Recovery directed left ventricular assist device: a new concept

To promote cardiac recovery, we developed a recovery directed left ventricular assist device (RDLVAD) that consists of a valved apical conduit, an afterload controlling chamber (ACC), and a pump. We evaluated its efficacy by comparison with an ordinary LVAD. In each of six pigs with ischemia-induced heart failure, flow and pressure measurements were made while maintaining the total blood flow and arterial pressure equal in the two groups. RDLVAD was able to direct all the blood ejected from the LV into the ACC (0-15 mm Hg) but not into the aorta (73 mm Hg). In the ordinary LVAD, however, some ejection occurred into the aorta despite vigorous suction of the LV. Thus, RDLVAD increased DPTI/SPTI 2.3 times (p < 0.005) and decreased left ventricular end-diastolic pressure by 40% and maximum dP/dt by 20% (p < 0.05). Even the apical valve, at approximately half the diameter of the aortic valve, was able to allow all the blood ejected from the LV to enter the ACC. In one control group pig that achieved almost no ejection into the aorta, left ventricular relaxation and dilatation was extremely limited. RDLVAD may promote cardiac recovery by ensuring less LV work, a greater blood supply/demand ratio in the coronary circulation, and full ventricular relaxation.     

Aortic valve closure for rapidly deteriorated aortic insufficiency after continuous flow left ventricular assist device implantation

A patient underwent aortic valve closure for de novo aortic insufficiency that had deteriorated to severe insufficiency during six months of support with a continuous flow left ventricular assist device (cf-LVAD). Aortic insufficiency was initially noted one month after LVAD implantation, and then deterioration quickly developed. Right heart catheterization revealed that when the rotational speed of the cf-LVAD was increased, the cardiac index was decreased by an increase in regurgitant volume, as shown by echocardiography. During surgery, fusion and shortening of the aortic leaflets as well as left coronary ostial occlusion were observed. Direct aortic closure improved hemodynamics. Thrombus formation on the aortic valve shown by echocardiography in the early postoperative period may be a trigger of aortic insufficiency. Control of the cf-LVAD rotational speed is likely required to prevent aortic insufficiency.     

Central aortic valve closure successfully treated aortic insufficiency of the patient with Jarvik 2000 continuous flow left ventricular assist device: a case report

Aortic insufficiency (AI) is a significant complication of long-term support of continuous flow left ventricular assist device (CF-LVAD) for patients with end-stage heart failure. A 26-year-old female with osteogenesis imperfecta (OI) was diagnosed with dilated phase hypertrophic cardiomyopathy (d-HCM)) and was implanted with Jarvik 2000, for bridge to transplantation. AI gradually developed and surgical intervention was indicated. We performed central aortic valve closure (CAVC) instead of valve replacement 20 months after CF-LVAD implantation. Patient’s symptoms dramatically improved postoperatively. This is the first report of CAVC for a patient supported with Jarvik 2000.     

Outflow graft anastomosis site design could be correlated to aortic valve regurgitation under left ventricular assist device support

Aortic valve regurgitation (AR) is a critical complication during circulatory support with a left ventricular assist device (LVAD). The time-course of AR and related factors, including outflow graft anastomosis site design, were investigated. Twenty-three patients who had continuous-flow LVAD implantation and were supported for more than 6 months were investigated. AR grade (none, 0; trivial, 0.5; mild, 1; mild-moderate, 1.5; moderate, 2; moderate-severe, 2.5; severe, 3) and aortic valve opening were evaluated with echocardiography. Computed tomography was performed to all the patients postoperatively. The angle of the outflow graft to the aorta (O-A angle, parallel 0; tangent 90°, 0–180°), aortic diameter at the anastomosis site, sino-tubular junction (STJ) diameter, distance between the STJ and the anastomosis site, and distance between the anastomosis site and the brachiocephalic artery were measured. The patients’ age was 38?±?11 years. Support duration was 686?±?354 days. Mean AR grade after continuous-flow LVAD implantation was increased to around mild and was maintained thereafter. No patient needed any intervention to the aortic valve. The aortic valves of 82.6% of patients were closed continuously. The O-A angle (83?±?14) was positively correlated with maximum AR grade (p?=?0.0095). The O-A angle was significantly smaller in patients with maximum AR grade of 1 or less (77?±?9°) than in those with 1.5 or greater (94?±?15°, p?=?0.021). The other CT measurements had no correlation with AR grade. In conclusion, the O-A angle was correlated with AR grade progression. The O-A angle appears to be one of the important factors related to AR under continuous-flow LVAD support.     

Regenerating a ventricular cavity during left ventricular assist device implantation

Journal of Artificial Organs - Ten months after an ineffective percutaneous coronary stent placement, a 53-year-old patient was rehospitalized with NYHA functional class IV congestive heart...     

Anticoagulation during use of a left ventricular assist device

Thirty-six mongrel dogs underwent 24hr left ventricular assist. The VAD was placed between the left atrium and the descending aorta, and the dogs were divided into four groups according to type of anticoagulation: no anticoagulation, argatroban, nafamostat mesylate, and nafamostat mesylate + prostacyclin analog. Results of this animal experiment revealed that a newly developed synthetic thrombin inhibitor argatroban can prevent activation of the intrinsic coagulation pathway. Argatroban is efficient under any blood coagulative condition, even lack of anti-thrombin III, because of its direct inhibitory effect on thrombin, making argatroban more useful than heparin as an anticoagulant for LVAD. Argatroban, as well as heparin, provides marked and significant prolongation of the prothrombin time from early assisted circulation, but produces a bleeding tendency. Nafamostat mesylate can maintain blood coagulation parameters within the acceptable range. Combined administration of nafamostat mesylate and a prostacyclin analog cause the least decrease in fibrinogen and alpha2-plasmin inhibitor among the four groups and causes no significant prolongation of prothrombin time.     

Use of aortic valvo-pumps placed in valve annulus for long-term left ventricular assist

To provide better anatomical fit and physiologic adaptation, three aortic valvo-pumps with different dimensions were developed. Each pump has a rotor with an impeller and drive magnets and a stator consisting of a motor coil with iron core and an outflow guide vane. The devices had outer diameters of 21 mm, 23 mm, and 25 mm, respectively, and weighted 27 g, 31 g, and 40 g, respectively. Laboratory testing demonstrated that the rotating speed for maintaining a diastolic pressure of 80 mm Hg at zero flow rate should be 17500 rpm, 15000 rpm, and 12500 rpm, respectively; the largest flow at these same speeds will be 5 l/min, 7 l/min, and 10 l/min, respectively, with approximately 50 mm Hg pressure head increase. Therefore, these three pumps may meet the hemodynamic requirements of patients with body weights of 40-60 kg, 60-80 kg, and 80-100 kg. The first in vivo trial exhibited that the 25 mm valvo-pump can be sewn onto the aortic valve annulus of a 80 kg body weight pig without harm to adjacent organ functions. The devices occupy no additional anatomic space and deliver the blood directly from ventricle to the aorta, thus producing less physiologic disturbance to the natural circulation. Neither connecting conduits nor bypass circuits are necessary, thus eliminating the most dangerous sites of thrombosis in traditional left ventricular assist devices.     

Prediction of aortic valve regurgitation after continuous-flow left ventricular assist device implantation using artificial intelligence trained on acoustic spectra

Significant aortic regurgitation (AR) is a common complication after continuous-flow left ventricular assist device (LVAD) implantation. Using machine-learning algorithms, this study was designed to examine valuable predictors obtained from LVAD sound and to provide models for identifying AR. During a 2-year follow-up period of 13 patients with Jarvik2000 LVAD, sound signals were serially obtained from the chest wall above the LVAD using an electronic stethoscope for 1 min at 40,000 Hz, and echocardiography was simultaneously performed to confirm the presence of AR. Among the 245 echocardiographic and acoustic data collected, we found 26 episodes of significant AR, which we categorized as “present”; the other 219 episodes were characterized as “none”. Wavelet (time–frequency) analysis was applied to the LVAD sound and 19 feature vectors of instantaneous spectral components were extracted. Important variables for predicting AR were searched using an iterative forward selection method. Seventy-five percent of 245 episodes were randomly assigned as training data and the remaining as test data. Supervised machine learning for predicting concomitant AR involved an ensemble classifier and tenfold stratified cross-validation. Of the 19 features, the most useful variables for predicting concomitant AR were the amplitude of the first harmonic, LVAD rotational speed during intermittent low speed (ILS), and the variation in the amplitude during normal rotation and ILS. The predictive accuracy and area under the curve were 91% and 0.73, respectively. Machine learning, trained on the time–frequency acoustic spectra, provides a novel modality for detecting concomitant AR during follow-up after LVAD.

     

The 50cc Penn State left ventricular assist device: a parametric study of valve orientation flow dynamics

We investigated the flow fields associated with the Bjork-Shiley Monostrut mechanical heart valve in the mitral position of the 50 cc Penn State left ventricular assist device. The valve orientation was adjusted whereby flow field data was collected using planar particle image velocimetry. The mitral valve was rotated from 0 to 45 degrees, in 15-degree increments. For each valve orientation, measurements were made in three planes (3, 5, and 8 mm from the front wall) parallel to the device pusher plate. Penetration of the inlet jet was affected by the valve orientation with more intense and longer duration wall washing motion occurring at 45 degrees. As a result, the 45-degree mitral valve orientation is recommended to help prevent areas of thrombus deposition. Valve orientation is an important aspect of assist device design.     

Development of a percutaneous pediatric ventricular assist device

Remarkable progress has been made on ventricular assist devices for adult patients. Unfortunately, similar devices are not yet available in the United States for pediatric heart patients. The goal of this project is to demonstrate the feasibility of a percutaneous ventricular assist device for pediatric patients above 2 kg. The proposed system consists of an extracorporeal centrifugal blood pump, a transseptal venous cannula that takes blood from the left atrium to the pump, an arterial cannula that returns the blood to the arterial system, and a controller to adjust pump speed/flow. Using an ad hoc pediatric pump prototype and a spectrum of specially designed cannulae of various sizes, benchtop studies showed that the proposed system could deliver blood flow in a range of 0.3 to 3.0 l/min. For smaller patients (2-35 kg), the transseptal cannula was designed to be placed in the internal jugular vein and the arterial cannula in the internal carotid artery. For larger patients (> 35 kg), the femoral vein and artery would be used. Further development effort will be focused on reducing the hemolysis of the pump design, refining the cannula design, and demonstrating the safety and functionality in animal studies.     

Mechanical mitral prosthesis with a short-term left ventricular assist device

Mechanical circulatory support with ventricular assist devices in patients with mechanical valvular prostheses may predispose to thromboembolic and hemodynamic complications. Conventional approaches to reduce these risks involve redo valve replacement to a bioprosthesis. Careful management of the ventricular assist device to allow flow across the prosthesis may obviate the need for redo valve replacement. Avoidance of further myocardial ischemia during redo valve replacement carries particular importance for patients in whom the aim is recovery. We report a successful outcome from retention of a mechanical mitral prosthesis during a 10-day period of mechanical circulatory support and review the pertinent literature.     

Infective endocarditis of bovine pericardial patch in the aortic position in a patient with left ventricular assist device

Journal of Artificial Organs - A 53-year old woman, who had a history of left ventricular assist device implantation for acromegalic cardiomyopathy and aortic valve closure with bovine pericardial...     

Mechanical heart valve performance in a pulsatile pediatric ventricular assist device

A pulsatile pediatric ventricular assist device with a dynamic stroke volume of 12 ml is currently under development at the Pennsylvania State University. A monoleaflet valve (Bj?rk-Shiley Monostrut) and a bileaflet valve (CPHV, CarboMedics Prosthetic Heart Valve) were examined in this study. A high-speed video and data acquisition system was used to simultaneously record video images, pressure waveforms, and flow waveforms for an array of in vitro test conditions that varied heart rate and systolic duration. The CPHV in both the horizontal and vertical orientations have larger regurgitant volumes than the Monostrut valves at all operating conditions in both the inlet and outlet positions. However, the CPHV has higher stroke volumes and cardiac outputs than the Monostrut valve at higher heart rates and longer systolic durations. In addition, the hydrodynamic performance of the Monostrut valve is more sensitive to changes in operating conditions for the pulsatile pediatric ventricular assist device than the CPHV in both orientations. Additional testing is under way to identify the optimal operating conditions for each type of valve.     

一种经皮植入式左心辅助装置的泵流量测试

目的 研究设计一种能用于心血管急危重症的经皮植入式左心辅助装置（血泵）。方法 根据机翼理论,设计一种经皮植入的左心辅助装置,通过测量3种不同参数（叶片旋转角度、血泵出水口距离、血泵出水口长度）的血泵所能产生的流量,最终选择最优化的血泵设计。结果 经过简易流量测定装置测量,当血泵采取单叶设计,血泵叶片的旋转角度为720°时,或血泵出水口与叶片的距离为0 mm时,血泵出水口长度为4 mm时,血泵流量最大。结论 选择能产生最大流量的参数值,研制出一种可在体外正常运转的经皮植入式左心辅助装置,为最终研制一种可用于临床的经皮植入式左心辅助装置提供理论和数据支持。     

The effect of aortic valve incompetence on the hemodynamics of a continuous flow ventricular assist device in a mock circulation

There is evidence that the incidence of aortic valve incompetence (AI) and other valvular pathologies may increase as more patients are submitted to longer periods of ventricular assist device (VAD) support. There is a need to better understand the mechanisms associated with the onset of these conditions and other possible complications related to the altered hemodynamics of VAD patients. In this study, the effect of AI on the hemodynamic response of continuous flow VAD (C-VAD) patients was measured in a mock loop over a range of pump speeds and level of native cardiac function. Our results showed that, in the presence of sufficient ventricular function, decreasing the C-VAD speed can allow a transition from series to parallel flow. Our study demonstrated that AI reduces the aortic pressure and flow when system impedance is unchanged. AI produces wasteful recirculation that substantially increases the pump work and decreases systemic perfusion, in particular during series flow conditions coupled with higher C-VAD speeds. The hematologic consequence of this regurgitant flow is a much higher exposure to shear for the blood, increasing the likelihood of hemolysis and thrombosis. While a certain degree of AI can be tolerated by a heart with good cardiac function, the consequences of AI for patients with VADs and poor cardiac function are much greater. Valve dysfunction in VAD patients may be related to structural changes in the tissue induced by altered biomechanics and excessive stress.