Five‐year outcomes of rapid‐deployment aortic valve replacement with the Edwards Intuity valve

Abstract

Background This report presents 5‐year outcomes of the rapid‐deployment Edwards Intuity valve in a prospective, single‐center study. Methods All patients who underwent an aortic valve replacement (AVR) with an Edwards Intuity bioprosthesis at La Timone Hospital, Marseille, France, from July 2012 to June 2015 were assessed over a 5‐year follow‐up period. The primary outcome was overall mortality at 5 years. Secondary outcomes were reoperation, overall mortality and stroke, cardiovascular mortality, composite endpoints defined by the updated Valve Academic Research Consortium‐2 (VARC‐2), periprosthetic regurgitation, prosthesis‐patient mismatch, and the need for new pacemaker implantation. Results In total, 170 consecutive patients were assessed, of which 67.1% were males. The mean age was 76 years, mean EuroSCORE II was 3.5% and 5‐year overall mortality was 12.4%. At 5 years, reoperation was 2.9%, overall mortality and stroke was 4.1% per patient‐year, and cardiovascular mortality was 4.7%. VARC clinical efficacy and VARC time‐related valve safety were achieved in 46.0% and 59.9% of patients, respectively. At one month VARC device success was 71.2% and VARC early safety was 87.1%. At one year, mild and moderate periprosthetic regurgitation were 2.4% and 0.6%, respectively, and moderate and severe prosthesis‐patient mismatch were 18.8% and 4.8%, respectively. Conduction disturbances needing new PPI occurred in 3.5% patients. Conclusion The 5‐year outcomes of AVR with the Edwards Intuity valve system demonstrate satisfactory midterm safety and excellent haemodynamic performance.

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.…”

“…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].…”

“…Surgical aortic valve replacement (SAVR) with use of biological prosthesis remains the treatment of choice in case of aortic valve disease, reasonable surgical risk, and adequate patient's age. Recently, the rapid deployment Intuity™ heart valve system (Edwards Lifesciences, Irvine, CA, USA) has been developed in order to improve the surgical implanting time and facilitate the aortic valve replacement in minimally invasive settings [1][2][3]. 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.…”

Rapid deployment valves: Another tool in the toolbox

“…Pelce et al 13 from La Timone Hospital in Marseille, France, report their 5‐year outcomes in 170 elderly patients with the Intuity and Intuity Elite valves. The mean age was 76 years.…”

“…11 The Perceval valve is a self-expanding, completely sutureless, bovine pericardial, stentless valve. 12 Pelce et al 13 from La Timone Hospital in Marseille, France, report their 5-year outcomes in 170 elderly patients with the Intuity and Intuity Elite valves. The mean age was 76 years.…”