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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04689451

Collaborator

(none)

Enrollment

22.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock Extracorporeal Membrane Oxygenation Myocarditis Hypertension, Pulmonary Pulmonary Embolism Heart Arrest Medication Overdoses

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Perclose ProGlide Perclose ProGlide group: use Perclose ProGlide to suture the artery
Surgical Arterial Repair Surgical Arterial Repair group : suture the artery by surgery

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.