The clinical impact of incomplete left atrial appendage closure with the watchman device in patients with atrial fibrillation: A PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients with Atrial Fibrillation) substudy

Juan Viles Gonzalez, Saibal Kar, Pamela Douglas, Srinivas Dukkipati, Ted Feldman, Rodney Horton, David Holmes, Vivek Y. Reddy

Research output: Contribution to journalArticle

279 Citations (Scopus)

Abstract

Objectives: The purpose of this study was to investigate the frequency and clinical impact of incomplete left atrial appendage (LAA) sealing and consequent peri-device residual blood flow in patients undergoing percutaneous LAA closure with the Watchman device (Atritech, Inc., Plymouth, Minnesota). Background: During percutaneous LAA closure for stroke prophylaxis, the geometric variability of the LAA ostium may result in an incomplete seal of the LAA. On the one hand, this could enhance thrombus formation and embolization of thrombi around the device into the circulation; on the other hand, the relatively small size of these leaks may preclude clinically relevant embolizations. Methods: Patients randomly assigned to device implantation in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial were analyzed. Transesophageal echocardiography was performed at 45 days, 6 months, and 12 months. Per the study protocol, patients discontinued warfarin therapy if the 45-day Transesophageal echocardiogram revealed either minimal or no peri-device flow (jet ≤5 mm width). The impact of peri-device flow severity, defined as minor, moderate, or major (<1 mm, 1 mm to 3 mm, >3 mm, respectively) on the composite primary efficacy endpoint (stroke, systemic embolism, and cardiovascular death) is expressed as hazard ratio (HR) with 95% confidence interval (CI). Results: Transesophageal echocardiography follow-up revealed that 32.0% of implanted patients had at least some degree of peri-device flow at 12 months. The HR of the primary efficacy endpoint per 1 mm larger per-device flow was 0.84 (95% CI: 0.62 to 1.14; p = 0.256). Compared to patients with no peri-device flow, the HRs were 0.85 (95% CI: 0.11 to 6.40), 0.83 (95% CI: 0.33 to 2.09), and 0.48 (95% CI: 0.11 to 2.09) for minor, moderate, and major peri-device flow, respectively (p = 0.798). Compared to patients with no peri-device flow who discontinued warfarin, the HR for patients with any peri-device flow and continuing warfarin was 0.63 (95% CI: 0.14 to 2.71; p = 0.530). Conclusions: These data indicate that residual peri-device flow into the LAA after percutaneous closure with the Watchman device was common, and is not associated with an increased risk of thromboembolism. This finding should be interpreted with caution as the low event rate decreases the confidence of this conclusion.

Original languageEnglish
Pages (from-to)923-929
Number of pages7
JournalJournal of the American College of Cardiology
Volume59
Issue number10
DOIs
StatePublished - Mar 6 2012
Externally publishedYes

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Atrial Appendage
Warfarin
Atrial Fibrillation
Stroke
Equipment and Supplies
Confidence Intervals
Therapeutics
Transesophageal Echocardiography
Thrombosis
Thromboembolism
Embolism

Keywords

  • atrial fibrillation
  • left atrial appendage
  • occlusion device
  • stroke
  • Watchman

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

The clinical impact of incomplete left atrial appendage closure with the watchman device in patients with atrial fibrillation : A PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients with Atrial Fibrillation) substudy. / Viles Gonzalez, Juan; Kar, Saibal; Douglas, Pamela; Dukkipati, Srinivas; Feldman, Ted; Horton, Rodney; Holmes, David; Reddy, Vivek Y.

In: Journal of the American College of Cardiology, Vol. 59, No. 10, 06.03.2012, p. 923-929.

Research output: Contribution to journalArticle

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title = "The clinical impact of incomplete left atrial appendage closure with the watchman device in patients with atrial fibrillation: A PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients with Atrial Fibrillation) substudy",
abstract = "Objectives: The purpose of this study was to investigate the frequency and clinical impact of incomplete left atrial appendage (LAA) sealing and consequent peri-device residual blood flow in patients undergoing percutaneous LAA closure with the Watchman device (Atritech, Inc., Plymouth, Minnesota). Background: During percutaneous LAA closure for stroke prophylaxis, the geometric variability of the LAA ostium may result in an incomplete seal of the LAA. On the one hand, this could enhance thrombus formation and embolization of thrombi around the device into the circulation; on the other hand, the relatively small size of these leaks may preclude clinically relevant embolizations. Methods: Patients randomly assigned to device implantation in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial were analyzed. Transesophageal echocardiography was performed at 45 days, 6 months, and 12 months. Per the study protocol, patients discontinued warfarin therapy if the 45-day Transesophageal echocardiogram revealed either minimal or no peri-device flow (jet ≤5 mm width). The impact of peri-device flow severity, defined as minor, moderate, or major (<1 mm, 1 mm to 3 mm, >3 mm, respectively) on the composite primary efficacy endpoint (stroke, systemic embolism, and cardiovascular death) is expressed as hazard ratio (HR) with 95{\%} confidence interval (CI). Results: Transesophageal echocardiography follow-up revealed that 32.0{\%} of implanted patients had at least some degree of peri-device flow at 12 months. The HR of the primary efficacy endpoint per 1 mm larger per-device flow was 0.84 (95{\%} CI: 0.62 to 1.14; p = 0.256). Compared to patients with no peri-device flow, the HRs were 0.85 (95{\%} CI: 0.11 to 6.40), 0.83 (95{\%} CI: 0.33 to 2.09), and 0.48 (95{\%} CI: 0.11 to 2.09) for minor, moderate, and major peri-device flow, respectively (p = 0.798). Compared to patients with no peri-device flow who discontinued warfarin, the HR for patients with any peri-device flow and continuing warfarin was 0.63 (95{\%} CI: 0.14 to 2.71; p = 0.530). Conclusions: These data indicate that residual peri-device flow into the LAA after percutaneous closure with the Watchman device was common, and is not associated with an increased risk of thromboembolism. This finding should be interpreted with caution as the low event rate decreases the confidence of this conclusion.",
keywords = "atrial fibrillation, left atrial appendage, occlusion device, stroke, Watchman",
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T1 - The clinical impact of incomplete left atrial appendage closure with the watchman device in patients with atrial fibrillation

T2 - A PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients with Atrial Fibrillation) substudy

AU - Viles Gonzalez, Juan

AU - Kar, Saibal

AU - Douglas, Pamela

AU - Dukkipati, Srinivas

AU - Feldman, Ted

AU - Horton, Rodney

AU - Holmes, David

AU - Reddy, Vivek Y.

PY - 2012/3/6

Y1 - 2012/3/6

N2 - Objectives: The purpose of this study was to investigate the frequency and clinical impact of incomplete left atrial appendage (LAA) sealing and consequent peri-device residual blood flow in patients undergoing percutaneous LAA closure with the Watchman device (Atritech, Inc., Plymouth, Minnesota). Background: During percutaneous LAA closure for stroke prophylaxis, the geometric variability of the LAA ostium may result in an incomplete seal of the LAA. On the one hand, this could enhance thrombus formation and embolization of thrombi around the device into the circulation; on the other hand, the relatively small size of these leaks may preclude clinically relevant embolizations. Methods: Patients randomly assigned to device implantation in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial were analyzed. Transesophageal echocardiography was performed at 45 days, 6 months, and 12 months. Per the study protocol, patients discontinued warfarin therapy if the 45-day Transesophageal echocardiogram revealed either minimal or no peri-device flow (jet ≤5 mm width). The impact of peri-device flow severity, defined as minor, moderate, or major (<1 mm, 1 mm to 3 mm, >3 mm, respectively) on the composite primary efficacy endpoint (stroke, systemic embolism, and cardiovascular death) is expressed as hazard ratio (HR) with 95% confidence interval (CI). Results: Transesophageal echocardiography follow-up revealed that 32.0% of implanted patients had at least some degree of peri-device flow at 12 months. The HR of the primary efficacy endpoint per 1 mm larger per-device flow was 0.84 (95% CI: 0.62 to 1.14; p = 0.256). Compared to patients with no peri-device flow, the HRs were 0.85 (95% CI: 0.11 to 6.40), 0.83 (95% CI: 0.33 to 2.09), and 0.48 (95% CI: 0.11 to 2.09) for minor, moderate, and major peri-device flow, respectively (p = 0.798). Compared to patients with no peri-device flow who discontinued warfarin, the HR for patients with any peri-device flow and continuing warfarin was 0.63 (95% CI: 0.14 to 2.71; p = 0.530). Conclusions: These data indicate that residual peri-device flow into the LAA after percutaneous closure with the Watchman device was common, and is not associated with an increased risk of thromboembolism. This finding should be interpreted with caution as the low event rate decreases the confidence of this conclusion.

AB - Objectives: The purpose of this study was to investigate the frequency and clinical impact of incomplete left atrial appendage (LAA) sealing and consequent peri-device residual blood flow in patients undergoing percutaneous LAA closure with the Watchman device (Atritech, Inc., Plymouth, Minnesota). Background: During percutaneous LAA closure for stroke prophylaxis, the geometric variability of the LAA ostium may result in an incomplete seal of the LAA. On the one hand, this could enhance thrombus formation and embolization of thrombi around the device into the circulation; on the other hand, the relatively small size of these leaks may preclude clinically relevant embolizations. Methods: Patients randomly assigned to device implantation in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial were analyzed. Transesophageal echocardiography was performed at 45 days, 6 months, and 12 months. Per the study protocol, patients discontinued warfarin therapy if the 45-day Transesophageal echocardiogram revealed either minimal or no peri-device flow (jet ≤5 mm width). The impact of peri-device flow severity, defined as minor, moderate, or major (<1 mm, 1 mm to 3 mm, >3 mm, respectively) on the composite primary efficacy endpoint (stroke, systemic embolism, and cardiovascular death) is expressed as hazard ratio (HR) with 95% confidence interval (CI). Results: Transesophageal echocardiography follow-up revealed that 32.0% of implanted patients had at least some degree of peri-device flow at 12 months. The HR of the primary efficacy endpoint per 1 mm larger per-device flow was 0.84 (95% CI: 0.62 to 1.14; p = 0.256). Compared to patients with no peri-device flow, the HRs were 0.85 (95% CI: 0.11 to 6.40), 0.83 (95% CI: 0.33 to 2.09), and 0.48 (95% CI: 0.11 to 2.09) for minor, moderate, and major peri-device flow, respectively (p = 0.798). Compared to patients with no peri-device flow who discontinued warfarin, the HR for patients with any peri-device flow and continuing warfarin was 0.63 (95% CI: 0.14 to 2.71; p = 0.530). Conclusions: These data indicate that residual peri-device flow into the LAA after percutaneous closure with the Watchman device was common, and is not associated with an increased risk of thromboembolism. This finding should be interpreted with caution as the low event rate decreases the confidence of this conclusion.

KW - atrial fibrillation

KW - left atrial appendage

KW - occlusion device

KW - stroke

KW - Watchman

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