HYBRID REVASCULARIZATION OF EXTENDED ILIO-FEMORAL ... · HYBRID REVASCULARIZATION OF EXTENDED ILIO-FEMORAL OCCLUSION FOLLOWING UNSUCCESSFULL ENDOVASCULAR TREATMENT • 52 years •

Ilaria Ficarelli

Service of Vascular Surgery “Antonio Cardarelli” Hospital - Naples (Italy)

HYBRID REVASCULARIZATION OF EXTENDED ILIO-FEMORAL OCCLUSION FOLLOWING

UNSUCCESSFULL ENDOVASCULAR TREATMENT

•  52 years •  Smoker •  Arterial hypertension

S. R.

•  Diabetes mellitus yes •  Coronary artery disease no •  Chronic hearth failure no •  Cerebral ischemia no •  Chronic renal failure no

Lee Index

July 2010

October 2010

2. SFA stenting (Protegè 6x200 e 7x80 mm)

1. Unsuccessfull left SFA recanalization

LONG SUPERFICIAL FEMORAL ARTERY OCCLUSION

Intermittent claudication left leg

Rutheford class 3

Claudication intermittens June 2011

Left iliac artery bifurcation stenting (Protege 8X60 mm)

•  Rest pain •  Non healing- infected leg ulcer

Vascular Surgery A.O.R.N. Cardarelli

October 2011

THERAPEUTIC STRATEGY

Femoro-femoral by pass

Femoro-popliteal by pass Aorto-ilio-femoral by pass

Hybrid ilio-femoral treatment Hybrid ilio-femoral treatment

Inflow

Evercross 7X40 mm

Left Iliac artery stenting

Protegè 9 X 80 + 9 X 40 mm

Saphenous vein femoro-popliteal by pass BK

Femoro popliteal by pass GSV

FPA Superficial femoral vein

Stent External iliac artery

External iliac artery @ 1 month

GSV

SFV GSV

LONG SUPERFICIAL FEMORAL ARTERY OCCLUSION

Intermittent claudication

What is the role of endovascular procedures ?

Hirsch. Circulation 2006;113:e463-654

Norgren. J Vasc Surg 2007;45:S5-S67

ACC/AHA 2005 Practice Guidelines for the Management ofPatients With Peripheral Arterial Disease (Lower Extremity,

Renal, Mesenteric, and Abdominal Aortic)A Collaborative Report from the American Association for Vascular

Surgery/Society for Vascular Surgery,* Society for Cardiovascular Angiographyand Interventions, Society for Vascular Medicine and Biology, Society of

Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines(Writing Committee to Develop Guidelines for the Management of

Patients With Peripheral Arterial Disease)Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation;National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic

Inter-Society Consensus; and Vascular Disease Foundation

WRITING COMMITTEE MEMBERSAlan T. Hirsch, MD, FACC, FAHA, Chair; Ziv J. Haskal, MD, FAHA, FSIR, Co-Chair;Norman R. Hertzer, MD, FACS, Co-Chair; Curtis W. Bakal, MD, MPH, FAHA, FSIR;

Mark A. Creager, MD, FACC, FAHA; Jonathan L. Halperin, MD, FACC, FAHA†;Loren F. Hiratzka, MD, FACC, FAHA, FACS; William R.C. Murphy, MD, FACC, FACS;

Jeffrey W. Olin, DO, FACC; Jules B. Puschett, MD, FAHA; Kenneth A. Rosenfield, MD, FACC;David Sacks, MD, FACR, FSIR‡; James C. Stanley, MD, FACS§; Lloyd M. Taylor, Jr, MD, FACS§;

Christopher J. White, MD, FACC, FAHA, FESC, FSCAI¶; John White, MD, FACS§;Rodney A. White, MD, FACS§

TASK FORCE MEMBERSElliott M. Antman, MD, FACC, FAHA, Chair; Sidney C. Smith, Jr, MD, FACC, FAHA, Vice-Chair;

Cynthia D. Adams, MSN, APRN-BC, FAHA; Jeffrey L. Anderson, MD, FACC, FAHA;David P. Faxon, MD, FACC, FAHA**; Valentin Fuster, MD, PhD, FACC, FAHA, FESC**

Raymond J. Gibbons, MD, FACC, FAHA††; Jonathan L. Halperin, MD, FACC, FAHA;Loren F. Hiratzka, MD, FACC, FAHA, ACS**; Sharon A. Hunt, MD, FACC, FAHA;

Alice K. Jacobs, MD, FACC, FAHA; Rick Nishimura, MD, FACC, FAHA;Joseph P. Ornato, MD, FACC, FAHA; Richard L. Page, MD, FACC, FAHA;

Barbara Riegel, DNSc, RN, FAHA

TABLE OF CONTENTS1. INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e465

1.1. Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e4651.2. Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e4661.3. Vascular History and Physical Examination. . . e470

2. LOWER EXTREMITY PAD. . . . . . . . . . . . . . . . . . . . . . e4712.1. Epidemiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e471

2.1.1. Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . e4712.1.2. Prevalence . . . . . . . . . . . . . . . . . . . . . . . . . . . . e472

2.2. Prognosis and Natural History . . . . . . . . . . . . . . . e4752.2.1. Coprevalence of Coronary Artery Disease

and Carotid Disease . . . . . . . . . . . . . . . . . . . e4752.2.2. Risk of Cardiovascular Events . . . . . . . . . e4762.2.3. Prognosis of the Limb. . . . . . . . . . . . . . . . . e476

2.3. Other Causes of Lower Extremity PAD . . . . . . e4762.4. Clinical Presentation . . . . . . . . . . . . . . . . . . . . . . . . . e477

2.4.1. Asymptomatic . . . . . . . . . . . . . . . . . . . . . . . . . e4772.4.2. Claudication . . . . . . . . . . . . . . . . . . . . . . . . . . e4802.4.3. Critical Limb Ischemia . . . . . . . . . . . . . . . . e483

2.4.4. Acute Limb Ischemia . . . . . . . . . . . . . . . . . e4872.4.5. Prior Limb Arterial Revascularization. . e489

2.5. Diagnostic Methods . . . . . . . . . . . . . . . . . . . . . . . . . e4902.5.1. Ankle- and Toe-Brachial Indices,

Segmental Pressure Examination. . . . . . . e4912.5.2. Pulse Volume Recording . . . . . . . . . . . . . . e4972.5.3. Continuous-Wave Doppler Ultrasound . . . e4982.5.4. Treadmill Exercise Testing With and

Without ABI Assessments and 6-MinuteWalk Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . e498

2.5.5. Duplex Ultrasound . . . . . . . . . . . . . . . . . . . . e5002.5.6. Computed Tomographic Angiography. . e5012.5.7. Magnetic Resonance Angiography . . . . . e5022.5.8. Contrast Angiography . . . . . . . . . . . . . . . . . e503

2.6. Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e5052.6.1. Cardiovascular Risk Reduction . . . . . . . . e505

2.6.1.1. Lipid-Lowering Drugs . . . . . . . . e5052.6.1.2. Antihypertensive Drugs . . . . . . . e5062.6.1.3. Diabetes Therapies. . . . . . . . . . . . e506

e463

ACC/AHA Practice Guidelines

at GOOD SAMARITAN HOSP on February 15, 2013http://circ.ahajournals.org/Downloaded from

Inter-Society Consensus for the Management ofPeripheral Arterial Disease (TASC II)L. Norgren,a W.R. Hiatt,b J.A. Dormandy, M.R. Nehler, K.A. Harris, and F.G.R. Fowkes on behalf ofthe TASC II Working Group, Örebro, Sweden and Denver, Colorado

INTRODUCTION

The Trans-Atlantic Inter-Society Consensus Docu-ment on Management of Peripheral Arterial Disease(TASC) was published in January 20001-3 as a result ofcooperation between fourteen medical and surgical vas-cular, cardiovascular, vascular radiology and cardiologysocieties in Europe and North America. This compre-hensive document had a major impact on vascular careamongst specialists. In subsequent years, the field hasprogressed with the publication of the CoCaLis docu-ment4 and the American College of Cardiology/Ameri-can Heart Association Guidelines for the Management ofPeripheral Arterial Disease.5 Aiming to continue to reacha readership of vascular specialists, but also physicians inprimary health care who see patients with peripheralarterial disease (PAD), another consensus process wasinitiated during 2004. This new consensus document hasbeen developed with a broader international representa-tion, including Europe, North America, Asia, Africa andAustralia, and with a much larger distribution and dis-semination of the information. The goals of this newconsensus are to provide an abbreviated document(compared with the publication in 2000), to focus onkey aspects of diagnosis and management, and to updatethe information based on new publications and thenewer guidelines, but not to add an extensive list ofreferences. Unreferenced statements are, therefore, to befound, provided they are recognized as common practiceby the authors, with existing evidence. The recommen-dations are graded according to levels of evidence. Itshould also be emphasized that good practice is based ona combination of the scientific evidence described below,patients’ preferences, and local availability of facilitiesand trained professionals. Good practice also includesappropriate specialist referral.

Process

Representatives of sixteen societies from Europe,North America, Australia, South Africa and Japan wereelected from their respective society and were calledtogether in 2004 to form the new Working Group.Specialists in health economics, health outcomes andevidence-based medicine were also included to elaborateon the text for the following sections: history, epidemi-ology and risk factors; management of risk factors; inter-mittent claudication; critical limb ischemia; acute limbischemia; and technologies (intervention/revasculariza-tion and imaging).

The Working Group reviewed the literature and,after extensive correspondence and meetings, proposed aseries of draft documents with clear recommendationsfor the diagnosis and treatment of PAD. Each participat-ing society reviewed and commented on these draftconsensus documents. The liaison member from eachsociety then took these views back to the WorkingGroup, where all of the amendments, additions andalterations suggested by each participating society werediscussed, and the final Consensus Document was agreedupon.

The participating societies were then again invited toreview the final document and endorse it if they agreedwith its contents. If an individual participating societydid not accept any specific recommendation, this isclearly indicated in the final document. Therefore, ex-cept where such specific exclusions are indicated, thisConsensus Document represents the views of all of theparticipating societies.

Compared with the original TASC, more emphasishas been put on diabetes and PAD. The text is presentedin such a way that vascular specialists will still find most ofthe information they require, while general practitionersand primary health physicians will easily find guidancefor diagnosis and diagnostic procedures, referral of pa-tients and expected outcome of various treatment op-tions.

Grading of recommendations

Recommendations and selected statements are ratedaccording to guidance issued by the former US Agency forHealth Care Policy and Research,6 now renamed theAgency for Healthcare Research and Quality:

From the Department of Surgery, University Hospital,a and University ofColorado School of Medicine and Colorado Prevention Center.b

Correspondence: L. Norgren, Department of Surgery, University Hospital,Örebro, Sweden (e-mail: [email protected]) and W.R. Hiatt, Uni-versity of Colorado School of Medicine, Denver, CO (e-mail:[email protected]).

0741-5214/$32.00Copyright © 2007 by The Society for Vascular Surgery.doi:10.1016/j.jvs.2006.12.037

S5A

Lower limb peripheralarterial disease: diagnosis andmanagement

Issued: August 2012

NICE clinical guideline 147guidance.nice.org.uk/cg147

NHS Evidence has accredited the process used by the Centre for Clinical Practice at NICE toproduce guidelines. Accreditation is valid for 5 years from September 2009 and applies to guidelinesproduced since April 2007 using the processes described in NICE's 'The guidelines manual' (2007,updated 2009). More information on accreditation can be viewed at www.evidence.nhs.uk

© NICE 2012


Issued: August 2012



© NICE 2012


Issued: August 2012



© NICE 2012


Issued: August 2012



© NICE 2012

ESC GUIDELINES

ESC Guidelines on the diagnosis and treatment ofperipheral artery diseasesDocument covering atherosclerotic disease of extracranial carotidand vertebral, mesenteric, renal, upper and lower extremity arteries

The Task Force on the Diagnosis and Treatment of PeripheralArtery Diseases of the European Society of Cardiology (ESC)

Endorsed by: the European Stroke Organisation (ESO)

Authors/Task Force Members: Michal Tendera (Chairperson)* (Poland),Victor Aboyans (Co-Chairperson)* (France), Marie-Louise Bartelink (TheNetherlands), Iris Baumgartner (Switzerland), Denis Clement (Belgium),Jean-Philippe Collet (France), Alberto Cremonesi (Italy), Marco De Carlo (Italy),Raimund Erbel (Germany), F. Gerry R. Fowkes (UK), Magda Heras (Spain),Serge Kownator (France), Erich Minar (Austria), Jan Ostergren (Sweden),Don Poldermans (The Netherlands), Vincent Riambau (Spain), Marco Roffi(Switzerland), Joachim Rother† (Germany), Horst Sievert (Germany),Marc van Sambeek (The Netherlands), Thomas Zeller (Germany).ESC Committee for Practice Guidelines (CPG): Jeroen Bax (CPG Chairperson) (The Netherlands),AngeloAuricchio (Switzerland), HelmutBaumgartner (Germany), ClaudioCeconi (Italy), VeronicaDean (France),Christi Deaton (UK), Robert Fagard (Belgium), Christian Funck-Brentano (France), David Hasdai (Israel),Arno Hoes (The Netherlands), Juhani Knuuti (Finland), Philippe Kolh (Belgium), Theresa McDonagh (UK),Cyril Moulin (France), Don Poldermans (The Netherlands), Bogdan Popescu (Romania), Zeljko Reiner (Croatia),Udo Sechtem (Germany), Per Anton Sirnes (Norway), Adam Torbicki (Poland), Alec Vahanian (France),StephanWindecker (Switzerland).

† Representing the European Stroke Organisation (ESO).

* Corresponding authors. Michal Tendera, 3rd Division of Cardiology, Medical University of Silesia, Ziolowa 47, 40-635 Katowice, Poland. Tel: +48 32 252 3930, Fax: +48 32 2523930, Email: [email protected]. Victor Aboyans, Department of Cardiology, Dupuytren University Hospital, 2 Martin Luther King ave., Limoges 87042, France. Tel: +33 555056 310, Fax: +33 555 056 384, Email: [email protected].

ESC entities having participated in the development of this document:Associations: European Association for Cardiovascular Prevention and Rehabilitation (EACPR), European Association of Percutaneous Cardiovascular Interventions (EAPCI),Heart Failure Association (HFA).Working Groups: Atherosclerosis and Vascular Biology, Thrombosis, Hypertension and the Heart, Peripheral Circulation, Cardiovascular Pharmacology and Drug Therapy,Acute Cardiac Care, Cardiovascular Surgery.Councils: Cardiology Practice, Cardiovascular Imaging, Cardiovascular Nursing and Allied Professions, Cardiovascular Primary Care.The content of these European Society of Cardiology (ESC) Guidelines has been published for personal and educational use only. No commercial use is authorized. No part of theESC Guidelines may be translated or reproduced in any form without written permission from the ESC. Permission can be obtained upon submission of a written request to OxfordUniversity Press, the publisher of the European Heart Journal and the party authorized to handle such permissions on behalf of the ESC.Disclaimer. The ESC Guidelines represent the views of the ESC and were arrived at after careful consideration of the available evidence at the time they were written. Healthprofessionals are encouraged to take them fully into account when exercising their clinical judgement. The guidelines do not, however, override the individual responsibility of healthprofessionals to make appropriate decisions in the circumstances of the individual patients, in consultation with that patient, and, where appropriate and necessary the patient’sguardian or carer. It is also the health professional’s responsibility to verify the rules and regulations applicable to drugs and devices at the time of prescription.

& The European Society of Cardiology 2011. All rights reserved. For permissions please email: [email protected]

European Heart Journal (2011) 32, 2851–2906doi:10.1093/eurheartj/ehr211

by guest on June 29, 2013http://eurheartj.oxfordjournals.org/

Dow

nloaded from

Tendera. European Heart Journal 2011;32:2851-2906

INTERMITTENT CLAUDICATION Current Treatment

Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: Management of asymptomatic disease and claudication Conte, JVS 2015;61:2S-41S


Conservative treatment

•  Cardiovascular risk reduction •  Exercise therapy •  Pharmacotherapy


Conservative treatment

Lower limb revascularization

Failure

Endovascular Surgical

Poppelwell. Eur J Vasc Endovasc Surg 2014; 48(6): 608-610

EDITORIAL

Why Do Health Systems Not Fund Supervised Exercise Programmes forIntermittent Claudication?

In August 2012 the UK National Institute for Heath andCare Excellence (NICE) published Clinical Guideline (CG)147 on Peripheral Arterial Disease (PAD).1 The recom-mendations within CG 147 were based on a comprehen-sive analysis of the available evidence by a multi-disciplinary team of experts from vascular surgery, inter-ventional radiology, vascular nursing, podiatry, primarycare, and other stake-holder groups.2 The process wassupported by NICE-appointed experts in systematic re-views and statistical/health economic analyses who wereworking according to well-defined NICE policies and pro-cedures.3 CG 147 was supported by the publication ofNICE Pathways (Fig. 1) and Quality Standards to assistprimary/secondary clinicians and healthcare purchasers(termed commissioners in the UK) to facilitate the imple-mentation of the recommendations across the UK NationalHealth Service (NHS).4,5

Regarding the management of intermittent claudica-tion (IC), the commonest clinical manifestation of PAD,NICE CG 147 made strong recommendations regardingthe primacy of a supervised exercise programme in thetreatment hierarchy (Table 1), while QS 52 recommendsthat “people with intermittent claudication are offered asupervised exercise programme (SEP)”.5 NICE is apowerful body within the UK, whose work drives and isdriven by national health planning and policy at thehighest level; for example, the National CardiovascularOutcomes Strategy and the NHS Outcomes Framework2013e2014.6,7

Why then has all this work not (as yet) led to a majorchange in the management of IC across the UK, that is awayfrom early endovascular or surgical revascularisation andtowards best medical treatment (BMT) and SEP, withintervention being reserved for a relatively small group ofpatients who fail to improve or progress despite theseevidence-based non-interventional measures? Why is it thatNHS (as opposed to research) funded SEPs are still absentfrom most UK hospitals (NHS Trusts), while at the same timeNHS Commissioners appear to be placing no limits on thenumber of interventions performed for IC? Although this isa complex issue, the reasons seem to fall into three maincategories.

HEALTHCARE PURCHASERS (COMMISSIONERS) DON’T LIKESEP

NICE recognises that further research is needed to explore theeffects of SEP on quality of life (QoL) and walking behaviour.The CG 147 research question 4.2 reads “What is the clinicaland cost effectiveness of supervised exercise programmescompared with unsupervised exercise for treating peoplewith intermittent claudication, taking into account the effectson long-term outcomes and continuing levels of exercise?”.Although a recent Cochrane review showed statistically sig-nificant improvements in maximal treadmill walking distancewith SEP (as compared with unsupervised programmes), noimprovement in QoL was observed.8 Another small study hasshown improvement in QoL when SEP was combined withpercutaneous angioplasty.9

So, doubts about the benefits of SEP over unsupervisedexercise, as well as uncertainty regarding the optimum formof SEP, may well be inhibiting NHS Commissioners frominvesting in non-interventional treatments for IC.

Other concerns may include: (i) most randomised trialsare small and often under-powered, at least when it comesto sub-group analyses. This has led to calls for more“rigorous and fully powered trials” in exercise therapies.10

(ii) SEP has not been standardised (either in nature orduration), thereby making comparisons difficult.11,12 Arecent review article has also highlighted the variability indelivery observed in many randomised trials.13 (iii) A varietyof different outcomes measures have been used (treadmill,various walking tests, patient reported outcomes measuresbased on QoL, health economic metrics such as cost perQALY) and these have resulted in different conclusions be-ing drawn.14e18 (iv) Will the patients turn up and continueto do so? The potential loss of clinical and cost-effectivenessassociated with non-attendance is unpopular with pur-chasers. (v) What happens when the patients stop exer-cising (under supervision)? Are the observed improvementsmaintained or will the patients quickly revert to baselinelevels of activity?19,20 Only limited evidence is availableattesting to the long-term benefits of SEP.21 (vi) How manypatients are actually suitable for SEP? Many PAD patientshave other comorbidities such as chronic obstructive air-ways disease and coronary disease that may make themunsuitable and may increase the risks.22

PATIENTS DON’T LIKE SEP

It could also be reasonably argued that the lifestyle choices,behaviours, and personality traits that lead people to

1078-5884/$ e see front matter ! 2014 European Society for VascularSurgery. Published by Elsevier Ltd. All rights reserved.http://dx.doi.org/10.1016/j.ejvs.2014.07.008

Please cite this article in press as: Popplewell MA, Bradbury AW, Why Do Health Systems Not Fund Supervised Exercise Programmes for IntermittentClaudication?, Funding Supervised Exercise Programmes for Intermittent Claudication (2014), http://dx.doi.org/10.1016/j.ejvs.2014.07.008

Eur J Vasc Endovasc Surg (2014) -, 1e3

Supervised Exercise Programmes (SEP) are underused

EDITORIAL















EDITORIAL















“Patients don’t like SEP”

•  They may not be compliant to SEP •  They are just looking for a “quick fix” •  They prefer a one-day angioplasty to weeks of SEP

“Clinicians don’t like SEP”

•  We like to exercise the skills we have acquired •  We like to improve our reputation (& income) •  We cannot escape the influence of the industry

Poppelwell. Eur J Vasc Endovasc Surg 2014; 48(6): 608-610

ACC/AHA 2005 Practice Guidelines for the Management ofPatients With Peripheral Arterial Disease (Lower Extremity,

Renal, Mesenteric, and Abdominal Aortic)A Collaborative Report from the American Association for Vascular

Surgery/Society for Vascular Surgery,* Society for Cardiovascular Angiographyand Interventions, Society for Vascular Medicine and Biology, Society of

Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines(Writing Committee to Develop Guidelines for the Management of

Patients With Peripheral Arterial Disease)Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation;National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic

Inter-Society Consensus; and Vascular Disease Foundation

WRITING COMMITTEE MEMBERSAlan T. Hirsch, MD, FACC, FAHA, Chair; Ziv J. Haskal, MD, FAHA, FSIR, Co-Chair;Norman R. Hertzer, MD, FACS, Co-Chair; Curtis W. Bakal, MD, MPH, FAHA, FSIR;

Mark A. Creager, MD, FACC, FAHA; Jonathan L. Halperin, MD, FACC, FAHA†;Loren F. Hiratzka, MD, FACC, FAHA, FACS; William R.C. Murphy, MD, FACC, FACS;

Jeffrey W. Olin, DO, FACC; Jules B. Puschett, MD, FAHA; Kenneth A. Rosenfield, MD, FACC;David Sacks, MD, FACR, FSIR‡; James C. Stanley, MD, FACS§; Lloyd M. Taylor, Jr, MD, FACS§;

Christopher J. White, MD, FACC, FAHA, FESC, FSCAI¶; John White, MD, FACS§;Rodney A. White, MD, FACS§

TASK FORCE MEMBERSElliott M. Antman, MD, FACC, FAHA, Chair; Sidney C. Smith, Jr, MD, FACC, FAHA, Vice-Chair;

Cynthia D. Adams, MSN, APRN-BC, FAHA; Jeffrey L. Anderson, MD, FACC, FAHA;David P. Faxon, MD, FACC, FAHA**; Valentin Fuster, MD, PhD, FACC, FAHA, FESC**

Raymond J. Gibbons, MD, FACC, FAHA††; Jonathan L. Halperin, MD, FACC, FAHA;Loren F. Hiratzka, MD, FACC, FAHA, ACS**; Sharon A. Hunt, MD, FACC, FAHA;

Alice K. Jacobs, MD, FACC, FAHA; Rick Nishimura, MD, FACC, FAHA;Joseph P. Ornato, MD, FACC, FAHA; Richard L. Page, MD, FACC, FAHA;

Barbara Riegel, DNSc, RN, FAHA

TABLE OF CONTENTS1. INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e465

1.1. Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e4651.2. Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e4661.3. Vascular History and Physical Examination. . . e470

2. LOWER EXTREMITY PAD. . . . . . . . . . . . . . . . . . . . . . e4712.1. Epidemiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e471

2.1.1. Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . e4712.1.2. Prevalence . . . . . . . . . . . . . . . . . . . . . . . . . . . . e472

2.2. Prognosis and Natural History . . . . . . . . . . . . . . . e4752.2.1. Coprevalence of Coronary Artery Disease

and Carotid Disease . . . . . . . . . . . . . . . . . . . e4752.2.2. Risk of Cardiovascular Events . . . . . . . . . e4762.2.3. Prognosis of the Limb. . . . . . . . . . . . . . . . . e476

2.3. Other Causes of Lower Extremity PAD . . . . . . e4762.4. Clinical Presentation . . . . . . . . . . . . . . . . . . . . . . . . . e477

2.4.1. Asymptomatic . . . . . . . . . . . . . . . . . . . . . . . . . e4772.4.2. Claudication . . . . . . . . . . . . . . . . . . . . . . . . . . e4802.4.3. Critical Limb Ischemia . . . . . . . . . . . . . . . . e483

2.4.4. Acute Limb Ischemia . . . . . . . . . . . . . . . . . e4872.4.5. Prior Limb Arterial Revascularization. . e489

2.5. Diagnostic Methods . . . . . . . . . . . . . . . . . . . . . . . . . e4902.5.1. Ankle- and Toe-Brachial Indices,

Segmental Pressure Examination. . . . . . . e4912.5.2. Pulse Volume Recording . . . . . . . . . . . . . . e4972.5.3. Continuous-Wave Doppler Ultrasound . . . e4982.5.4. Treadmill Exercise Testing With and

Without ABI Assessments and 6-MinuteWalk Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . e498

2.5.5. Duplex Ultrasound . . . . . . . . . . . . . . . . . . . . e5002.5.6. Computed Tomographic Angiography. . e5012.5.7. Magnetic Resonance Angiography . . . . . e5022.5.8. Contrast Angiography . . . . . . . . . . . . . . . . . e503

2.6. Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e5052.6.1. Cardiovascular Risk Reduction . . . . . . . . e505

2.6.1.1. Lipid-Lowering Drugs . . . . . . . . e5052.6.1.2. Antihypertensive Drugs . . . . . . . e5062.6.1.3. Diabetes Therapies. . . . . . . . . . . . e506

e463

ACC/AHA Practice Guidelines


Hirsch et al. 2005ACC/AHA Practice Guidelines

ACC - www.acc.orgAHA - www.americanheart.org

Patients who present with symptoms of claudication before50 years of age may have a more virulent form of athero-sclerosis and have a poorer response to vascular surgicalinterventions, frequently requiring graft revisions or replace-ments (481). Olsen and associates noted a high mortality ratesecondary to cardiovascular events, a high amputation rate,and an increasing disability rate in patients less than 40 yearsof age who required surgical intervention for claudication(482). In a study comparing the outcome of patients requir-ing aortobifemoral bypass for PAD who were less than 50years of age with those who were older, Reed and colleaguesnoted poorer results in the younger patients (481). Youngerpatients had lower patency rates and required more subse-quent surgical intervention than did older patients. Green andcollaborators noted in a multi-institutional, prospective, ran-domized trial of prosthetic femoral-popliteal bypass graftingthat patients younger than 65 years of age had a higher inci-dence of graft occlusion (483). Therefore, despite the pres-ence of significant claudication symptoms in an age groupthat is often more physically active and employed, surgeryfor these younger patients should be avoided if possible.

2.6.2.5.2. PREOPERATIVE EVALUATION.

RECOMMENDATION

Class IA preoperative cardiovascular risk evaluation shouldbe undertaken in those patients with lower extremityPAD in whom a major vascular surgical interventionis planned. (Level of Evidence: B)

Lower extremity PAD is associated with the presence ofcoronary artery disease and marks high short- and long-termcoronary ischemic risk, and therefore, a preoperative cardio-vascular risk evaluation should be undertaken. The specifictesting strategy that might be used for a specific patient isbeyond the scope of this guideline. Perioperative ischemicrisk is increased for all lower extremity vascular surgicalprocedures (inclusive of aortic, femoral, and infrapoplitealsegments). This risk is further increased in those patientswith an established history of ischemic heart disease, currentangina, or an abnormal electrocardiogram and may be chal-lenging to assess in those individuals in whom a sedentarylifestyle limits assessment of functional capacity. The preop-erative cardiovascular risk evaluation is summarized in moredetail in the “ACC/AHA Guideline Update for PerioperativeCardiovascular Evaluation for Noncardiac Surgery” (484).

2.6.2.5.3. CORRELATION OF SYMPTOMS AND LESIONS.

Surgical intervention must be directed at the lesionscausative of the patient’s symptoms to relieve claudication.The patient’s symptoms and vascular studies must beanatomically consistent. Symptoms associated with lowerextremity PAD are usually manifested in the muscle groupsdistal to the site of a hemodynamically significant stenosis orocclusion.

2.6.2.5. Surgery for Claudication

2.6.2.5.1. INDICATIONS.

RECOMMENDATIONS

Class ISurgical interventions are indicated for individualswith claudication symptoms who have a significantfunctional disability that is vocational or lifestyle lim-iting, who are unresponsive to exercise or pharma-cotherapy, and who have a reasonable likelihood ofsymptomatic improvement. (Level of Evidence: B)

Class IIbBecause the presence of more aggressive atheroscle-rotic occlusive disease is associated with less durableresults in patients younger than 50 years of age, theeffectiveness of surgical intervention in this popula-tion for intermittent claudication is unclear. (Level ofEvidence: B)

Class IIISurgical intervention is not indicated to prevent pro-gression to limb-threatening ischemia in patients withintermittent claudication. (Level of Evidence: B)

Claudication usually does not progress to limb-threateningischemia, and therefore, there is no automatic mandate toproceed to surgical intervention. Surgery is infrequentlyneeded to treat the individual with claudication and in gener-al should only be considered after atherosclerosis risk factorshave been treated and an appropriate trial of exercise and/orclaudication pharmacotherapy has been utilized. Most majorvascular care centers report the use of surgical intervention inonly 25% of those individuals with claudication who arereferred to vascular surgeons. The indications for surgicaltreatment of lower extremity ischemia are defined by theseverity of leg ischemic symptoms, with limb hemodynamicdata serving primarily to confirm the lower extremity PADand claudication diagnosis. Thus, intermittent claudication isconsidered a relative indication for surgical treatment and isusually reserved for individuals (a) who do not derive ade-quate functional benefit from nonsurgical therapies, (b) whohave limb arterial anatomy that is favorable to obtaining adurable clinical result, and (c) in whom the cardiovascularrisk of surgical revascularization is low. The 2 traditionalfunctional indications for surgical intervention are exerciseimpairment sufficient to threaten the patient’s employmentor to require significant alterations in the patient’s lifestyleafter failure of nonsurgical or endovascular therapy. Becausethe impact of job and lifestyle-threatening alterations is notusually quantitated, the significance of these symptoms as anindication for surgery must be decided on a per case basis bythe patient, primary clinician, and surgeon. Successful lowerextremity arterial surgical revascularization, however, caneffectively reduce or eliminate the symptoms of claudication.

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ACC - www.acc.orgAHA - www.americanheart.org

2.6.2.3. Role of Revascularization for Claudication

Because of the variability of individual limb ischemic symp-toms and variable impact of these symptoms on quality oflife, patients should be selected for revascularization on thebasis of the severity of their symptoms; a significant disabil-ity as assessed by the patient; failure of medical therapies;lack of significant comorbid conditions; vascular anatomysuitable for the planned revascularization; and a favorablerisk/benefit ratio. These recommendations have been sum-marized previously in an international PAD consensus state-ment and are summarized in Table 19 (1). Patients selectedfor possible revascularization may then undergo additionalimaging studies as required, such as duplex ultrasound,MRA or CTA, and/or catheter angiography, to determinewhether their arterial anatomy is suitable for percutaneous orsurgical revascularization.

2.6.2.4. Endovascular Treatment for Claudication

RECOMMENDATIONS

Class I1. Endovascular procedures are indicated for individu-

als with a vocational or lifestyle-limiting disability dueto intermittent claudication when clinical featuressuggest a reasonable likelihood of symptomaticimprovement with endovascular intervention and (a)there has been an inadequate response to exercise orpharmacological therapy and/or (b) there is a veryfavorable risk-benefit ratio (e.g., focal aortoiliacocclusive disease). (Level of Evidence: A)

prospective, randomized, blinded trial has been performed tocorroborate this meta-analysis. These findings suggest thatginkgo biloba may be considered as alternative therapy totreat patients with intermittent claudication; however, theoutcome is likely to be of marginal clinical importance.

Vitamin E is a lipid soluble antioxidant that protectspolyunsaturated fatty acids from oxidation. Vitamin E mayimprove red blood cell deformability and therefore transportthrough the microcirculation, because polyunsaturated fattyacids are incorporated into the erythrocyte membrane. A sys-tematic review evaluated 5 placebo-controlled trials com-prising 265 subjects that compared vitamin E with placebo inpatients with intermittent claudication (407). Each of thesewas conducted between 1953 and 1975. The trials weresmall, measured different physical outcomes, and were ofgenerally poor quality. No conclusions could be drawnregarding the efficacy of vitamin E for intermittent claudica-tion. The Alpha-tocopherol, Beta carotene Cancer PreventionStudy randomized patients to 50 mg of vitamin E (alpha-tocopherol) per day, 20 mg of beta carotene per day, both, orplacebo in a 2-by-2 factorial design. Intermittent claudicationwas reported via the Rose questionnaire. No effect of alpha-tocopherol on claudication was observed during a mean fol-low-up of 3.7 years (408). Two large trials examined the effi-cacy of vitamin E on adverse cardiovascular events inpatients with atherosclerosis, including those with PAD(112,299). There was no benefit of vitamin E compared withplacebo on cardiovascular outcomes such as MI, stroke, orvascular death. Taken together, these data indicate that vita-min E is not recommended as a treatment for patients withintermittent claudication.

Chelation Therapy. Disodium ethylenediaminetetraaceticacid (EDTA) combines with polyvalent cations, such as cal-cium ions, and forms a soluble nonionic complex that can beexcreted. It is used in the treatment of heavy metal poisoningand has been used in the treatment of patients with intermit-tent claudication. On the basis of the somewhat antiquatedunderstanding of the biology of atherosclerosis, EDTA ispurported to leach calcium out of atherosclerotic plaques,resulting in plaque regression and reduction in the severity ofstenoses. It is administered intravenously 2 or more times perweek. Two systematic reviews evaluated placebo-controlledtrials of EDTA in patients with intermittent claudication andconcluded that there was no evidence to support the use ofEDTA in these patients (409,410). The systematic reviewsincluded 4 trials, 3 deemed to be of good quality, that evalu-ated the effect of EDTA on walking distance (411-414).Overall, there were no significant changes in pain-free ormaximal walking distance. One trial also obtainedangiograms and found no effect of treatment with EDTA onseverity of atherosclerosis (412). Potential serious adverseeffects of EDTA include hypocalcemia, which may be life-threatening, renal insufficiency, proteinuria, and gastroin-testinal distress. Given its lack of efficacy and importantsafety concerns, EDTA should not be used to treat patientswith intermittent claudication.

Table 19. Indications for Revascularization in IntermittentClaudication

Before a patient with intermittent claudication is offered the option ofany invasive revascularization therapy, whether endovascular or surgi-cal, the following considerations must be taken into account:

a predicted or observed lack of adequate response to exercise ther-apy and claudication pharmacotherapies

the presence of a severe disability, with the patient either beingunable to perform normal work or having very serious impair-ment of other activities important to the patient

absence of other disease that would limit exercise even if the clau-dication was improved (e.g., angina or chronic respiratory dis-ease)

the anticipated natural history and prognosis of the patient

the morphology of the lesion, which must be such that the appro-priate intervention would have low risk and a high probability ofinitial and long-term success

Adapted from J Vasc Surg, 31, Dormandy JA, Rutherford RB, for the TransAtlantic Inter-Society Consensus (TASC) Working Group, Management of peripheral arterial disease(PAD), S1-S296, Copyright 2000, with permission from Elsevier (1).

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Type A lesions

Type B lesions

Type C lesions

Type D lesions

Endovascular therapy

Type A

Type B and C

Type D


Surgery

TRIALS SUPERFICIAL FEMORAL ARTERY STENTING

Year Stent

RCT

FAST 2007 Luminexx

ABSOLUTE 2007 Dynalink

RESILIENT 2012 Lifestent

SUPERB 2015 Supera

Zilver PTX 2013 Zilver PTX

VIASTAR 2015 HB-Viabhan

Single Arm

DURABILITY II 2013 Protégé Supera 500 registry 2014 Supera

Zilver PTX 2013 Zilver PTX

N Lenght (cm)

Stent POBA

244 4.5 4.4

104 11.2 9.3

206 7.1 6.4

264 7.8 7.8

479 6.3 6.6

141 19 17.3

287 8.9 - 439 12.6 -

787 9.9 -

DURABILITY 200 2011 Protégé

VIPER 2013 HB-Viabhan

100 24 -

113 19 -

Occlusions

31%

66%

19%

25%

31%

72%

48% 53%

38%

N.P.

56%

* BMS

Primary patency

12 mo 24 mo

32

64

81.3 -

79 -

84.4 74.8

70.9 63.1

77.2 - 83.3 72.8

82.8 -

64.8 - 74 -

TRIALS SUPERFICIAL FEMORAL ARTERY STENTING Stent

RCT

FAST Luminexx

ABSOLUTE Dynalink

RESILIENT Lifestent

SUPERB Supera

Zilver PTX Zilver PTX

VIASTAR HB-Viabhan

Single Arm

DURABILITY II Protégé Supera 500 registry Supera

Zilver PTX Zilver PTX

Lenght (cm)

Stent POBA

4.5 4.4

11.2 9.3

7.1 6.4

7.8 7.8

6.3 6.6

19 17.3

8.9 - 12.6 -

9.9 -

DURABILITY 200 Protégé VIPER HB-Viabhan

24 - 19 -

Occlusions

31%

66%

19%

25%

31%

72%

48% 53%

38%

N.P. 56%

* BMS

% Binary restenosis

“… high complication rates and poor outcome, including major amputations.” Bockler. J Endovasc Ther 2005;12:13-21

“Early failure … alters the distal target in 30% of early failure patients if open bypass is planned.” Joels. J Vasc Surg 2008;47:562-5

“… lesions classified as TASC C or D are more likely to fail with occlusion, lose run-off vessels, and alter the site of subsequent open operation …” Gur. J Vasc Surg 2011; 53:658-67

FAILURE OF ENDOVASCULAR TREATMENT

“Bypass surgery outcomes after failed balloon angioplasty are significantly worse than for bypass surgery performed as a first revascularization attempt.” Bradbury. J Vasc Surg 2010;51:18S-31S

•  57 years, Intermittent claudication •  Bilateral occlusion “full metal jacket” @ 14 months

Femoro-posterior tibial artery by pass GSV

Femoro-anterior tibial artery by pass (PTFE+GSV)

Left superfical artery stenting “full metal jacket” Intermittent claudication

@ 7 months

•  Stent fracture •  Neointimal hyperplasia

External iliac artery-profunda femoral artery by pass

“Leaving nothing behind” Drug eluting balloons

Extended SFA stenting

LONG SUPERFICIAL FEMORAL ARTERY LESION

“Full metal jacket”

???

Year DCB N

RCT

FemPac 2004 Paccocath 87

THUNDER 2011 Paccocath 154

PACIFIER 2012 INPACT Pacific 85

LEVANT I 2014 Lutonix 101

LEVANT II 2015 Lutonix 476

In.Pact SFA 2015 In.Pact Admiral 331

Single arm

Italian registry

2012 In.Pact Admiral 105 -

7.6 83.7 72.4

DCB IN SFA TREATMENT

LLL (mm) TLR(%) Primary patency

p value 12 mo 12 mo 24 mo

0.031 7 _ _

< 0.001 10 _ 21

0.001 7.1 _ _

0.016 29 67 57

_ 38 65.2 _

_ 2.4 82.2 78.9

* TLR 5 years

DCB

RCT

FemPac Paccocath

THUNDER Paccocath

PACIFIER In.Pact Pacific

LEVANT I Lutonix

LEVANT II Lutonix

In.Pact SFA In.Pact Admiral

Single arm

Italian registry

In.Pact Admiral

7.6 _ 30% 12.3

DCB IN SFA TREATMENT

Lenght (cm)

DCB POBA

4.7 4.0

7.5 7.4

7.0 6.6

8.0 8.0

6.3 6.3

8.9 8.8

Occlusions

DCB

16%

26%

31%

42%

21%

24%

Bailout stenting

%

9

4

20.5

3

2.5

7.3

LONG SUPERFICIAL FEMORAL ARTERY OCCLUSION Intermittent claudication

Conservative treatment Not compliant patients

Endovascular treatment

???

Saphenous vein / (Prosthetic graft)

Selected patients Good life expetancy

Comorbidity

Lifestyle limiting claudication

•  Drug eluting technologies •  New generation stents

Surgical treatment

Reasonable run-off

Ilaria Ficarelli

Service of Vascular Surgery “Antonio Cardarelli” Hospital - Naples (Italy)

HYBRID REVASCULARIZATION OF EXTENDED ILIO-FEMORAL OCCLUSION FOLLOWING

UNSUCCESSFULL ENDOVASCULAR TREATMENT

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HYBRID REVASCULARIZATION OF EXTENDED ILIO-FEMORAL ... · HYBRID REVASCULARIZATION OF EXTENDED ILIO-FEMORAL OCCLUSION FOLLOWING UNSUCCESSFULL ENDOVASCULAR TREATMENT • 52 years •