Clinical Valve Thrombosis After Transcatheter Aortic Valve-in-Valve Implantation

Mohamed Abdel-Wahab, Matheus Simonato, Azeem Latib, Patrick J. Goleski, Abdelhakim Allali, Jatinderjit Kaur, Ali N. Azadani, Eric Horlick, Luca Testa, Katia Orvin, Ran Kornowski, Malek Kass, Creighton W. Don, Gert Richardt, John G. Webb, Danny Dvir

Research output: Contribution to journalArticle

Abstract

Background Limited data exist on clinical valve thrombosis after transcatheter aortic valve-in-valve (ViV) implantation. Our objective was to determine the incidence, timing, clinical characteristics, and treatment outcomes of patients diagnosed with clinical ViV thrombosis. Methods and Results Centers participating in the Valve-in-Valve International Data Registry were surveyed for thrombosis cases, and clinical valve thrombosis was defined based on a combination of the presence of new valve dysfunction and an imaging evidence of leaflet thrombosis. Three hundred ViV implantations were included. The surgical valve was stented in 86.3% and stentless in 13.7% of cases; and the transcatheter heart valve was self-expanding in 50%, balloon-expandable in 49%, and mechanically expanding in 1.0%. The incidence of clinical valve thrombosis was 7.6% (n=23), diagnosed at a median time of 101 days (interquartile range, 21-226) after the procedure. Fifteen patients (65%) presented with worsening symptoms and 21 (91%) with transvalvular mean gradient elevation. The mean gradient at the time of diagnosis (median 39 mm Hg; interquartile range, 30-44) was significantly higher than immediately post-ViV (13 mm Hg; interquartile range, 8-20.5; P<0.001) and was significantly reduced after oral anticoagulation therapy (17.5 mm Hg; interquartile range, 11-20.5; P<0.001). There were no deaths or strokes related to valve thrombosis. Factors associated with valve thrombosis were oral anticoagulation (odds ratio [95% confidence limits]: 0.067 [0.008-0.543], P=0.011), surgical valve true internal diameter indexed to body surface area (0.537 [0.331-0.873], P=0.012), and Mosaic or Hancock II stented porcine bioprostheses (4.01 [1.287-12.485], P=0.017). Conclusions Clinical valve thrombosis after transcatheter aortic ViV implantation is common, especially in patients not on oral anticoagulation. Although aortic ViV is commonly associated with elevated gradients, valve thrombosis should be ruled out if gradients increase compared with early postprocedural values. A higher incidence was observed after treatment of certain stented porcine surgical valve types, suggesting a specific adjustment of the adjunctive antithrombotic therapy in this subset of ViV patients.

Original languageEnglish
Pages (from-to)e006730
JournalCirculation. Cardiovascular interventions
Volume11
Issue number11
DOIs
Publication statusPublished - Nov 1 2018

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Aortic Valve
Thrombosis
Surgical Instruments
Incidence
Swine
Bioprosthesis
Body Surface Area
Heart Valves
Registries
Therapeutics
Stroke
Odds Ratio

Keywords

  • aortic valve
  • bioprosthesis
  • incidence
  • stroke
  • thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Abdel-Wahab, M., Simonato, M., Latib, A., Goleski, P. J., Allali, A., Kaur, J., ... Dvir, D. (2018). Clinical Valve Thrombosis After Transcatheter Aortic Valve-in-Valve Implantation. Circulation. Cardiovascular interventions, 11(11), e006730. https://doi.org/10.1161/CIRCINTERVENTIONS.118.006730

Clinical Valve Thrombosis After Transcatheter Aortic Valve-in-Valve Implantation. / Abdel-Wahab, Mohamed; Simonato, Matheus; Latib, Azeem; Goleski, Patrick J.; Allali, Abdelhakim; Kaur, Jatinderjit; Azadani, Ali N.; Horlick, Eric; Testa, Luca; Orvin, Katia; Kornowski, Ran; Kass, Malek; Don, Creighton W.; Richardt, Gert; Webb, John G.; Dvir, Danny.

In: Circulation. Cardiovascular interventions, Vol. 11, No. 11, 01.11.2018, p. e006730.

Research output: Contribution to journalArticle

Abdel-Wahab, M, Simonato, M, Latib, A, Goleski, PJ, Allali, A, Kaur, J, Azadani, AN, Horlick, E, Testa, L, Orvin, K, Kornowski, R, Kass, M, Don, CW, Richardt, G, Webb, JG & Dvir, D 2018, 'Clinical Valve Thrombosis After Transcatheter Aortic Valve-in-Valve Implantation', Circulation. Cardiovascular interventions, vol. 11, no. 11, pp. e006730. https://doi.org/10.1161/CIRCINTERVENTIONS.118.006730
Abdel-Wahab, Mohamed ; Simonato, Matheus ; Latib, Azeem ; Goleski, Patrick J. ; Allali, Abdelhakim ; Kaur, Jatinderjit ; Azadani, Ali N. ; Horlick, Eric ; Testa, Luca ; Orvin, Katia ; Kornowski, Ran ; Kass, Malek ; Don, Creighton W. ; Richardt, Gert ; Webb, John G. ; Dvir, Danny. / Clinical Valve Thrombosis After Transcatheter Aortic Valve-in-Valve Implantation. In: Circulation. Cardiovascular interventions. 2018 ; Vol. 11, No. 11. pp. e006730.
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title = "Clinical Valve Thrombosis After Transcatheter Aortic Valve-in-Valve Implantation",
abstract = "Background Limited data exist on clinical valve thrombosis after transcatheter aortic valve-in-valve (ViV) implantation. Our objective was to determine the incidence, timing, clinical characteristics, and treatment outcomes of patients diagnosed with clinical ViV thrombosis. Methods and Results Centers participating in the Valve-in-Valve International Data Registry were surveyed for thrombosis cases, and clinical valve thrombosis was defined based on a combination of the presence of new valve dysfunction and an imaging evidence of leaflet thrombosis. Three hundred ViV implantations were included. The surgical valve was stented in 86.3{\%} and stentless in 13.7{\%} of cases; and the transcatheter heart valve was self-expanding in 50{\%}, balloon-expandable in 49{\%}, and mechanically expanding in 1.0{\%}. The incidence of clinical valve thrombosis was 7.6{\%} (n=23), diagnosed at a median time of 101 days (interquartile range, 21-226) after the procedure. Fifteen patients (65{\%}) presented with worsening symptoms and 21 (91{\%}) with transvalvular mean gradient elevation. The mean gradient at the time of diagnosis (median 39 mm Hg; interquartile range, 30-44) was significantly higher than immediately post-ViV (13 mm Hg; interquartile range, 8-20.5; P<0.001) and was significantly reduced after oral anticoagulation therapy (17.5 mm Hg; interquartile range, 11-20.5; P<0.001). There were no deaths or strokes related to valve thrombosis. Factors associated with valve thrombosis were oral anticoagulation (odds ratio [95{\%} confidence limits]: 0.067 [0.008-0.543], P=0.011), surgical valve true internal diameter indexed to body surface area (0.537 [0.331-0.873], P=0.012), and Mosaic or Hancock II stented porcine bioprostheses (4.01 [1.287-12.485], P=0.017). Conclusions Clinical valve thrombosis after transcatheter aortic ViV implantation is common, especially in patients not on oral anticoagulation. Although aortic ViV is commonly associated with elevated gradients, valve thrombosis should be ruled out if gradients increase compared with early postprocedural values. A higher incidence was observed after treatment of certain stented porcine surgical valve types, suggesting a specific adjustment of the adjunctive antithrombotic therapy in this subset of ViV patients.",
keywords = "aortic valve, bioprosthesis, incidence, stroke, thrombosis",
author = "Mohamed Abdel-Wahab and Matheus Simonato and Azeem Latib and Goleski, {Patrick J.} and Abdelhakim Allali and Jatinderjit Kaur and Azadani, {Ali N.} and Eric Horlick and Luca Testa and Katia Orvin and Ran Kornowski and Malek Kass and Don, {Creighton W.} and Gert Richardt and Webb, {John G.} and Danny Dvir",
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T1 - Clinical Valve Thrombosis After Transcatheter Aortic Valve-in-Valve Implantation

AU - Abdel-Wahab, Mohamed

AU - Simonato, Matheus

AU - Latib, Azeem

AU - Goleski, Patrick J.

AU - Allali, Abdelhakim

AU - Kaur, Jatinderjit

AU - Azadani, Ali N.

AU - Horlick, Eric

AU - Testa, Luca

AU - Orvin, Katia

AU - Kornowski, Ran

AU - Kass, Malek

AU - Don, Creighton W.

AU - Richardt, Gert

AU - Webb, John G.

AU - Dvir, Danny

PY - 2018/11/1

Y1 - 2018/11/1

N2 - Background Limited data exist on clinical valve thrombosis after transcatheter aortic valve-in-valve (ViV) implantation. Our objective was to determine the incidence, timing, clinical characteristics, and treatment outcomes of patients diagnosed with clinical ViV thrombosis. Methods and Results Centers participating in the Valve-in-Valve International Data Registry were surveyed for thrombosis cases, and clinical valve thrombosis was defined based on a combination of the presence of new valve dysfunction and an imaging evidence of leaflet thrombosis. Three hundred ViV implantations were included. The surgical valve was stented in 86.3% and stentless in 13.7% of cases; and the transcatheter heart valve was self-expanding in 50%, balloon-expandable in 49%, and mechanically expanding in 1.0%. The incidence of clinical valve thrombosis was 7.6% (n=23), diagnosed at a median time of 101 days (interquartile range, 21-226) after the procedure. Fifteen patients (65%) presented with worsening symptoms and 21 (91%) with transvalvular mean gradient elevation. The mean gradient at the time of diagnosis (median 39 mm Hg; interquartile range, 30-44) was significantly higher than immediately post-ViV (13 mm Hg; interquartile range, 8-20.5; P<0.001) and was significantly reduced after oral anticoagulation therapy (17.5 mm Hg; interquartile range, 11-20.5; P<0.001). There were no deaths or strokes related to valve thrombosis. Factors associated with valve thrombosis were oral anticoagulation (odds ratio [95% confidence limits]: 0.067 [0.008-0.543], P=0.011), surgical valve true internal diameter indexed to body surface area (0.537 [0.331-0.873], P=0.012), and Mosaic or Hancock II stented porcine bioprostheses (4.01 [1.287-12.485], P=0.017). Conclusions Clinical valve thrombosis after transcatheter aortic ViV implantation is common, especially in patients not on oral anticoagulation. Although aortic ViV is commonly associated with elevated gradients, valve thrombosis should be ruled out if gradients increase compared with early postprocedural values. A higher incidence was observed after treatment of certain stented porcine surgical valve types, suggesting a specific adjustment of the adjunctive antithrombotic therapy in this subset of ViV patients.

AB - Background Limited data exist on clinical valve thrombosis after transcatheter aortic valve-in-valve (ViV) implantation. Our objective was to determine the incidence, timing, clinical characteristics, and treatment outcomes of patients diagnosed with clinical ViV thrombosis. Methods and Results Centers participating in the Valve-in-Valve International Data Registry were surveyed for thrombosis cases, and clinical valve thrombosis was defined based on a combination of the presence of new valve dysfunction and an imaging evidence of leaflet thrombosis. Three hundred ViV implantations were included. The surgical valve was stented in 86.3% and stentless in 13.7% of cases; and the transcatheter heart valve was self-expanding in 50%, balloon-expandable in 49%, and mechanically expanding in 1.0%. The incidence of clinical valve thrombosis was 7.6% (n=23), diagnosed at a median time of 101 days (interquartile range, 21-226) after the procedure. Fifteen patients (65%) presented with worsening symptoms and 21 (91%) with transvalvular mean gradient elevation. The mean gradient at the time of diagnosis (median 39 mm Hg; interquartile range, 30-44) was significantly higher than immediately post-ViV (13 mm Hg; interquartile range, 8-20.5; P<0.001) and was significantly reduced after oral anticoagulation therapy (17.5 mm Hg; interquartile range, 11-20.5; P<0.001). There were no deaths or strokes related to valve thrombosis. Factors associated with valve thrombosis were oral anticoagulation (odds ratio [95% confidence limits]: 0.067 [0.008-0.543], P=0.011), surgical valve true internal diameter indexed to body surface area (0.537 [0.331-0.873], P=0.012), and Mosaic or Hancock II stented porcine bioprostheses (4.01 [1.287-12.485], P=0.017). Conclusions Clinical valve thrombosis after transcatheter aortic ViV implantation is common, especially in patients not on oral anticoagulation. Although aortic ViV is commonly associated with elevated gradients, valve thrombosis should be ruled out if gradients increase compared with early postprocedural values. A higher incidence was observed after treatment of certain stented porcine surgical valve types, suggesting a specific adjustment of the adjunctive antithrombotic therapy in this subset of ViV patients.

KW - aortic valve

KW - bioprosthesis

KW - incidence

KW - stroke

KW - thrombosis

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