Hence the interest of minimally invasive methods

In April 2002, Alain Cribier, head of the Department of Cardiology of the Centre hospitalier University of Rouen, realized a first ranging implanting an artificial valve into the aorta of a dying man of fifty-seven years, the sending to the heart via the femoral artery, where it had then been deployed, without the need for open heart surgery that the patient could not withstand. Five years and hundreds of settlements, the procedure is unmarked and moved from the status of "first" to "innovation". Number of physicians Europeans thus came to form to Rouen, where they can include exercise on simulators, follow a transaction online but also achieve their first intervention accompanied by an expert.

But Alain Cribier did not remained there. Indeed, when the aortic valve is ill, the femoral artery is often also in poor condition, which makes passage difficult catheter. Hence the idea of direct access to the heart, through a small incision intercostal to bring a catheter by the tip of the heart, through the left ventricle, until the damaged aortic valve. "The transapical way, that is passing through the apex, which is the tip of the heart, is therefore now an alternative to non-eligible patients in thoracic surgery and implantation via femoral," explains Alain Cribier.

Minimally invasive methods

These procedures are naturally the hope in many patients suffering from aortic stenosis. 25 of those 65 to 74 years are in effect affected and 48 of people over 80 years. Most often due to calcification, this progressive narrowing of the opening of the valve reduces blood flow with a fatal outcome in two or three years from the onset of symptoms. Surgery heart open is currently the reference treatment, but some patients cannot withstand the. Hence the interest of minimally invasive methods. Yet, some 20,000 euros unit, medical devices on which they are based have a cost that no hospital can withstand on its current expenses. Where the need to determine the actual risk / benefit for patients and to define precisely the patients target, before giving the green light to their use in routine.

In France, the high authority for health (HAS), which has a role of evaluation of the therapeutic approaches, became interested in 2008 in the two procedures (femoral and transapical pathway). So far, only the American Edwards LifeSciences and the CoreValve Franco-American, recently acquired by Medtronic (read below), make these valves and systems for their implementation. To date, in the world, some 5,000 patients have already received with equal distribution between Edwards and CoreValve devices. The report of the HAS concluded for one as for the other to a significant improvement of the medical service rendered (costed at 5 on a scale of 1 to 5) and therefore expressed for support for three years by health insurance, subject to further analysis.

This assessment was based on feasibility studies, conducted by Edwards since 2002 and CoreValve since 2004. In both cases, even if the available data were heterogeneous, the success rate was above 90 and the survival of 75 in six months, for CoreValve and 70 in two years for Edwards "while most of these patients, otherwise, died in the year", says Alain Cribier.

CE marking

As of mid-2007, the two companies have obtained the CE marking. They have therefore ceased free distribution devices in research protocols. In order to continue to treat our patients at the beginning, we had we fend for themselves and for example to purchase devices on the appropriations for research of the hospital, or with assistance from the regional hospitalization agency", explains Alain Cribier, who works with Edwards valves. But, since three months, the Ministry of health has released a special envelope for 250 valves and budgeted for the next three years, implementation of 600 valves per year. Finally, the inclusion in hospital pricing (therefore the reimbursement) would be imminent.

This figure of 600 valves owes nothing to chance. It is, according to the study of the HAS, among patients likely to benefit from new methods of implementation. Surgery remains in effect, the treatment of reference for the replacement of the aortic valves some 11,000 interventions a year in France with mortality reduced to only 3.