A study protocol for comparing the treatment of varicose tributaries either concomitantly with or separately from endovenous laser ablation of the incompetent saphenous trunk (the FinnTrunk Study). A multicenter parallel-group randomized controlled study.

BACKGROUND: Opinions on the treatment of varicose tributaries in relation to saphenous ablation in varicose disease vary. Moreover, the possible role of the tributaries regarding the recurrence of varicose disease remains unclear. The aim of the FinnTrunk study is to compare two different treatment strategies for varicose disease in a randomized setting. In group one, the initial treatment will entail endovenous laser ablation (EVLA) of the incompetent saphenous trunk without tributary treatment. In group two, the varicose tributaries will be treated with ultrasound-guided foam sclerotherapy (UGFS) concomitantly with truncal ablation. The primary outcome measure is the need for additional procedures during the follow-up. The secondary outcome measures are the cost of treatment and recurrence of varicose disease. METHODS: Consecutive patients with symptomatic varicose disease (CEAP clinical class C2-C3) will be screened for the study. Patients who fulfil the study criteria and give their informed consent will be scheduled for the procedure and randomized to either study group. Patients will be followed-up at 3 months, 1 year, 3 years, and 5 years. The post-procedure pain score based on a numeric rating scale (NRS) and also the use of analgesics, as well as possible procedure-related complications will be recorded at 3 months. Patient-reported outcome measures (PROMs) will be recorded at 1 year. Data pertaining to the additional treatment of varicose tributaries, the Aberdeen Varicose Vein Questionnaire (AVVQ), the Venous Clinical Severity Score (VCSS), and the health-related quality of life (EQ-5D-5L) will be collected at each follow-up visit. A duplex ultrasound (DUS) examination will be performed at each visit, and data on varicose tributaries and the need for additional treatment will be recorded. TRIAL REGISTRATION: Registered on ClinicalTrials.gov, ID NCT04774939.

Femoral nerve blockade during endovenous laser ablation of great saphenous vein decreases pain but does not affect the use of opioids during the procedure.

BACKGROUND: Endovenous laser ablation (EVLA) using tumescent anesthesia for treatment of an insufficient great saphenous vein (GSV) can be painful and require intravenous pain management and, sometimes, sedation with propofol. Femoral nerve blockade (FNB) anesthetizes the femoral nerve distribution and is usually used for anterior thigh and knee procedures. It is easy to inject with ultrasound guidance because the nerve is easy to visualize in the groin. The aim of the present double-blind, randomized controlled trial was to determine whether FNB before tumescent anesthesia decreases the pain of GSV EVLA combined with local phlebectomy. METHODS: Eighty patients who underwent GSV EVLA combined with local phlebectomy under tumescent anesthesia were randomized into two groups. The placebo group (control group; 40 patients) was given placebo FNB with 0.9% saline before tumescent injection. The FNB group (intervention group; 40 patients) received 1% lidocaine with adrenaline for FNB before tumescent injection. Only the study nurse, who performed the randomization, knew which patients were in which group. The patients and operating surgeon were unaware of the randomization group. FNB was performed under ultrasound guidance. The effectiveness of anesthesia was tested 10 minutes after injection using the pin-prick test and a numeric rating scale (NRS). The NRS was completed before and during tumescent anesthesia and during EVLA ablation and local phlebectomy. The motor function of the femoral nerve was tested at the end of the procedure and 1 hour after using the Bromage method. Patients had a follow-up visit 1 month after the procedure, and their need for pain medication and the duration of sick leave were recorded. RESULTS: No differences were found in the gender distribution, age, or GSV dimensions at baseline. The mean length of the treated GSV segment was 28 cm and 30 cm and the mean energy used was 1911 J and 2059 J in the placebo and FNB groups, respectively. The median NRS score for pain during tumescent injection around the GSV was 2 (interquartile range [IQR], 1-4) in the placebo group compared with 1 (IQR, 1-3) in the FNB group. Very little pain was experienced during laser ablation. The median NRS score was 0 (IQR, 0-0) and 0 (IQR, 0-0.75) in the placebo and FNB groups, respectively. The most painful stage was injection of tumescence to the local phlebectomy sites in both groups. The median NRS score was 4 (IQR, 3-7) in the placebo group and 2 (IQR, 1-4) in the FNB group (P = .01). During local phlebectomy, the NRS score was 2 (IQR, 0-4) vs 1 (IQR, 0-3) in the placebo and FNB groups, respectively. Only the difference in pain during injection of tumescence before local phlebectomy was significant. CONCLUSIONS: FNB seems to decrease pain during EVLA combined with local phlebectomy. Patients experienced the highest pain when tumescence was injected before local phlebectomy, and those in the FNB group experienced significantly less pain than the placebo group. No indication for routine use of FNB is indicated. However, it could be used to decrease the pain for patients who experience strong pain during varicose vein surgery, especially if extensive local phlebectomies are required.

Patient injuries in the treatment of superficial venous insufficiency registered in Finland between 2004 and 2017.

OBJECTIVES: This study aimed to identify the unintended incidents that led to patient injuries (PIs) in the treatment of superficial venous insufficiency (SVI). METHODS: PI claims filed with the Finnish Patient Insurance Centre between 2004 and 2017 involving SVI were reviewed. Factors contributing to PI were identified and classified. RESULTS: Eighteen (13.2%) of 136 compensated PIs in the specialty of vascular surgery were related to SVI. Only 4.7% of 383 SVI claims were compensated. The incidence of PIs was 9.9 per 100 000 patients. Fifteen patients had open surgery (83.3%) and three (16.7%) endovenous treatment. Two (11.1%) patients had necrotising fasciitis, four (22.1%) had deep vein injuries and two (11.1%) had a permanent nerve injury. Two (11.1%) patients had retained endovenous material that required surgical removal. CONCLUSIONS: PIs were identifiable during all stages of care, perioperative injuries related to open surgery being the most common.

Efficacy of endovascular treatment for pelvic congestion syndrome.

BACKGROUND: Chronic pelvic pain is not a rare health problem among women. One of the most common causes of chronic pelvic pain is pelvic congestion syndrome (PCS). We have reviewed all medical literature on the endovascular treatment of PCS and hereby provide a brief overview of the anatomy, pathophysiology, and clinical aspects of ovarian and pelvic varices. We describe the technique of transcatheter embolization, the complications thereof and the clinical results of the treatment. METHODS: A literature search was performed using PubMed, Science Direct, Google Scholar, and Scopus to identify case series on the endovascular treatment of PCS up until the end of November 2014. RESULTS: Twenty studies with a total of 1081 patients were included in the review. There were no randomized trials, and only one study included a control group. The immediate technical success rate in the occlusion of the affected veins was 99%. Seventeen studies reported the 1- to 3-month clinical success of 641 patients. Of these, 88.1% reported moderate to significant relief in the symptoms and 11.9% reported little or no relief. In 17 studies, long-term results were reported, and the follow-up varied between 7.3 months and 5 years. In late follow-up, 86.6% reported relief of the symptoms and 13.6% experienced little or no relief. CONCLUSIONS: The immediate success rate for the endovascular treatment of PCS is good and the complication rate low. Most patients report relief in the symptoms for up to 5 years after the procedure. However, there are no randomized or high-quality controlled trials, and the level of evidence therefore remains at C.

Temporary Axillorenal Bypass in Complex Aorto-Renal Surgery.

BACKGROUND: Prolonged renal ischemia during vascular surgery carries high morbidity and mortality. We report an alternative technique for maintaining renal circulation during suprarenal aortic or renal artery clamping. METHODS: Between October 2007 and May 2012, 16 patients undergoing aorto-renal surgery (13 men, 3 women) were operated using temporary axillorenal bypass. Operations were performed for supra- and juxtarenal aortic aneurysms (11), occlusive aortic disease (2), renal artery stenoses (2), and abdominal myofibroblastic tumor (1). In elective cases, axillorenal bypass was planned, when prolonged renal ischemia was expected based on preoperative information. Preoperative risk factors (renal dysfunction, hypertension, coronary disease, diabetes, smoking) and intraoperative variables (operating time, blood loss, renal ischemia time) were assessed and compared with postoperative kidney function (serum creatinine, urine output, dialysis) and in-hospital or 30-day-mortality. Even though renal blood flow was restored between clampings, the total cumulative ischemia time was used in analysis. Acute renal failure postoperatively was based on RIFLE criteria. RESULTS: Preoperatively, 44% (7) of the patients had normal renal function (S-crea ≤ 100 mmol/L). Renal function was moderately present in 50% (8) (S-crea 100-200 mmol/L) and severely in 6% (1) (S-crea ≥ 200 mmol/L). Median operation time was 393 min (251-535 min) and median renal ischemia time was 24.5 min (range 8-50 min). Transient acute renal dysfunction occurred in 6 (38%) patients, and 4 of them had renal insufficiency preoperatively. Transient renal replacement therapy was needed in 1 (6%) patient only. In 1-month control, postoperative renal function had returned to its baseline level or improved and in-hospital or 30-day mortality was zero. CONCLUSIONS: Temporary axillorenal bypass is a considerable option to minimize renal ischemia time during high-risk vascular surgery.

Quality of life and costs of levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of menorrhagia: a 10-year randomized controlled trial.

OBJECTIVE: Menorrhagia is a common problem impairing the quality of life (QOL) of many women. Both levonorgestrel-releasing intrauterine system (LNG-IUS) and hysterectomy are effective treatment modalities but no long-term comparative studies of QOL and costs exist. The objective of this study was to compare QOL and costs of LNG-IUS or hysterectomy in the treatment of menorrhagia during 10-year follow-up. STUDY DESIGN: A total of 236 women, aged 35-49 years, referred for menorrhagia to 5 university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 10 years. The main outcome measures were health-related QOL (HRQOL), psychosocial well-being, and cost-effectiveness. RESULTS: A total of 221 (94%) women were followed for 10 years. Although 55 (46%) women assigned to the LNG-IUS subsequently underwent hysterectomy, the overall costs in the LNG-IUS group ($3423) were substantially lower than in the hysterectomy group ($4937). Overall, levels of HRQOL and psychosocial well-being improved during first 5 years but diminished between 5 years and 10 years and the improved HRQOL returned close to the baseline level. There were no significant differences between LNG-IUS and hysterectomy groups. CONCLUSION: Both LNG-IUS and hysterectomy improved HRQOL. The improvement was most striking during the first 5 years. Although many women eventually had hysterectomy, LNG-IUS remained cost-effective.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on premenstrual symptoms in women treated for menorrhagia: secondary analysis of a randomized controlled trial.

OBJECTIVE: To study the effect of hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS) on premenstrual symptoms in women treated for menorrhagia. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Five university hospitals in Finland. SAMPLE: A cohort of 236 women, aged 35-49 years (mean 43 years) referred for menorrhagia between 1994 and 1997. Women were not diagnosed with premenstrual syndrome. METHODS: Women were randomized to treatment by hysterectomy (n=117) or LNG-IUS (n=119). Analyses were performed using the intention-to-treat and actual treatment principles. Women using estrogen therapy and women who underwent bilateral salpingo-oophorectomy were excluded from the analyses. MAIN OUTCOME MEASURES: The occurrence of premenstrual symptoms evaluated by questionnaires at baseline and at follow-up visits six and 12 months after the treatment and five years after the randomization. RESULTS: Premenstrual symptoms decreased significantly in both groups by six months (p≤0.028) without significant differences between the groups, except that in the LNG-IUS group the decrease of breast tenderness was seen first by 12 months (p=0.048). Even though 42% of the women assigned to treatment with LNG-IUS were hysterectomized during the follow-up period, the results of intention-to-treat and actual treatment analyses were comparable. CONCLUSIONS: Both hysterectomy and LNG-IUS seem to alleviate premenstrual symptoms of women treated for menorrhagia, while the effect of these treatments on premenstrual syndrome remains unsettled.

Infrapopliteal percutaneous transluminal angioplasty versus bypass surgery as first-line strategies in critical leg ischemia: a propensity score analysis.

INTRODUCTION: Recently, endovascular revascularization (percutaneous transluminal angioplasty [PTA]) has challenged surgery as a method for the salvage of critically ischemic legs (CLI). Comparison of surgical and endovascular techniques in randomized controlled trials is difficult because of differences in patient characteristics. To overcome this problem, we adjusted the differences by using propensity score analysis. MATERIALS AND METHODS: The study cohort comprised 1023 patients treated for CLI with 262 endovascular and 761 surgical revascularization procedures to their crural or pedal arteries. A propensity score was used for adjustment in multivariable analysis, for stratification, and for one-to-one matching. RESULTS: In the overall series, PTA and bypass surgery achieved similar 5-year leg salvage (75.3% vs 76.0%), survival (47.5% vs 43.3%), and amputation-free survival (37.7% vs 37.3%) rates and similar freedom from any further revascularization (77.3% vs 74.4%), whereas freedom from surgical revascularization was higher after bypass surgery (94.3% vs 86.2%, P < 0.001). In propensity-score-matched pairs, outcomes did not differ, except for freedom from surgical revascularization, which was significantly higher in the bypass surgery group (91.4% vs 85.3% at 5 years, P = 0.045). In a subgroup of patients who underwent isolated infrapopliteal revascularization, PTA was associated with better leg salvage (75.5% vs 68.0%, P = 0.042) and somewhat lower freedom from surgical revascularization (78.8% vs 85.2%, P = 0.17). This significant difference in the leg salvage rate was also observed after adjustment for propensity score (P = 0.044), but not in propensity-score-matched pairs (P = 0.12). CONCLUSIONS: When feasible, infrapopliteal PTA as a first-line strategy is expected to achieve similar long-term results to bypass surgery in CLI when redo surgery is actively utilized.

Finnvasc score and modified Prevent III score predict long-term outcome after infrainguinal surgical and endovascular revascularization for critical limb ischemia.

BACKGROUND: Estimation of the risk of adverse long-term outcome is of paramount importance in the treatment of critical limb ischemia (CLI). METHODS: We evaluated the accuracy of two specific risk score systems, the Finnvasc score and the modified Prevent III (mPIII) score, in 1425 CLI patients who underwent unilateral, infrainguinal surgical (47.6%) or endovascular (52.4%) revascularization. The receiver operating characteristic (ROC) curve analysis was used to estimate the predictive value of these risk scoring methods. RESULTS: The area under the ROC curve of Finnvasc score for prediction of 30-day amputation was 0.609 (95% confidence interval [CI] 0.549-0.677) and of mPIII score 0.533 (95% CI 0.457-0.609). The area under ROC curve of Finnvasc score for prediction of 30-day amputation-free survival was 0.622 (95% CI 0.573-0.671) and of mPIII score 0.588 (95% CI 0.533-0.642). The area under the ROC curve of Finnvasc score for prediction of 1-year amputation-free survival was 0.630 (95% CI 0.597-0.663, P<.0001) and of mPIII score 0.634 (95% CI 0.600-0.667, P<.0001). Finnvasc score predicted leg salvage (relative risk [RR] 1.431, 95% CI 1.319-1.551), survival (RR 1.233, 95% CI 1.116-1.363), and amputation-free survival (RR 1.422, 95% CI 1.319-1.534). mPIII score also predicted leg salvage (RR 1.190, 95% CI 1.108-1.277), survival (RR 1.245, 95% CI 1.193-1.300), and amputation-free survival (RR 1.223, 95% CI 1.176-1.272). CONCLUSIONS: Finnvasc and modified PIII risk scoring methods predict long-term outcome of patients undergoing infrainguinal revascularization for CLI. Finnvasc score seems to perform well also in predicting immediate postoperative outcome.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on lower abdominal pain and back pain among women treated for menorrhagia: a five-year randomized controlled trial.

OBJECTIVE: The purpose of this study was to evaluate the changes in lower abdominal pain and back pain among women with menorrhagia treated by hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS). DESIGN: A randomized controlled trial. SETTING: Five university hospitals in Finland. SAMPLE: A total of 236 women, aged 35-49 years. METHODS: Women were randomly assigned to treatment by hysterectomy (n = 117) or LNG-IUS (n = 119). MAIN OUTCOME MEASURES: Frequency and intensity of lower abdominal pain and back pain were evaluated by questionnaires at baseline and after 6 months, 12 months and 5 years. RESULTS: By six months, women in both groups had less frequent back pain than before treatment (p < 0.001). Lower abdominal pain decreased only in the hysterectomy group (p = 0.02) with significant differences between the groups. Between 12 months and 5 years, frequency of lower abdominal pain (p = 0.05) and back pain (p = 0.002) decreased more in the LNG-IUS group than in the hysterectomy group. Between baseline and five years, the lower abdominal pain score (including frequency and intensity of pain) decreased in both groups (p < 0.001, p = 0.01). Back pain score decreased only in the LNG-IUS group and the difference between the groups was significant (p = 0.02). However, some women experienced more pain after both treatments than before treatment. In multivariate analyses, LNG-IUS use was associated with a decrease in lower abdominal pain and back pain. CONCLUSIONS: In the treatment of menorrhagia, both hysterectomy and LNG-IUS decrease lower abdominal pain. LNG-IUS use, but not hysterectomy, has beneficial effects on back pain.

Effect of hysterectomy or LNG-IUS on serum inhibin B levels and ovarian blood flow.

OBJECTIVES: Nearly one third of women complain of heavy menstrual bleeding during their reproductive years. Hysterectomy and levonorgestrel-releasing intrauterine system (LNG-IUS) are effective treatment options for menorrhagia. However, the influence of these two treatment modalities on ovarian function remains unclear. The aim of the study was to evaluate the effect of hysterectomy or LNG-IUS on ovarian function. METHODS: Of 107 women, aged 35-49 years, referred for menorrhagia to the University of Helsinki, Finland, 54 were randomised to hysterectomy group and 53 to LNG-IUS group. Serum concentrations of inhibin B were measured at baseline, at 6-month, and at 12-month follow-up visits. The pulsatility indeces (PI) of ovarian and intraovarian arteries were measured by transvaginal ultrasound on the same visits. Changes in outcome measures between the groups were tested by Student's t-test for independent samples and within the group by Wilcoxon signed rank test. To test association between outcome variables and explaining factors a multiple linear regression model was used. RESULTS: Serum inhibin B concentrations decreased after the first 6 months in both groups (P<0.05). No change was observed in PI of the ovarian arteries in either group. PI of the intraovarian arteries decreased at 6 and 12 months (P<0.05) in the hysterectomy group, which was not seen among LNG-IUS users. Change in PIs between the treatment arms was also significant (P<0.05). In multiple linear regression model treatment modality explained the change in serum inhibin B concentration and the change in PI of intraovarian artery (P<0.05). CONCLUSIONS: Hysterectomy but not LNG-IUS alters intraovarian blood flow and may impair ovarian function.