今日の臨床サポート

静脈瘤

著者: 古森公浩 名古屋大学大学院医学系研究科血管外科

監修: 今井靖 自治医科大学 薬理学講座臨床薬理学部門・内科学講座循環器内科学部門

著者校正済:2021/08/04
現在監修レビュー中
参考ガイドライン:
日本静脈学会:下肢静脈瘤に対する血管内焼灼術のガイドライン2019
日本静脈学会:下肢静脈瘤に対するシアノアクリレート系接着材による血管内治療のガイドライン
患者向け説明資料

概要・推奨   

  1. 下肢静脈瘤の患者に対しては、CEAP分類を用いて臨床的重症度や病態を評価することを推奨する(推奨度1)。
  1. 超音波検査は、下肢静脈瘤患者に対する第1選択の診断学的検査である(推奨度1)。
  1. 空気容積脈波法(air plethysmography、APG)は、静脈還流機能を評価する無侵襲的検査法として有用である(推奨度2)。
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要と なります。閲覧に はご契約が必要と なります。閲覧にはご契約が必要となります。閲覧にはご契約が
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要
薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
古森公浩 : 奨学(奨励)寄付など(第一三共,日本ゴア,テルモ)[2021年]
監修:今井靖 : 講演料(第一三共株式会社)[2021年]

改訂のポイント:
  1. 定期レビューを行い、手術適応、手術の選択について加筆修正を行った。 

病態・疫学・診察

疾患情報(疫学・病態)  
  1. 静脈瘤とは静脈が拡張、蛇行している状態で、静脈血の還流障害を来した形態的、機能的障害である。
  1. 静脈瘤は下肢に好発し、女性に多く、血管疾患のなかで最も頻度の高い疾患で、30歳以上では62%のなんらかのタイプの静脈がみられる[1]
  1. 基本的には良性疾患であるが、慢性進行性であるため、放置すれば美容上の問題だけでなく、日常生活に支障を来す種々の静脈うっ滞症状を合併するようになることがある。
  1. 静脈瘤が一次性(原発性)か二次性(続発性)によって治療法が異なるが、理学的所見や機能的、画像的診断法などから客観的に評価、鑑別し、早期より患者のニーズに合わせた的確な治療を開始する必要がある。
 
慢性静脈不全症例134例におけるVFI値による症状の出現頻度

VFIの正常値は2mL/秒以下である。VFIが高値であればあるほど、症状の発現頻度が増加する。

出典

img1:  Venous reflux: quantification and correlation with the clinical severity of chronic venous disease.
 
 Br J Surg. 1988 Apr;75(4):352-6.
問診・診察のポイント  
  1. 下肢静脈瘤の危険因子を確認する。

これより先の閲覧には個人契約のトライアルまたはお申込みが必要です。

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文献 

著者: Peter Gloviczki, Anthony J Comerota, Michael C Dalsing, Bo G Eklof, David L Gillespie, Monika L Gloviczki, Joann M Lohr, Robert B McLafferty, Mark H Meissner, M Hassan Murad, Frank T Padberg, Peter J Pappas, Marc A Passman, Joseph D Raffetto, Michael A Vasquez, Thomas W Wakefield, Society for Vascular Surgery, American Venous Forum
雑誌名: J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
Abstract/Text The Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) have developed clinical practice guidelines for the care of patients with varicose veins of the lower limbs and pelvis. The document also includes recommendations on the management of superficial and perforating vein incompetence in patients with associated, more advanced chronic venous diseases (CVDs), including edema, skin changes, or venous ulcers. Recommendations of the Venous Guideline Committee are based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system as strong (GRADE 1) if the benefits clearly outweigh the risks, burden, and costs. The suggestions are weak (GRADE 2) if the benefits are closely balanced with risks and burden. The level of available evidence to support the evaluation or treatment can be of high (A), medium (B), or low or very low (C) quality. The key recommendations of these guidelines are: We recommend that in patients with varicose veins or more severe CVD, a complete history and detailed physical examination are complemented by duplex ultrasound scanning of the deep and superficial veins (GRADE 1A). We recommend that the CEAP classification is used for patients with CVD (GRADE 1A) and that the revised Venous Clinical Severity Score is used to assess treatment outcome (GRADE 1B). We suggest compression therapy for patients with symptomatic varicose veins (GRADE 2C) but recommend against compression therapy as the primary treatment if the patient is a candidate for saphenous vein ablation (GRADE 1B). We recommend compression therapy as the primary treatment to aid healing of venous ulceration (GRADE 1B). To decrease the recurrence of venous ulcers, we recommend ablation of the incompetent superficial veins in addition to compression therapy (GRADE 1A). For treatment of the incompetent great saphenous vein (GSV), we recommend endovenous thermal ablation (radiofrequency or laser) rather than high ligation and inversion stripping of the saphenous vein to the level of the knee (GRADE 1B). We recommend phlebectomy or sclerotherapy to treat varicose tributaries (GRADE 1B) and suggest foam sclerotherapy as an option for the treatment of the incompetent saphenous vein (GRADE 2C). We recommend against selective treatment of perforating vein incompetence in patients with simple varicose veins (CEAP class C(2); GRADE 1B), but we suggest treatment of pathologic perforating veins (outward flow duration ≥500 ms, vein diameter ≥3.5 mm) located underneath healed or active ulcers (CEAP class C(5)-C(6); GRADE 2B). We suggest treatment of pelvic congestion syndrome and pelvic varices with coil embolization, plugs, or transcatheter sclerotherapy, used alone or together (GRADE 2B).

Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
PMID 21536172  J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/・・・
著者: P Coleridge-Smith, N Labropoulos, H Partsch, K Myers, A Nicolaides, A Cavezzi
雑誌名: Eur J Vasc Endovasc Surg. 2006 Jan;31(1):83-92. doi: 10.1016/j.ejvs.2005.07.019. Epub 2005 Oct 14.
Abstract/Text OBJECTIVES: Duplex ultrasound investigation has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this paper was an initiative of the Union Internationale de Phlébologie (UIP). The aim was to obtain a consensus of international experts on the methodology to be used for assessment of veins in the lower limb by ultrasound imaging.
DESIGN: Consensus conference leading to a consensus document.
METHODS: The authors invited a group of experts from a wide range of countries to participate in this project. Electronic submissions from the experts were made available to all participants via the UIP website. The authors prepared a draft document for discussion at a UIP Chapter meeting held in San Diego, USA in August 2003. Following this meeting a revised manuscript was circulated to all participants and further comments were received by the authors and included in subsequent versions of the manuscript. Eventually all participants agreed the final version of the paper.
RESULTS: The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination as well as the interpretation of images and measurements obtained. This document suggests a methodology for complete assessment of the superficial and perforating veins of the lower limbs, including recommendations on reporting results and training of personnel involved in these investigations.
CONCLUSIONS: The authors and a large group of experts have agreed a methodology for the investigation of the lower limbs venous system by duplex ultrasonographpy.

PMID 16226898  Eur J Vasc Endovasc Surg. 2006 Jan;31(1):83-92. doi: 10・・・
著者: D G Christopoulos, A N Nicolaides, G Szendro, A T Irvine, M L Bull, H H Eastcott
雑誌名: J Vasc Surg. 1987 Jan;5(1):148-59.
Abstract/Text Leg volume changes during exercise have been measured in absolute units (milliliters) by means of a new method of air-plethysmography. Venous volume (VV), venous filling time, and venous filling index on standing from the recumbent position, ejected volume (EV) and ejection fraction (EF = EV x 100/VV) with one tiptoe movement, and residual volume (RV) and residual volume fraction (RVF = RV x 100/VV) after 10 tiptoe movements were measured in normal limbs, limbs with superficial venous incompetence, and limbs with deep venous disease. The same measurements were repeated with a graduated medium compression stocking in limbs with SVI and graduated high compression stockings in limbs with DVD. Ambulatory venous pressure was measured at the same time, with a needle in a vein in the foot. The results indicate that this method of air-plethysmography is not only of diagnostic value but offers a new and unique technique to assess and study the hemodynamic effects of different forms of elastic compression. The lower ambulatory venous pressure, produced by the elastic compression, was the result of a reduction in reflux and an improvement in the calf muscle ejecting ability during rhythmic exercise.

PMID 3795381  J Vasc Surg. 1987 Jan;5(1):148-59.
著者: A N Nicolaides, Cardiovascular Disease Educational and Research Trust, European Society of Vascular Surgery, ,The International Angiology Scientific Activity Congress Organization, International Union of Angiology, Union Internationale de Phlebologie at the Abbaye des Vaux de Cernay
雑誌名: Circulation. 2000 Nov 14;102(20):E126-63.
Abstract/Text This consensus document provides an up-to-date account of the various methods available for the investigation of chronic venous insufficiency of the lower limbs (CVI), with an outline of their history, usefulness, and limitations. CVI is characterized by symptoms or signs produced by venous hypertension as a result of structural or functional abnormalities of veins. The most frequent causes of CVI are primary abnormalities of the venous wall and the valves and secondary changes due to previous venous thrombosis that can lead to reflux, obstruction, or both. Because the history and clinical examination will not always indicate the nature and extent of the underlying abnormality (anatomic extent, pathology, and cause), a number of diagnostic investigations have been developed that can elucidate whether there is calf muscle pump dysfunction and determine the anatomic extent and severity of obstruction or reflux. The difficulty in deciding which investigations to use and how to interpret the results has stimulated the development of this consensus document. The aim of this document was to provide an account of these tests, with an outline of their usefulness and limitations and indications of which patients should be subjected to the tests and when and of what clinical decisions can be made. This document was written primarily for the clinician who would like to learn the latest approaches to the investigation of patients with CVI and the new applications that have emerged from recent research, as well as for the novice who is embarking on venous research. Care has been taken to indicate which methods have entered the clinical arena and which are mainly used for research. The foundation for this consensus document was laid by the faculty at a meeting held under the auspices of the American Venous Forum, the Cardiovascular Disease Educational and Research Trust, the European Society of Vascular Surgery, the International Angiology Scientific Activity Congress Organization, the International Union of Angiology, and the Union Internationale de Phlebologie at the Abbaye des Vaux de Cernay, France, on March 5 to 9, 1997. Subsequent input by co-opted faculty members and revisions in 1998 and 1999 have ensured a document that provides an up-to-date account of the various methods available for the investigation of CVI.

PMID 11076834  Circulation. 2000 Nov 14;102(20):E126-63.
著者: D Christopoulos, A N Nicolaides, G Szendro
雑誌名: Br J Surg. 1988 Apr;75(4):352-6.
Abstract/Text Air-plethysmography has been used to measure, in ml and in ml 100 ml-1 of tissue, the blood volume that filled the leg veins on changing posture from the recumbent position to standing. The venous filling index (VFI) (average filling range) was measured in ml s-1 and in ml 100 ml-1 min-1. We studied 24 normal legs (N), 21 with primary varicose veins without chronic swelling, skin changes (liposclerosis, eczema, pigmentation) or ulceration (PVV) and 59 with chronic swelling and/or skin changes and/or ulceration; of these 59 legs, 31 had primary varicose veins (PVV/S) and 28 had popliteal reflux (PR). The classification was done according to clinical examination, Duplex scanning, ambulatory venous pressure measurements and venography. There was an increased incidence of sequelae with increasing values of VFI. The incidence of these sequelae was irrespective of whether reflux was in the deep or in the superficial veins. VFI is a practical non-invasive measurement of reflux. It should be used to study the effect of therapy and particularly to evaluate new reconstructive procedures designed to abolish reflux in the deep veins.

PMID 3359149  Br J Surg. 1988 Apr;75(4):352-6.
著者: Bo Eklöf, Robert B Rutherford, John J Bergan, Patrick H Carpentier, Peter Gloviczki, Robert L Kistner, Mark H Meissner, Gregory L Moneta, Kenneth Myers, Frank T Padberg, Michel Perrin, C Vaughan Ruckley, Philip Coleridge Smith, Thomas W Wakefield, American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification
雑誌名: J Vasc Surg. 2004 Dec;40(6):1248-52. doi: 10.1016/j.jvs.2004.09.027.
Abstract/Text The CEAP classification for chronic venous disorders (CVD) was developed in 1994 by an international ad hoc committee of the American Venous Forum, endorsed by the Society for Vascular Surgery, and incorporated into "Reporting Standards in Venous Disease" in 1995. Today most published clinical papers on CVD use all or portions of CEAP. Rather than have it stand as a static classification system, an ad hoc committee of the American Venous Forum, working with an international liaison committee, has recommended a number of practical changes, detailed in this consensus report. These include refinement of several definitions used in describing CVD; refinement of the C classes of CEAP; addition of the descriptor n (no venous abnormality identified); elaboration of the date of classification and level of investigation; and as a simpler alternative to the full (advanced) CEAP classification, introduction of a basic CEAP version. It is important to stress that CEAP is a descriptive classification, whereas venous severity scoring and quality of life scores are instruments for longitudinal research to assess outcomes.

PMID 15622385  J Vasc Surg. 2004 Dec;40(6):1248-52. doi: 10.1016/j.jvs・・・
著者: A Fletcher, N Cullum, T A Sheldon
雑誌名: BMJ. 1997 Sep 6;315(7108):576-80.
Abstract/Text OBJECTIVE: To estimate the clinical and cost effectiveness of compression systems for treating venous leg ulcers.
METHODS: Systematic review of research. Search of 19 electronic databases including Medline, CINAHL, and Embase. Relevant journals and conference proceedings were hand searched and experts were consulted.
MAIN OUTCOME MEASURES: Rate of healing and proportion of ulcers healed within a time period.
STUDY SELECTION: Randomised controlled trials, published or unpublished, with no restriction on date or language, that evaluated compression as a treatment for venous leg ulcers.
RESULTS: 24 randomised controlled trials were included in the review. The research evidence was quite weak: many trials had inadequate sample size and generally poor methodology. Compression seems to increase healing rates. Various high compression regimens are more effective than low compression. Few trials have compared the effectiveness of different high compression systems.
CONCLUSIONS: Compression systems improve the healing of venous leg ulcers and should be used routinely in uncomplicated venous ulcers. Insufficient reliable evidence exists to indicate which system is the most effective. More good quality randomised controlled trials in association with economic evaluations are needed, to ascertain the most cost effective system for treating venous leg ulcers.

PMID 9302954  BMJ. 1997 Sep 6;315(7108):576-80.
著者: H Partsch, M Flour, P Coleridge Smith, International Compression Club
雑誌名: Int Angiol. 2008 Jun;27(3):193-219.
Abstract/Text AIM: The aim of this study was to review published literature concerning the use of compression treatments in the management of venous and lymphatic diseases and establish where reliable evidence exists to justify the use of medical compression and where further research is required to address areas of uncertainty.
METHODS: The authors searched medical literature databases and reviewed their own collections of papers, monographs and books for papers providing information about the effects of compression and randomized clinical trials of compression devices. Papers were classified in accordance with the recommendations of the GRADE group to categorize their scientific reliability. Further classification was made according to the particular clinical problem that was addressed in the papers. The review included papers on compression stockings, bandages and intermittent pneumatic compression devices.
RESULTS: The International Compression Club met once in Vienna and corresponded by email in order to reach an agreement of how the data should be interpreted. A wide range of compression levels was reported to be effective. Low levels of compression 10-30 mmHg applied by stockings are effective in the management of telangiectases after sclerotherapy, varicose veins in pregnancy, the prevention of edema and deep vein thrombosis (DVT). High levels of compression produced by bandaging and strong compression stockings (30-40 mmHg) are effective at healing leg ulcers and preventing progression of post-thrombotic syndrome as well as in the management of lymphedema. In some areas no reliable evidence was available to permit recommendations of level of compression or duration of treatment. These included: management of varicose veins to prevent progression, following surgical treatment or sclerotherapy for varicose veins, and the level of compression required to treat acute DVT.
CONCLUSION: This review shows that whilst good evidence for the use of compression is available in some clinical indications, there is much still to be discovered. Little is know about dosimetry in compression, for how long and at what level compression should be applied. The differing effects of elastic and short-stretch compression are also little understood.

PMID 18506124  Int Angiol. 2008 Jun;27(3):193-219.
著者: J C Mayberry, G L Moneta, L M Taylor, J M Porter
雑誌名: Surgery. 1991 May;109(5):575-81.
Abstract/Text A nonoperative approach to venous stasis ulceration of the lower extremity, consisting of initial bedrest, ulcer cleansing, dressing changes, and ambulatory elastic compression stocking therapy, has been maintained for over 15 years. All patients had class III, severe chronic venous insufficiency. One hundred five of 113 patients (93%) experienced complete ulcer healing in a mean of 5.3 months. One hundred two patients were compliant with elastic compression stockings, and 11 patients were noncompliant. Complete ulcer healing occurred in 99 of 102 patients (97%) who were compliant versus six of 11 patients (55%) who were noncompliant (p less than 0.0001). The influence of noncompliance, previous venous ulceration, previous venous surgery, previous known deep venous thrombosis, peripheral arterial insufficiency (ankle brachial systolic blood pressure index less than or equal to 0.60), pretreatment ulcer duration, ulcer size, age, sex, diabetes, smoking, and photoplethysmography venous refill time on ulcer healing was determined by logistic regression analysis. Only noncompliance with elastic compression stockings (p less than 0.0001) and a pretreatment ulcer duration of more than 9 months (p = 0.02) significantly decreased initial ulcer healing. Posthealing follow-up was available in 73 patients for a mean of 30 months. Fifty-eight patients (79%) continued to be compliant with stockings; 15 patients were noncompliant. Total ulcer recurrence in patients who were compliant was 16%. Five-year lifetable recurrence was 29%. All patients who were noncompliant had recurrent ulceration by 36 months. Previous ulceration, previous venous surgery, and peripheral arterial insufficiency had no effect on ulcer recurrence (p greater than 0.05).

PMID 2020902  Surgery. 1991 May;109(5):575-81.
著者: M R Perrin, J J Guex, C V Ruckley, R G dePalma, J P Royle, B Eklof, P Nicolini, G Jantet
雑誌名: Cardiovasc Surg. 2000 Jun;8(4):233-45.
Abstract/Text
PMID 10950599  Cardiovasc Surg. 2000 Jun;8(4):233-45.
著者: Craig Nesbitt, Ron Kg Eifell, Peter Coyne, Hassan Badri, Vish Bhattacharya, Gerard Stansby
雑誌名: Cochrane Database Syst Rev. 2011 Oct 5;(10):CD005624. doi: 10.1002/14651858.CD005624.pub2. Epub 2011 Oct 5.
Abstract/Text BACKGROUND: Minimally invasive techniques to treat great saphenous varicose veins include ultrasound-guided foam sclerotherapy (USGFS), radiofrequency ablation (RFA) and endovenous laser therapy (EVLT). Compared with conventional surgery (high ligation and stripping (HL/S)), proposed benefits include fewer complications, quicker return to work, improved quality of life (QoL) scores, reduced need for general anaesthesia and equivalent recurrence rates.
OBJECTIVES: To review available randomised controlled clinical trials (RCT) data comparing USGFS, RFA, EVLT to HL/S for the treatment of great saphenous varicose veins.
SEARCH STRATEGY: The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialised Register (July 2010) and CENTRAL (The Cochrane Library 2010, Issue 3). In addition the authors performed a search of EMBASE (July 2010). Manufacturers of EVLT, RFA and sclerosant equipment were contacted for trial data.
SELECTION CRITERIA: All RCTs of EVLT, RFA, USGFS and HL/S were considered for inclusion. Primary outcomes were recurrent varicosities, recanalisation, neovascularisation, technical procedure failure or need for re-intervention, patient quality of life (QoL) scores and associated complications. Secondary outcomes were type of anaesthetic, procedure duration, hospital stay and cost.
DATA COLLECTION AND ANALYSIS: CN, RE, VB, PC, HB and GS independently reviewed, assessed and selected trials which met the inclusion criteria. CN and RE extracted data. The Cochrane Collaboration's tool for assessing risk of bias was used. CN contacted trial authors to clarify details.
MAIN RESULTS: Thirteen reports from five studies with a combined total of 450 patients were included. Rates of recanalisation were higher following EVLT compared with HL/S, both early (within four months) (5/149 versus 0/100; odds ratio (OR) 3.83, 95% confidence interval (CI) 0.45 to 32.64) and late recanalisation (after four months) (9/118 versus 1/80; OR 2.97 95% CI 0.52 to 16.98), although these results were not statistically significant. Technical failure rates favoured EVLT over HL/S (1/149 versus 6/100; OR 0.12, 95% CI 0.02 to 0.75). Recurrence following RFA showed no difference when compared with surgery. Recanalisation within four months was observed more frequently following RFA compared with HL/S although not statistically significant (4/105 versus 0/88; OR 7.86, 95% CI 0.41 to 151.28); after four months no difference was observed. Neovascularisation was observed more frequently following HL/S compared with RFA, but again this was not statistically significant (3/42 versus 8/51; OR 0.39, 95% CI 0.09 to 1.63). Technical failure was observed less frequently following RFA compared with HL/S although this was not statistically significant (2/106 versus 7/96; OR 0.48, 95% CI 0.01 to 34.25). No randomised clinical trials comparing HL/S versus USGFS met our study inclusion criteria. QoL scores and operative complications were not amenable to meta-analysis.
AUTHORS' CONCLUSIONS: Currently available clinical trial evidence suggests RFA and EVLT are at least as effective as surgery in the treatment of great saphenous varicose veins. There are insufficient data to comment on USGFS. Further randomised trials are needed. We should aim to report and analyse results in a congruent manner to facilitate future meta-analysis.

PMID 21975750  Cochrane Database Syst Rev. 2011 Oct 5;(10):CD005624. d・・・
著者: Renate van den Bos, Lidia Arends, Michael Kockaert, Martino Neumann, Tamar Nijsten
雑誌名: J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.
Abstract/Text BACKGROUND: Minimally invasive techniques such as endovenous laser therapy, radiofrequency ablation, and ultrasound-guided foam sclerotherapy are widely used in the treatment of lower extremity varicosities. These therapies have not yet been compared with surgical ligation and stripping in large randomized clinical trials.
METHODS: A systematic review of Medline, Cochrane Library, and Cinahl was performed to identify studies on the effectiveness of the four therapies up to February 2007. All clinical studies (open, noncomparative, and randomized clinical trials) that used ultrasound examination as an outcome measure were included. Because observational and randomized clinical trial data were included, both the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) and Quality Of Reporting Of Meta-analyses (QUORUM) guidelines were consulted. A random effects meta-analysis was performed, and subgroup analysis and meta-regression were done to explore sources of between-study variation.
RESULTS: Of the 119 retrieved studies, 64 (53.8%) were eligible and assessed 12,320 limbs. Average follow-up was 32.2 months. After 3 years, the estimated pooled success rates (with 95% confidence intervals [CI]) for stripping, foam sclerotherapy, radiofrequency ablation, and laser therapy were about 78% (70%-84%), 77% (69%-84%), 84% (75%-90%), and 94% (87%-98%), respectively. After adjusting for follow-up, foam therapy and radiofrequency ablation were as effective as surgical stripping (adjusted odds ratio [AOR], 0.12 [95% CI, -0.61 to 0.85] and 0.43 [95% CI, -0.19 to 1.04], respectively). Endovenous laser therapy was significantly more effective compared with stripping (AOR, 1.13; 95% CI, 0.40-1.87), foam therapy (AOR, 1.02; 95% CI, 0.28-1.75), and radiofrequency ablation (AOR, 0.71; 95% CI, 0.15-1.27).
CONCLUSION: In the absence of large, comparative randomized clinical trials, the minimally invasive techniques appear to be at least as effective as surgery in the treatment of lower extremity varicose veins.

PMID 18692348  J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2・・・
著者: M Hassan Murad, Fernando Coto-Yglesias, Magaly Zumaeta-Garcia, Mohamed B Elamin, Murali K Duggirala, Patricia J Erwin, Victor M Montori, Peter Gloviczki
雑誌名: J Vasc Surg. 2011 May;53(5 Suppl):49S-65S. doi: 10.1016/j.jvs.2011.02.031.
Abstract/Text OBJECTIVES: Several treatment options exist for varicose veins. In this review we summarize the available evidence derived from comparative studies about the relative safety and efficacy of these treatments.
METHODS: We searched MEDLINE, Embase, Current Contents, Cochrane Central Register of Controlled Trials (CENTRAL) expert files, and the reference section of included articles. Eligible studies compared two or more of the available treatments (surgery, liquid or foam sclerotherapy, laser, radiofrequency ablations, or conservative therapy with compression stockings). Two independent reviewers determined study eligibility and extracted descriptive, methodologic, and outcome data. We used random-effects meta-analysis to pool relative risks (RR) and 95% confidence intervals (CI) across studies.
RESULTS: We found 39 eligible studies (30 were randomized trials) enrolling 8285 participants. Surgery was associated with a nonsignificant reduction in the risk of varicose vein recurrence compared with liquid sclerotherapy (RR, 0.56; 95% CI, 0.29-1.06) and all endoluminal interventions (RR, 0.63; 95% CI, 0.37-1.07). Studies of laser and radiofrequency ablation and foam sclerotherapy demonstrated short-term effectiveness and safety. The quality of evidence presented in this review was limited by imprecision (small number of events), short-term follow-up, and indirectness (use of surrogate outcomes).
CONCLUSION: Low-quality evidence supports long-term safety and efficacy of surgery for the treatment of varicose veins. Short-term studies support the efficacy of less invasive treatments, which are associated with less periprocedural disability and pain.

Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
PMID 21536173  J Vasc Surg. 2011 May;53(5 Suppl):49S-65S. doi: 10.1016・・・
著者: Nick Morrison, Kathleen Gibson, Michael Vasquez, Robert Weiss, Andrew Jones
雑誌名: J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):978-989. doi: 10.1016/j.jvsv.2019.12.080. Epub 2020 Mar 20.
Abstract/Text OBJECTIVE: The proprietary cyanoacrylate closure (CAC) system vs radiofrequency ablation (RFA) trial (VenaSeal Sapheon Closure System Pivotal Study [VeClose]) showed that CAC, a nontumescent, nonthermal, nonsclerosant ablation technique, was effective and noninferior to RFA in vein closure with good 36-month outcomes. Conducted under a separate protocol, the aim of this extended follow-up was to assess the long-term safety and effectiveness of CAC and RFA for the treatment of incompetent great saphenous veins (GSV) at 5 years (60 months) of follow-up.
METHODS: This 60-month extension study was conducted for all patients who completed the randomized VeClose study and who were willing to participate. The pivotal VeClose study included patients with symptomatic moderate to severe varicosities (Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] class C2-C4b) and symptomatic GSV incompetence who were randomly assigned (1:1) to either CAC or RFA. The primary outcome measure of this 60-month extension study was complete closure of the target vein, with planned exploratory analysis of noninferiority. Secondary outcomes included CEAP class; completion of the Venous Clinical Severity Score, EuroQol-Five Dimension survey, and Aberdeen Varicose Vein Questionnaire; patient satisfaction with treatment; adverse events (AEs) related to target GSV; and details of adjunctive procedures.
RESULTS: A total of 89 patients completed the 60-month visit, which included 47 from the CAC group, 33 from the RFA group, and 9 CAC roll-in patients. No new recanalization events have been observed in the groups between 36 and 60 months of follow-up. At 60 months, Kaplan-Meier estimates for freedom from recanalization in the randomized CAC and RFA groups were 91.4% and 85.2%, respectively, demonstrating noninferiority of CAC compared with RFA. Both groups demonstrated sustained improvements in EuroQol-Five Dimension and quality of life measures through 60 months. Whereas patients assigned to C0 or C1 clinical class were excluded from the original study, more than half of all returning patients (64% [57/89]) were now assigned to C0 or C1, suggesting an improved clinical class from baseline. Furthermore, 41.1% of returning CAC patients and 39.4% of returning RFA patients are presently at least two CEAP clinical classes lower than at baseline. No long-term device- or procedure-related serious AEs occurred in either group between 36- and 60-month follow-up.
CONCLUSIONS: CAC and RFA were effective in achieving complete target vein closure of the GSV at long-term follow-up, with CAC demonstrating continued noninferiority to RFA. CAC was also associated with sustained improvements in symptoms and quality of life, lower CEAP class, and high level of patient satisfaction without serious AEs between 36 and 60 months.

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.
PMID 32205125  J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):978-98・・・
著者: Erdinc Eroglu, Alptekin Yasim
雑誌名: Eur J Vasc Endovasc Surg. 2018 Oct;56(4):553-560. doi: 10.1016/j.ejvs.2018.05.028. Epub 2018 Jul 2.
Abstract/Text OBJECTIVE: To compare early and two year results for N-butyl cyanoacrylate (NBCA), radiofrequency ablation (RFA), and endovenous laser ablation (EVLA) in the treatment of varicose veins.
METHODS: This was a randomised clinical trial. Five hundred and twenty five patients were blindly randomised into NBCA, RFA, and EVLT groups (175 patients to each group; block randomisation using sealed envelopes). Four hundred and fifty six patients were monitored for 2 years (ultrasound at 2 days, and 6, 12, and 24 months). The primary endpoint was the saphenous vein occlusion rates, and the secondary endpoints were peri- and post-procedural pain, complications, and time to return to work. No simultaneous phlebectomies were performed.
RESULTS: The numbers of patients lost to follow up were NBCA seven, RFA 26, and EVLA 36. Occlusion rates were similar at 6, 12, and 24 months (6 months [NBCA 98.1%, RFA 94.1%, and EVLA 95.1%, p = .14], 1 year [NBCA 94.7%, RFA 92.5%, and EVLA 94.2%, p = .72], 2 years [NBCA 92.6%, RFA 90.9%, and EVLA 91.5%, p = .89]). Peri-procedural pain was significantly lower after NBCA (p < .001), but complication rates (DVT, bleeding, and phlebitis) were similar. Time to return to work was shortest after NBCA (NBCA 1.04 days, RFA 1.56 days and EVLA 1.31 days (p < .001) with 95% (NBCA), 50% (RFA) and 75% (EVLA) of patients returning to work on Day 1. Pre-procedural venous clinical severity scores (VCSSs) were the same in all groups. A decrease was observed in VCSS values in all groups at 6 months, and this persisted at 1 and 2 years. However, VCSS scores at 6 months and 2 years were significantly lower in the NBCA group (p < .001). Foam sclerotherapy was subsequently applied to varicose tributaries in 18 patients from all groups.
CONCLUSION: No differences were observed in occlusion rates between the three modalities, but NBCA appeared superior with respect to peri-procedural pain, return to work and decreased VCSS.

Copyright © 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
PMID 30042039  Eur J Vasc Endovasc Surg. 2018 Oct;56(4):553-560. doi: ・・・
著者: Cornelis G Vos, Çağdaş Ünlü, Jan Bosma, Clarissa J van Vlijmen, A Jorianne de Nie, Michiel A Schreve
雑誌名: J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):880-896. doi: 10.1016/j.jvsv.2017.05.022. Epub 2017 Jul 21.
Abstract/Text BACKGROUND: Endothermal treatment of the great saphenous vein (GSV) has become the first-line treatment for superficial venous reflux. Nonthermal ablation has potential benefits for acceptability by patients and decreased risk of nerve injury. We performed a systematic review and meta-analysis to evaluate the efficacy of mechanochemical endovenous ablation (MOCA) and cyanoacrylate vein ablation (CAVA) for GSV incompetence.
METHODS: MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and Cochrane databases were searched for papers published between January 1966 and December 2016. Eligible articles were prospective studies that included patients treated for GSV incompetence and described the primary outcome. Exclusion criteria were full text not available, case reports, retrospective studies, small series (n < 10), reviews, abstracts, animal studies, studies of small saphenous vein incompetence, and recurrent GSV incompetence. Primary outcome was anatomic success. Secondary outcomes were initial technical success, Venous Clinical Severity Score, Aberdeen Varicose Vein Questionnaire score, and complications.
RESULTS: Fifteen articles met the inclusion criteria. Pooled anatomic success for MOCA and CAVA was 94.7% and 94.8% at 6 months and 94.1% and 89.0% at 1 year, respectively. Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire score significantly improved after treatment with MOCA and CAVA.
CONCLUSIONS: These results are promising for these novel techniques that could serve as alternatives for thermal ablation techniques. However, to determine their exact role in clinical practice, high-quality randomized controlled trials comparing these novel modalities with well-established techniques are required.

Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
PMID 29037363  J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):880-89・・・
著者: Daniele Bissacco, Silvia Stegher, Fabio Massimo Calliari, Marco Piercarlo Viani
雑誌名: Minim Invasive Ther Allied Technol. 2019 Feb;28(1):6-14. doi: 10.1080/13645706.2018.1464029. Epub 2018 Apr 19.
Abstract/Text BACKGROUND: To review published evidence regarding an n-butyl-cyanoacrylate (NBCA) injection device for great (GSV) and small (SSV) saphenous vein incompetence in terms of occlusion rate, postoperative complications and quality of life improvement.
MATERIAL AND METHODS: International bibliographic databases (PubMed, EMBASE, Scopus) were searched to identify possible target articles. The only inclusion criterion was the use of the Variclose® system (Biolas, Ankara, Turkey) for superficial vein insufficiency. Exclusion criteria were case reports, review, meta-analysis, article with <6-month follow-up data, abstracts and congress presentations. PRISMA guidelines were used to lead articles selection.
RESULTS: Seven studies were included in the final data analysis. A total of 918 patients (1000 limbs) underwent an NBCA procedure for GSV (947 cases) or SSV (53 cases) incompetence. The average procedure duration was 11.7 min. The most common postoperative complications were postoperative pain (4.8%) and superficial vein thrombosis (2.1%). No deep vein thrombosis or pulmonary embolism cases were described. The occlusion rates at six, 12 and 30 months were 97.3%, 96.8% and 94.1%, respectively.
CONCLUSION: NBCA injection with the Variclose device seems to be a feasible, effective and safe treatment in GSV incompetence. Long-term follow-up studies and randomized controlled trials are needed to achieve high-quality evidence.

PMID 29671660  Minim Invasive Ther Allied Technol. 2019 Feb;28(1):6-14・・・
著者: Michael A Vasquez, Eberhard Rabe, Robert B McLafferty, Cynthia K Shortell, William A Marston, David Gillespie, Mark H Meissner, Robert B Rutherford, American Venous Forum Ad Hoc Outcomes Working Group
雑誌名: J Vasc Surg. 2010 Nov;52(5):1387-96. doi: 10.1016/j.jvs.2010.06.161. Epub 2010 Sep 27.
Abstract/Text In response to the need for a disease severity measurement, the American Venous Forum committee on outcomes assessment developed the Venous Severity Scoring system in 2000. There are three components of this scoring system, the Venous Disability Score, the Venous Segmental Disease Score, and the Venous Clinical Severity Score (VCSS). The VCSS was developed from elements of the CEAP classification (clinical grade, etiology, anatomy, pathophysiology), which is the worldwide standard for describing the clinical features of chronic venous disease. However, as a descriptive instrument, the CEAP classification responds poorly to change. The VCSS was subsequently developed as an evaluative instrument that would be responsive to changes in disease severity over time and in response to treatment. Based on initial experiences with the VCSS, an international ad hoc working group of the American Venous Forum was charged with updating the instrument. This revision of the VCSS is focused on clarifying ambiguities, updating terminology, and simplifying application. The specific language of proven quality-of-life instruments was used to better address the issues of patients at the lower end of the venous disease spectrum. Periodic review and revision are necessary for generating more universal applicability and for comparing treatment outcomes in a meaningful way.

Copyright © 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
PMID 20875713  J Vasc Surg. 2010 Nov;52(5):1387-96. doi: 10.1016/j.jvs・・・
著者: Donna L Lamping, Sara Schroter, Xavier Kurz, Susan R Kahn, Lucien Abenhaim
雑誌名: J Vasc Surg. 2003 Feb;37(2):410-9. doi: 10.1067/mva.2003.152.
Abstract/Text OBJECTIVE: The purpose of this study was to develop a practical and scientifically rigorous, patient-reported outcome measure to evaluate quality of life and symptoms across the range of conditions (eg, telangiectasias, varicose veins, edema, skin changes, leg ulcers) in chronic venous disorders of the leg (CVDL).
METHODS: This study was a psychometric study within the VEnous INsufficiency Epidemiological and Economic Study (VEINES), an international, prospective cohort study to evaluate clinical outcomes, quality of life, costs, and use of health services in CVDL. The study was set in the 166 general practices and 116 specialist clinics in Belgium, France, Italy, and Canada (Quebec) that participated in the VEINES study plus in additional specialist clinics in Ottawa and Montreal. Field testing was carried out in three samples of patients in four countries (Belgium, France, Italy, Canada), including participants in the VEINES study (n dagger 1531) and patients recruited in additional samples of 88 English-speaking patients (Canada) and 53 French-speaking patients (Belgium, France). The reliability and validity sample (n = 615) included 527 VEINES patients and 88 patients from the supplementary English-speaking sample. The test-retest sample (n = 135) included 53 French-speaking and 82 English-speaking patients from the supplementary samples. The responsiveness sample included 1516 VEINES patients. The 26-item VEINES-QOL/Sym is a new, patient-reported questionnaire to evaluate symptoms and quality of life and is available in four language versions (English, French, Italian, French Canadian).
RESULTS: Standard psychometric tests confirmed the acceptability (missing data, item endorsement frequencies, floor and ceiling effects), reliability (internal consistency, item-total, inter-item correlations) and validity (content, construct, convergent, discriminant, known groups) of the four language versions of the VEINES-QOL/Sym and the test-retest reliability of the English and French versions and provided preliminary evidence of responsiveness in a pooled language sample.
CONCLUSION: The VEINES-QOL/Sym is a practical and scientifically sound, patient-reported measure of outcomes in CVDL that has been developed with rigorous methods. As the only fully validated measure of quality of life and symptoms that is appropriate for use across the full spectrum of CVDL-related conditions, that is quick and easy to administer, and that is available in four languages, the VEINES-QOL/Sym provides a rigorous tool for improving the evaluation of outcomes in clinical trials, epidemiologic studies, and audit.

PMID 12563215  J Vasc Surg. 2003 Feb;37(2):410-9. doi: 10.1067/mva.200・・・
著者: R Launois, A Mansilha, G Jantet
雑誌名: Eur J Vasc Endovasc Surg. 2010 Dec;40(6):783-9. doi: 10.1016/j.ejvs.2010.03.034. Epub 2010 Oct 29.
Abstract/Text OBJECTIVE: To review the psychometric validation of the Chronic Venous dIsease quality of life Questionnaire (CIVIQ-20) in the countries that have used it since 1996.
DESIGN: Prospective, clinical, international study in 18 countries.
PATIENTS: Patients with venous disease of the lower limb in the clinical, aetiological, anatomical and pathophysiological (CEAP) clinical stages C0s to C4 presenting to surgical outpatient departments and general practices and receiving drug treatment for 6 months.
METHODS: Quantification of symptoms on a four-point scale and pain on a visual analogue scale, and self-administration of CIVIQ-20 to patients before visit (baseline, 2, 4 and 6 months).
RESULTS: In 3956 patients, CIVIQ-20 showed good internal consistency and reliability (above 0.80) through test-retest correlations. The discriminating power of items was good in known groups of patients. Factor analysis identified physical, psychological and pain factors as important, but revealed instability of the social factor. CIVIQ-20 was highly sensitive to changes in the quality of life of patients clinically improved after drug treatment.
CONCLUSION: CIVIQ-20 is valuable in assessing treatment effects in longitudinal, multinational studies, but comparisons of different populations should use the global score rather than scores per dimension.

Copyright © 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
PMID 20920862  Eur J Vasc Endovasc Surg. 2010 Dec;40(6):783-9. doi: 10・・・
著者: A M Garratt, L M Macdonald, D A Ruta, I T Russell, J K Buckingham, Z H Krukowski
雑誌名: Qual Health Care. 1993 Mar;2(1):5-10.
Abstract/Text OBJECTIVE: To develop a valid and reliable outcome measure for patients with varicose veins.
DESIGN: Postal questionnaire survey of patients with varicose veins.
SETTING: Surgical outpatient departments and training general practices in Grampian region.
SUBJECTS: 373 patients, 287 of whom had just been referred to hospital for their varicose veins and 86 who had just consulted a general practitioner for this condition and, for comparison, a random sample of 900 members of the general population.
MAIN MEASURES: Content validity, internal consistency, and criterion validity.
RESULTS: 281(76%) patients (mean age 45.8; 76% female) and 542(60%) of the general population (mean age 47.9; 54% female) responded. The questionnaire had good internal consistency as measured by item-total correlations. Factor analysis identified four important health factors: pain and dysfunction, cosmetic appearance, extent of varicosity and complications. The validity of the questionnaire was demonstrated by a high correlation with the SF-36 health profile, which is a general measure of patients' health. The perceived health of patients with varicose veins, as measured by the SF-36, was significantly lower than that of the sample of the general population adjusted for age and a lower proportion of women.
CONCLUSION: A clinically derived questionnaire can provide a valid and reliable tool to assess the perceived health of patients with varicose veins.
IMPLICATIONS: The questionnaire may be used to justify surgical treatment of varicose veins.

PMID 10132081  Qual Health Care. 1993 Mar;2(1):5-10.

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