Merit Medical Research Articles

Long-term outcomes of mechanochemical ablation using the Clarivein device for the treatment of great saphenous vein incompetence

ObjectiveThe short-term anatomical success rates of mechanochemical ablation using the Clarivein device (Merit Medical) in the treatment of great saphenous vein (GSV) incompetence are high. However, the anatomical success rates seem to drop over time. The aim of this study was to determine the long-term outcomes of GSV treatment using the Clarivein and to assess whether specific anatomical features better correlate with clinical or quality of life (QoL)-related outcomes. MethodsThis is a single-center, prospective cohort study in follow-up of a multicenter, randomized controlled trial using Clarivein with liquid polidocanol for the treatment of GSV incompetence. The primary outcome was anatomical success (AS), defined as complete occlusion or a recanalized segment, irrespective of reflux, of <10 cm in length. In addition, reflux-free anatomical success (RF-AS) was determined, and defined as complete occlusion or a recanalized segment with <10 cm of reflux. Clinical success was assessed using the Venous Clinical Severity Score (VCSS), and QoL was assessed using the Dutch version of the Aberdeen Varicose Vein Questionnaire (DAVVQ) and the 36-Item Short Form Health Survey (SF-36). Subgroup analyses were performed based on whether AS or RF-AS was achieved or not. ResultsA total of 109 patients (115 limbs) were included. The mean follow-up time was 8.4 ± 0.9 years (range, 5.5-10.3 years). AS was seen in 60.5% of limbs, and RF-AS was seen in 72.8% of limbs. Compared with baseline, the overall mean VCSS improved from 5.3 ± 2.4 to 4.1 ± 2.4, and the overall median DAVVQ score from 13.5 (interquartile range [IQR], 8.7-20.0) to 10.5 (IQR, 5.3-16.2) (P < .001). Improvement in VCSS was only significant in patients with successful treatment: from 5.5 ± 2.7 to 3.7 ± 2.5 (P < .001) if AS was achieved and from 5.0 ± 1.7 to 4.5 ± 1.9 (P = .20) if AS was not achieved. The same results were found for DAVVQ scores: improvement from13.5 (IQR, 8.7-20.6) to 10.3 (IQR, 3.0-14.5) (P < .01) if AS was achieved and from 12.9 (IQR, 8.3-19.3) to 10.8 (IQR, 6.7-18.2) (P = .35) if AS was not achieved. Regarding the overall SF-36 scores, the domains of vitality, mental health, and general health worsened significantly. ConclusionsIn over 8 years of follow-up, the anatomical success rate after the treatment of GSV incompetence using the Clarivein device decreased to 60.5%. However, clinical scores and disease-specific QoL still improved significantly compared with baseline. We found no convincing evidence that the absence of reflux correlates better with clinical and QoL-related outcomes compared with recanalization irrespective of reflux.

Abstract PO4-18-12: MELODY: A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions (EUBREAST-4/iBRA-NET, NCT 05559411)

Abstract Background: In the last decades, the proportion of breast cancer patients receiving breast-conserving surgery has increased, reaching 70-80% in developed countries. In case of non-palpable lesions, surgical excision requires some form of breast localization. While wire-guided localization has long been considered gold standard, it carries several limitations, including logistical difficulties, the potential for displacement and patient discomfort, and re-excision rates reaching 21%. Other techniques (radioactive seed or radio-occult lesion localization, intraoperative ultrasound, magnetic, radiofrequency and radar localization) have been developed with the aim of overcoming these disadvantages. However, comparative data on the rates of successful lesion removal, negative margins and re-operations are limited. In the majority of studies, the patient’s perspective with regard to discomfort and pain level has not been evaluated. The aim of MELODY (MEthods for LOcalization of Different types of breast lesions) is to evaluate different imaging-guided localization methods with regard to oncological safety, patient-reported outcomes, and surgeon and radiologist satisfaction. Methods: The EUBREAST and the iBRA-NET have initiated the MELODY study to assess breast localization techniques and devices from several perspectives (NCT05559411, http://melody.eubreast.com). MELODY is a prospective intergroup cohort study which enrolls female and male pts. requiring breast-conserving surgery and imaging-guided localization for invasive breast cancer or DCIS. Multiple or bilateral lesions and neoadjuvant chemotherapy are allowed. Primary outcomes are: 1) Intended target lesion and/or marker removal, independent of margin status on final histopathology, and 2) Negative resection margin rates at first surgery. Secondary outcomes are, among others: rates of second surgery and secondary mastectomy, Resection Ratio (defined as actual resection volume divided by the calculated optimum specimen volume), duration of surgery, marker dislocation rates, rates of marker placement or localization failure, comparison of patient-reported outcomes, rates of “lost markers” and diagnostician/radiologist’s and surgeon’s satisfaction as well as the health economic evaluation of the different techniques. Target accrual: 7,416 patients. Enrollment started in January 2023. The study will be conducted in 30 countries and is supported by the Oncoplastic Breast Consortium (OPBC), AWOgyn, AGO-B and SENATURK. Financial support will be provided by Endomag, Merit Medical, Sirius Medical and Hologic. Citation Format: Maggie Banys-Paluchowski, Thorsten Kühn, Yazan Masannat, Nina Ditsch, Antonio Esgueva, Neslihan Cabıoğlu, Dawid Murawa, Nuh Zafer Canturk, Isabel Rubio, Jana de Boniface, Andreas Karakatsanis, Rajiv Dave, Shelley Potter, Ashutosh Kothari, Oreste Davide Gentilini, Walter Weber, Natalia Krawczyk, Steffi Hartmann, Guldeniz Karadeniz Cakmak, Markus Hahn, Michael P. Lux, Tove Tvedskov, Lina Pankratjevaite, Michalis Kontos, Florentia Peintinger, Aoife Lowery, Marjolein Smidt, Lia Rebaza, Maria Vasconcelos, Bahadir M. Gulluoglu, Bilge Aktas Sezen, Rosa Di Micco, Sarah Nietz, Francois Malherbe, Maria Luisa Gasparri, Séverine Alran, SVS Deo, Mah Muneer Khan, James Harvey. MELODY: A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions (EUBREAST-4/iBRA-NET, NCT 05559411) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-18-12.

Axillary necklace graft salvage of a locally infected Haemodialysis with Reliable Outflow (HeRO®) graft.

A 48-year-old patient presented 4 months after insertion of a right sided Haemodialysis with Reliable Outflow (HeRO®, Merit Medical) graft with a discharging abscess at the site of the brachial artery anastomosis. There was localised involvement of the arterial Gore® Acuseal inflow graft that necessitated its removal. The venous outflow component was thought salvageable as infection was well localised to the region of the antecubital fossa. Alternative access options were limited so we sought to preserve the venous outflow portion of the patient's original graft - minimising tissue damage and avoiding the need for a dialysis line. The infected arterial graft was excised, leaving behind the original SuperHero® connector and venous graft. A left sided tunnelled axillary necklace technique was utilised to restore arterial inflow. After a four-day recovery, the patient went on to successfully resume their usual haemodialysis regimen without any complications. Convalescent imaging, repeat blood cultures, and monitoring of inflammatory markers showed no signs of residual infection at 6 weeks. The originality of this case was the way in which an axillary necklace inflow graft was connected to the pre-existing venous outflow portion of the HeRO® haemodialysis graft system, allowing the excision of the infected inflow graft at the brachial anastomosis. This technique could be viewed as an effective salvage procedure as it allowed the venous outflow portion of the original graft to remain in situ, minimised tissue damage and enabled the patient to swiftly resume haemodialysis without the need for a line.

A novel troubleshooting technique for below-the-knee artery occlusions with proximal cap ambiguity: Transpedal Retrograde Wire Just Marker Technique.

Chronic total occlusions with ambiguous proximal caps pose a challenging problem in below-the-knee artery endovascular interventions. We defined a new technique for antegrade puncture and penetration of an ambiguous proximal cap in a 52-year old male patient with a non-healing wound on his right forefoot. Anterior tibial artery (ATA) was determined as the target vessel; however, its origin and course could not be determined. A retrograde guidewire (Asahi Gladius 0.018 inch, Asahi Intecc) was advanced into the distal ATA via transpedal loop following pedal loop angioplasty. This guidewire was advanced through and parked to the tibioperoneal trunk with a small distal loop at the tip. While the looped wire was held in its position as a marker for ATA ostium, a second guidewire (Asahi Gladius 0.018 inch, Asahi Intecc) with the guidance of 4F vertebral catheter (Vert Catheter, Merit Medical) successfully penetrated the ambiguous cap and subsequent target vessel revascularization was achieved with 2.5/150mm peripheral balloon angioplasty catheter (Minerva SC 0.018 inch, BrosMed Medical). Transpedal Retrograde Wire Just Marker Technique is a novel and practical technique which can be used in chronic total occlusions of below-the-knee arteries with ambiguous proximal caps.

Use of the lateral arm in tomosynthesis-guided SCOUT Reflector placement procedures

Preoperative localization procedures are important for guiding surgical excision of non-palpable findings in the breast. The SCOUT Reflector (Merit Medical, South Jordan UT, USA) is a non-wire-based localization device that has been incorporated into clinical use with great success. SCOUT Reflectors can be placed using several imaging modalities, including tomosynthesis. One drawback to SCOUT Reflector placement under tomosynthesis guidance is an inability to directly visualize the introducer needle tip, a factor that limits precision. In this brief communication, we describe the use of a lateral arm attachment for tomosynthesis guided SCOUT Reflector placement. Precise SCOUT Reflector placement can be achieved using the lateral arm due to the ability to clearly visualize the introducer needle and the SCOUT Reflector within the introducer needle bore prior to deployment.

Effectiveness of AERO Stent Placement for Malignant Airway Disorder in Patients with a Poor Performance Status.

Objective Airway stenting is an established procedure for treating various airway disorders. The AERO stent (Merit Medical Systems, South Jordan, USA) is a fully covered self-expandable metallic stent approved for use in Japan in 2014. However, its effectiveness in treating malignant airway disorders in patients with a poor performance status remains unclear. Therefore, we investigated the safety and efficacy of the AERO stent in patients with malignant airway disorders and a poor performance status. Methods We retrospectively reviewed the medical records of all patients who underwent AERO stent placement at our institute between April 2016 and March 2022, and 21 patients underwent 25 procedures for malignant airway disorders. All AERO stenting procedures were performed using an over-the-wire delivery system with flexible and/or rigid bronchoscopy. Results Eighteen of the 21 patients (85.7%) had a poor general condition (Eastern Cooperative Oncology Group performance status 3 or 4). AERO stents were successfully placed in 23 of the 25 procedures and migrated in the remaining 2 cases. Complications occurred in 10 cases, with infection being the most common (3 cases). Fourteen patients (66.6%) showed an improvement in their performance status. In addition, 5 of the 6 intubated patients were extubated following AERO stenting, and 11 patients subsequently received anticancer treatment. Conclusion The placement of the AERO stent is useful in patients with a poor performance status, including those who are intubated and afflicted with malignant airway disorders.

SwiftNINJA steerable microcatheter: a new kid on the block for selective catheterization of vascular and valvular congenital lesions.

SwiftNINJA (Merit Medical Systems, USA) is a novel steerable microcatheter intended for coronary and peripheral vascular interventions. We evaluate and report the first use of SwiftNINJA in pediatric catheterization of congenital heart defects (CHDs). We performed a retrospective clinical data review of children with CHDs in whom SwiftNINJA was used during cardiac catheterization between April 2022 and June 2023. Utility, application, and standard safety were described comprehensively. We identified 19 patients (78.9% males) with a median age of 5.3 months (IQR, 2-13.9), and a median weight of 5.3 kg (IQR, 4-7.7). 36.8% of the catheterizations were transarterial and 78.9% were interventional. SwiftNINJA was applied upfront in 3/19 patients to cannulate precisely the right pulmonary artery and eliminate the risk of dislocating a freshly implanted left pulmonary flow restrictor. In 16/19 patients, SwiftNINJA was applied after a median of 5 (IQR, 5-7) failed catheterization attempts using various combinations of catheters, microcatheters, and wires to cannulate challenging vasculature in seven, engage the lumen of stented vessels in five, cross complex aortic valve stenosis in three, and cross an apical ventricular septal defect in one patient with Damus-Kaye-Stansel repair. After the SwiftNINJA application, catheterization was done from the first attempt in 12/16 patients and from the second attempt in 4/16 patients. The median applied tip angulation was 90 degrees (IQR, 85-95). All procedures were completed successfully. No device malfunction or adverse events occurred. SwiftNINJA is a valuable addition for selective catheterization of challenging vasculatures or valvular anatomies in children with CHDs.

In Vitro Characterization of Drug-Loaded Superabsorbent Polymer Microspheres: Absorption and Release Capacity of Contrast Material, Antibiotics and Analgesics.

To examine the characteristics of drug-loaded superabsorbent polymer microspheres (SAP-MS) such as drug absorption, drug release, diameter, and visibility. SAP-MS (HepaSphere150-200µm; Merit Medical, South Jordan, UT, USA) were suspended in drug solutions: (a) cefazolin, (b) lidocaine, (c) iopamidol and cefazolin, (d) iopamidol and lidocaine, and (e) iopamidol, cefazolin, and lidocaine. The concentrations of drugs were measured, and the amount of each drug absorbed was calculated. Filtered drug-loaded SAP-MS were mixed with saline, and the drug release rates were calculated. The diameter changes of SAP-MS during absorption were observed. Radiography of drug-loaded SAP-MS was evaluated as radiopacity by contrast-to-noise ratio (CNR). The drug concentration did not change during absorption. The release rates increased for 10min and then came to an equilibrium. The mean amounts of drug absorbed at 180min and mean release rates at 24h were (a) cefazolin: 265.4mg, 64.2%; (b) lidocaine: 19.6mg, 75.6%; (c) iopamidol: 830.2mg, 22.5%; cefazolin: 137.6mg, 21.2%; (d) iopamidol: 1620.6mg, 78.5%; lidocaine: 13.5mg, 81.4%; and (e) iopamidol: 643.7mg, 52.9%; cefazolin: 194.0mg, 51.6%; lidocaine: 5.3mg, 58.4%. The diameter of SAP-MS increased for approximately 15min. Finally, the diameters of SAP-MS were (a) 3.9 times, (b) 5.0 times, (c) 2.2 times, (d) 5.5 times, and (e) 3.6 times larger than the original size. Drug-loaded SAP-MS containing iopamidol were visible under X-ray imaging, with CNRs of (c) 3.0, (d) 9.0, and (e) 4.5. SAP-MS can absorb and release iopamidol, cefazolin, and lidocaine.

Occlusion of rectal arteries in the treatment of recurrent hemorrhoidal disease after transanal surgical interventions

The article presents data on variant X-ray anatomy of the superior rectal artery and types of arterial architectonics of the rectum. The causes of recurrent hemorrhoidal disease after traditional transanal surgical interventions are highlighted. The possibilities of endovascular occlusion of rectal arteries in the treatment of relapses of chronic hemorrhoids are shown. Its technical variants are given depending on the number of hemorrhoidal arteries and types of arterial architectonics of the rectum.Over a 2-year period, clinical results of endovascular occlusion of hemorrhoidal arteries were evaluated in 11 patients with relapse of the disease after various transanal interventions: after latex ligation of internal hemorrhoids – in 5, transanal desarterization of internal hemorrhoids with mucopexia – in 4, hemorrhoidectomy – in 2. The average age of patients was 44.2 ± 12.5 years. Men – 5, women – 6. Superselective occlusion of the target hemorrhoidal branches of the upper rectal artery was performed with EmboGold (Merit Medical) microparticles, 500–700/300–500 mkm in size. Immediate results: cessation of bleeding on the first day – in 4 patients, after 3 days – in 5, after 7 days – in 2. Terms of hospitalization – 1 day, disability – 4.3 ± 0.7 days. Long-term results (from 1 to 2 years) were observed in all 11 patients. The course is relapse-free.As an illustration, a clinical case is presented – successful treatment of a patient with recurrent hemorrhoidal disease by endovascular occlusion of hemorrhoidal arteries after five traditional transanal surgical interventions: sclerosing, ligation, dearterization of internal hemorrhoids, dearterization of internal hemorrhoids with mucopexia, removal of external hemorrhoids. Within 3 months after endovascular occlusion – complete regression of all symptoms of hemorrhoidal disease. According to the questionnaire (after 1 and 2 years) there is no relapse of the disease, the patient is subjectively satisfied with the endovascular treatment.

What’s New in Transradial Access

Transradial access (TRA) is a key strategy to avoid bleeding during percutaneous coronary intervention (PCI) and coronary angiography, as it reduces the risk of bleeding associated with transfemoral access (TFA). The distal radial artery (dRA) is located at the anatomical snuffbox, or radial fossa, which is a triangular depression on the lateral aspect of the dorsum of the hand. Distal transradial access (dTRA) at the anatomical snuffbox has recently gained interest as a non-femoral alternative access route for vascular procedures. Opportunities and challenges in the TRA/dTRA space include adoption of different and more complex procedures, technical innovation in access and haemostasis, and financial savings for institutions and healthcare systems. Historically, the adoption of TRA has been concentrated among interventional cardiologists, with much less adoption in the interventional radiology, vascular surgery, and neurointerventional radiology communities. This article highlights key aspects of the Think Radial webinar, an educational training session conducted by Merit Medical. The training session was conducted by three experts: Sandeep Nathan, Department of Cardiology, University of Chicago Medicine, Illinois, USA; Darren Klass, Department of Radiology, University of British Columbia, Vancouver, and Department of Radiology, Vancouver General Hospital, British Columbia, Canada; and Ajit Puri, New England Center for Stroke Research, Department of Radiology, University of Massachusetts Medical Center, Worcester, USA, all of whom have a wealth of experience in vascular access. The experts provided valuable insights into topics such as why and how to adopt a dTRA approach, the value of ultrasound for guided vascular access, and dTRA and ultrasound tips and techniques. The experts also explored the challenges in transradial intervention and management of radial access complications. Drawing on their individual specialist knowledge, the experts concluded with presentations on PCI, radial approaches in interventional radiology, and dRA access in neurointervention. The aim of this educational article is to disseminate key information on TRA provided by the experts to guide and update healthcare practitioners, particularly interventional cardiologists and interventional radiologists, working in vascular access.

Use of steerable sheaths for complex aortic procedures.

To demonstrate the ease with which steerable sheaths, designed for cardiac electrophysiological applications, can be used to aid endovascular treatment of a wide range of non-cardiac vascular disease and to assist with target vessel cannulation in branched and fenestrated aortic grafts. A retrospective medical chart review was carried out to identify cases from a single vascular surgery unit (2019-2022) where the HeartSpan Steerable Sheath (HSS) (Merit Medical, South Jordan, UT, USA) was utilised to enable endovascular management of complex vascular pathology. A case presentation of branch graft insertion performed entirely via distal access is described and used to help identify pertinent sheath characteristics and technical considerations, and to illustrate the advantages and disadvantages of the design for modified use in target vessel cannulation. The HSS was used in the endovascular treatment of different vascular pathologies in 15 patients (23 target vessels) where access to the vessels using standard catheters and approaches was not possible. Cannulation and subsequent stenting were successful for 21 of the 23 target vessels in total. Of these cases, the HSS was used as an adjunct for deployment of fenestrated endovascular graft systems when conventional techniques for canulation of target vessels had failed on five occasions. On another four occasions, the HSS enabled full deployment of the entire Zenith® t-Branch™ Thoracoabdominal Endovascular Graft system from an exclusively femoral approach. An additional three cases involved use of the HSS for superior mesenteric artery cannulation in patients with mesenteric ischaemia. The device was also used once in each of the following cases: contralateral common iliac cannulation, cannulation of contralateral internal iliac artery for coil embolisation, and access of a contralateral iliac branched device. There were no stent dislocations and all aortic branches that were patent at the completion of each case remained so 1-year post procedure. Steerable sheaths designed for cardiac electrophysical applications, like the HSS Introducer, can be successfully utilised for cannulation of challenging target vessels in a wide range of aortic endovascular procedures. This modified approach may salvage cases that would otherwise be considered inoperable in regions of the world where steerable sheaths designed for aortic use are not readily available.

Optimisation of Volume Flow Rates when Using Endovascular Shunting Techniques: An Experimental Study in Different Bench Flow Circuits

Acute tissue ischaemia may arise due to arterial emergencies or during more complex vascular procedures and may be mitigated by temporary shunting techniques. Endovascular shunting (ES) techniques enable percutaneous access and shunting from the donor artery without the need to completely interrupt the arterial flow in the donor artery. An endoshunt system may also cover longer distances than most conventional shunts. The aim was to investigate and optimise the flow rates in different endovascular shunt systems. Step 1: The flow capacity of different ES configurations was compared with the flow capacity of a 9 Fr Pruitt-Inahara shunt (PIS). An intravenous bag with 0.9% NaCl, pressurised to 90mmHg, was connected simultaneously to a PIS and to one of the tested ES configurations. The two shunt systems were then opened at the same time. The delivered fluid volumes from the shunt systems were collected and measured. The volume flow rate was subsequently calculated. Steps 2 and 3: Within a heart lung machine circuit, pressure-flow charts were constructed for the individual ES components and for the fully connected optimised endoshunt systems. The flow rate was increased in steps of 40-50 mL/min while monitoring the driving pressure, enabling the creation and comparison of the pressure-flow charts for the individually tested components. In total, seven individual inflow and outflow potential ES components were investigated with inflow and outflow diameters ranging from 6 to 15 Fr. ES systems based on standard donor introducers led to substantially lower volume flow than the corresponding PIS volume flow, whereas ES systems based on dedicated 6 or 8 Fr dialysis access introducers (Prelude Short Sheet, Merit Medical) matched PIS flow rates. The introduction of 30 cm long ¼'' perfusion tubing within the ES system did not affect volume flow for any of the tested ES configurations. Endoshunting techniques can match PIS volume flow rates over short and long distances. The achieved ES flow rate is highly dependent on the components used within the ES system.

Safety and Feasibility of Steerable Radiofrequency Ablation in Combination with Cementoplasty for the Treatment of Large Extraspinal Bone Metastases.

Background: Radiofrequency ablation (RFA) and cementoplasty, individually and in concert, has been adopted as palliative interventional strategies to reduce pain caused by bone metastases and prevent skeletal related events. We aim to evaluate the feasibility and safety of a steerable RFA device with an articulating bipolar extensible electrode for the treatment of extraspinal bone metastases. Methods: All data were retrospectively reviewed. All the ablation procedures were performed using a steerable RFA device (STAR, Merit Medical Systems, Inc., South Jordan, UT, USA). The pain was assessed with a VAS score before treatment and at 1-week and 3-, 6-, and 12-month follow-up. The Functional Mobility Scale (FMS) was recorded preoperatively and 1 month after the treatment through a four-point scale (4, bedridden; 3, use of wheelchair; 2, limited painful ambulation; 1, normal ambulation). Technical success was defined as successful intraoperative ablation and cementoplasty without major complications. Results: A statistically significant reduction of the median VAS score before treatment and 1 week after RFA and cementoplasty was observed (p < 0.001). A total of 6/7 patients who used a wheelchair reported normal ambulation 1 month after treatment. All patients with limited painful ambulation reported normal ambulation after the RFA and cementoplasty (p = 0.003). Technical success was achieved in all the combined procedures. Two cement leakages were reported. No local recurrences were observed after 1 year. Conclusions: The combined treatment of RFA with a steerable device and cementoplasty is a safe, feasible, and promising clinical option for the management of painful bone metastases, challenging for morphology and location, resulting in an improvement of the quality of life of patients.

PREDICTING LONG-TERM RISK OF RECURRENT UPPER GASTROINTESTINAL BLEEDING: A CASE- CONTROL STUDY

Mantej Sehmbhi: NO financial relationship with a commercial interest | Pavan Paka: NO financial relationship with a commercial interest | Nour Al Khalili: NO financial relationship with a commercial interest | Shabari Shenoy: NO financial relationship with a commercial interest | Sera Satoi: NO financial relationship with a commercial interest | Erica Park: NO financial relationship with a commercial interest | Michael Smith: YES financial relationship with a commercial interest;CDx Diagnostics:Consulting;Steris Endoscopy:Consulting;Metronic GI Health:Speaking and Teaching;GI Supply:Consulting;Merit Medical:Consulting;PavMed/Lucid Diagnostics:Consulting

Abstract No. 515 Single center long term follow up of patients after UFE with HydroPearl microspheres

Embospheres (Merit Medical Inc) are one of the most widely used microspheres in treatment of fibroids using uterine fibroid embolization (UFE). We report short- and long-term outcomes of patients who underwent with HydroPearl Microspheres (Terumo Inc) by assessing both clinical and imaging changes.

Use of a Novel Catheter, the MOT-C, for Selective Angiography of the Internal Mammary Artery From Ipsilateral Radial Access.

We describe a novel catheter, the MOT-C (Merit Medical Systems), for selective diagnostic angiography of the internal mammary artery from radial access. We analyzed the pattern of radial versus femoral access for bypass angiography at our institution between 2012 and 2020. We also examined the difference in contrast volume and fluoroscopy time between radial and femoral access and between MOT-C and traditional internal mammary artery (IMA) catheter for bypass angiography. Since the introduction of MOT-C catheter to our laboratory in 2016, there has been a 1.5-fold increase in the use of radial access for bypass angiography. No significant difference in contrast volume or fluoroscopy time was noted between radial and femoral access for bypass angiography. The MOT-C catheter was successfully used in 46% of all cases and 77% of all radial cases between 2016 and 2020 to selectively engage the IMA. When compared with the traditional IMA catheter, no statistically significant difference was noted in contrast volume or fluoroscopy time with the use of MOT-C for bypass angiography, although there was a trend toward lower contrast use. Furthermore, no catheter-related complications occurred. The MOT-C facilitates improved engagement of IMA grafts with minimal manipulation and allows for high-quality diagnostic angiograms with a potential decrease in contrast volume compared with the more traditionally used IMA catheter.

Preoperative Endovascular Embolization of Glomus Jugulare Tumors: A Retrospective Case Series of 22 Embolizations in 20 Patients and Literature Review

Abstract Objective Glomus jugulare tumors, or tympanojugular paragangliomas, are rare, highly vascularized skull base tumors originated from paraganglion cells of the neural crest. With nonabsorbable embolic agents, embolization combined with surgery has become the norm. The authors assess the profile and outcomes of patients submitted to preoperative embolization in a Brazilian tertiary care hospital. Methods The present study is a single-center, retrospective analysis; between January 2008 and December 2019, 22 embolizations were performed in 20 patients in a preoperative character, and their medical records were analyzed for the present case series. Results Hearing loss was the most common symptom, present in 50% of the patients, while 40% had tinnitus, 30% had dysphagia, 25% had facial paralysis, 20% had hoarseness, and 10% had diplopia. In 7 out of 22 embolization procedures (31%) more than a single embolic agent was used; Gelfoam (Pfizer, New York, NY, USA) was used in 18 procedures (81%), in 12 of which as the single agent, followed by Embosphere (Merit Medical, South Jordan, UT, USA) (31%), Onyx (Medtronic, Minneapolis, MN, USA) (9%), and polyvynil alcohol (PVA) and Bead Block (Boston Scientific, Marlborough, MA, USA) in 4,5% each. The most common vessel involved was the ascending pharyngeal artery, involved in 90% of the patients, followed by the posterior auricular artery in 15%, the internal maxillary artery or the occipital artery in 10% each, and the superficial temporal or the lingual arteries, with 6% each. Only one patient had involvement of the internal carotid artery. No complications from embolization were recorded. Conclusions Preoperative embolization of glomus tumors is safe and reduces surgical time and complications, due to the decrease in size and bleeding.

PP126 Radiofrequency Ablation For Metastatic Spinal Lesions

IntroductionAbout 70 percent of metastatic breast, lung, and prostate cancers affect the bones. When this phase of the disease affects the spine, the mobility and quality of life of patients are severely impaired. Radiofrequency ablation (RFA) has become a feasible option in the palliative treatment of vertebral metastases due to its minimal invasiveness and short procedure time. This health technology assessment report aimed to identify, evaluate, and synthesize evidence on the safety, effectiveness, and cost effectiveness of RFA for vertebral metastases.MethodsA systematic search was conducted to identify literature published from December 2016 to July 2019 in the following databases: Medline, Embase, the Cochrane Library, and the Centre for Reviews and Dissemination. Systematic reviews, randomized and non-randomized controlled trials, and case series studies evaluating the efficacy and safety of RFA in patients with vertebral metastases were included.ResultsSixteen studies were included: two systematic reviews, 13 case series studies, and one comparative study. None of the systematic reviews identified any randomized controlled trials. Of the 14 included primary studies, 10 evaluated RFA in combination with vertebroplasty, three evaluated RFA in combination with kyphoplasty, and one study evaluated a combination of RFA and radiation therapy. In all cases, the evaluated patients had different types of cancer (e.g., breast, lung, or liver). The follow-up periods varied between the studies from one day to 12 months. The most commonly used RFA devices were the STAR™ Tumour Ablation System (Merit Medical Systems) and the OsteoCool™ Radiofrequency Ablation System (Medtronic).ConclusionsRFA reduces pain, improves functional capacity, and provides greater local control of disease, potentially giving patients a higher quality of life, even in the context of metastatic disease. Although there is evidence on the safety and efficacy of this technology for the palliative treatment of vertebral metastases, more studies with higher methodological quality are needed. There were no studies available on the cost effectiveness of RFA for this indication.

A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence

BackgroundThe purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah). MethodsWe performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications. ResultsFrom 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033). ConclusionsThe results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future.

HeRO® graft: technical application and clinical experience in 73cases

Zunehmendes Alter, Komorbiditäten und die Dauer der chronischen Dialysepflichtigkeit erschweren die Anlage und den Erhalt eines funktionierenden Gefäßzugangs bei Patienten mit terminaler Niereninsuffizienz. Dabei steigt durch zentralvenöse Katheter und kardiologische bzw. onkologische Eingriffe das Risiko einer zentralen Stenose bzw. Okklusion. Die Implantation des Hemodialysis-Reliable-Outflow(HeRO®)-Grafts (Merit Medical Systems Inc., South Jordan, UT, USA) ist ein inzwischen etabliertes kombiniert chirurgisch/interventionelles Verfahren zur Wiederherstellung des stenosierten oder okkludierten venösen Abstroms. Hierdurch kann der Gefäßzugang an der oberen Extremität erhalten bleiben und die wichtige Gefäßressource der unteren Extremität geschont werden. In unserem Zentrum wurden seit 2013 insgesamt 73 Grafts erfolgreich mit steigendem Bedarf implantiert. Der operative Eingriff ist bei uns ein etabliertes und risikoarmes Verfahren geworden. Nach der Implantation ist bei akuter Thrombosierung jedoch 2‑ bis 3‑mal jährlich eine Reintervention erforderlich. Entsprechende Erfahrung vorausgesetzt, sind diese Revisionseingriffe technisch einfach durchzuführen. Bei vollständiger Okklusion der zentralvenösen Strombahn im Bereich der V. cava superior, die nicht durch den HeRO®-Graft passiert werden kann, ist ein Kombinationseingriff mit dem Surfacer®-Sytem (Inside-out-Verfahren) möglich und sinnvoll. Der HeRO®-Graft kann bei Bedarf an eine früh punktierbare Prothese angeschlossen werden. Hierdurch können passagere Dialysekatheter vollständig umgangen werden. Trotz steigender Zahl der HeRO®-Graft-Implantationen bleibt diese Option in unserem Zentrum ein Reserveverfahren. Die interventionellen Verfahren ohne Implantation von Fremdmaterial sollten zunächst ausgeschöpft und etablierte gefäßchirurgische Alternativen (wie beispielsweise der V.-jugularis-Anschluss) vorrangig durchgeführt werden.