title: Comparison of closure strategies after balloon aortic valvuloplasty: suture mediated versus collagen based versus manual.
abstract: OBJECTIVE
  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 in 18 (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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cariology, Washington Hospital Center, Washington, DC, USA.
authors.forename: Itsik
authors.initials: I
authors.lastname: Ben-Dor
authors.forename: Patrick
authors.initials: P
authors.lastname: Looser
authors.forename: Nelson
authors.initials: N
authors.lastname: Bernardo
authors.forename: Gabriel
authors.initials: G
authors.lastname: Maluenda
authors.forename: Rebecca
authors.initials: R
authors.lastname: Torguson
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Xue
authors.forename: Joseph
authors.initials: J
authors.lastname: Lindsay
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.forename: Lowell F
authors.initials: LF
authors.lastname: Satler
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000628:therapy*; D002404:Catheterization / Q000009:adverse effects*; D016009:Chi-Square Distribution; D003094:Collagen / Q000009:adverse effects / Q000627:therapeutic use*; D004219:District of Columbia; D004867:Equipment Design; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation; D006801:Humans; D016015:Logistic Models; D008297:Male; D011312:Pressure; D011677:Punctures; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013536:Suture Techniques / Q000009:adverse effects / Q000295:instrumentation; D016896:Treatment Outcome
chemical_list: D003094:Collagen