BACKGROUND:To evaluate Inferior vena cava (IVC) filter retrieval practices over a 9-year period at an academic hospital with a prospectively maintained IVC filter registry.METHOD:An IVC filter registry was maintained prospectively within our institution. We reviewed cases between August 2011 and June 2020, following filter status, retrieval plans, and eventual retrieval date. The validity of the database was cross referenced with a Picture Archiving and Communication System and patient records.RESULTS:Three hundred forty-three patients had IVC filters inserted. Three filter types were used, Celect (Cook Medical) in 189, Gunther Tulip (GT) (Cook Medical) in 65, ALN (ALN) in 89. 196 (57%) filters were retrieved, 108 (31.5%) were made permanent, 36 (10.5%) died before retrieval, and 3 (1%) were yet to be retrieved. Retrieval rates were 92.5% overall (86% for GT, 93% for Celect and 94.5% for ALN). The mean dwell time for successful retrieval was 59 days with the majority of insertions (85%) removed in under 100 days. Failed initial retrieval occurred in 23 patients, 10 (43%) were retrieved at second attempt, 13/23 filters remained in-situ and were deemed permanent.CONCLUSION:The removal of IVC filters, when indication for insertion has past, is no longer the sole responsibility of the referring physician but also the responsibility of the Interventionalist. Our retrieval rates of 92.5% of eligible IVC filters highlights the value of maintaining a prospective IVC filter registry.

INTRODUCTION:'Button' gastrostomy insertion is traditionally a two-step procedure with an initial longer gastrostomy tube inserted followed by placement of the shorter 'button' gastrostomy in 6 weeks when the track is mature. The aim of this study is to assess whether the placement of a Button gastrostomy de novo is a safe and effective method of radiologically inserted gastrostomy (RIG) insertion.METHODS:Using our Picture Archive and Communication System (PACS) and electronic patient charts we identified all patients who underwent primary 'button' gastrostomy over an 8-year period with at least a 1-year follow-up period. We evaluated technical success rate, indications for insertion, major and minor complications, 30-day mortality and the number of exchanges performed.RESULTS:Overall, 482 patients underwent a primary button RIG insertion during this period with an overall success rate of 97.1%. Indications for RIG insertion included neurological and neurosurgical disorders 236 (48.9%), head and neck malignancy 182 (37.8%), oesophageal malignancy 27 (5.6%) and other indications in 37 (7.7%). The mean age was 59.55 years (range 18-88 years) with 290 men (60.2%) and 192 women (39.8%). Major complications were recorded in 0.8% and minor complications in 1.7%. A 30-day mortality of 1% was identified (five patients), mortality was directly related to the RIG insertion in one patient (0.2%). A total of 65 exchanges/replacements took place over this period of time, with 33 (50.1%) due to 'inadvertent removal'.CONCLUSION:Primary button RIG insertion is a procedure that has a high success rate and low morbidity and mortality. We believe it is a safe and effective alternative to deliver enteral nutrition.

Background: De novo and acquired resistance to HER2 directed therapy is frequently encountered. Upregulation of the phosphatidylinositol-3-kinase (PI3K) pathway is an important mediator of treatment resistance. This can occur through an activating mutation of the PIK3CA gene or PTEN loss. PIK3CA mutations are present in approximately 20% of HER2 positive breast cancers and as such, the PI3K pathway has emerged as an attractive target for restoring sensitivity to HER2 directed therapy. Methods: We performed a single arm, multicentre, open label Phase Ib/II trial. Patients (pts) with advanced HER2-positive breast cancer whose disease had progressed on at least 1 line of Trastuzumab/T-DM1 based treatment in the metastatic setting were eligible if they met following criteria: ECOG PS ≤ 2 and adequate organ function. Pts with treated, controlled brain metastases were permitted to enrol. Exclusion criteria included uncontrolled hypertension or diabetes mellitus. Pts on Phase IB were treated according to a 6+6 study design with a dose escalation schedule of Copanlisib IV (level 1 = 45mg, level 2 = 60mg) on Day 1, 8 and 15 of a 28-day cycle along with a fixed dose of Trastuzumab 2mg/kg weekly. Phase II treatment was the MTD (maximum tolerated dose) of Copanlisib in combination with Trastuzumab. Archival tumour tissue, voluntary biopsies and serial plasma samples were collected for genomic sequencing. Primary endpoints were MTD (Phase I) and clinical benefit rate (CBR) which was defined as complete response (CR) or partial response (PR) at any time point; or stable disease (SD) lasting at least 24 weeks (Phase II). Secondary endpoints included safety and tolerability, tumor response rate, duration of response, time to treatment failure (TTF) and progression free (PFS) and overall survival (OS). Results: Twelve pts were enrolled in Phase IB. No dose limiting toxicity was observed. The MTD was established as Copanlisib 60mg and Trastuzumab 2mg/kg. Fourteen pts were enrolled in Phase II (6 pts treated at the MTD in Phase IB were included in the final Phase II analysis resulting in a total of 20 pts). The median number of lines of prior treatment in the metastatic setting was 3 (1-8). The most common grade 3-4 toxicities encountered in the Phase Ib/II cohorts included hypertension (n=7, 27%), hyperglycaemia (n=2, 8%) and vomiting (n=2, 8%). Three pts discontinued treatment due to toxicity. The median follow-up for the Phase II cohort was 7.5 months (95% CI 6.0-14.5). PR was observed in 4 pts (20%) and SD (at any time point) was seen in 8 pts (40%). The CBR was 30% (n=6). The duration of response was 15.0 weeks (95% CI 4.9 - 16.1). The median TTF was 11.9 weeks (95% CI 7.5 - 21.1). The median PFS was 3.0 mo (95% CI 0.2 - 5.8) and OS was 14.0 mo (95% CI 5.2-22.8). At the time of analysis, 9 of 20 patients were alive. PIK3CA mutations were detectable in the archival tissue of 11 of 26 pts (42%). PIK3CA hotspot mutations (H1047R, E542K and E545K) were detectable in the plasma of all 26 pts at various points throughout treatment. Pre and post treatment biopsies of 2 pts in the Phase IB trial revealed somatic mutations in DNAH3 and TRRAP, the latter of which encodes a PI3K-like protein kinase. Targeted next generation sequencing was performed on the circulating tumour DNA of 20 pts in the Phase II cohort taken before, during and after treatment to further validate these findings and to assess for other mechanisms of response or resistance. The final translational results will be presented at the meeting. Conclusions: The combination of Copanlisib and Trastuzumab is a safe and tolerable regimen and is associated with clinical efficacy in a heavily pre-treated metastatic HER2-positive breast cancer population. Translational studies may have identified novel resistance biomarkers in this pt cohort. Citation Format: Lisa Prior, Niamh M Keegan, Simon J Furney, Janice M Walshe, Giuseppe Gullo, John Crown, M John Kennedy, Diarmuid Smith, John McCaffrey, Catherine M Kelly, Keith Egan, Jennifer Kerr, Mark Given, Niall Sheehy, Peter O'Donovan, Andres Hernando, Ausra Teiserskiene, Imelda Parker, Elaine Kay, Ray McDermott, Maccon M Keane, Seamus O'Reilly, Liam Grogan, Oscar Breathnach, Patrick G Morris, Sinead Toomey, Bryan T Hennessy. Phase Ib/II trial evaluating safety and efficacy of copanlisib (PI3K inhibitor) and trastuzumab in pre-treated advanced HER2-positive breast cancer: Results from the PantHER study [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-16-08.

BACKGROUND:Activation of the phosphoinositide-3 kinase (PI3K) pathway is a resistance mechanism to anti-human epidermal growth factor receptor 2 (HER2) therapy. This phase Ib trial was conducted to determine the maximum tolerated dose (MTD) of copanlisib, an intravenous (IV) pan-class I PI3K inhibitor, combined with trastuzumab.METHODS:Patients with advanced HER2-positive breast cancer and disease progression following at least one prior line of HER2 therapy in the metastatic setting were treated with copanlisib (45 or 60 mg) IV on days 1, 8 and 15 of a 28-day cycle with a fixed dose of trastuzumab 2 mg/kg weekly.RESULTS:Twelve patients were enrolled. The MTD was determined as copanlisib 60 mg plus trastuzumab 2 mg/kg weekly. The most common adverse events of any grade occurring in more than two patients were hyperglycaemia (58%), fatigue (58%), nausea (58%) and hypertension (50%). Stable disease was confirmed at 16 weeks in six participants (50%). PIK3CA mutations were detected in archival tumour of six participants (50%). PIK3CA hotspot mutations, were detectable in pre- and on-treatment plasma of all participants. Pre- and post-treatment tumour biopsies for two patients identified temporal genomic heterogeneity, somatic mutations in the TRRAP gene, which encodes a PI3K-like protein kinase, and emergent somatic mutations related to protein kinase signalling.CONCLUSION:Copanlisib and trastuzumab can be safely administered with fair overall tolerability. Preliminary evidence of tumour stability was observed in patients with heavily pre-treated, metastatic HER2 positive breast cancer. Several potential biomarkers were identified for further study in the current phase 2 clinical trial. NCT: 02705859.

Long‐term efficacy of treatment with varicocele embolization is poorly documented from the patient’s perspective. This study assessed patients’ perceived changes in pain scores pre‐ and post‐testicular vein embolization. In addition, the effect of testicular vein embolization on quality of life (QoL) parameters was assessed.

Percutaneous biopsy is an essential part of staging pulmonary and extrathoracic tumors. Computed tomography guidance is the method of choice for guidance. Accuracy of 80% to 98% is achieved by the use of cutting needles and avoidance of necrotic areas of the tumor. Cytopathologist attendance improves outcome and minimizes the need for repeat procedures. Pleurocentesis is performed with ultrasound guidance.

IntroductionArteriovenous fistulas (AVF) are the preferred method of vascular access for chronic haemodialysis. However, excess shunting through the AVF can result in dialysis-access steal syndrome (DASS) or high-output cardiac failure. Percutaneous AVF banding is a minimally-invasive technique for treating DASS with good short-intermediate term results.Materials and methodsWe review a case series of percutaneous AVF banding procedures for DASS and high-output cardiac failure to illustrate the technique and limitations of this technique.ResultsTwo representative cases from our local experience were selected to illustrate the technique in a stepwise manner. Both cases were performed for DASS, with good technical success. However, clinical success was limited in one case due to underlying arterial insufficiency. The technique, selection of appropriate banding diameter for flow reduction, limitations and complications of alternative surgical techniques are discussed.ConclusionsPercutaneous AVF banding is a relatively straightforward and effective minimally-invasive technique for treatment of DASS supported by short-intermediate term data.

1036 Background: PI3K pathway activation is implicated in resistance to trastuzumab (T) therapy in breast cancer (BC). Copanlisib (C) is a pan-class I PI3K inhibitor with particular activity against PI3Kα, the isoform encoded by the PIK3CA gene. PIK3CA mutation may predict response to PI3K inhibition. Methods: The maximum tolerated dose (MTD) and safety of C + T were evaluated in an open label, single arm, adaptive multicenter phase Ib dose escalation clinical trial in patients (pts) with HER-2 positive BC. Eligible pts had disease progression following at least one line of (T) or TDM-1 based therapy in the metastatic setting. Pts were treated with T (4mg/kg loading dose then 2mg/kg weekly) given with C intravenously on Day 1, 8 + 15 of 28 day cycle at one of two dose levels (DL) according to a modified 3+3 (6+6) design. Cycle 1 safety data were used to determine dose limiting toxicities (DLTs). Disease assessments were made every 8 weeks. PIK3CA mutation status was determined in formalin-fixed paraffin-embedded (FFPE) primary tumor blocks by standard sequencing and in serial samples of plasma circulating tumor DNA (ctDNA) during treatment by droplet digital PCR. Results: Twelve pts were treated with C + T, 6 on DL1 (45mg) and 6 on DL2 (60mg). Median age was 53yrs. Pts had 15 to 85 months of prior therapy in the metastatic setting with a median of 4 prior lines. There were no DLTs. The MTD and recommended dose for phase II is 60mg. Eleven SAEs were reported. Of these, 36% (n = 4) were infections requiring hospitalization and all resolved with no changes in dose. Grade(G) 3 lung infection and G3 abdominal pain SAEs were reported possibly related to C. All others were considered unlikely or not related to C. G3 liver enzyme rise was reported in 1 pt with a single episode of G4 rise in GGT. G3 hypertension was reported in 33% (n = 4) pts. Best response was stable disease in 9/12 pts and 6 pts continued treatment ≥16 weeks. PIK3CA mutation was positive in 6/12 (50%) of tumors. Concordance between PIK3CA mutation in tissue and plasma pre-treatment was 80% with evidence of dynamic change in quantity of mutation during treatment. Conclusions: C+T is a safe, well tolerated combination. Efficacy of C+T will be assessed in a phase 2 study at the MTD of 60mg. Clinical trial information: NCT02705859.

PURPOSE:We aimed to evaluate limb salvage, defined as freedom from major amputation, and to identify predictors of major amputation in patients with infrapopliteal peripheral arterial disease (PAD) based on the updated 2015 TASC II anatomic classification treated by percutaneous transluminal angioplasty (PTA).METHODS:This was a retrospective study of infrapopliteal PTA procedures performed for PAD over a 4-year period. Patient demographics, medical comorbidities, risk factors, angiographic imaging, technical details, and clinical follow-up were analyzed to determine limb salvage rates, technical success, and all-cause mortality. Predictors of major amputation following PTA were identified.RESULTS:A total of 112 patients were treated by infrapopliteal PTA. Most lesions consisted of TASC C (44%) and D (34%) categories, were over 10 cm in length, and were occlusive and heavily calcified (89%). Overall technical success was 75%, with limb salvage rates of 77% at 1 year and 65% at 3 years following PTA. Smoking, previous stroke or cardiovascular events, and anticoagulation use were associated with an increased risk of major amputation following PTA.CONCLUSION:PTA of complex infrapopliteal PAD is associated with good intermediate term limb salvage rates.

BACKGROUND:Despite their well-recognised shortcomings, haemodialysis catheters (HDCs) remain an important form of haemodialysis access for many patients. There are several HDCs commercially available, each differing considerably in design, which is known to significantly influence performance and survival. We sought to determine which of two tunnelled HDCs, DuraMax® (Angiodynamics, NY, USA) or SplitCath® (MedComp, PA, USA) delivers the best performance, safety and reliability for dialysis patients.METHODS:Eighty-six patients were prospectively randomised to receive either DuraMax® (DM) or SplitCath® (SC). Outcomes included: (i) mean flow rates (mL/min) averaged over the first 10 weeks of dialysis, and urea reduction ratio (URR); and (ii) long-term catheter survival with appraisal of any events leading to catheter dysfunction and early removal.RESULTS:Median flow rates (interquartile range) in the DM and SC groups were 321 (309-343) and 309 (294-322) mL/min, respectively (p = 0.002). URR values for the DM and SC groups were 71 (65-76) and 74 (70-78), respectively, (p = 0.094). There was no significant difference in long-term survival or frequency of incidents that required early HDC removal (9/43 in the DM group, 5/43 patients SC). A slightly higher incidence of HDC dislodgement was noted in the DM group, although this study was not statistically powered to determine its significance.CONCLUSIONS:We conclude that DM yields slightly higher flow rates in the first 10 weeks of dialysis, and a similar low incidence of complications and long-term survival for both DM and SC HDCs.

Purpose: To report a systematic review of endovascular management of visceral and renal artery aneurysms (VRAA) and results at a tertiary referral center.Materials and Methods: A literature review was performed via a comprehensive electronic search of PubMed, MEDLINE, EMBASE, and Cochrane databases, followed by retrospective analysis of all VRAAs treated at a tertiary referral center from January 1999 to December 2015.Results: The systematic review included 22 studies published between 2005 and 2016 describing endovascular treatment of VRAA. In the systematic review cohort, 646 aneurysms (432 true, 151 false, 63 unclassified) were treated using endovascular methods with 93.2% technical success, 99.3% visceral preservation, 3.5% major complication (classified based on Society of Interventional Radiology criteria), 1.5% 30-day periprocedural mortality, and 4.6% reintervention rates. In the local cohort, 19 aneurysms (12 true, 7 false) were treated with 100% technical success, 94.7% visceral preservation, and 10.5% major complication rates. There was no periprocedural mortality. Over Mean follow-up of 31.9 months (range, 2-170 months), there were 2 aneurysm reperfusions, which required no further treatment. Results incorporating data from the systematic review and local cohorts (665 aneurysms) showed 93.6% technical success, 99.1% visceral preservation, 3.7% major complication, 1.5% periprocedural mortality, and 4.4% reintervention rates.Conclusions: Endovascular treatment of VRAA is associated with excellent technical success and visceral preservation rates. Major complication and periprocedural mortality rates are comparatively low. A few VRAA (4.4%) required future reintervention suggesting that imaging follow-up is essential after initial treatment.

PURPOSE:To prospectively compare the procedural time and complication rates of ultrasound-guided and fluoroscopy-assisted antegrade common femoral artery (CFA) puncture techniques.MATERIALS AND METHODS:Hundred consecutive patients, undergoing a vascular procedure for which an antegrade approach was deemed necessary/desirable, were randomly assigned to undergo either ultrasound-guided or fluoroscopy-assisted CFA puncture. Time taken from administration of local anaesthetic to vascular sheath insertion in the superficial femoral artery (SFA), patients' age, body mass index (BMI), fluoroscopy radiation dose, haemostasis method and immediate complications were recorded. Mean and median values were calculated and statistically analysed with unpaired t tests.RESULTS:Sixty-nine male and 31 female patients underwent antegrade puncture (mean age 66.7 years). The mean BMI was 25.7 for the ultrasound-guided (n = 53) and 25.3 for the fluoroscopy-assisted (n = 47) groups. The mean time taken for the ultrasound-guided puncture was 7 min 46 s and for the fluoroscopy-assisted technique was 9 min 41 s (p = 0.021). Mean fluoroscopy dose area product in the fluoroscopy group was 199 cGy cm(2). Complications included two groin haematomas in the ultrasound-guided group and two retroperitoneal haematomas and one direct SFA puncture in the fluoroscopy-assisted group.CONCLUSION:Ultrasound-guided technique is faster and safer for antegrade CFA puncture when compared to the fluoroscopic-assisted technique alone.