Achieving low mortality without a 'diffusion penalty': nationwide analysis of 412,947 elective atrial fibrillation ablations
K Inoue, K Kanaoka, Y Iwanaga, Y Ueda, H Abe, K Ikeoka, T Mishima, T Ozaki, T Ohashi, S Osaki, Y Sakata, Y MatsumuraAbstract
Background
The safety of atrial fibrillation (AF) ablation during rapid procedural dissemination remains controversial, with clinical registries reporting extremely low mortality compared with administrative databases suggesting 10-fold higher rates with worsening trends. (Ref 1, 2) Moreover, as observed in percutaneous coronary intervention (3) and transcatheter aortic valve replacement, (4) the widespread dissemination of complex cardiovascular technologies is historically associated with a transient deterioration in outcomes driven by the widening "efficacy-effectiveness gap" as procedures migrate from specialized centers to general practice: a phenomenon we refer to as a "diffusion penalty". We investigated whether this phenomenon occurred during the rapid nationwide expansion of elective catheter ablation for AF.
Methods
We utilized the JROAD-DPC nationwide database (Fiscal Years 2012–2022), which captures the vast majority of AF ablation in Japan, covering the rapid diffusion phase from "early adopters" to the "early majority". A major strength of this study is the strict reimbursement-linked verification of procedure codes, admission type (scheduled vs. emergency), and discharge status (survival vs. death). Leveraging this high-fidelity data, the cohort was restricted to scheduled elective admissions for transseptal AF ablation, systematically excluding emergency cases. The primary and secondary endpoints were mortality during index hospitalization and 30-day mortality during readmission, respectively.
Results
We analyzed 412,947 procedures. Consistent with the transition to the early majority phase, annual volume increased >5-fold (10,969 to 63,014), and participating centers expanded from 198 to 515. Patient complexity rose significantly: median age increased from 64 to 70 years, and patients with a Charlson Comorbidity Index (CCI) ≥3 increased from 2.5% to 5.9%. Despite this expansion, in-hospital mortality remained exceptionally low at 0.029% (119 deaths) and exhibited a statistically significant downward trend (P=0.037). (Figure 1) Thirty-day deaths during readmission were also rare (0.017%), indicating minimal uncaptured mortality risk. (Figure 2) Among deaths during the index hospitalization, the most frequent concurrent complications were cardiac tamponade (21.8%), pneumothorax/hemothorax (14.3%), and stroke (9.2%). In multivariable analysis, independent predictors of mortality included CCI ≥3 (OR 4.59; 95%CI 2.59–8.14) and low institutional volume (≤50 cases/year; OR 1.84; 95%CI 1.02–3.33), whereas age showed a modest association.
Conclusion
Rapid nationwide expansion of elective AF ablation was achieved while maintaining exceptionally low mortality despite increasing patient complexity. These findings demonstrate the absence of a "diffusion penalty" during the transition to general practice and establish a contemporary global safety benchmark for this complex cardiovascular therapy.Figure 1.Trends in In-Hospital MortalityFigure 2.Trends in 30-Day Outcomes