TP10.1.1Unveiled by Covid-19: The True Rate of Emergency General Surgery

Aims The Covid-19 pandemic has impacted every NHS service, including the provision of elective and emergency surgery. National lockdown, travel restrictions and intercollegiate guidance on conservative management of acute surgical conditions were introduced in an effort to reduce the burden on emergency services. This service evaluation aimed to evaluate the impact of the Covid-19 pandemic on emergency general surgical presentations and operations, and to determine whether the rate of surgical intervention changed. Methods Patients presenting to the surgical emergency unit in a large tertiary centre were identified through electronic admission records between March to April 2019 and the same period in 2020. Data on presentation, admission and operations were collected and compared between the two periods. Results Presentations in 2020 reduced by 38% from 1324 to 823. Operations performed decreased by 44% from 334 to 188. The proportion of presentations requiring emergency operations was 23% in 2020 compared to 25% in 2019. Emergency laparotomies increased from 30 to 40, constituting a greater proportion of operations (9% vs. 21%). Rates of appendicectomies remained the same at 26% vs. 27%. Urgent procedures including cholecystectomies, hernia repairs and abscess drainage decreased from 55% to 42% of all cases. Conclusions There was an absolute reduction in emergency presentations and operations between the two periods. This reduction could be accounted for by decreased presentations of patients with non-surgical abdominal pain due to lockdown. However, more critically unwell patients presented indicated by the increased number of laparotomies demonstrating the ongoing need for emergency surgery.

Bilateral Neck Exploration May Not Reduce the Risk of Persistence but Shows a Perspective Advantage

There is still no consensus for an optimal surgical treatment of primary hyperpararthyroidism (PHPT). Virtually, most of the patients could be successfully treated with the selective parathyroidectomy (SPTE) based on preoperative visualization. However, this approach still has a “blind area” of undetected multiglandular disease (MGD). Bilateral neck exploration (BNE) may serve as a reasonable alternative but it meets the higher requirements for the surgical technique. A retrospective cohort study was conducted in order to reveal factors associated with the persistence of PHPT. 587 cases of PHPT patients who had received surgical treatment at SPSU Hospital in 2017–2018 were included. All the patients have at least one preoperative visualization study (neck ultrasound performed by a surgeon) before the operation. In 356 cases two studies were performed (additional 4D CT or MIBI scan) and 116 cases had all three. A surgeon was free to choose a type of the operation (selective or explorative) according to their strategic preferences. Bilateral neck exploration was performed in 160 cases. There was no difference in bilateral exploration rate (p = 0.3896) between the groups (with 1, 2 or 3 studies performed) indicating that the additional visualization does not allow to avoid bilateral exploration. MGD rate accounted for 7.4% (40 cases). It is important that any set of preoperative visualization modalities prove the absence of MGD reliably and select patients for SPTE precisely. Negative predictive value for different combinations of concordant studies (US+MIBI, US+CT and US+CT+MIBI) did not differ significantly and was 96.95%, 97.4% and 97.7% respectively. 26 cases of persistent disease were reported with no significant difference between BNE and SPTE groups. (6 vs 20 respectively, p = 0.792). A history of the thyroid or parathyroid operations was found to be the only factor predicting the higher risk of persistence (OR = 7.98; 95% CI [2.62 - 24.27]), while neither the number of parathyroid glands found during the surgery nor the number of preoperative visualization studies showed statistical significance. Only 47,5% cases of BNE was reported to have all four glands visualized. There rate of failure to found each gland was similar. Surprisingly, the superior parathyroid adenomas (P4) were more likely to be removed (chi-squared 10.378, p = 0.0006) but not in the cases with all four glands visualized intraoperatively (chi-squared 1.822, p = 0.0884). The true rate difference due to a hypothetical feature of parathyroid physiology seems to be not very likely. One may rather suggest than it is not an uncommon for a surgeon to identify a P3 gland as a P4 unless all for glands are visualized. This fact shows a perspective advanantage which may prevent some cases of persistence.

A78 THE IMPACT OFGASTROINTESTINAL FOLLOW UP CARE ON HEALTHCARE UTILIZATION IN PATIENTS WITH ESINOPHILICESOPHAGITID (EOE).

Background EOE is an increasingly recognized gastrointestinal condition that causes significant morbidity ranging from dietary limitations to food impactions requiring emergency room visits. There are a variety of dietary, pharmacologic and endoscopic treatments available but most are more practically guided by a subspecialist familiar and experienced with the condition. There is a perception among some physicians that follow up is sporadic and may be related at least in part to patient compliance. Aims To assess the true rate of EOE patients follow up rate at Lodon Health Scince Center Methods We used a retrospective cohort of patients diagnosed with EoE between July 2011 and June 2014 who met the traditional diagnostic criteria. As part of a quality improvement initiative, local follow up over the ensuing 5–7 years was tracked. The impact of follow up on subsequent healthcare utilization was analyzed. Results 123 patients with biopsy confirmed EoE were analyzed. Follow up appointments were made for 114/123 (92%) patients. 55/123 (45%) had repeat elective endoscopy booked. Only 10/114 (8.7%) of initial appointments went unattended but 15/55 (27.2%) of the patients offered ongoing follow up failed to attend. There were no complications (ie. perforation or bleeding) attributable to any of the procedures. 5/123 (4%) patients required repeat emergency room endoscopy for food impaction. Two patients required this on multiple occasions. 4/5 patients requiring repeat emergency room endoscopy for food impaction had received some sort of follow up, although 4/5 of these had at least one missed appointment. 2/5 patients having emergency room endoscopy required overnight admission. There were no perforations in the cohort. Conclusions Patients with a confirmed diagnosis of EOE do have a risk of requiring subsequent emergency endoscopy for food impaction although it is not clear that scheduled follow up significantly reduces that risk. Contrary to the perception of some physicians, patients with EoE are very likely to attend their first follow up visit although the attrition rate for subsequent scheduled visits is not insignificant. Funding Agencies None

Abstract P297: The Accuracy of the Comprehensive Stroke Performance CSTK-5b Measure Rates

Introduction: Symptomatic intracerebral hemorrhage (ICH) is a feared complication of reperfusion therapy in acute ischemic stroke. The Joint Commission (JC) national quality measure Comprehensive Stroke (CSTK-5b) reflects the rate of symptomatic ICH after mechanical thrombectomy (MT) and is used as a marker of comprehensive stroke center (CSC) performance. We sought to determine the accuracy of the CSKT-5b as determined by vascular neurologists. Methods: We reviewed the CSTK-5b failures in our JC certified CSC program for the years 2018 and 2019. Our CSC abstractors follow the instructions from the Joint Commission National Quality Measures manual without deviation and do not allow for clinician over-ride or adjudication (consistent with manual instructions). All CSKT-5b failures were reviewed by study neurologists to determine the true CSTK-5b rate. Data was collected on National Institute of Health Stroke Scale (NIHSS), symptomatic ICH, and neuroimaging results. European Cooperative Acute Stroke Study (ECASS) definitions were used and included hemorrhagic infarction (HI) (grade 1 or 2) and parenchymal hematoma (PH) (grade 1 or 2). Results: Among 361 MT patients for the 2 year period, the CSTK-5b failure rate reported to JC was 34/250 (13.6%), whereas the true rate was 21/250 (8.4%). Among the 13 cases that were miscoded, the ECASS grading included 1 HI-1, 7 HI-2, 1 PH-1, and 4 subarachnoid hemorrhage, and all had a 4 point change in NIHSS that was determined to be clinically unrelated to ICH. Comparing annual data, the 2018 CSTK-5b failure rate was 14/111 (12.6%) whereas the true CSTK-5b failure rate was 7/111 (6.3%). In 2019, the CSTK 5b failure rate was 20/139 (14.4%), whereas the true CSTK-5b failure rate was 14/139 (10.1%). Conclusions: Non-physician abstractors relying on instructions from the JC manual over-estimate the rate of CSKT-5b measure failure. The determination of symptomatic ICH after MT is complex and requires clinical knowledge for accuracy.

Titanium Corrosion in Peri-Implantitis

Titanium (Ti) corrodes clinically in the presence of bacteria. We investigated this phenomenon as a function of Ti particles found in biopsied tissues around peri-implantitis sites and surface roughness of failed Ti implants. Tissue biopsies were surgically collected from peri-implantitis sites, processed, and embedded in resin. The resin-embedded samples were hand trimmed to the region of interest and semi-thick (500 nm) sections were collected onto coverslips. One section was toluidine blue post-stained as a reference. The remainder sections were left unstained for energy-dispersive X-ray spectroscopy (EDX) analysis. Processed samples were examined under scanning electron microscopy (SEM) and EDX. Corresponding failed implants were also removed and examined under SEM and EDX. Five out of eight biopsied samples demonstrated the presence of Ti particles in the soft tissue, suggesting the true rate among all failures was between 24.5% and 91.5% (the lower bound of a 95% confidence interval for the true rate of Ti presence). SEM analysis of failed implant bodies also indicated changes in surface morphology and appeared less detailed with decreased weight percent of Ti on the surface of the failed implants. In conclusion, Ti particles were noted in 5/8 biopsied samples. Surface morphologies were smoother in failed implants compared with the reference implant.

A Phase 1 Study of HMPL-523, Highly Selective and Potent a Small Molecule Inhibitor of Spleen Tyrosine Kinase in Patients with Relapsed or Refractory Lymphoma

Background: The B-cell receptor (BCR) signaling pathway plays a critical role in the pathogenesis of lymphomas, particularly in non-Hodgkin lymphomas (NHL). Despite availability of therapeutic agents targeting BCR pathway, there continue to be unmet medical need for more effective and less toxic therapeutic agents for patients with advanced relapsed, refractory or resistant lymphoma. HMPL-523 is a novel, orally available, highly selective, and potent small molecule inhibitor of spleen tyrosine kinase (SYK), a crucial component of BCR signaling pathway. A clinical study is currently ongoing in the USA and in EU countries of France, Italy, Poland, and Spain. Preliminary results from dose escalation and expansion stages of these trials are expected soon. Herein is the description of an ongoing phase 1 open-label, multi-center, single-arm study of HMPL-523 in patients with advanced relapsed, refractory or resistant (R/R) NHL (NCT03779113). Study Population: Targeted patient population is adult patients with histologically confirmed advanced relapsed, R/R NHL. To be eligible for enrollment, patients must have exhausted all approved therapeutic options available. Objectives and Endpoints: The primary objective is to assess safety and tolerability of HMPL-523 and to determine the maximum-tolerated dose (MTD)/recommended phase 2 dose (RP2D). The primary endpoints are the incidence of dose-limiting toxicity (DLT) and safety parameters, including treatment-emergent adverse events and laboratory abnormalities The secondary objectives are to characterize the pharmacokinetic (PK) parameters and to evaluate the safety and preliminary efficacy of HMPL-523. The secondary endpoints are the incidence of treatment-emergent adverse events (TEAE), PK parameters, and efficacy parameters, including objective response rate, duration of response, time to response, and progression-free survival. Study Design: Study consists of a dose escalation stage and an expansion stage. The dose-escalation utilizes a modified 3+3 design, with anticipated enrollment of approximately 24 patients until MTD is reached, and RP2D is determined. The proposed doses of escalation cohorts are 100, 200, 400, 600 and 800 mg, QD, PO in a 28-day cycle. Patients will be treated until disease progression, intolerable toxicity, no further benefit, withdrawal, end of study, or death. The expansion stage will be dosed at the MTD to further evaluate safety, tolerability, PK, drug exposure, target engagement, PD and their correlation with clinical benefit of HMPL-523. Approximately 10 patients will be enrolled in each of the following cohorts: Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),Mantle cell lymphoma (MCL),Follicular lymphoma (FL)Marginal zone lymphoma (MZL)Peripheral T-cell lymphoma (PTCL)Cutaneous B-cell lymphomaWaldenström's macroglobulinemia / lymphoplasmacytic lymphoma (WM) Statistical Methods: For the escalation stage, the sample size is based on the dose-escalation rules of the 3+3 design. For a given AE with a true rate of 10%, 5%, or 1%, the probability of observing at least one such AE in a given cohort of 6 patients is 46.9%, 26.5%, and 5.8%, respectively. For the dose expansion stage, a total of 70 patients (10 patients per expansion cohort) will provide robust safety data in the study patient populations. For a given AE with a true rate of 10%, 5%, or 1%, the probability of observing at least one such AE in 70 patients is 99.9%, 97.2%, and 50.5%, respectively. For preliminary assessment of anti-tumor activity based on ORR, if at least 8 patients in a specific lymphoma subtype are evaluable for tumor response, the chance of observing at least one response is 94.2%, if the true ORR is 30%. Safety parameters, including DLTs, recorded TEAEs, clinical laboratory parameters, vital signs, 12-lead ECG parameters and physical examination findings, will be summarized by dose level across both dose escalation and dose expansion stages. Efficacy endpoints will be summarized by dose level for each type of malignancy. Significance: This study is the first global clinical study of HMPL-523, a novel inhibitor of the BCR signaling pathway currently enrolling patients with advanced relapsed, refractory or resistant NHL who have exhausted all approved therapeutics options available. Disclosures Lawrence: Hutchison MediPharma International, Inc:Current Employment, Current equity holder in publicly-traded company.Hahka-Kemppinen:Hutchison MediPharma International, Inc:Current Employment, Current equity holder in publicly-traded company.Kania:Hutchison MediPharma International, Inc:Current Employment, Current equity holder in publicly-traded company.

Incidence of atrial fibrillation in an opportunistic screening campaign in a general practitioner setting: a prospective population study

Introduction The detection of atrial fibrillation (AF) largely depends on the method used, thus the reported true rate of incident AF is controversial. The detection of symptomatic AF is straight forward in most cases, while it is unclear which strategies provide the best results for the detection of silent AF. Traditional methods like pulse palpation have a low accuracy and pulse guided ECG confirmation is not deemed cost-effective. Purpose The aim of the study was to detect the incidence symptomatic AF, using ECG, and opportunistic screening of silent AF, using an AF-detection capable automatic sphygmomanometer, in patients ≥65 years old in the general practitioner (GP) setting. Methods This was a population-based prospective cohort study of unselected general population referred for routine visits in 93 randomly selected GPs. Patients of both sexes of ≥65 years without previous diagnosis of AF were considered for the study. Each patient if symptomatic was directly referred to perform an ECG, otherwise if asymptomatic, underwent blood pressure monitoring with an AF-detection capable automatic sphygmomanometer followed by an ECG in case the device signaled AF. Results The final population comprised of 14987 individuals of ≥65 years old. The follow up extended to 16838 patient-years. The overall incidence of AF was 2.25% patient-years (95% CI 2.03–2.48). AF incidence was significantly higher in male (male/female ratio 1.29), overweight (BMI: 28.2 kg/m2 vs 27.0 kg/m2), older (79.1 vs 75.4 years old) individuals, with 44.9% belonging to the ≥80-year-old group. Other risk factors for incident AF were higher systolic BP measurements, history of stroke/TIA, congestive heart failure and chronic kidney disease. On multivariate analysis, age (annual increment), mitral valve disease, previous stroke and the number of annual visits (>10), were independent predictors of incidental AF. About 25% of cases were silent AF (0.56% patient-years, 95% CI 0.46–0.69) and were identified using the AF-detection capable automatic sphygmomanometer. Independent predictors of silent AF were age (per year increment), overweight (BMI >28 kg/m2) and the number of visits (>10) in the GPs' office. Conclusions We found a higher than previously reported incidence of AF possibly due to capturing silent AF. This simple protocol, using an AF-capable automatic sphygmomanometer, might be feasible and easily implemented on the routine GP care where high rates of coverage can be achieved. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Veneto Region Italy

Risk factors for new-onset diabetes mellitus after distal pancreatectomy

IntroductionSeveral previous studies have reported the incidence of new-onset diabetes mellitus (NODM) after pancreatectomy. Nevertheless, the results were inconsistent. The true rate of NODM after distal pancreatectomy (DP) is still unknown.Research design and methodsThe aim of this study was to investigate the incidence of and the risk factors for NODM after DP. This study enrolled patients who underwent DP between January 2004 and February 2016 at Peking Union Medical College Hospital. Patients with preoperative diabetes mellitus or diagnosed with pancreatic cancer were excluded. The primary outcome was NODM.ResultsA total of 485 patients were enrolled. The median (IQR) of follow-up duration was 30.95 (9.26–180.30) months. The accumulative incidence of NODM was 8.9% at postoperative 6 months, 14.0% at postoperative year one, 22.3% at year three, 27.1% at year five, and 35.5% at year ten. Multivariate analysis showed that the risk of postoperative NODM was positively correlated with age (HR 1.029 (1.013–1.045), p<0.001), preoperative body mass index (BMI) (HR 1.042 (1.003–1.083), p=0.001), operative blood loss (HR 1.0003 (1.0002–1.0010), p<0.001), and length of resected pancreas (HR 1.079 (1.013–1.148), p=0.017). Moreover, concomitant splenectomy (HR 2.001 (1.202–3.331), p=0.008) was associated with significantly higher risk of postoperative NODM.ConclusionNODM incidence increased with postoperative time progression. Age, BMI, surgical blood loss, length of resected pancreas and splenectomy were independent risk factors for NODM after DP.Trial registration numberNCT03030209.