A feasibility study of a novel left atrial appendage device (Ultraseal, Cardia) indicates that the device is associated with a high rate of procedural success and a fast learning curve. It also suggests that the device has an extremely low complication rate.
Paolo A Pagnotta (Humanitas Clinical and Research Institute, Milan, Italy) and others report in the Journal of Interventional Cardiology that European guidelines recommend that left atrial appendage closure be considered in patients with atrial fibrillation who cannot receive oral anticoagulation (because of a high risk of bleeding etc). Noting that several left atrial appendage closure devices have now been developed, they write that the Ultraseal is a novel device that “conforms to left atrial appendage closure anatomy”. “The Ultraseal device is a fully retrievable and repositionable self-expandable nitinol device composed by a distal soft bulb, which takes advantage of 12 stabilising hooks to anchor the device to the left atrial appendage and by proximal three-leaflet sail covered by a polyvinyl alcohol foam for left atrial appendage occlusion,” the authors explain.
The aim of the present study was to provide an initial assessment of the feasibility and safety profile of the device in patients with non-vavlular atrial fibrillation and contraindications to long-term oral anticoagulation therapy. Therefore, 23 patients were enrolled in the study and received the device. Pagnotta et al report that mean procedure time was 83 minutes and that “it was progressively shorter in the last procedures (first procedure: 106 minutes; last procedure: 69 minutes”. They add this indicates a fast learning curve with the device, which they attributed to the device’s “intuitive loading and implantation”. Procedural success was achieved in 21 out of 23 cases (91%) and there were not any other immediate complications. Furthermore, final angiography and transoesophageal echocardiography (TOE) did not indicate any major leaks but a mild leak and a moderate leak (with incorrect device deployment) were observed in the two patients without procedural success.
At the follow-up point (45 days), all patients were alive aside from one who died during the index hospitalisation (because of respiratory arrest related to pneumonia). Pagnotta et al comment: “No episodes of major or minor bleeding and of ischaemic stroke were observed. All patients underwent TOE at 30–45 days. No thrombus was revealed by TOE in any patient.
The authors conclude: “Our results show a promising feasibility and safety profile of the Ultraseal device in patients with non-valvular atrial fibrillation and high risk for stroke but unsuitable for long-term anticoagulation.” They add that further studies with a large sample size and prolonged follow-up were necessary to definitively assess the safety and efficacy of this novel device.”
Pagnotta told Cardiovascular News: “Generally the morphology of the left appendage is very varied (‘chicken wings’ anatomy is the most frequent); therefore, a solution of double-section device (distal bulb and proximal disc) may be a more appropriate option for a complete exclusion of the left appendage compared to the devices with a single body (bulb). Moreover, the Ultraseal technology, with a very articulated connection between bulb and proximal disc, allows a valid adaptation of the device inside of the appendage. Additionally, the soft nitinol technology, with lower metal density, allows easy and soft adaptation even in cases of high-calibre discrepancy between the ostium and main diameter of the lobe (in which we choose to release the distal bulb of the Ultraseal device) compared with other double-body devices.”