Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR

Official title

PROspective Evaluation of Pre-empTive Left Atrial Venoarterial Extra-Corporeal Membrane oxygenaTion for Complex High-risk Transcatheter Aortic Valve Replacement: PROTECT-TAVR

Overview

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

Interventions

• Device Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)
  Pre-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 outcome measures

• Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery. [Time frame: From enrollment through hospital discharge (up to 30 days post-procedure)]

Secondary outcome measures (1)

• 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. [Time frame: From enrollment through hospital discharge (up to 30 days post-procedure)]

Eligibility criteria

Inclusion criteria

\- Patients are required to have either a Class III hemodynamic status OR type B or type C anatomical complexity with Class II (at risk) hemodynamics (Figure 2).

• 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
• Evidence of end-organ damage including: acute kidney injury, liver dysfunction, elevated lactate or altered mentation
• Minor Criteria (Class II)

• Left ventricular ejection fraction <35%
• Pulmonary hypertension (pulmonary artery systolic pressure >60 mmHg) with right ventricular dysfunction
• Pulmonary capillary wedge pressure >30 mmHg
• Anatomic criteria

• Major Criteria (Type C)

• Native or valve-in-valve TAVR requiring single-leaflet modification for a large area of myocardium at risk (e.g. patients with large or dominant left circulation)
• Native or valve-in-valve TAVR requiring dual-leaflet modification
• Severe bioprosthetic aortic regurgitation
• Severe 3-vessel coronary artery disease not amenable to revascularization (SYNTAX score >33)
• Minor Criteria (Type B)

• Native or valve-in-valve TAVR requiring single-leaflet modification
• Severe commissural misalignment requiring leaflet modification
• High-risk for coronary occlusion not amenable to leaflet modification
• Critical low-flow low-gradient aortic stenosis (defined as an estimated aortic valve area ≤0.5 cm2)

Exclusion criteria

• 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).
• Pre-existing Impella treatment.
• Onset of shock >12 hours.
• Preceding cardiac arrest with prolonged resuscitation (>40 minutes).
• Other severe concomitant disease with life expectancy <6 months.
• Participation in another trial with an intervention.
• Any class I hemodynamic status
• Type A anatomical complexity with class I or II hemodynamic status

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 2 centers

• Center for Structural Heart Disease Henry Ford Hospital — Detroit
• Valve and Structural Heart Center Morristown Medical Center — Morristown

Publications

• VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun PMID 33888385
• Golzarian H, Thiel A, Hempfling G, Otto M, Otto T, Shappell E, Racer L, Martz D, Recker-Herman CM, Laird A, Cole WC, Sirak J, Patel SM. Severe aortic insufficiency-induced cardiogenic shock treated with left atrial VA-ECMO and emergent valve-in-valve TAVR. ESC Heart Fail. 2023 Dec;10(6):3718-3724. doi: 10.1002/ehf2.14561. Epub 2023 Oct 27. PMID 37890858
• Giustino G, O'Neill BP, Wang DD, Frisoli T, Fang JX, Engel-Gonzalez P, Lee J, Fadel R, O'Neill WW, Villablanca PA. Feasibility and safety of transcaval venoarterial extracorporeal membrane oxygenation in severe cardiogenic shock. EuroIntervention. 2024 Apr 15;20(8):e511-e513. doi: 10.4244/EIJ-D-23-01046. No abstract available. PMID 38629421
• Fraccaro C, Karam N, Mollmann H, Bleiziffer S, Bonaros N, Teles RC, Carrilho Ferreira P, Chieffo A, Czerny M, Donal E, Dudek D, Dumonteil N, Esposito G, Fournier S, Hassager C, Kim WK, Krychtiuk KA, Mehilli J, Pregowski J, Stefanini GG, Ternacle J, Thiele H, Thielmann M, Vincent F, von Bardeleben RS, Tarantini G. Transcatheter interventions for left-sided valvular heart disease complicated by card PMID 37624587
• Villablanca PA, Al-Darzi W, Boshara A, Hana A, Basir M, O'Neill B, Frisoli T, Lee J, Wang DD, O'Neill WW. Left Atrial Venoarterial Extracorporeal Membrane Oxygenation for Patients in Cardiogenic Shock and Acute Aortic Regurgitation. JACC Cardiovasc Interv. 2022 Oct 24;15(20):2112-2114. doi: 10.1016/j.jcin.2022.08.015. Epub 2022 Sep 28. No abstract available. PMID 36265949
• Sabharwal A, Tsiouris A, Slaughter MS, Lemor A, Jeyakumar AKC, Protos A, Hernandez GA. Left Atrial-Veno Arterial Extracorporeal Membrane Oxygenation as a Bridge to Surgery for Endocarditis-Related Acute Severe Aortic Regurgitation. ASAIO J. 2024 Apr 1;70(4):e61-e64. doi: 10.1097/MAT.0000000000002077. Epub 2023 Nov 1. PMID 37913501
• Lemor A, Basir MB, O'Neill BP, Cowger J, Frisoli T, Lee JC, Wang DD, Alaswad K, O'Neill W, Villablanca PA. Left Atrial-Veno-Arterial Extracorporeal Membrane Oxygenation: Step-By-Step Procedure and Case Example. Struct Heart. 2022 Oct 31;6(6):100117. doi: 10.1016/j.shj.2022.100117. eCollection 2022 Nov. PMID 37288119
• Lama von Buchwald C, Gonzalez PE, O'Neill B, Wang DD, Frisoli T, O'Neill WW, Villablanca PA. Percutaneous Retrieval of an Aortic Valve Vegetation Causing Severe Regurgitation and Cardiogenic Shock. JACC Cardiovasc Interv. 2023 May 22;16(10):1301-1303. doi: 10.1016/j.jcin.2023.03.027. Epub 2023 May 3. No abstract available. PMID 37140503

Identifiers

NCT: NCT07309029 · 2337824

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗