Comparative Safety and Efficacy of Left Atrial Appendage Occlusion with the Watchman Device and Amplatzer Cardiac Plug: Results of the Russian National Registry.

PURPOSE: This multicenter, prospective registry evaluated the comparative safety and efficacy of left atrial appendage occlusion (LAAO) using the Watchman device (WD) and the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (NVAF) in real-world clinical practice in Russia. METHODS: The study included data from 200 consecutive NVAF patients (66.8 ± 7.8 years, 44.5% female, median CHA2DS2VASc 4, median HAS-BLED 3) who had undergone LAAO implantation using WD (n = 108) or ACP (n = 92) from September 2015 to December 2017 in 5 medical centers in Russia. The primary safety endpoint was the procedure-related major adverse events, and the primary efficacy endpoint was the composite of thromboembolic events, device thrombosis, hemorrhagic events, and unexplained death during the 12-month follow-up. RESULTS: Successful LAAO was performed in all 92 (100%) patients with ACP and 105 (97.2%) with WD (p = 0.053). At 12 months, primary safety endpoint occurred in 6.5% of patients in the ACP group with no events in the WD group (6.5% vs. 0%, p = 0.008). During the 12-month follow-up, the primary efficacy endpoint has occurred in 8.3% of patients in the WD group (n = 9) and 1.1% of patients in the ACP group (n = 1) (p = 0.016). CONCLUSIONS: In this multicenter prospective registry, LAA closure with the WD was associated with significantly higher thromboembolic events rate in NVAF patients. Patients, receiving the ACP, had more procedure-related major adverse events. However, further multicenter studies are necessary to evaluate these findings.

CaSiO3-HAp Structural Bioceramic by Sol-Gel and SPS-RS Techniques: Bacteria Test Assessment.

The article presents an original way of getting porous and mechanically strong CaSiO3-HAp ceramics, which is highly desirable for bone-ceramic implants in bone restoration surgery. The method combines wet and solid-phase approaches of inorganic synthesis: sol-gel (template) technology to produce the amorphous xonotlite (Ca6Si6O17·2OH) as the raw material, followed by its spark plasma sintering-reactive synthesis (SPS-RS) into ceramics. Formation of both crystalline wollastonite (CaSiO3) and hydroxyapatite (Ca10(PO4)6(OH)2) occurs "in situ" under SPS conditions, which is the main novelty of the method, due to combining the solid-phase transitions of the amorphous xonotlite with the chemical reaction within the powder mixture between CaO and CaHPO4. Formation of pristine HAp and its composite derivative with wollastonite was studied by means of TGA and XRD with the temperatures of the "in situ" interactions also determined. A facile route to tailor a macroporous structure is suggested, with polymer (siloxane-acrylate latex) and carbon (fibers and powder) fillers being used as the pore-forming templates. Microbial tests were carried out to reveal the morphological features of the bacterial film Pseudomonas aeruginosa that formed on the surface of the ceramics, depending on the content of HAp (0, 20, and 50 wt%).