Endo Pat 2000

The medical community has long sought a cost-effective, reliable, non-invasive method to improve the detection of endothelial dysfunction, in order to screen larger segments of the population safely and reliably, and to enhance follow-up for sufferers of cardiac disease. Itamar Medical’s Endo-PAT2000 is meeting this challenge, and is ideally suited to enhance the traditional clinical settings’ diagnostic capabilities. The Endo-PAT2000 can be used in any setting, from hospital bedside to outpatient clinic.

Endo-PAT2000 is the leading medical device for noninvasive endothelial function assessment. It is FDA-cleared, CE-marked and used in preeminent clinical institutions, research centers and Pharmaceutical clinical phase studies in over 40 countries. It is incorporated into numerous multi-center and population-based studies such as the Framingham Heart Study. Research using Endo-PAT has yielded more than 100 articles in peer-reviewed journals and abstracts. It is becoming widely recognized as the standard method for endothelial function assessment. Some of the features that make Endo-PAT appealing are its ease of use, user-independence and immediate, automatically calculated test results. It provides clinicians with a reliable and reproducible index of endothelial function in a 15-minute, office-based test.

In recent years investigators have observed that the onset of erectile dysfunction is often followed a few years later by the onset of cardiovascular events¹. The evidence is pointing towards endothelial dysfunction as the clinical connection between these two afflictions. This is hardly surprising, as endothelial dysfunction is a systemic disease, afflicting multiple target organs. Endothelial dysfunction is increasingly recognized as the root cause of atherosclerotic plaque formation. Its clinical manifestations are coronary artery disease, erectile dysfunction, stroke and other cardiovascular diseases.

The clinical implications of endothelial dysfunction are so grave that in 2003 investigators from the Mayo Clinic stated that “endothelial dysfunction may be regarded as the ultimate risk of the risk factors” ².

The impact of these new findings on patient management is immense: from viewing erectile dysfunction as a harbinger of future cardiovascular events³, to prevention of erectile dysfunction itself.

Erectile dysfunction and cardiovascular disease – size matters!

The degenerative remodeling of the vascular walls is a silently progressive process called subclinical atherosclerosis. It develops over years, even decades. Usually, smaller vessels, such as in the penile vasculature, become occluded more quickly than larger vascular beds, such as the coronaries. This means that, generally, erectile dysfunction will have an earlier clinical presentation than in the larger coronaries.

Lately urologists are beginning to equate endothelial dysfunction with erectile dysfunction⁴. In 2006 the European Urology Association pointed to office-based endothelial function tests as useful in stratifying cardiovascular disease risk in patients who present with erectile dysfunction.

The obvious goal is to detect cardiovascular disease progression while it is still in its subclinical stages. As endothelial dysfunction is the earliest clinically detectable stage of cardiovascular diseases, it is a prime candidate for this purpose. What makes endothelial dysfunction even more appealing is that it is treatable, and unlike the plaque, even reversible.

This means that monitoring endothelial function provides clinicians with both better management of erectile dysfunction, as well as better control of cardiovascular disease risk.

References:

• 1. IM Thompson et al.; “Erectile Dysfunction and Subsequent Cardiovascular Disease” JAMA2005; 294:2996-3002
• 2. PO Bonetti et al.: “Endothelial Dysfunction A Marker of Atherosclerotic Risk” Arteriosclerosis, Thrombosis, and Vascular Biology. 2003;23:168
• 3. RA. Kloner; “Erectile Dysfunction: The New Harbinger for Major Adverse Cardiac Events in the Diabetic Patient” J Am Coll Cardiol 2008 51: 2051-2052
• 4. A Muller, JP Mulhall; “Cardiovascular disease, metabolic syndrome and erectile dysfunction” Current Opinion in Urology; November 2006;16(6):435-443

Further reading:

The connection between erectile dysfunction and endothelial dysfunction:

• Tamler R, Bar-Chama N. “Assessment of endothelial function in the patient with erectile dysfunction: an opportunity for the urologist” International Journal of Impotence Research,2008 ,1-8
• H Solomon et al.; “Erectile dysfunction and the cardiovascular patient: endothelial dysfunction is the common denominator.” Heart 2003; 89; 251-253

The connection between endothelial dysfunction and cardiovascular disease:

• Celermajer, David S. “Reliable Endothelial Function Testing: At Our Fingertips?” Circulation 2008; 117(19): 2428-2430
• JE Deanfield et al.; “Endothelial Function and Dysfunction: Testing and Clinical Relevance” Circulation 2007; 115;1285-1295

The timeline of progression between erectile dysfunction and cardiovascular disease:

• IM Thompson et al.; “Erectile Dysfunction and Subsequent Cardiovascular Disease” JAMA2005; 294:2996-3002

Endothelial Dysfunction is the result of the cumulative damage to the endothelium by cardiovascular disease risk factors such as genetics, smoking, Diabetes, high blood pressure and others. These risk factors cause the endothelium to malfunction: it secretes less of the protective molecules, such as Nitric-Oxide, and secretes substances which promote atherosclerotic plaque formation. Leading doctors at the Mayo Clinic proclaimed in a 2003 paper that “endothelial dysfunction may be regarded as the ‘ultimate risk of the (cardiovascular) risk factors.’” It was identified as the missing link between cardiovascular risk factors and subclinical atherosclerosis. Endothelial dysfunction is now widely recognized in the medical community as the earliest clinically-detectable indication of heart disease.  Unlike subclinical atherosclerosis , endothelial dysfunction, with proper treatment, is reversible.

How is endothelial dysfunction diagnosed?

Until recently, experts used various methods to assess endothelial function. These methods are categorized as either:

Invasive – which is painful and with a certain amount of risk; or

Noninvasive – which is user-dependent, meaning test results are prone to high variability between users, limiting its use to expert research sites.

To diagnose something as serious as endothelial dysfunction, a method is needed that can function with consistent accuracy, independently of the user. The Endo-Pat2000  provides this combination of noninvasive, ease-of-use, independent of the user, while providing reliability. It has been scientifically validated in close to a hundred publications from clinical studies in top research centers (e.g., Framingham Heart Study, Harvard, Mayo Clinic and hundreds of others) around the world and is the method used to assess endothelial function in leading centers.

In order to avoid confusion, please note that there are several noninvasive methodologies to assess cardiovascular disease risk. But all of them target subclinical atherosclerosis, which is when vascular health has already been compromised to a certain extent. This degeneration of the vasculature is irreversible. While endothelial dysfunction plays a key role throughout these phases of the atherosclerotic disease, it is not what these tests of cardiovascular risk measure.

The “normal” or healthy endothelium is involved in regulating homeostasis by secreting substances which protect vascular health. Chief among these substances is Nitric-Oxide – a two atom molecule, which is considered to be the hallmark of normal endothelial function. Together with several other substances, Nitric Oxide is involved in locally regulating processes such as

• Vascular tone
• Inflammation
• Coagulation
• Oxidation

If these processes are not strictly regulated, they can lead to impairment of vascular health, leading the way to subclinical atherosclerosis, all the way to cardiovascular disease.

The Endo-PAT2000 is a compact, easy to use device that adds an important dimension to cardiovascular medicine by enabling physicians to reliably, easily and non-invasively measure endothelial function.

The Endo-PAT2000 is FDA approved, and  has been extensively studied, with over 100,000 tests performed, and 70 peer reviewed publications.  It is now available for clinical use by general practitioners, cardiologists, urologists, and other MDs.