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Background BiVACOR is a novel total artificial heart (TAH) utilizing a single centrifugal magnetically levitated rotor with the ability to modulate pulsatile flow. The device has been successfully tested in a bovine model. We undertook a multicenter anatomical and virtual fitting study of the BiVACOR in patients undergoing heart transplantation. Methods 10 patients were recruited across two heart transplant centers. A sterilized 1:1 titanium model of the device was inserted into the patient's chest post heart explant, prior to implantation of the donor heart. Measurements were recorded in situ. The device was then removed. Following this, retrospective 3D reconstructions were created from computed tomography chest scans to simulate a virtual fitting. Results Mean age was 53 years (range 38-67). Mean BMI was 28 (range 20-37). Heart failure etiology was varied-with ischemic cardiomyopathy being the most common. Mean spine-to-sternum distance at the tenth thoracic vertebrae (T10) was 14 cm (range 11-18). Mean aorta to aortic Port distance was 0.2 cm (range 0-0.5). Mean pulmonary artery to pulmonary artery port distance was 4.2 cm (range 1-7). The device fitted suitably in all patients without gross distortion to the geometry between native vessel/chamber and port. Conclusions This study described the anatomical and virtual fitting of the BiVACOR TAH. The device fit well within the chest cavities of all 10 patients, who represented a variety of body morphologies and heart failure etiology.

Continuous flow left ventricular assist devices (cfLVADS) result in a significant reduction in aortic valve (AV) opening, which has been associated with several complications. Reliable monitoring of AV opening is needed to determine whether pump speed adjustment may be able to minimize adverse outcomes. We assessed AV status continuously by echocardiography for 4 minutes in 3 states in 18 HeartWare HVAD patients: 2 minutes at rest, and 1 minute each following Valsalva maneuver and supine leg-raising. Using a previously described algorithm, beat-to-beat AV status was compared with the area under the curve of the normalized power spectral density analysis (PSD-AUC) for the corresponding beats of the pump speed waveform. Five thousand five hundred twenty-seven beats were analyzed. AV opening varied between 0% and 100% for the cohort with the median AV opening frequency 21.5%, and median duration of opening of 124 msec (range 0-279). The receiver operating characteristic (ROC) curve area for AV opening by the PSD-AUC algorithm was 0.95 (P < 0.0001). A PSD-AUC cut-off of 0.82 distinguished between an open and closed AV with 86% sensitivity and 93% specificity. Accuracy was similar in regular cardiac rhythm, atrial fibrillation or with frequent ventricular ectopic beats. Valsalva maneuver and leg-raising had no impact on accuracy. The PSD-AUC was strongly predictive of AV opening duration (P < 0.0001). We found that AV status and opening duration can be determined with high accuracy on a beat-to-beat basis irrespective of cardiac rhythm and with low level exercise and changes in filling.

As the aortic valve (AV) opens, the pump pressure head remains constant, which is reflected as a "notch/plateau" in pump pressure and flow signals. However, instantaneous flow estimation may be influenced by friction and is particularly difficult in axial pumps. Therefore, a new method to determine the duration of AV opening based on the area under the curve (AUC) of the power spectral density analysis of pump speed signal was developed. Data from patients implanted with HeartWare HVAD left ventricular assist device were studied at different pump speeds, with simultaneous transthoracic echocardiography in two cohorts. In the first group, pump data of 15 patients were used to investigate the ability to discriminate between an open and closed AV. In the second cohort of a further 13 patients, the duration of AV opening was measured from digitized M-mode images, and the relationship between the AV opening time and the new method assessed. In 14 of the initial 15 patients, AV status could be discriminated using only one threshold for all patients. In the second cohort, gradual speed reduction resulted in aortic valve opening in 12 of the 13 patients. The correlation between AV opening duration and AUC was 0.96 ± 0.03. Regression analysis indicated a linear relationship in each of the patients with a small error between the fit and the measured opening time (root mean square error = 11.0 ± 7.6 ms). However, the slopes (69.0 ± 52.8) and intercepts (-31.4 ± 78.0) varied widely between patients. The sensitivity and specificity for the new method using AUC threshold of 0.95 for aortic valve closure was 95% and 91%, respectively. The newly developed method to detect AV opening not only provides information on the AV status during LVAD support (open/closed) but also gives insight into the duration of AV opening. Because the slope of the relationship varies from patient to patient, initial training and adaptation of the method to each patient seems to be required.

It is important to accurately monitor residual cardiac function in patients under long-term continuous-flow left ventricular assist device (cfLVAD) support. Two new measures of left ventricular (LV) chamber contractility in the cfLVAD-unloaded ventricle include IQ, a regression coefficient between maximum flow acceleration and flow pulsatility at different pump speeds; and K, a logarithmic relationship between volumes moved in systole and diastole. We sought to optimize these indices. We also propose RIQ, a ratio between maximum flow acceleration and flow pulsatility at baseline pump speed, as an alternative to IQ. Eleven patients (mean age 49 ± 11 years) were studied. The K index was derived at baseline pump speed by defining systolic and diastolic onset as time points at which maximum and minimum volumes move through the pump. IQ across the full range of pump speeds was markedly different between patients. It was unreliable in three patients with underlying atrial fibrillation (coefficient of determination R(2) range: 0.38-0.74) and also when calculated without pump speed manipulation (R(2) range: 0.01-0.74). The K index was within physiological ranges, but poorly correlated to both IQ (P = 0.42) and RIQ (P = 0.92). In four patients there was excellent correspondence between RIQ and IQ, while four other patients showed a poor relationship between these indices. As RIQ does not require pump speed changes, it may be a more clinically appropriate measure. Further studies are required to determine the validity of these indices.

This multicenter study examines in detail the spontaneous increase in pump flow at fixed speed that occurs in exercise. Eight patients implanted with the VentrAssist rotary blood pump were subjected to maximal and submaximal cycle ergometry studies, the latter being completed with patients supine and monitored with right heart catheter and echocardiography. Maximal exercise studies conducted in each patient at three different pump speeds on separate days established initially the magnitude and consistency of increases in pump flow that correlated well with changes in heart rate. However, there was considerable variation, coefficients of variation for mean heart rate and pump flow being 47.9 and 49.3%, respectively. Secondly, these studies indicated that increasing pump flows caused significant improvements in maximal exercise capacity. An increase of 2.1 L/min (35%) in maximum blood flow caused 12 W (16%) further increase in achievable work, 1.26 (9.3%) mL/kg/min in maximal oxygen uptake, and 2.3 (23%) mL/kg/min in anaerobic threshold. Mean increases in lactate were 0.85mm (24%), but mean B-type natiuretic peptide fell by 126mm, (-78%). From submaximal supine exercise studies, multiple linear regression of pump flow on factors thought to underlie the spontaneous increase in pump flow indicated that it was associated with increases in heart rate (P=0.039), pressure gradient across the left ventricle (P=0.032), and right atrial pressure (P=0.003). These changes have implications for the recently reported Starling-like controller for pump flow based on pump pulsatility values, which emulates the Starling curve relating pump output to left ventricular preload. Unmodified, the controller would not permit the full benefits of this effect to be afforded to patients implanted with rotary blood pumps. A modification to the pump control algorithm is proposed to eliminate this problem

The current recommended anticoagulation regimen during continuous flow centrifugal left ventricular device support is a combination of antiplatelet therapy as well as oral anticoagulation. Despite this, pump thrombosis occurs in rare situations. We report the risk factors and nonsurgical management and outcomes of five patients implanted with continuous flow centrifugal left ventricular assist devices who displayed clinical, hemodynamic, and laboratory features of intrapump thrombosis. This information may support the use of intravenous thrombolytics for suspected pump thrombus in these newer generation devices.

It is important to accurately monitor residual cardiac function in patients under long-term continuous-flow left ventricular assist device (cfLVAD) support. Two new measures of left ventricular (LV) chamber contractility in the cfLVAD-unloaded ventricle include IQ, a regression coefficient between maximum flow acceleration and flow pulsatility at different pump speeds; and K, a logarithmic relationship between volumes moved in systole and diastole. We sought to optimize these indices. We also propose RIQ, a ratio between maximum flow acceleration and flow pulsatility at baseline pump speed, as an alternative to IQ. Eleven patients (mean age 49 ± 11 years) were studied. The K index was derived at baseline pump speed by defining systolic and diastolic onset as time points at which maximum and minimum volumes move through the pump. IQ across the full range of pump speeds was markedly different between patients. It was unreliable in three patients with underlying atrial fibrillation (coefficient of determination R(2) range: 0.38-0.74) and also when calculated without pump speed manipulation (R(2) range: 0.01-0.74). The K index was within physiological ranges, but poorly correlated to both IQ (P = 0.42) and RIQ (P = 0.92). In four patients there was excellent correspondence between RIQ and IQ, while four other patients showed a poor relationship between these indices. As RIQ does not require pump speed changes, it may be a more clinically appropriate measure. Further studies are required to determine the validity of these indices.

The current recommended anticoagulation regimen during continuous flow centrifugal left ventricular device support is a combination of antiplatelet therapy as well as oral anticoagulation. Despite this, pump thrombosis occurs in rare situations. We report the risk factors and nonsurgical management and outcomes of five patients implanted with continuous flow centrifugal left ventricular assist devices who displayed clinical, hemodynamic, and laboratory features of intrapump thrombosis. This information may support the use of intravenous thrombolytics for suspected pump thrombus in these newer generation devices.