Phlebology Forum November - December 2013

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NOVEMBER - DECEMBER 2013

Differences in Saphenous Vein Reflux Detection According to Patient Positioning PAGE 8

Evaluation of surveillance bias and the validity of the venous thromboembolism quality measure PAGE 19



nov-dec ‘13

From the Editor-in-Chief

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Nick Morrison, MD, FACS, FACPh, RPhS

Contributing Editor/Reviewer: Attilio Cavezzi, MD Associate Editor: Diana Neuhardt, RVT, RPhS

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Frequency of Malignant Neoplasms in 257 Chronic Leg Ulcers

Compression Stockings after Endovenous Laser Ablation of the Great Saphenous Vein: A Prospective Randomized Controlled Trial

Contributing Editor/Reviewer: Tania Phillips, MD

Contributing Editor/Reviewer: Paul Pittaluga MD

Associate Editor: Mitchel Goldman, MD, FACPh

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Associate Editor: Stephanie Dentoni, MD

Evaluation of surveillance bias and the validity of the venous thromboembolism quality measure

Iliac Vein Stenting as a Durable Option for Residual Stenosis after CatheterDirected Thrombolysis and Angioplasty of Iliofemoral Deep Vein Thrombosis Secondary to May-Thurner Syndrome

Contributing Editor/Reviewer: Fedor Lurie, MD, PhD

Contributing Editor/Reviewer: Seshadri Raju, MD, FACS

Associate Editor: Mark Forrestal, MD, FACPh

contents

Differences in Saphenous Vein Reflux Detection According to Patient Positioning

19

Associate Editor: Lowell Kabnick, MD, FACS, FACPh

22

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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 (President-Elect)

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

5


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From the

Editor-in-Chief Dear Readers Welcome to the final issue of Phlebology Forum for 2013. Included are a number of articles and reviews on a variety of venous topics: from the basics of appropriate patient positioning for duplex evaluation to the association of malignant neoplasms and non-healing leg ulcers; from an examination of the necessity of compression following superficial venous treatment to a discussion of the necessity of stenting following thrombolytic/angioplasty treatment of iliofemoral DVT in compression syndromes; and an evaluation of bias in the validity thrombembolism quality measure, which could dramatically affect the availability of care for patients with these life-threatening problems in pay-for-performance programs. I believe you will find that the reviews of these articles are well-reasoned and add significant perspective from expert investigators.

I wish to thank our editorial board for their insightful work this past year, I hope for our readers a wonderful holiday respite with family and friends, and I look forward to another great year for Phlebology Forum in 2014. Nick Morrison, MD Editor-in-Chief Phlebology Forum

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Differences in Saphenous Vein Reflux Detection According to Patient Positioning Author: Marresa Houle, BS, RVT; Diana L. Neuhardt, RVT; Nicole T. Straight, CRT; Sergio X. Salles-Cunha, PhD, RVT, FSVU The Journal for Vascular Ultrasound 37(2):81–84, 2013 Contributing Editor/Reviewer: Attilio Cavezzi, MD Associate Editor: Diana Neuhardt, RVT , RPhS

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ABSTRACT The authors investigated by means of colour-duplex ultrasound (CDU) in different positions 40 limbs of 20 female patients, mean age 54 years, affected by varicose veins. In order to achieve uniformity in the sample cohort several exclusion criteria were fixed prior to the study. The aim was to show any difference in saphenous reflux detection using a standardized protocol but different patient position: a) supine, b) reverse Trendelenburg and c) standing. The great saphenous vein (GSV) was measured and tested at 6 different levels (three in the thigh and three in the calf), whereas the small saphenous vein (SSV) was measured and tested at three different levels. Common femoral vein/saphenofemoral junctions (CFV/SFJ) were measured and tested as well. Reflux above 1

...in order to obtain higher accuracy and lower false negative rate, the authors emphasize the need of the standing position for female

second was considered a pathologic finding. A

patients with varicose veins to

total of 171 measurement comparisons were made

be investigated by means of

and false-negative (FN) results were calculated for standing and non standing positions compared

colour-duplex ultrasound.

with positive results obtained in the other position.

FN results in the non standing position were 49% (16/33), 38% (12/32), 27% (12/45), and 26% (9/35) for GSV in the leg, GSV in the thigh, SSV, and CFV/SFJ, respectively. FN results for the standing position were 6% (1/18) and 7% (2/28) for GSV in the leg and CFV/SFJ, respectively. Statistical analysis showed a significant difference with p value of 0.05 for CFV/SFJ or 0.002 for GSV in the leg.

In conclusion, in order to obtain higher accuracy and lower FN rate, the authors emphasize the need of the standing position for female patients with varicose veins to be investigated by means of CDU.

Commentary The need to standardise CDU investigation in chronic venous diseases led UIP and several experts to develop and publish a few documents containing recommendations for pre-post/operative duplex investigation in varicose vein/chronic venous disease (1-3). Basically the standing position of the patient has been strictly recommended in these consensus documents when investigating superficial veins, whereas supine position or sitting position can be used for deep veins and perforators respectively.

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This article elegantly demonstrates superiority of standing position over supine or reverse Trendelemburg position in varicose vein CDU examination.

From the pathophysiologic point of view eliciting reflux involves two components: the energy (pressure gradient) and the necessary compliance (4). Pressure gradient is created by Valsalva manoeuvre for patients in supine position and standing position, while distal compression/release manoeuvre is mostly used for patients standing. Compliance is lower with Valsalva in standing position than in supine position, but this is just the opposite when using the compression/release manoeuvre. Furthermore transmural pressure dramatically changes in standing vs. supine position, so vein calibre obviously increases in erect position, which significantly facilitates CDU assessment of vein morphology and hemodynamics. The authors focused their work on women only, but we can likely extrapolate these outcomes to the male population as well.

As the authors correctly pointed out GSV terminal/pre-terminal valves were not taken into consideration and this may have been a little limitation of the study, but as a matter of fact false negative CDU examinations are much more common with patients in the lying position.

In the supine/reverse Trendelenburg positions compression/release is not adequate, hence only the Valsalva maneuver is employed. The Valsalva maneuver transmits hyperpressure distal to competent valves (see the vein dilation below a competent valve), but this effect decreases over distance. Conversely gravitational gradient takes place with the distal compression/release maneuver in the standing position, independent of possible competent valves above the targeted area of investigation.

One final brief comment on the fainting issue for patients in the standing position: in our experience more than 99,5% showed no problems of dizziness or fainting during routine CDU investigation in standing patients, especially when limiting duration of Valsalva maneuver.

Notwithstanding the universally accepted necessity to have patients in the upright position when performing CDU investigation of varicose patients, still, relevant differences exist in protocols of different teams from different countries. For this and other reasons this article is to be considered of significant utility in clinical practice, and also the paper highlights the need for standardization in methods of CDU examination, in order to compare similar prepost/treatment findings.

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Frequency of Malignant Neoplasms in 257 Chronic

Leg Ulcers Author: Misciali C , Dika E, Fanti PA et al Dermatol Surg 2013; 39; 849-854 Contributing Editor/Reviewer: Tania Phillips, MD Associate Editor: Mitchel Goldman, MD, FACPh


ABSTRACT This was an observational study of 257 chronic leg ulcers seen during a 3-year period at the University of Bologna. All patients admitted to the wound unit with ulcers were biopsied. Ten patients were found to have ulcers of neoplastic origin. The majority of these (9) were basal cell carcinomas. One patient had an ulcerated porocarcinoma (sweat gland carcinoma.) Mean duration of leg ulcers before a diagnosis of skin cancer was made was 3.3 years(range 6 moths to 10 years) Most of the malignant ulcers were larger than 5cm². Clinically the ulcers appear to show granulation with frequent bleeding and little or no response to conventional medical treatments. Overall, approximately 4% of the total number of patients in the series had ulcerated skin cancers. This study illustrates the importance of routine screening of chronic leg ulcers for underlying malignancy, particularly those that are of long-standing duration and not responding to conventional treatment.

Commentary

It...seems very reasonable to consider a wound biopsy in a chronic ulcer which is not responding to standard care.

It is important to consider the possibility of underlying malignancy in chronic wounds that fail to heal. In 1828, Marjolin first described malignant changes in ulcerated chronic burn scars.

Since then, there have been reports of malignant changes in chronic wounds of various etiologies, including radiotherapy sites, osteomyelitis, pressure ulcers and more rarely, venous ulcers. Traditionally squamous cell carcinomas have been reported in venous ulcers. In 1991, we published a small series of seven basal cell carcinomas (BCC) presenting as non-healing venous leg ulcers1. All the ulcers appeared clinically benign, with apparently healthy granulation tissue at the base and none of the classic signs of BCC. In our clinic the overall incidence of BCC in leg ulcers was high, (9%). Another publication documented histologic evidence of multifocal BCC development in skin adjacent to venous ulcers2. The authors suggested that chronic venous insufficiency can induce epidermal hyperplasia which might lead to frank basal cell carcinomatous changes. It has been suggested that vascular insufficiency may be associated with altered local immunity and over-expression of proto-oncogenes3. In 2012 a prospective cross-sectional study was performed to determine the frequency of skin cancers associated with chronic leg ulcers that had failed 1 Phillips TJ, Salman S, Rogers GS Non healing leg ulcer; a manifestation of basal cell carcinoma Journal of the American Academy of Dermatology 1991; 25: 47-49]. 2 Black MM Walkden VM Basal cell carcinomatous changes on the lower leg, a possible association with venous stasis Histopathology 1983; 7: 219-227 3 Oahes N Phillips TJ Park H. Expression of c fos and h ras proto-oncogenes is induced in human chronic wounds, Dermatologic Surgery 1998; 24: 1354-8

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to heal despite 3 months or more of appropriate treatment4. 144 patients had at least 2 6mm skin punch biopsies performed, one at the wound edge, and one in the wound bed, in the most clinically suspicious areas. This group of patients was found to have an overall skin cancer frequency of 10.4%: nine squamous cell, 5 basal cell carcinomas, 1 melanoma, and 1 leiomyosarcoma. Fifty-three percent of the ulcers had persisted for at least 3 years. In this study wound area or duration was not significantly associated with skin cancer. However, older patient age, abnormal excessive granulation tissue at the wound edges, high clinical suspicion of cancer, and number of biopsies were significantly associated with skin cancer.

In these 2 recently published prospective studies skin cancer rates in non-healing, chronic leg ulcers were high. It is possible that previously published retrospective reviews may be have underestimated the risk of skin cancers in chronic leg ulcers.

It, therefore, seems very reasonable to consider a wound biopsy in a chronic ulcer which is not responding to standard care. Some physicians may hesitate to perform biopsies of wounds due to concerns about possible infection or wound enlargement. However, we have found that wound biopsy sites in chronic wounds heal rapidly and do not result in delayed overall healing of the wound. We do not suture the biopsy site and use an absorbable gelatin sponge or alginate dressing for hemostasis.

There is no consensus about when a wound should be biopsied to exclude malignancy. Some researchers recommend early biopsy of wounds within 2 weeks of non-healing. Other guidelines recommend biopsy between 6 weeks – 3 months5. Based upon my personal experience I would recommend routine biopsy of chronic wounds that have not healed or shown any signs of improvement despite 3 months of good wound care, including well-applied compression bandaging. Wounds that have hyperkeratotic borders, heaped up granulation tissue, or a nodular appearance are biopsied immediately. Misciali et al recommend biopsy specimens both from the border and the bed of the ulcer. While this is usually adequate, sometimes it may be necessary to perform multiple punch biopsies, or even a wedge biopsy to ascertain the diagnosis. If the wound is large or the index of suspicion is high sampling error can always be a problem. I have followed several patients who had multiple biopsies performed which were negative for skin cancer but eventually turned out to have positive pathology on the 4th or 5th biopsy. Wounds in an unusual location, or on a background of photodamaged skin, are also biopsied early. One should always consider malignancy in any leg ulcer that fails to heal.

4 Senet P, Combemale P, Debure C et al Malignancy and Chronic Ulcers Arch Dermatolol 2012;148: 704-708 5 Bennet et al and Robson MC et al, Guidelines for the treatment of venous ulcers. Wound repair regeneration 2006; 14: 649-662

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Compression Stockings after Endovenous Laser Ablation of the Great Saphenous Vein: A Prospective Randomized Controlled Trial Author: N.A. Bakker and coll. Eur J Vasc Endovasc Surg. 2013 Nov;46(5):588-92. doi: 10.1016/j.ejvs.2013.08.001. Epub 2013 Sep 5. Contributing Editor/Reviewer: Paul Pittaluga MD Associate Editor: Stephanie Dentoni, MD

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ABSTRACT The objective of this paper was to determine if the duration of wearing compression stockings after endovenous laser ablation (EVLA) of the great saphenous vein (GSV) matters for the postoperative pain and quality of life (QoL).

The design consisted of an RCT evaluating the wearing continually day and night of a compression stocking (thigh stocking 35 mmHg), splitting the patients in two groups; a group A (n=37) in which the compression stocking was worn for 48 hours and a group B (n=32) in which the duration of the wearing was extended to 7 days after the treatment. The patient characteristics were comparable in both groups.

The treatment consisted of endovenous laser ablation (EVLA) of the GSV at the thigh using an 810nm diode laser with a bare-tip fiber (14 W, continuous mode, 70J/mm) under perivascular local tumescent anesthesia, and with no additional treatment on varicose tributaries.

...the conclusion is against the recent trend to reduce the time of wearing the post-procedure compression...

At 1 week of follow-up, the results showed significantly better outcomes in group B for the QoL physical function and vitality score (SF-36) (respectively 95.7 vs 85.1 P<.001 and 83.7 vs 75 P<.03), and for the pain score (visual analog scale) (2.0 vs 3.7 P<.001). No difference was observed between both groups for the QoL or the pain scores at 48 hours and 6 weeks postop.

The authors concluded that the wearing of a compression stocking longer than 2 days after EVLA of the GSV at the thigh has a positive influence on pain and QoL.

COMMENTARY It is usual to recommend the wearing of compression stockings after treatment of varicose veins by surgery, endovenous treatment or by sclerotherapy1 with the objective to reduce the short term side-effects and complications after the treatment.

1 Partsch H, Flour M, Smith PC; International Compression Club. Indications for compression therapy in venous and lymphatic disease consensus based on experimental data and scientific evidence. Under the auspices of the IUP. Int Angiol. 2008;27(3):193-219.

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But there are contradictory observations in the literature for the benefit of a compression stocking after treatment for varicose veins, and especially it is unclear what duration of wearing is the most appropriate. Indeed, some recent studies have reported that this duration can be short after surgery2 or even that there is no evidence for a benefit to wearing compression after treatment for limiting side-effects 3.

In this interesting well-designed RCT, the conclusion is against the recent trend to reduce the time of wearing the postprocedure compression, since the study suggests that a longer duration than 2 days improves the postoperative course for the QoL and the pain, even if the procedure is minimally-invasive, with EVLA performed under tumescent local anesthesia without any additional treatment of the tributaries.

However, with regards to the procedure performed in this paper, some limitations have to be pointed out. As the authors mentioned, one of these limitations is that the EVLA was done using a 810 nm diode laser with bare-tip fiber. Several studies have shown that this wavelength and type of fiber results in more postoperative side effects than the higher wavelength lasers such as the 1470 nm endovenous laser, especially with a radial fiber which reduces the perforations of the GSV with less hematoma, ecchymosis and pain4 . It has to be noted that in this paper the frequency of hematoma after the EVLA was high in both groups (61.1% and 50%) and it is interesting to observe that there was no significant advantage in group B for reducing this postoperative side-effect despite a longer duration of wearing the compression stocking.

Another explanation of the benefit for a longer duration for the wearing of the compression stocking which was shown in this study could be the absence of treatment on the varicose tributaries, which can be associated with more postoperative symptoms because of the persistence of the venous clusters after the procedure, with a risk of superficial thrombosis, which is not precisely reported by the authors.

In addition it is not clear if additional sedation was used during the EVLA procedure.

We have recently reported a prospective controlled study5 showing no value in wearing the compression stocking after surgical treatment of varicose veins beyond the 1st postoperative day for pain, ecchymosis, the QoL or for the

2 O’Hare JL, Stephens J, Parkin D, Earnshaw JJ. Randomized clinical trial of different bandage regimens after foam sclerotherapy for varicose veins. Br J Surg. 2010;97:650-6. 3 Houtermans-Auckel JP, van Rossum E, Teijink JA, Dahlmans AA, Eussen EF, Nicolaï SP, Welten RJ. To wear or not to wear compression stockings after varicose vein stripping: a randomised controlled trial. Eur J Vasc Endovasc Surg. 2009;38:387-9 4 Pannier F, Rabe E, Rits J, Kadiss A, Maurins U. Endovenous laser ablation of great saphenous veins using a 1470 nm diode laser and the radial fibre--followup after six months. Phlebology. 201;26:35-9 5 Partsch H, Flour M, Smith PC; International Compression Club. Indications for compression therapy in venous and lymphatic disease consensus based on experimental data and scientific evidence. Under the auspices of the IUP. Int Angiol. 2008;27(3):193-219.

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prevention of thrombosis evaluated one week after a surgical treatment. But we have highlighted in our paper that all surgical procedures were done with a very minimally-invasive approach (large volume local tumescent anesthesia, micro-incisions, precise skin-marking), with extensive ablation of the clusters and immediate and active ambulation.

Even if the study of Bakker and coll. is interesting and has to be taken in account, it doesn’t clarify well enough the genuine benefit of compression stockings after an EVLA because of several limitations, in particular the use of a 810 nm laser known for being associated with more common side effects compared to higher wavelength lasers reported more recently.

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Evaluation of surveillance bias and the validity of the venous thromboembolism quality measure Author: Bilimoria KY, Chung J, Ju MH, Haut ER, Bentrem DJ, Ko CY, Baker DW. JAMA. 2013 Oct 9;310(14):1482-9. Contributing Editor/Reviewer: Fedor Lurie, MD, PhD Associate Editor: Mark Forrestal, MD, FACPh

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abstract Postoperative venous thromboembolism (VTE) rates are widely reported quality metrics soon to be used in payfor-performance programs. These metrics are potentially subjected to a surveillance bias, which occurs when some clinicians use imaging studies to detect VTE more frequently than other clinicians. Because they look more, they find more VTE events, paradoxically worsening their

...hospitals with higher quality scores had higher

hospital’s VTE quality measure performance.

VTE prophylaxis

This study was designed to examine whether a

rates but worse

surveillance bias influences the validity of reported VTE rates. 2010 Hospital Compare and American Hospital Association data from 2838 hospitals were merged. Next, 2009-2010 Medicare claims data for 954,926 surgical patient discharges from 2786 hospitals that were undergoing 1 of 11 major operations were used to calculate VTE imaging (duplex ultrasonography, chest computed tomography/magnetic resonance imaging, and

risk-adjusted VTE rates, because they search more frequently for VTE.

ventilation-perfusion scans) and VTE event rates. The association between hospital VTE prophylaxis adherence and risk-adjusted VTE event rates was examined. The relationship between a summary score of hospital structural characteristics reflecting quality (hospital size, numbers of accreditations/quality initiatives) and performance on VTE prophylaxis and risk-adjusted VTE measures was examined.

The study has demonstrated that greater hospital VTE prophylaxis adherence rates were weakly associated with worse risk-adjusted VTE event rates (r2 = 4.2%; P = .03). Hospitals with increasing structural quality scores had higher VTE prophylaxis adherence rates (93.3% vs 95.5%, lowest vs highest quality quartile; P < .001) but worse risk-adjusted VTE rates (4.8 vs 6.4 per 1000, lowest vs highest quality quartile; P < .001). Mean VTE diagnostic imaging rates ranged from 32 studies per 1000 in the lowest imaging use quartile to 167 per 1000 in the highest quartile (P < .001). Risk-adjusted VTE rates increased significantly with VTE imaging use rates in a stepwise fashion, from 5.0 per 1000 in the lowest quartile to 13.5 per 1000 in the highest quartile (P < .001).

The authors concluded that hospitals with higher quality scores had higher VTE prophylaxis rates but worse riskadjusted VTE rates. Increased hospital VTE event rates were associated with increasing hospital VTE imaging use rates. Surveillance bias limits the usefulness of the VTE quality measure for hospitals working to improve quality and patients seeking to identify a high-quality hospital.

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Commentary The authors of this paper have carefully examined the effect of surveillance bias on the validity of VTE rate as a quality measure. They performed three separate analyses1. Using national hospital-level data they examined the relationship between hospital’s adherence to VTE prophylaxis and VTE rates.1-2 Using the same data they analyzed the relationship between general quality standing of a hospital and the rates of VTE3. Using patient-level Medicare claims data, they analyzed relationship between rates of VTE imaging and VTE events.

Instead of finding the expected relationship between higher VTE prophylaxis adherence rates and lower VTE events rates, they found that hospitals with higher quality standing have higher VTE rates, and that hospital adherence to VTE prophylaxis is associated with increasing VTE rates. Not surprisingly, they found that more imaging is associated with higher VTE incidence. The latter is an explanation for the former. Higher quality hospitals are also more adherent to VTE prevention, and perform more imaging studies, which results in higher apparent VTE rate. The real problem is that hospitals with lower adherence to VTE prevention perform less imaging studies, decreasing the rate of diagnosed VTE. This study confirms two previous reports showing no association between adherence to VTE prevention and VTE rates.1-2 By performing rigorous scientific analysis, the authors pointed at a substantial flaw in current and future healthcare policies. The risk-adjusted postoperative VTE rate measure is incorporated in multiple quality improvement programs and public reporting initiatives. The result may be misrepresentation of the true quality of a hospital in public reporting and performance-based payments. This publication is especially timely, since the Centers for Medicare & Medicaid Services included this measure in 2015 Value-based Purchasing program.

It is interesting to note the disconnect between current evidence-based guidelines for VTE prevention that steer away from overutilization of imaging for suspected VTE and the quality metrics that use mandatory imaging. Existence of such metrics paradoxically leads to increased rates of chemoprophylaxis in low-risk populations, and increase use of inferior vena cava filters. 3

The results of this study provide a solid basis for the authors’ conclusion that “the publically reported VTE outcome measure reflects the intensity of VTE imaging rather than actual quality of care and should likely not be used for accountability purposes in quality measurement.”

1 Altom LK, Deierhoi RJ, Grams J, Richman JS, Vick CC, Henderson WG, Itani KM, Hawn MT. Association between Surgical Care Improvement Program venous thromboembolism measures and postoperative events. Am J Surg. 2012 Nov;204(5):591-7. 2 Nicholas LH, Osborne NH, Birkmeyer JD, Dimick JB. Hospital process compliance and surgical outcomes in medicare beneficiaries. Arch Surg. 2010 Oct;145(10):999-1004. 3 Baker DW, Qaseem A. Evidence-based performance measures: preventing unintended consequences of quality measurement. Ann Intern Med. 2011 Nov 1;155(9):638-40.

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Iliac Vein Stenting as a Durable Option for Residual Stenosis after CatheterDirected Thrombolysis and Angioplasty of Iliofemoral Deep Vein Thrombosis Secondary to May-Thurner Syndrome Authors: Park, J. Y, Ahn, J. H, Jeon, Y. S, Cho, S. G, Kim, J. Y and Hong, K. C. Phlebology; Epublished date: 2013/06/14 Contributing Editor/Reviewer: Seshadri Raju, MD, FACS Associate Editor: Lowell Kabnick, MD, FACS, FACPh


ABSTRACT The authors review their experience with lytic treatment of iliac vein thrombosis associated with May-Thurner syndrome (MTS) over a 6 year period (2005-2011). The diagnosis was made with a combination of duplex and CTV imaging. IVUS was not available for use. The median age was 70 (range 44-86). Catheter directed thrombolysis (CDT) with Urokinase alone was used in nearly 2/3 of patients; pharmaco-mechanical thrombolysis (PMT) as an adjunct or alone was used in the rest. A temporary vena cava filter was used in nearly all the patients but it was retrieved in only 41%. All patients received a stent post-lysis to correct the MTS lesion. The majority (84%) of stents used were 14 mm in diameter with a few 12 mm stents in the rest. Procedural complications were few (4%) related to the access site. There were no major bleeds or mortality. Late complications included recurrent thrombosis or DVT in 8%. Cumulative stent patency at 2 years was 84%. No follow up clinical results are reported.

Commentary This report highlights the current practice standard of aggressively treating iliac vein thrombosis with lytic

This report highlights the current practice standard of aggressively treating iliac vein thrombosis with lytic regimens. A majority of such patients will require venous stenting to correct an underlying stenosis.

regimens. A majority of such patients will require venous stenting to correct an underlying stenosis. As usual in a rapidly evolving field, management details vary between institutions and one can find areas of controversy to argue about. A listing of current controversies with a brief commentary on each follows:

1. Use of temporary IVC filter during lytic regimens. Some centers (including our own) do not employ temporary filters and have had no adverse consequences. Others, perhaps a majority, use them on the valid argument that even a single instance of pulmonary embolus is one too many. The problem is that the bulk of “removable” filters are never removed with a high incidence (≈50%) of filter related complications such as filter site stenosis or IVC thrombosis which prompted a recent advisory warning from the FDA. A consensus seems to be emerging that use of a permanent filter with a documented low complication rate may be indicated because of a “floating” thrombus or continuing threat of recurrent thromboembolism.1

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2. Method of thrombolysis An early concern with catheter directed thrombolysis (CDT) was the occasional but unpredictable incidence of hemorrhagic stroke. This threat has diminished with reduced lytic dosing (strength and duration) and exclusion of older patients (>60). The advent of PMT devices represents a major treatment paradigm shift. In most patients lysis is achieved with PMT alone, used in a single short session2 without major bleeding or mortality. This means older patients may be considered and hospital stay and costs can be reduced.

1 Sharifi M, Bay C, Skrocki L, Lawson D, Mazdeh S. Role of IVC filters in endovenous therapy for deep venous thrombosis: the FILTER-PEVI (filter implantation to lower thromboembolic risk in percutaneous endovenous intervention) trial. Cardiovascular and interventional radiology.2012; 35: 1408-13

2 Stanley GA, Murphy EH, Plummer MM, Chung J, Mordall JG, Arko FR. Midterm results of percutaneous endovascular treatment for acute and chronic deep venous thrombosis. J Vasc surg Venous and Lym dis.2013; 1: 52-8.

March 27-29-2014 Club Med Trancoso-BA - Brazil Before

We are pleased to welcome you to participate in the International Meeting on Aesthetic Phlebology. Plan your trip to interact with IMAP and enjoy the gorgeous Club Med Trancoso, Brazil. The core of IMAP is Clinica Miyake’s 51 years' experience on leg vein treatment with an important concern on the aesthetic point of view. We will also share the results we have gotten since we tested the ďŹ rst VeinViewer prototype in 2005. As IMAP is a problem based learning event, share your experience with the audience. One big room and plenty time for discussion.

After

Photography, tennis, golf and archery contest for those who plan to spend the whole week (pre-congress, hands-on activities from 24th to 27th and IMAP from 27th to 29th March 2014) Warm regards Kasuo Miyake, MD, PhD President of IMAP www.congressovenoso.com facebook.com/phlebologymeeting

Augmented Reality: a milestone in Phlebology

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3. Technique of venous stenting IVUS is emerging as the gold standard in assessment of iliac vein lesions. It is superior to venography to guide stent placement.3 MTS lesions resulting in thrombosis are intraluminal and may not be visible on contrast based imaging.4

The purpose of venous stenting is not merely to establish patency but reduce peripheral venous hypertension which is the basis of post-thrombotic syndrome (PTS). Adequate peripheral venous decompression may not be achieved unless the recanalized segment is stented with large caliber stents approximating normal venous lumen.5 The common iliac vein in an adult has a diameter of about 16 mm. We recommend the use of 18 mm diameter stents dilated to 16 mm. Use of undersized stents may lead to migration, embolization or thrombosis. Importantly, they may saddle the patient with a permanent iatrogenic stenosis, nearly impossible to correct.

4. Is thrombolysis the optimal standard of care in iliac vein thrombosis ? Definitive evidence to support this notion is lacking. Several multi-center trials are ongoing to answer this question. Current practice has outpaced evidence because several surrogate markers for post-thrombotic syndrome (PTS) argue for establishment of flow in the iliac vein segments. Occlusion of this pivotal outflow is associated with a high incidence of PTS and residual lesions that predispose to re-thrombosis - a major factor in PTS evolution. PTS may not manifest in a proportion of patients until after years or even decades had passed following the initial thrombotic event, when re-thrombosis or other insult decompensates a previously damaged venous system that had remained occult without symptoms.4

What should a physician advise the patient in the interim pending a definitive answer? wThe best practice is to remove the clot pending evidence to the contrary emerging in the future.

3 Neglen P, Hollis KC, Olivier J, Raju S. Stenting of the venous outflow in chronic venous disease: long-term stent-related outcome, clinical, and hemodynamic result. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter.2007; 46: 979-90. 4 Raju S, Oglesbee M, Neglen P. Iliac vein stenting in postmenopausal leg swelling. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter.2011; 53: 123-30.

5 Raju S, Kirk O, Davis M, Olivier J. Hemodynamics of ‘critical’ venous stenosis and stent treatment. J Vasc Surg: venous & Lym Dis Epublished July 18, 2013.

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fellowship in vein care at NYU train in the treatment of deep and superficial venous disease at one of the nation’s leading institutions for vascular medicine.

In partnership with the New York Univeristy Langone Medical Center, the American College of Phlebology (ACP) is offering a fellowship to qualified candidates, which provides 12-months of postgraduate training in the AMA self-designated practice specialty of phlebology. The program is designed to train fellows in the diagnosis and treatment of both deep and superficial venous disease through a comprehensive curriculum of fundamental principles, diagnostic evaluation, treatment and adjunctive education. Fellows will train with NYU Vein Center Director and Phlebology Program Director, Lowell Kabnick, MD, FACS, FACPh, RPhS. Dr. Kabnick is an internationally recognized leader in the field of vein care and has pioneered several breakthrough technologies for treating the underlying causes of many vein problems. In addition, fellows will learn from twelve physicians in the Division of Vascular and Endovascular Surgery under the leadership of Dr. Mark Adelman.

apply today For more information and to apply, please contact: Felicia Brockett Fellowship Coordinator Vascular Surgery NYU Department of Surgery e: Felicia.Brockett@nyumc.org p: 212-263-6378

advancing vein care

www.phlebology.org

510.346.6800


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