Objective: This study aimed to evaluate the efficacy and safety of a newly developed, leak closure Internal Compression Therapy (ICT) (Invamed, Ankara, Turkey) device during a single-session procedure in a group of patients with primary deep valve incompetence. Methods: There were 286 patients who were diagnosed with deep venous reflux by duplex scanning. They underwent valvular leak operations to treat primary deep venous insufficiency. Follow-up visits were on the third day, first month, sixth month and twelfth month. At each visit, duplex scanning and a clinical examination were performed. Successful treatment was defined as deep vein valves without reflux. Any patency or reflux over 1 sec was considered a failure. Results: The study enrolled 286 patients with deep venous insufficiency. Procedural technical success was 100%. At the one-year follow-up, the overall success, among all patients, was 92%. No significant morbidity or mortality related to the procedure were observed. All patients had major improvements in venous clinical severity score (VCSS) scores postoperatively. VCSS scores at pre-intervention, and at the twelfth month, were 20.7±5.9 and 3.9±0.9, respectively (p<0.001). Conclusion: After the twelve-month follow-up, the postprocedural outcomes indicate the ICT device is safe and effective.
Objective: This study aimed to evaluate the efficacy and safety of a newly developed, leak closure Internal Compression Therapy (ICT) (Invamed, Ankara, Turkey) device during a single-session procedure in a group of patients with primary deep valve incompetence. Methods: There were 286 patients who were diagnosed with deep venous reflux by duplex scanning. They underwent valvular leak operations to treat primary deep venous insufficiency. Follow-up visits were on the third day, first month, sixth month and twelfth month. At each visit, duplex scanning and a clinical examination were performed. Successful treatment was defined as deep vein valves without reflux. Any patency or reflux over 1 sec was considered a failure. Results: The study enrolled 286 patients with deep venous insufficiency. Procedural technical success was 100%. At the one-year follow-up, the overall success, among all patients, was 92%. No significant morbidity or mortality related to the procedure were observed. All patients had major improvements in venous clinical severity score (VCSS) scores postoperatively. VCSS scores at pre-intervention, and at the twelfth month, were 20.7±5.9 and 3.9±0.9, respectively (p<0.001). Conclusion: After the twelve-month follow-up, the postprocedural outcomes indicate the ICT device is safe and effective.
Authors: Mark H Meissner; Bo Eklof; Phillip Coleridge Smith; Michael C Dalsing; Ralph G DePalma; Peter Gloviczki; Gregory Moneta; Peter Neglén; Thomas O' Donnell; Hugo Partsch; Seshadri Raju Journal: J Vasc Surg Date: 2007-12 Impact factor: 4.268
Authors: Gudmundur Danielsson; Berndt Arfvidsson; Bo Eklof; Robert L Kistner; Elna M Masuda; Dean T Satoc Journal: Vasc Endovascular Surg Date: 2004 May-Jun Impact factor: 1.089