Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion

Trevor Simard; Richard G. Jung; Kyle Lehenbauer; Kerstin Piayda; Radoslaw Pracoń; Gregory G. Jackson; Eduardo Flores-Umanzor; Laurent Faroux; Kasper Korsholm; Julian K.R. Chun; Shaojie Chen; Moniek Maarse; Kristi Montrella; Zakeih Chaker; Jocelyn N. Spoon; Luigi E. Pastormerlo; Felix Meincke; Abhishek C. Sawant; Carmen M. Moldovan; Mohammed Qintar; Mehmet K. Aktas; Luca Branca; Andrea Radinovic; Pradhum Ram; Rayan S. El-Zein; Thomas Flautt; Wern Yew Ding; Bassel Sayegh; Tomás Benito-González; Oh Hyun Lee; Solomon O. Badejoko; Christina Paitazoglou; Nabeela Karim; Ahmed M. Zaghloul; Himanshu Agrawal; Rachel M. Kaplan; Oluseun Alli; Aamir Ahmed; Hussam S. Suradi; Bradley P. Knight; Venkata M. Alla; Sidakpal S. Panaich; Tom Wong; Martin W. Bergmann; Rashaad Chothia; Jung Sun Kim; Armando Pérez de Prado; Raveen Bazaz; Dhiraj Gupta; Miguel Valderrabano; Carlos E. Sanchez; Mikhael F. El Chami; Patrizio Mazzone; Marianna Adamo; Fred Ling; Dee Dee Wang; William O'Neill; Wojtek Wojakowski; Ashish Pershad; Sergio Berti; Daniel Spoon; Akram Kawsara; George Jabbour; Lucas V.A. Boersma; Boris Schmidt; Jens Erik Nielsen-Kudsk; Josep Rodés-Cabau; Xavier Freixa; Christopher R. Ellis; Laurent Fauchier; Marcin Demkow; Horst Sievert; Michael L. Main; Benjamin Hibbert; David R. Holmes; Mohamad Alkhouli

doi:10.1016/j.jacc.2021.04.098

Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion

Trevor Simard, Richard G. Jung, Kyle Lehenbauer, Kerstin Piayda, Radoslaw Pracoń, Gregory G. Jackson, Eduardo Flores-Umanzor, Laurent Faroux, Kasper Korsholm, Julian K.R. Chun, Shaojie Chen, Moniek Maarse, Kristi Montrella, Zakeih Chaker, Jocelyn N. Spoon, Luigi E. Pastormerlo, Felix Meincke, Abhishek C. Sawant, Carmen M. Moldovan, Mohammed QintarMehmet K. Aktas, Luca Branca, Andrea Radinovic, Pradhum Ram, Rayan S. El-Zein, Thomas Flautt, Wern Yew Ding, Bassel Sayegh, Tomás Benito-González, Oh Hyun Lee, Solomon O. Badejoko, Christina Paitazoglou, Nabeela Karim, Ahmed M. Zaghloul, Himanshu Agrawal, Rachel M. Kaplan, Oluseun Alli, Aamir Ahmed, Hussam S. Suradi, Bradley P. Knight, Venkata M. Alla, Sidakpal S. Panaich, Tom Wong, Martin W. Bergmann, Rashaad Chothia, Jung Sun Kim, Armando Pérez de Prado, Raveen Bazaz, Dhiraj Gupta, Miguel Valderrabano, Carlos E. Sanchez, Mikhael F. El Chami, Patrizio Mazzone, Marianna Adamo, Fred Ling, Dee Dee Wang, William O'Neill, Wojtek Wojakowski, Ashish Pershad, Sergio Berti, Daniel Spoon, Akram Kawsara, George Jabbour, Lucas V.A. Boersma, Boris Schmidt, Jens Erik Nielsen-Kudsk, Josep Rodés-Cabau, Xavier Freixa, Christopher R. Ellis, Laurent Fauchier, Marcin Demkow, Horst Sievert, Michael L. Main, Benjamin Hibbert, David R. Holmes, Mohamad Alkhouli^*

^*Corresponding author for this work

Medicine, Cardiology Division

Research output: Contribution to journal › Article › peer-review

168 Scopus citations

Abstract

Background: Device-related thrombus (DRT) has been considered an Achilles’ heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited. Objectives: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT. Methods: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT. Results: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors. Conclusions: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.

Original language	English (US)
Pages (from-to)	297-313
Number of pages	17
Journal	Journal of the American College of Cardiology
Volume	78
Issue number	4
DOIs	https://doi.org/10.1016/j.jacc.2021.04.098
State	Published - Jul 27 2021

Funding

Dr Maarse has received an unrestricted grant from Boston Scientific. Dr Pérez de Prado has served as a proctor for Boston Scientific. Dr Gupta has served as a proctor for Abbott. Dr Sanchez has served as a speaker and proctor for Boston Scientific. Dr Demkow has served as a proctor for Abbott and Boston Scientific. Dr Alkhouli has served as a consultant for Boston Scientific. Dr Wang has been a consultant for Edwards LifeSciences, Boston Scientific, and Neochord; and has received research grant support from Boston Scientific assigned to employer Henry Ford health system. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The authors acknowledge the contributions of Perry S. Nemecheck, NP (University of Rochester Medical Center) for their dedicated efforts to this work.

Keywords

ACP
Amplatzer cardiac plug
Amulet
DRT
LAAO
Watchman
Watchman FLX
device-related thrombus
left atrial appendage occlusion

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jacc.2021.04.098

Cite this

Simard, T., Jung, R. G., Lehenbauer, K., Piayda, K., Pracoń, R., Jackson, G. G., Flores-Umanzor, E., Faroux, L., Korsholm, K., Chun, J. K. R., Chen, S., Maarse, M., Montrella, K., Chaker, Z., Spoon, J. N., Pastormerlo, L. E., Meincke, F., Sawant, A. C., Moldovan, C. M., ... Alkhouli, M. (2021). Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion. Journal of the American College of Cardiology, 78(4), 297-313. https://doi.org/10.1016/j.jacc.2021.04.098

@article{e16e6d3e2f414e5d9f96a49649c0e2e9,

title = "Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion",

abstract = "Background: Device-related thrombus (DRT) has been considered an Achilles{\textquoteright} heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited. Objectives: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT. Methods: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT. Results: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors. Conclusions: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.",

keywords = "ACP, Amplatzer cardiac plug, Amulet, DRT, LAAO, Watchman, Watchman FLX, device-related thrombus, left atrial appendage occlusion",

author = "Trevor Simard and Jung, {Richard G.} and Kyle Lehenbauer and Kerstin Piayda and Radoslaw Praco{\'n} and Jackson, {Gregory G.} and Eduardo Flores-Umanzor and Laurent Faroux and Kasper Korsholm and Chun, {Julian K.R.} and Shaojie Chen and Moniek Maarse and Kristi Montrella and Zakeih Chaker and Spoon, {Jocelyn N.} and Pastormerlo, {Luigi E.} and Felix Meincke and Sawant, {Abhishek C.} and Moldovan, {Carmen M.} and Mohammed Qintar and Aktas, {Mehmet K.} and Luca Branca and Andrea Radinovic and Pradhum Ram and El-Zein, {Rayan S.} and Thomas Flautt and Ding, {Wern Yew} and Bassel Sayegh and Tom{\'a}s Benito-Gonz{\'a}lez and Lee, {Oh Hyun} and Badejoko, {Solomon O.} and Christina Paitazoglou and Nabeela Karim and Zaghloul, {Ahmed M.} and Himanshu Agrawal and Kaplan, {Rachel M.} and Oluseun Alli and Aamir Ahmed and Suradi, {Hussam S.} and Knight, {Bradley P.} and Alla, {Venkata M.} and Panaich, {Sidakpal S.} and Tom Wong and Bergmann, {Martin W.} and Rashaad Chothia and Kim, {Jung Sun} and {P{\'e}rez de Prado}, Armando and Raveen Bazaz and Dhiraj Gupta and Miguel Valderrabano and Sanchez, {Carlos E.} and {El Chami}, {Mikhael F.} and Patrizio Mazzone and Marianna Adamo and Fred Ling and Wang, {Dee Dee} and William O'Neill and Wojtek Wojakowski and Ashish Pershad and Sergio Berti and Daniel Spoon and Akram Kawsara and George Jabbour and Boersma, {Lucas V.A.} and Boris Schmidt and Nielsen-Kudsk, {Jens Erik} and Josep Rod{\'e}s-Cabau and Xavier Freixa and Ellis, {Christopher R.} and Laurent Fauchier and Marcin Demkow and Horst Sievert and Main, {Michael L.} and Benjamin Hibbert and Holmes, {David R.} and Mohamad Alkhouli",

note = "Publisher Copyright: {\textcopyright} 2021 American College of Cardiology Foundation",

year = "2021",

month = jul,

day = "27",

doi = "10.1016/j.jacc.2021.04.098",

language = "English (US)",

volume = "78",

pages = "297--313",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier Inc.",

number = "4",

}

Simard, T, Jung, RG, Lehenbauer, K, Piayda, K, Pracoń, R, Jackson, GG, Flores-Umanzor, E, Faroux, L, Korsholm, K, Chun, JKR, Chen, S, Maarse, M, Montrella, K, Chaker, Z, Spoon, JN, Pastormerlo, LE, Meincke, F, Sawant, AC, Moldovan, CM, Qintar, M, Aktas, MK, Branca, L, Radinovic, A, Ram, P, El-Zein, RS, Flautt, T, Ding, WY, Sayegh, B, Benito-González, T, Lee, OH, Badejoko, SO, Paitazoglou, C, Karim, N, Zaghloul, AM, Agrawal, H, Kaplan, RM, Alli, O, Ahmed, A, Suradi, HS, Knight, BP, Alla, VM, Panaich, SS, Wong, T, Bergmann, MW, Chothia, R, Kim, JS, Pérez de Prado, A, Bazaz, R, Gupta, D, Valderrabano, M, Sanchez, CE, El Chami, MF, Mazzone, P, Adamo, M, Ling, F, Wang, DD, O'Neill, W, Wojakowski, W, Pershad, A, Berti, S, Spoon, D, Kawsara, A, Jabbour, G, Boersma, LVA, Schmidt, B, Nielsen-Kudsk, JE, Rodés-Cabau, J, Freixa, X, Ellis, CR, Fauchier, L, Demkow, M, Sievert, H, Main, ML, Hibbert, B, Holmes, DR & Alkhouli, M 2021, 'Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion', Journal of the American College of Cardiology, vol. 78, no. 4, pp. 297-313. https://doi.org/10.1016/j.jacc.2021.04.098

TY - JOUR

T1 - Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion

AU - Simard, Trevor

AU - Jung, Richard G.

AU - Lehenbauer, Kyle

AU - Piayda, Kerstin

AU - Pracoń, Radoslaw

AU - Jackson, Gregory G.

AU - Flores-Umanzor, Eduardo

AU - Faroux, Laurent

AU - Korsholm, Kasper

AU - Chun, Julian K.R.

AU - Chen, Shaojie

AU - Maarse, Moniek

AU - Montrella, Kristi

AU - Chaker, Zakeih

AU - Spoon, Jocelyn N.

AU - Pastormerlo, Luigi E.

AU - Meincke, Felix

AU - Sawant, Abhishek C.

AU - Moldovan, Carmen M.

AU - Qintar, Mohammed

AU - Aktas, Mehmet K.

AU - Branca, Luca

AU - Radinovic, Andrea

AU - Ram, Pradhum

AU - El-Zein, Rayan S.

AU - Flautt, Thomas

AU - Ding, Wern Yew

AU - Sayegh, Bassel

AU - Benito-González, Tomás

AU - Lee, Oh Hyun

AU - Badejoko, Solomon O.

AU - Paitazoglou, Christina

AU - Karim, Nabeela

AU - Zaghloul, Ahmed M.

AU - Agrawal, Himanshu

AU - Kaplan, Rachel M.

AU - Alli, Oluseun

AU - Ahmed, Aamir

AU - Suradi, Hussam S.

AU - Knight, Bradley P.

AU - Alla, Venkata M.

AU - Panaich, Sidakpal S.

AU - Wong, Tom

AU - Bergmann, Martin W.

AU - Chothia, Rashaad

AU - Kim, Jung Sun

AU - Pérez de Prado, Armando

AU - Bazaz, Raveen

AU - Gupta, Dhiraj

AU - Valderrabano, Miguel

AU - Sanchez, Carlos E.

AU - El Chami, Mikhael F.

AU - Mazzone, Patrizio

AU - Adamo, Marianna

AU - Ling, Fred

AU - Wang, Dee Dee

AU - O'Neill, William

AU - Wojakowski, Wojtek

AU - Pershad, Ashish

AU - Berti, Sergio

AU - Spoon, Daniel

AU - Kawsara, Akram

AU - Jabbour, George

AU - Boersma, Lucas V.A.

AU - Schmidt, Boris

AU - Nielsen-Kudsk, Jens Erik

AU - Rodés-Cabau, Josep

AU - Freixa, Xavier

AU - Ellis, Christopher R.

AU - Fauchier, Laurent

AU - Demkow, Marcin

AU - Sievert, Horst

AU - Main, Michael L.

AU - Hibbert, Benjamin

AU - Holmes, David R.

AU - Alkhouli, Mohamad

PY - 2021/7/27

Y1 - 2021/7/27

N2 - Background: Device-related thrombus (DRT) has been considered an Achilles’ heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited. Objectives: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT. Methods: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT. Results: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors. Conclusions: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.

AB - Background: Device-related thrombus (DRT) has been considered an Achilles’ heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited. Objectives: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT. Methods: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT. Results: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors. Conclusions: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.

KW - ACP

KW - Amplatzer cardiac plug

KW - Amulet

KW - DRT

KW - LAAO

KW - Watchman

KW - Watchman FLX

KW - device-related thrombus

KW - left atrial appendage occlusion

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UR - http://www.scopus.com/inward/citedby.url?scp=85109533701&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2021.04.098

DO - 10.1016/j.jacc.2021.04.098

M3 - Article

C2 - 34294267

AN - SCOPUS:85109533701

SN - 0735-1097

VL - 78

SP - 297

EP - 313

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 4

ER -

Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion

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UN SDGs

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