title: Efficacy of a balloon-expandable vascular access system in transfemoral TAVI patients.
abstract: BACKGROUND
  Vascular complications (VC) are a serious and frequent complication of transfemoral transcatheter aortic valve implantation (TAVI) and result in increased morbidity and mortality. It has been suggested that newly developed vascular sheaths may increase the ability to perform transfemoral TAVI in patients with normal and access-limiting peripheral artery disease (PAD) and reduce vascular complications.
  
  
  OBJECTIVE
  We sought to assess the safety and efficacy of the 19 French (F) SoloPath balloon-expandable transfemoral vascular access system in patients who underwent transfemoral TAVI at our center between 2011 and 2014.
  
  
  RESULTS
  Single-center retrospective study of 90 patients who underwent transfemoral TAVI with the use of the SoloPath sheath. Patients were categorized into two groups according to a sheath to femoral artery ratio (SFAR) of less than or equal to 1.05, or greater than 1.05. Overall, the incidence of major bleeding complications was low, 4.4%. No significant differences were found in technical or procedural success rates (100% in both groups and 100% vs. 91.3; P = 0.09; respectively), total vascular complications (20.8 vs. 21.7; P = 0.92) or total bleeding complications (20.8 vs. 30.4; P = 0.36 between those with SFAR greater or less than 1.05.
  
  
  CONCLUSIONS
  The use of the SoloPath balloon-expandable sheath is feasible and safe even in patients with SFAR > 1.05, showing no increased vascular or bleeding complications compared to patients with larger vascular access. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Canada.
authors.forename: Xavier
authors.initials: X
authors.lastname: Millán
authors.affiliation: Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Canada.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Azzalini
authors.affiliation: Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Canada.
authors.forename: Razi
authors.initials: R
authors.lastname: Khan
authors.affiliation: Montreal Health Innovations Coordinating Center, Montreal, Canada.
authors.forename: Daniel
authors.initials: D
authors.lastname: Cournoyer
authors.affiliation: Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Canada.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Dorval
authors.affiliation: Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Canada.
authors.forename: Reda
authors.initials: R
authors.lastname: Ibrahim
authors.affiliation: Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Canada.
authors.forename: Raoul
authors.initials: R
authors.lastname: Bonan
authors.affiliation: Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Canada.
authors.forename: Anita W
authors.initials: AW
authors.lastname: Asgar
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000293:injuries / Q000503:physiopathology; D006349:Heart Valve Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D058729:Peripheral Arterial Disease / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011677:Punctures; D011792:Quebec; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D057772:Vascular System Injuries / Q000209:etiology
keywords: Structural Heart Disease Intervention (SHDI); Transcatheter Valve Implantation (TVI); Vascular Complications (VCOM)