Comparison of Suture-Based Vascular Closure Devices in Transfemoral Transcatheter Aortic Valve Implantation

EuroIntervention. 2015 Oct;11(6):690-7. doi: 10.4244/EIJV11I6A137.

Abstract

Aims: The aim of this study was to compare outcomes with the use of two haemostasis strategies after transfemoral transcatheter aortic valve implantation (TAVI) - one Prostar® vs. two ProGlide® devices (Abbott Vascular Inc., Santa Clara, CA, USA).

Methods and results: This was a retrospective study enrolling consecutive patients undergoing fully percutaneous transfemoral TAVI in our centre (Ferrarotto Hospital, Catania, Italy) from January 2012 to October 2014. All patients were dichotomised according to the vascular closure device (VCD) used for common femoral artery haemostasis (Prostar vs. ProGlide). All outcomes were defined according to VARC-2 criteria. The study population encompassed a total of 278 patients. Of these, 153 (55.1%) underwent TAVI using the Prostar, and 125 (44.9%) using two ProGlide devices. Vascular complications occurred in 48 patients (17.3%), being more frequent in the ProGlide group (11.8% vs. 24.0%, p=0.007). Patients who had TAVI using the ProGlide were also more likely to have a higher rate of percutaneous closure device failure (4.6% vs. 12.8%, p=0.013). Percutaneous peripheral intervention was performed in 13.7% and 28.0% of Prostar and ProGlide cases, respectively (p=0.003).

Conclusions: Patients undergoing transfemoral TAVI had significantly lower rates of vascular complications and percutaneous closure device failures when the Prostar was used compared with two ProGlide devices.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve*
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / methods*
  • Catheterization, Peripheral / adverse effects
  • Catheterization, Peripheral / methods*
  • Chi-Square Distribution
  • Equipment Design
  • Female
  • Femoral Artery* / diagnostic imaging
  • Heart Valve Diseases / diagnosis
  • Heart Valve Diseases / therapy*
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / methods*
  • Hemorrhage / etiology
  • Hemorrhage / prevention & control*
  • Hemostatic Techniques / instrumentation*
  • Humans
  • Italy
  • Male
  • Multivariate Analysis
  • Odds Ratio
  • Punctures
  • Radiography
  • Retrospective Studies
  • Risk Factors
  • Suture Techniques*
  • Treatment Outcome
  • Vascular Closure Devices*