CAFE and Strong Heart Studies Highlights Importance of SphygmoCor Central Blood Pressure Monitoring

Noninvasive system detects drug effects that brachial measurements miss.

Two major clinical trials--CAFE and The Strong Heart Study—highlight the importance of measuring central blood pressures in individual patients and study populations.

“This is news,” said Dr. Raymond Townsend, Professor of Medicine and Director of The Hypertension Program, Hospital of the University of Pennsylvania, in an interview with The Saturday Evening Post. “ Most people who practice medicine—nurse or nurse practitioner, physician assistant or doctor—do not understand the relationship of blood pressure in the arm to the heart. They think blood pressure is the same throughout the body. And it isn’t”

CAFE (Conduit Artery Function Evaluation) [Link to Abstract] is the largest study undertaken to evaluate the effects of cardiovascular drugs on noninvasively monitored central blood pressure. “The results of this study are clear-cut, dramatic and potentially important, “said Brian Williams MD, Professor of Medicine, Department of Cardiovascular Studies at the University of Leicester, United Kingdom. Dr. Williams was the principal investigator of the Conduit Artery Function Evaluation (CAFE) study in ASCOT. “This study demonstrates for the first time in a large clinical outcomes trial that blood pressure-lowering drugs have a profoundly different effect on central aortic pressures and hemodynamics, despite a similar impact on brachial blood pressure,” Dr. Williams stated.

In the study, researchers used the SphygmoCor noninvasive central blood pressure monitoring system to monitor central aortic pressures noninvasively in a group of 2,073 patients. The SphygmoCor system allowed researchers to monitor central blood pressure noninvsively, by recording the radial pressure waveform and deriving the pressure
waveform in the ascending aorta. The ascending aorta pressure more clearly reflects the pressure experienced by the vital organs, such as the heart, brain and kidney, than does brachial pressure.

The SphygmoCor system uses a pressure sensor the size of a ballpoint pen pressed against the patient’s wrist to capture the arterial pressure wave in the radial artery, and then derives the aortic pressure wave, using a validated transfer function. To receive FDA marketing clearance, SphygmoCor was required to prove functional equivalence to an intra-arterial monitoring catheter—it has since been used in over 180 published clinical trials..

The SphygmoCor® system records the radial waveform and derives the waveform at the ascending aorta

Commenting on the study results, John Cockroft MD, Professor of Cardiology at the Wales Heart Research Institute in Cardiff, United Kingdom, said, “CAFE should also stimulate measurement of central blood pressure in further large intervention studies, and perhaps in the future it will be central blood pressure reduction that counts.”

The Strong Heart Study—Central Pressure a Better Predictor of Cardiovascular Events

The Strong Heart Study, [Link to Abstract] a population-based, longitudinal study of 3,520 American Indians monitored brachial blood pressure and central blood pressure, find that central pressure, determined using the SphygmoCor system was a better e predictor of cardiovascular events than brachial pressure, “In conclusion noninvasively –determined central pulse pressure is more strongly related to vascular hypertrophy, extent of atherosclerosis, and cardiovascular events than is brachial blood pressure,” the investigators stated.

Assessing and managing cardiovascular risk in drug development—and beyond

Joe Alexander MD PhD, Director of Global Clinical Technology for Pfizer, believes that noninvasive central pressure monitoring could play an important role at virtually every stage of drug development. “Central pressures monitoring could give you important information in choosing between competing compounds, identifying groups of patient responders and non-responders, even help in “rescuing” therapeutically valuable drugs whose development had been halted because of cardiovascular side-effects,” Dr, Alexander said in an interview published in AAPS Today.. “After a drug is in the marketplace, central pressure monitoring could also play a role in optimizing therapy and outcomes,” Dr. Alexander added.

Cardiovascular risk reduction for ex-NFL players—and aging Baby Boomers

Noninvasive central pressure monitoring, used in diagnosis, risk stratification and drug therapy management, is making a difference in clinical practice, as well as in research. Into clinical practice, used in diagnosis, risk stratification and drug therapy management. The SphygmoCor system is being used in 10 of the 14 hospitals on the US News & World Report “Best Hospitals” Honor Roll, in leading physician practices around the world, and in executive health and cardiovascular risk management programs, including that offered for ex-NFL players by The Living Heart Foundation.

The most important benefit: SphygmoCor allows clinicians and researchers to noninvasively measure the pressures that are actually affecting the brain, heart and kidneys, a vitally important innovation. “People die from conditions that affect the aorta and its branches, like the coronary and the carotid,” Dr. Townsend pointed out. ” Not from the arteries that course just above your hand.”

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