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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Cardiogenic Shock Extracorporeal Membrane Oxygenation Myocarditis Hypertension, Pulmonary Pulmonary Embolism Heart Arrest Medication Overdoses

Keywords

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decannulation veno-arterial extracorporeal membrane oxygenation ProGlide vascular complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Perclose ProGlide

Perclose ProGlide group: use Perclose ProGlide to suture the artery

No interventions assigned to this group

Surgical Arterial Repair

Surgical Arterial Repair group : suture the artery by surgery

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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xin xu, Master

Role: CONTACT

Phone: 13857138821

Email: [email protected]

Other Identifiers

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xuxin@GICU

Identifier Type: -

Identifier Source: org_study_id