Skip to main content
Erschienen in: Clinical Research in Cardiology 3/2016

01.03.2016 | Original Paper

Efficacy and safety of percutaneous left atrial appendage closure to prevent thromboembolic events in atrial fibrillation patients with high stroke and bleeding risk

verfasst von: Julia Seeger, Carlo Bothner, Tillman Dahme, Birgid Gonska, Dominik Scharnbeck, Sinisa Markovic, Wolfgang Rottbauer, Jochen Wöhrle

Erschienen in: Clinical Research in Cardiology | Ausgabe 3/2016

Einloggen, um Zugang zu erhalten

Abstract

Aims

The randomized PROTECT AF trial demonstrated non-inferiority of left atrial appendage (LAA) closure to oral anticoagulation with warfarin. Current guidelines give a class IIb recommendation for LAA closure. We evaluated the efficacy and safety of LAA closure in a consecutive series of non-valvular atrial fibrillation patients with contraindications to long-term oral anticoagulation or at high bleeding risk.

Methods and results

101 consecutive non-valvular atrial fibrillation patients (age 74.7 ± 7.5 years) at high risk for stroke (CHA2DS2-VASc Score 4.4 ± 1.6) and high bleeding risk (HAS-BLED Score 4.2 ± 1.3) received LAA closure with either the Watchman closure device (n = 38) or the Amplatzer cardiac plug (n = 63). Dual antiplatelet therapy with aspirin and clopidogrel was recommended for 3–6 months after device implantation, followed by long-term antiplatelet therapy with aspirin. No anticoagulation was given after device implantation. Mean follow-up was 400 days. One patient (1 %) experienced a transient ischemic attack, and two patients (2 %) suffered from ischemic stroke. While on recommended antiplatelet therapy, bleeding occurred in 12/101 patients (12 %). Bleeding was significantly reduced with 3 compared with 6 months dual antiplatelet therapy (3.0 vs. 16.2 %, p < 0.05) while ischemic or thrombotic events were similar.

Conclusion

Left atrial appendage closure in patients with non-valvular atrial fibrillation and high risk for stroke and bleeding events effectively prevented stroke and reduced cerebral ischemic events compared to expected stroke rate according to CHA2DS2-VASc Score. Dual antiplatelet therapy for 3 months reduced the rate of bleeding events compared to 6 months therapy with no increase of thrombotic events.
Literatur
1.
Zurück zum Zitat Wolf PA, Abbott RD, Kannel WB (1991) Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 22:983–988CrossRefPubMed Wolf PA, Abbott RD, Kannel WB (1991) Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 22:983–988CrossRefPubMed
2.
Zurück zum Zitat Blackshear JL, Odell JA (1996) Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg 61:755–759CrossRefPubMed Blackshear JL, Odell JA (1996) Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg 61:755–759CrossRefPubMed
3.
Zurück zum Zitat Di Biase L, Santangeli P, Anselmino M, Mohanty P, Salvetti I, Gili S, Horton R, Sanchez JE, Bai R, Mohanty S, Pump A, Cereceda Brantes M, Gallinghouse GJ, Burkhardt JD, Cesarani F, Scaglione M, Natale A, Gaita F (2012) Does the left atria appendage morphology correlate with the risk of stroke in patients with atrial fibrillation? Results from a multicenter study. J Am Coll Cardiol 60:531–538CrossRefPubMed Di Biase L, Santangeli P, Anselmino M, Mohanty P, Salvetti I, Gili S, Horton R, Sanchez JE, Bai R, Mohanty S, Pump A, Cereceda Brantes M, Gallinghouse GJ, Burkhardt JD, Cesarani F, Scaglione M, Natale A, Gaita F (2012) Does the left atria appendage morphology correlate with the risk of stroke in patients with atrial fibrillation? Results from a multicenter study. J Am Coll Cardiol 60:531–538CrossRefPubMed
4.
Zurück zum Zitat Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D, PROTECT AF Steering Committee and Investigators (2014) Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA 312:1988–1998CrossRefPubMed Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D, PROTECT AF Steering Committee and Investigators (2014) Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA 312:1988–1998CrossRefPubMed
5.
Zurück zum Zitat Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY (2014) Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol 64:1–12CrossRefPubMed Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY (2014) Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol 64:1–12CrossRefPubMed
6.
Zurück zum Zitat Reddy VY, Möbius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H (2013) Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol 61:2551–2556CrossRefPubMed Reddy VY, Möbius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H (2013) Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol 61:2551–2556CrossRefPubMed
7.
Zurück zum Zitat Hanazawa K, Brunelli M, Geller JC (2014) Thromboembolic stroke after cardioversion with incomplete left atrial appendage closure. Clin Res Cardiol 103:835–837CrossRefPubMed Hanazawa K, Brunelli M, Geller JC (2014) Thromboembolic stroke after cardioversion with incomplete left atrial appendage closure. Clin Res Cardiol 103:835–837CrossRefPubMed
8.
Zurück zum Zitat Saw J, Lempereur M (2014) Percutaneous left atrial appendage closure: procedural techniques and outcomes. JACC Cardiovasc Interv 11:1205–1220CrossRef Saw J, Lempereur M (2014) Percutaneous left atrial appendage closure: procedural techniques and outcomes. JACC Cardiovasc Interv 11:1205–1220CrossRef
9.
Zurück zum Zitat Gage BF, van Walraven C, Pearce L, Pearce L, Hart RG, Koudstaal PJ, Boode BS, Petersen P (2004) Selecting patients with atrial fibrillation for anticoagulation: stroke risk stratification in patients taking aspirin. Circulation 110:2287–2292CrossRefPubMed Gage BF, van Walraven C, Pearce L, Pearce L, Hart RG, Koudstaal PJ, Boode BS, Petersen P (2004) Selecting patients with atrial fibrillation for anticoagulation: stroke risk stratification in patients taking aspirin. Circulation 110:2287–2292CrossRefPubMed
10.
Zurück zum Zitat Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbäcker T, Kanagaratnam P, Nietlispach F, Aminian A, Kasch F, Freixa X, Danna P, Rezzagh M, Vermeersch P, Stock F, Stolcova M, Costa M, Ibrahim R, Schillinger W, Meier B, Park JW (2015) Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention 10(10). doi:10.4244/EIJY15M01_06 Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbäcker T, Kanagaratnam P, Nietlispach F, Aminian A, Kasch F, Freixa X, Danna P, Rezzagh M, Vermeersch P, Stock F, Stolcova M, Costa M, Ibrahim R, Schillinger W, Meier B, Park JW (2015) Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention 10(10). doi:10.​4244/​EIJY15M01_​06
11.
Zurück zum Zitat Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ (2010) Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest 137:263–272CrossRefPubMed Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ (2010) Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest 137:263–272CrossRefPubMed
12.
Zurück zum Zitat Poli D, Lip GY, Antonucci E, Grifoni E, Lane D (2010) Stroke risk stratification in a “real-world” elderly anticoagulated atrial fibrillation population. J Cardiovasc Electrophysiol 22:25–30CrossRef Poli D, Lip GY, Antonucci E, Grifoni E, Lane D (2010) Stroke risk stratification in a “real-world” elderly anticoagulated atrial fibrillation population. J Cardiovasc Electrophysiol 22:25–30CrossRef
13.
Zurück zum Zitat Sedaghat A, Nickenig G, Hammerstingl C (2014) Left atrial appendage closure in a patient with atrial fibrillation after mechanical mitral valve replacement and cardio-embolic stroke despite effective oral anticoagulant therapy: a case report. Clin Res Cardiol 103:587–589CrossRefPubMed Sedaghat A, Nickenig G, Hammerstingl C (2014) Left atrial appendage closure in a patient with atrial fibrillation after mechanical mitral valve replacement and cardio-embolic stroke despite effective oral anticoagulant therapy: a case report. Clin Res Cardiol 103:587–589CrossRefPubMed
14.
Zurück zum Zitat Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S (2013) The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study. Circulation 128:237–243CrossRefPubMed Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S (2013) The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study. Circulation 128:237–243CrossRefPubMed
15.
Zurück zum Zitat Halperin JL, Hankey GJ, Wojdyla DM, Piccini JP, Lokhnygina Y, Patel MR, Breithardt G, Singer DE, Becker RC, Hacke W, Paolini JF, Nessel CC, Mahaffey KW, Califf RM, Fox KA, ROCKET AF Steering Committee and Investigators (2014) Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Circulation 130:138–146CrossRefPubMed Halperin JL, Hankey GJ, Wojdyla DM, Piccini JP, Lokhnygina Y, Patel MR, Breithardt G, Singer DE, Becker RC, Hacke W, Paolini JF, Nessel CC, Mahaffey KW, Califf RM, Fox KA, ROCKET AF Steering Committee and Investigators (2014) Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Circulation 130:138–146CrossRefPubMed
16.
Zurück zum Zitat Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L, ARISTOTLE Committees and Investigators (2011) Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365:981–992CrossRefPubMed Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L, ARISTOTLE Committees and Investigators (2011) Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365:981–992CrossRefPubMed
17.
Zurück zum Zitat Roldán V, Marín F, Manzano-Fernández S, Gallego P, Vílchez JA, Valdés M, Vicente V, Lip GY (2013) The HAS-BLED score has better prediction accuracy for major bleeding than CHADS2 or CHA2DS2-VASc scores in anticoagulated patients with atrial fibrillation. J Am Coll Cardiol 62:2199–2204CrossRefPubMed Roldán V, Marín F, Manzano-Fernández S, Gallego P, Vílchez JA, Valdés M, Vicente V, Lip GY (2013) The HAS-BLED score has better prediction accuracy for major bleeding than CHADS2 or CHA2DS2-VASc scores in anticoagulated patients with atrial fibrillation. J Am Coll Cardiol 62:2199–2204CrossRefPubMed
18.
Zurück zum Zitat Nakai T, Lesh MD, Gerstenfeld EP, Virmani R, Jones R, Lee RJ (2002) Percutaneous left atrial appendage occlusion (PLAATO) for preventing cardioembolism: first experience in canine model. Circulation 105:2217–2222CrossRefPubMed Nakai T, Lesh MD, Gerstenfeld EP, Virmani R, Jones R, Lee RJ (2002) Percutaneous left atrial appendage occlusion (PLAATO) for preventing cardioembolism: first experience in canine model. Circulation 105:2217–2222CrossRefPubMed
19.
Zurück zum Zitat Chun KR, Bordignon S, Urban V, Perrotta L, Dugo D, Fürnkranz A, Nowak B, Schmidt B (2013) Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: a prospective single-center experience. Heart Rhythm 10:1792–1799CrossRefPubMed Chun KR, Bordignon S, Urban V, Perrotta L, Dugo D, Fürnkranz A, Nowak B, Schmidt B (2013) Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: a prospective single-center experience. Heart Rhythm 10:1792–1799CrossRefPubMed
20.
Zurück zum Zitat Gloekler S, Shakir S, Doblies J, Khattab AA, Praz F, Guerios Ê, Koermendy D, Stortecky S, Pilgrim T, Buellesfeld L, Wenaweser P, Windecker S, Moschovitis A, Jaguszewski M, Landmesser U, Nietlispach F, Meier B (2015) Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation. Clin Res Cardiol 104:656–665CrossRefPubMed Gloekler S, Shakir S, Doblies J, Khattab AA, Praz F, Guerios Ê, Koermendy D, Stortecky S, Pilgrim T, Buellesfeld L, Wenaweser P, Windecker S, Moschovitis A, Jaguszewski M, Landmesser U, Nietlispach F, Meier B (2015) Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation. Clin Res Cardiol 104:656–665CrossRefPubMed
Metadaten
Titel
Efficacy and safety of percutaneous left atrial appendage closure to prevent thromboembolic events in atrial fibrillation patients with high stroke and bleeding risk
verfasst von
Julia Seeger
Carlo Bothner
Tillman Dahme
Birgid Gonska
Dominik Scharnbeck
Sinisa Markovic
Wolfgang Rottbauer
Jochen Wöhrle
Publikationsdatum
01.03.2016
Verlag
Springer Berlin Heidelberg
Erschienen in
Clinical Research in Cardiology / Ausgabe 3/2016
Print ISSN: 1861-0684
Elektronische ISSN: 1861-0692
DOI
https://doi.org/10.1007/s00392-015-0910-8

Weitere Artikel der Ausgabe 3/2016

Clinical Research in Cardiology 3/2016 Zur Ausgabe

Screening-Mammografie offenbart erhöhtes Herz-Kreislauf-Risiko

26.04.2024 Mammografie Nachrichten

Routinemäßige Mammografien helfen, Brustkrebs frühzeitig zu erkennen. Anhand der Röntgenuntersuchung lassen sich aber auch kardiovaskuläre Risikopatientinnen identifizieren. Als zuverlässiger Anhaltspunkt gilt die Verkalkung der Brustarterien.

Niedriger diastolischer Blutdruck erhöht Risiko für schwere kardiovaskuläre Komplikationen

25.04.2024 Hypotonie Nachrichten

Wenn unter einer medikamentösen Hochdrucktherapie der diastolische Blutdruck in den Keller geht, steigt das Risiko für schwere kardiovaskuläre Ereignisse: Darauf deutet eine Sekundäranalyse der SPRINT-Studie hin.

Therapiestart mit Blutdrucksenkern erhöht Frakturrisiko

25.04.2024 Hypertonie Nachrichten

Beginnen ältere Männer im Pflegeheim eine Antihypertensiva-Therapie, dann ist die Frakturrate in den folgenden 30 Tagen mehr als verdoppelt. Besonders häufig stürzen Demenzkranke und Männer, die erstmals Blutdrucksenker nehmen. Dafür spricht eine Analyse unter US-Veteranen.

Adipositas-Medikament auch gegen Schlafapnoe wirksam

24.04.2024 Adipositas Nachrichten

Der als Antidiabetikum sowie zum Gewichtsmanagement zugelassene Wirkstoff Tirzepatid hat in Studien bei adipösen Patienten auch schlafbezogene Atmungsstörungen deutlich reduziert, informiert der Hersteller in einer Vorab-Meldung zum Studienausgang.

Update Kardiologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.