OBJECTIVES: To evaluate the feasibility, safety and efficacy of suture-mediated closure devices using a modified "preclosure" technique for access site management after percutaneous aortic valve replacement (PAVR). BACKGROUND: PAVR using a retrograde transfemoral approach has recently evolved to an endovascular alternative to open surgery in high-risk patients. However, large-bore femoral artery access is required, commonly demanding surgical closure and general anesthesia. A truly percutaneous intervention would be desirable to reduce procedural complexity and diminish the need of vascular surgery and general anaesthesia. METHODS: After direct puncture of the common femoral artery, three conventional suture-mediated closure devices (6F Perclose) were deployed. The preloaded sutures were tied at the end of the procedure. If no immediate hemostasis was achieved, an additional device was deployed thereafter. RESULTS: PAVR with percutaneous access site closure was attempted in 15 consecutive patients and could successfully be achieved in all patients allowing conscious sedation in all but three cases. Following complications occurred: one retroperitoneal bleeding caused by removal of the valve delivery sheath requiring surgical repair, as well as two cases of femoral and iliac artery dissection caused by delivery sheath introduction and treated by stenting and vascular surgery, respectively. Vascular surgery became only necessary due to total vessel occlusion after suture closure and remains the only closure-related complication. However, treatment led to recovery in all patients. CONCLUSIONS: The modified "preclosure" technique is a feasible and safe method for hemostasis after PAVR improving procedural management and diminishing the need for general anesthesia. (c) 2008 Wiley-Liss, Inc.
OBJECTIVES: To evaluate the feasibility, safety and efficacy of suture-mediated closure devices using a modified "preclosure" technique for access site management after percutaneous aortic valve replacement (PAVR). BACKGROUND: PAVR using a retrograde transfemoral approach has recently evolved to an endovascular alternative to open surgery in high-risk patients. However, large-bore femoral artery access is required, commonly demanding surgical closure and general anesthesia. A truly percutaneous intervention would be desirable to reduce procedural complexity and diminish the need of vascular surgery and general anaesthesia. METHODS: After direct puncture of the common femoral artery, three conventional suture-mediated closure devices (6F Perclose) were deployed. The preloaded sutures were tied at the end of the procedure. If no immediate hemostasis was achieved, an additional device was deployed thereafter. RESULTS: PAVR with percutaneous access site closure was attempted in 15 consecutive patients and could successfully be achieved in all patients allowing conscious sedation in all but three cases. Following complications occurred: one retroperitoneal bleeding caused by removal of the valve delivery sheath requiring surgical repair, as well as two cases of femoral and iliac artery dissection caused by delivery sheath introduction and treated by stenting and vascular surgery, respectively. Vascular surgery became only necessary due to total vessel occlusion after suture closure and remains the only closure-related complication. However, treatment led to recovery in all patients. CONCLUSIONS: The modified "preclosure" technique is a feasible and safe method for hemostasis after PAVR improving procedural management and diminishing the need for general anesthesia. (c) 2008 Wiley-Liss, Inc.