The development of technologies in the field of organ transplantation is a highly relevant topic due to the significant impact these techniques have on improving the quality of life of patients with kidney diseases. This...The development of technologies in the field of organ transplantation is a highly relevant topic due to the significant impact these techniques have on improving the quality of life of patients with kidney diseases. This work presents the description of an invention designed to be used as a single-use, affordable product in hypothermic perfusion machines. The invention, named Renal Container, is a flexible polyvinyl chloride (PVC) receptacle, disposable, single-use, highly resistant, with an internal cradle designed to accommodate the kidney. The results of pilot experiments of hypothermic machine perfusion using the Renal Container showed good process performance over 4 hours of perfusion, with no visible histological alterations in the perfused renal tissues.
Neuroleptic malignant syndrome (NMS) is a rare, life-threatening hypermetabolic reaction to dopamine-antagonist drugs that may progress to profound rhabdomyolysis, extreme hyperkalemia, and cardiac arrest (CA). Evidence...Neuroleptic malignant syndrome (NMS) is a rare, life-threatening hypermetabolic reaction to dopamine-antagonist drugs that may progress to profound rhabdomyolysis, extreme hyperkalemia, and cardiac arrest (CA). Evidence guiding extracorporeal cardiopulmonary resuscitation (ECPR) for metabolic or toxic etiologies is scarce, and its use in NMS has not yet been described. We report the case of a 23 year old woman who presented with hyperthermia, severe muscular rigidity and laboratory evidence of NMS. In the emergency-department arrival she developed witnessed asystolic CA, unresponsive to conventional treatment. After a transient return of spontaneous circulation and a second refractory CA, veno-arterial extracorporeal membrane oxygenation (V-A ECMO) was initiated. Continuous hemodiafiltration facilitated rapid correction of extreme hyperkalemia, whereas dantrolene and active cooling normalized core temperature. Valid cardiac activity recovered after 36 hours, allowing ECMO weaning. However, devastating hypoxic-ischemic brain injury led to brain death, which was declared on day 5. Heart and liver procurement for transplantation were successfully performed. To our knowledge, implementation of ECPR in the context of NMS was not previously documented in the literature. Our case suggests that timely V-A ECMO might bridge extreme hyperkalemic arrest to cardiac recovery, offering both a chance of patient survival and, when neurological prognosis is dismal, an opportunity for organ donation.
Hemolysis is a recognized complication of a microaxial flow pump (Impella CP) support, but its incidence and associated risk factors remain unclear. We retrospectively analyzed 24 patients with cardiogenic shock who rece...Hemolysis is a recognized complication of a microaxial flow pump (Impella CP) support, but its incidence and associated risk factors remain unclear. We retrospectively analyzed 24 patients with cardiogenic shock who received Impella CP support at a single tertiary center between January 2022 and December 2024. Serial serum haptoglobin measurements were used to assess hemolysis, with low haptoglobin defined as a minimum level of <19 mg/dl during Impella CP support. Clinical variables were compared between patients with and without low haptoglobin, and multivariable logistic regression was performed to identify independent predictors. After applying exclusion criteria, 24 patients who received Impella CP support alone were eligible for this study. Low haptoglobin occurred in 67% (16/24) of patients, with 94% of cases detected within 24 hours of intensive care unit (ICU) admission. Patients with low haptoglobin had significantly higher P-levels and lower pulmonary artery pulsatility index scores at ICU admission. Multivariable analysis identified a P-level ≥5 (odds ratio 63.61; p = 0.001) as an independent predictor of low haptoglobin. In conclusion, low haptoglobin is common during Impella CP support and occurs early after initiation. A higher P-level is associated with low haptoglobin and may help identify patients at increased risk for hemolysis.
Computational fluid dynamics (CFD) assessments in blood pumps (BPs) typically rely on constant boundary conditions, despite the dynamic nature of the cardiovascular system. Consensus on CFD methodologies for simulating B...Computational fluid dynamics (CFD) assessments in blood pumps (BPs) typically rely on constant boundary conditions, despite the dynamic nature of the cardiovascular system. Consensus on CFD methodologies for simulating BPs under realistic conditions is lacking, and qualitative validation against in vitro data, particularly regarding the dynamic pressure head-flow rate (HQ) hysteresis curve, remains absent. This study aims to validate a CFD framework capable of capturing HQ hysteresis. Time-varying boundary conditions were derived from a hybrid in vitro mock circulation. Computational fluid dynamics parameters, including boundary conditions (pressure versus mass flow), time step size (4°-72° per step), rotation modeling (frozen rotor versus sliding mesh), and turbulence modeling (none versus k - ω SST), were iteratively refined. Results were validated by assessing the overlap of simulated and measured HQ hysteresis using the Jaccard Index (JI). Dynamic HQ hysteresis was captured only with mass flow boundary conditions, not with pressure boundary conditions (JI = 0.62 vs. 0.37). Time step size, rotation modeling (except for frozen rotor without averaging), and turbulence modeling had minimal effect on HQ hysteresis but significantly influenced flow field resolution and computational efficiency. Critical parameters emerged in boundary conditions and motion modeling, whereas others involved trade-offs between flow field accuracy and computational cost.
Bedside pressure-flow variables in cardiogenic shock (CS) incompletely characterize ventricular energetics and coupling. We prospectively derived bedside pressure-volume (PV) loop surrogates from paired pulmonary artery...Bedside pressure-flow variables in cardiogenic shock (CS) incompletely characterize ventricular energetics and coupling. We prospectively derived bedside pressure-volume (PV) loop surrogates from paired pulmonary artery catheter and echocardiographic data in 68 patients (263 paired assessments) with acute myocardial infarction-related CS (AMI-CS) or heart failure-related CS (HF-CS) during microaxial support, intra-aortic balloon pump (IABP) support, or medical therapy. In AMI-CS with microaxial support, arterial elastance decreased (-1.22 mm Hg/ml) with improved coupling (ventriculoarterial coupling [VAC] -1.42), stroke work increased (+140 mm Hg·ml), and pressure-volume area declined (PVA -103 mm Hg·ml), yielding an efficiency rise from ~32% to ~40%, suggesting unloading. In HF-CS, microaxial support reduced elastance modestly (-0.35) with probable efficiency gain (+5%) but heterogeneous PVA changes. In AMI-CS treated with IABP, coupling improved (VAC -0.42) with modest energetic augmentation, whereas HF-CS showed pressure and energy amplification (end-systolic pressure +23.9 mm Hg; PVA +220.6 mm Hg ·ml). Without mechanical support, AMI-CS demonstrated reduced elastance and pressure, while HF-CS exhibited ventricular dilation (end-diastolic volume [EDV]/end-systolic volume ESV increase) with higher energetic demand. Pressure-volume-derived metrics identify device-specific energetic signatures not fully captured by conventional hemodynamic assessment and may provide mechanistic insight into ventricular unloading strategies; validation against conductance catheter-derived PV measurements remains warranted.
Native heart survival following Impella 5.5 support for cardiogenic shock is a desirable outcome that remains poorly characterized, especially amid evolving transplant policies and growing use of temporary mechanical cir...Native heart survival following Impella 5.5 support for cardiogenic shock is a desirable outcome that remains poorly characterized, especially amid evolving transplant policies and growing use of temporary mechanical circulatory support. We conducted a single-center retrospective analysis of adults treated with Impella 5.5 for refractory cardiogenic shock between December 2020 and December 2024 to evaluate long-term outcomes among those who survived to discharge without durable support or transplant. Of 198 patients treated, 68 (31.3%) achieved native heart survival. Survival was 92.6% at 30 days, 91.2% at 90 days, and 76.5% at 1 year. Common etiologies were acute myocardial infarction (45.6%) and acute decompensated heart failure (33.8%), with no significant difference in 1 year survival between groups (77.4% vs. 82.6%, p = 0.74). Outcomes and complications were similar across subgroups. These findings highlight that native heart survival is achievable for a meaningful proportion of patients treated with Impella 5.5. In the context of shortened transplant waitlist times following the 2018 United Network for Organ Sharing (UNOS) allocation changes, structured weaning and medical optimization may enhance opportunities for recovery and reduce reliance on long-term support or transplantation.
Thrombotic complications during mechanical circulatory support (MCS) are infrequent but potentially devastating, often presenting prohibitive surgical risks. We report the case of a patient bridged with veno-arterial ext...Thrombotic complications during mechanical circulatory support (MCS) are infrequent but potentially devastating, often presenting prohibitive surgical risks. We report the case of a patient bridged with veno-arterial extracorporeal life support (V-A ECLS) and Impella CP, known as ECPELLA support, to HeartMate 3 left ventricular assist device (LVAD) and subsequent temporary right ventricular assist device (RVAD) implantation for severe biventricular failure. Postoperatively, despite therapeutic anticoagulation, a massive, mobile thrombus, most likely originating during ECPELLA support, was identified in the descending aorta. Given the patient's critical hemodynamic stability on biventricular support and specific contraindications to systemic fibrinolysis (subacute cerebral lesions), open surgical thrombectomy was deemed too high-risk. Consequently, the patient underwent urgent percutaneous mechanical thrombectomy using the Inari FlowTriever system. The procedure, facilitated by a simultaneous, temporary reduction of both LVAD and RVAD flows to stabilize the thrombus position and maximize vacuum efficiency, resulted in the complete removal of a 14 cm thrombus without embolization or hemorrhagic complications. This report demonstrates that catheter-based aspiration thrombectomy can serve as a viable salvage strategy in complex MCS scenarios. It offers a crucial, minimally invasive alternative when conventional surgical and pharmacological options are precluded.
Right ventricular (RV) failure is a significant complication in left ventricular assist devices (LVADs). The optimal pacing mode and its impact on RV function and clinical outcomes remain unclear. We retrospectively anal...Right ventricular (RV) failure is a significant complication in left ventricular assist devices (LVADs). The optimal pacing mode and its impact on RV function and clinical outcomes remain unclear. We retrospectively analyzed HeartMate3 patients at our center between 2014 and 2023, categorizing to biventricular (BiV), RV, and no/limited pacing (<50% pacing). Outcomes included RV function, survival, late RV failure, hemocompatibility-related adverse event (HRAE), and ventricular arrhythmias (VA). We included 359 patients (age 60; 84.7% male, 57.2% nonischemic cardiomyopathy), 23.9% BiV, 8.8% RV, and 67.3% no/limited pacing. Post-LVAD echocardiographic and invasive hemodynamic assessments revealed no significant differences in RV function. Ventricular arrhythmia episodes were more frequent in the BiV (23.9%) and RV (23.1%) compared with the no/limited pacing (8.0%) (p = 0.001). Two-year survival was similar between the RV (96.2%) and no/limited pacing (96.1%), but lower in the BiV (87.3%, p = 0.042). Survival free of late RV failure was highest in the no/limited pacing (p = 0.003), as was survival free of the composite outcome (late RV failure, HRAE, and VA) (p = 0.012). Pacing, irrespective of mode, did not impact RV hemodynamics in this cohort. Patients with no pacing/low pacing burden had a lower incidence of VA and improved survival free of RV failure. Patients with BiV pacing had the worst overall survival.
Extracorporeal life support (ECLS) is required in 8-24% of neonates following the Norwood operation and is associated with high morbidity and mortality. Early identification of patients at risk may enable timely interven...Extracorporeal life support (ECLS) is required in 8-24% of neonates following the Norwood operation and is associated with high morbidity and mortality. Early identification of patients at risk may enable timely intervention and resource optimization. We developed and internally validated a bedside risk score at arrival to the cardiac intensive care unit (CICU) to predict ECLS requirement in the first 7 days postoperatively. In a retrospective cohort of 322 neonates undergoing the Norwood procedure between January 2010 and December 2023, 71 (22%) required postoperative ECLS. Multivariable logistic regression identified six independent predictors: moderate-severe atrioventricular valve regurgitation (5 points), modified Blalock-Taussig-Thomas (m-BTT) shunt (5 points), cardiopulmonary bypass time greater than 173.5 minutes (5 points), vasoactive inotropic score greater than 19.5 on CICU arrival (7 points), delayed sternal closure (5 points), and postoperative inhaled nitric oxide use (7 points). The resulting score (range 0-29) stratified patients into low- (0-10), moderate- (12-19), and high-risk (20-29) groups, with corresponding ECLS rates of 8%, 31%, and 65%. The model demonstrated good discrimination (area under the receiver operating characteristic curve [AUC]: 0.78). This novel risk tool may support early clinical decision-making and triage in high-risk neonates following Norwood palliation. External validation is warranted to assess generalizability and clinical utility.
Patients with fulminant myocarditis accompanied by severe hemodynamic deterioration, cardiogenic shock, or refractory arrhythmias often require venoarterial extracorporeal membrane oxygenation (VA-ECMO) treatment. When l...Patients with fulminant myocarditis accompanied by severe hemodynamic deterioration, cardiogenic shock, or refractory arrhythmias often require venoarterial extracorporeal membrane oxygenation (VA-ECMO) treatment. When left ventricular (LV) dilation, elevated LV end-diastolic pressure, or severe pulmonary congestion occurs during VA-ECMO, LV venting may be necessary to protect the left ventricle. In this case series, we describe a percutaneous LV venting technique in three pediatric patients with fulminant myocarditis treated with VA-ECMO. Specifically, a pigtail catheter was retrogradely inserted into the LV and used as a venting device. Effective LV unloading was achieved in all patients, allowing successful weaning from ECMO. One patient developed limb ischemia requiring distal perfusion, but no additional catheter-related complications occurred. This approach offers a less invasive option for LV unloading in pediatric VA-ECMO, providing technical simplicity and reducing both the surgical burden and bleeding risk. To the best of our knowledge, this is the first case series to detail the use of a pigtail catheter for LV unloading in pediatric VA-ECMO.
Infection remains a major complication in patients receiving contemporary left ventricular assist devices (LVADs). This retrospective single-center study evaluated the diagnostic accuracy of 18F-fluorodeoxyglucose positr...Infection remains a major complication in patients receiving contemporary left ventricular assist devices (LVADs). This retrospective single-center study evaluated the diagnostic accuracy of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for detecting different types of infections. Seventy-five scans from 40 HeartMate 3 patients performed before May 2024 were included and blindly assessed by an experienced nuclear medicine specialist. Both visual and semi-quantitative analyses of 18F-FDG uptake were performed. Compared with the final clinical diagnosis established by a multidisciplinary team, the sensitivity of 18F-FDG PET/CT for driveline and central device infections was 96% (95% confidence interval [CI], 81-99) and 81% (95% CI, 48-97), with corresponding specificities of 48% (95% CI, 29-67) and 37% (95% CI, 23-53), respectively. In semi-quantitative analyses, a cut-off maximum standardized uptake value (SUVmax) of 4.15 provided optimal accuracy for driveline infections (sensitivity 78%, specificity 80%), whereas a cut-off SUVratio-liver of 1.29 yielded the best accuracy for central device infections (sensitivity 73%, specificity 69%). 18F-fluorodeoxyglucose uptake was also noted at various device regions in patients without infection or with non-mechanical circulatory support-specific infections, with false-positive rates of 80% and 63%, respectively. 18F-fluorodeoxyglucose PET/CT shows high sensitivity but considerable false positives and should be used as a complementary tool within a multidisciplinary framework for infection management.
Extracorporeal membrane oxygenation (ECMO) and endovascular balloon occlusion of the aorta (REBOA) have been reported to manage hemodynamics and reduce blood loss and transfusion requirements during high-risk abdominal s...Extracorporeal membrane oxygenation (ECMO) and endovascular balloon occlusion of the aorta (REBOA) have been reported to manage hemodynamics and reduce blood loss and transfusion requirements during high-risk abdominal surgeries. We investigated whether a venoarterial ECMO perfusion system with small-bore femoral arterial and venous cannulas (8F/10F) and endovascular hemorrhage control devices placed in the aorta and inferior vena cava (REBOAVC) can prolong the duration of survivable occlusion in a porcine hemorrhage model. Pigs underwent 30% controlled hemorrhage with subsequent supraceliac/suprahepatic REBOAVC (90 minutes full occlusion) with (n = 10) or without (n = 3) ECMO. Balloon deflation was followed by immediate transfusion of hemorrhaged blood and a 3 hour reperfusion/critical care period. A subset of ECMO pigs (n = 5) underwent hemofiltration with an Oxiris filter. Extracorporeal membrane oxygenation pigs showed greater survival (90% vs. 0%), improved lactate clearance (3.7 ± 0.8 vs. 13.7 ± 1.8 mmol/L), decreased norepinephrine requirement (18 ± 5 vs. 56 ± 3 μg/kg), and reduced histologic jejunum and kidney ischemia scores versus no ECMO (p < 0.05). Hemofiltration successfully managed hyperkalemia, decreased systemic inflammatory cytokine levels, and aided in acid-base correction from ischemia-reperfusion injury during resuscitation. Small-bore cannulas provided sufficient perfusion to distal organs in a porcine model suggesting that an integrated ECMO-REBOAVC-hemofiltration system has the potential to improve survivability for prolonged occlusion time.
Psychiatric comorbidities are increasingly common among patients with left ventricular assist devices (LVADs) and are associated with adverse outcomes. Access to inpatient psychiatric care for these patients is limited d...Psychiatric comorbidities are increasingly common among patients with left ventricular assist devices (LVADs) and are associated with adverse outcomes. Access to inpatient psychiatric care for these patients is limited due to their specialized care needs, lack of staff training and hospital protocols, and regulatory requirements. We present a case of a patient with an LVAD and severe depression requiring inpatient psychiatric hospitalization treated at our center. We outline a multidisciplinary framework for staff training, patient monitoring, and regulatory compliance that allows for safe and effective patient care in the inpatient psychiatry unit. This framework can serve as a model for other centers to expand access to inpatient psychiatric care for this underserved population.
When the risk of cardiopulmonary arrest during intubation is high, "awake" extracorporeal membrane oxygenation (ECMO) cannulation with sedation and a natural airway may provide hemodynamic stability and gas exchange to m...When the risk of cardiopulmonary arrest during intubation is high, "awake" extracorporeal membrane oxygenation (ECMO) cannulation with sedation and a natural airway may provide hemodynamic stability and gas exchange to mitigate the hazards of intubation. This retrospective case series characterizes patient selection, clinical periprocedural management, and frequency of "awake" pediatric ECMO cannulations in nonintubated patients at a quaternary pediatric hospital. Between 2014 and 2024, 58 patients (7-18 years) with nonpostoperative cardiac indications underwent ECMO support, with six (10%) "awake" venoarterial ECMO cannulations. Of the "awake" cohort median age was 13 years, with pulmonary hypertension, myocarditis, dilated cardiomyopathy with arrhythmia, and severe mitral stenosis diagnoses. Five were emergent or urgent with cannulations performed after interdisciplinary discussions in the cardiac intensive care unit or catheterization lab. Access was via femoral cutdown with one patient requiring additional neck venous access. Postcannulation, five of six patients were intubated, with one later extubated, such that two were managed extubated while supported on ECMO. All survived to hospital discharge, one received a bilateral lung transplant, and none sustained neurological injuries. We describe ECMO cannulation in spontaneously breathing children with varied physiology who were considered at high risk for cardiopulmonary arrest during induction of anesthesia and intubation. Though rare in pediatric practice, this approach is feasible with appropriate preparation and team expertise.
Limited information exists regarding the effectiveness of oxygenated right ventricular assist devices (OxyRVAD) versus standard right ventricular assist device (RVAD) configurations in patients with acute right ventricul...Limited information exists regarding the effectiveness of oxygenated right ventricular assist devices (OxyRVAD) versus standard right ventricular assist device (RVAD) configurations in patients with acute right ventricular failure (aRVF). We analyzed 345 patients (n = 197 OxyRVAD; n = 148 RVAD) with aRVF from a multicenter registry (PLACE study). Propensity scores were estimated using generalized boosted models. Inverse probability of treatment weighting was applied to balance groups. The primary endpoint was 30 day mortality; secondary endpoints included in-hospital mortality, complications, and successful weaning. Subgroup and interaction analyses were conducted to assess effect modification, particularly by baseline PaO2. Oxygenated right ventricular assist device use was not associated with improved 30 day mortality (Hazard Ratio [HR]: 1.09, 95% confidence interval [CI]: 0.72-1.65) but was linked to higher risks of thromboembolism (Odds Ratio [OR]: 1.68, 95% CI: 1.04-2.71), bleeding (OR: 1.53, 95% CI: 1.01-2.39), and renal replacement therapy (OR: 1.61, 95% CI: 1.01-2.61). Subgroup analysis revealed a significant interaction between PaO2 and treatment group (p = 0.019), with a mortality benefit observed in patients with PaO2 of less than 60 mm Hg (HR: 0.67, 95% CI: 0.45-0.99). In non-hypoxemic aRVF patients, OxyRVAD use was associated with increased complications and no survival benefit. These findings support a physiologically stratified approach to temporary RV support and discourage unselected, patient phenotype-oriented OxyRVAD use in the presence of refractory aRVF.
Aortic insufficiency (AI) is a progressive complication of continuous-flow left ventricular assist device support and remains inconsistently graded during HeartMate 3 (HM3) therapy. Using a closed-loop cardiovascular sim...Aortic insufficiency (AI) is a progressive complication of continuous-flow left ventricular assist device support and remains inconsistently graded during HeartMate 3 (HM3) therapy. Using a closed-loop cardiovascular simulation, we analyzed 2,312 physiologically screened HM3 profiles at pump speeds of 5,000 and 6,000 rpm to evaluate Doppler-based approaches for AI detection, defined by regurgitant fraction of greater than or equal to 30%. Established Doppler markers, including systolic-to-diastolic ratio (S/D), diastolic acceleration, and diastolic flow fraction (DFF), were compared with a derived Diastolic Dominance Index (DDI), which integrates systolic attenuation and diastolic predominance into a single metric. Systolic-to-diastolic ratio demonstrated strong discrimination (area under the receiver-operating characteristic curve [AUC]: 0.93 at 5,000 RPM; 0.86 at 6,000 RPM). Diastolic Dominance Index showed comparable performance (AUC: 0.87 and 0.83) and exhibited more stable discrimination across pump speeds, while providing a zero-centered index in which positive values indicate AI severity. Pump power alone was nondiagnostic, but in cases near the DDI decision boundary, it improved classification, achieving an AUC of 0.93 at 6,000 RPM. Simple rule-based combinations of DDI and power achieved greater than 90% accuracy at both speeds. By unifying established Doppler features into a single physiologic index and pairing it with an energetic adjudicator, this framework enables speed-robust, reproducible, and clinically interpretable AI grading during HM3 support. https://links.lww.com/ASAIO/B917.
The transvalvular microaxial flow pump (mAFP) is increasingly used to unload the failing left ventricle (LV), yet the hemodynamic strategy to maximize unloading remains uncertain. Using a mock circulatory loop with an Im...The transvalvular microaxial flow pump (mAFP) is increasingly used to unload the failing left ventricle (LV), yet the hemodynamic strategy to maximize unloading remains uncertain. Using a mock circulatory loop with an Impella CP, we tested how systemic vascular resistance (SVR) and pump flow levels influence LV workload. Left ventricle pressure-volume area (PVA) was evaluated across SVR 600-2,000 dyne·s·cm -5 , pump settings P0-P9, and LV contractility (healthy LV, mild, and severe LV dysfunction [LVD]) using two-way analysis of variance (ANOVA) and linear regression. Higher SVR significantly increased PVA, whereas increasing pump setting reduced PVA. However, across all contractility conditions, SVR explained greater than or equal to 4.68-fold more variance in PVA than pump setting (ANOVA sums of squares [×10 6 ]: 171.2-238.7 vs. 8.5-51.0), and regression confirmed a strong association between SVR and PVA ( p < 0.01) while pump setting was not significant ( p = 0.37-0.85). At the highest setting (P9), LV afterload increased, particularly in LVD (mild-severe LVD; p < 0.01), reducing unloading effect and increasing aortic regurgitation. In conclusion, this benchtop mock-loop study suggests lowering SVR may be more effective than escalating mAFP flow to optimize LV unloading, and excessive pump flow may paradoxically impair unloading in LV dysfunction.