As usual we start from the figures, to define the size of a problem such as aortic stenosis and other valve pathologies. And these say that we are faced with a condition that requires answers. To rattle the numbers and to make operational proposals are the experts gathered in Milan on the occasion of the Congress of the Italian Society of Interventional Cardiology (Gise).
First yes, remember that the routes to intervene on the valve are different. More and more, especially in the third age, it does not focus on the scalpel but rather on the Tavi procedures (i.e. mininvasive techniques that allow you to replace the sick valve without resorting to classic surgery, which still has precise indications).
But what are the answers? According to what was reported at the conference, with about 13 thousand interventions carried out in 2024, it is thought that over 10 thousand Italian patients nominated for the procedure remain outside. All this, with a geographical distribution of the tavi not properly optimal and with access differences. To resolve the current critical issues, several hypotheses are under consideration, including that of carefully selected patients can be treated safely and effectively also in hospitals without cardiac surgery on site. In short, we try to work to improve the situation, also through the availability of targeted data.
In Italy the Tavi AT-HOME multicenter register and the Tracs international study, partially financed by the Ministry of Health, the first randomized study in the world that aims to evaluate this hypothesis are underway. To draw the future.
What the indications say today and how to do it
The new European guidelines (ESC/Eacts 2025) have lowered the age threshold for Tavi at 70 years and recommend its use also in asymptomatic patients with severe stenosis, strengthening the first choice role in most patients with aortic valve stenosis. Tavi is a minimally invasive procedure that allows you to replace a sick aortic valve without resorting to open heart surgery.
As Francesco Saia, president of Gise explains
“It has become a consolidated and life -saving treatment for patients with severe symptomatic aortic stenosis, mostly performed by the cardiologists who intervene in the hemodynamics laboratories spread throughout the national territory. In recent years, technological progress and the increased experience of the operators have made the procedure even safer, drastically reducing complications that require emergency surgery. The data show that these complications are They verify in less than 0.5% of cases.
A multidisciplinary advice
International guidelines, even the most recent, recommend that Tavi is performed only in centers with cardiac surgery on site.
“This practice, based on prudence, has allowed the development of this therapy in absolute safety but, with the expansion of the indications and the needs, this can generate access problems”
explains Alfredo Marchese, president elected Gise.
“In addition, the demand for short -term TAVI procedures will exceed the current ability of specialized centers, bringing, in some geographical realities to prolonged waiting lists with an increased risk of death or hospitalization for heart failure”.
In this sense, from the Congress it emerges how the researchers to assume that a Tavi path managed by a team of interventionists experts expert in a cardiac surgery center in place is not less than the traditional path. The idea is that, with a careful selection of patients by a Heart Team, that is, of a multidisciplinary team of specialists, and a meticulous planning of the procedure, it is possible to minimize risks and make the Tavi accessible to several people.
What the Tracs study can say for the health organization
The research involves 566 patients with severe aortic stenosis, considered inoperable or high surgical risk. These patients will be randomly assigned to one of the two groups: Tavi in a center with cardiac surgery on site or in a center without.
“The objectives of the study are clear: the first is to evaluate the death rate for all causes, strokes and readmission to the hospital for cardiovascular causes one year after the procedure. The second is to verify the number of deaths due to periprocede complications that would have requested an emergency surgery”
Saia explains.
The most recent data document that the Tavi procedure is so sure that the events that require urgent surgery are extremely rare. The enrollment of patients for the Tracs Trial began in May 2023, with the aim of completing it by next December.
“If the results of the study confirm the premises, new paths for health care can be opened. The possibility of carrying out the Tavi in a greater number of hospitals could: reduce waiting times, improve access to patients who live away from large specialized centers and free resources, allowing centers with on -site surgery to focus on more complex cases”
Saia and Marquis conclude.
