COMPARISON OF POSTOPERATIVE ATRIAL FIBRILLATION, STROKE, MORTALITY, AND ECONOMIC OUTCOMES IN LOW-RISK TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PATIENTS: A SYSTEMATIC REVIEW USING THE PARTNER 3 TRIAL AS A COMPARATOR TO REAL-WORLD EVIDENCE
Author(s)
Anitha Rajagopalan, MS1, Mary E. Ritchey, PhD, FISPE2, Chintan Dave, PharmD, PhD1.
1Center for Health Outcomes, Policy, and Economic (HOPE), Rutgers University, New Brunswick, NJ, USA, 2Center for Health Outcomes, Policy, and Economic (HOPE), Rutgers University, Med Tech Epi, LLC, Philadelphia, Pennsylvania, New Brunswick, NJ, USA.
1Center for Health Outcomes, Policy, and Economic (HOPE), Rutgers University, New Brunswick, NJ, USA, 2Center for Health Outcomes, Policy, and Economic (HOPE), Rutgers University, Med Tech Epi, LLC, Philadelphia, Pennsylvania, New Brunswick, NJ, USA.
Presentation Documents
OBJECTIVES: To systematically evaluate real-world evidence (RWE) on postoperative atrial fibrillation (POAF), stroke, mortality, and economic outcomes in low-risk TAVR patients, and compare findings with the PARTNER 3 randomized trial.
METHODS: A systematic literature review was conducted for studies published January 1, 2019 - June 30, 2025, following PRISMA 2020 guidelines. Databases searched included PubMed, Embase, Scopus, Cochrane Library and registries. Eligible studies reported POAF, stroke, mortality, or economic outcomes in low-risk TAVR patients (STS-PROM ≤4% or study-defined). Data on patient characteristics, interventions, and outcomes were extracted. Risk of bias was assessed using ROBINS-I. Outcomes were synthesized narratively and compared with PARTNER 3.
RESULTS: Real-world low-risk populations were older (68-85 vs 73 years), with higher comorbidity (diabetes 14-48%, prior AF/AFL 0.3-35%) and more complex anatomy. Clinical outcomes showed higher AF/POAF (1-35% vs 5%), PPM implantation (1.8-19% vs 6.5%), stroke (0.6-3.3% vs 0.6%), 30-day mortality (0.7-4% vs 0.4%), and 1-year mortality (1-10.3% vs 1%). PVL, LOS (4-8.8 vs 3 days), and readmissions (1-24% vs 6.6%) were also increased. Trial-based economic outcomes (USD 2020) indicated that TAVR had lower cumulative costs than SAVR ($66,834 vs $68,864), shorter ICU LOS (0.8 vs 2.7 days), and slightly higher QALYs (+0.05). Real-world data (AUD 2017-2018) showed the TAVR index plus 30-day costs were lower than SAVR at a device cost of AUD 25,000 (-10%), but savings diminished at higher device prices. Risk of bias was moderate-to-serious due to confounding, inconsistent outcome definitions, and incomplete adjustment for confounders.
CONCLUSIONS: Real-world studies indicate that clinical outcomes of TAVR in low-risk patients, particularly POAF and 30-day stroke rates, are generally consistent with PARTNER 3. However, real-world economic evidence remains limited, emphasizing the need for further research to assess costs and resource utilization in this population to guide clinical and policy decisions.
METHODS: A systematic literature review was conducted for studies published January 1, 2019 - June 30, 2025, following PRISMA 2020 guidelines. Databases searched included PubMed, Embase, Scopus, Cochrane Library and registries. Eligible studies reported POAF, stroke, mortality, or economic outcomes in low-risk TAVR patients (STS-PROM ≤4% or study-defined). Data on patient characteristics, interventions, and outcomes were extracted. Risk of bias was assessed using ROBINS-I. Outcomes were synthesized narratively and compared with PARTNER 3.
RESULTS: Real-world low-risk populations were older (68-85 vs 73 years), with higher comorbidity (diabetes 14-48%, prior AF/AFL 0.3-35%) and more complex anatomy. Clinical outcomes showed higher AF/POAF (1-35% vs 5%), PPM implantation (1.8-19% vs 6.5%), stroke (0.6-3.3% vs 0.6%), 30-day mortality (0.7-4% vs 0.4%), and 1-year mortality (1-10.3% vs 1%). PVL, LOS (4-8.8 vs 3 days), and readmissions (1-24% vs 6.6%) were also increased. Trial-based economic outcomes (USD 2020) indicated that TAVR had lower cumulative costs than SAVR ($66,834 vs $68,864), shorter ICU LOS (0.8 vs 2.7 days), and slightly higher QALYs (+0.05). Real-world data (AUD 2017-2018) showed the TAVR index plus 30-day costs were lower than SAVR at a device cost of AUD 25,000 (-10%), but savings diminished at higher device prices. Risk of bias was moderate-to-serious due to confounding, inconsistent outcome definitions, and incomplete adjustment for confounders.
CONCLUSIONS: Real-world studies indicate that clinical outcomes of TAVR in low-risk patients, particularly POAF and 30-day stroke rates, are generally consistent with PARTNER 3. However, real-world economic evidence remains limited, emphasizing the need for further research to assess costs and resource utilization in this population to guide clinical and policy decisions.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
RWD37
Topic
Real World Data & Information Systems
Topic Subcategory
Reproducibility & Replicability
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)