title: Vascular complication can be minimized with a balloon-expandable, re-collapsible sheath in TAVR with a self-expanding bioprosthesis.
abstract: OBJECTIVE
  This study evaluates the feasibility and safety of a balloon-expandable, re-collapsible sheath for TAVR patients, including those with small iliofemoral access (≤5.0 mm).
  
  
  BACKGROUND
  The recommended iliofemoral diameter for the CoreValve TAVR system is ≥6.0 mm, but the lowest limit has not been determined.
  
  
  METHODS
  Of 322 consecutive patients who underwent TAVR from 1/2014 to 8/2015 at two institutions, 64 underwent transfemoral CoreValve implantation, using an 11/19-French balloon-expandable, re-collapsible sheath, which has a 4.45 mm outer diameter (OD) on arterial entry, expands to 7.67 mm, then re-collapses upon removal. Valve sizing and vascular access were determined by computed tomography, and outcomes were assessed using the Valve Academic Research Consortium 2 (VARC-2) definitions.
  
  
  RESULTS
  Thirteen of 64 patients had a minimal iliofemoral artery luminal diameter (MLD) of ≤5.0 mm (mean 4.38+/-0.59 mm, range 3.1-5.0 mm), with vessel calcification ≤90° to 360° and tortuosity <45° to >90°. At the MLD point, the sheath-to-artery ratios, based on the fully expanded 7.67 mm OD, ranged 1.53-2.47, higher than previously reported ratios that risk vascular complications. Major comorbidities included chronic renal failure, severe chronic obstructive pulmonary disease, extreme thrombocytopenia, cirrhosis, prior cardiac surgery, poor ventricular function, and frailty. All 64 patients had TAVR with IV sedation and local anesthesia, with 0% sheath malfunction, 0% vascular complications, and 0% bleeding in-hospital and at 30 days per VARC-2 definitions.
  
  
  CONCLUSIONS
  TAVR using a balloon-expandable, re-collapsible sheath is safe, including in small iliofemoral access ≤5.0 mm, thus considerably expanding the population suitable for transfemoral approach. © 2015 Wiley Periodicals, Inc.
authors.affiliation: Houston Methodist DeBakey Heart & Vascular Center, Department of Cardiovascular Surgery, Houston Methodist Hospital, Houston, Texas.
authors.forename: Walid K
authors.initials: WK
authors.lastname: Abu Saleh
authors.affiliation: Section of Cardiothoracic Surgery, Westchester Medical Center, New York Medical College, Valhalla, New York.
authors.forename: Gilbert H L
authors.initials: GH
authors.lastname: Tang
authors.affiliation: Division of Cardiology, Westchester Medical Center, New York Medical College, Valhalla, New York.
authors.forename: Hasan
authors.initials: H
authors.lastname: Ahmad
authors.affiliation: Division of Cardiology, Westchester Medical Center, New York Medical College, Valhalla, New York.
authors.forename: Martin
authors.initials: M
authors.lastname: Cohen
authors.affiliation: Section of Cardiothoracic Surgery, Westchester Medical Center, New York Medical College, Valhalla, New York.
authors.forename: Cenap
authors.initials: C
authors.lastname: Undemir
authors.affiliation: Section of Cardiothoracic Surgery, Westchester Medical Center, New York Medical College, Valhalla, New York.
authors.forename: Steven L
authors.initials: SL
authors.lastname: Lansman
authors.affiliation: Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Manuel
authors.initials: M
authors.lastname: Reyes
authors.affiliation: Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Colin M
authors.initials: CM
authors.lastname: Barker
authors.affiliation: Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: Houston Methodist DeBakey Heart & Vascular Center, Department of Cardiovascular Surgery, Houston Methodist Hospital, Houston, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: Houston Methodist DeBakey Heart & Vascular Center, Department of Cardiovascular Surgery, Houston Methodist Hospital, Houston, Texas.
authors.forename: Basel
authors.initials: B
authors.lastname: Ramlawi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation*; D000072226:Computed Tomography Angiography; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D061330:Multidetector Computed Tomography; D009518:New York; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D013781:Texas; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014652:Vascular Diseases / Q000209:etiology / Q000517:prevention & control*
keywords: TAVR; VARC-2; solopath; transfemoral; vascular complication