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The aim of this work was the development of an isolated heart setup to delineate the interactions between intraventricular flow features, hemodynamic parameters and mechano-energetics after certain mitral valve therapies. Five porcine hearts were explanted and prepared for (i) edge-to-edge mitral valve repair, (ii) implantation of a rotatable biscupid mechanical valve prosthesis. Flow structures were visualized using echocardiography while hemodynamics was recorded in terms of pressures, flow rates and ventricular volume. Hemodynamic and cardiac mechano-energetics implied a marginal effect (

Realistic training of cardiologic interventions in a heart catheter laboratory is hardly achievable with simple tools and requires animal experiments. Therefore, first a simple mock circuit connected to a porcine heart mimicking the natural heart motion was developed. In a second step the setup was duplicated to drive both sides of the heart independently to generate motion and physiologic pressures and flows. Using this simple setup cardiologic interventions (arterial and ventricular septal defects ASD/VSD closure) were performed successfully and allowed realistic training under the C-arm, echocardiography, placement of catheters and repair of ASD/VSD. With the second setup flows of up to 4 l/min were achieved in both sides of the heart at maximum left and right ventricular pressures of 80 mm Hg and 30 mm Hg respectively. This method is inexpensive and represents a realistic alternative to training in animal experiments.

Abstract Background Interruption of cardiopulmonary resuscitation (CPR) impairs the perfusion of the fibrillating heart, worsening the chance for successful defibrillation. Therefore ECG-analysis during ongoing chest compression could provide a considerable progress in comparison with standard analysis techniques working only during "hands-off" intervals. Methods For the reduction of CPR-related artifacts in ventricular fibrillation ECG we use a localized version of the coherent line removal algorithm developed by Sintes and Schutz. This method can be used for removal of periodic signals with sufficiently coupled harmonics, and can be adapted to specific situations by optimal choice of its parameters (e.g., the number of harmonics considered for analysis and reconstruction). Our testing was done with 14 different human ventricular fibrillation (VF) ECGs, whose fibrillation band lies in a frequency range of [1 Hz, 5 Hz]. The VF-ECGs were mixed with 12 different ECG-CPR-artifacts recorded in an animal experiment during asystole. The length of each of the ECG-data was chosen to be 20 sec, and testing was done for all 168 = 14 × 12 pairs of data. VF-to-CPR ratio was chosen as -20 dB, -15 dB, -10 dB, -5 dB, 0 dB, 5 dB and 10 dB. Here -20 dB corresponds to the highest level of CPR-artifacts. Results For non-optimized coherent line removal based on signals with a VF-to-CPR ratio of -20 dB, -15 dB, -10 dB, -5 dB and 0 dB, the signal-to-noise gains (SNR-gains) were 9.3 ± 2.4 dB, 9.4 ± 2.4 dB, 9.5 ± 2.5 dB, 9.3 ± 2.5 dB and 8.0 ± 2.7 (mean ± std, n = 168), respectively. Characteristically, an original VF-to-CPR ratio of -10 dB, corresponds to a variance ratio var(VF):var(CPR) = 1:10. An improvement by 9.5 dB results in a restored VF-to-CPR ratio of -0.5 dB, corresponding to a variance ratio var(VF):var(CPR) = 1:1.1, the variance of the CPR in the signal being reduced by a factor of 8.9. Discussion The localized coherent line removal algorithm uses the information of a single ECG channel. In contrast to multi-channel algorithms, no additional information such as thorax impedance, blood pressure, or pressure exerted on the sternum during CPR is required. Predictors of defibrillation success such as mean and median frequency of VF-ECGs containing CPR-artifacts are prone to being governed by the harmonics of the artifacts. Reduction of CPR-artifacts is therefore necessary for determining reliable values for estimators of defibrillation success. Conclusions The localized coherent line removal algorithm reduces CPR-artifacts in VF-ECG, but does not eliminate them. Our SNR-improvements are in the same range as offered by multichannel methods of Rheinberger et al., Husoy et al. and Aase et al. The latter two authors dealt with different ventricular rhythms (VF and VT), whereas here we dealt with VF, only. Additional developments are necessary before the algorithm can be tested in real CPR situations.

The majority of patients with continuous-flow left ventricular assist devices (cf-LVADs) experience exertional symptoms despite adequate unloading at rest. We utilized pressure-volume (PV) loops to analyze the hemodynamic effects of exercise at varying pump speeds in stable HeartWare HVAD patients. Data were obtained at baseline pump speed and +400RPM, at rest and during supine cycle ergometry to 45W. PAWP, right atrial pressure (RAP) and mean arterial pressure (MAP) were measured invasively. From derived PV loops, left ventricular end-diastolic pressure (LVEDP) and volume (LVEDV), stroke volume, stroke work (SW), and maximum derivative of left ventricular pressure (dP/dt) were calculated. We also assessed the association between exercise PAWP and admissions for hemocompatibility related adverse events (HCRE). Thirteen patients were assessed, generating 52 PV loops. Exercise significantly increased PAWP (p<0.001) and RAP (p<0.001) but not MAP (p=0.69). Increased pump speed significantly reduced PAWP at baseline (p<0.001) but not during exercise (p=0.08). The change in PAWP during exercise correlated linearly with both change in RAP (p=0.008) and change in MAP (p=0.002). PV loop analysis revealed exercise-induced increase in LVEDP (p<0.001), LVEDV (p=0.001), stroke work (p<0.001), maximum dP/dt (p=0.001), and stroke volume (p=0.007), consistent with increased preload and ventricular contraction. Patients with exercise PAWP <25mmHg had significantly higher stroke work (p=0.010) and greater change in maximum dP/dt (p=0.005) with exercise, compared to those with exercise PAWP >25mmHg. Admissions for HCRE occurred more frequently in the higher PAWP group compared to the lower PAWP group (p=0.015). Patients with optimal exercise hemodynamics under cf-LVAD support have significantly greater left ventricular contractile reserve as measured by PV loops and less admissions for HCRE. [ABSTRACT FROM AUTHOR]

Intrinsic pump performance data have become helpful tools for patient management readily available with previous left ventricular assist devices. To overcome the monitoring limitations (low sampling rate, no flow waveform) of the HeartMate 3 (HM3), this study investigated the capabilities of a novel in-house developed pump monitoring system (HM3 SNOOPY) in echocardiography guided speed ramp tests. In this prospective, single-center study (ClinicalTrials.gov ID: NCT04641416), the non-invasive HM3 SNOOPY was used for continuous data acquisition (1Hz sampling rate) during echocardiographic speed ramp tests with additional loading changes induced by Valsalva-maneuvers. Pump performance data were extracted from communication packages transmitted between HM3 pump and controller using a non-invasive pickup coil attached onto the HM3 driveline connector. Ramp speed sensitive parameters from HM3 monitoring were selected for analysis and evaluated combined with results from clinical diagnostics (echocardiography, blood pressure measurement and Valsalva testing) using linear correlations. In 24 patients (age: 58.9 ± 8.8 years, BMI: 28.1 ± 5.1 kg/m², female: 20.8%), 35 echocardiographic speed ramp tests were performed with speed changes in the range of 1000 (IQR: 1000) rpm with a baseline speed of 5443 ± 244 rpm and a mean blood pressure of 75 ± 12 mmHg at median post-operative day 341 (IQR: 406). Ten of 39 parameters that are not routinely available were selected for analysis, of which 5 parameters (e.g., pulsatility index (PI)) were barely affected by pump speed (r < 0.7). Low to moderate correlations (r < 0.5) with clinical diagnostics were demonstrated for HM3 parameters. Changes in loading condition resulted in echo determined suction events in 7 (14%) tests and low speed activation in 5 (71.5%) tests. Two mechanisms triggering PI-events were identified using the per-second max and min flows available exclusively with the HM3 SNOOPY: i) suction (drop of per-second min flow) and ii) loss of pulsatility (convergence of max and min flow). In this study, the non-invasive HM3 SNOOPY was successfully used to acquire intrinsic pump data. Pump parameters provide additional clinical diagnostic information on heart pump interaction during various echocardiographic assessments and allow time course analysis of mechanisms activating PI events. [ABSTRACT FROM AUTHOR]

Background: Temporal trends of routinely obtained parameters may provide valuable information for predicting BSIs, but this association has not yet been established in LVAD patients., Methods: This retrospective analysis included data from 347 consecutive recipients of three rotary LVAD types. Study endpoints included the incidence of BSI, the association of temporal trends of routinely obtained blood biomarkers with the development of BSIs, the incidence of BSIs, and survival on LVAD support., Results: During follow-up, 47.8% (n = 166) of the patients developed BSI. In multivariate analyses, the development of BSI was a significant predictor of mortality (HR 5.78, 95% CI 4.08-8.19, p < 0.0001). In univariate analyses, after adjusting for potential confounders, albumin (SHR 0.94, 95% CI 0.91-0.97, p < 0.00010), creatinine (SHR 1.49, 95% CI 1.03-2.15, p = 0.033), and C-reactive protein (SHR 1.19, 95% CI 1.08-1.32, p = 0.0007) significantly predicted the development of BSIs during LVAD support. Notably, the strength of the association of parameter changes with the prediction of BSIs demonstrated a time-dependent correlation in the cases of albumin (p = 0.045) and creatinine (p = 0.003)., Conclusion: Bloodstream infections are highly prevalent among LVAD recipients and are independent predictors of mortality. Temporal biomarker trends significantly predict the development of BSIs. These findings suggest opportunities for interventions aiming to reduce the incidence of BSIs., (© 2024 The Author(s). Artificial Organs published by International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Comprehensive optimization of rotodynamic blood pumps (RBPs) requires the consideration of three partially conflicting objectives: size, hemocompatibility, and motor efficiency. Optimizing these individual objectives independently, the potential of multiobjective optimizations often remains untapped. This study aimed at the multiobjective optimization of an RBP for cavopulmonary support accounting for all three objectives simultaneously. Hydraulic and electromagnetic design spaces were characterized using computational fluid dynamics and computational electromagnetics, respectively. Design variables included secondary flow gap widths, impeller diameters, and stator heights. The size objective encompassed the RBP widths and heights, the hemocompatibility objective was a weighted composite measure of well-established metrics, and the motor objective was determined by motor losses. Multiobjective optimization was performed through Pareto analysis. 81 designs were considered, and 21 Pareto-optimal designs were identified. The Pareto analysis indicated that hemocompatibility performance could be improved by 72.4% with a concomitant 1.5% reduction in the baseline pump volume. This, however, entailed an increase in motor losses by 0.2 W, while still meeting design requirements, with maximum local temperature rises remaining below 0.4 K. The multiobjective optimization led to a Pareto front, demonstrating the feasibility to improve hemocompatibility at reduced pump volume, however, at the cost of a diminished yet still acceptable motor performance., Competing Interests: Disclosure: M.G. received personal fees and grants from BerlinHeart GmbH. The other authors have no conflicts of interest to report., (Copyright © ASAIO 2024.)

Objective: Conventional mock circulatory loops (MCLs) cannot replicate realistic hemodynamic conditions without inducing blood trauma. This constrains in-vitro hemocompatibility examinations of blood pumps to static test loops that do not mimic clinical scenarios. This study aimed at developing an atraumatic MCL based on a hardware-in-the-loop concept (H-MCL) for realistic hemocompatibility assessment., Methods: The H-MCL was designed for 450 ± 50 ml of blood with the polycarbonate reservoirs, the silicone/polyvinyl-chloride tubing, and the blood pump under investigation as the sole blood-contacting components. To account for inherent coupling effects a decoupling pressure control was derived by feedback linearization, whereas the level control was addressed by an optimization task to overcome periodic loss of controllability. The HeartMate 3 was showcased to evaluate the H-MCL's accuracy at typical hemodynamic conditions. To verify the atraumatic properties of the H-MCL, hemolysis (bovine blood, n = 6) was evaluated using the H-MCL in both inactive (static) and active (minor pulsatility) mode, and compared to results achieved in conventional loops., Results: Typical hemodynamic scenarios were replicated with marginal coupling effects and root mean square error (RMSE) below 1.74 ± 1.37 mmHg while the fluid level remained within ±4% of its target value. The normalized indices of hemolysis (NIH) for the inactive H-MCL showed no significant differences to conventional loops ( ∆NIH = -1.6 mg/100 L). Further, no significant difference was evident between the active and inactive mode in the H-MCL ( ∆NIH = +0.3 mg/100 L)., Conclusion and Significance: Collectively, these findings indicated the H-MCL's potential for in-vitro hemocompatibility assessment of blood pumps within realistic hemodynamic conditions, eliminating inherent setup-related risks for blood trauma.

Effective treatment of heart failure with preserved ejection fraction (HFpEF) remains an unmet medical need. Although left atrial decompression using mechanical circulatory support devices was previously suggested, the heterogeneous HFpEF population and the lack of tailored devices have prevented the translation into clinical practice. This study aimed to evaluate the feasibility of left atrial decompression in HFpEF patients with a HeartMate 3 (HM3, Abbott Inc, Chicago, USA) in silico and in vitro . Anatomic compatibility of the HM3 pump was assessed by virtual device implantation into the left atrium through the left atrial appendage (LAA) and left atrial posterior wall (LAPW) of 10 HFpEF patients. Further, the efficacy of left atrial decompression was investigated experimentally in a hybrid mock loop, replicating the hemodynamics of an HFpEF phenotype at rest and exercise conditions. Virtual implantation without substantial intersection with surrounding tissues was accomplished through the LAA in 90% and 100% through the LAPW. Hemodynamic analysis in resting conditions demonstrated normalization of left atrial pressures without backflow at a pump speed of around 5400 rpm, whereas a range of 6400-7400 rpm was required during exercise. Therefore, left atrial decompression with the HM3 may be feasible in terms of anatomic compatibility and hemodynamic efficacy., Competing Interests: Disclosure: M.G. received personal fees and research grants from BerlinHeart GmbH and research grants from 4Fontan AG. D.Z. received personal fees from Abbott, Medtronic, Abiomed, Edwards, and Daiichi Sankyo and research grants from Abbott, Medtronic, Berlin Heart, Edwards, and Corcym. The other authors have no conflicts of interest to report., (Copyright © ASAIO 2023.)

Objective: Total artificial hearts (TAH) serve as a temporary treatment for severe biventricular heart failure. The limited durability and complication rates of current devices hamper long-term cardiac replacement. The aim of this study was to assess the feasibility of a novel valveless pumping principle for a durable pulsatile TAH (ShuttlePump)., Methods: The pump features a rotating and linearly shuttling piston within a cylindrical housing with two in- and outlets. With a single moving piston, the ShuttlePump delivers pulsatile flow to both systemic and pulmonary circulation. The pump and actuation system were designed iteratively based on analytical and in silico methods, utilizing finite element methods (FEM) and computational fluid dynamics (CFD). Pump characteristics were evaluated experimentally in a mock circulation loop mimicking the cardiovascular system, while hemocompatibility-related parameters were calculated numerically., Results: Pump characteristics cover the entire required operating range for a TAH, providing 2.5-9 L/min of flow rate against 50-160 mmHg arterial pressures at stroke frequencies of 1.5-5 Hz while balancing left and right atrial pressures. FEM analysis showed mean overall copper losses of 8.84 W, resulting in a local maximum blood temperature rise of <2 K. The CFD results of the normalized index of hemolysis were 3.57 mg/100 L, and 95% of the pump's blood volume was exchanged after 1.42 s., Conclusion and Significance: This study indicates the feasibility of a novel pumping system for a TAH with numerical and experimental results substantiating further development of the ShuttlePump.

Several device designs for cavopulmonary mechanical circulatory support (MCS) are under investigation, however, challenged by the Fontan population's heterogeneity in size, cardiovascular and thoracic anatomy. This study aimed to preclinically assess the anatomical compliance of proposed device designs in silico. Representative double- and single-outlet cavopulmonary assist device (CPAD) designs were virtually implanted into CT imaging data of 10 patients previously palliated with total cavopulmonary connection (TCPC) for functionally univentricular hearts. Anatomical device compatibility was characterized concerning pump proximity to cardiovascular, respiratory and thoracic structures, as well as pump in- and outflow graft configuration. In 10 Fontan patients with a median age of 10.4 years (interquartile range [IQR] 5.0-15.3 years) and a median body surface area of 1.09 m2 (IQR 0.76-1.28 m2), implantation of a double-outlet CPAD was feasible in 1 patient (10%). In all other, adverse device intersection with the trachea and (neo-)aorta, or posterior pulmonary artery outflow graft kinking were observed. A single-outlet design permitted enhanced device mobilization adapting to individual anatomical conditions, resulting in device fit in nine of 10 patients (90%). Despite vast anatomical variations among single ventricle patients, a single-outlet device design may provide intracorporeal cavopulmonary MCS to a broad spectrum of failing Fontan patients., Competing Interests: Disclosure: M.G. received personal fees and research grants from BerlinHeart GmbH and research grants from 4Fontan AG. D.Z. received personal fees from Abbott, Medtronic, Abiomed, Edwards, Daiichi Sankyo and research grants from Abbott, Medtronic, Berlin Heart, Edwards, Corcym. The other authors have no conflicts of interest to report., (Copyright © ASAIO 2023.)

Computational fluid dynamics (CFD) is a powerful tool for the in-silico evaluation of rotodynamic blood pumps (RBPs). Corresponding validation, however, is typically restricted to easily accessible, global flow quantities. This study showcased the HeartMate 3 (HM3) to identify feasibility and challenges of enhanced in-vitro validation in third-generation RBPs. To enable high-precision acquisition of impeller torques and grant access for optical flow measurements, the HM3 testbench geometry was geometrically modified. These modifications were reproduced in silico , and global flow computations validated along 15 operating conditions. The globally validated flow in the testbench geometry was compared with CFD-simulated flows in the original geometry to assess the impact of the necessary modifications on global and local hydraulic properties. Global hydraulic properties in the testbench geometry were successfully validated (pressure head: r = 0.999, root mean square error [RMSE] = 2.92 mmHg; torque: r = 0.996, RMSE = 0.134 mNm). In-silico comparison with the original geometry demonstrated good agreement ( r > 0.999, relative errors < 11.97%) of global hydraulic properties. Local hydraulic properties (errors up to 81.78%) and hemocopatibility predictions (deviations up to 21.03%), however, were substantially affected by the geometric modifications. Transferability of local flow measures derived on advanced in-vitro testbenches toward original pump designs is challenged by significant local effects associated with the necessary geometrical modifications., Competing Interests: Disclosure: M.G. received personal fees and grants from BerlinHeart GmbH; D.Z. received personal fees from Abbott, Medtronic, Abiomed, Edwards, Daiichi Sankyo and research grants from Abbott, Medtronic, Berlin Heart, Edwards, Corcym. The other authors have no conflicts of interest to report., (Copyright © ASAIO 2023.)

Both single- and double-outflow cavopulmonary assist devices (CPADs) were recently proposed for the Fontan population, whereas single-outflow configurations were evaluated in large animal trials and double-outflow concepts are lacking an equivalent in vivo assessment. The aim of this study was to test the hemodynamic properties of a double-outflow CPAD device in an acute sheep model. The two inflow cannulae of a CPAD were anastomosed to the caval veins. Outflow graft connection was performed via end-to-side anastomosis to the right (RPA) and main pulmonary artery (MPA). Speed ramp protocols were conducted, and hemodynamic effects were monitored in terms of caval flows, cardiac output (CO), central venous pressure (CVP), pulmonary artery pressure (PAP), and left atrial pressure (LAP). Six experiments were conducted (53.35 ± 5.1 kg). In three experiments, the animal model was established, the CPAD was examined, and restoration of biventricular equivalency in terms of venous return was achieved. Venous pressures (CVP) declined linearly with increasing pump speed (r > 0.879), whereas caval flow (r > 0.973), CO (r > 0.993), PAP (r > 0.973), and LAP (r > 0.408) increased. Despite the considerable complexity of the sheep model caused by the sheep pulmonary arterial anatomy that requires substantial graft bending, the CPAD was evaluated in three acute experiments and showed the potential to completely substitute a subpulmonary ventricle., Competing Interests: Disclosure: M.G. received personal fees and research grants from BerlinHeart GmbH and research grants from 4Fontan AG; T.S. received personal fees and grants from Abbott, Medtronic, CorWave. U.K. received grants from Berlin Heart GmbH; D.Z. received personal fees from Abbott, Medtronic, Abiomed, Edwards, Daiichi Sankyo and research grants from Abbott, Medtronic, Berlin Heart, Edwards, Corcym. The other authors have no conflicts of interest to report., (Copyright © ASAIO 2023.)

Background: The use of polytetrafluoroethylene (PTFE) material as a protective cover for left ventricular assist device (LVAD) outflow grafts (OG) is a common practice. However, it has descriptively been linked to the development of blood flow obstruction (BFO)., Methods: Patient data from 194 consecutive HVAD (Medtronic Inc; Medtronic, Minneapolis, MN) recipients implanted between March 2006 and January 2021 were retrospectively analyzed. PTFE covers were used in 102 patients. Study outcomes included the incidence of BFO and survival on LVAD support., Results: Thirty-seven patients (19.1%) developed BFO during the study period. On a multivariable Cox regression analysis, PTFE use was an independent predictor for the development of BFO (HR 2.15, 95% CI 1.03-4.48, p = .04). BFO comprised of 2 types of device malfunction: eleven patients (5.7%) developed outflow graft stenosis (OGS), and 31 patients (16.0%) developed pump thrombosis (PT). There was a significantly higher cumulative incidence of OGS in patients with PTFE cover than in those without (Gray's test, p =.03). However, the observed higher cumulative incidence of PT in PTFE patients was non-significant (Gray's test, p =.06). In a multivariable Cox regression model, the effect of PTFE use on survival was non-significant (HR 0.95, 95% CI 0.60-1.48, p =.81), while the development of BFO was independently associated with increased mortality (HR 3.43, 95% CI 1.94-6.06, p < .0001)., Conclusions: The use of PTFE OG cover in LVAD patients is associated with an increased cumulative probability of development of BFO, the latter adversely impacting survival and is therefore, harmful., (Copyright © 2022 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objective: In preclinical examinations, rotodynamic blood pumps (RBPs) are predominantly evaluated at design-point conditions. In clinical practice, however, they run at diversified modes of operation. This study aimed at extending current preclinical evaluation of hemolytic profiles in RBPs toward broader, clinically relevant ranges of operation., Methods: Two implantable RBPs - the HeartMate 3 (HM3) and the HeartWare Ventricular Assist Device (HVAD) - were analyzed at three pump speeds (HM3: 4300, 5600, 7000 rpm; HVAD: 1800, 2760, 3600 rpm) with three flow rates (1-9L/min) per speed setting. Hemolysis measurements were performed in heparinized bovine blood. The delta free hemoglobin (dfHb) and the normalized index of hemolysis (NIH) served as hemolytic measures. Statistical analysis was performed by multiple comparison of the 9 operating conditions. Moreover, computational fluid dynamics (CFD) was applied to provide mechanistic insights into the interrelation between hydraulics and hemolysis by correlating numerically computed hydraulic losses with in-vitro hemolytic measures., Results: In both devices, dfHb increased toward increasing speeds, particularly during low but also during high flow condition. By contrast, in both RBPs magnitudes of NIH were significantly elevated during low flow operation compared to high flow conditions (p<0.0036). Maps of hemolytic metrics revealed morphologically similar trends to in-silico hydraulic losses (r>0.793)., Conclusions: While off-design operation is associated with increased hemolytic profiles, the setting of different operating conditions render a preclinical prediction of clinical impact with current hemolysis metrics difficult., Significance: The identified increase in hemolytic measures during episodes of off-design operation is highlighting the need to consider worst-case operation during preclinical examinations.

Background: A relation between the left ventricular assist device inflow cannula (IC) malposition and pump thrombus has been reported. This study aimed to investigate if the pump position, derived from chest X-rays in HeartMate 3 (HM3) patients, correlates with neurological dysfunction (ND), ischemic stroke (IS), hemorrhagic stroke (HS) and survival., Methods: This analysis was performed on routinely acquired X-rays of 42 patients implanted with a HM3 between 2014 and 2017. Device position was quantified in patients with and without ND from frontal and lateral X-rays characterizing the IC and pump in relation to spine, diaphragm or horizontal line. The primary end-point was freedom from stroke and survival one-year after HM3 implantation stratified by pump position., Results: The analysis of X-rays, 33.5 (41.0) days postoperative, revealed a significant smaller IC angle of HM3 patients with ND versus no ND (0.1° ± 14.0° vs. 12.9° ± 10.1°, p = 0.005). Additionally, the IC angle in the frontal view, IS: 4.1 (20.9)° versus no IS: 13.8 (7.5)°, p = 0.004 was significantly smaller for HM3 patients with IS. Using receiver operating characteristics derived cut-off, IC angle <10° provided 75% sensitivity and 100% specificity (C-statistic = 0.85) for predicting IS. Stratified by IC angle, freedom from IS at 12 months was 100% (>10°) and 60% (<10°) respectively (p = 0.002). No significant differences were found in any end-point between patients with and without HS. One-year survival was significantly higher in patients with IC angle >10° versus <10° (100% vs. 71.8%, p = 0.012)., Conclusions: IC malposition derived from standard chest X-rays serves as a risk factor for ND, IS and worse survival in HM3 patients., (© 2022 The Authors. Artificial Organs published by International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Successful therapy of heart failure with preserved ejection fraction (HFpEF) remains a major unmet clinical need. Device-based treatment approaches include the interatrial shunt device (IASD), conventional assist devices pumping blood from the left ventricle (LV-VAD) or the left atrium (LA-VAD) towards the aorta, and a valveless pulsatile assist device with a single cannula operating in co-pulsation with the native heart (CoPulse). Hemodynamics of two HFpEF subgroups during rest and exercise condition were translated into a lumped parameter model of the cardiovascular system. The numerical model was applied to assess the hemodynamic effect of each of the four device-based therapies. All four therapy options show a reduction in left atrial pressure during rest and exercise and in both subgroups (> 20%). IASDs concomitantly reduce cardiac output (CO) and shift the hemodynamic overload towards the pulmonary circulation. All three mechanical assist devices increase CO while reducing sympathetic activity. LV-VADs reduce end-systolic volume, indicating a high risk for suction events. The heterogeneity of the HFpEF population requires an individualized therapy approach based on the underlying hemodynamics. Whereas phenotypes with preserved CO may benefit most from an IASD device, HFpEF patients with reduced CO may be candidates for mechanical assist devices., (© 2022. The Author(s).)

Right heart failure (RHF) is a severe complication after left ventricular assist device (LVAD) implantation. The aim of this study was to analyze the incidence, risk factors, and biomarkers for late RHF including the possible superiority of the device and implantation method. This retrospective, single-center study included patients who underwent LVAD implantation between 2014 and 2018. Primary outcome was freedom from RHF over one-year after LVAD implantation; secondary outcomes included pre- and postoperative risk factors and biomarkers for RHF. Of the 145 consecutive patients (HeartMate 3/HVAD: n = 70/75; female: 13.8%), thirty-one patients (21.4%) suffered RHF after a mean LVAD support of median (IQR) 105 (118) days. LVAD implantation method (less invasive: 46.7% vs. 35.1%, p = 0.29) did not differ significantly in patients with or without RHF, whereas the incidence of RHF was lower in HeartMate 3 vs. HVAD patients (12.9% vs. 29.3%, p = 0.016). Multivariate Cox proportional hazard analysis identified HVAD (HR 4.61, 95% CI 1.12-18.98; p = 0.03), early post-op heart rate (HR 0.96, 95% CI 0.93-0.99; p = 0.02), and central venous pressure (CVP) (HR 1.21, 95% CI 1.05-1.39; p = 0.01) as independent risk factors for RHF, but no association of RHF with increased all-cause mortality (HR 1.00, 95% CI 0.99-1.01; p = 0.50) was found. To conclude, HVAD use, lower heart rate, and higher CVP early post-op were independent risk factors for RHF following LVAD implantation.

Treatment of univentricular hearts remains restricted to palliative surgical corrections (Fontan pathway). The established Fontan circulation lacks a subpulmonary pressure source and is commonly accompanied by progressively declining hemodynamics. A novel cavopulmonary assist device (CPAD) may hold the potential for improved therapeutic management of Fontan patients by chronic restoration of biventricular equivalency. This study aimed at translating clinical objectives toward a functional CPAD with preclinical proof regarding hydraulic performance, hemocompatibility and electric power consumption. A prototype composed of hemocompatible titanium components, ceramic bearings, electric motors, and corresponding drive unit was manufactured for preclinical benchtop analysis: hydraulic performance in general and hemocompatibility characteristics in particular were analyzed in-silico (computational fluid dynamics) and validated in-vitro. The CPAD's power consumption was recorded across the entire operational range. The CPAD delivered pressure step-ups across a comprehensive operational range (0-10 L/min, 0-50 mm Hg) with electric power consumption below 1.5 W within the main operating range. In-vitro hemolysis experiments (N = 3) indicated a normalized index of hemolysis of 3.8 ± 1.6 mg/100 L during design point operation (2500 rpm, 4 L/min). Preclinical investigations revealed the CPAD's potential for low traumatic and thrombogenic support of a heterogeneous Fontan population (pediatric and adult) with potentially accompanying secondary disorders (e.g., elevated pulmonary vascular resistance or systemic ventricular insufficiency) at distinct physical activities. The low power consumption implied adequate settings for a small, fully implantable system with transcutaneous energy transfer. The successful preclinical proof provides the rationale for acute and chronic in-vivo trials aiming at the confirmation of laboratory findings and verification of hemodynamic benefit., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: We reviewed our institutional experience with outflow graft stenosis (OGS) in 3 contemporary left ventricular assist devices (LVAD)., Methods: Data from 347 consecutive adult recipients of LVAD [Medtronic HVAD (n = 184, 53.0%), Abbott HeartMate II (n = 62, 17.9%) and Abbott HeartMate 3 (n = 101, 29.1%)] implanted between March 2006 and October 2019 were analysed retrospectively. Primary study end points were the incidence of OGS necessitating treatment and survival on LVAD support., Results: During the study period, 17 patients (4.9%) developed OGS requiring treatment with a probability of 0.6% at 1 year, 1.9% at 2 years, 3.8% at 3 years, 4.7% at 4 years and 5.9% at 5 years of LVAD support. Notably, in 13.8% of patients, a compression-related narrowing of the outflow graft with a probability of 1.5% at 6 months, 1.8% 1 year, 6.0% at 2 years, 12.3% at 3 years, 15.4% at 4 years and 16.6% at 5 years of LVAD support with no difference between devices (P = 0.26) was observed. There was a trend towards increased risk of mortality with OGS (hazard ratio 2.21, 95% confidence interval 0.87-5.51; P = 0.09). OGS preferentially occurred in segments of the outflow graft covered by a protective coating., Conclusions: OGS is a rare but potentially lethal complication during LVAD support. Modifications of pump design and implant techniques may be needed because OGS preferentially occurs within covered portions of the outflow graft. Systematic screening may be warranted., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Computational fluid dynamics find widespread application in the development of rotary blood pumps (RBPs). Yet, corresponding simulations rely on shear stress computations that are afflicted with limited resolution while lacking validation. This study aimed at the experimental validation of integral hydraulic properties to analyze global shear stress resolution across the operational range of a novel RBP. Pressure head and impeller torque were numerically predicted based on Unsteady Reynolds-averaged Navier-Stokes (URANS) simulations and validated on a testbench with integrated sensor modalities (flow, pressure, and torque). Validation was performed by linear regression and Bland-Altman analysis across nine operating conditions. In power loss analysis (PLA), in silico hydraulic power losses were derived based on the validated hydraulic quantities and balanced with in silico shear-dependent dissipative power losses. Discrepancies among both terms provided a measure of in silico shear stress resolution. In silico and in vitro data correlated with low discordance in pressure (r = 0.992, RMSE = 1.02 mmHg), torque (r = 0.999, RMSE = 0.034 mNm), and hydraulic power losses (r = 0.990, RMSE = 0.015W). PLA revealed numerically predicted dissipative losses to be up to 34.4% smaller than validated computations of hydraulic losses. This study confirmed the suitability of URANS settings to predict integral hydraulic properties. However, numerical credibility was hampered by lacking resolution of shear-dependent dissipative losses., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © ASAIO 2021.)