Left atrial appendage closure with the II generation Ultraseal device: An international registry. The LIGATE study.

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.

Fracture of an S-ICD lead after two prior transvenous lead-related complications with conventional defibrillators.

Six months after subcutaneous implantable cardioverter defibrillator (S-ICD) implantation a 26-year-old Brugada patient presented because of a beeping tone emitted by his device. Chest X-ray displayed two functionless transvenous shock leads and the S-ICD system with a lead fracture. During lead revision procedure, extensive preparation of the lead from unexpectedly firm surrounding fibrous tissue encapsulating the lead was necessary before it could be removed, and a new shock lead could be implanted. This is the first report of an S-ICD lead exchange due to very early lead fracture and unexpectedly severe fibrous tissue hampering surgical lead extraction.

Complications following transcatheter edge-to-edge mitral valve repair: Personal experience and review of the literature.

Mitral valve dysfunction affects around 2% of the population and its incidence is still increasing, making it the second most common valvular heart disease, after aortic stenosis. Depending on the etiology of the disease, it can be classified into primary or secondary mitral regurgitation. The first line of treatment is optimal medical therapy. If ineffective, mitral valve intervention can be considered. For patients disqualified from surgical treatment, transcatheter edge-to-edge repair with the use of MitraClip may be considered. Over 100,000 MitraClip procedures have been performed which makes this the most established transcatheter technique for the treatment of severe mitral regurgitation. The aim of this review is to discuss the technical details of the MitraClip procedure, clinical evidence regarding the efficacy of MitraClip, complications related to the clip implantation alongside with acute complications based on the currently available evidence and clinical experience.

[Implantable loop recorder of the Confirm family (St. Jude Medical)]. / Implantierbare Loop-Rekorder der Confirm-Familie (Fa. St. Jude Medical).

St. Jude Medical produces the implantable loop recorder (ILR) Confirm AF DM2102 which offers subcutaneous electrodes on both sides of the device, a specific sensing algorithm and extensive storage capacity for up to 147 episodes. The reliability of detection of atrial fibrillation (AF) has been evaluated in the DETECT-AF study. The device is MR-conditional and allows patients an interrogation at home. The data are transferred to the follow-up centre via telephone by the patient activator, although this process is currently rather complex and slow. Therefore, remote monitoring of the Confirm AF DM2102 is rarely an option for elderly patients. St. Jude medical announced the introduction of a new, substantially smaller ILR using more modern technology by the end of 2016.