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Background Preoperative aspirin use within 5 days of cardiac operations is controversial. Aspirin could reduce cardiovascular complications and yet might increase risk of bleeding. Recent reports showed conflicting results, and whether aspirin has variable effects for different cardiac surgical procedures is unclear. Methods A single-center retrospective cohort analysis was performed. After propensity score matching (PSM) for identified confounders, the relationship between preoperative aspirin use and 30-day all-cause mortality, postoperative renal failure, major adverse cardiocerebral events (MACE), blood transfusion, reoperation for bleeding, and postoperative infection were estimated with separate logistic regression models. Results Preoperative aspirin therapy was associated with a 49% (p = 0.04) increased risk of reoperation for bleeding among 868 matched pairs of patients undergoing valve operations. Among 725 matched patients undergoing coronary artery bypass grafting (CABG), preoperative aspirin therapy was not associated with a statistically significant higher risk of reoperation for bleeding. However, preoperative aspirin use, compared with nonuse, was not associated with risks of MACE, 30-day mortality, postoperative renal failure, blood transfusion, or postoperative infection in the entire cohort, in patients undergoing valve operations only, and in patients undergoing CABG only after PSM. Conclusions Preoperative aspirin use in all patients undergoing cardiac operations was not associated with risks of major cardiac, cerebral, or renal complications and infections and death; however, the risk of reoperation for bleeding was elevated among preoperative aspirin users compared with nonusers in a subpopulation of patients undergoing valve operations only.

We examined the relationship between depression (symptom type, diagnostic severity, and change over time) and adherence to HIV antiretroviral therapy (ART) with data from 3 longitudinal studies (N = 1021) of patients starting ART in Uganda. The Patient Health Questionnaire was used to assess depressive symptoms (total score; somatic and cognitive subscales) and categorize severity level. At baseline, 9% had major depression and 30% had minor depression; 82% were adherent (reported no missed ART doses in the past 7 days) at month 6 and 85% at month 12. Controlling for demographic and medical covariates, multivariate random-effects logistic regression models revealed that change in depression was not related to adherence; however, baseline total depression symptoms and cognitive symptoms in particular as well as major and minor depression were significant predictors of adherence. These findings highlight the need for early identification and aggressive treatment of depression to optimize ART adherence.

BACKGROUND: Contemporary ventricular assist device therapy results in a high rate of successful heart transplantation but is associated with bleeding, infections, and other complications. Further reductions in pump size, centrifugal design, and intrapericardial positioning may reduce complications and improve outcomes. METHODS AND RESULTS: We studied a small, intrapericardially positioned, continuous-flow centrifugal pump in patients requiring an implanted ventricular assist device as a bridge to heart transplantation. The course of investigational pump recipients was compared with that of patients implanted contemporaneously with commercially available devices. The primary outcome, success, was defined as survival on the originally implanted device, transplantation, or explantation for ventricular recovery at 180 days and was evaluated for both noninferiority and superiority. Secondary outcomes included a comparison of survival between groups and functional and quality-of-life outcomes and adverse events in the investigational device group. A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. Success occurred in 90.7% of investigational pump patients and 90.1% of controls, establishing the noninferiority of the investigational pump (P<0.001; 15% noninferiority margin). At 6 months, median 6-minute walk distance improved by 128.5 m, and both disease-specific and global quality-of-life scores improved significantly. CONCLUSIONS: A small, intrapericardially positioned, continuous-flow, centrifugal pump was noninferior to contemporaneously implanted, commercially available ventricular assist devices. Functional capacity and quality of life improved markedly, and the adverse event profile was favorable. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00751972. [ABSTRACT FROM AUTHOR]

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., (© 2024. The Author(s) under exclusive licence to Biomedical Engineering Society.)

Left ventricular assist devices (LVADs) are excellent therapies for advanced heart failure patients either bridged to transplant or for lifetime use. LVADs also allow for reverse remodeling of the failing heart that is often associated with functional improvement. Indeed, growing enthusiasm exists to better understand this population of patients, whereby the LVAD is used as an adjunct to mediate myocardial recovery. When patients achieve benchmarks suggesting that they no longer need LVAD support, questions related to the discontinuation of LVAD therapy become front and center. The purpose of this review is to provide a surgical perspective on the practical and technical issues surrounding LVAD deactivation., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Due to the discrepancy between patients awaiting a heart transplant and the availability of donor hearts, strategies to expand the donor pool and improve the transplant's success are crucial. This review aims to summarize current knowledge on the ex vivo heart preservation (EVHP) experience as an alternative to standard cold static storage (CSS). EVHP techniques can improve the preservation of the donor's heart before transplantation and allow for pre-transplant organ evaluation., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: CoRISMA MCS Systems Inc (Hamden CT) is developing an innovative mechanical circulatory support system (CMCS) as a durable therapeutic option for heart failure (HF) patients. The CMCS system is comprised of an axial flow pump, non-contacting hydrodynamic bearings, and integrated DC motor designed to be fully implantable in a left atrial (LA) to aortic (Ao) configuration; this unloading strategy may be particularly beneficial for HF patients with preserved ejection fraction (HFpEF). The small (5.5 cm 3 ), lightweight (20 g), and low power (5-7 W) device design should allow for a less invasive off-pump implant. We present early-stage engineering development and testing of the prototype CoRISMA pumps., Methods: Computational fluid dynamics (CFD) modeling was performed to evaluate flow and shear in two impeller (3 blades, 0.5 mm thickness, 8.9 mm diameter, 0.15 mm gap, polished titanium) and diffusor (5 blades, polished titanium) candidate designs. Test apparatuses were custom built to expedite development of the impeller/diffuser designs and iteratively refine the CFD models. Two candidate impeller/diffusor designs were fabricated and tested in each of the two test apparatuses (n = 4 impeller/diffuser + test fixture configurations) in static mock flow loops (hydrodynamic H-Q curves, 3.5 cP glycerol solution at 37 °C), and in dynamic mock flow loops (hemodynamics, 3.5 cP glycerol solution at 37 °C) tuned to HF conditions (mean aortic pressure 50 mmHg, central venous pressure 15 mmHg, aortic flow 3.0 L/min, and heart rate 80 bpm)., Results: CFD predicted flows of 4.56 L/min and 4.82 L/min at 100 mmHg for impellers/diffusers 1 and 2, respectively. Impeller 2 required less torque to generate a 6% increase in fluidic flow, and the diffuser had a larger area of high pressure, indicative of lower friction, which likely contributed to the increased efficiency. Experimental testing for all four configurations in the static and dynamic mock loops met performance metrics as evidenced by generating 4.0-4.5 L/min flow against 70-76 mmHg pressure at 25,000 rpm and restoring hemodynamics in the dynamic mock flow loop (MAP = 80 mmHg, CVP = 0 mmHg, total flow = 5.5 L/min) from baseline simulated HF test conditions., Conclusion: These results demonstrate proof-of-concept of the early engineering design and performance of the prototype CoRISMA pumps. Engineering specifications, challenges observed, and proposed solutions for the next design iteration were identified for the continued development of an effective, reliable, and safe LA-to-Ao CMCS system for HF patients. Current design plans are underway for incorporating a wireless energy transfer system for communication and power, eliminating the need for and complications associated with an external driveline, to achieve a fully-implantable system., (© 2024. The Author(s) under exclusive licence to Biomedical Engineering Society.)

There has been an increase in the use of extracorporeal membrane oxygenation (ECMO) to bridge critically ill patients to lung transplant (LTX). This study evaluates how ambulatory status on ECMO affected waitlist and post-LTX outcomes. The United Network of Organ Sharing (UNOS) database was queried for patients aged of greater than or equal to 18 years and between 2016 and 2021 to identify pre-LTX patients supported by ECMO. The patients were classified in venous-arterial (VA) ECMO and veno-venous (VV) ECMO cohorts and further classified as ambulatory (AMB) and non-AMB (nAMB). Each cohort was controlled against the non-ECMO patients. Univariate statistical tests, as well as Kaplan-Meier survival curves, were used for analysis. The 90 day waitlist survival was the highest among the non-ECMO group (96%), but both AMB VV and VA groups had superior survival compared to the nAMB group (85% vs. 75%, 78% vs. 65%, p < 0.01). After adjusting for the median lung allocation score (LAS) (88) in the VV ECMO group, the waitlist survival was superior in the AMB VV ECMO compared to those not on ECMO (86% vs. 78%, p > 0.01). The 1 year post-LTX survival between non-ECMO and AMB VV ECMO was comparable (88% vs. 88%, p = 0.66). Ambulating patients or use of physical therapy while on ECMO can help improve lung transplant outcomes., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © ASAIO 2024.)

We characterize the anatomy and function of never before studied total artificial hearts (TAHs) using established methods for testing mechanical circulatory support (MCS) devices. A historical review of TAHs is also presented to aid in benchmarking performance metrics. Six TAHs, ranging from spooky Halloween beating hearts to a cute colorful plush heart, were imaged, instrumented (mock flow loops) to measure their pressure, volume, and flow, and qualitatively evaluated by 3rd party cardiac surgeons for anatomical accuracy and surgical considerations. Imaging of Claw, Beating, and Frankenstein TAHs revealed internal motors, circuit boards, and speakers. Gummy TAH was ranked favorite TAH for tactile realism, while Frankenstein TAH had the most favorable audible/visual indicators, including an illuminated Jacob's Ladder. Beating TAH demonstrated superior pulsatile hemodynamic performance compared to Claw TAH (16mL vs 1.3mL stroke volume). Light Up TAH and Gummy TAH functioned only as passive compliance chambers. Cute TAH rapidly exsanguinated due to its porosity (-3.0 L/min flow). These TAHs demonstrated a wide range of anatomical accuracy, surgeon appeal, unique features, and hemodynamic performance. While Claw TAH and Beating TAH successfully generated a modicum of pulsatility, we recommend the clinical community continue to support pre-clinical development of emerging or use of clinically-approved TAHs., (Copyright © ASAIO 2024.)

Mechanical circulatory support for cardiogenic shock complicated by acute severe aortic regurgitation poses a unique challenge for traditional veno arterial extracorporeal membrane oxygenation (ECMO) because of rapidly rising left ventricular pressures accentuated by the increased afterload from retrograde flow in femoral cannulation. This process necessitates rapid left ventricular unloading while also allowing for adequate native left ventricular function. Herein, we describe a case of cardiogenic and septic shock secondary to methicillin-resistant Staphylococcus aureus complicated by acute severe aortic regurgitation temporized by left atrial-veno arterial (LA-VA) ECMO via the Livanova TandemHeart system. Left ventricular unloading created a window of hemodynamic stability allowing for optimization of multiorgan failure and infectious source control before surgical aortic valve replacement., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © ASAIO 2023.)

The shortcomings of expense, power requirements, infection, durability, size, and blood trauma of current durable LVADs have been recognized for many years. The LVADs of tomorrow aspire to be fully implantable, durable, mitigate infectious risk, mimic the pulsatile nature of the native cardiac cycle, as well as minimize bleeding and thrombosis. Power draw, battery cycle lifespan and trans-cutaneous energy transmission remain barriers to completely implantable systems. Potential solutions include decreases in pump electrical draw, improving battery lifecycle technology and better trans-cutaneous energy transmission, potentially from Free-range Resonant Electrical Energy Delivery. In this review, we briefly discuss the history of LVADs and summarize the LVAD devices in the development pipeline seeking to address these issues., (© 2024. The Japanese Society for Artificial Organs.)

Penetrating cardiac injuries usually require emergent surgical intervention. Our patient presented to the trauma centre with multiple stab wounds to the neck, chest, epigastric region and abdomen. She arrived haemodynamically stable, and her initial Focused Assessment with Sonography for Trauma exam was negative. Her chest X-ray did not show any evident pneumothorax or haemothorax. Due to her injury pattern, she was taken to the operating room for exploratory laparotomy and neck exploration. Postoperatively, she was taken for CT and found to have a contained cardiac rupture. The injury was contained within previous scar tissue from her prior cardiac surgery. Further evaluation revealed that the injury included a penetrating stab wound to the right ventricle and a traumatic ventricular septal defect (VSD). She subsequently underwent a redo sternotomy with the repair of the penetrating stab wound and the VSD. Cardiology, intensive care, trauma surgery and cardiothoracic surgery coordinated her care from diagnosis, management and recovery. This case highlights the challenges in the management of cardiac injuries and the benefits of a multidisciplinary approach to care for complex cardiac injuries., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Aortic aneurysms involving the proximal aortic arch, which require hemiarch-type repair, typically require circulatory arrest with antegrade cerebral perfusion. Left carotid antegrade cerebral perfusion (LCP) via distal arch cannulation without circulatory arrest was used in this study's patient population. The goal was to assess the operative efficiency and clinical outcomes of using a distal arch cannulation technique that would not require any hypothermic circulatory arrest (HCA) time compared with more traditional brachiocephalic artery cannulation with right-sided unilateral antegrade cerebral perfusion (RCP) and HCA., Methods: A single-center retrospective review of patients with replacement of the distal ascending aorta involving the proximal arch was performed. Patients with an intramural hematoma or dissection were excluded. Between January 2015 and December 2019, 68 adult patients had undergone a hemiarch repair because of aneurysmal disease. Analysis of baseline demographics, operative data, and clinical outcomes was performed., Results: Comparing the 68 patients: 21 patients were treated with RCP (via brachiocephalic artery graft with HCA), and 47 patients were treated with LCP (via distal aortic arch cannulation with cross-clamp between the brachiocephalic and left common carotid arteries without HCA). Baseline characteristics and outcomes were evaluated for both groups. The LCP group was younger (LCP median [IQR] age, 60 [53-65] years vs RCP median [IQR] age, 67 [59-71] years]. Sex, race, body mass index, comorbidities, and ejection fraction were similar between the groups. Cardiopulmonary bypass time (LCP, 123 minutes vs RCP, 149 minutes) and unilateral cerebral perfusion time (LCP, 17 minutes vs RCP, 22 minutes) were longer in the RCP group. Bleeding, prolonged ventilatory support, kidney failure, and length of stay were similar. In-hospital mortality was 2% in the LCP group vs 0% in the RCP group. Stroke occurred in 2 patients (4.2%) in the LCP group and in 0% of the RCP group. Mortality at 6 months in the LCP and RCP groups was 3% and 10%, respectively., Conclusion: Distal arch cannulation with LCP without HCA is a reasonable and safe alternative strategy for patients requiring hemiarch replacement for aneurysmal disease. This technique may provide additional benefits by avoiding circulatory arrest in these complex cases., (© 2024 The Authors. Published by The Texas Heart Institute®.)

Clinical predictors of posttransplant graft loss since the United Network for Organ Sharing (UNOS) heart allocation system change have not been well characterized. Single organ adult heart transplants from the UNOS database were identified (n = 10,252) and divided into a test cohort (n = 6,869, 67%) and validation cohort (n = 3,383, 33%). A Cox regression analysis was performed on the test cohort to identify recipient and donor risk factors for posttransplant graft loss. Based on the risk factors, a score (max 16) was developed to classify patients in the validation cohort into risk groups of low (≤1), mid (2-3), high (≥4) risk. Recipient factors of advanced age, Black race, recipient blood group O, diabetes, etiology of heart failure, renal dysfunction, elevated bilirubin, redo-transplantation, elevated pulmonary artery pressure, transplant with a durable ventricular assist device, or transplant on extracorporeal membrane oxygenation (ECMO) or ventilator were associated with more posttransplant graft loss. Donor factors of ischemic time and donor age were also associated with outcomes. One year graft survival for the low-, mid-, high-risk groups was 94%, 91%, and 85%, respectively. In conclusion, easily obtainable clinical characteristics at time of heart transplant can predict posttransplant outcomes in the current era., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © ASAIO 2023.)

Vein grafts are the most used conduits in coronary artery bypass grafting (CABG), even though many studies have suggested their lower patency compared to arterial alternatives. We have reviewed the techniques and technologies that have been investigated over the years with the aim of improving the quality of these conduits. We found that preoperative and postoperative optimal medical therapy and no-touch harvesting techniques have the strongest evidence for optimizing vein graft patency. On the other hand, the use of venous external support, endoscopic harvesting, vein preservation solution and anastomosis, and graft configuration need further investigation. We have also analyzed strategies to treat vein graft failure: when feasible, re-doing the CABG and native vessel primary coronary intervention (PCI) are the best options, followed by percutaneous procedures targeting the failed grafts.

Transfusions are extremely frequent after cardiac surgery, and they have a considerable economic burden and impact on outcomes. Optimal patient blood management could play a fundamental role in reducing the rate of transfusion and Jehovah's Witnesses (JW) represent the ideal surrogate study population. This meta-analysis compares outcomes of JWs and non-JWs' patients undergoing cardiac surgery, assessing the safety of a bloodless cardiac surgery. A scoping review was conducted using a search strategy for studies assessing outcomes of JW undergoing cardiac surgery. The primary outcome was perioperative mortality, and a random-effects meta-analysis was performed. Ten studies were included in our meta-analysis, involving 780 JW patients refusing any type of transfusion ("JW") and 1182 patients accepting transfusion if needed ("non-JW"). 86% of non-JW patients received at least 1 transfusion. There was no significant difference in terms of perioperative mortality (OR 0.91; 95% CI 0.55-1.52; p = 0.72). The volume blood loss was significantly less in the JW (p = 0.001), while the rate of reoperation for bleeding was also lower, but not statistically significative, in the JW (p = 0.16). Both preoperative and postoperative hemoglobin and hematocrit were significantly higher in the JW. Therefore, we concluded that bloodless cardiac surgery is safe and early outcomes are similar between JW and non-JW patients: optimal patient blood management is fundamental in guarantying these results. Further studies are needed to assess if a limitation of transfusion could have a positive long-term impact on outcomes., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Although surgical ablation has been shown to produce excellent outcomes at follow-up for patients with atrial fibrillation who underwent mitral valve replacement/repair (MVR), this procedure is not commonly performed. Our objective was to conduct a systematic review and meta-analysis to evaluate the outcomes of concomitant surgical ablation during MVR. Three databases were systematically reviewed for randomized clinical trials published by August 2022. The primary outcome was sinus rhythm (SR) at 12 months. Secondary outcomes included SR at discharge and 6 months, all-cause mortality, permanent pacemaker implantation, and stroke and thromboembolic events. A random-effects meta-analysis was performed, calculating odds ratios (ORs) for each outcome. Thirteen studies were included, involving 1,089 patients comparing patients who underwent either isolated MVR ("MVR-only") or concomitant surgical ablation during MVR ("MVR+Ablation"). The odds of SR were significantly higher in the MVR+Ablation group at discharge (OR 9.62, 95% confidence interval [CI] 4.87 to 19.02, I 2  = 55%), at 6-month follow-up (OR 7.21, 95% CI 4.30 to 12.11, I 2  = 34%), and at 1-year follow-up (OR 8.41, 95% CI 5.14 to 13.77, I 2  = 48%). All-cause mortality was not different in the groups, as were stroke and thromboembolic events, whereas the odds of permanent pacemaker implantation were slightly higher in the MVR+Ablation group (OR 1.87, 95% CI 1.11 to 3.17, I 2  = 0%). Concomitant surgical ablation during MVR showed excellent outcomes at short-term follow-up, despite a slightly higher rate of permanent pacemaker implantation. Further studies with longer follow-ups are needed to assess if the SR is maintained over the years., Competing Interests: Declaration of Competing Interest The authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

In June 2021, HVAD System distribution ceased due to observational data demonstrating increased mortality and neurological events compared to another commercial device, and a device malfunction with delay or failure to restart, especially in certain subpopulations. To assess ongoing risk for patients on support following subsequent device recalls, the manufacturer's Intermacs HVAD System 2022 Quarterly Reports were queried to identify mortality and adverse events trends in a contemporary cohort of 3110 primary HVAD implantations since October 2017, stratified by year-of-implant. Mean duration of support was 21 ± 16 months, with 33% alive on original device, 25% transplanted, 6% undergoing device exchange, 4% recovered, and 32% expired. Kaplan-Meier and event-per-patient-year estimates for survival, freedom from device explant, stroke, and pump thrombus were similar across year-of-implant. Following market withdrawal and recent device recalls, there appears to be no increase in mortality, stroke, pump thrombus, or explant for HVAD-supported patients. Quarterly report monitoring is ongoing., (Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Biventricular heart failure remains a clinically challenging condition to manage. Available literature describing the use of durable biventricular assist device (BiVAD) support has numerous limitations hindering the development of useful treatment algorithms. Analysis of BiVAD use within a large multicenter data set is needed to clarify outcomes associated with this therapy., Methods: The Society of Thoracic Surgeons Intermacs database was queried to identify adults aged ≥18 years who received durable circulatory support from January 1, 2010, to December 31, 2220. The data set was divided into the following cohorts: (1) left ventricular assist device (LVAD) only (n = 27,325), (2) LVAD and concurrent right ventricular assist device (RVAD) (n = 1090), and (3) LVAD and sequential RVAD (n = 556). Propensity score matching was used to compare 1-year mortality and adverse events between concurrent (n = 565) and sequential BiVADs (n = 565)., Results: Overall survival within 1 year was significantly worse for the BiVAD cohort compared with the LVAD-only cohort (12-month survival: 50.8% vs 82.6%; log-rank P < .001). In a propensity-matched cohort, patients implanted with a BiVAD concurrently had an improved survival compared with those implanted an LVAD and an RVAD sequentially (12-month survival: 55.8% vs 41.8%; log-rank P < .001). Early (<3 months) adverse event rates were higher among patients receiving sequential BiVADs for bleeding, infection, neurologic dysfunction, and renal dysfunction (P < .01)., Conclusions: After matching for patient and disease characteristics, patients with sequential BiVAD implantation have worse outcomes than patients with concurrent BiVAD implantation., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Since the time of their invention, implantable continuous flow left ventricular assist devices (LVADs) have improved the quality of life and extended survival for patients with advanced heart failure. The decision surgeons and their physician colleagues make with these patients to undergo implantation must come with full understanding of the immediate, short-term, and long-term implications of such a life-changing procedure. The presence of pathology regarding the aortic, mitral, and tricuspid valves introduces particularly complex problems for the surgical treatment strategy. Concomitant valve repair or replacement increases cardiopulmonary bypass and cross clamp times, and could potentially lead to worse outcomes in the perioperative setting. Following perioperative recovery, valvular pathology may worsen or arise de novo given the often drastic immediate physiologic changes in blood flow, septal function, and, over time, ventricular remodeling. Over the past two decades, there has been vast improvement in the device manufacturing, surgical techniques, and medical management surrounding LVAD implantation. Yet, addressing concomitant valvular pathology remains a complex question with no perfect solutions. This review aims to briefly describe the evolution of approach to valvular pathology in the LVAD patient and offer our opinion and treatment rationale., Competing Interests: Conflict of interestThe authors declare no competing interests., (© Indian Association of Cardiovascular-Thoracic Surgeons 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.)

Neointimal hyperplasia and lumen irregularities are major contributors to vein graft failure and the use of VEST (R) should prevent this. In this review, we aim to evaluate the angiographic outcomes of externally supported vein grafts. Medline, Embase and Cochrane Library were systematically reviewed for randomized clinical trials published by August 2022. The primary outcome was graft failure. Secondary outcomes included graft ectasia, intimal hyperplasia area and thickness, and graft nonuniformity. Odds ratios (OR) for dichotomous variables and mean difference (MD) for continuous variables with 95% confidence intervals (CI) were pooled using a fixed-effects model. Three randomized controlled trials with a total of 437 patients were included with follow-up ranging from 1 to 2 years. The odds of graft failure were similar in the 2 groups (OR 1.22; 95%CI 0.88-1.71; I² = 0%). Intimal hyperplasia area [MD -0.77 mm 2 ; 95%CI -1.10 to -0.45; I 2  = 0%] and thickness [MD -0.06 mm; 95% CI -0.08 to -0.04; I 2 =0%] were significantly lower in the VEST group. Fitzgibbon Patency Scale of II or III (representing angiographic conduit nonuniformity; OR 0.67; 95%CI 0.48-0.94; I 2  = 0%) and graft ectasia (OR 0.53; 95%CI 0.32-0.88; I 2  = 33%) were also significantly lower in the VEST group. At short-term follow-up, VEST does not seem to reduce the incidence of graft failure, although it is associated with attenuation of intimal hyperplasia and nonuniformity. Longer angiographic follow-up is warranted to determine whether these positive effects might translate into a positive effect in graft failure and in long-term clinical outcomes., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Left ventricular assist devices (LVADs) have become a mainstay of advanced heart failure therapy. The technical aspects of performing a device implant are nuanced and attention to these details allows for successful therapy with good outcomes. As more patient with heart failure are expected to benefit from mechanical circulatory support, the need for a concise and consistent technique for LVAD implantation is needed. Teaching this procedure is most comprehensible when broken down into separate steps, as with many other procedures. Here, we describe our standard protocol for LVAD implantation, as well as rudimentary outcomes of 6-year experience in our center. We hope this will provide some insight and guidance to centers who are expanding into the field of mechanical circulatory support and can help them form a foundation with which to build their own experience and success., Competing Interests: Conflict of interestThe authors have no competing interests or conflicts of interest to declare that are relevant to the content of this article., (© Indian Association of Cardiovascular-Thoracic Surgeons 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.)

Competing Interests: Disclosure: The authors have no conflicts of interest to report.

RT Cardiac Systems (RTCS, Raleigh, NC) is developing an intravascular percutaneous mechanical circulatory support (pMCS) device drive system for use during high-risk percutaneous coronary intervention and emergent cardiogenic shock. The proprietary pMCS device (US patent 10,780,206) consists of a miniaturized axial flow pump with an integrated motor connected via a short flexible drive system. This novel flexible drive system creates a flexible pump that is advantageous for percutaneous placement and conforming to anatomy. This design also has the benefit of not requiring a continuous external lubrication source. In this article, we present engineering development and feasibility testing of the prototype pMCS system. Computational fluid dynamics (CFD) modeling was performed to evaluate candidate blade set designs (impeller leading and trailing edges, diffuser) and predict hydrodynamic performance and hemolysis risk. Bench testing of candidate lip seal designs (radial interference, durometer, and seal angle) was evaluated for leak rate. Two 16Fr prototype devices were then fabricated and tested in a static mock flow loop. Experimental testing demonstrated 3 L/min flow against 110 mmHg and 4 L/min flow against 80 mmHg, which matched the CFD-predicted hydrodynamic performance. These results demonstrate feasibility of the engineering design and performance of the prototype devices., (Copyright © ASAIO 2023.)

Objective: Postoperative pulmonary complications are a series of disorders that can contribute to respiratory distress and prolonged mechanical ventilation postoperatively. We hypothesise that a liberal oxygenation strategy during cardiac surgery leads to a higher incidence of postoperative pulmonary complications than a restrictive oxygenation strategy., Methods: This study is a prospective, observer-blinded, centrally randomised and controlled, international multicentre clinical trial., Results: After obtaining a written informed consent, 200 adult patients undergoing coronary artery bypass grafting will be enrolled and randomised to receive either restrictive or liberal oxygenation perioperatively. The liberal oxygenation group will receive 1.0 fraction of inspired oxygen throughout the intraoperative period, including during cardiopulmonary bypass. The restrictive oxygenation group will receive the lowest fraction of inspired oxygen required to maintain arterial partial pressure of oxygen between 100 and 150 mmHg during cardiopulmonary bypass and a pulse oximetry reading of 95% or greater intraoperatively, but no less than 0.3 and not higher than 0.80 (other than induction and when the oxygenation goals cannot be reached). When patients are transferred to the intensive care unit, all patients will receive an initial fraction of inspired oxygen of 0.5, and then fraction of inspired oxygen will be titrated to maintain a pulse oximetry reading of 95% or greater until extubation. The lowest postoperative arterial partial pressure of oxygen/fraction of inspired oxygen within 48 hours of intensive care unit admission will be the primary outcome. Postoperative pulmonary complications, length of mechanical ventilation, intensive care unit stay, hospital stay, and 7-day mortality after cardiac surgery will be analysed as secondary outcomes., Conclusion: This is one of the first randomised controlled observer-blinded trials that prospectively evaluates the influence of higher inspired oxygen fractions on early postoperative respiratory and oxygenation outcomes in cardiac surgery patients using cardiopulmonary bypass.

Aims: We analyzed the impact of the revised pediatric heart allocation policy on types of ventricular assist device (VAD) utilization, and waitlist (WL) and post-heart transplant (HT) survival outcomes in congenital heart disease (CHD) versus non-CHD patients before (Era-1) and after (Era-2) pediatric heart allocation policy implementation., Methods: We retrospectively reviewed the UNOS database from December 16, 2011, through March 31, 2021, for patients < 18 years old and listed for primary HT. We compared the differences observed between Era-1 and Era-2., Results: 5551 patients were listed for HT, of whom 2447(44%) were in Era-1 and 3104(56%) were in Era-2. CHD patients were listed as status 1A unchanged, but the number of patients listed as status 1B decreased in Era-2, whereas the number of non-CHD patients listed as status 1A decreased, but status 1B increased. In Era-2 compared to Era-1, both temporary (1% to 4%, p < .001) and durable VAD (13.6% to 17.8%, p < .001) utilization increased, and the transplantation rate per 100-patient years increased in both groups. The median WL period for CHD patients increased marginally from 70 to 71 days (p = .06), whereas for non-CHD patients it decreased from 61 to 54 days (p < .001). Adjusted 90-day WL survival increased from 84% to 88%, p = .016 in CHD, but there was no significant change in non-CHD patients (p = .57). There was no significant difference in 1-year post-HT survival in CHD and non-CHD patients between Era-1 and Era-2., Conclusions: In summary, after the revised heart allocation policy implementation, temporary and durable VAD support increased, HT rate increased, waitlist duration marginally increased in the CHD cohort and decreased in the non-CHD cohort, and 90-day WL survival probability improved in children with CHD without significant change in 1-year post-HT outcomes. Future studies are needed to identify changes to the policy that may further improve the listing criteria to improve WL duration and post-HT survival., (© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

This retrospective study included children aged ≤18 years who had durable ventricular assist devices (VADs) as a bridge to transplantation from the United Network Organ Sharing (UNOS) database between 2011 and 2020. We evaluated 90 day waitlist mortality and 1 year posttransplant mortality after VAD implantation in children stratified by race/ethnicity: Black, White, and Others. The VAD was used in a higher proportion of Black children listed for heart transplantation (HT) (26%) versus Other (25%) versus White (22%); p < 0.01. Black children had Medicaid health insurance coverage (67%) predominantly at the time of listing for HT. There was no significant overall difference in waitlist survival among the three groups supported with VAD at the time of listing (log-rank p = 0.4). On the other hand, the 90 day waitlist mortality after the VAD implantation at listing and while listed was the lowest among Black (6%) compared with White (13%) and Other (14%) ( p < 0.01). The multivariate regression analysis showed that Other race (hazard ratio [HR], 2.29; p < 0.01), Black race (HR, 2.13; p < 0.01), use of mechanical ventilation (HR, 1.72; p = 0.01), and Medicaid insurance (HR, 1.54; p = 0.04) were independently associated with increased 1 year posttransplant mortality. In conclusion, Black children had more access to durable VAD support than White children. The 90 day waitlist mortality was significantly lower in Black children compared with White and Other after VAD implantation. However, Black and Other racial/ethnic children with VAD at transplant had higher 1 year posttransplant mortality than White children. Future studies to elucidate the reasons for these disparities are needed., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © ASAIO 2022.)

Background: Continuous flow left ventricular assist devices have improved outcomes in patients with end-stage heart failure that require mechanical circulatory support. Current devices have an adverse event profile that has hindered widespread application. The EVAHEART®2 left ventricular assist device (EVA2) has design features such as large blood gaps, lower pump speeds and an inflow cannula that does not protrude into the left ventricle that may mitigate the adverse events currently seen with other continuous flow devices., Methods: A prospective, multi-center randomized non-inferiority study, COMPETENCE Trial, is underway to assess non-inferiority of the EVA2 to the HeartMate 3 LVAS when used for the treatment of refractory advanced heart failure. The primary end-point is a composite of the individual primary outcomes: Survival to cardiac transplant or device explant for recovery; Free from disabling stroke; Free from severe Right Heart Failure after implantation of original device. Randomization is in a 2:1 (EVA2:HM3) ratio., Results: The first patient was enrolled into the COMPETENCE Trial in December of 2020, and 25 subjects (16 EVA2 and 9 HM3) are currently enrolled. Enrollment of a safety cohort is projected to be completed by third quarter of 2022 at which time an interim analysis will be performed. Short-term cohort (92 EVA2 subjects) and long-term cohort is expected to be completed by the end of 2023 and 2024, respectively., Conclusions: The design features of the EVA2 such as a novel inflow cannula and large blood gaps may improve clinical outcomes but require further study. The ongoing COMPETENCE trial is designed to determine if the EVA2 is non-inferior to the HM3., (Copyright © 2022 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Disclosure: The authors have no conflicts of interest to report.

Many patients with end-stage heart disease die because of the scarcity of donor hearts. A total artificial heart (TAH), an implantable machine that replaces the heart, has so far been successfully used in over 1,700 patients as a temporary life-saving technology for bridging to heart transplantation. However, after more than six decades of research on TAHs, a TAH that is suitable for destination therapy is not yet available. High complication rates, bulky devices, poor durability, poor biocompatibility and low patient quality of life are some of the major drawbacks of current TAH devices that must be addressed before TAHs can be used as a destination therapy. Quickly emerging innovations in battery technology, wireless energy transmission, biocompatible materials and soft robotics are providing a promising opportunity for TAH development and might help to solve the drawbacks of current TAHs. In this Review, we describe the milestones in the history of TAH research and reflect on lessons learned during TAH development. We summarize the differences in the working mechanisms of these devices, discuss the next generation of TAHs and highlight emerging technologies that will promote TAH development in the coming decade. Finally, we present current challenges and future perspectives for the field., (© 2022. Springer Nature Limited.)

Purpose: Pediatric heart failure patients remain in critical need of a dedicated mechanical circulatory support (MCS) solution as development efforts for specific pediatric devices continue to fall behind those for the adult population. The Inspired Pediatric VAD is being developed as a pediatric specific MCS solution to provide up to 30-days of circulatory or respiratory support in a compact modular package that could allow for patient ambulation during treatment., Methods: Hydrodynamic performance (flows, pressures), impeller/rotor mechanical properties (torques, forces), and flow shear stress and residence time distributions of the latest design version, Inspired Pediatric VAD V3, were numerically predicted and investigated using computational fluid dynamics (CFD) software (SolidWorks Flow Simulator)., Results: Hydrodynamic performance was numerically predicted, indicating no change in flow and pressure head compared to the previous device design (V2), while displaying increased impeller/rotor torques and translation forces enabled by improved geometry. Shear stress and flow residence time volumetric distributions are presented over a range of pump rotational speeds and flow rates. At the lowest pump operating point (3000 RPM, 0.50 L/min, 75 mmHg), 79% of the pump volume was in the shear stress range of 0-10 Pa with < 1% of the volume in the critical range of 150-1000 Pa for blood damage. At higher speed and flow (5000 RPM, 3.50 L/min, 176 mmHg), 65% of the volume resided in the 0-10 Pa range compared to 2.3% at 150-1000 Pa., Conclusions: The initial computational characterization of the Inspired Pediatric VAD V3 is encouraging and future work will include device prototype testing in a mock circulatory loop and acute large animal model., (© 2022. The Author(s) under exclusive licence to Biomedical Engineering Society.)