This page contains the following sections:

Clinical Benefits
FDA Status
Treatment Objectives
Selection Criteria
Contraindications
Preliminary Testing

Introduction

Overview Counterpulsation therapy is a non-invasive technique employing sequential inflation of three sets of lower extremity cuffs during diastole, with deflation at the onset of systole. Counterpulsation Therapy increases venous return, augments diastolic pressure and provides presystolic unloading. Counterpulsation provides benefits of decreased Anginal frequency, improved exercise tolerance and improved stress myocardial perfusion in patients with chronic Angina. It has been postulated from its similarities to the IABP that the hemodynamic effects of Counterpulsation result in collateral recruitment and/or development.

Clinical experience indicates that patients have demonstrated improvement after external counterpulsation treatment such as:

• Less recurrent Chest Pain
• Less ventricular fibrillation
• Reduction or elimination of shock symptoms
• Decrease in heart size
• Less progression to cardiac failure
• Afterload reduction
• Increase quality of life
• Decreased mortality rates

Published studies have demonstrated total relief ⁽¹⁾  from Angina pain and elimination or a significant reduction of the ischemic (oxygen deprived) areas of the heart in approximately 78% of stable Angina patients.

Clinical Benefits  |  TOP

Pre ECP				Post ECP

In a paper published in March of 2001 in a peer reviewed journal⁽²⁾, none of the 58 patients studied died or suffered a major cardiac event. Canadian cardiovascular Society Functional Classification System ("CCSF") classification showed improvement in all three CCSF groups. For the entire group of 58 patients, CCSF class was reduced from 2.67 to 1.71 (36%). Overall, 84% of the patients (49 of 58)experienced a reduction in their CCSF improvement. In addition, 91% of the patients experiences a reduction in their Anginal episodes per 24 hour period post-treatment. Of the 24 patients who had been hospitalized in the six months prior to treatment, only one (4%) required hospitalization in the six month period after treatment. Medication consumption also decreased 77.4%. The paper concluded that CardiAssist™ ECP significantly reduces CCSF Angina class, the incidence of Anginal episodes, hospitalization for Angina and anti-Anginal medication use.

(1) Lawson et.al., 1995, 1996, 2000
(2) Weisfogel et.al.2001

12 Month follow up studies have demonstrated the efficacy and stability of the results. The following 4 graphs are taken from a study performed at the University of Pittsburgh, Graduate School of Public Health (Sept 25, 2000, Of a total of 139 patients)
 

Before ECP Treatment: Graph #1 shows the distribution of Angina patients initially enrolled into the study.	View the graph
Post ECP Treatment: Immediately following the treatment, a review of the % of patients with Angin	View the graph
6 Month post ECP: Demonstrating a small change in the distribution of Angina classification	View the graph
12 Motnh post ECP: Demonstrating a clear stabilization of the results	View the graph

FDA Status  |  TOP

FDA Status Counterpulsation is FDA cleared for: Angina Pectoris, Acute MI, Cardiogenic Shock and most recently - for treatment in CHF patients. The following are the FDA approvals:

• FDA 510(k) approval #K022107 date 08/8/2002 (View PDF document)
  Approval of the Cardiomedics CardiAssist Counterpulsation system for the use in ischemic heart disease; treatment of congestive heart failure, Angina pectoris and enhanced coronary function
• FDA 510(k) approval #K872034 date 09/18/87.

Treatment Objectives   |  TOP

Counterpulsation demonstrates a potent ability to increase cardiac output and significantly augments retrograde diastolic flow. Due to its additional action of increasing venous return, the effect of ECP on cardiac output may be superior to the intra-aortic balloon pump (IABP).

In a 1996 study presented to the ACC, the following changes were noticed during ECP:

• Change in cardiac output = 60%
• Increase in average DTVI (diastolic time velocity integral) = 227%
• Increase in average (D/S) TVI = 116%

Patient Selection Criteria   |  TOP

Patients who were identified as Angina Pectoris patients, Acute MI and Cardiogenic shock, are candidates for ECP and the new indication approved by the FDA on 8/8/2002 for the treatment of CHF patients.

Contraindications  |  TOP

• Cardiac catheterization within 1-2 weeks.
• Cardiac surgery within 3 months.
• arrhythmia such as A-fib, Atrial flutter or ventricular tachycardia.
• Atrial pacemakers
• Aneurysm.
• Pregnancy.
• Bleeding diathesis (Coumadin therapy with PT>15).
• Severe hypertension (> 180/110 mmHg).
• Severe Peripheral Vascular Disease (PVD) and/or phlebitis.
• Aortic insufficiency where regurgitation would prevent diastolic augmentation.

For an in depth review of selection criteria, indications and contraindications click here.

Preliminary Testing  |  TOP

The following baseline measurements and test results must be provided by the referring physician prior to preliminary testing:

Blood pressure, less than 180/110 mmHg; Resting ECG ; Physician clearance from other contraindications (such as surgery, pregnancy, etc). In order to eliminate the possibility of other clinical contraindications, the following testing should be performed: Doppler Echocardiogram - Pulsed Doppler measurements of flow in the descending aorta to rule out the presence of regurgitation.

Abdominal Ultrasound - To rule out aneurysm Duplex Vascular Ultrasound of the extremities - to rule out deep vein thrombosis

Cardiac Gated SPECT nuclear stress test - To evaluate the extent of cardiac disease pre and post ECP therapy.

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