Perhaps because life expectancy levels in Hungary are lagging behind West European levels, there is a strong accentuation in Hungarian medical device manufacturing circles toward diagnostic instrumentation and especially to cardiovascular monitoring. Bearing in mind that the incidence of premature mortality (i.e., death before reaching the age of 65) as a result of cardiovascular disease is in Hungary three times the European Union average, an emphasis on cardiovascular monitoring is not surprising.

Innomed, Meditech and Tensiomed are three Budapest-based companies producing technologically advanced and cost-effective medical equipment. Innomed today heads Innomed-Medical, a Hungarian-American joint venture that develops, manufactures and markets ECG and X-ray devices. The company claims to have in excess of 60% of the private physicians' practice market in these sectors in Hungary.

Meditech's main focus is on ambulatory blood pressure monitoring. The EC-Go Holter system is a small, easy-to-use digital system that links to a PC via a wireless infra-red interface. The system stores up to 24 hours recording and the software performs an automatic scan for arrhythmia, ischemia and time-domain HRV analysis according to adjustable pre-set criteria.

Tensiomed has a 24-hour ambulatory blood pressure monitor, the TensioDay. Operating with TensioPhone, a digital BP monitor which features automatic telephone connection and the TensioCare Center, the company provides for continuous patient monitoring to decrease the risk of development of threatening cardiovascular situations.

CRP as a cost-effective predictor

An elevated C-reactive protein (CRP) level in patients admitted with unstable coronary artery disease has a predictive value for future ischemic heart disease. Screened patients with CRP levels in the upper 25 percentile are three times as likely to incur a heart attack as those with lower levels. Behavior modification is important with at-risk patients, since CRP levels have been shown to increase with conditions such as obesity, vitamin B6 deficiency or heavy smoking.

Hytest (Turku, Finland) has developed two monoclonal antibodies (C2 and C6) that are strongly specific for the CRP molecule and which can form a unique two-site combination for the development of fast and sensitive CRP assays, providing a novel method for detecting individuals at high risk of plaque rupture.

Nader Rifai, associate professor of pathology at Harvard Medical School (Boston, Massachusetts) has said that physicians should abandon conventional thinking that coronary artery disease is the sole consequence of a mechanical problem, the blockage in the blood flow caused by lipids and leading to an embolism. He cited recent research showing that even patients with a small blockage still have embolisms that result in heart attacks. This is caused, he said, by plaque build-up and ruptures that contain inflammatory cells, all associated with excessive levels of CRP.

CRP also is an acute phase protein widely used for the diagnosis and follow-up of infectious diseases. It is widely accepted that the diagnostic value of CRP is superior in this application to erythrocyte sedimentation rate and at least equal to a white cell blood count. Point-of-care (POC) CRP testing in physicians' consulting rooms was compared to laboratory diagnostic testing in a recent randomized crossover trial in Denmark, with POC testing proving to be cost-effective, not only in savings on avoidance of laboratory testing but also in earlier and more appropriate use of antibiotics and a significant decrease in follow-up consultations.

Avril Owen, principal biochemist at Gwynedd Hospital (Bangor, Wales), has made the point that routine troponin testing of all chest pain patients at time of admission has provided substantial overall savings from reduced length of hospital stays. She also notes that at the Gwynedd Hospital conventional cardiac enzyme testing for aspartate amino-transferase, lactate dehydragenase and hydroxybutyrate dehydrogenase has been dropped, since they are not cardio-specific, although the hospital uses the troponin T (cTnT) test from Roche Diagnostics (Mannheim, Germany). Owen says that both cTnT and cTnI (cardiac troponin I) measurements should now be considered as the "gold standard" biochemical tests for the diagnosis of myocardial damage.

European cath lab update

Cardinal Healthcare (Bristol, England) has put into operation its first modular and mobile cardiac angiography unit, which houses a full cardiac catheterization laboratory equipped with X-ray and imaging equipment, defibrillator and temporary pacing facilities. The articulated trailer unit is initially available in Britain and the Irish Republic.

Siemens Medical Solutions (Erlangen, Germany) has launched a new cath lab system combining angiography, fluoroscopy and radiography with advanced information technology and designed to make cardiology departments more efficient. Called Artis Fc, the system uses Siemens' common technology platform, syngo, to communicate with other modalities, including computed tomography, magnetic resonance imaging, ultrasound and the hospital information system. A built-in motion detector almost eliminates excess image noise and clinicians can set a minimum radiation dose for each test, with the system providing a graphical read out of accumulated dose as a percentage of the maximum allowable level.

The system is part of Siemens' Axion product line. "Artis represents a whole new direction for hospitals looking to transform the cath lab from a stand-alone facility into a more integral part of the cardiology department," said Klaus Hambuchen, president of Siemens' angiography systems division.

SCAP ligands may help lower cholesterol

In spite of high-profile problems with statins, such as the withdrawal of Bayer's (Leverkusen, Germany) cerivastatin (Baycol/Lipobay) last summer, the continuing success and wide usage of statin-based therapy indicates that the need will be to augment, rather than to replace, statins as the first line of defense against atherosclerosis.

The statin class of drugs already has made a big impact on lowering circulating levels of low-density lipoprotein (LDL), but statins do not work for everyone, and can occasionally give rise to serious side effects. So the discovery of a new class of hypolipidemic drugs, called SCAP ligands, as reported in December's Nature Medicine, is good news indeed.

Whereas statins work by directly inhibiting the rate-limiting enzyme in the cholesterol synthesis pathway, SCAP ligands seem to act indirectly, by increasing the level of expression of the cell-surface LDL receptor which removes cholesterol from the circulation. A University of Lille (Lille, France) research group has reported testing successfully the hypolipidemic potential of SCAP ligands in hamsters on a high fat diet, with one of the compounds reducing circulating LDL levels by about two-thirds, whereas levels of high-density lipoprotein (HDL) cholesterol (often called "good cholesterol") were unaffected.

SCAP ligands now take their place among a number of potential new therapies for lowering cholesterol, some of which are already in clinical trials.

7-day Holter recording

Reynolds Medical (Hertford, England) has bridged the gap between Holter and long-term-event recorders with the Lifescreen system. This consists of the LifeCard CF digital Holter recorder, its compact flash card and Lifescreen software to give seven days of continuous ECG monitoring.