Innovazioni tecnologiche nel trattamento dei pazienti con patologia valvolare, ad alto rischio chirurgico: confronto tra procedure transcatetere e chirurgia convenzionale e mininvasiva nel trattamento della stenosi aortica severa sintomatica.

ABSTRACT OBJECTIVES Surgical aortic valve replacement (AVR) is still the treatment of choice for patients with severe symptomatic aortic valve stenosis (SSAVS). During few last years novel technologies, like transcatheter aortic valve replacement (TAVI) and sutureless bioprosthesis have shown early good results. The aim of this study was to compare early and mid-term outcomes of high-risk patients undergoing TAVI procedures versus patients undergoing minimally invasive aortic valve replacement with sutureless valves and versus patients undergoing conventional surgical AVR for SSAVS. METHODS From January 2011 to December 2013, 69 patients with severe aortic stenosis underwent TAVI procedure at our centre. This prospective cohort of patients was matched by four categories of risk profile and three categories of age, to a prospective/retrospective cohort of patients undergoing conventional surgical AVR from May 2004 to December 2013 (CCH GROUP, n = 250 patients) and to a prospective cohort of patients undergoing minimally invasive AVR with a sutureless bioprosthesis from January 2011 and December 2013 (SUTURELESS GROUP, n = 73 patients) at our centre. Were created two groups of pairs: TAVI versus CCH, with 51 matched pairs with comparable preoperative risk profile and age, and TAVI and SUTURELESS, with 40 matched pairs with comparable preoperative risk profile and age. RESULTS TAVI versus CCH: After matching 1:1 for the entire population, 51 patients undergoing TAVI procedure were matched to the CCH GROUP. Major/minor vascular complications were significantly more frequent in the TAVI group than in the CCH group (15.7% versus 0%, p=0.0058). Median mechanical ventilation time and Median ICU stay were significantly lower in TAVI Group compared with CCH Group. In CCH group the rate of new onset of AF was significantly higher respect to TAVI group (31.4% (n16) vs. 8.5% (n4) respectively, p=0.0058). At discharge mean transvalvular gradient was significantly lower in TAVI group, while the incidence of moderate to severe paravalvular leak was significantly higher in patients undergoing TAVI (P<0.001), but in our experience the paravalvular regurgitation was not associated with increased one year mortality (P>0.001). At discharge mortality rate was higher in TAVI group compared with CCH group (7.8% vs. 0%, P = 0.1176), but one-year mortality rate was 6.5% (n = 3) in the TAVI group and 12% (n = 6) in the CCH group (P= 0.4898), and one year cumulative mortality was not significantly different among two cohorts. TAVI versus SUTURELESS: After matching 1:1 for the entire population, 40 patients undergoing TAVI procedure were matched to the SUTURELESS group. Major/minor vascular complications were significantly more frequents in the TAVI group than in the SUTURELESS group (15.0% versus 0%, p=0.0255). Median mechanical ventilation time and Median ICU stay were significantly lower in TAVI group compared with SUTURELESS group. In SUTURELESS group the rate of new onset of AF was higher respect to TAVI group 38.5% ((n = 15) vs. 10.8% (n = 4) respectively) (P=0.0083). At discharge and at one-year FU mean transvalvular gradient was comparable among two groups, while paravalvular regurgitation was more frequent after TAVI (P<0.001), but paravalvular regurgitation was not associated with increased one year mortality (P>0.001). At discharge mortality rate was higher in TAVI group compared with SUTURELESS group (7.5% vs. 2.5%) (P=0.6153), but one-year mortality rate was 5.6 % (n = 2) in the TAVI group and 13.2% (n = 5) in the SUTURELESS group (P= 0.4310), and the one year cumulative mortality was not significantly different among two cohorts. CONCLUSIONS In high-risk patients with a severe symptomatic aortic valve stenosis, transcatheter and surgical procedures (both conventional and MIAVR with sutureless) for aortic-valve replacement are associated with similar rates of survival at one year, although there were some differences in periprocedural complications and mid-term outcomes. All these therapeutic alternatives must be offered to our patients population and the most appropriate technique could be tailored to each patient.