Applicazione di un dispositivo innovativo per la modulazione della contrattilità cardiaca nel contesto di cura italiano: il Cardiac Contractility Modulation

[Autom. eng. transl.] Objectives - Heart Failure (HF) entails an important burden for our National Health Service and is associated with a high disease burden linked to the direct and indirect costs that are generated by the management of the pathology itself. Cardiac Contractility Modulation (CCM) could represent a new therapeutic possibility for patients with HF. This project therefore aims, through the involvement of various health professionals (cardiologists, electrophysiologists, public health professionals) to analyze and systematise the evidence currently available on CCM, in order to identify the key elements for a possible implementation of this innovative technology in the Italian healthcare context. Methodology - An analysis of the scientific literature was conducted on the epidemiological burden of HF, on the characteristics of the treatment path and on the absorption of resources for the treatment of HF, as well as on the scientific evidence currently available on CCM. Results - The burden of HF affects 64.3 million people worldwide, becoming increasingly common in patients aged 65 years or older. Approximately 50% of patients with HF die within 5 years of diagnosis and it is estimated that this syndrome will affect more than 8 million people in 2030. Over the last few years, new treatments, pharmacological or otherwise, have been developed for management of HF, such as, for example, pharmacological therapies (valsartan, ivabradine, etc.), cardiac resynchronization therapy (CRT) and ablation of atrial fibrillation. However, these therapeutic opportunities have proven effective only in HF with reduced Ejection Fraction (EF). It is, therefore, essential to identify alternative pharmacological and electrical strategies, especially in consideration of the fact that approximately 50% of patients are affected by HF with reduced EF and that only 30% of patients are indicated for CRT implantation. In this context, an innovative mechanism of action such as CCM could represent a new therapeutic possibility for patients with HF. This is a new technology capable of improving the contractility of the heart by stimulating the cardiac muscle with high voltage electrical impulses. With CCM stimulation there is a progressive reactivation of genes and proteins that regulate the release of calcium in the cell, increasing its availability with an improvement in cardiac function. CCM was approved by the FDA in March 2019, for the treatment of patients suffering from chronic HF with EF 25-45% in sinus rhythm with QRS <130 ms clinically symptomatic (NYHA class >II) despite optimized medical therapy (OMT). The indication was developed on the basis of the results of important clinical trials (FIX-HF-4, FIX-HF-5, FIX-HF-5C) which demonstrated the safety and effectiveness of the device. Furthermore, today we have a prospective observational CCM-REG registry but we do not have economic analyzes available on the use of the device in the Italian healthcare context. A cost-effectiveness analysis on CCM was recently published, carried out from the perspective of the English National Health Service, according to which CCM would be a cost-effective therapeutic option for the management of patients with heart failure with reduced EF and NYHA III class. From the analyzed evidence it appears that CCM is a promising response to the health needs of patients with HF. It will therefore be fundamental to evaluate its impact, in clinical, organizational and economic terms also in the Italian setting and through the active involvement of various stakeholders.