The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk transcatheter aortic valve replacement (TAVR). These patients include adults with severe aortic stenosis who are hemodynamically unstable or at risk of instability due to anatomical complexity. The main questions it aims to answer are:
1. Does pre-emptive LAVA-ECMO reduce the incidence of in-hospital death, intraprocedural cardiac arrest, or emergent cardiac surgery? 2. What are the safety outcomes related to LAVA-ECMO, including major vascular, bleeding, or cardiac structural complications? -This is a single-arm, prospective, multi-center study with no comparison group.
Participants will:
* Be screened for eligibility based on hemodynamic status and anatomical complexity * Undergo pre-emptive LAVA-ECMO cannulation prior to or during TAVR * Receive follow-up assessments at 30 days and 1 year, including clinical evaluation and echocardiography
Hemodynamic Criteria
Major Criteria (Class III)
Systolic blood pressure <90 mmHg or MAP<60 mmHg
Need for vasopressors or inotropes to maintain MAP>60 mmHg
Age <18 or pregnant
General absolute contraindications to TAVR
Severe peripheral artery disease with infeasibility for veno-arterial extracorporeal membrane oxygenation implantation.
Contraindications to transeptal cannulation (e.g. pre-existing interatrial septum occluder device).
Study participants will be recruited from Atlantic Health System hospitals and affiliated centers. Eligible individuals are adult patients diagnosed with severe native aortic stenosis or degenerated bioprosthetic aortic valves who are scheduled for transcatheter aortic valve replacement (TAVR). Patients are identified through institutional clinical practices and referrals, including those admitted to the cardiac care unit with signs of hemodynamic instability or anatomical complexity. Recruitment may include critically ill patients who are sedated or intubated, with consent obtained from legally authorized representatives when necessary.
Cohort
Other
Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)
DevicePre-emptive use of LAVA-ECMO involves transseptal cannulation of the left atrium to provide mechanical circulatory support and left ventricular unloading during high-risk transcatheter aortic valve replacement (TAVR). The device is placed prior to or at the start of the TAVR procedure in patients with unstable hemodynamics or complex anatomical features.
Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery.
Primary Safety Endpoint: Composite of VARC-3 major vascular complications, type 3 or 4 VARC-3 bleeding complications or major cardiac structural complications related to left atrial cannulation.
The primary safety endpoint includes a composite of major vascular, bleeding and cardiac structural complications according to the VARC-3 criteria. For the purpose of this trial the component of the primary safety endpoint will be differentiated between TAVR-related (e.g. associated with the vascular access used for TAVR, valve delivery system or valve implant) and LAVA-ECMO-related (e.g. associated with LAVA-ECMO cannulation including transseptal puncture).
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