Outcomes after noncardiac surgery in patients with left ventricular assist devices: a systematic review.

Background: The number of patients living with left ventricular assist devices (LVADs) has gradually increased in the past decade. Non-cardiac surgery (NCS) in patients with LVAD poses a unique situation with its inherent challenges. Aim: We conducted a comprehensive review to investigate the perioperative complications and mortality associated with emergent or elective NCS in patients with LVAD. Method: A comprehensive literature search for any papers referring to continuous LVAD patients with NCS. All publications with at least five durable LVAD patients who had NCS were eligible for inclusion. Result: Twenty articles matching our criteria were found and included in our study. This systematic review included 6,476 LVAD patients who underwent 6,824 NCS. There were 5-3,216 LVAD patients with NCS in each study. The median age was between 39 and 65 years, and most of the patients (78.8%) were male. Thirty-day postoperative mortality ranged from 0% to 60%. Eight studies reported no death within the 30 days of the operation. Common complications include gastrointestinal (GI) bleeding, intracranial bleeding, infection, acute kidney injury (AKI), urinary tract infection (UTI), stroke, sepsis, pneumonia, and VAD exchange. Emergent abdominal surgery had the highest (up to 60%) mortality rate, and vascular and neurological operations had the highest complication rates. Due to the diverse range of patients in each publication and the combination of outcomes presented in various publications, a meta-analysis was not conducted. Conclusion: In LVAD patients, noncardiac surgery may be performed effectively and safely. LVAD patients who undergo non-cardiac surgery may require more transfusions due to their complex coagulopathies. However, perioperative management of LVAD patients undergoing emergent NCS should be optimized to reduce mortality. Systematic Review Registration: https://osf.io/fetsb/.

Central versus Peripheral VA ECMO for cardiogenic shock: an 8-year experience of a tertiary cardiac surgery center in Greece.

BACKGROUND: VA ECMO has emerged as an effective rescue therapy in patients with cardiogenic shock refractory to standard treatment protocols and its use is rising worldwide in the last decade. Although experience and availability are growing, outcomes remain poor. There is need for evidence to ameliorate clinical practice and improve outcomes. METHODS: We retrospectively reviewed the medical records of all patients who were supported with VA ECMO for cardiogenic shock at our institution between January 2015 and January 2023. The study purpose was to compare outcomes between patients who were supported with central versus peripheral configuration. RESULTS: ECMO was applied in 108 patients of whom central configuration in 48 (44%) and peripheral in 60 (56%). Patients supported with central VA ECMO were more likely to be supported for post cardiotomy shock [OR 4.6 (CI 95% 2.03 - 10.41)], while patients in the peripheral group for chronic heart failure decompensation [OR 9.4 (CI 95% 1.16 - 76.3]. Central VA ECMO had worse survival during ECMO support (29.2% vs 51.7%, p=0.018) and at discharge (8% vs 37%, p=0.001). These patients were at high risk of complications, such as acute kidney injury (AKI), [OR 2.37 (CI 95% 1.06 - 5.3), p = 0.034] and major bleeding [OR 3.08 (CI 95% 1.36 - 6.94), p<0.001]. CONCLUSIONS: Patients on central VA ECMO were supported mainly for post cardiotomy shock, presented with more complications such as major bleeding and AKI and had worse survival to hospital discharge, compared with patients on peripheral VA ECMO. Patient selection, timing of implementation, cannulation strategy and configuration remain main determinants of clinical outcome.

OUTCOMES OF CONTROLLED DCDD LUNG TRANSPLANTATION AFTER THORACO-ABDOMINAL VS ABDOMINAL NORMOTHERMIC REGIONAL PERFUSION: THE SPANISH EXPERIENCE.

OBJECTIVE: Thoraco-abdominal normothermic regional perfusion (TA-NRP) has emerged as a strategy for evaluating and recovering the heart in controlled donation after the circulatory determination of death (cDCDD). However, its impact on lung grafts remains largely unknown. We aimed to assess the impact of TA-NRP on the outcomes of recipients of cDCDD lungs. METHODS: This is a retrospective, multicenter, nationwide study describing the outcomes of cDCDD lung transplants (LTs) performed in Spain from January 2021 to November 2023. Patients were divided in two groups based on the recovery technique: TA-NRP with the simultaneous recovery of the heart versus abdominal NRP (A-NRP) without simultaneous heart recovery. The primary endpoint was the incidence of Primary Graft Dysfunction (PGD) grade 3 at 72 hours. Secondary endpoints included the overall incidence of PGD, days on mechanical ventilation, ICU and hospital length of stay, early survival rates, and mid-term outcomes. RESULTS: 283 cDCDD LTs were performed during the study period, 28 (10%) using TA-NRP and 255 (90%) using A-NRP. No differences were observed in the incidence of PGD grade 3 at 72 hours between the TA-NRP and the A-NRP group (0% vs. 7.6%; p=0.231), though the overall incidence of PGD was significantly lower with TA-NRP (14.3%% vs. 41.5%; p=0.005). We found no significant differences between the groups regarding other post-transplant outcome variables. CONCLUSIONS: TA-NRP allows the simultaneous recovery of both the heart and the lungs in the cDCDD scenario with appropriate LT outcomes comparable to those observed with the A-NRP approach.

Temporary Microaxial Support in a Patient With Multiple Post-Myocardial Infarction Mechanical Complications: Bridge to Transplantation.

A 66-year-old man with post-myocardial infarction ventricular septal rupture, apical aneurysm, and pseudoaneurysm presenting in cardiogenic shock received a surgically placed temporary microaxial transvalvular left ventricular assist device. This stabilized hemodynamics and end-organ function, and he subsequently underwent successful heart transplantation. A temporary microaxial transvalvular left ventricular assist device can effectively bridge patients with select mechanical complications of myocardial infarction beyond ventricular septal rupture.

Anatomical compatibility of a novel total artificial heart-An in-silico study.

BACKGROUND: ShuttlePump is a novel total artificial heart (TAH) recently introduced to potentially overcome the limitations associated with the current state-of-the-art mechanical circulatory support devices intended for adults. In this study, we adapted the outflow cannulation of the previously established ShuttlePump TAH and evaluated the anatomical compatibility using the virtual implantation technique. METHODS: We retrospectively assessed the anatomical compatibility of the ShuttlePump using virtual implantation techniques within 3D-reconstructed anatomies of adult heart failure patients. Additionally, we examined the impact of outflow cannula modification on the hemocompatibility of the ShuttlePump through computational fluid dynamic simulations. RESULTS: A successful virtual implantation in 9/11 patients was achieved. However, in 2 patients, pump interaction with the thoracic cage was observed and considered unsuccessful virtual implantation. A strong correlation (r <-0.78) observed between the measured anatomical parameters and the ShuttlePump volume exceeding pericardium highlights the importance of these measurements apart from body surface area. The numerical simulation revealed that the angled outflow cannulation resulted in a maximum pressure drop of 1.8 mmHg higher than that of the straight outflow cannulation. With comparable hemolysis index, the shear stress thresholds of angled outflow differ marginally (<5%) from the established pump model. Similar washout behavior between the pump models indicate that the curvature did not introduce stagnation zone. CONCLUSION: This study demonstrates the anatomic compatibility of the ShuttlePump in patients with biventricular failure, which was achieved by optimizing the outflow cannulation without compromising hemocompatibility. Nevertheless, clinical validation is critical to ensure the clinical applicability of these findings.

Moderate hypothermia circulatory arrest as a brain-protective strategy for type a aortic dissection.

OBJECTIVES: Brain protective strategies for acute type A aortic dissection (TAAD) remain controversial. Moderate hypothermia circulatory arrest (MHCA) without cerebral perfusion is not commonly used. However, we aimed to assess its safety and efficacy in 358 patients who underwent hemiarch replacement with MHCA for acute type A aortic dissection at our institution from August 2012 to August 2022. METHODS: Clinical outcomes were compared according to circulatory arrest time (≤15 min [S group, n = 52] vs ≥ 16 min [L group, n = 306]). The primary outcome was postoperative stroke. RESULTS: The S group had more older patients (72.5 vs 68.8 years; p = 0.04), a greater incidence of carotid artery malperfusion (21% vs 11%; p = 0.043), and a lower body mass index (21.7 vs 23.6 kg/m2; p < 0.01) and haemodynamic instability (3.8% vs 16%; p = 0.02) than the L group. The incidence of postoperative stroke (7.7% vs 12%; p = 0.33) and the rate of 30-day mortality (5.8% vs 6.5%; p = 0.83) did not significantly differ between groups. After adjusting for all potential confounding factors pre- and intraoperatively, there was no significant difference in postoperative outcomes between groups. CONCLUSIONS: MHCA alone for TAAD had comparable postoperative outcomes with circulatory arrest times under and over 15 min. However, longer arrest times were associated with a higher risk of stroke.

Feasibility Testing of the Bionet Sonar Ultrasound Transcutaneous Energy Transmission (UTET) System for Wireless Power and Communication of a LVAD.

PURPOSE: To address the clinical need for totally implantable mechanical circulatory support devices, Bionet Sonar is developing a novel Ultrasonic Transcutaneous Energy Transmission (UTET) system that is designed to eliminate external power and/or data communication drivelines. METHODS: UTET systems were designed, fabricated, and pre-clinically tested using a non-clinical HeartWare HVAD in static and dynamic mock flow loop and acute animal models over a range of pump speeds (1800, 2400, 3000 RPM) and tissue analogue thicknesses (5, 10, 15 mm). RESULTS: The prototypes demonstrated feasibility as evidenced by meeting/exceeding function, operation, and performance metrics with no system failures, including achieving receiver (harvested) power exceeding HVAD power requirements and data communication rates of 10kB/s and pump speed control (> 95% sensitivity and specificity) for all experimental test conditions, and within healthy tissue temperature range with no acute tissue damage. CONCLUSION: During early-stage development and testing, engineering challenges for UTET size reduction and stable and safe operation were identified, with solutions and plans to address the limitations in future design iterations also presented.

Camouflaging endovascular stents with an endothelial coat using CD31 domain 1 and 2 mimetic peptides.

Objective: Implantation of an endovascular device disrupts the homeostatic CD31:CD31 interactions among quiescent endothelial cells (ECs), platelets, and circulating leukocytes. The aim of this study was to design an endothelial-mimetic coating of nitinol and cobalt-chromium (CoCr) surfaces and stents using synthetic CD31 peptides, to promote device endothelialization and pacific integration within the arterial wall. Methods: Peptides mimicking the domains 1 (D1) and 2 (D2) of CD31 were synthetized and immobilized onto experimental nitinol and CoCr surfaces using a three-step, dip-coating, mussel-inspired protocol using copper-free click chemistry. Human aortic EC phenotype and endothelialization assessment using parallel scratch tests were carried out using five synthetic CD31 peptides coated on 4.8-mm nitinol and CoCr flat disks and were compared with control disks. The CD31 peptide exhibiting the best results in vitro was then immobilized on clinical-grade 3 × 40-mm self-expanding nitinol and 2.5 × 20.0-mm balloon-expandable CoCr stents. Such devices were implanted in native arteries of White New Zealand rabbits, and compared with control uncoated bare metal stents (BMS) and drug-eluting stents 7 and 30 days after implantation using resin cross-sections and scanning electron microscopy (n = 2-3 per group at each time point). Results: Membrane-distal CD31 D1 and D2 peptides exhibited a distinct capability to foster a healthy endothelial phenotype and to promote endothelialization in vitro. By day 7 after implantation, CD31 nitinol and CoCr stents were evenly covered by wholesome ECs, devoid of thromboinflammatory signs, in contrast with both BMS and drug-eluting stents. Such results were consistent until day 30. Conclusions: Membrane-distal CD31 biomimetic peptides seem to camouflage the device surface effectively, preventing local reactions and promoting rapid and seamless endovascular integration.

Case Report: Unmasking sustainable left ventricular recovery in chronic heart failure with axillary temporary mechanical circulatory support.

Background: Mechanical circulatory support (MCS), temporary or durable, is essential in patients with acute heart failure presenting in cardiogenic shock (CS). MCS is fundamental in patients with advanced heart failure when used as a bridge to decision, transplant or left ventricular recovery. Limited data on acute-on-chronic heart failure (HF) patients exists in the era of axillary mechanical circulatory support with the Impella 5.5. We describe a case of chronic ischemic cardiomyopathy, HF-CS, in a patient who underwent Impella placement, medical optimization, and explant, now with sustained normalization in ejection fraction. Case summary: A Caucasian female in her 50 s was referred to our center for evaluation for advanced therapies, including transplantation or durable left ventricular assist device placement. Her initial ejection fraction was 30% with comorbidities including multivessel coronary artery disease revascularized with 3 vessel bypass grafting ten years prior, type 2 diabetes (A1c 8.6%), and peripheral vascular disease. During her evaluation, she had acute decompensation leading to cardiogenic shock and required hospitalization with inotrope initiation, which was unable to be weaned. She was approved for organ transplant and listed; however, she required escalation of support and eventual placement of right axillary Impella 5.5. While on Impella support, her vasoactive needs reduced, and she was found to have left ventricular recovery and tolerated the initiation of guideline medical therapy. After three weeks of support, the Impella was weaned and explanted, and the patient was discharged. She remains stable with a sustained ejection fraction of greater than 50% with NYHA class 1 functional status at follow-up. One year later, the patient showed sustained myocardial recovery with guideline-directed medical therapy (GDMT). Conclusion: Our case highlights a unique approach in patients with long-standing (>5 years) heart failure who may benefit from early consideration for axillary support and concomitant optimization with guideline-directed medical therapy to assess for explant and native heart recovery.

Effect of Delayed Surgery for Ventricular Septal Rupture on Postoperative Outcomes.

OBJECTIVES: The prognosis of ventricular septal rupture (VSR) after acute myocardial infarction remains poor; hence, surgical repair is essential. However, the appropriate timing for surgical intervention remains unclear. We aimed to compare the prognosis between early (<96 hours) and delayed (≥96 hours) surgery for VSR. METHODS: This single-center, retrospective cohort study used data from 49 patients who underwent VSR repair after acute myocardial infarction (AMI) between 2007 and 2022 at our institution. In-hospital and one-, three-, and 10-year mortality and major adverse cardiac and cerebrovascular events were compared between the early (group A) and delayed (group B) surgery after AMI. RESULTS: No significant differences were found between the patients' backgrounds of the two groups. The in-hospital mortality rates were 37.5 and 16.0% for groups A and B, respectively (P = 0.114). The overall survival rates estimated using Kaplan-Meier analysis were 66.5 ± 6.9, 58.2 ± 7.5, and 28.8 ± 10.6% after one, three, and 10 years, respectively. The mortality rates in group B at three (hazard risk ratio: 2.691; 95% confidence interval: 1.02-7.097) and 10 (hazard risk ratio: 2.575; 95% confidence interval: 1.125-5.891) years were significantly better than those in group A. Major adverse cardiac and cerebrovascular events were significantly different between the two groups at all time points. CONCLUSIONS: These results showed that patients who underwent surgery for VSR 96 hours after AMI had better long-term survival than those who underwent surgery within 96 hours.

Infections in Patients with Mechanical Circulatory Support.

Patients on mechanical circulatory support are at heightened risk for infection given the invasive nature of the devices with internal and external components, the surgical implantation of the devices, and the presence of foreign material susceptible to biofilm formation. This review discusses the new International Society for Heart and Lung Transplantation mechanical circulatory support device infection definitions, inclusive of durable and acute mechanical circulatory support infections, and describes their epidemiology, diagnosis, and management. A multidisciplinary approach is essential for optimal management. Timing of transplantation in the context of active infection is addressed, and areas of future research are highlighted.

The Role of Ventricular Assist Devices in Patients With Heart Failure Due to Dilated Cardiomyopathy: A Systematic Review.

Dilated cardiomyopathy (DCM) is a prevalent heart muscle disease characterized by ventricular dilation and systolic dysfunction, leading to severe heart failure (HF) and often requiring heart transplantation (HTx). This systematic review aimed to synthesize information regarding the role of ventricular assist devices (VADs) in managing HF patients due to DCM. A comprehensive search was conducted across PubMed, Embase, Scopus, Web of Science, and Cochrane databases for studies published between 2014 and 2024. Inclusion criteria were studies involving adult patients with HF due to DCM treated with VADs. Exclusion criteria included non-human studies, pediatric populations, and non-peer-reviewed articles. Thirty-one studies met the inclusion criteria. The included studies demonstrated that the use of VADs in patients with DCM resulted in significant improvements in left ventricular ejection fraction (LVEF), myocardial fibrosis reduction, and reverse ventricular remodeling. Studies reported enhanced survival rates, reduced symptoms, and better quality of life. VADs served as a critical bridge to HTx and, in some cases, as long-term destination therapy. However, complications such as thrombus formation, anemia, and kidney failure were noted, emphasizing the need for vigilant monitoring and management. Continuous advancements in VAD technology and patient management protocols were found to be essential for optimizing outcomes. We conclude that VADs play a crucial role in managing advanced HF due to DCM by providing mechanical circulatory support, improving cardiac function, and enhancing patient survival and quality of life. Despite associated complications, VADs are invaluable for patients with severe HF, offering both immediate and long-term therapeutic benefits. Future research should focus on minimizing complications and further improving VAD technology to enhance patient outcomes.

Liver function maximum capacity test during normothermic regional perfusion predicts graft function after transplantation.

Purpose: In an effort to reduce waitlist mortality, extended criteria donor organs, including those from donation after circulatory death (DCD), are being used with increasing frequency. These donors carry an increased risk for postoperative complications, and balancing donor-recipient risks is currently based on generalized nomograms. Abdominal normothermic regional perfusion (aNRP) enables individual evaluation of DCD organs, but a gold standard to determine suitability for transplantation is lacking. This study aimed to incorporate individualized and predictive measurements of the liver maximum capacity (LiMAx) test to objectively grade liver function during aNRP and prevent post-op complications. Methods: aNRP was performed to salvage 18 DCD liver grafts, otherwise discarded. Continuous variables were presented as the median with the interquartile range. Results: The liver function maximum capacity (LiMAx) test was successfully performed within the aNRP circuit in 17 aNRPs (94%). Donor livers with good lactate clearance during aNRP demonstrated significantly higher LiMAx scores (396 (301-451) µg/kg/h versus those who did not 105 (70-158) µg/kg/h; P = 0.006). This was also true for manifesting stress hyperglycemia > 20 mmol/l (P = 0.032). LiMAx score correlated with alanine aminotransferase (ALT; R = - 0.755) and aspartate transaminase (AST; R = - 0.800) levels during perfusion and distinguished livers that were selected for transplantation (397 (346-453) µg/kg/h) from those who were discarded (155 (87-206) µg/kg/h; P < 0.001). Twelve livers were accepted for transplantation, blinded for LiMAx results, and all had LiMAx scores of > 241 µg/kg/h. Postoperatively, LiMAx during aNRP displayed correlation with 24-h lactate levels. Conclusions: This study shows for the first time the feasibility to assess liver function during aNRP in individual donor livers. LiMAx presents an objective tool to predict donor liver function and risk of complications in the recipient, thus enabling individualized matching of donor livers for an individual recipient. The LiMAx test may present a valuable test for the prediction of donor liver function, preventing post-transplant complication, and personalizing the selection of donor livers for individual recipients. Supplementary Information: The online version contains supplementary material available at 10.1007/s13167-024-00371-7.

Outcomes in peripheral right ventricular device support: Comparing the dual lumen, single canula and femoral vein cannulation strategies for right ventricular support.

INTRODUCTION: The Protek Duo (PtD) dual lumen, single cannula was developed as a percutaneous system for temporary mechanical support, inserted through the internal jugular vein (IJ) for both atrial inflow and pulmonary artery outflow. Outcomes of PtD compared to alternative Peripheral Right Ventricular Assist Device (pRVAD) methods are limited. METHODS: A retrospective analysis was conducted of pRVAD recipients from January 2017 - February 2022 (n = 111). These were classified into PtD (n = 52) patients and Non-Protek [(N-PtD) (n = 59)] recipients undergoing cannulation of the IJ and femoral vein. Results were further stratified by indication for pRVAD support: cardiogenic etiologies of heart failure and progressive ARDS. RESULTS: No survival benefit was detected between PtD and N-PtD groups at 1-week (OR: 1.32, 95% CI: 0.49-3.56, p = 0.58) or 6-month (OR: 9.83, 95% CI: 0.37-1.84, p = 0.64) follow-up. There were no statistically significant differences in whether patients' mobility progressed to out-of-bed activity (p = 0.26) or ambulation (p = 0.38). No differences were noted in time to out-of-bed (p = 0.26) or time to ambulation (p = 0.36). On subgroup analysis of patients by indication for pRVAD cannulation, these results persisted; no difference was noted in mid-term mortality (Cardiogenic: p = 0.39; ARDS: p = 0.91), progression to out-of-bed (p = 0.59; p = 1.00), or ambulation (p = 0.51; p-0.68). Among secondary outcomes, PtD patients had an increased dialysis requirement (p = 0.02). There were no differences in ability to wean from RVAD (p = 0.06), tracheostomy (p = 0.88), major bleeding events (p = 0.57), stroke (p = 0.58), or hospital length of stay (p = 0.39). CONCLUSIONS: Outcomes with PtD are comparable to those of traditional pRVAD cannulation strategies. Of note, no mobility benefit was observed to the use of PtD across several metrics.

Infection epidemiology, preventive measures and principles of best practices involving the skin and dressing of patients with a ventricular assist device: A scoping review.

BACKGROUND: Specific knowledge of several domains for managing care in the driveline externalization area may be necessary for the broader application of left ventricular assist devices. OBJECTIVES: This study aimed to map the recommendations for adult patients undergoing left ventricular assist device implantation. DESIGN: This scoping review, is being registered in the Open Science Framework under DOI https://doi.org/10.17605/OSF.IO/Q76B3 (https://osf.io/q76b3/). METHOD: Left ventricular assist device coordinators and nurse specialists in dermatology and stomatherapy conducted a scoping review limited to the period between 2015 and 2022. The results of this scoping review will be discussed and presented separately in 3 articles. This third article synthesizes research evidence on the epidemiology of device infections, infection preventive measures, local skin care and dressings in adult patients with left ventricular assist devices. RESULTS: The initial search resulted in 771 studies. Sixty nine met the eligibility criteria and were included in the scoping review. Eighteen articles addressing the epidemiology of device infections, infection preventive measures, and local skin and dressing care that answered the question of this article were included. The most common bacterial pathogens reported have been Gram-positive bacteria, typically Staphylococcus species. With respect to infection preventive measures, there are evidence gaps in local skin care and transmission system dressings. CONCLUSION: The driveline still remains the most common type of device infection. There exists imperfect knowledge on the standardization of care with the dressing and the area of skin for left ventricular assist device patients. Furthermore, there is a methodological fragility of the studies. These elements imply an opportunity for future research on these subjects. IMPLICATIONS FOR CLINICAL PRACTICE: This review provides an overview of the principles of best practices involving the skin and dressing of patients with a ventricular assist device without local dermatological diseases or infectious diseases. The central figure of an experienced professional can make a difference.

Effect of the Duration of Deep Hypothermic Circulatory Arrest on the Neurodevelopmental Outcomes in Children Undergoing Cardiac Surgery.

Background/Objectives: Deep hypothermic circulatory arrest (DHCA) is safe, but subtle neurodevelopmental deficits may persist far beyond the perioperative period. We aimed to investigate the relationship between DHCA duration and neurodevelopmental outcomes in young children undergoing cardiac surgery with DHCA. Methods: Children aged < 42 months, including neonates who underwent cardiac surgery using DHCA without regional perfusion techniques, were included as the DHCA group. Children in the same age range who underwent cardiac surgery without DHCA were included as the control group. All enrolled patients underwent neurodevelopmental assessment using the Bayley Scales of Infant and Toddler Development (BSTID) by a trained pediatrician, and 17 DHCA patients and 6 control patients completed the BSTID assessment. Results: Both groups showed no significant preoperative, operative, or postoperative differences. Adjusted multivariable analysis revealed that prematurity and age at assessment were significant changing predictors of each of the BSTID components (p < 0.001), except for the gross motor component, where only age at assessment was a significant adjusting predictor. Longer DHCA was associated with lower fine and gross motor BSTID components; however, the association was not statistically significant (p = 0.06). Conclusions: Long-duration DHCA without regional perfusion techniques may be associated with less optimal neurodevelopmental outcomes.

Percutaneous femoral venoarterial ECMO decannulation at the bedside using the Manta vascular closure device.

A case of peripheral venoarterial extracorporeal membrane oxygenation decannulation using the Teleflex Manta vascular closure device is presented.

Predicting survival after Impella implantation in patients with cardiogenic shock: The J-PVAD risk score.

AIMS: Impella has become a new option for mechanical circulatory support in patients with cardiogenic shock (CS); however, prognostic models for patients after Impella are lacking. We aimed to identify the factors that predict in-hospital mortality in patients with CS requiring Impella and develop a new risk prediction model. METHODS AND RESULTS: We utilized the J-PVAD registry, which includes all cases where Impella was implanted in Japan. Two-thirds of the patients in the J-PVAD registry were randomly assigned to the derivation cohort (n = 1701), and the other third was assigned to the validation cohort (n = 850). A backward stepwise logistic regression model was developed to identify factors associated with in-hospital mortality. In the derivation cohort, 956 patients were discharged alive, and 745 patients (43.8%) died during hospitalization. Among 29 candidate variables, 12 were independently associated with in-hospital mortality and were applied as components of the risk model, including age, sex, body mass index, fulminant myocarditis aetiology, cardiac arrest in hospital, baseline veno-arterial extracorporeal membrane oxygenation use, mean arterial pressure, lactate, lactate dehydrogenase, total bilirubin, creatinine, and albumin levels. The comparison of predicted and observed in-hospital mortality according to the 7th quantiles using the J-PVAD risk score showed good calibration. The area under the curve for the J-PVAD risk score was 0.76 (95% confidence interval 0.73-0.78). In the validation cohort, the J-PVAD risk score showed good calibration and discrimination ability. CONCLUSIONS: The J-PVAD risk score can be calculated using variables easily obtained in routine clinical practice. It helps the accurate stratification of mortality risk and facilitates clinical decision-making.

Cold atmospheric plasma therapy as a novel treatment for Berlin Heart EXCOR pediatric cannula infections.

BACKGROUND: Cold atmospheric plasma (CAP) therapy has been recognized as effective treatment option for reducing bacterial load in chronic wounds, such as adult ventricular assist device (VAD) driveline exit-site infections. Currently, there have been no reports on the safety and efficacy of CAP therapy for pediatric cannula infections and inflammations in paracorporeal pulsatile VADs. METHODS: The mechanical strength of Berlin Heart EXCOR cannulas were tested both before and after CAP treatment (SteriPlas, Adtec Healthcare Limited, UK) to prove material safety. A ring tensile test of 20 untreated and 20 CAP-treated (5 min) EXCOR cannulas (Ø12mm), assessed the force at the breaking point of the cannulas (Fmax), at 25% (F25%) and 50% (F50%) of the maximum displacement. Additionally, the scanning electron microscope (SEM) micrographs for both groups examined any surface changes. Finally, the case of a 13-year-old male EXCOR patient with cannula infections, treated with CAP over 100 days, is presented. RESULTS: The in vitro measurements revealed no statistically significant differences in mechanical strength between the control and CAP group for F25% (8.18 ± 0.36 N, vs. 8.02 ± 0.43 N, p = 0.21), F50% (16.87 ± 1.07 N vs. 16.38 ± 1.32 N, p = 0.21), and FMAX (44.55 ± 3.24 N vs. 42.83 ± 4.32 N, p = 0.16). No surface structure alterations were identified in the SEM micrographs. The patient's cannula exit-sites showed a visible improvement in DESTINE wound staging, reduction in bacterial load and inflammatory parameters after CAP treatment without any side effects. CONCLUSION: Overall, CAP therapy proved to be a safe and effective for treating EXCOR cannula exit-site wound healing disorders in one pediatric patient, but further studies should investigate this therapy in more detail.