Surgical Risk Scores Research Articles

597 Comparison between low versus intermediate-high risk patients in a contemporary real-world multicentre TAVI registry using self-expanding supra-annular valves: a propensity score matched analysis

Abstract Aims Recent ESC VHD guidelines from 2021 recommend TAVI for intermediate-risk and in certain cases low-risk populations. There is relatively little data regarding the impact of transcatheter heart valve design in these populations. The aim of this study was to investigate the clinical outcomes of low-risk versus intermediate-high risk patients following TAVI in a large real-world contemporary registry. Methods In a large TAVI registry using self-expanding supra-annular bioprosthesis, we performed a comparison between low vs. intermediate-high risk population. Primary outcome was 1-year mortality and secondary outcomes, defined according to Valve Academic Research Consortium 2 criteria, included major and minor vascular complications, annular rupture, myocardial infarction, cardiac tamponade, new permanent pacemaker, stroke, and major and minor bleeding. Finally, we assessed the same investigation applying a propensity score matched (PSM) analysis. Results In the unmatched comparison, the low-risk (LR) group included 1698 patients compared to the 1690 patients of the Intermediate-to-high risk group (IHR). The IHR population showed a mean age of 84 years old vs. 81 of the LR (P<0.001), a higher prevalence of male sex (41% vs. 30%, P<0.001) and increased prevalence of co-morbidities as evidenced by the higher mean STS score 5.80% vs. 2.63% (P<0.001). About the echocardiographic characteristics, the LR presented a higher mean gradient (45.9±15 mmHg vs. 43.7±16.8 mmHg, P<0.001) but similar area compared to the IHR group (0.7 [0.8–0.6] for LR and 0.7 (0.8–0.55) for IHR, P=0.096). In the first unmatched comparison, we found a higher rate of major vascular complications (5.4% vs. 7.3%, P=0.026), new permanent pacemaker (10.5% vs. 13.7%, P=0.006) and major bleeding (2.9% vs. 5.0%, P=0.002) for the IHR group. After the PSM, we obtained 1015 matched patients observing similar outcomes except for minor vascular complications (7.4% vs. 11%, P=0.014) for the IHR group. At a median follow-up of 368 days, the mortality rate was 12.2% (104/1559) vs. 6.8% (104/1520) for the un-matched populations (P<0.001), and 10.4% (98/940) vs. 7.9% (71/898) for the matched patients (P=0.100), respectively for the IHR and the LR group. Conclusions In this large, contemporary real-world registry of TAVI patients, there was no difference in mortality observed between LR and IHR populations at a 1-year follow-up. This data suggests that additional factors beyond surgical risk scores should be considered during heart team evaluation of patients with severe aortic stenosis towards a single-patient tailored approach.

Abstract 12919: Impact of Small Valve Size After Transcatheter Aortic Valve Implantation on 1-year Outcomes in Women: Results From the WIN-TAVI Registry

Introduction: Women undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis are more likely to have a small aortic annulus compared with men. However, there is lack of data on the prognostic relevance of bioprostheses size in women. Hypothesis: To assess the impact of a small valve size on clinical outcomes in women undergoing TAVI. Methods: The Women's INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) registry was the first study to investigate the safety and efficacy of TAVI in women with aortic stenosis.Patients were stratified according to the size of aortic valve bioprosthesis, with small valve defined by a size≤23 mm and non-small valve defined by a size>23 mm. The primary outcome of interests was the occurrence of Valve Academic Research Consortium (VARC)-2-efficacy endpoint, a composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Results: Out of 934 patients, 388 (41.5%) received a small valve and had a lower body mass index, lower surgical risk scores and were less likely to suffer from atrial fibrillation as compared with patients receiving a larger valve. The latter were more likely to require post-dilation (18.6% vs. 10.4%, p<0.001) and had a trend for higher rates of residual aortic regurgitation grade ≥2 (8.7% vs. 5.1%, p = 0.051). At 1 year, the risk of the VARC-2 efficacy endpoint was similar between the two groups (16.0% in small valve vs. 16.3% in non-small valve, p = 0.8808; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00), Figure. No significant differences in the occurrence of the secondary endpoints were noted after multivariable adjustment. Conclusions: Among women undergoing TAVI, the valve size was associated with different baseline and procedural characteristics but was not an independent predictor of clinical outcomes.

P-POSSUM as mortality predictor in COVID-19-infected patients submitted to emergency digestive surgery. A retrospective cohort study

BackgroundCOVID-19 infection is associated with a higher mortality rate in surgical patients, but surgical risk scores have not been validated in the emergency setting. We aimed to study the capacity for postoperative mortality prediction of the P-POSSUM score in COVID-19-positive patients submitted to emergency general and digestive surgery. Material and methodsConsecutive patients undergoing emergency general and digestive surgery from March to June 2020, and from March to June 2019 in 25 Spanish hospitals were included in a retrospective cohort study. Main outcome: 30-day mortality. P-POSSUM discrimination was quantified by the area under the curve (AUC) of ROC curves; calibration was assessed by linear regression slope (β estimator); and sensitivity and specificity were expressed as percentage and 95% confidence interval (CI). Results4988 patients were included: 177 COVID-19-positive; 2011 intra-pandemic COVID-19-negative; and 2800 pre-pandemic. COVID-19-positive patients were older, with higher surgical risk, more advanced pathologies, and higher P-POSSUM values (1.79% vs. 1.09%, p < 0.001, in both the COVID-19-negative and control cohort). 30-day mortality in the COVID-19-positive, intra-pandemic COVID-19-negative and pre-pandemic cohorts were: 12.9%, 4.6%, and 3.2%. The P-POSSUM predictive values in the three cohorts were, respectively: AUC 0.88 (95% CI 0.81–0.95), 0.89 (95% CI 0.87–0.92), and 0.91 (95% CI 0.88–0.93); β value 0.97 (95% CI 0.74–1.2), 0.99 (95% CI 0.82–1.16), and 0.78 (95% CI 0.74–0.82); sensitivity 83% (95% CI 61–95), 91% (95% CI 84–96), and 89% (95% CI 80–94); and specificity 81% (95% CI 74–87), 76% (95% CI 74–78), and 80% (95% CI 79–82). ConclusionThe P-POSSUM score showed a good predictive capacity for postoperative mortality in COVID-19-positive patients submitted to emergency general and digestive surgery.

Comparison of risk scores for predicting outcomes after isolated tricuspid valve surgery.

Risk models play important roles in stratification and decision-making towards cardiac surgery. Isolated tricuspid valve surgery is a high risk but increasingly performed the operation, however, the performance of risk models has not been externally evaluated in these patients. We compared the prognostic utility of contemporary risk scores for isolated tricuspid valve surgery. Consecutive patients undergoing isolated tricuspid valve surgery at Cleveland Clinic during 2004-2018 were evaluated in this cohort study. EuroSCORE II, Society of Thoracic Surgeon's tricuspid (STS-TVS) score, and the Model for End-stage Liver Disease (MELD) score were retrospectively calculated, and their performance for predicting operative mortality, postoperative complications, and mortality during follow-up was assessed. Amongst 207 patients studied, the mean age was 54.1 ± 17.9 years, 116 (56.0%) were female, 92 (44.4%) had secondary tricuspid regurgitation, and 151 (72.9%) had a surgical repair. Mean EuroSCORE II, STS-TVS, and MELD scores were 6.3 ± 6.6%, 5.5 ± 6.2%, and 9.8 ± 4.7, respectively. C-statistics (95% confidence intervals) for operative mortality were 0.83 (0.74-0.93) for EuroSCORE II, 0.60 (0.45-0.75) for STS-TVS score, and 0.74 (0.58-0.89) for MELD score, while observed/expected ratios were 0.78 and 0.89 for the first two scores. All three scores were associated with mortality during follow-up and discriminated most postoperative complications. EuroSCORE II was superior to STS-tricuspid score for isolated TVS risk assessment. Although surgical risk scores traditionally underestimated operative mortality after isolated tricuspid valve surgery, they did not in our cohort, reflecting the excellent surgical results. The simple MELD score performed similarly to the EuroSCORE II, especially for discriminating morbidities.

EuroScore II is the best predictive model for the off pump coronary artery bypass graft surgery

Abstract Background Coronary artery bypass graft surgery (CABG) is the most common cardiac surgery performed in the world and a significant part of these surgeries are performed without cardiopulmonary bypass (off pump). Although none of the main surgical risk scores include pump use in their prediction model, the scores are widely used in risk stratification, including for patients who will be submitted to off pump CABG. Purpose To analyse and compare the predictive accuracy of EuroScore I, EuroScore II and STS Score for 30-day mortality after off pump CABG. Methods Single-centre cohort with 943 patients consecutively submitted to off pump CABG between January 2010 and December 2020. 31 baseline and operative variables were analysed. The primary outcome was the occurrence of death in the first 30 days after the surgery. Descriptive analysis, normality for quantitative data and univariate inference were performed to compare proportions and means between the survival group (n=930) and death group (n=13). Next, three logistic regression models were performed. Each of them had 30-day mortality as a dependent variable and one of the scores as an independent variable. The probabilities generated by the three models were saved and analysed by ROC curves. Thus, it was possible to assess the predictive accuracy of each of the scores. Finally, the values of the areas under the curves were compared using the DeLong test. The level of significance was 5% and the analysis was performed using the Python 3.0 programming language. Results The mean age of the general group was 63 years old and there was a predominance of male patients (68.4%). The means of the three evaluated risk scores were significantly higher in the Death group (p&amp;lt;0,05). This pattern confirmed the findings of higher prevalence of several comorbidities in the death group. The 30-day mortality rate was 1.37%. Through the analysis of regressions and the probabilities generated through them, it was possible to verify that the predictive accuracy of EuroScore II was significantly higher than that of the other two scores. While the predictive accuracy of EuroScore II was 77.3%, the accuracy of two other scores was in the range of 69% (AUC EsI: 0.697; AUC EsII: 0.773; AUC STS: 0.695; p=0.029). Conclusion EuroScore II seems to be the most adequate surgical risk score for the assessment of mortality risk of patients who will undergoing to off pump CABG. The score had a predictive accuracy of 77.3%, almost 8% more than the other two scores. Therefore, although EuroScore II does not include in its model the use of cardiopulmonary bypass, it has a satisfactory accuracy to be used in clinical-surgical practice. On the other hand, the EuroScore I and the STS Score showed predictive accuracy not adequate for this type of surgery. Funding Acknowledgement Type of funding sources: None. Predictive accuracies of risk scores

Management strategies for acutely decompensated aortic stenosis

Abstract Background Uncertainty exists over the optimal treatment strategy for patients presenting with acutely decompensated severe aortic stenosis (AS). The available options include a bridging balloon aortic valvuloplasty (BAV) or a direct transcatheter aortic valve implantation (TAVI). Purpose Our study compares TAVI outcomes in patients treated with two different strategies in acutely decompensated severe AS: bridged TAVI vs direct TAVI. Methods In this observational study all patients admitted with decompensated severe AS who underwent balloon aortic balloon valvuloplasty (BAV) and/or TAVI on the index admission were included. Comparison was made between bridged TAVI group (defined as initial BAV followed by TAVI) and direct TAVI group (TAVI on the index admission without bridging BAV). For this analysis we excluded patients in cardiogenic shock. Baseline characteristics, echocardiographic and periprocedural data were recorded in hospital database. Major adverse cardiovascular events (MACE) were defined as death, major bleeding, rehospitalisation for heart failure, or stroke). The follow-up data was obtained by outpatient visits and/or telephone calls. Results 178 patients with acutely decompensated AS were analysed: 58 bridged TAVI, 23 direct TAVI, 9 bridged SAVR and 88 destination BAV (defined as BAV non followed by a definite treatment). There was no statistically significant difference between bridged TAVI and direct TAVI group in mean age (83.6±6.6 vs 80.4±8.3 years), the prevalence major comorbidities (coronary, respiratory, neurological or peripheral vascular disease), renal function (eGFR 43.4±18.9 vs 45.2±20.9 ml/min/m2), the mean LV ejection fraction (53.4±13.8 vs 48.6±14.6%) or aortic valve gradient (39.4±13.0 vs 34.1±12.3mmHg), respectively. Direct TAVI patients had a higher mean surgical risk scores (STS 6.1±3.7 vs 9.1±7.0%, logES 18.8±11.5 vs 30.8±20.9%, p=0.01) and higher prevalence of significant aortic regurgitation (5% vs 43%, p=0.0001). The femoral TAVI access was used in 98% of bridged and 78% of direct TAVI patients (p=0.006). The estimated 1-year survival and 1-year MACE-free survival did not differ significantly between the bridged TAVI and direct TAVI groups (86.8% vs 78.3%, p=0.20 and 79.7% vs 64.2%, p=0.11, respectively). Conclusions A large proportion of patients admitted with acutely decompensated AS were not eligible for definite treatment. There is no difference in procedural success, 1-year all-cause mortality and 1-year major adverse cardiovascular events between the bridged TAVI or direct TAVI strategies in acute decompensated aortic stenosis allowing to personalize treatment strategy for individual patient. Funding Acknowledgement Type of funding sources: None. Table 1. Clinical and procedural data

Refined prediction and validation of individual risk using machine learning in transcatheter aortic valve implantation: TAVI Risk Machine (TRIM) scores

Abstract Background Given the recent option for treatment using TAVI irrespective of surgical risk, general surgical risk scores have become less relevant, while TAVI-specific scores require refinement. Additionally, post-TAVI risk models are lacking; however, such risk models can support decision between post-TAVI treatment approaches, such as early discharge or close surveillance. Purpose This study aimed to predict 30-day mortality following transcatheter aortic valve implantation (TAVI) based on machine learning (ML) using data from the German Aortic Valve Registry. Methods Mortality risk was determined using a random forest ML model that was condensed in the newly developed TAVI Risk Machine (TRIM) scores, designed to represent clinically meaningful risk modelling before (TRIMpre) and after (TRIMpost) TAVI. Algorithm was trained and cross-validated on data of 24,452 patients and generalisation was examined on data of 5,889 patients. Results TRIMpost demonstrated significantly better performance than traditional scores (C-statistics value, 0.79; 95% confidence interval [CI] [0.74; 0.83]). An abridged TRIMpost score comprising 25 features (calculated using a web interface) exhibited significantly higher performance than traditional scores (C-statistics value, 0.74; 95% CI [0.70; 0.78]). Conclusion TRIM scores have high performance for risk estimation before and after TAVI. Together with clinical judgement, they may support standardised and objective decision-making before and after TAVI. Funding Acknowledgement Type of funding sources: None.

Development and Validation of a Novel Nomogram for Preoperative Prediction of In-Hospital Mortality After Coronary Artery Bypass Grafting Surgery in Heart Failure With Reduced Ejection Fraction.

Background and Aims: Patients with heart failure with reduced ejection fraction (HFrEF) are among the most challenging patients undergoing coronary artery bypass grafting surgery (CABG). Several surgical risk scores are commonly used to predict the risk in patients undergoing CABG. However, these risk scores do not specifically target HFrEF patients. We aim to develop and validate a new nomogram score to predict the risk of in-hospital mortality among HFrEF patients after CABG.Methods: The study retrospectively enrolled 489 patients who had HFrEF and underwent CABG. The outcome was postoperative in-hospital death. About 70% (n = 342) of the patients were randomly constituted a training cohort and the rest (n = 147) made a validation cohort. A multivariable logistic regression model was derived from the training cohort and presented as a nomogram to predict postoperative mortality in patients with HFrEF. The model performance was assessed in terms of discrimination and calibration. Besides, we compared the model with EuroSCORE-2 in terms of discrimination and calibration.Results: Postoperative death occurred in 26 (7.6%) out of 342 patients in the training cohort, and in 10 (6.8%) out of 147 patients in the validation cohort. Eight preoperative factors were associated with postoperative death, including age, critical state, recent myocardial infarction, stroke, left ventricular ejection fraction (LVEF) ≤35%, LV dilatation, increased serum creatinine, and combined surgery. The nomogram achieved good discrimination with C-indexes of 0.889 (95%CI, 0.839–0.938) and 0.899 (95%CI, 0.835–0.963) in predicting the risk of mortality after CABG in the training and validation cohorts, respectively, and showed well-fitted calibration curves in the patients whose predicted mortality probabilities were below 40%. Compared with EuroSCORE-2, the nomogram had significantly higher C-indexes in the training cohort (0.889 vs. 0.762, p = 0.005) as well as the validation cohort (0.899 vs. 0.816, p = 0.039). Besides, the nomogram had better calibration and reclassification than EuroSCORE-2 both in the training and validation cohort. The EuroSCORE-2 underestimated postoperative mortality risk, especially in high-risk patients.Conclusions: The nomogram provides an optimal preoperative estimation of mortality risk after CABG in patients with HFrEF and has the potential to facilitate identifying HFrEF patients at high risk of in-hospital mortality.

Current treatment of symptomatic aortic stenosis in elderly patients: Do risk scores really matter after 80 years of age?

According to the guidelines, surgical aortic valve replacement (SAVR) is recommended in patients at low surgical risk (EuroSCORE II<4%), whereas for other patients, the decision between transcatheter aortic valve implantation (TAVI) and surgery should be made by the Heart Team, with TAVI being favoured in elderly patients. The RAC prospective multicentre survey assessed the respective contributions of age and surgical risk scores in therapeutic decision making in elderly patients with severe symptomatic aortic stenosis. In September and October 2016, 1049 consecutive patients aged ≥ 75 years were included in 32 centres with on-site TAVI and surgical facilities. The primary endpoint was the decision between medical management, TAVI or SAVR. Mean age was 84±5 years and 53% of patients were female. The surgical risk was classified as high (EuroSCORE II>8%) in 18% of patients, intermediate (EuroSCORE II 4-8%) in 34% and low (EuroSCORE II≤4%) in 48%. TAVI was preferred in 71% of patients, SAVR in 19% and medical treatment in 10%. The choice of TAVI over SAVR was associated with older age (P<0.0001) and a higher EuroSCORE II (P=0.008). However, the weight of EuroSCORE II in therapeutic decision making markedly decreased after the age of 80 years. Indeed, 77% of patients aged ≥ 80 years were referred for TAVI, despite a low estimated surgical risk. The impact of risk scores depends strongly on age, and decreases considerably after 80 years, most patients being referred for TAVI, independent of their estimated surgical risk. Despite medical advancements, 10% of patients were still denied any intervention.

Abstracts of the Annual Congress 2021 23‐24 September 2021, virtual conference

COVID-19 has led to a reduction in beds for elective surgery requiring postoperative level 2 or 3 care such as those undergoing pancreatoduodenectomy (PD) [1]. A post-anaesthetic care unit (PACU) has been established to deliver level 2 care for up to 23 h in order to reduce the requirement for critical care services. The aim of this study is to identify factors associated with successful discharge from PACU to the ward after PD surgery. Methods We conducted a single-centre retrospective observational study that utilised a prospectively maintained database of patients undergoing PD from December 2019 to January 2020. Data regarding duration of postoperative respiratory, cardiovascular and renal support requirements, epidural status and comorbidity details were obtained. These were compared between PD alone, PD with vein resection, PD and visceral resection and PD with arterial resection. Patients were categorised as 'suitable for PACU' if they met all of the pre-specified criteria: (1) inotropic support for ≥ 20 h, (2) no respiratory support and (3) no renal support. Binomial logistic regression was used to determine the suitability for PACU using gender, age, body mass index (BMI), Charlson Comorbidity Index (CCI), epidural status, Surgical Outcome Risk Score (SORT) and length of operation as independent variables of interest. Results There were 175 patients, of which 86 (49%) were categorised as 'suitable for PACU' after PD. Suitability for PACU was more likely with shorter operating times (p < 0.001), but less likely for male patients (p = 0.003) and with epidural analgesia (p = 0.002). PD with venous resection patients had a longer period of postoperative inotropy compared with those without venous resection. Discussion The high incidence of patients requiring organ support beyond 23 h suggests that PACU admission for PD patients will require a modification of current practice. It may not be appropriate to admit PD with venous resection to PACU. Epidural analgesia may not be appropriate for patients going to PACU, but further investigations are required to determine optimal analgesic solutions [2].

Stroke Severity in Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement: A Systematic Review and Meta-Analysis

ObjectivesAn assessment of the comparative incidence of fatal or disabling stroke may influence choice of intervention for patients with severe aortic stenosis. We explored whether transcatheter aortic valve implantation (TAVI) is associated with a lower incidence of fatal or disabling stroke, compared to surgical aortic valve replacement (SAVR). Materials & MethodsWe classified stroke into two categories; fatal or disabling, or non-disabling, and completed meta-analyses for each. We explored randomised controlled trials to assess the effect publication year, predicted operative risk, and route of TAVI access. ResultsThere was no difference between treatment groups per 100 person years of follow up for disabling or non-disabling stroke outcomes. In a stratified analysis by year of publication, there was a lower rate of fatal or disabling stroke with TAVI in trials published after 2015, compared to those published in 2015 or before (p-interaction = 0.01 at 30 days). Higher proportions of transfemoral route access (>90%), more common in recent trials, were associated with a lower rate of fatal or disabling stroke (p-interaction = 0.03 at 30 days). Lower average surgical risk scores were associated with lower rates of fatal or disabling stroke (p = 0.02 at 30 days). ConclusionWe found that treatment of aortic stenosis with TAVI compared with SAVR was not associated with an overall reduced risk in fatal or disabling stroke. Subgroup analyses suggested a lower risk of fatal or disabling stroke with TAVI in situations which reflect contemporary practice.

Risk Prediction Models for Postoperative Decompensation and Infection in Patients With Cirrhosis: A Veterans Affairs Cohort Study

Patients with cirrhosis have an increased risk of postoperative mortality for a range of surgeries; however, they are also at risk of postoperative complications such as infection and cirrhosis decompensation. To date, there are no prediction scores that specifically risk stratify patients for these morbidities. This was a retrospective study using data of patients with cirrhosis who underwent diverse surgeries in the Veterans Health Administration. Validated algorithms and/or manual adjudication were used to ascertain postoperative decompensation and postoperative infection through 90 days. Multivariable logistic regression was used to evaluate prediction models in derivation and validation sets using variables from the recently-published Veterans Outcomes and Costs Associated with Liver Disease (VOCAL)-Penn cirrhosis surgical risk scores for postoperative mortality. Models were compared with the Mayo risk score, Model for End-stage Liver Disease (MELD)-sodium, and Child-Turcotte-Pugh (CTP) scores. A total 4712 surgeries were included; patients were predominantly male (97.2%), white (63.3%), and with alcohol-related liver disease (35.3%). Through 90 postoperative days, 8.7% of patients experienced interval decompensation, and 4.5% infection. Novel VOCAL-Penn prediction models for decompensation demonstrated good discrimination for interval decompensation (C-statistic 0.762 vs 0.663 Mayo vs 0.603 MELD-sodium vs 0.560 CTP; P < .001); however, discrimination was only fair for postoperative infection (C-statistic 0.666 vs 0.592 Mayo [P= .13] vs 0.502 MELD-sodium [P < .001] vs 0.503 CTP [P < .001]). The model for interval decompensation had excellent calibration in both derivation and validation sets. We report the derivation and internal validation of a novel, parsimonious prediction model for postoperative decompensation in patients with cirrhosis. This score demonstrated superior discrimination and calibration as compared with existing clinical standards, and will be available at www.vocalpennscore.com.

External Validation of the VOCAL‐Penn Cirrhosis Surgical Risk Score in 2 Large, Independent Health Systems

Cirrhosis poses an increased risk of postoperative mortality, yet it remains challenging to accurately risk stratify patients in clinical practice. The VOCAL‐Penn cirrhosis surgical risk score was recently developed and internally validated in the national Veterans Affairs health system; however, to date this score has not been evaluated in independent cohorts. The goal of this study was to compare the predictive performance of the VOCAL‐Penn to the Mayo risk, Model for End‐Stage Liver Disease (MELD), and MELD‐sodium (MELD‐Na) scores in 2 large health systems. We performed a retrospective cohort study of patients with cirrhosis undergoing surgical procedures of interest at the Beth Israel Deaconess Medical Center or University of Pennsylvania Health System from January 1, 2008, to October 1, 2015. The outcomes of interest were 30‐day and 90‐day postoperative mortality. Concordance statistics (C‐statistics), calibration curves, Brier scores, and the index of prediction accuracy (IPA) were compared for each predictive model. A total of 855 surgical procedures were identified. The VOCAL‐Penn score had the numerically highest C‐statistic for 90‐day postoperative mortality (eg, 0.82 versus 0.79 Mayo versus 0.78 MELD‐Na versus 0.79 MELD), although differences were not statistically significant. Calibrations were excellent for the VOCAL‐Penn, MELD, and MELD‐Na; however, the Mayo score consistently overestimated risk. The VOCAL‐Penn had the lowest Brier score and highest IPA at both time points, suggesting superior overall predictive model performance. In subgroup analyses of patients with higher MELD scores, the VOCAL‐Penn had significantly higher C‐statistics compared with the MELD and MELD‐Na. The VOCAL‐Penn score (www.vocalpennscore.com) has excellent discrimination and calibration for postoperative mortality among diverse patients with cirrhosis. Overall performance is superior to the Mayo, MELD, and MELD‐Na scores. In contrast to the MELD/MELD‐Na, the VOCAL‐Penn retains excellent discrimination among patients with higher MELD scores.

Abnormal Microarray, Clinical Outcomes, and Surgical Risk Scores in Young Children with Cardiac Disease.

The clinical implications of abnormal chromosomal microarray (CMA) remain unclear for children less than 1year of age with critical heart disease. Our objective was to determine whether abnormal CMA was related to surgical severity scores or to pre-determined clinical outcomes, including cardiac arrest. Retrospective review of children under 1year of age admitted to a pediatric cardiac intensive care unit from December, 2014 to September, 2017. Associations between CMA result and cardiac arrest, syndromic abnormalities, and extracardiac anomalies were evaluated. A simple and multivariable logistic regression model was used to analyze associations between STAT mortality category and CMA result. The overall prevalence of abnormal microarray was 48/168 (29%), with peak prevalence in AV septal defects and left-sided obstructive lesions. There was no statistical association between surgical severity scores and abnormal CMA (STAT 1/2 vs. 3+, odds ratio 0.56, p = 0.196). Abnormal CMA was associated with a higher prevalence of cardiac arrest (5/48 abnormal CMA vs. 2/120 normal CMA, p = 0.02). Abnormal CMA was associated with a higher frequency of syndromic abnormalities (18/48 abnormal CMA vs. 13/120 normal CMA, p < 0.001). There was a high prevalence of abnormal CMA findings in the pediatric cardiac population less than 1year of age (29%), associated with cardiac arrest, but not associated with surgical risk score. The absence of a standardized protocol for ordering a CMA in the setting of congenital heart disease results in a highly variable prevalence data.

Predictors of Surgical Difficulty in Laparoscopic Total Mesorectal Excision.

Concerns have been raised regarding the oncological safety of laparoscopic total mesorectal excision (TME) as compared to an open approach. This study aimed to identify risk factors for surgically difficult laparoscopic TME. All consecutive laparoscopic rectal cancer cases were included from a prospectively maintained colorectal cancer database. The primary outcome was to identify risk factors for surgically difficult TME. A Surgical Difficulty Risk Score (SDRS) between 0 and 6 was calculated for each case with cases achieving an SDRS of 2 or greater being deemed as surgically difficult. A total of 2795 consecutive cases of laparoscopic TME were identified, with 464 (16.6%) surgically difficult cases. Univariate analysis found that operating in the male pelvis, performing abdomino-perineal resections, Hartmann's procedures, and proctocolectomies were all significantly associated with higher operative difficulty (P &lt; 0.001). A higher nodal stage of cancer (P = 0.046), and the resection of another organ (P = 0.003) were significantly associated with higher surgical difficulty. On multivariate analysis, a female pelvis was associated with a favorable laparoscopic resection (Odds ratio [OR] 0.54, 95% CI 0.43-0.67, P &lt; 0.001), whereas patients who had another organ resection (OR 2.6, 95% CI 1.53-4.42, P &lt; 0.001), nodal positivity (OR 1.37, 95% CI 1.11-1.69, P = 0.003), and high ASA scores had more difficult surgeries. Predictive factors for surgically difficult laparoscopic TME include male gender, high ASA scores, mid and low rectal cancer, positive nodal stage, and resection of another organ at time of surgery.

Perioperative pharmacokinetic-guided factor VIII concentrate dosing in haemophilia (OPTI-CLOT trial): an open-label, multicentre, randomised, controlled trial

Dosing of replacement therapy with factor VIII concentrate in patients with haemophilia A in the perioperative setting is challenging. Underdosing and overdosing of factor VIII concentrate should be avoided to minimise risk of perioperative bleeding and treatment costs. We hypothesised that dosing of factor VIII concentrate on the basis of a patient's pharmacokinetic profile instead of bodyweight, which is standard treatment, would reduce factor VIII consumption and improve the accuracy of attained factor VIII levels. In this open-label, multicentre, randomised, controlled trial (OPTI-CLOT), patients were recruited from nine centres in Rotterdam, Groningen, Utrecht, Nijmegen, The Hague, Leiden, Amsterdam, Eindhoven, and Maastricht in The Netherlands. Eligible patients were aged 12 years or older with severe or moderate haemophilia A (severe haemophilia was defined as factor VIII concentrations of <0·01 IU/mL, and moderate haemophilia as 0·01-0·05 IU/mL), without factor VIII inhibitors, and planned for elective low or medium risk surgery as defined by surgical risk score. Patients were randomly assigned (1:1) using a web-based randomisation system and treatment minimisation, stratified by method of administration of factor VIII concentrate (continuous infusion vs bolus administration) and risk level of surgery (low and medium risk surgery), to the pharmacokinetic-guided or standard treatment group. The primary endpoint was total amount of infused factor VIII concentrate (IU per kg bodyweight) during perioperative period (from day of surgery up to 14 days after surgery). Analysis was by intention to treat and the safety analysis population comprised all participants who underwent surgery with factor VIII concentrate. This study is registered with the Netherlands Trial Registry, NL3955, and is now closed to accrual. Between May 1, 2014, and March 1, 2020, 98 patients were assessed for eligibility and 66 were enrolled in the trial and randomly assigned to the pharmacokinetic-guided treatment group (34 [52%]) or the standard treatment group (32 [48%]). Median age was 49·1 years (IQR 35·0 to 62·1) and all participants were male. No difference was seen in consumption of factor VIII concentrate during the perioperative period between groups (mean consumption of 365 IU/kg [SD 202] in pharmacokinetic-guided treatment group vs 379 IU/kg [202] in standard treatment group; adjusted difference -6 IU/kg [95% CI -88 to 100]). Postoperative bleeding occurred in six (18%) of 34 patients in the pharmacokinetic-guided treatment group and three (9%) of 32 in the standard treatment group. One grade 4 postoperative bleeding event occurred, which was in one (3%) patient in the standard treatment group. No treatment-related deaths occurred. Although perioperative pharmacokinetic-guided dosing is safe, it leads to similar perioperative factor VIII consumption when compared with standard treatment. However, pharmacokinetic-guided dosing showed an improvement in obtaining factor VIII concentrations within the desired perioperative factor VIII range. These findings provide support to further investigation of pharmacokinetic-guided dosing in perioperative haemophilia care. Dutch Research Council (NWO)-ZonMw and Takeda.

Cirugía valvular tricúspide aislada. Resultados perioperatorios y supervivencia a medio plazo

Introduction and objectivesIsolated tricuspid valve surgery (TVS) is an infrequent procedure, and it is considered that it entails a high surgical mortality. The objective is to analyze the medium-term survival, and to determine the variables that impact perioperative and medium-term survival. The predictive accuracy of the usual surgical risk scores was also evaluated. MethodsUnicentric, observational retrospective study, which included all the patients operated on isolated TVS since 2012 to January 2020. Perioperative mortality was analyzed through logistic regression, and long-term survival was analyzed using the Kaplan-Meier survival curves. Results51 patients were operated on isolated TVS (18 annuloplasties and 33 replacements for prosthetic valves).The study population consisted of a 62.75% of female, with a mean age of 66.07 years (SD 10.57). In the 54% of the cases, the patient was in NYHA functional class of III-IV.Observed in-hospital mortality was 7.8%. The variables with a strongest association with perioperative mortality were a NYHA functional class of III-IV (0% vs 14.3% mortality; p Fisher=0.13) and preoperative anemia (OR: 11.1; CI 95%: 1.04-118.6; p=0.046).Complete clinical follow-up was achieved in the 94.1% of the study population, with a median follow-up of 26 months (interquartile interval 12-57 months). Overall survival was 90.1%, 84.3%, 80.2%, 75.2% at 1, 2, 3 and 4 years. In the final follow-up, 75% of the patients were in NYHA functional class I-II. ConclusionsPreoperative NYHA functional class and preoperative anemia are determining factors for early postoperative survival. Medium-term survival and NYHA improvement after isolated TVS are satisfactory.

Bias estimation in study design: a meta-epidemiological analysis of transcatheter versus surgical aortic valve replacement

BackgroundPaucity of RCTs of non-drug technologies lead to widespread dependence on non-randomized studies. Relationship between nonrandomized study design attributes and biased estimates of treatment effects are poorly understood. Our purpose was to estimate the bias associated with specific nonrandomized study attributes among studies comparing transcatheter aortic valve implantation with surgical aortic valve replacement for the treatment of severe aortic stenosis.ResultsWe included 6 RCTs and 87 nonrandomized studies. Surgical risk scores were similar for comparison groups in RCTs, but were higher for patients having transcatheter aortic valve implantation in nonrandomized studies. Nonrandomized studies underestimated the benefit of transcatheter aortic valve implantation compared with RCTs. For example, nonrandomized studies without adjustment estimated a higher risk of postoperative mortality for transcatheter aortic valve implantation compared with surgical aortic valve replacement (OR 1.43 [95% CI 1.26 to 1.62]) than high quality RCTs (OR 0.78 [95% CI 0.54 to 1.11). Nonrandomized studies using propensity score matching (OR 1.13 [95% CI 0.85 to 1.52]) and regression modelling (OR 0.68 [95% CI 0.57 to 0.81]) to adjust results estimated treatment effects closer to high quality RCTs. Nonrandomized studies describing losses to follow-up estimated treatment effects that were significantly closer to high quality RCT than nonrandomized studies that did not.ConclusionStudies with different attributes produce different estimates of treatment effects. Study design attributes related to the completeness of follow-up may explain biased treatment estimates in nonrandomized studies, as in the case of aortic valve replacement where high-risk patients were preferentially selected for the newer (transcatheter) procedure.

Expert Consensus on Sizing and Positioning of SAPIEN 3/Ultra in Bicuspid Aortic Valves.

Severe aortic stenosis patients with bicuspid anatomy have been excluded from the major transcatheter aortic valve replacement (TAVI) randomized clinical trials. As a result, there is no official recommendation on bicuspid TAVI. A panel of bicuspid experts was created to fill this gap. In this consensus statement, an algorithm is proposed to guide the choice of surgery or TAVI within this complex patient population, depending on aortic dilatation, age, surgical risk score, and anatomy. A step-by-step guide for sizing and positioning of the SAPIEN 3/Ultra TAVI bioprostheses is presented. Annular sizing remains the primary strategy in most bicuspid patients. However, some anatomies may require sizing at the supra-annular level, for which patients the panel recommends the circle method, a dedicated sizing and positioning approach for SAPIEN 3/Ultra. The consensus provides valuable pre-operative insights on the interactions between SAPIEN 3/Ultra and the bicuspid anatomy; understanding the valve–anatomy relationship is critical to avoid complications and to optimize outcomes for patients.

Risk scores for prediction of 30-day mortality after transcatheter aortic valve implantation: Results from a two-center study in Norway.

ObjectivesTranscatheter aortic valve implantation (TAVI)‐specific risk scores have been developed based on large registry studies. Our aim was to evaluate how both surgical and novel TAVI risk scores performed in predicting all cause 30‐day mortality. In addition, we wanted to explore the validity of our own previously developed model in a separate and more recent cohort.MethodsThe derivation cohort included patients not eligible for open surgery treated with TAVI at the University Hospital of North Norway (UNN) and Oslo University Hospital (OUS) from February 2010 through June 2013. From this cohort, a logistic prediction model (UNN/OUS) for all cause 30‐day mortality was developed. The validation cohort consisted of patients not included in the derivation cohort and treated with TAVI at UNN between June 2010 and April 2017. EuroSCORE, Logistic EuroSCORE, EurosSCORE 2, STS score, German AV score, OBSERVANT score, IRRMA score, and FRANCE‐2 score were calculated for both cohorts. The discriminative accuracy of each score, including our model, was evaluated by receiver operating characteristic (ROC) analysis and compared using DeLong test where P< .05 was considered statistically significant.ResultsThe derivation cohort consisted of 218 and the validation cohort of 241 patients. Our model showed statistically significant better accuracy than all other scores in the derivation cohort. In the validation cohort, the FRANCE‐2 had a significantly higher predictive accuracy compared to all scores except the IRRMA and STS score. Our model showed similar results.ConclusionExisting risk scores have shown limited accuracy in predicting early mortality after TAVI. Our results indicate that TAVI‐specific risk scores might be useful when evaluating patients for TAVI.