Clinical and hemodynamic outcomes of trans-apical aortic valve implantation. insights from the i-ta registry

Senile degenerative calcific aortic valve stenosis (AVS) is a progressive disease characterized by a peculiar natural history. When symptoms begin (congestive heart failure and dyspnea, angina, syncope) mortality rate rapidly increase and quality of life dramatically worsen. It has been estimated that the overall survival of patients with severe symptomatic AVS is less than 50% 2 years after the onset of symptoms. The number of patients suffering from AVS worldwide will increase over time as life expectancy progressively extends. The treatment of choice for severe symptomatic AVS is aortic valve replacement (AVR) that is usually performed under general anesthesia, with median sternotomy and cardiopulmonary bypass. AVR is a well-established procedure, with excellent early and long-term results and valve prostheses have now reached optimal hemodynamic performance and duration. During the last few years, the development of sutureless aortic bioprosthesis has made easier the surgical procedure. In fact, aortic valve replacement with sutureless valves (SU-AVR) needs shorter cardiopulmonary bypass and aortic cross clamp times and can be safely performed through a minimally invasive approach. However, a recent survey showed that around 30% of patients with severe symptomatic AVS does not undergo AVR for several reasons: they are not referred for surgery by their family physician or by their cardiologist because of age, they are declined surgery for a high preoperative risk profile; they are inoperable for severe ascending aortic calcification (porcelain aorta). Trans-catheter aortic valve implantation (TAVI) is an alternative therapeutic option in high-risk or inoperable patients. TAVI can be performed through several accesses: trans-femoral (TF-TAVI), trans-apical (TA-TAVI), trans-aortic (TAo-TAVI) and trans-subclavian (TS-TAVI). This thesis will focus on TAVI and in particular on TA-TAVI in terms of, indications, technique and outcomes. We will show the results of the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA) that includes the great majority of patients who underwent TA-TAVI in Italy since this procedure became commercially available in 2008. Furthermore we will present the results of a propensity-matched study that compared all the three available surgical options for patients with severe symptomatic aortic valve stenosis: surgical aortic valve replacement (SAVR), SU-AVR and TA-TAVI. From the results of these two studies it clearly appears that TA-TAVI is an excellent therapeutic options in patients with aortic valve stenosis. The two main issues that still need to be solved are the incidence of paravalvular leak, and valve durability. Paravalvular leak has been demonstrated to have a significant impact on long term survival while the assessment of valve durability needs a longer observation of these patients in order to reach time points when structural valve deterioration is more likely to occu