Elsevier

International Journal of Cardiology

Volume 168, Issue 2, 30 September 2013, Pages 1023-1027
International Journal of Cardiology

Left atrial appendage closure with the Amplatzer™ Cardiac Plug: Impact of shape and device sizing on follow-up leaks

https://doi.org/10.1016/j.ijcard.2012.10.031Get rights and content

Abstract

Background

The Amplatzer Cardiac Plug (ACP) is a relatively new system for left atrial appendage (LAA) closure. In general, the particular design of the device and the variability of the LAA anatomy make the sizing process challenging. The objective of our study was to analyze the impact of the shape and sizing of the device on the presence of follow-up leaks.

Methods

The shape was evaluated by angiography and classified as “strawberry-like”, “square-like” and “tire-like”. The presence of peri-device leaks was assessed by transesophageal echocardiography (TEE) and graded as: 1) severe, 2) major, 3) moderate, 4) minor and 5) absent.

Results

Twenty five patients were included. Overall, the device was oversized by 3.38 ± 2.26 mm and 1.58 ± 2.75 mm in relation to the largest angiographic and TEE diameter respectively. None of the patients presented any intra-procedural complication. After discharge, one patient was admitted for cardiac tamponade and another for stroke. In both, the device was optimally deployed. Follow-up TEE was done after a mean time of 7.9 ± 5.9 months. The presence of a leak was associated with a lower degree of device over-sizing by TEE (0.06 ± 3.31 mm if leak vs. 2.73 ± 1.85 mm if no leak; p = 0.04) and a trend towards by angiography (2.39 ± 3.06 mm if leak vs. 3.98 ± 1.57 mm if no leak; p = 0.16). The shape of the device was not associated with the presence of TEE leaks. Neither the shape nor the presence of leaks was associated with worse clinical outcomes.

Conclusions

Although the shape and sizing of the device were not linked to any particular clinical outcome, we found an association between a lower degree of over-sizing and the presence of follow-up leaks.

Introduction

Percutaneous left atrial appendage (LAA) closure is slowly establishing in reference centers around the world. Currently, the procedure is mostly performed in patients with atrial fibrillation (AF) with a high risk of stroke (CHADS2 score  1) and a formal contraindication or at high risk for anticoagulation therapy [1], [2], [3].

The PLAATO system (ev3 Inc., Plymouth, Minnesota) was the first dedicated device that showed promising results preventing ischemic strokes at short [4] and long-term follow-up [5] although it is not available on the market anymore. PROTECT AF was the first randomized trial comparing warfarin versus percutaneous LAA closure in patients with AF. The study demonstrated the non-inferiority of the WATCHMAN device (Atritech, Plymouth, MN) for the prevention of ischemic stroke as compared with oral anticoagulation [6].

The Amplatzer Cardiac Plug (ACP) (St-Jude Medical, Minneapolis, MN) represents a new generation of LAA closure devices. The novel asymmetric design with a distal lobe and a proximal disk makes this device special and unique. In fact, the device conforms to the LAA anatomy adopting different shapes according to the degree of expansion and the anatomy of the appendage [1]. Although initial experience with the ACP has shown satisfactory results [1], [2], [3], data on the optimal shape or recommended size are still scarce. Additionally and in contrast with other devices [4], [7], few data on the presence and impact of residual leaks have been published to date. Thus, we sought to analyze the role of the ACP shape and sizing after LAA closure on clinical outcomes and residual leaks.

Section snippets

Patient population

Patients who underwent percutaneous LAA closure with the ACP between November 2009 and September 2011 at the Montreal Heart Institute, University of Montreal, Montreal, Quebec, Canada were prospectively included in the study. The clinical, procedural, angiographic and echocardiographic outcome variables of these patients were prospectively collected and analyzed. All patients were more than 18 years old, had AF (paroxysmal, persistent or permanent) with a high risk for stroke (CHADS2 score  2),

Results

Within the study period, 25 consecutive patients underwent percutaneous LAA closure with the ACP. In all patients, the procedural indication was based on the inability to receive anticoagulation treatment in spite of a clear clinical indication. The main reason for contraindicating the oral anticoagulation was intracranial bleeding in 9 (36%), extracranial but non gastrointestinal bleeding in 8 (32%), gastrointestinal bleeding in 6 (24%) and other reasons in 2 (8%). Baseline and

Discusion

The main findings of our study were 1) the observed low percentage of significant peri-device leaks at follow-up, 2) the association between a lower degree of ACP over-sizing and the presence of follow-up leaks and 3) the absence of association between the shape of the device and the occurrence of residual leaks.

In our series, the percentage of successful LAA closure with the ACP was 91.6% post ACP implantation and 89.4% at follow-up. Nonetheless, 12.5% and 5.2% of patients presented a moderate

Limitations

The results must be interpreted with caution as this was an observational study with a small number of patients. Second, the small size of the sample led to a very low number of events that did not allow for a valid assessment of the clinical impact of residual leaks. Nonetheless, the main objective of our paper was helping operators to guide the sizing process in order to reduce the occurrence of follow-up leaks rather than showing the clinical impact of them. Third, follow-up TEE was not

Conclusions

The present study shows the initial experience of our group with the first 25 ACP implantations. According to our results, there is an association between a lower degree of device over-sizing and the presence of residual leaks at follow-up. Thus, precise sizing of the LAA based on TEE and angiography seems to play an important role in helping operators to choose the optimal size of the device and therefore reduce the future risk of residual leaks. We did not find any association between the

References (14)

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Conflict of interest: Dr. Reda Ibrahim is consultant for St. Jude Medical and Gore Medical.

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