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Objective: A less-invasive left atrial assist device (LAADx) is a novel and implantable, extracardiac blood pump concept, intended for the treatment of diastolic heart failure, represented by heart failure with preserved ejection fraction. Methods: A mixed-flow pump was used as the working LAADx model. Its performance was evaluated at 3 speeds, using an in vitro pulsatile mock circulatory loop, with a pneumatic pump that can simulate diastolic heart failure conditions by adjusting the diastolic drive pressure. The LAADx model was implanted in 4 healthy calves. The pump's inflow and outflow cannulas were inserted into the left atrium (LA) and left ventricle (LV), respectively, without cardiopulmonary bypass. The LAADx was operated at 3 speeds, and diastolic heart failure-like conditions were induced by inflating a balloon, inserted into the LV. Results: With the in vitro study, diastolic heart failure-like conditions were successfully induced, exhibiting decreased cardiac output and aortic pressure as well as increased mean LA pressure both mitigated with the LAADx support. With regard to the in vivo study, simulated diastolic heart failure conditions showed a decrease in aortic pressure and an increase in LA pressure and LV end-diastolic pressure, which were again mitigated by the LAADx. Echocardiography showed good positioning of the outflow cannula and neither cardiac dysfunction nor mitral interference was observed. Conclusions: Initial in vitro and in vivo results confirmed that the LAADx model, a device concept driven by creating an extracardiac route from the LA to LV, has the potential to mitigate high LA pressure and improve LV filling of heart failure with preserved ejection fraction pathology.

Background: The pediatric continuous-flow total artificial heart (P-CFTAH) is a novel double-ended centrifugal pump designed with the intent to provide circulatory support for pediatric heart failure. To enable continuous monitoring of pump hemodynamics, Hall effect sensors (HES) were embedded inside the P-CFTAH design to track both axial movement and position of the pump rotor postimplantation. Herein, we report an early in vivo evaluation of the P-CFTAH with HES, implanted in small-sized ovine models. Methods: Five healthy lambs were used for the P-CFTAH implantation via a full median sternotomy and cardiopulmonary bypass support. Successful evaluation of the P-CFTAH was achieved in 4 out of 5 (n = 4, 20.9 ± 1.3 kg). The hemodynamics and operating conditions were continuously recorded with varying pump speeds (2,800-5,000 rpm), systemic/pulmonary vascular resistance ratio, and high- and low-volume conditions. Among the 4 cases, P-CFTAH with HES embedded in the rotor was used in 2 cases. Results: All surgical procedures were uneventful, and the optimal anatomical fit of the pump was shown in the chest. Differences between the left and right atrial pressures were mostly maintained within the intended limit of ±10 mm Hg throughout the design range of systemic and pulmonary vascular resistance. The HES accurately traced the rotor position, showing a positive correlation with atrial pressure differences. Conclusions: The findings suggest that the P-CFTAH has the potential to provide self-balancing circulatory support for pediatric heart failure patients. The study contributes to the development of a pediatric-sized total artificial heart with improved monitoring.

BackgroundThis study aimed to determine the fit of two small-sized (pediatric and infant) continuous-flow total artificial heart pumps (CFTAHs) in congenital heart surgery patients.MethodsThis study was approved by Cleveland Clinic Institutional Review Board. Pediatric cardiac surgery patients (n = 40) were evaluated for anatomical and virtual device fitting (3D-printed models of pediatric [P-CFTAH] and infant [I-CFTAH] models). The virtual sub-study consisted of analysis of preoperative thoracic radiographs and computed tomography (n = 3; 4.2, 5.3, and 10.2 kg) imaging data.ResultsP-CFTAH pump fit in 21 out of 40 patients (fit group, 52.5%) but did not fit in 19 patients (non-fit group, 47.5%). I-CFTAH pump fit all of the 33 patients evaluated. There were critical differences due to dimensional variation (p

ObjectiveSevere biventricular heart failure (BHF) can be remedied using a biventricular assist device (BVAD). Two devices are currently in development: a universal ventricular assist device (UVAD), which will be able to assist either the left, right, or both ventricles, and a continuous-flow total artificial heart (CFTAH), which replaces the entire heart. In this study, the in vitro hemodynamic performances of two UVADs are compared to a CFTAH acting as a BVAD.MethodsFor this experiment, a biventricular mock circulatory loop utilizes two pneumatic pumps (Abiomed AB5000™, Danvers, MA, USA), in conjunction with a dual-output driver, to create heart failure (HF) conditions (left, LHF; right, RHF; biventricular, BHF). Systolic BHF for four different situations were replicated. In each situation, CFTAH and UVAD devices were installed and operated at two distinct speeds, and cannulations for ventricular and atrial connections were evaluated.ResultsBoth CFTAH and UVAD setups achieved our recommended hemodynamic criteria. The dual-UVAD arrangement yielded a better atrial balance to alleviate LHF and RHF. For moderate and severe BHF scenarios, CFTAH and dual UVADs both created excellent atrial pressure balance. Conversely, when CFTAH was atrial cannulated for LHF and RHF, the needed atrial pressure balance was not met.ConclusionComprehensive in vitro testing of two different BVAD setups exhibited self-regulation and exceptional pump performance for both (single- and dual-device) BHF support scenarios. For treating moderate and severe BHF, UVAD and CFTAH both functioned well with respect to atrial pressure regulation and cardiac output. Though, the dual-UVAD setup yielded a better atrial pressure balance in all BHF testing scenarios.

In contrast to the advanced development of the left ventricular assist device (LVAD) therapy for advanced heart failure, the mechanical circulatory support (MCS) with biventricular assist device (BVAD) and total artificial heart (TAH) options remain challenging. The treatment strategy of BVAD and TAH therapy largely depends on the support duration. For example, an extracorporeal centrifugal pump, typically referred to as a temporary surgical extracorporeal right ventricular assist device, is implanted for the short term with acute right ventricular failure following LVAD implantation. Meanwhile, off-label use of a durable implantable LVAD is a strategy for long-term right ventricular support. Hence, this review focuses on the current treatment strategies and clinical outcomes based on each ventricle support duration. In addition, the issue of heart failure post-heart transplantation (post-HT) is explored. We will discuss MCS therapy options for post-HT recipients.

The importance of right heart failure (RHF) treatment is magnified over the years due to the increased risk of mortality. Additionally, the multifactorial origin and pathophysiological mechanisms of RHF render this clinical condition and the choices for appropriate therapeutic target strategies remain to be complex. The recent change in the United Network for Organ Sharing (UNOS) allocation criteria of heart transplant may have impacted for the number of left ventricular assist devices (LVADs), but LVADs still have been widely used to treat advanced heart failure, and 4.1 to 7.4% of LVAD patients require a right ventricular assist device (RVAD). In addition, patients admitted with primary left ventricular failure often need right ventricular support. Thus, there is unmet need for temporary or long-term support RVAD implantation exists. In RHF treatment with mechanical circulatory support (MCS) devices, the timing of the intervention and prediction of duration of the support play a major role in successful treatment and outcomes. In this review, we attempt to describe the prevalence and pathophysiological mechanisms of RHF origin, and provide an overview of existing treatment options, strategy and device choices for MCS treatment for RHF.

The importance of the left atrium (LA) has been emphasized in recent years as the features of heart failure (HF), especially with regard to variability in patient and pathology phenotypes, continue to be uncovered. Of note, among the population with HF with preserved ejection fraction (HFpEF), pressure or size of the LA have become a target for advanced monitoring and a therapeutic approach. In the case of diastolic dysfunction or pulmonary hypertension, which are often observed in patients with HFpEF, a conventional approach with clinical symptoms and physical signs of decompensation turned out to have a poor correlation with LA pressure. Therefore, to optimize HF treatment for these populations, several devices that are applied directly to the LA have been developed. First, two LA pressure (LAP) sensors (Heart POD and V-LAP Device) were developed and may enable patient self-management remotely with LAP-guided and physician-directed style. Second, there are device-based approaches that aim to decompress the LA directly. These include: (1) interatrial shunt devices; (2) left ventricular assist devices with LA cannulation; and (3) the left atrial assist device. While these novel device-based therapies are not yet commercially available, there is expected to be a rise in the proposition and adoption of a wider range of choices for monitoring or treating LA using device-based options, based on LA dimensional reduction and optimization of the clinically significant pressure relief. Further development and evaluation are necessary to establish a more favorable management strategy for HF.

Background: The Advanced ventricular assist device (Advanced VAD) is designed as a universal pump intended to prevent backflow in the event of pump stoppage, to maintain physiological pulse pressure, and to be used as both a left and right VAD. The purpose of this study was to evaluate the performance of the Advanced VAD as both a left and right VAD in an acute in vivo study in calves. Methods: The Advanced VAD was implanted through a median sternotomy in 5 healthy calves (weight, 71.4-91.2 kg) as a left VAD (n = 3) or a right VAD (n = 2). After implantation, hemodynamic parameters, including general performance and pump stoppage, were evaluated. Results: The Advanced VAD was successfully implanted as a left and right VAD without cardiopulmonary bypass. The speed range of the Advanced VAD was 2500 to 3500 rpm as a left VAD and 2000 to 2500 rpm as a right VAD. Up to 4.3 L/min was achieved for both left and right VAD configurations. To demonstrate the automatic shut-off feature, the pump was stopped without clamping the outflow graft. The outflow graft was then clamped, which produced no significant changes in the arterial pressure waveform. The pulse pressures under the left VAD configuration were 38 mm Hg, 17 mm Hg, 14 mm Hg, and 16 mm Hg at baseline, 2500 rpm, 3000 rpm, and 3500 rpm, respectively. Conclusions: This acute in vivo study demonstrated the pump performance, anatomical fitting as both left VAD and right VAD, and regurgitant flow shut-off feature of the Advanced VAD.

Background Left ventricular assist device (LVAD) thrombosis is clinically devastating and impacts the cost effectiveness of LVAD therapy for advanced heart failure. Anticoagulation and antiplatelet therapies represent the standard of care to mitigate LVAD thrombosis. Phosphodiesterase type 5 inhibitors (PDE‐5is) exhibit hemodynamic, antiplatelet, and antithrombotic effects. Using a national registry, we examined the relationship of PDE‐5i use on thrombotic events in patients with continuous‐flow LVADs. Methods and Results We obtained data from 13 772 patients with continuous flow LVADs participating in a national registry. Patients implanted with primary LVADs from 2012 to 2017 were included in the analysis. The primary end point was a composite of LVAD thrombosis and ischemic stroke. Patients were analyzed according to any use of PDE‐5i after LVAD implantation (PDE‐5i group) versus no use after LVAD implantation (no PDE‐5i group). The primary end point was significantly lower in the PDE‐5i group compared with the no PDE‐5i group (hazard ratio [HR], 0.84; 95% CI, 0.77–0.91; P

In robotic assisted beating heart surgery, the control architecture for heart motion tracking has stringent requirements in terms of bandwidth of the motion that needs to be tracked. In order to achieve sufficient tracking accuracy, feed-forward control algorithms, which rely on estimations of upcoming heart motion, have been proposed in the literature. However, performance of these feed-forward motion control algorithms under heart rhythm variations is an important concern. In their past work, the authors have demonstrated the effectiveness of a receding horizon model predictive control-based algorithm, which used generalized adaptive predictors, under constant and slowly varying heart rate conditions. This paper extends these studies to the case when the heart motion statistics change abruptly and significantly, such as during arrhythmias. A feasibility study is carried out to assess the motion tracking capabilities of the adaptive algorithms in the occurrence of arrhythmia during beating heart surgery. Specifically, the tracking performance of the algorithms is evaluated on prerecorded motion data, which is collected in vivo and includes heart rhythm irregularities. The algorithms are tested using both simulations and bench experiments on a three degree-of-freedom robotic test bed. They are also compared with a position-plus-derivative controller as well as a receding horizon model predictive controller that employs an extended Kalman filter algorithm for predicting future heart motion.

Introduction: Currently, veno-arterial extracorporeal membrane oxygenation (VA ECMO) represents a valuable treatment option for patients presenting with severe cardiogenic shock. Although the overall usage of VA ECMO in experienced centers is expanding, some management aspects remain challenging, with no consensus among centers on well-defined assessment criteria, duration, and, particularly, weaning strategies. Area covered: This article aims to provide a review and evaluation of strategies reported in the literature to wean patients from VA ECMO, with a special emphasis on weaning protocols. A selected successful weaning protocol and rate of removal of adult patients from VA ECMO from recent reports will be also discussed. Expert commentary: To improve patient outcome, it is essential to remove patients from VA ECMO without weaning failure. Furthermore, the accurate evaluation of the patient's condition must be principal. However, as technology advances, the strategy of weaning patients from VA ECMO or drug therapies is changing, and we must periodically update our knowledge and use of VA ECMO. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Exclusion of the left atrial appendage has been proposed to reduce the risk of stroke in patients with atrial fibrillation. The aim of this study was to evaluate the feasibility and efficacy of the AtriClip PRO⋅V device (AOD2), now in development, for left atrial appendage exclusion in a canine model. METHODS: The newest AtriClip design comprises a dual-spring mechanism that allows the clip to open into a 'V' shape while still providing equivalent force along the length of the beam. The AOD2's hallmark is a distal tip closure to help retain the appendage during clip closure. Six dogs were implanted via thoracotomy with the clinically available AtriClip device (AOD1) on the right atrial appendage and the AOD2 on the left. At 90 days after implantation, all devices were evaluated by epicardial echocardiography, computed tomography, gross pathology and histology. System performance at the initial surgery was evaluated as well. RESULTS: The ease of use of the clinically available AtriClip device (AOD1) and AOD2 was deemed comparable in all cases. All animals survived for the planned 90-day duration without complications. The atrial appendages were fully occluded in all cases without device migration. On histology, all AtriClip devices demonstrated an acceptable biocompatibility response. CONCLUSIONS: The AOD2 achieved easy, reliable and safe exclusion of the left atrial appendage, with favourable histologic findings. Once approved for clinical application, the AOD2 could provide a new therapeutic option to lower the risks of stroke in patients with atrial fibrillation. [ABSTRACT FROM AUTHOR]

Research on the therapeutic modulation of cardiac autonomic tone by electrical stimulation has yielded encouraging early clinical results. Vagus nerve stimulation has reduced the rates of morbidity and sudden death from heart failure, but therapeutic vagus nerve stimulation is limited by side effects of hypotension and bradycardia. Sympathetic nerve stimulation that has been implemented in the experiment may exacerbate the sympathetic-dominated autonomic imbalance. In contrast, concurrent stimulation of both sympathetic and parasympathetic cardiac nerves increases myocardial contractility without increasing heart rate. This review assesses the current state of electrical stimulation of the cardiac autonomic nervous system to treat heart failure. [ABSTRACT FROM AUTHOR]

Background. We previously reported renal arterial periarteritis after implantation of a continuous-flow left ventricular assist device in calves. The purpose of the present study was to investigate whether the same periarteritis changes occur in the intrapulmonary arteries after implantation of a continuous-flow right ventricular assist device (CFRVAD) in calves and to determine the mechanism of those histologic changes. Methods. Ten calves were implanted with a CFRVAD for 29 ± 7 days, and we compared pulmonary artery samples and hemodynamic data before and after CFRVAD implantation prospectively. Results. After implantation, the pulsatility index (pulmonary arterial pulse pressure/pulmonary arterial mean pressure) significantly decreased (0.88 ± 0.40 before vs 0.51 ± 0.22 after; p < 0.05), with severe periarteritis of the intrapulmonary arteries in all animals. Periarterial pathology included hyperplasia and inflammatory cell infiltration. The number of inflammatory cells positive for the angiotensin II type 1 receptor was significantly higher after implantation (7.8 ± 6.5 pre-CFRVAD vs 313.2 ± 145.2 at autopsy; p < 0.01). Serum angiotensin-converting enzyme activity significantly decreased after implantation from 100% to 49.7 ± 17.7% at week 1 (p = 0.01). Tissue levels of angiotensin-converting enzyme also demonstrated a significant reduction (0.381 ± 0.232 before implantation vs 0.123 ± 0.096 at autopsy; p = 0.043). Conclusions. Periarteritis occurred in the intrapulmonary arteries of calves after CFRVAD implantation. The local renin-angiotensin system (not the angiotensin-converting enzyme pathway) plays an important role in such changes. [ABSTRACT FROM AUTHOR]