Left atrial appendage closure: Initial experience with the ultraseal device

Regueiro, Ander; Bernier, Martin; O’Hara, Gilles; O’Connor, Kim; Paradis, Jean‐Michel; Beaudoin, Jonathan; Rodríguez‐Gabella, Tania; Champagne, Jean; Rodés‐Cabau, Josep

doi:10.1002/ccd.26870

Cited by 19 publications

(13 citation statements)

References 13 publications

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“…Our results show a promising feasibility and safety profile of the Ultraseal device in patients with NVAF and high risk for stroke but unsuitable for long‐term anticoagulation. Similar data were reported in other two smaller case series with shorter follow‐up time …”

Section: Discussionsupporting

confidence: 91%

“…Moreover, procedural success was not achieved only in two patients, with an intraprocedural MI and an in‐hospital death due to pneumonia as the only in‐hospital adverse events, while no adverse events were observed at a mean follow‐up time of 166 ± 80 days, including the patients with incorrect device positioning. Similarly, in the series by Sabiniewicz et al no adverse events were reported at 1 month, while in the report by Regueiro et al, TEE performed at 45 days showed a device‐related thrombosis in one patient, without any adverse clinical events reported at follow‐up.…”

Section: Discussionmentioning

confidence: 62%

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Left atrial appendage closure with the Ultraseal device: Initial experience and mid‐term follow‐up

Pagnotta

Chiarito

Pllaha

et al. 2018

J Interven Cardiology

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 62%

Left atrial appendage closure with the Ultraseal device: Initial experience and mid‐term follow‐up

Pagnotta

Chiarito

Pllaha

et al. 2018

J Interven Cardiology

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show abstract

“…Further examples include needle ablation ( Sapp et al 2013 ), left atrial appendage closure ( Regueiro et al 2017 ; Saw et al 2015 ) and left atrial decompression ( Amat-Santos et al 2015 ). Some authors attributed approval of not only a procedure but also an entire program to the MDSAP.…”

Section: Resultsmentioning

confidence: 99%

“…The MDSAP approves the use of unlicensed alternatives to licensed medical devices when they are perceived to be clinically superior ( Almashham et al 2008 ; Abraham et al 2012 ; Bagur et al 2016 ; Campelo-Parada et al 2016 ; Humpl et al 2010 ; Nietlispach et al 2010 ; Raymond et al 2001 ; Regueiro et al 2017 ; Ricci et al 2017 ; Saw et al 2017 ). Peters' (2002) review of breast implants noted the availability of two types of implants: saline-filled (comprising 95% of implants), which were licensed, and gel-filled (5%), which, at the time, were unlicensed.…”

Section: Resultsmentioning

confidence: 99%

The Medical Devices Special Access Program in Canada: A Scoping Study

Maier

Menon

Stafinski

2018

hcpol

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New health technologies enter Canadian healthcare organizations in various ways, and understanding them is essential to the development of a pan-Canadian Health Technology Management (HTM) Strategy, now a priority of governments across Canada. One way is through Health Canada's Medical Devices Special Access Program (MDSAP), which permits unlicensed devices to be obtained by healthcare professionals. However, the circumstances around and implications of the current use of this program are not clear. A scoping literature review was conducted to clarify these and identify important roles and issues related to the MDSAP. Limited information was found on the MDSAP. Nevertheless, three themes demonstrating the roles of the MDSAP in HTM emerged: arbiter in technology selection, a route to technology procurement and facilitator of health technology innovation. No information suggesting that MDSAP is used to circumvent licensing was found. Rather, it enables desired patient outcomes and product commercialization.

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“…No episodes of bleeding, stroke, pericardial effusion or device embolization were noted at 45-day follow up. 36) …”

Section: Other Methods Of Left Atrial Appendage Occlusionmentioning

confidence: 99%

Left Atrial Appendages Occlusion: Current Status and Prospective

2018

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Stroke continues to be a major cause of morbidity and mortality in atrial fibrillation (AF) patients. Oral anticoagulation (OAC) provides protection against stroke and peripheral embolization in AF but significant proportion of patients could not be started on anticoagulation because of bleeding complications. Left atrial appendage harbors clot in about 90% of nonvalvular AF. The advent of left atrial appendage occlusion (LAAO) techniques has provided these patients with alternative to OAC for stroke prophylaxis. Multiple LAAO devices are currently available with Watchman and Amulet being the most commonly used in clinical practice. Randomized studies are available for Watchman device only. Data on Amplatzer Cardiac Plug, Amulet and Lariat devices are limited by the paucity of randomized data. Long-term data on different LAAO techniques are showing promising results. Device related thrombosis continues to be a serious complication associated with LAAO. Future studies should look into comparative effectiveness between different LAAO techniques, optimal patient selection, risk of complications, and anticoagulant treatment after LAAO. This article aims to provide current available evidence on efficacy and safety of different LAAO devices and future prospective.

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Left atrial appendage closure: Initial experience with the ultraseal device

Abstract: This initial experience with the Ultraseal LAA closure device demonstrates preliminary safety and feasibility. Further larger studies with longer follow-up are warranted. © 2016 Wiley Periodicals, Inc.

Cited by 19 publications

References 13 publications

Left atrial appendage closure with the Ultraseal device: Initial experience and mid‐term follow‐up

Left atrial appendage closure with the Ultraseal device: Initial experience and mid‐term follow‐up

The Medical Devices Special Access Program in Canada: A Scoping Study

Left Atrial Appendages Occlusion: Current Status and Prospective

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