricles in all regimens tested. An inverse association between cardiac output, beat rate, and high-molecular weight multimers ratio was found. CONCLUSIONS: We demonstrated that A-TAH does not cause hemolysis or AWVS. However, relationship between HMWM and cardiac output depending flow confirms relevance of VWF as a biological sensor of blood flow, even in normal range.
Assuntos
Coração Artificial , Doenças de von Willebrand , Adulto , Coração Artificial/efeitos adversos , Hemoglobinas , Hemólise , Humanos , Fator de von WillebrandRESUMO
A downsized version of the ReinHeart total artificial heart (TAH) was developed. Hemocompatibility needs to be revised since the operating point of the downsized TAH has changed to a higher pump frequency to accomplish the same cardiac output. A mock circulation loop was designed, containing a left side for hemocompatibility testing and a right side to mimic realistic work conditions. A protocol for hemolysis testing was established using pooled porcine blood with an operation point of 5 L/min, a mean outlet pressure of 100 mm Hg and a mean inlet pressure of 12 mm Hg. Six trials were performed testing two downsized TAH (one with a compliance chamber [CC] connected, necessary for a pneumatic decoupling of both membranes and one open to atmosphere) and a BPX-80 as reference pump. The average modified index of hemolysis and normalized index of hemolysis (NIH in mg/100L) from six individual trials of the reference pump were 0.34 (0.07) and 3.21 (0.61) and of the TAH open to atmosphere 4.18 (1.19) and 38.85 (10.59), respectively. In between TAH with and without CC, there was no significant difference. A NIH ratio of TAH and reference pump was calculated to minimize variation of the different blood batches used in individual trials. Due to the downsizing, the ReinHeart's hemolysis level increased by around 22% compared with the original size version. Comparing the results to clinically approved left ventricular assist devices, the level of hemolysis can still be considered acceptable.
Assuntos
Coração Artificial , Coração Auxiliar , Animais , Débito Cardíaco , Coração Artificial/efeitos adversos , Coração Auxiliar/efeitos adversos , Hemólise , Desenho de Prótese , SuínosRESUMO
Thrombogenic complications are a main issue in mechanical circulatory support (MCS). There is no validated in vitro method available to quantitatively assess the thrombogenic performance of pulsatile MCS devices under realistic hemodynamic conditions. The aim of this study is to propose a method to evaluate the thrombogenic potential of new designs without the use of complex in-vivo trials. This study presents a novel in vitro method for reproducible thrombogenicity testing of pulsatile MCS systems using low molecular weight heparinized porcine blood. Blood parameters are continuously measured with full blood thromboelastometry (ROTEM; EXTEM, FIBTEM and a custom-made analysis HEPNATEM). Thrombus formation is optically observed after four hours of testing. The results of three experiments are presented each with two parallel loops. The area of thrombus formation inside the MCS device was reproducible. The implantation of a filter inside the loop catches embolizing thrombi without a measurable increase of platelet activation, allowing conclusions of the place of origin of thrombi inside the device. EXTEM and FIBTEM parameters such as clotting velocity (α) and maximum clot firmness (MCF) show a total decrease by around 6% with a characteristic kink after 180 minutes. HEPNATEM α and MCF rise within the first 180 minutes indicate a continuously increasing activation level of coagulation. After 180 minutes, the consumption of clotting factors prevails, resulting in a decrease of α and MCF. With the designed mock loop and the presented protocol we are able to identify thrombogenic hot spots inside a pulsatile pump and characterize their thrombogenic potential.
Assuntos
Coração Artificial/efeitos adversos , Tromboelastografia/instrumentação , Trombose/etiologia , Animais , Desenho de Equipamento , Suínos/sangue , Tromboelastografia/métodosRESUMO
Cardiac tamponade after ventricular assist device or total artificial heart implantation can typically occur within days or weeks after surgery. This report describes the case of a woman who presented over 4 years after SynCardia 70cc total artificial heart implantation, with physiology consistent with right ventricular outflow tract obstruction. The cause was initially attributed to device membrane failure based on the device console waveform; however, during operative exploration, a large amount of proteinaceous exudate was surrounding the device and causing the obstruction. This report illustrates how tamponade can result years after device implantation, secondary to porosity of the outflow grafts.
Assuntos
Tamponamento Cardíaco/etiologia , Insuficiência Cardíaca/cirurgia , Coração Artificial/efeitos adversos , Complicações Pós-Operatórias , Implantação de Prótese/efeitos adversos , Tamponamento Cardíaco/diagnóstico , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Fatores de Tempo , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: With the limited number of available suitable donor hearts resulting in plateaued numbers of heart transplantations, short- and long-term mechanical circulatory support devices, including the implantation of total artificial hearts (TAHs) are modalities that are increasingly being used as treatment options for patients with end-stage heart failure. The superior vena cava syndrome has been described in this context in various disease processes. We report successful venoplasty for superior vena cava syndrome in a patient with a TAH. CASE PRESENTATION: A 65-year-old man with a history of nonischemic cardiomyopathy had received a left ventricular assist device, and then 2 years later, underwent orthotopic heart transplantation using the bicaval anastomosis technique. The postprocedural course was complicated by primary graft failure, resulting in the need for implantation of a TAH. About 5 months after TAH implantation, he started to develop complications such as volume retention, swelling of the upper extremities, and was diagnosed to have a superior vena cava syndrome. The patient underwent a successful venoplasty of his superior vena cava by interventional radiology with resolution of upper body edema, normalization of renal, and liver function. CONCLUSION: Potential fatal complications caused by catheter or wire entrapment in the right-sided mechanical valve of a TAH have been reported. We describe a safe method for the treatment of superior vena cava syndrome in patients with TAH.
Assuntos
Transplante de Coração/efeitos adversos , Transplante de Coração/métodos , Coração Artificial/efeitos adversos , Coração Auxiliar/efeitos adversos , Disfunção Primária do Enxerto/etiologia , Síndrome da Veia Cava Superior/etiologia , Síndrome da Veia Cava Superior/cirurgia , Procedimentos Cirúrgicos Vasculares/métodos , Veia Cava Superior/cirurgia , Idoso , Constrição Patológica/cirurgia , Humanos , Masculino , Radiografia Intervencionista , Cirurgia Assistida por Computador/métodos , Resultado do Tratamento , Veia Cava Superior/patologiaRESUMO
BACKGROUND: The incidence of hemodialysis (HD)-dependent renal failure after total artificial heart (TAH) implantation is high. We sought to determine the preoperative predictors of HD after TAH implantation. METHODS AND RESULTS: We studied 87 patients after TAH implantation at our institution between April 2006 and March 2017. Baseline clinical data were obtained from the medical records, and patients were followed until death or heart transplantation. We performed logistic regression analysis to identify predictors of HD after TAH implantation. Of the patients, 24 (28%) required postimplantation HD. Those requiring HD were more likely to have histories of coronary artery disease (58% vs 29%; Pâ¯=â¯0.01), required preoperative membrane oxygenation (33% vs 4.8%; Pâ¯=â¯0.001) and had lower baseline estimated glomerular filtration rates (54 ± 29 vs 67 ± 24 mL/min/1.73m2; Pâ¯=â¯0.04). Patients requiring HD were at a higher risk of death on device at 1 year (33% vs 5%, Pâ¯=â¯0.001; log rank test: P =0.001, hazard ratio 6.6 [95% CI:1.8-23], Pâ¯=â¯0.003). CONCLUSIONS: The incidence of postimplantation HD is high and is associated with increased likelihood of mortality. Lower baseline estimated glomerular filtration rates, histories of coronary artery disease and preoperative membrane oxygenation support are predictors of postimplantation requirement of HD. These data may help to identify patients at risk for adverse outcomes after TAH implantation.
Assuntos
Insuficiência Cardíaca , Transplante de Coração , Coração Artificial , Insuficiência Renal , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Coração Artificial/efeitos adversos , Humanos , Diálise Renal/efeitos adversos , Estudos RetrospectivosRESUMO
OBJECTIVE: Total artificial heart (TAH) is a viable bridge to transplant (BTT) strategy for patients with severe biventricular failure or complex congenital heart disease. These patients have higher mortality and morbidity than patients undergoing left ventricular assist device (LVAD) implantation. To assess national trends in in-hospital mortality, major complications, cost, length of stay, and disposition of patients undergoing TAH implantation. METHODS: Data from the National Inpatient Sample, the largest all-payer inpatient data set in the United States, and the US Census Bureau, for the years 2009 to 2015 were analyzed. Participants included all adult patients who received TAH from 2009 to 2015. Endpoints included in-hospital mortality, in-hospital complications, heart transplantation (HT) in the same admission, length of stay, cost, and disposition at the time of discharge. RESULTS: We identified a total of 143 (weighted = 703) TAH implantations. The number of TAH implants increased during the study period (average annual change +5.8%, p = 0.03). Rates of in-hospital mortality and major complications including ischemic stroke, major bleeding, postoperative infections, acute kidney injury requiring dialysis, and HT did not change significantly over the study period. Although the length of stay and disposition patterns did not change over time, we found a significant increase in cost of hospitalization (average annual change +44,362, p = 0.01). The number of HT during the same hospital stay decreased significantly (average annual change -8.1%, p = 0.02). CONCLUSION: In-hospital mortality and complication rates associated with TAH implantation remain increased and did not change in the era of continuous flow LVADs.
Assuntos
Insuficiência Cardíaca , Transplante de Coração , Coração Artificial , Coração Auxiliar , Adulto , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/cirurgia , Coração Artificial/efeitos adversos , Coração Auxiliar/efeitos adversos , Mortalidade Hospitalar , Humanos , Estudos Retrospectivos , Estados Unidos/epidemiologiaRESUMO
OBJECTIVES: The purpose of this study was to describe pre- and postoperative data from the EUROMACS registry with regard to indications, for and survival and complication rates of patients with primary continuous flow and pulsatile biventricular long-term assist devices (BiVADs) versus total artificial hearts (TAHs) or left ventricular assist devices (LVADs) + short-term right ventricular assist device (RVAD) implants. METHODS: We investigated patients who received implants between 1 January 2011 and 21 October 2017. Clinical baseline information about comorbidities, laboratory results, medical and device therapies and echocardiographic, haemodynamic and right ventricle (RV) parameters were evaluated along with the rates of deaths and complications. RESULTS: A total of 413 of 3282 patients (12.5%) needed a biventricular pump. We investigated 37 long-term BiVADs, 342 LVAD + short-term RVAD implants and 34 TAHs. Minor differences were found in the baseline characteristics of our population, which had an overall high morbidity profile. The 1-year survival rate was 55% for patients with a continuous flow BiVAD; 52% for patients with an LVAD + short-term RVAD; 37% for patients with pulsatile BiVADs; and 36% for patients with a TAH. No statistical difference was observed among the groups. Over 50% of patients with BiVAD support were classified as INTERMACS profiles 1 and 2. The percent of patients with ambulatory heart failure (INTERMACS 4â7) undergoing BiVAD implants was modest at <15%. No patients with a pulsatile BiVAD (n = 15) or a TAH (n = 34) were implanted as destination therapy, but 27% of the patients with continuous flow BiVADs (n = 6) and 23% of the patients with LVAD + short-term RVAD (n = 342) were implanted as 'destination'. The adverse events profile remained high, with no significant difference among pump types. The right ventricular stroke work index and right heart failure scores indicated poor RV function in all groups. After 3 months of LVAD + short-term RVAD support, 46.7% still required ongoing support, and only 18.5% were weaned from RVAD support; 33.1% died. CONCLUSIONS: The mortality rate after BiVAD support was high. Survival rates and adverse events were statistically not different among the investigated groups. In the future, composite study end points examining quality of life and adverse events beyond survival may help in shared decision-making prior to general mechanical circulatory support, particularly in patients with BiVAD implants.
Assuntos
Procedimentos Cirúrgicos Cardíacos , Coração Artificial , Adulto , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/instrumentação , Procedimentos Cirúrgicos Cardíacos/mortalidade , Procedimentos Cirúrgicos Cardíacos/estatística & dados numéricos , Comorbidade , Feminino , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/cirurgia , Coração Artificial/efeitos adversos , Coração Artificial/estatística & dados numéricos , Coração Auxiliar/efeitos adversos , Coração Auxiliar/estatística & dados numéricos , Hemodinâmica/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Falha de Prótese , Sistema de Registros , Estudos Retrospectivos , Disfunção Ventricular/epidemiologia , Disfunção Ventricular/mortalidade , Disfunção Ventricular/cirurgiaRESUMO
A long-standing goal in the field of biofluid mechanics has been to reliably predict hemolysis across the wide range of flows that can occur in prosthetic cardiovascular devices. A scalar representation of the complex three-dimensional fluid stresses that are exerted on cells is an attractive alternative for the simplicity that it lends to the computations. The appropriateness of the commonly used von-Mises-like scalar stress as a universal hemolysis scaling parameter was previously evaluated, finding that erythrocyte membrane tensions calculated for laminar shear and extensional flows and for three cases of turbulent flow were widely divergent for the same value of scalar stress. The same techniques are applied in this study to laminar and turbulent flows that each have the same energy dissipation rate. Results showed that agreement of membrane tension between laminar shear and turbulent shear inside an eddy was improved relative to the common scalar stress cases, but disagreement between laminar shear and laminar extension remained the same and disagreement between laminar shear and other turbulent flows increased. It is therefore concluded that energy dissipation rate alone is also likely not sufficient to universally scale blood damage across the range of different flows that can be encountered clinically.
Assuntos
Hemólise , Modelos Cardiovasculares , Algoritmos , Fenômenos Biomecânicos , Velocidade do Fluxo Sanguíneo , Próteses Valvulares Cardíacas/efeitos adversos , Coração Artificial/efeitos adversos , Humanos , Fluxo Pulsátil , Estresse MecânicoRESUMO
Along with the growing utilization of the total artificial heart (TAH) comes a new set of ethical issues that have, surprisingly, received little attention in the literature: (1) How does one apply the criteria of irreversible cessation of circulatory function (a core concept in the Uniformed Determination of Death Act) given that a TAH rarely stops functioning on its own? (2) Can one appeal to the doctrine of double effect as an ethical rationale for turning off a TAH given that this action directly results in death? And, (3) On what ethical grounds can a physician turn off a TAH in view of the fact that either the intent of such an action or the outcome is always, and necessarily, death? The aim of this article is not to answer these questions but to highlight why these questions must be explored in some depth given the growing use of TAH technology.
Assuntos
Coração Artificial/ética , Suspensão de Tratamento/ética , Morte , Coração Artificial/efeitos adversos , HumanosRESUMO
Artificial hearts are effective devices to treat heart failure in clinical practice and can be divided into two categories: artificial hearts and ventricular assist devices. The goal of this work was to investigate the fluidity and biological changes of in vitro sheep blood using a novel alternating current (AC) magnetohydrodynamic blood pump (central magnetic intensity: 0.9 T, alternating current frequency of the electric motor: 0-80 Hz). Blood samples were collected from five sheep and were divided into two groups: the control group (no exposure to an external magnetic field) and the exposed group (3 h of exposure to an alternating magnetic field). The blood cell counts, changes in blood viscosity, and ultrastructural changes of the blood cells under transmission electron microscopy were investigated. This study demonstrated several findings: (i) Continuous sheep blood flow can be achieved; (ii) The blood cell counts remained unchanged after 3 h of exposure to an alternating magnetic field; (iii) Compared with the control group, the high- and low-shear viscosities of the whole blood from the sheep significantly decreased after 3 h of exposure to an alternating magnetic field (P < 0.05 and P < 0.01, respectively). Plasma viscosity was significantly reduced after exposure to high-intensity alternating magnetic fields (P < 0.001); (iv) The cytoplasm of blood cells (especially erythrocytes) became lighter in color in the exposure group compared to the control group, and "beads-on-string" aggregations of black particles appeared. This work provides detailed and reliable scientific research data for the development of this type of blood pump, which may serve as a transition to the clinical artificial heart.