Percutaneous versus surgical VA ECMO insertion:
a pilot study to evaluate feasibility and safety

the traditional method for femoral cannulation in the setting of veno-arterial
extracorporeal membrane oxygenation (VA ECMO) is a surgical approach.
Techniques for percutaneous insertion have improved drastically over the recent
years, and this less invasive procedure has been associated with a lower
complication rate. Therefore, it has increasingly become first-line strategy in
ECMO-centers worldwide.

Primary objectives
As our primary efficacy objective, we will compare procedural success rate
between the two groups, which is defined as defined as the successful insertion
of both arterial and venous cannulas and subsequent initiation of ECMO-flow. A
percutaneous approach is considered feasible when a first line success rate of
75% is reached. Our primary safety objective is the comparison of a composite
of cannulation-associated adverse events, including vascular complications,
bleeding, limb ischemia and cannulation-site as well as systemic infection. A
percutaneous approach is considered safe when the cannulation-associated
adverse event rate is equal in both groups, or lower in the percutaneous group.

Secondary objectives
As our secondary efficacy objective, we will compare procedural
characteristics, such as number of attempts (including the number of failed
attempts), cross-over rates and procedure duration. Our secondary safety
objective consists of the comparison of each individual component of the
composite safety endpoint, as well as thirty-day mortality, between the two
groups.

Two-center randomized controlled trial, open

Percutaneous insertion of ECMO cannulas

Patients presenting with an indication for VA ECMO are critically ill and as
such, have a dismal prognosis. As outlined above, a selected group of patients
is eligible for this treatment modality to potentially improve outcomes.

For this study, these patients are randomized to either surgical implantation
of VA ECMO (standard of care), or percutaneous implantation (intervention
group). We expect complication rate in the intervention group to be similar or
lower, when compared to standard of care.

This study concerns a critically ill patient population. As a percutaneous
technique may be employed faster and as it may also be associated with a lower
complication rate, the potential benefit for this patient population outweighs
the known potential risks. Importantly, both surgical and percutaneous
implantation methods are widely established, standard of care interventions.
Risks associated with either procedure are deemed relatively low