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Published on: February 26, 2013
Peridevice Leak After Transcatheter Left Atrial Appendage Occlusion: An Analysis of the Amulet IDE Trial
Matthew J Price1, Christopher R Ellis2, Jens Erik Nielsen-Kudsk3
1Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA.
Insights
Peridevice leak (PDL) after left atrial appendage occlusion is linked to poorer patient outcomes. The Amulet device demonstrated superior closure rates compared to Watchman, reducing risks associated with PDL.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Trials
Background:
- Peridevice leak (PDL) remains a significant limitation in left atrial appendage occlusion procedures.
- Assessing PDL incidence and its impact on patient outcomes is crucial for device development.
Purpose of the Study:
- To evaluate the incidence and clinical outcomes associated with PDL in the Amulet IDE randomized controlled trial.
- To compare the closure efficacy of the Amulet (dual-occlusive) and Watchman 2.5 (single-occlusive) devices.
Main Methods:
- 1,593 patients with atrial fibrillation at high stroke risk were randomized to Amulet or Watchman 2.5.
- Transesophageal echocardiography assessed PDL (≥3 mm considered significant) at 45 days and 12 months.
- Kaplan-Meier method estimated 18-month event rates for ischemic stroke, systemic embolism, and cardiovascular death.
Main Results:
- The Amulet device achieved superior closure rates at 45 days (88.9% vs 74.1%) and 12 months (90.5% vs 78.3%) compared to Watchman.
- PDL was associated with a non-significant trend towards higher primary endpoint events (3.6% vs 1.8%).
- Clinically significant PDL was linked to a significantly higher risk of the secondary endpoint (stroke, systemic embolism, or cardiovascular death) at 18 months (8.1% vs 4.7%).
Conclusions:
- The dual-occlusive Amulet device offers superior left atrial appendage closure compared to the single-occlusive Watchman device.
- Significant peridevice leak is associated with increased adverse cardiovascular events, underscoring the importance of complete occlusion.
- Achieving complete closure of the left atrial appendage is critical for optimizing patient outcomes in occlusion procedures.
Background:
Peridevice leak (PDL) is a limitation of left atrial appendage occlusion.
Objectives:
The aim of this study was to assess the incidence of and outcomes associated with PDL in the Amulet IDE (AMPLATZER™ Amulet™ LAA Occluder Trial) randomized controlled trial.
Methods:
Patients with atrial fibrillation at increased stroke risk were randomly assigned to undergo either Amulet (dual occlusive mechanism) or Watchman 2.5 (single occlusive mechanism) device implantation. Transesophageal echocardiography was performed at 45 days and 12 months postprocedure. Clinically significant PDL was defined as ≥3 mm. The primary endpoint was ischemic stroke or systemic embolism, and the secondary endpoint was stroke, systemic embolism, or cardiovascular death. The Kaplan-Meier method was used to estimate 18-month cumulative event rates landmarked at day 45 postprocedure.
Results:
A total of 1,593 patients underwent successful left atrial appendage occlusion and had an evaluable transesophageal echocardiographic studies at 45 days. The dual-occlusive mechanism device provided superior closure (defined as leak <3 mm) compared with the single-occlusive mechanism device at 45 days (88.9% vs 74.1%; P < 0.01) and 12 months (90.5% vs. 78.3%; P < 0.01). Through 18 months, PDL was associated with a higher, but not statistically significant, risk for the primary endpoint (3.6% vs 1.8%; adjusted HR: 1.98; 95% CI: 0.93-4.19; P = 0.07) and a statistically significantly higher risk for the secondary endpoint (8.1% vs. 4.7%; adjusted HR: 1.66; 95% CI: 1.02-2.69; P = 0.04).
Conclusions:
The dual-occlusive mechanism device provided superior closure compared with the single-occlusive mechanism device at both 45 days and 1 year postprocedure. PDL ≥3 mm was associated with a significantly increased 18-month risk for the composite of stroke, systemic embolism, or cardiovascular death. Completeness of closure of the left atrial appendage has important implications for patient outcomes. (AMPLATZER™ Amulet™ LAA Occluder Trial [Amulet IDE]; NCT02879448).
