Most patients who experience a peridevice leak (PDL) at early imaging follow-up after left atrial appendage occlusion (LAAO) with implantation of Amplatzer devices continue to demonstrate PDL at 12 months’ follow-up, according to the results of a study published in the journal Catheterization & Cardiovascular Interventions.
A single-center, observational study of consecutive patients receiving LAAO with the Amplatzer Cardiac Plus or Amulet (Abbott) devices at Aarhus University hospital in Aarhus, Denmark, was conducted between 2010 and 2017. The researchers sought to examine changes in PDL from 2 until 12 months following LAAO via use of cardiac computed tomography (CT), as well as to evaluate the possible association between persistent PDL and clinical outcomes among study participants.
Per institutional practice, all patients in whom an Amplatzer device was implanted were scheduled for a 2-month post-LAAO follow-up, which included transesophageal echocardiography (TEE) and cardiac CT scan. A total of 206 patients who had received LAAO from 2010 to 2017 were scheduled for repeat TEE and cardiac CT scan at their 12-month follow-up. In these individuals, cardiac CT scan was not performed in those individuals with a glomerular filtration rate of less than 30 mL/min, thus leaving a total of 153 participants in the current study.
All of the CT images were analyzed blindly. PDL was determined by the frequency and size of the device disc, lobe, and LAA contrast patency. All of the participants were followed for the composite outcome of ischemic stroke, transient ischemic attack, systemic embolism, or all-cause death. The median follow-up from LAAO was 3.1 years (range, 2.3-4.3 years).
Contrast patency was observed in 66% of the participants at 2 months and in 47% of the participants at 12 months (P <.001). PDL was identified at the disc in 67% of the participants at 2 months, compared with 61% of the participants at 12 months (P =.08). Additionally, PDL was detected at the lobe in 19% of the participants at both 2 months and 12 months.
The median PDL area at the disc did not change significantly over time (Δ area, -8.95 mm; 95% CI, -18.9 to 1.01; P =.08). Further, the mean PDL width at the disc did not change significantly over time (Δ width, -0.03 mm; 95% CI, -0.35 to 0.28; P= .84). The PDL length was 12.2±10.5 mm at 2 months vs 11.5±10.8 mm at 12 months (Δ length, -0.75 mm; 95% CI, -1.82 to 0.32; P =.17).
Participants with persistent PDL (CT Grade 2-3) at the 12-month follow-up were more likely to have permanent atrial fibrillation (AF); a higher CHA2DS2-VASc risk score; and larger LAA diameters, as well as to have received a larger device implant.
Per multivariable analysis, only permanent AF was significantly associated with persistent PDL in cardiac CT scan at 12 months (P =.04). Persistent PDL vs no PDL was associated with a 62% worse clinical outcome, which was not statistically significant (HR, 1.62; 95% CI, 0.9-2.93; P =.11).
Limitations of the current study include its single-center, observational design, which has such inherent drawbacks as potential selection bias and lack of generalizability to other practice settings that use other LAAO platforms. The restricted sample size of this study is another drawback.
“Persistent PDL was associated with worse clinical outcomes, however, not statistically significant,” the study authors wrote. “The study data questions the need for repeated imaging after LAAO, however, the clinical consequence of PDL requires confirmation in larger studies.”
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Korsholm K, Jensen JM, Nørgaard BL, Nielsen-Kudsk JE. Temporal changes and clinical significance of peridevice leak following left atrial appendage occlusion with Amplatzer devices. Catheter Cardiovasc Interv. Published online May 18, 2022.