Heart operations without scalpels, how and when medical devices are needed

Let’s go back in time. It’s September 14, 1977: Andreas Grüntzig proposes to thirty-eight-year-old Adolph Bachman the possibility of undergoing the first percutaneous coronary angioplasty, or the “balloon” that dilates the artery to allow the passage of blood. The procedure is a success. And there is talk of a possible alternative to coronary artery bypass grafting, which is still performed when necessary with classic surgery.
The first one angioplasty it is only a first story, which was followed by many others. With always different indications and with the possibility of reaching the heart through a catheter inserted into a vessel and pushed up to the heart cavities, if it is necessary to intervene on a valve, or inside an artery.

Classic cardiac surgery, which remains fundamental in many cases, has therefore been added interventional cardiology, in a crescendo of indications and numbers of interventions, so much so that today this sector represents one of the spearheads of the use of what are defined as devices. According to data from Confindustria Dispositivi Medici relating to 2023, this sector (and we are obviously not just talking about cardiovascular diseases) generates a market worth 17.3 billion euros between exports and the domestic market and has 4,449 companies, which employ 118,837 employees.

However, our country is suffering a certain delay compared to other European nations. In Italy, according to what the association reports, total healthcare spending amounts to 167.7 billion euros, of which 71.6% is made up of public healthcare spending. Public spending on medical devices and services amounts to 9 billion euros and represents 7% of public health spending. In Italy, public spending per capita on medical devices is on average of 123 euros. We are still far from European standards, with an average difference of 161 euros per capita; furthermore, the international gap continues to widen year after year. All this, in a context that sees the regions moving at different paces. Consider that the region with the highest per capita spending is characterized by spending more than doubled compared to the region with the lowest per capita spending.

The wide room for maneuver of interventional cardiology

As emerges from the 2023 data of the Italian Society of Interventional Cardiology (GISE), the only Italian entity with a register of the activity of 273 hemodynamic and interventional cardiology laboratories in the country, a tendency towards development of these technological approaches to various cardiac pathologies. Interventional cardiology confirms itself as the cornerstone of the treatment of acute myocardial infarction in Italy, with a capillary network across the national territory that guarantees more than 36 thousand primary angioplasty procedures, reaching for several years the standards of need outlined by the epidemiology of this disease . Increase diagnostics with the most innovative imaging methods and techniques for studying cardiovascular function, but we are still far from the average of the most advanced European countries. Structural interventional cardiology procedures (operations on heart valves) are growing by up to 20%, but they still remain below the population’s needs and with regional differences still very marked.

More opportunities for valve work

The data, presented at the GISE Think Heart 2024 conference, indicates a constant growth of interventional cardiology in Italy, with over 300 thousand coronary angiographies performed in 2023, which in approximately 50% of cases led to the performance of a coronary angioplasty (156 thousand operations last year, thus returning almost to pre-Covid levels). However, they remain critical issues in structural interventions on heart valves: Percutaneous transcatheter aortic valve implantation (TAVR) procedures have increased by more than 10%. Percutaneous mitral valve repair operations are increasing by about a fifth. The use of the percutaneous closure procedure of the left atrial appendage, which is important for stroke prevention, also increased by 20%.

For further improve the quality of care in Italyfor the first time GISE proposes to include in the National Outcomes Plan a ‘dashboard’ of outcome indicators that allows monitoring and above all evaluating the performance of interventional cardiology, facilitating theintroduction of innovative technologies and abandonment of obsolete ones but above all by promoting increasingly appropriate, sustainable and equitable access to procedures throughout the country.

“The data collected by the GISE Report, deriving from the activity of 93% of the centers across the country, allow us to take a very accurate picture of interventional cardiology in Italy – observes Francesco Saia, president of GISE. The results show for example that 88% of the centers offer the service 24 hours a day, 7 days a week: a figure that confirms the widespread distribution throughout the national territory of an essential infrastructure for the timely treatment of acute myocardial infarction and other acute heart diseases, for which the effectiveness of the treatment is strictly time-dependent. However, some remain critical issuesbecause, for example, although imaging and functional study technologies are growing, only 20% of angioplasty procedures overall are guided by these methods, which are much underused compared to the average of European countries such as Germany, France, Spain, Holland and BENELUX The reasons are above all the economic constraints for acquiring the necessary tools and the absence of coding or tracking of these techniques, which, like GISE, we would like to spread more throughout the country”.

The importance of measuring outcomes

“Interventional cardiology represents one of the areas in which the technological innovation process is fastest. For this reason – observes Marco Marchetti, HTA manager at AGENAS – fast access of these devices can only be linked to a rigorous and scientific HT evaluation processA. In this regard, starting from January 2026, HTA evaluation activities will begin at European level (Joint Clinical Assessment) which also sees our country involved”.

Integrating the current panel of indicators in the cardiovascular field with additional clinical outcome indicators and with indicators that allow the identification of the main critical success factors is fundamental.
“For example, we propose to take into account not the single episode of hospitalization but the wholethe entire flow of care, considering among other elements the complications or rehospitalizations due to recurrence of symptoms – concludes Saia –. Or, again, we propose to insert indicators that evaluate organizational and process aspects to identify critical issues with an impact on clinical outcomes, such as the methods of taking charge and discharge according to PDTA, and to use indicators on the use of technologies to evaluate the contribution on the outcomes. All this will make it possible to move increasingly towards a therapy of value, centered on the patient and which facilitates the introduction of innovative technologies, discouraging the use of obsolete ones which are no longer adequate to the standards of effectiveness, safety and cost-effectiveness. The sustainability and resilience of the healthcare system inevitably depends on ability to correctly program resourcesguarantee the use of technologies that allow not only the improvement of clinical outcomes but also to respond to the needs of the system as a whole: correct detection of process, organizational and outcome indicators will be fundamental for the planning of activities and evaluation multidisciplinary approach to technologies that increase the capacity of the system and which will be fundamental for overcoming the health challenges of today and tomorrow”.