Left ventricular outflow tract (LVOT) calcium remains a challenge for transcatheter aortic valve implantation (TAVI) and is associated with an increased risk of debris embolization, permanent pacemaker requirement, and annular rupture. We report the results of the (EPROMPT) CoreValve Evolut PRO Prospective Registry, which sought to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter heart valve (THV) according to computed tomography-defined extent of LVOT calcium. The prospective, investigator-initiated, multicenter registry includes patients who underwent TAVI using the CoreValve Evolut PRO/PRO+ THV system. Analyzed patients were dichotomized on the basis of the severity of their LVOT calcium at baseline (none/mild vs moderate/severe). Patients were followed with 30-day clinical assessment and echocardiography. Of the 277 patients included, 177 had computed tomography-defined none/mild LVOT calcium (63.9%), and 100 had moderate/severe LVOT calcium (36.1%). Device success was similar in both cohorts (97.7% vs 95.0%; p = 0.217). Stroke rates were numerically higher in the moderate/severe LVOT calcium cohort (in-hospital and 30 day: 1.7% vs 4.0%; p = 0.240). Patients with none/mild LVOT calcium had higher rates of permanent pacemaker implantation (in-hospital: 21.5% vs 9.0%; p = 0.008 and 30-day: 22.0% vs 12.0%; p = 0.027). At 30 days, there were numerically higher rates of >mild paravalvular leak in patients with moderate/severe LVOT calcium (1.7% vs 4.0%; p = 0.240). Thirty-day mean gradients were similar (7.5 vs 7.6 mm Hg; p = 0.782). In conclusion, patients in the EPROMPT registry receiving the contemporary self-expanding CoreValve Evolut PRO/PRO+ THV demonstrated similar short-term outcomes and hemodynamics across the entire spectrum of LVOT calcium.
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http://dx.doi.org/10.1016/j.amjcard.2021.12.019 | DOI Listing |
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