Left atrial appendage closure with the Amplatzer™ Cardiac Plug: Impact of shape and device sizing on 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
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Cited by (52)
Left Atrial Appendage Occlusion: Current Stroke Prevention Strategies and a Shift Toward Data-Driven, Patient-Specific Approaches
2022, Journal of the Society for Cardiovascular Angiography and InterventionsCT assessment of the left atrial appendage post-transcatheter occlusion – A systematic review and meta analysis
2021, Journal of Cardiovascular Computed TomographyCitation Excerpt :Four studies11,15,18,20,21 evaluated adequate LAA device closure on CCTA by assessing both the peridevice gap and contrast enhancement in the LAA distal to the device. The prevalence of incomplete LAA closure in these studies was 60%, 98%, and 51%, amongst which 38%, 28%,43% of patients respectively had peridevice gap.27,30,32 Cochet et al.11 found LAA enhancement in 51 patients, amongst which the size of the leak could be assessed in 34 patients, i.e., 67%.
Modification of the left atrial appendage and its role in stroke risk reduction with non-valvular atrial fibrillation
2021, IJC Heart and VasculatureIncidence, Characterization, and Clinical Impact of Device-Related Thrombus Following Left Atrial Appendage Occlusion in the Prospective Global AMPLATZER Amulet Observational Study
2019, JACC: Cardiovascular InterventionsCitation Excerpt :Adequate device compression was reflected by the lobe depicting a “tire-like” shape on TEE and associated with concavity of the Amulet disc (reflecting the adequate anchorage of the lobe within the LAA neck). The device was considered as undersized if the lobe had a “square-like” shape, with a low level of compression, and poor or absent disc concavity (16,17). DRT was defined as diffuse if >50% of the disc surface was covered by thrombus and mobile when clear motion was observed in at least 3 sequential frames (10).
Left Atrial Appendage Occlusion: A Narrative Review
2019, Journal of Cardiothoracic and Vascular AnesthesiaCitation Excerpt :The incidence of device implantation-related complications such as pericardial effusion, device migration, dislodgement, and embolization decreases with operator experience.83 This improvement with experience could be related to better device selection and sizing in an effort to avoid device embolization, incomplete LAA occlusion, and instances of repositioning and recapturing86 the device several times. Improvement in technical skills by minimizing wire, sheath, and device manipulation also may reduce the risk of LAA perforation and pericardial effusion.
Role and Assessment of Peri-Device Leaks After Left Atrial Appendage Occlusion
2019, Canadian Journal of Cardiology
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Conflict of interest: Dr. Reda Ibrahim is consultant for St. Jude Medical and Gore Medical.