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Erschienen in:

12.12.2019 | Cerebral Ischemia

WATCHMAN implantation in patients with a history of atrial fibrillation and intracranial hemorrhage

verfasst von: William J. Hucker, Joshua A. Cohen, M. Edip Gurol, E. Kevin Heist, Carola Gianni, Jennifer Galvin, Donita Atkins, Sudha Bommana, Luigi Di Biase, Jeremy Ruskin, Sanghamitra Mohanty, Rodney Horton, Dhanunjaya Lakkireddy, Andrea Natale, Moussa Mansour

Erschienen in: Journal of Interventional Cardiac Electrophysiology | Ausgabe 2/2020

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Abstract

Purpose

Use of oral anticoagulation (OAC) in patients with a history of intracranial hemorrhage (ICH) is often considered high risk as OAC-related ICH is associated with high mortality rates. Left atrial appendage closure with a WATCHMAN device is an alternative management strategy to OAC to decrease thrombotic risk in atrial fibrillation patients; however use of OAC followed by dual antiplatelet therapy (DAPT) or DAPT therapy alone is required for 6 months post-procedurally. In this study, we examined the safety of WATCHMAN implantation followed by 6 months of anti-thrombotic therapy in patients with a history of ICH.

Methods

This is a retrospective analysis of 63 patients with a history of ICH prior to WATCHMAN implantation (Group I) and 95 patients without a history of ICH who underwent WATCHMAN placement (Group II). The primary outcome was death, stroke, or major bleeding within 6 months of WATCHMAN placement.

Results

The average CHA2DS2-VASc of Group I was 4.9 ± 1.7 vs 4.7 ± 1.4 for Group II (p = 0.34). The most common type of ICH in Group I was an intracerebral hemorrhage (57%). The median time between ICH and WATCHMAN implantation in Group I patients was 212 days. A total of 19% of Group I patients were managed with DAPT alone post-procedurally vs. 3% in Group II (p < 0.001). Similar to 89% of Group II (p = 0.19), 95% of Group I patients were free of the primary outcome at 6 months. No Group I patients had recurrent ICH within 6 months after WATCHMAN implantation.

Conclusion

In a retrospective, multicenter series of patients with a history of ICH prior to WATCHMAN implantation, WATCHMAN placement was performed safely with 6-month outcomes that were similar to patients without a history of ICH, encompassing the time during which a patient with a history of ICH would need antithrombotic therapy to facilitate WATCHMAN placement.
Literatur
1.
Zurück zum Zitat Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009;374(9689):534–42.CrossRefPubMed Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009;374(9689):534–42.CrossRefPubMed
2.
Zurück zum Zitat Reddy VY, Möbius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, et al. Left atrial appendage closure with the Watchman device in patients with a contraindication for Oral anticoagulation. J Am Coll Cardiol. 2013;61(25):2551–6.CrossRefPubMed Reddy VY, Möbius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, et al. Left atrial appendage closure with the Watchman device in patients with a contraindication for Oral anticoagulation. J Am Coll Cardiol. 2013;61(25):2551–6.CrossRefPubMed
3.
Zurück zum Zitat Gurol ME. Nonpharmacological Management of Atrial Fibrillation in patients at high intracranial hemorrhage risk. Stroke. 2018;49(1):247–54.PubMed Gurol ME. Nonpharmacological Management of Atrial Fibrillation in patients at high intracranial hemorrhage risk. Stroke. 2018;49(1):247–54.PubMed
4.
Zurück zum Zitat Majeed A, Kim YK, Roberts RS, Holmström M, Schulman S. Optimal timing of resumption of warfarin after intracranial hemorrhage. Stroke. 2010;41(12):2860–6.PubMed Majeed A, Kim YK, Roberts RS, Holmström M, Schulman S. Optimal timing of resumption of warfarin after intracranial hemorrhage. Stroke. 2010;41(12):2860–6.PubMed
5.
Zurück zum Zitat Fahmy P, Spencer R, Tsang M, Gooderham P, Saw J. Left atrial appendage closure for atrial fibrillation is safe and effective after intracranial or intraocular hemorrhage. Can J Cardiol. 2016;32(3):349–54.PubMed Fahmy P, Spencer R, Tsang M, Gooderham P, Saw J. Left atrial appendage closure for atrial fibrillation is safe and effective after intracranial or intraocular hemorrhage. Can J Cardiol. 2016;32(3):349–54.PubMed
6.
Zurück zum Zitat Hutt E, Wazni OM, Saliba WI, Kanj M, Tarakji KG, Aguilera J, et al. Left atrial appendage closure device implantation in patients with prior intracranial hemorrhage. Heart Rhythm. 2018;16(5):663–8.PubMed Hutt E, Wazni OM, Saliba WI, Kanj M, Tarakji KG, Aguilera J, et al. Left atrial appendage closure device implantation in patients with prior intracranial hemorrhage. Heart Rhythm. 2018;16(5):663–8.PubMed
8.
Zurück zum Zitat Tomaselli GF, Mahaffey KW, Cuker A, Dobesh PP, Doherty JU, Eikelboom JW, et al. 2017 ACC expert consensus decision pathway on Management of Bleeding in patients on Oral anticoagulants: a report of the American College of Cardiology Task Force on expert consensus decision pathways. J Am Coll Cardiol. 2017;70(24):3042–67.PubMed Tomaselli GF, Mahaffey KW, Cuker A, Dobesh PP, Doherty JU, Eikelboom JW, et al. 2017 ACC expert consensus decision pathway on Management of Bleeding in patients on Oral anticoagulants: a report of the American College of Cardiology Task Force on expert consensus decision pathways. J Am Coll Cardiol. 2017;70(24):3042–67.PubMed
9.
Zurück zum Zitat Holmes, D. R., Kar, S., Price, M. J., Whisenant, B., Sievert, H., Doshi, S. K., … Reddy, V. Y. (2014). Prospective randomized evaluation of the Watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy. Journal of the American College of Cardiology, 64(1), 1–12. D. Holmes, D. R., Kar, S., Price, M. J., Whisenant, B., Sievert, H., Doshi, S. K., … Reddy, V. Y. (2014). Prospective randomized evaluation of the Watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy. Journal of the American College of Cardiology, 64(1), 1–12. D.
10.
Zurück zum Zitat Majule DN, Jing C, Rutahoile WM, Shonyela FS. The efficacy and safety of the WATCHMAN device in LAA occlusion in patients with non-Valvular atrial fibrillation contraindicated to Oral anticoagulation: a focused review. Ann Thorac Cardiovasc Surg. 2018;24(6):271–8. Majule DN, Jing C, Rutahoile WM, Shonyela FS. The efficacy and safety of the WATCHMAN device in LAA occlusion in patients with non-Valvular atrial fibrillation contraindicated to Oral anticoagulation: a focused review. Ann Thorac Cardiovasc Surg. 2018;24(6):271–8.
11.
Zurück zum Zitat Hemphill, J. C., Greenberg, S. M., Anderson, C. S., Becker, K., Bendok, B. R., Cushman, M., … Council on Clinical Cardiology. (2015). Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke, 46(7), 2032–2060. Hemphill, J. C., Greenberg, S. M., Anderson, C. S., Becker, K., Bendok, B. R., Cushman, M., … Council on Clinical Cardiology. (2015). Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke, 46(7), 2032–2060.
12.
Zurück zum Zitat Nielsen PB, Larsen TB, Skjøth F, Gorst-Rasmussen A, Rasmussen LH, Lip GYH. Restarting anticoagulant treatment after intracranial hemorrhage in patients with atrial fibrillation and the impact on recurrent stroke, mortality, and BleedingCLINICAL PERSPECTIVE. Circulation. 2015;132(6):517–25.PubMed Nielsen PB, Larsen TB, Skjøth F, Gorst-Rasmussen A, Rasmussen LH, Lip GYH. Restarting anticoagulant treatment after intracranial hemorrhage in patients with atrial fibrillation and the impact on recurrent stroke, mortality, and BleedingCLINICAL PERSPECTIVE. Circulation. 2015;132(6):517–25.PubMed
13.
Zurück zum Zitat Nielsen PB, Larsen TB, Skjøth F, Lip GYH. Outcomes associated with resuming warfarin treatment after hemorrhagic stroke or traumatic intracranial hemorrhage in patients with atrial fibrillation. JAMA Intern Med. 2017;77(4):563–70. Nielsen PB, Larsen TB, Skjøth F, Lip GYH. Outcomes associated with resuming warfarin treatment after hemorrhagic stroke or traumatic intracranial hemorrhage in patients with atrial fibrillation. JAMA Intern Med. 2017;77(4):563–70.
14.
Zurück zum Zitat Tzikas A, Freixa X, Llull L, Gafoor S, Shakir S, Omran H, et al. Patients with intracranial bleeding and atrial fibrillation treated with left atrial appendage occlusion: results from the Amplatzer cardiac plug registry. Int J Cardiol. 2017;236:232–6.PubMed Tzikas A, Freixa X, Llull L, Gafoor S, Shakir S, Omran H, et al. Patients with intracranial bleeding and atrial fibrillation treated with left atrial appendage occlusion: results from the Amplatzer cardiac plug registry. Int J Cardiol. 2017;236:232–6.PubMed
15.
Zurück zum Zitat Renou P, Thambo J-B, Iriart X, Nicot S, Kabore N, Jalal Z, et al. Left atrial appendage closure in patients with atrial fibrillation and previous Intracerebral hemorrhage. Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association. 2017;26(3):545–51. Renou P, Thambo J-B, Iriart X, Nicot S, Kabore N, Jalal Z, et al. Left atrial appendage closure in patients with atrial fibrillation and previous Intracerebral hemorrhage. Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association. 2017;26(3):545–51.
16.
Zurück zum Zitat Dukkipati SR, Kar S, Holmes DR, Doshi SK, Swarup V, Gibson DN, et al. Device-related thrombus after left atrial appendage closure: incidence, predictors, and outcomes. Circulation. 2018;138:874–85.PubMed Dukkipati SR, Kar S, Holmes DR, Doshi SK, Swarup V, Gibson DN, et al. Device-related thrombus after left atrial appendage closure: incidence, predictors, and outcomes. Circulation. 2018;138:874–85.PubMed
17.
Zurück zum Zitat Reddy, V. Y., Doshi, S. K., Kar, S., Gibson, D. N., Price, M. J., Huber, K., Horton R.P., Buchbinder M., Neuzil P., Gordon N.T., Holmes DR Jr, PREVAIL and PROTECT AF Investigators PREVAIL and PROTECT AF Investigators. (2017). 5-year outcomes after left atrial appendage closure. J Am Coll Cardiol, 70(24), 2964–2975. Reddy, V. Y., Doshi, S. K., Kar, S., Gibson, D. N., Price, M. J., Huber, K., Horton R.P., Buchbinder M., Neuzil P., Gordon N.T., Holmes DR Jr, PREVAIL and PROTECT AF Investigators PREVAIL and PROTECT AF Investigators. (2017). 5-year outcomes after left atrial appendage closure. J Am Coll Cardiol, 70(24), 2964–2975.
Metadaten
Titel
WATCHMAN implantation in patients with a history of atrial fibrillation and intracranial hemorrhage
verfasst von
William J. Hucker
Joshua A. Cohen
M. Edip Gurol
E. Kevin Heist
Carola Gianni
Jennifer Galvin
Donita Atkins
Sudha Bommana
Luigi Di Biase
Jeremy Ruskin
Sanghamitra Mohanty
Rodney Horton
Dhanunjaya Lakkireddy
Andrea Natale
Moussa Mansour
Publikationsdatum
12.12.2019
Verlag
Springer US
Erschienen in
Journal of Interventional Cardiac Electrophysiology / Ausgabe 2/2020
Print ISSN: 1383-875X
Elektronische ISSN: 1572-8595
DOI
https://doi.org/10.1007/s10840-019-00678-w

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