The Value of Studying Very Long Term Results (10 years or more) After Varicose Vein Treatment

Like arterial surgery, venous treatments have become mainly endovascular. Endovenous treatment for varicose veins (VVs) and related chronic venous disease (CVD) is usually performed in an outpatient setting, under local (tumescent) anaesthesia, and with minimal post-interventional morbidity.1De Maeseneer M.G. Kakkos S.K. Aherne T. Baekgaard N. Black S. Blomgren L. 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: 184-267Abstract Full Text Full Text PDF PubMed Scopus (98) Google Scholar Open surgery for VVs used to be nicknamed the Cinderella of surgery: patients were often operated on by surgical trainees or surgeons without any particular interest in venous disease. Moreover, classic VV surgery (high ligation and stripping [HLS] and phlebectomies) not only requires the resources of an operating theatre and general or regional anaesthesia, but also causes more post-operative morbidity and a longer time off work. In recent years, open VV surgery has been modernised, which means it can also be performed under tumescent anaesthesia and with low post-operative morbidity.1De Maeseneer M.G. Kakkos S.K. Aherne T. Baekgaard N. Black S. Blomgren L. 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: 184-267Abstract Full Text Full Text PDF PubMed Scopus (98) Google Scholar When comparing treatment methods in scientific studies, durability is an important outcome. Compared with arterial patients, venous patients are younger and healthier, and hence will usually live longer. This means that the outcome of interventions can be studied over long (≥ 5 years) and very long term follow up (≥ 10 years),2De Maeseneer M. Pichot O. Cavezzi A. Earnshaw J. van Rij A. Lurie F. et al.Duplex ultrasound investigation of the veins of the lower limbs after treatment for varicose veins – UIP consensus document.Eur J Vasc Endovasc Surg. 2011; 42: 89-102Abstract Full Text Full Text PDF PubMed Scopus (153) Google Scholar not only based on clinical examination (recurrent VVs) and duplex ultrasound (recurrent reflux), but also on health related quality of life (HRQoL). Some of the recurrences after any kind of VV treatment are unavoidable due to progression of CVD, but a considerable number are due to technical or tactical failure related to the method or strategy, resulting in remnant refluxing tributaries or accessory veins in the groin, mainly the anterior accessory saphenous vein (AASV), recanalisation of the saphenous trunk, persistence of reflux in untreated segments, or residual varicosities.1De Maeseneer M.G. Kakkos S.K. Aherne T. Baekgaard N. Black S. Blomgren L. 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: 184-267Abstract Full Text Full Text PDF PubMed Scopus (98) Google Scholar The presence of a residual cluster of VVs in the lower leg may appear to be a minor problem, but for patients with a venous leg ulcer, persisting reflux may impede healing and or cause recurrences of the ulcer.3Pihlaja T. Vanttila L.M. Ohtonen P. Pokela M. Factors associated with delayed venous ulcer healing after endovenous intervention for superficial venous insufficiency.J Vasc Surg Venous Lymphat Disord. 2022; 10: 1238-1244Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar In addition to the causes of recurrence mentioned above, neovascularisation may play a role in the development of recurrent VVs, mainly after HLS. 1De Maeseneer M.G. Kakkos S.K. Aherne T. Baekgaard N. Black S. Blomgren L. 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: 184-267Abstract Full Text Full Text PDF PubMed Scopus (98) Google Scholar The prevalence of recurrent VVs has been amply studied for open surgery and one study even reported a case series with more than 30 years of follow up after HLS.4Fischer R. Linde N. Duff C. Jeanneret C. Chandler J.G. Seeber P. Late recurrent saphenofemoral junction reflux after ligation and stripping of the greater saphenous vein.J Vasc Surg. 2001; 34: 236-240Abstract Full Text Full Text PDF PubMed Scopus (222) Google Scholar For endovenous methods, ≥ 5 years of follow up has only recently become available.1De Maeseneer M.G. Kakkos S.K. Aherne T. Baekgaard N. Black S. Blomgren L. 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: 184-267Abstract Full Text Full Text PDF PubMed Scopus (98) Google Scholar Several randomised clinical trials (RCTs) comparing endovenous thermal ablation (EVTA) with HLS have contributed to support the level of evidence A and strength of recommendation Class I for EVTA and Class IIa for HLS in the 2022 European Society for Vascular Surgery guidelines.1De Maeseneer M.G. Kakkos S.K. Aherne T. Baekgaard N. Black S. Blomgren L. 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: 184-267Abstract Full Text Full Text PDF PubMed Scopus (98) Google Scholar Equally, the recently published Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society Clinical Practice Guidelines for the Management of VVs (Part I) also recommend treatment with EVTA over HLS, because of less post-operative morbidity, as well as an earlier return to previous activities (Grade 1, level of evidence B).5Gloviczki P. Lawrence P.F. Wasan S.M. Meissner M.H. Almeida J. Brown K. et al.The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society Clinical Practice Guidelines for the Management of Varicose Veins of the Lower Extremities: Part I. Duplex scanning and treatment of superficial truncal reflux.J Vasc Surg Venous Lymphat Disord. 2022; ([Epub ahead of print])https://doi.org/10.1016/j.jvsv.2022.09.004Abstract Full Text Full Text PDF Scopus (3) Google Scholar Recently, for the first time, very long term (≥ 10 years) results from a RCT comparing HLS with endovenous laser ablation (EVLA) of the great saphenous vein (GSV) have been reported.6Eggen C.A.M. Alozai T. Pronk P. Mooij M.C. Gaastra M.T.W. Ünlü Ç. et al.Ten-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 Venous Lymphat Disord. 2022; 10: 646-653Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar This study included 122 patients (130 limbs) with symptomatic GSV incompetence; 68 limbs were treated with HLS and 62 with EVLA. All interventions were performed under tumescent anaesthesia in an outpatient setting. After 10 years, the estimated freedom from duplex detected groin recurrence, according to Kaplan–Meier analysis, was higher in the HLS group than in the EVLA group (73% vs. 44%; p = .002), and freedom from clinically evident recurrence was also higher in the HLS group (77% vs. 58%; p = .034). After EVLA, three GSVs had recanalised, while new reflux in the AASV was found in 26 limbs, of which 21 had clinically obvious recurrent VVs. Nine re-interventions (17%) were deemed necessary in the HLS group vs. 18 (36%) in the EVLA group (p = .057). In the HLS group, all re-interventions consisted of foam sclerotherapy, whereas in the EVLA group foam sclerotherapy was performed in five limbs, high ligation in two limbs, and an endovenous procedure in 11. There were no significant differences in quality of life or relief of venous symptoms. It should be acknowledged that this was a small, single centre RCT, with 21% of included limbs lost to follow up at 10 years. It had been performed immediately after the introduction of EVLA to the department, and a 980 nm bare laser fibre was used. Nevertheless, it confirmed the findings of a previously published meta-analysis of the five year results of GSV treatment, with a lower rate of recurrent reflux at the saphenofemoral junction in the HLS group vs. the EVLA group (12% vs. 22%; p = .038).7Hamann S.A.S. Giang J. De Maeseneer M.G.R. Nijsten T.E.C. van den Bos R.R. Editor's Choice – Five year results of great saphenous vein treatment: a meta-analysis.Eur J Vasc Endovasc Surg. 2017; 54: 760-770Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar Technical success and recurrence of VVs after at least five years for different treatment techniques was also studied in a 2021 Cochrane review of interventions for GSV incompetence, including 24 RCTs.8Whing J. Nandhra S. Nesbitt C. Stansby G. Interventions for great saphenous vein incompetence.Cochrane Database Syst Rev. 2021; 8: CD005624PubMed Google Scholar The authors did not find any difference in ≥ 5 year recurrence of VVs between EVTA and HLS. Conclusions were limited owing to the relatively small number of studies for each comparison, differences in outcome definitions, and time points reported, but technical success was comparable between most treatment modalities. Favourable very long term results were also reported in another single centre cohort study of 203 patients treated with 1470 nm EVLA for GSV or small saphenous vein (SSV) incompetence and phlebectomies of the most prominent VVs.9Pavei P. Spreafico G. Bernardi E. Giraldi E. Ferrini M. Favorable long-term results of endovenous laser ablation of great and small saphenous vein incompetence with a 1470-nm laser and radial fiber.J Vasc Surg Venous Lymphat Disord. 2021; 9: 352-360Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar In this study, up to 98% of patients were asymptomatic or had significantly improved after EVLA, even if clinical VV recurrence was observed in 37% of patients treated for GSV incompetence and 17% of those treated for SSV incompetence. After the initial EVLA treatment, additional subsequent treatments (mainly foam sclerotherapy, in most cases within the first three years) had been performed in 21% of patients with GSV and 5% of those with SSV incompetence. The question is, in the very long term, what is the optimal outcome: freedom from venous reflux detected with DUS, freedom from venous symptoms, freedom from clinically visible VVs, freedom from re-intervention, or HRQoL? These different outcome criteria do not always correlate. Moreover, in studies reporting the number of re-interventions, it is not always clear what the indication for a new treatment was: duplex detected reflux that could be abolished, venous symptoms, cosmetic appearance, or VVs and or skin changes (C4 – C6, according to the CEAP classification)?10Lurie F. Passman M. Meisner M. Dalsing M. Masuda E. Welch H. et al.The 2020 update of the CEAP classification system and reporting standards.J Vasc Surg Venous Lymphat Disord. 2020; 8: 342-352Abstract Full Text Full Text PDF PubMed Scopus (237) Google Scholar For the latter indication, repeat treatment may be justifiable. Presumably, HRQoL and patient satisfaction are the most important outcome criteria in the long and very long term. Another question is: once recurrence of VVs becomes a real clinical problem, can these VVs not just be treated easily with foam sclerotherapy? This may largely depend on the healthcare system at hand. In countries where specialised phlebologists are available and easily accessible, multiple sessions of ultrasound guided foam sclerotherapy at regular intervals may be possible, whereas in other countries with long waiting lists for examination and treatment, a one stop treatment may be preferred. In conclusion, studies including very long term follow up after the treatment of superficial venous incompetence may be useful to better understand the disease process, the durability of different management strategies, and to further clarify the role of progression of CVD over time. Lena Blomgren received ALF funding from Region Örebro County.