Sternotomy Wound Infiltration With Liposomal Versus Plain Bupivacaine for Postoperative Analgesia After Elective Cardiac Surgery.

OBJECTIVES: Poor pain control after cardiac surgery can be associated with postoperative complications, longer recovery, and development of chronic pain. The authors hypothesized that adding liposomal bupivacaine (LB) to plain bupivacaine (PB) will provide better and long-lasting analgesia when used for wound infiltration in median sternotomy. STUDY DESIGN: Prospective, randomized, and double-blinded clinical trial. SETTING: Single institution, tertiary care university hospital. PARTICIPANTS: Adult patients who underwent elective cardiac surgery through median sternotomy. INTERVENTIONS: A single surgeon performed wound infiltration of LB plus PB or PB into the sternotomy wound, chest, and mediastinal tube sites. MEASUREMENTS AND MAIN RESULTS: Patients were followed up for 72 hours for pain scores, opioid consumption, and adverse events. Sixty patients completed the study for analysis (LB group [n = 29], PB group [n = 31]). Patient characteristics, procedural variables, and pain scores measured at specific intervals from 4 hours until 72 hours postoperatively did not reveal any significant differences between the groups. Mixed-model regression showed that the trend of mean pain scores at movement in the LB group was significantly (p = 0.01) lower compared with the PB group. Opioid consumption over 72 hours was not significantly different between the 2 groups (oral morphine equivalents; median [interquartile range], 139 [73, 212] mg in LB v 105 [54, 188] mg in PB, p = 0.29). Recovery characteristics and adverse events were comparable. CONCLUSIONS: LB added to PB for sternotomy wound infiltration during elective cardiac surgery did not significantly improve the quality of postoperative analgesia.

Charlson Comorbidity Index is Associated With Longer-Term Mortality and Re-Admissions Following Coronary Artery Bypass Grafting.

INTRODUCTION: The Charlson Comorbidity Index (CCI) is widely utilized for risk stratification by providers, payors, and administrative database researchers for non-cardiac surgical patients. CCI scores have not been validated in cardiac surgical patients. We hypothesize that the CCI will predict mid-term mortality and re-admissions, but performance may be different than purpose-built cardiac surgery risk calculators. METHODS: Patients undergoing isolated CABG between 2011 and 2017 were reviewed. Age-adjusted CCI scores were calculated based on clinical status at a time of index operation using prospectively captured data from institutional databases. Primary endpoint was 5-year mortality and 1-year re-admissions. The CCI, STS predicted mortality, and ASCERT 5-year mortality scores were compared in a sub-cohort of 500 patients. Patients underwent analysis using Cox Proportional Hazard ratios, Kaplan-Meier analysis, and ROC comparisons. RESULTS: Average CCI score for the overall population (n = 6064) was 3.40 ± 1.75. Kaplan-Meier analysis revealed significant difference in mortality stratified by CCI. Hazard ratio for 5-year mortality increased with each interval increase in CCI score value (HR 1.38 [1.33-1.43], P < 0.001), as did the risk of 1-year re-admission (HR 1.19 [1.15-1.22], P < 0.001). ROC curves for CCI, STS mortality, and ASCERT 5-year mortality risk demonstrate that all three scores are predictive at 5 y, but the ASCERT score performs best (ROC 0.76 versus 0.69, P = 0.004). CONCLUSIONS: The CCI can serve as a useful mid-term risk stratification tool in patients undergoing CABG when variables for the purpose-built STS and ASCERT scores are unavailable. However, the ASCERT score performs better at 5-year mortality calculation.

Comparison of Anticoagulation Strategies in Patients Requiring Venovenous Extracorporeal Membrane Oxygenation: Heparin Versus Bivalirudin.

OBJECTIVES: Extracorporeal membrane oxygenation is a life-sustaining therapy for severe respiratory failure. Extracorporeal membrane oxygenation circuits require systemic anticoagulation that creates a delicate balance between circuit-related thrombosis and bleeding-related complications. Although unfractionated heparin is most widely used anticoagulant, alternative agents such as bivalirudin have been used. We sought to compare extracorporeal membrane oxygenation circuit thrombosis and bleeding-related outcomes in respiratory failure patients receiving either unfractionated heparin or bivalirudin for anticoagulation on venovenous extracorporeal membrane oxygenation support. DESIGN: Retrospective cohort study. SETTING: Single-center, cardiothoracic ICU. PATIENTS: Consecutive patients requiring venovenous extracorporeal membrane oxygenation who were maintained on anticoagulation between 2013 and 2020. INTERNVENTIONS: IV bivalirudin or IV unfractionated heparin. MEASUREMENTS AND MAIN RESULTS: Primary outcomes were the presence of extracorporeal membrane oxygenation in-circuit-related thrombotic complications and volume of blood products administered during extracorporeal membrane oxygenation duration. One hundred sixty-two patients receiving unfractionated heparin were compared with 133 patients receiving bivalirudin for anticoagulation on venovenous extracorporeal membrane oxygenation. In patients receiving bivalirudin, there was an overall decrease in the number of extracorporeal membrane oxygenation circuit thrombotic complications (p < 0.005) and a significant increase in time to circuit thrombosis (p = 0.007). Multivariable Cox regression found that heparin was associated with a significant increase in risk of clots (Exp[B] = 2.31, p = 0.001). Patients who received bivalirudin received significantly less volume of packed RBCs, fresh frozen plasma, and platelet transfusion (p < 0.001 for each). There was a significant decrease in the number major bleeding events in patients receiving bivalirudin, 40.7% versus 11.7%, p < 0.001. CONCLUSIONS: Patients receiving bivalirudin for systemic anticoagulation on venovenous extracorporeal membrane oxygenation experienced a decrease in the number of extracorporeal membrane oxygenation circuit-related thrombotic events as well as a significant decrease in volume of blood products administered.

Platelet transfusion is associated with 90-day and 1-year mortality for adult patients requiring veno-arterial extracorporeal membrane oxygenation.

BACKGROUND: Studies examining one-year mortality respecting component blood transfusion are sparse. We hypothesize that component blood product transfusions are negatively associated with 90-day and 1-year survival for all patients requiring veno-arterial (VA) or veno-venous (VV) ECMO. STUDY DESIGN AND METHODS: This was an IRB-approved retrospective cohort analysis of 676 consecutive patients requiring ECMO at the University of Pittsburgh between 2005 and 2016. Patients were analysed both as an entire cohort and as two subsets with respect to ECMO modality (VA vs. VV). Additional data collected and analysed included patient characteristics, laboratory values and blood product transfusion. RESULTS: Multivariable analysis revealed that platelet transfusion was associated with 90-day mortality (OR: 1·05, P = 0·037) and one-year mortality for the entire cohort (OR = 1·05, P = 0·046,). Platelet transfusion volume was also associated with mortality in the VA-ECMO subset of patients at both 90 days (OR = 1·08, P = 0·03) and one year (OR: 1·11, P = 0·014). Age, peak International Normalized Raton ECMO, nadir haemoglobin (on ECMO) and final haemoglobin (after ECMO) were significantly associated with mortality for patients requiring VA-ECMO. For VV-ECMO patients, age, INR and peak creatinine on ECMO were associated with mortality. No individual component blood product was associated with one-year mortality for patients requiring VV-ECMO. CONCLUSION: Platelet transfusion was associated with increased 90-day and 1-year mortality for patients requiring VA-ECMO.

Acute right ventricular failure in a patient with nonischemic cardiogenic shock on left-sided mechanical circulatory support.

We report a case of acute right ventricular failure in a patient with cardiogenic shock on left-sided mechanical circulatory support with Impella 5.0. The patient was successfully bridged to heart transplantation using additional right-sided support with Protek Duo. Key learning points of the case include prompt recognition of acute right ventricular failure in patients on left-sided support, early consideration of right-ventricular mechanical support platforms, and timely deployment of right-sided mechanical support.

Remifentanil and perioperative glycaemic response in cardiac surgery: an open-label randomised trial.

BACKGROUND: This study investigated whether remifentanil infusion decreased intraoperative hyperglycaemia and insulin resistance compared with intermittent fentanyl administration in patients undergoing elective cardiac surgery. METHODS: This was a randomised, prospective, open-label trial. Patients undergoing elective cardiac surgery (n=116) were randomised to receive either continuous intravenous remifentanil infusion or intermittent fentanyl boluses. Hourly blood glucose values were obtained for 24 h starting from induction of anaesthesia. The difference in percentage of patients with ≥2 intraoperative blood glucose concentrations >10 mM (180 mg dl-1) between the groups was the primary outcome measure. Secondary outcome measures included insulin requirements, select stress hormone and inflammatory cytokine concentrations, and safety events and adverse outcomes. RESULTS: The trial included 106 subjects in the final intention-to-treat analysis. There were fewer patients with ≥2 intraoperative blood glucose values >10 mM (180 mg dl-1) in the remifentanil group (17 [31.5%]) compared with the fentanyl group (33 [63.5%]) (relative risk: 0.50; 95% confidence interval [CI]: 0.32-0.77; P=0.001). The administered intraoperative insulin was a median of 8.1 units (range: 0-46.7) in the fentanyl group and 2.9 units (range: 0-35.1) in the remifentanil group (median difference=5 units; 95% CI: 1-7; P=0.004). Cortisol and adrenocorticotropic hormone were increased less in the remifentanil group (P<0.001), but there was no relative decrease in this group in select inflammatory cytokines. Postoperative measures of glycaemic control and adverse clinical outcomes were not significantly different between groups. CONCLUSIONS: Compared with patients treated with intermittent fentanyl, patients receiving continuous remifentanil infusion had fewer episodes of hyperglycaemia and less need for insulin administration during the intraoperative period of cardiac surgery. CLINICAL TRIAL REGISTRATION: NCT02349152.

Outcomes of left ventricular assist device implantation in hypercoagulable patients.

BACKGROUND: The aim of this study was to evaluate outcomes of left ventricular assist devices (LVADs) in patients who tested positive for hypercoagulable hematologic disorders. METHODS: Adults undergoing continuous-flow LVAD implantation with preoperative hypercoagulability testing between 2004 and 2018 at a single center were reviewed. Hypercoagulability was defined as testing positive for antiphospholipid antibody, anticardiolipin antibody, lupus anticoagulant, protein C, protein S, factor V Leiden, and/or heparin-induced thrombocytopenia. The primary outcome was survival on the original LVAD. Secondary outcomes included rates of thromboembolic complications and readmission for intravenous heparin treatment. RESULTS: A total of 270 LVAD patients with pre-implant hypercoagulability testing were included, and 157 (58%) tested positive for a hypercoagulable disorder. Of those testing positive, 10 (6.4%) had a clinical pre-LVAD history of thromboembolic events. Survival was comparable between hypercoagulable and non-hypercoagulable patients (1 year: 73.3% vs 78.9%, P = .2195, 2-year: 60.7% vs 62.8%, P = .3627). Rates of pump thrombosis (14.0% vs 13.3%, P = .8618), hemolysis (4.5% vs 3.5%, P = .3536), stroke (18.5% vs 14.2%, P = .3483) and readmission for IV heparin therapy (87.3% (n = 137) vs 77.9% (n = 88), P = .7560) were similar. Outcomes were comparable in patients with positive hypercoagulable tests when stratified by pre-implant clinical history of hypercoagulability as well as stratified by recent preoperative exposure to heparin or warfarin. CONCLUSIONS: In this series, positive laboratory tests for hypercoagulability were common amongst patients undergoing LVAD implantation although few had positive clinical histories. Survival and freedom from thromboembolic complications were comparable to non-hypercoagulable patients. Hypercoagulability alone should therefore not serve as a contraindication to LVAD implantation.

Left Ventricular Assist Device Malfunctions: It Is More Than Just the Pump.

BACKGROUND: Reports of left ventricular assist device (LVAD) malfunction have focused on pump thrombosis. However, the device consists of the pump, driveline, and peripherals, all of which are potentially subject to failure. METHODS: Prospectively collected data were reviewed for all LVAD device malfunctions (DMs) occurring in rotary LVADs implanted at a single center between April 2004 and May 2016. Durable LVADs included 108 Heartmate II (HM II) and 105 HeartWare VAD (HVAD). DM data were categorized according to device type and into categories related to the component that failed: (1) controller, (2) peripheral components, and (3) implantable blood pump or its integral electric driveline. Pump-related events were analyzed as pump-specific (suspected or confirmed thrombosis) or nonpump-specific (driveline failure). DM rates were reported as events per 1000 patient-days, and Cox proportional hazard models were used for time-to-event analyses. Cumulative rates of malfunction were examined for the main components of each type of LVAD. RESULTS: Types of DM included controller failure (30%), battery failure (19%), or patient cable failure (14%), whereas only 13% were because of pump failure. DMs were more common in the HM II device (3.73 per 1000 patient-days versus 3.06 per 1000 patient-days for the HVAD, P<0.01). A higher rate of pump-specific malfunctions was discovered in those implanted with an HM II versus an HVAD (0.55 versus 0.39, respectively; P<0.01) and peripheral malfunctions (2.32 versus 1.78 for the HM II and HVAD, respectively; P<0.01); no difference occurred in the incidence of controller DM between the 2 LVADs. Patients with HVAD were 90% free of a pump-specific malfunction at 3 years compared with 56% for the HM II (log-rank P<0.003). Only 74% of the patients with HM II were free of pump thrombosis at 3 years compared with 90% of the patients with HVAD. Freedom from failure of the integrated driveline was 79% at 3 years for the HM II but 100% for the HVAD (log-rank P<0.02). CONCLUSIONS: Device malfunction is much broader than pump failure alone and occurs for different components at different rates based on the type of LVAD.

Predictors of intra-aortic balloon pump hemodynamic failure in non-acute myocardial infarction cardiogenic shock.

OBJECTIVES: To characterize patient profile and hemodynamic profile of those undergoing intra-aortic balloon pump (IABP) for cardiogenic shock and define predictors of hemodynamic failure of IABP support. BACKGROUND: Clinical characteristics of IABP support in cardiogenic shock not related to acute myocardial infarction (AMI) remain poorly characterized. METHODS: We retrospectively studied a cohort of 74 patients from 2010 to 2015 who underwent IABP insertion for cardiogenic shock complicating acute decompensated heart failure not due to AMI. RESULTS: In the overall cohort, which consisted primarily of patients with chronic systolic heart failure (89%), IABP significantly augmented cardiac index and lowered systemic vascular resistance (P<.05). Despite this improvement, 28% of these patients died (24%) or require urgent escalation in mechanical circulatory support (MCS) (4%). Multivariable regression revealed that baseline left ventricular cardiac power index (LVCPI), a measure of LV power output derived from cardiac index and mean arterial pressure (P=.01), and history of ischemic cardiomyopathy (P=.003) were significantly associated with the composite adverse-event endpoint of death or urgent MCS escalation. An IABP Failure risk score using baseline LVCPI <0.28 W/m2 and ischemic history predicted 28-day adverse events with excellent discrimination. CONCLUSION: Despite hemodynamic improvements with IABP support, patients with non-AMI cardiogenic shock still suffer poor outcomes. Patients with ischemic cardiomyopathy and low LVPCI fared significantly worse. These patients may warrant closer observation or earlier consideration of more advanced hemodynamic support.

Belatacept for maintenance immunosuppression in cardiothoracic transplantation: The potential frontier.

Current immunosuppressive regimens with calcineurin inhibitors have improved the management of patients after transplantation. However, their adverse effects are linked to increased morbidity and limit the long-term survival of heart and lung transplant recipients. Belatacept, a costimulation inhibitor interfering with the interaction between CD28 on T cells and the B7 ligands on antigen presenting cells, has shown success and is currently approved for use in renal transplant recipients. Furthermore, it lacks many of the cardiovascular, metabolic, neurologic, and renal adverse of effects of calcineurin inhibitors that have the largest impact on long-term survival in cardiothoracic transplant. Additionally, it requires no therapeutic drug monitoring and is only administered once a month. Limitations to belatacept use have been observed that must be considered when comparing immunosuppression options. Despite this, maintenance immunosuppression with belatacept has the potential to improve outcomes in cardiothoracic transplant recipients, as it has with kidney transplant recipients. However, no large clinical trials investigating belatacept for maintenance immunosuppression in heart and lung transplant recipients exist. There is a large need for focused research of belatacept in cardiothoracic transplantation. Belatacept is a viable treatment option for maintenance immunosuppression, and it is reasonable to pursue more evidence in cardiothoracic transplant recipients.

Disseminated cat-scratch disease presenting as nausea, diarrhea, and weight loss without fever in a heart transplant recipient.

We report the case of an afebrile 59-year-old heart transplant recipient presenting with nausea, vomiting, diarrhea, weight loss, and diffuse lymphadenopathy. Lymph node biopsies revealed non-caseating granulomatous inflammation. Cat-scratch disease was confirmed by serologic studies, Warthin-Starry staining, and polymerase chain reaction testing of lymph node tissue. The patient's symptoms resolved with 3 months of doxycycline. We review clinical presentations of Bartonella henselae infection and review diagnostic approaches for B. henselae in this patient population.

Cardiac Index Declines During Long-Term Left Ventricular Device Support.

To investigate longitudinal trends in valvular and ventricular function with long-term left ventricular assist device (LVAD) therapy, we analyzed hemodynamic and echocardiographic data of patients with at least 2 years of continuous LVAD support. All 130 patients who underwent HeartMate II implantation at our institution between 2005 and 2012 were reviewed. Twenty patients had hemodynamic and echocardiographic evaluations in both the early (0-6 months) and late (2-3 years) postoperative period. Patients on inotropic therapy or temporary mechanical support were excluded. The average times of early and late hemodynamic evaluations were 59 ± 41 days and 889 ± 160 days, respectively. Cardiac index (CI) declined by an average of 0.4 L/min/m2 (P = 0.04) with concomitant increase in pulmonary capillary wedge pressure (PCWP; P = 0.02). The right atrial pressure to PCWP (RAP:PCWP) ratio decreased during LVAD support suggesting improvement in right ventricular function. While there was an increase in degree of aortic insufficiency (AI) at the late follow-up period (P = 0.008), dichotomization by median decline in CI (-0.4 L/min/m2 ) indicated no difference in prevalence of AI among the groups. CI declined in patients with HeartMate II after 2 years of continuous support. An increase in preload and afterload was observed in those with the greatest decline in CI.

Blood Pressure Deviations From Optimal Mean Arterial Pressure During Cardiac Surgery Measured With a Novel Monitor of Cerebral Blood Flow and Risk for Perioperative Delirium: A Pilot Study.

OBJECTIVE: The aim of this study was to evaluate whether excursions of blood pressure from the optimal mean arterial pressure during and after cardiac surgery are associated with postoperative delirium identified using a structured examination. DESIGN: Prospective, observational study. SETTING: University hospital. PARTICIPANTS: The study included 110 patients undergoing cardiac surgery. INTERVENTIONS: Patients were monitored using ultrasound-tagged near-infrared spectroscopy to assess optimal mean arterial pressure by cerebral blood flow autoregulation monitoring during cardiopulmonary bypass and the first 3 hours in the intensive care unit. MEASUREMENTS AND MAIN RESULTS: The patients were tested preoperatively and on postoperative days 1 to 3 with the Confusion Assessment Method or Confusion Assessment Method for the Intensive Care Unit, the Delirium Rating Scale-Revised-98, and the Mini Mental State Examination. Summative presence of delirium on postoperative days 1 through 3, as defined by the consensus panel following Diagnostic and Statistical Manual of Mental Disorders-IV-TR criteria, was the primary outcome. Delirium occurred in 47 (42.7%) patients. There were no differences in blood pressure excursions above and below optimal mean arterial pressure between patients with and without summative presence of delirium. Secondary analysis showed blood pressure excursions above the optimal mean arterial pressure to be higher in patients with delirium (mean±SD, 33.2±26.51 mmHgxh v 23.4±16.13 mmHgxh; p = 0.031) and positively correlated with the Delirium Rating Scale score on postoperative day 2 (r = 0.27, p = 0.011). CONCLUSIONS: Summative presence of delirium was not associated with perioperative blood pressure excursions; but on secondary exploratory analysis, excursions above the optimal mean arterial pressure were associated with the incidence and severity of delirium on postoperative day 2.

Cerebral Autoregulation Monitoring with Ultrasound-Tagged Near-Infrared Spectroscopy in Cardiac Surgery Patients.

BACKGROUND: Individualizing mean arterial blood pressure (MAP) based on cerebral blood flow (CBF) autoregulation monitoring during cardiopulmonary bypass (CPB) holds promise as a strategy to optimize organ perfusion. The purpose of this study was to evaluate the accuracy of cerebral autoregulation monitoring using microcirculatory flow measured with innovative ultrasound-tagged near-infrared spectroscopy (UT-NIRS) noninvasive technology compared with transcranial Doppler (TCD). METHODS: Sixty-four patients undergoing CPB were monitored with TCD and UT-NIRS (CerOx™). The mean velocity index (Mx) was calculated as a moving, linear correlation coefficient between slow waves of TCD-measured CBF velocity and MAP. The cerebral flow velocity index (CFVx) was calculated as a similar coefficient between slow waves of cerebral flow index measured using UT-NIRS and MAP. When MAP is outside the autoregulation range, Mx is progressively more positive. Optimal blood pressure was defined as the MAP with the lowest Mx and CFVx. The right- and left-sided optimal MAP values were averaged to define the individual optimal MAP and were the variables used for analysis. RESULTS: The Mx for the left side was 0.31 ± 0.17 and for the right side was 0.32 ± 0.17. The mean CFVx for the left side was 0.33 ± 0.19 and for the right side was 0.35 ± 0.19. Time-averaged Mx and CFVx during CPB had a statistically significant "among-subject" correlation (r = 0.39; 95% confidence interval [CI], 0.22-0.53; P < 0.001) but had only a modest agreement within subjects (bias 0.03 ± 0.20; 95% prediction interval for the difference between Mx and CFVx, -0.37 to 0.42). The MAP with the lowest Mx and CFVx ("optimal blood pressure") was correlated (r = 0.71; 95% CI, 0.56-0.81; P < 0.0001) and was in modest within-subject agreement (bias -2.85 ± 8.54; 95% limits of agreement for MAP predicted by Mx and CFVx, -19.60 to 13.89). Coherence between ipsilateral middle CBF velocity and cerebral flow index values averaged 0.61 ± 0.07 (95% CI, 0.59-0.63). CONCLUSIONS: There was a statistically significant correlation and agreement between CBF autoregulation monitored by CerOx compared with TCD-based Mx.

Impact of controlled hypothermic preservation on outcomes following heart transplantation.

BACKGROUND: Severe primary graft dysfunction (PGD) is a major cause of early mortality after heart transplant, but the impact of donor organ preservation conditions on severity of PGD and survival has not been well characterized. METHODS: Data from US adult heart-transplant recipients in the Global Utilization and Registry Database for Improved Heart Preservation-Heart Registry (NCT04141605) were analyzed to quantify PGD severity, mortality, and associated risk factors. The independent contributions of organ preservation method (traditional ice storage vs controlled hypothermic preservation) and ischemic time were analyzed using propensity matching and logistic regression. RESULTS: Among 1,061 US adult heart transplants performed between October 2015 and December 2022, controlled hypothermic preservation was associated with a significant reduction in the incidence of severe PGD compared to ice (6.6% [37/559] vs 10.4% [47/452], p = 0.039). Following propensity matching, severe PGD was reduced by 50% (6.0% [17/281] vs 12.1% [34/281], respectively; p = 0.018). The Kaplan-Meier terminal probability of 1-year mortality was 4.2% for recipients without PGD, 7.2% for mild or moderate PGD, and 32.1%, for severe PGD (p < 0.001). The probability of severe PGD increased for both cohorts with longer ischemic time, but donor hearts stored on ice were more likely to develop severe PGD at all ischemic times compared to controlled hypothermic preservation. CONCLUSIONS: Severe PGD is the deadliest complication of heart transplantation and is associated with a 7.8-fold increase in probability of 1-year mortality. Controlled hypothermic preservation significantly attenuates the risk of severe PGD and is a simple yet highly effective tool for mitigating post-transplant morbidity.

Bivalirudin Versus Unfractionated Heparin in Patients With Cardiogenic Shock Requiring Venoarterial Extracorporeal Membrane Oxygenation.

This study evaluated differences in efficacy and safety outcomes with bivalirudin compared with unfractionated heparin (UFH) in patients with cardiogenic shock requiring venoarterial extracorporeal membrane oxygenation (VA ECMO). We performed a retrospective study at an academic medical center that included patients greater than 18 years of age supported with VA ECMO due to cardiogenic shock from January 2009 to February 2021. The primary endpoint was ECMO-associated thrombotic events normalized to duration of ECMO support. Secondary safety endpoints included major bleeding (per ELSO criteria) and blood product administration. Overall, 143 patients were included in our analysis with 54 having received bivalirudin and 89 having received UFH. Median duration of ECMO support was 92 (interquartile range, 56-172) hours. ECMO-associated thrombotic events per ECMO day were significantly less among those that received bivalirudin ( P < 0.001). In adjusted regression, bivalirudin was independently associated with an increased time to thrombosis when compared with UFH (Exp[B] -3.8; 95% confidence interval, 1.7-8.8; P = 0.002). Patients receiving bivalirudin experienced less major bleeding events ( P = 0.02) with less total red blood cell and fresh frozen plasma administration ( P = 0.04 and P = 0.03, respectively). Bivalirudin is a safe and efficacious alternative to UFH in patients requiring VA ECMO for cardiogenic shock.

A Paradigm Shift in Heart Preservation: Improved Post-transplant Outcomes in Recipients of Donor Hearts Preserved With the SherpaPak System.

Traditional ice storage has been the historic standard for preserving donor's hearts. However, this approach provides variability in cooling, increasing risks of freezing injury. To date, no preservation technology has been reported to improve survival after transplantation. The Paragonix SherpaPak Cardiac Transport System (SCTS) is a controlled hypothermic technology clinically used since 2018. Real-world evidence on clinical benefits of SCTS compared to conventional ice cold storage (ICS) was evaluated. Between October 2015 and January 2022, 569 US adults receiving donor hearts preserved and transported either in SCTS (n = 255) or ICS (n = 314) were analyzed from the Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN-Heart) registry. Propensity matching and a subgroup analysis of >240 minutes ischemic time were performed to evaluate comparative outcomes. Overall, the SCTS cohort had significantly lower rates of severe primary graft dysfunction (PGD) ( p = 0.03). When propensity matched, SCTS had improving 1-year survival ( p = 0.10), significantly lower rates of severe PGD ( p = 0.011), and lower overall post-transplant MCS utilization ( p = 0.098). For patients with ischemic times >4 hours, the SCTS cohort had reduced post-transplant MCS utilization ( p = 0.01), reduced incidence of severe PGD ( p = 0.005), and improved 30-day survival ( p = 0.02). A multivariate analysis of independent risk factors revealed that compared to SCTS, use of ice results in a 3.4-fold greater chance of severe PGD ( p = 0.014). Utilization of SCTS is associated with a trend toward increased post-transplant survival and significantly lower severe PGD and MCS utilization. These findings fundamentally challenge the decades-long status quo of transporting donor hearts using ice.

On-Hours Compared to Off-Hours Pediatric Extracorporeal Life Support Initiation in the United States Between 2009 and 2018-An Analysis of the Extracorporeal Life Support Organization Registry.

We aimed to investigate whether there are differences in outcome for pediatric patients when extracorporeal life support (ECLS) is initiated on-hours compared with off-hours. DESIGN: Retrospective cohort study. SETTING: Ten-year period (2009-2018) in United States centers, from the Extracorporeal Life Support Organization registry. PATIENTS: Pediatric (>30 d and <18 yr old) patients undergoing venovenous and venoarterial ECLS. INTERVENTIONS: The primary predictor was on versus off-hours cannulation. On-hours were defined as 0700-1859 from Monday to Friday. Off-hours were defined as 1900-0659 from Monday to Thursday or 1900 Friday to 0659 Monday or any time during a United States national holiday. The primary outcome was inhospital mortality. The secondary outcomes were complications related to ECLS and length of hospital stay. MEASUREMENTS AND MAIN RESULTS: In a cohort of 9,400 patients, 4,331 (46.1%) were cannulated on-hours and 5,069 (53.9%) off-hours. In the off-hours group, 2,220/5,069 patients died (44.0%) versus 1,894/4,331 (44.1%) in the on-hours group (p = 0.93). Hemorrhagic complications were lower in the off-hours group versus the on-hours group (hemorrhagic 18.4% vs 21.0%; p = 0.002). After adjusting for patient complexity and other confounders, there were no differences between the groups in mortality (odds ratio [OR], 0.95; 95% CI, 0.85-1.07; p = 0.41) or any complications (OR, 1.02; 95% CI, 0.89-1.17; p = 0.75). CONCLUSIONS: Survival and complication rates are similar for pediatric patients when ECLS is initiated on-hours compared with off-hours. This finding suggests that, in aggregate, the current pediatric ECLS infrastructure in the United States provides adequate capabilities for the initiation of ECLS across all hours of the day.

Primary Graft Dysfunction in Heart Transplant Recipients-Risk Factors and Longitudinal Outcomes.

Before the 33rd Annual International Society for Heart and Lung Transplantation conference, there was significant intercenter variability in definitions of primary graft dysfunction (PGD). The incidence, risk factors, and outcomes of consensus-defined PGD warrant further investigation. We retrospectively examined 448 adult cardiac transplant recipients at our institution from 2005 to 2017. Patient and procedural characteristics were compared between PGD cases and controls. Multivariable logistic regression was used to model PGD and immediate postoperative high-inotrope requirement for hypothesized risk factors. Patients were followed for a mean 5.3 years to determine longitudinal mortality. The incidence of PGD was 16.5%. No significant differences were found with respect to age, sex, race, body mass index, predicted heart mass mismatch, pretransplant amiodarone therapy, or pretransplant mechanical circulatory support (MCS) between recipients with PGD versus no PGD. Each 10 minute increase in ischemic time was associated with 5% greater odds of PGD (OR = 1.05 [95% CI, 1.00-1.10]; p = 0.049). Pretransplant MCS, predicted heart mass mismatch ≥30%, and pretransplant amiodarone therapy were associated with high-immediate postoperative inotropic requirement. The 30 day, 1 year, and 5 year mortality for patients with PGD were 28.4%, 38.0%, and 45.8%, respectively, compared with 1.9%, 7.1%, and 21.5% for those without PGD (log-rank, p < 0.0001). PGD heralded high 30 day, 1 year, and 5 year mortality. Pretransplant MCS, predicted heart mass mismatch, and amiodarone exposure were associated with high-inotrope requirement, while prolonged ischemic time and multiple perioperative transfusions were associated with consensus-defined PGD, which may have important clinical implications under the revised United Network for Organ Sharing allocation system.