Expanded polytetrafluoroethylene in external valvuloplasty for superficial or deep vein incompetence

The authors evaluated the long-term safety of expanded polytetrafluoroethylene (ePTFE) implants used in external valvuloplasty for treatment of incompetence of the long saphenous and common and superficial femoral veins. During a 15-year period patients with superficial and/or deep venous disease and hypertension due to pure superficial or deep vein incompetence underwent an external valvuloplasty with ePTFE sutures, or an ePTFE cardiovascular patch placed as a sleeve around the incompetent vein segment, or an ePTFE tubular graft placed around the venous segment. Postoperative follow-up evaluations consisted of clinical examinations, high-resolution ultrasonography, and color duplex scanning, and a complete blood count performed at 1, 3 and 6 months, and repeated for at least 4 years, every 2 years after the procedure. A total of 101 patients (38 men and 63 women; mean [+/- sd] age, 44+/-12 years) underwent external valvuloplasty between January 1983 and December 1998; 82 of them completed the 4-year follow-up. Forty of the 82 patients had been operated on for superficial vein incompetence, 42 for deep vein incompetence. Overall, the mean follow-up time was 7.8+/-3.6 years (range, 4 to 13). There were no infections, thromboses,foreign-body reactions to the ePTFE implants, or other prosthesis-related complications requiring explantation. One granuloma (noninfected) developed in association with a tubular ePTFE implant around a long saphenous vein, but it did not necessitate implant removal. Seven patients required (at least after 4 years) a second procedure for recurrent or new venous incompetence. Therefore, in this observational study, ePTFE implants used to treat or correct venous incompetence were well tolerated on a long-term basis.