Predictors of paravalvular leak following implantation of the ACURATE neo transcatheter heart valve: the PREDICT PVL study

Abstract

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.

Cerebral embolic protection during transcatheter aortic valve replacement: Insights from a consecutive series with the Sentinel cerebral protection device

“…Data were analyzed using a commercially available post‐processing software (Merlin, Phoenix‐PACS). Calcification of the aortic valve leaflets and left ventricular outflow tract (LVOT) were visually assessed on a scale from 0 to 3 (none, mild, moderate, extensive) 12 …”

“…Calcification of the aortic valve leaflets and left ventricular outflow tract (LVOT) were visually assessed on a scale from 0 to 3 (none, mild, moderate, extensive). 12 All Sentinel CPS devices were deployed by experienced operators trained in TAVR, radial access, and coronary interventions. TAVR was performed via transfemoral access whenever possible, with local anesthesia under conscious sedation.…”

Relevance of Motion Artifacts in Planning Computed Tomography on Outcomes After Transcatheter Aortic Valve Implantation

“…TAVI-planning CT was obtained in all patients with a Flash Dual Source scanner, Siemens Somatom Definition Flash (Siemens Medical, Erlangen, Germany) with ECG triggering in retrospective mode as previously described. 6 , 7 The phase between 30% and 70% of the heart rate was recorded and reconstruction was performed during systole as well as diastole. The complete data set was transferred to a dedicated postprocessing workstation, measurements and analyses were performed with a commercially available software (Merlin, Phoenix-PACS, Freiburg, Germany).…”

The management of paravalvular leaks post aortic valve replacement

“…This study was conducted 5 years ago. Since then the incidence of PVL, post‐TAVI, has decreased significantly over time; with improvements in transcatheter heart valve technology and implementation of an outer skirt that creates better annular sealing 15 …”