The instantaneous left ventricular assist device (LVAD) flow waveform of the HeartWare ventricular assist device (HVAD) device was previously used to assess hemodynamic parameters, which is not possible with the HeartMat...The instantaneous left ventricular assist device (LVAD) flow waveform of the HeartWare ventricular assist device (HVAD) device was previously used to assess hemodynamic parameters, which is not possible with the HeartMate 3 (HM3). The purpose of this study was to assess the ability of pulsed wave Doppler interrogation of the outflow graft (PWOG) and of a novel noninvasive pump data acquisition system (HM3 Snoopy) to obtain noninvasive flow waveforms (NIFW) and to determine whether these predict hemodynamic changes. The study was conducted using a fluid-filled, biventricular failure mock loop model with a flow probe (FP) placed around the distal outflow. Five different pump speeds, two distinct hematocrits, and preload and afterload changes were used to create 56 unique hemodynamic states. Noninvasive flow waveform parameters were assessed for correlation against FP-derived parameters. Subsequently, NIFW parameters were assessed for their predictive capabilities for preload and afterload changes. There was moderate correlation between NIFW and FP-derived systolic waveform parameters (r range: 0.43-0.81), and strong correlation for diastolic parameters (r range: 0.87-0.99). Flow waveform amplitude as obtained by echocardiography was the best preload predictor (r2 = 0.67). A multiple linear regression model of NIFW parameters provided adequate prediction of afterload (r2 = 0.85). HeartMate 3 Snoopy and PWOG are promising tools for generating flow waveform surrogates and detecting hemodynamic changes.
Despite the increasing prevalence of advanced heart failure among older patients, current guidelines remain cautious regarding the safety of heart transplantation (HT) in elderly recipients. This study aimed to evaluate...Despite the increasing prevalence of advanced heart failure among older patients, current guidelines remain cautious regarding the safety of heart transplantation (HT) in elderly recipients. This study aimed to evaluate early and late outcomes in older HT recipients. We retrospectively analyzed all patients aged ≥18 years who underwent HT at our center between January 2012 and December 2022, comparing early and late outcomes of recipients ≥65 years (group 1) vs. those <65 (group 2). Groups 1 and 2 comprised 73 (female = 10, median age = 67 years, interquartile range [IQR] = 66-69) and 212 patients (female = 58, median age = 54 years, IQR = 46-60), respectively. Group 1 presented a higher burden of cardiovascular (CV) risk factors and impaired renal function (p < 0.001); additionally, they more often received older donors (p < 0.001) with a higher incidence of coronary artery disease (p = 0.041). Group 1 experienced a significantly higher rate of postoperative complications and in-hospital mortality (n = 21, 28.8%; p < 0.001). At a median follow-up time of 4.2 years (IQR = 1.3-6.9), group 1 showed lower survival rates (p < 0.001) (1 year = 68%, 95% confidence interval [CI] = 58-80; 5 year = 62%, 95% CI = 51-74). In our experience, HT in patients aged ≥65 years shows worse early and late outcomes; however, among elderly recipients, modifiable factors such as donor age and perioperative complications significantly influence survival and may be targeted to improve clinical results.
An important goal in the development of an artificial womb is the avoidance of the use of heparin, due to the presumed risk of intracranial hemorrhage in premature infants. We developed the Experimental Oxygenator (Exp-O...An important goal in the development of an artificial womb is the avoidance of the use of heparin, due to the presumed risk of intracranial hemorrhage in premature infants. We developed the Experimental Oxygenator (Exp-Ox), featuring a small surface area and low priming volume, as an oxygenator to support the clinical application of the EXTra-uterine Environment for Neonatal Development (EXTEND) system. This study evaluated the durability and hemocompatibility of the Exp-Ox during prolonged use (exceeding 14 days) in premature lambs in the EXTEND system without systemic anticoagulation (heparin-free study) compared to the standard heparin-based EXTEND system (heparin study). Twelve animals (91-93 days gestational age) completed the study: six in the heparin and six in the heparin-free study. Oxygen and CO2 transfer per weight remained stable overall in both studies, with no significant differences observed in oxygen transfer efficiency between the studies (p = 0.61). The quantitative clot burden of the Exp-Ox on computed tomography scan images ranged from 3.91-29.94% to 1.28-11.77% in the heparin and heparin-free studies, respectively (p = 0.15, nonsignificant difference), with no correlation to study duration or oxygen transfer efficiency. The Exp-Ox sustained function and hemocompatibility for over 14 days in the EXTEND system without systemic anticoagulation.
Bari G, Mariani S, van Bussel BCT
… +36 more, Di Mauro M, Conci L, Saeed D, Pozzi M, Loforte A, Boeken U, Samalavicius R, Bounader K, Hou X, J H Bunge J, Buscher H, Salazar L, Meyns B, Mazzeffi M, Matteucci S, Sponga S, Sorokin V, Russo C, Formica F, Sakiyalak P, Fiore A, Camboni D, Maria Raffa G, Diaz R, Wang IW, Jung JS, Belohlavek J, Pellegrino V, Bianchi G, Pettinari M, Barbone A, P Garcia J, Shekar K, Whitman G, Lorusso R,
on behalf of the PELS Investigators
Aortic surgery carries high risks and complication rates, particularly when extracorporeal life support (ECLS) is required. We compared outcomes of patients receiving post-cardiotomy ECLS after surgeries involving or not...Aortic surgery carries high risks and complication rates, particularly when extracorporeal life support (ECLS) is required. We compared outcomes of patients receiving post-cardiotomy ECLS after surgeries involving or not involving the thoracic aorta, with a focus on emergency operations. This retrospective multicenter study included adults requiring veno-arterial (V-A) ECLS for post-cardiotomy shock. In-hospital outcomes and long-term survival were analyzed. Among 2,058 patients, 382 (18.6%) underwent aortic and 1,676 (81.4%) non-aortic surgery. Patients undergoing aortic operations were younger (63.0, interquartile range [IQR]: 54.4-70 years; non-aortic: 65.0, IQR: 55-72 years; p = 0.020), with more emergencies (n = 126, 33.1%; non-aortic: n = 402, 24.3%; p < 0.001), longer cross-clamp times (148, IQR: 101-203 mins; non-aortic: 90, IQR: 59-133 mins; p < 0.001) and more postoperative bleeding events (n = 234, 62.4%; non-aortic: n = 922, 56.0%; p = 0.024). Stroke was more frequent after aortic surgery (n = 60, 15.8%; non-aortic: n = 157, 9.4%; p < 0.001), especially in emergency cases (n = 27, 21.6%; p = 0.034). In-hospital mortality was greater after aortic surgery (n = 258, 67.5%; non-aortic: n = 986, 58.8%; p = 0.002), with 49.9% (n = 189) on-ECLS mortality. Neurological injury caused death in 8.9% (n = 22) of patients undergoing aortic and 4.0% (n = 36) non-aortic operations. Post-discharge survival was similar ( p = 0.32), and emergency status did not affect mortality in the aortic group ( p = 0.643). Veno-arterial extracorporeal life support after aortic surgery is associated with higher bleeding, stroke, and in-hospital mortality compared with non-aortic surgery, independent of emergency status.
Heart transplantation (HTx) from controlled donation after circulatory death (c-DCD) is a promising alternative to donation after brain death (DBD), though warm ischemia remains a concern. Thoraco-abdominal normothermic...Heart transplantation (HTx) from controlled donation after circulatory death (c-DCD) is a promising alternative to donation after brain death (DBD), though warm ischemia remains a concern. Thoraco-abdominal normothermic regional perfusion (TANRP) enables in situ functional assessment, but preserving grafts during transport under optimal hypothermic conditions is still a challenge. We describe the first clinical application of a novel temperature-controlled cold static preservation system-Pertravel (Aferetica s.r.l., Bologna, Italy)-in a c-DCD heart transplant. A 62 year old male donor underwent withdrawal of life-sustaining therapy (WLST) followed by 130 minutes of TANRP. After confirming graft viability, the heart was explanted and preserved in the Pertravel system during transport. The recipient, a 66 year old male with end-stage dilated cardiomyopathy, underwent transplantation after 161 minutes of cold ischemia. The Pertravel system maintained stable hypothermia, with no macroscopic graft damage observed. Postoperative recovery was uneventful, with excellent hemodynamic performance, normal echocardiographic findings, and no evidence of acute rejection on serial biopsies. This case demonstrates the feasibility and safety of the Pertravel system for c-DCD heart preservation. Its stable temperature control, ease of use, and favorable outcomes support further investigation in broader clinical settings.
Extracorporeal membrane oxygenation (ECMO) for trauma is underreported in Latin America. We conducted a cohort study in four centers from Argentina (2015-2024), including all adults with polytrauma (defined as Injury Sev...Extracorporeal membrane oxygenation (ECMO) for trauma is underreported in Latin America. We conducted a cohort study in four centers from Argentina (2015-2024), including all adults with polytrauma (defined as Injury Severity Score [ISS] ≥ 16) who developed acute respiratory distress syndrome (ARDS) with refractory respiratory failure and received veno-venous ECMO. Extracorporeal membrane oxygenation-related complications, in-hospital mortality, and prognostic performance of established scores were assessed retrospectively; long-term health-related quality of life (QoL) was assessed prospectively. Thirty-one patients were analyzed. Bleeding occurred in 25.8% (major in 16.1%); oxygenator/circuit thrombosis in 22.6%. In-hospital mortality was 38.7% (95% confidence interval [CI]: 22-58). Discrimination was modest: area under the ROC curve (AUROC; 95% CI) of 0.62 (0.42-0.82) for ISS, 0.55 (0.33-0.76) for Acute Physiology and Chronic Health Evaluation II (APACHE II), and 0.53 (0.32-0.73) for respiratory ECMO survival prediction (RESP)-score. Among 19 survivors, 11 (57.9%) completed follow-up a median of 7 years after discharge; EuroQol 5-Dimension 3-Level (EQ-5D-3L) utility had a median of 0.743 (bootstrap 95% CI: 0.653-0.831), and Katz Index was 6, indicating preserved independence despite frequent pain/anxiety. Extracorporeal membrane oxygenation achieved 59% in-hospital survival with durable functional status, but the limited prognostic performance of established predictive models highlights the need for trauma-specific tools and structured rehabilitation and follow-up. Limitations include a small sample size and substantial loss of follow-up, restricting precision and generalizability.
Bleeding is a major complication in patients on extracorporeal membrane oxygenation (ECMO). Acquired factor XIII (FXIII) deficiency develops during ECMO support; however, little is known about the effects of FXIII admini...Bleeding is a major complication in patients on extracorporeal membrane oxygenation (ECMO). Acquired factor XIII (FXIII) deficiency develops during ECMO support; however, little is known about the effects of FXIII administration on bleeding ECMO outcomes. Our study aimed to evaluate the effect of FXIII concentrate on bleeding during ECMO and suggest an FXIII threshold level. Retrospective review of pediatric ECMO patients who received FXIII infusion. The International Society on Thrombosis and Hemostasis (ISTH) bleeding definition was used to classify bleeding as none (0), minor (1), clinically relevant non-major (2), and major (3). Factor XIII levels and bleeding scores were compared pre- and post-FXIII concentrate. Twenty patients received 27 infusions of FXIII. Factor XIII concentrate dosing was 37 ± 8 units/kg. Factor XIII levels increased from 41% (interquartile range [IQR]: 37-46) to 68% (IQR: 57-82), p value of less than 0.001. Bleeding severity improved after FXIII infusion; the mean ISTH bleeding score decreased from 2.0 ± 0.7 to 0.8 ± 0.9, p value of less than 0.001. Sixteen patients were successfully off ECMO and survived to discharge. Factor XIII administration was associated with improvement in bleeding severity when the initial FXIII level value was less than 50%. Pediatric ECMO patients with persistent bleeding should have FXIII levels measured and consideration of FXIII administration should be made at FXIII level value of less than 50%.
Lang FM, Nasi GM, Allen J
… +24 more, Bakken K, Brown KJ, Carlson W, Coglianese E, Doucette M, Kahlon T, Kramer M, Mastoris I, McClelland R, Newton-Cheh C, Oseran AS, Shao E, Soydara C, Ton VT, Tsao L, Usherenko V, Yang BQ, Crowley J, Michel E, Secor JD, Kreso A, Lewis GD, D'Alessandro DA, Zlotoff DA
Heart transplantation (HT) is the definitive therapy for end-stage heart failure. Patients unwilling to receive blood product transfusions are often considered ineligible for HT due to the significant perioperative bleed...Heart transplantation (HT) is the definitive therapy for end-stage heart failure. Patients unwilling to receive blood product transfusions are often considered ineligible for HT due to the significant perioperative bleeding risk. "Bloodless" HT-that is, without use of blood product transfusions-provides the opportunity to extend this critical intervention to such patients. Here we describe our center's peri-transplant blood conservation protocol that supported successful bloodless HT in two patients unwilling to receive blood product transfusions. One of these patients represents the first described case of temporary mechanical circulatory support as a bridge to bloodless HT, which is of particular importance given the increasing use of such support before HT more broadly. Clinical management decisions and interventions that decreased blood loss, minimized bleeding risk, and stimulated erythropoiesis are highlighted. Utilization of similar strategies may allow for expansion of bloodless HT to centers that have previously not offered this therapy.
Fulminant myocarditis may present with rapidly progressive cardiogenic shock and biventricular failure. Although fulminant myocarditis often presents with global left ventricular (LV) failure, unusual right-ventricular-p...Fulminant myocarditis may present with rapidly progressive cardiogenic shock and biventricular failure. Although fulminant myocarditis often presents with global left ventricular (LV) failure, unusual right-ventricular-predominant forms can mimic inferior ST-elevation myocardial infarction (STEMI) and delay diagnosis. Mechanical circulatory support (MCS) is often required, and veno-arterial extracorporeal membrane oxygenation and Impella (EC-PELLA) has been used in select cases. However, guidance is limited regarding its role when recovery is uncertain. A previously well, 72 year old woman collapsed with complete heart block, inferior ST-elevation, and isolated right ventricular dysfunction-features that strongly suggested inferior STEMI, yet angiography was nonobstructive. Despite inotropes and mechanical ventilation, the patient deteriorated, prompting initiation of VA-ECMO. Progressive vasoplegia, end-organ failure, and pulmonary edema necessitated placement of an Impella CP device. Myocardial biopsy confirmed lymphocytic myocarditis. Despite maximal support; there was no LV recovery, and the patient developed multiorgan failure. After multidisciplinary review and family discussions, support was withdrawn. This case illustrates both the diagnostic pitfall of right-dominant fulminant myocarditis masquerading as STEMI and the escalating role of EC-PELLA when shock is refractory, while underscoring the challenge of determining futility in the absence of early recovery. We discuss hemodynamic goals, escalation strategy, and prognostic uncertainty, emphasizing the need for early collaborative decision-making frameworks.
Despite the increasing number of critically ill immunocompromised patients in intensive care unit, the outcome of different types of immunocompromised patients with respiratory failure managed with venovenous extracorpor...Despite the increasing number of critically ill immunocompromised patients in intensive care unit, the outcome of different types of immunocompromised patients with respiratory failure managed with venovenous extracorporeal membrane oxygenation (VV ECMO) remains unclear. What is the overall mortality of immunocompromised patients with respiratory failure managed on VV ECMO compared to immunocompetent patients? Are there differences between different types of immunocompromised states? This is a systematic review and meta-analysis using MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials for studies of any design that reported outcomes of immunocompromised adult patients managed on VV ECMO for respiratory failure. A total of 13 studies were included. The pooled mortality among immunocompromised patients undergoing VV ECMO was 63% (95% confidence interval [CI]: 49-76%, I2 : 94.23%), which was significantly higher than immunocompetent patients (odds ratio [OR]: 2.57, 95% CI: 1.22-5.41, p = 0.03, I2 : 48.18%). Among immunocompromised subgroups, only patients with hematologic malignancy exhibited significantly higher mortality (OR: 5.78, 95% CI: 1.07-31.29, p = 0.05, I2 : 0.00%). Immunocompromised patients with acute respiratory failure treated with VV ECMO were associated with higher mortality compared to immunocompetent patients. Mortality varied by underlying cause of immunosuppression, emphasizing the need for careful, individualized patient selection.
Unfractionated heparin has long been the conventional anticoagulant for pediatric mechanical circulatory support (MCS). As bivalirudin has gained traction in ventricular assist devices (VAD) management, its role in extra...Unfractionated heparin has long been the conventional anticoagulant for pediatric mechanical circulatory support (MCS). As bivalirudin has gained traction in ventricular assist devices (VAD) management, its role in extracorporeal membrane oxygenation (ECMO) is less well defined. We conducted a retrospective, single-center study investigating the safety and outcomes of bivalirudin, a direct thrombin inhibitor, compared to heparin in a pediatric cardiothoracic intensive care unit (ICU). Outcomes included thrombotic and bleeding events, neurologic complications, survival to decannulation/transplant, and discharge. There were 122 patients for a total of 130 ECMO runs. Bivalirudin was used in 30% of ECMO runs, and bivalirudin demonstrated a 33% risk reduction in major bleeding (95% confidence interval: [-49.9, -16.0], p < 0.01) with fewer circuit component changes per 10 ECMO days (0.64 [0.4-0.7] vs . 2.6 [1.9-5.0], p < 0.01). Extracorporeal membrane oxygenation patients on bivalirudin had greater odds of survival to decannulation (odds ratio [OR]: 3.7 [1.4, 11.5], p = 0.01) and discharge (OR: 3.1 [1.4, 7.2], p < 0.01). The use of bivalirudin for ECMO in the pediatric cardiothoracic ICU population appears safe with fewer major bleeding and thrombotic complications and may be associated with improved survival compared to heparin.
Hamed S, Kalampokas N, Beckendorf J
… +11 more, Meyer AL, Ballazs C, Mueller Y, Boeken U, Ehlermann P, Ünal B, Lichtenberg A, Karck M, Frey N, Aubin H, Schlegel P
Heart failure (HF) remains a progressive condition even with optimal medical therapy, often requiring advanced interventions like left ventricular assist devices (LVAD). Recent advancements in HF treatment, including sod...Heart failure (HF) remains a progressive condition even with optimal medical therapy, often requiring advanced interventions like left ventricular assist devices (LVAD). Recent advancements in HF treatment, including sodium-glucose co-transporter 2 inhibitors (SGLT2i), have demonstrated benefits such as reduced mortality, symptom improvement, and renal protection. Their effects in LVAD patients remain unexplored. This study aims to evaluate the safety and therapeutic potential of SGLT2i in LVAD recipients, addressing a critical gap in current knowledge. A retrospective analysis of 176 consecutive patients who underwent LVAD implantation at two major academic centers in Germany (2018-2023) was conducted. In 139 LVAD patients (58 SGLT2i vs. 81 controls), we compared clinical and laboratory parameters at 6 and 12 months. In an additional group of 37 SGLT2i naïve patients who were already established on LVAD support the clinical course was compared to the pre-SGLT2i era. Renal function and cardiac biomarkers were not negatively affected during the first year of SGLT2i use. Complication rates (eg, infections, hypovolemic events, acute kidney injury) were comparable to both the control group and pre-SGLT2i era. Sodium-glucose co-transporter 2 inhibitors as part of contemporary HF medication appear to be safe for LVAD patients. Further research and longer follow-up periods are necessary to draw robust conclusions on cardiovascular and renal outcomes.
Hong Y, Nasim U, Dorken-Gallastegi A
… +9 more, Iyanna N, Woolley BE, Machinski SN, Keebler ME, Sriwattanakomen R, Horn ET, Ramanan R, Hickey GW, Kaczorowski DJ
Heart transplantation practices have evolved significantly following the 2018 heart allocation policy changes and the introduction of donation after circulatory death (DCD) heart transplantation in 2019. Under the new sy...Heart transplantation practices have evolved significantly following the 2018 heart allocation policy changes and the introduction of donation after circulatory death (DCD) heart transplantation in 2019. Under the new system, candidates supported with durable left ventricular assist devices (DLVADs) experience longer waitlist times with worse outcomes. This study evaluates the impact of DCD heart utilization on waitlist outcomes among DLVAD candidates using the United Network for Organ Sharing (UNOS) registry. Adult candidates with DLVADs listed for isolated heart transplantation from December 1, 2019, to March 31, 2023, with a 2 year follow-up period extending to March 31, 2025. Candidates were stratified by approval status to accept DCD donor offers. The outcomes were 2 year cumulative incidences of transplantation, delisting due to death or clinical deterioration, and all-cause survival from the time of initial waitlisting. Among 2,993 candidates, 487 (16.3%) were approved to accept DCD donor offers. Approval for DCD donor offers was associated with a significantly lower risk of delisting, a higher likelihood of transplantation, and improved all-cause survival. Moreover, this survival improvement persisted in the multivariable Cox regression. These findings highlight the growing use and clinical value of DCD heart utilization in expanding access to transplantation and improving outcomes in DLVAD candidates awaiting transplantation.
ProtekDuo dual-lumen cannula implantation provides effective percutaneous right ventricular support in acute right heart failure. This retrospective study analyzed 60 patients who received ProtekDuo support for a mean of...ProtekDuo dual-lumen cannula implantation provides effective percutaneous right ventricular support in acute right heart failure. This retrospective study analyzed 60 patients who received ProtekDuo support for a mean of 14.9 ± 9.7 days. Hemodynamic improvements included reduced central venous pressure (17.8 ± 5.6-11.8 ± 5.0 mmHg, p < 0.001) and increased central venous oxygen saturation (60.6 ± 15.2-74.6% ± 7.8%, p < 0.001). End-organ function improved, with lower creatinine (2.9 ± 5.0-1.6 ± 0.8 mg/dl, p = 0.046) and lactate levels (26.0 ± 23.3-14.1 ± 10.4 mg/dl, p < 0.001). Bilirubin levels increased post-implantation (2.9 ± 3.2 to 5.7 ± 6.0 mg/dl, p < 0.001) but returned to baseline within 13.5 ± 19 days in weaned patients. Independent mortality risk factors were female sex (hazard ratio [HR] = 6.47, p < 0.001), older age (HR = 1.035, p = 0.036), and higher body mass index (BMI) (HR = 1.124, p = 0.003). These findings highlight the benefits of percutaneous ProtekDuo implantation in acute right heart failure, although patient selection remains critical. Further studies are needed to refine selection criteria and optimize outcomes.