Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves

Raj R Makkar; Gregory Fontana; Hasan Jilaihawi; Tarun Chakravarty; Klaus F Kofoed; Ole de Backer; Federico M Asch; Carlos E Ruiz; Niels T Olsen; Alfredo Trento; John Friedman; Daniel Berman; Wen Cheng; Mohammad Kashif; Vladimir Jelnin; Chad A Kliger; Hongfei Guo; Augusto D Pichard; Neil J Weissman; Samir Kapadia; Eric Manasse; Deepak L Bhatt; Martin B Leon; Lars Søndergaard

doi:10.1056/nejmoa1509233

Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves

Raj R Makkar, Gregory Fontana, Hasan Jilaihawi, Tarun Chakravarty, Klaus F Kofoed, Ole de Backer, Federico M Asch, Carlos E Ruiz, Niels T Olsen, Alfredo Trento, John Friedman, Daniel Berman, Wen Cheng, Mohammad Kashif, Vladimir Jelnin, Chad A Kliger, Hongfei Guo, Augusto D Pichard, Neil J Weissman, Samir KapadiaEric Manasse, Deepak L Bhatt, Martin B Leon, Lars Søndergaard

Department of Clinical Medicine

592 Citations (Scopus)

Abstract

Background A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation. Methods We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks [TIAs]). Results Reduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeutic anticoagulation with warfarin, as compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced leaflet motion (0% and 55%, respectively, P = 0.01 in the clinical trial; and 0% and 29%, respectively, P = 0.04 in the pooled registries). In patients who were reevaluated with follow-up CT, restoration of leaflet motion was noted in all 11 patients who were receiving anticoagulation and in 1 of 10 patients who were not receiving anticoagulation (P<0.001). There was no significant difference in the incidence of stroke or TIA between patients with reduced leaflet motion and those with normal leaflet motion in the clinical trial (2 of 22 patients and 0 of 33 patients, respectively; P = 0.16), although in the pooled registries, a significant difference was detected (3 of 17 patients and 1 of 115 patients, respectively; P =0.007). Conclusions Reduced aortic-valve leaflet motion was shown in patients with bioprosthetic aortic valves. The condition resolved with therapeutic anticoagulation. The effect of this finding on clinical outcomes including stroke needs further investigation.

Original language	English
Journal	New England Journal of Medicine
Volume	373
Issue number	21
Pages (from-to)	2015-24
Number of pages	10
ISSN	0028-4793
DOIs	https://doi.org/10.1056/nejmoa1509233
Publication status	Published - 19 Nov 2015

Keywords

Aged
Aged, 80 and over
Anticoagulants
Aortic Valve
Bioprosthesis
Female
Four-Dimensional Computed Tomography
Heart Valve Diseases
Heart Valve Prosthesis
Humans
Ischemic Attack, Transient
Male
Registries
Stroke
Thrombosis

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https://www.nejm.org/doi/pdf/10.1056/NEJMoa1509233?articleTools=true

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Makkar, R. R., Fontana, G., Jilaihawi, H., Chakravarty, T., Kofoed, K. F., de Backer, O., Asch, F. M., Ruiz, C. E., Olsen, N. T., Trento, A., Friedman, J., Berman, D., Cheng, W., Kashif, M., Jelnin, V., Kliger, C. A., Guo, H., Pichard, A. D., Weissman, N. J., ... Søndergaard, L. (2015). Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. New England Journal of Medicine, 373(21), 2015-24. https://doi.org/10.1056/nejmoa1509233

Makkar, RR, Fontana, G, Jilaihawi, H, Chakravarty, T, Kofoed, KF, de Backer, O, Asch, FM, Ruiz, CE, Olsen, NT, Trento, A, Friedman, J, Berman, D, Cheng, W, Kashif, M, Jelnin, V, Kliger, CA, Guo, H, Pichard, AD, Weissman, NJ, Kapadia, S, Manasse, E, Bhatt, DL, Leon, MB & Søndergaard, L 2015, 'Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves', New England Journal of Medicine, vol. 373, no. 21, pp. 2015-24. https://doi.org/10.1056/nejmoa1509233

@article{9852f107f50d4aa09b73fb23dbdc8636,

title = "Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves",

abstract = "Background A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation. Methods We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks [TIAs]). Results Reduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeutic anticoagulation with warfarin, as compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced leaflet motion (0% and 55%, respectively, P = 0.01 in the clinical trial; and 0% and 29%, respectively, P = 0.04 in the pooled registries). In patients who were reevaluated with follow-up CT, restoration of leaflet motion was noted in all 11 patients who were receiving anticoagulation and in 1 of 10 patients who were not receiving anticoagulation (P<0.001). There was no significant difference in the incidence of stroke or TIA between patients with reduced leaflet motion and those with normal leaflet motion in the clinical trial (2 of 22 patients and 0 of 33 patients, respectively; P = 0.16), although in the pooled registries, a significant difference was detected (3 of 17 patients and 1 of 115 patients, respectively; P =0.007). Conclusions Reduced aortic-valve leaflet motion was shown in patients with bioprosthetic aortic valves. The condition resolved with therapeutic anticoagulation. The effect of this finding on clinical outcomes including stroke needs further investigation.",

keywords = "Aged, Aged, 80 and over, Anticoagulants, Aortic Valve, Bioprosthesis, Female, Four-Dimensional Computed Tomography, Heart Valve Diseases, Heart Valve Prosthesis, Humans, Ischemic Attack, Transient, Male, Registries, Stroke, Thrombosis",

author = "Makkar, {Raj R} and Gregory Fontana and Hasan Jilaihawi and Tarun Chakravarty and Kofoed, {Klaus F} and {de Backer}, Ole and Asch, {Federico M} and Ruiz, {Carlos E} and Olsen, {Niels T} and Alfredo Trento and John Friedman and Daniel Berman and Wen Cheng and Mohammad Kashif and Vladimir Jelnin and Kliger, {Chad A} and Hongfei Guo and Pichard, {Augusto D} and Weissman, {Neil J} and Samir Kapadia and Eric Manasse and Bhatt, {Deepak L} and Leon, {Martin B} and Lars S{\o}ndergaard",

year = "2015",

month = nov,

day = "19",

doi = "10.1056/nejmoa1509233",

language = "English",

volume = "373",

pages = "2015--24",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "21",

}

TY - JOUR

T1 - Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves

AU - Makkar, Raj R

AU - Fontana, Gregory

AU - Jilaihawi, Hasan

AU - Chakravarty, Tarun

AU - Kofoed, Klaus F

AU - de Backer, Ole

AU - Asch, Federico M

AU - Ruiz, Carlos E

AU - Olsen, Niels T

AU - Trento, Alfredo

AU - Friedman, John

AU - Berman, Daniel

AU - Cheng, Wen

AU - Kashif, Mohammad

AU - Jelnin, Vladimir

AU - Kliger, Chad A

AU - Guo, Hongfei

AU - Pichard, Augusto D

AU - Weissman, Neil J

AU - Kapadia, Samir

AU - Manasse, Eric

AU - Bhatt, Deepak L

AU - Leon, Martin B

AU - Søndergaard, Lars

PY - 2015/11/19

Y1 - 2015/11/19

N2 - Background A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation. Methods We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks [TIAs]). Results Reduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeutic anticoagulation with warfarin, as compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced leaflet motion (0% and 55%, respectively, P = 0.01 in the clinical trial; and 0% and 29%, respectively, P = 0.04 in the pooled registries). In patients who were reevaluated with follow-up CT, restoration of leaflet motion was noted in all 11 patients who were receiving anticoagulation and in 1 of 10 patients who were not receiving anticoagulation (P<0.001). There was no significant difference in the incidence of stroke or TIA between patients with reduced leaflet motion and those with normal leaflet motion in the clinical trial (2 of 22 patients and 0 of 33 patients, respectively; P = 0.16), although in the pooled registries, a significant difference was detected (3 of 17 patients and 1 of 115 patients, respectively; P =0.007). Conclusions Reduced aortic-valve leaflet motion was shown in patients with bioprosthetic aortic valves. The condition resolved with therapeutic anticoagulation. The effect of this finding on clinical outcomes including stroke needs further investigation.

AB - Background A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation. Methods We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks [TIAs]). Results Reduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeutic anticoagulation with warfarin, as compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced leaflet motion (0% and 55%, respectively, P = 0.01 in the clinical trial; and 0% and 29%, respectively, P = 0.04 in the pooled registries). In patients who were reevaluated with follow-up CT, restoration of leaflet motion was noted in all 11 patients who were receiving anticoagulation and in 1 of 10 patients who were not receiving anticoagulation (P<0.001). There was no significant difference in the incidence of stroke or TIA between patients with reduced leaflet motion and those with normal leaflet motion in the clinical trial (2 of 22 patients and 0 of 33 patients, respectively; P = 0.16), although in the pooled registries, a significant difference was detected (3 of 17 patients and 1 of 115 patients, respectively; P =0.007). Conclusions Reduced aortic-valve leaflet motion was shown in patients with bioprosthetic aortic valves. The condition resolved with therapeutic anticoagulation. The effect of this finding on clinical outcomes including stroke needs further investigation.

KW - Aged

KW - Aged, 80 and over

KW - Anticoagulants

KW - Aortic Valve

KW - Bioprosthesis

KW - Female

KW - Four-Dimensional Computed Tomography

KW - Heart Valve Diseases

KW - Heart Valve Prosthesis

KW - Humans

KW - Ischemic Attack, Transient

KW - Male

KW - Registries

KW - Stroke

KW - Thrombosis

U2 - 10.1056/nejmoa1509233

DO - 10.1056/nejmoa1509233

M3 - Journal article

C2 - 26436963

SN - 0028-4793

VL - 373

SP - 2015

EP - 2024

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 21

ER -

Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves

Abstract

Keywords

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