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Background: Percutaneous interventional left atrial appendage occlusion (LAAO) is a reliable, safe, and effective alternative for stroke prevention in selected patients with atrial fibrillation (AF). Methods: In a retrospective observational study, 149 patients underwent LAAO between 2016 and 2022 at the Department of Cardiology of the Charité-Universitätsmedizin Berlin, Campus Virchow, with AF for prevention of thromboembolic complications. We compared patient characteristics, intraoperative details and postoperative outcomes between single-occlusive plug-type (SOPT) and dual-occlusive disc-type (DODT) devices. Results: In all patients, the device implantation was successful. 60 patients received a SOPT occluder, including Watchman (35%) and Watchman FLX Occluders (65%), while 89 patients received a DODT occluder, including Amplatzer Cardiac Plug (37.1%), the Amplatzer Amulet (25.8%), and the LAmbre occluder (37.1%) systems. Procedure duration was significantly longer for DODT occluder implantation (49 ± 33 vs. 41 ± 25â min, p = 0.018). There were no in-hospital deaths or thromboembolic events reported after LAAO in both groups. Beyond that, a low rate of bleeding or access-side-related complications and pericardial tamponades were observed. Anticoagulation at discharge varied. About 60.8% of patients received dual antiplatelet therapy at hospital discharge, and 33.1% received direct oral anticoagulants. A 6-month follow-up was obtained in 85% of the patients. All implanted devices were in the desired position. However, in 5.7% of the patients, a device-related thrombus formation was detected in the SOPT group, while no thrombus was seen in the DODT group (p = 0.11). Thromboembolic events were noticed in 3.1%, without any difference between the device types. There was a statistically non-significant trend for less residual device leaks after SOPT vs. DODT implantation (no leak in 71.7% vs. 62.2%, p = 0.07; minor leaks <5â mm, 9.4% vs. 20.3%, p = 0.1). In the SOPT group, less bleeding complications were reported after LAAO (11.3% vs. 17.6%, p = 0.1). Conclusion: Our data suggest the safety and efficiency of LAAO with a very high procedural implantation success rate irrespective of the used LAA device. Furthermore, no relevant procedural or device-related complication occurred during the 6-month follow-up in all patients.
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Introduction: There is a lack of real-world data directly comparing different valve prostheses for transaortic valve replacement (TAVR). We aimed to compare early clinical outcomes at 30-days between the self-expandable Portico valve (Abbott) with the balloon-expandable Edwards Sapien 3 valve (Edwards Lifesciences) (ES3). Methods: Out of 1,901 patients undergoing TAVR between January 2018 and December 2021, all patients who received either Portico valve or ES3 valve via transfemoral TAVR were matched using nearest-neighbor (1:1) propensity scoring. Primary endpoints were single safety endpoints and early safety composite endpoints defined by Valve Academic Research Consortium-2 (VARC-2) criteria. The secondary endpoint was to analyze risk predictors for new permanent pacemaker (PPM) implantation in TAVR. Results: Out of 661 complete cases, a total of 434 patients were successfully matched based on age, sex, Euro Score II and STS-score. In the matched cohort, 217 received either a Portico or valve and 217 received an ES3 valve. The VARC-2 early safety composite scores indicated a significantly greater overall 30-day safety risk in the Portico group at 9.2% (n = 20) compared to 3.7% (n = 8) in the ES3 group (p = 0.032). The requirement for new permanent pacemaker (PPM) implantation was also higher in the Portico group, at 21.2% (n = 46) vs. 13.4% (n = 29) in the ES3 group (p = 0.042). 30-day mortality was higher was 3.7% (n = 8) in Portico group compared to 0.9% in ES3 group (p = 0.11). Furthermore, implantation of the Portico valve was identified as a significant risk predictor for new PPM implantation, alongside higher age, preprocedural atrioventricular block (AVB) and longer total procedure duration. Conclusion: This study shows significantly higher rates of early clinical complications for Portico valve prostheses compared to ES3. These findings should be especially taken into consideration when selecting valve prosthesis for high-risk patients.
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BACKGROUND: Range-of-motion (ROM) data generated by the in vitro test methods of spine simulators with cadavers (SSCs) and finite element models (FEMs) are used alternatively and complementarily for in vitro evaluations. AIM OF REVIEW: Our purpose is to compare exemplary segmental ROM data from SSCs and FEMs before and after ball-and-socket total disc replacement (bsTDR) to determine whether the two test methods provide the same data for the same evaluation subjects. KEY SCIENTIFIC CONCEPTS OF REVIEW: We performed 70 meta-analyses (MAs) and 20 additional comparative analyses based on data from 21 SSC studies used for 39 MAs and 16 FEM studies used for 31 MAs. Only fifty-nine percent (n = 23/39) of SSC MAs show a restored ROM after bsTDR, whereas in FEM MAs, the ROM is restored in ninety percent (n = 28/31). Among the analyses comparing data from the same spinal segments, motion directions and bsTDR, SSC and FEM data are significantly different in ten percent (n = 2/20). According to our results, data generated by SSCs and FEMs cannot be used as alternative and complementary data without restriction. The quality of the evaluation methods itself as well as potential technical reasons for the discrepant results were not our evaluation target. Further SSC and FEM data should be compared using the same approach.