3-Year Outcomes of Balloon-Expandable Valves: 20-mm vs Larger Valves (≥23 mm)
Recommended Citation
Eng MH, Khalili H, Vavalle J, Al-Azizi KM, Waggoner T, Southard JA, Fang K, Hahn RT, Lee J, Wang DD, Eleid MF, O'Neill WW, and Abbas AE. 3-Year Outcomes of Balloon-Expandable Valves: 20-mm vs Larger Valves (≥23 mm). JACC Cardiovasc Interv 2024.
Document Type
Article
Publication Date
9-9-2024
Publication Title
JACC Cardiovasc Interv
Abstract
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 (Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes.
Medical Subject Headings
Humans; Male; Female; Heart Valve Prosthesis; Registries; Time Factors; Prosthesis Design; Treatment Outcome; Aged; Risk Factors; United States; Balloon Valvuloplasty; Aged, 80 and over; Aortic Valve; Transcatheter Aortic Valve Replacement; Risk Assessment; Hemodynamics; Aortic Valve Stenosis; Recovery of Function; Retrospective Studies; Heart Valve Prosthesis Implantation
PubMed ID
39177555
ePublication
ePub ahead of print
Volume
17
Issue
17
First Page
2041
Last Page
2051