Cardiologists in the UK are fighting an effort by the government to block coverage of drug-eluting stents (DES) in the wake of safety concerns reported over the past year. Those safety concerns already have led to more cautious use of the devices around the world.

Now, the British agency with the lead role in deciding what the country's health system pays for wants to stop reimbursements for the devices.

Aug. 28 was the deadline for public comment on the recommendation, being made by the National Institute for Health and Clinical Excellence (NICE).

Britain's health advisory body said that comments from doctors and the public could still influence its ultimate guidance.

"There is always the possibility that the recommendations could change," said spokeswoman Lucy Betterton. "We respond to reasoned arguments and will be looking to the feedback we've had on the draft recommendations."

If the proposed cuts are adopted, patients would either get a bare-metal stent (BMS) or have to pay for DES implantations out of pocket. The DES devices typically cost about $2,300, compared to about $700 for the bare-metal versions. This is seen as leading some patients to avoid angioplasty and choose surgery or medication.

Gabriel Steg, MD, a cardiologist at Bichat Hospital (Paris) and spokesman for the European Society of Cardiology (Sophia Antipolis, France), said, "Withdrawing drug-eluting stents altogether is probably not a good idea," he said, adding that the tiny mesh tubes can still be a good choice for certain patients.

Steg said that the health agency's plan would send the wrong message to patients who already are DES-implanted.

The British Cardiovascular Society said that it was "surprised, disappointed and very concerned" by the proposal. The British Cardiovascular Intervention Society called the advice "fundamentally flawed." Without the use of DES devices, the society said, some patients would be forced to live with untreatable chest pain.

UK consultation eyes future of stroke services in England

UK Health Secretary Alan Johnson reported recently that the UK government has launched a consultation into the future of stroke services, saying the challenge is to modernize those services at every stage and drive down death and disability caused by strokes.

As in the U.S. stroke is the third-biggest killer in England, and the Department of Health said that, despite more money being spent on stroke care in recent years, care for stroke patients is still lagging behind the other two major killers — heart disease and cancer.

The consultation on stroke services published by Heart and Stroke Director Professor Roger Boyle will look at how the National Health Service can bring the standard of stroke care into line with that of heart disease and cancer. The consultation will shape the final "Stroke Strategy," which will be rolled out later this year.

Johnson said that stroke mortality is falling, with the death rate for those under 65, down by 23% since 1993, but that more needs to be done.

UK heart units adhering to a new model of performance

Heart care units in the UK have signed up for what healthcare officials are calling "the most rigorous and transparent regime" ever for testing their performance. And their performance, in terms of survival rates, is within the range expected.

Last year, heart surgeons belonging to the Society of Cardiothoracic Surgeons of Great Britain and Ireland joined forces with the UK healthcare watchdog, the Healthcare Commission, to make survival rates from cardiac surgery available through a public web site. The surgeons and commission say that in the past 12 months the site has become "increasingly well-regarded," receiving thousands of visitors each month and allowing patients to make "more informed decisions about their treatment."

Survival rates for heart surgery in the 2005-2006 period have been collated and the site updated. Some of the data has also been adjusted according to a new UK model for calculating expected survival rates.

Last year, the EuroScore model was used.

This is an internationally recognized system that calculates expected survival rates for heart surgery, taking into account factors such as a patient's age and the severity of his or her illness in a process known as risk adjustment.

This tempered concerns some had expressed that simply publishing crude rates of survival or death without any such adjustments would deter surgeons from operating on patients that are higher risk — the very people who are most in need of the best surgeons. There have been suggestions, however, that EuroScore is becoming outdated, given recent improvements in technology and surgical and anesthetic techniques, and that this leads to the majority of hospitals achieving "better than expected" survival rates.

Heart surgery units in the UK agreed to put some of this year's figures through a new, "tougher" model for the website's annual update. This allows patients to see how the units have performed against recent standards in the UK as well as giving an indication of their performance against accepted European standards. Survival rates for the two most common heart operations — heart bypass and aortic valve replacement — were calculated using the new model. Every heart unit had satisfactory survival rates.

Nationally, the survival rate for heart bypass operations remains "better than expected." Between April 2005 and March 2006 there were 20,773 such operations in England and Wales — 98.4% of patients survived, above the expected range of 97.74% to 98.32%. And a survival rate of 98.03% for the 3,504 patients undergoing aortic valve operations was comfortably within the expected range of 96.63% to 98.20%.

Chinese regulators reject five St. Jude Medical pacemakers

China has returned five pacemakers imported from the U.S. in April after quality tests found problems the country's quality regulator said could be "major" health hazards. An August Bloomberg News report, said that labels on the pacemakers, made by St. Jude Medical (St. Paul, Minnesota), did not accurately reflect the devices' voltage settings. That information was attributed to a statement posted on the General Administration of Quality Supervision, Inspection and Quarantine web site.

The agency examined, in all, 272 St. Jude pacemakers. The products were tested by quality inspectors in Shanghai in April and five were returned "recently," according to the statement.

St. Jude acknowledged mislabeling on five devices but said that the mislabeling did not affect product performance or patient safety.

"St. Jude respects China's efforts to ensure standards of quality for medical devices. We are equally committed to these high standards for all of our products around the world," spokeswoman Kathleen Janasz told the news service.

The Xinhua News Agency reported last month that China's Food and Drug Administration launched an investigation in 2001 into four types of pacemakers produced by St. Jude because of reliability issues, resulting in imports of the pacemakers being banned. It didn't say whether the banned pacemakers were the same type as those returned to St. Jude recently.

Two more sites join up for CardioFit trial

BioControl Medical (Yehud, Israel) reported that cardiologists and surgeons at University Hospital Mannheim in Germany and Ospedali Riuniti di Bergamo in Italy have implanted the company's CardioFit device in the first patients to be enrolled at those sites in BioControl's international, multi-center clinical study of the CardioFit system for the treatment of advanced congestive heart failure.

The CardioFit system works by applying electrical impulses to the vagus nerve. A sensing electrode in the right ventricle detects the patient's heart rate and is used to control nerve stimulation.

The study is now in progress at investigation review board-approved sites in Europe, Israel and Australia. Bergamo and Mannheim join four other sites in Europe actively enrolling patients for the CardioFit system study, all of which have already successfully implanted the device in trial patients. A total of 30 patients will be enrolled in the study.

BioControl develops advanced implantable devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes.

In April 2006, American Medical Systems (Minnetonka, Minnesota) exclusively licensed BioControl's technology for its miniaturo system, to develop it as a treatment device for urge incontinence and interstitial cystitis. Funds secured from that transaction are being used by BioControl to support the development of the CardioFit system for the treatment of CHF.

St. Jude receives Japanese Approvals for new Angio-Seal

St. Jude Medical (St. Paul, Minnesota) reported receiving regulatory approval from Japan's Ministry of Health, Labor and Welfare (MHLW), for the Angio-Seal STS Plus vascular closure device.

It also has received reimbursement approval for the device. Approved for both percutaneous peripheral and cardiac interventional catheterization procedures, the device enables physicians to quickly seal femoral artery punctures made during those procedures.

The company said Angio-Seal STS Plus is designed to provide physicians with an improved method of sealing catheterization sites, "allowing patients increased comfort and offering hospitals improved efficiencies."

St. Jude said the device offers "a significant advantage" over the Angio-Seal Millennium vascular closure platform, which has been used in Japanese cath labs since 2004. With the addition of a self-tightening suture, the Angio-Seal STS Plus allows vascular closure to be completed entirely in the catheterization lab, saving labor and reducing the length of time required to complete the procedure.

The Angio-Seal STS Plus device includes a small bioresorbable anchor, suture and collagen pad. The anchor is placed in the artery through a small delivery system and secured against the artery's interior wall. Then the collagen pad, which is positioned on the outside of the artery, is bound together with the suture to form a secure seal. The self-tightening suture enables the physician to finalize the closure procedure immediately.

Unlike many other vascular closure devices, all components of the Angio-Seal STS Plus device are fully absorbed with 60 to 90 days, so no foreign material permanently remains in the body, the company said.

The company said the STS Plus device offers "quick, consistent and predictable hemostasis at the puncture site. Its fast, secure closure reduces the risk of complications and can allow patients to resume activities sooner than if managed with manual compression."

St. Jude said that if physicians need to repeat catheterization at a later time, they can re-access the original site, within 1 cm, when the Angio-Seal STS Plus device has been used to close the original site.

Micrus in distribution pact with Beijing TXF Medical

In other news from China, Micrus Endovascular (San Jose, California) reported signing a five-year, exclusive agreement with Beijing Tian Xin Fu Medical Appliances (TXF Medical), for the distribution in China of Micrus' implantable and disposable medical devices used in the treatment of neurovascular diseases.

Micrus said it expects to begin distributing its products in the Chinese market through TXF Medical upon receiving regulatory approval.

TXF Medical will distribute Micrus' full product line throughout China. Micrus said it plans to introduce its products during the World Federation of Interventional and Therapeutic Neuroradiology meeting in Beijing this month.

TXF Medical, founded in 1995, has established a marketing group composed of doctors and nurses with experience in clinical medicine and customer service. The TXF team has cooperated closely with specialized products manufacturers offering products and services in neurosurgery, orthopedics and cardiovascular sectors.

Micrus makes implantable and disposable devices used in the treatment of neurovascular diseases, used by interventional neuroradiologists and neurosurgeons, primarily to treat cerebral aneurysms responsible for hemorrhagic stroke.

British study eyes impact of family lifestyles on diabetes

Family lifestyles and their impact on the health of individual family members will be the focus of a new approach to preventing diabetes.

Diabetes currently affects an estimated 2 million people in the UK, of whom 90% have Type 2, or late-onset, diabetes that can lead to heart disease, stroke and blindness.

In the first study of its kind in Britain, researchers from the University of Edinburgh and the University of Glasgow will test whether involving whole families in weight loss and fitness initiatives is effective in preventing the development of Type 2 diabetes among high-risk family members.

The £1 million Prevention of Diabetes and Obesity in South Asians (PODOSA) study will focus specifically on people of Indian and Pakistani origin, who are five times more likely to develop late-onset diabetes than the rest of the population.

Researchers will look particularly at families with at least one member who has a high risk of diabetes, possibly because they are overweight or do little exercise. The study, which is currently recruiting participants living in Edinburgh and Glasgow, will encourage all family members to adopt a healthy lifestyle with the aim that this motivates and supports those individuals at risk.

The study is funded by the National Prevention Research Initiative (London) and aims to recruit 300 families. Dieticians will visit them in their homes over the next three years and provide what is termed "culturally-specific" advice on nutrition and exercise.

Researchers hope to reduce the incidence of Type II diabetes by 50%, and said they believe that by focusing on high-risk families, they will find strategies that can be applied more widely.

Project leader Raj Bhopal, professor of public health at the University of Edinburgh, said, "Diabetes is increasing rapidly as we get more obese and less active. If we don't take urgent action, it will spread in epidemic proportions."

Bhopal said such a family-based approach has never been tested before, "but by involving the siblings and parents of at-risk individuals, we hope to provide a motivational and supportive strategy that could prevent diabetes not only in the UK, but on a global scale."