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![The CardioWest Syncardia Total Artificial Heart. (A) Syncardia pumps. (B) C2 driver caddy (C) Freedom driver. (Courtesy: SynCardia Systems, Inc [78]).](profile/Sabine-Allida-2/publication/295250573/figure/fig5/AS:711510875709443@1546648820345/The-CardioWest-Syncardia-Total-Artificial-Heart-A-Syncardia-pumps-B-C2-driver-caddy.png)
The CardioWest Syncardia Total Artificial Heart. (A) Syncardia pumps. (B) C2 driver caddy (C) Freedom driver. (Courtesy: SynCardia Systems, Inc [78]).
Source publication
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 l...
Context in source publication
Similar publications
Cardiogenic shock (CS) is a challenging syndrome, associated with significant morbidity and mortality. Although pharmacological therapies are successful and can successfully control this acute cardiac illness, some patients remain refractory to drugs. Therefore, a more aggressive treatment strategy is needed. Temporary mechanical circulatory suppor...
Importance
Left ventricular assist devices (LVADs) are well established in the treatment of advanced heart failure, but it is unclear whether outcomes are different based on the intended goal of therapy in patients who are eligible vs ineligible for heart transplant.
Objective
To determine whether clinical outcomes in the Multicenter Study of MagL...
Introduction:
Improved understanding of the clinical course of ambulatory advanced chronic systolic heart failure may improve the provision of appropriate care and is central to the design of clinical trials in this population.
Methods:
Twenty-one implanting ventricular assist device (VAD) centers enrolled 400 subjects in the Registry Evaluation...
The full potential of mechanical circulatory systems in the treatment of cardiogenic shock is impeded by the lack of accurate measures of cardiac function to guide clinicians in determining when to initiate and how to optimally titrate support. The left ventricular end diastolic pressure (LVEDP) is an established metric of cardiac function that ref...
Heart transplantation is currently the most effective treatment for end-stage heart failure; however, the shortage in donor hearts constrains the undertaking of transplantation. Mechanical circulatory support (MCS) technology has made rapid progress in recent years, providing diverse therapeutic options and alleviating the dilemma of donor heart sh...
Citations
... Physiologic antegrade blood flow both in the systemic and pulmonary circulations, together with true RV and LV unloading, can be obtained by simultaneously implanting the Impella RP pump (Abiomed, Danvers, MA, USA) for RV support and the traditional Impella trans-aortic pump [11]. Known as "Bipella" [12], this promising approach has the potential to answer most of the needs of the ideal mechanical support device for the treatment of acute biventricular failure [13]. Unfortunately, this configuration cannot provide blood oxygenation, which can be severely impaired in the context of a cardiogenic pulmonary edema, and the Impella RP pump is approved for a maximum of 14 days of support, which limits its medium-term applications [14]. ...
Background:
When heart transplantation and myocardial recovery are unlikely, patients presenting with biventricular cardiogenic shock initially treated with extracorporeal membrane oxygenation (ECMO) may benefit from a mechanical support upgrade. In this scenario, a micro-invasive approach is proposed: the combination of the double-lumen ProtekDuo cannula (Livanova, London, UK) and the Impella 5.5 (Abiomed, Danvers, MA) trans-aortic pump that translates into a hybrid BiVAD.
Methods:
All consecutive ECMO patients presenting with biventricular cardiogenic shock and ineligibility to heart transplantation from August 2022 were prospectively enrolled. The clinical course, procedural details, and in-hospital events were collected via electronic medical records.
Results:
A total of three patients, who were temporarily not eligible for heart transplantation or durable LVAD due to severe acute pneumonia and right ventricular (RV) dysfunction, were implanted with a hybrid BiVAD. This strategy provided high-flow biventricular support while pulmonary function ameliorated. Moreover, by differentially sustaining the systemic and pulmonary circulation, it allowed for a more adequate reassessment of RV function. All the patients were considered eligible for isolated durable LVAD and underwent less invasive LVAD implantation paired with a planned postoperative RVAD. In all cases, RV function gradually recovered and the RVAD was successfully removed.
Conclusions:
The Hybrid BiVAD represents an up-to-date micro-invasive mechanical treatment of acute biventricular failure beyond ECMO. Its rationale relies on more physiological circulation across the lungs, the complete biventricular unloading, and the possibility of including an oxygenator in the circuit. Finally, the independent and differential control of pulmonary and systemic flows allows for more accurate RV function evaluation for isolated durable LVAD eligibility reassessment.
... In patients in whom these parameters indicate a high risk of RVF, optimization with diuretics, vasopressors/inotropes, dialysis, or temporary percutaneous mechanical circulatory support should be performed (COR I, LOE C). After optimization, if the RV function remains suboptimal, biventricular assist device support should be considered [64]. ...
In recent years, a significant improvement in left ventricular assist device (LVAD) technology has occurred, and the continuous-flow devices currently used can last more than 10 years in a patient. Current studies report that the 5-year survival rate after LVAD implantation approaches that after a heart transplant. However, the outcome is influenced by the correct selection of the patients, as well as the choice of the optimal time for implantation. This review summarizes the indications, the red flags for prompt initiation of LVAD evaluation, and the principles for appropriate patient screening.
... The Lion Heart study examining a completely implantable device without a driveline and requiring only transcutaneous power induction was associated with significant infection risk. This was thought to be secondary to volume and size of foreign material located within the chest (42). As devices become smaller, risk of infection is likely to decrease as well. ...
Background:
Significant right ventricular failure (RVF) complicating left ventricular assist device (LVAD) placement has been reported at 10-30%. Although primarily indicated for left ventricular failure, ventricular assist devices (VADs) have become utilized in a biventricular setup to combat right ventricular failure (RVF) following LVAD implantation. With the advent of continuous-flow LVADs (CF-LVADs) superseding their pulsatile predecessors, the shift towards CF-biventricular assist devices (CF-BiVADs) come with the prospect of improved outcomes over previous pulsatile BiVADs. We aim to review the literature and determine the outcomes of CF-BiVAD recipients.
Methods:
A systematic review was performed to determine the outcomes of CF-BiVADs. Pre-operative demographics and device configuration data was collected. Primary outcomes evaluated were short-term survival, long-term survival, duration of support, and survival to transplant. Secondary outcomes evaluated included intensive care unit (ICU) and hospital length of stay (ICU-LOS and HLOS, respectively), pump thrombosis, pump exchange. Median and interquartile range was reported where appropriate. A major limitation was the likely overlap of cohorts across publications, which may have contributed to some selection bias.
Results:
Of 1,282 screened, 12 publications were evaluated. Sample size ranged from 4 to 93 CF-BiVAD recipients, and follow-up ranged from 6 to 24 months. Mean age ranged from 34 to 52 years old. Forty-five percent of CF-BiVADs had right atrial (RA-) inflow cannulation, with the remaining being right ventricular (RV). Thirty-day survival was a median of 90% (IQR 82-97.8%) and 12-month survival was a median of 58.5% (IQR 47.5-62%). Where reported, rate of pump thrombosis (predominantly the right VAD) was a median of 31% (IQR 14-36%), although pump exchange was only 9% (IQR 1.5-12.5%).
Conclusions:
RVF post-LVAD implantation is a high morbidity and mortality complication. There is no on-label continuous-flow RVAD currently available. Thus, the modifications of LVADs for right ventricular support to combat pump thrombosis has resulted in various techniques. BiVAD recipients are predominantly transplant candidates, and complications of pump thrombosis and driveline infection whilst on wait-list are of great consequence. This study demonstrates the need for an on-label CF-BiVAD.
Temporary mechanical circulatory support is used when a patient’s heart function acutely decompensates and cannot provide adequate circulation. Depending on the heart failure etiology, these devices can support patients until their native heart’s function improves or as a bridge to durable left ventricular assist device or heart transplantation.
Medical management of end-stage chronic heart failure (HF) has evolved significantly over the past few decades. With a better understanding of the pathophysiology of HF, new pharmacological agents have been synthesized. However, survival in this cohort of patients with medical treatment remains extremely low. This has stimulated the development of surgical methods of treatment. Recent technological advances in the development of mechanical circulatory assist devices have made possible a single-stage implantation of two centrifugal pumps as an alternative to a total artificial heart. Today ventricular assist devices can be implanted to provide both univentricular and biventricular support depending on the severity of hemodynamic disorders, target organ damage, likelihood of recovery and heart transplantation.
Nearly half of all individuals with heart failure with reduced ejection fraction have biventricular dysfunction. By unloading the left ventricle and decreasing left atrial pressures, there is a reasonable chance for right ventricular recovery after left ventricular assist device. Unfortunately, the opposite is also true where right ventricular failure can be unmasked, develop, or worsen. This chapter will focus on the patient selection and management of individuals with pre-existing biventricular failure either from chronic left ventricular failure or dilated cardiomyopathies, as well as those who develop right ventricular failure after left ventricular assist devices have been placed. We will discuss methods for risk stratifying individuals with biventricular dysfunction and pre-, peri-, and postoperative management strategies for improving right ventricular recovery and survival to transplant in these patients.
Right ventricular failure following left ventricular assist devices implantation is a serious complication associated with high mortality. In patients with or at high risk of developing right ventricular failure, biventricular support is recommended. Because univentricular support is associated with high survival rates, biventricular support is often undertaken as a last resort. With the advent of newer right ventricular and biventricular systems under design and testing, better differentiation is required to ensure optimal patients care. Clear guidelines on patient selection, time of intervention and device selection are required to improve patient outcomes.
Heart failure is the basic and featured pathologic leading cause of death. From a clinical perspective, the most important objectives in caring for heart failure patients are diagnosis of the underlying mechanism and delivery of appropriate, effective treatment. In the majority of cases, the left ventricle is affected but the right ventricle functions normally until the end stage. Right ventricular failure (RVF) results from weakening of the right ventricular structures and/or by an increase in pulmonary vascular resistance. Post-implant RVF, a third type has been recognized in the last two decades. Right ventricular failure results in poor filling of the left ventricle and poor output, often necessitating additional right ventricular support in the form of inotropes or a mechanical right ventricular assist device (RVAD). Temporary mechanical support devices increase pulmonary blood circulation with or without extracorporeal oxygenation to provide adequate cardiac output. The preferred approach is to insert a temporary mechanical support device in percutaneous va-ECCPS configuration for acute RVF in the intensive care unit or in surgical vp-ECCS configuration for post-implant RVF in the operating room. For longer use, right ventricular or biventricular assist devices are used to provide circulatory support. Permanent RVADs provide a parallel or series artificial circulation to substitute for failed ventricles or they take over completely the pump function of a resected heart. Short-term RVADs are extracorporeal or paracorporeal pumps located outside the body, whereas durable RVADs are implanted inside the body. A novel development will be a true artificial heart without a need for anticoagulants; however, heart transplantation is still the gold standard for curative treatment.
