Pilot Assessment of Platelet Thrombus Area and Contractile Force in Pediatric Congenital Heart Surgery Patients Using a Microfluidic Device.

OBJECTIVES: This work was designed to evaluate maximum platelet contractile force and thrombus area before and after cardiopulmonary bypass (CPB) in pediatric patients having congenital heart disease (CHD) surgery using a microfluidic device. DESIGN: A prospective cohort study was designed. SETTING: The work took place at an academic medical center. PARTICIPANTS: Twenty pediatric CHD patients ≤8 years of age with expected CPB time >30 minutes were enrolled. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Blood was collected at baseline and post-CPB. Maximum platelet contractile force and thrombus area were evaluated in vitro using a microfluidic device (ATLAS PST). Post-CPB samples were supplemented with recombinant von Willebrand factor (rVWF) to explore the impact on contractile force and thrombus area. At baseline, the maximum thrombus area was 0.06 (0.05, 0.07), and the maximum force was 123.3 nN (68.4, 299.5). Linear mixed-effects regression models showed that the maximum thrombus area was larger post-CPB and post-CPB + rVWF compared with pre-CPB (estimated coefficient [Est] = 0.04, p = 0.002; Est = 0.09, p < 0.001, respectively). The maximum thrombus area was also larger post-CPB + rVWF compared with post-CPB (Est = 0.04, p = 0.001). Force was higher post-CPB + rVWF compared with pre-CPB (Est = 173.32, p = 0.044). CONCLUSIONS: In pediatric CHD patients, microfluidic testing demonstrated that platelet thrombus area increased slightly after CPB, while platelet contractile force did not change. In vitro addition of rVWF further increased thrombus area, suggesting augmentation of primary hemostasis. Microfluidic assessment of platelet contractile force and thrombus area in pediatric CHD patients appears feasible and can demonstrate changes after CPB. Further studies are needed to determine its accuracy, clinical utility, and normal values for pediatric patients.

Early Impressions and Adoption of the AtriAmp for Managing Arrhythmias Following Congenital Heart Surgery.

AtriAmp is a new medical device that displays a continuous real-time atrial electrogram on telemetry using temporary atrial pacing leads. Our objective was to evaluate early adoption of this device into patient care within our pediatric intensive care unit (PICU). This is a qualitative study using inductive analysis of semi-structured interviews to identify dominant themes. The study was conducted in a single-center, tertiary, academic 21-bed mixed PICU. The subjects were PICU multidisciplinary team members (Pediatric Cardiac Intensivists, PICU Nurse Practitioners, PICU nurses and Pediatric Cardiologists) who were early adopters of the AtriAmp (n = 14). Three prominent themes emerged: (1) Accelerated time from arrhythmia event to diagnosis and treatment; (2) Increased confidence in the accuracy of providers' arrhythmia diagnosis; and (3) Improvement in the ability to educate providers about post-operative arrhythmias. Providers also noted some learning curves, but none compromised medical care or clinical workflow. Insights from early adopters of AtriAmp signal the need for simplicity and fidelity in new PICU technologies. Our research suggests that such technologies can be pivotal to the support and growth of multi-disciplinary teams, even among those who do not participate in early implementation. Further research is needed to understand when and why novel technology adoption becomes widespread in high-stakes settings.

Concomitant Tricuspid Valve Ring Annuloplasty During Mitral Valve Surgery Versus Mitral Valve Surgery Alone: A Systematic Review and Meta-Analysis.

AIM: Although current guidelines recommend concomitant tricuspid annuloplasty for moderate or greater tricuspid regurgitation (TR) and/or dilated annulus, there remains significant variation in undertaking concomitant tricuspid valve surgery (TVA) across different centres. This meta-analysis aimed to compare the clinical outcomes of concomitant tricuspid valve surgery for patients with moderate or greater TR and/or dilated annulus at the time of mitral valve (MV) surgery. METHOD: A systematic review of the literature using six databases. Eligible studies include comparative studies on TVA concomitant with MV surgery versus MV surgery alone. A meta-analysis was performed on studies reporting outcomes of interest to quantify the effects of concomitant tricuspid ring annuloplasty. RESULTS: Two randomised controlled trials and six cohort studies were included in the analysis. 1,941 patients were included in the analysis, of whom, 1,090 underwent concomitant TVA and 851 underwent MV surgery alone. Pooled analysis demonstrated that there was less progression of moderate/severe TR in the concomitant group (3.0% vs 9.6%; odds ratio [OR] 0.29; 95% confidence interval [CI] 0.13-0.55; p=0.0001). There was no significant difference in in-hospital mortality (3.0% vs 3.8%; OR 0.79; 95% CI 0.47-1.34; p=0.38). The rate of permanent pacemaker implantation was higher in the concomitant group although this did not reach statistical significance (7.6% vs 5.3%; OR 1.30; 95% CI 0.85-1.98; p=0.23). Cardiopulmonary bypass was longer in the concomitant TVA group by 20 minutes (mean difference 13.9-26.0; p<0.00001). CONCLUSIONS: Our study demonstrated that concomitant tricuspid ring annuloplasty at the time of MV surgery is associated with a significantly lower rate of TR progression without increasing the operative mortality. There is a trend towards a higher permanent pacemaker implantation rate although this did not reach statistical significance.

Cardiac Angiosarcoma Presenting as Large Pericardial Effusion With Effusive-Constrictive Pericarditis.

Pericardial angiosarcoma is an extremely rare malignant tumor originating from the endothelial cells of blood vessels within the pericardium. We present a case of a 49-year-old male who presented with symptoms of pericardial effusion and was subsequently diagnosed with pericardial angiosarcoma. This case report highlights the diagnostic challenges and management options associated with this rare entity.

Is preoperative IABP insertion significantly reducing postoperative complication in augmented high-risk coronary artery bypass grafting patients?

BACKGROUND: The aim of this study was to determine whether pre-operative intra-aortic balloon pump (IABP) insertion improves surgical outcomes in high-risk coronary artery bypass grafting (CABG) patients. METHODS: Patients with a EuroSCORE II greater than 1.2% who underwent CABG from 2009 to 2016 were included in the study, while those who utilized intra-operative or post-operative IABP were excluded. The analysis included a total of 2907 patients, with 377 patients undergoing preoperative IABP insertion (EuroSCORE II > 5.018%) and 1198 patients in the non-IABP group before matching; after propensity score matching (PSM), both groups consisted of a matched cohort of 250 patients. RESULTS: 30-day mortality events occurred in 9 (3.6%) non-IABP group and in 12 (4.8%) IABP patients (OR: 1.33 95%CI: 0.52-3.58). Kaplan-Meier survival curve analysis showed no significant differences between the two groups in mortality up to one year after the operation (p = 0.72). On multivariate analysis, IABP usage among the PSM patients was associated with lower 30-day mortality (OR: 0.28, 95%CI: 0.07-0.92, P-value = 0.043), 90-day mortality (OR: 0.26, 95%CI: 0.08-0.78, P-value = 0.022) and reduced risk of developing severe respiratory disorders (OR: 0.10, 95%CI:0.01-0.50, P-value = 0.011). CONCLUSION: Pre-operative IABP use in high-risk patients reduces 30- and 90-day mortality rates, along with a notable decrease in rates of severe respiratory disorders.

The Significance of Systemic Inflammatory Markers in 'New-Onset Atrial Fibrillation' Following Cardiac Surgeries.

Postoperative atrial fibrillation (AF) is a known complication of postoperative morbidity and mortality in cardiac surgery. The purpose of this retrospective study was to look into the association between the incidence of new-onset AF in patients undergoing cardiac surgery and preoperative systemic inflammatory markers. Patients were divided into two groups (Group A: new-onset AF, Group B: no AF) depending on the occurrence of AF in the postoperative period, and a retrospective analysis was performed to look for the association between the incidence of new-onset AF and levels of systemic inflammatory markers. Five hundred patients were enrolled in the study, and the duration was three years. One-hundred and fifty out of 500 patients who underwent cardiac surgeries between 2020 and 2023 had higher levels of preoperative inflammatory markers. The systemic immune inflammation index (SII), neutrophil scores, platelet counts, and C-reactive protein (CRP) levels were examined. Compared to patients without AF (Group B), those who developed AF (Group A) had significantly higher mean levels of CRP (6.2 ± 1.8 mg/L), platelet count (320 ± 50 x109/L), neutrophil scores (4.6 ± 0.9), and SII (650 ± 120) (p<0.05 for all). Higher thresholds of these inflammatory markers were related to a notable increase in the prevalence of AF, with odds ratios showing significantly higher risks associated with raised marker levels. In summary, there was a significant correlation found between an increased risk of new-onset AF after surgery and elevated preoperative inflammatory markers, such as CRP levels, platelet counts, neutrophil scores, and SII. These findings could be used as prognostic markers to identify patients who are more likely to experience postoperative AF. Further prospective studies will be required to analyze their predictive value. Limitations of our study include the relatively small sample size, potential bias from single-institutional data, and the retrospective nature of the study design.

Incidence, Risk Factors and Outcomes of Acute Kidney Injury in Neonates Undergoing Open-heart Surgeries: Single Center Experience.

Background: Incidence and outcomes of acute kidney injury (AKI) among neonates who underwent open-heart surgery are not well highlighted in the literature. We aim to assess the incidence, risk factors, and outcome of AKI among neonates undergoing open-heart surgery. Methods: This is a retrospective cohort study between 2016 and 2021 for all neonates requiring open heart surgery. The cases were divided into 2 groups: the AKI (index) group and the non-AKI (control) group. The two groups were statistically compared for risk factors, needs for dialysis, and outcomes. Results: 100 patients fulfilled the inclusion criteria. Among them, 74 (74%) developed AKI, including 41 (55%), 15 (21%), and 18 (24%) patients in KDIGO stages 1, 2, and 3, respectively. Multivariate analysis comparing both groups demonstrated that low pre-operative creatinine (p = 0.01), prolonged bypass time (p = 0.0004) and high vasoactive inotropic score (VIS), (p = 0.0008) were risk factors for developing AKI post-operatively. Furthermore, in the AKI group, 17 (23%) neonates required renal replacement therapy in the form of peritoneal dialysis. The length of stay was higher in the AKI index group (p = 0.015). Patients who had AKI recovered their kidney function at discharge. There was no difference in mortality between both groups. Conclusion: The AKI occurred in 74% of neonates undergoing open-heart surgery, with 23% of them needing peritoneal dialysis. Low pre-operative creatinine, high VIS score, and prolonged bypass time are potential risk factors for AKI development after neonatal open-heart surgery. AKI may lead to prolonged hospitalization, though most affected patients recovered their normal kidney function at discharge.

Thirty-three-year follow-up of pseudoaneurysm of the mitral-aortic intervalvular fibrosa without surgical treatment: a case report and literature review.

BACKGROUND: Pseudoaneurysm of the mitral-aortic intervalvular fibrosa (PMAIF) is a rare complication of infective endocarditis or aortic valve surgery. Surgical treatment is suggested, but the long-term follow-up of conservative management remains unclear. CASE PRESENTATION: A 33-year follow-up of a patient who developed PMAIF six years after aortic valve replacement is reported. The patient presented to our center with dyspnea, and the echocardiography revealed an ejection fraction of 20% and a PMAIF measuring 7 × 10 mm. Despite being advised to undergo surgery, the patient declined due to fear of surgical outcomes. Consequently, conservative treatment with close observation but without surgery was initiated. During the 33-year follow-up period, the patient did not experience any adverse health effects. CONCLUSION: Surgical intervention should be considered whenever the PMAIF is diagnosed. However, in any case that the surgery was not applicable, conservative management might lead to long-term survival, based on this and similar case reports in the literature.

A comparative analysis of open heart surgery and minimally invasive cardiac surgery in exercise-based cardiac rehabilitation.

BACKGROUND: Historically, the majority of patients admitted to inpatient exercise-based cardiac rehabilitation (EBCR) have undergone open heart surgery (OHS). However, with advances in minimally invasive cardiac surgery (MICS), these patient groups are also increasingly referred for inpatient EBCR. Herein, we aimed to compare the progress of these groups during rehabilitation. METHODS: In this prospective, nonrandomized study, 403 inpatient EBCR patients were recruited from December 2022 until September 2023 and stratified into two groups: OHS, and MICS. Participants completed a 3-4-week certified EBCR program. The primary endpoint was defined as a change in the 6-minute walk test (6MWT). Moreover, a comprehensive panel of quality-of-life (QoL) assessments were performed at admission and discharge. RESULTS: At baseline, patients with OHS were older (66 years [IQR 59 - 72]), more often male (83%), and underwent emergency/urgent procedures more often (20%) than patients with MICS. Furthermore, patients with MICS showed a better 6MWT at admission (426 meters [IQR 336 - 483]) compared to patients with OHS (381 meters [IQR 299 - 453]). While all patients were able to increase the distance in the 6MWT, regression analyses in fully adjusted models showed no difference in improvements between the two groups (ß -5, 95% CI, -26 - 14, p = 0.58). Moreover, during EBCR, we observed significant improvements in all QoL measures in all groups. CONCLUSIONS: In this study, improvements in fitness, as assessed by the 6WMT were observed in all groups. Furthermore, multiple QoL measures improved equally across all groups. These encouraging results emphasize the importance of EBCR.

Open-heart surgery in preterm infants: A single-center experience.

Background: Open-heart surgery is challenging in preterm neonates and infants, and its feasibility in low-resource settings has not been defined. We describe our institutional experience with open-heart surgeries performed on consecutive preterm infants. Materials Methods and Results: This was a single-center retrospective cohort from a tertiary hospital in Southern India and included consecutive preterm neonates (<37 weeks) admitted for open-heart surgery. This report is limited to babies who were <3 months at the surgery. The salient features of the 15 preterm included twin gestation: 7 (46.7%); median gestational age at birth: 35 weeks (28-36 weeks); median corrected gestational age at surgery: 37 weeks (33-40 weeks); birth weight: 1.75 kg (1.0-2.6 kg); weight at surgery: 1.8 kg (1.2-2.9 kg); and small for gestational age: 12 (80%). The heart defects included transposition of the great arteries (7), total anomalous pulmonary venous return (3), large ventricular septal defect (VSD) (1), and VSD with coarctation of the aorta (4). Eleven (73%) were mechanically ventilated preoperatively and five had preoperative sepsis. The mean cardiopulmonary bypass time was 169.7 ± 61.5 min, and cross-clamp time was 99.7 ± 43.8 min. There was no inhospital mortality; one baby expired during follow-up at 1 month. Postoperative mechanical ventilation duration was 126.50 h (84.25-231.50 h), and intensive care unit stay was 13.5 days (9-20.8). The total hospital stay was 39 days (11-95 days). Two children (13.3%) had postoperative sepsis. Conclusion: Through collaborative multidisciplinary management, excellent outcomes are feasible in low-resource environments for selected preterm neonates undergoing corrective open-heart operations.

Sex and Psychosocial Differences in Acute Stress Symptoms Prior to Open-Heart Surgery.

BACKGROUND: Acute stress symptoms can occur while cardiac patients await open-heart surgery (OHS). The distress leads to poor outcomes. This study aimed to investigate the association of sex and psychosocial factors (quality-of-life and character strengths). METHOD: Our study cohort included 481 pre-OHS patients (female 42%; mean age 62 years). Medical indices/factors were obtained from the Society of Thoracic Surgeon's national database. Multiple regression analyses were performed following pre-planned steps and adjusting medical factors. RESULTS: Our findings revealed that sex differences in trauma-related symptoms were associated with poor mental well-being, alongside comorbidities. Both mental well-being and comorbidity factors were directly related to acute stress symptoms, while dispositional optimism had an inverse association with this outcome. CONCLUSION: To improve OHS outcomes, our findings suggest healthcare providers be attentive to pre-OHS acute stress symptoms, pay greater attention to the emotional well-being of their female patients, and develop supportive interventions to enhance personality strengths.

A randomized trial of the inflammatory cytokines levels and the blood transfusion rate between miniaturized tubing group and conventional tubing group in congenital heart disease open heart surgeries.

INTRODUCTION: We aimed to compare the inflammatory cytokines levels of the miniaturized and conventional extracorporeal circuit system. The miniaturized extracorporeal circuit system may be fewer possible inflammation-induced or blood transfusion-related complications. METHODS: We performed a prospective randomized controlled trial (RCT) of 101 patients undergoing congenital heart surgery with CPB (cardiopulmonary bypass, weight ≤15 kg, age ≤2 years). Patients were divided into two different CPB groups randomly by random data form. Blood samples at five different time points and the ultrafiltration fluid before and after CPB were collected in all patients. IL-6, IL-8, and TNF alpha were respectively tested with Abcam ELISA kit. RESULTS: The IL-6 level of blood serum in two groups had no statistical differences between the two groups at all time points. The IL-8 level of blood serum in two groups had no statistical differences right after anesthesia and 5 min after CPB. However, IL-8 level was significantly higher in conventional extracorporeal circuit group than that in miniaturized extracorporeal circuit group at 6 h, 12 h and 24 h after CPB. Blood serum TNF alpha in conventional extracorporeal circuit group was significantly higher at 6 h after CPB than that in miniaturized extracorporeal circuit group. No statistical differences in TNF alpha were found between two groups right after anesthesia and at 5 min after CPB, 12 h and 24 h after CPB. In ultrafiltration fluid, no statistical differences were found in IL-6, IL-8 nor TNF alpha between two groups in all time. No statistical differences were found in ICU (intensive care unit) stay and mechanical ventilation time between the two groups. The blood transfusion rate was significantly lower in miniaturized extracorporeal circuit group. CONCLUSION: Implementing the miniaturized extracorporeal circuit system could decrease the inflammatory cytokines at a certain level. The blood transfusion rate is significantly lower in miniaturized extracorporeal circuit group This indicates the miniaturized extracorporeal circuit system might be a safer CPB strategy with fewer possible inflammation-induced or blood transfusion-related complications.

Primary Cardiac Intimal Sarcoma: Multi-Layered Strategy and Core Role of MDM2 Amplification/Co-Amplification and MDM2 Immunostaining.

Primary cardiac tumours are relatively uncommon (75% are benign). Across the other 25%, representing malignant neoplasia, sarcomas account for 75-95%, and primary cardiac intimal sarcoma (PCIS) is one of the rarest findings. We aimed to present a comprehensive review and practical considerations from a multidisciplinary perspective with regard to the most recent published data in the specific domain of PCIS. We covered the issues of awareness amid daily practice clinical presentation to ultra-qualified management in order to achieve an adequate diagnosis and prompt intervention, also emphasizing the core role of MDM2 immunostaining and MDM2 genetic analysis. An additional base for practical points was provided by a novel on-point clinical vignette with MDM2-positive status. According to our methods (PubMed database search of full-length, English publications from January 2021 to March 2023), we identified three studies and 23 single case reports represented by 22 adults (male-to-female ratio of 1.2; male population with an average age of 53.75 years, range: 35-81; woman mean age of 55.5 years, range: 34-70) and a 4-year-old child. The tumour-related clinical picture was recognized in a matter of one day to ten months on first admission. These non-specific data (with a very low index of suspicion) included heart failure at least NYHA class II, mitral regurgitation and pulmonary hypertension, acute myocardial infarction, ischemic stroke, obstructive shock, and paroxysmal atrial fibrillation. Awareness might come from other complaints such as (most common) dyspnoea, palpitation, chest pressure, cough, asthenia, sudden fatigue, weakness, malaise, anorexia, weight loss, headache, hyperhidrosis, night sweats, and epigastric pain. Two individuals were initially misdiagnosed as having endocarditis. A history of prior treated non-cardiac malignancy was registered in 3/23 subjects. Distant metastasis as the first step of detection (n = 2/23; specifically, brain and intestinal) or during follow-up (n = 6/23; namely, intestinal, brain and bone, in two cases for each, and adrenal) required additional imagery tools (26% of the patients had distant metastasis). Transoesophageal echocardiography, computed tomography (CT), magnetic resonance imagery, and even 18F-FDG positronic emission tomography-CT (which shows hypermetabolic lesions in PCIS) represent the basis of multimodal tools of investigation. Tumour size varied from 3 cm to ≥9 cm (average largest diameter of 5.5 cm). The most frequent sites were the left atrium followed by the right ventricle and the right atrium. Post-operatory histological confirmation was provided in 20/23 cases and, upon tumour biopsy, in 3/23 of them. The post-surgery maximum free-disease interval was 8 years, the fatal outcome was at the earliest two weeks since initial admission. MDM2 analysis was provided in 7/23 subjects in terms of MDM2-positive status (two out of three subjects) at immunohistochemistry and MDM2 amplification (four out of five subjects) at genetic analysis. Additionally, another three studies addressed PCISs, and two of them offered specific MDM2/MDM2 assays (n = 35 patients with PCISs); among the provided data, we mention that one cohort (n = 20) identified a rate of 55% with regard to MDM2 amplification in intimal sarcomas, and this correlated with a myxoid pattern; another cohort (n = 15) showed that MDM2-positive had a better prognostic than MDM2-negative immunostaining. To summarize, MDM2 amplification and co-amplification, for example, with MDM4, CDK4, HMGA3, CCND3, PDGFRA, TERT, KIT, CCND3, and HDAC9, might improve the diagnosis of PCIS in addition to MDM2 immunostaining since 10-20% of these tumours are MDM2-negative. Further studies are necessary to highlight MDM2 applicability as a prognostic factor and as an element to be taken into account amid multi-layered management in an otherwise very aggressive malignancy.

Hybrid Interventions for Pulmonary Vein Stenosis: Leveraging Intraoperative Endovascular Adjuncts in Challenging Clinical Scenarios.

Background: Pediatric pulmonary vein stenosis (PVS) is often progressive and treatment-refractory, requiring multiple interventions. Hybrid pulmonary vein interventions (HPVIs), involving intraoperative balloon angioplasty or stent placement, leverage surgical access and customization to optimize patency while facilitating future transcatheter procedures. We review our experience with HPVI and explore potential applications of this collaborative approach. Methods: Retrospective chart review of all HPVI cases between 2009 to 2023. Results: Ten patients with primary (n = 5) or post-repair (n = 5) PVS underwent HPVI at median age of 12.7 months (range 6.6 months-9.5 years). Concurrent surgical PVS repair was performed in 7/10 cases. Hybrid pulmonary vein intervention was performed on 17 veins, 13 (76%) with prior surgical or transcatheter intervention(s). One patient underwent intraoperative balloon angioplasty of an existing stent. In total, 18 stents (9 bare metal [5-10 mm diameter], 9 drug eluting [3.5-5 mm diameter]) were placed in 16 veins. At first angiography (median 48 days [range 7 days-2.8 years] postoperatively), 8 of 16 (50%) HPVI-stented veins developed in-stent stenosis. Two patients died from progressive PVS early in the study, one prior to planned reintervention. Median time to first pulmonary vein reintervention was 86 days (10 days-2.8 years; 8/10 patients, 13/17 veins). At median survivor follow-up of 2.2 years (2.3 months-13.1 years), 1 of 11 surviving HPVI veins were completely occluded. Conclusions: Hybrid pulmonary vein intervention represents a viable adjunct to existing PVS therapies, with promising flexibility to address limitations of surgical and transcatheter modalities. Reintervention is anticipated, necessitating evaluation of long-term benefits and durability as utilization increases.

Pulmonary artery banding: a 20-year experience at a tertiary care center in a developing country.

Aim: Pulmonary artery banding serves as an important palliative procedure used for the management of several congenital heart lesions. This study aims to describe a 20-year experience of pulmonary artery banding at a tertiary care center in a developing country. Methods: This is a retrospective chart review of patients who underwent pulmonary artery banding over a 20-year period between January 2000 and July 2020 in a tertiary care center in a developing country. Data regarding demographics, indications, diagnosis, echocardiographic findings, postoperative complications, hospital stay, and outcomes were recorded. Results: A total of 143 patients underwent pulmonary artery banding between 2000 and 2020, with a decrease from approximately 15 surgeries per year in 2012 to 1-2 surgeries a year in 2020. At the time of banding, the median age of patients was approximately 90 days [interquartile range, IQR, 30-150 days]. Four patients (2.8%) died during the band placement. No significant association was observed between baseline characteristics or type of heart defect at presentation and postoperative morbidity and mortality. Conclusion: Pulmonary artery banding remains useful in a subset of congenital heart lesions and as a surgical palliation, with relatively low mortality, allowing postponement of total correction to a higher weight. This technique continues to be valuable in developing countries or for heart surgical programs with limited resources.

The Risk Of Waiting Up To One Year For Cardiac Surgery.

INTRODUCTION: Cardiac disease is associated with a risk of death, both by the cardiac condition and by comorbidities. The waiting time for surgery begins with the onset of symptoms and includes referral, completion of the diagnosis and surgical waiting list (SWL). This study was conducted during the COVID-19 pandemic, which affected surgical capacity and patients' morbidities. METHODS: The cohort includes 1914 consecutive adult patients (36.6% women, mean age 67 ±11 years), prospectively registered in the official SWL from January 2019 to December 2021. We analyzed waiting times ranging from 4 days to one year to exclude urgencies and outliers. Priority was classified by the national criteria for non-oncologic or oncology surgery. RESULTS: During the study period, 74% of patients underwent surgery, 19.2% were still waiting, and 4.3% dropped out. Most cases were valvular (41.2%) or isolated bypass procedures (34.2%). Patients were classified as non-priority in 29.7%, priority in 61.8%, and high priority in 8.6%, with significantly different SWL mean times between groups (p<0.001). The overall mean waiting time was 167 ± 135 days. Mortality on SWL was 2.5%, or 1.1 deaths per patient/weeks. There were two mortality independent predictors: age (HR 1.05) and the year 2021 versus 2019 (HR 2.07) and a trend toward higher mortality in priority patients versus non-priority (p=0.065). The overall risk increased with time with different slopes for each year. Using the time limits for SWL in oncology, there would have been a significant risk reduction (p=0.011). CONCLUSION: The increased risk observed in 2021 may be related to the pandemic, either by increasing waiting time or by direct mortality. Since risk stratification is not entirely accurate, waiting time emerges as the most crucial factor influencing mortality, and implementing stricter time limits could have led to lower mortality rates.

The left atrial appendage closure by surgery 2 trial: statistical analysis plan for a randomized multicenter trial exploring if the closure of the left atrial appendage during open-heart surgery reduces stroke irrespective of patients' stroke risk and preoperative atrial fibrillation status.

BACKGROUND: Surgical left atrial appendage (LAA) closure concomitant to open-heart surgery prevents thromboembolism in high-risk patients. Nevertheless, high-level evidence does not exist for LAA closure performed in patients with any CHA2DS2-VASc score and preoperative atrial fibrillation or flutter (AF) status-the current trial attempts to provide such evidence. METHODS: The study is designed as a randomized, open-label, blinded outcome assessor, multicenter trial of adult patients undergoing first-time elective open-heart surgery. Patients with and without AF and any CHA2DS2-VASc score will be enrolled. The primary exclusion criteria are planned LAA closure, planned AF ablation, or ongoing endocarditis. Before randomization, a three-step stratification process will sort patients by site, surgery type, and preoperative or expected oral anticoagulation treatment. Patients will undergo balanced randomization (1:1) to LAA closure on top of the planned cardiac surgery or standard care. Block sizes vary from 8 to 16. Neurologists blinded to randomization will adjudicate the primary outcome of stroke, including transient ischemic attack (TIA). The secondary outcomes include a composite outcome of stroke, including TIA, and silent cerebral infarcts, an outcome of ischemic stroke, including TIA, and a composite outcome of stroke and all-cause mortality. LAA closure is expected to provide a 60% relative risk reduction. In total, 1500 patients will be randomized and followed for 2 years. DISCUSSION: The trial is expected to help form future guidelines within surgical LAA closure. This statistical analysis plan ensures transparency of analyses and limits potential reporting biases. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03724318. Registered 26 October 2018, https://clinicaltrials.gov/study/NCT03724318 . PROTOCOL VERSION: https://doi.org/10.1016/j.ahj.2023.06.003 .