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Lower limb venous incompetence and the effect of radiofrequency ablation versus open surgery: Focus on haemodynamics, quality of life and health economic aspects
Linköping University, Department of Health, Medicine and Caring Sciences, Division of Diagnostics and Specialist Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart Center, Department of Thoracic and Vascular Surgery.ORCID iD: 0000-0003-1691-458X
2023 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Chronic venous incompetence (CVI) is a common condition, and varicose vein treatment is one of the most-common surgical procedures performed worldwide. Common symptoms of CVI are pain, cramps, itching, feeling of leg heaviness and venous claudication. Advanced CVI can lead to skin changes, eczema and venous ulcers. While the cause of the disease is un-known, it often starts with venous enlargement and valve dysfunction. The overall aims of this thesis are: 1) to develop quantitative diagnostic measurements using strain-gauge plethysmography (SGP) with standardised superficial venous occlusion and duplex ultrasound (DUS); 2) to evaluate the effects of radiofrequency ablation (RFA) and high ligation/stripping (HL/S) for patients with great saphenous vein (GSV) incompetence; and 3) to evaluate the cost-effectiveness of GSV treatment.   

The first of the four studies involved patients with GSV incompetence. For these patients, SGP with superficial venous occlusion was performed before and after GSV treatment. SGP was able to predict the haemodynamic outcome of the treatment in the majority of the limbs examined. The conclusion is that SGP with standardised superficial venous occlusion may be used for predicting the outcome of GSV treatment.   

The second study evaluated the short-term outcomes of GSV treatment using RFA and HL/S regarding haemodynamics and quality of life (QoL). Both treatments lead to significant improvements in QoL, with no signifcant differences between the treatments. Despite successful treatment, the majority of the limbs in both treatment groups had significant residual reflux located mainly in the calf (i.e., below the treated area). The residual reflux may be a risk factor for future symptom relapses and need to be examined in more-long-term studies.   

The third study examined quantitative DUS and SGP parameters in relation to clinical severity and QoL. DUS-derived volume flow and SGP re-flux time showed weak but significant correlations with clinical severity (C in CEAP). The conclusion is that the current gold standard using the qualitative DUS-derived reflux time for CVI diagnostics should be revised and replaced with a more-relevant quantitative parameter.   

The fourth study evaluated the cost-effectiveness of GSV treatment with 1 year of follow-up. Both RFA and HL/S provided significant improvements in QoL. RFA is very cost-effective and is associated with fewer days missed from work compared to HL/S. Cost-wise, both methods are well be-low the national threshold for cost-effective treatment. Due to its higher cost, HL/S should be reserved for cases that require this method.    

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2023. , p. 52
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 1846
Keywords [en]
Chronic venous incompetence, Varicose veins, Radiofrequency ablation, High ligation/stripping Duplex ultrasound, Strain-gauge plethysmography, Quality of Life, Health economic evaluation
National Category
Surgery
Identifiers
URN: urn:nbn:se:liu:diva-193176DOI: 10.3384/9789180751018ISBN: 9789180751001 (print)ISBN: 9789180751018 (electronic)OAI: oai:DiVA.org:liu-193176DiVA, id: diva2:1751693
Public defence
2023-05-19, Hasselquistsalen, building 511, entrance 76, 78., Campus US, Linköping, 13:00 (Swedish)
Opponent
Supervisors
Note

2023-04-19: ISBN (PDF) has been added in the electronic version.

2023-05-12: An minor error was corrected in the electronic version of the thesis on page 27, paragraph 2. The correct scentence is: "Differences with p-values < 0.05 were considered to be statistically significant." The correction is in line with the second edition of the printed thesis. Before this date the PDF has been downloaded 38 times.

Available from: 2023-04-19 Created: 2023-04-19 Last updated: 2023-12-28Bibliographically approved
List of papers
1. Prediction of Post-interventional Outcome in Great Saphenous Vein Incompetence: The Role of Venous Plethysmography with Selective Superficial Vein Occlusion
Open this publication in new window or tab >>Prediction of Post-interventional Outcome in Great Saphenous Vein Incompetence: The Role of Venous Plethysmography with Selective Superficial Vein Occlusion
2016 (English)In: European Journal of Vascular and Endovascular Surgery, ISSN 1078-5884, E-ISSN 1532-2165, Vol. 52, no 3, p. 377-384Article in journal (Refereed) Published
Abstract [en]

Objective/Background

To evaluate whether the outcome of radiofrequency ablation (RFA) treatment of great saphenous vein (GSV) incompetence may be predicted using strain-gauge plethysmography (SGP) with selective occlusion of the superficial venous system.

Methods

Seventeen patients (20 limbs) underwent endovenous RFA treatment for GSV incompetence (Clinical Etiology Anatomy Pathophysiology classification C2–C5; “C-group”). Duplex ultrasound (DUS) and SGP were performed with selective occlusion of superficial veins before and after RFA. Selective superficial occlusion was validated, in a control group (C-group) of 12 patients (14 legs), by ascending phlebography. In the RFA group, the time taken to reach 50% and 90% (T50, T90) of maximum venous volume was measured, as well as relative maximal reflux rates (%EV/min). The methodological error and coefficient of variation (CV) were assessed.

Results

Nineteen of 20 legs had complete post-operative GSV obliteration using DUS, and refilling times were improved after RFA (T50 11 ± 3 vs. 19 ± 3 s; p < .001; T90 27 ± 5 vs. 47 ± 6 s; p < .001). With SGP, the methodological error and CV for T50 were 4 s and 16%, respectively. Equivalence between pre-operative superficial occlusion and post-operative baseline measurements was achieved in 15 of 17 legs for T50, and 12 of 17 for T90 (three of the 20 legs were excluded due to treatment failure [n = 1], and untreated perforating veins [n = 2]). Mean differences (95% confidence interval) were within the equivalence ranges (T50 1 [–1 to 3] seconds; T90 –3 [–11 to 4] seconds). In the C-group superficial vein occlusion was possible in 12 of 14 legs. The remaining patient (two legs) showed incomplete superficial vein occlusion at ankle level (lipodermatosclerosis) and complete superficial vein occlusion at calf level.

Conclusion

SGP with standardized superficial venous occlusion seems to be a reliable method for identifying venous reflux and may be useful in predicting the results of successful RFA treatment.

Place, publisher, year, edition, pages
Elsevier, 2016
Keywords
Duplex ultrasound, Radiofrequency ablation, Strain-gauge plethysmography, Venous incompetence
National Category
Other Clinical Medicine Surgery
Identifiers
urn:nbn:se:liu:diva-131157 (URN)10.1016/j.ejvs.2016.05.032 (DOI)000383524200022 ()27405879 (PubMedID)
Note

Funding agencies:  Linkoping University, Linkoping, Sweden; Swedish Heart Lung Foundation

Available from: 2016-09-12 Created: 2016-09-12 Last updated: 2023-12-28Bibliographically approved
2. Impact on venous haemodynamics after treatment of great saphenous vein incompetence using plethysmography and duplex ultrasound
Open this publication in new window or tab >>Impact on venous haemodynamics after treatment of great saphenous vein incompetence using plethysmography and duplex ultrasound
2020 (English)In: Phlebology, ISSN 0268-3555, E-ISSN 1758-1125, Vol. 35, no 7, p. 495-504Article in journal (Refereed) Published
Abstract [en]

Objectives

To evaluate postoperative venous haemodynamics and quality of life after treatment of great saphenous vein (GSV) incompetence.

Methods

Radiofrequency ablation and high ligation and stripping were performed in 62 patients (65 limbs) and 58 (65 limbs), respectively. Phlebectomies were performed in both modalities. Strain-gauge plethysmography on the foot combined with superficial venous occlusion was used to measure refilling time after knee bends. Strain-gauge plethysmography, duplex ultrasound and quality of life were assessed before and one month after treatment.

Results

Duplex ultrasound displayed successful intervention in all but two limbs. Refilling time increased similar in radiofrequency ablation and high ligation and stripping after treatment (p < 0.001). Postoperatively, strain-gauge plethysmography detected remaining reflux in 71% of the patients. Multivariate analysis showed that two or more incompetent calf branches were associated with remaining reflux (OR 4.82 (95% CI: 1.33–17.5), p = 0.02). No difference in quality of life was seen in patients with remaining reflux.

Conclusions

Despite successful treatment, a majority of the limbs showed remaining reflux, in which incompetent calf branches appear to play an important role.

Clinicaltials.gov: Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery. Nr: NCT02397226

Place, publisher, year, edition, pages
Sage Publications, 2020
Keywords
Venous incompetence; radiofrequency ablation; high ligation; stripping; strain-gauge plethysmography; duplex ultrasound
National Category
Surgery
Identifiers
urn:nbn:se:liu:diva-163631 (URN)10.1177/0268355519898952 (DOI)000508777200001 ()31959059 (PubMedID)2-s2.0-85078192873 (Scopus ID)
Note

Funding Agencies|Linkoping University Hospital Research Fund, Linkoping, Sweden; ALF Grants, Region Ostergotland, Linkoping, Sweden

Available from: 2020-02-17 Created: 2020-02-17 Last updated: 2023-12-28Bibliographically approved
3. Relationship between clinical severity and hemodynamic impact of great saphenous vein incompetence using strain gauge plethysmography and duplex ultrasound
Open this publication in new window or tab >>Relationship between clinical severity and hemodynamic impact of great saphenous vein incompetence using strain gauge plethysmography and duplex ultrasound
2022 (English)In: Phlebology, ISSN 0268-3555, E-ISSN 1758-1125, Vol. 37, no 8, p. 579-587Article in journal (Refereed) Published
Abstract [en]

Objectives To evaluate the relation of quantitative Duplex ultrasound (DUS) and strain gauge plethysmography (SGP) parameters with clinical severity and quality of life in patients with superficial venous incompetence.

Methods DUS volume flow and distal SGP refilling times (T-50 and T-90) were evaluated in 152 patients (164 Limbs) with superficial incompetence. Clinical severity and quality of life were evaluated with C of the CEAP classification, venous clinical severity score (VCSS), Aberdeen varicose vein questionnaire (AVVQ), and EuroQol 5D-3L.

Results Higher DUS volume flow was associated with higher C in CEAP scores. Volume flow was also related to T-50 and T-90. Shorter T-50 and T-90 were associated with higher C in CEAP and VCSS. T-50 was also associated with EQ-5DVAS. Reflux extension to the foot wase associated with shorter T-50 and T-90 and higher DUS volume flow.

Conclusions DUS volume flow and SGP refilling times are related with clinical severity and provide quantitative information regarding venous function in patients with superficial incompetence.

Place, publisher, year, edition, pages
London, United Kingdom: Sage Publications, 2022
Keywords
Venous incompetence; duplex ultrasound; plethysmography
National Category
Radiology, Nuclear Medicine and Medical Imaging
Identifiers
urn:nbn:se:liu:diva-185390 (URN)10.1177/02683555221101711 (DOI)000798506500001 ()35549546 (PubMedID)
Note

Funding Agencies: Linköping University Hospital Research Fund [RO-857151, RO-760041, RO-653211]; Linköping, Sweden, ALF Grants, Region Östergotland (ALF Grants) [RO -700491, RO -794311, RO -900741]

Available from: 2022-06-01 Created: 2022-06-01 Last updated: 2023-12-28Bibliographically approved

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Nelzén, Oskar

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