Functional repair of the great saphenous vein by external valvuloplasty reduces the vein's diameter: 6-month results of a multicentre study

Objectives External valvuloplasty (eVP) is a reconstructive surgical method to repair the function of the terminal and preterminal valves. We evaluated the 6-month outcomes of eVP regarding the diameter of the great saphenous vein (GSV). Methods Patients from five vein centres were included in this observational study. Follow-up involved detailed duplex sonography of the GSV. The venous clinical severity score (VCSS) and the C class of the clinical, aetiologic, anatomic and pathophysiologic (CEAP) classification were recorded. Results We enrolled 210 patients, with a follow-up rate of 58%; eVP was sufficient in 95.24% of the patients. The GSV diameters decreased significantly from 4.4 mm (standard deviation (SD): 1.39) to 3.9 (SD: 1.12), 4 cm distal to the saphenofemoral junction (SFJ); from 3.7 mm (SD: 1.10) to 3.5 mm (SD: 1.02) at the mid-thigh; from 3.6 mm (SD: 1.14) to 3.3 mm (SD: 0.94) at the knee and from 3.1 mm (SD: 0.99) to 2.9 mm (SD: 0.78) at the mid-calf. VCSS decreased significantly from 4.76 (SD: 2.13) preoperatively to 1.77 (SD: 1.57) 6 months postoperatively. Conclusions GSV function can be restored by eVP; diameters over the total length of the GSV decreased significantly.

Use of a Novel Device in Reconstructive Venous Surgery: Preliminary Results

Evaluation of the outcomes of OSES (oval-shaped external support), a novel device for external valvuloplasty of the great saphenous vein (GSV) for the conservative treatment of superficial venous insufficiency. Between 2012 and 2015, 30 patients underwent external valvuloplasty of the GSV for a total of 32 limbs. Patients were subjected to clinical and instrumental follow-up by a half-year ultrasound for a minimum of 36 months. The main endpoints were the recurrence of varicose disease, persistent or recurrent venous reflux, and venous thrombosis. Varicose recurrence was verified in six limbs on 32 (18.75%). Four limbs (12.5%) presented a recurrence of the reflux even in the absence of varicose veins. Two limbs (6.25%) underwent saphenectomy after the valvuloplasty intervention at 12 and 18 months, respectively, because of the presence of saphenofemoral reflux and varicose recurrences. No case of venous thrombosis of the saphenous trunk was observed. The external valvuloplasty of the GSV is a well-known technique that used to treat the superficial venous insufficiency. The newly introduced OSES device seems to show better midterm results, due to a better alignment of the valve flaps. In our experience, the use of this device gives better long-term results and allowed to extend the indication to patients with saphenic diameters that were considered not eligible for repair. In conclusion, although our data needs further confirmation, OSES device might represents a new interesting opportunity for reconstructive venous surgery.

External valvuloplasty of the saphenofemoral junction in insufficient great saphenous veins – six weeks results of a prospective multicentre trial

Summary: Background: Varicosis of the great saphenous vein (GSV) is a common disease. Most of the therapeutic concepts attempt to remove or destroy the truncal vein. However, the absence of the GSV could be harmful for further treatments of artherosclerotic disease as the GSV is often used as bypass graft in lower extremity or coronary artery revascularisations. External valvuloplasty (EV) is one of the vein-sparing treatment options. The aim of this clinical study was to describe the outcome, safety and complications of this procedure in a prospective multicentre trial. Patients and methods: The function of the terminal and preterminal valve was restored by external valvuloplasty. Furthermore, multiple phlebectomies of tributaries were performed. Patients were reinvestigated six weeks after surgery. Primary endpoint was the function of the external valvuloplasty measured by diameter of the GSV and the prevalence of reflux in the GSV. The eligibility of the vein as a potential bypass graft was noticed. CEAP class and VCSS scores were analysed. Results: A total of 359 patients were included in the study. After six weeks 297 patients could be reinvestigated. The function of the external valvuloplasty was sufficient in 284 patients (95.6%). Treatment failed in 8 patients (2.6%) due to an occlusion or junctional reflux despite valvuloplasty. The GSV was estimated as suitable as a bypass graft in 261 patients (87.8%). Reflux at the saphenofemoral junction was significantly reduced after treatment and the diameter of the GSV near the saphenofemoral junction significantly decreased from 4.4 mm to 3.8 mm ( p < 0.05). The VCSS was significantly reduced from 4.6 preoperatively to 2.6 postoperatively. Conclusions: External repair of the great saphenous vein can reduce venous symptoms and may preserve the great saphenous vein as a bypass graft. Nevertheless, this treatment option is only suitable for a limited number of patients.