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Abstract Giant cell myocarditis (GCM) is a rare but fatal disease that can lead to cardiac failure. Survival with a cardiac standstill requires mechanical circulatory support or a biventricular assist device (BiVAD) and prolonged survival is extremely rare. Drug‐induced hypersensitivity syndrome (DIHS) is a severe cutaneous adverse reaction. Some cases of DIHS are reportedly associated with the onset of GCM. We present a case of a 28‐year‐old woman who developed GCM during steroid tapering after DIHS. She went into continuous cardiac standstill but survived for 74 days under BiVAD support. Our case is noteworthy because the histopathologic specimens obtained on three occasions contributed to the diagnosis of this particular condition over time. We also reviewed previous literature on concomitant cases of GCM and DIHS. We found that two are potentially associated and most cases of GCM occur within 3 months of DIHS during steroid tapering.

Giant cell myocarditis (GCM) is a rare but fatal disease that can lead to cardiac failure. Survival with a cardiac standstill requires mechanical circulatory support or a biventricular assist device (BiVAD) and prolonged survival is extremely rare. Drug‐induced hypersensitivity syndrome (DIHS) is a severe cutaneous adverse reaction. Some cases of DIHS are reportedly associated with the onset of GCM. We present a case of a 28‐year‐old woman who developed GCM during steroid tapering after DIHS. She went into continuous cardiac standstill but survived for 74 days under BiVAD support. Our case is noteworthy because the histopathologic specimens obtained on three occasions contributed to the diagnosis of this particular condition over time. We also reviewed previous literature on concomitant cases of GCM and DIHS. We found that two are potentially associated and most cases of GCM occur within 3 months of DIHS during steroid tapering. [ABSTRACT FROM AUTHOR]

PURPOSE: Ventricular arrhythmias (VAs) are common in patients after left ventricular assist device (LVAD) implant and are associated with worse outcomes. However, the prevalence and impact of VA in patients with durable biventricular assist device (BIVAD) is unknown. We performed a retrospective cohort study of patients with BIVADs to evaluate the prevalence of VA and their clinical outcomes. METHODS: Consecutive patients who received a BIVAD between June 2014 and July 2017 at our medical center were included. The prevalence of VA, defined as sustained ventricular tachycardia or fibrillation requiring defibrillation or ICD therapy, was compared between BIVAD patients and a propensity-matched population of patients with LVAD from our center. The occurrence of adverse clinical events was compared between BIVAD patients with and without VA. RESULTS: Of the 13 patients with BIVADs, 6 patients (46%) experienced clinically significant VA, similar to a propensity-matched LVAD population (38%, p = 1.00). There were no differences in baseline characteristics between the two cohorts, except patients in the non-VA group who had worse hemodynamics (mitral regurgitation and right-sided indices), had less history of VA, and were younger. BIVAD patients with VA had a higher incidence of major bleeding (MR 3.05 (1.07-8.66), p = 0.036) and worse composite outcomes (log-rank test, p = 0.046). The presence of VA was associated with worse outcomes in both LVAD and BIVAD groups. CONCLUSIONS: Ventricular arrhythmias are common in patients with BIVADs and are associated with worse outcomes. Future work should assess whether therapies such as ablation improve the outcome of BIVAD patients with VA.

This article describes a case study where a patient with ProtekDuo + oxygenator and Impella CP (PROpella) in biventricular failure and cardiogenic shock was reconfigured to venopulmonary-arterial (VP-A) extracorporeal membrane oxygenation (ECMO), secondary to leg ischemia. The ProtekDuo was subsequently used as double-lumen drainage cannula, returning blood into a newly percutaneously placed femoral arterial cannula, mimicking venoarterial (V-A) ECMO in VP-A configuration. The following day, an Impella 5.5 could be placed and the ProtekDuo was reconfigured back to its default venopulmonary (V-P) ECMO configuration, now again as PROpella with minimally invasive biventricular groin-free full mechanical circulatory support. However, while in VP-A, good drainage blood flows of up to 4.5 LPM could be achieved similar to the ProtekDuo forward flow. None of the lumens collapsed secondary to negative pressure in the system. Drainage through the ProtekDuo for VP-A ECMO is feasible and without complications for a 24-hour period. This new method extends the ProtekDuo's spectrum of use.

This article describes a case study where a patient with ProtekDuo + oxygenator and Impella CP (PROpella) in biventricular failure and cardiogenic shock was reconfigured to venopulmonary-arterial (VP-A) extracorporeal membrane oxygenation (ECMO), secondary to leg ischemia. The ProtekDuo was subsequently used as double-lumen drainage cannula, returning blood into a newly percutaneously placed femoral arterial cannula, mimicking venoarterial (V-A) ECMO in VP-A configuration. The following day, an Impella 5.5 could be placed and the ProtekDuo was reconfigured back to its default venopulmonary (V-P) ECMO configuration, now again as PROpella with minimally invasive biventricular groin-free full mechanical circulatory support. However, while in VP-A, good drainage blood flows of up to 4.5 LPM could be achieved similar to the ProtekDuo forward flow. None of the lumens collapsed secondary to negative pressure in the system. Drainage through the ProtekDuo for VP-A ECMO is feasible and without complications for a 24-hour period. This new method extends the ProtekDuo's spectrum of use. [ABSTRACT FROM AUTHOR]

Right heart failure is a huge challenge in left ventricular assist device therapy and its occurrence is associated with increased mortality and morbidity. Other options include the use od temporary right ventricular assist device, use of two continous flow biventricular assist devices, use of total artificial heart and the use of paracorporeal biventricular assist devices. In this report we described the successful use of the paracorporeal pulsatile Berlin Heart EXCOR system as a bridge to transplant in a 62 years old patient with end-stage biventricular heart failure. [ABSTRACT FROM AUTHOR]

Background: Interhospital transfers of pediatric patients on the Berlin Heart Excor have been published on an occasional basis. Methods: Nowadays medicine evolves away from just feasibility towards quality and safety issues. Management tools like risk analysis have found their way into clinical practice. Results: Exemplary, we present a case of a 20 months old boy on a Berlin Heart BiVAD Excor who underwent a 224 km ground transport. After a systematic review of the published literature, we describe our safety management with the aim was to provide highest quality of care for the transport. Conclusion: Besides a risk analysis, we also describe our training and simulation protocol. [ABSTRACT FROM AUTHOR]

Biventricular assist devices (BiVAD) are capable of providing mechanical support to the left and right ventricles to improve blood supply in heart failure, thereby maintaining patients' lives and improving their quality of life. But there is evidence that the incidence of aortic valve incompetence and other valvular pathologies is related to BiVAD support. Such as constant speed (CS) control may cause the valve to close completely and lose its normal valve function. The valve function is related to the percentage of valve opening which is approximately 30% of the cardiac cycle. This study developed a power-based control model for BiVAD that could regulate motors' speed by altering the power to satisfy objectives of keeping valve function and restoring physiologic perfusion. The effects of the power-based controller on the hemodynamics and valve function were investigated by simulating BiVAD under constant power and variable power controls. Different heart failure and activity levels were also mimicked under variable power control to obtain the BiVAD's critical parameters and the assist ratios. The results show that the power-based control can help the BiVAD to assist a patient with heart failure, and the power settings should comprehensively consider objectives of valve function and physiologic perfusion., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

We experienced a case of fulminant myocarditis complicated by severe lung ischemia–reperfusion injury after switching from veno-arterial extracorporeal membrane oxygenation to biventricular assist device. We controlled lung blood flow by hybrid veno-arterial extracorporeal membrane oxygenation, which was established by modifying the biventricular assist device circuit without resternotomy, blood delivery to the pulmonary artery and blood removal from the left ventricle in addition to central veno-arterial extracorporeal membrane oxygenation, and accelerated lung recovery. The patient's lung damage and cardiac function were restored, and she completely recovered and was discharged without any complications. Regulation of lung blood flow is important and effective for lung ischemia–reperfusion injury after biventricular assist device implantation. [ABSTRACT FROM AUTHOR]

Implantable mechanical circulatory support (MCS) systems for ventricular assist device (VAD) therapy have emerged as an important strategy due to a shortage of donor organs for heart transplantation. A growing number of patients are receiving permanent assist devices, while fewer are undergoing heart transplantation (Htx). Continuous-flow (CF) pumps, as devices that can be permanently implanted, show promise for the treatment of both young and old patients with heart failure (HF). Further improvement of these devices will decrease adverse events, enable pulse modulation of continuous blood flow, and improve automatic remote monitoring. Ease of use for patients could also be improved. We herein report on the current state of the art regarding implantable CF pumps for use as MCS systems in the treatment of advanced refractory HF.

Percutaneous biventricular assist devices (BiVAD) are a recently developed treatment option for severe cardiogenic shock. This systematic review sought to identify indications and outcomes of patients placed on percutaneous BiVAD support. An electronic search was performed to identify all appropriate studies utilizing a percutaneous BiVAD configuration. Fifteen studies comprising of 20 patients were identified. Individual patient survival and outcomes data were combined for statistical analysis. All 20 patients were supported with a microaxial LVAD, 12/20 (60%) of those patients were supported with a microaxial (RMA) right ventricular assist device (RVAD), and the remaining 8/20 (40%) patients were supported with a centrifugal extracorporeal RVAD (RCF). All patients presented with cardiogenic shock, and of these, 12/20 (60%) presented with a non-ischemic etiology vs 8/20 (40%) with ischemic disease. For the RMA group, RVAD support was significantly longer [RMA 5 (IQR 4–7) days vs RCF 1 (IQR 1–2) days, p = 0.03]. Intravascular hemolysis post-BiVAD occurred in three patients (27.3%) [RMA 3 (33.3%) vs RCF 0 (0%), p = 0.94]. Five patients received a durable left ventricular assist device, one patient received a total artificial heart, and one patient underwent a heart transplantation. Estimated 30-day mortality was 15.0%, and 78.6% were discharged alive. Both strategies for percutaneous BiVAD support appear to be viable options for severe cardiogenic shock. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide Open in new tab Download slide OBJECTIVES We evaluated the outcome of patients in cardiogenic shock receiving a paracorporeal pulsatile biventricular assist device as a bridge to transplantation. METHODS We performed a retrospective single-centre analysis of all patients who received a Berlin Heart Excor® at our institution between 2004 and 2019. RESULTS A total of 97 patients (90 adults, 7 paediatric) were analysed. Eighty-four patients were in Interagency Registry for Mechanically Assisted Circulatory Support level 1 (80 adults, 4 paediatric). Diagnoses were dilated cardiomyopathy (n  = 41), ischaemic cardiomyopathy (n  = 17) or myocardial infarction (n  = 4), myocarditis (n  = 15), restrictive cardiomyopathy (n  = 2), graft failure after heart transplant (n  = 7), postcardiotomy heart failure (n  = 5), postpartum cardiomyopathy (n  = 3), congenital heart disease (n  = 1), valvular cardiomyopathy (n  = 1) and toxic cardiomyopathy (n  = 1). All patients were in biventricular heart failure and had secondary organ dysfunction. The mean duration of support was 63 days (0–487 days). There was a significant decrease in creatinine values after assist device implantation (from 1.83 ± 0.79 to 1.12 ± 0.67 mg/dl, P  = 0.001) as well as a decrease in bilirubin values (from 3.94 ± 4.58 to 2.65 ± 3.61 mg/dl, P  = 0.084). Cerebral stroke occurred in 16 patients, bleeding in 15 and infection in 13 patients. Forty-eight patients died on support, while 49 patients could be successfully bridged to transplantation. Thirty-day survival and 1-year survival were 70.1% and 41.2%, respectively. CONCLUSIONS A pulsatile biventricular assist device is a reasonable therapeutic option in cardiogenic shock, when immediate high cardiac output is necessary to rescue the already impaired kidney and liver function of the patient. [ABSTRACT FROM AUTHOR]

We present a case of a 51-year-old woman diagnosed with light chain amyloidosis associated with monoclonal gammopathy of undetermined significance (MGUS). Initially, she presented with symptoms of heart failure, including palpitations, chest tightness, and shortness of breath, which were attributed to myocarditis based on cardiac magnetic resonance (CMR) imaging findings. However, her condition rapidly deteriorated, with recurrent admissions for worsening heart failure, cardiogenic shock, and stroke. A cardiac biopsy ultimately confirmed light chain amyloidosis, a rare complication of MGUS, which has a long-term risk of 0.8% in patients with light chain MGUS. Despite aggressive treatment, including chemotherapy and biventricular assist device implantation, her condition continued to decline, and she became ventilator-dependent and subsequently passed away. This case highlights the importance of considering amyloidosis in patients with MGUS and underscores the need for early diagnosis and intervention to prevent catastrophic outcomes., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Owolabi et al.)

The main challenges of Biventricular Assist Devices (BiVAD) as a treatment modality for patients with Bicardiac heart failure heart failure are the balance of systemic blood flow during changes in physiological activity and the prevention of ventricular suction. In this study, a model of the Biventricular Circulatory System (BCS) was constructed and a physiological combination controller based on Starling-Like controller and Sliding Mode Controller (SMC) was proposed. The effects of the physiological controller on the hemodynamics of the BCS were investigated by simulating two sets of physiological state change experiments: elevated pulmonary artery resistance and resting-exercise, with constant speed (CS) control and combined Starling-like and PI control (SL-PI) as controllers. Simulation and experimental results showed that the Starling-like and Sliding Mode Control (SL-SMC) physiological combination controller was effective in preventing the occurrence of ventricular suction, providing higher cardiac output, maintain balance of systemic blood flow, and have higher response speed and robustness in the face of physiological state changes., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Pure restrictive cardiomyopathy is a strong risk factor for poor outcomes in children with cardiomyopathy on ventricular assist devices. Owing to concomitant right heart failure, children with end-staged restrictive cardiomyopathy who are supported with a ventricular assist device often require a biventricular assist device, which is another risk factor for waitlist mortality in heart transplantation candidates. Herein, we report the case of a 3-year-old boy with pure restrictive cardiomyopathy who successfully underwent heart transplantation after 12 months of support with staged biventricular assist devices. Owing to the progression of diastolic dysfunction, the left ventricular assist device could not provide adequate circulation support. Despite the provision of biventricular assist device support, the patient required a complex management strategy that involved balancing the left and right ventricular assist device supports. We were able to stabilize the patient by careful synchronization of the supports and proceeded to heart transplantation. Trial registration: Clinical Registration No.: Institutional Review Board of Osaka University Hospital, approval no. 16105. [ABSTRACT FROM AUTHOR]

Patients with terminal heart failure, refractory to drug therapy, are severe category of cardiology. The possibility of effective correction of multi-organ failure and an increase in the life-time of patients with critical cardiac insuffi ciency has been proved with the use of biventricular assist device (BiVAD). In this report, we present the case of implantation of the BiVAD «Berlin Heart EXCOR» as a bridge to orthotopic cardiac transplantation to a patient with dilated cardiomyopathy, critical heart failure and a high risk of fatal complications. Despite the complex, long postoperative period after the implantation of «Berlin Heart EXCOR», proceeded with reversible multiorgan and heart failure, dysfunction of BiVAD pumps, it was achieved patient’s recovery, regress of heart failure phenomena and orthotopic heart transplantation was performed after 9 months with a good long-term result.

Right ventricular failure (RVF) remains the main cause of morbidity and mortality following the implantation of continuous flow (CF) left ventricular assist devices. Apart from the difficulties inherent in assessing right ventricular function, other factors that may confound the prediction of RVF intraoperative events include concomitant surgical procedures, postoperative changes in pulmonary hemodynamics, evolving mechanical circulatory support (MCS) technology, shifts in the target population, and device settings. In this commentary, the role of concomitant tricuspid valve repair, early planned temporary or durable MCS have been discussed. A focus on the current modifications in CF ventricular assist devices designed for the left ventricle to make them suitable for right ventricular support has been set. [ABSTRACT FROM AUTHOR]

Heart transplantation is limited by the scarcity of suitable donors. Patients with advanced biventricular failure may require biventricular support to provide optimal cardiac output and end-organ perfusion. We highlight the outcomes of using the HeartWare HVAD System (HVAD) in a biventricular configuration. This retrospective study included patients implanted with HVAD as a biventricular assist device (BiVAD) between 2009 and 2017 at 12 participating centers. When used as a right ventricular assist device (VAD) (RVAD), the HVAD can be attached to the right ventricle (RV) or the right atrium (RA). Kaplan–Meier survival estimates were calculated comparing the 2 RVAD implant locations. Comparisons were also made between the timing of RVAD implantation (primary vs staged) on adverse event (AE) profiles and survival. Among the 93 patients who were implanted with a HVAD BiVAD, Kaplan–Meier survivals at 1-year and 2-year were 56% and 47%, respectively. Survival was independent of the location of the HVAD RVAD implant or whether there was an interval between left VAD and RVAD implantation. The most common AEs were bleeding (35.5%), infection (25.8%), and respiratory failure (20.4%). This study illustrated similar survival in patients receiving a primary or staged HVAD BiVAD implant at 1 year and 2 years. This study also established that the locations of the RVAD implant (RV or RA) result in similar AE profiles. [ABSTRACT FROM AUTHOR]

Biventricular assist device (BVAD) implantation is the treatment of choice in patients with severe biventricular heart failure and cardiogenic shock. Our team has developed a miniaturized continuous flow, double-ended centrifugal pump intended for total artificial heart implant (CFTAH). The purpose of this initial in vivo study was to demonstrate that the scaled-down CFTAH (P-CFTAH) can be appropriate for BVAD support. The P-CFTAH was implanted in 4 acute lambs (average weight, 41.5 ± 2.8 kg) through a median sternotomy. The cannulation was performed through the left and right atria, and cannulae length adjustment was performed for atrial and ventricular cannulation. The BVAD system was tested at 3 pump speeds (3000, 4500, and 6000 rpm). The BVAD performed very well for both atrial and ventricular cannulation within the 3000-6000 rpm range. Stable hemodynamics were maintained after implantation of the P-CFTAH. The self-regulating performance of the system in vivo was demonstrated by the left (LAP) and right (RAP) pressure difference (LAP-RAP) falling predominantly within the range of -5 to 10 mm Hg with variation, in addition to in vitro assessment of left and right heart failure conditions. Left and right pump flows and total flow increased as the BVAD speed was increased. This initial in vivo testing of the BVAD system demonstrated satisfactory device performance and self-regulation for biventricular heart failure support over a wide range of conditions. The BVAD system keeps the atrial pressure difference within bounds and maintains acceptable cardiac output over a wide range of hemodynamic conditions. [ABSTRACT FROM AUTHOR]

Summary: Severe coronavirus disease 2019 (COVID‐19) is a multisystem inflammatory disorder and knowledge and experience with severe acute respiratory failure in infected patients has grown considerably since reports of the first few cases. Little is known about the effect of the severe acute respiratory syndrome‐coronavirus‐2 (SARS‐CoV‐2) virus on the heart, and it has been suggested that fulminant cardiac failure, with or without respiratory failure, may occur several weeks following infection. A young man presented after a recent viral illness. He was in severe cardiogenic shock and was implanted with an emergency biventricular assist device, which also incorporated an extracorporeal membrane oxygenator. He stabilised soon after and, despite an intracerebral haemorrhage which resolved and bleeding into the trachea following percutaneous tracheostomy, he survived to explant and was successfully stepped down to a rehabilitation unit on postoperative day 50. He tested positive for SARS‐CoV‐2 antibodies when the test became available on postoperative day 33. We envisage there will be many more such presentations of acute COVID‐19‐associated cardiogenic shock and we recommend clinicians consider this diagnosis when presented with an acutely unwell patient with an unclear diagnosis following a viral illness. These patients should be discussed as early as possible with a transplant/mechanical circulatory support team. [ABSTRACT FROM AUTHOR]

Purpose of the Review: Although still a relatively new technology, long-term left ventricular assist devices (LVADs) for management of advanced heart failure is rapidly increasing. Initially designed as a bridge to transplant, these invasive devices are increasingly used as a destination therapy, creating unique and long-term infection risks. The aim of this comprehensive review is to highlight current evidence about the prevention, diagnosis, and management of LVAD-specific infections. Recent Findings: There are two recent, major societal guidelines (The International Society for Heart and Lung Transplantation, 2017, and the American Society of Transplantation, 2019) specifically on the diagnosis and management of infections in LVAD patients. A third guideline from the European Association for Cardio-Thoracic Surgery (2019) on general LVAD management contains a section on infection management. Recommendations tend to be concordant across the guidelines without major disagreements and suggest that for superficial infections, limited-course durations of antimicrobials are acceptable. For infections of deeper portions of the device, long-term antimicrobial regimens, often with chronic suppressive strategies remain the mainstay of treatment; however, this recommendation is based primarily on expert opinion as high-quality evidence to support best practices remains limited. The role of surgical management remains unknown. Summary: Management of long-term, device-related infections in patients with advanced heart failure is challenging and should include input from a multi-disciplinary team of providers to determine the best management strategy. A strong emphasis on best prevention practices is a necessity. With this relatively new technology, evidence-based data to guide best practices remains limited and is an important area of future research. [ABSTRACT FROM AUTHOR]

Abstract Background Fulminant myocarditis is a life-threatening disease, and myocardial damage expands the right ventricle as well as the left ventricle in some cases. There is a mortality rate of over 40% in patients with fulminant myocarditis who need mechanical circulatory support by peripheral venoarterial extracorporeal membrane oxygenation. Case presentation We report a case of a 27-year-old Japanese woman who was successfully bridged to recovery by using a biventricular assist device. She was diagnosed with fulminant myocarditis, and peripheral venoarterial extracorporeal membrane oxygenation was established on the same day. Her left ventricular ejection fraction rapidly decreased from 40% to 5% in 3 days and weaning from venoarterial extracorporeal membrane oxygenation was deemed difficult. Therefore, we performed a ventricular assist device implantation on day 4. A left ventricular assist device was implanted first. However, adequate blood flow did not circulate to the left side of her heart because of right-sided heart failure. Thus, an additional implant of a right ventricular assist device was performed during the operation. Her left ventricular ejection fraction recovered to 50% on day 10. The biventricular assist device was successfully removed on day 14. She has not experienced worsening of biventricular function during her follow-ups for 4 years. Conclusions Ventricular assist device therapy should be considered if there is no improvement in cardiac function in patients with fulminant myocarditis regardless of several days of support by venoarterial extracorporeal membrane oxygenation. A right ventricular assist device should always be implemented when necessary because biventricular involvement is not uncommon in fulminant myocarditis.

Preoperative calculations showed that the 9-mm inlet, 6-mm outlet, 25-cc pump chambers and 65-73 bpm would be optimal for a 5-year-old patient suffering from restrictive cardiomyopathy, with a body surface area of 0.59 m2 (1.5 L/min flow for a cardiac index of 2.5). After re-sternotomy and standard bicaval cannulation for cardiopulmonary bypass, the procedure was performed under normothermic conditions and on the beating heart. Biventricular support was established with the Berlin Heart Excor using biatrial cannulation. For left atrial cannulation, induced ventricular fibrillation was used. The 9-mm inlet cannulas were inserted into the left and right atria, respectively. The 6-mm outlet cannulas were implanted using 8-mm interposition vascular grafts for the aorta and the main pulmonary artery, respectively. Cannulas were tunnelled through the epigastric space, with systems crossing outside of the body. The 25-cc chambers were used for both right ventricular assist device and left ventricular assist device support, which subsequently showed full emptying and filling., (© The Author 2024. Published by MMCTS on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

In this case series we present our initial experience with the implantation of the SynCardia total artificial heart (TAH) in three patients, the first of which was the first SynCardia TAH implantation in the Visegrad Four (V4) countries. The first and the third patients, after 195 and 126 days of TAH support respectively, experienced successful heart transplants, while the second patient on postoperative day 11 died due to a ruptured undiagnosed brain aneurysm. Our results show that the SynCardia TAH is an alternative therapy in patients with severe end-stage biventricular heart failure waiting for heart transplantation. It is an intermediate step until the development of genetically modified animal hearts, engineered bioartificial hearts or hearts from induced pluripotent stem cells could replace the failing heart in patients with end-stage heart disease. [ABSTRACT FROM AUTHOR]

View large Download slide View large Download slide Mechanical circulatory support gained a significant value in the armamentarium of heart failure therapy because of the increased awareness of the prevalence of heart failure and the tremendous advances in the field of mechanical circulatory support during the last decades. Current device technologies already complement a heart transplant as the gold standard of treatment for patients with end-stage heart failure refractory to conservative medical therapy. This article reviews important aspects of mechanical circulatory support therapy and focuses on currently debated issues. [ABSTRACT FROM AUTHOR]

INTRODUCTION: Implantation of a total artificial heart is an alternative to durable biventricular assist device support in selected patients. We present our initial experience with the implantation of the SynCardia total artificial heart (TAH) in three patients. The first patient, was the first SynCardia (TAH) implantation in the Visegrad Four (V4) countries. METHOD: Three patients with severe refractory end stage biventricular heart failure listed for heart transplant were indicated for SynCardia TAH implantation. RESULTS: We present in details the perioperative and postoperative outcomes of these patients. The first and the third patient, after 195 and 126 days of TAH support respectively, had a successful heart transplants, the second patient died on 11th postoperative day. The cause of death was brain bleeding due to ruptured undiagnosed brain aneurysm. CONCLUSION: SynCardia TAH is an alternative therapy in patients with end-stage biventricular heart failure waiting for heart transplantation. The SynCardia TAH with pulsatility resembles the physiologic circulation, improves the condition of the patients and increases survival compared to the biventricular assist devices. It is an intermediate step until the development of genetically modified animal hearts, engineered bioartificial hearts or hearts from induced pluripotent stem cells that would replace the failing heart in the patients with end-stage heart disease (Tab. 2, Fig. 1, Ref. 27). Text in PDF www.elis.sk. [ABSTRACT FROM AUTHOR]

Aim. To estimate the results of 6-year experience of heart transplantation (HT) in Federal Almazov North-West Medical Research Centre. Methods. From 2010 to 2015 we have performed 65 HT. Mean age was 44.3 ± 14 years old (from 10 to 64 years old). We used biventricular assist device (BIVAD, Berlin Heart Excor) support in 7 heart transplant candidates before HT. 19 patients (29%) received thymoglobulin, whereas 46 patients (71%) had basiliximab to induce immunosuppression.Results. Extracorporeal membrane oxygenation machines were implanted in 5 patients (7.7%) after HT due to acute right ventricular failure. Suture annuloplasty (the Batista procedure) for tricuspid valve repair was carried out in 3 cases (4.6%). Venovenous hemodiafi ltration was used in 11 patients (16.9%). A total of 598 endomyocardial biopsies (EMB) were performed after HT. Evidence of cellular rejection (R1 and R2) was presented in 286 biopsies (48%). The 30-day in-hospital mortality rate was 3.1%. The 6-month survival rate after HT was 92%, 1-year – 91% and overall survival for the 6-year period of observation – 89.2%. Maximum observation period was 71 months.Conclusions. The 6-year experience of HT in our Center has shown a high level of survival. BIVAD Excor support can be effectively used as a «bridge» to HT. Prevention of graft loss due to acute rejection in heart transplant recipients can be achieved only through regular EMB monitoring. The rate of viral infection increased in 2 months after HT.

Severe aortic regurgitation (AR) is a rare but significant complication of ventricular assist device therapy. Experience with transcatheter aortic valve replacement (TAVR) in this setting of patients is very limited, while the scarcely reported cases exclusively refer to TAVR under continuous‐flow left ventricular assist devices. Here, we present the first successful TAVR while running a pulsatile‐flow biventricular assist device (PF‐BiVAD). Clinical data were collected based on the patient's electronic medical records after the patient's consent was obtained. We describe the case of a 57‐year‐old man in whom a PF‐BiVAD (EXCOR, Berlin Heart, Berlin, Germany) had been initially inserted after fulminant myocarditis with subsequent severe dilated cardiomyopathy as bridge‐to‐transplantation therapy. Over the following 2 years, the patient developed severe de novo AR under PF‐BiVAD therapy. This, along with progressive cardiac decompensation, led to the decision for TAVR by our heart team as a minimal invasive approach for severe AR. TAVR using two Edwards SAPIEN 3 bioprostheses as a valve‐in‐valve procedure resulted in a significant reduction of AR from severe to mild, with trace paravalvular leakage and without significant pressure gradients. The patient underwent total orthotopic heart transplantation afterwards. This is the first report of successful TAVR in a patient with severe de novo AR while running a PF‐BiVAD. [ABSTRACT FROM AUTHOR]

Abstract Objectives We report our experience with temporary postoperative venopulmonary arterial extracorporeal life support as short-term right ventricular support in patients with biventricular failure undergoing HeartWare (HeartWare Inc, Framingham, Mass) left ventricular assist device implantation and compared these outcomes with isolated left ventricular assist device support and long-term biventricular assist device support. Methods A total of 112 consecutive patients were studied, 75 with the isolated HeartWare left ventricular assist device, 23 with a concomitant left ventricular assist device and venopulmonary arterial extracorporeal life support, and 14 with durable biventricular assist device support. The decision concerning short-term or durable biventricular support was based on the clinical characteristics, echocardiography, and hemodynamic profile. Results Patients who required venopulmonary arterial extracorporeal life support after left ventricular assist device insertion required the greatest support preoperatively and were more likely to have Interagency Registry for Mechanical Assisted Circulatory Support level 1 (left ventricular assist device 19%, venopulmonary arterial extracorporeal life support 48%, biventricular assist device 57%, P <.001). They were more likely to require preoperative mechanical support (left ventricular assist device 9%, venopulmonary arterial extracorporeal life support 43%, and biventricular assist device 29%, P <.001) or preoperative ventilation (9%, 38%, and 21%, respectively, P <.05). Preoperative echocardiographic and hemodynamic parameters were more similar to those requiring isolated left ventricular assist device, with patients requiring durable biventricular assist device support more likely to have elevated right atrial pressure (left ventricular assist device 14.3 ± 6.7 vs venopulmonary arterial extracorporeal life support 13.6 ± 4.8 vs biventricular assist device 18.7 ± 6.0 mm Hg, P <.05); right atrial/pulmonary capillary wedge pressure ratio (0.53 ± 0.23 vs 0.51 ± 0.17, vs 0.69 ± 0.22, respectively, P <.02); and tricuspid regurgitation grade (1.7 ± 1.5 vs 1.7 ± 1.6 vs 2.8 ± 1.6, respectively, P <.01). One-year survival was 84% for those with an isolated left ventricular assist device compared with 62% for those with venopulmonary arterial extracorporeal life support and 64.3% for biventricular assist device. Conclusions In critically unwell patients requiring temporary biventricular support, planned venopulmonary arterial extracorporeal life support provides acceptable outcomes, similar to durable biventricular assist device support. Requirement for venopulmonary arterial extracorporeal life support is more determined by the level of preoperative acuity than echocardiographic or hemodynamic parameters. [ABSTRACT FROM AUTHOR]

BACKGROUND Severe right ventricular failure necessitating a right ventricular assist device (RVAD) complicates 6% to 11% of left ventricular assist device (LVAD) implants. Patient outcomes for those receiving durable continuous-flow VADs in a biventricular configuration (i.e., BiVAD) have been reported in limited case series. METHODS Data from United States centers with ≥ 6 BiVAD implants were collected. Characteristics and outcomes of patients receiving contemporaneous (i.e., same surgery) vs staged implantation of the HVAD as a BiVAD were compared. RESULTS From 2011 to 2017, 46 patients received durable BiVADs and had the following characteristics: median age, 46 years (interquartile range [IQR], 19–67 years), non-ischemic cardiomyopathy (80%), bridge to transplant (83%), Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 or 2 (92%), use of temporary circulatory support (37%), right atrial pressure 19 mm Hg (IQR, 14–23 mm Hg), and cardiac index of 1.6 liters/min/m2 (IQR, 1.2–2.1 liters/min/m2). Operative mortality was 33%. Equal numbers of patients received a right atrial or right ventricular implant. Contemporaneous BiVAD implantation occurred in 31 patients (67%), and compared with 15 patients (33%) with staged implants, these patients had a shorter intensive care unit length of stay of 12 days (IQR, 7–23 days) vs 42 days (IQR, 28–48 days, p = 0.035) and were more likely to be discharged from the hospital on BiVAD support (61% vs 27%, p = 0.04). RVAD thrombosis developed in 17 patients (37%). Patients with contemporaneous BiVAD implants had a 1-year survival of 74% compared with 40% in staged BiVAD patients ( p = 0.11). CONCLUSIONS Patients receiving durable BiVADs represent a critically ill patient population with severe biventricular failure who have high operative mortality and RVAD thrombosis rates. The 1-year survival for patients receiving contemporaneous BiVADs in experienced centers mirrors other contemporary durable biventricular support strategies. [ABSTRACT FROM AUTHOR]

Abstract: Use of ventricular assist devices is increasing in the pediatric population. This has included the extended use of adult continuous‐flow devices in the pediatric population. In a minority of cases, biventricular support may be needed. In these situations, biventricular support with continuous‐flow devices can be surgically challenging, and therefore, only few cases have been reported. Here, we present a case of implantation of two HeartWare HVAD devices for biventricular support for a decompensating patient with acute myocarditis as well as present an alternative implantation surgical strategy. [ABSTRACT FROM AUTHOR]

Rotary blood pumps are used to provide mechanical circulatory support to the failing heart in patients who are ineligible or waiting for a transplant. One of the major challenges when implementing two rotary blood pumps for biventricular support is the difficulty in maintaining pulmonary and systemic circulatory volume balance. In this study, a novel multiobjective neural predictive controller (MONPC) hybridized with a preload-based Frank-Starling-like controller (PFS) has been proposed for a dual rotary blood pump biventricular assist device in two different configurations: PFS L -MONPC R and MONPC L -PFS R . The flow rate of one pump is regulated by PFS as a function of preload, while the other pump is controlled by MONPC, which is intended to meet cardiac demand, avoid pulmonary congestion and ventricular suction. A comparative assessment was performed between the proposed controllers and a Dual Independent Frank-Starling-like control system (DI-FS) as well as a constant speed controller. The numerical simulation results showed that MONPC L -PFS R helped unload the congested left ventricle while maintaining high cardiac output during exercise. In contrast, improper flow regulation by DI-FS has resulted in pulmonary congestion. During blood loss, PFS L -MONPC R delivered the lowest suction risk, as compared to the constant speed mode, which produced negative right ventricular preload. When sensor noise and time delays were introduced in the flow and end-diastolic pressure signals, the proposed controllers were able to respond with adequate robustness during the transition from rest to exercise. This study demonstrated that the proposed controllers are superior in matching the pump flow with the cardiac demand without causing hemodynamic instabilities. [ABSTRACT FROM AUTHOR]

We experienced a case of ventricular assist with both a pulsatile-flow and a continuous-flow pump in a pediatric patient, and herein report the clinical course and characteristics of the pumps. A 6-year-old female was diagnosed with fulminant myocarditis and transferred to our hospital for mechanical support. After 12 days of extracorporeal membrane oxygenation, we implanted a left ventricular assist device (LVAD) and a right ventricular assist device (RVAD) using centrifugal Gyro pumps with a membrane oxygenator in a paracorporeal fashion. The membrane oxygenator was removed on postoperative day (POD) 4, and the patient was weaned from the respirator on POD 6. The LVAD was exchanged on POD 13 and 17, and the RVAD was exchanged on POD 14 because of thrombus formation inside the pumps. The RVAD was removed on POD 25. On POD 32, the patient experienced cerebral infarction and the centrifugal Gyro pump was switched to an extracorporeal pulsatile pump. No thromboembolic event occurred after pump conversion, although continuous administration of vasodilators was required to avoid hypertension. She underwent successfully heart transplantation in the USA after 8 months of ventricular support. A centrifugal pump is considered useful for pediatric patients, as pump flow and blood pressure can be relatively easily controlled in the postoperative acute phase compared with the pulsatile pump. However, special care should be taken to monitor for thrombus formation when support length becomes longer than 13 days, and a switch to a pulsatile pump should be considered once the hemodynamic status stabilizes. [ABSTRACT FROM AUTHOR]

The aim of this work is to develop and test a lumped parameter model of the cardiovascular system to simulate the simultaneous use of pulsatile (P) and continuous flow (C) ventricular assist devices (VADs) on the same patient. Echocardiographic and hemodynamic data of five pediatric patients undergoing VAD implantation were retrospectively collected and used to simulate the patients' baseline condition with the numerical model. Once the baseline hemodynamic was reproduced for each patient, the following assistance modalities were simulated: (a) CVAD assisting the right ventricle and PVAD assisting the left ventricle (RCF + LPF), (b) CVAD assisting the left ventricle and PVAD assisting the right ventricle (LCF + RPF). The numerical model can well reproduce patients' baseline. The cardiac output increases in both assisted configurations (RCF + LPF: +17%, LCF + RPF: +21%, P = ns), left (right) ventricular volumes decrease more evidently in the configuration LCF + RPF (RCF + LPF), left (right) atrial pressure decreases in the LCF + RPF (RCF + LPF) modality. The pulmonary arterial pressure slightly decreases in the configuration LCF + RPF and it increases with RCF + LPF. Left and right ventricular external work increases in both configurations probably because of the total cardiac output increment. However, left and right artero-ventricular coupling improves especially in the LCF + RPF (−36% for the left ventricle and −21% for the right ventricle, P = ns). The pulsatility index decreases by 8.5% in the configuration LCF + RPF and increases by 6.4% with RCF + LPF ( P = 0.0001). A numerical model could be useful to tailor on patients the choice of the VAD that could be implanted to improve the hemodynamic benefits. Moreover, a model could permit to simulate extreme physiological conditions and innovative configurations, as the implantation of both CVAD and PVAD on the same patient. [ABSTRACT FROM AUTHOR]

Mechanical circulatory assist devices are now commonly used in the treatment of severe heart failure as bridges to cardiac transplant, as destination therapy for patients who are not transplant candidates, and as bridges to recovery and "decision-making". These devices, which can be used to support the left or right ventricles or both, restore circulation to the tissues, thereby improving organ function. Left ventricular assist devices (LVADs) are the most common support devices. To care for patients with these devices, health care providers in emergency departments (EDs) and intensive care units (ICUs) need to understand the physiology of the devices, the vocabulary of mechanical support, the types of complications patients may have, diagnostic techniques, and decision-making regarding treatment. Patients with LVADs who come to the ED or are admitted to the ICU usually have nonspecific clinical symptoms, most commonly shortness of breath, hypotension, anemia, chest pain, syncope, hemoptysis, gastrointestinal bleeding, jaundice, fever, oliguria and hematuria, altered mental status, headache, seizure, and back pain. Other patients are seen for cardiac arrest, psychiatric issues, sequelae of noncardiac surgery, and trauma. Although most patients have LVADs, some may have biventricular support devices or total artificial hearts. Involving a team of cardiac surgeons, perfusion experts, and heart-failure physicians, as well as ED and ICU physicians and nurses, is critical for managing treatment for these patients and for successful outcomes. This review is designed for critical care providers who may be the first to see these patients in the ED or ICU. [ABSTRACT FROM AUTHOR]

Cardiac transplantation remains the optimal treatment for end stage heart failure in selected patients. However, the shortage of donor hearts, rigorous eligibility criteria and long waiting lists have increased the demand for alternative treatment strategies such as mechanical circulatory support. While many patients are adequately supported with left ventricular assist devices, frequently there is right heart failure or involvement of the right ventricle, requiring biventricular support. Pulsatile flow biventricular devices and total artificial hearts approved for temporary biventricular support have limitations including size, high rates of adverse events and restricted mobility which makes them unsuitable for long term support. A number of centres have reported dual continuous flow left ventricular assist devices as a means of supporting the left and right heart. This review will summarise the literature on the outcomes and complications from current biventricular support devices and assess the role of dual continuous flow VAD therapy, and the new continuous flow total heart replacement devices. [ABSTRACT FROM PUBLISHER]