First Independent Review of the Vascade Vascular Closure Device: The Only Device Marketed as “Proven” Safer than Manual Compression

Final ID:

463 

Type:

Original Scientific Research-Oral or Poster 

Poster Type:

ePoster 

Authors:

A Choksi1, S Tsymbalyuk1, B Tolaymat1, G Li2, D Gandhi3, T Miller3, G Jindal4, C Chao3

Institutions:

1University of Maryland School of Medicine, Baltimore, MD, 2University of Maryland Medical Center, Baltimore, MD, 3University of Maryland, Baltimore, MD, 4University of Maryland, United States

First Author:

Ankur Choksi  
University of Maryland School of Medicine
Baltimore, MD

Co-Author(s):

Solomiya Tsymbalyuk  
University of Maryland School of Medicine
Baltimore, MD
Besher Tolaymat  
University of Maryland School of Medicine
Baltimore, MD
Guang Li  
University of Maryland Medical Center
Baltimore, MD
Dheeraj Gandhi  
University of Maryland
Baltimore, MD
Tim Miller  
University of Maryland
Baltimore, MD
Gaurav Jindal, MD  
University of Maryland
United States
Cherng Chao  
University of Maryland
Baltimore, MD

Poster Presenter:

Ankur Choksi  
University of Maryland School of Medicine
Baltimore, MD

Presenting Author:

Ankur Choksi  
University of Maryland School of Medicine
Baltimore, MD

Purpose:

In seeking FDA device approval, arterial access closure devices have only sought non-inferiority to manual compression. However, for the Vascade arterial access closure device, the company submitted its sponsored RESPECT trial data finding superiority of its device. Mean time to hemostasis by IR was 5.5 minutes and minor complication rate was 1.1%. No other device has been found superior to manual compression. No other published studies have analyzed this device for arterial access closure. As the MAUDE database illustrates, experiences with devices outside of a controlled trial can deviate from clinical trial data. To evaluate the device in practice, we reviewed our experience using Vascade for arterial access closure.

Materials:

We reviewed imaging and medical charts for procedures where the Vascade was deployed by Radiology at a large academic institution for 3 months leading to the end of the 2017 academic year. Patient demographics, labs, device used, time to hemostasis and complications were reviewed. For statistical significance, Wilcoxon test is used to test continuous variables and Fisher's exact for categorical variables.

Results:

There were 120 cases using the Vascade device for femoral artery access closure, 60% used the 5F system and 40% used the 6/7F system. Average time to hemostasis was 5.3 minutes; specifically, 4.5 minutes with the 5F system versus 6.5 minutes with the 6/7F system (p < 0.05). The only reported complications were hematomas treated with manual compression. Hematomas occurred 4.5% of the time with a higher incidence of 7.4% with the 6/7F system versus 2.5% with the 5F system but this was not statistically significant (p = 0.16). Oozing was noted at the access site 2.5% of the time with a slightly higher rate of 4.9% with the 6/7F system versus 0.8% with the 5F system (p = 0.16). The mean patient INR was 1.06 and the mean platelet level was 235. The average patient age was 60 and 46% of the cases involved a male patient.

Conclusions:

Our experience with the Vascade for arterial access closure had a similar time to hemostasis to the RESPECT trial of just over 5 minutes but our hematoma complication rate of 4.5% was higher than that reported by the RESPECT trial.

Abstract Categories:

Arterial Interventions: Other

Keywords:

Arterial closure devices
Hematoma