title: First-in-man assessment of the InSeal VCD, a novel closure device for large puncture accesses.
abstract: OBJECTIVE
  To demonstrate the feasibility and efficacy of the novel InSeal VCD for the closure of large puncture holes following percutaneous structural interventions.
  
  
  RESULTS
  Prospective, non-randomised, single-arm, single-centre study with a series of patients submitted to endovascular treatment of abdominal and thoracic aortic aneurysm as well as transcatheter aortic valve implantation in whom the InSeal VCD was used to close the access site. These patients were followed up for one year with clinical examination, ankle-brachial index and Doppler ultrasound. The primary endpoint was the occurrence of major vascular complications at the puncture site. From a total of nine patients screened, seven were selected to receive the InSeal VCD. Technical and therapeutic successes were achieved in all cases. The sheath profiles used in these procedures ranged from 18 Fr to 25 Fr. No major vascular complications were observed during the follow-up period. Average ankle-brachial index pre-intervention and at one-month follow-up were 0.85 and 0.82, respectively.
  
  
  CONCLUSIONS
  The InSeal VCD was shown to be effective in achieving acute and chronic haemostasis after usage of higher profile endovascular devices in this study. These results translated into no clinical complications up to one-year clinical follow-up.
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
authors.forename: Antonio M
authors.initials: AM
authors.lastname: Kambara
authors.forename: Patrick
authors.initials: P
authors.lastname: Bastos Metzger
authors.forename: J
authors.initials: J
authors.lastname: Ribamar Costa
authors.forename: Samuel M
authors.initials: SM
authors.lastname: Moreira
authors.forename: Avi
authors.initials: A
authors.lastname: Penner
authors.forename: Amanda
authors.initials: A
authors.lastname: Sousa
authors.forename: J Eduardo
authors.initials: JE
authors.lastname: Sousa
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001014:Aortic Aneurysm / Q000601:surgery; D001021:Aortic Valve / Q000601:surgery; D000082882:Bicuspid Aortic Valve Disease; D015331:Cohort Studies; D057510:Endovascular Procedures / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006330:Heart Defects, Congenital / Q000601:surgery; D006349:Heart Valve Diseases / Q000601:surgery; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011677:Punctures / Q000379:methods*; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods; D065506:Vascular Closure Devices; D058106:Wound Closure Techniques / Q000295:instrumentation*