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LINC Review Publishing and Production MediFore Limited Course Chairman Dierk Scheinert Editor-in-Chief Peter Stevenson Editors Tatum Anderson Ryszarda Burmicz Becky McCall Caroline Chambers Design Peter Williams Industry Liaison Manager Lorraine Tighe Project Manager Fiona Campbell Head Office 51 Fox Hill London SE19 2XE United Kingdom Telephone: +44 (0) 20 8771 8046 editor@medifore.co.uk www.medifore.co.uk Copyright © 2020: LINC and Provascular GmbH (Paul – List – Str. 11, 04103 Leipzig). All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, transmitted in any form or by any other means, electronic, mechanical, photocopying, recording or otherwise without prior permission in writing of LINC or Provascular. The content of the LINC Review does not necessarily reflect the opinion of the LINC 2020 Course Directors or the LINC Organisational Committee.
Introduction Contents LINC in numbers 5 The 16th Leipzig Interventional Course, held 28–31 January 2020, saw almost 5,000 participants Lutonix data: No link between paclitaxel & mortality 6 fill the Trade Fair Leipzig in order to witness a renowned international meeting committed to ARIVA trial updates on anticoagulation & venous stents 10 advancing the scientific and clinical evaluation and treatment of patients with complex vascular Good patient selection is key to PVE 12 disease through an interdisciplinary discussion of novel endovascular techniques. EKOS™ tackles deep vein thrombosis 14 Over four days, all in attendance were exposed to explorations of cutting-edge interventional ‘Incredible efficacy’ of DES in long BTK lesions 18 practice, formed over a multidisciplinary programme of lectures, debates, trial updates, device Treating traumatic aortic injuries 20 innovations and expert-driven narrative. Of course, LINC also included dedicated “First-time Lesion type informs decision in fem-pop atherectomy 22 data release” sessions, running throughout the programme, which offered the first glimpses of How to be safe in BTK atherectomy 24 data from the latest important studies and technologies. Total IN.PACT from pooled DCB data 26 Live cases also featured in abundance, with satellite transmissions from Italy, Ireland, USA, Limitations & risks with CO2 angio 28 France, Switzerland, as well as centres in Leipzig and across Germany. Ever engaging, and always Failing TEVAR, keep up the surgical work 30 exciting to watch, these cases placed a spotlight on the latest-and-greatest techniques, devices, Endo AV access 32 tips and tricks, and demonstrated how to tackle challenging situations head on. EVAR in nonagenarians? 34 LINC also welcomed collaborators from leading vascular courses around the world, including: Snapshots from LINC 2020 36 The Charing Cross (CX) Symposium, Vascular InterVentional Advances (VIVA); the International The pave-and-crack technique at seven years 37 Congress of Interventional Surgery (CICE); the International Symposium on Endovascular TIPS improves transplant survival 38 Therapeutics (SITE); Complex Cardiovascular Therapeutics (CCT); the China Endovascular Course (CEC); the Japan Endovascular Treatment (JET) Conference; the VEITHsymposium; the First presentation of global, real-world Lutonix data 40 Pan Arab Interventional Radiology Society (PAIRS); the German Society for Angiology/Vascular Endovascular treatment for genetic aortic disorders 42 Medicine (DGA); as well as the online learning Vascupedia platform and the Aortic and Peripheral Pedal-plantar loop techniques 44 Surgery “How to do it” congress. Impressive Tack record for TOBA trials 47 The LINC Review brings you just some of the highlights from the hundreds and hundreds of First-time data from COMPARE trial 50 presentations, cases, discussions and debates that took place during the entire LINC 2020 Cutting-edge CLTI approaches 52 meeting. For even more, we encourage you to head to the LINC website and dedicated LINC App TOPOS takes on DVTs 56 to view a selection of key sessions, live cases and presentation slides. Diagnosis is key in PCS 58 Thank you to all delegates and industry sponsors for your continued support. We look forward AAAs: Endo or open? 60 to seeing you next year at LINC 2021, held January 25–30! Taking a DETOUR into long lesions 62 LOCOMOTIVE: long lesions & spot stenting 64 Venous stents given the bench test 66 Faculty at LINC 2020 68 Industry support 71
Society and association accreditation LINC 2020 was accredited by: The Sächsische Landesärztekammer with The Swiss Society for Angiology with The Dutch Association for Vascular Surgery 21 cmE points. 20 Credits. with 20 accreditation points in Category I. www.slaek.de www.angioweb.ch www.vaat-chirurgie.nl LINC 2020 was endorsed by The Italian Society of Vascular and The National Education Course for The European Society for Endovascular Surgery Vascular Intervention and Medicine Vascular Medicine www.sicve.it https://vivaphysicians.org/ www.vascular-medicine.org LINC 2020 has been rated compliant LINC 2020 was under the patronage of: with the Medtech Europe Code of Ethical Business Practice The German Society for Angiology The German Society of Vascular Surgery www.ethicalmedtech.eu www.dga-gefaessmedizin.de www.gefaesschirurgie.de LINC 2020 – Organisation and production Congress production Congress organisation AV support the LINC Review Provascular GmbH, Congress Organisation and More GmbH mediAVentures MediFore Paul-List-Strasse 11 Ruffinistrasse 16 St. Jozefstraat 18 51 Fox Hill 04103 Leipzig, Germany 80637 Munich 9820 Merelbeke London www.provascular.de Germany Belgium SE19 2XE E-mail: info@cong-o.de E-Mail: info@mediaventures.be United Kingdom Phone: +49 89 23 75 74-65 Phone: +32 9 239 0110 Telephone: +44 (0) 20 8771 8046 Fax: +49 89 23 75 74-70 Fax: +32 9 231 8920 editor@medifore.co.uk 4 www.cong-o.com www.mediaventures.be www.medifore.co.uk
LINC in numbers 50 100 150 200 250 300 350 400 1,265 Germany United States Italy Spain 5,027 United Kingdom +2.3% 4,956 Netherlands 4,913 4,913 +0.9% 4,837 +1.6% 4,866 +1.0% Poland -3.2% Switzerland 4,734 +2% Belgium +17% Japan France Russian Federation Participants at LINC Austria Brazil 2012–2020 Egypt Islamic Republic of Iran Israel Turkey Ireland India Sweden 4,028 Continents from which China +11% Greece Czech Republic Distribution of medical Saudia Arabia Denmark professionals by country delegates originated 3,607 Republic of Korea +26% Norway Thailand Slovenia Hungary Finland Australia Europe Portugal 3,625 South Africa United Arab Emirates Argentina Bulgaria Ukraine Croatia Lebanon Singapore Costa Rica Iraq Distribution of medical Lithuania New Zealand Romania Australasia Serbia Colombia Hong Kong professionals by specialty 27 North America Indonesia Asia 445 Jordan 618 Africa Mexico South Peru 109 America Slovakia Taiwan, Province of China 122 Canada Latvia Angiologists/ Luxembourg Cardiologists Tunisia Costa Rica Vascular 27% Estonia Kazakhstan Surgeons Pakistan Bangladesh 47% Iceland Republic of Moldova Uruguay Azerbaijan Bahrain Interventional Belarus Radiologists Bolivarian Republic of Venezuela Bosnia and Herzegovina 26% Burkina Faso Curaçao Georgia Guinea Kuwait Kyrgyzstan Malaysia 2012 2013 2014 2015 2016 2017 2018 2019 2020 Morocco Nigeria Saint Barthélemy 5 Swaziland Syrian Arab Republic United Republic of Tanzania LINC 2020 was a great success with a registration count of 4,946 from more than 80 countries
Independent analysis of Lutonix DCB Data reveals no plausible link between paclitaxel and mortality L atest insights into the in-depth independent safety safety and efficacy of analysis of the Lutonix (BD, USA) drug-coated devices took drug-coated balloon (DCB) – a centre stage on the first 2 µg/mm2 paclitaxel-eluting day of LINC 2020, with balloon catheter which has been a large proportion of the session extensively studied in the LEVANT dedicated to paclitaxel safety. 11, LEVANT 22 and LEVANT Japan3 Speaking during the session series of trials. was Kenneth Ouriel, Founder, “Lutonix was the first DCB President and CEO of Syntactx approved by the Food and Drug (New York, NY, USA), a full-service Administration in the US,” said Clinical Research Organisation Dr Ouriel. “Approval was based (CRO) that delivers high-quality on a rigorous preclinical and clinical research services, clinical scientific programme including heading-up clinical that demonstrated both safety trials for medical device and and effectiveness.” pharmaceutical companies. The independent Lutonix “The need for a CRO is exactly analysis Dr Ouriel presented is in what my talk is about because it part a response to the questions is useful for medical device and raised about paclitaxel safety by pharmaceutical companies to the Katsanos et al. meta-analysis two groups of patients, one with have an independent assessor (2018) which found a late all- “There is no significant increase in an uncoated balloon and one of data,” Dr Ouriel told the LINC cause mortality signal for patients the hazard ratio for mortality in any with a paclitaxel-coated balloon, Review ahead of his presentation. treated with paclitaxel balloons why there is a mortality signal? “And the reason for that is more to and stents.4 As Dr Ouriel noted, analysis of the Lutonix DCB, nor any Some of the smartest people in do with perceived, rather that real, Syntactx has since been doing the field have been asking the conflicts of interest.” an independent analysis of the plausible mechanism for mortality or same question. There definitely In other words, CROs ensure Katsanos data as well – a task evidence of paclitaxel causation.” is a signal there, but not a single that any perceived bias that which has proven challenging clinician that I know believes that people may have of company- indeed: “It’s been a lot of work Kenneth Ouriel it’s related to the small amount sponsored trial data is put to bed but it has been intellectually of paclitaxel which is found on via robust and independently rewarding,” he said. the balloon. verified analyses of datasets. “However, we haven’t been “Most of us, myself included, 6 In his talk, Dr Ouriel presented able to figure out, when you have Continued on page 7
believe that it’s probably related to some facet of trial design – more than likely due to missed follow-up visits (that are not at random). As we work towards more complete follow-up on virtually every patient, the mortality signal almost disappears once the vital statistics on patient survival become clear.” Indeed, several of the trials from leading manufacturers that fed into the meta-analysis had patients lost to follow-up, noted Dr Ouriel, which could have impacted the apparent mortality signal observed. Not least, he added, given that follow-up was different for the DCB cohorts versus non-DCBs. Crucially, patient-level data was not included in the Katsanos et al. meta-analysis, leading many to question if differences in follow-up care in DCB versus percutaneous transluminal angioplasty (PTA) comparators could be driving at least some of the mortality signal. Focusing back on Syntactx’s when pooling the data from the signal could be seen with the of death within a category, (does mortality increase following independent analysis of Lutonix Continued Access cohort,” noted Lutonix data, Dr Ouriel asserted causation is not supported.” index procedure?) and analogy data, Dr Ouriel relayed that Dr Ouriel. “This is an appropriate that, of the 173 deaths seen in Staying on the topic of (could the effects be due to patient-level data was used way to remove the bias associated the LEVANT 1 and 2 datasets, no causality, Dr Ouriel underlined immunogenic particulates?). to compare safety outcomes with differences in the make-up of deaths were classified as related the importance of using Bradford Save for the last two criteria from 1,093 Lutonix and 250 PTA patient groups that are not from to paclitaxel based upon the Hill criteria – a nine-point system (temporality is present, and patients across the LEVANT series the same RCT. We also performed known side-effects of the drug. that explores epidemiologic particulates have been implicated of trials, including the LEVANT time-dependent analyses to “Mechanistically, if paclitaxel evidence of a causal relationship in other situations), the rest 2 Continued Access cohort – account for factors that change caused death, there should be between a presumed cause and of the criteria can be ruled enrolled specifically to assess over time, and performed a disproportionate frequency an observed effect. Criteria span out, commented Dr Ouriel: paclitaxel safety. multivariable analyses to identify of mortality in one category or consistency, strength of effect, “The absence of seven of the “We utilised additional statistical key predictors of mortality.” a group of related categories,” specificity, plausibility, coherence, nine criteria is consistent with methods to assess the data, Cutting to the chase with explained Dr Ouriel. “That was not biological gradient (dose association, but not causation.” including propensity adjustment regards to whether any mortality observed. Thus, without clustering response), coherence, temporality Continued on page 8 7
Independent analysis of Lutonix DCB “People have market isn’t anywhere near what it was before,” he said. felt reasonably “I think this has really impressed comfortable going upon people that you do need complete follow-up beyond the back to using primary endpoint, especially given the primary endpoint for many paclitaxel devices, trials was a year or less. Even although I’m though the primary endpoint is earlier, people are pretty much sure the market doing five-year trials now in the isn’t anywhere lower extremities.” He concluded: “There is near what it was no significant increase in the hazard ratio for mortality in any before.” analysis of the Lutonix DCB, nor any plausible mechanism for Kenneth Ouriel mortality or evidence of paclitaxel causation. Based on all of our Continued from page 7 thus superseded paclitaxel as with paclitaxel devices, which study was lower than that of the analyses to date in a large dataset, He went on to explore whether predictors of outcome. increases drug exposure,” PAD population as reported in the the Lutonix DCB continues to there were patient or treatment- As such, the burning question continued Dr Ouriel. “Some of Swedish Vascular Registry (Sartipy offer meaningful benefit relative related variables associated remains: “Is there a relationship the other analyses that have et al. 2018) at five years.” to risk in indicated patients.” with increased risk, i.e. is there a between additional exposure to been reported did not account What this boils down to is that plausible mechanism for mortality paclitaxel and risk of mortality?” for reinterventions. Almost 20% subjects in clinical trials may do References associated with paclitaxel – or said Dr Ouriel. of subjects in the LEVANT 2 RCT better with additional clinical 1. Scheinert D, Duda S, Zeller T, et al. management, said Dr Ouriel, while The LEVANT I (Lutonix paclitaxel- with any other biological feature Looking at the LEVANT 2 RCT were treated with a paclitaxel coated balloon for the prevention of of DCB treatment – even through and Continued Access data, the device at some point during their reducing subsequent interventions femoropopliteal restenosis) trial for some unknown mechanism? effect of initial paclitaxel dose on five-year follow-up. is beneficial for patients, it also femoropopliteal revascularization: first- in-human randomized trial of low-dose Using a propensity-adjusted survival was analysed in four dose “Subjects in both groups, DCB reduces additional “touch points” drug-coated balloon versus uncoated multivariate analysis of mortality groups: > 0 to ≤ 2 mg; > 2 mg to and PTA, who subsequently with health care providers. balloon angioplasty. JACC Cardiovasc out to five years in the LEVANT ≤ 3.5 mg; > 3.5 mg ≤ 5 mg; and underwent an intervention with Commenting on the outlook Interv. 2014;7(1):10–19. 2. Rosenfield K, Jaff MR, White CJ, et al. 2 data, Dr Ouriel and colleagues > 5 mg. “No significant dose- a paclitaxel device had higher for paclitaxel, Dr Ouriel noted Trial of a Paclitaxel-Coated Balloon for identified several variables as response relationship was five-year survival rates than those that as more data is added into Femoropopliteal Artery Disease. N Engl J analyses, the proposed signal Med. 2015;373(2):145–153. predictors of mortality, including identified,” commented Dr Ouriel, that did not. This finding was 3. ClinicalTrials.gov. LEVANT Japan Clinical age, Rutherford category, left adding that when adjusting confirmed in our other studies, for mortality using paclitaxel Trial. Available at: https://clinicaltrials. limb, diabetes, anticoagulants at for age – the most significant and would be counter-intuitive if becomes even weaker, thus he gov/ct2/show/NCT01816412 4. Katsanos K, Spiliopoulos S, Kitrou P, et al. discharge and prior treatment. predictor of mortality in both DCB additional paclitaxel exposure is is optimistic that the reputation Risk of Death Following Application of However, these variables or PTA groups – no identifiable indeed harmful in the long-run. of paclitaxel will recover. “People Paclitaxel-Coated Balloons and Stents in were shown to be predictors dose-relationship could be seen. “It should be noted that the have felt reasonably comfortable the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of mortality irrespective of We also looked at the effect mortality rate in both the PTA going back to using paclitaxel of Randomized Controlled Trials. J Am 8 treatment arm, i.e. DCB or PTA, of subsequent interventions and DCB groups in the LEVANT 2 devices, although I’m sure the Heart Assoc. 2018;7(24):e011245.
ARIVA trial updates on anticoagulation after venous stenting A n eagerly awaited update from the “ARIVA is very important because to date Aspirin® Plus we do not have any prospective randomised Rivaroxaban Versus Rivaroxaban Alone for controlled studies on antithrombotic or the Prevention of Venous Stent Thrombosis in Patients With PTS anticoagulant treatment in patients after (ARIVA) trial was showcased at venous stenting.” LINC, giving all in attendance an insight as to what to expect Oliver Schlager from the multicentre study being conducted in sites in Austria, ago1 in which medical experts best and could be recommended Germany and Switzerland. were asked what anticoagulation in patients.” Running through the details treatment or antithrombotic Back then, the authors of the of the trial was Oliver Schlager, treatment they would recommend survey wrote that although a a medical interventionalist from after venous stenting, and the number of studies have focused the General Hospital and Medical results were analysed to achieve a on technical factors associated University in Vienna, Austria. Delphi consensus. with stent occlusion, there is a Dr Schlager, who specialises in But the survey revealed that paucity of research examining the patients with a range of chronic amongst experts in the UK, role of antithrombotic therapy conditions from chronic post- between 10 and 15 different in maintaining stent patency. thrombotic venous occlusion to anticoagulation regimes were They also commented that there non-thrombotic iliac vein lesions used after venous stenting, were no controlled studies that (NIVL), is principal investigator (PI) noted Dr Schlager. Of the 106 previously investigated the use for the Austrian portion of the trial. experts, a third chose life-long of anticoagulants or antiplatelet The German PIs will be Christian anticoagulation with a vitamin-K agents following venous stenting. Erbel, Houman Jalaie and Michael antagonist (VKA), 19% chose Today there are still several Lichtenberg, and Nils Kucher life-long anticoagulation with a single-arm studies that assess from University Hospital, Zurich, direct oral anticoagulant (DOAC), the use of different venous Switzerland is the overall PI. anticoagulant in combination with randomised controlled studies on 7% used antiplatelet therapy (APT) stents, and patients within these ARIVA is an investigator- aspirin,” explained Dr Schlager. antithrombotic or anticoagulant following stent placement alone studies receive anticoagulation initiated academic trial whose The primary outcome of the treatment in patients after venous and 13% used APT in combination after venous stent placement, primary aim is to assess different trial is patency at six months, i.e. stenting,” he said. “Therefore, it’s with an anticoagulant. “What was but most are driven by venous anticoagulation regimes after without the occurrence of either very important to start this study interesting in this publication was stent companies. “None of these venous stenting in patients with occlusion of at least a part of the as soon as possible.” the variety of different treatment studies specifically address the chronic post-thrombotic venous stent segment or a re-intervention What’s apparent is that while a regimes after venous stenting,” anticoagulation regime after lesions. “People who undergo to maintain patency of the range of anticoagulants are used said Dr Schlager. venous stenting,” said Dr Schlager. endovascular revascularisation treated segment. after venous stenting, there is no “This underlines the need for “Existing single-arm studies focus and venous stenting will be What’s important about ARIVA, clear evidence on which works a large multicentre prospective on the stents but not on the randomised to receive either noted Dr Schlager, is that it is better. Indeed, Dr Schlager cited randomised controlled study accompanying medical treatment, anticoagulation-only therapy the first trial of its kind. “To date an interesting electronic survey which will give us information which is absolutely necessary.” 10 [rivaroxaban] or to receive the we do not have any prospective conducted in the UK several years on which treatment regime is There are three major factors
impacting on the patency of treatment is a key issue for “Anticoagulation was no significant difference in on offer. “I think that we need venous stents, said Dr Schlager. stent patency after venous patency between patients who more prospective randomised One is the type of lesion – stenting. The interventionalist treatment is a received anticoagulation for a controlled studies after venous either chronic post-thrombotic, should either be familiar with limited period in comparison stenting, and the ARIVA trial will acute thrombotic, or non- different anticoagulation key issue for stent with patients who received help us to get this information,” he thrombotic, while the second regimes by themselves or should patency after anticoagulation for an said in closing. lies in haemodynamics. “This is cooperate with angiologists extended period.” more about the inflow coming and haematologists who venous stenting.” Of course, the study was a References from the veins below the inguinal are able to take care of the retrospective analysis rather than 1. Milinis K, Thapar A, Shalhoub J, et al. ligament, which has to be granted anticoagulation regime.“ Oliver Schlager a prospective randomised control Antithrombotic Therapy Following Venous Stenting: International Delphi through stent patency after stent During his presentation, Dr study, noted Dr Schlager. “It was Consensus. Eur J Vasc Endovasc placement,” he said. “But the third Schlager stepped outside of the placement.2 “This is an interesting a nice study, but it shows how Surg. 2018;55:537–544. 2. Sebastian T, Engelberger R, Spirk D, et most important factor, of course, ARIVA trial to address other new study into patients who received important the ARIVA trial is.” al. Cessation of anticoagulation therapy is the anticoagulation treatment, research into anticoagulation. For anticoagulation treatment for a In his concluding remarks, Dr following endovascular thrombus for which there is no study so far.” example, a study conducted by Tim limited period, and patients who Schlager reiterated that going removal and stent placement for acute iliofemoral deep vein thrombosis. That’s why there is a need Sebastian at the University Hospital received anticoagulation for forward there is a clear need Vasa. 2019;48(4):331–339. for collaboration amongst Zurich, which was published last an extended period after stent for many more randomised different specialties, Dr Schlager year, looked at the duration of placement,” said Dr Schlager. controlled trials looking at the The ARIVA trial is planned for went on: “Anticoagulation anticoagulation following stent “What he showed is that there different anticoagulation therapies completion in August 2022. 11
Preoperative portal vein embolisation in liver cancer The three cornerstones of good patient selection A rnaud Hocquelet required. It is not the same if you (CHUV, Lausanne, are going to treat a large anterior Switzerland) discussed hepatocholangiocarcinoma of indications and 7 cm, or several small metastases patient selection of around 1 cm in the liver. Also, in preoperative portal vein you have to discuss the complexity embolisation (PVE). of the surgery. Indeed, a prolonged Dr Hocquelet told audiences liver ischaemia period from that surgical resection of vessel clamping is a risk factor of hepatic tumours is often the postoperative liver failure.” only curative treatment for large The second cornerstone, primary tumours or for patients continued Dr Hocquelet, is with several small secondary the FRL volume percentage of tumours. However, for many total liver volume. He cited the patients, their tumours are work of Yiglitler et al. (2003), considered unresectable because who identified a more difficult of insufficiency of future remnant postoperative course in those patients left with a smaller FRL2: “Now we have a cheap, fast and accurate on CT you can find signs of portal liver (FRL). hypertension without cirrhosis. PVE serves as a potential “There is a strong correlation method of assessing liver function – This is an SOS: it should alert you remedy to this issue. It leads to between the amount of the liver about liver function. Now we a redistribution of flow and has after surgery and the overall hepatobiliary scintigraphy.” have a cheap, fast and accurate been shown to induce local morbidity. Under 30%, your rate method of assessing liver function hypertrophy of the liver1. “The of morbidity is around 50%. This Arnaud Hocquelet – hepatobiliary scintigraphy. In indication of PVE is to increase correlation is well-known in our centre, we use the cutoff of the FRL volume before resection,” several studies.” healthy liver, and 40% for others. contraindication for PVE. Indeed, 2.69 mm/min/kg for the FRL, to explained Dr Hocquelet, “In Dr Hocquelet also noted more “To accurately assess your FRL, there is a very strong correlation allow surgery. order to increase surgical margin recent research demonstrating you need a good quality contrast- between a small initial size “‘Volume is not function’ is and to improve postoperative how combining the albumin- enhanced CT scan with hepatic of the FRL and a high degree true before any intervention. liver function.” bilirubin score (the ALBI vein visible, in order to perform of hypertrophy4.” In one study, they found very He outlined the three score) with FLR predicts post- segmentation using automatic, The last cornerstone is the FRL weak correlation between liver cornerstones of PVE that underpin hepatectomy liver failure3. semi-automatic or hand-free function. “Volume is not function, volume and liver function5. This good patient selection. The Before major liver resection, the methods – depending on what it is very important to understand is also true after PVE. After PVE, first is the type of intervention. FRL volume can be calculated software you have available in that,” stressed Dr Hocquelet. you will observe an increase “You have to talk with your according to the equation: FRL% your centre. “Obviously, for a cirrhotic patient, in volume, but you will have a surgeons about the amount of = FRL / (whole functional liver “One interesting thing is that everybody thinks about liver bigger increase in function. But liver to be resected during the volume, excluding tumour), where a very small left lobe (< 10%) function. But for a young patient after ALPPS [Associating Liver 12 intervention, and the margin the usual cutoff is > 30% for the should not be considered a receiving intra-arterial oxaliplatin, Partition and Portal vein Ligation
for Staged hepatectomy] – the surgical alternative to PVE – at two weeks you will have a very strong increase in volume but no increase in liver function. If you have the volume but not the function, you will have postoperative liver failure.” He concluded: “PVE is here to improve surgery quality by improving margins, to improve postoperative outcomes by avoiding liver failure, and to bring curative treatment to unresectable patients. “To do that, you need to talk with your surgeons, have a good CT to assess liver volume, and you have to assess liver function using hepatobiliary scintigraphy. Of course, you have to avoid treating patients with contraindications.” References 1. Denys A, Bize P, Demartines N et al. Quality Improvement for Portal Vein Embolization. Cardiovasc Intervent Radiol. 2010;33:452–6. 2. Yigitler C, Farges O, Kianmanesh R, et al. The small remnant liver after major liver resection: how common and how relevant? Liver Transpl. 2003;9(9):S18–S25. 3. Zou H, Wen Y, Yuan K, et al. Combining albumin-bilirubin score with future liver remnant predicts post-hepatectomy liver failure in HBV-associated HCC patients. Liver Int. 2018;38(3):494–502. 4. Hocquelet A, Frulio N, Gallo G, et al. Point-shear wave elastography predicts liver hypertrophy after portal vein embolization and postoperative liver failure. Diagn Interv Imaging. 2018;99(6):371–9. 5. Bennink RJ, Dinant S, Erdogan D, et al. Preoperative assessment of postoperative remnant liver function using hepatobiliary scintigraphy. J Nucl Med. 2004;45(6):965–71. 13
Deep vein thrombosis and EKOS™ Interventional treatment to “If you’re treating minimise post-thrombotic a patient with syndrome and maximise outcome iliofemoral M aximal reduction and freedom from PTS of over DVT, there and treatment of 90% at three years, if proper really shouldn’t post-thrombotic patient selection and procedural/ syndrome (PTS) post-procedural management be anyone with by optimal are performed. moderate or interventional treatment of Referring to data from the deep vein thrombosis (DVT), past three years from centres severe PTS if it’s together with the safety and in Bern and Zurich, as collected efficacy of EKOS™ Acoustic in the Swiss Venous Stent a first-time DVT Pulse Thrombolysis™ treatment Registry (SVSR), Professor and they have no were the first two topics under Kucher shared his experience discussion at a symposium of the interventional treatment chronic venous led by BTG, now a part of of acute iliofemoral DVT with insufficiency.” Boston Scientific. venous stenting. Together the Nils Kucher (University centres have treated 160 patients, Nils Kucher Hospital Zurich, Switzerland) comprising more women than chaired the event and gave a men, with an overall mean age presentation addressing how of 48 years old. Most (78%) DVTs to optimise reduction in PTS were on the left side, and mainly Scientific), and the mean patients had patent stents,” added Professor Kucher then numbers when treating acute DVT due to May-Thurner syndrome. number of stents deployed was Professor Kucher. addressed the differences interventionally. He was joined “I want to highlight that 16% had 1.7. “We are shifting towards Villalta scores showed that between the major trials in the by colleagues Mert Dumantepe varicose veins as a risk factor, single session treatment in the 90% of patients had no PTS at area: the Swiss Registry, ATTRACT (Acibadem University School and already had chronic venous majority of patients now,” said three years, and 9% had mild and CaVenT. “Why did these trials of Medicine, Istanbul, Turkey) insufficiency. This is why the Professor Kucher. PTS. Professor Kucher went fail so badly?” he asked. who discussed the treatment Villalta score is inappropriate Primary patency rate at three on: “Two patients had higher “All of our patients [in the of femoral PTS with EKOS™, in clinical trials because many years was 79.4% (CI 95% [71.7, scores. These patients had severe Swiss Registry] had descending and Stefan Stortecky (Swiss patients already have increased 87.1]) with the majority of stent chronic venous insufficiency at iliofemoral DVT, and by Cardiovascular Centre Bern, Villalta scores,” remarked failures occurring early on. baseline; one had an active ulcer comparison CaVenT and ATTRACT Switzerland) who reported his Professor Kucher. Assisted primary patency was at the time of DVT. You cannot had 48% and 57%, respectively. centre’s data on the treatment of Of those treated, 44% 84.9% (CI 95% [78.1, 91.7]), and improve the Villalta score in such The remainder were ascending high-risk and intermediate high- underwent catheter-directed secondary patency at three years a patient. If you’re treating a femoropopliteal DVTs but these risk pulmonary embolism (PE). thrombolysis (CDT) – either was 95.6% (CI 95% [91.8, 99.4]). patient with iliofemoral DVT, there should not be touched – they Professor Kucher emphasised EKOS™ or conventional, “We did not give up if someone really shouldn’t be anyone with need blood thinners. that interventional treatment of 21% were treated in a single needed a secondary intervention moderate or severe PTS if it’s a “Also, 21% of our patients acute iliofemoral DVT may lead session (Angiojet ZelanteDVT™ because a stent became first-time DVT and they have no had single session treatment 14 to primary patency of over 95%, thrombectomy catheter, Boston occluded. At three years almost all chronic venous insufficiency.” compared to 0% in CaVenT, and
an unknown number if ATTRACT. “Our results is confirmed.” months in May-Thurner syndrome of complaints who had failed on CDT first was used in 79% of our Regarding his procedural cases; while Duplex surveillance conservative therapy and had a patients versus 100% and 59% in showed that recommendations, among the and Villalta scores need to be Villalta score greater than eight. CaVenT and ATTRACT.” 75% of patients key criteria listed by Professor carried out at 2 weeks, 3, 6 and 12 The primary efficacy endpoint He added that 100% of patients Kucher were: popliteal access months, and then annually. was reduction in Villalta score of received a stent, compared to 17% reached the with ultrasound guidance, Following Professor Kucher, Dr over six points at day 30 versus and 30% respectively in CaVenT deciding whether to use CDT first, Dumantepe took to the podium baseline, and increased blood and ATTRACT, noting: “I wonder primary or single session thrombectomy; and discussed how endovascular flow in the relevant segment. how many patients in ATTRACT endpoint.” diagnosing compressed iliac veins intervention using EKOS™ with The primary safety endpoint had spontaneous flow at the end using venographic criteria; and Acoustic Pulse Thrombolysis™ was major bleeding within 72 of the procedure – not many Mert Dumantepe using intravascular ultrasound treatment is safe and effective hours of starting the procedure I think.” (IVUS) in cases where venography for patients suffering from and incidence of PE within 30 Professor Kucher summarised technique to identify the distal is equivocal. femoral PTS. days post ultrasound-assisted, what he felt was key to success thrombus extent,” he said. “If the Post-procedure he He referred to his single- catheter-directed, low-dose with respect to diagnosis for popliteal cannot be compressed recommended oral anticoagulation centre experience where they thrombolysis (UACDT). descending DVT. “Colour Duplex then it might not be thrombosed, for at least three months, and included over 200 patients with A total of 202 femoropopliteal [ultrasound] with calf compression and if it is not thrombosed then no platelet inhibitors; oral symptomatic femoropopliteal PTS patients were included with is the only reliable imaging a descending iliofemoral DVT anticoagulants stopped at 3–6 DVTs with more than six months Continued on page 16 15
Deep vein thrombosis and EKOS™ Continued from page 15 Last on the stand was angiographic obstruction mean DVT age of 27.1 months, Professor Stortecky who over 48 hours, without any and with mean dose/duration discussed treatment of high-risk intracranial haemorrhage. of tissue-type plasminogen and intermediate-risk PE with Moreover, the OPTALYSE Trial activator (tPA) of 23.3 mg and 22 Acoustic Pulse Thrombolysis™. was able to show that also very hours, respectively. He familiarised the audience with low doses of tPA over a very “Our results showed that 75% the EKOS™ system, explaining short treatment period was able of patients reached the primary that it uses targeted ultrasonic to effectively decrease RV/LV endpoint [p < 0.001],” reported Dr waves in combination with clot- ratio. Indeed, a tPA rate as low Dumantepe. “We only saw two dissolving drugs. The system as 1mg/hour/catheter over a 4 major bleeding events, and nine uses a sophisticated catheter and hour treatment period was able recurrent DVTs. Doppler showed an ultrasonic core to effectively to significantly decrease RV/LV that patency was around 90% target an entire clot, along with ratio by 0.35 and was as effective for each segment, and similar at fibrin separation and active as a higher dose regimen. one year.” drug delivery into the clot by Based on the data, it is likely He also highlighted the acoustic streaming. that EKOS™ is also effective in importance of freedom from Professor Stortecky said the PE reducing RV/LV ratio with even ulceration: “We saw a 91% response team treated three- lower dose tPA regimens and ulceration healing rate. Washout quarters of patients with EKOS™ . shorter treatment times, Professor [time to washout of the femoral “Some received medical therapy, Stortecky concluded. vein] also significantly improved some surgical thrombectomy but Optimising the reduction in PTS after EKOS™ treatment for second very few received systemic lysis,” numbers when treating acute DVT day. Villalta score also showed he said. “In fact, the vast majority systolic pressure continuously interventionally, or treating PE improvement of 10.2 points from of patients received EKOS™ in “You can rest decreased up to 48 hours. with EKOS™, these results serve baseline at 360 days, while venous the intermediate- and high-risk assure that No patients had intracranial to further reinforce the benefits clinical severity score (VCSS) score patient groups.” haemorrhage and there were of using ultrasound-assisted showed a reduction of 8.1 points He referred to the ULTIMA trial EKOS™ will not very low rates of major bleeding CDT and add to an increasing from baseline at 360 days. Quality led by Nils Kucher, the primary interfere with events, added Professor Stortecky. wealth of evidence to support its of life scores also improved endpoint of which was reduction The protocol for EKOS™ in the growing use. by 21.3 points on the VEINES in the right-to-left ventricle your procedure.” SEATTLE II study involved patients scoring system.” diameter (RV/LV) ratio. Results having symptoms less than 14 days References After presenting a couple of showed that the combination of Stefan Stortecky due to massive or sub-massive 1. Kucher N, Boekstegers P, Müller OJ, case studies from his centre EKOS™ and heparin led to a ratio PE, and a RV/LV diameter of > et al. Randomized, controlled trial of ultrasound-assisted catheter- in Istanbul, he closed his of 0.3, versus 0.03 in those patients bleeding, but you can rest assure 0.9. The PE was confirmed by CT directed thrombolysis for acute presentation with a call to action. on heparin alone over 24 hours.1 that EKOS™ will not interfere with scan. UACDT was used with a total intermediate-risk pulmonary embolism. “The ACCESS PTS treatment “There was also a significant your procedure.” tPA dose of 24 mg. Outcomes Circulation. 2014;129(4):479–486. protocol reduces PTS scores, difference seen between the The SEATTLE II single-arm included a 25% decrease in CT- 2. Piazza G, Hohlfelder B, Jaff MR, et al. A Prospective, Single-Arm, Multicenter that is Villalta and VCSS, improves heparin plus EKOS™ versus study2 in 150 patients (31 massive measured RV/LV diameter ratio Trial of Ultrasound-Facilitated, quality of life, and these benefits heparin alone at 90 days,” noted PE, 119 sub-massive) showed over 48 hours, a 30% decrease Catheter-Directed, Low-Dose have persisted for 365 days so far,” Professor Stortecky. “There was the RV/LV ratio was significantly in pulmonary arterial systolic Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The said Dr Dumantepe. “It’s time to a small and statistically non- decreased over 48 hours, as well pressure by procedure end and SEATTLE II Study. JACC Cardiovascular 16 stop saying nothing can be done.” significant increase in minor as the mean pulmonary artery a 30% decrease in pulmonary Interventions. 2015;8(10):1382–1392.
‘Incredible efficacy’ of DES treatment in long BTK lesions D uring an update occlusions that are difficult to One of these is a self-expanding on clinical trials treat with balloon angioplasty.1 polymer-based drug-eluting and new data in “For those patients who are paclitaxel stent – [studied in] peripheral vascular failing balloon angioplasty, the Saval trial4. Another is on disease, including we have yet to realise the the MicroStent [Micro Medical femoral, below-the-knee (BTK) ideal technology to overcome Solutions, USA] which is a bare and critical limb ischaemia (CLI), these limitations,” Dr metal, interwoven stent for the Robert Lookstein (Icahn School Lookstein commented. BTK circulation. Both of these of Medicine at Mount Sinai, New Exploring BTK treatment trials are currently enrolling and York City, USA) presented 10-year options to date, he further the preliminary results are not yet findings of the LONG DES-BTK explained that investigations publicly available5.” study of the use of drug-eluting of drug-coated balloons (DCB) In the meantime, the body of stents (DES) in the treatment of have so far been unsuccessful data on the use of short coronary BTK disease. in improving upon outcomes of balloon-expandable stents for The study seeks to expand balloon angioplasty. “We have two the treatment of infrapopliteal on the existing datasets of DES, negative prospective randomised disease has grown. These have as part of continuing efforts to trials and a third trial where we been summarised in a systematic determine when and in whom this don’t have 12-month follow review and meta-analysis by technology is best suited. up yet.” Varcoe et al. (2019), which “We hope that this LONG-DES The first of these two included data pertaining to seven dataset will inform practitioners prospective randomised trials, randomised controlled trials with that even in lesions where IN.PACT DEEP, included 358 mid-term (12-month) follow-up, you require three overlapping CLI patients randomised to with the conclusion that DES coronary stents, results are safe receive IN.PACT Amphirion significantly improved rates of and effective in achieving limb DCB (Medtronic, Ireland) or primary patency, freedom from salvage with very, very low rates plain balloon angioplasty. reintervention, and freedom from of reintervention,” Dr Lookstein No statistically significant major amputation compared to told the LINC Review ahead of differences were detected in control therapy (plain balloon the session. the primary efficacy outcomes “The only implants to date that have angioplasty, BMS, or DCB). In infrapopliteal disease, the use of balloon angioplasty with of clinically-driven target lesion revascularisation and late lumen demonstrated efficacy have been balloon- The investigators also found that stents coated in sirolimus bail-out bare metal stenting loss at one year.2 expandable coronary DES.” analogues were more effective (BMS) in cases of residual stenosis The second prospective than paclitaxel.1 or flow-limiting dissection is randomised trial of BTK DCB was Robert Lookstein These randomised trials associated with poor long- BIOLUX P-II, which included 72 included relatively short lesions term patency and the need for patients randomised to receive with mean lesion lengths ranging reintervention. Patients with BTK either the Passeo-18 Lux DCB balloon. Major amputations were to date that have demonstrated from 15.9 mm to 34 mm.1 The disease frequently have comorbid (Biotronik, Germany) or plain also similar at 12 months.3 efficacy have been balloon- only included trial with lesions diabetes, renal insufficiency, and balloon. Here, the primary As such, he continued, expandable coronary DES,” over 100 mm – the IDEAS trial6, have a history of tobacco smoking endpoint of six-month patency numerous investigators globally he said. which randomised a real-world – all of which are associated loss was not significantly inferior have looked to scaffolds as a “There are ongoing studies patient cohort with long BTK 18 with long, calcified stenoses and in the DCB group relative to plain viable solution. “The only implants evaluating novel technologies. lesions to DCB or coronary
DES – had multiple issues, as Dr use of stent implantation. Lookstein described: “There were “For the past 10 years, we have multiple DES allowed in the study. been using a single coronary The only published data that has DES platform for infrapopliteal ever been presented publicly lesions below the knee: the was of the six-month follow up. Xience everolimus-eluting stent Lastly, DES was compared to an [Abbott Vascular, USA]. We arm of heterogeneous DCB. So have placed stents in the BTK it was much more of a real world circulation for patients with CLI registry dataset of all-comers, in over 375 individuals now, and randomising two different we have been following all of our technologies for long lesions.” patients with a routine clinical and imaging protocol.” “We have placed A key aim of the LONG DES- BTK study at Mount Sinai was to stents in the BTK ascertain how safety and efficacy outcomes related to the number circulation for of stents implanted in a single patients with case. Like most coronary stents being applied in the peripheries, CLI in over 375 the Xience stent has a maximum individuals now.” length of 38 mm, and as such even a relatively short lesion of 45 mm would require the Robert Lookstein implantation of two overlapping subset of long infrapopliteal stents. In the cohort of 75 patients lesions that have failed balloon References Passeo-18 PTA balloon catheter in subjects requiring revascularization of in LONG DES-BTK, lesion lengths angioplasty, amputation-free 1. Varcoe RL, Paravastu SC, Thomas infrapopliteal arteries) JACC Cardiovasc No DCB or DES are currently ranged from around 50 mm to survival for the entire cohort SD, et al. The use of drug-eluting Interv. 2015;8:1614–22. stents in infrapopliteal arteries: an approved for the BTK circulation 150 mm, requiring the tandem (including Rutherford 4, 5 and 4. The DES BTK Vascular Stent System updated systematic review and vs PTA in Subjects With Critical Limb in the US, Dr Lookstein noted. implantation of two to four stents. 6) was 73% at one year. When meta-analysis of randomized trials. Int Ischemia (SAVAL). ClinicalTrials.gov. Turning to his own centre’s “These were all patients that you look at the cohort broken Angiol. 2019;38(2):121–35. https://clinicaltrials.gov/ct2/show/ 2. Zeller T, Baumgartner I, Scheinert D, et approach, he explained: “Our were treated with this technology down by Rutherford category, al; IN. PACT DEEP Trial Investigators. NCT03551496 (accessed Jan 2020). for the Rutherford 4 and 5 5. A Clinical Evaluation of the MicroSTent® clinical protocol at Mount Sinai not as a primary therapy, but after Drug-eluting balloon versus standard PeripherAl Vascular SteNt in Subjects is to cross infrapopliteal lesions, bail-out following suboptimal patients, amputation-free survival balloon angioplasty for infrapopliteal arterial revascularization in critical limb With Arterial Disease Below the perform prolonged long balloon angioplasty. So the patient had at one year was over 90%, and ischemia: 12-month results from the Knee (STAND). ClinicalTrials.gov. angioplasty, and then perform a to undergo revascularisation, for the Rutherford 6 patients IN.PACT DEEP randomized trial. J Am https://clinicaltrials.gov/ct2/show/ Coll Cardiol. 2014;64:1568–76. NCT03477604 (accessed Jan 2020). subsequent repeat angiographic fail balloon angioplasty (defined this fell down to almost 50%. 3. Zeller T, Beschorner U, Pilger E, et 6. Siablis D, Kitrou PM, Spiliopoulos S, et al. assessment of the lesion that was as either significant elastic So we are seeing significant al. Paclitaxel-Coated Balloon in Paclitaxel-coated balloon angioplasty treated. Unfortunately, we find recoil with a > 50% residual benefit for amputation-free Infrapopliteal Arteries: 12-Month Results versus drug-eluting stenting for the From the BIOLUX P-II Randomized treatment of infrapopliteal long- that in [up to] 30% of cases, there luminal narrowing, or a flow- survival favouring the use of this Trial (BIOTRONIK’S-First in Man study segment arterial occlusive disease: the is significant elastic recoil or flow- limiting dissection). technology in Rutherford 4 and of the Passeo-18 LUX drug releasing IDEAS randomized controlled trial. JACC limiting dissection requiring the “In this very challenging 5 patients.” PTA Balloon Catheter vs. the uncoated Cardiovasc Interv 2014;7:1048–56. 19
Treating traumatic aortic injuries C hallenges and solutions in the endovascular management of traumatic aortic injuries were laid bare by Sanjeev Kumar, an interventional radiologist within the department of cardiovascular radiology and endovascular interventions at the All India Institute of Medical Sciences (AIIMS), New Delhi, India. Dr Kumar started by highlighting the high rates of mortality for patients with traumatic aortic injuries: “Seventy percent of them die on the spot, and of those patients who reach a trauma centre, 50% will die within 24 hours – before they are treated,” he said. “Hence time is crucial when you are talking about traumatic aortic injuries in this group of patients.” Dr Kumar stressed that the treatment paradigm for traumatic aortic injuries has changed drastically over the last two decades. Endovascular haemodynamically unstable. “Since patients are young with a “Since time is successful outcome,” he added. With polytrauma patients there exposure, he said. Elaborating on each challenge repair has largely replaced open repair, for example, resulting in a small radius of the curvature of life, optimising is also a risk of intra-procedural in turn, Dr Kumar started major reduction in mortality and the aortic arch, conformity of the haemorrhage, requiring by looking at the effect of procedure-related paraplegia, device to the arches is an issue,” the timing for optimum anticoagulation. hypovolaemia on device sizing. yet conversely it is associated he explained. a repair is very In addition, remodelling and “As we know, hypovolaemia with increases in early graft- Tears are usually located in ageing of the aorta occurs with decreases aortic diameter,” he related complications. the vicinity of the isthmus, noted important for time. “And since they are young said. “It’s been studied in unstable Such rises are indicative of Dr Kumar, thus the coverage a successful patients, the natural history of patients with a mean arterial the many challenges in carrying of the subclavian artery (SCA) this ageing is not widely studied,” pressure (MAP) of 75 mmHg and out endovascular repair, said Dr in emergency situations poses outcome.” added Dr Kumar. Similarly, a heart rate of more than 130 Kumar. The sizing of the grafting a great problem. “Since time is optimal follow-up for such beats per minute.” The aortic presents a particular challenge life, optimising the timing for Sanjeev Kumar patients should be addressed size in such patients has been 20 because many patients are so a repair is very important for a to limit the cumulative radiation underestimated by as much as
13%, he underlined, therefore when you are treating aortic there may be a mismatch trauma patient, device selection between the aortic diameter becomes very important,” and the endograft which could he explained. theoretically result in an increased Dr Kumar went on to discuss risk of endoleak or other vessel diameter. “Often at times endograft-related complications. because young patients have “In this group of patients, if they inotropic support, you must are haemodynamically unstable, consider the access vessel in we should do a 10% over-sizing these patients,” he explained. Such over and above the normal over- patients may be on the borderline, sizing,” he explained. said Dr Kumar. “But still you can Most of these trauma patients consider higher thresholds in this are young, too – at least patient because of the young compared to patients typically experiencing aortic aneurysms. “In higher- “They have a smaller radius of aorta curvature compared with grade lesions, aneurysmal patients,” said Dr endovascular Kumar. “And, because of the sharp aortic angulation distal to the left interventions are operative management results in these patients are bleeding from In his concluding remarks, Dr SCA, the conformity of the device to the aortic arch – and hence recommended.” mortality rates as high as 50% in these patients.” everywhere, such as liver trauma.” Indeed, heparinisation with an Kumar said that minimal aortic injury, i.e. patients with grade I and provision of an adequate ceiling – He outlined coverage of anti-clotting time in the range of grade II lesions without external is always a challenge.” Too much Sanjeev Kumar the left SCA. “Because of the 200 is recommended, and routine contour abnormality, should oversizing risks graft corrugations vicinity of the trauma, often in an heparinisation should be provided be managed conservatively. or collapse, he added. and elastic nature of the vessels,” emergency situation will you need at a lower dose than administered “Endovascular repair is still Dr Kumar outlined an he added. to cover this left SCA and you are during elective TEVAR. Spinal considered a procedure of choice older case in which a typical “However, if your access vessel not able to assess the adequacy drainage, on the other hand, is not in suitable morphology patients,” aortic arch injury – an isthmic is inadequate, you can always go of the Circle of Willis or the routinely recommended in such he said. “In higher-grade lesions, pseudoaneurysm – was treated to the iliac, for example, which dominance of the left tibial artery,” patients, noted Dr Kumar. endovascular interventions with a GORE TAG (WL Gore & was done in [one of my] patients he said. Summing up, Dr Kumar said are recommended. Associates, USA) device. The for a successful aortic repair.” “However, if the left SCA is that the long-term natural history “Urgent repair should be follow-up CT showed poor But Dr Kumar’s abiding covered, you should check the is still unknown in such young carried out within 24 hours positioning and nonconformity message is of prompt treatment. dominance of the right vertebral patients. “There are certain or at least before the hospital of the device. This led to graft “Urgent repair within 24 hours is artery and Circle of Willis and, morphological changes of the discharge. This is the ideal time for collapse that was ultimately recommended in the guidelines if the anatomy is unfavourable, aorta which take place over time,” the treatment,” he said. “We still treated by a proximal overlapping if there are no other serious surgical revascularisation should he said. “And also, the follow- need to devise the optimal follow- stent graft (Valiant, Medronic, concomitant injuries,” he said. be considered in this patient,” up strategy and the cumulation up and understand the natural Ireland). “Nowadays we have a “But at least the patients should he said. of radiation exposure is a key history of these patients, and see lot of devices on our shelf which be repaired before hospital Heparinisation is a major component in managing this how they progress over a period improve conformability, hence discharge because non- challenge, he went on: “You know patient with endovascular repair.” of time.” 21
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