ECP or EECP in 2013

External Counterpulsation Therapy (ECP or EECP) for 2013?

External Counterpulsation Therapy (also known as ECP or EECP) is known to be an exceptional investment both clinically and financially. With the rapidly changing landscape in the Healthcare in the U.S, would ECP be considered a good investment for 2013?

By now, most cardiology facilities have heard of External Counterpulsation Therapy. There are several ways ECP or EECP Therapy is perceived among Cardiologist. Some believe it serves a useful purpose, others still remain skeptical as to either its clinical application, or the viability of the financial investment.

2013 is unfolding as a different year in many ways. Physicians in Cardiology are now forced to be much more sensitive to how they invest their practice dollars. Continual cuts in reimbursement coupled with a climate where cost cutting is on the forefront, those in Cardiology are in need of smart investments that make both clinical and financial sense. For a large number of Cardiology practices, ECP is now back on the table. Lets take a look in detail.

In Theory, Does ECP Fit my Patient Population?

ECP or EECP is a non-surgical solution specifically indicated for patients that suffer from symptomatic Coronary Artery Disease. Lets take a look at the available statistics relating to the prevalence of Angina and Heart Failure:

• 9 million Angina patients in the U.S./ 400,000 new cases a year 3
• 13.6 million angina attacks per week despite medication
• 25.6% of patients have angina 1 year post angioplasty or stent4
• 10.5% of patients have angina 1 year post CABG5

We see that the number of patients remain abundant. As a clinician, what are the primary goals Management of Coronary Artery Disease (CAD) and Angina?

• Reduce Mortality and Morbidity
• Eliminate angina or equivalent symptoms (i.e. SOB, fatigue, and palpitations)
• Return the patient to a normal active lifestyle, including the ability to exercise

Although these statistics are indisputable, we now reach the point at which the management of these patients becomes quite controversial. Cardiologists and provider have many tools in their bags when it comes to achieving their objectives with patient care. The preferred treatment options can vary drastically among specialists in Cardiology. Some prefer a preventative approach, some specialize in interventional, or minimally invasive while others remain non-invasive. The common denominator among all areas of expertise, is that they are all necessary!. It is the application of each area is where Cardiologists can differ. Rather than draw a contrast among the different schools of though in Cardiology, lets investigate the proven benefits of ECP or EECP Therapy and how it can be applicable in a medical facility for 2013.

Proven Clinical Evidence

External Counterpulsation Therapy is Clinically proven improves symptoms & decrease long-term morbidity through the mechanical inflation process. The inflation (or squeeze) counter to each heart beat during therapy, acts as an external cardiac assist device.

Hemodynamic changes from EECP Therapy include:

• Increase in Venous return
• Increase in Preload/stretch
• Increase in Cardiac Output
• Increased Retrograde arterial flow
• Augmented Diastolic pressure with increased intra-coronary perfusion
• Improvement in Vascular recoil and systolic unloading
• Lowering of Systemic vascular resistance
• Decrease in after-load
• Decrease in myocardial oxygen consumption

All physicians understand the hemodynamics of counterpulsation, but what are the real lasting effects of EECP when a patients is not undergoing treatment.

• Those Improvement in endothelial function
• Promotion of collateralization
• Enhancement of ventricular function
• Improvement in oxygen consumption (VO2)
• Regression of atherosclerosis
• Peripheral training effects similar to exercise2

ECP Therapy is proven to be effective when used with the appropriate patient. Patient selection is critical. So who actually qualifies for treatment under the current guidelines?

• Ischemic Cardiomyopathy including those with low EF or those that are medically compensated
• Patients who refuse invasive treatment
• The elderly, diabetics
• Unsuitable coronary anatomy such as small, diffuse and/or distal vessel disease
• Prior failed revascularization
• Ischemic valve dysfunction
• Stunned or hibernating myocardium with reduced wall motion
• Renal insufficiency
• Multiple co-morbid medical problems
• Moderate to severe angina who cannot tolerate medical therapy
• Silent ischemia and early positive stress test
• Severe anatomy
• Prinzmetal Angina or Micro-vascular angina
• Excessive nitrate use
• Exercise intolerant
• Patients whose quality of life is significantly impaired and become sedentary due to fear of inducing angina symptoms of chest pain, S.O.B., fatigue or palpitations.

What is the Actual Medicare Inclusion Criteria for ECP Therapy?

Patients with documented Coronary Artery Disease or Ischemia by non-invasive or invasive testing such as: angiography, stress, nuclear stress, ECG or Holter monitor. Patients need to be deemed to fit the Canadian Classification for Angina Classification of Class III or IV. These typically are interpreted as symptoms (chest pain, SOB, fatigue, palpitations) on physical functional activity such as walking up 1 flight of stairs or walking 2 blocks. Most physicians will say “that is everyone in my practice” but the difference is how these symptoms can be managed pharmacologically or through minimally invasive procedures such as PTCA. If the case is neither, then ECP can be a viable option. Medicare inclusion criteria is strict in that documentation must prove the patient was inoperable due to risk, or inadequate relief from medical therapies.

Recent trends in Coverage and ECP Reimbursement:

Contraindications: Absolute

• Abdominal Aortic Aneurysm (surgical size AAA ≥ 5cm)
• Active Deep Vein Thrombophlebitis on any limb subject to treatment
• Aortic Insufficiency (moderate to severe A.I. may exacerbate regurgitation)
• Peripheral Vascular Disease involving occlusion of the ileofemoral arteries

Contraindication: Relative and Precautionary subject to proper management

• Surgical intervention within 6 weeks prior to ECP
• Cardiac catheterization within 1-2 weeks prior to ECP
• Uncontrolled arrhythmias if they interfere with device triggering
• Atrial pacing if it interferes with device triggering
• Anti-coagulation therapy with INR>2.6
• Uncontrolled BP (Systolic ≥ 180, Diastolic ≥ 110)
• Heart Rates ≤35 or ≥125
• Severe pulmonary disease (safety data on severe pulmonary HTN unavailable)
• Local infection or Vasculitis of the extremities
• Burn, wound or fracture on any limb subject to treatment
• Pregnancy

Summary of The Benefits of Providing ECP Therapy:

ECP & EECP Therapy is a proven to be an effective treatment option for a medical facility. In addition to the clinical benefits, some of the other ancillary benefits include:

• Safe, Office Based Treatment
• More Patients Eligible with revised coverage description
• Sound Reimbursement – $5,000 per patient average in 2013
• Lower Device Costs – New and refurbished prices range from $20,000 – $50,000
• No Physician Time
• Low Cost, Non-Invasive in nature fits evolving demands of US Healthcare

For more details, visit “Is ECP Right for my Facility“