A Medical Device Daily

Italian heart specialists are calling on healthcare providers throughout Europe to give urgent consideration to introducing ECG screening for all babies at three to four weeks of age to pick up a life-threatening genetic condition called long QT syndrome (LQTS).

They report gathering evidence from ECGs in a prospective study of 45,000 infants, coupled with a cost-effectiveness analysis, demonstrating that significant numbers of sudden deaths could be prevented for less than €12,000 per year-of-life saved.

The findings from the study were published recently on-line by European Heart Journal, the journal of the European Society of Cardiology.

LQTS is an inherited disorder of the electrical rhythm of the heart. It rarely produces symptoms but is a leading cause of sudden death in children and young adults, and when it occurs in infants their deaths are usually mislabeled as sudden infant death syndrome (SIDS).

The researchers studied more than 200 victims of SIDS from Norway and found genetic mutations diagnostic for long QT syndrome in almost 10%. This indicates that early treatment of LQTS would prevent some deaths regarded as SIDS because it can be successfully treated with medication, occasionally by sympathetic denervation or the use of implantable defibrillators.

The research also unexpectedly revealed four cases involving two other life-threatening heart conditions – coarctation of the aorta and anomalous origin of the left coronary artery from the pulmonary artery – which had gone undetected in initial neonatal checks. This finding led to the researchers extending their cost-effectiveness analysis to include these two congenital heart diseases.

The study was led by Professor Peter Schwartz of the University of Pavia, who said: “Our study clearly demonstrates that neonatal ECG screening is highly cost-effective and that a significant number of lives can be saved – possibly up to 230-250 a year, for example, in the 15 countries of the pre-enlarged EU – for an objectively small cost. The time is ripe for those involved in the administration of public health to consider the implementation by the National Health Services of such a program, with the objective of reducing the number of preventable sudden cardiac deaths in infants, children and young adults.“

He said that although there could be some differences in specific costs in different countries, their calculation for its introduction in Italy varied all probabilities and costs by plus or minus 30% so as to be valid for most European countries.

There have been various estimates in medical literature in the past about the prevalence of LQTS, with figures ranging from one in 5,000 to one in 20,000, but none was based on actual data. The Pavia team's research is the first large prospective study on an unselected population. They performed ECG between days 15 and 25 in 45,000 babies and found a markedly prolonged QT interval in almost one in 1,000. In more than 50% of these infants Schwartz has identified gene mutations responsible for LQTS. “Therefore this means that the prevalence is probably around one in 2,500 – higher than previous estimates,“ he said.

“The cost per year-of-life saved by identifying and treating LQTS is really very low – EUR 11,740; for saving one entire life of 70 years we are looking at just EUR 820,000. When, to account for what happens in the real world, we also consider the two other congenital heart diseases that routine ECG screening can pick up, then the cost per year-of-life saved is only just over EUR 7,000 or around EUR 490,000 over a 70-year lifetime.“

He said that 220 out of 550,000 newborns per year in Italy are affected by LQTS. Without screening 13.5% would die early. But screening would cut this to 3.2%, saving 23 lives a year. Additionally, screening would prevent four more deaths due to the two congenital heart diseases. In total therefore, screening in Italy would save an estimated 27 lives a year from the three conditions combined.

Schwartz outlined the potential clinical benefits of screening for LQTS:

• “We can treat the baby, protecting it from life-threatening arrhythmias, thus reducing deaths in childhood and later years as well;
• we can identify other family members affected by LQTS who are at risk of sudden death as well; and
• by treating all the infants who show manifest LQTS, we would also protect those at risk of dying in the first few months of life and whose deaths would be labelled 'SIDS.'
• In addition, our unexpected finding of these two other conditions means we have an opportunity to pick up the few, but life-threatening cases of congenital heart diseases that might escape routine medical checks, for which surgery can radically change the prognosis.”

“Parents of a newborn child have the right to know about the existence of an uncommon disease, which is potentially lethal but for which effective and safe treatments exist, and which can be diagnosed by a simple ECG. European citizens and taxpayers also need to be informed about what is possible to do, and at what cost, to reduce the tragic burden of sudden deaths in the young,“ Schwartz concluded.

New HQ and UK office for Corgenix

Corgenix Medical (Denver), a developer of diagnostic test kits, has relocated its international business office in the UK, as well as its headquarters and manufacturing facility, to meet expected worldwide growth in its sales of diagnostic products.

The new 32,000-square-foot Denver headquarters is more than double the size of the previous combined sites. The new building houses corporate headquarters and administration, research and product development, quality and regulatory affairs management, manufacturing and North American sales and marketing management.

The UK office manages Corgenix's international distribution network and serves as a distribution center for company products sold throughout Europe and the Middle East.

“This expansion and relocation is a significant strategic move for our company, signifying our expectation for greatly increased sales of our diagnostic products worldwide,” said Douglass Simpson, Corgenix president and CEO. “Our existing U.S. and international offices were constraining our ability to grow, and these changes directly address this problem.”

Report eyes endovascular therapy market

Millennium Research Group (Waltham, Massachusetts), a medical technology market intelligence firm, said that demand for endovascular therapy is on the rise in Europe.

Millions of Europeans are affected by peripheral vascular disease (PVD), resulting in an increase of minimally invasive treatments for PVD. Millennium's new report, European Markets for Peripheral Vascular Devices 2006, finds that the aging European population, combined with growing incidences of obesity, diabetes, and end stage renal disease, will drive demand for PV procedures higher throughout the next decade.

The reports says the most rapid growth in the PV stent market over the next five years will occur in carotid, femoral-popliteal and infrapopliteal indications.

In recent years, carotid artery stenting has emerged as a less-invasive alternative to traditional carotid endarterectomy and will continue to penetrate the existing surgical patient population over the forecast period, according to the report.

Similarly, an industry-wide focus on expanding the clinical applications of stent technology will lead to better success of lower extremity stenting and drive procedural and revenue growth in femoral-popliteal and infrapopliteal market segments, according to Millennium.