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N Engl J Med. 2016 Jul 28;375(4):335-44. doi: 10.1056/NEJMoa1505643.

Von Willebrand Factor Multimers during Transcatheter Aortic-Valve Replacement.

Author information

1
From the Departments of Cardiology (E.V.B., F.V., C.H., J.-B.D., N. Debry, C.D., J.-L.A., G.S., G.L., B.M., K.M., A.M., J.-J.B., F.L., J.-C.B.), Hematology and Transfusion (A.R., E.J., C.P., A.D.-P., S.H., C.C., C.Z., B.S., J.G., S.S.), and Cardiac Surgery (E.R., N.R., A.V., F.J., V.L.), Centre Hospitalier Universitaire (CHU) Lille, INSERM Unité 1011 (E.V.B., A.R., F.V., E.R., N.R., A.V., F.J., C.P., A.D.-P., F.M., B.M., D.C., C.Z., B.S., J.G., S.S.), Université Lille, INSERM Unité 1011 - European Genomic Institute for Diabetes (E.V.B., A.R., F.V., E.R., N.R., A.V., F.J., C.P., A.D.-P., F.M., B.M., D.C., C.Z., J.G., S.S.), INSERM Unité 1167 (J.D.), Institut Pasteur de Lille (E.V.B., A.R., F.V., E.R., N.R., J.D., A.V., F.J., C.P., A.D.-P., F.M., B.M., D.C., C.Z., J.G., S.S.), and Université Lille, CHU Lille, Equipe d'accueil 2694 - Santé Publique: Epidemiologie et Qualité des Soins (J.L., A.D.), Lille, Pole d'Activité Médico-chirurgicale Cardio-vasculaire, Nouvel Hôpital Civil, CHU, Université de Strasbourg, Strasbourg (M.K., T.C., O.M.), INSERM Unité 1048 and Université Toulouse III (J.L., A.D.), Institut des Maladies Métaboliques et Cardiovasculaires (M.L., N. Dumonteil), and Laboratoire d'Hematologie (M.L.), and Service de Cardiologie (N. Dumonteil), CHU de Toulouse, Toulouse, Unité Mixte de Recherche (UMR), Centre Nationale de la Recherche Scientifique 7213, Laboratoire de Biophotonique et Pharmacologie, Faculté de Pharmacie, Université de Strasbourg, Illkirch (O.M.), and INSERM UMR-S Unité 1176, Université Paris-Sud, Université Paris-Saclay, Le Kremlin-Bicêtre (P.L., P.J.L.) - all in France.

Abstract

BACKGROUND:

Postprocedural aortic regurgitation occurs in 10 to 20% of patients undergoing transcatheter aortic-valve replacement (TAVR) for aortic stenosis. We hypothesized that assessment of defects in high-molecular-weight (HMW) multimers of von Willebrand factor or point-of-care assessment of hemostasis could be used to monitor aortic regurgitation during TAVR.

METHODS:

We enrolled 183 patients undergoing TAVR. Patients with aortic regurgitation after the initial implantation, as identified by means of transesophageal echocardiography, underwent additional balloon dilation to correct aortic regurgitation. HMW multimers and the closure time with adenosine diphosphate (CT-ADP), a point-of-care measure of hemostasis, were assessed at baseline and 5 minutes after each step of the procedure. Mortality was evaluated at 1 year. A second cohort (201 patients) was studied to validate the use of CT-ADP in order to identify patients with aortic regurgitation.

RESULTS:

After the initial implantation, HMW multimers normalized in patients without aortic regurgitation (137 patients). Among the 46 patients with aortic regurgitation, normalization occurred in 20 patients in whom additional balloon dilation was successful but did not occur in the 26 patients with persistent aortic regurgitation. A similar sequence of changes was observed with CT-ADP. A CT-ADP value of more than 180 seconds had sensitivity, specificity, and negative predictive value of 92.3%, 92.4%, and 98.6%, respectively, for aortic regurgitation, with similar results in the validation cohort. Multivariable analyses showed that the values for HMW multimers and CT-ADP at the end of TAVR were each associated with mortality at 1 year.

CONCLUSIONS:

The presence of HMW-multimer defects and a high value for a point-of-care hemostatic test, the CT-ADP, were each predictive of the presence of aortic regurgitation after TAVR and were associated with higher mortality 1 year after the procedure. (Funded by Lille 2 University and others; ClinicalTrials.gov number, NCT02628509.).

PMID:
27464202
DOI:
10.1056/NEJMoa1505643
[Indexed for MEDLINE]
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