PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients: Results from the European PLAATO study

Yves Laurent Bayard, Heyder Omran, Petr Neuzil, Leif Thuesen, Maximilian Pichler, Edward Rowland, Angelo Ramondo, Witold Ruzyllo, Werner Budts, Gilles Montalescot, Pedro Brugada, Patrick W. Serruys, Alec Vahanian, Jean François Piéchaud, Antonio Bartorelli, Jean Marco, Peter Probst, Karl Heinz Kuck, Stefan H. Ostermayer, Franziska BüscheckEvelyn Fischer, Michaela Leetz, Horst Sievert

Research output: Contribution to journalArticle

125 Citations (Scopus)

Abstract

Aims: The European PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) study was performed to determine the safety and efficacy of left atrial appendage occlusion by catheter technique. Embolic stroke due to atrial fibrillation is a common observation, especially in the elderly. Most thrombi in atrial fibrillation form in the left atrial appendage (LAA), its occlusion may therefore reduce the incidence of stroke in these patients. Methods and results: One hundred and eighty patients with non-rheumatic atrial fibrillation and contraindication to warfarin therapy were enrolled in the PLAATO study. Patients were eligible if they had a history of transient ischaemic attack (TIA) or stroke or at least two independent risk factors for stroke such as age ≥75 years, hypertension, congestive heart failure or diabetes. The primary endpoint was LAA closure as determined by transesophageal echocardiography (TEE) two months after the procedure and stroke rate at 150 patient years. Left atrial appendage occlusion was successful in 162/180 patients (90%, 95% CI 83.1% to 92.9%). Two patients died within 24 hours of the procedure (1.1%, 95% CI 0.3% to 4%). Six cardiac tamponades were observed (3.3%, 95% CI 1.5% to 7.1%). In two cases, surgical drainage of the tamponade was necessary (1.1%, 95% CI 0.3% to 4%). In one patient, the device that was chosen was too small and embolised into the aorta after its release (0.6%, 95% CI 0.1% to 3.1%). It was snared and replaced without further complications. Successful occlusion of the LAA was achieved in 126/ 140 (90%, 95% CI 83.5% to 94.2%) of patients as noted by TEE at the two months follow-up. In a follow-up time of 129 documented patient years, three strokes occurred (2.3% per year). The expected incidence of stroke according to the CHADS2-Score was 6.6% per year. The trial was halted prematurely during the follow-up phase for financial considerations. Conclusions: Left atrial appendage closure is relatively safe and effective. However, severe complications can occur. It might become an alternative for atrial fibrillation patients who are ineligible for long-term anticoagulation therapy.

Original languageEnglish
Pages (from-to)220-226
Number of pages7
JournalEuroIntervention
Volume6
Issue number2
DOIs
Publication statusPublished - Jun 2010

Fingerprint

Atrial Appendage
Atrial Fibrillation
Stroke
Transesophageal Echocardiography
Cardiac Tamponade
Transient Ischemic Attack
Incidence
Warfarin
Aorta
Drainage
Thrombosis
Catheters
Heart Failure
Observation
Hypertension
Safety

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients : Results from the European PLAATO study. / Bayard, Yves Laurent; Omran, Heyder; Neuzil, Petr; Thuesen, Leif; Pichler, Maximilian; Rowland, Edward; Ramondo, Angelo; Ruzyllo, Witold; Budts, Werner; Montalescot, Gilles; Brugada, Pedro; Serruys, Patrick W.; Vahanian, Alec; Piéchaud, Jean François; Bartorelli, Antonio; Marco, Jean; Probst, Peter; Kuck, Karl Heinz; Ostermayer, Stefan H.; Büscheck, Franziska; Fischer, Evelyn; Leetz, Michaela; Sievert, Horst.

In: EuroIntervention, Vol. 6, No. 2, 06.2010, p. 220-226.

Research output: Contribution to journalArticle

Bayard, YL, Omran, H, Neuzil, P, Thuesen, L, Pichler, M, Rowland, E, Ramondo, A, Ruzyllo, W, Budts, W, Montalescot, G, Brugada, P, Serruys, PW, Vahanian, A, Piéchaud, JF, Bartorelli, A, Marco, J, Probst, P, Kuck, KH, Ostermayer, SH, Büscheck, F, Fischer, E, Leetz, M & Sievert, H 2010, 'PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients: Results from the European PLAATO study', EuroIntervention, vol. 6, no. 2, pp. 220-226. https://doi.org/10.4244/EIJV6I2A35
Bayard, Yves Laurent ; Omran, Heyder ; Neuzil, Petr ; Thuesen, Leif ; Pichler, Maximilian ; Rowland, Edward ; Ramondo, Angelo ; Ruzyllo, Witold ; Budts, Werner ; Montalescot, Gilles ; Brugada, Pedro ; Serruys, Patrick W. ; Vahanian, Alec ; Piéchaud, Jean François ; Bartorelli, Antonio ; Marco, Jean ; Probst, Peter ; Kuck, Karl Heinz ; Ostermayer, Stefan H. ; Büscheck, Franziska ; Fischer, Evelyn ; Leetz, Michaela ; Sievert, Horst. / PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients : Results from the European PLAATO study. In: EuroIntervention. 2010 ; Vol. 6, No. 2. pp. 220-226.
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abstract = "Aims: The European PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) study was performed to determine the safety and efficacy of left atrial appendage occlusion by catheter technique. Embolic stroke due to atrial fibrillation is a common observation, especially in the elderly. Most thrombi in atrial fibrillation form in the left atrial appendage (LAA), its occlusion may therefore reduce the incidence of stroke in these patients. Methods and results: One hundred and eighty patients with non-rheumatic atrial fibrillation and contraindication to warfarin therapy were enrolled in the PLAATO study. Patients were eligible if they had a history of transient ischaemic attack (TIA) or stroke or at least two independent risk factors for stroke such as age ≥75 years, hypertension, congestive heart failure or diabetes. The primary endpoint was LAA closure as determined by transesophageal echocardiography (TEE) two months after the procedure and stroke rate at 150 patient years. Left atrial appendage occlusion was successful in 162/180 patients (90{\%}, 95{\%} CI 83.1{\%} to 92.9{\%}). Two patients died within 24 hours of the procedure (1.1{\%}, 95{\%} CI 0.3{\%} to 4{\%}). Six cardiac tamponades were observed (3.3{\%}, 95{\%} CI 1.5{\%} to 7.1{\%}). In two cases, surgical drainage of the tamponade was necessary (1.1{\%}, 95{\%} CI 0.3{\%} to 4{\%}). In one patient, the device that was chosen was too small and embolised into the aorta after its release (0.6{\%}, 95{\%} CI 0.1{\%} to 3.1{\%}). It was snared and replaced without further complications. Successful occlusion of the LAA was achieved in 126/ 140 (90{\%}, 95{\%} CI 83.5{\%} to 94.2{\%}) of patients as noted by TEE at the two months follow-up. In a follow-up time of 129 documented patient years, three strokes occurred (2.3{\%} per year). The expected incidence of stroke according to the CHADS2-Score was 6.6{\%} per year. The trial was halted prematurely during the follow-up phase for financial considerations. Conclusions: Left atrial appendage closure is relatively safe and effective. However, severe complications can occur. It might become an alternative for atrial fibrillation patients who are ineligible for long-term anticoagulation therapy.",
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T1 - PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients

T2 - Results from the European PLAATO study

AU - Bayard, Yves Laurent

AU - Omran, Heyder

AU - Neuzil, Petr

AU - Thuesen, Leif

AU - Pichler, Maximilian

AU - Rowland, Edward

AU - Ramondo, Angelo

AU - Ruzyllo, Witold

AU - Budts, Werner

AU - Montalescot, Gilles

AU - Brugada, Pedro

AU - Serruys, Patrick W.

AU - Vahanian, Alec

AU - Piéchaud, Jean François

AU - Bartorelli, Antonio

AU - Marco, Jean

AU - Probst, Peter

AU - Kuck, Karl Heinz

AU - Ostermayer, Stefan H.

AU - Büscheck, Franziska

AU - Fischer, Evelyn

AU - Leetz, Michaela

AU - Sievert, Horst

PY - 2010/6

Y1 - 2010/6

N2 - Aims: The European PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) study was performed to determine the safety and efficacy of left atrial appendage occlusion by catheter technique. Embolic stroke due to atrial fibrillation is a common observation, especially in the elderly. Most thrombi in atrial fibrillation form in the left atrial appendage (LAA), its occlusion may therefore reduce the incidence of stroke in these patients. Methods and results: One hundred and eighty patients with non-rheumatic atrial fibrillation and contraindication to warfarin therapy were enrolled in the PLAATO study. Patients were eligible if they had a history of transient ischaemic attack (TIA) or stroke or at least two independent risk factors for stroke such as age ≥75 years, hypertension, congestive heart failure or diabetes. The primary endpoint was LAA closure as determined by transesophageal echocardiography (TEE) two months after the procedure and stroke rate at 150 patient years. Left atrial appendage occlusion was successful in 162/180 patients (90%, 95% CI 83.1% to 92.9%). Two patients died within 24 hours of the procedure (1.1%, 95% CI 0.3% to 4%). Six cardiac tamponades were observed (3.3%, 95% CI 1.5% to 7.1%). In two cases, surgical drainage of the tamponade was necessary (1.1%, 95% CI 0.3% to 4%). In one patient, the device that was chosen was too small and embolised into the aorta after its release (0.6%, 95% CI 0.1% to 3.1%). It was snared and replaced without further complications. Successful occlusion of the LAA was achieved in 126/ 140 (90%, 95% CI 83.5% to 94.2%) of patients as noted by TEE at the two months follow-up. In a follow-up time of 129 documented patient years, three strokes occurred (2.3% per year). The expected incidence of stroke according to the CHADS2-Score was 6.6% per year. The trial was halted prematurely during the follow-up phase for financial considerations. Conclusions: Left atrial appendage closure is relatively safe and effective. However, severe complications can occur. It might become an alternative for atrial fibrillation patients who are ineligible for long-term anticoagulation therapy.

AB - Aims: The European PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) study was performed to determine the safety and efficacy of left atrial appendage occlusion by catheter technique. Embolic stroke due to atrial fibrillation is a common observation, especially in the elderly. Most thrombi in atrial fibrillation form in the left atrial appendage (LAA), its occlusion may therefore reduce the incidence of stroke in these patients. Methods and results: One hundred and eighty patients with non-rheumatic atrial fibrillation and contraindication to warfarin therapy were enrolled in the PLAATO study. Patients were eligible if they had a history of transient ischaemic attack (TIA) or stroke or at least two independent risk factors for stroke such as age ≥75 years, hypertension, congestive heart failure or diabetes. The primary endpoint was LAA closure as determined by transesophageal echocardiography (TEE) two months after the procedure and stroke rate at 150 patient years. Left atrial appendage occlusion was successful in 162/180 patients (90%, 95% CI 83.1% to 92.9%). Two patients died within 24 hours of the procedure (1.1%, 95% CI 0.3% to 4%). Six cardiac tamponades were observed (3.3%, 95% CI 1.5% to 7.1%). In two cases, surgical drainage of the tamponade was necessary (1.1%, 95% CI 0.3% to 4%). In one patient, the device that was chosen was too small and embolised into the aorta after its release (0.6%, 95% CI 0.1% to 3.1%). It was snared and replaced without further complications. Successful occlusion of the LAA was achieved in 126/ 140 (90%, 95% CI 83.5% to 94.2%) of patients as noted by TEE at the two months follow-up. In a follow-up time of 129 documented patient years, three strokes occurred (2.3% per year). The expected incidence of stroke according to the CHADS2-Score was 6.6% per year. The trial was halted prematurely during the follow-up phase for financial considerations. Conclusions: Left atrial appendage closure is relatively safe and effective. However, severe complications can occur. It might become an alternative for atrial fibrillation patients who are ineligible for long-term anticoagulation therapy.

KW - Atrial fibrillation

KW - Left atrial appendage closure

KW - Prevention

KW - Stroke

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