Transcatheter Aortic Valve Implantation in Low-Risk Tricuspid or Bicuspid Aortic Stenosis: The NOTION-2 Trial.

BACKGROUND AND AIMS: Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤ 75 years of age, including both tricuspid and bicuspid AS. METHODS: The NOTION-2 trial enrolled and 1:1 randomized low-risk patients aged ≤ 75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke or rehospitalization (related to the procedure, valve or heart failure) at 12 months. RESULTS: A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group (absolute risk difference 3.1%; 95% confidence interval [CI], -2.7% to 8.8%; hazard ratio (HR) 1.4, 95% CI: 0.7 to 2.9; p=0.3). Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation and moderate-or-greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0, 95% CI: 0.5 to 2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8, 95% CI: 0.8 to 18.5) treated with TAVI or surgery, respectively (P for interaction=0.1). CONCLUSIONS: Among low-risk patients aged ≤ 75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at one year was similar between TAVI and surgery. TAVI outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134).

Mitral Valve Segmentation and Tracking from Transthoracic Echocardiography Using Deep Learning.

OBJECTIVE: Valvular heart diseases (VHDs) pose a significant public health burden, and deciding the best treatment strategy necessitates accurate assessment of heart valve function. Transthoracic echocardiography (TTE) is the key modality to evaluate VHDs, but the lack of standardized quantitative measurements leads to subjective and time-consuming assessments. We aimed to use deep learning to automate the extraction of mitral valve (MV) leaflets and annular hinge points from echocardiograms of the MV, improving standardization and reducing workload in quantitative assessment of MV disease. METHODS: We annotated the MV leaflets and annulus points in 2931 images from 127 patients. We propose an approach for segmenting the annotated features using Attention UNet with deep supervision and weight scheduling of the attention coefficients to enforce saliency surrounding the MV. The derived segmentation masks were used to extract quantitative biomarkers for specific MV leaflet scallops throughout the heart cycle. RESULTS: Evaluation performance was summarized using a Dice score of 0.63 ± 0.14, annulus error of 3.64 ± 2.53 and leaflet angle error of 8.7 ± 8.3°. Leveraging Attention UNet with deep supervision robustness of clinically relevant metrics was improved compared with UNet, reducing standard deviations by 2.7° (angle error) and 0.73 mm (annulus error). We correctly identified cases of MV prolapse, cases of stenosis and healthy references from a clinical material using the derived biomarkers. CONCLUSION: Robust deep learning segmentation and tracking of MV morphology and motion is possible by leveraging attention gates and deep supervision, and holds promise for enhancing VHD diagnosis and treatment monitoring.

The importance of concomitant mitral regurgitation for estimates of mitral valve area by pressure half time in patients with chronic rheumatic heart disease.

AIMS: Aim was to study how concomitant mitral regurgitation (MR) assessed by qualitative and quantitative methods influence mitral valve area (MVA) calculations by the pressure half time method (MVAPHT) compared to reference MVA (planimetry) in patients with rheumatic heart disease. METHODS AND RESULTS: In 72 patients with chronic rheumatic heart disease, MVAPHT was calculated as 220 divided by the pressure half time of the mitral early inflow Doppler spectrum. Direct measurement by planimetry was used as reference MVA and was mean (SD) 0.99 (0.69-1.99) cm2. Concomitant MR was present in 82%. MR severity was assessed qualitatively in all, semi-quantitatively by measuring the vena contracta width in 58 (81%), and quantitatively by calculation of the regurgitant volume in 28 (39%). MVA was significantly underestimated by MVAPHT, with increasing MR. In regression analyses MVAPHT underestimated MVA by 0.19 cm2 per higher grade of MR severity in qualitative assessment, and by 0.12-0.13 cm2 per mm larger vena contracta width and 10 ml larger regurgitant volume, respectively. The presented associations were more evident when i) MR severity was quantified compared to qualitative assessment and ii) reference measurements were made by three-dimensional transoesophageal recordings compared to transthoracic recordings. CONCLUSION: MVAPHT underestimated mitral valve area compared to planimetry in patients with MS and concomitant MR. This study highlights the importance of taking the MR severity into account when evaluating MVA based on the PHT method. Direct measurements should be included in clinical decision making.

The Zanzibar Heart Survey: A special report from a humanitarian cardiology program at the Mnazi Mmoja referral hospital, Zanzibar, United Republic of Tanzania by Haukeland University Hospital in Bergen, Norway.

A Norwegian cardiology delegation comprised of Cardiologists and Researchers travelled voluntarily to Zanzibar to undertake 4 humanitarian missions in 2022. The principal aims of this were to: 1) Train local cardiologists in transthoracic echocardiography and perform echocardiographic screening in patients with cardiac symptoms who had not undergone any prior cardiac imaging, 2) Conduct a hypertension survey to improve awareness, treatment and control of hypertension and 3) Implant permanent pacemakers in patients with significant bradyarrhythmias for the first time in the Archipelago. The current report details our experience at the Mnazi Mmoja Referral Hospital. We describe the challenges in managing common cardiovascular conditions such as hypertension, cardiomyopathies, coronary artery disease and rhythm disturbances. Furthermore, we propose that improvement to care may be achieved by implementing systematic access to echocardiography and hypertension services to the island. In our survey, we found that hypertension and hypertension-mediated target organ damage were highly prevalent and hypertension was poorly controlled in Zanzibar. The common reasons for poor BP control were reported to be partly the issue of cost, affordability and availability of antihypertensive medications, and partly due to lack of awareness. Women were on average 10 years younger than men and were more likely to be obese, while men had higher burden of established cardiovascular disease (CAD, stroke, chronic kidney disease, and atrial fibrillation). Humanitarian healthcare missions by Western countries provide invaluable contributions to the healthcare of patients elsewhere in the world. Although their impact can be felt immediately, there is the propensity for these benefits to dissipate rapidly following the departure of visiting delegations. There is a need for more sustainable solutions whereby local healthcare systems are empowered to develop their own local capacities and initiate a system whereby local training can occur, the utilisation of facilities can be maximised and new skills can be transferred to health care practitioners to ensure universal access to diagnostics and treatments of cardiovascular diseases in Zanzibar. Our report indicates that measurable changes can be achieved in a relatively short time frame. These may in turn translate to improvements in access and quality of healthcare to the local population.

The influence of socio-demographic and clinical factors on sick leave and return to work after open-heart surgery: a nationwide registry-based cohort study.

AIMS: To estimate sick leave (SL) duration after first-time elective open-heart surgery and identify factors contributing to increased SL. METHODS AND RESULTS: A retrospective nationwide cohort study combined data from the Norwegian Register for Cardiac Surgery and SL data from the Norwegian Labour and Welfare Administrations. All able-bodied adults who underwent first-time elective open-heart surgery in Norway between 2012 and 2021 were followed until one year after surgery. The impact of socio-demographic and clinical factors on SL after surgery was analysed using logistic regression and odds ratios. Of 5456 patients, 1643 (30.1%), 1798 (33.0%), 971 (17.8%), 1035 (18.9%), and 9 (0.2%) had SL of <3, 3-6, 6-9, and 9-12 months, and one year, respectively. SL > 6 months was associated with female gender, primary education only, and average annual income. Postoperative stroke, postoperative renal failure, New York Heart Association Functional Classification system (NYHA) score > 3, earlier myocardial infarction, and diabetes mellitus increased the odds of SL > 6 months. CONCLUSION: This study demonstrates that socio-demographic and clinical factors impact SL after first-time elective open-heart surgery. Patients who experience a stroke or develop renal failure after surgery have the highest odds of SL > 6 months. Females and patients with low education levels, earlier myocardial infarction, or NYHA scores III-IV have a twofold chance of SL > 6 months. The findings allow for future investigations of pre- and post-surgery interventions that can most effectively reduce SL and aid return to work.

The association between perception of noise from a mechanical heart valve and symptoms of anxiety and depression.

AIM: Patients with symptomatic aortic valve stenosis are efficiently treated by aortic valve replacement (AVR), using a biological or mechanical valve. For some patients with mechanical valves, the metallic clicking sound may be problematic. The aim of this study was to investigate the perceived disturbance from the sound of a mechanical valve and the association between noise perception and symptoms of anxiety and depression. METHODS: and results: The study had a cross-sectional design. In April 2013, all patients who had undergone AVR at one university hospital during the period 2000-2012 were invited by post to participate. The primary variables were assessed using a valve-specific questionnaire and the Hospital Anxiety and Depression Scale (HADS).Of the 912 (77%) respondents, 245 had mechanical valves. Of these, fifty-nine (24%) were women, the mean (standard deviation: SD) age was 61 (11) years, and the mean time since surgery was 7 (3) years. The valve-specific questionnaire showed that 84% of the patients could sometimes or often hear the valve sound. A moderate positive correlation was found between valve prosthesis noise disturbance and anxiety, r = 0.35 (p = 0.001), and depression, r = 0.27 (p = 0.001). In a multiple linear regression analysis, valve noise perception was only significantly associated with anxiety among several other biopsychosocial factors. CONCLUSION: This study shows an association between valve noise disturbance and symptoms of anxiety, and highlights the importance of preparing all patients for the sound from the mechanical valves that arises after surgery.

Anxiety and depression in patients aged 80 years and older following aortic valve therapy. A six-month follow-up study.

BACKGROUND: Little is known about mental health following advanced cardiac procedures in the oldest patients. AIMS: To study changes in anxiety and depression from baseline to one- and six-month follow-up in older patients following transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). METHODS: Prospective cohort study of patients ≥ 80 years undergoing elective TAVI or SAVR in a tertiary university hospital. Anxiety and depression were assessed with the Hospital Anxiety and Depression Scale. Differences between TAVI/SAVR were analyzed using Welch's t test or chi-squared. Changes over time and group differences were established with longitudinal models using generalized least squares. RESULTS: In 143 patients (83.5 ± 2.7 years), 46% (n = 65) received TAVI. Anxiety was identified in 11% of TAVI patients at baseline. One- and six-months later, percentages were 8% and 9%. In SAVR patients, 18% had baseline scores indicating anxiety. One and six-months later, percentages were 11% and 9%. Depression was identified in 15% of TAVI patients. One- and six-months later, percentages were 11% and 17%. At baseline, 11% of SAVR patients had scores indicating depression. One- and six-months after SAVR, percentages were 15% and 12%. Longitudinal analyses showed reductions (P < 0.001) in anxiety from baseline to one-month, and stable scores between one- and six-months for both treatment groups. There was no change over time for depression among treatment groups (P = 0.21). DISCUSSION AND CONCLUSIONS: SAVR or TAVI in patients ≥ 80 years was associated with anxiety reduction between baseline and follow-up. For depression, there was no evidence of change over time in either treatment group.

Mitral annular dynamics are influenced by left ventricular load and contractility in an acute animal model.

The purpose of this study was to investigate the effects of loading conditions and left ventricular (LV) contractility on mitral annular dynamics. In 10 anesthetized pigs, eight piezoelectric transducers were implanted equidistantly around the mitral annulus. High-fidelity catheters measured left ventricular pressures and the slope of the end-systolic pressure-volume relationship (Ees ) determined LV contractility. Adjustments of pre- and afterload were done by constriction of the inferior caval vein and occlusion of the descending aorta. Mitral annulus area indexed to body surface area (MAAi ), annular circularity index (ACI), and non-planarity angle (NPA) were calculated by computational analysis. MAAi was more dynamic in response to loading interventions than ACI and NPA. However, MAAi maximal cyclical reduction (-Δr) and average deformational velocity (- v ¯ $$ \overline{v} $$ ) did not change accordingly (p = 0.31 and p = 0.22). Reduced Ees was associated to attenuation in MAAi -Δr and MAAi - v ¯ $$ \overline{v} $$ (r2 = 0.744; p = 0.001 and r2 = 0.467; p = 0.029). In conclusion, increased cardiac load and reduced LV contractility may cause deterioration of mitral annular dynamics, likely impairing coaptation and increasing susceptibility to valvular incompetence.

In silico analysis provides insights for patient-specific annuloplasty in Barlow's disease.

Objective: To predict the required mitral annular area reduction in patients with Barlow's disease to obtain a predefined leaflet area index by a novel in silico modeling method. Methods: Three-dimensional echocardiography was used to create patient-specific mitral valve models of 8 patients diagnosed with Barlow's disease and bileaflet prolapse preoperatively. Six patients were also studied postoperatively in a finite element framework, to quantify the optimal coaptation area index. For the patient-specific finite element analyses, realistic papillary muscle and annular motion are incorporated, also for the in silico annuloplasty analyses. The annuloplasty ring size is reduced moderately until the optimal coaptation area index is achieved for each patient. Results: The mean mitral annular area at end-diastole was reduced by 58 ± 7% postoperatively (P < .001), resulting in a postoperative coaptation area index of 20 ± 5%. To achieve the same coaptation area index with moderate annular reductions and no leaflet resection the annular reduction was 31 ± 6% (P < .001). Conclusions: In silico analysis in selected patients diagnosed with Barlow's disease demonstrates that annuloplasty with only moderate annular reduction may be sufficient to achieve optimal coaptation as compared to conventional surgical procedures.

Mechanical behavior and collagen structure of degenerative mitral valve leaflets and a finite element model of primary mitral regurgitation.

Degenerative mitral valve disease is the main cause of primary mitral regurgitation with two phenotypes: fibroelastic deficiency (FED) often with localized myxomatous degeneration and diffuse myxomatous degeneration or Barlow's disease. Myxomatous degeneration disrupts the microstructure of the mitral valve leaflets, particularly the collagen fibers, which affects the mechanical behavior of the leaflets. The present study uses biaxial mechanical tests and second harmonic generation microscopy to examine the mechanical behavior of Barlow and FED tissue. Three tissue samples were harvested from a FED patient and one sample is from a Barlow patient. Then we use an appropriate constitutive model by excluding the collagen fibers under compression. Finally, we built an FE model based on the echocardiography of patients diagnosed with FED and Barlow and the characterized material model and collagen fiber orientation. The Barlow sample and the FED sample from the most affected segment showed different mechanical behavior and collagen structure compared to the other two FED samples. The FE model showed very good agreement with echocardiography with 2.02±1.8 mm and 1.05±0.79 mm point-to-mesh distance errors for Barlow and FED patients, respectively. It has also been shown that the exclusion of collagen fibers under compression provides versatility for the material model; it behaves stiff in the belly region, preventing excessive bulging, while it behaves very softly in the commissures to facilitate folding. STATEMENT OF SIGNIFICANCE: This study quantifies for the first time the collagen microstructure and mechanical behavior of degenerative mitral valve (DMV) leaflets. These data will then be used for the first disease-specific finite element (FE) model of DMV. While current surgical repair of DMV is based on surgical experience, FE modeling has the potential to support decision-making and make outcomes predictable. We adopt a constitutive model to exclude collagen fiber under compressions, an important consideration when modeling the mitral valve, where the leaflets are folded to ensure complete closure. The results of this study provide essential data for understanding the relationship between collagen microstructure and degenerative mitral valve mechanics.

Comorbidities, injury severity and complications predict mortality in thoracic trauma.

PURPOSE: Thoracic trauma accounts for 25-50% of posttraumatic mortality. Data on epidemiology of thoracic trauma in Scandinavia and risk factors for mortality are scarce. This study aims to provide an overview of epidemiology, clinical events and risk factors for mortality of patients with severe thoracic injuries. METHODS: A retrospective study including adult thoracic trauma patients with abbreviated injury scale ≥ 3, between 2009 and 2018 at Haukeland University Hospital was performed. Subgroup analyses were performed for specific patient groups: (1) isolated thoracic trauma, (2) polytrauma without Traumatic Brain Injury (TBI) and (3) polytrauma with TBI. Logistic regression analyses were applied to find risk factors for 30-days mortality. Age, sex, comorbidity polypharmacy score (CPS), trauma and injury severity score (TRISS) and comprehensive complication index (CI) were included in the final model. RESULTS: Data of 514 patients were analyzed, of which 60 (12%) patients died. Median (IQR) injury severity score (ISS) was 17 (13-27). Data of 463 patients, of which 39 patients died (8%), were included in multivariate analyses. Female sex odds ratio (OR) (2.7, p = 0.04), CPS > 9 (OR 4.8; p = 0.01), TRISS ≤ 50% (OR 44; p < 0.001) and CI ≥ 30 (OR 12.5, p < 0.001) were significant risk factors for mortality. Subgroup analyses did not demonstrate other risk factors. CONCLUSION: Comorbidities and associated pharmacotherapies, TRISS, female sex, and complications during admission predict in-hospital mortality after thoracic trauma. Current findings might help to recognize patients at risk of an adverse outcome, and thereby prevent complications. TRIAL REGISTRATION: RETROSPECTIVELY REGISTERED: The regional committees for medical and health research ethics file number is 2017/293.

Left ventricular venting during extracorporeal membrane oxygenation; the effects on cardiac performance in a porcine model of critical post-cardiotomy failure.

INTRODUCTION: Left ventricular distension is a major concern with postcardiotomy veno-arterial extracorporeal membrane oxygenation (VA-ECMO) supporting a critical heart failure after cardiac surgery. This porcine study evaluates the effects of left ventricular venting on cardiac function during ECMO-supported circulation and after weaning from ECMO. METHODS: Twenty anaesthetised open-chest pigs were put on cardiopulmonary bypass with aortic cross-clamping and suboptimal cardioplegic arrest for 40 min. After declamping and defibrillation, the animals were supported by VA-ECMO for 180 min either with or without additional left ventricular venting. Continuous haemodynamic evaluations were performed at baseline and at cardiac arrest, during VA-ECMO and for 120 min after weaning from circulatory support. Left ventricular perfusion and function were evaluated with microspheres, pressure-volume loops and epicardial echocardiography at baseline and after 1 and 2 h with unsupported circulation. RESULTS: In vented animals both mean aortic and left ventricular peak systolic pressure increased at the end of the ECMO-supported period compared to those not vented and remained increased also after weaning. Both at 60 min and 120 min after weaning from circulatory support, left ventricular stroke work and pressure-volume area were increased in vented compared to not vented animals. At 120 min left ventricular stroke volume was increased in vented compared to not vented animals, myocardial perfusion did not differ. The left ventricular mechanical efficiency, defined as the ratio between pressure volume area and myocardial perfusion, was increased (53.2 ± 5 vs 36.2 ± 2.1 J/mL/g, p = 0.011) in vented- compared to not vented hearts. CONCLUSION: This experimental study demonstrate that left ventricular venting during post-cardiotomy veno-arterial ECMO for 3 h attenuates deterioration of left ventricular function and haemodynamics early after weaning from circulatory support.

A case report of giant cell myocarditis complicated by severe heart failure: the value of early endomyocardial biopsy and mechanical circulatory support.

Background: Giant cell myocarditis (GCM) is a rare, probably underdiagnosed and potentially fatal disease in young and middle-aged patients. Disease progression is often rapid, and life-threatening arrhythmias and cardiogenic shock due to progressive left ventricular failure are among the most feared complications. Although cardiac biomarkers and multimodality imaging are used as initial diagnostic tests in most patients, endomyocardial biopsy (EMB) is often required for a definitive diagnosis. However, there are still gaps in our knowledge in terms of the etiology, early diagnosis, management and prognosis of GCM. Case Description: We present the case of a male patient in his early 50s admitted to Haukeland University Hospital with fulminant GCM. He had no significant medical history in the past apart from hypertension, and presented to hospital in cardiogenic shock after a few weeks of progressive shortness of breath. Rapid initiation of methylprednisolone had an immediate effect on reducing myocardial inflammation, and sustained treatment with a combination of immunosuppressive agents along with optimal heart failure medications led to complete recovery of the heart function and clinical remission over several years. The case study highlights the urgency of an early EMB, access to mechanical circulatory support (MCS) and the efficacy of immunosuppressive treatment and optimal medical management for heart failure. Finally, our review of the literature also provides an updated guidance on the contemporary management of GCM patients. Conclusions: Accurate and early diagnosis with EMB in patients with GCM are crucial for better outcomes. Rapid initiation of methylprednisolone reduces myocardial inflammation and the risk of death. Sustained treatment with a combination of immunosuppressive agents together with optimal heart failure medications are essential for myocardial recovery and long-term stabilization. The use of MCS is the cornerstone in the management of GCM with a clear survival benefit.

Finite element analysis of mitral valve annuloplasty in Barlow's disease.

Barlow's Disease affects the entire mitral valve apparatus causing mitral regurgitation. Standard annuloplasty procedures lead to an average of 55% annular area reduction of the end diastolic pre-operative annular area in Barlow's diseased valves. Following annular reduction, mitral valvuloplasty may be needed, usually with special focus on the posterior leaflet. An in silico pipeline to perform annuloplasty by utilizing the pre- and -postoperative 3D echocardiographic recordings was developed. Our objective was to test the hypothesis that annuloplasty ring sizes based on a percentage (10%-25%) decrease of the pre-operative annular area at end diastole can result in sufficient coaptation area for the selected Barlow's diseased patient. The patient specific mitral valve geometry and finite element model were created from echocardiography recordings. The post-operative echocardiography was used to obtain the artificial ring geometry and displacements, and the motion of the papillary muscles after surgery. These were used as boundary conditions in our annuloplasty finite element analyses. Then, the segmented annuloplasty ring was scaled up to represent a 10%, 20% and 25% reduction of the pre-operative end diastolic annular area and implanted to the end diastolic pre-operative finite element model. The pre-operative contact area decrease was shown to be dependent on the annular dilation at late systole. Constraining the mitral valve from dilating excessively can be sufficient to achieve proper coaptation throughout systole. The finite element analyses show that the selected Barlow's diseased patient may benefit from an annuloplasty ring with moderate annular reduction alone.

Treatment of acute aortic dissection type A with paraplegia and distal limb ischemia within a hybrid operating room.

OBJECTIVE: Acute aortic dissection type A is among the most lethal surgical emergencies. Patients may suffer from occlusion of the aorta or its branches causing end-organ malperfusion complicating the diagnosis and worsening the prognosis. Paraplegia is a rare manifestation that affects less than 5% of patients. If type A aortic dissection and occlusion of the downstream thoraco-abdominal aorta occur simultaneously and require acute treatment, a medical dilemma occurs; what should be treated first? CASE REPORT: We describe a case with an extensive acute type A aortic dissection with signs of consciousness and severe malperfusion syndrome. RESULTS: The treatment was successfully performed within a hybrid surgery suite with simultaneous open surgery and endovascular repair techniques supported by cardiopulmonary bypass circulation. CONCLUSION: A hybrid operating room might offer the opportunity to simultaneously repair complicated aortic dissection with malperfusion syndrome, by open aortic surgery and endovascular techniques.

Alpha-2-adrenergic receptor agonists for the prevention of delirium and cognitive decline after open heart surgery (ALPHA2PREVENT): protocol for a multicentre randomised controlled trial.

INTRODUCTION: Postoperative delirium is common in older cardiac surgery patients and associated with negative short-term and long-term outcomes. The alpha-2-adrenergic receptor agonist dexmedetomidine shows promise as prophylaxis and treatment for delirium in intensive care units (ICU) and postoperative settings. Clonidine has similar pharmacological properties and can be administered both parenterally and orally. We aim to study whether repurposing of clonidine can represent a novel treatment option for delirium, and the possible effects of dexmedetomidine and clonidine on long-term cognitive trajectories, motor activity patterns and biomarkers of neuronal injury, and whether these effects are associated with frailty status. METHODS AND ANALYSIS: This five-centre, double-blind randomised controlled trial will include 900 cardiac surgery patients aged 70+ years. Participants will be randomised 1:1:1 to dexmedetomidine or clonidine or placebo. The study drug will be given as a continuous intravenous infusion from the start of cardiopulmonary bypass, at a rate of 0.4 µg/kg/hour. The infusion rate will be decreased to 0.2 µg/kg/hour postoperatively and be continued until discharge from the ICU or 24 hours postoperatively, whichever happens first.Primary end point is the 7-day cumulative incidence of postoperative delirium (Diagnostic and Statistical Manual of Mental Disorders, fifth edition). Secondary end points include the composite end point of coma, delirium or death, in addition to delirium severity and motor activity patterns, levels of circulating biomarkers of neuronal injury, cognitive function and frailty status 1 and 6 months after surgery. ETHICS AND DISSEMINATION: This trial is approved by the Regional Committee for Ethics in Medical Research in Norway (South-East Norway) and by the Norwegian Medicines Agency. Dissemination plans include publication in peer-reviewed medical journals and presentation at scientific meetings. TRIAL REGISTRATION NUMBER: NCT05029050.

Development and validation of patients' surgical safety checklist.

BACKGROUND: Poor uptake and understanding of critical perioperative information represent a major safety risk for surgical patients. Implementing a patient-driven surgical safety checklist might enhance the way critical information is given and increase patient involvement in their own safety throughout the surgical pathway. The aim of this study was to develop and validate a Surgical Patient Safety Checklist (PASC) for use by surgical patients. METHOD: This was a prospective study, involving patient representatives, multidisciplinary healthcare professionals and elective surgical patients to develop and validate PASC using consensus-building techniques in two Norwegian hospitals. A set of items intended for PASC were rated by patients and then submitted to Content Validation Index (CVI) analyses. Items of low CVI went through a Healthcare Failure Mode and Effect Analysis (HFMEA) Hazard Scoring process, as well as a consensus process before they were either kept or discarded. Reliability of patients' PASC ratings was assessed using Intraclass Correlation Coefficient analysis. Lastly, the face validity of PASC was investigated through focus group interviews with postoperative patients. RESULTS: Initial development of PASC resulted in a checklist consisting of two parts, one before (32 items) and one after surgery (26 items). After achieving consensus on the PASC content, 215 surgical patients from six surgical wards rated the items for the CVI analysis on a 1-4 scale and mostly agreed on the content. Five items were removed from the checklist, and six items were redesigned to improve PASCs' user-friendliness. The total Scale-level index/Average (S-CVI/Ave) before revision was 0.83 and 0.86 for pre- and post-operative PASC items, respectively. Following revision, these increased to 0.86 and 0.93, respectively. The PASC items reliability score was 0.97 (95% confidence interval 0.96 to 0.98). The qualitative assessment identified that patients who used PASC felt more in control of their situation; this was achieved when PASC was given to them at what they felt was the right time and healthcare professionals took part in its usage. CONCLUSION: Multidisciplinary perioperative care staff and surgical patients agreed upon PASC content, the checklist ratings were reliable, and qualitative assessment suggested good face validity. PASC appears to be a usable and valid checklist for elective surgical patients across specialties.

A Health Economic Evaluation of the World Health Organization Surgical Safety Checklist: A Single Center Assessment.

OBJECTIVES: To evaluate cost-effectiveness of the WHO Surgical Safety Checklist. BACKGROUND: The clinical effectiveness of surgical checklists is largely understood. Few studies to-date have evaluated the cost-effectiveness of checklist use. METHODS: An economic evaluation was carried out using data from the only available randomized controlled trial of the checklist. Analyses were based on 3702 procedures. Costs considered included checklist implementation costs and length and cost of hospital stay, costs of warming blanket use, blood transfusions and antibiotics used in the operating room, and the cost of clinical time in the operating room - all calculated for each procedure and its associated admission. Nonparametric bootstrapping was used to simulate an empirical distribution of the mean effect of the checklist on total admission costs and the probability of observing a complication-free admission and to quantify sampling uncertainty around mean cost estimates. RESULTS: The overall cost of checklist implementation was calculated to be $900 per 100 admissions. Implementation of the WHO checklist resulted in an additional 5.9 complication-free admissions per 100 admissions and an average of 110 bed-days saved per 100 admissions. Accounting for all costs included in the analysis, for every 100 admissions, use of the WHO checklist was estimated to save $55,899. CONCLUSIONS: Implementation of the WHO checklist was a cost-effective strategy for improving surgical safety.

PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation: Part 2: Study results-prostheses, positions, and economic development.

Objectives: The Prospective Randomized On-X Mechanical Prosthesis Versus St Jude Medical Mechanical Prosthesis Evaluation (PROSE) trial purpose was to investigate whether a current-generation mechanical prosthesis (On-X; On-X Life Technologies/Artivion Inc) reduced the incidence of thromboembolic-related complications compared with a previous-generation mechanical prosthesis (St Jude Medical Mechanical Prosthesis; Abbott/St Jude Medical). This second report documents the valve-related complications by individual prostheses and by Western and Developing populations. Methods: The PROSE trial study was conducted in 28 worldwide centers and incorporated 855 subjects randomized between 2003 and 2016. The study enrollment was discontinued on August 31, 2016. The study protocol, and analyses of 10 demographic variables and 24 risk factors were published in detail in 2021. Results: The total patient population (N = 855) included patients receiving an On-X valve (n = 462) and a St Jude Medical valve (n = 393). The overall freedom evaluation showed no differences at 5 years between the prostheses for thromboembolism or for valve thrombosis. There were also no differences in mortality. There were several differences between Developing and Western populations. The freedom relations at 5 years for mortality favored Western over Developing populations. Valve thrombosis was differentiated by position and site: aortic < mitral (P = .007) and Western < Developing (P = .005). In the mitral position there were no cases in Western populations, whereas there were 8 in Developing populations (P = .217). Conclusions: The On-X valve and St Jude Medical valve performed equally well in the study with no differences found. The only differentiation occurred with valve thrombosis in the mitral position more than the aortic position and occurring in Developing more than Western populations. The occurrence of valve thrombosis was also related to a younger population possibly due to anticoagulation compliance based on record review.

Survival after aortic root replacement with a stentless xenograft is determined by patient characteristics.

OBJECTIVES: Our objective was to examine intermediate-term survival and reinterventions in unselected patients, stratified according to indication, who received a Freestyle (Medtronic Inc, Minneapolis, Minn) bioprosthesis as a full aortic root replacement. METHODS: Data from medical records were retrospectively collected for patients who had aortic root replacement using Freestyle bioprostheses between 1999 and 2018 at 6 North-Atlantic centers. Survival status was extracted from national registries and results stratified according to indication for surgery. RESULTS: We included 1030 implantations in 1008 patients with elective indications for surgery: aneurysm (39.8%), small root (8.3%), and other (13.8%), and urgent/emergent indications: endocarditis (26.7%) and Stanford type A aortic dissection (11.4%). Across indications, 46.3% were nonelective cases and 34.0% were reoperations. Median age was 66.0 (interquartile range, 58.0-71.8) years and median follow-up was 5.0 (interquartile range, 2.6-7.9) years. Thirty-day mortality varied from 2.9% to 27.4% depending on indication. Intermediate survival for 90-day survivors with elective indications were not different from the general population standardized for age and sex (P = .95, .83, and .16 for aneurysms, small roots, and other, respectively). In contrast, patients with endocarditis and type A dissection had excess mortality (P < .001). Freedom from valve reinterventions was 95.0% and 94.4% at 5 and 8 years, respectively. In all, 52 patients (5.2%) underwent reinterventions, most because of endocarditis. CONCLUSIONS: At intermediate term follow-up this retrospective study provides further support for the use of the Freestyle bioprosthesis in the real-world setting of diverse, complex, and often high-risk aortic root replacement and suggests that outcome is determined by patient and disease, rather than by prosthesis, characteristics.