Revie w - Leipzig Interventional Course

Page created by Timothy Hunt
 
CONTINUE READING
Revie w - Leipzig Interventional Course
over run

         caption

Rev iew
  2020             Continued on page 1
Revie w - Leipzig Interventional Course
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.
Revie w - Leipzig Interventional Course
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
Revie w - Leipzig Interventional Course
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
Revie w - Leipzig Interventional Course
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
Revie w - Leipzig Interventional Course
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
Revie w - Leipzig Interventional Course
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
Revie w - Leipzig Interventional Course
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.
Revie w - Leipzig Interventional Course
Revie w - Leipzig Interventional Course
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
You can also read