Groin Complications in Open Vs. Percutaneous Peripheral Cannulation in Minimally Invasive Cardiac Surgery

Jessa Hospital

Overview

The aim of this randomized trial is to investigate the groin complications in open vs percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery

The femoral artery (FA) and vein (FV) are considered the preferred site for peripheral cannulation during cardiac surgery. Normally, a small incision is made to access the FA and FV, which is also called open surgical cannulation. Afterwards, the incision site is traditionally closed with sutures (1, 2). However, groin complications such as hematoma, access-site infection and fistulas are complications that can eventually lead to a longer hospital stay (3). Recently, suture-mediated closure systems (SMCS) have been developed to achieve hemostasis (4). This allows for percutaneous cannulation. Still, little is known about the effects on groin complications after percutaneous cannulation in cardiac surgery. Therefore, a prospective randomized study is now being conducted to investigate the groin complications in open vs. percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Cardiovascular Diseases

Interventions

Open cannulationPROCEDURE

A small incision is made to access the FA and FA. Afterwards, the incision site is traditionally closed with sutures.

Percutaneous cannulationPROCEDURE

Cannulation is performed through a suture-mediated closure system.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \>18 years * Patients undergoing elective endoscopic cardiac surgery Exclusion Criteria: * Patients that do no understand Dutch, French, or English * Heavily calcified cannula introduction site * Central cannulation

Outcomes

Primary Outcomes

Number of participants with groin complications

Groin complications consist of groin-related bleeding, dissection, pseudoaneurysm, seroma, infection of the groin, artery occlusion, and reintervention in the groin. Groin complications are diagnosed by an ultrasound.

Time frame: Until 30 days postoperatively

Data from ClinicalTrials.gov

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