Potentially futile outcome after uncomplicated TAVI: Insights from the TRITAVI registry.
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D'Ascenzo Fabrizio, De Filippo Ovidio, Pelliccia Francesco, Pasceri Vincenzo, Dangas George, Mehran Roxana, Porto Italo, Radico Francesco, Biancari Fausto, Saia Francesco, Luzi Giampaolo, Bedogni Francesco, Santos Ignacio J Amat, De Marzo Vincenzo, Dimagli Arnaldo, Mäkikallio Timo, Sandrone Samuele, Stabile Eugenio, B-Turrión Sara, Testa Luca, Barbanti Marco, Costa Giuliano, Fabbiocchi Franco, Chilmeran Ahmed, Stefanini Giulio, Conrotto Federico, Tamburino Corrado, Spaccarotella Carmen, Cao Davide, Macchione Andrea, La Torre Michele, Bendandi Francesco, Wańha Wojciech, Wojakowski Wojtek, Benedetto Umberto, Indolfi Ciro, Hildick-Smith David, Capodanno Davide, Miraldi Fabio, Dobrev Dobromir, Zimarino Marco, TRITAVI study group.
Аннотация
METHODS: Transfusion requirements in transcatheter aortic valve implantation (TRITAVI; NCT03740425) is an international, investigator-initiated registry designed to collect data on patients with symptomatic severe aortic stenosis undergoing TAVI at 18 European sites. The primary end point of the study was all-cause death occurring in patients between 30 days and 1 year without major peri‑procedural complications (major vascular complications, stage 2 to 3 acute kidney injury (AKI) and transfusions) during the procedure.
RESULTS: A total of 11,246 patients were included (mean age 82 years; 52% female). Among them, 454 (4%) died between 1 and 12 months without major peri‑procedural complications. Patients who died were also elderly (mean age 82 years) and 50% were female. Of these, 78 (0.7%) died for cardiovascular reasons, while 376 (3.3%) died for noncardiovascular reasons. COPD (HR: 1.35, 95% CI: 1.05-1.73, P = .002), Atrial Fibrillation (HR: 1.46, 95% CI: 1.16-1.84, P = .001), severe Chronic Kidney Disease (CKD) (HR: 1.70, 95% CI: 1.10-2.62, P = .018), moderate and severe reduction of LVEF (respectively HR: 1.42, 95% CI: 1.07-1.90, P = .017 and HR 1.62, 95% CI 1.17-2.23, P = .003) were associated with and increased risk of the primary end point. At competitive risk analysis, risk of non-CV death appeared to be more relevant and to steadily increase across the year, while risk of CV death was lower. Consistently, baseline creatinine (HR: 1.2, 95% CI: 1.1-1.4, P = .002) and AF (HR: 1.4, 95% CI: 1.1-1.8, P = .008) related to increased risk of non-CV death, while higher baseline LVEF related to lower risk (HR: 0.9, 95% CI: 0.8-0.99, P < .001).
CONCLUSION: Risk of death between 30 days and 1 year after noncomplicated TAVI is not negligible even for patients without major peri‑procedural complications. It appears mainly driven by non-CV reasons and predicted by baseline renal function, baseline LVEF, and atrial fibrillation.