Venous reflux repair with cryopreserved vein valves

Abstract

Purpose: The purpose of this study was to evaluate the immediate and short-term outcome of inserted cryopreserved vein valve allografts and the clinical outcome of treated limbs. Method: Twenty-seven cryovalves were inserted in 25 postthrombotic limbs because of active leg ulcer (20 limbs) or severe disabling leg pain (five limbs) as a procedure of last resort. Previous venous surgery had been performed in 80% of the limbs. Main stem superficial reflux and iliac venous outflow obstruction were controlled before cryovalve insertion. The most common insertion site was the superficial femoral or popliteal vein. Patients were followed up with clinical examination and with intermittent duplex Doppler scanning or ascending venography to assess patency and competency of the valve station. Results: After thawing, but before insertion, 74% of the cryovalves were incompetent and needed repair with transcommissural valvuloplasty. After insertion, mortality was zero. Morbidity was 48%, mainly because of seroma formation and deep wound infection. One cryovalve was explanted because of acute rejection. Six cryovalves occluded early (<6 weeks), and five occluded late. Cumulative rates of patent cryovalves and both patent and competent cryovalves at 24-month follow-up were 41% and 27%, respectively. Cumulative ulcer recurrence-free rate at 36 months was 50%. Pain relief was poor, and degree of swelling remained the same. Conclusion: Compared with autologous vein transfer, cryovalve insertion is associated with high morbidity, high occlusion rate, poor cumulative midterm rate of patent graft with competent valve, and poor clinical results. The procedure should not be used as a primary technique for valve reconstruction, and it is questionable whether it is useful even in patients in whom autologous reconstruction techniques have been exhausted. The basis of the high failure rate is unclear; it may be immunologic or due to loss of endothelial cover after implantation. If cryovalves are to be a viable valve repair alternative, improved cryopreservation technique, immunologic modifications, or better matching must be achieved.