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BACKGROUND: Radial access is the default approach in interventional cardiology. The Axiostat® surgical hemostatic dressing, using chitosan as its active component, has demonstrated potential in accelerating blood clotting. This study aims to assess the efficacy and the safety of the Axiostat® dressing in achieving hemostasis in patients undergoing transradial coronary angioplasty (TRCA). METHODS: This prospective, single-center observational study, conducted in 2022, enrolled consecutive patients undergoing TRCA, with a target of 150 participants. The primary outcome was the success rate of radial artery hemostasis at 120 min, without bleeding necessitating immediate re-compression. The secondary outcome included Axiostat® performance at 24 h and 30 days Postprocedure. RESULTS: The study was terminated prematurely for ethical and patient safety reasons, after inclusion of 41 consecutive TRCA patients due to an unexpectedly high radial artery thrombosis rate (19.5%, n = 8/41) observed 24 h Postprocedure. The success rate of radial hemostasis with the Axiostat® dressing was 78.0%. Procedural details and patient characteristics were comparable between successful Axiostat® removal and device failure cases. CONCLUSION: The use of the Axiostat® dressing to achieve hemostasis after TRCA is effective but is associated with an unexpectedly high incidence of radial thrombosis. Our results should encourage caution in the future evaluation and use of this device for radial artery compression following TRCA.
RESUMO
OBJECTIVE: The aim of our study was to evaluate the outcome of patients with severe aortic stenosis presenting with acute decompensated heart failure (ADHF) and planned for transcatheter aortic valve implantation (TAVI) and to study the variables influencing their prognosis. METHODS: Our retrospective study included 801 patients planned for TAVI in our center. Seven hundred and fifty-six underwent TAVI and were categorized according to ADHF as the initial clinical presentation into two groups: ADHF group (n = 261) and no-ADHF group (n = 495). Pre as well as periprocedural outcomes and 1 year mortality were analyzed. RESULTS: Among the patients planned for the TAVI procedure, 45 patients remained untreated: 35 patients died while waiting to undergo TAVI which represented 20% of all deaths in our study, ADHF was observed in 23 of 45 (51%) these untreated patients. The 1-year all-cause mortality rate was significantly higher in the ADHF group versus the no-ADHF group (27% vs. 15%, p < .0001). In multivariate analysis, male gender (odds ratio [OR] =2.5, 95% confidence interval [CI]: 1.37-4.57, p = .03), body mass index <25 kg/m2 (OR = 2.76, 95% CI: 1.51-5.04, p = .0009), and logistic EuroSCORE II ≥20% (OR = 3.04, 95% CI: 1.56-5.94, p = .001) were associated with a higher 1-year mortality in the ADHF group. CONCLUSION: The patients eligible for TAVI presenting with ADHF were associated with a higher mortality for both: while on the waiting list for TAVI as well as at 1-year follow-up and thus asking for clearer criteria to prioritize action in this high-risk TAVI patients.
