G. Belcaro et al., Expanded polytetrafluoroethylene in external valvuloplasty for superficialor deep vein incompetence, ANGIOLOGY, 51(8), 2000, pp. S27-S32
The authors evaluated the long-term safety of expanded polytetrafluoroethyl
ene (ePTFE) implants used in external valvuloplasty for treatment of incomp
etence of the long saphenous and common and superficial femoral veins. Duri
ng a 15-year period patients with superficial and/or deep venous disease an
d hypertension due to pure superficial or deep vein incompetence underwent
an external valvuloplasty with ePTFE sutures, or an ePTFE cardiovascular pa
tch placed as a sleeve around the incompetent vein segment, or an ePTFE tub
ular graft placed around the venous segment. Postoperative follow-up evalua
tions 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 proce
dure. A total of 101 patients (38 men and 63 women; mean [+/- sd] age, 44 /- 12 years) underwent external valvuloplasty between January 1983 and Dece
mber 1998; 82 of them completed the 4-year follow-up. Forty of the 82 patie
nts had been operated on for superficial vein incompetence, 42 for deep vei
n incompetence. Overall, the mean followup time was 7.8 +/- 3.6 years (rang
e, 4 to 13). There were no infections, thromboses, foreign-body reactions t
o the ePTFE implants, or other prosthesis-related complications requiring e
xplantation. One granuloma (noninfected) developed in association with a tu
bular ePTFE implant around a long saphenous vein, but it did not necessitat
e implant removal. Seven patients required (at least after 4 years) a secon
d procedure for recurrent or new venous incompetence. Therefore, in this ob
servational study, ePTFE implants used to treat or correct venous incompete
nce were well tolerated on a longterm basis.