Rapid-Deployment Aortic Valve Replacement in a Real-World All-Comers Population

Abstract

Background This study was conducted to evaluate the mid-term outcomes of rapid-deployment aortic valve replacement (AVR) using Edwards Intuity. Methods A total of 215 patients underwent rapid-deployment AVR using Edwards Intuity at our institution. The median follow-up duration was 22 months (interquartile range, 8–36). Primary outcomes were overall survival, cumulative incidence of cardiac death, and major adverse cardiac events. Secondary outcomes were early and 1-year hemodynamic performances of the bioprosthetic valve. Results The mean age was 68.6 ± 10.5 years, and EuroSCORE II was 3.09 ± 4.5. The study population included 113 patients (52.6%) with bicuspid valves (24 patients with type 0 bicuspid valves), 20 patients (9.3%) with pure aortic regurgitation, and 3 patients (1.4%) with infective endocarditis. Isolated AVR was performed in 70 patients (32.4%) and concomitant procedures were performed in 146 patients (67.6%), including aorta surgery (42.3%) and mitral valve procedure (22.3%). Operative mortality was 2.8%. Complete atrioventricular block occurred in 12 patients, but most of them were transient and only 3 patients received permanent pacemaker implantation before discharge. Overall survival at 3 years was 92.3%. Early hemodynamic data showed mean pressure gradients of 15.5 ± 5.0 and 12.7 ± 4.2 mm Hg in the 19 and 21 mm valve, respectively. One-year hemodynamics were also excellent with mean pressure gradients of 14.7 ± 5.3 and 10.7 ± 3.6 mm Hg in the 19 and 21 mm valve, respectively. Conclusion Based on a real-world all-comers population, rapid-deployment AVR using Edwards Intuity could be performed for various indications, including bicuspid valve, pure aortic regurgitation, and infective endocarditis, and the clinical and hemodynamic outcomes were excellent.

Comparable Outcomes of Bicuspid Aortic Valves for Rapid-Deployment Aortic Valve Replacement

“…In our institution, a single surgeon (K.H.K.) used Edwards Intuity exclusively for patients who planned to receive a bioprosthetic valve, regardless of the etiology of aortic valve disease [ 10 ]. The fact that BAVs were present in 52.6% of the entire cohort and that 11.2% of the study population had type 0 BAVs demonstrates that our series was indeed a real-world all-comers setting, because more than 50% of all AVRs for aortic stenosis are estimated to be due to BAVs according to a previous report [ 20 ].…”

“…By investing several extra minutes in additional anchoring sutures, we were able to achieve complete annulus fitting and substantially reduce the occurrence of PVL. We also believe that this complete annulus fitting contributed to the lower incidence of pacemaker implantation in our series (1.4% before discharge and 2.3% during follow-up) [ 10 ].…”

“…Concomitant procedures were more frequently performed in the BAV group (77.6% versus 59.0%, p=0.002), and this finding was primarily attributed to concomitant aorta surgery (63.3% versus 24.8%, p<0.001). The number of stitches for AVR was larger in the BAV group than in the TAV group (9 [IQR, [7][8][9][10][11] versus 9 [IQR, 5-10], p=0.024) (Supplementary Table 1).…”

“…Our group recently reported excellent early and mid-term outcomes of AVR using RD valves in a real-world all-comers population [ 10 ]. In that report, rapid-deployment AVR (RDAVR) using Edwards Intuity was performed for various indications, including bicuspid valve, pure aortic regurgitation, and infective endocarditis.…”

Rapid deployment versus its conventional counterpart in aortic valve replacement: comparison of early hemodynamic outcomes

“…Even in cases of aortic valves with elliptical opening, Intuity valve can be well-fixed and takes best advantage of our modified technique. Distorted geometry of native annulus was frequently observed, particularly in bicuspid aortic valves, and with additional anchoring sutures, the sewing ring of Intuity valve could be completely fitted to the native annulus ( 24 ). The skirt portion of Intuity valve also have advantages in reducing turbulent flow and optimizing the hemodynamic performance by reshaping the left ventricular outflow tract, particularly in patients with elliptical or distorted LVOT.…”