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

Pagnotta, Paolo; Chiarito, Mauro; Pllaha, Elton; Parenti, Dennis Zavalloni; Rossi, Marco; Mantovani, Riccardo; Pisano, Francesco; Reimers, Bernhard

doi:10.1111/joic.12541

Cited by 5 publications

(4 citation statements)

References 22 publications

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“…One patient presented device related thrombus without clinical consequences. Another study in 23 consecutive patients with NVAF has also demonstrated a high success rate of implantation (21/23) and extremely low complication rate at a mean follow-up of 166 ± 80 days [100]. In a multicenter experience of 126 patients from 15 Canadian and European centers [101], this device was successfully implanted in 97% of patients, and major periprocedural adverse events (pericardial effusion, stroke, or device embolization) occurred in only three (2.4%) patients.…”

Section: Ultraseal Devicementioning

confidence: 83%

Percutaneous Left Atrial Appendage Occlusion Therapy: Past, Present, and Future

Han

Dong

Benditt

2023

CVIA

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Atrial fibrillation (AF), the most common sustained cardiac arrhythmia, is increasing in incidence and prevalence worldwide. AF significantly increases the risk of intracardiac thrombus formation and, if left untreated, ischemic stroke. In patients with nonvalvular AF (NVAF), the left atrial appendage (LAA) has been determined to be the source of thrombus development in 91% to 99% of cases. In this regard, oral anticoagulants (OACs) have become the standard treatment for stroke prevention in most patients with AF; however, OACs are associated with a risk of bleeding complications, and their efficacy depends on optimal patient compliance. Among alternative approaches to embolic stroke prevention, surgical LAA excision for stroke prevention for valvular AF was attempted as early as the late 1940s. LAA excision remains recommended in surgical guidelines for patients with NVAF requiring open-heart coronary bypass or valvular replacement/repair surgeries. However, owing to the traumatic/invasive nature and suboptimal outcomes of conventional surgical LAA intervention, clinical application of this approach is limited in current cardiology practice. Percutaneous LAA occlusion (LAAO) is increasingly being performed as an alternative to OAC for stroke prevention, particularly in patients with elevated bleeding risk. Substantial progress has been made in percutaneous LAAO therapy since its inception approximately 20 years ago. This article systematically reviews the literature leading to the development of LAAO and the evidence-based clinical experience supporting the application of this treatment strategy for NVAF, with a focus on recently published critical evaluations of US FDA and CE mark approved LAAO devices. Future perspectives regarding knowledge and technology gaps are also discussed, recognizing the many ongoing clinical trials that are likely to be transformative and the critical unanswered questions regarding LAAO therapy.

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Section: Ultraseal Devicementioning

confidence: 83%

Percutaneous Left Atrial Appendage Occlusion Therapy: Past, Present, and Future

Han

Dong

Benditt

2023

CVIA

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“…DRT was found in one patient, without clinical consequences. Another study in 23 consecutive NVAF patients also demonstrated high success rate of implantation (21/23) and extremely low complication rate at a mean follow-up of 166

80 days [ 94 ]. In multicenter experience of 126 patients from 15 Canadian and European centers [ 95 ] the device was successfully implanted in 97% of patients, with major periprocedural adverse events (pericardial effusion, stroke, device embolization) occurring in only 3 (2.4%) instances.…”

Section: Laao Devicesmentioning

confidence: 98%

“…Timelines of device preclinical, United States Food and Drug Administration (US FDA) and Conformité Européenne (Commercial Sale of Licensed Product in the EU) (CE-Mark) approval, and main relevant studies are summarized in Table 1 (Ref. [ 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 ]).…”

Section: Laao Devicesmentioning

confidence: 99%

Percutaneous Left Atrial Appendage Occlusion Therapy: Evolution and Growing Evidence

Han¹,

Benditt²

2023

Rev. Cardiovasc. Med.

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Atrial fibrillation (AF) is the most common cardiac arrhythmia and if untreated, significantly increases both the risk of intracardiac thrombus formation and ischemic stroke. In patients with nonvalvular AF (NVAF), the left atrial appendage (LAA) has been estimated to be the source of thrombus development in 91% to 99% of cases. Consequently, oral anticoagulation (OAC) to provide stroke prevention has become the standard of care for most AF patients; however, OACs are associated with a risk of bleeding and their efficacy depends on optimal patient compliance. In terms of alternative approaches to preventing embolic events, surgical LAA excision was attempted as early as in the late 1940s in patients with valvular AF; LAA excision remains a recommendation in surgical guidelines for NVAF patients who need open-heart coronary bypass or valvular replacement/repair surgeries. However, due to its invasive nature surgical LAA intervention has limited clinical application in present cardiology practice. Percutaneous LAA occlusion (LAAO) is increasingly being performed as an alternative to OAC for stroke prevention; this is particularly the case in patients at increased bleeding risk. Substantial progress has been made in percutaneous LAAO therapy since its inception some twenty years ago. Herein we systematically review both the critical literature that led to the development of LAAO, and the increasing clinical evidence supporting the application of this treatment strategy in NVAF. To this end we focus on recently published critical evaluations of United States Food and Drug Administration (US FDA) and Conformité Européenne (Commercial Sale of Licensed Product in the EU) (CE-Mark) approved LAAO devices, summarize the current status of LAAO therapy, and discuss the future perspectives regarding the knowledge and technology gaps in this area by recognizing the potential contributions of many ongoing but likely transformative clinical trials.

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“…28 Another smaller, single-center study by Pagnotta et al also reported on the feasibility and safety of the Ultraseal device in their experience based on 23 patients with a mean follow-up of 166 days ± 80 days. 29…”

Section: Ultrasealmentioning

confidence: 99%

Left Atrial Appendage Anatomy: Implications for Endocardial Catheter-based Device Closure

Maan¹,

Heist²

2020

J Innov Cardiac Rhythm Manage.

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

Abstract: Our results suggest that the Ultraseal device is a feasible option for LAA occlusion. Notably, the learning curve in this registry was fast, paralleled by extremely low complication rates. These results should be considered hypothesis generating and larger studies are mandatory.

Cited by 5 publications

References 22 publications

Percutaneous Left Atrial Appendage Occlusion Therapy: Past, Present, and Future

Percutaneous Left Atrial Appendage Occlusion Therapy: Past, Present, and Future

Percutaneous Left Atrial Appendage Occlusion Therapy: Evolution and Growing Evidence

Left Atrial Appendage Anatomy: Implications for Endocardial Catheter-based Device Closure

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