Impella Supported OPCABG

Lucian Archambault Durham III

Status: Active, not recruiting

Conditions: Ischemic Cardiomyopathy

Treatments: Device: Impella 5.5 with SmartAssist Supported OPCABG

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04339452

37481

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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) or Left main disease
• Adequate Distal target caliber (as determined by the PI or operating surgeon)

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
  • Suspected or known pregnancy