Outcomes of Early vs Delayed Aortic Valve Replacement: Analysis of the EARLY TAVR Valve Implant Population
Recommended Citation
Généreux P, Schwartz A, Pibarot P, Lindman BR, Cohen DJ, Oldemeyer JB, Fearon WF, Babaliaros V, Daniels D, Chhatriwalla AK, Suradi HS, Shah PB, Szerlip M, Mack MJ, Dahle T, Goel K, O'Neill WW, Davidson CJ, Makkar RR, Sheth T, Williams M, Russo MJ, Guerrero M, McCabe J, Leipsic J, Zhao Y, Hahn RT, Blanke P, and Leon MB. Outcomes of Early vs Delayed Aortic Valve Replacement: Analysis of the EARLY TAVR Valve Implant Population. JACC Cardiovasc Interv 2025;18(22):2761-2773.
Document Type
Article
Publication Date
11-24-2025
Publication Title
JACC Cardiovasc Interv
Keywords
Humans, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Time Factors, Male, Female, Treatment Outcome, Risk Factors, Aged, Aortic Valve, Aged, 80 and over, Severity of Illness Index, Time-to-Treatment, Risk Assessment, Asymptomatic Diseases, Heart Valve Prosthesis, Stroke, Heart Failure, United States
Abstract
BACKGROUND: For patients with asymptomatic, severe aortic stenosis (AS), the EARLY TAVR (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis) trial demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) with respect to the primary endpoint in the intention-to-treat population.
OBJECTIVES: The aim of this study was to compare postprocedural outcomes in the valve implant population.
METHODS: The valve implant population comprised patients randomized to early TAVR who underwent the procedure and those randomized to CS who underwent delayed aortic valve replacement (AVR). The impact of the clinical presentation at time of delayed AVR was also assessed as progressive valve syndrome (eg, NYHA functional class II) vs acute valve syndrome (AVS; eg, NYHA functional class III or IV, syncope). The primary outcome was the composite of death, stroke, or heart failure hospitalization 2 years postprocedure.
RESULTS: Across 75 sites, 97.6% of early TAVR patients (444 of 455) underwent the index procedure, and 87.0% of CS patients (388 of 446) underwent delayed AVR through 5 years; 39.2% presented with AVS and 58.5% with progressive valve syndrome (median time to delayed AVR 11.1 months). Early TAVR demonstrated a benefit compared with delayed AVR for the primary composite (adjusted HR [aHR]: 0.61; 95% CI: 0.38-0.99; P = 0.045). When examined by clinical presentation, delayed AVR with AVS was significantly associated with worse outcomes compared with early TAVR (aHR: 2.12; 95% CI: 1.19-3.78; P = 0.01), driven largely by stroke (aHR: 2.92; 95% CI: 1.26-6.76; P = 0.01).
CONCLUSIONS: Among patients with asymptomatic, severe AS, delayed AVR with AVS is associated with higher rates of death, stroke, or heart failure hospitalization compared with early TAVR, highlighting a benefit for early TAVR before symptoms develop given the unpredictability of AS progression. (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis [EARLY TAVR]; NCT03042104).
Medical Subject Headings
Humans; Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Time Factors; Male; Female; Treatment Outcome; Risk Factors; Aged; Aortic Valve; Aged, 80 and over; Severity of Illness Index; Time-to-Treatment; Risk Assessment; Asymptomatic Diseases; Heart Valve Prosthesis; Stroke; Heart Failure; United States
PubMed ID
41297989
Volume
18
Issue
22
First Page
2761
Last Page
2773
