Left atrial appendage occlusion with the AMPLATZER Amulet device: Periprocedural and early clinical/echocardiographic data from a global prospective observational study

Ulf Landmesser, Boris Schmidt, Jens Erik Nielsen-Kudsk, Simon Cheung Chi Lam, Jai Wun Park, Giuseppe Tarantini, Ignacio Cruz-Gonzalez, Volker Geist, Paolo Della Bella, Antonio Colombo, Tobias Zeus, Heyder Omran, Christopher Piorkowski, Juha Lund, Claudio Tondo, David Hildick-Smith, on behalf of the Amulet Observational Study Investigators

Research output: Contribution to journalArticle

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Abstract

Aims: The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study. Methods and results: This multicentre prospective real-world registry included 1,088 patients (75±8.5 years, 64.5% male, CHA2DS2-VASc: 4.2±1.6, HAS-BLED: 3.3±1.1) with non-valvular atrial fibrillation; 82.8% of patients were considered to have an absolute or relative contraindication to long-term anticoagulation and 72.4% had had a previous major bleeding. Periprocedural results, clinical outcomes up to the first three months and the available TEE results from the first scheduled follow-up (one to three months post implant) are reported. Successful device implantation was achieved in 99.0% of patients. During the procedure and index hospitalisation, major adverse events occurred in 3.2% of patients. Patients were discharged on a single antiplatelet agent (23.0%), dual antiplatelets (54.3%) or an oral anticoagulant (18.9%). TEE follow-up 67±23 days post procedure in 673 patients showed adequate (<3 mm jet) occlusion of the appendage in 98.2% of patients and device thrombus in 10 patients (1.5%), as evaluated by core laboratory analysis. Conclusions: This large real-world prospective registry of catheter-based LAAO using the AMPLATZER Amulet device reports a high implant success rate and a low periprocedural complication rate in a population with a high risk of stroke and bleeding. Transoesophageal echo data confirm good closure rates during follow-up and low rates of device-associated thrombus.

Original languageEnglish
Pages (from-to)867-876
Number of pages10
JournalEuroIntervention
Volume13
Issue number7
DOIs
Publication statusPublished - Sep 1 2017

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Atrial Appendage
Observational Studies
Prospective Studies
Equipment and Supplies
Registries
Thrombosis
Hemorrhage
Platelet Aggregation Inhibitors
Anticoagulants
Atrial Fibrillation
Hospitalization
Catheters
Stroke

Keywords

  • Atrial fibrillation
  • Bleeding
  • Left atrial appendage closure
  • Stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Landmesser, U., Schmidt, B., Nielsen-Kudsk, J. E., Lam, S. C. C., Park, J. W., Tarantini, G., ... on behalf of the Amulet Observational Study Investigators (2017). Left atrial appendage occlusion with the AMPLATZER Amulet device: Periprocedural and early clinical/echocardiographic data from a global prospective observational study. EuroIntervention, 13(7), 867-876. https://doi.org/10.4244/EIJ-D-17-00493

Left atrial appendage occlusion with the AMPLATZER Amulet device : Periprocedural and early clinical/echocardiographic data from a global prospective observational study. / Landmesser, Ulf; Schmidt, Boris; Nielsen-Kudsk, Jens Erik; Lam, Simon Cheung Chi; Park, Jai Wun; Tarantini, Giuseppe; Cruz-Gonzalez, Ignacio; Geist, Volker; Della Bella, Paolo; Colombo, Antonio; Zeus, Tobias; Omran, Heyder; Piorkowski, Christopher; Lund, Juha; Tondo, Claudio; Hildick-Smith, David; on behalf of the Amulet Observational Study Investigators.

In: EuroIntervention, Vol. 13, No. 7, 01.09.2017, p. 867-876.

Research output: Contribution to journalArticle

Landmesser, U, Schmidt, B, Nielsen-Kudsk, JE, Lam, SCC, Park, JW, Tarantini, G, Cruz-Gonzalez, I, Geist, V, Della Bella, P, Colombo, A, Zeus, T, Omran, H, Piorkowski, C, Lund, J, Tondo, C, Hildick-Smith, D & on behalf of the Amulet Observational Study Investigators 2017, 'Left atrial appendage occlusion with the AMPLATZER Amulet device: Periprocedural and early clinical/echocardiographic data from a global prospective observational study', EuroIntervention, vol. 13, no. 7, pp. 867-876. https://doi.org/10.4244/EIJ-D-17-00493
Landmesser, Ulf ; Schmidt, Boris ; Nielsen-Kudsk, Jens Erik ; Lam, Simon Cheung Chi ; Park, Jai Wun ; Tarantini, Giuseppe ; Cruz-Gonzalez, Ignacio ; Geist, Volker ; Della Bella, Paolo ; Colombo, Antonio ; Zeus, Tobias ; Omran, Heyder ; Piorkowski, Christopher ; Lund, Juha ; Tondo, Claudio ; Hildick-Smith, David ; on behalf of the Amulet Observational Study Investigators. / Left atrial appendage occlusion with the AMPLATZER Amulet device : Periprocedural and early clinical/echocardiographic data from a global prospective observational study. In: EuroIntervention. 2017 ; Vol. 13, No. 7. pp. 867-876.
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abstract = "Aims: The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study. Methods and results: This multicentre prospective real-world registry included 1,088 patients (75±8.5 years, 64.5{\%} male, CHA2DS2-VASc: 4.2±1.6, HAS-BLED: 3.3±1.1) with non-valvular atrial fibrillation; 82.8{\%} of patients were considered to have an absolute or relative contraindication to long-term anticoagulation and 72.4{\%} had had a previous major bleeding. Periprocedural results, clinical outcomes up to the first three months and the available TEE results from the first scheduled follow-up (one to three months post implant) are reported. Successful device implantation was achieved in 99.0{\%} of patients. During the procedure and index hospitalisation, major adverse events occurred in 3.2{\%} of patients. Patients were discharged on a single antiplatelet agent (23.0{\%}), dual antiplatelets (54.3{\%}) or an oral anticoagulant (18.9{\%}). TEE follow-up 67±23 days post procedure in 673 patients showed adequate (<3 mm jet) occlusion of the appendage in 98.2{\%} of patients and device thrombus in 10 patients (1.5{\%}), as evaluated by core laboratory analysis. Conclusions: This large real-world prospective registry of catheter-based LAAO using the AMPLATZER Amulet device reports a high implant success rate and a low periprocedural complication rate in a population with a high risk of stroke and bleeding. Transoesophageal echo data confirm good closure rates during follow-up and low rates of device-associated thrombus.",
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T2 - Periprocedural and early clinical/echocardiographic data from a global prospective observational study

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AU - Schmidt, Boris

AU - Nielsen-Kudsk, Jens Erik

AU - Lam, Simon Cheung Chi

AU - Park, Jai Wun

AU - Tarantini, Giuseppe

AU - Cruz-Gonzalez, Ignacio

AU - Geist, Volker

AU - Della Bella, Paolo

AU - Colombo, Antonio

AU - Zeus, Tobias

AU - Omran, Heyder

AU - Piorkowski, Christopher

AU - Lund, Juha

AU - Tondo, Claudio

AU - Hildick-Smith, David

AU - on behalf of the Amulet Observational Study Investigators

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N2 - Aims: The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study. Methods and results: This multicentre prospective real-world registry included 1,088 patients (75±8.5 years, 64.5% male, CHA2DS2-VASc: 4.2±1.6, HAS-BLED: 3.3±1.1) with non-valvular atrial fibrillation; 82.8% of patients were considered to have an absolute or relative contraindication to long-term anticoagulation and 72.4% had had a previous major bleeding. Periprocedural results, clinical outcomes up to the first three months and the available TEE results from the first scheduled follow-up (one to three months post implant) are reported. Successful device implantation was achieved in 99.0% of patients. During the procedure and index hospitalisation, major adverse events occurred in 3.2% of patients. Patients were discharged on a single antiplatelet agent (23.0%), dual antiplatelets (54.3%) or an oral anticoagulant (18.9%). TEE follow-up 67±23 days post procedure in 673 patients showed adequate (<3 mm jet) occlusion of the appendage in 98.2% of patients and device thrombus in 10 patients (1.5%), as evaluated by core laboratory analysis. Conclusions: This large real-world prospective registry of catheter-based LAAO using the AMPLATZER Amulet device reports a high implant success rate and a low periprocedural complication rate in a population with a high risk of stroke and bleeding. Transoesophageal echo data confirm good closure rates during follow-up and low rates of device-associated thrombus.

AB - Aims: The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study. Methods and results: This multicentre prospective real-world registry included 1,088 patients (75±8.5 years, 64.5% male, CHA2DS2-VASc: 4.2±1.6, HAS-BLED: 3.3±1.1) with non-valvular atrial fibrillation; 82.8% of patients were considered to have an absolute or relative contraindication to long-term anticoagulation and 72.4% had had a previous major bleeding. Periprocedural results, clinical outcomes up to the first three months and the available TEE results from the first scheduled follow-up (one to three months post implant) are reported. Successful device implantation was achieved in 99.0% of patients. During the procedure and index hospitalisation, major adverse events occurred in 3.2% of patients. Patients were discharged on a single antiplatelet agent (23.0%), dual antiplatelets (54.3%) or an oral anticoagulant (18.9%). TEE follow-up 67±23 days post procedure in 673 patients showed adequate (<3 mm jet) occlusion of the appendage in 98.2% of patients and device thrombus in 10 patients (1.5%), as evaluated by core laboratory analysis. Conclusions: This large real-world prospective registry of catheter-based LAAO using the AMPLATZER Amulet device reports a high implant success rate and a low periprocedural complication rate in a population with a high risk of stroke and bleeding. Transoesophageal echo data confirm good closure rates during follow-up and low rates of device-associated thrombus.

KW - Atrial fibrillation

KW - Bleeding

KW - Left atrial appendage closure

KW - Stroke

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