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Aim: The aim of this study was to investigate the perceptions of registered nurse (RN) preceptors working in psychiatric care concerning the organisation of clinical placements and their own preceptor role with undergraduate nursing students. Background: Clinical placements play a central role in undergraduate nursing education, and it is crucial that psychiatric care clinical placements are of high quality. Methods: The RNs’ perceptions before and after the introduction of changes in the organisation of clinical placements were compared. A total of 103 surveys with quantitative and qualitative data were returned, from 59 RN preceptors at baseline and 44 RN preceptors at follow-up. Data were analysed with non-parametrical statistics and qualitative content analysis. Results: The majority of RN preceptors perceived the changes to have been beneficial, but there was still a desire for the students to have more time in their psychiatric care clinical placements according to the RN preceptors. At follow-up, significantly more RN preceptors perceived that they had an intentional pedagogical foundation for their precepting. Conclusions: We conclude that the changes introduced into the clinical placement are beneficial, but there is still need for further improvement in relation to the amount of time student nurses spend in psychiatric clinical placements and in the opportunities provided for RN preceptors to attend preceptor preparation courses. © 2021 The Authors, open access

Aim: The aim of this study was to investigate the perceptions of registered nurse (RN) preceptors working in psychiatric care concerning the organisation of clinical placements and their own preceptor role with undergraduate nursing students. Background: Clinical placements play a central role in undergraduate nursing education, and it is crucial that psychiatric care clinical placements are of high quality. Methods: The RNs’ perceptions before and after the introduction of changes in the organisation of clinical placements were compared. A total of 103 surveys with quantitative and qualitative data were returned, from 59 RN preceptors at baseline and 44 RN preceptors at follow-up. Data were analysed with non-parametrical statistics and qualitative content analysis. Results: The majority of RN preceptors perceived the changes to have been beneficial, but there was still a desire for the students to have more time in their psychiatric care clinical placements according to the RN preceptors. At follow-up, significantly more RN preceptors perceived that they had an intentional pedagogical foundation for their precepting. Conclusions: We conclude that the changes introduced into the clinical placement are beneficial, but there is still need for further improvement in relation to the amount of time student nurses spend in psychiatric clinical placements and in the opportunities provided for RN preceptors to attend preceptor preparation courses. © 2021 The Authors, open access

Aim: The aim of this study was to investigate the perceptions of registered nurse (RN) preceptors working in psychiatric care concerning the organisation of clinical placements and their own preceptor role with undergraduate nursing students. Background: Clinical placements play a central role in undergraduate nursing education, and it is crucial that psychiatric care clinical placements are of high quality. Methods: The RNs’ perceptions before and after the introduction of changes in the organisation of clinical placements were compared. A total of 103 surveys with quantitative and qualitative data were returned, from 59 RN preceptors at baseline and 44 RN preceptors at follow-up. Data were analysed with non-parametrical statistics and qualitative content analysis. Results: The majority of RN preceptors perceived the changes to have been beneficial, but there was still a desire for the students to have more time in their psychiatric care clinical placements according to the RN preceptors. At follow-up, significantly more RN preceptors perceived that they had an intentional pedagogical foundation for their precepting. Conclusions: We conclude that the changes introduced into the clinical placement are beneficial, but there is still need for further improvement in relation to the amount of time student nurses spend in psychiatric clinical placements and in the opportunities provided for RN preceptors to attend preceptor preparation courses. © 2021 The Authors, open access

Aim: The aim of this study was to investigate the perceptions of registered nurse (RN) preceptors working in psychiatric care concerning the organisation of clinical placements and their own preceptor role with undergraduate nursing students. Background: Clinical placements play a central role in undergraduate nursing education, and it is crucial that psychiatric care clinical placements are of high quality. Methods: The RNs’ perceptions before and after the introduction of changes in the organisation of clinical placements were compared. A total of 103 surveys with quantitative and qualitative data were returned, from 59 RN preceptors at baseline and 44 RN preceptors at follow-up. Data were analysed with non-parametrical statistics and qualitative content analysis. Results: The majority of RN preceptors perceived the changes to have been beneficial, but there was still a desire for the students to have more time in their psychiatric care clinical placements according to the RN preceptors. At follow-up, significantly more RN preceptors perceived that they had an intentional pedagogical foundation for their precepting. Conclusions: We conclude that the changes introduced into the clinical placement are beneficial, but there is still need for further improvement in relation to the amount of time student nurses spend in psychiatric clinical placements and in the opportunities provided for RN preceptors to attend preceptor preparation courses. © 2021 The Authors, open access

Aim: The aim of this study was to investigate the perceptions of registered nurse (RN) preceptors working in psychiatric care concerning the organisation of clinical placements and their own preceptor role with undergraduate nursing students. Background: Clinical placements play a central role in undergraduate nursing education, and it is crucial that psychiatric care clinical placements are of high quality. Methods: The RNs’ perceptions before and after the introduction of changes in the organisation of clinical placements were compared. A total of 103 surveys with quantitative and qualitative data were returned, from 59 RN preceptors at baseline and 44 RN preceptors at follow-up. Data were analysed with non-parametrical statistics and qualitative content analysis. Results: The majority of RN preceptors perceived the changes to have been beneficial, but there was still a desire for the students to have more time in their psychiatric care clinical placements according to the RN preceptors. At follow-up, significantly more RN preceptors perceived that they had an intentional pedagogical foundation for their precepting. Conclusions: We conclude that the changes introduced into the clinical placement are beneficial, but there is still need for further improvement in relation to the amount of time student nurses spend in psychiatric clinical placements and in the opportunities provided for RN preceptors to attend preceptor preparation courses. © 2021 The Authors, open access

Background: Global longitudinal strain (GLS) is associated with major adverse cardiovascular outcomes independent of LVEF. However, the association of GLS with the development of adverse left ventricular remodelling (LVR) is not well established. Aim(s): To study the relationship between abnormal GLS (>-16%) and LVR in patients with normal resting LVEF. Method(s): Embase, Medline and Cochrane databases were systematically searched to identify studies utilising GLS and LVEF in predicting LVR. The primary outcome was mean difference in GLS in patients who develop LVR compared to those who do not develop LVR at >=3 months. The reviewers followed PRISMA protocol. Result(s): Eleven studies were included in the final quantitative analysis of 700 patients (mean age 59.5 +/- 11.9, Male = 68%). When patients who developed LVR were compared with those without LVR, mean baseline LVEF was: 56.1% (95%CI = 54.9-57.3, P < 0.0001) vs. 61.6% (60.6-62.6, P < 0.0001) and mean baseline GLS was: -15.7% (-16.5 to -15.1, P < 0.0001) vs. -19.5% (-20 to -18.9, P < 0.0001) whereas, mean differences of baseline GLS and EF in LVR group were statistically significant: 3.8% (3.0-4.6, P < 0.0001) and -5.5% (-7.0 to -3.9, P < 0.0001) respectively. When baseline and follow-up LVEF and GLS are compared in LVR group, mean LVEF difference was 3.62 (2.06 to 5.18, I2 = 38%, P < 0.0001) and mean GLS difference was -2.17 (-3.21 to -1.13, I2 = 71%, P < 0.0001) (Fig. 1 ) whilst in those without LVR, mean LVEF and GLS difference were 2.71 (-4.92 to -0.50, I2 = 75%, P = 0.02) and 0.64 (-0.74 to 2.03, I2 = 84%, P = 0.36). Conclusion(s): Abnormal GLS at baseline and further worsening at follow-up is associated with the development of adverse LVR. Therefore, patients with abnormal resting GLS may benefit from closer surveillance and earlier therapy.Copyright © 2019, P. Thein, MonashHeart and Monash Cardiovascular Research Centre, Monash Health and Monash University, Melbourne, Australia, CONFERENCE ABSTRACT

Introduction: Hybrid epicardial and endocardial ablation has been proven to be an effective method for attaining rhythm control in persistent atrial fibrillation where anti-arrhythmic drug therapy and lone catheter ablation has been disappointing. We present mid-term findings on the safety and effectiveness of hybrid ablation in persistent atrial fibrillation. Method(s): Between 2017 and 2019, nineteen patients with persistent atrial fibrillation underwent totally thoracoscopic radiofrequency ablation with pulmonary vein isolation, posterior left atrial box lesion and left atrial appendage exclusion with Atriclip. They subsequently underwent endocardial mapping three months later. Any gaps from epicardial ablation were re-ablated. All patients were followed up prospectively. Result(s): Mean age of patients was 59.8+/-6.8 years. Median time of duration of atrial fibrillation preoperatively was 24 months. The average number of failed DCRs was 2.1+/-1.1. Average left atrial volume index was 55.45+/-11.5mL/m2. Average LVEF was 50.8+/-7.3%. At a mean follow-up of 395 days post hybrid ablation, all patients were in sinus rhythm at their most recent follow-up. 21% of patients had a recurrence of atrial arrhythmias. One patient had a minor complication of a left sided pleural effusion after the epicardial ablation. One patient had a pericardial effusion without tamponade requiring pericardiocentesis after epicardial ablation. There were no deaths, conversion to median sternotomy, strokes or pacemaker implantation. Conclusion(s): Sequential hybrid ablation for persistent atrial fibrillation is safe and effective.Copyright © 2020, CONFERENCE ABSTRACT

Background: Coronary artery disease (CAD) is the leading cause of mortality in Australian women. We identified gender differences in healthy lifestyle adherence in patients treated with percutaneous coronary intervention (PCI) for CAD. Method(s): Consecutive patients were prospectively recruited from three Australian institutions (2016-2017). The primary endpoint at 1 year follow-up was healthy lifestyle adherence defined as 3/3 of: a heart-healthy diet, being physically active and not smoking. Secondary endpoints included cardiac rehabilitation attendance, medication use and lipid levels. Result(s): From 729 participants (n=192, 26.3% women) 56% were adherent to all three lifestyle measures with no gender difference overall. Compared to men, women were less likely to smoke (7.7% versus 12.2%, p<0.001) to be physically active (61.5% versus 78.2%; p<0.0001), attend cardiac rehabilitation (58.2% versus 66.4%; p<0.045), and take statin therapy (85.4% versus 94.7%; p<0.0001). Female gender independently predicted physical inactivity (OR 2.41, 95% CI 1.57-3.68, p<0.001). Conclusion(s): Important gender differences exist in patients treated with PCI for CAD, namely, significant lower physical activity, cardiac rehabilitation attendance and statin use in women. These all represent key targets for gender-specific secondary prevention interventions.Copyright © 2020

Introduction and importance: Colonic ventriculoperitoneal shunt (VPS) migration with trans-anal protrusion remains uncommon. Patients may be asymptomatic, and diagnosis may only be made on visualization of the prolapsed catheter from the anus. This unique case of early post-operative trans-anal shunt protrusion highlight the possibility of this rare complication specially when shunt revision accompanies bowel surgery. Case presentation: The authors present a case of early postoperative colonic shunt migration in a thirteen-year-old female with who underwent Malone Antegrade Continence Enema (MACE) with concomitant revision of the distal part of the peritoneal catheter. She presented two weeks post operatively with shunt catheter protruding from the anus. This was noticed by her carer and she was asymptomatic on her presentation. Clinical discussion: Delayed post-operative shunt related bowel perforation and trans-anal shunt protrusion is an uncommon complication after ventriculoperitoneal shunting. Most cases present months after surgery and majority are asymptomatic on presentation. The exact pathophysiology is not established, and mechanisms have been proposed. Early post -operative trans-anal shunt protrusion is rare and suggests inadvertent occult bowel injury especially when shunt placement or revision accompanies extensive bowel surgery. Conclusion(s): The authors recommended shunt imaging within the first two to three weeks after shunt revision in patient who undergo concomitant bowel surgery with risk of inadvertent bowel injury to identify early colonic migration and avoid its potentially fatal sequelae.Copyright © 2021

Introduction and importance: Spinal dural arteriovenous fistula (SDAVF) is an uncommon cause of longitudinal extensive transverse myelitis (LETM). It usually presents with vague congestive myelopathy symptoms and diagnosis is usually difficult on initial presentation. Common daily neurological interventions can aggravate the underlying pathophysiology leading to undesirable acute neurological deterioration. Intravenous steroids administration and lumbar (LP) puncture as a diagnostic tool are amongst the most commonly reported aggravating interventions. This rare case presentation highlights this association with its negative impact on the patient outcome in misdiagnosed cases. Case presentation: The authors present a sixty-eight-year-old male with paraplegia following steroid administration and LP for presumed inflammatory/autoimmune LETM in the setting of misdiagnosed SDAVF. The absence of flow voids on the conventional T2-weighted magnetic resonance image (MRI) lead to misdiagnosis. He had satisfactory neurological recovery few hours after surgical disconnection. Clinical discussion: SDAVF is known to cause congestive myelopathy symptoms. Spinal angiogram is the gold standard for diagnosis. Although the exact mechanism is not fully understood, misdiagnosed cases like our case can develop severe neurological deterioration with steroid administration and lumbar puncture. Conclusion(s): Although SDAVF is an uncommon cause of LETM, Clinicians should carefully exclude it before proceeding to steroid administration or performing LP as they can lead to devastating neurological deterioration.Copyright © 2021

Background: Coronary artery disease (CAD) is the leading cause of mortality in Australian women. We identified gender differences in healthy lifestyle adherence in patients treated with percutaneous coronary intervention (PCI) for CAD. Method(s): Consecutive patients were prospectively recruited from three Australian institutions (2016-2017). The primary endpoint at 1 year follow-up was healthy lifestyle adherence defined as 3/3 of: a heart-healthy diet, being physically active and not smoking. Secondary endpoints included cardiac rehabilitation attendance, medication use and lipid levels. Result(s): From 729 participants (n=192, 26.3% women) 56% were adherent to all three lifestyle measures with no gender difference overall. Compared to men, women were less likely to smoke (7.7% versus 12.2%, p<0.001) to be physically active (61.5% versus 78.2%; p<0.0001), attend cardiac rehabilitation (58.2% versus 66.4%; p<0.045), and take statin therapy (85.4% versus 94.7%; p<0.0001). Female gender independently predicted physical inactivity (OR 2.41, 95% CI 1.57-3.68, p<0.001). Conclusion(s): Important gender differences exist in patients treated with PCI for CAD, namely, significant lower physical activity, cardiac rehabilitation attendance and statin use in women. These all represent key targets for gender-specific secondary prevention interventions.Copyright © 2020

Introduction and importance: Colonic ventriculoperitoneal shunt (VPS) migration with trans-anal protrusion remains uncommon. Patients may be asymptomatic, and diagnosis may only be made on visualization of the prolapsed catheter from the anus. This unique case of early post-operative trans-anal shunt protrusion highlight the possibility of this rare complication specially when shunt revision accompanies bowel surgery. Case presentation: The authors present a case of early postoperative colonic shunt migration in a thirteen-year-old female with who underwent Malone Antegrade Continence Enema (MACE) with concomitant revision of the distal part of the peritoneal catheter. She presented two weeks post operatively with shunt catheter protruding from the anus. This was noticed by her carer and she was asymptomatic on her presentation. Clinical discussion: Delayed post-operative shunt related bowel perforation and trans-anal shunt protrusion is an uncommon complication after ventriculoperitoneal shunting. Most cases present months after surgery and majority are asymptomatic on presentation. The exact pathophysiology is not established, and mechanisms have been proposed. Early post -operative trans-anal shunt protrusion is rare and suggests inadvertent occult bowel injury especially when shunt placement or revision accompanies extensive bowel surgery. Conclusion(s): The authors recommended shunt imaging within the first two to three weeks after shunt revision in patient who undergo concomitant bowel surgery with risk of inadvertent bowel injury to identify early colonic migration and avoid its potentially fatal sequelae.Copyright © 2021

Introduction and importance: Spinal dural arteriovenous fistula (SDAVF) is an uncommon cause of longitudinal extensive transverse myelitis (LETM). It usually presents with vague congestive myelopathy symptoms and diagnosis is usually difficult on initial presentation. Common daily neurological interventions can aggravate the underlying pathophysiology leading to undesirable acute neurological deterioration. Intravenous steroids administration and lumbar (LP) puncture as a diagnostic tool are amongst the most commonly reported aggravating interventions. This rare case presentation highlights this association with its negative impact on the patient outcome in misdiagnosed cases. Case presentation: The authors present a sixty-eight-year-old male with paraplegia following steroid administration and LP for presumed inflammatory/autoimmune LETM in the setting of misdiagnosed SDAVF. The absence of flow voids on the conventional T2-weighted magnetic resonance image (MRI) lead to misdiagnosis. He had satisfactory neurological recovery few hours after surgical disconnection. Clinical discussion: SDAVF is known to cause congestive myelopathy symptoms. Spinal angiogram is the gold standard for diagnosis. Although the exact mechanism is not fully understood, misdiagnosed cases like our case can develop severe neurological deterioration with steroid administration and lumbar puncture. Conclusion(s): Although SDAVF is an uncommon cause of LETM, Clinicians should carefully exclude it before proceeding to steroid administration or performing LP as they can lead to devastating neurological deterioration.Copyright © 2021

Aim: The aim of this study was to investigate the perceptions of registered nurse (RN) preceptors working in psychiatric care concerning the organisation of clinical placements and their own preceptor role with undergraduate nursing students. Background: Clinical placements play a central role in undergraduate nursing education, and it is crucial that psychiatric care clinical placements are of high quality. Methods: The RNs’ perceptions before and after the introduction of changes in the organisation of clinical placements were compared. A total of 103 surveys with quantitative and qualitative data were returned, from 59 RN preceptors at baseline and 44 RN preceptors at follow-up. Data were analysed with non-parametrical statistics and qualitative content analysis. Results: The majority of RN preceptors perceived the changes to have been beneficial, but there was still a desire for the students to have more time in their psychiatric care clinical placements according to the RN preceptors. At follow-up, significantly more RN preceptors perceived that they had an intentional pedagogical foundation for their precepting. Conclusions: We conclude that the changes introduced into the clinical placement are beneficial, but there is still need for further improvement in relation to the amount of time student nurses spend in psychiatric clinical placements and in the opportunities provided for RN preceptors to attend preceptor preparation courses. © 2021 The Authors, open access

Background: Treatment of venous thromboembolism in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. The aim of our study was to compare the efficacy and safety of rivaroxaban versus standard anticoagulants in children with venous thromboembolism. Methods: In a multicentre, parallel-group, open-label, randomised study, children (aged 0–17 years) attending 107 paediatric hospitals in 28 countries with documented acute venous thromboembolism who had started heparinisation were assigned (2:1) to bodyweight-adjusted rivaroxaban (tablets or suspension) in a 20-mg equivalent dose or standard anticoagulants (heparin or switched to vitamin K antagonist). Randomisation was stratified by age and venous thromboembolism site. The main treatment period was 3 months (1 month in children <2 years of age with catheter-related venous thromboembolism). The primary efficacy outcome, symptomatic recurrent venous thromboembolism (assessed by intention-to-treat), and the principal safety outcome, major or clinically relevant non-major bleeding (assessed in participants who received ≥1 dose), were centrally assessed by investigators who were unaware of treatment assignment. Repeat imaging was obtained at the end of the main treatment period and compared with baseline imaging tests. This trial is registered with ClinicalTrials.gov, number NCT02234843 and has been completed. Findings: From Nov 14, 2014, to Sept 28, 2018, 500 (96%) of the 520 children screened for eligibility were enrolled. After a median follow-up of 91 days (IQR 87–95) in children who had a study treatment period of 3 months (n=463) and 31 days (IQR 29–35) in children who had a study treatment period of 1 month (n=37), symptomatic recurrent venous thromboembolism occurred in four (1%) of 335 children receiving rivaroxaban and five (3%) of 165 receiving standard anticoagulants (hazard ratio [HR] 0·40, 95% CI 0·11–1·41). Repeat imaging showed an improved eff

Background: Testicular-epididymal fusion anomalies (TEFA) have been documented in the literature. The pathological significance of TEFA and their relationship to testicular maldescent is unclear. We aimed to clarify the real incidence of TEFA in children with undescended testes and their impact on testicular development after surgery. Method(s): We conducted a retrospective review (2010-2018) of all patients who underwent orchidopexy. Cases with TEFA confirmed intra-operatively were matched against controls with normal fusion for age at the time of surgery. Records from follow-up visits were assessed to compare testicular size at six-months. A systematic review and meta-analysis of the literature (1980-2019) was also performed. Result(s): In our retrospective review, 54 (21.4%) of 252 cryptorchid testes were found to have TEFA (Table). Intra-abdominal testes were more likely to exhibit TEFA than inguinal testes (20.4% vs. 9.6%, RR 1.8 [1.0-3.1], P = 0.03). There were no differences in testicular size at the time of surgery (P = 0.29) or the six-month followup (P = 0.18). The systematic review identified eight studies with 4871 children (5240 orchidopexies). The overall rate of TEFA was 25.8% [95% CI 15.2-38.0]. Tail nonfusion (NF) (10.7% [95% CI 5.4-17.4]) was the most common followed by head NF (7.2% [95% CI 3.2-12.5]) and complete NF (6.3% [95% CI 3.7-9.5]). Intra-abdominal testes were more likely to exhibit TEFA than inguinal testes RR 2.6 [95% CI 1.9-3.5]; P < 0.001. Conclusion(s): Data from our retrospective review and the literature indicate that TEFA are present in approximately one-quarter of cryptorchid testes and are more commonly associated with intra-abdominal cryptorchidism. There appears to be no impact on testicular size at short-term followup. The clinical significance of TEFA remains unclear; long-term followup studies are necessary to better understand their impact on testicular development and function. [Table presented]Copyright © 2020 Journal of

Background: The impact of radiotherapy (RT) on the efficacy and toxicity of immune checkpoint inhibitors in patients (pts) with metastatic non-small cell-lung cancer (NSCLC) is unclear. Method(s): We retrospectively identified pts with metastatic NSCLC treated with the anti-programmed death 1 (PD-1) antibodies nivolumab or pembrolizumab between January 2016 and May 2019 at two major oncology centres in Melbourne, Australia. Patient demographics, tumour characteristics, treatment history including radiotherapy (RT) use and toxicity were collected. Disease control rate (DCR), progression free survival (PFS) and overall survival (OS) were analysed and correlated with RT use. Result(s): 132 pts identified with interim analysis of 54 reported here. Median follow up was 19.4 months. Majority were male (61%) and 87% were smokers. 80% had non-squamous histology, of these 9% had an EGFR mutation. Brain metastases were present in 41%. The median number of cycles of anti-PD1 treatment received was 5 and only 7% started anti-PD-1 as first-line therapy. 36% received RT treatment either during or within 3 months of starting anti-PD1 treatment. Of patients that received RT, 74% were treated with extra-thoracic RT. The use of RT before or during anti-PD1 treatment did not result in an increase in high grade immune-related adverse events. The DCR was 35%. The median PFS was 2 months (95% CI 0.5 - 29) and OS 9.7 months (95% CI 1.0 - 31). Pts who received RT had a numerically shorter PFS than those that did not (1.5 vs 2 months, p = 0.668) but numerically longer OS (8.1 vs 7.2 months, p = 0.857). Updated analysis with the full cohort and with longer follow-up will be presented. Conclusion(s): Radiotherapy did not significantly impact on survival in pts with metastatic NSCLC treated with anti-PD1 therapy. Legal entity responsible for the study: The authors. Funding(s): Has not received any funding. Disclosure: All authors have declared no conflicts of interest.Copyright © 2019 European

Background: Unresectable LAPC has a poor prognosis. Current standard-of-care (SoC) is limited to chemotherapy or chemo-radiotherapy. Phosphorus-32 (P-32) microparticles comprise a brachytherapy device that implants a predetermined dose of beta radiation-emitting P-32 into pancreatic tumors via endoscopic ultrasound (EUS) guidance. Here, we report updated results of the pilot PanCO study of P-32 microparticles combined with SoC chemotherapy in patients with unresectable LAPC. Method(s): Eligible patients could receive either gemcitabine + nab-paclitaxel (GNP; 28-day cycles) or FOLFIRINOX (14-day cycles) chemotherapy. P-32 microparticles (OncoSilTM; OncoSil Medical) implantation was planned at weeks 4-5. P-32 activity was calculated from patients' tumor volume (TV) to deliver 100 Gy absorbed dose, with implantation assessment by EUS and Bremsstrahlung SPECT/CT imaging. The primary endpoint was safety and tolerability, graded using CTCAE v4.0. Response was assessed using RECIST 1.1 with 8-weekly CT scans and FDG-PET scans at baseline and week 12. Result(s): A total of 50 patients were enrolled (Intention-to-Treat [ITT] population), of which 42 were implanted with the device (Per Protocol [PP] population); 40 patients received GNP and 10 FOLFIRINOX (PP: 34/8, respectively). Median age was 65 years; 28 (56%) male; all 50 were ECOG PS 0/1. Median longest target lesion diameter was 4.5 cm (range 2.6-7.1). Median follow-up was 16.1 months. In the PP/safety population, a median of 5 GNP cycles (range, 1-14) and 6 FOLFIRINOX cycles (range, 3-13) were administered. A total of 988 adverse events (AEs) were reported (PP population); 148 were grade >=3 involving 81% of patients. The most common AEs of grade >=3 were hematological (50% patients) and gastrointestinal (GI) disorders (38%). Of these, 330 AEs (33%) occurred pre-implantation (35 grade >=3) vs 658 (67%) AEs post-implantation (113 grade >=3); median follow-up: 1 vs 15.1 months, respectively. AE incidence overall and by k

Background: Preclinical studies have shown potential synergism from blocking both programmed cell death protein-1 (PD-1) and programmed death-ligand 1 (PD-L1). BGB-A333 is an investigational humanized monoclonal antibody against PD-L1 that has antitumor activity in xenograft models. Tislelizumab, a clinical-stage anti-PD-1 antibody, showed clinical activity in patients (pts) with advanced solid tumors. We report results from the expansion cohort (phase IIB) of an open-label phase I/II study (NCT03379259) of BGB-A333 plus tislelizumab in pts with previously treated advanced urothelial carcinoma (UC). Method(s): Patients received BGB-A333 1350 mg IV Q3W + tislelizumab 200 mg IV Q3W. Eligible pts had locally advanced or metastatic UC without prior PD-(L)1 therapy, could not tolerate or progressed during/after treatment with platinum-based chemotherapy, and had an ECOG performance status of <=1. The primary endpoint was investigator-assessed objective response rate (ORR) per RECIST v1.1. Key secondary endpoints included duration of response (DoR) per RECIST v1.1, progression-free survival (PFS) estimated with Kaplan-Meier analysis, and the safety/tolerability profile evaluated by monitoring adverse events (AEs). Result(s): As of 10 March 2020, 12 pts (median age, 69.5 yr; 92% male) with UC were enrolled; median study follow-up, 8.3 mo. Most pts (n=10, 83%) had 1 prior systemic therapy. Median duration of treatment for both BGB-A333 and tislelizumab was 5.5 mo (range: 1.2, 9.9). Confirmed ORR was 42% (95% CI: 15.2, 72.3); 3 pts had complete responses, 2 had partial responses, 4 had stable disease (SD; 2 had SD >6 mo), 2 had progressive disease, and 1 was not evaluable (due to missing postbaseline assessment). Median DoR was not reached; median PFS was 6.1 mo (95% CI: 1.9, not estimable). Across the entire study (n=39), treatment-related AEs (TRAEs) occurred in 19 pts. Of the 24 pts receiving combination treatment, four pts (including one with UC) had grade >=3 TRAEs. One

Background: Bioresorbable scaffolds (BRS) are a novel technology in coronary intervention. However, recent trials demonstrate higher rates of device failure compared to contemporary drug-eluting stents. This study sought to utilise a clinical quality registry to assess the medium-term safety of the Abbott Absorb BRS (Abbott Vascular, Santa Clara, CA, USA), in an Australian context. Method(s): A prospective, observational study of 192 BRS percutaneous coronary interventions (PCI) compared to 31,773 non-BRS PCIs entered in the Victorian Cardiac Outcomes Registry from 2013 to 2017. The main outcome measure was patient-oriented composite endpoint (POCE) events comprising all-cause mortality, any myocardial infarction (MI), and any revascularisation. Result(s): Bioresorbable scaffolds patients (mean age 61.6+/-10.5 years, 79% male) were younger, had less comorbidity, less prior PCI, fewer ST elevation myocardial infarction (STEMI) presentations, lower rates of multi-lesion disease and more adjuvant devices compared to non-BRS PCI (all p<0.01). All-cause mortality was 2.1%, myocardial infarction (MI) 2.1%, scaffold thrombosis 3.1% and any revascularisation 14.1% (mean follow-up 27.4+/-8.9 months). POCE events occurred in 11.5% at 1 year and 16.9% at 2 years, comparable to pooled-trial data. Multivariate predictors of POCE were >1 scaffold used (odds ratio [OR] 4.6, 95% confidence interval [CI] 1.9-11.4, p<0.01) and scaffold diameter <=2.5 mm (OR 3.3, 95% CI 1.4-7.6, p=0.02). Over 95% guideline adherence was achieved in six of eight patient selection criteria and four of six device deployment criteria. Conclusion(s): In an Australian setting, BRS were used in non-complex patients. Most guidelines for use were adhered to and outcomes were comparable to pooled trial data. Clinical quality registries are effective in assessing novel treatments and technologies when potential safety concerns develop.Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Su

Vitamin D deficiency is associated with higher all-cause mortality, but associations with specific causes of death are unclear. We investigated the association between circulating 25-hydroxyvitamin D (25(OH)D) concentration and cause-specific mortality using a case-cohort study within the Melbourne Collaborative Cohort Study (MCCS). Eligibility for the case-cohort study was restricted to participants with baseline dried blood spot samples and no pre-baseline diagnosis of cancer. These analyses included participants who died (n = 2307) during a mean follow-up of 14 years and a sex-stratified random sample of eligible cohort participants ('subcohort', n = 2923). Concentration of 25(OH)D was measured using liquid chromatography-tandem mass spectrometry. Cox regression, with Barlow weights and robust standard errors to account for the case-cohort design, was used to estimate hazard ratios (HRs) and 95 % confidence intervals (CIs) for cause-specific mortality in relation to 25(OH)D concentration with adjustment for confounders. Circulating 25(OH)D concentration was inversely associated with risk of death due to cancer (HR per 25 nmol/L increment = 0.88, 95 % CI 0.78-0.99), particularly colorectal cancer (HR = 0.75, 95 % CI 0.57-0.99). Higher 25(OH)D concentrations were also associated with a lower risk of death due to diseases of the respiratory system (HR = 0.62, 95 % CI 0.43-0.88), particularly chronic obstructive pulmonary disease (HR = 0.53, 95 % CI 0.30-0.94), and diseases of the digestive system (HR = 0.44, 95 % CI 0.26-0.76). Estimates for diabetes mortality (HR = 0.64, 95 % CI 0.33-1.26) and cardiovascular disease mortality (HR = 0.90, 95 % CI 0.76-1.07) lacked precision. The findings suggest that vitamin D might be important for preventing death due to some cancers, respiratory diseases, and digestive diseases.Copyright © 2020 Elsevier Ltd

Introduction: Hybrid epicardial and endocardial ablation has been proven to be an effective method for attaining rhythm control in persistent atrial fibrillation where anti-arrhythmic drug therapy and lone catheter ablation has been disappointing. We present mid-term findings on the safety and effectiveness of hybrid ablation in persistent atrial fibrillation. Method(s): Between 2017 and 2019, nineteen patients with persistent atrial fibrillation underwent totally thoracoscopic radiofrequency ablation with pulmonary vein isolation, posterior left atrial box lesion and left atrial appendage exclusion with Atriclip. They subsequently underwent endocardial mapping three months later. Any gaps from epicardial ablation were re-ablated. All patients were followed up prospectively. Result(s): Mean age of patients was 59.8+/-6.8 years. Median time of duration of atrial fibrillation preoperatively was 24 months. The average number of failed DCRs was 2.1+/-1.1. Average left atrial volume index was 55.45+/-11.5mL/m2. Average LVEF was 50.8+/-7.3%. At a mean follow-up of 395 days post hybrid ablation, all patients were in sinus rhythm at their most recent follow-up. 21% of patients had a recurrence of atrial arrhythmias. One patient had a minor complication of a left sided pleural effusion after the epicardial ablation. One patient had a pericardial effusion without tamponade requiring pericardiocentesis after epicardial ablation. There were no deaths, conversion to median sternotomy, strokes or pacemaker implantation. Conclusion(s): Sequential hybrid ablation for persistent atrial fibrillation is safe and effective.Copyright © 2020

Background: Peptide receptor radionuclide therapy (PRRT) is an established treatment modality for advanced midgut neuroendocrine tumours (NET) (1), based on the presence of somatostatin receptors (SSTR). This therapy should be effective for SSTR expressing NETs from all sites of origin. SSTR expression correlates with grade, with higher expression seen in lower grade disease (2). No trials of PRRT have been undertaken in patients with typical carcinoid (TC) or atypical carcinoid (AC) of bronchial origin. Most guidelines for bronchopulmonary NET either do not comment on PRRT or acknowledge lack of data. However, small retrospective case series, reporting 11 to 34 patients, suggest potential benefit from lutetium (177Lu)-based PRRT (3-10). Method(s): We undertook a retrospective chart review of patients with TC and AC who had received at least one dose of lutetium-based PRRT in six major NET centres across Australia. Demographics, histopathology and information on clinical course were collected. Result(s): Data was collected from 53 patients treated across six centres between January 2002 and 2019. Patient details from four centres are presented in the table. Each of these four centres had 1, 8, 9 and 15 eligible patients respectively. Of these 33 patients, 22 are still alive, with the duration of follow up post the first cycle of PRRT ranging from 3 to 67 months. Analysis of the whole cohort for treatment, dose, response, patient and disease outcomes will be presented. [Table presented] Conclusion(s): This is the largest series of patients with bronchial carcinoid treated with PRRT to be reported to date. Evaluation of lutetium-based PRRT in a prospective clinical trial is of interest to validate its efficacy as a therapeutic option. Legal entity responsible for the study: Monash Health. Funding(s): Has not received any funding. Disclosure: All authors have declared no conflicts of interest.Copyright © 2019 European Society for Medical Oncology

Background: Bifurcation percutaneous coronary intervention (PCI) remains a challenging frontier in interventional cardiology, especially in the setting of ST-elevation myocardial infarction (STEMI). We examined the procedural and clinical outcomes of this patient subset. Method(s): We conducted a retrospective case-control study. Between February 2006 and March 2011, 129 patients with STEMI underwent bifurcation PCI at our institution. One hundred and twenty-nine (129) control STEMI patients with non-bifurcation PCI were selected from the institutional database, matched for age, gender, culprit vessel, and lesion location. Patients with cardiac arrest, cardiogenic shock, or who required mechanical ventilation were excluded. Twelve (12)-month follow-up data were collected by telephone calls and examination of the medical records. Result(s): The average age of patients presenting with STEMI was 61.6 +/- 13.1 in the bifurcation group and 61.5 + 31.1 in the non-bifurcation group. There was no difference in lesion type, use of thrombus aspiration catheters, or glycoprotein inhibitors (GPI) among them. Also, the use of drug eluting stent (DES), total cumulative length of stent used, and diameter of the post-dilation balloon were similar. Final kissing balloon post-dilation was performed in 40.3% of bifurcation PCI cases. The incidence of procedural failure (TIMI 0 flow) was 1.5% vs. 0%; p = 0.478. At 12-months follow-up, the bifurcation PCI group had higher incidence of target lesion revascularisation (TLR) (10.9% vs. 3.9%, p = 0.050), mortality (10.1% vs. 2.3%, p = 0.020), and stent thrombosis (9.3% vs. 1.6%; p = 0.013); comprising one acute, nine subacute, and two late vs. two subacute stent thromboses. Conclusion(s): During acute STEMI, bifurcation PCI has excellent acute procedural outcomes, but significantly increased incidence of TLR, stent thrombosis and mortality at 12 months.Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZ

Background: Prophylactic intra-aortic balloon counterpulsation (IABC) is commonly used in selected patients undergoing coronary artery bypass graft (CABG) surgery, but definitive evidence is lacking. The aim of the multicentre PINBALL Pilot randomised controlled trial (RCT) was to assess the feasibility of performing a definitive trial to address this question. Method(s): Patients listed for CABG surgery with impaired left ventricular function and at least one additional risk factor for postoperative low cardiac output syndrome were eligible for inclusion if the treating surgical team was uncertain as to the benefit of prophylactic IABC. The primary outcome of feasibility was based on exceeding a pre-specified recruitment rate, protocol compliance and follow-up. Result(s): The recruitment rate of 0.5 participants per site per month did not meet the feasibility threshold of two participants per site per month and the study was stopped early after enrolment of 24 out of the planned sample size of 40 participants. For 20/24 (83%) participants, preoperative IABC use occurred according to study assignment. Six (6)-month follow-up was available for all enrolled participants, [IABC 1 death (8%) vs. control 1 death (9%), p = 0.95]. Conclusion(s): The PINBALL Pilot recruitment rate was insufficient to demonstrate feasibility of a multicentre RCT of prophylactic IABC in high risk patients undergoing CABG surgery.Copyright © 2019

Background: Rheumatoid arthritis (RA) is the most common inflammatory arthritis and is associated with increased risk of cardiovascular events and mortality. Data regarding long-term percutaneous coronary intervention (PCI) outcomes are limited. Method(s): The Melbourne Interventional Group PCI registry (2005-2018) was used to identify 756 patients with RA and outcomes were compared to the remaining cohort (N=38,579). Cox regression analysis was performed to assess risk of adverse events. Result(s): Patients with RA were older and more often female, with higher rates of hypertension, previous stroke, peripheral vascular disease, obstructive sleep apnoea, chronic lung disease, prior myocardial infarction, and poor renal function, while rates of current smoking were lower, all p<0.05. Lesions were more frequently complex (ACC/AHA type B2/C), required longer stents, and rates of no reflow were higher, all p<0.05. Mortality at 30-days was higher (4.4% vs 3.3%, p=0.04) mainly relating to higher non-cardiac mortality (1.6% vs 0.8%, p=0.01). Risk of long-term mortality was higher for RA patients (28% vs 19%, mean follow-up 5.4 years, Hazard Ratio [HR] 1.44, 95% CI 1.25-1.67 adjusted for age, sex and comorbidities) and varied by PCI indication subtype (STEMI HR 1.38, 95% CI 1.06-1.81; NSTEACS HR 1.86, 95% CI 1.49-2.34; non-ACS HR 1.09, 95% CI 0.75-1.59). Risk of 30-day mortality, MACE, bleeding, and target lesion revascularisation were similar. Conclusion(s): Patients with RA undergoing PCI have more comorbidities and longer, more complex coronary lesions. Risk of short-term adverse outcomes are similar, while risk of long-term mortality is higher, especially among patients with acute coronary syndromes.Copyright © 2020

The COVID-19 pandemic poses a significant stress on health resources in Australia. The Heart Rhythm Council of the Cardiac Society of Australia and New Zealand aims to provide a framework for efficient resource utilisation balanced with competing risks when appropriately treating patients with cardiac arrhythmias. This document provides practical recommendations for the electrophysiology (EP) and cardiac implantable electronic devices (CIED) services in Australia. The document will be updated regularly as new evidence and knowledge is gained with time.Copyright © 2020

Background: The East Timor Hearts Fund (ETHF) is a charitable organisation of Australian cardiologists providing outreach screening in Timor-Leste. For patients requiring intervention, ETHF arranges logistics, procedures, and postoperative care. The aim of this project is to evaluate outcomes of patients requiring intervention. Method(s): The ETHF database of all patients was utilised to identify patients with disease warranting surgical or percutaneous intervention. Both patients who underwent intervention and those who did not proceed to intervention were included in this study. Patients who had intervention arranged by other organisations but have then had follow-up with ETHF were also included. Overall demographics and pre and postoperative factors were assessed, with sub-group analysis of adult and paediatric patients to identify any differences in care. Result(s): Of 221 patients requiring intervention, 101 patients underwent intervention, receiving 22 different operations or procedures. Patients were predominantly young (median age 17.5 years) and female (64.7%), with rheumatic heart disease (63.8%). Twenty-four (24) (33.3%) women aged 15-45 years old with cardiac disease warranting intervention were documented as pregnant or breastfeeding at time of clinic assessment. Of patients who did not proceed to intervention, adults were more likely to be lost to follow-up (42.4% vs 18.5%) while paediatric patients were more likely to experience progression of disease (18.5% vs 7.5%, p=0.005). Median waitlist time was 5 months, with no significant difference between adults and children, correlating with a preoperative mortality rate of 5.4%. For patients who underwent intervention, post-procedure mortality was extremely low (0.9%) and attendance of at least one post-procedure review was excellent (99.0%). Eleven (11) (10.9%) patients have required repeat intervention, with no difference in rates between adult and paediatric patients. Length of follow-up extends up to

Background: Bioresorbable scaffolds (BRS) are a novel technology in coronary intervention. However, recent trials demonstrate higher rates of device failure compared to contemporary drug-eluting stents. This study sought to utilise a clinical quality registry to assess the medium-term safety of the Abbott Absorb BRS (Abbott Vascular, Santa Clara, CA, USA), in an Australian context. Method(s): A prospective, observational study of 192 BRS percutaneous coronary interventions (PCI) compared to 31,773 non-BRS PCIs entered in the Victorian Cardiac Outcomes Registry from 2013 to 2017. The main outcome measure was patient-oriented composite endpoint (POCE) events comprising all-cause mortality, any myocardial infarction (MI), and any revascularisation. Result(s): Bioresorbable scaffolds patients (mean age 61.6+/-10.5 years, 79% male) were younger, had less comorbidity, less prior PCI, fewer ST elevation myocardial infarction (STEMI) presentations, lower rates of multi-lesion disease and more adjuvant devices compared to non-BRS PCI (all p<0.01). All-cause mortality was 2.1%, myocardial infarction (MI) 2.1%, scaffold thrombosis 3.1% and any revascularisation 14.1% (mean follow-up 27.4+/-8.9 months). POCE events occurred in 11.5% at 1 year and 16.9% at 2 years, comparable to pooled-trial data. Multivariate predictors of POCE were >1 scaffold used (odds ratio [OR] 4.6, 95% confidence interval [CI] 1.9-11.4, p<0.01) and scaffold diameter <=2.5 mm (OR 3.3, 95% CI 1.4-7.6, p=0.02). Over 95% guideline adherence was achieved in six of eight patient selection criteria and four of six device deployment criteria. Conclusion(s): In an Australian setting, BRS were used in non-complex patients. Most guidelines for use were adhered to and outcomes were comparable to pooled trial data. Clinical quality registries are effective in assessing novel treatments and technologies when potential safety concerns develop.Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Su

Vitamin D deficiency is associated with higher all-cause mortality, but associations with specific causes of death are unclear. We investigated the association between circulating 25-hydroxyvitamin D (25(OH)D) concentration and cause-specific mortality using a case-cohort study within the Melbourne Collaborative Cohort Study (MCCS). Eligibility for the case-cohort study was restricted to participants with baseline dried blood spot samples and no pre-baseline diagnosis of cancer. These analyses included participants who died (n = 2307) during a mean follow-up of 14 years and a sex-stratified random sample of eligible cohort participants ('subcohort', n = 2923). Concentration of 25(OH)D was measured using liquid chromatography-tandem mass spectrometry. Cox regression, with Barlow weights and robust standard errors to account for the case-cohort design, was used to estimate hazard ratios (HRs) and 95 % confidence intervals (CIs) for cause-specific mortality in relation to 25(OH)D concentration with adjustment for confounders. Circulating 25(OH)D concentration was inversely associated with risk of death due to cancer (HR per 25 nmol/L increment = 0.88, 95 % CI 0.78-0.99), particularly colorectal cancer (HR = 0.75, 95 % CI 0.57-0.99). Higher 25(OH)D concentrations were also associated with a lower risk of death due to diseases of the respiratory system (HR = 0.62, 95 % CI 0.43-0.88), particularly chronic obstructive pulmonary disease (HR = 0.53, 95 % CI 0.30-0.94), and diseases of the digestive system (HR = 0.44, 95 % CI 0.26-0.76). Estimates for diabetes mortality (HR = 0.64, 95 % CI 0.33-1.26) and cardiovascular disease mortality (HR = 0.90, 95 % CI 0.76-1.07) lacked precision. The findings suggest that vitamin D might be important for preventing death due to some cancers, respiratory diseases, and digestive diseases.Copyright © 2020 Elsevier Ltd

Background: ENZA, a potent androgen receptor inhibitor, provides benefit in men with castration-resistant prostate cancer (CRPC). In post hoc analyses, the role of ENZA + ADT in mHSPC patients (pts) randomized within the multinational, double-blind, PBO-controlled, Phase 3 ARCHES study (NCT02677896) was determined by disease volume and risk group stratification. Method(s): mHSPC pts were randomized 1:1 to ENZA (160 mg/day) + ADT or PBO + ADT. The primary endpoint was radiographic progression-free survival (rPFS). Secondary endpoints included prostate-specific antigen (PSA) progression and radiographic responses, overall survival (OS), and quality of life (QoL). Analyses were completed by CHAARTED-defined disease volume and LATITUDE-defined risk groups. Result(s): 1150 pts were randomized (ENZA + ADT, n = 574; PBO + ADT, n = 576). Median follow-up was 14.4 months. ENZA + ADT significantly improved rPFS (hazard ratio [95% CI] 0.39 [0.30, 0.50]; p < 0.0001). ENZA + ADT pts significantly benefited from prolonged rPFS in all subgroups (Table). Significant treatment benefits were observed with ENZA + ADT in several secondary clinical endpoints in the overall population and in both high and low disease volume and risk groups (Table). High QoL at baseline was maintained over time. OS data are immature. Adverse events (AEs) were reported in 85.1% of ENZA + ADT vs. 85.9% of PBO + ADT pts, with no unexpected AEs. [Table presented] Conclusion(s): ENZA + ADT treatment showed efficacy benefit across all mHSPC pts, irrespective of disease volume and risk group. Similar delays in rPFS, symptomatic skeletal events, PSA progression, castration resistance, and improvements in radiographic responses and PSA declines, with maintenance of high QoL over time, were observed. Preliminary safety analysis appears consistent with the safety profile of ENZA in previous CRPC clinical trials. Clinical trial identification: NCT02677896. Editorial acknowledgement: Beatrice Vetter-Ceriotti and Laure

Background: The impact of radiotherapy (RT) on the efficacy and toxicity of immune checkpoint inhibitors in patients (pts) with metastatic non-small cell-lung cancer (NSCLC) is unclear. Method(s): We retrospectively identified pts with metastatic NSCLC treated with the anti-programmed death 1 (PD-1) antibodies nivolumab or pembrolizumab between January 2016 and May 2019 at two major oncology centres in Melbourne, Australia. Patient demographics, tumour characteristics, treatment history including radiotherapy (RT) use and toxicity were collected. Disease control rate (DCR), progression free survival (PFS) and overall survival (OS) were analysed and correlated with RT use. Result(s): 132 pts identified with interim analysis of 54 reported here. Median follow up was 19.4 months. Majority were male (61%) and 87% were smokers. 80% had non-squamous histology, of these 9% had an EGFR mutation. Brain metastases were present in 41%. The median number of cycles of anti-PD1 treatment received was 5 and only 7% started anti-PD-1 as first-line therapy. 36% received RT treatment either during or within 3 months of starting anti-PD1 treatment. Of patients that received RT, 74% were treated with extra-thoracic RT. The use of RT before or during anti-PD1 treatment did not result in an increase in high grade immune-related adverse events. The DCR was 35%. The median PFS was 2 months (95% CI 0.5 - 29) and OS 9.7 months (95% CI 1.0 - 31). Pts who received RT had a numerically shorter PFS than those that did not (1.5 vs 2 months, p = 0.668) but numerically longer OS (8.1 vs 7.2 months, p = 0.857). Updated analysis with the full cohort and with longer follow-up will be presented. Conclusion(s): Radiotherapy did not significantly impact on survival in pts with metastatic NSCLC treated with anti-PD1 therapy. Legal entity responsible for the study: The authors. Funding(s): Has not received any funding. Disclosure: All authors have declared no conflicts of interest.Copyright © 2019 European

Background: Unresectable LAPC has a poor prognosis. Current standard-of-care (SoC) is limited to chemotherapy or chemo-radiotherapy. Phosphorus-32 (P-32) microparticles comprise a brachytherapy device that implants a predetermined dose of beta radiation-emitting P-32 into pancreatic tumors via endoscopic ultrasound (EUS) guidance. Here, we report updated results of the pilot PanCO study of P-32 microparticles combined with SoC chemotherapy in patients with unresectable LAPC. Method(s): Eligible patients could receive either gemcitabine + nab-paclitaxel (GNP; 28-day cycles) or FOLFIRINOX (14-day cycles) chemotherapy. P-32 microparticles (OncoSilTM; OncoSil Medical) implantation was planned at weeks 4-5. P-32 activity was calculated from patients' tumor volume (TV) to deliver 100 Gy absorbed dose, with implantation assessment by EUS and Bremsstrahlung SPECT/CT imaging. The primary endpoint was safety and tolerability, graded using CTCAE v4.0. Response was assessed using RECIST 1.1 with 8-weekly CT scans and FDG-PET scans at baseline and week 12. Result(s): A total of 50 patients were enrolled (Intention-to-Treat [ITT] population), of which 42 were implanted with the device (Per Protocol [PP] population); 40 patients received GNP and 10 FOLFIRINOX (PP: 34/8, respectively). Median age was 65 years; 28 (56%) male; all 50 were ECOG PS 0/1. Median longest target lesion diameter was 4.5 cm (range 2.6-7.1). Median follow-up was 16.1 months. In the PP/safety population, a median of 5 GNP cycles (range, 1-14) and 6 FOLFIRINOX cycles (range, 3-13) were administered. A total of 988 adverse events (AEs) were reported (PP population); 148 were grade >=3 involving 81% of patients. The most common AEs of grade >=3 were hematological (50% patients) and gastrointestinal (GI) disorders (38%). Of these, 330 AEs (33%) occurred pre-implantation (35 grade >=3) vs 658 (67%) AEs post-implantation (113 grade >=3); median follow-up: 1 vs 15.1 months, respectively. AE incidence overall and by k

Background: Preclinical studies have shown potential synergism from blocking both programmed cell death protein-1 (PD-1) and programmed death-ligand 1 (PD-L1). BGB-A333 is an investigational humanized monoclonal antibody against PD-L1 that has antitumor activity in xenograft models. Tislelizumab, a clinical-stage anti-PD-1 antibody, showed clinical activity in patients (pts) with advanced solid tumors. We report results from the expansion cohort (phase IIB) of an open-label phase I/II study (NCT03379259) of BGB-A333 plus tislelizumab in pts with previously treated advanced urothelial carcinoma (UC). Method(s): Patients received BGB-A333 1350 mg IV Q3W + tislelizumab 200 mg IV Q3W. Eligible pts had locally advanced or metastatic UC without prior PD-(L)1 therapy, could not tolerate or progressed during/after treatment with platinum-based chemotherapy, and had an ECOG performance status of <=1. The primary endpoint was investigator-assessed objective response rate (ORR) per RECIST v1.1. Key secondary endpoints included duration of response (DoR) per RECIST v1.1, progression-free survival (PFS) estimated with Kaplan-Meier analysis, and the safety/tolerability profile evaluated by monitoring adverse events (AEs). Result(s): As of 10 March 2020, 12 pts (median age, 69.5 yr; 92% male) with UC were enrolled; median study follow-up, 8.3 mo. Most pts (n=10, 83%) had 1 prior systemic therapy. Median duration of treatment for both BGB-A333 and tislelizumab was 5.5 mo (range: 1.2, 9.9). Confirmed ORR was 42% (95% CI: 15.2, 72.3); 3 pts had complete responses, 2 had partial responses, 4 had stable disease (SD; 2 had SD >6 mo), 2 had progressive disease, and 1 was not evaluable (due to missing postbaseline assessment). Median DoR was not reached; median PFS was 6.1 mo (95% CI: 1.9, not estimable). Across the entire study (n=39), treatment-related AEs (TRAEs) occurred in 19 pts. Of the 24 pts receiving combination treatment, four pts (including one with UC) had grade >=3 TRAEs. One

Background: Bifurcation percutaneous coronary intervention (PCI) remains a challenging frontier in interventional cardiology, especially in the setting of ST-elevation myocardial infarction (STEMI). We examined the procedural and clinical outcomes of this patient subset. Method(s): We conducted a retrospective case-control study. Between February 2006 and March 2011, 129 patients with STEMI underwent bifurcation PCI at our institution. One hundred and twenty-nine (129) control STEMI patients with non-bifurcation PCI were selected from the institutional database, matched for age, gender, culprit vessel, and lesion location. Patients with cardiac arrest, cardiogenic shock, or who required mechanical ventilation were excluded. Twelve (12)-month follow-up data were collected by telephone calls and examination of the medical records. Result(s): The average age of patients presenting with STEMI was 61.6 +/- 13.1 in the bifurcation group and 61.5 + 31.1 in the non-bifurcation group. There was no difference in lesion type, use of thrombus aspiration catheters, or glycoprotein inhibitors (GPI) among them. Also, the use of drug eluting stent (DES), total cumulative length of stent used, and diameter of the post-dilation balloon were similar. Final kissing balloon post-dilation was performed in 40.3% of bifurcation PCI cases. The incidence of procedural failure (TIMI 0 flow) was 1.5% vs. 0%; p = 0.478. At 12-months follow-up, the bifurcation PCI group had higher incidence of target lesion revascularisation (TLR) (10.9% vs. 3.9%, p = 0.050), mortality (10.1% vs. 2.3%, p = 0.020), and stent thrombosis (9.3% vs. 1.6%; p = 0.013); comprising one acute, nine subacute, and two late vs. two subacute stent thromboses. Conclusion(s): During acute STEMI, bifurcation PCI has excellent acute procedural outcomes, but significantly increased incidence of TLR, stent thrombosis and mortality at 12 months.Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZ

Introduction: Hybrid epicardial and endocardial ablation has been proven to be an effective method for attaining rhythm control in persistent atrial fibrillation where anti-arrhythmic drug therapy and lone catheter ablation has been disappointing. We present mid-term findings on the safety and effectiveness of hybrid ablation in persistent atrial fibrillation. Method(s): Between 2017 and 2019, nineteen patients with persistent atrial fibrillation underwent totally thoracoscopic radiofrequency ablation with pulmonary vein isolation, posterior left atrial box lesion and left atrial appendage exclusion with Atriclip. They subsequently underwent endocardial mapping three months later. Any gaps from epicardial ablation were re-ablated. All patients were followed up prospectively. Result(s): Mean age of patients was 59.8+/-6.8 years. Median time of duration of atrial fibrillation preoperatively was 24 months. The average number of failed DCRs was 2.1+/-1.1. Average left atrial volume index was 55.45+/-11.5mL/m2. Average LVEF was 50.8+/-7.3%. At a mean follow-up of 395 days post hybrid ablation, all patients were in sinus rhythm at their most recent follow-up. 21% of patients had a recurrence of atrial arrhythmias. One patient had a minor complication of a left sided pleural effusion after the epicardial ablation. One patient had a pericardial effusion without tamponade requiring pericardiocentesis after epicardial ablation. There were no deaths, conversion to median sternotomy, strokes or pacemaker implantation. Conclusion(s): Sequential hybrid ablation for persistent atrial fibrillation is safe and effective.Copyright © 2020

Background: Peptide receptor radionuclide therapy (PRRT) is an established treatment modality for advanced midgut neuroendocrine tumours (NET) (1), based on the presence of somatostatin receptors (SSTR). This therapy should be effective for SSTR expressing NETs from all sites of origin. SSTR expression correlates with grade, with higher expression seen in lower grade disease (2). No trials of PRRT have been undertaken in patients with typical carcinoid (TC) or atypical carcinoid (AC) of bronchial origin. Most guidelines for bronchopulmonary NET either do not comment on PRRT or acknowledge lack of data. However, small retrospective case series, reporting 11 to 34 patients, suggest potential benefit from lutetium (177Lu)-based PRRT (3-10). Method(s): We undertook a retrospective chart review of patients with TC and AC who had received at least one dose of lutetium-based PRRT in six major NET centres across Australia. Demographics, histopathology and information on clinical course were collected. Result(s): Data was collected from 53 patients treated across six centres between January 2002 and 2019. Patient details from four centres are presented in the table. Each of these four centres had 1, 8, 9 and 15 eligible patients respectively. Of these 33 patients, 22 are still alive, with the duration of follow up post the first cycle of PRRT ranging from 3 to 67 months. Analysis of the whole cohort for treatment, dose, response, patient and disease outcomes will be presented. [Table presented] Conclusion(s): This is the largest series of patients with bronchial carcinoid treated with PRRT to be reported to date. Evaluation of lutetium-based PRRT in a prospective clinical trial is of interest to validate its efficacy as a therapeutic option. Legal entity responsible for the study: Monash Health. Funding(s): Has not received any funding. Disclosure: All authors have declared no conflicts of interest.Copyright © 2019 European Society for Medical Oncology

Background: Testicular-epididymal fusion anomalies (TEFA) have been documented in the literature. The pathological significance of TEFA and their relationship to testicular maldescent is unclear. We aimed to clarify the real incidence of TEFA in children with undescended testes and their impact on testicular development after surgery. Method(s): We conducted a retrospective review (2010-2018) of all patients who underwent orchidopexy. Cases with TEFA confirmed intra-operatively were matched against controls with normal fusion for age at the time of surgery. Records from follow-up visits were assessed to compare testicular size at six-months. A systematic review and meta-analysis of the literature (1980-2019) was also performed. Result(s): In our retrospective review, 54 (21.4%) of 252 cryptorchid testes were found to have TEFA (Table). Intra-abdominal testes were more likely to exhibit TEFA than inguinal testes (20.4% vs. 9.6%, RR 1.8 [1.0-3.1], P = 0.03). There were no differences in testicular size at the time of surgery (P = 0.29) or the six-month followup (P = 0.18). The systematic review identified eight studies with 4871 children (5240 orchidopexies). The overall rate of TEFA was 25.8% [95% CI 15.2-38.0]. Tail nonfusion (NF) (10.7% [95% CI 5.4-17.4]) was the most common followed by head NF (7.2% [95% CI 3.2-12.5]) and complete NF (6.3% [95% CI 3.7-9.5]). Intra-abdominal testes were more likely to exhibit TEFA than inguinal testes RR 2.6 [95% CI 1.9-3.5]; P < 0.001. Conclusion(s): Data from our retrospective review and the literature indicate that TEFA are present in approximately one-quarter of cryptorchid testes and are more commonly associated with intra-abdominal cryptorchidism. There appears to be no impact on testicular size at short-term followup. The clinical significance of TEFA remains unclear; long-term followup studies are necessary to better understand their impact on testicular development and function. [Table presented]Copyright © 2020 Journal of

Background: Prophylactic intra-aortic balloon counterpulsation (IABC) is commonly used in selected patients undergoing coronary artery bypass graft (CABG) surgery, but definitive evidence is lacking. The aim of the multicentre PINBALL Pilot randomised controlled trial (RCT) was to assess the feasibility of performing a definitive trial to address this question. Method(s): Patients listed for CABG surgery with impaired left ventricular function and at least one additional risk factor for postoperative low cardiac output syndrome were eligible for inclusion if the treating surgical team was uncertain as to the benefit of prophylactic IABC. The primary outcome of feasibility was based on exceeding a pre-specified recruitment rate, protocol compliance and follow-up. Result(s): The recruitment rate of 0.5 participants per site per month did not meet the feasibility threshold of two participants per site per month and the study was stopped early after enrolment of 24 out of the planned sample size of 40 participants. For 20/24 (83%) participants, preoperative IABC use occurred according to study assignment. Six (6)-month follow-up was available for all enrolled participants, [IABC 1 death (8%) vs. control 1 death (9%), p = 0.95]. Conclusion(s): The PINBALL Pilot recruitment rate was insufficient to demonstrate feasibility of a multicentre RCT of prophylactic IABC in high risk patients undergoing CABG surgery.Copyright © 2019

Background: Rheumatoid arthritis (RA) is the most common inflammatory arthritis and is associated with increased risk of cardiovascular events and mortality. Data regarding long-term percutaneous coronary intervention (PCI) outcomes are limited. Method(s): The Melbourne Interventional Group PCI registry (2005-2018) was used to identify 756 patients with RA and outcomes were compared to the remaining cohort (N=38,579). Cox regression analysis was performed to assess risk of adverse events. Result(s): Patients with RA were older and more often female, with higher rates of hypertension, previous stroke, peripheral vascular disease, obstructive sleep apnoea, chronic lung disease, prior myocardial infarction, and poor renal function, while rates of current smoking were lower, all p<0.05. Lesions were more frequently complex (ACC/AHA type B2/C), required longer stents, and rates of no reflow were higher, all p<0.05. Mortality at 30-days was higher (4.4% vs 3.3%, p=0.04) mainly relating to higher non-cardiac mortality (1.6% vs 0.8%, p=0.01). Risk of long-term mortality was higher for RA patients (28% vs 19%, mean follow-up 5.4 years, Hazard Ratio [HR] 1.44, 95% CI 1.25-1.67 adjusted for age, sex and comorbidities) and varied by PCI indication subtype (STEMI HR 1.38, 95% CI 1.06-1.81; NSTEACS HR 1.86, 95% CI 1.49-2.34; non-ACS HR 1.09, 95% CI 0.75-1.59). Risk of 30-day mortality, MACE, bleeding, and target lesion revascularisation were similar. Conclusion(s): Patients with RA undergoing PCI have more comorbidities and longer, more complex coronary lesions. Risk of short-term adverse outcomes are similar, while risk of long-term mortality is higher, especially among patients with acute coronary syndromes.Copyright © 2020

The COVID-19 pandemic poses a significant stress on health resources in Australia. The Heart Rhythm Council of the Cardiac Society of Australia and New Zealand aims to provide a framework for efficient resource utilisation balanced with competing risks when appropriately treating patients with cardiac arrhythmias. This document provides practical recommendations for the electrophysiology (EP) and cardiac implantable electronic devices (CIED) services in Australia. The document will be updated regularly as new evidence and knowledge is gained with time.Copyright © 2020

Background: The East Timor Hearts Fund (ETHF) is a charitable organisation of Australian cardiologists providing outreach screening in Timor-Leste. For patients requiring intervention, ETHF arranges logistics, procedures, and postoperative care. The aim of this project is to evaluate outcomes of patients requiring intervention. Method(s): The ETHF database of all patients was utilised to identify patients with disease warranting surgical or percutaneous intervention. Both patients who underwent intervention and those who did not proceed to intervention were included in this study. Patients who had intervention arranged by other organisations but have then had follow-up with ETHF were also included. Overall demographics and pre and postoperative factors were assessed, with sub-group analysis of adult and paediatric patients to identify any differences in care. Result(s): Of 221 patients requiring intervention, 101 patients underwent intervention, receiving 22 different operations or procedures. Patients were predominantly young (median age 17.5 years) and female (64.7%), with rheumatic heart disease (63.8%). Twenty-four (24) (33.3%) women aged 15-45 years old with cardiac disease warranting intervention were documented as pregnant or breastfeeding at time of clinic assessment. Of patients who did not proceed to intervention, adults were more likely to be lost to follow-up (42.4% vs 18.5%) while paediatric patients were more likely to experience progression of disease (18.5% vs 7.5%, p=0.005). Median waitlist time was 5 months, with no significant difference between adults and children, correlating with a preoperative mortality rate of 5.4%. For patients who underwent intervention, post-procedure mortality was extremely low (0.9%) and attendance of at least one post-procedure review was excellent (99.0%). Eleven (11) (10.9%) patients have required repeat intervention, with no difference in rates between adult and paediatric patients. Length of follow-up extends up to