Irwin M. Toonder

Conservative versus surgical treatment of venous leg ulcers: 10-year follow up of a randomized, multicenter trial

Introduction Leg ulcers have a large socio-economic impact. Treatment modalities are either conservative or surgical. Conservative treatment involves local treatment and compression therapy. Surgical treatment of venous ulcers is based on correcting venous hypertension, by treating incompetent superficial, deep, and perforating veins. A prospective randomized multicenter trial comparing surgical treatment (combined superficial and perforating vein surgery) with ambulatory compression therapy was conducted during 1998 and 2001. This paper presents the results of a 10-year follow-up period of this trial. Materials and methods All patients enrolled in the original prospective trial were approached and invited for additional examination and duplex ultrasound evaluation. Secondary, disease specific and generic quality-of-life (QoL) was assessed. Current ulcer state and recurrence during the follow-up period was assessed. Results After a mean of 97 months follow up, 80 (41%) out of 196 legs could be inspected. The incidence of “ulcer-free”, the main outcome, was significantly (p = 0.007) higher in the surgical group (58.9%), compared to the conservative group (39.6%). Observed ulcer recurrence was 48.9% for the surgical group and 94.3% for the conservative group. The number of incompetent perforating veins appears to be a significant (p < 0.001) risk factor for not being ulcer-free. Disease specific QoL showed no significant difference between the surgical and conservative groups. Conclusions The addition of surgical treatment in patients with venous ulceration leads to a significantly higher chance of being ulcer-free, than just ambulatory compression therapy. This effect persists after 10 years of follow up. The number of incompetent perforating veins has a significant effect on the ulcer-state and recurrence.

Clarivein® mechano-chemical ablation an interim analysis of a randomized controlled trial dose-finding study

Objectives The ClariVein® system is an endovenous technique that uses mechano-chemical ablation to treat incompetent truncal veins. This study was conducted to identify the ideal Polidocanol dosage and form for mechano-chemical ablation in order to occlude the great saphenous vein. When adhering to safe dosage levels, sclerosants with higher concentrations potentially limit the extent of treatment. It has been demonstrated that this problem may be overcome by using Polidocanol as a microfoam. This paper was established on findings of a preliminary analysis. Material and methods The initial study was a single-blinded multicenter randomized controlled trial where patients are allocated to three treatment arms. Group 1 consisted of mechano-chemical ablation +2% Polidocanol liquid, group 2: mechano-chemical ablation +3% Polidocanol liquid and group 3: mechano-chemical ablation +1% Polidocanol foam Results Eighty-seven, 34 males and 53 females (60.9%), mean age 55 years s.d. 16.0 (range 24–84), were enrolled in the study. Treatment length was 30 cm (range 10–30) for 95.2% of the patients. Mean operating time was 16 minutes (range 5–70). The mean saphenofemoral junction diameter (7.7 mm) was similar in all three groups. At 6 weeks post-treatment duplex ultrasound showed that 25 out of 25 = 100%, 27 out of 28 = 96.4% and 13 out of 23 = 56.5% were occluded in the mechano-chemical ablation + 2% Polidocanol liquid, mechano-chemical ablation + 3% Polidocanol liquid and mechano-chemical ablation + 1% Polidocanol microfoam respectively (p < 0.001). However, stricter scrutiny showed that the anatomical success rate defined as occlusion of at least 85% of the treated length to be 88.0%, 85.7% and 30.4% respectively (p < 0.001). Conclusion Mechano-chemical ablation using ClariVein® combined with 1% Polidocanol microfoam is significantly less effective and should not be considered as a treatment option of incompetent truncal veins. Further investigation to determine the ideal Polidocanol liquid dosage with mechano-chemical ablation is advocated and is being conducted accordingly.

Cyanoacrylate adhesive perforator embolization (CAPE) of incompetent perforating veins of the leg, a feasibility study

Consideration of treating incompetent perforating veins remains a conundrum based on scientific evidence available till date. While subfascial endoscopic perforator surgery (SEPS) proved to be a worthy alternative for open surgery, other even less invasive techniques were being introduced by the late nineties of the last century. Percutaneous thermo-ablation techniques are still being used today and seem more effective than non-thermal techniques. However, thermal techniques require anaesthesia and potentially may cause inadvertent damage to surrounding tissues such as nerves. Cyanoacrylate adhesive has a proven record, but not for the treatment of chronic venous disease of the leg. Innovation has led to the development of the VenaSeal® Sapheon Closure System which has been designed to use a modified cyanoacrylate glue as a new therapy for truncal vein incompetence. This paper explores the feasibility of ultrasound guided cyanoacrylate adhesive perforator embolization (CAPE). Results show a 76% occlusion rate of incompetent perforating veins without serious complications leading to the conclusion that further investigation with a dedicated delivery device in a larger patient population is warranted.

Quality-of-life in interventionally treated patients with post-thrombotic syndrome

Introduction New developments in the treatment of complex deep venous disease have become available in the last decade. Besides analysing patencies as a surrogate outcome for these treatments we analysed the Quality-of-Life (QoL) changes for successful and failed deep venous treatments. Materials and methods Patients with proven venous occlusive disease, referred to our department of Venous Surgery at the Maastricht University Medical Centre, were included. After inclusion patients were treated by percutaneous transluminal angioplasty and stenting and when indicated endophlebectomy with an arteriovenous fistula. QoL was assessed with the disease specific VEINES-QOL/Sym and the generic Short-Form (SF)-36 questionnaires preoperatively at baseline and post-operatively after 3, 12 and 24 months. Results One hundred fifty-three interventions were analysed, showing a primary, assisted primary and secondary patency of respectively 65%, 78% and 89% at 24 months. The VEINES-QOL and Sym scores improved at 3, 12 and 24 months. The overall improvement at 24 months is 22.7 for QoL and 18.18 for Sym with respective p values of 0.013 and 0.016. The improvement of the VEINES-QOL and Sym scores after a successful (patent) treatment remained highly significant (QoL: p < 0.001, Sym: p = 0.004). Also the generic QoL (Short-Form 36v2) shows significant improvement after 12 months for physical functioning (p = 0.004) and role physical (p = 0.004) scales. Conclusions The overall patencies of interventions for deep venous pathology are exceptionally good after two years. Concomitantly the VEINES-Sym and VEINES-QOL scores improve significantly for 3, 12, and 24 months when compared to the baseline (T0) after treatment. Successful interventions showed, as expected, a significant greater QoL improvement between T0 and T3, T12, T24 for both VEINES-QOL and VEINES-Sym scores when compared to the failed interventions. The one-year linear improvement of two SF-36 scales (PF and RP) is also significant.

Intravenous pressure changes in patients with postthrombotic deep venous obstruction: results using a treadmill stress test

Essentials Little is known about the hemodynamic consequences of deep venous obstructive disease. We investigated pressure changes in 22 patients with unilateral postthrombotic obstruction. Common femoral vein pressure significantly increased after walking, compared to control limbs. Common femoral vein hypertension could explain the debilitating effect of venous claudication.

Ultrasound-guided Percutaneous Coil Embolization of Incompetent Perforating Veins: Not Effective for Treatment of Venous Ulcers and Recurrent Varicosities☆

PURPOSE To investigate the feasibility of ultrasound-guided percutaneous coil embolization of incompetent perforating veins as minimally invasive treatment for venous ulcers and recurrent varicosities in the lower leg. This could be an alternative to surgical ligation of perforating veins. MATERIALS AND METHODS In 15 patients (six women, nine men; mean age, 50 years), 18 incompetent perforating veins in the lower leg were treated by ultrasound-guided percutaneous placement of embolization coils. RESULTS Successful vein occlusion with one or more coils was achieved in 12 of the 18 veins (technical success rate, 67%). Clinical symptoms improved in only three of the 15 patients (clinical success rate, 20%). During follow-up (2-12 months), recanalization of coil embolized veins occurred in nine of the 12 initially occluded veins. CONCLUSION Percutaneous ultrasound-guided coil embolization does not appear to be as effective as subfascial endoscopic perforator surgery in the treatment of incompetent perforator veins.

In Vitro Evaluation of a New Autologous Valve-Stent for Deep Venous Incompetence:

Purpose: To report the results of in vitro hydrostatic bench testing of a new vein-stent combination to correct deep venous incompetence. Methods: Twelve valves were constructed from a modified Palmaz stent encased in a segment of great saphenous vein harvested from patients during routine varicose vein surgery. An in vitro flow circuit was set up to evaluate opening and closing pressures (in cm H2O), and the valve was subsequently subjected to repetitive cycles of increasing prograde flow and reflux pressures. Duplex scanning was used to evaluate valve closure time and detect any possible reflux. Results: The valve mechanism required only 1 to 3 cm H2O for opening and 2 to 4 cm H2O for closing. Prograde flow of up to 1000 mL/min passed easily through this valve, which remained competent with reflux pressures up to 180 cm H2O. Mean valve closure time was 0.15±0.07 seconds. Unligated side branches or damage from dissection impaired the competence of 3 valves. Conclusion: This new vein-stent valve functions as a normal deep vein valve, requiring only minimal pressures for opening and closing. It allows high flow passage and still remains competent at high reflux pressures. This valve may provide a minimally invasive solution for the correction of deep venous incompetence using autologous material. Further in vivo evaluation will be mandatory.

Tumescent, how do I do it?

Local perivenous anaesthesia has evolved from tumescent anaesthesia which has had a huge impact on liposuction procedures. Perivenous anaesthesia has had a similar effect on peripheral venous surgery. Safety during its application is further enhanced when combined with skilled ultrasound guidance and astute operator awareness.

A review of a new Dutch guideline for management of recurrent varicose veins

In 2013, the new Dutch guideline for “Venous Pathology” was published. The guideline was a revision and update from the guideline “Diagnostics and Treatment of Varicose Veins” from 2009 and the guideline “Venous Ulcer” from 2005. A guideline for “Deep Venous Pathology” and one for “Compression Therapy” was added to the overall guideline “Venous Pathology.” The chapter about treatment of recurrent varicose veins after initial intervention was recently updated in 2015 and is reviewed here. The Dutch term “recidief varices” or the French “récidive de varices” should be used analogous to the English term “recurrent varicose veins.” The DCOP Guideline Development Group Neovarices concluded that “recidief” in Dutch actually suggests recurrence after apparent successful treatment and ignores the natural progression of venous disease in its own right. So the group opted to use the term “neovarices.” In the Dutch guideline, neovarices is meant to be an all embracing term for recurrent varicose veins caused by technical or tactical failure, evolvement from residual refluxing veins or natural progression of varicose vein disease at different locations of the treated leg after intervention. This report reviews the most important issues in the treatment of varicose vein recurrence, and discusses conclusions and recommendations of the Dutch Neovarices Guideline Committee.

The inability of venous occlusion air plethysmography to identify patients who will benefit from stenting of deep venous obstruction

Background The aim of this study was to assess whether venous occlusion plethysmography can be used to identify venous obstruction and predict clinical success of stenting. Method Receiver operated characteristic curves were used to determine the ability of venous occlusion plethysmography to discriminate between the presence and absence of obstruction, measured by duplex ultrasound and magnetic resonance venography, and to discriminate between successful and non-successful stenting, measured by VEINES-QOL/Sym. Result Two hundred thirty-seven limbs in 196 patients were included. Areas under the curve for post-thrombotic obstruction were one-second outflow volume 0.71, total venous volume 0.69 and outflow fraction 0.59. Stenting was performed in 45 limbs of 39 patients. Areas under the curve for identifying patients with successful treatment at one year after stenting were 0.57, 0.54 and 0.63, respectively. Conclusion Venous occlusion plethysmography cannot be used to identify venous obstruction proximal to the femoral confluence or to distinguish which patients will benefit from treatment.