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, MS;
Getinge, Senior Manager, Professional Affairs, East Brunswick, NJ, USA
Getinge, Senior Manager, Professional Affairs, East Brunswick, NJ, USA
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)