Relationship between indexed surgery and postcardiotomy extracorporeal life support outcomes.

OBJECTIVES: Veno-arterial extracorporeal life support (V-A ECLS) is increasingly being utilized for postcardiotomy shock (PCS), though data describing the relationship between type of indexed operation and outcomes are limited. This study compared V-A ECLS outcomes across four major cardiovascular surgical procedures. METHODS: This was a single-center retrospective study of patients who required V-A ECLS for PCS between 2015 and 2022. Patients were stratified by the type of indexed operation, which included aortic surgery (AoS), coronary artery bypass grafting (CABG), valve surgery (Valve), and combined CABG and valve surgery (CABG + Valve). Factors associated with postoperative outcomes were assessed using logistic regression. RESULTS: Among 149 PCS patients who received V-A ECLS, there were 35 AoS patients (23.5%), 29 (19.5%) CABG patients, 59 (39.6%) Valve patients, and 26 (17.4%) CABG + Valve patients. Cardiopulmonary bypass times were longest in the AoS group (p < 0.01). Regarding causes of PCS, AoS patients had a greater incidence of ventricular failure, while the CABG group had a higher incidence of ventricular arrhythmia (p = 0.04). Left ventricular venting was most frequently utilized in the Valve group (p = 0.07). In-hospital mortality was worst among CABG + Valve patients (p < 0.01), and the incidence of acute kidney injury was highest in the AoS group (p = 0.03). In multivariable logistic regression, CABG + Valve surgery (odds ratio (OR) 4.20, 95% confidence interval 1.30-13.6, p = 0.02) and lactate level at ECLS initiation (OR, 1.17; 95% CI, 1.06-1.29; p < 0.01) were independently associated with mortality. CONCLUSIONS: We demonstrate that indications, management, and outcomes of V-A ECLS for PCS vary by type of indexed cardiovascular surgery.

Minimally invasive extracorporeal circulation versus conventional cardiopulmonary bypass in patients undergoing cardiac surgery (MiECS): Rationale and design of a multicentre randomised trial.

INTRODUCTION: The ultimate answer to the question whether minimal invasive extracorporeal circulation (MiECC) represents the optimal perfusion technique in contemporary clinical practice remains elusive. The present study is a real-world study that focuses on specific perfusion-related clinical outcomes after cardiac surgery that could potentially be favourably affected by MiECC and thereby influence the future clinical practice. METHODS: The MiECS study is an international, multi-centre, two-arm randomized controlled trial. Patients undergoing elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or combined procedure (CABG + AVR) using extracorporeal circulation will be randomized to MiECC or contemporary conventional cardiopulmonary bypass (cCPB). Use of optimized conventional circuits as controls is acceptable. The study design includes a range of features to prevent bias and is registered at clinicaltrials.gov (NCT05487612). RESULTS: The primary outcome is a composite of postoperative serious adverse events that could be related to perfusion technique occurring up to 30 days postoperatively. Secondary outcomes include use of blood products, ICU and hospital length of stay (30 days) as well as health-related quality of life (30 and 90 days). CONCLUSIONS: The MiECS trial has been designed to overcome perceived limitation of previous trials of MiECC. Results of the proposed study could affect current perfusion practice towards advancement of patient care.

Pain Intensity After Cardiac Surgery and its Association With Kinesiophobia: A Descriptive Study.

PURPOSE: Severe pain and fear of pain may decrease physical activity and restrict movements after cardiac surgery. This study aimed to determine pain intensity after cardiac surgery and its association with kinesiophobia. DESIGN: This was a descriptive and correlational study. METHODS: The study was conducted with cardiac surgery patients (n = 170). The sample size was calculated by using the G*POWER 3.1 program. According to the power analysis, the sample size was calculated as 170, taking into account the dependent variable with the largest sample size (kinesiophobia) and 20% loss. The outcome measures were pain and kinesiophobia collected using the Visual Analog Scale and Tampa Kinesiophobia Scale. FINDINGS: Married patients were at the greatest risk for kinesiophobia, higher than that for single patients (ß = -3.765, ß = -3.609; P < .05). Obese patients were at the greatest risk for kinesiophobia higher when compared to patients of normal weight (ß = -2.907, P < .05). No statistically significant correlation was found between the pain intensity and kinesiophobia scores (P > 0.05). CONCLUSIONS: Kinesiophobia was higher in patients after cardiac surgery. Married and obese patients were predictors of kinesiophobia; however, pain was not associated with kinesiophobia.

Re-sternotomy in complex aortic surgery: careful individualized planning for a safe opening.

An increasing number of patients have required cardiac reoperations in recent decades, and this trend is expected to continue. Hence, re-sternotomy is and will be a common practice in high-volume centres. Re-sternotomy in complex aortic reinterventions carries a high risk of injuring major vascular and heart structures. To avoid catastrophic injuries, preoperative planning and case individualization are essential to minimize complications. Designing a safe and tailored strategy for each patient is believed to have an impact on postoperative outcomes. The arterial cannulation site, the need for hypothermia, left ventricle decompression and the use of an aortic occlusion balloon catheter are some of the preoperative decisions that must be made on a case-by-case basis to ensure adequate brain and visceral perfusion and to minimize major bleeding and circulatory interruption in case of re-entry injury.

Effects and trend of steroid dosage reduction during cardiac surgery: A three-year retrospective analysis at a tertiary medical center.

BACKGROUND: Current adult cardiac surgery guidelines recommend against the routine use of prophylactic intravenous corticosteroids during cardiopulmonary bypass (CPB) due to concerns about myocardial injury, despite their potential to reduce postoperative atrial fibrillation. Traditionally, a high dose of 1,000 mg of methylprednisolone was used to attenuate the inflammatory response associated with CPB. Our institution aligned with guideline recommendations and gradually reduced methylprednisolone dosages; thus, we reevaluated the impact on postoperative clinical outcomes. METHODS: Our study reviewed 1341 cases from a total of 1680 adult cardiac surgeries performed between June 2019 and May 2022 after excluding cases with off-pump procedures, ventricular assist device implantations, heart transplants, and aortic surgeries requiring systemic circulatory arrest. The study timely sorted periods including a baseline data from 2018, and other three periods since 2019 to analyze the effects of three different methylprednisolone dosage: 0 mg, 500 mg, and 1000 mg. We assessed the annual trends in methylprednisolone administration and compared morbidity and mortality rates across the groups. RESULTS: We observed a significant decline in steroid use, with no-steroid surgeries increasing from 23% to 66.5% by period 3. Despite the decreased use of steroids, our study showed no increase in mortality, new-onset atrial fibrillation, acute kidney injury, cerebrovascular event and prolonged ventilation when compared to baseline data. Notably, less surgical site infection rate was observed in the no-steroid group. CONCLUSION: The data indicates that a reduction or discontinuation of steroids during CPB can be performed without compromising patient outcomes. This could support a transition towards a more conservative use of steroids in adult cardiac surgery, aligning with current guidelines, and potentially reducing certain postoperative complications.

Characterization of atrial arrhythmias following mitral valve repair: Incidence and risk factors.

OBJECTIVES: This study aims to investigate the occurrence, type and correlation of early and late atrial arrhythmias following mitral valve repair in patients with no preoperative history of atrial arrhythmias. METHODS: Patients undergoing mitral valve (MV) repair for degenerative disease were included. Early and late postoperative electrocardiograms were evaluated for the incidence and type of atrial arrhythmia (atrial fibrillation [AF] or atrial tachycardia [AT]). RESULTS: The 192 patients were included. Early atrial arrhythmias occurred in 100/192 (52.1%) patients; AF in 61 (31.8%) patients, early AT in 15 (7.8%) and both in 24 (12.5%). In total 89% of patients were discharged in sinus rhythm. During a follow-up time of 7.3 years, 14 patients (7.3%) died and 49 (25.5%) patients developed late atrial arrhythmias. At 10 years, the cumulative incidence of any late atrial arrhythmia, with death as competing risk, was 64% (95% confidence interval [CI] = 55%-72%). On Fine-Gray model analysis, only early postoperative AF lasting >24 h was related to the development of late AF (hazard ratio 5.99, 95% CI = 1.78%-20.10%, p = .004). Early postoperative ATs were related to the development of late tachycardias, independent of their duration (<24 h hazard ratio 4.25, 95% CI = 1.89-9.57, p = .001 and >24 h hazard ratio 3.51, 95% CI = 1.65-7.46, p = .001). CONCLUSIONS: Early and late atrial arrhythmias were common after MV repair surgery. Only early postoperative AF lasting >24 h was a risk factor for the occurrence of late AF. Conversely, any postoperative AT was correlated to the development of late ATs.

Prediction of cardiac surgery associated acute kidney injury using response to loop diuretic and urine neutrophil gelatinase associated lipocalin.

BACKGROUND: Cardiac surgery associated acute kidney injury (CS-AKI) is common. Urine response to loop diuretic and urine neutrophil gelatinase associated lipocalin (uNGAL) are separately associated with CS-AKI. We aimed to determine whether urine response to loop diuretic and uNGAL together were associated with postoperative day 2-4 CS-AKI. METHODS: Two-center prospective observational study (ages 0-18 years). uNGAL (8-12 h after admission) (ng/mL) and urine response to loop diuretic (6 h for bolus furosemide and 12 h for infusion bumetanide) (mL/kg/hr) were measured. All diuretic doses were converted to furosemide equivalents. The primary outcome was day 2-4 CS-AKI. Patients were sub-phenotyped using a priori cutoffs (uNGAL + ≥ 100 ng/mL and UOP + < 1.5 mL/kg/hr) and optimal cutoffs (uNGAL + ≥ 127 ng/mL and UOP + ≤ 0.79 mL/kg/hr): 1) uNGAL-/UOP-, 2) uNGAL-/UOP + , 3) uNGAL + /UOP-, and 4) uNGAL + /UOP + . Multivariable regression was used to assess the association of uNGAL, UOP and each sub-phenotype with outcomes. RESULTS: 476 patients were included. CS-AKI occurred in 52 (10.9%). uNGAL was associated with 2.59-fold greater odds (95%CI: 1.52-4.41) of CS-AKI. UOP was not associated with CS-AKI. Compared with uNGAL + alone, uNGAL + /UOP + improved prediction of CS-AKI using a priori and optimal cutoffs respectively (AUC 0.70 vs. 0.75). Both uNGAL + /UOP + (IQR OR:4.63, 95%CI: 1.74-12.32) and uNGAL + /UOP- (IQR OR:5.94, 95%CI: 2.09-16.84) were associated with CS-AKI when compared with uNGAL-/UOP-. CONCLUSIONS: uNGAL is associated with CS-AKI. The sub-phenotype association was largely driven by uNGAL. Future studies standardizing diuretic dose and timing may be needed to refine the combined performance for clinical decision making.

Levosimendan: A New Therapeutical Strategy in Patients with Renal Insufficiency.

Levosimendan, a Ca2 + sensitizer with positive inotropic effects, is primarily employed for the short-term treatment of acute decompensated heart failure (ADHF). Levosimendan exerts renal function protection through various mechanisms, including anti-apoptosis, anti-inflammatory, and antioxidant effects in vivo. Additionally, levosimendan may have a protective effect on individuals with heart failure and renal insufficiency, as well as on renal function impairment after cardiac surgery. However, the application of levosimendan in patients with severe renal dysfunction remains controversial. This article delves into the use of levosimendan in severe renal insufficiency, explores its impact on renal function, and provides a comprehensive overview of its impact on renal function after cardiac surgery.

The analgesic effects of combined bilateral parasternal block and serratus anterior plane block for coronary artery bypass grafting surgery.

BACKGROUND: Severe pain occurs after cardiac surgery in the sternum and chest tubes sites. Although analgesia targeting the sternum is often prioritized, the analgesia of the drain site is sometimes overlooked. This study of patients undergoing coronary artery bypass grafting (CABG) aimed to provide optimized analgesia for both the sternum and the chest tubes area by combining parasternal block (PSB) and serratus anterior plane block (SAPB). METHODS: Ethics committee approval (E.Kurul-E2-24-6176, 07/02/2024) was received for the study. Then, the trial was registered on www. CLINICALTRIALS: gov ( https://clinicaltrials.gov/ ) under the identifier NCT05427955 on 17/03/2024. Twenty patients between the ages of 18-80, with ASA physical status classification II-III, undergoing coronary artery bypass grafting CABG with sternotomy, were included. While the patients were under general anesthesia, PSB was performed through the second and fourth intercostal spaces, and SAPB was performed over the sixth rib. The primary outcome was VAS (Visual Analog Scale) during the first 12 h after extubation. The secondary outcomes were intraoperative remifentanil consumption and block-related side effects. RESULTS: The average age of the patients was 64 years. Five patients were female, and 15 were male. For the sternum area, only one patient had resting VAS scores of 4, while the VAS scores for resting for the other patients were below 4. For chest tubes area, only two patients had resting VAS scores of 4 or above, while the resting VAS scores for the other patients were below 4. The patients' intraoperative remifentanil consumption averaged 2.05 mg. No side effects related to analgesic protocol were observed in any of the patients. CONCLUSIONS: In this preliminary study where PSB and SAPB were combined in patients undergoing CABG, effective analgesia was achieved for the sternum and chest tubes area.

A case of anaphylactic shock to human fibrinogen infusion during cardiac surgery.

Human fibrinogen (FIB) has been clinically proven to be considerably effective for the treatment of postoperative bleeding, with reported cases of allergic reactions to human FIB being rare. Here, we report a case of an anaphylactic shock in 27-year-old patients with rheumatic heart valve disease who received a human FIB infusion during mitral valve replacement, aortic valve replacement, and tricuspid valve-shaping surgery. The patients showed generalised profuse sweating, a barely noticeable skin rash, faint pulse, systolic pressure < 50 mmHg, and a heart rate of 71 beats/min. We share insights from a case of severe allergy to human FIB infusion during cardiac surgery, through which we have gained experience in the processes of diagnosing and treating. This report aims to provide a preliminary summary of the characteristics of this case to serve as a reference for fellow clinicians.

Nurse Practitioner and Physician Assistant-led Cardiovascular Surgery Postoperative Intensive Care Unit Staffing Model.

OBJECTIVES: To determine whether a nurse practitioner and physician assistant (NP/PA)-led rapid staffing. Model in the cardiac surgical intensive care unit (ICU) can optimize resource utilization without compromising safety or increasing hospital length of stay (LoS). DESIGN: Retrospective observational cohort study comparing before-and-after implementation of an NP/PA-led rapid recovery pathway. SETTING: A large tertiary referral academic cardiac surgery ICU. PARTICIPANTS: There were 116 patients in the prerapid recovery cohort and 153 in the postimplementation rapid recovery phase. INTERVENTIONS: Low-risk cardiac surgery patients were selected for postoperative care by an NP/PA-led ICU staffing model. MEASUREMENTS AND MAIN RESULTS: Mean hospital LoS in the prerapid recovery cohort was 5.7 days compared to 5.2 days in the rapid recovery pathway cohort (P = .02). Thirty-day hospital readmission in the prerapid recovery pathway cohort was 7.8% compared with 2.0% in the rapid recovery cohort (P = .04). The ICU readmission rate for prerapid recovery cohort was 4.3%, while the rapid recovery percentage was 2.0% (P = .30). CONCLUSIONS: Overall, implementation of an NP/PA-led postcardiac surgical ICU team (rapid recovery pathway) was associated with similar ICU LoS, hospital LoS, ICU readmission rates, 30-day readmission rates, and no significant signal of increased adverse events or safety concerns.

Kinetics of Renin Concentrations in Infants Undergoing Congenital Cardiac Surgery.

BACKGROUND: Elevated renin has been shown to predict poor response to standard vasoactive therapies and is associated with poor outcomes in adults. Similarly, elevated renin was associated with mortality in children with septic shock. Renin concentration profiles after pediatric cardiac surgery are unknown. The purpose of this study was to characterize renin kinetics after pediatric cardiac surgery. METHODS: Single-center retrospective study of infants who underwent cardiac surgery with cardiopulmonary bypass (CPB) utilizing serum samples obtained in the perioperative period to measure plasma renin concentrations (pg/mL). Time points included pre-bypass and 1, 4, and 24 h after initiation of CPB. RESULTS: Fifty patients (65% male) with a median age 5 months (interquartile range (IQR) 3.5, 6.5) were included. Renin concentrations peaked 4 h after CPB. There was a significant difference in preoperative and 4 h post-CPB renin concentration (4 h post-CPB vs preoperative: mean difference 100.6, 95% confidence interval (CI) 48.9-152.4, P < .001). Median renin concentration at 24 h after CPB was lower than the preoperative baseline. CONCLUSIONS: We describe renin kinetics in infants after CPB. Future studies based on these data can now be performed to evaluate the associations of elevated renin concentrations with adverse outcomes.

Cardiopulmonary Bypass Blood Flow Rates and Major Adverse Kidney Events in Cardiac Surgery: A Propensity Score-adjusted Before-After Study.

OBJECTIVES: Cardiac surgery associated-acute kidney injury is a common and serious postoperative complication of cardiac surgery, which is associated with increased postoperative morbidity and mortality. This study aimed to explore the association between cardiopulmonary bypass (CPB) blood flow rate (BFR), and major adverse kidney events (MAKEs) at day 30. DESIGN: Retrospective single-center before-after observational study. Patients were divided in 2 groups according to CPB flow rates: a first group with an institutional protocol targeting a CPB-BFR of >2.2 L/min/m² (low CPB-BFR group), and a second group with a modified institutional protocol targeting a CPB-BFR of >2.4 L/min/m² (high CPB-BFR group). The primary outcome was MAKE at 30 days, defined as the composite of death, renal replacement therapy or persistent renal dysfunction. SETTING: The data were collected from clinical routines in university hospital. PARTICIPANTS: Adult patients who underwent elective and urgent cardiac surgery without severe chronic renal failure, for whom CPB duration was ≥90 minutes. INTERVENTIONS: We included 533 patients (low CPB-BFR group, n = 270; high CPB-BFR group, n = 263). MEASUREMENTS AND MAIN RESULTS: A significant decrease in MAKE at 30 days was observed in the high CPB-BFR group (3% v 8%; odds ratio [OR], 0.779; 95% confidence interval [CI], 0.661-0.919; p < 0.001) mainly mediated by a lower 30-day mortality in the high CPB-BFR group (1% v 5%; OR, 0.697; 95% CI, 0.595-0.817; p = 0.001), as was renal replacement therapy (1% v 4%; OR, 0.739; 95% CI, 0.604-0.904; p = 0.016). CONCLUSIONS: In patients undergoing cardiac surgery, increased CPB-BFR was associated with a decrease in MAKE at 30 days including mortality and renal replacement therapy.

Racial and Ethnic Disparities in Peri-and Post-operative Cardiac Surgery.

Purpose of Review: Despite efforts to curtail its impact on medical care, race remains a powerful risk factor for morbidity and mortality following cardiac surgery. While patients from racial and ethnic minority groups are underrepresented in cardiac surgery, they experience a disproportionally elevated number of adverse outcomes following various cardiac surgical procedures. This review provides a summary of existing literature highlighting disparities in coronary artery bypass surgery, valvular surgery, cardiac transplantation, and mechanical circulatory support. Recent Findings: Unfortunately, specific causes of these disparities can be difficult to identify, even in large, multicenter studies, due to the complex relationship between race and post-operative outcomes. Current data suggest that these racial/ethnic disparities can be attributed to a combination of patient, socioeconomic, and hospital setting characteristics. Summary: Proposed solutions to combat the mechanisms underlying the observed disparate outcomes require deployment of a multidisciplinary team of cardiologists, anesthesiologists, cardiac surgeons, and experts in health care equity and medical ethics. Successful identification of at-risk populations and the implementation of preventive measures are necessary first steps towards dismantling racial/ethnic differences in cardiac surgery outcomes.

Comparison of 4% Albumin and Ringer's Acetate on Hemodynamics in On-pump Cardiac Surgery: An Exploratory Analysis of a Randomized Clinical Trial.

OBJECTIVES: Compare hemodynamics between 4% albumin and Ringer's acetate. DESIGN: Exploratory analysis of the double-blind randomized ALBumin In Cardiac Surgery trial. SETTING: Single-center study in Helsinki University Hospital. PARTICIPANTS: We included 1,386 on-pump cardiac surgical patients. INTERVENTION: We used 4% albumin or Ringer's acetate administration for cardiopulmonary bypass priming, volume replacement intraoperatively and 24 hours postoperatively. MEASUREMENTS AND MAIN RESULTS: Hypotension (time-weighted average mean arterial pressure of <65 mmHg) and hyperlactatemia (time-weighted average blood lactate of >2 mmol/L) incidences were compared between trial groups in the operating room (OR), and early (0-6 hours) and late (6-24 hours) postoperatively. Associations of hypotension and hyperlactatemia with the ALBumin In Cardiac Surgery primary outcome (≥1 major adverse event [MAE]) were studied. In these time intervals, hypotension occurred in 118, 48, and 17 patients, and hyperlactatemia in 313, 131, and 83 patients. Hypotension and hyperlactatemia associated with MAE occurrence. Hypotension did not differ between the groups (albumin vs Ringer's: OR, 8.8% vs 8.5%; early postoperatively, 2.7% vs 4.2%; late postoperatively, 1.2% vs 1.3%; all p > 0.05). In the albumin group, hyperlactatemia was less frequent late postoperatively (2.9% vs 9.1%; p < 0.001), but not earlier (OR, 22.4% vs 23.6%; early postoperatively, 7.9% vs 11.0%; both p > 0.025 after Bonferroni-Holm correction). CONCLUSIONS: In on-pump cardiac surgery, hypotension and hyperlactatemia are associated with the occurrence of ≥1 MAE. Compared with Ringer's acetate, albumin did not decrease hypotension and decreased hyperlactatemia only late postoperatively. Albumin's modest hemodynamic effect is concordant with the finding of no difference in MAEs between albumin and Ringer's acetate in the ALBumin In Cardiac Surgery trial.

Periareolar minimally invasive approach for cardiac surgery: a case series and description of technique with a review of literature.

BACKGROUND: Minimally invasive cardiac surgery (MICS) has garnered significant attention for its potential benefits, including decreased surgical trauma, accelerated recovery, and improved aesthetic outcomes. This case series aims to elucidate the technical aspects and assess the aesthetic, functional, and quality of life outcomes associated with the utilization of a periareolar incision approach in female patients undergoing cardiac surgery. METHODS: The periareolar MICS technique, performed with or without high-definition (HD) 3D endoscopic visualization, limited rib-spreading, and a periareolar incision spanning the 3 to 9 o'clock positions, was employed. We present a case series encompassing five female patients who underwent various cardiac procedures for different pathologies using this approach. RESULTS: No intraoperative complications occurred, and all patients experienced uneventful postoperative recoveries. The periareolar approach resulted in well-healed incisions with minimal scaring, preserving breast contour and yielding satisfactory cosmetic outcomes. Patients reported negligible pain levels and expressed contentment with the scar appearance. CONCLUSION: The periareolar incision technique in MICS represents an efficacious approach characterized by favorable aesthetic outcomes and enhanced patient experience. Further investigations are warranted to compare different MICS approaches with respect to pain management and their impact on quality-of-life domains.

Effects of red blood cell transfusion on patients undergoing cardiac surgery in Queensland - a retrospective cohort study.

BACKGROUND: Packed red blood cell (pRBC) transfusion is a relatively safe and mainstay treatment commonly used in cardiac surgical patients. However, there is limited evidence on clinical effects of transfusing blood nearing end-of shelf life that has undergone biochemical changes during storage. OBJECTIVE: To investigate evidence of associations between morbidity/mortality and transfusion of blood near end of shelf-life (> 35 days) in cardiac surgical patients. METHODS: Data from the Queensland Health Admitted Patient Data Collection database 2007-2013 was retrospectively analysed. Coronary artery bypass graft and valvular repair patients were included. Multivariable logistic regression was used to examine the effect of pRBC age (< 35 days vs. ≥ 35 days) on in-hospital mortality and morbidity. As secondary analysis, outcomes associated with the number of pRBC units transfused (≤ 4 units vs. ≥ 5 units) were also assessed. RESULTS: A total of 4514 cardiac surgery patients received pRBC transfusion. Of these, 292 (6.5%) received pRBCs ≥ 35 days. No difference in in-hospital mortality or frequency of complications was observed. Transfusion of ≥ 5 units of pRBCs compared to the ≤ 4 units was associated with higher rates of in-hospital mortality (5.6% vs. 1.3%), acute renal failure (17.6% vs. 8%), infection (10% vs. 3.4%), and acute myocardial infarction (9.2% vs. 4.3%). Infection carried an odds ratio of 1.37 between groups (CI = 0.9-2.09; p = 0.14) and stroke/neurological complications, 1.59 (CI = 0.96-2.63; p = 0.07). CONCLUSION: In cardiac surgery patients, transfusion of pRBCs closer to end of shelf-life was not shown to be associated with significantly increased mortality or morbidity. Dose-dependent differences in adverse outcomes (particularly where units transfused were > 4) were supported.

Unmet need for heart transplantation in Africa.

Heart transplantation is a critical treatment option for end-stage heart failure patients, offering a lifeline for those with severe cardiac conditions. However, in Africa, the unmet need for heart transplantation is a significant issue that poses challenges to the healthcare system and patient outcomes. Africa faces multiple barriers to heart transplantation, including limited infrastructure, a shortage of skilled healthcare professionals, a lack of funding, and inadequate organ donation systems. These challenges result in a considerable gap between the demand for heart transplants and the available resources to meet this need. As a result, many patients in Africa do not have access to life-saving heart transplantation procedures, leading to high mortality rates among those awaiting transplants. Addressing the unmet need for heart transplantation in Africa requires a multifaceted approach. The authors recommend that Africa as a continent build up a heart transplantation workforce involving a multidisciplinary team that consists of transplant surgeons, transplant physicians, nurses, anesthetists, pharmacists, etc. Heart transplant education and training programs should be well-constructed to ensure the delivery of safe and effective transplantation services. International collaborations have proven to be effective and should be encouraged between African institutions and transplant centers worldwide to facilitate knowledge transfer. Foreign and local organizations should promote public awareness about organ donation to address the myths about heart transplantation and promote heart donation. With these, African countries can improve access to heart transplantation, enhance patient outcomes, save lives in the region, and ultimately reduce the mortality rate in Africa.

Predictors of premature termination of cardiac surgery trials: insights from the clinicaltrial.gov database.

OBJECTIVES: Clinical trials that are terminated prematurely may generate incomplete and potentially biased data and the reasons for premature trials termination are poorly understood. Our objective was to describe the incidence of premature trial termination and identify factors associated with it. METHODS: We performed a systematic search on ClinicalTrials.gov to identify all cardiac surgery trials from 1991 to 2023. Trials that were terminated prematurely were identified. Factors independently associated with premature termination were identified using multivariable logistic regression analysis. RESULTS: A total of 746 clinical trials were included; of them 577 were completed and 169 (22.6%) were terminated prematurely. Most of the trials originated from North America (294 [39.4%]), Europe (264 [35.4%]) or Asia (141 [18.9%]). Fourteen of the trials terminated prematurely (8.3%) were phase 1, 75 (44.4%) phase 2, 49 (29.0%) phase 3, and 31 (18.3%) phase 4. Fifty (29.6%) trials were terminated because of slow recruitment, 20 (11.8%) because of sponsor decision and 12 (7.1%) because lack of funding. Left ventricular assist device (LVAD) trials (odds ratio [OR] 3.65, 95% CI: [1.65-8.00] P = 0.001), valve surgery trials (OR 4.30, 95% CI: [2.33-8.00] P < 0.001), aortic surgery trials (OR 2.86 95% CI [1.22-6.43] P = 0.012), Phase 2 (OR 3.02, 95% CI [1.31-7.93] P = 0.015) and phase 4 trials (OR 3.62, 95% CI: [1.43-10.23] P = 0.010) were at higher risk of premature termination while trials performed in Asia (OR 0.18, 95% CI [0.07-0.39] P ≤ 0.001) and Europe (OR 0.49, 95% CI: [0.30-0.80] P = 0.004) were less likely to be terminated prematurely. CONCLUSIONS: Slow recruitment is the most common reason for premature termination of cardiac surgery trials. Trials on LVAD, valve surgery, aortic surgery, phase 2 trials and phase 4 trials are more likely to be terminated, while trials conducted in Asia and Europe are less likely to be terminated prematurely.