Impella Supported OPCABG

Impella-supported Off-pump Coronary Artery Bypass Grafting in High Risk Revascularizations: A Single Center Prospective Observational Study

The present study introduces a novel approach to coronary revascularization through the use of a short term minimally-invasive left ventricular assist device (LVAD) to minimize myocardial injury and eliminate low output state during the perioperative period

Study Overview

• Status: Recruiting
• Conditions: Ischemic Cardiomyopathy
• Intervention / Treatment: Device: Impella 5.0 and Impella 5.5 with SmartAssist Supported OPCABG

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Krissa Packard, MS; Phone Number: 4149551861; Email: kpackard@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • The Medical College of Wisconsin
      • Contact: James Zelten, MS; Phone Number: 414-955-6994; Email: jzelten@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients fitting inclusion criteria will undergo Impella supported OPCABG using coronary shunts. Inclusion criteria will target patients with ischemic cardiomyopathy, similarly defined to the STICH trial which evaluated coronary revascularization in the setting of heart failure (defined by an EF≤35%). Patients would be considered for enrollment in the setting of symptomatic severe multi-vessel coronary artery disease with target vessels that are amenable to bypass (as determined by the operating surgeon).

Description

Inclusion Criteria:

• Age ≥ 18 years old
• Ejection fraction ≤ 35%
• Symptomatic three vessel Coronary Artery Disease with target vessels that are amenable to bypass (as determined by the operating surgeon)
• Adequate Distal target caliber (as determined by the PI)

Exclusion Criteria:

• Exclusion criteria will include the existing contraindications to either Impella therapy or OPCABG revascularization:

  • Patients with structural heart disease requiring cardiopulmonary bypass
  • Patients with cardiogenic shock who require a period of short-term mechanical circulatory support
  • Patients with mechanical aortic valve
  • Patients with previous median sternotomy
  • Patients with evidence of non-viability on preoperative cardiac MRI or CT scan
  • Insufficient conduit
  • BMI over 50
  • Patients who are COVID-19 positive at the time of screening

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative hemodynamic stability	Intraoperative hemodynamic stability, defined as mean arterial pressure (MAP), cardiac index (CI), central venous pressure (CVP), and cerebral perfusion as measured by NIRS maintained within normal ranges for the entire operative time except potentially for short periods not exceeding 10 minutes in total time.	Intraoperative

Collaborators and Investigators

• Sponsor: Lyle Joyce
• Collaborators: Abiomed Inc.
• Investigators: Principal Investigator: Lyle D Joyce, MD, PhD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 37481

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: Yes