UK Centres Research Articles

Short- and long-term outcomes of adrenalectomy for primary aldosteronism in a single UK center: rear-mirror view

Abstract Purpose Primary aldosteronism (PA), which is the commonest cause of secondary hypertension, can be cured by unilateral adrenalectomy. We report the short-and long-term outcomes after adrenalectomy performed at a single UK center over a period of 24 years. Methods Retrospective analysis of biochemical (potassium, aldosterone, renin, and ARR) radiological (CT/MRI, AVS, and nuclear scans), and clinical (surgical complications, blood pressure, and number of antihypertensive medications) short-and long-terms outcomes in patients who underwent adrenalectomy for PA between 1998 and 2021. Standardized PASO and Clavien-Dindo criteria to assess biochemical, clinical, and surgical outcomes were used. Results A total of 82 patients were treated via adrenalectomy for PA over a 24-year period. Short-term follow-up data (within 3 months after surgery) was available for all 82 patients (M45, F37, mean age 51.7 years): 24 of them were followed up for at least 60 months (range 60 to 72 months) and 77 (93.9%) patients had laparoscopic surgery (one conversion). Seven patients had postoperative complications classified as Clavien-Dindo II (4), IIIa(1) and IVa(2). Median LOS was 2.5 days (1–12). Complete and partial clinical success was achieved in 29 and 58.3% and 41.7 and 45.8% of patients in the short and the long term, respectively. Clinical benefit was observed in 88% of patients. Complete biochemical success was achieved in 95.8% of patients in the short and the long term. Conclusion Unilateral adrenalectomy in patients with PA showed clinical benefit in 88% and achieved biochemical cure in almost all of them. Our data suggest that these benefits persisted for at least 5 years.

BN SO38 - Bile Duct Injuries Referrals and Management in a Tertiary Centre in UK– A 6-year study

Abstract Background Laparoscopic Cholecystectomy (LC) is the standard treatment for symptomatic cholelithiasis. It has been associated with serious complications, such as vascular/biliary injuries (0.4-0.7% of cases) requiring surgical, endoscopic or radiological interventions. Objective To evaluate the management, intervention and outcomes post bile duct injuries (BDI) Methods We conducted a retrospective analysis on all patients referred with BDIs from regional centres, following a planned LC operation and treated at the HPB unit of Queen Elizabeth Hospital Birmingham between 2018 - 2023. Patients were followed up for at least one year. Results In our unit, 22 (12 male) patients, with a median age of 60 years (16-85) were treated, primarily for gallstone disease (n=14). Most sustained grade E injury (n=19) and were recognised and transferred on average in 4 days (0-43 days). 20 patients had a hepaticojejunostomy. Using the Clavien-Dindo classification, three patients had grade III complications requiring intervention, and one had grade IV complication with sepsis and cardiac failure, necessitating ITU transfer for inotropic support. Discharge occurred within 10 days (4-96), with follow-up over 18.8 months (5-65). Seven await further follow-up, six were discharged and two await PTC for anastomotic stricture. Conclusion Our cohort underscores the complexity and critical nature of these injuries. Most patients required hepaticojejunostomy, with a median recognition and transfer of four days. While the early discharge and follow-up outcomes are promising, ongoing monitoring is essential, as patients might commonly develop anastomotic strictures, requiring conservative, radiological or surgical management. These findings highlight the necessity for prompt recognition and referral to specialised HPB units to optimise patient outcomes and reduce the long-term complications associated with BDIs.

A06 - OGC LAsting Symptoms after Oesophageal Resectional Surgery (LASORS): Multicentre validation cohort study

Abstract Background Patients are living longer with the long-term morbidity of oncological and surgical therapies as oesophageal cancer outcomes improve. Existing symptomatology and quality of life tools are cumbersome and moreover not designed for the post-treatment survivorship setting. The LASER study identified six key symptoms thought to predict poor health-related quality of life. The current study aimed to validate this six-symptom LAsting Symptoms after Oesophageal Resection (LASOR) clinical tool, and assess its clinical utility. Method Between 2015 and 2019, patients from UK centres who underwent curative-intent oesophageal cancer treatment, and were disease-free at least one year postoperatively, were asked to complete LASOR, EORTC QLQ-C30 and QLQ-OG25 questionnaires. LASOR symptoms (low mood, reduced energy, thoracotomy pain, heartburn, diarrhoea, and bloating after eating) were correlated with EORTC HRQOL scores. Multivariable regression analysis identified symptoms associated with poor HRQoL. Receiver operating characteristic curve analysis was used to validate the LASOR tool. Results 263 patients, spanning a combination of surgical approaches (two-stage, three-stage, left thoracoabdominal, transhiatal), techniques (open, minimally invasive, hybrid), and disease stage, completed the questionnaires. Four of the six LASOR symptoms were associated with poor HRQoL: reduced energy (OR 2.13; 95% CI 1.20-2.87), low mood (OR 1.86; 95% CI 1.4503.12), diarrhoea (OR 1.48; 95% CI 1.06-2.05), and bloating after eating (OR 1.35; 95% CI 1.03-1.77). The LASOR tool produced an area under the curve of 0.85. Conclusion The six-symptom LASOR tool generated a reliable model for identification of patients with a poor HRQOL, with an overall diagnostic accuracy of over 80%. This is the first clinical symptom and quality of life tool to be validated in esophageal cancer patients post-curative treatment. The LASOR tool is straightforward to administer and acceptable to patients. Clinical utility lies both in identifying patients at risk of poor HRQoL and in planning survivorship services.

OGC SO27 - Management of oesophageal defects with Microtech VAC stents (MVS): A single centre case series

Abstract Background Oesophageal defects following cancer resection, dilatation or Boerhaave’s syndrome are increasingly managed with endoscopic approaches. Surgical management is associated with high morbidity and mortality. Pigtails stents (PS), oesophageal stents and negative pressure therapy (eso-sponge) have all been described with variation in efficacy. Microtech VAC stents (MVS) have emerged as a means of providing an oesophageal luminal stent and negative pressure to the mediastinum. Method Between June 2023 to June 2024, 19 MVS have been used in four patients with transmural oesophageal defects. Two patients had anastomotic leak (one was a quaternary referral) following Ivor Lewis Oesophagectomy. One patient had a perforation from a dilatation of a gastro-jejunostomy anastomotic stricture post-gastric bypass at another centre, then admitted as an emergency. One patient had Boerhaave’s syndrome. Results Four patients were treated with MVS. In two patients, one post dilatation perforation and one with Boerhaave’s, one MVS was sufficient to resolve the mucosal defect after seven and 11 days respectively. The other two patients with anastomotic leak required seven and 10 MVS respectively. In these patients MVS and antibiotics controlled mediastinitis, but did not completely resolve the mucosal defect. For chronic leak management MVS were exchanged for PS to enable ambulatory care. No complications with MVS changes within seven days. One patient had ingrowth of mucosa into the MVS after 11 days, but was successfully removed. Conclusion MVS therapy has been demonstrated to be safe and feasible in the management of oesophago-gastric perforations in a UK centre. Exchange of VS every 5-7 days does have additional burden to a busy endoscopy unit. No adverse events were observed.

Clonal hematopoiesis in patients with autoimmune thrombocytopenia: an international multicenter study.

Diagnostic boundaries between immune thrombocytopenia (ITP) and other thrombocytopenic states such as thrombocytopenic myelodysplastic syndromes, may be difficult to establish, and the detection of somatic mutations by next generation sequencing (NGS) may be of aid. Here we aimed at characterizing the prevalence and clinical significance of clonal hematopoiesis in ITP. In this multicentric retrospective observational study we enrolled 167 adult ITP patients, followed at 13 centers in Italy, UK, and USA. Patients underwent NGS evaluation after a median of 3.6 years from ITP onset and 83% had received at least one therapy line, median 2 (0-9) lines; 51 out of 167 patients had at least one mutation (30%). After exclusion of germline variants and polymorphisms, 18.5% (31/167) were defined as having clonal hemopoiesis. Most commonly mutated genes were TET2, DNMT3A, SRSF2, and ASXL1 (median VAF 29%); 19 of 31 subjects (68%) had high-risk variants, and 8 multiple mutations. Mutated patients were more frequently elderly males and showed a shorter time from first to second line therapy, particularly with TPO-RA. Additionally, clonal hematopoiesis was associated with increased thrombotic risk (26% vs 8% in NGS-negative cases, p=0.01), independently from TPO-RA exposure, though with an age effect. These data demonstrated the prevalence of clonal hematopoiesis in 18% of adult ITP patients, being associated with older age, relapsed/refractory disease, and high risk of thrombotic complications.

Delivery of Supported Self-Management in Primary Care Asthma Reviews: Insights From the IMP2ART Programme.

Supported self-management (SSM) for asthma reduces the risk of asthma attacks and improves asthma control and quality of life. SSM optimally includes patient-centred communication and behaviour change support, however, the extent to which this occurs in routine primary care is unclear. This project was nested within the IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) programme; a UK-wide trial evaluating an implementation strategy (including healthcare professional (HCP) training on behaviour change strategies and patient-centred care) to improve support for asthma self-management. To provide an understanding of how healthcare professionals deliver SSM in UK clinical practice; through assessing time spent on SSM strategies, how and to what extent patient-centred care and behaviour change discussions are delivered, and to explore whether factors such as mode of review or implementation support influence delivery. We conducted an observational study using video-recordings of 12 HCPs delivering routine face-to-face and telephone asthma reviews (n = 64) in a sample of general practices participating in the IMP2ART trial (implementation n = 4; control n = 6). Analytical methods included: ALFA Toolkit Multi-Channel Video Observation (to code and quantify tasks undertaken); the Patient-Centred Observation Form; and The Behaviour Change Counselling Index (to assess patient-centeredness and behaviour change counselling used by HCPs). HCPs mostly spent time during routine asthma reviews discussing: an individual's asthma condition and management (average of 27.8% of consultation time); collaboratively reviewing and completing a personalised asthma action plan (6.3%) and training for practical self-management activities (5.4%). Areas of patient-centred care delivery and behavioural discussions included: creating and maintaining relationships, discussing asthma action plans and medication reconciliation. Professionals in IMP2ART implementation group practices delivered more SSM strategies. Comparison of face-to-face and remote consultations found no significant differences in HCP delivery of SSM. HCPs in UK primary care spent half the time in both face-to-face and remote asthma reviews delivering components of SSM suggesting that either mode of delivery may be acceptable. Reviews carried out in IMP2ART implementation group practices demonstrated more behaviour change and collaborative SSM strategies compared to those in the control group. Asthma UK Centre for Applied Research (AUKCAR) PPI members were involved throughout, including project conception, providing feedback on participant-facing documents, and discussing implications of study findings.

Implementing a novel selection criteria and pathway for same-day discharge after TAVI

Abstract Background The expansion in indications for transcatheter aortic valve implantation (TAVI) has fuelled an increase in demand worldwide. Prolonged waiting lists and waiting list mortalities are not infrequent and often arise from limited hospital capacity and infrastructure. Approaches to address this have included procedural modifications – ‘minimalist TAVI’ and more recently the development of pathways to facilitate early discharge post-TAVI, such as same-day discharge (SDD) post-procedure. Purpose This study aims to evaluate the safety and effectiveness of a novel SDD pathway a large volume tertiary referral cardiac centre. Methods A new SDD pathway was established between March 2023 and February 2024 at a large-volume tertiary cardiac centre in UK. All patients accepted for TAVI were screened for SDD suitability based on three factors: 1) availability of adequate social support, (defined as presence of able-bodies adult individual to assist in home recovery), 2) technically suitable for transfemoral approach and 3) presence of previous pacemaker or low risk for conduction abnormalities (defined as no baseline conduction disturbances). Following TAVI, patients were deemed suitable for SDD if they were clinically stable, the procedure was technically successful and there were no procedural complications. Demographic, clinical, procedural and outcome data were collected for all patients enrolled onto the SDD pathway and reasons for non-SDD were identified. Ethical approval was obtained in accordance with local institutional policies. Results From March 2023 to February 2024, 81 out of 305 patients (26.6%) were enrolled onto the SDD pathway (median age 82 years old, 66.7% male, median STS risk score 2.34%). Indications for TAVI were severe native aortic stenosis (74/81, 91.4%), severe native aortic regurgitation (2/81, 2.5%) and severe surgical valve degeneration (5/81, 6.2%). SDD was feasible for 58/81 (71.6%) of patients, with 10/81 (12.3%) discharged the following day and 13/81 (16.0%%) requiring >24 hours hospital admission (Figure 1). Reasons for non-SDD included new conduction abnormality (10/81, 12.3%), vascular complication (6/81, 7.4%), acute stroke (3/81, 3.7%), patient preference (2/81, 2.5%) and haemodynamic instability (2/81, 2.5%). Out of the 58 SDD patients, 25/58 (43.1%) had no previous permanent pacemaker system and in these patients a balloon-expandable valve was selected for 24/25 (96.0%) of patients (Figure 2). Conclusions Patient selection based on the presence of social support at home, low risk of conduction abnormalities or previous pacemaker combined with appropriate valve selection can facilitate a safe and effective SDD post-TAVI programme.

Detection of chronic obstructive pulmonary disease and frequency of cardiopulmonary events in patients with a significant smoking history hospitalised for acute myocardial infarction

Abstract Background Smoking is a major risk factor for chronic obstructive pulmonary disease (COPD) and also myocardial infarction (MI). Patients with COPD are more likely to have MI than those without and adequately treating COPD might improve cardiovascular outcomes. Reliable diagnosis is important for appropriate treatment. Prevalence of COPD in those hospitalised for MI has not been accurately established. Blood eosinophil count is an important guide to the benefit of inhaled corticosteroid (ICS) treatment in COPD. We aimed to accurately characterise lung function, symptom burden, eosinophil count and cardiopulmonary events in those with a significant smoking history hospitalised for acute MI. Methods Participants (n=216) with a smoking history of ≥10 pack-years currently hospitalised for acute MI were recruited at a single UK centre. Microspirometry and completion of the COPD Assessment Test (CAT) questionnaire were performed at enrolment. Presence and severity of COPD was graded using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. A high burden of COPD symptoms was defined as a CAT score of >10. Repeat CAT and assessment for relevant cardiopulmonary events was undertaken at 3 months and 1 year after enrolment. Results In the enrolled cohort, median age was 60 years (IQR 53-67), 26% were female, 57% were current smokers and median pack-year history was 32 (23-45). 41 of 216 (19 %, [95% CI 14-25]) had evidence of COPD, defined as FEV1/FEV6 <0.7 on best-attempt microspirometry, with 39 (95%) being GOLD2 or greater. Of the 41 with detected COPD, only 15 (37%, [22-53]) had a prior diagnosis. In those with evidence of COPD, a high burden of COPD symptoms was present in 63% of participants at enrolment, 40% at 3 months and 45% at 1 year. 20% [9-35] were receiving inhaled corticosteroids at enrolment. 63% [47-78] had eosinophil count ≥100 cells/mm3 and 17% [7-32] ≥300 cells/mm3. Among those with detected COPD, after 1 year 19.5% (95% CI 9-35%) had suffered a respiratory illness requiring prescription of medication, which was numerically but not statistically significantly higher than those without detected COPD (14.3% [10-20%]). In the COPD cohort, death, infection requiring hospitalisation, MI or unplanned coronary revascularisation, and bleeding requiring hospitalisation each occurred on two occasions (4.9%). Conclusions Based on these data, the prevalence of microspirometry-diagnosed COPD of any severity in patients with significant smoking history hospitalised for MI is around 19%. There is a high rate of undiagnosed and untreated disease, a significant burden of symptoms, including during convalescence, and around a 20% incidence of respiratory illness requiring medical treatment at 1 year. Gathering accurate data from this group is helpful in planning research and service improvement. Increasing detection of COPD in patients with MI would lead to improved cardiopulmonary outcomes.

Infliximab versus interferon-alpha in the treatment of Behçet's Syndrome: Clinical data from the BIO-BEHÇET'S randomised controlled trial.

Whilst biologic therapy is used for Behçet's Syndrome of all subtypes refractory to first-line immunomodulation, there has been an absence of high-quality evidence-and no predictive biomarkers to optimally inform choice. BIO-BEHÇET'S was a randomised, controlled, head-to-head clinical trial comparing the two most frequently used biologics in active refractory Behçet's. Bayesian-designed, pragmatic, standard of care, two-arm, parallel head-to-head trial at four UK centres. Patients with active disease randomised to infliximab or interferon-α2a, and received follow-up with symptom-directed examination at Weeks 12 and 24. Primary outcome was Behçet's Disease Activity Index (BDAI) at 12 weeks. Secondary outcomes included BDAI at 24 weeks and significant improvement in individual organ systems, including ocular symptoms, oral and genital ulcers, arthritis pain, quality of life, disease activity, and steroid use. Biomarkers were also investigated but are reported elsewhere. 79 patients were recruited. Both treatments were equally effective, with a mean difference of 0.13 in BDAI (80% CI: -0.19, 0.46). No significant differences were observed for secondary outcomes, though there were clinically significant within-group reductions for each over time. A modest steroid-sparing effect was observed, with complete cessation of steroids in 20% and 44% of those randomised to infliximab and interferon-α2a, respectively. There was a trend for minor benefit in favour of infliximab in terms of tolerability and persistence. In this first reported, high-quality, head-to-head trial of two biologics in Behçet's, both infliximab and interferon-α2a showed comparable short-term clinical efficacy and safety in refractory active disease of all subtypes. EudraCT: 2014-005390-36; ISRCTN: ISRCTN49793874.

Outcomes of cardiac resynchronization therapy (CRT) in cardiac sarcoidosis patients with a range of ejection fractions.

In cardiac sarcoidosis (CS) patients, the benefit of cardiac resynchronization therapy (CRT) remains unclear. We sought to assess the short-term and long-term effects of CRT in CS patients with a range of left ventricular (LV) ejection fractions (LVEFs). Consecutive CS patients with heart failure with reduced ejection fraction (HFrEF; LVEF≤40%), mildly reduced ejection fraction (HFmrEF; LVEF 41%-49%) and preserved ejection fraction (HFpEF; LVEF≥50) treated with CRT under the care of a tertiary UK centre between 2008 and 2023 were reviewed. CRT response was defined by >5% improvement in serial LVEF. The primary endpoint was a composite of all-cause mortality, cardiac transplantation or unplanned hospitalization for decompensated heart failure. The secondary endpoint included ventricular arrhythmic events. Of the 100 patients enrolled (age 58±10years; 71% male), 63 had HFrEF, 17 had HFmrEF and 20 had HFpEF. After short-term follow-up (9.8±5.4months), HFrEF patients demonstrated significant LVEF response (P<0.01). On Kaplan-Meier analysis (follow-up 38±32months), HFrEF non-responders had significantly worse event-free survival compared with HFrEF responders for the primary (P<0.001) and secondary (P=0.001) endpoints. Despite short-term LV function improvement, CRT responders still had worse event-free survival compared with HFmrEF/HFpEF patients for the primary endpoint (P<0.001). On multivariable Cox analysis, age [hazard ratio (HR) 1.05, 95% confidence interval (CI) 1.01-1.10, P=0.008] and HFrEF CRT non-response (HR 12.33, 95% CI 2.45-61.87, P=0.002) were associated with the primary endpoint. In CS patients with HFrEF, CRT response is associated with a better long-term prognosis than non-response. However, HFrEF CRT responders still have worse long-term prognosis than HFmrEF/HFpEF patients.

MANAGEMENT OF THE OLDER PATIENT WITH GLIOBLASTOMA IN THE UK: AN INITIAL REPORT FROM THE HISTO-MOL GBM COLLABORATIVE

Abstract AIMS The management of older (&amp;gt;70 years old) patients with glioblastoma is challenging with significant variation in practice. Using the Histo-Mol GBM database we analysed the variation in practice across 11 UK centres. METHOD Biopsy confirmed glioblastoma patients diagnosed between 01/01-31/12/2021 were identified. Descriptive statistics were used to compare demographic, tumour and treatment characteristics, and the Kaplan-Meier method was used to analyse survival, assessed from surgery date. Differences in treatment between centres were assessed using one way ANOVA. RESULTS In 2021, 81/330 (24.5%) patients with glioblastoma were &amp;gt;70. Compared to younger patients, the older cohort had a greater proportion of males (79.0% vs 59.0%, p&amp;lt;0.001), a worse performance status (66.7% vs 79.5% ECOG PS 0-1, p&amp;lt;0.001), and more likely to have MGMT promoter methylation (30.9% vs 22.9%, p=0.027). Most patients received biopsy only (31/81, 38.3%), followed by subtotal resection (85-94% tumour resection) (26/81, 32.1%), whilst 8/81 (9.9%) underwent debulking, 8/81 near-total resection (95-99% tumour resection), and 8/81 gross total resection, with statistically significant variation in resection extent between centres (p=0.031). Adjuvant radiotherapy was used in 56/81 patients (69.1%) with no difference between centres (p=0.220). However, there was a statistically significant difference in radiotherapy regime between centres (p=0.041). 6/81 (7.4%) received conventional chemoradiotherapy, 28/81 (34.6%) hypofractionated chemoradiotherapy, 16/81 (19.8%) hypofractionated radiotherapy alone, 2/81 (2.5%) temozolomide alone both with MGMT promoter methylation, and 21/81 (25.9%) received no oncological treatment. Median progression free survival was 5.9 months and median overall survival (OS) was 7.1 months with no difference between centres (p=0.199 and p=0.083 respectively). Median OS was 8.4 months with conventional fractionation chemoradiotherapy, 11.2 months with hypofractionated chemoradiotherapy, 7.3 months with hypofractionated radiotherapy alone, 1.8 months with temozolomide alone, and 2.5 months with no oncological treatment. CONCLUSION We identify variations in the treatment of elderly glioblastoma patients across the UK, although these do not significantly impact survival.

Self-reported skin severity and quality of life in systemic sclerosis: multicentre validation of PASTUL.

The aim of this study was to validate the Patient self-Assessment of Skin Thickness in Upper Limb questionnaire (PASTUL) in systemic sclerosis (SSc) and assess impact of skin involvement on health-related quality of life (HRQoL). Participants were included in four UK centres. PASTUL specifies a grading of skin at 8 sites corresponding to the modified Rodnan Skin Score (mRSS). Construct validity was assessed by comparing PASTUL scores with mRSS. HRQoL was evaluated with EQ5D5L and Leeds SSc HRQoL questionnaires. Additionally, correlation between PASTUL and Scleroderma Skin Patient reported Outcome (SSPRO) was explored. Follow-up was 12 months. In total, 196 participants were included, mean age was 56.4 years (SD 13.9), 80.6% female (n = 158), mean disease duration 11.9 years (SD 9.9), 110 (56.1%) had limited cutaneous (lcSSc) and 81 (41.3%) diffuse cutaneous SSc (dcSSc). PASTUL and upper limb mRSS were well correlated at baseline, 6 and 12 months (ICC = 0.67, 0.78 and 0.62, p< 0.001). Test-retest reliability was good (ICC = 0.83, p< 0.001). There was a stronger correlation between PASTUL and upper limb mRSS in dcSSc compared with lcSSc (0.69 vs 0.51, p< 0.001). In participants with early disease (< 4 years) PASTUL was moderately correlated with HRQoL (r = 0.53, p< 0.001), correlations were weaker in the whole group. Mean time to do the PASTUL self-assessment was 5.0 min (SD 3.7). PASTUL is a feasible outcome tool that adds to assessments as SSPRO. Skin thickening is correlated with HRQoL, particularly in early disease.

Assessing disease control in inflammatory bowel disease: a real world cross-sectional study in the UK (PODCAST-IBD)

Objective Proportion Of suboptimal Disease Control And Strategy of Treatment in IBD (PODCAST-IBD) was an international real-world study which aimed to quantify disease control in IBD using STRIDE-II recommendations. Design/Method Cross-sectional assessment of IBD patients attending routine clinic appointments in four UK centers October 2022 to January 2023. Clinician-reported outcomes, patient-reported outcomes and retrospective data from medical chart review were used to assess IBD control against red flags aligned to STRIDE-II. Results Data were available from 198 UK patients. IBD was suboptimally controlled in 52.4% (54/103) of patients with Crohn’s disease (CD) and 45.3% (43/95) with ulcerative colitis (UC). Impaired quality of life (QOL), defined as Short inflammatory bowel disease questionnaire (SIBDQ) score <50, was the main contributor to suboptimal disease control. Suboptimal disease control has a detrimental impact on fatigue and disability with significantly lower mean Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) score in suboptimally controlled disease (CD: 81.5 vs 125, UC: 87.4 vs 122.8) and IBD Disk. Suboptimal disease control results in higher health care resource use (HCRU) (CD: £4,746 vs £1,924; UC: £2,428 vs £1,121) and higher rates of work productivity loss (CD: 41.7% vs 11.9%, UC: 38.0% vs 22.6%). Conclusion IBD was suboptimally controlled in around one-half of patients. Impaired QOL was the most common contributor (64%, 62/97) to suboptimal control. Suboptimal control had a considerable economic impact; HCRU more than doubled and productivity fell. Physicians could consider regular QOL assessments to prompt timely disease monitoring to enable identification of early active disease and appropriate treatment.

The move to 24/7 mechanical thrombectomy provision for ischaemic stroke: an observational study of the impact on referrals, activity, procedural efficacy, and safety at a supra-regional centre.

Health systems are striving to improve delivery of mechanical thrombectomy (MT) for ischaemic stroke. With the move to 24/7 provision, we aimed to assess (1) the change in referral and procedural frequency and timing, (2) reasons referrals did not proceed to MT, and (3) nocturnal procedural efficacy and safety. This was an observational study comparing 12-month data for an extended daytime service (2021/2022, hours, 0800-2000) to that for a 12-month period delivering 24/7 cover (2023-2024). Nocturnal and daytime outcomes (rate of recanalisation using modified TICI scoring), extent of postprocedural infarction (using ASPECTS grading), rate of early neurological improvement (using 24-h NIHSS change), 90-day mortality, and complicating symptomatic intracranial haemorrhage (SICH) in the latter period were compared. Both referrals (432 to 851) and procedural caseload (191 to 403) approximately doubled with the move to 24/7 cover; 36% of procedures occurred overnight (n= 145). The dominant reasons for referrals not proceeding to MT were a large core infarct (n= 144) or absence of a large vessel occlusion on baseline imaging (n= 140). There were no significant differences in successful recanalisation (TICI 2B/3: 85.5% vs 87.1%, P= .233), rates of postprocedural ASPECTS≥7 (74.9% vs 75.8%, P= .987), early neurological improvement (NIHSS reduction ≥30%: 43.4% vs 42.4%, P= .917), 90-day mortality (19.6% vs 18.6%, P= .896), or SICH (1.9% vs 4.1%, P= .214) obtained for daytime vs nighttime hours. 24/7 MT provision has resulted in a rapid rise in the number of patients who may benefit from MT. This service can be provided with an acceptable safety profile during nighttime hours in a high-volume comprehensive UK centre.

Risk factors and early outcomes associated with prolonged pleural effusion/chylothorax after paediatric cardiac surgery.

Prolonged pleural effusion/chylothorax (PPE/C) is a less investigated complication following paediatric cardiac surgery, and its true incidence, risk factors and impact on postoperative outcomes are not well described. We aim to address these gaps in knowledge using data from a prospective, multicentre study. Data on 9 post-operative morbidities (unplanned reinterventions, extracorporeal life support, necrotising enterocolitis, PPE/C, renal replacement therapy, major adverse events, acute neurological events, feeding issues and postsurgical infection) were prospectively collected at 5 UK centres between 2015 and 2017, following paediatric cardiac surgery. Incidence of PPE/C, associations with procedure types, and risk factors were described. Mortality (30-day and 6-month) and hospital length of stay (HLoS) were compared between those with isolated PPE/C, single non-PPE/C morbidity, no morbidity, multimorbidity PPE/C and non-PPE/C multimorbidity. A total of 3090 procedures (2861 patients) were included (median age, 228 days). There were 202 PPE/C (incidence of 6.5%), occurring at a median of 6 days postoperatively (IQR: 3-10). PPE/C was associated with excess early mortality only when complicating scenarios where at least two other post-operative morbidities occurred. On average PPE/C is associated with 8 more HLoS days, but the relative impact is greatest when comparing isolated PPE/C with no morbidity (p < 0.001), whereas in multimorbidity scenarios, PPE/C does not significantly contribute to an increase of HLoS. Addition of PPE/C increases mortality but not HLoS in multimorbidity and HLoS only in single morbidity scenarios. This reinforces the important role of prevention, early detection and management of PPE/C in complex situations.

7692 Morning Cortisol Levels In Patients With Established Primary Adrenal Insufficiency

Abstract Disclosure: A. Prete: Research Investigator; Self; Diurnal. V. Theiler-Schwetz: Research Investigator; Self; Diurnal. W. Arlt: Research Investigator; Self; Diurnal. I.O. Chifu: Research Investigator; Self; Diurnal. B. Harbeck: Research Investigator; Self; Diurnal. C. Napier: Research Investigator; Self; Diurnal. J.D. Newell-Price: Research Investigator; Self; Diurnal. A. Rees: Research Investigator; Self; Diurnal. N. Reisch: Research Investigator; Self; Diurnal. G.K. Stalla: Research Investigator; Self; Diurnal. N. Aslam: Employee; Self; Diurnal. H. Coope: Employee; Self; Diurnal. K. Maltby: Employee; Self; Diurnal. J. Porter: Employee; Self; Diurnal. J. Quirke: Employee; Self; Diurnal. R.J. Ross: Consulting Fee; Self; Diurnal. Background: Primary adrenal insufficiency (PAI) is rare: prevalence ∼100-140/million and incidence 4:1 000 000/year in Western societies [1]. The diagnosis of PAI is suggested by an early-morning cortisol &amp;lt;140 nmol/L (5 µg/dL) [1]. The commonest cause in adults is autoimmunity (∼90% in Western countries) and it is generally considered progressive once the diagnosis is made, although it has been reported that residual cortisol secretion is present in ∼30% of patients 2. We have developed a modified-release formulation of hydrocortisone to replace the physiological cortisol circadian rhythm and are undertaking a Double-Blind, Double-Dummy, Two-Way Cross-Over, Randomised, Phase II Study of Modified-Release Hydrocortisones: Chronocort® Versus Plenadren® in PAI. During recruitment, we were surprised by the number of patients who were ineligible as they had detectable morning cortisol levels. Methods: Main inclusion criteria: Participants with known PAI on stable glucocorticoid replacement therapy and an early morning pre-dose cortisol &amp;lt;50 nmol/L (1.8 µg/dl). Baseline serum cortisol was taken at ∼0700h and measured in a central laboratory by ADVIA Centaur® immunoassay with the lower limit of detection &amp;lt;14nmol/l (&amp;lt;0.5 µg/dL). Results: 86 patients with PAI (autoimmune aetiology in 71), median age 52 years (range 20-73), 60 female, were screened in 8 centres in UK and Germany. 18 (21%) patients were excluded from the study based on morning cortisol &amp;gt;50 nmol/L (1.8 µg/dL), and of those 68 patients who qualified on the main inclusion criteria 51 (59% of screened) had a cortisol &amp;lt;14 nmol/L (&amp;lt;0.5 µg/dL). Of the 18 patients (autoimmune aetiology in 10) excluded based on their morning cortisol level, 9 (50%) were female and 11 (13% of screened), had morning cortisol ≥140 nmol/L (5.0 µ/dL). 12 patients with morning cortisol of &amp;gt;50nmol/L (1.8 µ/dL) were retested and only 2 then qualified; their initial morning cortisol levels were 70 and 51 nmol/L. In patients retested the median difference between retest and the initial sample was 13 nmol/L (range 1-421 nmol/L). Conclusions: In patients with an established diagnosis of PAI, the majority had undetectable morning cortisol, but cortisol was detectable in 41% of patients and above 140 nmol/L in 13% confirming previous publications 2. Retesting patients with a cortisol &amp;gt;50nmol/L showed very similar results suggesting that the detectable cortisol was not an artefact and likely due to background cortisol secretion. 1. Bornstein SR, et al. J Clin Endocrinol Metab 2016;101:364-89.2.Pearce SHS, et al. European Journal of Endocrinology (2021) 184, R61–R67 Presentation: 6/1/2024

Use of sirolimus-coated balloon in de novo coronary lesions; long-term clinical outcomes from a multi-center real-world population.

Sirolimus-coated balloon (SCB), a relatively novel technology appears attractive due to the drug properties (safety and efficacy) and sirolimus remains the drug of choice in stents. However, there is limited data long-term data on SCB. In this study, we have explored the clinical outcomes following the use of SCB in de-novo lesions from a real-world practice. To report long-term clinical outcomes following the use of Siroliumus coated balloon in de novo lesions. We analyzed all patients treated with an SCB in de novo lesions between 2016 and 2023 at four high-volume centers in UK and Italy. The outcomes measured included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularization (TLR) and major adverse cardiac events (MACE). During the study period, 771 patients had SCB in de novo lesions. Diabetes mellitus was noted in 36% of patients (n = 280), of which 14% (n = 108) were insulin dependent. Fifteen percent (n = 117) had chronic kidney disease, Fifty-two percent (n = 398) of cases were in the setting acute coronary syndrome (ACS) and of which 51 cases (7%) were ST-segment elevation myocardial infarction. Small vessels (<3.0 mm) accounted for 78% (n = 601) of cases and 76% (n = 584) were long lesions ( 20 mm). The mean diameter of SCB was 2.6 ± 0.4 mm and the mean length was 25 ± 10.39 mm. Bailout stenting following SCB was required in 9% lesions (n = 67). During the median follow-up 640 days, total death occurred in 39 (5%) patients and of which, cardiac death occurred in 10 patients (1.3%). TVMI occurred in 20 patients (2.6%). TLR and TVR were 5.6% and 5.8% respectively. The overall MACE rate was 8%. We had no documented case of acute vessel closure. The results from this long-term follow-up in a real-world population are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite a complex group of patients. Our data suggest that SCBs are safe in coronary intervention with good clinical outcomes in the long term.

Induction chemotherapy followed by standard chemoradiotherapy versus standard chemoradiotherapy alone in patients with locally advanced cervical cancer (GCIG INTERLACE): an international, multicentre, randomised phase 3 trial

Locally advanced cervical cancer is treated with chemoradiotherapy (standard of care), but many patients still relapse and die from metastatic disease. We investigated chemoradiotherapy with or without induction chemotherapy to determine whether induction chemotherapy improves both progression-free survival and overall survival. The INTERLACE trial was a multicentre, randomised phase 3 trial done at 32 medical centres in Brazil, India, Italy, Mexico, and the UK. Adults (aged ≥18 years) with locally advanced cervical cancer (FIGO 2008 stage IB1 disease with nodal involvement, or stage IB2, IIA, IIB, IIIB, or IVA disease) were randomly assigned (1:1), by minimisation, using a central electronic system, to standard cisplatin-based chemoradiotherapy (once-a-week intravenous cisplatin 40 mg/m2 for 5 weeks with 45·0-50·4 Gy external beam radiotherapy delivered in 20-28 fractions plus brachytherapy to achieve a minimum total 2 Gy equivalent dose of 78-86 Gy) alone or induction chemotherapy (once-a-week intravenous carboplatin area under the receiver operator curve 2 and paclitaxel 80 mg/m2 for 6 weeks) followed by standard cisplatin-based chemoradiotherapy. Stratification factors were recruiting site, stage, nodal status, three-dimensional conformal radiotherapy or intensity modulated radiotherapy, age, tumour size, and histology (squamous vs non-squamous). Primary endpoints were progression-free survival and overall survival within the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01566240, and EUDRACT, 2011-001300-35. Between Nov 8, 2012, and Nov 17, 2022, 500 eligible patients were enrolled and randomly assigned to the chemoradiotherapy alone group (n=250) or the induction chemotherapy with chemoradiotherapy group. Of 500 patients, 354 (70%) had stage IIB disease and 56 (11%) stage IIIB disease. Pelvic lymph nodes were positive in 215 (43%) patients. 230 (92%) patients who received induction chemotherapy had at least five cycles. Median interval between induction chemotherapy and chemoradiotherapy was 7 days. Four or more cycles of cisplatin were given to 212 (85%) participants in the induction chemotherapy with chemoradiotherapy group and to 224 (90%) of participants in the chemoradiotherapy alone group. 462 (92%) participants received external beam radiotherapy and brachytherapy with a median overall treatment time of 45 days. After a median follow-up of 67 months, 5-year progression-free survival rates were 72% in the induction chemotherapy with chemoradiotherapy group and 64% in the chemoradiotherapy alone group with a hazard ratio (HR) of 0·65 (95% CI 0·46-0·91, p=0·013). 5-year overall survival rates were 80% in the induction chemotherapy with chemoradiotherapy group and 72% in the chemoradiotherapy alone group, with an HR of 0·60 (95% CI 0·40-0·91, p=0·015). Grade 3 or greater adverse events were reported in 147 (59%) of 250 individuals in the induction chemotherapy with chemoradiotherapy group versus 120 (48%) of 250 individuals in the chemoradiotherapy alone group. Short-course induction chemotherapy followed by chemoradiotherapy significantly improves survival of patients with locally advanced cervical cancer. Cancer Research UK and University College London-University College London Hospitals Biomedical Research Centre.

356P A retrospective review of adult Duchenne muscular dystrophy patients in a UK centre of excellence and report the results of adherence to the standards of care guidelines for cardiac management

356P A retrospective review of adult Duchenne muscular dystrophy patients in a UK centre of excellence and report the results of adherence to the standards of care guidelines for cardiac management

207P Mobile muscle clinics operating from a UK centre of excellence: report of patient experience and quality of care

207P Mobile muscle clinics operating from a UK centre of excellence: report of patient experience and quality of care