Image – Interventional flashlight

DOI: 10.4244/EIJ-D-18-01084

First-in-man percutaneous closure of left atrial appendage using the Ultraseal II device

Ignatio Cruz-González1; Rocío González Ferreiro1; Manuel Barreiro Pérez1; Pedro Luis Sánchez Fernández1

Figure 1. First-in-human experience with the Ultraseal II. A) LAA occlusion with the Ultraseal II device and (B) comparison between the first Ultraseal device and the new Ultraseal II.

A 74-year-old man with atrial fibrillation and spontaneous intra-cerebral haemorrhage was admitted for percutaneous closure of the left atrial appendage (LAA). We present the first-in-man experience with the Ultraseal II device (Cardia, Inc., Eagan, MN, USA).

Under conscious sedation, the procedure was carried out using transoesophageal echocardiography (TEE) with an S8-3t microprobe (Philips Medical Systems, Andover, MA, USA) and fluoroscopic guidance. A 22 mm Ultraseal II was selected. The sheath was positioned at the intended landing zone, then the bulb was deployed. Next, the sheath was retracted until the sail was deployed, achieving a complete sealing of the LAA (Figure 1A, Moving image 1-Moving image 3). Follow-up TEE showed no device-related thrombus and no residual leak.

The initial experience with this device has already been reported, with a high success rate and a low complication rate. However, modifications were warranted in order to facilitate deployment and retrieval and potentially to reduce the rate of device thrombosis (see Supplementary Table 1 for additional information). The Ultraseal II is a self-expanding nitinol device composed of two parts – the bulb, which secures the device position but does not seal the appendage, and the sail. These are connected by an articulating joint (Figure 1B, dashed arrow) that allows the sail to conform naturally to the LAA ostium. The new device is shorter, so the minimum required depth is smaller (Figure 1B, red arrows). The distal centre post has been removed (Figure 1B, black arrow), so the new device is more flexible. The joint is less articulated to enhance the anchoring of the bulb, without allowing the device to roll over easily, but being able to adapt to different LAA anatomies. The sail covering has been moved, the polyester coating is placed outside and the polyvinyl alcohol (PVA) inside, which makes it easier to load and retrieve the device. It will be necessary to evaluate whether this improvement could have an impact on the rate of thrombosis related to the device. The main distinctive features of the Ultraseal II compared to other disc-lobe devices are: the articulating joint that allows the sail to conform naturally to the LAA anatomy, the soft and flexible bulb, with low radial force, which allows a safe deep implant in the case of limited usable length and permitted oversizing if required, and the option of partial or total recapture up to five times.

In conclusion, the new device has the potential to adapt to different LAA morphologies and could be very useful in difficult anatomies.

Conflict of interest statement

The authors have no conflicts of interest to declare.

Supplementary data

To read the full content of this article, please download the PDF.

Moving image 1. Angiography evaluating the left atrial appendage morphology.

Moving image 2. Complete deployment of the Ultraseal II device.

Moving image 3. Angiography showing the final position of the Ultraseal II device and successful sealing of the LAA.

Volume 15 Number 9
Oct 4, 2019
Volume 15 Number 9
View full issue


Key metrics

Suggested by Cory

Image – Interventional flashlight

10.4244/EIJ-D-21-00624 Jun 3, 2022
Percutaneous left atrial appendage closure in a surgically ligated left atrial appendage
Wong I et al
free

EXPERT REVIEW

10.4244/EIJ-D-17-00469 Nov 20, 2017
Residual leaks following percutaneous left atrial appendage occlusion: assessment and management implications
Raphael CE et al
free

IMAGE IN CARDIOLOGY

10.4244/EIJV12I2A44 Jun 10, 2016
The plug for the appendage
Buellesfeld L et al
free

CLINICAL RESEARCH

10.4244/EIJY14M07_03 Aug 20, 2015
Double device left atrial appendage closure
Guérios E et al
free

10.4244/EIJV12SXA10 May 16, 2016
Left atrial appendage closure: patient, device and post-procedure drug selection
Tzikas A and Bergmann M
free

10.4244/EIJV11I14A307 Apr 8, 2016
Percutaneous left atrial appendage occlusion in 2016
Tzikas A et al
free
Trending articles
152.9

Clinical research

10.4244/EIJ-D-20-01125 Oct 20, 2021
An upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation
Costa G et al
free
47.8

NEW INNOVATION

10.4244/EIJ-D-15-00467 Feb 20, 2018
Design and principle of operation of the HeartMate PHP (percutaneous heart pump)
Van Mieghem NM et al
free
39.1

Clinical research

10.4244/EIJ-D-22-00558 Feb 6, 2023
Permanent pacemaker implantation and left bundle branch block with self-expanding valves – a SCOPE 2 subanalysis
Pellegrini C et al
free
X

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

EuroPCR EAPCI
PCR ESC
Impact factor: 7.6
2023 Journal Citation Reports®
Science Edition (Clarivate Analytics, 2024)
Online ISSN 1969-6213 - Print ISSN 1774-024X
© 2005-2024 Europa Group - All rights reserved