Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves
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Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. / Makkar, Raj R; Fontana, Gregory; Jilaihawi, Hasan; Chakravarty, Tarun; Kofoed, Klaus F; de Backer, Ole; Asch, Federico M; Ruiz, Carlos E; Olsen, Niels T; Trento, Alfredo; Friedman, John; Berman, Daniel; Cheng, Wen; Kashif, Mohammad; Jelnin, Vladimir; Kliger, Chad A; Guo, Hongfei; Pichard, Augusto D; Weissman, Neil J; Kapadia, Samir; Manasse, Eric; Bhatt, Deepak L; Leon, Martin B; Søndergaard, Lars.
In: New England Journal of Medicine, Vol. 373, No. 21, 19.11.2015, p. 2015-24.Research output: Contribution to journal › Journal article › Research › peer-review
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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. (Funded by St. Jude Medical and Cedars-Sinai Heart Institute; Portico-IDE ClinicalTrials.gov number, NCT02000115; SAVORY registry, NCT02426307; and RESOLVE registry, NCT02318342.).
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. (Funded by St. Jude Medical and Cedars-Sinai Heart Institute; Portico-IDE ClinicalTrials.gov number, NCT02000115; SAVORY registry, NCT02426307; and RESOLVE registry, NCT02318342.).
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
VL - 373
SP - 2015
EP - 2024
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 21
ER -
ID: 162222591