TY - BOOK AU - Rogers, Toby AU - Waksman, Ron TI - Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis SN - 0002-9149 PY - 2018/// KW - *Aortic Valve Stenosis/su [Surgery] KW - *Dilatation/mt [Methods] KW - *Heart Valve Prosthesis KW - *Transcatheter Aortic Valve Replacement/mt [Methods] KW - Acute Kidney Injury/ep [Epidemiology] KW - Aged KW - Aged, 80 and over KW - Bundle-Branch Block/ep [Epidemiology] KW - Bundle-Branch Block/th [Therapy] KW - Cardiac Pacing, Artificial KW - Echocardiography KW - Female KW - Hemodynamics KW - Humans KW - Male KW - Mortality KW - Myocardial Infarction/ep [Epidemiology] KW - Pacemaker, Artificial KW - Severity of Illness Index KW - Stroke/ep [Epidemiology] KW - Treatment Outcome KW - MedStar Heart & Vascular Institute KW - Journal Article N1 - Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006 N2 - Copyright (c) 2018 Elsevier Inc. All rights reserved; The impact of predilatation (Pre-Dil) on prosthesis hemodynamics and clinical outcomes of subjects who underwent transcatheter aortic valve implantation (TAVI) with a self-expanding prosthesis remains unclear. Two thousand seven hundred twenty-one subjects from the extreme- and high-risk CoreValve Continued Access Study (CAS) were included in the analysis. Subjects who underwent Pre-Dil before TAVI were compared with subjects who underwent TAVI without Pre-Dil. Clinical outcomes included death, stroke, myocardial infarction, acute kidney injury, and new permanent pacemaker implantation. Serial echocardiograms were analyzed to evaluate prosthesis hemodynamics, specifically paravalvular regurgitation, effective orifice area, and mean gradient. Two thousand one hundred eighteen and 603 subjects underwent TAVI with and without Pre-Dil, respectively. Subjects in the Pre-Dil cohort were more commonly male, while subjects in the no Pre-Dil cohort had higher rates of previous stroke and lower mean aortic valve gradients. Outcomes at 30 days were comparable between Pre-Dil and no Pre-Dil subjects, with no significant difference in mortality (5.5% vs 4.3%, p=0.27), major stroke (2.6% vs 2.2%, p=0.54), major vascular complications (6.9% vs 8.0%, p=0.37), major bleeding (24.4% vs 26.1%, p=0.40), and permanent pacemaker implantation (21.3% vs 23.4%, p=0.36). There were no significant differences in the same outcomes at 12 months. Effective orifice area and mean gradient were comparable between Pre-Dil and no-Pre-Dil subjects at discharge, at 30 days, and at 12 months. In conclusion, when performing TAVI with the self-expanding CoreValve device, performing direct implantation without Pre-Dil maintains an acceptable safety profile and still achieves desired and consistent prosthesis hemodynamics UR - https://dx.doi.org/10.1016/j.amjcard.2018.02.008 ER -