Predictive role of cardiopulmonary bypass exposure indexed to body surface area on postoperative organ dysfunction: a retrospective cohort study.

OBJECTIVES: Long cardiopulmonary bypass times are associated with adverse postoperative outcomes and increased healthcare resources use. It is likely that this effect is pronounced in smaller patients. Previous studies have been criticized for not taking into consideration that prolonged bypass times are often due to higher complexity. The purpose of this study was to investigate the relationship between bypass index (bypass time/body surface area) and adverse postoperative events. METHODS: Single-centre, retrospective cohort study including 2413 patients undergoing cardiac surgery on cardiopulmonary bypass from June 2018 to April 2020. Length of hospital stay, as surrogate marker of post-operative morbidity, was selected as primary outcome. The strength of association between BI and the primary outcome was assessed with linear regression analysis. Secondary outcomes included new onset renal, pulmonary or cardiac rhythm dysfunction. The predictive value of bypass index was assessed with linear regression analysis; univariate and multiple regression were used to assess the strength of association between Bi and the secondary outcomes. RESULTS: Bypass index was predictive for length of stay at univariate (RR 1.004, p < 0.001) and at multivariable (RR 1.003, p < 0.001) analysis. The association between bypass index and new renal (mean difference 14.1 min/m2, p < 0.001) and cardiac rhythm dysfunction (mean difference 12.6 min/m2) was significant. This was not true of postoperative lung dysfunction (mean difference -1.5 min/m2, p = 0.293). CONCLUSIONS: Bypass index, calculated as total bypass time/patient body surface area, is predictive of postoperative morbidity and resource utilization after cardiac surgery on pump.

Selenoprotein deficiency disorder predisposes to aortic aneurysm formation.

Aortic aneurysms, which may dissect or rupture acutely and be lethal, can be a part of multisystem disorders that have a heritable basis. We report four patients with deficiency of selenocysteine-containing proteins due to selenocysteine Insertion Sequence Binding Protein 2 (SECISBP2) mutations who show early-onset, progressive, aneurysmal dilatation of the ascending aorta due to cystic medial necrosis. Zebrafish and male mice with global or vascular smooth muscle cell (VSMC)-targeted disruption of Secisbp2 respectively show similar aortopathy. Aortas from patients and animal models exhibit raised cellular reactive oxygen species, oxidative DNA damage and VSMC apoptosis. Antioxidant exposure or chelation of iron prevents oxidative damage in patient's cells and aortopathy in the zebrafish model. Our observations suggest a key role for oxidative stress and cell death, including via ferroptosis, in mediating aortic degeneration.

Safe Implementation of a Next-Generation Surgical Robot: First Analysis of 2,083 Cases in the Versius Surgical Registry.

OBJECTIVE: To present the first report of data from the Versius Surgical Registry, a prospective, multicenter data registry with ongoing collection across numerous surgical indications, developed to accompany the Versius Robotic Surgical System into clinical practice. BACKGROUND: A data registry can be utilized to minimize risk to patients by establishing the safety and effectiveness of innovative medical devices and generating a thorough evidence base of real-world data. METHODS: Surgical outcome data were collected and inputted through a secure online platform. Preoperative data included patient age, sex, body mass index, surgical history, and planned procedures. Intraoperative data included operative time, complications during surgery, conversion from robot-assisted surgery to an alternative surgical technique, and blood loss. Postoperative outcome data included length of hospital stay, complications following surgery, serious adverse events, return to the operating room, readmission to the hospital, and mortality within 90 days of surgery. RESULTS: This registry analysis included 2083 cases spanning general, colorectal, hernia, gynecologic, urological, and thoracic indications. A considerable number of cases were recorded for cholecystectomy (n=539), anterior resection (n=162), and total laparoscopic hysterocolpectomy (n=324) procedures. The rates of conversion to an alternative technique, serious adverse events, and 90-day mortality were low for all procedures across all surgical indications. CONCLUSIONS: We report the large-scale analysis of the first 2083 cases recorded in this surgical registry, with substantial data collected for cholecystectomies, anterior resections, and total laparoscopic hysterectomies. The extensive surgical outcome data reported here provide real-world evidence for the safe implementation of the surgical robot into clinical practice.

Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System.

Objectives: To describe a new, international, prospective surgical registry developed to accompany the clinical implementation of the Versius Robotic Surgical System by accumulating real-world evidence of its safety and effectiveness. Interventions: This robotic surgical system was introduced in 2019 for its first live-human case. With its introduction, cumulative database enrollment was initiated across several surgical specialties, with systematic data collection via a secure online platform. Main outcome measures: Pre-operative data include diagnosis, planned procedure(s), characteristics (age, sex, body mass index and disease status) and surgical history. Peri-operative data include operative time, intra-operative blood loss and use of blood transfusion products, intra-operative complications, conversion to an alternative technique, return to the operating room prior to discharge and length of hospital stay. Complications and mortality within 90 days of surgery are also recorded. Results: The data collected in the registry are analyzed as comparative performance metrics, by meta-analyses or by individual surgeon performance using control method analysis. Continual monitoring of key performance indicators, using various types of analyses and outputs within the registry, have provided meaningful insights that help institutions, teams and individual surgeons to perform most effectively and ensure optimal patient safety. Conclusions: Harnessing the power of large-scale, real-world registry data for routine surveillance of device performance in live-human surgery from first use will enhance the safety and efficacy outcomes of innovative surgical techniques. Data are crucial to driving the evolution of robot-assisted minimal access surgery while minimizing risk to patients. Trial registration number: CTRI/2019/02/017872.

Formal consensus study on surgery to replace the aortic valve in adults aged 18-60 years.

OBJECTIVE: There is uncertainty about surgical procedures for adult patients aged 18-60 years undergoing aortic valve replacement (AVR). Options include conventional AVR (mechanical, mAVR; tissue, tAVR), the pulmonary autograft (Ross) and aortic valve neocuspidisation (Ozaki). Transcatheter treatment may be an option for selected patients. We used formal consensus methodology to make recommendations about the suitability of each procedure. METHODS: A working group, supported by a patient advisory group, developed a list of clinical scenarios across seven domains (anatomy, presentation, cardiac/non-cardiac comorbidities, concurrent treatments, lifestyle, preferences). A consensus group of 12 clinicians rated the appropriateness of each surgical procedure for each scenario on a 9-point Likert scale on two separate occasions (before and after a 1-day meeting). RESULTS: There was a consensus that each procedure was appropriate (A) or inappropriate (I) for all clinical scenarios as follows: mAVR: total 76% (57% A, 19% I); tAVR: total 68% (68% A, 0% I); Ross: total 66% (39% A, 27% I); Ozaki: total 31% (3% A, 28% I). The remainder of percentages to 100% reflects the degree of uncertainty. There was a consensus that transcatheter aortic valve implantation is appropriate for 5 of 68 (7%) of all clinical scenarios (including frailty, prohibitive surgical risk and very limited life span). CONCLUSIONS: Evidence-based expert opinion emerging from a formal consensus process indicates that besides conventional AVR options, there is a high degree of certainty about the suitability of the Ross procedure in patients aged 18-60 years. Future clinical guidelines should include the option of the Ross procedure in aortic prosthetic valve selection.

Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation.

OBJECTIVES: The Amaze trial showed that adding atrial fibrillation (AF) surgery to cardiac operations increased return to sinus rhythm (SR) without impact on quality of life or survival at 2 years. We report outcomes to 5 years. METHODS: In a multicentre, phase III, pragmatic, double-blind, randomized controlled superiority trial, cardiac surgery patients with >3 months of AF were randomized 1:1 to adjunct AF surgery or control. Primary outcomes of 1-year SR restoration and 2-year quality-adjusted survival were already reported. This study reports on rhythm, survival, quality-adjusted survival, stroke, medication and safety to 5 years. RESULTS: Between 2009 and 2014, 352 patients were randomized. By 5 years 79 died, 58 withdrew, 34 were lost to follow-up and the remaining 182 provided data. AF surgery significantly increased the odds of remaining in SR at 5 years {odds ratio = 2.98 [95% confidence interval (CI) 1.23, 7.17], P = 0.015}. There was a non-significant decrease in stroke incidence [odds ratio = 0.605 (95% CI 0.284, 1.287), P = 0.19], but no improved survival [5-year survival: AF surgery 77.3% (95% CI 71.1%, 83.5%), controls 77.8% (95% CI 71.7%, 84.0%), P = 0.85]. Quality-adjusted survival difference was negligible (-0.03; 95% CI -0.33, 0.27, P = 0.85). The composite of survival free of stroke and AF was better in the AF surgery group [odds ratio = 2.34 (95% CI 1.03, 5.31)]. There were no other differences. CONCLUSIONS: Adjunct AF surgery confers a higher rate of SR to 5 years and a better composite outcome of survival free of stroke and AF but has no impact on overall or quality-adjusted survival or other clinical outcomes. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN82731440.

Social and emotional factors as predictors of poor outcomes following cardiac surgery.

OBJECTIVES: Existing risk prediction models in cardiac surgery stratify individuals based on their predicted risk, including only medical and physiological factors. However, the complex nature of risk assessment and the lack of parameters representing non-medical aspects of patients' lives point towards the need for a broader paradigm in cardiac surgery. Objectives were to evaluate the predictive value of emotional and social factors on 4 outcomes; death within 90 days, prolonged stay in intensive care (≥72 h), prolonged hospital admission (≥10 days) and readmission within 90 days following cardiac surgery, as a supplement to traditional risk assessment by European System for Cardiac Operative Risk Evaluation (EuroSCORE). METHODS: The study included adults undergoing cardiac surgery in Denmark 2014-2017 including information on register-based socio-economic factors, and, in a nested subsample, self-reported symptoms of anxiety and depression. Logistic regression analyses were conducted, adjusted for EuroSCORE, of variables reflecting social and emotional factors. RESULTS: Amongst 7874 included patients, lower educational level (odds ratio 1.33; 95% confidence interval 1.17-1.51) and living alone (1.25; 1.14-1.38) were associated with prolonged hospital admission after adjustment for EuroSCORE. Lower educational level was also associated with prolonged intensive care unit stay (1.27; 1.00-1.63). Having a high income was associated with decreased odds of prolonged hospital admission (0.78; 0.70-0.87). No associations or predictive value for symptoms of anxiety or depression were found on any outcomes. CONCLUSIONS: Social disparity is predictive of poor outcomes following cardiac surgery. Symptoms of anxiety and depression are frequent especially amongst patients with a high-risk profile according to EuroSCORE. SUBJ COLLECTION: 105, 123.

Prosthesis-Patient Mismatch Increases Early and Late Mortality in Low Risk Aortic Valve Replacement.

The concept of prosthesis-patient mismatch (PPM) has gained much attention since first described 40 years ago. Previous studies have shown conflicting evidence regarding increased early and late morbidity and mortality with PPM after aortic valve replacement (AVR). The aim of this study was to evaluate the effects of PPM on short- and long-term mortality in low-risk patients after isolated AVR. A retrospective, single-center study involving 1707 consecutive patients ≤80 years of age with preserved left ventricular systolic function who underwent elective, primary isolated AVR operations from 2008 to 2018. Patients were stratified into 2 groups according to the presence of PPM (n = 96), defined as effective orifice area index <0.85 cm2/m2 body surface area, and no-PPM (n = 1611). The effect of PPM on mortality was evaluated with univariate and multivariate analyses. 30-day mortality was 0.8% (4.2% in PPM group vs 0.6 in no-PPM group; P = 0.005). PPM occurred more in female gender, obese and older patients. PPM was highly associated with long-term all-cause mortality (median 4 years [Q1-Q3 2-7]; HR: 1.79, 95% CI: 1.27-2.55, P = 0.002), and remained strongly and independently associated after adjustment for other risk factors (HR: 1.60, 95% CI: 1.10-2.34, P = 0.014). In propensity score-matched analysis, the adjusted mortality risk was higher in PPM group (HR: 2.03, 95% CI: 1.22-3.39, P = 0.006) compared to no-PPM group. In a single-centre observational study, PPM increased early mortality and was independently associated with long-term all-cause mortality after low-risk, primary isolated AVR operations. Strategies to avoid PPM should be explored and implemented.

Inferior outcomes following cardiac surgery in patients with a functioning renal allograft.

OBJECTIVES: Renal transplantation is an effective treatment for end-stage renal failure. The aim of this study was to evaluate outcomes for these patients undergoing cardiac surgery. METHODS: A retrospective analysis identified patients with a functioning renal allograft at the time of surgery. A 2:1 propensity matching was performed. Patients were matched on: age, sex, left ventricle function, body mass index, preoperative creatinine, operation priority, operation category and logistic EuroSCORE. RESULTS: Thirty-eight patients undergoing surgery with a functioning renal allograft were identified. The mean age was 62.4 years and 66% were male. A total of 44.7% underwent coronary artery bypass grafting and 26.3% underwent a single valve procedure. The mean logistic EuroSCORE was 10.65. The control population of 76 patients was well matched. Patients undergoing surgery following renal transplantation had a prolonged length of intensive care unit (3.19 vs 1.02 days, P < 0.001) and hospital stay (10.3 vs 7.17 days, P = 0.05). There was a higher in-hospital mortality (15.8% vs 1.3%, P = 0.0027). Longer-term survival on Kaplan-Meier analysis was also inferior (P < 0.001). One-year survival was 78.9% vs 96.1% and 5-year survival was 63.2% vs 90.8%. A further subpopulation of 11 patients with a failed renal allograft was identified and excluded from the main analysis; we report demographic and outcome data for them. CONCLUSIONS: Patients with a functioning renal allograft are at higher risk of perioperative mortality and inferior long-term survival following cardiac surgery. Patients in this population should be appropriately informed at the time of consent and should be managed cautiously in the perioperative period with the aim of reducing morbidity and mortality.

Supplementing prediction by EuroSCORE with social and patient-reported measures among patients undergoing cardiac surgery.

OBJECTIVES: The risk of poor outcomes is traditionally attributed to biological and physiological processes in cardiac surgery. However, evidence exists that other factors, such as emotional, behavioral, social, and functional, are predictive of poor outcomes. Objectives were to evaluate the predictive value of several emotional, social, functional, and behavioral factors on four outcomes: death within 90 days, prolonged stay in intensive care, prolonged hospital admission, and readmission within 90 days following cardiac surgery. METHODS: This prospective study included adults undergoing cardiac surgery 2013-2014, including information on register-based socioeconomic factors and self-reported health in a nested subsample. Logistic regression analyses to determine the association and incremental value of each candidate predictor variable were conducted. Multiple regression analyses were used to determine the incremental value of each candidate predictor variable, as well as discrimination and calibration based on the area under the curve (AUC) and Brier score. RESULTS: Of 3217 patients, 3% died, 9% had prolonged intensive care stay, 51% had prolonged hospital admission, and 39% were readmitted to hospital. Patients living alone (odds ratio, 1.19; 95% confidence interval, 1.02-1.38), with lower educational levels (1.27; 1.04-1.54) and low health-related quality of life (1.43; 1.02-2.01) had prolonged hospital admission. Analyses revealed living alone as predictive of prolonged intensive care unit (ICU) stay (Brier, 0.08; AUC, 0.68), death (0.03; 0.71), and prolonged hospital admission (0.24; 0.62). CONCLUSION: Living alone was found to supplement EuroSCORE in predicting death, prolonged hospital admission, and prolonged ICU stay following cardiac surgery. Low educational level and impaired health-related quality of life were, furthermore, predictive of prolonged hospital admission.

Two decades on - cardiothoracic surgical care practitioners in the UK: a narrative review.

BACKGROUND: The role of Surgical Care Practitioner (SCP) was first introduced by the NHS in the field of cardiothoracic surgery more than two decades ago to overcome the chronic shortage of junior doctors, and subsequently evolved into other surgical specialties. This review aims to provide evidence on the current situation of SCPs' clinical outcomes within their surgical extended role, with an emphasis on the cardiothoracic surgical field. METHOD: A systematic search of PubMed, Scopus, Embase via Ovid, Web of Science and TRIP was conducted with no time restriction to explore the evidence on SCPs. All included articles were reviewed by three researchers using the selection criteria, and a narrative synthesis was undertaken. FINDINGS: Ten out of the 38 studies identified were selected for inclusion. Only one study specifically investigated cardiothoracic SCPs. Three themes were identified: (1) clinical outcomes (six studies), (2) workforce impact (two studies) and (3) colleagues' opinions (two studies). All studies demonstrated that SCPs provided safe practice, added value and were of benefit to workforce environments and surgical teams. CONCLUSION: Although the current literature provides assurances that the presence of SCPs within surgical teams is beneficial in terms of their clinical outcomes, their impact on the workforce and colleagues' opinions, a significant gap was identified around the SCPs' role within their surgical extended role, specifically in cardiac surgery. Thus, prospective clinical research is required to evaluate SCPs' clinical impact.

Updating EuroSCORE by including emotional, behavioural, social and functional factors to the risk assessment of patients undergoing cardiac surgery: a study protocol.

INTRODUCTION: Conventional risk assessment in cardiac surgery focus on medical and physiological factors and have been developed to predict mortality. Other relevant risk factors associated with increased risk of poor outcomes are not included. Adding non-medical variables as potential prognostic factors to risk assessments direct attention away from specific diagnoses towards a more holistic view of the patients and their predicament. The aim of this paper is to describe the method and analysis plan for the development and validation of a prognostic screening tool as a supplement to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) to predict mortality, readmissions and prolonged length of admission in patients within 90 days after cardiac surgery, as individual outcomes. METHODS AND ANALYSIS: The development of a prognostic screening tool with inclusion of emotional, behavioural, social and functional factors complementing risk assessment by EuroSCORE will adopt the methods recommended by the PROGnosis RESearch Strategy Group and report using the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis statement. In the development stage, we will use data derived from three datasets comprising 1143, 3347 and 982 patients for a prospective cohort study of patients undergoing cardiac surgery, respectively. We will construct logistic regression models to predict mortality, prolonged length of admission and 90-day readmissions. In the validation stage, we will use data from a separate sample of 333 patients planned to undergo cardiac surgery to assess the performance of the developed prognostic model. We will produce validation plots showing the overall performance, area under the curve statistic for discrimination and the calibration slope and intercept. ETHICS AND DISSEMINATION: The study will follow the requirements from the Ethical Committee System ensuring voluntary participation in accordance with the Helsinki declarations. Data will be filed in accordance with the requirements of the Danish Data Protection Agency.

Time to expand risk evaluation systems for cardiac surgery? Looking beyond physiological parameters.

Risk assessment in cardiac surgery traditionally consists of medical and physiological parameters. However, non-physiological factors have also been found to be predictive of poor outcomes following cardiac surgery. Therefore, the isolated focus on physiological parameters is questionable. This paper describes the emotional, behavioural, social and functional factors that have been established to play a role in outcomes following cardiac surgery. This forms a basis for future research, testing the value of these factors above and beyond the physiological parameters. By including such non-physiological factors, the accuracy of the existing risk scoring systems could potentially be improved.