CARDIOVASCULAR
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Clinical Evidence

The studies shown below are examples of the safety and benefits that Perclose ProGlide™ SMCS may provide patients requiring small or large sheaths in artieral or venous access procedures.

Perclose Proglide™ SMCS vs. Manual Compression

A study showing ambulation times, costs and patient satisfaction between the two methods of hemostasis approaches.

Study Overview

Femoral arterial closure using ProGlide™ is more efficacious and cost-effective when ambulating early following cardiac catheterization.
International Journal of Cardiology: Heart and Vasculature, 2016

 

Background

It is unclear whether early ambulation with Perclose ProGlide™ Suture-Mediated Closure System is safe or is associated with patient satisfaction and cost savings as compared with manual compression.

 

Objective

Evaluate the efficacy and cost-effectiveness of early ambulation (within 30 minutes) following femoral artery closure with the Perclose ProGlide™ SMCS in patients undergoing diagnostic cardiac catheterization compared with manual compression.

 

Method

Prospective, single-center study of 170 patients equally split into two arms measuring patient ambulation (20 feet within 30 minutes), time to hemostasis, and time to discharge. Using a fully allocated cost model, a cost analysis of both Perclose ProGlide™ SMCS and manual compression was performed. Also, a multivariate analysis was used to determine predictors of patient satisfaction.

 

Primary Endpoint

The primary endpoint was time-to-ambulation (TTA) following device closure.

Clinical Outcomes

  Perclose ProGlide™ SMCS
(n = 85)
Manual Compression
(n = 85)
P-value
Time to hemostasis (mean) 1.5 min 20.4 min <0.001
Time to ambulation (mean) 27.1 min 248.0 min <0.001
Time to discharge (mean) 59.6 min 349.9 min <0.001
Procedural success 100% (85/85) 96% (82/85) 0.12
Overall complications 3.5% (3/85) 11.8% (10/85) 0.08

Cost Analysis

Perclose ProGlide™ SMCS provided nearly $1,000 in cost savings per patient compared to manual compression.

 

  Perclose ProGlide™ SMCS
(n = 85)
Manual Compression
(n = 85)
Total procedural cost
(without hemostasis device)
$564.5 ± 132.3 $553.7 ± 121.0
Hemostasis device cost1 $278.2 ± 77.4 $41.6 ± 22.4
Post-procedural cath lab holding2 $308.5 ± 78.8 $1,190.8 ± 333.6
Total adjusted nursing costs3 $99.1 ± 41.1 $389.5
Hospital adjusted in-patient expenses4 $0.0 $2,052.6 ± 250.2
Total cost $1,250.3 ± 146.4 $2,248.1 ± 910.2
Incremental savings per patient $983.6  

Patient Satisfaction

Perclose ProGlide™ SMCS helps reduce severe levels of patient discomfort as compared to manual compression.

Proglide vs Manual Compression

Summary

  • Perclose ProGlide™ SMCS provided significantly shorter times to hemostasis, ambulation, and discharge.
  • Perclose ProGlide™ SMCS provided nearly $1,000 in cost savings per patient compared to manual compression.
  • Perclose ProGlide™ SMCS helped reduce severe levels of patient discomfort as compared to manual compression.

Perclose ProGlide™ SMCS U.S. Large-Hole Study for EVAR

An overview of the Least Invasive Fast-Track EVAR (LIFE) Registry

Study Overview

Fast-Track Endovascular Aortic Repair: Final Results from the Prospective LIFE registry.
VIVA 2016

 

Objective

Demonstrate the clinical and cost benefits associated with the ultra-low profile (14F) Ovation Abdominal Stent Graft platform under the least invasive conditions, including percutaneous access, no general anesthesia, no ICU admission, and next-day discharge.

 

Method

Prospective, non-randomized, multi-center post-market study of 250 patients at 35 U.S. centers

 

Primary Endpoint

Major adverse event within 30 days (10.4% target performance goal)

 

Secondary Endpoint
  • Treatment success (completion of Fast-Track protocol)
  • Procedure, fluoroscopy, and anesthesia time; access complications; ambulatory status, hospital stay; quality of life
  • Freedom from type I/III endoleak; conversion to open repair, rupture, AAA-related reintervention; mortality

Clinical Outcomes

Perclose ProGlide™ SMCS had a high technical success rate with no device or procedure-related major adverse events.

 

  Perclose ProGlide™ SMCS
(n = 250)
Technical success 97.6%
Device-related MAE 0%
Procedure-related MAE 0%
Hours to ambulation (median) 7.9 Hours
Hospital stay (mean) 1.2 days

Cost Analysis

The Fast-Track EVAR approach demonstrates $21,100 in savings as compared to the Standard EVAR approach, with the hospital stay contributing to the majority of the amount.

  Standard EVAR1-2 Fast-Track EVAR Fast-Track Savings
Anesthesia General, 84%
$500
Local, 100%
$300
$200
Access Cutdown3
$300
Bilateral PEVAR
$1,200
($900)
ICU 1.4 Days, 51%
$15,300
0 Days, 0%
$0
$15,300
Non-ICU 2.3 Days
$12,900
1.2 Days
$6,700
$6,200
30-Day Reintervention $29,400, 1.1%
$300
0%
$0
$300
Total $29,300 $8,200 $21,100

Summary

Perclose ProGlide™ SMCS had a high technical success rate with no device- or procedure-related major adverse events.

The Fast-Track EVAR approach demonstrates $21,100 in savings as compared to the Standard EVAR approach, with the longer hospital stay contributing to the majority of the difference.

Important Safety Information

MAT-2002632 v2.0

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.