Mid-term outcomes of rapid deployment aortic prostheses in patients with small aortic annulus

Abstract

OBJECTIVES The Edwards Intuity valve is a rapid deployment aortic prosthesis that favours less invasive approaches. However, evidence about the clinical behaviour of their smaller sizes is scarce. Herein, we studied haemodynamic behaviours and clinical outcomes of small Intuity prostheses (19–21 mm) in comparison to larger Intuity prostheses (>21 mm). METHODS This is an observational study including patients implanted with an Edwards Intuity rapid deployment aortic prosthesis. Patients with prosthesis sizes 19–21 and >21 mm were included. Baseline and perioperative variables, as well as adverse events during the follow-up were recorded and compared between groups. RESULTS A total of 122 patients (37% female, mean age 75 ± 4.5 years) were included, of whom 54 (45%) were implanted with a small prosthesis and 68 (55%) with a prosthesis >21 mm. There were no significant differences between patients with small Intuity prostheses and patients with larger prostheses regarding in-hospital mortality (2% vs 4%, P = 0.43) or mortality during the follow-up (3.41 vs 2.45 per 100 patients-years; P = 0.58). Survival in the small Intuity valve group was 95% at 1 year and 83% at 6 years, whereas in the larger Intuity valve group was 96% at 1 year and 78% at 6 years. The presence of a small prosthesis did not influence mid-term survival (log-rank P-value = 0.62). CONCLUSIONS This study showed good clinical performance of Intuity aortic prostheses with appropriate mid-term survival in patients with the small aortic annulus. Thus, the Edwards Intuity rapid deployment aortic prosthesis may be considered as a potential option in patients with the small aortic annulus.

The Aortic Annulus Stabilization Technique Prevents Paravalvular Leaks after Rapid Deployment Aortic Valve Implantation

“…The major findings are the confirmation of the good Intuity valve hemodynamic at 1-year follow-up and the absence of any degree of paravalvular leak both at postoperative and at 1-year echocardiographic control. The Intuity valve system has already proven its good hemodynamic characteristics in previously published studies when compared to the well-renowned standard counterpart (the Perimount valve), but there is still a debate when the risk of permanent pacemaker implantation or the presence of paravalvular leaks are concerned [1][2][3][5][6][7]9,10]. In fact, the rapid deployment Intuity valve features a sub-annular balloon-expanding stent that is dilated after the placement of the valve into the annulus.…”

“…In fact, the rapid deployment Intuity valve features a sub-annular balloon-expanding stent that is dilated after the placement of the valve into the annulus. The effectiveness of this anchoring system depends on the intraoperative valve sizing as well as on the characteristics of the aortic annulus when the radial forces of the stent apply against it [7,[11][12][13]. In order to reduce the risk of PVL and to anchor the valve, the balloon-expanding stent is intraoperatively ballooned with 4.5 or 5.0 atmospheres, depending on the valve size.…”

“…Moreover, despite the enlargement of the sub-valvular stent, there is still a risk of postoperative PVL, which can lead to an increased mortality rate when moderate or severe, or can cause haemolysis when it is generated by small defects with high-velocity jets [14]. In the TRITON study as well as in other published retrospective studies, the average rate of mild-to-severe postoperative paravalvular leak after Intuity valve implantation still ranges between 1.4% and 13%, and some patients required surgical reoperations in order to address this issue [1][2][3][5][6][7][9][10][11][12][13].…”

“…placed below the sewing ring level. The Intuity valve has already shown excellent hemodynamic results in published studies, as well as an extreme versatility, but still carries the risk of postoperative mild to moderate paravalvular leak (PVL), mainly related to the intrinsic characteristics of both the aortic annulus and the fixation system [4][5][6][7]. Therefore, we recently proposed an innovative surgical technique aimed at reducing the risk of PVL following the implantation of the Intuity valve system.…”

“…This bioprosthesis combines the excellent hemodynamic characteristics of the well-known Peri-mount™ pericardial valve (Edwards Lifesciences, Irvine, CA, USA) with the advantages of an innovative implanting system consisting of a balloon-expanding stent placed below the sewing ring level. The Intuity valve has already shown excellent hemodynamic results in published studies, as well as an extreme versatility, but still carries the risk of postoperative mild to moderate paravalvular leak (PVL), mainly related to the intrinsic characteristics of both the aortic annulus and the fixation system [4][5][6][7]. Therefore, we recently proposed an innovative surgical technique aimed at reducing the risk of PVL following the implantation of the Intuity valve system.…”