Choosing Wisely in France, for the Treatment of Saphenous Vein Insufficiency and Recurrences

Abstract

Choosing wisely is an idea originally created in North America. It was designed to help maintaining a dialogue with patients to allow taking best decisions in the care and treatment of patients. As a consequence, despite guidelines outlining evidence of different treatments, choosing wisely takes the patient’s point of view into the focus and helps priorising therapeutic strategies in the context of specialisation, country, reimbursement and culture.

In France this dialogue was performed under the auspices of the National Professional Council of Vascular Medicine (CNPMV- Conseil National Professionnel de Médecine Vasculaire), which brings together all the societies of vascular medicine in France (representing, more than 2,000 vascular doctors).

They have elaborated 10 recommendations to choose wisely regarding the treatment of saphenous veins insufficiency and recurrences. The history, discussion and results are presented in this article.

 

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Zusammenfassung

Die Idee des „Choosing wisely“, des klugen Entscheidens, kommt ursprünglich aus Nordamerika. Sie wurde entworfen, um mit den Patienten besser in den Dialog zu kommen. Dadurch kann bei der Pflege und Behandlung der Patienten die bestmögliche Entscheidung getroffen werden. Als Konsequenz, trotz Leitlinien in denen die Evidenz für verschiedene Behandlungen dargelegt wird, stellt „Choosing wisely“ den Blickwinkel des Patienten in den Fokus. Es hilft bei der Priorisierung therapeutischer Strategien im Zusammenhang mit Spezialisierung, Ländern, Kostenerstattung und Kultur.

In Frankreich wurde dieser Dialog unter dem National Professional Council of Vascular Medicine (CNPMV- Conseil National Professionnel de Médecine Vasculaire) durchgeführt, der alle französischen Gesellschaften für Gefäßmedizin zusammenführt (vertreten werden mehr als 2.000 Gefäßmediziner).

Sie haben 10 Empfehlungen zum “Choosing wisely” in Bezug auf Stammveneninsuffizienz und Rezidiven ausgearbeitet. Die Geschichte dazu, die Diskussion sowie die Ergebnisse werden in diesem Artikel aufgezeigt.

 

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Schlüsselwörter

klug entscheiden - Stammvenen - endovenöse thermische Ablation - ultraschallgesteuerte Schaum-Sklerotherapie

Keywords

choosing wisely - saphenous vein - endovenous thermal ablation - ultrasound-guided foam sclerotherapy

Originally created in North America, “Choosing Wisely” (CW) help initiate dialogue with patients, help health professionals make decisions about care choices, harmonize practices, reduce unnecessary or at-risk treatments and procedures, and promote relevant procedures. These elements are a first step towards the necessary prioritisation of therapeutic strategies.

In France, like in many western countries, varicose veins are a major economic issue. They are estimated to affect about 30% of the French general population, 40% of whom have insufficient saphenous veins corresponding potentially to 8 million people [1]. Conventional surgery is still overused and generates very high costs, especially in terms of work stoppages. Endovenous techniques are less invasive and should be encouraged, while good practices must be respected.

In this context, the National Professional Council of Vascular Medicine (CNPMV- Conseil National Professionnel de Médecine Vasculaire), which brings together all the societies of vascular medicine in France, i.e., more than 2,000 vascular doctors, has elaborated 10 CW, based on relevant and wise choices, regarding the treatment of saphenous veins insufficiency and recurrences.

Drafted by a group of experts and submitted to a review group of 29 vascular doctors, these CW are not intended to become enforceable but seek primarily to guide the patient and the practitioner towards the most relevant therapies in a quality and safety approach, and a cost reduction.

This has been done in consultation with the National Health Insurance (CNAM-Caisse Nationale d’Assurance Maladie), then transmitted to the Health High Authorities (HAS-Haute Autorité de Santé).

The “CNPMV-Choosing Wisely” (CW) were published in “Phlébologie-Annales Vasculaires” in 2018 [2].

As a result, new pricing provisions have been introduced in 2019, to promote endovenous methods over surgery: the reimbursement of ultrasound-guided foam sclerotherapy of the saphenous veins and recurrences has been significantly increased, and both Radiofrequency (RFA) and EndoVenous Laser Ablation (EVLA) have been reimbursed by the CNAM. However, the CNAM demands guarantees and requires vascular doctors to refer to and comply with the “CNPMV- CW”.

These “choosing wisely” imply that the decision to treat or not must be made with the patient, after weighing the pros and cons of occluding saphenous veins against preserving them, particularly in the light of cardiovascular risk factors. The various medical or surgical conservative treatments were not covered in these instructions as they were not directly concerned by the issue. Mechanical Occlusion Chemically Assisted (MOCA) and glue were not addressed as they are not reimbursed in France, by the CNAM.

The 10 CW are presented here with highlights and comments on their objectives and relevance. Mentioned references supporting the CW are indicative, not exhaustive and some are “country-specific”.

1. Use of duplex ultrasound before, during and immediately after the procedure for endovenous chemical or thermal ablation of saphenous veins or their recurrences.

   CW N°1: “Chemical or thermal ablation of saphenous veins or their recurrences must be performed with a Duplex scan examination before, during and immediately after the procedure”

   Objectives: allows to optimise the evaluation of the initial venous network, the relevance of the choice of treatment and its tactical planning, the security of the treatment, and the evaluation of the immediate results.

2. Report of procedure and iconography of the target vein for ultrasound-guided sclerotherapy (UGFS) of saphenous veins or their recurrences.

   CW N°2: “Ultrasound-guided sclerotherapy of saphenous veins or their recurrences must be accompanied by a report of the procedure including injection site(s), type and form of the sclerosing agent with concentration(s) used and volume(s) of foam injected, and by an iconography of the target vein just before the procedure and just after injection”

   Objectives: to ensure compliance with good practice, secure treatment, and assess immediate results. Allows verification by the National Health Insurance (CNAM).

3. Choice of saphenous vein treatment for large diameters (> 8 mm)

   CW N°3: “If saphenous vein treatment is considered, for a diameter greater than 8mm* thermal ablation must be offered as a first-line treatment if achievable; ultrasound-guided foam sclerotherapy remains a possible option depending on the context, but with a lower definitive occlusion rate”

   * Inner trunk diameter measured at mid-thigh for the great saphenous vein (GSV) and mid-calf for the small saphenous vein (SSV), patient standing.

   Objectives: to optimise results, improve the benefit for the patient while respecting the benefit-risk balance in particular by avoiding large volumes of foam.

   According to the literature, it is likely that this CW will be changed in the future to a diameter limit of 6 mm instead of 8 mm, as several studies have shown that the results of sclerotherapy in terms of occlusion or persistence of occlusion were less good on saphenous veins of 6 mm diameter and above [3] [4] [5] [6] [7].

4. Sclerotherapy of saphenous vein insufficiency or its recurrence with a sclerosing agent in liquid or foam form

   CW N°4: “Except in special cases and contraindications, the foam form of a sclerosing agent should be used rather than the liquid form for the sclerotherapy treatment of a saphenous vein insufficiency or its recurrence. In case of contraindication to foam, thermal ablation is recommended if feasible”

   Objectives: to optimise the relevance of the choice of treatment, results, and safety (less sclerosing agent injected with foam; foam is echoic) with reference to the literature.

   RCTs have demonstrated the superior efficacy of foam over liquid in sclerotherapy of saphenous veins [8] [9] [10] [11] .

5. Choice of saphenous vein treatment for diameters < 4 mm

   CW N°5: “If saphenous vein treatment is considered, for a diameter of less than 4mm* ultrasound-guided foam sclerotherapy must be offered as a first-line treatment if achievable; thermal ablation remains a possible option depending on the context, but with a significant cost increase compared to that of foam sclerotherapy”

   * Inner trunk diameter measured at mid-thigh for the GSV and mid-calf for the SSV, patient standing.

   Objectives: to optimise the relevance of the choice of treatment with reference to the literature; to consider the feasibility and to reduce costs [4] [5] [6] [7] .

6. Choice of treatment for saphenous vein insufficiency in patients at high thrombotic risk

   CW N°6: “If treatment of saphenous vein insufficiency in a patient at high thrombotic risk (repeated thromboembolic episodes, known severe thrombophilias, hypercoagulability, active cancer) is being considered, it is preferable, except in special cases, to offer thermal ablation as a first line of action if this is feasible. However, ultrasound-guided foam sclerotherapy remains a possible option, depending on the context. In all cases, the individual risk-benefit ratio must be assessed and an appropriate thromboprophylaxis performed.”

   Objectives: to optimise the relevance of the choice of treatment, prudence, and safety while maintaining the possibility of adaptability.

   Thermal ablation, when feasible, and performed in this case under thromboprophylaxis, makes it possible to obtain occlusion of the saphenous vein in a single step and with greater certainty and should be the first-line treatment. However, ultrasound-guided foam sclerotherapy remains a possible option depending on the context and must also be performed under adapted thromboprophyplaxis [1] [11] [12] [13] .

7. Treatment of saphenous vein insufficiency or recurrence by conventional open surgery (high ligation and stripping)

   CW N°7: “Once a decision has been made to treat a saphenous vein or its recurrence, conventional open surgery (high ligation and stripping) should not be offered, except in very rare cases (such as very large dysmorphic junctional or truncal ectasia). This does not apply to the so-called “modern” or “minimally invasive” surgery performed under strict local tumescent anaesthesia”.

   Objectives: to optimise benefit to the patient, avoid comorbidities and time off work, and reduce costs.

   “Conventional” open surgery of saphenous vein consists in a high ligation of the saphenofemoral or saphenopopliteal junction associated with trunk stripping (by pin-stripper or a similar Babcock device) often complemented by phlebectomies. In France, this surgery is still largely performed under general anaesthesia, with significant co-morbidity, particularly during surgical procedures for recurrences of varicose veins in the territory of a previously operated saphenous vein. In addition, according to the national health insurance (CNAM), it results in an average work stoppage of 26 days per patient.

   Outcomes of conventional surgery are not better than those of the endovenous techniques, which are less invasive and preferred to surgery in the international recommendations.

   Therefore, the first-line treatment for saphenous veins is thermal ablation, which can give way to foam sclerotherapy for some recurrences.

   Nowadays, with no exception, conventional surgery should not be offered for the treatment of saphenous veins or their recurrence, and endovenous thermal ablation should be considered even for treating large saphenous trunks (>12 mm). Therefore, this CW should be amended and extended without exception [14] [15] [16] [17] [18] [19] .

8. Failure of an initial treatment of a saphenous vein by ultrasound-guided foam sclerotherapy

   CW N°8: “Two consecutive failures of an initial treatment of the great saphenous vein with ultrasound-guided foam sclerotherapy or a failure on the small saphenous vein should lead to a reassessment of the situation and alternative therapeutic solutions, considering the benefit-risk balance.

   Objectives: to optimise the relevance of the choice of the treatment, results, benefit to the patient, and safety (avoidance of large volumes of foam); for the national health insurance fund, to avoid abuse of quotation.

   Without prejudging the remote retreatment that may be necessary in the event of subsequent recanalisation, studies on foam sclerotherapy of the saphenous veins show that during initial treatment, venous occlusion can often be obtained in 1 to 2 sessions for the GSV and a single session for the SSV, for moderate to medium calibre veins [9] [15] [20] .

9. Anesthesia in the treatment of the saphenous vein by endovenous thermal ablation

   CW N°9: “During treatment by endovenous thermal ablation (laser or radiofrequency) of a saphenous vein, local tumescent anaesthesia is mandatory. General, spinal, or femoral block anaesthesia is contraindicated except in very rare cases, for which ultrasound-guided tumescence remains mandatory”.

   Objectives: to optimise outcomes and safety using local tumescent anesthesia, especially to avoid neurological damage; to avoid unnecessary anaesthetic risks and comorbidities, optimise patient recovery, and reduce costs.

   The standard method for anaesthesia during endovenous thermal ablation of a saphenous vein is a strict local tumescent anaesthesia (LTA), performed under ultrasound guidance to ensure its quality. LTA seeks not only to provide local analgesia, but also to empty the vein of its blood, thus improving the contact of the probe or fibre with the venous wall, and to protect the perivenous structures, in particular cutaneous and nervous structures, from heat.

   It should be kept in mind that safety requires that in the event of a nerve heating, the patient should be able to report any painful signals to the practitioner immediately so that the practitioner can stop the application of energy immediately [17] [21] [22] [23] [24] .

10. Choice of treatment for endovenous thermal ablation of small saphenous vein

    CW N°10: “Whenever a thermal ablation of a small saphenous vein is chosen, it is preferable to offer an endovenous laser ablation as a first-line treatment. The 3-cm segmental radiofrequency, bipolar and monopolar radiofrequency are possible options, but the 7-cm segmental radiofrequency is not recommended.”

    Objectives: to optimise the relevance of the choice of treatment with reference to the literature and optimise safety (minimise neurological damage risks).

    The small saphenous vein (SSV) is a short vein that runs in areas close to the nerves.

    Compared to surgery, the thermal endovenous techniques can significantly reduce the rate of side effects, especially neurological complications (4.8% for laser versus 19.6% for surgery). A review of the literature on the treatment of the SSV, with meta-analysis, shows that studies carried out with endovenous laser (EVL) significantly outnumber those carried out with radiofrequency (RF) (2950 SSV treated by EVL, 386 by RF) with very good occlusion rates in both cases (98.5% for EVL,97.1% for RF) and very good safety (4.8% for neurological events for EVL and 9.7% for RF). [14]

    A 3-cm segmental RF probe has been marketed but has not been studied extensively in this indication. The same is true for bipolar and monopolar radiofrequency systems, whose very short active segment appears to meet safety criteria, but evaluation studies are still needed.

Conclusion

These 10 CW developed in France by the representative bodies of vascular physicians show that it is possible to work intelligently, quickly, and efficiently, in consultation with the representatives of the national health insurance funds, on “sensitive” public health issues. Proposals based on literature, recommendations, and good practice but also on common sense, aim to optimise the treatment of saphenous veins and recurrences while preserving the interests of the patient, the doctors, and the insurance funds. Because of the COVID pandemic and despite the rapid implementation of these CW by the French regulatory authorities, it is still too early to assess the impact of these measures on changes in practices and costs.

Of course, these instructions are appropriate for the French situation, and are probably not all applicable to all countries. However, they could be adapted to various countries, and CW model deserves to be more developed in different areas of public health.

This article is based on the publication: Hamel-Desnos C, Miserey G. Choosing wisely for Chemical or Thermal Ablation in the treatment of incomptent Saphenous Veins and Recurrences. Phlébologie-Annales Vasculaires 2018: 71: 1–9

 

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Conflict of Interest

CHD declares to have received fees from Medtronic for practical training. She has participated in phlebology training courses and workshops for Kreussler, and in a study conducted by STD, as investigator. She holds shares in and has family ties to I2M laboratories.

• References

• 1 Occlusion de veine saphène par laser par voie veineuse transcutanée. Actualisation de l’évaluation conduite en 2008. Service évaluation des actes professionnels. Rapport de la Haute Autorité de Santé (HAS), décembre 2016. https://www.has-sante.fr/upload/docs/application/pdf/2016-12/rapport_laser_endoveineux_vd.pdf
• 2 Hamel-Desnos C, Miserey G. Varices saphènes et récidives. Traitements d’occlusion chimique ou thermique dans l’insuffisance des veines saphènes et des récidives. Phlébologie 2018; 71: 1-8
• 3 Hamel-Desnos C, De Maeseneer M, Josnin M. et al. Great Saphenous Vein Diameters in Phlebological Practice in France: A Report of the DIAGRAVES Study by the French Society of Phlebology. Eur J Vasc Endovasc Surg 2019; 58: 96103
• 4 Myers KA, Jolley D, Clough A. et al. Outcome of Ultrasound-guided Sclerotherapy for Varicose Veins: Medium-term Results Assessed by Ultrasound Surveillance. Eur Vasc Endovasc Surg 2007; 33: 116-121
• 5 Van der Velden SK, Pichot O, van den Bos RR. et al. Management strategies for patients with varicose veins (C2-C6): results of a worldwide survey. Eur J Vasc Endovasc Surg 2015; 49: 213-220
• 6 Shadid N, Neleman P, Lawson J. et al. Predictors of recurrence of great saphenous vein reflux following treatment with ultrasound-guided foam sclerotherapy. Phlebology 2015; 30: 194-199
• 7 Venermo M, Saarinen J, Eskelinen E. et al. Randomized clinical trial comparing surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy for the treatment of great saphenous varicose veins. BJS 2016; 103: 1438-1444
• 8 Hamel-Desnos C, Desnos P, Wollmann JC. et al. Evaluation of the efficacy of polidocanol in the form of foam compared with liquid form in sclerotherapy of the greater saphenous vein: initial results. Dermatol Surg 2003; 29: 1170-1175
• 9 Rabe E, Otto J, Schliephake D. et al. Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial. Eur J Vasc Endovasc Surg 2008; 35: 238-245
• 10 Hamel-Desnos C, Allaert FA. Liquid versus foam sclerotherapy. Phlebology 2009; 24: 240-246
• 11 Rabe E, Breu FX, Cavezzi A. et al. European guidelines for sclerotherapy in chronic venous disorders. Phlebology 2014; 29: 338-354
• 12 Nyamekye IK, Campbell B. UK Royal Society of Medicine Venous Forum VTE Advice 2020. Phlebology 2021; 36: 88-90
• 13 Rabe E, Breu FX, Flessenkämper I. et al. Sclerotherapy in the treatment of varicose veins. Der Hautarzt 2021; 72: 23-36
• 14 Boersma D, Kornmann VNN, van Eekeren RRJP. et al. Treatment Modalities for Small Saphenous Vein Insufficiency: Systematic Review and Meta-analysis. J Endovasc Ther 2016; 23: 199-211
• 15 Lawaetz M, Serup J, Lawaetz B. et al. Comparison of endovenous ablation techniques, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Extended 5-year follow-up of a RCT. International Angiology 2017; 36: 281-288
• 16 National Institute for Health and Clinical Excellence (NICE). Varicose veins in the legs. The diagnosis and management of varicose veins. 2013. NICE clinical guideline 168. https://www.nice.org.uk/guidance/cg168/chapter/1- recommendations
• 17 De Maeseneer MG, Kakkos SK, Aherne T. et al. Editor's Choice – European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg 2022; 63: 184-267
• 18 Dabbs EB, Mainsiouw LE, Holdstock JM. et al. A description of the ’smile sign’ and multi-pass technique for endovenous laser ablation of large diameter great saphenous veins. Phlebology 2018; 33: 534-539
• 19 Woo HY, Kim SM, Kim D. et al. Outcome of ClosureFAST radiofrequency ablation for large-diameter incompetent great saphenous vein. Ann Surg Treat Res 2019; 96: 313-318
• 20 Hamel-Desnos C, Guias BJ, Desnos PR. et al. Foam sclerotherapy of the saphenous veins: randomized controlled trial with or without compression. Eur J Vasc Endovasc Surg 2010; 39: 500-507
• 21 Hamel-Desnos C, Desnos P, Allaert F-A. et al. Thermal ablation of saphenous veins is feasible and safe in patients older than 75 years: a prospective study (EVTA study). Phlebology 2015; 30: 525-532
• 22 Gauw SA, Lawson JA, van Vlijmen-van Keulen CJ. et al. Five-year follow-up of a randomized, controlled trial comparing saphenofemoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anesthesia. J Vasc Surg 2016; 63: 420-428
• 23 Rasmussen LH, Lawaetz M, Bjoern L. et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg 2011; 98: 1079-1087
• 24 Rass K, Frings N, Glowacki P. et al. Same site recurrence is more frequent after endovenous laser ablation compared with high ligation and stripping of the great saphenous vein: 5-year results of a randomized clinical trial (RELACS Study). Eur J Vasc Endovasc Surg 2015; 50: 648-656

Publikationsverlauf

Artikel online veröffentlicht:
02. August 2022