Feasibility and Safety of Total Percutaneous Closure of Femoral Arterial Access Sites in the Veno-arterial ECMO Patients

• Conditions: Pulmonary Embolism; Medication Overdoses; Cardiogenic Shock; Extracorporeal Membrane Oxygenation; Myocarditis; Heart Arrest; Hypertension, Pulmonary

• Registration Number: NCT04689451
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

The most frequent access site for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is the common femoral artery (CFA), using either an open or percutaneous technique. Currently, percutaneous closure devices for femoral arterial access sites are approved for use only when a 10-F or smaller sheath has been used. However, the availability of the Perclose ProGlide (Abbott Laboratories, Chicago, IL) device has now made it possible to perform percutaneous vessel closure after using larger sheaths.The preclose technique using Perclose ProGlide, has been widely used in endovascular procedures. In a prospective randomized study, complication rates at the access site were similar in patients who underwent total percutaneous access (including percutaneous arteriotomy closure) than in those who underwent surgical cutdown and subsequent surgical closure. Total percutaneous closure of femoral arterial access sites increases patient comfort and decreases the rate of wound infections and lymphatic fistulas.\[6,7\] Furthermore, patients are mobilized and discharged earlier following the use of closure devices than with compression alone. Despite the above observations, no data have been published regarding percutaneous closure of femoral artery access sites in patients who have undergone VA-ECMO. In this study, we evaluated the safety and feasibility of a percutaneous closure technique using Perclose ProGlide to close the CFA access site after VA-ECMO.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2020-12-27
• Last Update Submitted: 2020-12-27
• Study First Posted: 2020-12-30
• Last Update Posted: 2020-12-30
• Study Start: 2021-02-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• The study included all patients who underwent VA-ECMO and in whom Perclose ProGlide was deployed to achieve hemostasis during closure of the CFA site.

Exclusion Criteria

• Patients were excluded if 24 hour and 30-day follow-up data regarding the access sites and other clinical outcomes were not available.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perclose technical success	1day	successful arterial closure of the CFA access site without the need for adjunctive successful arterial closure of the CFA access site without the need for adjunctive surgical or endovascular procedures.
Primary device failure	1day	obvious closure site bleeding after 2 Perclose ProGlides deployed, and complete device failure was defined as closure site bleeding which need surgical intervention

Secondary Outcome Measures

Name	Time	Method
Access-related complications	up to 24 hours after closure and during 30 days of follow-up.	events that occurred at the arterial access site, including periprocedural bleeding equiring transfusion, acute lower limb ischemia, groin infection, device failure, arterial thrombosis, arterial dissection, pseudoaneurysm, femoral arterial stenosis, arteriovenous fistula, hematoma, and lymphocele in the periprocedural period