Combination of an OMEGA^TM LAA-occluder with the Amplatzer Amulet^TM Delivery Sheath for Complex LAA Device Closure

Transcatheter Left Atrial Appendage Occlusion (LAAO) has been evolved as an alternative treatment option for the reduction of stroke risk in patients with Atrial Fibrillation (Afib) and contraindications to life-long Oral Anticoagulant Therapy (OAC) [1]. With evolving evidence, LAAO is increasingly used in selected high-risk patients after OAC failure or at prohibitive bleeding risk [2]. After almost two decades of experience with LAAO in different clinical szenarios, it is important to further optimize treatment strategies and efficacy, depending on the patient’s individual’s anatomy. With this case we demonstrate the usefulness of a patient centered adaption of the procedural strategy by combining two different LAAO systems allowing for successful LAAO in an “untreatable” patient.

A 90-year-old male with atrial fibrillation (Afib; CHADS-Vasc: 6, HAS-BLED: 4) was admitted for interventional LAA-closure after recurrent severe gastrointestinal bleedings under reduced NOAC doses, complicated by renal anemia. Following preprocedural-planning with 3DTEE we decided to proceed with implanting the new OMEGA™-Device due to its unique characteristics consisting of a self-centering anchoring cup enabling atraumatic and safe device-positioning combined with an articulated disc covering the LAA-ostium and pulmonary ridge. The intervention was performed under general anaesthesia. After ultrasound-guided puncture of the right femoral vein, infero-posterior transseptal access was achieved by using the VersaCross™ Radiofrequency-Wire. According to the dimensions of the device landing zone we opted of a 18mm-OMEGA™-Device via a 14Fr-Sheath. Attributed to the patient’s complex anatomy with an extreme posterior-superior orientation of the LAA, it was not possible to advance the preshaped OMEGA™-Delivery-Sheath coaxially into the intended device landing zone (Panel A) (Figures 1).

Figure 1:

We therefore decided to adapt our interventional strategy accordingly by combining the unique features of the OMEGA™- Device with the favourable characteristics of a 14Fr-double curve Amulet™-Delivery-Sheath (Panel B). After modification of the device loader, it was possible to advance the occluder into the Amulet sheath with reconnection of the OMEGA™-hemostatic valve with the 14Fr Amulet™ sheath adapter (Panel C, D). This finally allowed for an optimal positioning of the 18mm-OMEGA™-Device in the preselected landing zone with good sealing of the LAA ostium and pulmonary ridge (Panels E, F; supplemental video).

Since the early start of transcatheter LAAc in 2005, different treatment strategies have been published aiming to facilitate the procedure [3]. All suggested techniques aim to optimize treatment results and thereby long-term outcomes. The EHRA/EAPCI expert consensus statement on LAAO emphasize the importance of preprocedural planning with 3D imaging, which can be used to virtually simulate every single procedural step. The group of De Baker et al. was able to demonstrate the impact of preprocedural planning with Computed Tomography (CT) on acute outcome parameters [4]. Nevertheless, every procedure comes with unique challenges and small iterations of the procedural plan can have relevant impact on procedural outcomes. The transvenous transeptal access of the left atrium determines the important first step of the LAAO procedure with relevant impact on procedural results. Every LAAO device comes with a preshaped sheath, which have been developed over the years with the intend to facilitate LAAO in more than 80% of so called “standard- anatomies”. The presented case nicely illustrates the usefulness of having different LAAO devices available during such complex structural interventions. This allows a customized approach to LAAO in patients with atypical anatomical conditions and thereby potentially impacts on the treated patient’s outcomes. To the best of our knowledge this is the first report on successful combination of two different device systems to optimize LAAO with a tailor-made approach.

LAAO is a complex structural intervention and each procedural step potentially impacts on treatment success. Having different LAAO devices available during LAAO procedures allows for a customized approach in patients with atypical anatomical conditions with potential impact on the treated patients outcomes.

1. Saw J, Holmes DR, Cavalcante JL, Freeman JV, Goldsweig AM, et al. (2023) SCAI/HRS expert consensus statement on transcatheter left atrial appendage closure. JACC Cardiovasc Interv 16(11): 1384-400.
2. Lakkireddy D, Thaler D, Ellis CR, Swarup V, Gambhir A, et al. (2023) 3-Year outcomes from the amplatzer amulet left atrial appendage occluder randomized controlled trial (Amulet IDE). JACC Cardiovasc Interv 16(15): 1902-13.
3. Glikson M, Wolff R, Hindricks G, Mandrola J, Camm AJ, et al. (2020) EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion-an update. Europace 22(2): 184.
4. De Backer O, Iriart X, Kefer J, Nielsen-Kudsk JE, Aminian A, et al. (2023) Impact of computational modeling on transcatheter left atrial appendage closure efficiency and outcomes. JACC Cardiovasc Interv 16(6): 655-66.