ABSTRACT
OBJECTIVES: This study sought to assess the clinical outcomes and hemodynamic performance associated with a strategy of underexpanding balloon-expandable transcatheter heart valves (THV) when excessive oversizing is a concern. BACKGROUND: Transcatheter aortic valve replacement depends on the selection of an optimally sized THV. An undersized THV may lead to paravalvular regurgitation, whereas excessive oversizing may lead to annular injury. METHODS: Patients (n = 47) who underwent transcatheter aortic valve replacement with an intentionally underexpanded THV (balloon-filling volume reduced ~10%) were compared with consecutive control patients who had nominal THV balloon deployment (n = 87). Pre- and post-procedural computed tomography imaging and echocardiography were performed to assess THV stent expansion and hemodynamics. RESULTS: Underfilling resulted in THV underexpansion that was maximal at the THV inflow (85.0 ± 7.4% vs. 102.5 ± 6.2%, p < 0.001), in study versus control groups, respectively. The study group received larger THV, although annular injury was not observed. Post-dilation was required in 10.6% and 4.6% of patients of the study and control groups, respectively (p = 0.165). Echocardiographic THV area, gradient, paravalvular regurgitation, and in-hospital outcomes were similar. CONCLUSIONS: Intentionally underexpanding balloon-expandable THV by underfilling the deployment balloon did not adversely affect procedural clinical outcomes, THV gradients, or THV areas. A strategy of underexpansion, with post-dilation as necessary, might play in role in reducing the risk of annular injury and paravalvular regurgitation in selected patients.
Subject(s)
Aortic Valve Stenosis/surgery , Cardiac Catheterization/methods , Heart Valve Prosthesis Implantation/methods , Patient Selection , Aged, 80 and over , Aortic Valve Stenosis/diagnosis , Echocardiography, Transesophageal , Female , Follow-Up Studies , Humans , Male , Multidetector Computed Tomography , Prosthesis Design , Tomography, X-Ray Computed , Treatment OutcomeABSTRACT
AIMS: We sought to assess the impact of low-profile sheaths on vascular complications during transfemoral transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: This retrospective single-study population comprised a total of 375 consecutive patients with severe aortic stenosis who underwent transfemoral TAVR from January 2008 to November 2012. Of these, 204 (54.4%) underwent TAVR using 14-18 Fr sheaths (low-profile sheath [LPS] group), and 171 (45.6%) using 19-24 Fr sheaths (high-profile sheath [HPS] group). Vascular complications and bleeding were defined according to the VARC-2 definitions. Lower-profile sheaths were associated with a lower incidence of major vascular complications (0.5% vs. 10.5%, p<0.001), as well as a lower rate of life-threatening or major bleeding (3.4% vs. 8.3%, p=0.038). Finally, at multivariable analysis, sheath size ≥19 Fr (adjusted odds ratio [OR]: 3.06, 95% confidence interval [CI]: 1.20-7.83; p=0.019) and a sheath external diameter/minimal femoral artery diameter ratio ≥1.05 (adjusted OR: 5.79, 95% CI: 1.29-15.92, p=0.022) were found to be the only independent predictors of major and minor vascular complications. CONCLUSIONS: The introduction of lower-profile sheaths has dramatically reduced the incidence of vascular complications after transfemoral TAVR, thus enhancing the safety of the procedure.