Comparison of closure strategies after balloon aortic valvuloplasty: Suture mediated versus collagen based versus manual

Objectives: To compare complication rates of a collagen‐mediated closure device, suture‐mediated closure technique and manual compression for access site management following balloon aortic valvuloplasty (BAV). Background: Vascular complications, including perforation, limb ischemia, ateriovenous fistulas, and pseudoaneurysm, are a common source of morbidity in patients undergoing BAV with large bore femoral artery access. The available options for closure of the access site include manual compression, suture‐mediated closure devices, and recently reported collagen‐based closure devices. Methods: The study cohort consisted of 333 patients with severe aortic stenosis undergoing BAV. Patients were divided into four groups according to access closure method: (1) Manual compression in 64 (19.2%); (2) Proglide 6 Fr in 162 (48.6%); (3) Angio‐Seal 8 Fr in 89 (26.75%); and (4) Prostar 10 Fr in18 (5.4%). Results: There were no significant differences in baseline characteristics among the groups; although the Prostar group was had more males and the Angio‐Seal group reported a lower incidence of renal failure and peripheral vascular disease. The Angio‐Seal group had shorter procedural duration times compared with the other groups. In the Angio‐Seal group (n = 47, 52.8%), a 10 Fr sheath size was primarily used to access the femoral artery, as compared with the manual compression and Proglide groups, which used a 12 Fr sheath in 29 (45.3%) and 66 patients (40.7%), respectively. A 13 Fr sheath was used in the Prostar group (n = 11, 61.1%), P < 0.001. The device failure rate was significantly higher in the Proglide group (n = 20, 12.3%) as compared with Angio‐Seal (n = 3, 3.3%) and Prostar groups (n = 1, 5.5%), P = 0.03. Serious vascular complications requiring intervention were significantly higher in the manual compression group (n = 11, 17.1%) compared with the Proglide (n = 11, 6.7%), Angio‐Seal (n = 5, 5.6%), and Prostar groups (n = 5, 1%), P < 0.001. The requirement for blood transfusion in the Angio‐Seal group was significantly lower (n = 7, 7.8%) as compared with the manual compression (n = 20, 31.2%), Proglide (n = 35, 21.6%), and Prostar groups (n = 5, 27.7%), P < 0.001. Conclusion: In our case series, collagen‐based closure devices and suture‐mediated closure devices had fewer vascular complications than manual compression for hemostasis following BAV. Patient selection for collagen‐based versus suture‐mediated closure requires further study. © 2011 Wiley‐Liss, Inc.