Outcomes associated with absent blood product utilization in Jehovah's witness patients compared to the standard of care in cardiac surgery: A ten-year experience.

INTRODUCTION: For Jehovah's Witness (JW) patients requiring cardiac surgery, various strategies such as preoperative use of erythropoietin stimulating agents (ESAs), intravenous iron (IVI), and non-pharmacologic interventions have emerged to prevent complications from blood loss given transfusion is not acceptable in this population. METHODS: Retrospective case-control of cardiac surgeries performed by the same surgeon between 1/1/2011 and 8/30/2021. JW patients were matched to non-JW who received blood products and non-JW who did not receive blood products on a 1:2:2 basis. Patients were matched on procedure, age, gender, and Society of Thoracic Surgeons morbidity score. Eligible patients were aged >18 years and had a sternotomy procedure. The primary efficacy and safety outcomes included mean hematocrit values perioperatively and thrombotic events. RESULTS: A total of 27 JW, 52 non-JW transfused, and 53 non-JW not transfused patients were included in the analysis. JW patients had significantly higher mean hematocrits at every time point when compared to non-JW transfused patients and at all time points except clinic and the last recorded operating room value when compared to non-JW not transfused patients. No significant differences in thrombotic rates were found between groups, however there was a numerically higher incidence in the JW population (JW: 7.4%; non-JW transfused: 0%; non-JW not transfused: 1.9%; p = .106). CONCLUSION: A blood conservation protocol in a JW population was associated with higher perioperative hematocrit values when compared to matched controls. Further prospective study is warranted before applying similar protocols to other populations given the possibility for an increased rate of venous thromboembolism.

Comparison of Medical Therapy, Valve Surgery, and Percutaneous Mechanical Aspiration for Tricuspid Valve Infective Endocarditis.

BACKGROUND: The opioid pandemic, and particularly injection drug use, has led to an increase in cases of tricuspid valve infective endocarditis. Indications for valve surgery in right-sided infective endocarditis are not well-defined. Percutaneous mechanical aspiration is considered an alternative in patients at high risk for re-infection of a prosthetic valve but lacks robust outcomes data. This retrospective analysis compares the primary outcome of death within 1 year for patients with isolated tricuspid valve infective endocarditis treated with medical therapy alone vs percutaneous mechanical aspiration or valve surgery. METHODS: The authors performed a retrospective cohort study of patients with isolated tricuspid valve infective endocarditis over a 10-year period. Medical record review was performed to collect demographic-and outcomes-related data. The association between treatment group and outcomes was assessed using Cox proportional hazard regression with inverse probability of treatment weighting. RESULTS: Between January 1, 2009, and December 31, 2018, 215 patients with isolated tricuspid valve infective endocarditis and surgical indications were identified. One hundred patients (46.5%) were managed medically, 49 (22.8%) were managed surgically, and 66 (30.7%) underwent percutaneous mechanical aspiration. There was no significant difference in 1-year mortality between the 3 treatment groups (P = .15). Vegetation size > 2.0 cm was associated with increased 1-year mortality (hazard ratio 3.01; P = .03). Addiction medicine consultation was associated with decreased 1-year mortality (hazard ratio 0.117; P = .0008). CONCLUSION: The study highlights that surgery or percutaneous mechanical aspiration in addition to medical therapy does not improve 1-year mortality in patients with isolated tricuspid valve infective endocarditis. Addiction medicine consultation was associated with decreased 1-year mortality in patients with injection drug use-associated isolated tricuspid valve infective endocarditis.

Invasive Candida Infection in Patients With Bacterial Infective Endocarditis.

Over 21 months, 12 patients with invasive Candida infections detected during the course of treatment of bacterial endocarditis, including 11 with candidemia, were identified. Invasive Candida infections can occur as a complication of bacterial endocarditis and may occur more frequently in patients with injection drug use and broad-spectrum antibiotic exposure.

Shared Decision-Making for Partial Oral Antibiotic Treatment of Infective Endocarditis: A Case Series.

Although literature has demonstrated the noninferiority of oral antibiotics in the treatment of infectious endocarditis, widespread adoption of this practice has yet to occur in the United States. We report on 32 patients with infectious endocarditis treated by a multidisciplinary endocarditis team and a standardized approach to partial oral antibiotic therapy with a high rate of clinical success.

Beyond a team: The comprehensive interdisciplinary endocarditis program in the United States.

Although multidisciplinary teams have been shown to decrease in-hospital mortality for patient with infectious endocarditis, most studies have focused on the inpatient role of these teams, and are primarily based at European tertiary care centers. There is limited literature available on the optimal longitudinal care of this patient population. Here we outline our experience developing an interdisciplinary endocarditis program at the University of Kentucky, which cares for patients from their index hospitalization into the outpatient setting, while also coordinating transfers from regional hospitals and offering education to regional providers.

Evaluation of the efficacy and safety of amustaline/glutathione pathogen-reduced RBCs in complex cardiac surgery: the Red Cell Pathogen Inactivation (ReCePI) study-protocol for a phase 3, randomized, controlled trial.

BACKGROUND: Red blood cell (RBC) transfusion is a critical supportive therapy in cardiovascular surgery (CVS). Donor selection and testing have reduced the risk of transfusion-transmitted infections; however, risks remain from bacteria, emerging viruses, pathogens for which testing is not performed and from residual donor leukocytes. Amustaline (S-303)/glutathione (GSH) treatment pathogen reduction technology is designed to inactivate a broad spectrum of infectious agents and leukocytes in RBC concentrates. The ReCePI study is a Phase 3 clinical trial designed to evaluate the efficacy and safety of pathogen-reduced RBCs transfused for acute anemia in CVS compared to conventional RBCs, and to assess the clinical significance of treatment-emergent RBC antibodies. METHODS: ReCePI is a prospective, multicenter, randomized, double-blinded, active-controlled, parallel-design, non-inferiority study. Eligible subjects will be randomized up to 7 days before surgery to receive either leukoreduced Test (pathogen reduced) or Control (conventional) RBCs from surgery up to day 7 post-surgery. The primary efficacy endpoint is the proportion of patients transfused with at least one study transfusion with an acute kidney injury (AKI) diagnosis defined as any increased serum creatinine (sCr) level ≥ 0.3 mg/dL (or 26.5 µmol/L) from pre-surgery baseline within 48 ± 4 h of the end of surgery. The primary safety endpoints are the proportion of patients with any treatment-emergent adverse events (TEAEs) related to study RBC transfusion through 28 days, and the proportion of patients with treatment-emergent antibodies with confirmed specificity to pathogen-reduced RBCs through 75 days after the last study transfusion. With ≥ 292 evaluable, transfused patients (> 146 per arm), the study has 80% power to demonstrate non-inferiority, defined as a Test group AKI incidence increase of no more than 50% of the Control group rate, assuming a Control incidence of 30%. DISCUSSION: RBCs are transfused to prevent tissue hypoxia caused by surgery-induced bleeding and anemia. AKI is a sensitive indicator of renal hypoxia and a novel endpoint for assessing RBC efficacy. The ReCePI study is intended to demonstrate the non-inferiority of pathogen-reduced RBCs to conventional RBCs in the support of renal tissue oxygenation due to acute anemia and to characterize the incidence of treatment-related antibodies to RBCs.

Caught in the Act: A Recurrent Tamponade After Coronary Artery Bypass Grafting With Culprit Lesion Identified on Computed Tomography Angiogram.

Delayed cardiac tamponade after cardiac surgery is a rare complication with significant diagnostic challenges. The recurrence of cardiac tamponade physiology after initial intervention creates another degree of difficulty in the management of already medically complex patients. We present the case of a 65-year-old male who underwent four-vessel coronary artery bypass grafting that was complicated by the delayed presentation of cardiac tamponade requiring mediastinal exploration. Following this he developed a recurrence of cardiac tamponade with bleeding from a vein graft identified on multiphase spiral computed tomography angiography.

Covid-19 positive donor utilization for heart transplantation: The new frontier for donor pool expansion.

BACKGROUND: Hearts from COVID-19 positive donors (CPD) are being utilized for heart transplantation by some centers; however, this is in the setting of the lack of guidelines or robust evidence. The paucity of evidence is reflected in the recent Organ Procurement and Transplantation Network (OPTN) communication describing CPD utilization as an "unknown risk." METHODS AND RESULTS: We analyzed the UNOS database for adult heart transplants performed between January 2021 to December 2022, and CPD comprised of a significant percentage of donors, being used in >10% of recipients in some UNOS regions. Between July 2022 and December 2022, 7.9% of heart transplants were with CPD, and in the same period Hepatitis C positive donors accounted for 7.1% and donation after circulatory death (DCD) accounted for 10.3%. CONCLUSION: If the transplant community comes up with a standardized approach and guidance in using CPD hearts, this could provide an effective donor pool expansion strategy.

Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.

BACKGROUND: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve. METHODS: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin. RESULTS: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P <.001) in the low-dose and standard-dose warfarin groups, respectively. Primary end point rates were 11.9% per patient-year in the low-dose group and 12.0% per patient-year in the standard-dose group (difference, -0.07%; 95% CI, -3.40% to 3.26%). The CI >1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding. CONCLUSIONS: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525).

Patterns and outcomes of COVID-19 donor utilization for heart transplant.

BACKGROUND: The outcomes following COVID-19 positive donor (CPD) utilization for heart transplant are unknown. METHODS: UNOS database was analyzed for heart transplants performed from the declaration of COVID-19 pandemic until September 30, 2022. RESULT: Since the onset of pandemic, there were 9876 heart transplants reported. COVID-19 antigen or NAT results were available in 7698 adult donors within 14 days of donation, of which 177 (2.3%) were positive. There was no difference in recipient demographics, including age (COVID positive donor vs. negative: 55 vs. 56 years, p = .2) and BMI. Listing status 1 and 2 were similar in both groups (7% vs. 10% and 48% vs. 49% respectively, p = .4). Durable and temporary mechanical support were similar in both groups pre-transplant (both groups 33%, p = .9). There was no difference in days on the waitlist (median 31 days, p = .9). Simultaneous renal transplant rates were similar (11% vs. 10%, p = .9). CPD utilization has increased since the onset of the pandemic, and the adoption is present across most UNOS regions. Post-transplant, there was no difference in length of stay (median 16 vs. 17 days, p = .9) and acute rejection episodes prior to discharge (3% vs. 8%, p = .1). In survival analysis of 90-day follow up, number of deaths reported were comparable (5% in both groups, p = .9) Follow-up LVEF was comparable (62% vs. 60%, p = .4). CONCLUSION: Active COVID-19 infection in donors did not affect survival or rejection rates in the short-term post-heart transplant.

Autologous CD133 + Cells and Laser Revascularization in patients with severe Ischemic Cardiomyopathy.

OBJECTIVE: We tested the hypothesis that targeted TMLR combined with intramyocardial injection of autologous CD 133+ progenitor cells is safe and feasible in patients with chronic ischemic cardiomyopathy (ICM) and no revascularization options. METHODS: Eight male patients (age 62 ± 2.4 years) with multivessel severe ischemic heart disease and no revascularization options were enrolled. Autologous CD 133 + endothelial progenitor cells were derived and purified from the bone marrow on the day of surgery using the clinical-grade closed CliniMACS system. Using a lateral thoracotomy approach, TMLR was performed, followed by transmyocardial transplantation of purified CD133 + cells (mean number of transplanted cells: 12.5 × 106) in the region surrounding the TMLR sites. These sites were selected based on ischemia on pre-procedure perfusion imaging. We performed clinical and myocardial perfusion imaging pre-procedure and then at 6- and 12-month follow-up. RESULTS: No major complications or death occurred during the procedure or during the peri-operative hospital stay. One patient died of cardiac cause 6 months post-procedure. There was a reported short-term improvement in anginal and heart failure symptoms and a modest reduction in the ischemic score as assessed by perfusion imaging. CONCLUSIONS: Our phase 1 clinical study examining the combination therapy of targeted transmyocardial laser revascularization therapy and autologous CD133 + endothelial progenitor cells in patients with chronic ICM and no revascularization options demonstrates the feasibility and short-term safety of this combined approach and warrants future larger phase 2 randomized clinical studies.

Paradoxical embolisation in right-sided infective endocarditis and patent foramen ovale.

Intravenous drug use (IVDU) is a growing public health crisis worldwide. A known complication of IVDU is right-sided infective endocarditis (RSIE) involving the tricuspid valve. As the tricuspid valve is burdened with infectious vegetations, it becomes a potential source of pulmonary and, very rarely, paradoxical systemic emboli. We report two patients with RSIE involving the tricuspid valve presenting with acute change in mental status. Subsequent imaging demonstrated embolisation to the brain in the setting of elevated right atrial pressures and the presence of a patent foramen ovale (PFO) with right-to-left shunting. We employed a strategy of percutaneous closure of PFO, to prevent further embolisation, as a successful bridge to definitive surgical management of RSIE. We emphasise that clinicians should evaluate for intracardiac shunting and pursue transesophageal echocardiography when encountering systemic emboli of unknown origin, particularly in patients with RSIE.

Percutaneous Intervention of Cabrol Graft-Left Main Anastomosis.

The Cabrol technique involves surgical reimplantation of coronary arteries after aortic root replacement. It uses a Dacron graft interposed between the aortic root graft and the native coronary artery. A stenosis of the graft-coronary anastomosis requires either surgical or percutaneous correction. An understanding of the Cabrol and modified Cabrol techniques and the associated anatomy is essential for a successful percutaneous intervention. We report a case of percutaneous intervention of a Cabrol graft-left main coronary artery stenosis in a patient who presented with exertional angina.

WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial.

This article has been withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.

Comparison of Bivalirudin Versus Unfractionated Heparin for Anticoagulation in Adult Patients on Extracorporeal Membrane Oxygenation.

Extracorporeal membrane oxygenation (ECMO) contributes to coagulopathy, necessitating systemic anticoagulation to prevent thrombosis. Traditionally, unfractionated heparin (UFH) has been the anticoagulant of choice, however, due to many inadequacies new evidence suggests benefit with the use of direct thrombin inhibitors. This retrospective cohort sought to evaluate the safety and efficacy of bivalirudin compared to UFH in ECMO patients. Primary endpoints included incidence of bleeding and thrombosis. Percent time in therapeutic range (TR), time to achieve TR and number of dose titrations required to maintain TR were calculated to assess efficacy of institutional protocols. Overall incidence of thrombosis was low, with one event in the bivalirudin group and no events in the UFH group. No difference was found in rates of bleeding between groups (6% vs . 10%, P = 0.44). Bivalirudin yielded higher percent time in TR (86% vs. 33%, P < 0.001), faster time to TR (2 vs . 18 hr, P < 0.001) and required fewer dose adjustments to maintain TR (2 vs . 11, P < 0.001) compared to UFH. These results suggest bivalirudin and UFH are associated with similar rates of bleeding and thrombosis in patients requiring ECMO support. Our results demonstrate the favorable pharmacokinetic profile of bivalirudin, and its ability to consistently maintain TR when compared to UFH.

Cardiac surgeons' concerns, perceptions, and responses during the COVID-19 pandemic.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has had an unprecedented impact on health care and cardiac surgery. We report cardiac surgeons' concerns, perceptions, and responses during the COVID-19 pandemic. METHODS: A detailed survey was sent to recruit participating adult cardiac surgery centers in North America. Data regarding cardiac surgeons' perceptions and changes in practice were analyzed. RESULTS: Our study comprises 67 institutions with diverse geographic distribution across North America. Nurses were most likely to be redeployed (88%), followed by advanced care practitioners (69%), trainees (28%), and surgeons (25%). Examining surgeon concerns in regard to COVID-19, they were most worried with exposing their family to COVID-19 (81%), followed by contracting COVID-19 (68%), running out of personal protective equipment (PPE) (28%), and hospital resources (28%). In terms of PPE conservation strategies among users of N95 respirators, nearly half were recycling via decontamination with ultraviolet light (49%), followed by sterilization with heat (13%) and at home or with other modalities (13%). Reuse of N95 respirators for 1 day (22%), 1 week (21%) or 1 month (6%) was reported. There were differences in adoption of methods to conserve N95 respirators based on institutional pandemic phase and COVID-19 burden, with higher COVID-19 burden institutions more likely to resort to PPE conservation strategies. CONCLUSIONS: The present study demonstrates the impact of COVID-19 on North American cardiac surgeons. Our study should stimulate further discussions to identify optimal solutions to improve workforce preparedness for subsequent surges, as well as facilitate the navigation of future healthcare crises.

Cardioplastic Approach to Omental Flap Coverage for Severe Aortic Root Infections in the Opioid Era.

Aortic root abscesses are severe sequelae of endocarditis that clinically manifest as life-threatening infection. As the opioid epidemic continues to yield a national crisis, the incidence and severity of this disease process have increased. Reconstruction of the aortic root is a challenging undertaking and carries the risk of recurrent infection. The omentum has an established reputation as a reliable flap in thoracic reconstruction, given its amorphous form and immunogenic properties, but it has not been utilized for aortic root infections. We present a novel indication for the omental flap using a cardioplastic approach in coverage of aortic root reconstruction. Four patients were treated with pedicled omental flap coverage after aortic root reconstruction. All patients had successful flap healing with no evidence of recurrent infection. This series demonstrates the technical feasibility and clinical utility for providing soft tissue coverage and antimicrobial protection when used in aortic root reconstruction.

Securing the Future for a Major Academic Cardiovascular Program: Hardwiring a Referral Network and Preparing for a Transition to Value-Based Reimbursement.

The University of Kentucky College of Medicine and Albert B. Chandler Hospital opened over 50 years ago to serve Kentucky. After initial growth and expansion, both were struggling clinically, academically, and financially in the early 2000s. Difficulties were apparent in cardiovascular (CV) services, which captured only 11% of the regional patients hospitalized for cardiac disease. Over the next 15 years, CV services dynamically transformed to become the leading provider with a large network of regional partners, garnering 42% of market share. This article describes strategic plans and initiatives leading to clinical and academic growth. Future value-based initiatives are also described.