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

A Trial to Compare the Feasibility and Safety of Total Percutaneous Closure of Femoral Arterial Access Sites in the Veno-arterial ECMO Patients With Surgical Arterial Repair

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients who underwent VA-ECMO

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Perclose ProGlide; Perclose ProGlide group: use Perclose ProGlide to suture the artery
Surgical Arterial Repair; Surgical Arterial Repair group : suture the artery by surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perclose technical success	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.	1day
Primary device failure	obvious closure site bleeding after 2 Perclose ProGlides deployed, and complete device failure was defined as closure site bleeding which need surgical intervention	1day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access-related complications	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	up to 24 hours after closure and during 30 days of follow-up.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 27, 2020
• First Submitted That Met QC Criteria: December 27, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 27, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: decannulation; vascular complications; veno-arterial extracorporeal membrane oxygenation; ProGlide
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Shock; Cardiomyopathies; Myocardial Infarction; Infarction; Hypertension; Embolism; Myocarditis; Heart Arrest; Hypertension, Pulmonary; Shock, Cardiogenic; Pulmonary Embolism
• Other Study ID Numbers: xuxin@GICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No