Phlebology Forum Sept-Oct 2014

SEPT - OCT 2014

The effect of single phlebectomies of a large varicose tributary on great saphenous vein reflux PAGE 7

Home versus in-hospital treatment in outpatients with acute deep vein thrombosis of the lower limbs PAGE 17

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

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contents

The effect of single phlebectomies of a large varicose tributary on great saphenous vein reflux Contributing Editor/Reviewer: Paul Pittaluga, MD

From the Editor-in-Chief

5

Nick Morrison, MD, FACS, FACPh, RPhS

Associate Editor: Sherry Scovell, MD

7 Therapeutic Effect of Compression Stockings Versus no Compression on Isolated Superficial Vein Thrombosis of the Legs: A Randomized Clinical Trial

Compression of left common iliac vein is independently associated with leftsided deep vein thrombosis Contributing Editor/Reviewer: Fedor Lurie, MD, PhD Associate Editor: Stephen F. Daugherty, MD, FACS, FACPh,

RVT, RPhS

Contributing Editor/Reviewer:

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Lars Rasmussen, MD, DMSC Associate Editor: Diana Neuhardt, RVT, RPhS

Home versus inhospital treatment in outpatients with acute deep vein thrombosis of the lower limbs Contributing Editor/Reviewer: Anthony Comerota, MD, FACS Associate Editor: Mark Forrestal, MD, FACPh

17

14

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

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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,

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Ted King, MD, FAAFP, FACPh

ACP BOD, Leadership Development, Annual Congress Planning, Public Education

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BTG International: Consultant/Advisory Board Member/Principal Investigator; Veniti: Advisory Board/ Consultant; Sapheon: Investigator

Mark Meissner, MD

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

9/8/13

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Nick Morrison, MD, FACS, FACPh

ACP Foundation (Chair), ACP Ethics and Industrial Advisory Committees, Phlebology Forum (Editor-in-Chief)

2/24/14

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

Eric Mowatt-Larssen, MD

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6/25/12

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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

9/8/13

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Pauline RaymondMartimbeau, MD, FACPh

ACP Foundation BOD

From the

Editor-in-Chief Dear Readers

In this issue of Phlebology Forum we present reviews of a number of articles from recent vascular literature dealing with acute venous thrombosis, both deep and superficial, as well as an article on the approach to segmental superficial truncal reflux, all of which strongly question the dogma of traditional treatment. These are thought-provoking articles and we present equally thought-provoking reviews by recognized experts. We wish to thank the reviewers and associate editors for their work and we look forward to seeing our readers at the ACP Annual Congress in Scottsdale, Arizona, November 6-9, 2014. The program will be of very high scientific quality and we hope you have the opportunity to enjoy the autumnal weather in Scottsdale.

Nick Morrison, MD Editor-in-Chief Phlebology Forum

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The effect of single phlebectomies of a large varicose tributary on great saphenous vein reflux Author: Anke A.M. Biemans, et al.

Journal of Vascular Surgery: Venous and Lymphatic Disorders, Volume 2, Issue 2, Pages 179-187 Contributing Editor/Reviewer: Paul Pittaluga, MD Associate Editor: Sherry Scovell MD

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ABSTRACT The objective of this paper was to evaluate the outcomes of phlebectomy alone in patients with an incompetent great saphenous vein (GSV).

The design consisted of a prospective multicenter study including consecutive adult patients with symptomatic primary GSV incompetence and a visible and unique varicose tributary of the GSV at the thigh (with or without extension below the knee).

All patients were assessed by duplex ultrasound (DUS) with the performance of a reflux elimination test by digital compression of the varicose tributary at the thigh. This test was considered positive when it led to the elimination of the GSV reflux during the digital compression.

...single phlebectomies improve the hemodynamics of the venous system and the clinical outcomes even in presence of a GSV reflux.

The phlebectomies were performed under local anesthesia through multiple small incisions using a traditional hook technique. A 20 mmHg compression stocking was used for one week postoperatively.

A total of 94 patients were analyzed (mean age 53 years, 69.1% women) among whom 55.3% were classified C2, 35% C3 and 9.6% C4.

At 1 year of follow-up, the GSV reflux completely disappeared in 50% of the patients (P<.01) and the mean diameter of the GSV above the varicose tributary decreased significantly from 0.55cm to 0.39 cm (p<.01). A lower CEAP class C was found in 73% of the cases and no patient deteriorated. In two thirds of the patients symptoms resolved completely.

The Venous Clinical Severity Score (VCSS) and the Aberdeen Varicose Vein Questionnaire (AVVQ) were improved in all cases, more significantly in the group of patient with a disappearance of the GSV reflux after treatment. An additional GSV ablation was performed in 34% of the cases in patients with persisting symptoms and GSV reflux. The GSV reflux was more often abolished when the following parameters were present preoperatively: C2 (P < .001); short (<10 cm) refluxing segment (P < .001); reflux in only one GSV segment (P < .001); smaller diameters of GSV and tributary (P < .001 and P < .009); positive result of the reflux elimination test (P < .001); and low VCSS (P < .001) and AVVQ score (P < .001).

Patients with a positive test have a more than 65% chance of success. A phlebectomy reflux elimination success test (PREST) prediction model was developed including C classification, number of refluxing segments, GSV diameter (above the tributary), and reflux elimination test result, in order to give a score that correlates with a probability of restoring GSV competence.

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The authors concluded that presently the treatment for varicose veins should be oriented toward a less invasive approach, for instance single phlebectomies in properly selected patients, using the predictors for success found in the present study.

COMMENTARY This study confirms previous publications, which showed that single phlebectomies improve the hemodynamics of the venous system and the clinical outcomes even in presence of a GSV reflux. 1 2

It also adds a new argument in favor of the hypothesis increasingly published, that the varicose vein disease has a multifocal origin (often ascending from the tributaries) 3, rather than the traditional univocal descending evolution in which all reflux takes its origin at the saphenous vein, especially at the terminal valve.

This study also calls into question the usual approach to systematic treatment of the GSV by stripping, or by endothermal or chemical ablation in the presence of varicose veins with GSV reflux. On the contrary it leads to a modern concept of an individualized “à la carte treatment” since every patient has a different clinical and hemodynamic situation of the disease at the time of treatment, which cannot match to a “one size fits all” that represents the traditional strategy.

Biemans and al have also reported that the abolition of the reflux may not be the only end-point to take into account in order to evaluate the success of the treatment, because a large number of patients had a significant improvement of symptoms and VCSS-AVVQ scores and did not need additional treatment after single phlebectomies, even if the GSV reflux was persisting.

However, despite the fact that we published this approach and identified it as the ambulatory selective ablation under local anesthesia method (ASVAL) 9 years ago,4 a very limited number of studies have been published on this topic by other teams than ours, and the systematic destruction of the GSV in presence of a GSV reflux is still widely used.

That could be explained by the fact that the criteria for the indication of ASVAL are difficult to determine in absence of an adequate validation in the literature, especially by randomized control trials (RCTs), leading to a low grade of recommendation for this approach in the international guidelines. 5 1

Zamboni P, Cisno C, Marchetti F, Quaglio D, Mazza P, Liboni A. Reflux elimination without any ablation or disconnection of the saphenous vein. A haemodynamic model for venous surgery. Eur J Vasc Endovasc Surg 2001;21:361-9.

2 Pittaluga P, Chastanet S, Rea B, Barbe R. Midterm results of the surgical treatment of varices by phlebectomy with conservation of a refluxing saphenous vein. J Vasc Surg 2009;50:107-18.

3 Labropoulos N, Kokkosis A, Spentzouris G , Gasparis, A, and Tassiopoulos A. The distribution and significance of varicosities in the saphenous trunks. J Vasc Surg 2010;51:96-103.

4 Pittaluga P, Rea B, Barbe R. Méthode ASVAL (Ablation Sélective des Varices sous Anesthésie Locale): principes et résultats préliminaires. Phlébologie 2005;2 :175-181 5

Gloviczki P and al. The care of patients with varicose veins and associated chronic venous diseases: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011;53:2S-48S

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Therefore this well-designed prospective study could be the first step for changing this situation. Indeed the paper of Biemans and al brings for the first time some predictors to evaluate the probability of a hemodynamic and clinical success of single phlebectomies. One of the most promising results observed in this paper is that the reflux elimination test is an independent and strong predictor for the treatment success, and since this test is very simple to perform during the preoperative DUS assessement it could be very helpful.

This paper opens the door to other authors to go forward with the evaluation of limiting the treatment to single phlebectomies. This evaluation should be done because, as the authors of this paper say, sparing the GSV regains its role as one of the main veins of the superficial venous system, leads to fewer and less expensive operations, which is safer for the patient and costs less and preserves a material that can be used as a natural bypass.

We look forward to seeing the result of the RCT that the authors have announced, for the comparaison of endovascular thermal ablation with phlebectomies vs phlebectomies alone.

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Compression of left common iliac vein is independently associated with left-sided deep vein thrombosis Authors: Feng Chen, PhD, Jun Den, PhD, Qing Wen Yuan, MD, Wei Min Zhou, PhD Journal of Vascular Surgery: Venous and Lymphatic Disorders Volume 1, Issue 4 , Pages 364-369, October 2013 Contributing Editor/Reviewer: Fedor Lurie, MD, PhD Associate Editor : Stephen F. Daugherty, MD, FACS, FACPh, RVT, RPhS

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COMMENTARY The study is a retrospective analysis of computed tomography images of 79 patients with unilateral proximal DVT (19 right , 60-left). The comparison group was formed by a frequency match by gender from hospitalized patients who had a CT scan done for non-vascular indications. Common Iliac Vein (CIV) diameters were measured, and the % of stenosis in left CIV was defined in comparison to the diameter of the right ICV, under the assumption that left and right ICVs should have an equal diameter if not compressed from the outside.

The findings were that 79.4% of patients with no DVT had greater than 25% compression of the left CIV, 51.8%

patients with severe left CIV compression should receive more emphasis on left

had greater than 50% and 24.3% had greater than 70%

DVT prophylaxis

compression. Mean LCIV diameter was smaller in left DVT

because they are the

(2.39 mm) than in right DVT (6.18 mm) or normal control (5.39 mm). Mean left CIV stenosis was higher in patients with left DVT (77.57%) than in those with right DVT (38.01%) or patients with no DVT (49.31%). Patients with left CIV stenosis

high-risk population of left DVT .

>75%, had prevalence of left DVT 11 times more frequent than those that had less than 75% stenosis. Patients with left CIV diameter <2.5 mm, had left DVT 13.5 times more frequently compared to those with left CIV diameter greater than 2.5 mm. Unprovoked and provoked left DVT patients had similar LCIV compression, and left DVT patients had more significant left CIV compression than right DVT patients.

The authors concluded that left CIV compression was a normal anatomical pattern with an increased risk of left DVT and that left CIV compression might be the essential and prerequisite factor for left DVT. They suggested that patients with severe left CIV compression should receive more emphasis on left DVT prophylaxis because they are the high-risk population of left DVT.

Publication of this manuscript once again emphasizes the need for more good quality studies to investigate the increasingly clinically relevant problem of iliac vein obstruction. I cannot refrain myself from asking the readers to finally stop calling hospitalized patients “normal population”. They are not. Selection of hospitalized patients who had CT scans as a comparison group could be appropriate, but generalizing the findings to “normal population” is a mistake.

We should also clearly distinguish external compression of the CIV and the syndrome described by J. Turner and R. May. Their anatomical study of 430 cadavers was entirely focused on intra-luminal structures – ‘spurs” in iliac veins, which they found only in the left iliac vein in 80 out of 342 adult cadavers, and none in embryos and newborns. They

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did not study the compression of the vein by the artery. In 31 of 80 veins with “spurs” they found acute thrombus, which led them to the hypothesis of causal relationships between the presence of “spurs” and thrombosis.

The relationships between the compression of the left CIV and thrombosis are not obvious. The authors found that the mean diameter of the left CIV in patients with right CIV thrombosis was 6.18 mm compared to 10.58 mm diameter of the right CIV. This indicates that some patients with significant compression of the left CIV developed thrombosis in right, not in the left CIV. This observation effectively defeats the argument that left CIV compression is “essential and prerequisite factor for left DVT”, since at least some of the patients in pro-thrombotic state developed DVT in a “normal” vein even though the vein on the other side was significantly stenotic.

Despite its limitations this study demonstrated that the prevalence of left CIV thrombosis is significantly higher in patients with 75%-80% stenosis of the left CIV compared to gender matched controls (OR=27.98). In addition this prevalence was higher in patients with >75% stenosis than in those with <75% stenosis (OR=11.1). These findings suggest that patients with a high degree of left CIV compression develop left CIV thrombosis more frequently than hospitalized patients with lesser degree of left CIV compression. Another conclusion may be that compression of the left CIV to less than 50% of its diameter is not associated with increased incidence of thrombosis.

However, in order to transition from possible associations found by this study to estimates of risk for thrombosis we need to have prospective data on DVT incidence in patients with different degree of iliac vein compression identified prior to the acute episode. These data should also include the presence or absence of intra-luminal “spurs,” and known history of prior thrombotic events. 1234

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Therapeutic Effect of Compression Stockings Versus no Compression on Isolated Superficial Vein Thrombosis of the Legs: A Randomized Clinical Trial Authors: Boehler K., et al Eur J Vasc Endovasc Surg. 2014 Aug 9 Contributing Editor/Reviewer: Lars Rasmussen, MD, DMSC Associate Editor: Diana Neuhardt, RVT, RPhS

Abstract Eighty patients with superficial venous thrombosis (SVT) were randomized to treatment with class 2 (23-32 mmHg) thigh length compression stockings or no compression in addition to LMWH and NSAID for 21 days. The study was open-label and performed in a single center. Patients with deep vein involvement were excluded from the trial. Weekly examination with duplex scan and evaluation of pain on a visual analogue scale, use of NSAID, erythema, thrombus length, D-dimer and Quality of Life (SF-36), revealed no difference between the groups. At day 7 a faster thrombus regression in the compression group was found. No patients developed DVT during the study. Compression stockings, in addition to treatment with LMWH and NSAID does not benefit patients with SVT.

Commentary The present study is the first to compare the value of compression with no compression in patients with SVT not involving the deep veins. Well designed and thoroughly performed the study investigated relevant clinical and para-clinical variables, but failed

The study failed to show any relevant differences in

to show any relevant differences in outcome between the groups.

outcome between

A number of arguments may help explain why no benefit of compression was revealed. Compliance with compression therapy

the groups.

is known to be variable and often low, but it was not reported

A number of

in the study. Thus, in other studies of compression therapy in venous disease, less than half of the patients actually used the compression stockings as prescribed. Still, the compliance in the

arguments may help explain why...

present study probably reflects the situation in daily life, and the results were correctly analyzed according to the intentionto-treat principle. One other reason why the class 2 stockings did not influence the outcome of SVT, might be that the compression was insufficient. As the authors point out, in the upright position, a local pressure > 40 mmHg must be obtained in order to reduce the diameter of leg veins. Such pressure was not acquired with class 2 stockings.

Other reasons why no difference between the groups was found might be, that the patients in both groups received treatment with LMWH and NSAID. Treatment with LMWH probably reduce the risk of progression to DVT and might also relieve symptoms and superficial progression. In addition, NSAID relieve inflammation and pain.

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The results in the present study are in line with recent trials comparing the effect of compression after surgery, foam or endovenous laser ablation in patients with varicose veins. In those studies no benefit of post-treatment compression has been shown.

In conclusion, on account of the present knowledge, compression treatment cannot be recommended in patients with SVT in addition to treatment with LMWH and NSAID. Whether it will benefit patients without such additional treatment is not known, but because LMWH treatment for SVT is not common practice everywhere, it is a relevant question.

1 2 3 4 5

1

Hamel-Desnos CM, Guias BJ, Desnos PR, Mesgard A. Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression. European journal of vascular and endovascular surgery. EJVES, 2010 Apr;39(4):500-7.

2 Biswas S, Clark A, Shields DA. Randomised clinical trial of the duration of compression therapy after varicose vein surgery. EJVES, 2007 May;33(5):631-7.

3

Houtermans-Auckel JP, van Rossum E, Teijink JA, Dahlmans AA, Eussen EF, Nicolai SP, et al. To wear or not to wear compression stockings after varicose vein stripping: a randomised controlled trial. EJVES, 2009 Sep;38(3):387-91.

4 Raraty MGT GM, Blair SD. There is No Benefit from 6 Weeksâ&#x20AC;&#x2122; Postoperative Compression after Varicose Vein Surgery: A Prospective Randomised Trial.

Phlebology, 2009 (14):21-5.

5 Shouler PJ, Runchman PC. Varicose veins: optimum compression after surgery and sclerotherapy. Annals of the Royal College of Surgeons of England,1989 Nov;71(6):402-4.

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Home versus in-hospital treatment in outpatients with acute deep vein thrombosis of the lower limbs Author: F. Lozano, et al.

J Vasc Surg. 2014 May;59(5):1362-7.e1.

Contributing Editor/Reviewer: Anthony Comerota, MD, FACS Associate Editor: Mark Forrestal, MD, FACPh

ABSTRACT Background: Since some physicians remain concerned about the safety and efficacy of home therapy for patients with acute deep venous thrombosis, the authors performed this analysis comparing the early outcomes of patients with acute DVT treated as outpatients or in-hospital.

Methods: Data from the RIETE registry from 2001 through

Outpatients presenting with acute deep venous thrombosis have better outcomes when treated at home than when treated in-hospital.

2012 were used to compare the outcomes of 13,493 consecutive patients with acute lower limb DVT according to initial treatment at home or in the hospital. The primary endpoint was patient outcome after initial therapy, which included pulmonary embolism (PE), death, and major bleeding. A propensity score-matching analysis was carried out using a logistic regression model.

Results: 4456 patients were treated at home and 9037 were treated in- hospital. During the first week of anticoagulation, 0.2% suffered pulmonary embolism, 0.09% recurrent DVT, 0.38% major bleeding and 0.59% died. Of the patients who were treated at home, 0.27% had PE, 0.09% recurrent DVT, 0.13% bleeding, and 0.09% mortality. Interestingly, there were no fatal pulmonary emboli and there were three fatal bleeds. Following a propensity analysis, there was no difference in the rate of venous thromboembolism recurrence in patients treated at home, but there was a lower rate of major bleeding (P=0.04) and a lower mortality (P=0.009) within the first week compared to patients who were hospitalized.

Conclusions: Outpatients presenting with acute deep venous thrombosis have better outcomes when treated at home than when treated in-hospital.

COMMENTARY The RIETE registry is a multinational, prospective registry of consecutive patients presenting with symptomatic venous thromboembolism (VTE).

These investigators compared the outcome of outpatients with acute DVT of the lower limbs at the end of initial therapy with anticoagulation (7-10 days) according to home or in-hospital treatment.1 One would anticipate that hospitalized patients would be older and have significantly more comorbidities, which was the case. In general, patients selected for outpatient 1 Lozano F, Trujillo-Santos J, Barr贸n M, et al. Home versus in-hospital treatment of outpatients with acute deep venous thrombosis of the lower limbs. J Vasc Surg 2014; 59(5): 1362-67.

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management were younger and otherwise healthier than those receiving in-hospital care. To correct for this inherent bias, the investigators performed a propensity score-matching analysis using a logistic regression model including the clinical characteristics of the patients, risk factors for VTE, and underlying diseases to get the propensity score to be treated at home versus in the hospital. The investigators monitored data quality regularly both electronically and by periodic visits to participating hospitals by a contract research organization that compared submitted data to source documents.

As much as possible, treatment was standardized between both groups, essentially initial therapy with low-molecular-weight heparin converted to vitamin K antagonists. Patients who were initially treated with unfractionated heparin, thrombolytics, oral direct Xa or IIa inhibitors were excluded. Patients who received no anticoagulation and those treated with an IVC filter were also excluded from analysis.

When patients were hospitalized, the median duration of hospital stay was 6 days with a mean of 10.5 days. At the beginning of the study period, only 16% of patients were treated at home, which gradually increased to 50% by the end of the study period.

The complications of pulmonary embolism and bleeding were low in both treatment groups. What was impressive was that case fatality rates of PE and major bleeding were 22% and 22.9% respectively.

The findings of this study have been confirmed in prior randomized trials, to which the authors refer in their manuscript.

Patients treated at home with low-molecular-weight heparin as a lead in to a vitamin K antagonist had fewer VTE recurrences and major bleeding events as well as a lower mortality than patients receiving in-hospital care. Patients enjoyed a better quality of life when they received treatment at home. It is evident that there are enormous cost savings when hospitalizations are avoided.

Certain patients, such as those with symptomatic occlusive iliofemoral venous thrombosis may be better served by an initial treatment strategy of thrombus removal, 2 3 4which of course will be associated with obligate hospitalization. These patients may safely receive initial anticoagulation and have their hospitalization coordinated within several days of their initial presentation. Hospital stay would then be minimized, and in most cases should be less than the mean or even median of the hospitalized patients reported by Lozano et al.

2 Comerota AJ, Throm RC, Mathias SD, Haughton S, Mewissen M. Catheter-directed thrombolysis for iliofemoral deep venous thrombosis improves healthrelated quality of life. J Vasc Surg 2000; 32(1): 130-7.

3 Elsharway M, Elzayat E. Early results of thrombolysis vs anticoagulation in iliofemoral venous thrombosis. A randomized clinical trial. Eur J Vasc Endovasc Surg 2002; 24(3): 209-14.

4 Enden T, Haig Y, Klow NE, et al. Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomized controlled trial. Lancet 2012; 379(9810): 31-38.

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In summary, this is another important contribution from the RIETE registry. Their observation that hospitalization does not confer any survival advantage over treatment at home and that outpatient therapy may in fact be safer in most patients becomes particularly pertinent in this age of target specific oral anticoagulants. As is becoming increasingly evident, the need for self-administered heparin as initial therapy is no longer necessary. The safety and efficacy of the target specific oral anticoagulants have that established.5 6 The observations from this study confirm the advantage of outpatient therapy in the majority of patients with acute DVT.

5 Bauersachs R, Berkowitz SD, Brenner, B, et al, for The EINSTEIN Investigators. Oral Rivaroxaban for Symptomatic Venous Thromboembolism. N Engl J Med 2010; 363(26):2499-510.

6 Agnelli G, Buller HR, Cohen A, et al, for the AMPLIFY Investigators. N Engl J Med 2013; 369(9): 799-808.

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