Treatment Of High-risk Patients Research Articles

Catching Gall Bladder Cancer Early- Importance of Cholelithiasis and Radiologist

Introduction: Increased relative risk of Gall Bladder (GB) cancer in patients with gall stones has been reported in literature but there are few reports on nature of stones. However, it is difficult to predict which patient suffering from cholelithiasis and cholecystitis may develop or already has early stages of carcinoma. Aim: The present study was undertaken to assess the malignant potential and relevance of gall stones, age and gender in GB carcinoma to propose a screening protocol and early intervention for high risk patients. Materials and Methods: This was a retrospective study done at Moti Lal Nehru Medical College, Prayagraj, Uttar Pradesh, India from May 2012 to May 2019. This study included 200 histopathologically- Fine Needle Aspiration Cytology (FNAC) or postoperative specimen biopsy proven GB carcinoma and 200 control patients with upper abdominal pain but without any evidence of neoplastic changes on USG. All cases and controls were subjected to USG evaluation first followed by plain CT scan with oral contrast only and Contrast Enhanced CT (CECT) scan of whole abdomen as per protocol. Scans were evaluated for detection of gall stone profile in terms of number (solitary/multiple), size (small/large) and density (radio-opaque/ radiolucent). The statistical analysis was done by using IBM Statistical Package for the Social Sciences (SPSS) version 18.0. Results: Male to female ratio in this study was 1:2. GB calculi cannot be considered as bystander as overall 25% patients of both sexes had cholelithiasis. In the present study, 25% who were having carcinoma GB have been detected to have gall stones and out of which 74% were having small calculi. The study showed the association between GB cancer and solitary and multiple large calculi over different age groups to be not statistically significant (p-value=0.3976; χ2=0.716). Association of small and multiple calculi came out to be highly significantly associated with carcinoma in 67% of patients. Furthermore, it was observed that the association between multiple small calculi and GB cancer over the different age groups came out to be extremely statistically significant (p-value=0.0001; χ2=28.62). The association between gall stones in GB cancer patients differ statistically significant over the age groups from cases with gall stones in control group (p-value=0.005497; χ2=7.7082). Conclusion: From the findings of the study author proposed screening via ultrasound and guided FNAC for females over 40 years of age with multiple small calculi not undergoing immediate cholecystectomy to detect early emergence of carcinoma. It is also suggested that clinicians should post patients with multiple, small GB calculi for cholecystectomy on a priority basis and histopathology should be done in each case of GB wall thickening.

Long-term Outcomes of Clopidogrel Monotherapy versus Prolonged Dual Antiplatelet Therapy beyond 12 Months after Percutaneous Coronary Intervention in High-risk Patients.

BackgroundThere are no data on comparison between clopidogrel monotherapy and prolonged dual antiplatelet therapy (DAPT) in patients at high-risk undergoing percutaneous coronary intervention (PCI).MethodsOf 2,082 consecutive patients undergoing PCI using second-generation drug-eluting stent (DES), we studied 637 patients at high-risk either angiographically or clinically who received clopidogrel longer than 24 months and were event-free at 12 months after index PCI. Patients were divided into 2 groups: the clopidogrel monotherapy group and the prolonged DAPT group. The primary outcome was a composite of all-cause death, non-fatal myocardial infarction (MI), definite or probable stent thrombosis, or stroke between 12 months and 36 months after the index PCI.ResultsIn propensity score-matched population (246 pairs), the cumulative rate of primary outcome was 4.5% in the clopidogrel monotherapy group and 4.9% in the prolonged DAPT group (hazard ratio, 1.21; 95% confidence interval, 0.54–2.75; P = 0.643). There was no significant difference in all-cause death, MI, stent thrombosis, stroke between the clopidogrel monotherapy group and the prolonged DAPT group.ConclusionCompared with prolonged DAPT, clopidogrel monotherapy showed similar long-term outcomes in patients at high-risk after second-generation DES implantation.

Ethnic Difference of Thrombogenicity in Patients with Cardiovascular Disease: a Pandora Box to Explain Prognostic Differences.

Arterial and venous atherothrombotic events are finely regulated processes involving a complex interplay between vulnerable blood, vulnerable vessel, and blood stasis. Vulnerable blood ('thrombogenicity') comprises complex interactions between cellular components and plasma factors (inflammatory, procoagulant, anticoagulant, and fibrinolytic factors). The extent of thrombogenicity may determine the progression of atheroma and the clinical manifestation of atherothrombotic events, with the highest thrombogenicity in African Americans and lowest in East Asians. Inherent thrombogenicity may influence clinical efficacy and safety of specific antithrombotic treatments in high-risk patients, which may in part explain the observation that East Asian patients have reduced anti-ischemic benefits and elevated bleeding risk with antithrombotic therapy compared to Caucasian patients. In this review, we discuss available evidence regarding the racial differences in thrombogenicity and its impact on clinical outcomes among patients with atherosclerotic cardiovascular disease.

In-Hospital and Mid-Term Outcomes of ECMO Support During Coronary, Structural, or Combined Percutaneous Cardiac Intervention in High-Risk Patients – A Single-Center Experience

IntroductionEvidence regarding the impact of prophylactic implantation of Extracorporeal Membrane Oxygenation (ECMO) during coronary or structural procedures is limited. The purpose of this paper is to evaluate the in-hospital and medium term outcomes of ECMO support in complex percutaneous coronary or structural intervention. MethodsThe present is an observational prospective study including consecutive patients who underwent to prophylactic ECMO implantation for percutaneous coronary intervention (PCI), structural or combined interventions between July 2018 and July 2020 in Maria Pia Hospital GVM Care & Research, Turin, Italy. Primary endpoints were in-hospital and medium term all-cause death. Secondary endpoints were vascular complication, bleeding and procedural success. Results27 patients were included with a mean age of 80 ± 6 years, 10 (37%) being diabetics and 19 (70%) with severe left ventricle dysfunction. Mean Logistic Euroscore was 28.7 ± 18.7. Seven patients (26%) underwent complex coronary revascularization, 7 (26%) combined PCI + TAVI, 5 (19%) combined PCI + Mitraclip, 5 (19%) TAVI alone and finally 3 (11%) combined TAVI + Mitraclip. The procedural success was 96%, with only one in-hospital death due to major vascular complication at the ECMO vascular access. At a mean follow-up of 11 ± 6.8 months 4 deaths were recorded (3 from not cardiovascular causes). ConclusionsProphylactic use of ECMO may be beneficial for high risk patients undergoing complex combined coronary/structural percutaneous interventions with good in-hospital and mid-term outcomes in term of safety and procedural success.

Association between ionised calcium and severity of postpartum haemorrhage: a retrospective cohort study

BackgroundPostpartum haemorrhage (PPH) is often complicated by impaired coagulation. We aimed to determine whether the level of ionised calcium (Ca2+), an essential coagulation co-factor, at diagnosis of PPH is associated with bleeding severity. MethodsThis was a retrospective cohort study of women diagnosed with PPH during vaginal delivery between January 2009 and April 2020. Ca2+ levels at PPH diagnosis were compared between women who progressed to severe PPH (primary outcome) and those with less severe bleeding. Severe PPH was defined by transfusion of ≥2 blood units, arterial embolisation or emergency surgery, admission to ICU, or death. Associations between other variables (e.g. fibrinogen concentration) and bleeding severity were also assessed. ResultsFor 436 patients included in the analysis, hypocalcaemia was more common among patients with severe PPH (51.5% vs 10.6%, P<0.001). In a multivariable logistic regression model, Ca2+ and fibrinogen were the only parameters independently associated with PPH severity with odds ratios of 1.14 for each 10 mg dl−1 decrease in fibrinogen (95% confidence interval [CI], 1.05–1.24; P=0.002) and 1.97 for each 0.1 mmol L−1 decrease in Ca2+ (95% CI, 1.25–3.1; P=0.003). The performance of Ca2+ or fibrinogen was not significantly different (area under the curve [AUC]=0.79 [95% CI, 0.75–0.83] vs AUC=0.86 [95% CI, 0.82–0.9]; P=0.09). The addition of Ca2+ to fibrinogen improved the model, leading to AUC of 0.9 (95% CI, 0.86–0.93), P=0.03. ConclusionsCa2+ level at the time of diagnosis of PPH was associated with risk of severe bleeding. Ca2+ monitoring may facilitate identification and treatment of high-risk patients.

Benefits and Risks of Prolonged Duration Dual Antiplatelet Therapy (Clopidogrel and Aspirin) After Percutaneous Coronary Intervention in High-Risk Patients With Diabetes Mellitus

The efficacy and safety of prolonged (>1-year) dual antiplatelet therapy (DAPT) duration in high-risk patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) remain unknown. All patients undergoing PCI at Fuwai hospital between January 2013 and December 2013 were prospectively enrolled into the Fuwai PCI registry. A total of 3,696 high-risk diabetics patients with at least one additional atherothrombotic risk factor were screened for inclusion. The primary efficacy outcome was the composite of all-cause mortality, myocardial infarction, or stroke. The median follow-up duration was 887 days. 69.8% of DM patients were on DAPT at 1 year without discontinuation. Based on multivariate Cox regression model and inverse probability of treatment weighting (IPTW) analysis, long-term (>1-year) DAPT reduced the risk of primary efficacy outcome (1.7% vs 4.1%; adjusted hazard ratio [adjHR]: 0.382, 95% confidence interval [CI]: 0.252 to 0.577; IPTW-HR: 0.362 [0.241 to 0.542]), as well as cardiovascular death and definite/probable stent thrombosis, compared with short-course (≤1-year) DAPT. Risk of the safety end point of clinically relevant bleeding (adjHR: 0.920 [0.467 to 1.816]; IPTW-HR: 0.969 [0.486 to 1.932]) was comparable between longer DAPT and shorter DAPT. A lower number of net clinical benefit adverse outcomes was observed with >1-year DAPT versus ≤1-year DAPT (adjHR: 0.471 [0.331 to 0.671]; IPTW-HR: 0.462 [0.327 to 0.652]), which appeared increasingly favorable in those with multiple atherothrombotic risk characteristics. In high-risk patients with DM receiving PCI who were event free at 1 year, DAPT prolongation resulted in significant reduction in the risk of ischemic events not offset by increase of clinically meaningful bleeding events, thereby achieving a net clinical benefit. Extending DAPT beyond the period mandated by guidelines seems reasonable in high-risk DM patients not deemed at high bleeding risk.

Abstract 13274: Predictors of Mortality in Critically Ill Covid-19 Patients - A Multicenter Prospective Analysis of 159 Patients

Introduction: Certain patient demographics and biomarkers have been shown to predict survival in patients infected with COVID-19. However, predictors of outcome in patients who are critically ill and require advanced respiratory support are unclear. Methods: We performed a multicenter analysis of 159 consecutive patients with confirmed COVID-19 who were admitted to Intensive Care Unit (ICU) between March 01, 2020 and April 30, 2020. Patients were then followed until May 23, 2020. Demographic data (age, sex, race, BMI) and past medical history (hypertension, diabetes, COPD, CKD, history of cardiac ischemic disease, atrial fibrillation and heart failure) were recorded. Laboratory values (troponin, CPK, pro-BNP, ferritin, LDH and d-dimer) were analyzed. Patient status was classified as either alive or deceased at hospital discharge or the end of follow up period. Results: Mean patient age was 66+/-15 and 53% were male. Mean BMI was 31+/- 9. Mean hospital ICU stay was 11+/-8 days. Mortality rate of this ICU cohort at the end of follow-up was 63%. Fifty-five (34%) patients were discharged from the hospital. A multivariable logistic regression analysis identified four factors (age, prior history of diabetes, prior history of atrial fibrillation and elevated troponin) that had significant and independent contributions to the likelihood of survival. Each increase in decade of age above 40 (p = 0.010) was predicted to reduce survival by 30%, the presence of diabetes (p = 0.041) by 57%, a prior history of atrial fibrillation (p= 0.011) by 75%, and each increase of 0.1 ng/mL of troponin above 0.05 ng/ml (p = 0.001) by 55%. Conclusion: Mortality of critically ill COVID-19 patients is high. Early aggressive treatment of high-risk patients identified in this study (advanced age, history of diabetes and atrial fibrillation and elevated troponin) could improve clinical outcome. The highly predictive value of elevated troponin levels on survival may indicate cardiac involvement of COVID-19 infection as a determinant of mortality. Additionally, of available published literature at this time, this is the first study that suggests a relationship between atrial fibrillation and increased mortality from COVID-19. Larger studies are needed to confirm these findings.

Early Sequential Risk Stratification Assessment to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children with Acute Kidney Injury: Taking Focus 2 Process Article.

Acute Kidney Injury (AKI) is common in critically ill children and is associated with increased morbidity and mortality. Recognition and management of AKI is often delayed, predisposing patients to risk of clinically significant fluid accumulation (Fluid Overload (FO)). Early recognition and intervention in high risk patients could decrease fluid associated morbidity. We aim to assess an AKI Clinical Decision Algorithm (CDA) using a sequential risk stratification strategy integrating the Renal Angina Index (RAI), urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) and the Furosemide Stress Test (FST) to optimize AKI and FO prediction and management in critically ill children. This single center prospective observational cohort study evaluates the AKI CDA in a Pediatric Intensive Care Unit (PICU). Every patient ≥ 3 months old has the risk score RAI calculated automatically at 12 hours of admission. Patients with a RAI ≥ 8 (fulfilling renal angina) have risk further stratified with a urine NGAL and, if positive (NGAL ≥ 150ng/mL), subsequently by their response to a standardized dose of furosemide (namely FST). RAI negative or NGAL negative patients are treated per usual care. FST-responders are managed conservatively, while non-responders receive fluid restrictive strategy and/or continuous renal replacement therapy (CRRT) at 10%-15% of FO. 2100 patients over 3 years will be evaluated to capture 210 patients with severe AKI (KDIGO Stage 2 or 3 AKI), 100 patients with >10% FO, and 50 requiring CRRT. Primary analyses: Standardizing a pediatric FST and assessing prediction accuracy of CDA for severe AKI, FO>10% and CRRT requirement in children. Secondary analyses in patients with AKI: Renal function return to baseline, RRT and mortality within 28 days. This will be the first prospective evaluation of feasibility of AKI CDA, integrating individual prediction tools in one cohesive and comprehensive approach, and its prediction of FO>10% and AKI, as well as the first to standardize the FST in the pediatric population. This will increase knowledge on current AKI prediction tools and provide actionable insight for early interventions in critically ill children based on their level of risk.

Determinants of Choice of Front-Line Tyrosine Kinase Inhibitor for Chronic Phase CML: A Study from the “Registro Italiano LMC & Campus CML”

Introduction : therapy of chronic phase (CP) chronic myeloid leukemia (CML) is based on tyrosine kinase inhibitors (TKIs) in virtually all patients. Three TKIs are approved for first-line therapy in Italy: imatinib and two second-generation (2G) TKIs, dasatinib and nilotinib. Choice of the front-line TKI is based on a combined evaluation of patient's and disease characteristics, age, risk, comorbidities and concomitant medications. Treating physician's preference and, in some cases, economic considerations, particularly after the advent of generic imatinib, may play a role in TKI selection. However, to date, few data are available on TKI use in a whole nation and on the possible drivers of treatment choice. Aim of the present work was to analyse the use of front-line TKI therapy in a large, unselected cohort of Italian CP-CML patients, correlating patient's features to drug choice. Methods: in the framework of the national Campus CML program, we retrospectively evaluated 1422 patients with CP-CML diagnosed from 2012 and 2019 in 21 haematologic Centres, mostly in academic and/or tertiary hospitals, widespread through the entire Italian territory and treated frontline with imatinib, dasatinib or nilotinib. Results: median age at diagnosis was 59.9 years [interquartile range (IQR) 47.1 - 71.7], with 317 (22.3%) patients under 45 years, 552 (38.8%) between 45 and 65 years and 553 (38.9%) older than 65 years; 821 (57.7%) patients were males. Among 1364 evaluable patients, CML risk according to Sokal score was low in 540 (39.6%), intermediate in 610 (44.7%) and high in 214 (15.7%) patients respectively; the number at low, intermediate or high risk according to the novel ELTS score among 1325 evaluable patients was 759 (57.3%), 402 (30.3%) and 164 (12.4%) respectively. Considering comorbidities, 1003 (70.6%) patients had at least one active disease at the time of CML diagnosis, the most common being hypertension (n=547, 38.5%), previous neoplasms (n=185, 13.0%), diabetes (n=150, 10.6%), chronic bronchopulmonary diseases (n=114, 8.0%), acute myocardial infarction (n=95, 6.7%), previous stroke (n=36, 2.5%) and other vascular diseases (n=98, 6.9%). Among 1335 evaluable patients, 813 (60.9%) were taking at least one concomitant medication, with 280 (21.0%) taking 3-5 drugs and 140 (10.5%) taking 6+ drugs at time of TKI start. As to the frontline therapy, 794 (55.8%) received imatinib and 628 (44.2%) were treated with 2G-TKIs, (226 dasatinib and 402 nilotinib) respectively. According to age, 2G-TKIs were chosen for majority of patients aged &amp;lt;45 (69.1%) while imatinib was used in 76.9% of patients over 65 (p&amp;lt;0.001). There was a predominance of imatinib use across all Sokal (51.1% in low, 61.3% in intermediate and 51.4% in high) and ELTS (50.3% in low, 60.4% in intermediate and 66.5%) risk categories. We observed a prevalent use of 2G-TKIs in patients presenting with higher WBC counts (55.1% if WBC &amp;gt;100,000/mm3 vs 38.2% if WBC &amp;lt;100,000/mm3; p&amp;lt;0.001), lower Hb (53.8% if Hb &amp;lt;10 g/dl vs 41.9 if Hb &amp;gt;10 g/dl; p=0.001) and bigger spleen (65.1% if spleen &amp;gt;5 cm vs 44.8% if spleen 1-5 cm vs 37.3% if spleen not palpable; p&amp;lt;0.001). There was a decreasing use of 2G-TKIs with higher number of concomitant drugs: 64.4% for 0, 47.7% for 1-2, 27.0% for 3-5 and 13.6% for &amp;gt;5 drugs, respectively (p&amp;lt;0.001). Concordantly, there was a significant higher use of imatinib in patients with hypertension (69.8%), diabetes (70.0%), COPD (73.7%), previous neoplasms (73.0%), AMI (86.3%) or stroke (97.2%) history (p&amp;lt;0.001 for all conditions). Lastly, we observed a wider use of imatinib (61.1%) in patients diagnosed in years 2018-19, compared to those of the period 2012-17 (53.7%; p=0.01). In multivariable analysis, factors correlated with imatinib use were age &amp;gt; 45 years, intermediate or high Sokal risk, presence of some comorbidities (2nd neoplasia and stroke) and number of concomitant medications. Conclusions: preliminary results of this observational study on almost 1500 patients show that around 55% of newly diagnosed Italian CP-CML patients receive imatinib as front-line therapy, and that the use of 2G-TKI is prevalent in the younger patients and in those with no concomitant clinical conditions. The counterintuitive finding of imatinib prevalence as frontline treatment in high risk patients might be explained by the older age of these patients. Introduction of the generic formulation in 2018 seems to have fostered the use of imatinib. Figure Disclosures Breccia: Novartis: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Incyte: Consultancy, Honoraria; Abbvie: Consultancy; Bristol-Myers Squibb/Celgene: Consultancy, Honoraria. Cavazzini:Pfize: Honoraria; Incyte: Honoraria; Novartis: Honoraria. Saglio:Bristol-Myers Squibb: Research Funding; Pfizer: Research Funding; Incyte: Research Funding; Novartis: Research Funding; Ariad: Research Funding; Roche: Research Funding.

First Line Treatment with Hydroxyurea in Patients with Policitemia Vera: Evaluation of Efficacy in the Current Clinical Practice Beyond ELN Criteria

First Line Treatment with Hydroxyurea in Patients with Policitemia Vera: Evaluation of Efficacy in the Current Clinical Practice Beyond ELN Criteria

Diabetic foot and its serial treatment in high-risk patients: focusing on the individual.

To assess knowledge about diabetic foot, care measures, and the importance attached to serial treatment in a group of high-risk diabetic foot patients. This is a cross-sectional study, carried out in a tertiary hospital, with 25 patients undergoing serial treatment for diabetic foot. The tabulation of the data occurred through the use of three methodological figures: core idea, key expressions, and the collective subject discourse. It became evident that even among high-risk patients with diabetic foot, there is no complete knowledge about the definition of the disease. Despite this, all participants reported practicing daily care measures, including frequent inspection of the feet, food care, and attention to footwear. Regarding the importance of serial treatment, there was unanimous recognition of the relevance of this practice, which improves self-care discipline, optimizes the understanding of the disease, and helps to prevent progression. Authentic speeches in the context of a pathology of considerable prevalence manifested, in an unprecedented way, with conceptions about its definition, care measures, and importance of serial treatment in a high-risk group.

S0006 Efficacy of Combining Aggressive Hydration With Rectal Indomethacin in Preventing Post-ERCP Pancreatitis: A Systemic Review and Network Meta-Analysis

INTRODUCTION: Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is a major adverse event after endoscopic retrograde cholangiopancreatography. No RCT has compared the efficacy of all American Society of Gastrointestinal Endoscopy (ASGE)- and European Society of Gastrointestinal Endoscopy (ESGE)-recommended interventions for PEP prevention. We assessed the effectiveness of these interventions and their combinations amongst each other using network meta-analysis approach. METHODS: We conducted a literature search of PubMed, EMBASE, and Cochrane databases from inception to January 14, 2020, to identify RCTs comparing ASGE-and ESGE-recommended interventions -including rectal NSAIDs, pancreatic stent (PS), aggressive hydration (AH), sublingual nitrate or combinations of those - with each other or with the control group for PEP prevention (primary outcome). RCTs defining PEP only as per cotton's criteria or consensus criteria were included. Odds ratios (ORs) with 95% credible intervals (CrIs) were reported for network comparisons. We also did a subgroup network meta-analysis for high-risk patients. We used the surface under the cumulative ranking curve to rank interventions in terms of PEP prevention. Model consistency was assessed with the node splitting method. RESULTS: We identified a total of 38 RCTs with ten different interventions (Figure 1Figure 1.: Network Plots Showing Direct Comparisons Available Among Interventions. A) All interventions. B) Interventions for high-risk patients. The thickness of the line connecting two interventions are proportional to available RCTs comparing them.). Each intervention was protective against PEP on network meta-analysis compared to controls as shown in Figure 2Figure 2.: League table showing results of all possible comparison of all interventions. Odds ratio with 95% CrI in a particular cell represents a comparison of column defining treatment to raw defining treatment. All statistically significant comparisons are highlighted in green colour. AH: Aggressive hydration; I: Indomethacin; D: Diclofenac; N: Nitrate; S: Stent. “+” represents a combination of intervention.. Except AH+diclofenac and NSAIDs + sublingual nitrate, AH+indomethacin was associated with a significant reduction in risk of PEP compared to PS (OR: 0.09; CrI: 0.003–0.71), indomethcin+PS (OR: 0.09; CrI: 0.003–0.85), diclofenac (OR: 0.09; CrI: 0.003–0.65), AH (OR: 0.09; CrI: 0.003–0.65), sublingual nitrate (OR: 0.07; CrI: 0.002–0.63), and indomethacin (OR: 0.06; 0.002–0.43). AH with either rectal NSAIDs or sublingual nitrate had similar efficacy as shown in Figure 2. AH+indomethacin was the best intervention for preventing PEP with 95.3% probability of being ranked first (Figure 3AFigure 3.: SUCRA Based on Cumulative Probabilities. A) All interventions. B) Interventions for high-risk patients. AH indicates aggressive hydration; D, rectal diclofenac; I, rectal indomethacin; N, sublingual nitrate; S, pancreatic stent; SUCRA, surface under the cumulative.). For high-risk patients, although the efficacy of PS and indomethacin were comparable, PS had an 80.8% probability of being ranked first (Figure 3B). Node splitting with P-value < 0.05 for direct and indirect comparison confirmed model consistency. CONCLUSION: Combination of rectal indomethacin with aggressive hydration seems the best intervention for preventing PEP. For high-risk patients, pancreatic stent seems the most effective strategy.

Posterolateral Plate Fixation with Pantalarlock® is More Stable than Nail Fixation in Tibiotalocalcaneal Arthrodesis in a Biomechanical Cadaver Study

Category:Ankle; Ankle ArthritisIntroduction/Purpose:Despite the promising results of ankle joint arthroplasty, the tibiotalocalcaneal (TTC) arthrodesis remains an established procedure in treatment of combined pathology of the ankle and subtalar joint. Despite the promising results in biomechanical investigations, nonunion rates of up to 24% are described in recent studies. The objective of this work was a comparative study of the biomechanical properties of the posterolateral plate fixation with retrograde intramedullary nail fixation.Methods:Twenty four fresh-frozen human lower leg specimens (12 pairs) were used for the comparative biomechanical testing. Every specimen was preconditioned with 100N over 200 cycles. After every 250 cycles the force was increased by 50N from 200 to 600N. This was followed by cyclic loading in dorsi-/plantiflexion with 800N for 3000 cycles. All specimens were subjected to bone densitometry (DXA) and computed tomography.Results:Significantly higher number of spacimens with nails (4) failed during the cycling testing in dorsi-/plantarflexion and futher two during the cyclic testing with 800N. Two specimens with plates failed during the cyclic testing with 800N. Statistical analysis showed that the specimens with the plate were significantly more stable in each test direction. The Pearson correlation demonstrated for the specimens with plate a linear relationship between the stiffness and the determined bone density.Conclusion:We expect a considerable reduction of the pseudarthrosis rate and shorten the postoperative treatment phase in clinical set up and appropriate advantages in the treatment of high risk patients with severe deformity of the ankle, bone defects, neuropathic deformity, poor bone quality and osteoporosis. The choice of most predictable and stable implant is essential for the successful fusion. In conclusion, the posterolateral plate ostesynthesis for TTC arthrodesis is significantly stiffer compared to the nail osteosynthesis in osteoporotic bone model.

Improved Transcatheter aortic valve implantation for aortic regurgitation using a new-type stent: the first preclinical experience

BackgroundIn this study, we sought to evaluate the feasibility of improved transcatheter aortic valve implantation (TAVI) in noncalcified aortic valve by using the novel concept of double-layer ChenValve prosthesis. TAVI was initially considered as an alternative treatment for high-risk patients with aortic stenosis. However, non noncalcified aortic valve disease was considered as a contraindication to TAVI.MethodsChenValve prosthesis, which consisted of a self-expanding Nitinol ring, a balloon-expandable cobalt-chromium alloy stent and a biological valve, was implanted at the desired position under fluoroscopic guidance in a transapical approach through a 20F sheath in 10 goats. Aortic angiography was performed to measure the diameter of the aotic annulus and assess the performance of the artificial valve. The ultrasound was used to evaluate the regurgitation or paravalvular leakage and trans-prosthetic vascular flow velocity postoperatively. The aortogram and transthoracic echocardiography were applied to observe whether the valve stent was implanted at the desired position.ResultsChenValve prosthesis was successfully transppical implanted in all animals. The aortogram and transthoracic echocardiography performed immediately after implantation revealed that the valve stent was implanted at the desired position. There was no significant paravalvular leakage, obstruction of coronary artery ostia, stent malpositioning or dislodgement occurred.ConclusionsThis preliminary trial with the novel double-layer ChenValve prosthesis demonstrated the feasibility of improved TAVI in noncalcified aortic valve. The mechanism of Nitinol ring-guided locating the aortic sinus enables us to anatomically correct position the artifact valve. This improved strategy seems to make the TAVI process more safe and repeatable in noncalcified aortic valve.

MitraClip in secondary mitral regurgitation as a bridge to heart transplantation: 1-year outcomes from the International MitraBridge Registry

Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition. We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34). Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan-Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement. MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF.

565 POST-OPERATIVE WEIGHT LOSS AND OUTCOMES FOLLOWING ESOPHAGECTOMY

Abstract Oesophageal cancer is the 11th most common cancer worldwide, with oesophagectomy remaining the mainstay curative treatment, despite significant associated morbidity and mortality. Postoperative weight loss remains a significant problem and is directly correlated to poor prognosis. Measures such as the Enhanced Recovery After Surgery (ERAS) programme and intraoperative jejunostomy feed have looked to tackle this. This study investigates the impact of these on mortality, length of hospital stay and postoperative weight loss. Methods Patients undergoing oesophagectomy between January 1st 2012—December 2014 and 28th October 2015–December 31st 2019 in a national tertiary oesophagogastric unit were included retrospectively. Variables measured included comorbidities, operation, histopathology, weights (pre- and post-operatively), length of hospital stay, postoperative complications and mortality. Pre-operative body weight was measured at elective admission, and further weights were identified from a prospectively maintained database, during further clinic appointments. Other data was collected through patient notes. Results 594 patients were included. Mean age at diagnosis was 65.9 years (13–65). Majority of cases were adenocarcinoma (63.3%), with varying stages of disease (TX-4, NX-3). Benign pathology accounted for 8.75% of cases. Mean weight loss post-oesophagectomy exceeded 10% at 6 months (SD 14.49). Majority (60.1%) of patients were discharged with feeding jejunostomy, and 5.22% of these required this feed to be restarted post-discharge. Length of stay was mean 16.5 days (SD 22.3). Complications occurred in 68.9% of patients, of which 13.8% were infection driven. Mortality occurred in 26.6% of patients, with 1.83% during hospital admission. 30-day mortality rate was 1.39%. Conclusion Failure to thrive and prolonged weight-loss following oesophagectomy can contribute to poor recovery, with associated complications and poor outcomes, including increased length of stay and mortality. Further analysis of data to investigate association between weight loss and poor outcomes for oesophagectomy patients will allow for personalised treatment of high-risk patients, in conjunction with members of the multidisciplinary team, including dieticians.

Survival patterns of childhood neuroblastoma: an analysis of clinical data from Southern-Eastern European countries.

The prognosis of children with neuroblastoma (NBL) can be dismal with significant variations depending on the stage and biology of the tumor. We assessed the event-free (EFS) and overall (OS) survival using harmonized data from three Southern-Eastern European (SEE) countries. Data for 520 incident NBL cases (2009-2018) were collected from Greece, Slovenia and Russia. Kaplan-Meier curves were fitted, and EFS/OS were derived from Cox proportional models by study variables including the protocol-based risk-group (low/observation, intermediate, high). Over one-third of cases were coded in the high-risk group, of which 23 children (4.4%) received treatment with anti-ganglioside 2 (GD2) mAb. Survival rates were inferior in older (OS 5-year; 1.5-4.9 years: 61%; EFS 5-year; 1.5-4.9 years: 48%) compared to children younger than 1.5 years (OS 5-year; <1.5 years: 91%; EFS 5-year; <1.5 years: 78%). Predictors of poor OS included stage 4 (hazard ratio, HR OS : 18.12, 95% confidence intervals, CI: 3.47-94.54), N-myc amplification (HR OS : 2.16, 95% CI: 1.40-3.34), no surgical excision (HR OS : 3.27, 95% CI: 1.91-5.61) and relapse/progression (HR OS : 5.46, 95% CI: 3.23-9.24). Similar unfavorable EFS was found for the same subsets of patients. By contrast, treatment with anti-GD2 antibody in high-risk patients was associated with decreased risk of death or unfavorable events (HR OS : 0.11, 95% CI: 0.02-0.79; HR EFS : 0.19, 95% CI: 0.07-0.52). Our results confirm the outstanding prognosis of the early NBL stages, especially in children <1.5 years, and the improved outcomes of the anti-GD2 treatment in high-risk patients. Ongoing high-quality clinical cancer registration is needed to ensure comparability of survival across Europe and refine our understanding of the NBL biology.

Patient Management Assisted by a Neural Network Reduces Mortality in an Intermediate Care Unit

IntroductionMortality risk prediction for Intermediate Respiratory Care Unit's (IRCU) patients can facilitate optimal treatment in high-risk patients. While Intensive Care Units (ICUs) have a long term experience in using algorithms for this purpose, due to the special features of the IRCUs, the same strategics are not applicable. The aim of this study is to develop an IRCU specific mortality predictor tool using machine learning methods. MethodsVital signs of patients were recorded from 1966 patients admitted from 2007 to 2017 in the Jiménez Díaz Foundation University Hospital's IRCU. A neural network was used to select the variables that better predict mortality status. Multivariate logistic regression provided us cut-off points that best discriminated the mortality status for each of the parameters. A new guideline for risk assessment was applied and mortality was recorded during one year. ResultsOur algorithm shows that thrombocytopenia, metabolic acidosis, anemia, tachypnea, age, sodium levels, hypoxemia, leukocytopenia and hyperkalemia are the most relevant parameters associated with mortality. First year with this decision scene showed a decrease in failure rate of a 50%. ConclusionsWe have generated a neural network model capable of identifying and classifying mortality predictors in the IRCU of a general hospital. Combined with multivariate regression analysis, it has provided us with an useful tool for the real-time monitoring of patients to detect specific mortality risks. The overall algorithm can be scaled to any type of unit offering personalized results and will increase accuracy over time when more patients are included to the cohorts.

Applicability of Dynamic Risk Stratification for Differentiated Thyroid Cancer (DTC) in a Resource Limited Setting.

Dynamic risk stratification (DRS) in DTC has been considered necessary to deliver correct follow-up (FU) treatment, avoiding overtreatment of low risk/intermediate risk patients as well as inadequate treatment of high risk patients. However, it's clinical applicability has been questioned in comparison with more conventional FU protocols. We aimed to know the predictive reliability of DRS in monitoring FU of DTC in a resource-constrained setting across various risk groups, especially when compared with clinical examination alone.

Stepwise external wrapping procedure for type A intramural hematoma.

The optimal treatment for Stanford type A acute intramural hematoma remains controversial, especially in elderly or high-risk patients. We have developed a new surgical approach using artificial grafts (stepwise external wrapping) for high-risk patients. The aim of this study is to report our results using the stepwise external wrapping procedure in the treatment of high-risk patients with type A intramural hematoma. Among the 129 patients admitted for type A intramural hematoma between January 2016 and January 2020, 49 patients underwent stepwise external wrapping. The mean patient age was 78±7years. The new standard European system for cardiac operative risk evaluation II was 54%±23%. The mean overall operation and cardiopulmonary bypass times were 96±13minutes and 35±10minutes, respectively. There were no hospital deaths. Two cases of temporary neurologic disorder, 1 case of renal failure, and 2 cases of wound infection occurred during the postoperative period. The intensive care unit and hospital stays were 2±1days and 10±3days, respectively. The thickness of intramural hematoma that had been the target of the stepwise external wrapping procedure decreased significantly from 18.0±10.7mm preoperatively to 5.2±4.4mm at 3months after surgery (P<.05). The follow-up survival was 97.7%±4.4 % at 1year after surgery and 89.8%±11.4% at 3years after surgery. There was no aortic-related death during follow-up. Our stepwise external wrapping is a feasible alternative to conventional graft replacement for high-risk patients with type A intramural hematoma. The early and midterm outcomes of the procedure were satisfactory, but further careful follow-up is needed.