Hypertension management is largely carried out in physicians' offices, while cardiac hypertrophy, which further increases the relative risk of stroke and heart attack, can only be diagnosed in the hospital or clinic using echocardiography or magnetic resonance imaging.
Matrix Therapeutics (Nottingham, United Kingdom) has started clinical assessment of a new blood test called DO2 which can provide a simple new method of diagnosing cardiac hypertrophy in patients with hypertension and can also predict whether a hypertensive patient is at risk of developing an enlarged heart. The test measures levels of a gene product that is normally produced during the neonatal period, but is suppressed in adult life and appears to be produced again in cardiac hypertrophy.
Ian Rubin, CEO at Matrix, said, "The use of this particular gene product to indicate cardiac hypertrophy in combination with hypertension hasn't been described before, and we've already filed patents, which have yet to be published, relating to that use." The company aims to take the DO2 blood test product through the proof-of-concept stage and will then look for a corporate partner for further development.
Proteome Sciences (Cobham, United Kingdom) also is developing a blood test for stroke and other disorders, based on changes in protein expression. The company has raised $9 million to finance the project.
Biosite Diagnostics (San Diego, California) has its Triage BNP heart failure diagnostic test under investigational use in Germany, Italy, and Norway. The test already has been launched in Belgium, the Netherlands, Switzerland, and the United Kingdom.
Although the Triage BNP test, which measures B-type natriuretic peptide in whole blood or plasma, has been initially rejected by an FDA advisory panel, Biosite says, "At this time, we do not expect the FDA panel decision to have any impact on European sales."
Biosite is gathering additional clinical data and hopes to file an amended PMA by late summer. "Timing of the resubmission will largely be driven by the time it takes to gather the additional data. At this time, we estimate that the process could take three to six months – we are confident that we will file our amendment by year-end, but with favorable timing, we could submit as early as late summer," the company said.
Quantitative coronary analysis software
Pie Medical Equipment (Maastricht, the Netherlands) has updated its CAAS11 quantitative coronary analysis software package, QCA 6v2, to provide tools to study geographical miss and to produce a range of brachytherapy parameters.
Interventional cardiologists say that brachytherapy is a breakthrough in invasive cardiology and that it will play an important role in the treatment of patients with coronary restenosis. To carry out the associated radiation procedure successfully, the avoidance of a geographic mismatch between the dilated injured segment and the irradiated area is clearly important.
This updated package has been used in the clinical validation of stent implantation in coronary vessels. QCA6v2 is intended for use in off-line analysis from 35mm files and DICOM CD-Rom, as well as for on-line analysis from angiographic X-ray imaging systems.
Cardiovascular blood volume monitoring
The anesthesiology team in the operating theater normally takes care of the patient's ventilation and endeavors to maintain a normal circulation function in addition to administering anesthetics. Ventilation control is well developed and subject to continuous monitoring. In comparison, the monitoring of circulation is less effective, since conventional methods for measuring heart rate, blood pressure and central venous pressure are relatively insensitive to even considerable loss of blood.
Danmeter (Odense, Denmark) has developed the C-Guard noninvasive blood volume monitor to provide continuous monitoring of central blood volume (CB) during and after surgery. Clinical studies in adults and children have shown that transthoracic electrical impedance measurements can detect changes in CB as small as 250 ml. Based on the system's measurements, blood loss can be compensated for by the infusion of blood or plasma/NaCl. Using a noninvasive measuring technique, an index of changes in blood volume is produced every 15 seconds.
First implants for Integrity pacemakers
European surgeons have performed the first human implants of St. Jude Medical's (St. Paul, Minnesota) dual-chamber rate responsive Integrity AFx pacemaker system. The device combines the Dynamic Atrial Overdrive algorithm for suppressing atrial fibrillation with its Beat-by-Beat AutoCapture pacing system. European launch of the Integrity AFx system will be at the Cardiostim congress in Nice, France, this month.
Separately, St Jude Medical has reported completion of CE marking on the Photon DR dual-chamber implantable defibrillator, which combines bradycardia capabilities with advanced and effective tachycardia therapy.
Beating heart bypass system gets CE Mark
Heartport's (Redwood City, California) PrecisionOP beating heart bypass system has received the CE mark. The system includes a disposable StillSite stabilizer for the stabilization of target arteries.
Separately, Intuitive Surgical (Mountain View, California) is negotiating a deal with Heartport on patents relating to using a robotic device inside the body. Intuitive is collaborating with a number of European surgical centers on developing endoscopic, computer-assisted cardiac procedures. Its daVinci surgical system, which was recently used in a mitral valve repair procedure at the Deutches Herzzentrum (Berlin, Germany), is in clinical trials in the U.S.
Effectiveness in renal stenosis
A recent Dutch study showed no significant difference in blood pressure at 12-month follow-up on patients receiving renal angioplasty or antihypertensive drug therapy.
Brigit van Jaarsveld from the Erasmus University Hospital (Rotterdam, the Netherlands) and colleagues from other Dutch cardiology clinics, randomly assigned patients with high blood pressure and renal artery stenosis to either angioplasty or continued drug therapy. At three months and 12 months, there was no significant difference in blood pressure between the groups.
Eberhard Ritz of Ruperto Carola University (Heidelberg, Germany) and Johannes Mann of Schwabing Hospital (Munich), commenting on the study results, said they felt that a 12-month follow-up was not long enough. In addition, since the time of the study (between 1993 and 1998), there has been an increased use of newer techniques such as stenting, they said.
Axis-Shield, AstraZeneca collaboration
Axis-Shield (Dundee, Scotland) is to provide its Activated Factor X11 (AFT) test kits to AstraZeneca (London) for use in the latter's trial program for lipid-lowering superstatin ZD4522. Some statins already have been shown to reduce high levels of AFT, a known risk factor in cardiovascular disease.
Axis-Shield hopes that use of the AFT kits in the ZD4522 trials will help show that prescribing statins could be based on patient levels of AFT, and that AFT may prove to be a more reliable indicator of cardiovascular disease than total cholesterol measurements.
Cocaine, alcohol induce cardiac insufficiency
A study by Dr Ragoucy-Sengler on patients in Point- -Pitre, Guadaloupe (West Indies), with samples analyzed at the Forensic Institute (Strasbourg, France) confirmed the presence of cocaethylene, a transesterification product of cocaine in the presence of alcohol, in blood, urine, saliva, and hair of up to 47% of addicted patients hospitalized at the Centre Hospitalier Universitaire in Point- -Pitre. Cardiac function was adversely effected only in patients chronically using cocaine and alcohol. The author estimated an increasing risk 18 to 25 times greater of sudden cardiac death where both products are involved.