Because an uncovered arch scaffold does not provide a covered seal across an unresected arch tear, we evaluated a source-adjudicated sequential eligibility framework separating study-defined stop gates from residual-risk modifiers. Methods: We retrospectively analyzed 266 patients with acute DeBakey type I dissection treated by hemiarch repair alone (No. = 160) or hemiarch plus AMDS (No. = 106). Blinded preoperative CT-scan re-review validated Gate 1 (visible arch tear), and operative-report review confirmed Gate 2 (tear directly observed at open inspection). Supra-aortic false-lumen communication was assessed only after both gates were negative. Results: Sixty-nine patients (25.9%) passed both study-defined gates (AMDS = 32; hemiarch = 37). Twelve-month CT-scan was available in 45/69 (65.2%; AMDS 24/32, hemiarch 21/37). Among imaged patients, complete zone 2–3 false-lumen exclusion occurred in 20/24 (83.3%) after AMDS and 0/21 after hemiarch (risk difference +83.3 percentage points, 95% CI +58.7 to +93.3; p < 0.001). DANE occurred in 4/32 (12.5%) and 16/37 (43.2%), respectively (p = 0.007). Under the adverse opposing missingness scenario, the exclusion risk difference narrowed to +19.3 percentage points (95% CI −4.2 to +39.9; p = 0.148). Conclusions: These findings are hypothesis-generating and apply to a selected post hoc subgroup; treatment comparisons are non-causal. Prospective external validation of the study-defined hierarchy remains required.

Sequential Arch-Tear Eligibility for Uncovered Aortic Arch Stent in Acute DeBakey Type I Aortic Dissection / Petrone, D.. - In: JOURNAL OF CARDIOVASCULAR DEVELOPMENT AND DISEASE. - ISSN 2308-3425. - STAMPA. - 13:(2026), pp. 10.1-10.14. [10.3390/jcdd13100496]

Sequential Arch-Tear Eligibility for Uncovered Aortic Arch Stent in Acute DeBakey Type I Aortic Dissection

Petrone Dario;Bruno Chiarello;Giulia Bessi;Beatrice Bacchi;Francesco Cabrucci;Antonio Rosciano;Massimo Bonacchi.
2026

Abstract

Because an uncovered arch scaffold does not provide a covered seal across an unresected arch tear, we evaluated a source-adjudicated sequential eligibility framework separating study-defined stop gates from residual-risk modifiers. Methods: We retrospectively analyzed 266 patients with acute DeBakey type I dissection treated by hemiarch repair alone (No. = 160) or hemiarch plus AMDS (No. = 106). Blinded preoperative CT-scan re-review validated Gate 1 (visible arch tear), and operative-report review confirmed Gate 2 (tear directly observed at open inspection). Supra-aortic false-lumen communication was assessed only after both gates were negative. Results: Sixty-nine patients (25.9%) passed both study-defined gates (AMDS = 32; hemiarch = 37). Twelve-month CT-scan was available in 45/69 (65.2%; AMDS 24/32, hemiarch 21/37). Among imaged patients, complete zone 2–3 false-lumen exclusion occurred in 20/24 (83.3%) after AMDS and 0/21 after hemiarch (risk difference +83.3 percentage points, 95% CI +58.7 to +93.3; p < 0.001). DANE occurred in 4/32 (12.5%) and 16/37 (43.2%), respectively (p = 0.007). Under the adverse opposing missingness scenario, the exclusion risk difference narrowed to +19.3 percentage points (95% CI −4.2 to +39.9; p = 0.148). Conclusions: These findings are hypothesis-generating and apply to a selected post hoc subgroup; treatment comparisons are non-causal. Prospective external validation of the study-defined hierarchy remains required.
2026
13
1
14
Petrone, Dario, Bruno Chiarello, Giulia Bessi, Alan Ciardo, Beatrice Bacchi, Francesco Cabrucci, Aleksander Dokollari, Antonio Rosciano, Edvin Prifti,...espandi
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1492472
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