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The UK Department of Health has launched a consultation on a new chapter of the National Service Framework (NSF) on Coronary Heart Disease. The new area will cover heart arrhythmias, which will form an important part of the heart disease agenda. Cardiac arrhythmia covers a range of conditions from a transient loss of consciousness and reflex anoxic seizures to cardiomyopathy and sudden adult death syndrome (SADS). Around 700,000 people in the UK suffer from arrhythmia, with severity ranging from a minor health inconvenience to a fatal rhythm disturbance. That means about one person in 85 has a heart that occasionally or consistently beats abnormally fast, abnormally slowly or irregularly.

The consultation document was launched by Dr. Roger Boyle, national director for heart disease, at a House of Commons event marking the launch of Arrhythmia Awareness Week, a joint venture of the charities Syncope Trust and Reflex Anoxic Seizures, SADS UK and the Cardiomyopathy Association.

Boyle said, "The strength of the existing National Service Framework has been that it is based on the views of clinicians, patients and their families. Its aims and approaches have credibility with those who deliver it and those who benefit from it. The aim of this consultation paper is to invite initial comments from everyone with an interest in these issues to ensure that we can build a similar consensus for this new NSF chapter."

He said the views received would be considered by a new expert group the Department of Health is establishing to move forward with the task of writing the new NSF chapter. The group will include patients, relatives of patients, patient organizations, professional bodies, experts in the field, health service managers and other government departments. Boyle said, "I look forward to working with everyone involved to drive real improvements for patients and their families."

Health Minister Melanie Johnson said, "The prospect of a new NSF chapter setting out the standards and models of care for these conditions marks a major step forward for cardiac patients in England."

Trudie Lobban, coordinator of Arrhythmia Awareness Week, said the inclusion of arrhythmias into the National Service Framework is welcome news. "Following the response we have had with this campaign, we are joining forces with medical groups, charities and our industry allies to form the Arrhythmia Alliance. This means that once the NSF has been implemented, doctors and clinicians will receive training and education promptly to diagnose and treat those suffering with all forms of arrhythmias."

Statin to be available without prescription

As a result of advice by the Committee on Safety of Medicines (CSM), the statin drug simvastatin soon will become available without a prescription in the UK. Statins, which reduce cholesterol levels, are presently prescribed to 1.8 million persons in the UK and are estimated to save 6,000 to 7,000 lives annually. Based on those results, CSM advised that simvastatin be available in a 10 mg dose on a nonpresciption basis.

In announcing that he was accepting the committee's recommedation, Health Secretary John Reid said the move "will allow more people to protect themselves from the risk of coronary heart disease and heart attacks. By extending access to this drug, we are giving people more choice about how they protect their health." Noting that coronary heart disease kills more than 110,000 people in England every year, Reid said, "By lowering cholesterol levels, statins can reduce heart attacks by as much as one-third after three years of taking the drug."

He said the UK already has seen a 23% fall in premature death rates from heart disease and stroke over the past five years, which he said was "on line to meet our target of a 40% reduction by 2010." The availability of simvastatin on a nonprescription basis will, he said, allow more people to protect themselves from the risk of coronary heart disease and heart attacks.

Reid said pharmacists will ask people a series of questions and, where appropriate, offer a range of health tests to ensure that it is safe to issue the drug. He said the move also will give pharmacists "a greater role in helping people to stay healthy allowing them to fulfill their full potential in offering health advice and treatment."

Statins will still be available by prescription.

Dr. Gillian Hawksworth, president of the Royal Pharmaceutical Society of Great Britain, said the society "welcomes the reclassification of simvastatin 10 mg and believes there is a clear public health benefit to be gained from making this important medicine available through pharmacies." Hawksworth said the switch "will enhance patient care and give pharmacists more opportunity to use their skills; it will also provide a perfect opportunity to discuss other risk factors such as smoking, obesity and diet with a customer."

New CRT defibrillator launched

ELA Medical (Le Plessis-Robinson, France) last month initiated the European launch of the Alto 2 MSP 627 cardiac resynchronization therapy (CRT) defibrillator. The company said the device complements its CRT product line, offering physicians a wide range of products for the management of heart failure patients. Heart failure often is accompanied by ventricular asynchrony due to abnormal activation of the two ventricles of the heart. And sudden cardiac death may occur in as many as 40% of all patients who suffer from heart failure.

CRT, also referred to as biventricular pacing, seeks to restore cardiac coordination, improving heart function and enhancing the quality of life for heart failure patients. Implantable cardioverter defibrillator (ICD) therapy with backup ventricular pacing increases survival in patients with life-threatening ventricular arrhythmias and prevents sudden cardiac death.

"The market introduction of Alto 2 MSP further reinforces ELA's commitment to delivering optimal care to heart failure patients," said Bruno Inguaggiato, company president. "ELA's pioneering involvement in cardiac resynchronization therapy dates back to the early 1990s with the first worldwide implant of a biventricular pacemaker." He noted that ELA also sponsored the first prospective randomized trial the MUSTIC study to assess the efficacy of CRT in heart failure patients.

The Alto 2 MSP system incorporates ELA Medical's PARAD/PARAD+ arrhythmia discrimination, which identifies and analyzes complex arrhythmias; fully configurable biventricular function with programmable ventricle-to-ventricle delay and independent left ventricular output; rate-responsive biventricular and flexible pacing into tachycardia detection zones; and right ventricular sensing, along with complete diagnostics and advanced follow-up tools.

ELA said the system is small and long-lasting, and can be used in conjunction with a full range of advanced left ventricular leads that can accommodate all venous anatomies. "Alto 2 MSP also is available with [our] Telassistance function, which provides remote real-time viewing of the patient's data," added Alain Ripart, vice president. "Using this secure link, physicians can participate in patient follow-up, providing support in peripheral clinics where specialist knowledge may not be present. They also have the opportunity to consult and share experience with colleagues on difficult cases."

ELA Medical is a Sorin Group (Milan, Italy) company. It manufactures pacemakers, ICDs, leads, Holter equipment and electrophysiology catheters for Europe, the U.S. and Japan.

Added countries broaden healthcare market

The addition of 10 central and eastern European countries to the European Union (EU) last month has created a single trading zone for the healthcare industry of almost 500 million customers, according to Frost & Sullivan (New York). It is forecasting that the total EU healthcare industry including medical devices and equipment, pharmaceuticals and drugs, and health services will grow at a compound annual growth rate of 6.4% from 2003 to 2008.

"The growth of the pharmaceuticals and drugs as well as medical devices and equipment segments is directly linked to the health services segment," said Frost & Sullivan research analyst Lasya Narasimhachari. "Increases in the number of hospitals, nursing homes, home healthcare services, dental services and laboratory services are given high priority in national healthcare expenditure, which could help in the growth of the three segments."

Narasimhachari said the process of economic integration in Europe "has been a catalyst to the diffusion of health technology and opened national markets to competition, tending to equalize prices and reduce costs. Technological progress is expected to become a key factor for economic growth and help meet the challenges posed by an aging society."

Frost & Sullivan said the European market for medical devices is thriving, having totaled $41.2 billion in 2002. It said that growth could have something to do with the acknowledgement that prevention "is just as important as therapy."

On the pharmaceuticals side, Narasimhachari said the future availability of new drugs is expected to be influenced by the "radical differences in economic and market conditions and healthcare coverage for medicines" between the existing 15 EU member states and the accession countries.

The huge aging population in Europe also is likely to drive research on more effective drugs, Frost & Sullivan said. Increasing life expectancy has resulted in Europe having a growing percentage people over 65. "This can have a deep impact on the healthcare system, especially drug development, since the over-65 age group is the single largest user of pharmaceutical products," Narasimhachari's report noted.

With expansion comes the concern of ensuring that products of uniform high quality are available throughout the EU, Frost & Sullivan said. "This can be achieved by enforcing international standards of intellectual property protection and a sustainable basis for the industry to supply innovative medicines throughout the EU," according to Narasimhachari.

Health policies in the EU can affect all three segments, with public and private health insurance funds playing a critical role in drafting reimbursement policies. The social protection structure is expected to undergo changes and the resultant reforms could lead to increased out-of-pocket expenditures, Frost & Sullivan said.

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