Phlebology Forum July-Aug 2015

JULY - AUG 2015

RANDOMIZED TRIAL COMPARING CYANOACRYLATE EMBOLIZATION AND RADIOFREQUENCY ABLATION FOR INCOMPETENT GREAT SAPHENOUS VEINS (VECLOSE) PAGE 7

PATTERNS AND DISTRIBUTION OF DEEP VEIN THROMBUS IN THE LOWER EXTREMITY PAGE 10

IAC Vein Center Accreditation Introducing a method for vein centers to voluntarily document their commitment to quality patient care.

From the Editor-in-Chief Nick Morrison, MD

july-aug ‘15

contents

Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose) Contributing Editor/Reviewer: Tristan R A Lane, MBBS, BSc, MRCS and Alun H Davies, MD

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7

Associate Editor: Sherry Scovell, MD

Patterns and Distribution of Deep Vein Thrombus in the Lower Extremity

Reduction Internal Valvuloplasty is a new technical improvement on plication internal valvuloplasty for primary deep vein valvular incompetence.

Contributing Editor/Reviewer: Armen L. Roupenian, MD, FACS, RVT, RPhS, RPVI

Contributing Editor/Reviewer: Robert L. Kistner, MD

Associate Editor: Diana Neuhardt, RVT, RPhS

Associate Editor: Sherry Scovell, MD

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disclosure of interests

Name

ACP Role

Date Submitted

Disclosure

Stephanie Dentoni, MD

Recruitment & Retention(Chair), Leadership Development

9/8/13

Nothing to Disclose

Mark Forrestal, MD, FACPh

ACP BOD(President-Elect) Advocacy(Chair), Nominating, Finance, Exhibitor Advisory, Phlebology Forum,

9/8/13

Cooltouch Lasers: Speaker, Trainer

Mitchel Goldman, MD, FACPh

Phlebology Forum

9/8/13

Merz Aesthetics/Kreussler: Consultant/Research; New Star Lasers: Consultant

Jean-Jerome Guex, MD, FACPh

ACP BOD, Advocacy Standing, AMA HOD Task Force, International Affairs, VeinLine, Leadership Development, Annual Congress Planning

9/8/13

Servier International: Speaker/Consultant; Thusane: Scientific Committee Member; Vascular Insights: Scientific Committee Member

Lowell Kabnick, MD, FACS, FACPh

Phlebology Forum

9/8/13

Angiodynamics: Consultant, Shareholder, Patent; Veniti, Scientific Advisory Board; BTG: Consultant

Neil Khilnani, MD, FACPh

ACP BOD(Secretary), Member Engagement(Chair), CME Standing, CME, CME Workgorup 1,

9/8/13

Sapheon: Data Safety Board Member

Mark Meissner, MD

ACP BOD, Eductation, CME, Fellowship Training(Chair)

9/8/13

Nothing to Disclose

Nick Morrison, MD, FACS, FACPh

ACP Foundation (Chair), ACP Ethics and Industrial Advisory Committees, Phlebology Forum

2/24/14

medi: Educational Grant; Merz: Consultant/Speakers Bureau; Sapheon: Principle Investigator; VeinX: Scientific Advisory Board

Eric Mowatt-Larssen, MD

ACP Leadership Development CME Workgroup 2 & 3

6/25/12

BTG International, Inc.: Consultant

Diana Neuhardt, RVT, RPhS

ACP BOD, Member Engagement, Education, VeinLine, Phlebology Forum, Leadership Development, Public Education(Chair), CME-Workgroup 2

6/15/12

Nothing to Disclose

Pauline RaymondMartimbeau, MD, FACPh

ACP Foundation BOD

9/8/13

Nothing to Disclose

Sherry Scovell, MD

Phlebology Forum (Editor-In-Chief)

7/31/15

Nothing to Disclose

From the

Editor-in-Chief Dear Readers

As you know this publication was begun upon John Bergan’s retirement and the subsequent end of his Venous Digest. The ACP made the decision to begin publishing a similar on-line publication entitled Phlebology Forum. It has been my privilege to have served as Editor-in-Chief since the inception of Phlebology Forum.

Now as I take on my responsibilities as President of the International Union of Phlebology, I find my commitment to the Phlebology Forum cannot be as robust as it has been. For that reason, and after a careful search we have asked Sherry Scovell, a vascular surgeon from Harvard and Massachusetts General Hospital to assume the position of Editor-in-Chief. Sherry is very energetic and will bring a great deal to Phlebology Forum.

I have greatly enjoyed working with you and I thank you for your support of this important publication.

Nick Morrison, MD Editor-in-Chief Phlebology Forum

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+ Opportunities to improve patient care at all levels of skill from foundational through advanced + Presentations and exhibitors of leading research, technology and trends in the field of vein care + Hands-on workshops and demonstrations with renowned experts from all over the world, including topics such as sclerotherapy, compression, non-thermal saphenous vein treatments and superficial venous imaging

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Register Today For more information and to register, visit the ACP Congress website at:

acpcongress.org www.phlebology.org | 510.346.6800

advancing vein care

Randomized trial comparing

cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose) Authors: Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, et al.

Journal of Vascular Surgery. 2015 Apr;61(4):985–94.

Contributing Editor/Reviewer: Tristan R A Lane and Alun H Davies Associate Editor: Sherry Scovell MD

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ABSTRACT The Veclose Study provides a welcome comparison of segmental endovenous ablation with the new non-tumescent, non-thermal and no post-operative compression cyanoacrylate ablation.1 In this robustly designed multi-centre randomised controlled trial, patients with primary Great Saphenous Vein incompetence were assigned to truncal ablation with either Covidien Venefit ClosureFAST segmental radiofrequency ablation or Sapheon Veclose chemical occlusion catheter. This study is the latest to investigate the new non-thermal non-tumescent ablation technique offered by cyanoacrylate glue occlusion, and the first randomised study. This study also serves as a pivotal study for obtaining Federal Drug Agency pre-market approval in the United States. Previous studies on cyanoacrylate glue occlusion have offered small numbers of patients at up to 2 years of follow-up with excellent results.2 The evidence for the control group (radiofrequency ablation) is extensive, with recent work showing durable results at up to five years post treatment.3

This study randomised 222 patients who were carefully selected to provide easy comparison between treatments, and these patients were followed-up to 3 months post-procedure. The study recruited 242 patients over its 10 sites in just 6 months, with the first 2 cases at each site acting as a training phase. Patients with very large veins (>12mm) and complex disease (CEAP C5 or C6) were excluded, however

The early outcomes

the symptom and clinical scores of patients were within the

presented on occlusion

range expected in other studies (VCSS 5.5-5.6, AVVQ 18.9-19.4),

are encouraging, with

including National Health Service studies. Treatments were solely truncal vein treatment with adjunctive procedures forbidden prior to the end of the 3 month trial follow-up.

The primary endpoint was occlusion of the GSV at 3 months.

predictive modelling suggesting 99%

Failure was defined as any >5cm patent segment of the GSV.

occlusion in test arm and

Core laboratory assessment was also undertaken of the duplex

96% in the control arm.

ultrasound scans.

The early outcomes presented on occlusion are encouraging, with predictive modelling suggesting 99% occlusion in test arm and 96% in the control arm. Whilst the statistical work is robust and appropriate it has been presented in 1

Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). JVS. 2015 Apr;61(4):985–94.

2

Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology. 2014 Apr 30.

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Proebstle TM, Alm BJ, Göckeritz O, Wenzel C, Noppeney T, Lebard C, et al. Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. BJS. 2015 Jan 27;102(3):212–8.

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a moderately confusing manner. The use of a predictive model showing worst and best case scenarios from missing data is an excellent method, but is seldom used in the literature and so can confuse. The take home message is that cyanoacrylate closure is non-inferior to radiofrequency ablation from a technical viewpoint.

COMMENTARY The aim of non-thermal, non-tumescent ablation techniques such as cyanoacrylate is to provide similar efficacy (as shown in this study) with reduced peri-procedural pain and reduced procedural time (both due to the lack of tumescent requirement), such as seen in studies with mechanochemical ablation.4 However this study showed similar pain profiles for radiofrequency and cyanoacrylate and in fact the cyanoacrylate group took longer to treat (24 minutes versus 19 minutes). This raises questions as to the benefit of the new (and more costly) device, especially if phlebectomy is planned concomittantly (as the evidence recommends5). Foam sclerotherapy can of course be utilised with both radiofrequency ablation and cyanoacrylate occlusion.

The quality of life, clinical outcome and side effect profile for both treatment arms were equivalent, although the occurrence of phlebitis and paraesthesia around the treatment zone in cyanoacrylate occlusion is concerning, it is not clear whether this phlebitis of tributary branch or paraesthesia from the cannulation site. Irrespective, however, initial reports of increased phlebitic reactions from cyanoacrylate occlusion are not borne out by this study.6 Questions still remain as to how this phlebitic reaction is caused by the cyanoacrylate. Additionally the question must be posed as to why there are equivalent levels of ecchymosis and paraesthesia in both single puncture non-thermal treatment and thermal ablation with multiple needle punctures, side-effects normally associated with thermal ablation.7

The short term nature of this initial study allows for early comparison but few fixed conclusions, and the longer term follow-up is eagerly awaited. The study has been well conceived and robustly designed to ensure that these longer term outcomes can be used reliably when they arrive.

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Vun SV, Rashid ST, Blest NC, Spark JI. Lower pain and faster treatment with mechanico-chemical endovenous ablation using ClariVein®. Phlebology. SAGE Publications; 2014 Oct 8;:0268355514553693.

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Lane TRA, Kelleher D, Shepherd AC, Franklin IJ, Davies AH. Ambulatory Varicosity avUlsion Later or Synchronized (AVULS): A Randomized Clinical Trial.

Ann Surg. 2015 Apr 1;261(4):654–61.

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Proebstle TM, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. JVS:VLD. 2015 Jan;3(1):2–7.

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Anwar MA, Lane TRA, Franklin IJ, Davies AH. Complications of radiofrequency ablation of varicose veins. Phlebology. 2012;27(Suppl 1):34–9.

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Patterns and Distribution of Deep Vein Thrombus in the Lower Extremity Authors: Sapp, Brian; Craddock, Jr., Garnet; Sapp, James Journal for Vascular Ultrasound, Volume 39, Number 2, June 2015, pp. 71-77(7) Contributing Editor/Reviewer: Armen L. Roupenian, MD, FACS, RVT, RPhS, RPVI Associate Editor : Diana Neuhardt, RVT, RPhS

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COMMENTARY This study is a retrospective review of 11,503 venous studies performed in one Center over an eight-year period documenting the incidence (382) of acute primary venous thrombosis. The authors categorized thrombus by anatomical location and three patient demographics (age, sex and laterality). Their findings are summarized in Table 1.

Based on their aggregate data, the authors then developed an eleven factor-prediction tool (DVTrax 2.0) demonstrating the potential trajectories of any given patient’s DVT with their associated probabilities.

Table 1 Female predominant

54.71% vs 44.76%

In the example given in Table 2, a patient

Left side predominant

57.85% vs 42.15%

with thrombus in the peroneal vein would,

Median age

62 years 8 months

for example, have a 24% increased risk of thrombus in the IVC. However, it is important to understand that this model does not predict the incidence but rather the increased risk over baseline. This is an important differentiation that readers must understand when interpreting their data.

Above knee 36.39% IVC

3.66%

Iliac

9.42%

CFV

17.54%

Femoral vein

29.84%

Deep femoral

1.83%

Popliteal above knee

32.20%

A significant finding in this study is the high

Popliteal fossa 37.17%

incidence of calf vein thrombus associated

Popliteal below knee 38.74%

with proximal DVT (98.17%). It was also determined that 54% of identified thrombus would have been missed had the calf veins not been routinely visualized. Based on the results of this retrospective review, the authors call for standardization of deep

Calf vein

98.17%

Peroneal

63.61%

Posterior tibial

50%

Anterior tibial

0.79%

Muscular calf veins (MCV)

venous studies to routinely include the

Gastrocnemius veins

36.91%

deep calf and muscular veins of the lower

Soleal veins

28.53%

extremity.

Superficial

14.4%

GSV

10%

SSV

18.5%

Varicosities

2%

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Table 2

In the above scenario, the patient is found to have DVT in the peroneal vein. The peroneal vein was the most common area of thrombus visualized in the study.

Observe the associated thrombus within the patient data.

COMMENTARY The authors should be commended both for their detailed analysis and raising an issue that needs to be addressed by the vascular community: Is femoral-popliteal imaging alone sufficient in the diagnosis of acute deep venous thrombosis?

The primary argument against routine imaging of calf veins for DVT has always been the number of indeterminate studies due to the difficulty in visualizing these small vessels. Most of the data to support this premise dates back twenty years or more and fails to recognize the improvement in grey scale imaging that has occurred during the interim.

Also, without requiring infrapopliteal imaging as routine in the diagnosis of deep vein thrombosis, many technologists and physicians never gain the experience and subsequent expertise to adequately image these structures especially when encountering the difficult patient when it matters most.

Another argument against routine imaging is that distal (infrapopliteal) DVT often resolves spontaneously and is rarely associated with PE or other complications. This is simply not the case.

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The literature is mixed regarding the incidence of PE in C- DVT with variable rates from 1.5 to 6.2% during surveillance and rates much higher when one looks at C- DVT at initial presentation (Partsch1 35.1%).

Kageyama2 performed 60 autopsies on patients who suffered a fatal pulmonary embolism and found that the soleal veins were the most frequent site of DVT for both fresh and organized thrombus.

Whatever the exact incidence, it is indisputable that thrombus involving the calf veins has the potential to embolize even without propagation into the proximal venous system.

One of the least discussed issues in determining the significance of infrapopliteal DVT is the associated incidence of PTS (post thrombotic syndrome). Meissner3 documented that 23% of patients experienced symptoms of pain, edema or both one-year after an episode of C-DVT. Within that patient cohort, 24% of patients developed valvular incompetence. Asbeutah4 reported that at 5 years, 10% of patients with C-DVT were in advanced CEAP categories 4-6.

They also confirmed Meissner’s findings of a high incidence of subsequent valvular incompetence at 36%.

The Intersocietal Accreditation Agency (IAC) has recognized the importance of calf vein imaging in non-reflux venous studies making it a requirement for accreditation in Peripheral Venous Imaging.5 ACCP 2012 Guidelines6 include treatment paradigms in the management of both symptomatic and asymptomatic calf vein thrombus recognizing defacto the importance of thrombus involving these vessels.

Thrombus load, multifocality, proximity to the proximal deep venous system are all factors that help those of us who manage acute calf vein DVT in identifying patients at high risk for propagation, recurrence and embolization. All these variables are important in the decision making process of managing acute thrombus at any level.

The burden of proof lies with those who argue against routine imaging to prove that VTE involving the calf veins does not have immediate and long-term consequences for this patient population.

I concur with the authors in calling for standardization of venous studies performed for DVT to routinely include imaging of the infrapopliteal venous system.

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1

Partsch H. Therapy of deep vein thrombosis with low molecular weight heparin, leg compression and immediate ambulation. VASA 2001; 2003; 85-B:841-4

2

Kageyama et al Significance of the soleal vein and it drainage veins in cases of massive pulmonary embolism Ann Vasc Dis Vol . No. 1; 2008 35-39

3

Meissner MH. et al. Early outcome after isolated calf vein thrombosis. J Vasc Surg 1997; 26:749-56

4 5

Asbeutah, AM et al Five year outcome study of deep vein thrombosis in the lower limbs. J Vasc surg 2004;40:1184-9 IAC Guidelines for Peripheral Venous Imaging Section B 41-47

6

Antithrombotic Therapy for VTE Disease Chest 2012 Feb 141 (2 suppl) 22s)

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Masuda, E et al. the controversy of managing calf vein thrombosis J Vasc Surg. 2012 Feb;55(2):550-61

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Reduction Internal Valvuloplasty is a new

technical improvement on plication internal valvuloplasty for primary deep vein valvular incompetence.

Authors: Himanshu Verma, MS, FEVS, Rajesh Srinivas, MS, MRCS, Robbie K. George, MS, FRCS, Ramesh K. Tripathi, MD, FRCS, FRACS Journal of Vascular Surgery (in press) 05/2014; DOI: 10.1016/j.jvsv.2014.04.013 Contributing Editor/Reviewer: Robert L. Kistner, MD Associate Editor: Sherry Scovell, MD

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ABSTRACT This report from the service of a vascular surgeon highly experienced in venous reconstruction presents a novel surgical technique to actually re-shape the valve cusp in Primary Venous Disease (PVI). It is termed the RIVAL procedure, an acronym for Reduction Internal Valvuloplasty. This technique provides a new perspective on the repair of the valve by excision of the redundant portion of the valve cusp. Their group believes it has improved their results of valve repair in PVI by eliminating post-operative thrombosis and resorption of the valve cusp.

The RIVAL technique was performed in 18 patients who had 25 limbs and 44 valve sites repaired since January 2008. The results are reported with a follow-up of 6 months in 44 valves, 12 months in 42 valves, and 24 months in 24 valves.

The report accentuates technical aspects in both ultrasound diagnosis and surgical treatment. It provides a detailed description of the case selection process with strict limitations of the patients chosen for the procedure, and defines venous patients who were excluded from the series Diagnosis of the valve morphology was limited to ultrasound techniques without mention of phlebography. Description of

The results reported

measurements of the valve cusps with ultrasound pre- and post-

in this report

operatively and open measurements at the time of the surgical procedure exceed conventional methods; it will require a more detailed description than is contained in this article for this reviewer to fully comprehend and evaluate their merits.

Details of operative technique include exposure of valve cusps using the trapdoor exposure that the senior author has devised and previously reported. The valve repair is achieved by resection of the redundant portion of the valve cusp under direct vision with

establish that in their experience the new technique has materially improved the results in the first 6-24 months...

the valve laid open using the trapdoor technique, followed by suture of the free edge of the cusp to the vein wall with running 7-0 Prolene. As the venotomy is closed valve competence is checked and external repair along the commissural line is added until the valve is totally competent to milking maneuvers.

The series includes two-level repairs in 19 limbs (38 repairs) and single-level repair in 6 limbs. Of the 19 two level repairs, 9 had CFV + FV repair, 8 had CFV + A-K popliteal repairs, and 2 had FV + B-K Popliteal repairs.

Single level

repairs were placed in the CFV (4) and FV (2) sites. This selection of techniques is unique to this report in two ways, namely, there is dominant use of 2-level repairs and there is frequent use of CFV repairs, the majority (17/21) of which were combined with a more distal repair.

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COMMENTARY In their discussion the authors review their previous experience with the “reefing techniques”, the term they use to describe the open procedures of Kistner, Raju, Sottiurai, and previous reports by Tripathi. All of these are lumped together as ‘reefing techniques’ in spite of their distinctive differences in surgical technique. They hypothesize that rugal folds in the valve cusp that may develop from the reefing technique can lead to thrombosis in the valve cusp, and this can be eliminated by the RIVAL technique of precise modeling of the valve cusp. The authors point out that their experience with these techniques was marked by valve thrombosis in 6.7% of the previous series and there were an additional 6% of cases with valve cusp resorption. In contrast, they have found no case of valve thrombosis or cusp resorption in this series treated by the RIVAL technique.

The authors do not report failures attendant on the learning curve for performing the RIVAL technique but this has to be a serious consideration for other surgeons who wish to employ this technique. In view of the fact they have developed new instruments for performing the RIVAL repair one would have to assume the learning curve has more than a few bumps.

The concept of performing surgical repair of the venous valve in PVI has at least two separate components needed to establish its validity. One of these is the proof that the valve repair actually has resulted in a competent valve; the second is whether the existence of the newly competent valve will result in healing of the ulcer, and reduce the incidence of recurrent ulceration. This presentation of a new method for operative correction of primary valve reflux focuses on the valve itself and analyzes the post-operative competence of the valve, or lack of same. It provides a direct approach to the valve by re-molding the physical outlines of the valve cusp to create a more ideal valve contour. The authors admit that their RIVAL technique “is more technically demanding” – this could become a limiting factor for its widespread use since many surgeons relate that the present techniques are overly demanding and the introduction of added complexity could be the wrong direction for the future.

The results reported in this report establish that in their experience the new technique has materially improved the results in the first 6-24 months, average 12 months. This is very important since post-operative thrombosis for certain, and post-operative valve resorption probably, can be expected to occur in this time frame. Although the series is small with only 18 patients, their statement that these results are viewed by their team to be convincing evidence for switching from reefing techniques to valve molding techniques as devised by them is logical. Whether future surgeons will be able to reproduce their results remains to be seen.

The second component of long term improvement in results of ulcer healing and reduction in ulcer recurrence is premature because it will require longer follow-up of 4-8 years to know these results.

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The future of this technique will depend upon certain developments:

1.

Corroborative studies by other venous reconstruction surgeons to validate the technical ability to re-shape the valve cusp successfully and to eliminate post-operative thrombosis and valve resorption. If the learning curve is too difficult the technique could result in too many complications in the deep veins.

2.

The concept that “reefing� potentially creates a thrombogenic surface for either valve thrombosis or resorption deserves further investigation.

3.

Long term studies of the effect of the procedure to establish that 4-8 year results of valve competency exceed the presently available result of 65-75% long term competence by present techniques (ref). The present series reports valve competence to be 87.5% at 2 years.

1

Evidence summary for internal valvuloplasty: Table X. in: Management of venous leg ulcers: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2014;60:38S

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