Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Control	Conductance catheterization	Control subjects undergoing left heart catheterization with an LV ejection fraction \> 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
IABP recipient	Conductance catheterization	Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.

Primary Outcome Measures

Name	Time	Method
Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.	24 hours	We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.

Secondary Outcome Measures