Sylvestre Maréchaux1, Dan Rusinaru2, Yannick Jobic3, Stéphane Ederhy4, Erwan Donal5, Patricia Réant6, Elise Arnalsteen7, Jacques Boulanger8, Thierry Garban9, Pierre-Vladimir Ennezat10, Antoine Jeu2, Catherine Szymanski11, Christophe Tribouilloy12. 1. INSERM U 1088, Université de Picardie, Amiens, France Université Lille Nord de France, GCS-Groupement des Hôpitaux de l'Institut Catholique de Lille/Faculté de médecine et de maïeutique, Université Catholique de Lille, Lille 59000, France. 2. Pôle cardiovasculaire et thoracique, Centre Hospitalier Universitaire Amiens, Amiens, France. 3. Département de Cardiologie, Hôpital de la Cavale Blanche, Brest 29609, France. 4. Hôpital Saint-Antoine, Université Pierre et Marie Curie, Paris VI, Service de Cardiologie, Paris 75012, France. 5. Service de Cardiologie et Maladies Vasculaires et CIC-IT 804, LTSI INSERM U 642, Centre Hospitalier Universitaire Rennes, Hôpital Pontchaillou, Rennes, France. 6. Hôpital Cardiologique Haut - Lévêque, Centre Hospitalier Universitaire de Bordeaux, CIC0005, Pessac 33604, France Université Bordeaux 2, Bordeaux 33000, France. 7. Service de Médecine Interne et Cardiologie, Centre Hospitalier de Beauvais, Beauvais 60021, France. 8. Centre Hospitalier de Compiègne, Service de Cardiologie, Compiègne 60200, France. 9. Hôpital Universitaire G et R Laennec, Nantes, France. 10. Centre Hospitalier Régional et Universitaire de Lille, Hôpital cardiologique, Lille 59037, France. 11. INSERM U 1088, Université de Picardie, Amiens, France Pôle cardiovasculaire et thoracique, Centre Hospitalier Universitaire Amiens, Amiens, France. 12. INSERM U 1088, Université de Picardie, Amiens, France Pôle cardiovasculaire et thoracique, Centre Hospitalier Universitaire Amiens, Amiens, France tribouilloy.christophe@chu-amiens.fr.
Abstract
AIMS: The Food and Drug Administration (FDA) criteria for diagnosis of drug-induced valvular heart disease (DIVHD) are only based on the observation of aortic regurgitation ≥ mild and/or mitral regurgitation ≥ moderate. We sought to evaluate the diagnostic value of FDA criteria in a cohort of control patients and in a cohort of patients exposed to a drug (benfluorex) known to induce VHD. METHODS AND RESULTS: This prospective, multicentre study included 376 diabetic control patients not exposed to valvulopathic drugs and 1000 subjects previously exposed to benfluorex. Diagnosis of mitral or aortic DIVHD was based on a combined functional and morphological echocardiographic analysis of cardiac valves. Patients were classified according to the FDA criteria [mitral or aortic-FDA(+) and mitral or aortic-FDA(-)]. Among the 376 control patients, 2 were wrongly classified as mitral-FDA(+) and 17 as aortic-FDA(+) (0.53 and 4.5% of false positives, respectively). Of those exposed to benfluorex, 48 of 58 with a diagnosis of mitral DIVHD (83%) were classified as mitral-FDA(-), and 901 of the 910 patients (99%) without a diagnosis of the mitral DIVHD group were classified as mitral-FDA(-). All 40 patients with a diagnosis of aortic DIVHD were classified as aortic-FDA(+), and 105 of the 910 patients without a diagnosis of aortic DIVHD (12%) were classified aortic-FDA(+). Older age and lower BMI were independent predictors of disagreement between FDA criteria and the diagnosis of DIVHD in patients exposed to benfluorex (both P ≤ 0.001). CONCLUSIONS: FDA criteria solely based on the Doppler detection of cardiac valve regurgitation underestimate for the mitral valve and overestimate for the aortic valve the frequency of DIVHD. Therefore, the diagnosis of DIVHD must be based on a combined echocardiographic and Doppler morphological and functional analysis of cardiac valves. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: The Food and Drug Administration (FDA) criteria for diagnosis of drug-induced valvular heart disease (DIVHD) are only based on the observation of aortic regurgitation ≥ mild and/or mitral regurgitation ≥ moderate. We sought to evaluate the diagnostic value of FDA criteria in a cohort of control patients and in a cohort of patients exposed to a drug (benfluorex) known to induce VHD. METHODS AND RESULTS: This prospective, multicentre study included 376 diabetic control patients not exposed to valvulopathic drugs and 1000 subjects previously exposed to benfluorex. Diagnosis of mitral or aortic DIVHD was based on a combined functional and morphological echocardiographic analysis of cardiac valves. Patients were classified according to the FDA criteria [mitral or aortic-FDA(+) and mitral or aortic-FDA(-)]. Among the 376 control patients, 2 were wrongly classified as mitral-FDA(+) and 17 as aortic-FDA(+) (0.53 and 4.5% of false positives, respectively). Of those exposed to benfluorex, 48 of 58 with a diagnosis of mitral DIVHD (83%) were classified as mitral-FDA(-), and 901 of the 910 patients (99%) without a diagnosis of the mitral DIVHD group were classified as mitral-FDA(-). All 40 patients with a diagnosis of aortic DIVHD were classified as aortic-FDA(+), and 105 of the 910 patients without a diagnosis of aortic DIVHD (12%) were classified aortic-FDA(+). Older age and lower BMI were independent predictors of disagreement between FDA criteria and the diagnosis of DIVHD in patients exposed to benfluorex (both P ≤ 0.001). CONCLUSIONS: FDA criteria solely based on the Doppler detection of cardiac valve regurgitation underestimate for the mitral valve and overestimate for the aortic valve the frequency of DIVHD. Therefore, the diagnosis of DIVHD must be based on a combined echocardiographic and Doppler morphological and functional analysis of cardiac valves. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Catherine Szymanski; Sylvestre Maréchaux; Patrick Bruneval; Michel Andréjak; Vincent Thomas de Montpréville; Emre Belli; Christophe Tribouilloy Journal: Int J Cardiol Heart Vasc Date: 2015-09-21