Early Clinical Outcomes of Transcatheter Aortic Valve Replacement in Left Ventricular Outflow Tract Calcification: New-Generation Device vs Early-Generation Device.

ABSTRACT

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in cases with left ventricular outflow tract calcification (LVOT-CA) remains a challenging procedure. The aim of this study was to compare the early outcomes of patients undergoing TAVR in LVOT-CA with new-generation devices vs early-generation devices. METHODS: Between January 2014 and December 2016, a total of 433 patients with severe aortic stenosis who had a preprocedural multidetector computed tomography underwent TAVR in a LVOT-CA. After propensity matching, data from 119 patients in each group were analyzed. TAVR endpoints and adverse events were defined according to the Valve Academic Research Consortium-2. RESULTS: Compared with early-generation devices (Edwards Sapien/Sapien XT/CoreValve), new-generation devices (Sapien 3/Evolut R) had significantly lower incidence of mild-moderate paravalvular leak (PVL) (1.7% new vs 7.6% early; P=.03), tended to have lower incidence of moderate or severe PVL (5.0% new vs 11.8% early; P=.06), had no significant difference in device success (89.1% new vs 83.2% early; P=.19), and had a significantly higher early safety rate at 30 days (93.3% new vs 84.9% early; P=.04). For cardiac conduction disturbances, new-generation and early-generation devices had similarly high rates of new permanent pacemaker implantation (16.8% new vs 15.1% early; P=.72), whereas the number of patients who developed new-onset left bundle-branch block (LBBB) were significantly higher in those with new-generation devices (16.0% new vs 6.7% early; P=.03). CONCLUSION: In the setting of LVOT-CA, patients with new-generation devices compared to those with early-generation devices had acceptable clinical outcomes except for cardiac conduction disturbances, especially in new-onset LBBB.