Figure - available from: Mini-invasive Surgery
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(A) The WATCHMAN and WATCHMAN FLX devices consist of a self-expandable nitinol cage covered by a membrane of polyethylene terephthalate (PTFE). (B) Heart tissue grows over the PTFE membrane guaranteeing device endothelialization and left atrial appendage (LAA) sealing. (C) The interatrial septum is crossed, and the device is released in the LAA.
Source publication
Atrial fibrillation is the most common cardiac arrhythmia and is associated with morbidity and mortality due to cerebral or systemic embolization, with cardiac thrombi mainly forming in the left atrial appendage (LAA). Anticoagulation is the treatment of choice; however, in patients who do not tolerate anticoagulation, LAA occlusion (LAAO) is a val...
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Objectives: Through the screening analysis of stroke population in Northern Henan from 2014 to 2020, to understand the distribution characteristics of high-risk population of stroke and the correlation between high-risk population of stroke and risk factors, to provide basis for stroke prevention and treatment in Northern Henan province.
Methods: A...
Introduction
Left atrial appendage closure (LAAC) is a novel treatment for stroke prevention in high-risk patients with non-valvular atrial fibrillation (NVAF). However, the long-term outcomes after LAAC in Chinese NVAF patients are still lacking.
Methods
This was a single-center, bidirectional, nonrandomized registered study. Patients who underwe...
Background and purpose:
Left atrial appendage occlusion (LAAO) is an accepted therapeutic option for stroke prevention; however, the ideal technique and device have not yet been identified. In this study we evaluate the potential role of a heart team approach for patients contraindicated for oral anticoagulants and indicated for left atrial append...
Background:
In the recent years, antithrombotic prophylaxis in patients with atrial fibrillation (AF) has changed significantly. The main aim of this study is to assess the temporal trends of antithrombotic therapy and identify factors predisposing oral anticoagulant (OAC) use in stroke prevention in AF patients.
Methods:
The present study is a...
In patients with atrial fibrillation and high stroke risk, anticoagulation with direct oral anticoagulants or vitamin K antagonists is the standard of care for stroke prevention. The benefit of anticoagulation is driven by attenuating the risk of thrombus formation in the left atrial appendage. Percutaneous left atrial appendage occlusion offers an...
Citations
... Percutaneous LAAO uses a mechanical device to occlude the LAA via a catheter-based transseptal approach. LAAO devices are endovascularly delivered devices that consist of a lobe or umbrella that, when completely endothelialized, obstructs the neck of the LAA, excluding it from the atrial cavity [41] . This method was developed to overcome the disadvantages and side effects of longterm OACs use [42] . ...
Left atrial appendage occlusion (LAAO) was found to be non-inferior to warfarin. In non-valvular atrial fibrillation (AF), there is still a scarcity of data comparing LAAO versus non-vitamin K oral anticoagulants (NOACs). Our purpose was to compare the clinical benefits between LAAO and NOACs in non-valvular AF patients. The patient, intervention, comparison, and outcome principles were used to develop the research question in this systematic review and meta-analysis. Literature searches were conducted in online scientific databases such as ProQuest, PubMed, and ScienceDirect. All important information was extracted. The random-effect model was applied to estimate all pooled effects. The Mantel-Haenszel statistical method was used to determine the pooled risk ratio (RR) and 95% confidence interval (CI). A total of 4411 participants from 5 studies were involved. LAAO significantly decreased the cardiovascular mortality risk compared to NOACs (RR = 0.56; 95% CI = 0.42 to 0.75; p <0.01). Major bleeding risk in the LAAO group was significantly lower than in the NOACs group (RR = 0.66; RR = 0.53 to 0.82; p <0.01). A significantly lower risk of major bleeding or non-major bleeding in the patients receiving LAAO than NOACs was also observed in this meta-analysis (RR = 0.66; 95% CI = 0.54 to 0.81; p <0.01). LAAO was superior to the NOACs in reducing cardiovascular mortality, major bleeding, and major or non-major bleeding risks in non-valvular AF patients. In high-risk for thromboembolism and bleeding patients, LAAO can be considered first as a long-term treatment strategy.
... [9][10][11] Left atrial appendage closure (LAAC) might represent a valid alternative to chronic OAC for stroke prophylaxis in patients with nonvalvular AF 12 and may be considered in those with a contraindication to OAC as recommended by current international guidelines (class of recommendation IIb, level of evidence B in the European guidelines; class of recommendation IIb, level of evidence B-Not Randomized in the American guidelines). 13,14 Among available devices, 15 the Ultraseal (CARDIA Inc.) is a selfexpandable bulb-and-sail device designed for transcatheter LAAC. If the first generation has been evaluated in a prior small registry providing good short-term efficacy and safety profile, 16 there is little data regarding the second generation of this novel device. ...
Objectives:
To assess feasibility and safety of second-generation left atrial appendage closure (LAAC) Ultraseal device in patients with nonvalvular atrial fibrillation (NVAF).
Background:
LAAC with first-generation Ultraseal device (Cardia, Eagan, Minnesota) has been shown to be a feasible therapeutic option in patients with NVAF. However, there is a paucity of data regarding the novel second-generation Ultraseal device.
Methods:
All patients with NVAF undergoing second-generation Ultraseal device implantation between February 2018 and September 2020 were included in a multicenter international registry. Periprocedural and post-discharge events were collected through 6-month follow-up. Co-primary efficacy endpoints were device success and technical success while primary safety endpoint was in-hospital major adverse event (MAE) occurrence.
Results:
A total of 52 patients were included: mean age 75 ± 8, 30.8% women, mean HAS-BLED 3 ± 1. The device was successfully implanted in all patients. Technical success was achieved in 50 patients (96.1%). In-hospital MAEs occurred in three patients (5.8%). The incidence of 6-month all-cause death and major bleeding was 11.6% and 2.1%, respectively. No strokes, transient ischemic attacks, systemic embolisms, or device embolization were reported after discharge.
Conclusions:
Second-generation Ultraseal device implantation was associated with high success rates and a low incidence of peri-procedural complications. Larger studies with longer follow-up are warranted to further evaluate the safety and the efficacy of this device, especially at long-term follow-up.
