3-Year Outcomes of Balloon-Expandable Valves: 20-mm vs Larger Valves (≥23 mm).

Background: A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry-based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV).
Objectives: The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes.
Methods: Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality.
Results: In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF).
Conclusions: Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes.
Competing Interests: Funding Support and Author Disclosures Dr Eng is a clinical proctor for Medtronic and Edwards Lifesciences. Dr Khalili has received a research grant from Edwards Lifesciences; and has received speaker fees from Abbott Vascular. Dr Vavalle is a consultant for Edwards Lifesciences. Dr Southard has received personal fees from Edwards Lifesciences and Boston Scientific. Dr Hahn has received speaker fees from Boston Scientific, Baylis Medical, Edwards Lifesciences, and Medtronic; has received consulting fees from Abbott Structural, Edwards Lifesciences, Gore Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity with Navigate; and is chief scientific officer of the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Wang has received research grant support from Boston Scientific; and is a consultant for Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Materialise. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology, the Society of Thoracic Surgeons, or the TVT Registry.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)