Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery

Etem Caliskan, Ayhan Sahin, Murat Yilmaz, Burkhardt Seifert, Ricarda Hinzpeter, Hatem Alkadhi, James Lewis Cox, Tomas Holubec, Diana Reser, Volkmar Falk, Jürg Grünenfelder, Michele Genoni, Francesco Maisano, Sacha P. Salzberg, Maximilian Y. Emmert*

*Corresponding author for this work

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Aims Left atrial appendage (LAA) occlusion has emerged as an interesting alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). We report the safety, efficacy, and durability of concomitant device-enabled epicardial LAA occlusion during open-heart surgery. In addition to long-term follow-up, we evaluate the impact on stroke risk in this selected population. Methods and results A total of 291 AtriClip devices were deployed epicardially in patients (mean CHA2DS2-VASc-Score: 3.1± 1.5) undergoing open-heart surgery (including isolated coronary artery bypass grafting, valve, or combined procedures) comprising of forty patients from a first-in-man device trial (NCT00567515) and 251 patients from a consecutive institutional registry thereafter. In all patients (n= 291), the LAA was successfully excluded and overall mean follow-up (FU) was 36± 23months (range: 1?97months). No device-related complications were detected throughout the FU period. Longterm imaging work-up (computed tomography) in selected patients >5years post-implant (range: 5.1?8.1 years) displayed complete LAA occlusion with no signs of residual reperfusion or significant LAA stumps. Subgroup analysis of patients with discontinued OAC during FU (n= 166) revealed a relative risk reduction of 87.5% with an observed ischaemic stroke-rate of 0.5/100 patient-years compared with what would have been expected in a group of patients with similar CHA2DS2-VASc scores (expected rate of 4.0/100 patient-years). No strokes occurred in the subgroup with OAC. Conclusion The long-term results from our first-in-man prospective human trial plus our institutional registry of epicardial LAA occlusion with the AtriClip in patients with AF undergoing cardiac surgery demonstrate the safety and durability of the procedure. In addition, our data are suggestive for the potential efficacy of LAA occlusion in reducing the incidence of stroke. If validated in future large randomized trials, routine LAA occlusion in patients undergoing cardiac surgery (with contraindications to treatment with oral anticoagulants) may represent a reasonable adjunct procedure to reduce the risk of future stroke.

Original languageEnglish (US)
Pages (from-to)e105-e114
JournalEuropace
Volume20
Issue number7
DOIs
StatePublished - Jul 1 2018

Fingerprint

Atrial Appendage
Atrial Fibrillation
Thoracic Surgery
Stroke
Incidence
Equipment and Supplies
Registries
Safety
Risk Reduction Behavior
Coronary Artery Bypass
Anticoagulants
Reperfusion

Keywords

  • Alternatives to anticoagulation
  • Atrial fibrillation
  • Bleeding
  • CHA2DS2-VASc-Score
  • Epicardial
  • HAS-BLED
  • Left atrial appendage occlusion
  • Nonvitamin- K-dependent oral anticoagulant (NOAC)
  • Oral anticoagulation
  • Stroke
  • Warfarin

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Caliskan, Etem ; Sahin, Ayhan ; Yilmaz, Murat ; Seifert, Burkhardt ; Hinzpeter, Ricarda ; Alkadhi, Hatem ; Cox, James Lewis ; Holubec, Tomas ; Reser, Diana ; Falk, Volkmar ; Grünenfelder, Jürg ; Genoni, Michele ; Maisano, Francesco ; Salzberg, Sacha P. ; Emmert, Maximilian Y. / Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery. In: Europace. 2018 ; Vol. 20, No. 7. pp. e105-e114.
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abstract = "Aims Left atrial appendage (LAA) occlusion has emerged as an interesting alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). We report the safety, efficacy, and durability of concomitant device-enabled epicardial LAA occlusion during open-heart surgery. In addition to long-term follow-up, we evaluate the impact on stroke risk in this selected population. Methods and results A total of 291 AtriClip devices were deployed epicardially in patients (mean CHA2DS2-VASc-Score: 3.1± 1.5) undergoing open-heart surgery (including isolated coronary artery bypass grafting, valve, or combined procedures) comprising of forty patients from a first-in-man device trial (NCT00567515) and 251 patients from a consecutive institutional registry thereafter. In all patients (n= 291), the LAA was successfully excluded and overall mean follow-up (FU) was 36± 23months (range: 1?97months). No device-related complications were detected throughout the FU period. Longterm imaging work-up (computed tomography) in selected patients >5years post-implant (range: 5.1?8.1 years) displayed complete LAA occlusion with no signs of residual reperfusion or significant LAA stumps. Subgroup analysis of patients with discontinued OAC during FU (n= 166) revealed a relative risk reduction of 87.5{\%} with an observed ischaemic stroke-rate of 0.5/100 patient-years compared with what would have been expected in a group of patients with similar CHA2DS2-VASc scores (expected rate of 4.0/100 patient-years). No strokes occurred in the subgroup with OAC. Conclusion The long-term results from our first-in-man prospective human trial plus our institutional registry of epicardial LAA occlusion with the AtriClip in patients with AF undergoing cardiac surgery demonstrate the safety and durability of the procedure. In addition, our data are suggestive for the potential efficacy of LAA occlusion in reducing the incidence of stroke. If validated in future large randomized trials, routine LAA occlusion in patients undergoing cardiac surgery (with contraindications to treatment with oral anticoagulants) may represent a reasonable adjunct procedure to reduce the risk of future stroke.",
keywords = "Alternatives to anticoagulation, Atrial fibrillation, Bleeding, CHA2DS2-VASc-Score, Epicardial, HAS-BLED, Left atrial appendage occlusion, Nonvitamin- K-dependent oral anticoagulant (NOAC), Oral anticoagulation, Stroke, Warfarin",
author = "Etem Caliskan and Ayhan Sahin and Murat Yilmaz and Burkhardt Seifert and Ricarda Hinzpeter and Hatem Alkadhi and Cox, {James Lewis} and Tomas Holubec and Diana Reser and Volkmar Falk and J{\"u}rg Gr{\"u}nenfelder and Michele Genoni and Francesco Maisano and Salzberg, {Sacha P.} and Emmert, {Maximilian Y.}",
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Caliskan, E, Sahin, A, Yilmaz, M, Seifert, B, Hinzpeter, R, Alkadhi, H, Cox, JL, Holubec, T, Reser, D, Falk, V, Grünenfelder, J, Genoni, M, Maisano, F, Salzberg, SP & Emmert, MY 2018, 'Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery', Europace, vol. 20, no. 7, pp. e105-e114. https://doi.org/10.1093/europace/eux211

Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery. / Caliskan, Etem; Sahin, Ayhan; Yilmaz, Murat; Seifert, Burkhardt; Hinzpeter, Ricarda; Alkadhi, Hatem; Cox, James Lewis; Holubec, Tomas; Reser, Diana; Falk, Volkmar; Grünenfelder, Jürg; Genoni, Michele; Maisano, Francesco; Salzberg, Sacha P.; Emmert, Maximilian Y.

In: Europace, Vol. 20, No. 7, 01.07.2018, p. e105-e114.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery

AU - Caliskan, Etem

AU - Sahin, Ayhan

AU - Yilmaz, Murat

AU - Seifert, Burkhardt

AU - Hinzpeter, Ricarda

AU - Alkadhi, Hatem

AU - Cox, James Lewis

AU - Holubec, Tomas

AU - Reser, Diana

AU - Falk, Volkmar

AU - Grünenfelder, Jürg

AU - Genoni, Michele

AU - Maisano, Francesco

AU - Salzberg, Sacha P.

AU - Emmert, Maximilian Y.

PY - 2018/7/1

Y1 - 2018/7/1

N2 - Aims Left atrial appendage (LAA) occlusion has emerged as an interesting alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). We report the safety, efficacy, and durability of concomitant device-enabled epicardial LAA occlusion during open-heart surgery. In addition to long-term follow-up, we evaluate the impact on stroke risk in this selected population. Methods and results A total of 291 AtriClip devices were deployed epicardially in patients (mean CHA2DS2-VASc-Score: 3.1± 1.5) undergoing open-heart surgery (including isolated coronary artery bypass grafting, valve, or combined procedures) comprising of forty patients from a first-in-man device trial (NCT00567515) and 251 patients from a consecutive institutional registry thereafter. In all patients (n= 291), the LAA was successfully excluded and overall mean follow-up (FU) was 36± 23months (range: 1?97months). No device-related complications were detected throughout the FU period. Longterm imaging work-up (computed tomography) in selected patients >5years post-implant (range: 5.1?8.1 years) displayed complete LAA occlusion with no signs of residual reperfusion or significant LAA stumps. Subgroup analysis of patients with discontinued OAC during FU (n= 166) revealed a relative risk reduction of 87.5% with an observed ischaemic stroke-rate of 0.5/100 patient-years compared with what would have been expected in a group of patients with similar CHA2DS2-VASc scores (expected rate of 4.0/100 patient-years). No strokes occurred in the subgroup with OAC. Conclusion The long-term results from our first-in-man prospective human trial plus our institutional registry of epicardial LAA occlusion with the AtriClip in patients with AF undergoing cardiac surgery demonstrate the safety and durability of the procedure. In addition, our data are suggestive for the potential efficacy of LAA occlusion in reducing the incidence of stroke. If validated in future large randomized trials, routine LAA occlusion in patients undergoing cardiac surgery (with contraindications to treatment with oral anticoagulants) may represent a reasonable adjunct procedure to reduce the risk of future stroke.

AB - Aims Left atrial appendage (LAA) occlusion has emerged as an interesting alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). We report the safety, efficacy, and durability of concomitant device-enabled epicardial LAA occlusion during open-heart surgery. In addition to long-term follow-up, we evaluate the impact on stroke risk in this selected population. Methods and results A total of 291 AtriClip devices were deployed epicardially in patients (mean CHA2DS2-VASc-Score: 3.1± 1.5) undergoing open-heart surgery (including isolated coronary artery bypass grafting, valve, or combined procedures) comprising of forty patients from a first-in-man device trial (NCT00567515) and 251 patients from a consecutive institutional registry thereafter. In all patients (n= 291), the LAA was successfully excluded and overall mean follow-up (FU) was 36± 23months (range: 1?97months). No device-related complications were detected throughout the FU period. Longterm imaging work-up (computed tomography) in selected patients >5years post-implant (range: 5.1?8.1 years) displayed complete LAA occlusion with no signs of residual reperfusion or significant LAA stumps. Subgroup analysis of patients with discontinued OAC during FU (n= 166) revealed a relative risk reduction of 87.5% with an observed ischaemic stroke-rate of 0.5/100 patient-years compared with what would have been expected in a group of patients with similar CHA2DS2-VASc scores (expected rate of 4.0/100 patient-years). No strokes occurred in the subgroup with OAC. Conclusion The long-term results from our first-in-man prospective human trial plus our institutional registry of epicardial LAA occlusion with the AtriClip in patients with AF undergoing cardiac surgery demonstrate the safety and durability of the procedure. In addition, our data are suggestive for the potential efficacy of LAA occlusion in reducing the incidence of stroke. If validated in future large randomized trials, routine LAA occlusion in patients undergoing cardiac surgery (with contraindications to treatment with oral anticoagulants) may represent a reasonable adjunct procedure to reduce the risk of future stroke.

KW - Alternatives to anticoagulation

KW - Atrial fibrillation

KW - Bleeding

KW - CHA2DS2-VASc-Score

KW - Epicardial

KW - HAS-BLED

KW - Left atrial appendage occlusion

KW - Nonvitamin- K-dependent oral anticoagulant (NOAC)

KW - Oral anticoagulation

KW - Stroke

KW - Warfarin

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DO - 10.1093/europace/eux211

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SN - 1099-5129

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