DOI: 10.5281/zenodo.18235163
title: Validation of the Study: Data Sources and Evidence The study synthesizes 25 years of registry data (2000–2025) to provide a comprehensive analysis of cardiac tamponade complicating Type A acute aortic dissection (AAD). The following sections outline the key data sources, their methodologies, and the evidence that validates the study's findings.

description: Cardiac Tamponade Complicating Type A Acute Aortic Dissection: Insights From 25 Years of Registry Research” (published in JACC: Advances in 2025) draws its primary data from the International Registry of Acute Aortic Dissection (IRAD), a well-established, multicenter, international collaborative registry founded in 1996. IRAD is widely regarded as one of the most authoritative and comprehensive sources for real-world data on acute aortic dissection, including type A cases (TAAAD).

Key Data Sources and Methodology

•  Primary Source: IRAD DatabaseThe analysis includes all enrolled adult patients with TAAAD from January 1996 to August 2022 across 63 high-volume aortic centers (42 in North America, 16 in Europe, and 5 in Asia). This spans approximately 26–27 years of prospective data collection, often rounded to “25 years” in summaries. The total cohort comprised 6,014 patients with TAAAD, of whom 865 (14.4%) presented with preoperative cardiac tamponade (TMP).IRAD uses standardized data collection forms, with ongoing updates over time to capture evolving variables (e.g., clinical presentation, imaging, management, and outcomes). Comparisons between TMP and non-TMP groups employed statistical tests such as Fisher’s exact test for categorical variables and Wilcoxon rank-sum/Mood’s median tests for continuous variables. Multivariable modeling identified factors linked to TMP presence, and Kaplan-Meier survival curves assessed long-term outcomes (median follow-up: 35.8 months, interquartile range 11.6–59.4 months).

•  Registry Strengths for ValidationIRAD is a prospective, multicenter registry designed specifically for acute aortic syndromes, minimizing selection bias common in single-center studies. It has produced numerous landmark publications on TAAAD epidemiology, risk factors, management, and prognosis. Earlier IRAD analyses (e.g., from 2009) reported higher TMP incidence (~18.7%) and in-hospital mortality (~54% with TMP vs. ~24.6% without), providing historical benchmarks that the current study updates and refines with a much larger, more contemporary cohort. The lower TMP rate in this analysis (14.4%) may reflect improved early recognition, diagnostic imaging, or shifts in patient demographics over time.

Evidence Supporting the Study’s Validity and Findings

•  Consistency with Prior IRAD and External DataThe findings align with established literature: TMP remains a high-risk feature in TAAAD, linked to older age, female sex (less male predominance), syncope, altered consciousness, and doubled in-hospital mortality (38.4% with TMP vs. 15.4% without; P < 0.001). Surgical management rates were similar between groups (~87.5–87.7%), and post-discharge long-term survival (e.g., 4-year) was comparable among hospital survivors (log-rank P = 0.767), emphasizing that TMP primarily impacts acute-phase outcomes.These results are consistent with prior IRAD reports and other studies on TAAAD complications, reinforcing the registry’s reliability.

•  Methodological RigorMulticenter design, large sample size, standardized definitions (e.g., preoperative TMP), and appropriate statistical adjustments enhance generalizability and reduce confounding. The study’s funding (partly from sources like W.L. Gore & Associates, common in aortic research) and author disclosures are transparently reported, with no evident conflicts undermining core conclusions.

•  Limitations Acknowledged in ContextSome variables may have incomplete entries due to evolving data forms over 25+ years, a common registry challenge. However, this does not invalidate the core comparisons or outcomes.

Overall, the study’s reliance on IRAD—a gold-standard, collaborative registry with decades of validated output—provides robust, high-quality evidence. The findings offer updated, comprehensive insights into TMP as a predictor of acute mortality in TAAAD while highlighting the benefit of prompt surgical intervention for survivors. This positions the analysis as a credible extension of prior IRAD work rather than an outlier.