Paravalvular leak with ACURATE neo and neo2: a comparative study with calcium quantification

Abstract

Introduction and objectives: Moderate or severe paravalvular leak (PVL) following transcatheter aortic valve implantation (TAVI) has been associated with worse outcomes. Aortic valve (AV) calcification is a strong predictor of PVL. ACURATE neo (Boston Scientific Corporation, United States) is a self-expanding transcatheter heart valve to treat degenerative aortic stenosis. We evaluated PVL after ACURATE neo and neo2 implantation, and the role of AV calcification. Methods: We analyzed patients referred for TAVI with ACURATE neo and neo2 from a large volume tertiary center. All cardiac computed tomography scans were analyzed using 3Mensio Structural Heart software (Pie Medical Imaging, The Netherlands). The volume of AV calcium was quantified using contrast-enhanced cardiac computed tomography series. The 30-day clinical and echocardiographic data were prospectively recorded. Results: We included 165 patients referred for TAVI with ACURATE (neo = 87; neo2 = 78). Median age was 82 years-old, 65% were women with a median EuroSCORE II of 4.7 [IQR, 2.4-6.1]. Patients in the neo group showed a larger amount of total AV calcium (320 mm 3 vs 200 mm 3 ; P = .0305). We found no significant inter-group differences regarding clinical outcomes both in-hospital or at 30-days. At 30-days, the rate of PVL ≥ mild (61% vs 34%; P < .001) and ≥ moderate (15.9% vs 5.4%; P = .0365) were higher in the neo group. After propensity score matching adjusted by the total amount of AV calcium, neo2 was associated with a lower risk of PVL ≥ mild (OR, 0.35, 95%CI, 0.18-0.69; P = .003), and ≥ moderate (OR, 0.16; 95%CI, 0.03-0.74; P = .019). Conclusions : TAVI with ACURATE neo2 vs neo is associated with a lower risk of any degree of PVL and a reduced risk of PVL ≥ moderate. After adjusting for AV calcium volume, ACURATE neo2 was still associated with a lower risk of PVL.