Implementation of a varicose vein module added to Swedvasc, the Swedish National Registry for vascular surgery.

OBJECTIVES: The addition of a varicose veins (VV) module to the existing Swedish National Registry for Vascular Surgery (Swedvasc) and its impact on quality of care were evaluated. METHODS: Vascular departments and private VV clinics were invited to enter data from 2016. RESULTS: Registrations were approximately 10,000 yearly but dropped to 5390 in 2022 when a fee was introduced for private clinics due to reduced funding. 88% more interventions were reported to Swedvasc 2020 than to the National Board of Health and Welfare. Regions differed in interventions per 100,000 inhabitants/year from 21 to 233 and in preoperative CEAP C4-6 from 30.8%-90.4%. Follow-up was 9.4%. These data contributed to the decision to prioritize the patient group for national guidelines and pathways of care, which will be monitored by Swedvasc. CONCLUSIONS: A national VV registry with high coverage is possible and can contribute to national quality of care. The main challenge is funding.

Does eradication of superficial vein incompetence after superficial vein thrombosis reduce the risk of recurrence and of deep vein thrombosis? A pilot study evaluating clinical practice in Örebro county, Sweden.

BACKGROUND: Elective eradication of superficial vein incompetence (SVI) is advocated after superficial vein thrombosis (SVT) to prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), and to prevent recurrent SVT. However, this practice currently lacks evidence and not all SVT patients are referred. METHOD: Pilot study based on retrospective review of medical records for patients in Örebro county, Sweden; diagnosed with SVT during 2019. Patients in primary care without venous intervention were compared with patients from a vascular service treated with eradication for SVI, regarding prevalence of VTE and recurrent SVT during one-year follow-up. RESULTS: Out of 236 records reviewed, 97(41%) were included, 44 in the vascular care, and 53 in primary care. Erroneous diagnosis and coding were common causes for exclusion. The groups differed in ultrasound verified SVT 25(47.2%) and 35(79.5%) (p = .001), LMWH treatment 13(24.5%) and 24(54.5%) (p = .002), and history of prior SVT 19(35.8%) and 31(70.5%) (p = .001).There was no difference in the incidence of VTE during follow-up, 1(1.9%) and 1(2.3%) (p = 1.000), or recurrent SVT, 7(13.2%) and 6(13.6%), respectively (p = .951). CONCLUSIONS: This pilot study cannot confirm if elective eradication of SVI after SVT reduces the risk of VTE and recurrent SVT, however, the incidence of VTE was low in both groups. Limitations of the study are the small sample size and the lack of duplex ultrasound in all cases in both groups at diagnosis and at follow-up. Further prospective studies on homogenous populations are needed.

Health-related quality of life and prosthesis use among patients amputated due to peripheral arterial disease - a one-year follow-up.

PURPOSE: A major amputation affects the patients' independence, well-being and HRQoL. However, prosthesis use and the impact on the patient's HRQoL are scarcely described. The aim was to compare HRQoL between walker and non-walker amputees. Secondary aim was to evaluate prosthesis use and habits. METHOD: Ninety-eight patients with a major amputation due to peripheral arterial disease were included during 2014-2018. They were interviewed using EQ-5D-3L (HRQoL), Stanmore Harold Wood mobility grade (prosthesis use) and Houghton scale (prosthesis habits). RESULTS: Seventy-three patients completed the one-year follow-up, out of them 56 got a prosthesis. Twenty-three used it to walk both inside and outside. EQ-5D-3L at follow-up was increased in all patients in comparison to baseline (0.16 versus 0.59, p < 0.001). Patients walking with prosthesis had the largest improvement (0.12 versus 0.78, p < 0.001). A sub-analysis aiming to study the importance of independent movement showed an improved HRQoL at follow-up among those classified as prosthesis-user (p<0.001) and walker (p<0.001), but not among non-prosthesis users (p = 0.245). CONCLUSION: Learning how to use, not exclusively to walk with, a prosthesis after an amputation is important for the patients' HRQoL. At follow-up, patients using their prosthesis to walk or to move to a wheelchair, showed an improved HRQoL compared to baseline.IMPLICATIONS FOR REHABILITATION Walking ability with a prosthesis is important for the patient's perceived HRQoL after an amputation.Rehabilitation of amputees should focus on independence and movability and not only on walking ability.Wider use of prescribing prostheses after an amputation also to those predicted as non-walkers, may increase the number of patients with independence and improved HRQoL.When using their prosthesis for independent movement, patients who were otherwise unable to walk due to their amputation were able to achieve HRQoL comparable to walking amputees.

Plasma levels of leucocyte elastase-generated cross linked fibrin degradation products (E-XDP) are elevated in chronic venous disease.

Patients with chronic venous disease (CVD) have elevated levels of leucocyte elastase (LE) released from the activation of leucocytes. In acute deep venous thrombosis (DVT), LE can degrade fibrin from the thrombus resulting in cross-linked fibrin degradation products (E-XDP) being released into the bloodstream. In patients with CVD the levels and significance of circulating E-XDP are unknown. We aimed to investigate the association between plasma E-XDP concentration and severity of CVD. Levels of E-XDP were quantified with a specific enzyme-linked immunosorbent assay (ELISA) in plasma from 142 consecutively recruited CVD patients (mean age 64 years, (range 23-89), 81 were females and 61 males). Patients were also divided into three groups based on CVD severity using the C-class of the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification, with C 0-1 class as the reference group, C 2-3 as the second group and C 4-6 as the third group with the most severely affected patients. We found significantly elevated levels of E-XDP in patients with C 4-6 compared with patients with C 0-1 (p = 0.007) and increased with increasing disease severity across the groups (p = 0.02). Significant independent association was observed between levels of E-XDP and the classes C 4-6 after adjustment for age and sex (p < 0.05), but the association was no longer significant after further adjustment for use of statins, use of anticoagulants and history of DVT (p = 0.247). This exploratory study shows that E-XDP levels are elevated in patients with CVD, encouraging further studies on the role of E-XDP in CVD.

Risk factors for reamputations in patients amputated after revascularization for critical limb-threatening ischemia.

OBJECTIVE: Despite vascular intervention, patients with critical limb-threatening ischemia (CLTI) have a high risk of amputation. Furthermore, this group has a high risk for stump complications and reamputation. The primary aim of this study was to identify risk factors predicting reamputation after a major lower limb amputation in patients revascularized because of CLTI. The secondary aim was to investigate mortality after major lower limb amputation. METHODS: There were 288 patients who underwent a major ipsilateral amputation after revascularization because of CLTI in Stockholm, Sweden, during 2007 to 2013. The main outcome was ipsilateral reamputation. RESULTS: Of 288 patients, 50 patients had a reamputation and 222 died during the 11-year follow-up. Patients with ischemic pain as an indication for primary amputation had nearly four times higher risk for a reamputation compared with those with a nonhealing ulcer (subdistribution hazard ratio, 3.55; confidence interval, 1.55-8.17). Higher age was associated with an increased risk for death in the multivariable analysis (hazard ratio, 1.03; confidence interval, 1.02-1.04). CONCLUSIONS: Patients with ischemic pain as an indication for amputation have an elevated risk of reamputation. Ischemic pain may be indicative of a more extensive and proximal ischemia compared with patients with foot tissue loss. An extended evaluation of the preoperative circulation before amputation may facilitate the choice of amputation level and could lead to a reduction of reamputations.

[Varicose vein treatment is underreported in Sweden]. / Behandling av varicer i Sverige ­ underrapporteringen är stor.

The aim of this study was to estimate the number of treatments for varicose veins (VV) performed in Sweden annually and the proportion of these unknown to the National Board of Health and Welfare or to the Swedish National Registry for Vascular Surgery, Swedvasc. Aggregated data was collected from the National Patient Registry (NPR), Swedvasc and inquiries sent to hospitals and private clinics for the years 2016-2018, the calculated volumes from these three sources were comparable with extrapolated volumes obtained from a coverage control between NPR and Swedvasc for treatments of the great saphenous vein. The approximated volumes of VV interventions annually were 8 650, 10 750 and 12 250, the proportion not registered in NPR 29%, 51% and 58% respectively, the corresponding figures for Swedvasc 56%, 33% and 20%. Interventions for VV are thus underreported in Sweden and this has implications for allocation of resources and quality control.

Validation of a Swedish version of a short patient-reported outcome measure for superficial venous insufficiency.

OBJECTIVE: Patient-reported outcome measures (PROMs) are increasingly used to measure symptoms and treatment effects, and a short PROM is more user friendly. The aim of this study was to test whether a Swedish seven-item version of the PROM used in the Vascular Quality Initiative Varicose Vein Registry can be used to measure quality of life in a Swedish cohort of patients with superficial venous insufficiency (SVI) equally well as the 26-item Swedish version of the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym-S) and measure treatment effect. METHODS: Consecutive patients with SVI and Clinical-Etiology-Anatomy-Pathophysiology (CEAP) clinical class ≥C2 were recruited at three private clinics and one county hospital between January 2018 and October 2019. The patients were asked to answer both the VEINES-QOL/Sym-S and the Swedish seven-item version, called VARIShort, at two assessment points, baseline (cohort 1, 252 patients) and 1 week later (cohort 2, 138 patients), and the VARIShort at baseline and 8 weeks after an endovenous procedure (cohort 3, 106 patients). The mean age was 58.3 years (range, 20-93 years), 61.4 years (range, 20-93 years), and 57.2 years (range, 20-89 years) in cohorts 1, 2, and 3, respectively; the majority were female (59%, 55%, and 64%), and most were CEAP C4 (39%, 46%, and 38%). The VARIShort was evaluated with regard to its validity, test-retest reliability, internal consistency reliability, sensitivity, and responsiveness. RESULTS: There was a strong correlation between the VEINES-QOL-S and the VARIShort (rs = -0.819; P < .001). The VARIShort showed both excellent internal consistency with Cronbach's α of 0.93 and a high response to clinical change as measured with Cohen's d, overall score of 1.17. CONCLUSIONS: The Swedish seven-item PROM, the VARIShort, may be used for assessment of symptoms of SVI and outcome after treatment in Swedish SVI patients. The short PROM shows degree of SVI symptom impact on quality of life in the same manner as the 26-item VEINES-QOL/Sym-S.

Residual incompetent tributaries after varicose vein surgery increased the need for reintervention after 8 years.

OBJECTIVE: The aim of this study was to determine whether residual incompetent tributaries after varicose vein surgery affected the reintervention rate after longer follow-up. METHODS: The study is a retrospective review of data from a cohort of a previous randomized controlled study comparing surgery with and without preoperative duplex ultrasound, with follow-up after 2 months, 2 years, and 5 to 9 years clinically and with duplex ultrasound. The cohort was subdivided according to the duplex ultrasound findings 2 months after surgery: no venous incompetence, residual incompetent tributaries only, truncal incompetence, and combined truncal and tributary incompetence. Reintervention rates were compared between groups. RESULTS: There were 280 patients (326 legs) who attended follow-up 2 months postoperatively and 164 patients (190 legs) after a median of 8 years (5-9 years). Another 53 patients (62 legs) were interviewed by telephone or had been reoperated on earlier during follow-up; thus, information was available for 217 patients (252 legs). Of the 252 legs, 56 (22%) were reoperated on during follow-up. In the subgroup with no venous incompetence at all 2 months postoperatively, 4 of 74 legs (5%) were reoperated on; and in the group with residual incompetent tributaries without truncal incompetence, 16 of 56 legs (29%) were reoperated on (P = .000). There was no significant difference in reintervention rate of the group with incompetent tributaries only compared with those with truncal incompetence without incompetent tributaries (12/42 legs [29%]; P = 1) or with combined incompetence of truncal vein and tributaries (22/64 legs [34%]; P = .495). The presence of perforating vein incompetence at 2 months postoperatively did not significantly alter the rate of reoperations (P = .159). In legs that had not been reoperated on, more incompetent veins could be seen progressively. In the group without any incompetent veins postoperatively, 37% still had normal findings at 8 years. CONCLUSIONS: Residual incompetent tributaries after treatment of varicose veins will increase the reintervention rate in the long term, as much as leaving a trunk vein untreated. Patients should be informed about the increased risk of reintervention if not all incompetent veins are targeted.

Risk factors for amputation are influenced by competing risk of death in patients with critical limb ischemia.

OBJECTIVE: Patients with critical limb ischemia (CLI) have a high risk of amputation and death. Death is a competing risk that affects the estimated amputation risk. Our aim was to find the specific risk factors for amputation for patients with CLI using competing risk analyses and compared these results with those from standard Cox regression analysis. METHODS: Patients who had undergone revascularization for CLI (2009-2013, with follow-up data until 2017) in Stockholm were identified from the Swedish National Registry for Vascular Surgery. The main outcome was major amputation. The risk factors for amputation were assessed using competing risk analysis and compared with the risk factors for amputation-free survival identified using Cox proportional hazards regression analysis. RESULTS: Of 855 patients with CLI, 178 had required a major amputation and 415 had died during the 8-year follow-up period. In the competing risk regression, age (subdistribution hazard ratio [sub-HR], 0.98; 95% confidence interval [CI], 0.97-1.00), ambulatory status (independent vs bedridden; sub-HR, 4.10; 95% CI, 2.14-7.86), and ischemic wound vs rest pain (sub-HR, 3.03; 95% CI, 1.72-5.36) were associated with amputation, considering death as a competing risk. In contrast, Cox regression analysis identified female vs male (hazard ratio [HR], 0.77; 95% CI, 0.64-0.94), age (HR, 1.02; 95% CI, 1.01-1.03), renal impairment (HR, 2.08; 95% CI, 1.61-2.67), ambulatory status (independent vs bedridden; HR, 3.45; 95% CI, 2.30-5.18), and ischemic wound vs rest pain (HR, 2.41; 95% CI, 1.78-3.25) as risk factors. CONCLUSIONS: The risk factors associated with amputation differed when analyzing the data using competing risk regression vs Cox regression. The differences between the analyses indicated that a risk exists for biased estimates using standard survival methods when a strong competing risk such as death is present.

Cultural adaptation and validation of the Swedish VEINES-QOL/Sym in patients with venous insufficiency.

Objectives To translate and evaluate the psychometric properties of the Venous Insufficiency Epidemiological and Economic Studies (VEINES) questionnaire, divided into two subscales; symptoms (VEINES-Sym) and quality of life (VEINES-QOL), in a Swedish cohort of patients with venous disease. Methods The original questionnaire was translated into Swedish with forward-backward translation and administered to 112 patients who were consecutively recruited and had varying degrees of chronic venous disease. Mean age was 54.5 ± 15.2 years (range: 19-83) and 75% of the participants were female. All patients completed the RAND 36-item health survey and the VEINES-QOL/Sym. Results The results showed excellent internal consistency for both VEINES-QOL (Cronbach's alpha (α) = 0.93) and VEINES-Sym (α = 0.89). Both the VEINES-QOL and VEINES-Sym correlated well to all the RAND-36 domains, demonstrating good construct validity. Exploratory factor analysis confirmed both subscales of the VEINES-QOL/Sym. Conclusions The Swedish VEINES-QOL/Sym is a valid health-related quality of life instrument for chronic venous disease, both for research purposes and for clinical evaluation.

The patient's experience of amputation due to peripheral arterial disease.

It is not uncommon that patients with peripheral arterial disease (PAD) need to undergo a lower limb amputation, with or without previous revascularization attempts. Despite that, the patient's experience of the amputation has been scarcely studied. The aim of this qualitative study was to describe the patient's experience of amputation due to PAD. Thirteen interviews were conducted with vascular patients who had undergone a lower limb amputation at tibia, knee, or femoral level. Data were analyzed with content analysis. Our findings of the patient's experiences during the amputation process resulted in three themes with additional time sequences: the decision phase "From irreversible problem to amputation decision", the surgical phase "A feeling of being in a vacuum," and the rehabilitation phase "Adaptation to the new life". One main finding was that the patients felt abandoned during the surgical period. Despite that, most of the participants were satisfied with the decision, some of them even regretted that they had not undergone an amputation earlier in the process. It is important for the patient's well-being to develop a partnership with the surgeon to increase a feeling of being participating in the care. Vascular patients need better information on lower limb amputation, and its consequences so as to be better prepared for the whole process. To increase the patient's quality of life and reduce unnecessary suffering, amputation may be presented earlier in the process as a valuable treatment option.

A comparison of magnetic resonance venography findings and venous occlusion plethysmography variables in postthrombotic syndrome.

Objective The relation between venous morphology and venous function in postthrombotic syndrome is poorly understood. The aim of this study was to compare obstruction and collateralization as seen with magnetic resonance venography with variables of venous occlusion plethysmography in patients with postthrombotic syndrome. Methods Medical records, magnetic resonance venography and venous occlusion plethysmography data were analyzed in 28 patients (33 legs). Magnetic resonance venography images were scored for degree of obstruction and collateralization in segments of pelvic and abdominal veins and correlated to venous occlusion plethysmography data. Results Obstruction of the inferior vena cava correlated with an overall increase of collaterals ( p < 0.001). The summary scores of collaterals or obstructions did not correlate with venous occlusion plethysmography variables. Relative expelled volume at 4 s correlated inversely with obstruction of the inferior vena cava ( p = 0.045) and vertebral collateralization ( p = 0.033). Conclusions Modest correlations were found between magnetic resonance venography scores and venous occlusion plethysmography variables. Prospective studies with refined scoring and magnetic resonance venography techniques may increase our knowledge further.

Venous hemodynamic changes in lower limb venous disease: the UIP consensus according to scientific evidence.

There are excellent guidelines for clinicians to manage venous diseases but few reviews to assess their hemodynamic background. Hemodynamic concepts that evolved in the past have largely remained unchallenged in recent decades, perhaps due to their often complicated nature and in part due to emergence of new diagnostic techniques. Duplex ultrasound scanning and other imaging techniques which evolved in the latter part of the 20th century have dominated investigation. They have greatly improved our understanding of the anatomical patterns of venous reflux and obstruction. However, they do not provide the physiological basis for understanding the hemodynamics of flow, pressure, compliance and resistance. Hemodynamic investigations appear to provide a better correlation with post-treatment clinical outcome and quality of life than ultrasound findings. There is a far better prospect for understanding the complete picture of the patient's disability and response to management by combining ultrasound with hemodynamic studies. Accordingly, at the instigation of Dr Angelo Scuderi, the Union Internationale de Phlebologie (UIP) executive board commissioned a large number of experts to assess all aspects of management for venous disease by evidence-based principles. These included experts from various member societies including the European Venous Forum (EVF), American Venous Forum (AVF), American College of Phlebology (ACP) and Cardiovascular Disease Educational and Research Trust (CDERT). Their aim was to confirm or dispel long-held hemodynamic principles and to provide a comprehensive review of venous hemodynamic concepts underlying the pathophysiology of lower limb venous disorders, their usefulness for investigating patients and the relevant hemodynamic changes associated with various forms of treatment. Chapter 1 is devoted to basic hemodynamic concepts and normal venous physiology. Chapter 2 presents the mechanism and magnitude of hemodynamic changes in acute deep vein thrombosis indicating their pathophysiological and clinical significance. Chapter 3 describes the hemodynamic changes that occur in different classes of chronic venous disease and their relation to the anatomic extent of disease in the macrocirculation and microcirculation. The next four chapters (Chapters 4-7) describe the hemodynamic changes resulting from treatmen by compression using different materials, intermittent compression devices, pharmacological agents and finally surgical or endovenous ablation. Chapter 8 discusses the unique hemodynamic features associated with alternative treatment techniques used by the CHIVA and ASVAL. Chapter 9 describes the hemodynamic effects following treatment to relieve pelvic reflux and obstruction. Finally, Chapter 10 demonstrates that contrary to general belief there is a moderate to good correlation between certain hemodynamic measurements and clinical severity of chronic venous disease. The authors believe that this document will be a timely asset to both clinicians and researchers alike. It is directed towards surgeons and physicians who are anxious to incorporate the conclusions of research into their daily practice. It is also directed to postgraduate trainees, vascular technologists and bioengineers, particularly to help them understand the hemodynamic background to pathophysiology, investigations and treatment of patients with venous disorders. Hopefully it will be a platform for those who would like to embark on new research in the field of venous disease.

Venous occlusion plethysmography in patients with post-thrombotic venous claudication.

OBJECTIVE: Post-thrombotic venous claudication is a serious condition that may be treated with iliac vein stenting or open surgery, and there is a need for hemodynamic tests in the preoperative evaluation. The purpose of this study was to describe the results of venous occlusion plethysmography in patients with venous claudication and to analyze the outflow curve to find variables that best describe the functional abnormality in this patient group. METHODS: Twenty-nine patients with previous deep venous thrombosis and with clinical evidence of venous claudication were retrospectively identified. The results of venous occlusion plethysmography in these patients were compared with results obtained in a group of 63 healthy control subjects of similar age and sex. Computerized strain-gauge plethysmography was used in a capacitance mode where the occlusion time is determined by an electronic detector allowing the maximal venous volume to be achieved in all limbs. Outflow volumes (OV1, OV4) and outflow fractions (OF1, OF4) were calculated at 1 and 4 seconds after cuff release. Outflow fraction is OV divided by maximal venous volume. RESULTS: Both outflow volumes and outflow fractions were significantly reduced in patients compared with healthy control subjects. Outflow fractions were more sensitive than outflow volumes in identifying patients with venous claudication. The most discriminating variable was OF4 that was reduced below the normal lower limit in 69% of the patients, most severely reduced in patients with severe claudication. CONCLUSIONS: Patients with venous claudication attributable to remaining post-thrombotic iliofemoral obstructive disease are characterized by a functional disturbance shown with venous occlusion plethysmography as a reduced venous outflow during the initial 4 seconds following cuff release in relation to their true maximal venous volume. Our results suggest that venous occlusion plethysmography can be a valuable tool in the preoperative workup for selection of patients with iliofemoral vein obstruction that may benefit from venous intervention.

Quality of life after surgery for varicose veins and the impact of preoperative duplex: results based on a randomized trial.

In a prospective randomized study, we found that the addition of a preoperative duplex scan before varicose vein (VV) surgery reduced recurrences and reoperations after 2 years. The aim of the present study was to investigate whether this correlates with an improved quality of life (QoL). We studied 293 patients scheduled for VV surgery with or without preoperative duplex. QoL was assessed preoperatively at 1 month, 1 year, and 2 years with the Short Form-36 (SF-36). Scores were compared with matched reference groups from the Swedish population. The 237 complete responders (81%) had a mean age of 47 (range 22-73) years, 169 (71%) were women, and 43 (18%) had skin changes. Both groups of VV patients scored significantly worse than the reference group in the domain Bodily Pain preoperatively (p < 0.001) and better after 1 year (p = 0.04), with no difference found after 2 years. There was no significant difference in QoL between the duplex and control groups at any time. We conclude that preoperative duplex before VV surgery did not significantly improve QoL after 2 years in spite of improved surgical results. VV surgery per se improved QoL as measured with the SF-36.