ObjectivesReport predictors and the natural course of paravalvular leak (PVL) following implantation of the ACURATE neo transcatheter heart valve (THV).BackgroundUnderstanding the mechanisms of PVL may help to improve patient selection, patient outcomes and the design of next-generation THVs.MethodsA total of 30 patients (mean age 81±5 years, 47% women) undergoing transcatheter aortic valve replacement with the ACURATE neo were enrolled in the PREDICT PVL study. The effective regurgitant orifice area (EROA, in mm2) of PVL was assessed by transthoracic and transoesophageal echocardiography before discharge and at 6 months follow-up.ResultsPVL was none/trace in 10 (33%), mild in 18 (60%) and moderate in 2 (7%) patients and occurred in distinct locations with largest EROAs in the area of the left coronary cusp and its adjacent commissures. Independent predictors for EROA were implantation depth (r coefficient −1.9 mm2 per mm implantation depth, p=0.01), leaflet calcification (6.2 mm2 per calcification grade, p=0.03) and THV size L (7.6 mm2 more than size S or M, p=0.01). At 6 months follow-up, EROA decreased by 29% from 13.7±9.7 mm2 to 9.5±7.9 mm2 (p<0.01). Patients with smaller EROAs were more likely to be in New York Heart Association class 1 than patients with larger EROAs (p<0.01).ConclusionsPVL occurred predominantly in the region of the left coronary cusp and decreased by 29% during 6 months of follow-up. Our results underscore the importance of adequate patient selection and optimal implantation depth.
Background: Patients with severe kidney disease and severe aortic stenosis requiring transcatheter aortic valve implantation (TAVI) represent a growing cohort. In this context, we investigated the feasibility and safety of a novel integrated approach, including gadolinium-free magnetic resonance tomography (MR) in order to minimize use of any contrast media (CM) in those patients.Methods and results: Out of a cohort of 168 patients undergoing TAVI, 20 (12%) patients with severe chronic kidney disease (CKD) were managed by applying an integrated approach using minimal dosage of CM. Coronary angiographies were performed with 54±35 ml and 85±44 ml of CM in patients with severe CKD and patients without severe CKD, respectively (p <0.01). In patients with severe CKD, gadolinium-free magnetic resonance tomographies (MR) were performed for annular and iliofemoral assessment. All other patients were screened with ECGgated multislice computed tomography using 63±14 ml of CM. In patients with severe versus without severe CKD, TAVIs were performed with 40± 32 ml versus 112±50 ml of contrast media, respectively (p <0.01). During followup, stage 2 or 3 acute kidney injury (AKI) occurred in 1 (5%) versus 4 (2.8%, p = 0.05). At 30 days, there were no strokes, and survival was 100% and 98%, respectively. Conclusions: We were able to reduce the total amount of CM required for pre-procedural planning and TAVI by 64% from 260±79 ml to 94±54 ml. This study indicates that gadolinium-free MR can be used for pre-procedural annular and iliofemoral assessment, and thus selection of prosthesis size.
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