Simple Index for Identifying Patients at Increased Risk of Suboptimal Forward-Flow Hemodynamics After Transcatheter Aortic Valve Replacement.
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Leone Pier Pasquale, Regazzoli Damiano, Sturla Matteo, Millin Antonella, Pagnesi Matteo, Torrado Juan, Echarte-Morales Julio, Cannata Francesco, Teles Rui Campante, Adamo Marianna, Taramasso Maurizio, De Marco Federico, Giannini Francesco, Ohno Yohei, Saia Francesco, Buono Andrea, Ielasi Alfonso, Ribichini Flavio, Maffeo Diego, Bedogni Francesco, Kim Won-Keun, Maisano Francesco, Van Mieghem Nicolas, Barbanti Marco, Costa Giuliano, Assafin Manaf, Ho Edwin C, Colombo Antonio, Reimers Bernhard, Herrmann Howard C, Latib Azeem
Аннотация
METHODS: The TAVI-SMALL 2 (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli 2) observational, retrospective, international cohort study enrolled patients with severe aortic stenosis and small annuli in 16 high-volume centers between 2011 and 2020. Analyses comparing patients with low (ie, ≤2 cm2/m2) and high AAA index (ie, >2 cm2/m2) were conducted adopting propensity score methodology. Primary end points were predischarge device forward-flow composite (including mean aortic gradient ≥20 mm Hg or severe prosthesis-patient mismatch), and clinical efficacy composite (including all-cause death, transient ischemic attack/stroke, or hospitalization for heart failure) at 1-year follow-up.
RESULTS: A total of 1256 patients were included in the analysis. In the 1:1 propensity score-matched population (n=688), the primary predischarge forward-flow composite end point occurred in 48 patients (7.5%) overall and was more common in low versus high AAA index (9.7% versus 5.3%, P=0.034). The primary composite clinical efficacy end point occurred in 95 patients (18.1%), and no difference between groups was observed at 1-year follow-up (11.5% [95% CI, 7.8%-16.8%] versus 14.4% [95% CI, 10.4%-19.9%], hazard ratio, 0.89 [95% CI, 0.59-1.33]; Plog-rank=0.842).
CONCLUSIONS: Among patients with small aortic annuli undergoing transcatheter aortic valve replacement, the novel AAA index further identifies patients at increased risk of predischarge suboptimal forward-flow hemodynamics. No difference in clinical efficacy at 1-year follow-up was observed according to the AAA index.