1. TRIVALVE Score: A Risk Score for Mortality/Hospitalization Prediction in Patients Undergoing Transcatheter Tricuspid Valve Intervention.
- Author
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Russo G, Pedicino D, Pires Marafon D, Adamo M, Alessandrini H, Andreas M, Braun D, Connelly KA, Denti P, Estevez-Loureiro R, Fam N, Hahn RT, Harr C, Hausleiter J, Himbert D, Kalbacher D, Ho E, Latib A, Lentini N, Lubos E, Ludwig S, Lurz P, Metra M, Monivas V, Nickenig G, Pastorino R, Pedrazzini G, Pozzoli A, Praz F, Rodes-Cabau J, Besler C, Rommel KP, Schofer J, Scotti A, Piayda K, Sievert H, Tang GHL, Thiele H, Schlotter F, von Bardeleben RS, Webb JG, Windecker S, Leon M, Enriquez-Sarano M, Maisano F, Crea F, and Taramasso M
- Subjects
- Humans, Risk Assessment, Male, Female, Risk Factors, Aged, Time Factors, Aged, 80 and over, Treatment Outcome, Reproducibility of Results, Clinical Decision-Making, Middle Aged, Predictive Value of Tests, Registries, Tricuspid Valve physiopathology, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Patient Readmission, Tricuspid Valve Insufficiency mortality, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery, Cardiac Catheterization adverse effects, Cardiac Catheterization mortality, Cardiac Catheterization instrumentation, Decision Support Techniques, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Heart Valve Prosthesis Implantation instrumentation, Severity of Illness Index
- Abstract
Background: Transcatheter tricuspid valve intervention (TTVI) has been increasingly adopted in recent years for the treatment of patients with tricuspid regurgitation (TR). However, no dedicated risk stratification has been established for patients undergoing TTVI., Objectives: The aim of the present study was to propose a dedicated risk score for patients affected by severe TR undergoing TTVI., Methods: The score was derived from the TRIVALVE (International Multisite Transcatheter Tricuspid Valve Therapies Registry; NCT03416166) registry, according to data availability. A stepwise model approach was used on predictor variables to develop a scoring system for predicting 12-month mortality or rehospitalization using multivariable logistic regression. Internal discrimination, calibration, and validation were assessed using receiver-operating characteristic curve analysis and bootstrapping with 1,000 resamples., Results: A total of 483 patients were included in the study, with an overall 12-month mortality or rehospitalization rate of 19% (n = 94). The final risk score, ranging from 0 to 4.5, included the following 5 parameters (adjusted for age and gender): 1) atrial fibrillation at baseline; 2) glomerular filtration rate <30 mL/min; 3) elevated gamma-glutamyl transferase/bilirubin levels; 4) signs of right heart failure; and 5) left ventricular ejection fraction <50%. The bias-corrected area under the receiver-operating characteristic curve was 68% (95% CI: 62%-75%). A cutoff value of 2.5 demonstrated sensitivity of 65.4% and specificity of 60.5% for the outcome., Conclusions: The present study proposes a dedicated risk score for patients undergoing TTVI, providing an additional and simple tool for heart teams to select the best therapy for patients affected by severe TR., Competing Interests: Funding Support and Author Disclosures Dr Russo has received a fellowship training grant from the European Association of Percutaneous Cardiovascular Interventions, sponsored by Edwards Lifesciences. Dr Adamo has received personal fees from Abbott Vascular, Medtronic, and Novartis. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has stock options with NaviGate; and is chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, and Zoll; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI Solutions. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences. Dr Estevez-Loureiro is a consultant for Abbott Vascular, Boston Scientific, and Edwards Lifesciences. Dr Nickenig has received honoraria for lectures or advisory board membership from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Schofer is a consultant for Edwards Lifesciences. Dr Sievert has received study honoraria to the institution, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Adona Medical, Akura Medical, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Cardiac Dimensions, Cardiac Success, Cardimed, Cardionovum, CeloNova Biosciences, Contego, Coramaze, CroíValve, CSL Behring, CVRx, Dinova, Edwards Lifesciences, EndoBar, Endologix, EndoMatic, Esperion Therapeutics, Hangzhou Nuomao Medtech, Holistick Medical, InterShunt Technologies, Intervene, K2, Laminar, Life Tech Care, Magenta, Maquet Getinge Group, Metavention, Mitralix, Mokita, Neurotronic, NXT Biomedical, Occlutech, Recor, Renal Guard, Shifamed, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, Vivasure Medical, Vvital Biomed, and WhiteSwell. Dr Tang has served as a physician proctor for Medtronic; has served as a consultant for Medtronic, Abbott Structural Heart, and NeoChord; has served on the transcatheter aortic valve replacement advisory board for Abbott Structural Heart; and has served on the physician advisory board for JenaValve. Dr von Bardeleben has served for trials and as a principal investigator for Abbott, Edwards Lifesciences, and Medtronic. Dr Windecker has received research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, Cardiovalve, CorFlow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, Infraredx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an advisory board member and/or a member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis, with payments to the institution but no personal payments; and is a member of the steering or executive committee groups of several investigator-initiated trials that receive funding from industry, without impact on his personal remuneration. Dr Enriquez-Sarano is a consultant for Edwards Lifesciences, ChemImage, Cryolife, and HighLife. Dr Maisano is a consultant for Abbott Vascular, Medtronic, Edwards Lifesciences, Perifect, Xeltis, Transseptal Solutions, Magenta, and Cardiovalve; has received grant support from Abbott Vascular, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties from Edwards Lifesciences and 4Tech; and is a cofounder and shareholder of Transseptal Solutions, 4Tech, Cardiovalve, Magenta, Perifect, Coregard and SwissVortex. Dr Taramasso has received consultancy fees from Abbott Vascular, Edwards Lifesciences, 4Tech, Boston Scientific, CoreMedic, Mitraltech, and SwissVortex (outside the submitted work). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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