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A national survey on management of varicose veins in China
A national survey on management of varicose veins in China Mingyi Zhang, MD,a Tao Qiu, MD,a Xiaoqing Bu, MD, PhD,b Xiangtao Li, MD,a Gangzhu Liang, MD,a Huan Zhang, MD,a Luyuan Niu, MD,a Hui Zhao, MD,c and Fuxian Zhang, MD,a Beijing and Chongqing, China
ABSTRACT Objective: This study aimed to investigate the current clinical practice and management strategies for varicose veins among Chinese physicians in general and in specific case vignettes. Methods: A questionnaire survey was conducted among 726 Chinese physicians who were attending the vascular surgery academic conferences during August 2016 to May 2017 in China. Physicians were eligible if they were familiar with several currently used treatment techniques for varicose veins. Results: A total of 681 physicians from 527 hospitals in 29 provinces across China completed the questionnaire. Of them, 80.0% were vascular surgeons, 13.1% were general surgeons, and 6.9% were interventional radiologists. More than half (67.0%) of them had >5 years of experience in management of varicose veins. A third of the participants performed routine venography for patients with suspected varicose veins. Moreover, 87.5% believed that the patient’s medical insurance would influence their choice of treatment modalities. Only 38.5% of the participants’ departments could perform day surgery for varicose veins. The most common average hospitalization time was 4 to 7 days, with an average cost of 4000 to 8000 yuan per leg. In the basic case (Clinical, Etiology, Anatomy, and Pathophysiology classification C2,SEpAsPr2,3), 63.8% preferred traditional surgery for great saphenous vein reflux, followed by endovenous laser ablation (24.3%), radiofrequency ablation (5.6%), and ultrasound-guided foam sclerotherapy (3.1%). Physicians in coastal China were more likely to choose endovenous thermal ablation than those from western China (P < .05). In modified case vignettes complicated with hyperpigmentation and lipodermatosclerosis or ulceration, more participants chose traditional surgery for great saphenous vein (73.2% vs 63.8% [P < .001]; 75.9% vs 63.8% [P < .001]) compared with the basic case. Moreover, 31.9% preferred continuation of compression therapy for patients with varicose veins and deep venous reflux, and 65.4% preferred correction of iliac vein compression before treatment of varicose veins. Distributions of management strategies were significantly different between the basic and modified case vignettes (all P < .01). Conclusions: Both traditional surgery and minimally invasive techniques are used for patients with varicose veins in China, but traditional surgery is the mainstay of treatment for varying degrees of varicose veins. Related clinical factors, duplex ultrasound scan findings, medical insurance, and economy may have influenced the physicians’ choice of treatment modality for varicose veins. (J Vasc Surg: Venous and Lym Dis 2018;-:1-9.)
Varicose veins affect about 25% of the adult population worldwide.1-3 In China, the prevalence is reported to be 8.9%, with >100 million people suffering from the disease.4 Varicose veins and associated complications may lead to decreased quality of life, loss of working days, and health care costs.3 Compression therapy may alleviate symptoms, especially in the early stages of disease.5,6 For patients who fail to respond to compression therapy, traditional surgery consisting of high ligation From the Department of Vascular Surgery, Beijing Shijitan Hospital,a and Department of Vascular Surgery, Beijing Luhe Hospital,c Capital Medical University, Beijing; and the Department of Epidemiology, School of Public Health and Management, Chongqing Medical University, Chongqing.b Author conflict of interest: none. Additional material for this article may be found online at www.jvsvenous.org. Correspondence: Fuxian Zhang, MD, Beijing Shijitan Hospital, Capital Medical University, 10 Tieyi Rd, Haidian District, Beijing 100038, China (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 2213-333X Copyright Ó 2017 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvsv.2017.10.018
and vein stripping (HL/S) was historically regarded as “gold standard” treatment for primary saphenous veins.7 During the past decade and a half, a variety of minimally invasive techniques have become available, including endovenous laser ablation (EVLA),8 radiofrequency ablation (RFA),9 and ultrasound-guided foam sclerotherapy (UGFS).10 Although long-term outcomes of endovenous therapies are awaited, notable clinical and quality of life benefits have been consistently reported for these new techniques.11,12 The minimally invasive procedures have largely replaced traditional surgery in Europe, North America, and South Korea and have been recommended to be the primary treatment for primary symptomatic varicose veins.13-15 During the past decade, the minimally invasive procedures have been gradually introduced to China. Although China might have the largest population of patients with varicose veins, there are no national data on the diagnosis and management of chronic venous insufficiency. Moreover, there is not yet a standardized protocol for management of patients with varicose veins in combination with thrombophlebitis or iliac vein compression syndrome in China. A greater understanding of the 1
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current varicose vein treatment may be helpful for making clinical guidelines and for designing appropriate health care policies in China. This study aimed to analyze the current practice and management strategies for patients with varicose veins among Chinese physicians.
ARTICLE HIGHLIGHTS d
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METHODS Participants. The survey was conducted among a sample of physicians who were attending four of the Chinese vascular surgery conferences during September 2016 to May 2017: China Endovascular Course, Thirteenth Chinese Vascular Surgery Congress, Endovascology 2016, and Vascular and Endovascular Conference 2017. Physicians were considered eligible if they were familiar with the use of traditional surgery, endovenous thermal ablation techniques, and UGFS for varicose veins and had been performing varicose vein treatments in the past year. If there were more than two physicians from the same hospital eligible and willing to participate in the survey, we included only the first two per registration time. A total of 726 eligible physicians were invited to participate in the survey. Because this survey was conducted during conference coffee breaks, 45 of them (6.2%) did not complete the questionnaire for reasons of time, resulting in a response rate of 93.8%. Questionnaire. The questionnaire was designed by the core committee of the Chinese Association of Phlebology and an epidemiologist. A pilot study was conducted among 10 vascular surgeons from three hospitals in Beijing before the start of this survey. The questionnaire was modified slightly according to their advice and answers. It comprised three parts and 28 points. The first part aimed to collect data on the physicians’ characteristics and clinical practices, including specialty, years of experience in treatment of varicose veins, working affiliations, location of current clinical practice, disease stages of their patients, indications for varicose vein operation, and whether medical insurance influences their choice of treatment modalities. The second part focused on obtaining information about the respondents’ departments (eg, annual number of operations for varicose veins, available procedures, types of anesthesia, average hospitalization time, and cost). The third part was designed to investigate the physicians’ management choices for case vignettes of patients with varying degrees of varicose veins (Table I). The basic case vignette described a patient who had a primary great saphenous vein (GSV) reflux with a strong desire to relieve symptoms and to improve quality of life by surgery after 3 months’ oral administration of venoactive drugs and 6 months’ wearing of medical compression stockings without any alleviation of symptoms. Participants were asked to choose their preferred treatment for this case from a list of proposed answers: HL/S, EVLA, RFA, UGFS, and others for GSV; ambulatory
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Type of Research: Survey of physicians attending vascular conferences Take Home Message: Answers of 681 physicians from 527 hospitals to a questionnaire revealed that traditional surgery continues to be the mainstay of treatment of varicose veins in China. For treatment of simple varicose veins, traditional surgery was recommended in 63.8%, laser ablation in 24.3%, radiofrequency ablation in 5.6%, and ultrasound-guided foam sclerotherapy in 3.1%. Clinical class of the disease, deep vein reflux and obstruction, medical insurance, and local economy and customs likely influenced choice of treatment. Recommendation: Findings of this survey suggest that traditional surgery is the most prevalent treatment of varicose veins and more advanced chronic venous insufficiency in China, but the survey had significant limitations due to selection bias of the participants.
phlebectomy, sclerotherapy, transilluminated powered phlebectomy, ambulatory phlebectomy and sclerotherapy, and others for tributaries; and ligation, subfascial endoscopic perforator surgery, ultrasound-guided sclerotherapy, endovenous thermal ablation, and others for perforator veins. The term others included no treatment, compression therapy, and other procedures not listed. Afterward, the basic case vignette was modified step by step, changing clinical findings and duplex ultrasound (DUS) scan results (Table I, vignettes 2 to 5). Participants were then asked if they would like to change their treatment strategies for the modified cases and, if so, to indicate which procedure they would prefer. Statistical analysis. Basic descriptive statistics were conducted, with results presented as numbers and percentages. Proportions of endovenous thermal ablation for varicose veins were compared between different economic regions of China using the c2 test. Proportions of preferred procedures were compared between the basic and modified case vignettes using the McNemar test, with multiple testing corrected by the Bonferroni method. In addition, the distributions of management strategies between the basic and modified vignettes were compared using the Bhapkar test, which is widely used to compare paired proportions between two or more groups.16 All analyses were performed using SAS statistical software (version 9.3; SAS Institute, Cary, NC). Two-tailed P < .05 was considered to be statistically significant.
RESULTS Characteristics of the study participants. A total of 681 vascular physicians completed the questionnaire. They
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Table I. Basic and modified case vignettes Cases (CEAP classification)
Descriptions
Basic case (C2,SEpAsPr2,3)
A 52-year-old woman (body mass index, 22.8 kg/m2) presented with typical symptoms of venous dysfunction, including heaviness, fatigue, and itching of the left leg. There was no edema or skin changes on the left leg. Doppler ultrasound examination showed a reversed flow from the terminal valve at the saphenofemoral junction of about 3 seconds using the Valsalva maneuver. The GSV diameter was 7 mm at midthigh level. Superficial vein tributaries (largest diameter, 5 mm) were seen at the medial calf. Refluxing perforating veins were not seen at the medial calf level. There was no small saphenous vein reflux below the knee. The deep venous system was patent and competent. The patient did not have history of lower extremity deep venous thrombosis or nonthrombotic iliac vein obstruction.
Vignette 1 (C2,4a,SEpAs,pPr2,3,18 or C2,4b,SEpAs,pPr2,3,18)
The patient had hyperpigmentation and lipodermatosclerosis of the skin and perforator vein reflux (duration $500 milliseconds; diameter $3.5 mm).
Vignette 2 (C2,4,5,SEpAs,pPr2,3,18 or C2,4,6,SEpAs,pPr2,3,18)
The patient had healed or unhealed ulceration of calf and perforator vein reflux (duration $500 milliseconds; diameter $3.5 mm).
Vignette 3 (C2,4a,SEpAs,p,dPr2,3,13,14)
The patient had deep venous reflux (severe dysfunction in the femoral popliteal venous flap).
Vignette 4
The patient had thrombophlebitis.
Vignette 5
The patient had nonthrombotic left iliac vein compression syndrome.
CEAP, Clinical, Etiology, Anatomy, and Pathophysiology; GSV, great saphenous vein.
were from 527 hospitals in 29 provinces (municipalities and autonomous regions) across China (Fig 1). Of the participants, 545 (80.0%) were vascular surgeons, 89 (13.1%) were general surgeons, and 47 (6.9%) were interventional radiologists (Table II). Two-thirds of the physicians had >5 years of experience in treatment of varicose veins. Most (84.0%) of them practiced in a tertiary A hospital. In addition, half of them were from coastal China. Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class C3-C4 seems to be the most common stage of
disease among patients who received surgery from the study physicians, followed by C5-C6 and C1-C2. For the question asking to which stage most of the surgery patients were assigned, 52.0% of the participants chose C3-C4; 29.8% chose C3-C4 and C5-C6; 8.4% chose C5-C6; 3.8% chose C1-C2, C3-C4, and C5-C6; 3.7% chose C1-C2 and C3-C4; and 2.4% chose C1-C2 (Table II). The majority of the participants (84.7%) replied that indications for surgical treatment were based on ultrasound results with or without symptoms or signs. Moreover, 29.7% performed routine venography for their patients. When asked about
Fig 1. Geographic distribution of the study hospitals. The study participants were from 527 hospitals of 29 provinces (municipalities and autonomous regions) across China.
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Table II. Characteristics of study participants Characteristics
No. (%)
Table III. Information about the participants’ clinical departments Variables
Specialty
2018
No. (%)
Annual No. of operations for varicose veins
Vascular surgery
545 (80.0)
General surgery
89 (13.1)
<100
124 (18.2)
47 (6.9)
100-199
263 (38.6)
200-299
181 (26.6)
Interventional radiology Years of experience <5 5-9
228 (33.0)
300-400
53 (7.8)
253 (37.2)
>400
60 (8.8)
Day surgery for varicose veins
10-14
117 (17.2)
15-20
45 (6.6)
Yes
262 (38.5)
38 (5.6)
No
419 (61.5)
>20
Procedures available in the department
Hospital grades 572 (84.0)
HL/S
465 (89.8)
Tertiary B
73 (10.7)
EVLA
260 (50.2)
Secondary
35 (5.1)
RFA
44 (8.5)
Tertiary A
UGFS
Economic regions of China Northeastern
54 (7.9)
CHIVA Ambulatory phlebectomy
147 (28.4) 1 (0.2) 471 (91.0)
Coastal
341 (50.1)
Central
126 (18.5)
Transilluminated powered phlebectomy
98 (18.9)
Western
160 (23.5)
Subfascial endoscopic perforator surgery
36 (7.0)
Valve reconstruction
31 (6.0)
CEAP stages of your patients who received surgery (multiple-choice question [one or more answers])
Anesthesia types Local or tumescent anesthesia
164 (24.1)
C1C2
16 (2.4)
Spinal or epidural anesthesia
528 (77.5)
C1C2 þ C3C4
25 (3.7)
General anesthesia
218 (32.0)
C1C2 þ C3C4 þ C5C6
26 (3.8)
Average hospitalization time, days
C3C4
354 (52.0)
1-3
111 (16.3)
C3C4 þ C5C6
203 (29.8)
4-7
435 (63.9)
57 (8.4)
8-12
135 (19.8)
C5C6 Indications for operations Ultrasound results and symptoms or signs
Average hospitalization cost for single leg, CNU 394 (76.0)
<4000
29 (4.3)
Ultrasound results
45 (8.7)
4000-5999
156 (23.0)
Symptoms or signs
79 (15.3)
6000-7999
224 (33.0)
8000-9999
166 (24.4) 101 (14.9)
Routine venography Yes
202 (29.7)
10,000-15,000
No
479 (60.3)
>15,000
Does the patient’s medical insurance influence your choice of treatment methods? Yes
596 (87.5)
No
85 (12.5)
5 (0.7)
CHIVA, Cure Conservatrice et Hémodynamique de l’Insuffisance Veineuse en Ambulatoire (ie, ambulatory conservative hemodynamic treatment of varicose veins); EVLA, endovenous laser ablation; HL/S, high ligation and vein stripping; RFA, radiofrequency ablation; UGFS, ultrasound-guided foam sclerotherapy.
Is the DUS examination conducted by yourself or by ultrasound technicians? Myself
89 (13.1)
Ultrasound technicians
491 (72.1)
Both
101 (14.8)
CEAP, Clinical, Etiology, Anatomy, and Pathophysiology; DUS, duplex ultrasound.
whether the patients’ medical insurance would influence their choice of treatment modalities, 87.5% responded yes. Moreover, the majority (72.1%) reported that the
DUS examination was conducted by an ultrasound technician rather than by themselves (Table II). Information about the participants’ departments. Information about the respondents’ departments is presented in Table III. Most departments (80.7%) had >100 varicose vein operations per year. About one-third of the departments could perform day surgery for varicose veins. The majority of the departments (89.7%) could perform traditional surgery for varicose veins, followed by EVLA (50.2%), UGFS (28.4%), and RFA (8.5%). Spinal or
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Fig 2. Management strategies for great saphenous veins (GSVs) in basic and modified case vignettes. The distributions of management strategies for GSVs were significantly different between the basic and modified case vignettes (P < .05). EVLA, Endovenous laser ablation; HL/S, high ligation and stripping; RFA, radiofrequency ablation; UGFS, ultrasound-guided foam sclerotherapy.
epidural anesthesia was the most common type of anesthesia (77.5%), followed by general anesthesia (32.0%) and local or tumescent anesthesia (24.1%). In addition, the most common average hospitalization time was 4 to 7 days, with an average cost of CN U4000 to U9999 (U.S. $580-$1450) per leg. Management strategies for basic and modified case vignettes. The participants proposed a variety of methods for GSV and tributaries in the basic and modified case vignettes (Figs 2 and 3). In the basic case, twothirds of the participants preferred HL/S for GSV, followed by EVLA (24.3%), RFA (5.6%), and UGFS (3.1%; Fig 2). Physicians in coastal China (26.6%) were more likely than those from western China (17.1%) to choose endovenous thermal ablations for GSV (P < .05; Supplementary Fig 1, online only). For tributaries, 53.3% of them chose ambulatory phlebectomy, followed by sclerotherapy (19.1%) and ambulatory phlebectomy and sclerotherapy (17.9%; Fig 3).
In the modified case vignettes, 35.3% to 55.9% of the participants proposed to adapt their treatment strategies according to the modifications (Figs 2 and 3, vignettes 1-4). The distribution of management strategies changed significantly for all modified vignettes compared with the basic case (all P < .01). If the patient had hyperpigmentation and lipodermatosclerosis (vignette 1), more participants were likely to perform traditional surgery for GSV (73.2% vs 63.8%; P ¼ .0006) and phlebectomy for tributaries (60.7% vs 53.5%; P ¼ .006) compared with the basic case vignette. Similarly, if the patient was suffering from a healed or unhealed ulceration (vignette 2), many more physicians preferred HL/S for GSV and ambulatory phlebectomy for tributaries. When a deep venous reflux was present (vignette 3), a large amount (31.9%) of the participants recommended continuation of compression therapy rather than any surgical treatment for either the GSV or tributaries. If the patient had thrombophlebitis, 67.2% of them would prescribe anticoagulant with or without
Fig 3. Management strategies for tributary veins in basic and modified case vignettes. The distributions of management strategies for tributary veins were significantly different between the basic and modified case vignettes (P < .05). TIPP, Transilluminated powered phlebectomy.
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nonsteroidal anti-inflammatory drugs for the patients before any operations. A significant conversion to more invasive treatment was observed both for GSV and for tributaries after the inflammation was controlled (Figs 2 and 3, vignette 4). Furthermore, if the patient had iliac vein compression syndrome, 65.4% of the respondents preferred to correct the iliac vein compression syndrome before treatment of the varicose veins, and 9.8% preferred to treat the two conditions simultaneously (Supplementary Fig 2, online only). When DUS revealed a perforator vein reflux (duration $500 milliseconds and diameter $3.5 mm), more than half of the respondents chose ligation to treat the perforating veins, either for patients with hyperpigmentation and lipodermatosclerosis or for patients with healed or unhealed ulceration (Fig 4, vignettes 1 and 2). Moreover, 10.1% and 6.7% of the participants preferred “no treatment” for the perforating veins in vignette 1 and vignette 2, respectively. The distributions of management strategies were similar between the two case vignettes (P ¼ .192).
DISCUSSION Results of this study indicate, first, that physicians in China use many different management strategies for patients with varicose veins. Second, although a variety of minimally invasive techniques are being used, traditional surgery remains the mainstay of treatment for GSV, tributaries, and perforating veins in China. Third, besides patient-related factors, the health care system and economy might also influence physicians’ decisions on treatment methods for varicose veins in China. To our knowledge, this is the first study to investigate the current practice and management strategies for patients with varicose veins among Chinese physicians. Our study results are different from those of some other studies.17,18 An international online survey on the management of GSV reflux and refluxing tributaries was conducted in 2013 among members of the International Union of Phlebology. A total of 211 physicians (70% from Europe and 19% from America) participated in the survey. Of them, 69% proposed performance of endovenous thermal ablation for a patient with varicose veins (CEAP classification C2,SEpAsPr,2,5), whereas only 6% preferred traditional surgery.17 In this study, only 29.9% of the respondents preferred endovenous thermal ablation in a similar case vignette, whereas 63.8% preferred traditional surgery. In another online survey that was conducted among vein specialist members of the American Venous Forum, 79% of the respondents preferred RFA for saphenous vein reflux, 66% laser, and 29% foam sclerotherapy.18 Why Chinese vascular physicians preferred traditional surgery rather than minimally invasive procedures for varicose veins might be due to several reasons. First, the Chinese Vascular Surgery Expert Consensus does not
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Fig 4. Management strategies for perforator veins in modified case vignette 1 and vignette 2. More than half of the respondents chose ligation to treat the perforating veins, either for patients with hyperpigmentation and lipodermatosclerosis or for patients with healed or unhealed ulceration. SEPS, Subfascial endoscopic perforator surgery.
recommend a primary treatment for GSV; instead, they state that both traditional and minimally invasive operations may be performed as appropriate on the basis of individual clinical judgment, with consideration of the patient’s clinical stage, the available health care resources, the surgeon’s experience, the patient’s requirements, and so on.19 Vascular physicians might make the decisions on the basis of their personal preferences, available instruments, and patients’ medical insurance. Second, the health care system has influenced the physician’s choice. In the study, most of the physicians replied that health care played an important role in their decisions on treatment method. Traditional surgery for varicose veins is a reimbursed item in all kinds of medical insurance in China, whereas minimally invasive procedures, except for laser ablation, are not reimbursed yet.20 In addition, financial restrictions might also be an important reason. We found that the proportion of endovenous therapies was higher in coastal China than in western China. As we all know, cities such as Beijing and Shanghai in coastal China produce much greater economic output than those in western China. Finally, physicians might be worrying about the safety and efficacy of the minimally invasive procedures because the longterm outcomes of these procedures are still awaited.11 In comparison with the international increasing outpatient management of varicose veins, a main reason for the high proportion of hospitalized patients in China is that the health care reimbursement is different between in-hospital and outpatient treatment.20 For in-hospital patients, most of the services, such as vascular ultrasound scanning, laboratory testing, operation, and drugs, are reimbursed. The average reimbursement rate is 40% to 50% for patients with the New Cooperative Medical Scheme, 60% to 70% for the Urban Employee Basic Medical Insurance, and 100% for the Government Medical Insurance. Outpatient services, especially operation, have not yet been reimbursed.20 In North America, the Centers of Medicare and Medicaid Services raised the reimbursement rates for office-based endovascular interventions to promote more outpatient procedures in 2008.21 Today, 90% of Medicare beneficiaries undergo
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office-based vein procedures in North America compared with only 1% in 2006.21 In addition, the Chinese guidelines do not make recommendations on the choice of in-hospital or outpatient treatment.19 Traditional surgery is still the mainstay of treatment for varicose veins in China. Traditional operations using general or spinal anesthesia are often performed in the hospital for perioperative safety, whereas minimally invasive techniques are usually conducted as office-based procedures with local or tumescent anesthesia. Results of this study are consistent with those in some European countries. In a survey conducted in 2006 in Great Britain and Ireland,22 half of the respondents preferred traditional surgery for primary varicose veins, whereas only 14% preferred endovascular treatments because of restrictions on the treatment of varicose veins in their National Health Service practice. Another survey that was conducted in 2001 among 675 surgeons reported that the two procedures most often performed in France were HL/S and tributaries stab avulsion (71.9%) and HL/S (17.3%).23 In addition, the analysis of data on 89,647 patients collected from 2001 to 2009 in Germany showed that open varicose vein surgery accounted for 79.9%, RFA for 9.7%, and endovenous laser therapy for 2.9%.24 It will be interesting to observe the change in European practice with new guidance from the National Institute for Health and Care Excellence25 and from the European Society for Vascular Surgery13 recommending thermal-based endovenous therapy as the first-line treatment for primary symptomatic GSV. In recent years, more and more Chinese physicians are beginning to examine minimally invasive treatments among Chinese patients with varicose veins.26-30 Overall, these studies indicate that minimally invasive therapies result in faster recovery, less pain, and higher patient satisfaction vs traditional surgery at an equal recurrence rate. With the safety, efficacy, and cost-effectiveness of minimally invasive techniques being evaluated in Chinese patients, the rapid development of the Chinese economy, and the gradually increasing acceptance of physician-performed DUS, the proportion of minimally invasive therapies is expected to increase in the future in China. The international guidelines recommend against treatment of perforating vein incompetence in patients with simple varicose veins (CEAP class C2) and suggest treatment of pathologic perforating veins located underneath healed or active ulcers (CEAP class C5-C6).14 A systematic review of 12 practice guidelines and 4 randomized clinical trials concluded that perforating vein interruption added no benefit for patients of CEAP class C2-C3.31 Whether to treat the pathologic perforating veins in patients of CEAP class C4 remains unclear. In this study, most Chinese physicians chose to treat the pathologic perforators in patients with hyperpigmentation and lipodermatosclerosis (vignette 1, CEAP class C4a or C4b) for
the prevention of progression of disease from “preulcer stages” CEAP C4 to C6. Recently, the guideline for management of venous leg ulcers recommended treatment of incompetent perforating veins simultaneously or staged with the correction of axial reflux in patients with skin changes (CEAP class C4b).32 For patients with suspected varicose veins, DUS is recommended as the first diagnostic test.14,25 Interestingly, besides DUS, about 30% of the participants in this study proposed routine venography for varicose veins. This might be because most patients who seek medical care in China have severe varicose veins (CEAP class C3-C6). Iliac vein compression is not uncommon in this group of patients.33 Venography has been considered the gold standard for diagnosis of iliac vein compression syndrome.34 In addition, the Chinese Vascular Surgery Expert Consensus recommends venography, if necessary, for patients with moderate to severe varicose veins.19 Another important reason might be that few physicians in China conduct DUS themselves. Complementary venography might be conducted to help locate the affected lesion and develop a treatment plan. There is still no effective treatment for patients with mixed reflux in superficial and deep veins.13,35 In China, some vascular physicians proposed full-valve annuloplasty in treatment of primary deep venous valvular incompetence,36 but others did not find an extra benefit of using this method in combination with HL/S of the GSV.37 Therefore, it is not surprising that nearly onethird of the participants in this study chose to continue compression therapy for patients with deep venous reflux, even though the patients had a strong desire to receive surgery to alleviate their symptoms. In addition, the timing of varicose vein treatment or iliac vein correction remains unclear in patients with varicose veins accompanied by iliac vein compression syndrome.33,38 In this study, most Chinese vascular physicians preferred to correct the compression syndrome before treatment of the varicose veins. There are three grades of hospital in China. Tertiary hospitals are comprehensive hospitals at a provincial or national level (bed capacity >500). Secondary hospitals (100-500 beds) are affiliated with a medium-sized city, county, or district. Primary hospitals (<100 beds) are typically township hospitals. These three grades of hospital are further subdivided into three subsidiary levels of A, B, and C according to their levels of service provision, size, medical equipment, management, and medical quality.20 Currently, most varicose vein patients can visit specialists in tertiary hospitals directly without referral by family physicians in China. The department of vascular surgery started late in China. During the past 20 years, independent vascular surgery centers or vascular surgery divisions belonging to the department of general surgery were gradually established in tertiary hospitals in China. Only a few secondary hospitals carry out vascular surgery.
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Primary hospitals are tasked with providing preventive care, minimal health care, and rehabilitation services and rarely conduct vascular surgery. Therefore, most of the participants in this study are from tertiary hospitals. Further surveys focusing on treatment of varicose veins in secondary and primary hospitals are needed. We believe that minimally invasive techniques to manage varicose veins will become a new trend in China. However, the vascular surgeons’ decisions on treatment modalities are made within their available health care resources, patient beliefs, local economics, and even local culture and social customs. There is still a long way to go for the treatment of varicose veins in China. The study must be interpreted with caution in light of several limitations. First, this survey reflects the practice and views of vascular surgeons mostly from tertiary hospitals who attended the four Chinese vascular surgery conferences. Therefore, a selection bias cannot be excluded. In addition, we did not include dermatologists, who are more likely to deliver minimally invasive treatments because of cosmetic concerns. However, the majority of varicose veins in China are managed by vascular surgeons, interventional radiologists, and general surgeons. Moreover, we did not collect information on medicinal treatments, such as natural and synthetic venoactive drugs and Chinese Medicine.
CONCLUSIONS Both traditional surgery and minimally invasive techniques are used for patients with varicose veins in China, but traditional surgery is the mainstay of treatment for varying degrees of varicose veins. Related clinical factors, DUS findings, medical insurance, and economy may have influenced the physicians’ choice of treatment modality for varicose veins. The authors thank Dr Yan Li and Dr Shuai Niu for their contributions to data collection. In addition, we are grateful to all the participating physicians for their generous support.
AUTHOR CONTRIBUTIONS Conception and design: MZ, FZ Analysis and interpretation: MZ, XB, FZ Data collection: MZ, TQ, XL, GL, HZhang, LN, HZhao Writing the article: MZ, XB, GL, FZ Critical revision of the article: TQ, XL, HZhang, LN, HZhao Final approval of the article: MZ, TQ, XB, XL, GL, HZhang, LN, HZhao, FZ Statistical analysis: XB Obtained funding: Not applicable Overall responsibility: FZ
2018
REFERENCES 1. Callam MJ. Epidemiology of varicose veins. Br J Surg 1994;81: 167-73. 2. Evans CJ, Allan PL, Lee AJ, Bradbury AW, Ruckley CV, Fowkes FG. Prevalence of venous reflux in the general population on duplex scanning: the Edinburgh vein study. J Vasc Surg 1998;28:767-76. 3. Meissner MH, Gloviczki P, Bergan J, Kistner RL, Morrison N, Pannier F, et al. Primary chronic venous disorders. J Vasc Surg 2007;46(Suppl S):54s-67s. 4. Zhang PH, Jiang ME, Dai LT, Huang XT. Investigation on peripheral vascular disease in four provinces and one city in East China [in Chinese]. Chin J Gen Surg 1993;8:162-4. 5. Mauck KF, Asi N, Elraiyah TA, Undavalli C, Nabhan M, Altayar O, et al. Comparative systematic review and metaanalysis of compression modalities for the promotion of venous ulcer healing and reducing ulcer recurrence. J Vasc Surg 2014;60:71S-90S.e1-2. 6. Shingler S, Robertson L, Boghossian S, Stewart M. Compression stockings for the initial treatment of varicose veins in patients without venous ulceration. Cochrane Database Syst Rev 2013;12:CD008819. 7. Keller WL. A new method of extirpating the internal saphenous and similar veins in varicose conditions: a preliminary report. N Y Med J 1905;82:385. 8. Mundy L, Merlin TL, Fitridge RA, Hiller JE. Systematic review of endovenous laser treatment for varicose veins. Br J Surg 2005;92:1189-94. 9. Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study). J Vasc Surg 2003;38:207-14. 10. Darke SG, Baker SJ. Ultrasound-guided foam sclerotherapy for the treatment of varicose veins. Br J Surg 2006;93:969-74. 11. Nesbitt C, Bedenis R, Bhattacharya V, Stansby G. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices. Cochrane Database Syst Rev 2014;7:CD005624. 12. Marston WA, Crowner J, Kouri A, Kalbaugh CA. Incidence of venous leg ulcer healing and recurrence after treatment with endovenous laser ablation. J Vasc Surg Venous Lymphat Disord 2017;5:525-32. 13. Wittens C, Davies AH, Baekgaard N, Broholm R, Cavezzi A, Chastanet S, et al. Editor’s choicedmanagement of chronic venous disease: clinical practice guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 2015;49:678-737. 14. Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011;53:2s-48s. 15. Jon JH, Park HC, Kim WS, Jung IM, Park KH, Yun WS, et al. The clinical outcomes of endovenous radiofrequency ablation of varicose veins: results from the Korean radiofrequency ablation registry. Korean J Vasc Endovasc Surg 2013;29:91-7. 16. Bhapkar VP. A note on the equivalence of two test criteria for hypotheses in categorical data. J Am Stat Assoc 1966;61: 228-35. 17. van der Velden SK, Pichot O, van den Bos RR, Nijsten TE, De Maeseneer MG. Management strategies for patients with varicose veins (C2-C6): results of a worldwide survey. Eur J Vasc Endovasc Surg 2015;49:213-20.
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18. Aziz F, Diaz J, Blebea J, Lurie F. Practice patterns of endovenous ablation therapy for the treatment of venous reflux disease. J Vasc Surg Venous Lymphat Disord 2017;5:75-81.e1. 19. Chinese experts consensus on diagnosis and treatment of lower extremity chronic venous disease. Chin J Gen Surg 2014;4:246-52. 20. Yip WC, Hsiao WC, Chen W, Hu S, Ma J, Maynard A. Early appraisal of China’s huge and complex health-care reforms. Lancet 2012;379:833-42. 21. Singh MJ, Hager ES. The treatment of venous disease in North America. In: Dardik A, editor. Vascular surgery: a global perspective. Cham, Switzerland: Springer International Publishing; 2017. p. 211-5. 22. Edwards AG, Baynham S, Lees T, Mitchell DC. Management of varicose veins: a survey of current practice by members of the Vascular Society of Great Britain and Ireland. Ann R Coll Surg Engl 2009;91:77-80. 23. Perrin M, Guidicelli H, Rastel D. [Surgical techniques used for the treatment of varicose veins: survey of practice in France]. J Mal Vasc 2003;28:277-86. 24. Noppeney T, Storck M, Nullen H, Schmedt CG, Kellersmann R, Bockler D, et al. Perioperative quality assessment of varicose vein surgery: commission for quality assessment of the German Society for Vascular Surgery. Langenbecks Arch Surg 2016;401:375-80. 25. Marsden G, Perry M, Kelley K, Davies AH. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ 2013;347:f4279. 26. Sun Y, Li X, Chen Z, Li X, Ren S. Feasibility and safety of foam sclerotherapy followed by a multiple subcutaneously interrupt ligation under local anaesthesia for outpatients with varicose veins. Int J Surg 2017;42:49-53. 27. Yin H, He H, Wang M, Li Z, Hu Z, Yao C, et al. Prospective randomized study of ultrasound-guided foam sclerotherapy combined with great saphenous vein high ligation in the treatment of severe lower extremity varicosis. Ann Vasc Surg 2017;39:256-63. 28. Lu X, Ye K, Li W, Lu M, Huang X, Jiang M. Endovenous ablation with laser for great saphenous vein insufficiency and tributary varices: a retrospective evaluation. J Vasc Surg 2008;48:675-9. 29. Zhu HP, Zhou YL, Zhang X, Yan JL, Xu ZY, Wang H, et al. Combined endovenous laser therapy and pinhole high
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ligation in the treatment of symptomatic great saphenous varicose veins. Ann Vasc Surg 2014;28:301-5. Shi H, Liu X, Lu M, Lu X, Jiang M, Yin M. The effect of endovenous laser ablation of incompetent perforating veins and the great saphenous vein in patients with primary venous disease. Eur J Vasc Endovasc Surg 2015;49:574-80. Tenbrook JA Jr, Iafrati MD, O’Donnell TF Jr, Wolf MP, Hoffman SN, Pauker SG, et al. Systematic review of outcomes after surgical management of venous disease incorporating subfascial endoscopic perforator surgery. J Vasc Surg 2004;39:583-9. O’Donnell TF Jr, Passman MA, Marston WA, Ennis WJ, Dalsing M, Kistner RL, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2014;60:3s-59s. Raju S, Neglen P. High prevalence of nonthrombotic iliac vein lesions in chronic venous disease: a permissive role in pathogenicity. J Vasc Surg 2006;44:136-43; discussion: 144. Ye KC, Lu XW, Li WM, Huang Y, Huang XT, Lu M, et al. Value of ascending venography in diagnosis of nonthrombotic iliac vein compression syndrome. J Shanghai Jiaotong Univ (Med Sci) 2009;29:4. Hardy SC, Riding G, Abidia A. Surgery for deep venous incompetence. Cochrane Database Syst Rev 2004;3: CD001097. Chen CJ, Guo SG, Luo D, Huang YQ. Full-valve annuloplasty in treatment of primary deep venous valvular incompetence of the lower extremities. Chin Med J (Engl) 1992;105: 256-9. Zhao J, Dong GX. The surgical treatment of varicose veins of lower extremity with primary deep venous insufficiency. Chin J Gen Surg 2002;17:2. Ye KC, Lu XW, Li WM, Huang Y, Huang XT, Lu M, et al. Endovascular treatment of nonthrombotic iliac vein compression syndrome. Chin J Front Med Sci 2011;3:3.
Submitted Jul 20, 2017; accepted Oct 28, 2017.
Additional material for this article may be found online at www.jvsvenous.org.
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Supplementary Fig 1 (online only). Proportions of physicians who chose endovenous thermal ablation (laser or radiofrequency) for great saphenous veins (GSVs) by economic regions of China. Physicians in coastal China were more likely than those from western China to choose endovenous thermal ablations for GSV.
Supplementary Fig 2 (online only). Treatment order for patients with varicose veins and left iliac vein compression syndrome. More than two-thirds of the respondents preferred to correct the iliac vein compression syndrome before the treatment of varicose veins.
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ABSTRACT Objective: This study aimed to investigate the current clinical practice and management strategies for varicose veins among Chinese physicians in general and in specific case vignettes. Methods: A questionnaire survey was conducted among 726 Chinese physicians who were attending the vascular surgery academic conferences during August 2016 to May 2017 in China. Physicians were eligible if they were familiar with several currently used treatment techniques for varicose veins. Results: A total of 681 physicians from 527 hospitals in 29 provinces across China completed the questionnaire. Of them, 80.0% were vascular surgeons, 13.1% were general surgeons, and 6.9% were interventional radiologists. More than half (67.0%) of them had >5 years of experience in management of varicose veins. A third of the participants performed routine venography for patients with suspected varicose veins. Moreover, 87.5% believed that the patient’s medical insurance would influence their choice of treatment modalities. Only 38.5% of the participants’ departments could perform day surgery for varicose veins. The most common average hospitalization time was 4 to 7 days, with an average cost of 4000 to 8000 yuan per leg. In the basic case (Clinical, Etiology, Anatomy, and Pathophysiology classification C2,SEpAsPr2,3), 63.8% preferred traditional surgery for great saphenous vein reflux, followed by endovenous laser ablation (24.3%), radiofrequency ablation (5.6%), and ultrasound-guided foam sclerotherapy (3.1%). Physicians in coastal China were more likely to choose endovenous thermal ablation than those from western China (P < .05). In modified case vignettes complicated with hyperpigmentation and lipodermatosclerosis or ulceration, more participants chose traditional surgery for great saphenous vein (73.2% vs 63.8% [P < .001]; 75.9% vs 63.8% [P < .001]) compared with the basic case. Moreover, 31.9% preferred continuation of compression therapy for patients with varicose veins and deep venous reflux, and 65.4% preferred correction of iliac vein compression before treatment of varicose veins. Distributions of management strategies were significantly different between the basic and modified case vignettes (all P < .01). Conclusions: Both traditional surgery and minimally invasive techniques are used for patients with varicose veins in China, but traditional surgery is the mainstay of treatment for varying degrees of varicose veins. Related clinical factors, duplex ultrasound scan findings, medical insurance, and economy may have influenced the physicians’ choice of treatment modality for varicose veins. (J Vasc Surg: Venous and Lym Dis 2018;-:1-9.)
Varicose veins affect about 25% of the adult population worldwide.1-3 In China, the prevalence is reported to be 8.9%, with >100 million people suffering from the disease.4 Varicose veins and associated complications may lead to decreased quality of life, loss of working days, and health care costs.3 Compression therapy may alleviate symptoms, especially in the early stages of disease.5,6 For patients who fail to respond to compression therapy, traditional surgery consisting of high ligation From the Department of Vascular Surgery, Beijing Shijitan Hospital,a and Department of Vascular Surgery, Beijing Luhe Hospital,c Capital Medical University, Beijing; and the Department of Epidemiology, School of Public Health and Management, Chongqing Medical University, Chongqing.b Author conflict of interest: none. Additional material for this article may be found online at www.jvsvenous.org. Correspondence: Fuxian Zhang, MD, Beijing Shijitan Hospital, Capital Medical University, 10 Tieyi Rd, Haidian District, Beijing 100038, China (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 2213-333X Copyright Ó 2017 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvsv.2017.10.018
and vein stripping (HL/S) was historically regarded as “gold standard” treatment for primary saphenous veins.7 During the past decade and a half, a variety of minimally invasive techniques have become available, including endovenous laser ablation (EVLA),8 radiofrequency ablation (RFA),9 and ultrasound-guided foam sclerotherapy (UGFS).10 Although long-term outcomes of endovenous therapies are awaited, notable clinical and quality of life benefits have been consistently reported for these new techniques.11,12 The minimally invasive procedures have largely replaced traditional surgery in Europe, North America, and South Korea and have been recommended to be the primary treatment for primary symptomatic varicose veins.13-15 During the past decade, the minimally invasive procedures have been gradually introduced to China. Although China might have the largest population of patients with varicose veins, there are no national data on the diagnosis and management of chronic venous insufficiency. Moreover, there is not yet a standardized protocol for management of patients with varicose veins in combination with thrombophlebitis or iliac vein compression syndrome in China. A greater understanding of the 1
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current varicose vein treatment may be helpful for making clinical guidelines and for designing appropriate health care policies in China. This study aimed to analyze the current practice and management strategies for patients with varicose veins among Chinese physicians.
ARTICLE HIGHLIGHTS d
d
METHODS Participants. The survey was conducted among a sample of physicians who were attending four of the Chinese vascular surgery conferences during September 2016 to May 2017: China Endovascular Course, Thirteenth Chinese Vascular Surgery Congress, Endovascology 2016, and Vascular and Endovascular Conference 2017. Physicians were considered eligible if they were familiar with the use of traditional surgery, endovenous thermal ablation techniques, and UGFS for varicose veins and had been performing varicose vein treatments in the past year. If there were more than two physicians from the same hospital eligible and willing to participate in the survey, we included only the first two per registration time. A total of 726 eligible physicians were invited to participate in the survey. Because this survey was conducted during conference coffee breaks, 45 of them (6.2%) did not complete the questionnaire for reasons of time, resulting in a response rate of 93.8%. Questionnaire. The questionnaire was designed by the core committee of the Chinese Association of Phlebology and an epidemiologist. A pilot study was conducted among 10 vascular surgeons from three hospitals in Beijing before the start of this survey. The questionnaire was modified slightly according to their advice and answers. It comprised three parts and 28 points. The first part aimed to collect data on the physicians’ characteristics and clinical practices, including specialty, years of experience in treatment of varicose veins, working affiliations, location of current clinical practice, disease stages of their patients, indications for varicose vein operation, and whether medical insurance influences their choice of treatment modalities. The second part focused on obtaining information about the respondents’ departments (eg, annual number of operations for varicose veins, available procedures, types of anesthesia, average hospitalization time, and cost). The third part was designed to investigate the physicians’ management choices for case vignettes of patients with varying degrees of varicose veins (Table I). The basic case vignette described a patient who had a primary great saphenous vein (GSV) reflux with a strong desire to relieve symptoms and to improve quality of life by surgery after 3 months’ oral administration of venoactive drugs and 6 months’ wearing of medical compression stockings without any alleviation of symptoms. Participants were asked to choose their preferred treatment for this case from a list of proposed answers: HL/S, EVLA, RFA, UGFS, and others for GSV; ambulatory
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Type of Research: Survey of physicians attending vascular conferences Take Home Message: Answers of 681 physicians from 527 hospitals to a questionnaire revealed that traditional surgery continues to be the mainstay of treatment of varicose veins in China. For treatment of simple varicose veins, traditional surgery was recommended in 63.8%, laser ablation in 24.3%, radiofrequency ablation in 5.6%, and ultrasound-guided foam sclerotherapy in 3.1%. Clinical class of the disease, deep vein reflux and obstruction, medical insurance, and local economy and customs likely influenced choice of treatment. Recommendation: Findings of this survey suggest that traditional surgery is the most prevalent treatment of varicose veins and more advanced chronic venous insufficiency in China, but the survey had significant limitations due to selection bias of the participants.
phlebectomy, sclerotherapy, transilluminated powered phlebectomy, ambulatory phlebectomy and sclerotherapy, and others for tributaries; and ligation, subfascial endoscopic perforator surgery, ultrasound-guided sclerotherapy, endovenous thermal ablation, and others for perforator veins. The term others included no treatment, compression therapy, and other procedures not listed. Afterward, the basic case vignette was modified step by step, changing clinical findings and duplex ultrasound (DUS) scan results (Table I, vignettes 2 to 5). Participants were then asked if they would like to change their treatment strategies for the modified cases and, if so, to indicate which procedure they would prefer. Statistical analysis. Basic descriptive statistics were conducted, with results presented as numbers and percentages. Proportions of endovenous thermal ablation for varicose veins were compared between different economic regions of China using the c2 test. Proportions of preferred procedures were compared between the basic and modified case vignettes using the McNemar test, with multiple testing corrected by the Bonferroni method. In addition, the distributions of management strategies between the basic and modified vignettes were compared using the Bhapkar test, which is widely used to compare paired proportions between two or more groups.16 All analyses were performed using SAS statistical software (version 9.3; SAS Institute, Cary, NC). Two-tailed P < .05 was considered to be statistically significant.
RESULTS Characteristics of the study participants. A total of 681 vascular physicians completed the questionnaire. They
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Table I. Basic and modified case vignettes Cases (CEAP classification)
Descriptions
Basic case (C2,SEpAsPr2,3)
A 52-year-old woman (body mass index, 22.8 kg/m2) presented with typical symptoms of venous dysfunction, including heaviness, fatigue, and itching of the left leg. There was no edema or skin changes on the left leg. Doppler ultrasound examination showed a reversed flow from the terminal valve at the saphenofemoral junction of about 3 seconds using the Valsalva maneuver. The GSV diameter was 7 mm at midthigh level. Superficial vein tributaries (largest diameter, 5 mm) were seen at the medial calf. Refluxing perforating veins were not seen at the medial calf level. There was no small saphenous vein reflux below the knee. The deep venous system was patent and competent. The patient did not have history of lower extremity deep venous thrombosis or nonthrombotic iliac vein obstruction.
Vignette 1 (C2,4a,SEpAs,pPr2,3,18 or C2,4b,SEpAs,pPr2,3,18)
The patient had hyperpigmentation and lipodermatosclerosis of the skin and perforator vein reflux (duration $500 milliseconds; diameter $3.5 mm).
Vignette 2 (C2,4,5,SEpAs,pPr2,3,18 or C2,4,6,SEpAs,pPr2,3,18)
The patient had healed or unhealed ulceration of calf and perforator vein reflux (duration $500 milliseconds; diameter $3.5 mm).
Vignette 3 (C2,4a,SEpAs,p,dPr2,3,13,14)
The patient had deep venous reflux (severe dysfunction in the femoral popliteal venous flap).
Vignette 4
The patient had thrombophlebitis.
Vignette 5
The patient had nonthrombotic left iliac vein compression syndrome.
CEAP, Clinical, Etiology, Anatomy, and Pathophysiology; GSV, great saphenous vein.
were from 527 hospitals in 29 provinces (municipalities and autonomous regions) across China (Fig 1). Of the participants, 545 (80.0%) were vascular surgeons, 89 (13.1%) were general surgeons, and 47 (6.9%) were interventional radiologists (Table II). Two-thirds of the physicians had >5 years of experience in treatment of varicose veins. Most (84.0%) of them practiced in a tertiary A hospital. In addition, half of them were from coastal China. Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class C3-C4 seems to be the most common stage of
disease among patients who received surgery from the study physicians, followed by C5-C6 and C1-C2. For the question asking to which stage most of the surgery patients were assigned, 52.0% of the participants chose C3-C4; 29.8% chose C3-C4 and C5-C6; 8.4% chose C5-C6; 3.8% chose C1-C2, C3-C4, and C5-C6; 3.7% chose C1-C2 and C3-C4; and 2.4% chose C1-C2 (Table II). The majority of the participants (84.7%) replied that indications for surgical treatment were based on ultrasound results with or without symptoms or signs. Moreover, 29.7% performed routine venography for their patients. When asked about
Fig 1. Geographic distribution of the study hospitals. The study participants were from 527 hospitals of 29 provinces (municipalities and autonomous regions) across China.
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Table II. Characteristics of study participants Characteristics
No. (%)
Table III. Information about the participants’ clinical departments Variables
Specialty
2018
No. (%)
Annual No. of operations for varicose veins
Vascular surgery
545 (80.0)
General surgery
89 (13.1)
<100
124 (18.2)
47 (6.9)
100-199
263 (38.6)
200-299
181 (26.6)
Interventional radiology Years of experience <5 5-9
228 (33.0)
300-400
53 (7.8)
253 (37.2)
>400
60 (8.8)
Day surgery for varicose veins
10-14
117 (17.2)
15-20
45 (6.6)
Yes
262 (38.5)
38 (5.6)
No
419 (61.5)
>20
Procedures available in the department
Hospital grades 572 (84.0)
HL/S
465 (89.8)
Tertiary B
73 (10.7)
EVLA
260 (50.2)
Secondary
35 (5.1)
RFA
44 (8.5)
Tertiary A
UGFS
Economic regions of China Northeastern
54 (7.9)
CHIVA Ambulatory phlebectomy
147 (28.4) 1 (0.2) 471 (91.0)
Coastal
341 (50.1)
Central
126 (18.5)
Transilluminated powered phlebectomy
98 (18.9)
Western
160 (23.5)
Subfascial endoscopic perforator surgery
36 (7.0)
Valve reconstruction
31 (6.0)
CEAP stages of your patients who received surgery (multiple-choice question [one or more answers])
Anesthesia types Local or tumescent anesthesia
164 (24.1)
C1C2
16 (2.4)
Spinal or epidural anesthesia
528 (77.5)
C1C2 þ C3C4
25 (3.7)
General anesthesia
218 (32.0)
C1C2 þ C3C4 þ C5C6
26 (3.8)
Average hospitalization time, days
C3C4
354 (52.0)
1-3
111 (16.3)
C3C4 þ C5C6
203 (29.8)
4-7
435 (63.9)
57 (8.4)
8-12
135 (19.8)
C5C6 Indications for operations Ultrasound results and symptoms or signs
Average hospitalization cost for single leg, CNU 394 (76.0)
<4000
29 (4.3)
Ultrasound results
45 (8.7)
4000-5999
156 (23.0)
Symptoms or signs
79 (15.3)
6000-7999
224 (33.0)
8000-9999
166 (24.4) 101 (14.9)
Routine venography Yes
202 (29.7)
10,000-15,000
No
479 (60.3)
>15,000
Does the patient’s medical insurance influence your choice of treatment methods? Yes
596 (87.5)
No
85 (12.5)
5 (0.7)
CHIVA, Cure Conservatrice et Hémodynamique de l’Insuffisance Veineuse en Ambulatoire (ie, ambulatory conservative hemodynamic treatment of varicose veins); EVLA, endovenous laser ablation; HL/S, high ligation and vein stripping; RFA, radiofrequency ablation; UGFS, ultrasound-guided foam sclerotherapy.
Is the DUS examination conducted by yourself or by ultrasound technicians? Myself
89 (13.1)
Ultrasound technicians
491 (72.1)
Both
101 (14.8)
CEAP, Clinical, Etiology, Anatomy, and Pathophysiology; DUS, duplex ultrasound.
whether the patients’ medical insurance would influence their choice of treatment modalities, 87.5% responded yes. Moreover, the majority (72.1%) reported that the
DUS examination was conducted by an ultrasound technician rather than by themselves (Table II). Information about the participants’ departments. Information about the respondents’ departments is presented in Table III. Most departments (80.7%) had >100 varicose vein operations per year. About one-third of the departments could perform day surgery for varicose veins. The majority of the departments (89.7%) could perform traditional surgery for varicose veins, followed by EVLA (50.2%), UGFS (28.4%), and RFA (8.5%). Spinal or
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Fig 2. Management strategies for great saphenous veins (GSVs) in basic and modified case vignettes. The distributions of management strategies for GSVs were significantly different between the basic and modified case vignettes (P < .05). EVLA, Endovenous laser ablation; HL/S, high ligation and stripping; RFA, radiofrequency ablation; UGFS, ultrasound-guided foam sclerotherapy.
epidural anesthesia was the most common type of anesthesia (77.5%), followed by general anesthesia (32.0%) and local or tumescent anesthesia (24.1%). In addition, the most common average hospitalization time was 4 to 7 days, with an average cost of CN U4000 to U9999 (U.S. $580-$1450) per leg. Management strategies for basic and modified case vignettes. The participants proposed a variety of methods for GSV and tributaries in the basic and modified case vignettes (Figs 2 and 3). In the basic case, twothirds of the participants preferred HL/S for GSV, followed by EVLA (24.3%), RFA (5.6%), and UGFS (3.1%; Fig 2). Physicians in coastal China (26.6%) were more likely than those from western China (17.1%) to choose endovenous thermal ablations for GSV (P < .05; Supplementary Fig 1, online only). For tributaries, 53.3% of them chose ambulatory phlebectomy, followed by sclerotherapy (19.1%) and ambulatory phlebectomy and sclerotherapy (17.9%; Fig 3).
In the modified case vignettes, 35.3% to 55.9% of the participants proposed to adapt their treatment strategies according to the modifications (Figs 2 and 3, vignettes 1-4). The distribution of management strategies changed significantly for all modified vignettes compared with the basic case (all P < .01). If the patient had hyperpigmentation and lipodermatosclerosis (vignette 1), more participants were likely to perform traditional surgery for GSV (73.2% vs 63.8%; P ¼ .0006) and phlebectomy for tributaries (60.7% vs 53.5%; P ¼ .006) compared with the basic case vignette. Similarly, if the patient was suffering from a healed or unhealed ulceration (vignette 2), many more physicians preferred HL/S for GSV and ambulatory phlebectomy for tributaries. When a deep venous reflux was present (vignette 3), a large amount (31.9%) of the participants recommended continuation of compression therapy rather than any surgical treatment for either the GSV or tributaries. If the patient had thrombophlebitis, 67.2% of them would prescribe anticoagulant with or without
Fig 3. Management strategies for tributary veins in basic and modified case vignettes. The distributions of management strategies for tributary veins were significantly different between the basic and modified case vignettes (P < .05). TIPP, Transilluminated powered phlebectomy.
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nonsteroidal anti-inflammatory drugs for the patients before any operations. A significant conversion to more invasive treatment was observed both for GSV and for tributaries after the inflammation was controlled (Figs 2 and 3, vignette 4). Furthermore, if the patient had iliac vein compression syndrome, 65.4% of the respondents preferred to correct the iliac vein compression syndrome before treatment of the varicose veins, and 9.8% preferred to treat the two conditions simultaneously (Supplementary Fig 2, online only). When DUS revealed a perforator vein reflux (duration $500 milliseconds and diameter $3.5 mm), more than half of the respondents chose ligation to treat the perforating veins, either for patients with hyperpigmentation and lipodermatosclerosis or for patients with healed or unhealed ulceration (Fig 4, vignettes 1 and 2). Moreover, 10.1% and 6.7% of the participants preferred “no treatment” for the perforating veins in vignette 1 and vignette 2, respectively. The distributions of management strategies were similar between the two case vignettes (P ¼ .192).
DISCUSSION Results of this study indicate, first, that physicians in China use many different management strategies for patients with varicose veins. Second, although a variety of minimally invasive techniques are being used, traditional surgery remains the mainstay of treatment for GSV, tributaries, and perforating veins in China. Third, besides patient-related factors, the health care system and economy might also influence physicians’ decisions on treatment methods for varicose veins in China. To our knowledge, this is the first study to investigate the current practice and management strategies for patients with varicose veins among Chinese physicians. Our study results are different from those of some other studies.17,18 An international online survey on the management of GSV reflux and refluxing tributaries was conducted in 2013 among members of the International Union of Phlebology. A total of 211 physicians (70% from Europe and 19% from America) participated in the survey. Of them, 69% proposed performance of endovenous thermal ablation for a patient with varicose veins (CEAP classification C2,SEpAsPr,2,5), whereas only 6% preferred traditional surgery.17 In this study, only 29.9% of the respondents preferred endovenous thermal ablation in a similar case vignette, whereas 63.8% preferred traditional surgery. In another online survey that was conducted among vein specialist members of the American Venous Forum, 79% of the respondents preferred RFA for saphenous vein reflux, 66% laser, and 29% foam sclerotherapy.18 Why Chinese vascular physicians preferred traditional surgery rather than minimally invasive procedures for varicose veins might be due to several reasons. First, the Chinese Vascular Surgery Expert Consensus does not
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Fig 4. Management strategies for perforator veins in modified case vignette 1 and vignette 2. More than half of the respondents chose ligation to treat the perforating veins, either for patients with hyperpigmentation and lipodermatosclerosis or for patients with healed or unhealed ulceration. SEPS, Subfascial endoscopic perforator surgery.
recommend a primary treatment for GSV; instead, they state that both traditional and minimally invasive operations may be performed as appropriate on the basis of individual clinical judgment, with consideration of the patient’s clinical stage, the available health care resources, the surgeon’s experience, the patient’s requirements, and so on.19 Vascular physicians might make the decisions on the basis of their personal preferences, available instruments, and patients’ medical insurance. Second, the health care system has influenced the physician’s choice. In the study, most of the physicians replied that health care played an important role in their decisions on treatment method. Traditional surgery for varicose veins is a reimbursed item in all kinds of medical insurance in China, whereas minimally invasive procedures, except for laser ablation, are not reimbursed yet.20 In addition, financial restrictions might also be an important reason. We found that the proportion of endovenous therapies was higher in coastal China than in western China. As we all know, cities such as Beijing and Shanghai in coastal China produce much greater economic output than those in western China. Finally, physicians might be worrying about the safety and efficacy of the minimally invasive procedures because the longterm outcomes of these procedures are still awaited.11 In comparison with the international increasing outpatient management of varicose veins, a main reason for the high proportion of hospitalized patients in China is that the health care reimbursement is different between in-hospital and outpatient treatment.20 For in-hospital patients, most of the services, such as vascular ultrasound scanning, laboratory testing, operation, and drugs, are reimbursed. The average reimbursement rate is 40% to 50% for patients with the New Cooperative Medical Scheme, 60% to 70% for the Urban Employee Basic Medical Insurance, and 100% for the Government Medical Insurance. Outpatient services, especially operation, have not yet been reimbursed.20 In North America, the Centers of Medicare and Medicaid Services raised the reimbursement rates for office-based endovascular interventions to promote more outpatient procedures in 2008.21 Today, 90% of Medicare beneficiaries undergo
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office-based vein procedures in North America compared with only 1% in 2006.21 In addition, the Chinese guidelines do not make recommendations on the choice of in-hospital or outpatient treatment.19 Traditional surgery is still the mainstay of treatment for varicose veins in China. Traditional operations using general or spinal anesthesia are often performed in the hospital for perioperative safety, whereas minimally invasive techniques are usually conducted as office-based procedures with local or tumescent anesthesia. Results of this study are consistent with those in some European countries. In a survey conducted in 2006 in Great Britain and Ireland,22 half of the respondents preferred traditional surgery for primary varicose veins, whereas only 14% preferred endovascular treatments because of restrictions on the treatment of varicose veins in their National Health Service practice. Another survey that was conducted in 2001 among 675 surgeons reported that the two procedures most often performed in France were HL/S and tributaries stab avulsion (71.9%) and HL/S (17.3%).23 In addition, the analysis of data on 89,647 patients collected from 2001 to 2009 in Germany showed that open varicose vein surgery accounted for 79.9%, RFA for 9.7%, and endovenous laser therapy for 2.9%.24 It will be interesting to observe the change in European practice with new guidance from the National Institute for Health and Care Excellence25 and from the European Society for Vascular Surgery13 recommending thermal-based endovenous therapy as the first-line treatment for primary symptomatic GSV. In recent years, more and more Chinese physicians are beginning to examine minimally invasive treatments among Chinese patients with varicose veins.26-30 Overall, these studies indicate that minimally invasive therapies result in faster recovery, less pain, and higher patient satisfaction vs traditional surgery at an equal recurrence rate. With the safety, efficacy, and cost-effectiveness of minimally invasive techniques being evaluated in Chinese patients, the rapid development of the Chinese economy, and the gradually increasing acceptance of physician-performed DUS, the proportion of minimally invasive therapies is expected to increase in the future in China. The international guidelines recommend against treatment of perforating vein incompetence in patients with simple varicose veins (CEAP class C2) and suggest treatment of pathologic perforating veins located underneath healed or active ulcers (CEAP class C5-C6).14 A systematic review of 12 practice guidelines and 4 randomized clinical trials concluded that perforating vein interruption added no benefit for patients of CEAP class C2-C3.31 Whether to treat the pathologic perforating veins in patients of CEAP class C4 remains unclear. In this study, most Chinese physicians chose to treat the pathologic perforators in patients with hyperpigmentation and lipodermatosclerosis (vignette 1, CEAP class C4a or C4b) for
the prevention of progression of disease from “preulcer stages” CEAP C4 to C6. Recently, the guideline for management of venous leg ulcers recommended treatment of incompetent perforating veins simultaneously or staged with the correction of axial reflux in patients with skin changes (CEAP class C4b).32 For patients with suspected varicose veins, DUS is recommended as the first diagnostic test.14,25 Interestingly, besides DUS, about 30% of the participants in this study proposed routine venography for varicose veins. This might be because most patients who seek medical care in China have severe varicose veins (CEAP class C3-C6). Iliac vein compression is not uncommon in this group of patients.33 Venography has been considered the gold standard for diagnosis of iliac vein compression syndrome.34 In addition, the Chinese Vascular Surgery Expert Consensus recommends venography, if necessary, for patients with moderate to severe varicose veins.19 Another important reason might be that few physicians in China conduct DUS themselves. Complementary venography might be conducted to help locate the affected lesion and develop a treatment plan. There is still no effective treatment for patients with mixed reflux in superficial and deep veins.13,35 In China, some vascular physicians proposed full-valve annuloplasty in treatment of primary deep venous valvular incompetence,36 but others did not find an extra benefit of using this method in combination with HL/S of the GSV.37 Therefore, it is not surprising that nearly onethird of the participants in this study chose to continue compression therapy for patients with deep venous reflux, even though the patients had a strong desire to receive surgery to alleviate their symptoms. In addition, the timing of varicose vein treatment or iliac vein correction remains unclear in patients with varicose veins accompanied by iliac vein compression syndrome.33,38 In this study, most Chinese vascular physicians preferred to correct the compression syndrome before treatment of the varicose veins. There are three grades of hospital in China. Tertiary hospitals are comprehensive hospitals at a provincial or national level (bed capacity >500). Secondary hospitals (100-500 beds) are affiliated with a medium-sized city, county, or district. Primary hospitals (<100 beds) are typically township hospitals. These three grades of hospital are further subdivided into three subsidiary levels of A, B, and C according to their levels of service provision, size, medical equipment, management, and medical quality.20 Currently, most varicose vein patients can visit specialists in tertiary hospitals directly without referral by family physicians in China. The department of vascular surgery started late in China. During the past 20 years, independent vascular surgery centers or vascular surgery divisions belonging to the department of general surgery were gradually established in tertiary hospitals in China. Only a few secondary hospitals carry out vascular surgery.
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Primary hospitals are tasked with providing preventive care, minimal health care, and rehabilitation services and rarely conduct vascular surgery. Therefore, most of the participants in this study are from tertiary hospitals. Further surveys focusing on treatment of varicose veins in secondary and primary hospitals are needed. We believe that minimally invasive techniques to manage varicose veins will become a new trend in China. However, the vascular surgeons’ decisions on treatment modalities are made within their available health care resources, patient beliefs, local economics, and even local culture and social customs. There is still a long way to go for the treatment of varicose veins in China. The study must be interpreted with caution in light of several limitations. First, this survey reflects the practice and views of vascular surgeons mostly from tertiary hospitals who attended the four Chinese vascular surgery conferences. Therefore, a selection bias cannot be excluded. In addition, we did not include dermatologists, who are more likely to deliver minimally invasive treatments because of cosmetic concerns. However, the majority of varicose veins in China are managed by vascular surgeons, interventional radiologists, and general surgeons. Moreover, we did not collect information on medicinal treatments, such as natural and synthetic venoactive drugs and Chinese Medicine.
CONCLUSIONS Both traditional surgery and minimally invasive techniques are used for patients with varicose veins in China, but traditional surgery is the mainstay of treatment for varying degrees of varicose veins. Related clinical factors, DUS findings, medical insurance, and economy may have influenced the physicians’ choice of treatment modality for varicose veins. The authors thank Dr Yan Li and Dr Shuai Niu for their contributions to data collection. In addition, we are grateful to all the participating physicians for their generous support.
AUTHOR CONTRIBUTIONS Conception and design: MZ, FZ Analysis and interpretation: MZ, XB, FZ Data collection: MZ, TQ, XL, GL, HZhang, LN, HZhao Writing the article: MZ, XB, GL, FZ Critical revision of the article: TQ, XL, HZhang, LN, HZhao Final approval of the article: MZ, TQ, XB, XL, GL, HZhang, LN, HZhao, FZ Statistical analysis: XB Obtained funding: Not applicable Overall responsibility: FZ
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Submitted Jul 20, 2017; accepted Oct 28, 2017.
Additional material for this article may be found online at www.jvsvenous.org.
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Supplementary Fig 1 (online only). Proportions of physicians who chose endovenous thermal ablation (laser or radiofrequency) for great saphenous veins (GSVs) by economic regions of China. Physicians in coastal China were more likely than those from western China to choose endovenous thermal ablations for GSV.
Supplementary Fig 2 (online only). Treatment order for patients with varicose veins and left iliac vein compression syndrome. More than two-thirds of the respondents preferred to correct the iliac vein compression syndrome before the treatment of varicose veins.
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