TY - JOUR
T1 - Derivation and Validation of a Clinical Risk Score for COAPT-Ineligible Patients Who Underwent Transcatheter Edge-to-Edge Repair
AU - MiZüBr and GIOTTO Investigators
AU - Scotti, Andrea
AU - Latib, Azeem
AU - Rubbio, Antonio Popolo
AU - Testa, Luca
AU - Adamo, Marianna
AU - Denti, Paolo
AU - Melillo, Francesco
AU - Taramasso, Maurizio
AU - Sisinni, Antonio
AU - De Marco, Federico
AU - Grasso, Carmelo
AU - Giordano, Arturo
AU - Bartorelli, Antonio L.
AU - Buzzatti, Nicola
AU - Citro, Rodolfo
AU - De Felice, Francesco
AU - Indolfi, Ciro
AU - Monteforte, Ida
AU - Villa, Emmanuel
AU - Giannini, Cristina
AU - Petronio, Anna Sonia
AU - Crimi, Gabriele
AU - Tarantini, Giuseppe
AU - Colombo, Antonio
AU - Agricola, Eustachio
AU - Metra, Marco
AU - Zangrillo, Alberto
AU - Margonato, Alberto
AU - Tamburino, Corrado
AU - Maisano, Francesco
AU - Bedogni, Francesco
AU - Godino, Cosmo
N1 - Funding Information:
The GIOTTO registry is an independent study sponsored by the Italian Society of Invasive Cardiology, including an unrestricted grant of moderate amount by Abbott Vascular, Santa Clara, California.
Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2023/1/1
Y1 - 2023/1/1
N2 - Up to half of real-world patients with secondary mitral regurgitation who underwent transcatheter edge-to-edge repair (TEER) do not meet the highly selective COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) criteria. No randomized trials or standardized and validated tools exist to evaluate the risk: benefit ratio of TEER in this specific population. We sought to derive and externally validate a clinical risk score to predict the risk of death or heart failure (HF) hospitalization for COAPT-ineligible patients who underwent TEER (CITE score). The study population consisted of patients with secondary mitral regurgitation having at least 1 exclusion criterion of the COAPT trial. The derivation cohort included 489 patients from the GIOTTO (GIse registry of Transcatheter treatment of Mitral Valve regurgitaTiOn) registry. Cox proportional hazards regression was used to identify predictors of 2-year death/HF hospitalization and develop a numerical risk score. The predictive performance was assessed in the derivation cohort and validated in 268 patients from the MiZüBr (Milan-Zürich-Brescia) registry. The CITE score (hemodynamic instability, left ventricular impairment, New York Heart Association class III/IV, peripheral artery disease, atrial fibrillation, brain natriuretic peptide, and hemoglobin) showed a c-index for 2-year death or HF hospitalization of 0.70 (95% confidence interval [CI] 0.67 to 0.73) in the derivation cohort, and 0.68 (95% CI 0.64 to 0.73) in the validation cohort. A cutoff of <12 points was selected to identify patients at lower risk of adverse outcomes, hazard ratio of 0.35 (95% CI 0.26 to 0.46). In conclusion, the CITE score is a simple 7-item tool for the prediction of death or HF hospitalization at 2 years after TEER in COAPT-ineligible patients. The score may support clinical decision-making by identifying those patients who, even if excluded from clinical trials, can still benefit from TEER.
AB - Up to half of real-world patients with secondary mitral regurgitation who underwent transcatheter edge-to-edge repair (TEER) do not meet the highly selective COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) criteria. No randomized trials or standardized and validated tools exist to evaluate the risk: benefit ratio of TEER in this specific population. We sought to derive and externally validate a clinical risk score to predict the risk of death or heart failure (HF) hospitalization for COAPT-ineligible patients who underwent TEER (CITE score). The study population consisted of patients with secondary mitral regurgitation having at least 1 exclusion criterion of the COAPT trial. The derivation cohort included 489 patients from the GIOTTO (GIse registry of Transcatheter treatment of Mitral Valve regurgitaTiOn) registry. Cox proportional hazards regression was used to identify predictors of 2-year death/HF hospitalization and develop a numerical risk score. The predictive performance was assessed in the derivation cohort and validated in 268 patients from the MiZüBr (Milan-Zürich-Brescia) registry. The CITE score (hemodynamic instability, left ventricular impairment, New York Heart Association class III/IV, peripheral artery disease, atrial fibrillation, brain natriuretic peptide, and hemoglobin) showed a c-index for 2-year death or HF hospitalization of 0.70 (95% confidence interval [CI] 0.67 to 0.73) in the derivation cohort, and 0.68 (95% CI 0.64 to 0.73) in the validation cohort. A cutoff of <12 points was selected to identify patients at lower risk of adverse outcomes, hazard ratio of 0.35 (95% CI 0.26 to 0.46). In conclusion, the CITE score is a simple 7-item tool for the prediction of death or HF hospitalization at 2 years after TEER in COAPT-ineligible patients. The score may support clinical decision-making by identifying those patients who, even if excluded from clinical trials, can still benefit from TEER.
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U2 - 10.1016/j.amjcard.2022.10.024
DO - 10.1016/j.amjcard.2022.10.024
M3 - Article
C2 - 36356428
AN - SCOPUS:85143379741
SN - 0002-9149
VL - 186
SP - 100
EP - 108
JO - American Journal of Cardiology
JF - American Journal of Cardiology
ER -