Today in Western Europe, close to 90% of physicians in primary care locations are using electronic medical records, and hospitals are increasingly adopting digital storage systems for diagnostic data. As a result, over the past 10 years we have seen PC-based ECG systems taking an annually increasing market share from conventional ECG. Additionally, PC-based ECG solutions have been adapting to an increasing need for new technology.

Cardio Control (Delft, the Netherlands) expects to launch this year in Europe its CardioControl workstation, a 32-bit Windows package based on Microsoft SQL server 7 technology. The software will operate under Windows 95, 98, NT4 and 2000. The database is connected with applications for rest ECG, stress ECG, spirometry and ambulatory blood pressure. For hospital applications, the workstation has interfaces for hospital information systems (HIS) and electronic medical records (EMR) based on HL7, ActiveX and other systems. It also has integrated facilities for secure transmission of data from outpatient clinics, primary care physicians and emergency health care locations.

H&C Medical Devices (Milan, Italy) clearly had in mind this rapid changeover from analog to digital communication and file systems. With H&C's latest addition to the Cardiette series of electrocardiographs, the Microtel, it is possible to integrate analogic and digital components in the same system. The Microtel ECG is also classified suitable for use in telemedicine networks. Terminals are electrocardiographs designed for fixed or mobile stations, including emergency and home care units.

The VisioCor 12-lead ECG event recorder from Mediag (Jonquieres, France) has been updated to add the capability to record and transmit the ECG by GSM or modem. Recording improvements that offer the possibility of entering telephone numbers, patient ID and recording protocol make possible a fully automatic transmission.

The new Aria paper-sized Holter monitor from Del Mar Medical (Irvine, California) is available in Europe as a Holter recorder that can acquire 24 hours of uncompressed data. Del Mar's new Impresario software program can accommodate recordings from a wide range of Holter devices. It is available either as a complete standalone Holter analysis system or to integrate with a customer-provided PC platform.

Medtronic (Minneapolis, Minnesota) has launched on the European market the Reveal Plus Insertable Loop Recorder (ILR), a second-generation successor to the Reveal recorder, launched in 1998 and implanted in more than 5,000 patients worldwide. The ILR is inserted under the skin of the upper chest using local anesthesia and can be programmed to capture automatically the ECG when a heart rhythm problem arises. The information is stored on a 42-minute "loop" and can be noninvasively retrieved by the physician.

"Capturing an ECG during a spontaneous symptomatic event is widely considered the gold standard in diagnosis, yet in patients with infrequent symptoms such as fainting, this can be extremely difficult to do," said Hans Hartog, cardiologist at the Diakonessenhuis hospital (Utrecht, the Netherlands). "With up to 14 months of continuous ECG monitoring and new auto-activation capabilities, the Reveal Plus recorder helps me solve some of the most perplexing diagnostic problems."

Carmeda heparin coating on Cordis stent

The Bx Velocity Hepacoat stent from Cordis (Miami Lakes, Florida) uses a proprietary heparin coating, the Carmeda BioActive Surface (CBAS) developed by Carmeda of Sweden. The CBAS coating retains thromboresistant properties for several months when implanted into blood vessels and remains on the surface of the stent, enhancing the hemocompatibility of the device.

Patrick Serruys of the Thorax Centre at Erasmus University (Rotterdam, the Netherlands), who was chief investigator in the Benestent II clinical study, said the use of the Carmeda heparin-coated stents in major randomized clinical trials "strongly suggests a lower rate of thrombosis than might have been anticipated with an uncoated stent in these clinical situations."

No advantage for angioplasty over drugs

A recent randomized, 106-patient trial at 26 medical centers in the Netherlands found that angioplasty showed little advantage over antihypertensive drugs in the treatment of patients with hypertension and renal-artery stenosis. While percutaneous transluminal balloon angioplasty lowered blood pressure in some patients, only a few obtained pressure reductions to normal.

After 12 months, the Dutch researchers found that blood pressure was no higher in the drug therapy group as a whole than it was in the group that had angioplasty. In other words, both groups experienced similar blood pressure decreases.

The researchers propose that angioplasty be limited to those patients whose hypertension persists in spite of treatment with three or more drugs or to those who show symptoms of progressive occlusive renovascular disease.

Plaque temperature an AMI indicator

A research group led by Christodoulos Stefanadis of the Hippokration Hospital (Athens, Greece) found that measurement of the temperature of coronary plaque in patients with unstable angina or acute myocardial infarction (AMI) could help to identify those patients more at risk of an adverse cardiac event later on.

Using a thermography catheter, they measured the temperature of atherosclerotic lesion in 86 patients suffering from effort angina, unstable angina or AMI and treated by balloon angioplasty. They found that the temperature measurements were higher in those patients with unstable angina or AMI and that, with an average 1.5 year follow-up, 21 patients of that group had suffered a cardiac event – cardiac death, AMI or recurrent angina.

The researchers concluded that an increase in temperature of a target lesion is a strong independent predictor of future adverse cardiac events and could be an indicator for identifying patients where therapeutic strategies are needed to stabilize plaque.

Digital X-ray gives better image detail

The digital technology of the Innova 2000 X-ray system from GE Medical (Buc, France) is said by the company to make possible viewing of hard-to-see blood vessels as well as devices like stents, guidewires and catheters used during procedures.

Dr. Marie-Claude Morice, co-director of the Cardiovascular Institute (Paris) and interventional cardiologist at the Jacques Cartier Hospital (Massy, France), where the first Innova 2000 operational unit was installed, said the system "enables faster procedures, requires significantly less radiation exposure and gives us the ability to see details better."

Commenting on the further potential of digital technology and of the use of the company's Revolution flat panel digital detector, Thierry Lefevre, head of the interventional cardiology department at the Jacques Cartier Hospital, considers that since the image is entirely digital, the development of complex computer processes such as a 3-D reconstruction of the coronary artery or measurement of flow magnitude using color should become possible.

Conversion of X-ray signals into digital images at the point of acquisition means the detector captures data with minimal loss over a wide range of typical exposures. In addition, it reduces the artifacts and distortions associated with conventional image intensifier chains. Since the system is fully compliant with DICOM, it can be integrated with any DICOM image information network, including cardiology and hospital information networks.

Bayer funds platelet function theranostic assay

Bayer Diagnostics (Munich, Germany, and Tarrytown, New York) is to continue funding development by PharmaNetics (Raleigh, North Carolina) of a whole blood in vitro theranostic test for platelet function, based on its own paramagnetic iron oxide particles (PIOP) technology combined with coated bead technology licensed from Somagen (Troy, Michigan).

The new test is being developed to monitor patient response to platelet inhibitors like eptifibatide (COR Therapeutics' Integrilin) and abciximab (Centocor's ReoPro). Bayer intends to add the test to its Rapidpoint Coag platform, so that clinicians can monitor platelet inhibitor effect at the same time as other anticoagulants on a single POC instrument.

PharmaNetics estimates that 2.5 million people in the U.S. each year will be candidates for intravenous antiplatelet therapy. Fran Tuttle, general manager of near-patient testing at Bayer Diagnostics, said monitoring of platelet inhibitors will be "an essential component to maximizing their safety and efficacy."

MBO at AngioDynamics Irish unit

The management team at the AngioDynamics' (Queensbury, New York) subsidiary in County Wexford, Ireland, led by Andrew Jones, managing director, has acquired the company from its U.S. parent for an undisclosed sum.

Jones plans to broaden the company's line of cardiology products and to provide contract production facilities. He forecast sales of $4.5 million this year, rising to more than $15 million in the next five years.

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