CDU

Recent guidance from the UK's National Institute for Clinical Excellence (NICE; London) may result in an increase of 300% in the present defibrillator implantation rate of 17 per million. In its report, NICE recommended that the National Health Service (NHS) should routinely consider using implantable cardioverter defibrillators (ICDs) to treat arrythmia in patients with specified types of cardiac disease.

The cost to the NHS of implanting 1,800 ICDs each year in England and Wales would be almost $70 million on a basis of $38,000 per procedure. In Western Europe, there were an average of 30 implants per million population last year, with Germany having the highest rate at 69 per million.

In the UK, cardiovascular disease is the leading cause of death, with around 300,000 fatalities each year, of which 25% to 30% are defined as sudden cardiac death (SCD), which ICD implantation aims to avert. The NICE guidance specifically recommends that ICDs routinely be considered in secondary and primary prevention, categorized according to risk factors associated with SCD. Risk factors include a previous SCD episode, previous ventricular tachycardia (VT) or previous myocardial infarct, coronary artery disease, family history of SCD and familial cardiac conditions, low left ventricular ejection fraction and heart failure. NICE, however, has excluded from its initial recommendations patients presenting with syncope of unknown causes, with hemodynamically significant sustained VT or ventricular fibrillation induced at electrophysiological testing and in the presence of impaired cardiac function. The institute considers that presently there is insufficient evidence to recommend implantation in these cases, although these guidelines will become due for review in September 2003.

Donor heart shortages fuel LVAD interest

Currently, only 500 donor hearts are available each year in Germany in spite of efforts from hospital and physician organizations to encourage donation. "Although it is important to create awareness, advertising [of the need for organ donors] brings with it serious ethical considerations," said Dr. Robert Schafer of the NordRhein Westphalia physicians association (AKNo), referring to advertising for organ donation. He foresees little change in the availability of donor hearts in the next two or three years.

German cardiologists are being forced to consider implantation of left ventricular-assist devices (LVADs) more frequently and on a more permanent basis. At present, these pulsatile pumps are only being used on a short-term basis as a bridge while patients wait for donor organs. With so few donor hearts available, it is inevitable that a large number of patients die during the waiting process. Bernard Egger of Germany's largest Krankenkasse (statutory health insurance) group, AOK, said the greatest problem in the use of an artificial heart is the cost, which could be in the region of $80,000, highlighting the problem of reimbursement.

New miniaturized implantable LVADs like the DeBakey device from MicroMed (Houston, Texas) and the Jarvik 2000 from Jarvik Heart (New York) have been implanted so far in close to 50 patients in Europe, with considerable success. In view of their simplicity of design using an axial flow pump, and their small size, these pumps should be priced more accessibly. Michael DeBakey, developer of the MicroMed device, said, "It ought to be a lot cheaper to manufacture and therefore be much more accessible." He estimated a price around one-third of current levels.

MicroMed already has filed for CE-marking for the DeBakey device and hopes to commence marketing shortly in Europe, according to Dallas Anderson, the company's president.

UK to get more fast-track chest pain clinics

The UK Department of Health has announced the opening by April 2001 of another 84 rapid-access chest pain clinics at a cost of $22 million. The existing 55 clinics have been refurbished and upgraded, giving a total by next spring of 139 in England and Wales. This is a substantial increase on the original target of 50 clinics announced in March.

These new centers are intended to speed early diagnosis of non-emergency heart disease symptoms. The target is for 60% to 70% of patients to be given an immediate initial diagnosis and to receive priority status, if appropriate. The government has allocated $180 million for additional expenditure over two years to March 2002 for expansion of cardiology services generally.

Lp-PLA2 assay a cardiac risk predictor

Chris Packard and his team at the University of Glasgow (Glasgow, Scotland) have measured Lp-PLA2 (lipoprotein-associated phospholipase A2) enzyme in blood levels in 580 men who had suffered an adverse coronary event and in 1,160 controls. They found that men with the highest Lp-PLA2 enzyme level were nearly twice as likely to have a heart attack as those with the lowest levels. In addition, they found that elevated Lp-PLA2 levels and cardiac events were apparently independent of other known risk factors.

"Not everyone who suffers a heart attack is found to have an above-normal cholesterol level," Packard said. "So it is important that we examine other potential factors like Lp-PLA2."

Packard used an Lp-PLA2 assay developed by diaDexus (Santa Clara, California). Patrick Plewman, president and CEO at diaDexus, said the company plans to commercialize the assay initially as a research diagnostic kit. "Ultimately we will seek to develop an FDA-approved (or equivalent European regulatory authority) diagnostic test," he said.

German stent clinicals with paclitaxel begin

A Phase I clinical trial of the NIR coronary stent coated with the antiproliferative agent paclitaxel has started at two sites in Germany. The 60-patient, randomized study is determined at this stage solely to establish the safety of the device. Patients will be monitored at 30 days and at six months, using intravascular ultrasound and angiography to assess any major adverse cardiac events.

Boston Scientific (Natick, Massachusetts) said that, based on its own data and the preliminary data being reported in other trials, it is "cautiously optimistic" about the use of its paclitaxel-coated stent. The use of paclitaxel has the potential to significantly reduce the level of restenosis, the company says.

Sonus dropping EchoGen imaging agent

Sonus Pharmaceuticals (Bothell, Washington), which has ceased clinical development work aimed at gaining FDA clearance for the EchoGen ultrasound contrast imaging agent, is expected to decide against launching in Europe, even though EchoGen has been CE-marked since 1998. Guerbet (Aulnay-sous-Bois, France) has chosen not to exercise an option to license the echocardiography imaging product exclusively in Europe.

Sonus terminated its licensing agreement with Daiichi (Tokyo) in 1998, claiming slow progress in clinical trials for Japan, while Abbott (Abbott Park, Illinois), which had marketing exclusivity for the U.S. dating from 1996, terminated the agreement in April.

SynerGraft heart valve CE-marked

CryoLife (Kennesaw, Georgia) has obtained CE-marking for its tissue-engineered SynerGraft heart valve, which is, according to the company, the only valve that has the potential to repopulate itself with the patient's own cells.

The Synergraft valve provides a collagen matrix that can be colonized by the recipient's own cells and has the normal function of a human heart valve. Developed from the basis of a porcine heart valve that has been depopulated of its own porcine cells, the Synergraft does not use the glutaraldehyde fixative which is a standard with most biological valves and which has been reported as causing calcification in some patients.