Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

The primary objective of this study is to develop normative hemodynamic data (means and standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and 3D-echocardiographic analyses.

Inclusion Criteria:

• Male or females between 18-75 years of age
• NYHA Class III-IV heart failure at the time of MEGA deployment
• Stage C-D systolic heart failure
• Non-ischemic cardiomyopathy
• Preserved right ventricular function defined by 2D-echocardiography
• Clinically indicated left and right heart catheterization and MEGA-IABP placement
• Clinically indicated MEGA-IABP support for 12 hours minimum

Exclusion Criteria:

• Ischemic cardiomyopathy
• Active myocardial ischemia or acute coronary syndrome
• Severe peripheral vascular disease
• Severe aortic or mitral valve insufficiency
• Severe aortic or mitral valve stenosis
• Right ventricular failure
• Inability to tolerate left and right heart catheterization
• Severe hemodynamic instability defined as a systolic BP <80mmHg despite vasopressor/inotropic support
• Sustained ventricular tachycardia (>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours
• Pacemaker dependent rhythm
• Left ventricular thrombus
• Rapid atrial fibrillation (HR>120 bpm)
• Unable to provide informed consent
• Pregnancy