Long-term Outcomes of Patients Undergoing ECMO-assisted PCI

Long-term Outcomes of Patients Undergoing Extracorporeal Membrane Oxygenator-assisted Percutaneous Coronary Intervention

Evidence regarding the long-term outcomes of patients undergoing Veno-arterial extracorporeal membrane oxygenator (VA-ECMO) assisted percutaneous coronary intervention (PCI) and the impact of the operator experience is limited.

The purpose of this retrospective single-center, observational registry in China is to investigate the long-term outcomes of patients undergoing VA-ECMO-assisted PCI and the impact of the operator experience.

Study Overview

• Status: Active, not recruiting
• Conditions: Complex High-risk and Indicated Patients
• Intervention / Treatment: Device: VA-ECMO-assisted PCI

Detailed Description

In the past four decades, there has been a widespread percutaneous coronary intervention (PCI) in coronary artery disease (CAD). Guidelines recommended that PCI is a reasonable option to improve survival, compared with medical therapy, in selected patients with low-to-medium anatomic complexity of CAD equally suitable for coronary artery bypass grafting (CABG); for complex and diffuse CAD, CABG was associated with a more significant clinical benefit. However, CABG is not always feasible due to patient preferences or the excess risk of perioperative morbidity and mortality. In selected patients with functionally significant multivessel disease (MVD) and LVEF ≤ 35% who are at high surgical risk or inoperable, PCI may be considered as an alternative to CABG. The recent 2024 European Society of Cardiology guidelines for the management of chronic coronary syndromes provided IIb B recommendation under such settings. However, such a subset of patients is considered at high risk for PCI complications due to the risk of hemodynamic collapse during balloon inflations or complex procedures.

Mechanical circulatory support (MCS) devices for elective high-risk PCI can provide hemodynamic support preventing hemodynamic failure during PCI. Several studies have suggested that intra aortic balloon pump (IABP) showed no significant benefits. Impella with a larger hemodynamic support also failed to demonstrate benefits, despite a tendency favoring the device. Venoarterial extracorporeal membrane oxygenation (VA -ECMO) is an alternative option for mechanical support, providing more extensive hemodynamic support in patients with potential or ongoing circulation failure. Initial reports on the use of VA-ECMO showed controversial results in the treatment of cardiogenic shock due to myocardial infarction. However, available evidence for the use of VA-ECMO in high-risk PCI has been restricted to retrospective small sizes; large-volume studies about the long-term outcome in this patient are limited.

ECMO requires a complex multidisciplinary approach and advanced technology. The potential benefits of hemodynamic support may be outweighed by the risk of device-associated complications, particularly bleeding and peripheral vascular events. Two studies have demonstrated that ECMO center experience may be associated with lower mortality in patients with cardiorespiratory failure. However, the relationship between operator experience and long-term outcomes post-VA-ECMO-assisted PCI in high-risk patients, and the ideal threshold to classify an operator as "experienced" have not been previously studied. Therefore, the aim of the present study was also to analyze the association between operator experience and one-year mortality post-VA-ECMO-assisted PCI.

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients treated with VA-ECMO-assisted PCI

Description

Inclusion Criteria:

1. Aged 18 years or older
2. Coronary artery disease of the left main and/or multivessel disease
3. Combined with severely impaired left ventricular ejection fraction (LVEF), defined as LVEF ≤ 35% or decompensated heart failure
4. The heart team and the patient rejected CABG or OMT

Exclusion criteria were VA-ECMO support applied for cardiogenic shock or extracorporeal cardiopulmonary resuscitation (ECPR)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VA-ECMO-assisted PCI	Device: VA-ECMO-assisted PCI; A total of 220 consecutive patients with VA-ECMO-assisted PCI will be enrolled. Data related to medical history, procedural characteristics, and outcomes were collected. Clinical follow-up will be conducted in the periprocedural and postoperative at 1 month, 1 year, 2 years, 3 years, 4 years, and 5 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause death	The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac death	The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.	30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
myocardial infarction	The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.	30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
stroke	Including ischemic stroke and hemorrhagic stroke. The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.	30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
revascularization	Including target vessel revascularization and non-target vessel revascularization. The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.	30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
rehospitalization	The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.	30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
periprocedural complications	The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.	30 days

Collaborators and Investigators

• Sponsor: Ling Tao, MD, PhD
• Investigators: Study Chair: Chao Gao, M.D., Ph.D., Xijing Hospital; Study Chair: Ling Tao, M.D., Ph.D, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; ECMO; high-risk PCI
• Other Study ID Numbers: KY20242366-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No