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CHIVA method for the treatment of chronic venous insufficiency

  1. Sergi Bellmunt-Montoya1,*,
  2. Jose Maria Escribano2,
  3. Jaume Dilme1,
  4. Maria José Martinez-Zapata3

Editorial Group: Cochrane Peripheral Vascular Diseases Group

Published Online: 3 JUL 2013

Assessed as up-to-date: 22 DEC 2012

DOI: 10.1002/14651858.CD009648.pub2


How to Cite

Bellmunt-Montoya S, Escribano JM, Dilme J, Martinez-Zapata MJ. CHIVA method for the treatment of chronic venous insufficiency. Cochrane Database of Systematic Reviews 2013, Issue 7. Art. No.: CD009648. DOI: 10.1002/14651858.CD009648.pub2.

Author Information

  1. 1

    Hospital de la Santa Creu i Sant Pau, IBB Sant Pau, Angiology, Vascular and Endovascular Surgery, Barcelona, Spain

  2. 2

    Hospital Universitario Vall d'Hebron, Angiology, Vascular and Endovascular Surgery, Barcelona, Barcelona, Spain

  3. 3

    CIBER Epidemiología y Salud Pública (CIBERESP), Spain, Iberoamerican Cochrane Centre. Universitat Autònoma de Barcelona. Institute of Biomedical Research Sant Pau (IIB Sant Pau), Barcelona, Barcelona, Catalonia, Spain

*Sergi Bellmunt-Montoya, Angiology, Vascular and Endovascular Surgery, Hospital de la Santa Creu i Sant Pau, IBB Sant Pau, Sant Quinti No. 89, Barcelona, 08041, Spain. sbellmunt@santpau.cat.

Publication History

  1. Publication Status: New
  2. Published Online: 3 JUL 2013

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Characteristics of included studies [ordered by study ID]
Carandina 2008

MethodsDesign: randomized controlled trial

Number of participating centers: 1

Setting: hospital

Country: Italy

Unit of randomization: participant

Unit of analysis: participant

Follow-up: participants were reviewed postoperatively at 1, 6, 12 months, and subsequently, after 3 and 10 years


ParticipantsNumber of participants: 150 (75 surgery and 75 CHIVA)

Sex: 33 men and 91 women

Age (mean): 48-50 years

Inclusion criteria: primary chronic venous insufficiency with no history of surgery or sclerotherapy, presence of saphenofemoral reflux and incompetence of the saphenous trunk, presence of a competent deep venous system, at least 1 re-entry perforator located in the trunk of the saphenous and 1 or more veins and incompetent tributaries of the great saphenous vein

Exclusion criteria: aged ≥ 70 years, people with deficiency of the calf muscle pump or unable to walk; people with diabetes, autoimmune diseases, malignancies, severe kidney disease, liver disease, cardio-respiratory disease, or previous history of deep vein thrombosis


Interventions1) Stripping procedure: saphenofemoral ligation, great saphenous vein stripping from groin to knee, multiple phlebectomies of the tributaries and subfascial ligation of thigh perforating veins

2) CHIVA: saphenofemoral ligation, disconnection from the great saphenous vein of the varicose tributaries and their avulsion through cosmetic incisions

Postoperative management: people treated with CHIVA wore class 2 medical compression stockings above the knee for 3 weeks. Limbs that had been treated by saphenous stripping were bandaged to minimize bruising. Bandages were replaced with class 2 medical compression stockings above the knee after 1-3 days and then worn for 14 days. Study participants were usually discharged from hospital on the day of surgery


OutcomesPrimary outcome: recurrence of varicose veins at 10 years of follow-up. Recurrence was defined as class C or D of the Hobbs' score (Hobbs 1974) ( Table 2) and the presence of reflux on duplex ultrasonography with a demonstrable escape point

Secondary outcome: functional or cosmetic results

Both clinical and ultrasound examinations were performed at each visit

Clinical assessment of surgical results: 3 independent assessors, who had not been involved in previous surgical decision making and operative procedures, examined all limbs. They assigned a score to each limb according to the method reported by Hobbs. Subsequently, participants were further analyzed by duplex scanning using a standard methodology. Functional and cosmetic results were self assessed by the participants at the time of the last examination in hospital

Assessment of recurrences: were considered varicose veins recurrence if:

1) the remaining or newly formed varicose veins had a diameter > 5 mm and the presence of incompetent main trunks and perforator (Hobbs' score C and D)

2) there was presence of reflux, as measured by duplex ultrasonography, with a demonstrable escape point and change of venous network


NotesSample size was specified in the 'methods' section


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Study randomisation was by a computer-generated randomisation list of the 150 patients, structured in balanced blocks of 4 patients and blinded to the treating physicians. The allocated treatment was disclosed shortly before surgical treatment and patients were treated with saphenous stripping or CHIVA, 75 patients by each technique"

Comment: study randomization was by a computer-generated randomization list, structured in balanced blocks

Allocation concealment (selection bias)Low riskQuote: "Study randomisation was by a computer-generated randomisation list of the 150 patients, structured in balanced blocks of 4 patients and blinded to the treating physicians. The allocated treatment was disclosed shortly before surgical treatment and patients were treated with saphenous stripping or CHIVA, 75 patients by each technique"

Comment: allocation was blinded to the treating physicians. The allocated treatment was disclosed shortly before surgical treatment

Blinding of participants and personnel (performance bias)
All outcomes (participants)
Unclear riskIt is not specified if the participants were blinded

Blinding of participants and personnel (performance bias)
All outcomes (personnel)
High riskThe surgeon that applied the intervention was unblinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "At the time of scoring the surgical outcome the assessors were unaware of the procedure each patient"

Comment: the assessor was blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskThere were 26 (17.3%) participants lost in 10 years of follow-up, with no differences between groups. The reasons for losses were not specified

Selective reporting (reporting bias)Low riskThe results of all outcomes prespecified in the methods of the trial report were presented. The trial protocol was not requested from the study authors

Iborra-Ortega 2006

MethodsDesign: randomized controlled trial

Number of participating centers: 1

Setting: hospital

Country: Spain

Unit of randomization: participant

Unit of analysis: participant.

Follow-up: first week after surgery; 1, 3, and 6 months; and thereafter annually to 5 years


ParticipantsNumber of participants: 100 (49 stripping and 51 CHIVA)

Sex: 38 men and 62 women

Age (mean): 49 years (range 26-69)

Inclusion criteria: according to the guidelines of the Society of Angiology and Vascular Surgery (SEAVC) including the presence of symptomatic varicose veins with saphenous involvement or perforating veins (or both), or asymptomatic large varicose veins with a potential risk of complications (varicophlebitis or bleeding)

Exclusion criteria: people with alterations in the deep venous system, with a history of venous thrombosis, with previous treatment (surgery or sclerotherapy), morbidly obese people, aged ≥ 70 years


Interventions1) CHIVA: according to the cartographic map, different strategies were applied: CHIVA 1 (superficial venous drainage system with a single surgical procedure), CHIVA 2 (required 2 possible surgical steps to ensure the drainage of the system) and CHIVA 1+2 (with a single surgical procedure, the superficial system is not drained and therefore represents a conservative but not hemodynamic treatment)

2) Vein stripping


OutcomesPrimary endpoint: rate of complications and, clinical and hemodynamic outcomes

Secondary outcomes: type of anesthesia, surgical time, level of activity after 1 week of the intervention, time off work and cosmetic results at 1 and 6 months and annually, number of reoperations performed during the follow-up

Assessment: the week after surgery when the stitches were removed; at the first, third and sixth postoperative months; and annually thereafter to complete 5 years of follow-up

Assessment of recurrences:

"Finally, a patient was considered cured when he was clinically asymptomatic or was better, he was pleased with the aesthetic results and the objective assessment of varicosities was not visible or they were of a diameter less than 5 mm." "Thus, patients not included in this characterization would be considered as disease recurrence"


NotesGrants from Fundació August Pi i Sunyer (Hospital Universitari de Bellvitge) and SEACV (Sociedad Española de Angiología y Cirugía Vascular)

Sample size not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "The patients were randomized with the software Excel of Window"

Comment: we assume that the generation of random sequence was performed by computer

Allocation concealment (selection bias)Low riskQuote: "the patients were allocated by phone"

Comment: there was allocation concealment because the investigator did not know the random sequence

Blinding of participants and personnel (performance bias)
All outcomes (participants)
High riskThe participants knew the intervention to which they were assigned

Blinding of participants and personnel (performance bias)
All outcomes (personnel)
High riskThe personnel knew the intervention assigned to the participant

Blinding of outcome assessment (detection bias)
All outcomes
High riskThere was no blinding of outcome assessors

Incomplete outcome data (attrition bias)
All outcomes
Low riskThe losses were minimal at 4% at 5-year follow-up (2 participants in each group)

Selective reporting (reporting bias)Low riskThe results of all outcomes prespecified in the methods of the trial report were presented. The trial protocol was not requested from the authors

Pares 2010

MethodsDesign: randomized controlled trial

Number of participating centers: 1

Setting: hospital

Country: Spain

Unit of randomization: participant

Unit of analysis: participant

Follow-up: immediately postoperatively and 3, 6, 12, 24, 36, 48, and 60 months after surgery


ParticipantsNumber of participants: 501 (156 striping with clinical marking, 159 stripping with duplex marking, 160 CHIVA)

Sex: 147 men and 354 women

Age: 48-50 years (standard deviation 12)

Inclusion criteria: people diagnosed with varicose veins by a vascular surgeon in the outpatient clinic and according to the criteria of the CEAP classification of venous insufficiency

Exclusion criteria: people with congenital venous disease, varicose veins secondary to previous thrombosis, post-thrombotic side effects, sclerotherapy, recurrent varicose veins, associated systemic diseases or people who did not agree to participate in the study, who refused surgery, who could not participate in long-term monitoring or women who had been pregnant for less than 6 months


Interventions1) Group CHIVA: disconnection of the point reflux and preservation of the superficial venous system drainage

Points of venous reflux were closed by ligation and division reflux of the saphenofemoral junction (preserving draining veins and tributaries), ligation and division of the saphenopopliteal union (preserving the Giacomini vein drainage) or subfascial closure of perforating veins, preservation of the incompetent segments of great saphenous vein or short saphenous vein (or both), removal of secondary reflux points originating the varicose vein, the preservation of re-entry points (perforating vein), and phlebectomy of collateral veins with improper drainage

Physical and Doppler ultrasound examination to identify incompetent segments. A map was produced and printed with venous images, points of reflux, the diameter of the saphenous vein and superficial and re-entry points. These documents were the baseline for comparison in follow-up

2) Stripping with clinic marking: remove the incompetent superficial venous system

Before surgery, the surgeon decided which segments were incompetent and to be removed. The decision was based on physical examination, identification of incompetent segments and points of re-entry. The surgical procedure consisted of the closing of the points of reflux, by ligation and division of the saphenofemoral junction, tributaries veins in the groin or ligation and division of the saphenopopliteal union or subfascial closure of perforating veins, and removal of all the great saphenous vein or superficial venous system (or both) or phlebectomy.

3) Stripping with duplex marking: remove the incompetent superficial venous system

Surgical strategy was based on the closing of the points of reflux by ligation and division of the saphenofemoral junction in the groin, or ligation of tributary veins and division of the union or saphenopopliteal subfascial closure, of perforating veins, removal of only the incompetent segment of great saphenous vein or the superficial venous system (or both), phlebectomy of varicose veins and closing points of re-entry

The physical examination and Doppler ultrasound were used to identify incompetent segments. Authors carried out a map of varicose veins and ultrasound images were stored. Points of reflux were marked, also the diameter of the great saphenous vein and minor saphenous vein and re-entry points. These documents were the baseline for comparison in follow-up

Postoperative management: pressure bandage from the groin to the foot for 48 hours, then elastic stockings for 4 weeks. Analgesic and antithrombotic prophylaxis treatment were common to all participants


OutcomesPrimary endpoint: recurrence rate of varicosity (using Hobbs' classification) (Hobbs 1974) ( Table 2)

Secondary outcomes: ultrasonographic recurrence of varicose veins, descriptive baseline characteristics, type of anesthesia, days of convalescence, clinical cure, clinical improvement and complications (deep vein thrombosis, pulmonary thromboembolism, death, bruises, subcutaneous inguinal hemorrhage, neuralgia of the saphenous nerve, wound infection and phlebitis)

Postsurgical complications were evaluated at 8 days' postintervention

Clinical follow-up and duplex ultrasonography with venous mapping were at 3, 6, 12, 24, 36 48, and 60 months after surgery


NotesAuthors were contacted to obtain information on the randomization process

Funding: Institute of Health Carlos III, Ministry of Health (Spanish Ministry of Health) and Consumption, by 2 research grant FIS 94/5365 and FIS 97/0694 (Spain), and a research grant from the Non-Invasive Vascular Diagnosis Area of the Spanish Society for Angiology and Vascular Surgery and Endovascular (Spanish Society of Angiology and Vascular Surgery), 2003

The sample size was specified in the methods section


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe publication does not specify the method of generating the randomization sequence. We contacted the authors who explained that the method of sequence generation was centralized and independent of the clinicians: randomization generated by computer in blocks of 6

Allocation concealment (selection bias)Low riskThe publication does not specify the method of allocation concealment. We contacted the authors who explained that the allocation was centralized by telephone and independent of the clinicians

Blinding of participants and personnel (performance bias)
All outcomes (participants)
High riskQuote: "This was a randomized, open-label controlled trial"

Comment: it was an open study

Blinding of participants and personnel (performance bias)
All outcomes (personnel)
High riskQuote: "This was a randomized, open-label controlled trial"

Comment: it was an open study

Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: "This was a randomized, open-label controlled trial"

Comment: it was an open study

Incomplete outcome data (attrition bias)
All outcomes
Low riskThe losses were minimal: 15 (3%) participants

Selective reporting (reporting bias)Low riskThe results of all outcomes prespecified in the methods of the trial report were presented. The trial protocol was not requested from the authors

Zamboni 2003

MethodsDesign: randomized controlled trial

Number of participant centers: 1

Setting: hospital

Country: Italy

Unit of randomization: participant

Unit of analysis: ulcer and participant

Follow-up: twice a year for 3 years


ParticipantsNumber of participants: 45

Ulcers: 47 ulcers (21 people with 23 ulcers treated with CHIVA; 24 people with 24 ulcers treated with compression)
Sex: 18 men and 27 women
Age (mean): 63 years

Inclusion criteria: people with venous ulcer

Exclusion criteria: aged ≥ 80 years, inability to walk, ulcers < 2 cm2 or > 12 cm2, diabetes, peripheral arterial disease or an ankle brachial index < 0.9, secondary or congenital venous disease (history of deep venous thrombosis or ultrasound evidence of deep venous obstruction or reflux (or both), congenital angiodysplasia)


Interventions1) CHIVA group: operations were performed under local anesthesia and Doppler ultrasound. Depending on the location of the re-entry of the perforator were 2 different minimally invasive techniques:
a) The opening was located on the main venous trunk (type I cases)
b) The opening was located in the venous branches (type III cases)

Cases of type I: the operation included high ligation of the venous saphenofemoral or popliteal union completed by ligation and division of the venous saphenous trunk and insufficient branches. The result was the creation of a drainage flow down into the venous saphenous trunk re-entering the deep circulation through perforators
Cases of type III: the operation involved ligation and disconnection of the venous saphenous trunk insufficient branches. The process could contain a second step consisting of high ligation
Participants began to walk 1 hour after the operation with the ulcer protected with a bandage and with half elastic compression at the ankle. Participants were discharged after 3 hours and were visited twice per week the first week and then every week until the ulcer healed

2) Compression group: treated with foam dressing, zinc oxide and an inelastic bandage applied from the foot to the knee. Antibiotics were used selectively according to sensitivities. The dressing was changed every 3-5 days the first month and then every 7 days until the ulcer was healed. Once ulcers healed, elastic stockings were prescribed. In the case of recurrence, the dressing protocol was repeated

Monitoring: participants in both groups were reviewed clinically, completed the questionnaire on quality of life (SF-36), and underwent a Doppler ultrasound and plethysmography twice a year for 3 years


OutcomesPrimary outcomes: healing rate, recurrence rate
Secondary outcomes: ulcerated area, quality of life (SF-36 questionnaire)


NotesStudy authors were contacted to obtain information on the randomization process
Sample size was calculated

Grant funding: "Venous Ulcers: TISSUE AND GROWTH FACTORS HAEMODYNAMICS of the Italian Ministry of the University and Scientific and Technological Research (MURST)"


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskWe contacted the first study author by e-mail. His response was: "

The study was preceded by a computer-generated randomisation list, structured in balanced blocks of 4 patients and prepared by the local dept. of mathematics, of course blinded to the treating physicians. Once the patient was included in the study the physician called the secretary of the department, who communicated him/her the arm. I hope this clear"

Comment: the generation of random sequence was blinded

Allocation concealment (selection bias)Low riskWe contacted the first study author by e-mail. His response was: "

The study was preceded by a computer-generated randomisation list, structured in balanced blocks of 4 patients and prepared by the local dept. of mathematics, of course blinded to the treating physicians. Once the patient was included in the study the physician called the secretary of the department, who communicated him/her the arm"

Comment: there was allocation concealment

Blinding of participants and personnel (performance bias)
All outcomes (participants)
High riskIt was an open study

Blinding of participants and personnel (performance bias)
All outcomes (personnel)
High riskIt was an open study

Blinding of outcome assessment (detection bias)
All outcomes
High riskIt was an open study

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo losses to follow-up (3 years)

Selective reporting (reporting bias)Unclear riskThe paper did not report the results of quality of life. It is not clear if data of recurrence were based in ultrasounds or clinical parameters. There were insufficient data about the time to heal the ulcer to include in the analysis of the review

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Maeso 2001Controlled trial, not randomized, case-review study

Solis 2009Prospective, controlled trial, not randomized

Zamboni 1995Prospective, controlled trial, not randomized

Zamboni 1996Prospective, non-controlled clinical trial

Zamboni 1998Prospective, controlled trial, not randomized

 
Comparison 1. CHIVA versus stripping

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Recurrence of varicose veins3721Risk Ratio (M-H, Fixed, 95% CI)0.63 [0.51, 0.78]

 2 Re-treatment1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Free from reflux2Risk Ratio (M-H, Random, 95% CI)Totals not selected

 4 Esthetic improvement assessed by the participant1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 5 Esthetic improvement assessed by the participant1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 6 Esthetic improvement assessed by the investigator1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 7 Cure or no clinical symptoms2601Risk Ratio (M-H, Fixed, 95% CI)1.73 [1.36, 2.19]

 8 Clinical improvement2601Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.71, 1.21]

 9 Side effects2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    9.1 Bruises
1501Risk Ratio (M-H, Fixed, 95% CI)0.63 [0.53, 0.76]

    9.2 Limb infection
1501Risk Ratio (M-H, Fixed, 95% CI)1.33 [0.38, 4.66]

    9.3 Superficial vein trombosis
2601Risk Ratio (M-H, Fixed, 95% CI)2.23 [0.60, 8.33]

    9.4 Nerve damage
2601Risk Ratio (M-H, Fixed, 95% CI)0.05 [0.01, 0.38]

 10 Recurrence of varicose veins. Sensitivity analysis.3751Risk Ratio (M-H, Fixed, 95% CI)0.73 [0.60, 0.89]

    10.1 Intention-to-treat
3751Risk Ratio (M-H, Fixed, 95% CI)0.73 [0.60, 0.89]

 
Comparison 2. CHIVA versus compression dressing

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Recurrence of venous ulcer1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 2 Cure of venous ulcer1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Summary of findings for the main comparison.

CHIVA compared with stripping for varicose veins

Patient or population: adults with varicose veins

Settings: hospital

Intervention: CHIVA

Comparison: stripping

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

StrippingCHIVA

Recurrence of varicose veins

(follow-up: 60 months - 10 years)
Study populationRR 0.63

(0.51 to 0.78)
721
(3 studies)
⊕⊕⊕⊝
moderate1

471 per 1000297 per 1000
(240 to 368)

Moderate6

383 per 1000241 per 1000
(195 to 299)

Side effects - bruises

(follow-up: 60 months)
Study population5 RR 0.63

(0.53 to 0.76)
501
(1 study)
⊕⊕⊕⊝
moderate2

719 per 1000453 per 1000
(381 to 546)

Side effects - limb infection

(follow-up: 60 months)
Study population5 RR 1.33

(0.38 to 4.66)
501
(1 study)
⊕⊕⊝⊝2,3
low

18 per 100024 per 1000
(7 to 84)

Side effects - superficial vein thrombosis

(follow-up: 60 months - 5 years)
Study populationRR 2.23

(0.6 to 8.33)
601
(2 studies)
⊕⊕⊝⊝1,3
low

10 per 100023 per 1000
(6 to 83)

Moderate6

6 per 100013 per 1000
(4 to 50)

Side effects - nerve damage

(follow-up: 60 months - 5 years)
Study populationRR 0.05

(0.01 to 0.38)
601
(2 studies)
⊕⊕⊕⊝1,3,4
moderate

68 per 10003 per 1000
(1 to 26)

Moderate6

135 per 10007 per 1000
(1 to 51)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 The studies were open: participants and assessors knew the intervention.
2 The study was open: participants and assessors knew the intervention.
3 There was imprecision due to low number of events.
4 CHIVA method is unlikely to cause nerve damage. We have upgraded the quality of evidence for the large effect.
5 Assumed risk is mean baseline risk from study population.
6 Assumed risk is the median control group risk from studies on meta-analysis
 
Table 1. CEAP clinical classification (C)

ClassClinical indication

0No visible or palpable signs of venous disease

1Telangiectases or reticular veins

2Varicose veins

3Edema

4Skin changes ascribed to venous disease (e.g. pigmentation, venous eczema, lipodermatosclerosis)

5Skin changes as defined here with healed ulceration

6Skin changes as defined here with active ulceration

 
Table 2. Hobbs' classification and scores

ClassClinical indication

Class A (score 1)No visible and palpable varicose veins

Class B (score 2)A few visible and palpable varicose veins with diameter < 5 mm

Class C (score 3)Remaining or newly formed varicose veins with diameter > 5 mm

Class D (score 4)Incompetent main trunks and perforator