Phlebology Forum September - October 2013

SEPTEMBER - OCTOBER 2013

Penicillin to prevent recurrent Leg cellulitus PAGE 7

Endovenous management of venous leg ulcers PAGE 11

sep - oct ‘13

From the Editor-in-Chief Dr. Nick Morrison

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Contributing Editor/Reviewer: Robert A. Weiss, MD, FAAD Associate Editor: Mark Forrestal, MD, FACPh

Endovenous management of venous leg ulcers Contributing Editor/Reviewer: Stephen F. Daugherty, MD, FACS, RVT, RPhS Associate Editor: Eric Mowatt-Larssen MD, FACPh, RPhS

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contents

Penicillin to prevent recurrent leg cellulitus

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Name

ACP Role

Date Submitted

Disclosure

Stephanie Dentoni, MD

Recruitment & Retention (Chair)

6/25/12

Nothing to Disclose

Mark Forrestal, MD, FACPh

ACP

6/25/12

New Star Lasers Cooltouch: Speaker, Trainer

Mitchel Goldman, MD, FACPh

Phlebology Forum Task Force

2/14/2013

American Society for Dermatologic Surgery, President, Merz Aesthetics/Kreussler, Consultant

Jean-Jerome Guex, MD, FACPh

ACP BOD, Communications, Standing Committee, Leadership Development, UIP 2013 Task Force, AMA HOD Task Force, International Affairs (Chair),

6/14/12

Kreussler: Speaker; Sigvaris: Speaker, Investigator, Consultant; Innotech: Principal Investigator; Pierre Fabre: Consultant; Boerighr Ingelheim: Consultant, Medical Writer; Servier: Investigator, Consultant, Speaker

Lowell Kabnick, MD, FACS, FACPh

UIP 2013 Task Force

7/17/12

Angiodynamics: Consultant, Shareholder, Patent; Vascular Insights: Scientific Advisory Board

Neil Khilnani, MD, FACPh

ACP BOD, Member Services (Chair)

7/24/12

Sapheon: Data Safety Board Member

Ted King, MD, FAAFP, FACPh

ACP BOD, Leadership Development, PES-QM Task Force, Public Education

6/14/12

BTG: Investigator; Merz: Speaker

Mark Meissner, MD

ACP BOD, Education Standing Committee

7/13/12

Nothing to Disclose

Nick Morrison, MD, FACS, FACPh

UIP 2013 Task Force (Chair), Phlebology Forum Task Force (Chair), Annual Congress Planning Committee (Chair)

6/13/12

Medi: Speakers Bureau; Merz: Speakers Bureau; Sapheon: Principle Investigator; VeinX: Scientific Advisory Board

Eric Mowatt-Larssen, MD

ACP CME Committee

6/25/12

BTG International, Inc.: Consultant

Diana Neuhardt, RVT, RPhS

ACP BOD, Member Services, Audit, UIP 2013 Task Force, Phlebology Forum Task Force, Veinline, Recruitment & Tetention, CME, Distance Learning, Public Education (Chair)

6/15/12

Nothing to Disclose

Pauline RaymondMartimbeau, MD, FACPh

UIP 2013 Task Force

6/22/12

Nothing to Disclose

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From the

Editor-in-Chief Dear Readers This edition of Phlebology Forum concerns the higher “C� classification patients for which appropriate treatment often is difficult to determine and implement. These two articles and reviews should help the practitioner sort out and clarify some of these difficulties.

I would like to take this opportunity to personally thank everyone involved in a very successful UIP World Congress in Boston, hosted by the President of the International Union of Phlebology, Angelo Scuderi. First and foremost I believe you will agree that the Scientific Chair, Mark Meissner, and his committee (Tony Gasparis, Steve Zimmet, JJ Guex, Tom Wakefield, Mel Rosenblatt, and Nicos Labropoulos) put together one of the most comprehensive scientific meetings ever for the UIP. The ACP staff contributed a tremendous amount of work over the past 5 years for which I am greatly indebted. And finally I wish to thank all of the volunteers from the ACP, the AVF, and international societies who worked countless hours to bring the United States onto the world stage of Phlebology.

Congratulations to the Australasian College of Phlebology and its President, Kurosh Parsi, for their successful bid to hold the XVIII UIP World Congress in 2017-18 in Melbourne. As President and President-Elect of the UIP, Angelo Scuderi and I look forward to seeing you at the next UIP Regional Meeting in Seoul, South Korea, under the direction of Professor Dong-Ik Kim. Nick Morrison, MD Editor-in-Chief Phlebology Forum

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Penicillin to Prevent Recurrent Leg Cellulitus Author: Thomas KS, Crook AM, Nunn AJ, Foster KA, Mason JM,, et al.

N Engl J Med. 2013 May 2;368(18):1695703. doi: 10.1056/NEJMoa1206300 Contributing Editor/Reviewer: Robert A. Weiss, MD, FAAD Associate Editor: Mark Forrestal, MD, FACPh

Summary This study compared prophylactic low-dose penicillin versus placebo for the prevention of recurrent cellulitis in patients (N=274) who have had two or more episodes of recurrent cellulitis . Prophylaxis was provided for 12 months.

Subjects were recruited in a hospital clinic or through direct advertising. Patients who had had a recurrent episode of leg cellulitis within the previous 24 weeks were eligible for inclusion. Patients were considered to have recurrent cellulitis if they had had at least two episodes of lower leg cellulitis within the

Patients with a high BMI, preexisting edema, or

previous 3 years as diagnosed by a dermatologist .

at least three episodes

Participants received low-dose oral penicillin (250

of previous cellulitis

mg) or placebo twice daily after completion of treatment for the episode of cellulitis previous to enrollment in the study. The primary outcome measure was the duration from recruitment

were less likely to have a response to prophylaxis

into the study to the next medically confirmed episode of cellulitis. Results detailed that median time to the first confirmed recurrence of cellulitis was 626 days in the penicillin group and 532 days in the placebo group. During the prophylaxis phase, 30 of 136 participants who received penicillin (22%) had a recurrence, as compared with 51 of 138 participants who received placebo (37%) In the placebo group, 53% of participants had at least one recurrence during the 3-year trial. Patients with a high BMI, preexisting edema, or at least three episodes of previous cellulitis were less likely to have a response to prophylaxis.

Commentary This study further clarifies the current guidelines for the prevention of cellulitis. While it is known that recurrent cellulitis is common among patients who have previously had two or more episodes, the best antibiotic, correct dose or duration of treatment are not agreed upon. The main cause of cellulitis is group A streptococci, for which resistance to penicillin has not yet occurred to any clinically significant degree.

The study data clearly demonstrated that low-dose prophylactic penicillin given for a period of 12 months approximately halved the risk of recurrence. Furthermore, patients who received prophylaxis had significantly fewer recurrent episodes over the 3-year period than those who received placebo. This study is well planned and executed.

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It adds significant new information to the management of recurrent cellulitis. This trial provides solid evidence that patients with two or more episodes of leg cellulitis should be given prophylactic penicillin 250 BID for 12 months to reduce recurrent cellulitis without any increase in adverse effects. As each recurrent episode of cellulitis results in further damage to the lymphatic system with additional morbidity, long term prophylaxis is clearly indicated.

The most problematic patients are those with a BMI of 33 or higher, multiple previous episodes of cellulitis, or lymphedema of the leg, who had a reduced likelihood of a response to prophylaxis. As the authors suggest, the poor treatment response in participants with a high BMI may mean that a higher dose of penicillin is required in these patients. Reducing edema with compression in patients with leg lymphedema may also be helpful to reduce risks of recurrent cellulitis. This is not addressed.

Additional problems with the study are that patients are not evaluated in terms of severity of CVI, there is no data on CEAP class or duplex ultrasound findings of the superficial and deep venous systems. Collecting this data might help define those patients who are more likely to benefit from prophylaxis or who might achieve long-term clearance of cellulitis by intervention.

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Endovenous management

of venous leg ulcers Author: Seshadri Raju, Orla K. Kirk, Tamekia L. Jones Journal of Vascular Surgery: Venous and Lymphatic Disorders, Volume 1, Issue 2, Pages 165-172 Contributing Editor/Reviewer: Stephen F. Daugherty, MD, FACS, RVT, RPhS Associate Editor: Eric Mowatt-Larssen MD, FACPh, RPhS

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ABSTRACT Compression therapy has been standard management for venous leg ulcers (VLU) for thousands of years. Treatment of saphenous vein reflux has been viewed until recently as a means to reduce the rate of ulcer recurrence, but not to shorten ulcer healing time. This series of 192 consecutive limbs treated with endovenous techniques for VLU after failed conservative treatment at one center from July, 2000 through September, 2011 is analyzed.

Thirty limbs were treated with endovenous saphenous LASER ablation alone, 89 were treated with iliac vein stenting, and 69 were treated with both technologies. Residual deep vein reflux was not treated. Compression was continued if it was in use prior to the intervention, but compression was not added for those who previously had not been using compression. Thirtyeight percent of patients did not use elastic compression. Local care consisted of cleansing and an absorbent, nonadherent dressing without aggressive debridement or topical chemicals or antibiotics.

One of the most important findings is the frequency of iliac vein obstruction in VLU patients.

Endovenous saphenous ablation was performed in limbs with a refluxing saphenous vein 5 mm or greater in diameter and no clinical indication of iliac vein obstruction such as limb swelling or severe diffuse limb pain. Combined saphenous vein ablation and iliac vein stenting were performed if the refluxing saphenous vein diameter was <5 mm and if symptoms of iliac vein obstruction were dominant in the presence of intravascular ultrasound (IVUS) findings of obstruction. Iliac vein stenting alone was performed for iliac vein obstruction in the absence of saphenous vein reflux.

By 14 weeks after treatment, 81% of the ulcers up to 1 inch in diameter healed, but only 15% of the larger ulcers healed.

By 23 weeks, only 23% of the larger ulcers healed. Healing time was not observed to be affected by post-thrombotic etiology, presence of uncorrected deep vein reflux, demographics, or compression stocking use. There were 47 unhealed ulcers or recurrences (24%) and 5 of those involved stent occlusions or stenosis. At 5 years, 87% of the non-thrombotic limbs and 66% of the post-thrombotic limbs remained healed. Long term ulcer healing was inferior in limbs with a reflux segment score of 3 or more, but 66% of the post-thrombotic patients with a score of 3 or more remained healed.

The recommended algorithm to treat VLU is to treat the saphenous reflux in a saphenous vein 5 mm or larger in diameter. If no significant saphenous reflux is identified, IVUS examination and stenting of iliac vein stenosis, if found, is recommended. If a refluxing saphenous vein is less than 5 mm in diameter, combined saphenous vein ablation and

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IVUS with iliac vein stenting (if iliac vein stenosis is identified) are recommended for consideration. An adjunctive therapy suggested is local ablation of a refluxing perforating vein beneath an ulcer bed in a non-thrombotic limb.

Commentary This is an important report which should stimulate a paradigm change in the way we evaluate and treat patients with VLU. One of the most important findings is the frequency of iliac vein obstruction in VLU patients. The authors treated 158 of 192 patients with iliac vein stents with or without saphenous ablation. Some may argue that the criteria for iliac vein stenting are too liberal (>50% cross-sectional area stenosis by IVUS or the finding of “balloon waisting”), but the median cross-sectional area stenosis by IVUS was 70%.

The authors utilize venography and IVUS to evaluate VLU patients who have signs suggesting iliac vein obstruction.

While CT or MR venography may be highly specific for significant iliac vein stenosis, they are insensitive and highly dependent upon technique and interpretive skill. Trans-abdominal color duplex ultrasound (CDU) is very dependent upon technologist skill and effort, but it is much more sensitive in our experience because the anatomic findings may be correlated with hemodynamic changes at the lesion or abnormal flow in collateral veins before and after treadmill exercise. IVUS provides excellent anatomic measurements, but it remains unsettled as to what represents a hemodynamically significant stenosis. Our experience is that iliac vein lesions which are found by CDU to be hemodynamically significant almost always are associated with a >50% diameter stenosis by IVUS which usually is considerably worse than a 50% cross-sectional area stenosis. Dr. Raju utilizes balloon-waisting to identify lesions missed by IVUS and we occasionally note such a lesion.

Raju argues for identification of obstruction and reflux in the VLU patient with failed conservative treatment and for treatment of the causes of venous hypertension rather than prolonged aggressive local ulcer care with multiple debridements and expensive wound care programs. His data support treatment of small ulcers though results with large ulcers are less impressive.

This report reviews consecutive patients treated after failed conservative therapy of an unspecified duration and there is no control group of patients continuing conservative care. Additionally, the criteria for stenting are anatomic and are not fully accepted. Dr. Raju notes that “rigorous comparative trials” are needed to establish validity of variant findings. The most interesting of these is the apparent failure of elastic compression to affect healing time. I urge those who read this report not to abandon compression and perhaps consider the use of inelastic compression as an alternative.

I believe that the evidence is sufficient to encourage early identification and treatment of iliac vein obstruction and/or saphenous vein reflux in VLU patients. Randomized controlled clinical trials need to be performed to better delineate

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the best technologies to identify clinically significant iliac vein stenosis and the role of compression after endovenous treatment in ulcer healing time and prevention of recurrent VLU. Earlier ulcer healing and avoidance of protracted, expensive wound care may reduce costs of care and should reduce the costs of disability and travel costs associated with lengthy courses of VLU care.

All physicians who treat VLU should read the entire report carefully. Dr. Raju and colleagues have made important observations which should be understood and further evaluated.

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If you treat or have an interest in venous and lymphatic disease, the ACP is an unequivocal resource for your practice.

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