[Use of a percutaneous suture-mediated closure system after 6 - 8F transfemoral approaches: results for 2200 patients].

PURPOSE

The safety and effectiveness of a percutaneous suture-mediated closure system for achieving hemostasis using a transarterial femoral approach were investigated.

MATERIALS AND METHODS

A percutaneous suture closure system (Perclose/Proglide, Abbott Vascular, Redwood City, California) was used in 2200 patients (average age 67.5 ± 12.5 years) who had undergone an angiographic intervention. Vascular access sites (1331 retrograde, 869 antegrade) with a sheath size of between 6F and 8F were closed. Platelet aggregation was inhibited with 100 mg/d ASA and all patients additionally received 5000 IU heparin peri-interventionally. After application of the suture-mediated closure system and achievement of sufficient hemostasis, a light compression bandage was applied in all patients and 6 hours of bed rest were recommended. The puncture site of all patients was checked using color-coded duplex sonography post-interventionally (following day and after 6 weeks).

RESULTS

Immediate hemostasis was achieved in 2103/2200 patients (95.6 %). In the remaining 97/2200 cases, correct development of the suture was not possible, because of calcifications. In such cases, hemostasis was achieved by manual compression. Major complications (0.4 %) involved 3 infections that required vascular surgical debridement with the use of an interposition graft. In addition, there were 5 cases of secondary bleeding requiring transfusion. Minor complications (15.6 %) involved 3 (0.14 %) pseudoaneurysms, 256 (11.6 %) groin hematomas (up to max. 3 cm) and 85 (3.9 %) palpable suture granulomas.

CONCLUSION

At a puncture size of 6 - 8F, safe and effective hemostasis is possible with the percutaneous suture-mediated closure system.