Vascular complication can be minimized with a balloon-expandable, re-collapsible sheath in TAVR with a self-expanding bioprosthesis

Walid K. Abu Saleh, Gilbert H.L. Tang, Hasan Ahmad, Martin Cohen, Cenap Undemir, Steven L. Lansman, Manuel Reyes, Colin M. Barker, Neal S. Kleiman, Michael J. Reardon, Basel Ramlawi

Research output: Contribution to journalArticle

6 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)135-143
Number of pages9
JournalCatheterization and Cardiovascular Interventions
Volume88
Issue number1
DOIs
StatePublished - Jul 1 2016

Keywords

  • TAVR
  • VARC-2
  • solopath
  • transfemoral
  • vascular complication

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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