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Background: LAAO is an emerging option for thromboembolic event prevention in patients with NVAF. We previously reported data on comparison between LAAO and DOAC at two-year follow-up in NVAF patients at HBR (HAS-BLED ≥3)., Aims: Limited data are available on long term follow-up. We aimed to evaluate the efficacy and safety of DOACs versus LAAO indication after 5 years., Methods: We enrolled 193 HBR treated with LAAO and 189 HBR patients with DOACs. At baseline, LAAO group had higher HAS-BLED (4.2 vs 3.3, p < 0.001) and lower CHADS-VASc (4.3 vs. 4.7, p = 0.005). After 1:1 PSM, 192 patients were included (LAAO n = 96; DOACs n = 96)., Results: At 5-year follow-up the rate of the combined safety and effectiveness endpoint (ISTH major bleeding and thromboembolic events) was significantly higher in LAAO group (p = 0.042), driven by a higher number of thromboembolic events (p = 0.047). The rate of ISTH-major bleeding events was similar (p = 0.221). After PSM no significant difference in the primary effectiveness (LAAO 13.3% vs DOACs 9.5%, p = 0.357) and safety endpoint (LAAO 7.5% vs DOACs 7.5%; p = 0.918) were evident. Overall bleeding rate was significantly higher in DOACs group (25.0% vs 13.7%, p = 0.048), while a non-significant higher number of TIA was reported in LAAO group (5.4% vs 1.1%, p = 0.098). All-cause and cardiovascular mortality were higher in LAAO group at both unmatched and matched analysis., Conclusion: We confirmed safety and effectiveness of both DOAC and LAAO in NVAF patients at HBR, with no significant differences in thromboembolic events or major bleeding were at 5-year follow-up. The observed increased mortality after LAAO warrants further investigations in RCTs., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology., Methods: Clinical and echocardiographic follow-up were assessed in 250 patients diagnosed with moderate TR between January 2016 and July 2020. TR progression at follow-up was defined as TR grade increase to at least severe. The primary endpoint was all-cause death; secondary endpoints were cardiovascular (CV) death and the composite of heart failure (HF) hospitalization plus tricuspid valve (TV) intervention., Results: After a median follow-up of 3.6 years, TR progression occurred in 84 patients (34%). At multivariate analyses, atrial fibrillation (AF, OR 1.81, CI 1.01-3.29, p = 0.045) and right ventricular end-diastolic diameter (RVEDD, OR 2.19, CI 1.26-3.78, p = 0.005) were independent predictors of TR progression. The primary endpoint occurred in 59 patients (24%) and was significantly more frequent in the group with TR progression (p = 0.009). At multivariate analyses, chronic kideney disease (OR 2.80, CI 1.30-6.03, p = 0.009), left ventricular ejection fraction (OR 0.97, CI 0.94-0.99, p = 0.041) and TR progression (OR 2.32, CI 1.31-4.12, p = 0.004) were independent predictors of the primary outcome. Moreover, both the secondary endpoints of CV death and HF hospitalization plus TV intervention were more frequent in the TR progression group (p = 0.001 and p < 0.001, respectively)., Conclusions: Moderate TR progresses in a significant proportion of patients over a long-term follow-up, leading to a worse prognosis. TR progression is an independent determinant of hard clinical events and AF and RVEDD are associated with TR progression., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: In terms of pathophysiology, tricuspid regurgitation (TR), right ventricular function and pulmonary artery pressure are linked to each other. Our aim was to analyze whether the echocardiography-derived right ventricular free wall longitudinal strain/pulmonary artery systolic pressures (RVFWLS/PASP) ratio can improve risk stratification in patients with severe tricuspid regurgitation (TR)., Methods: In this single-center retrospective study, 250 consecutive patients with severe TR were enrolled from December 2015 to December 2018. Baseline clinical and echocardiographic parameters were collected. Echocardiography-derived TAPSE/PASP and RVFWLS/PASP were evaluated. The primary endpoint was all-cause mortality., Results: Out of 250 consecutive patients, 171 meet inclusion criteria. Patients were predominantly female, with several cardiovascular risk factors and comorbidities. RVFWLS/PASP ≤0.34%/mmHg (AUC 0.68, p < 0.001, sensitivity 70%, specificity 67%) was associated with baseline clinical RV heart failure (p = 0.03). After univariate and multivariate analyses, RVFWLS/PASP, but not TAPSE/PASP, independently correlated with all-cause mortality (HR 0.004, p = 0.02). Patients with RVFWLS/PASP >0.26%/mmHg (AUC 0.74, p < 0.001, sensitivity 77%, specificity 52%) showed higher survival rates (p = 0.02). In addition at 24 months follow-up, the Kaplan-Meyer curves showed patients with RVFWLS >14% & RVFWLS/PASP >0.26%/mmHg had the best survival rate compared to patients without., Conclusion: RVFWLS/PASP is independently associated with baseline RV heart failure and poor long-term prognosis in patients with severe TR., Competing Interests: Declaration of Competing Interest None. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Each author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Objectives: This study evaluated the incidence, management, and outcome of patients who experienced MitraClip (Abbott Vascular) failure secondary to loss of leaflet insertion (LLI), single leaflet detachment (SLD), or embolization., Background: Transcatheter edge-to-edge repair with MitraClip is an established therapy for the treatment of mitral regurgitation (MR), but no data exist regarding the prevalence and outcome according to the mode of clip failure., Methods: Between January 2009 and December 2020, we retrospectively screened 4,294 procedures of MitraClip performed in 19 centers. LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets., Results: A total of 147 cases of MitraClip failure were detected (overall incidence = 3.5%), and these were secondary to LLI or SLD in 47 (31.9%) and 99 (67.3%) cases, respectively, whereas in 1 (0.8%) case clip embolization was observed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR, and 16 (10.8%) with mixed etiology. Although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%) including 4 cases of surgical conversion of the index procedure and 7 cases of bailout surgery after unsuccessful redo MitraClip. After a median follow-up of 163 days (IQR: 22-720 days), 50 (43.9%) subjects presented moderate to severe MR, and 43 (29.3%) patients died. An up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death., Conclusions: MitraClip failure secondary to LLI and SLD is not a rare phenomenon and may occur during and also beyond hospitalization. Redo MitraClip strategy demonstrates a trend toward a reduced risk of death compared with bailout surgery and conservative management. A third of those patients remained with more than moderate MR and had substantial mortality at the intermediate-term follow-up., Competing Interests: Funding Support and Author Disclosures Dr Mangieri has received a research grant (to the institution) from Boston Scientific; and has served on a medical advisory board for Boston Scientific. Dr Tagliari has received a research grant from Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil (finance code 001). Dr Denti received speaker honoraria from Abbott and Edwards Lifesciences; and is a consultant for Innovheart. Dr De Marco serves as a proctor for Boston Scientific and Kardia. Dr Montorfano serves as a proctor for Edwards Lifesciences, Abbott, and Kardia. Dr Toggweiler is a proctor and consultant for Boston Scientific, Medtronic, and Biosensors/NVT; is a proctor for Abbott Vascular; and is a consultant for Medira, Shockwave, Teleflex, AtHeart, VeoSource, and Equity in Hi-D Imaging. Dr Sievert has received study honoraria, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, pfm Medical, Recor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. Dr Latib has served on advisory boards for Medtronic and Abbott; and has been a consultant to Edwards Lifesciences. Dr Fam serves as consultant for Edwards Lifesciences and Abbott. Dr Maisano received a grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, and Terumo; has received consulting fees and honoraria personal and an institutional grant from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, Mtex; royalty income/IP rights from Edwards Lifesciences; and is a shareholder (including share options) of Cardiogard, Cardiovalve, Magenta, SwissVortex, Transseptalsolutions, 4Tech, and Perifect. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr Montorfano has received honoraria from Abbott, Boston Scientific, Edwards Lifesciences, Kardia, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Introduction: Recently, observational data have raised concerns about safety of selfexpandable (SE) compared to balloon-expandable (BE) valves in TAVI, although potentially limited by patient selection bias., Methods: All Randomized Controlled Trials (RCTs) comparing BE vs. SE TAVI or/and vs. aortic valve replacement (AVR) were included and compared through Network Meta Analysis (NMA). All-cause and cardiovascular (CV) mortality were the primary endpoints, stroke, rates of permanent pacemaker implantation (PPI), moderate/severe paravalvular leak (PVL) and reintervention were the secondary endpoints. Results We obtained data from 11 RCTs, encompassing 9752 patients. After one and two years, no significant differences for allcause and CV mortality were observed. Compared to surgical bioprostheses, both BE and SE TAVI reduced the risk of acute kidney injury (OR 0.42; CI 95% 0.30-0.60 and OR 0.44; CI 95% 0.32-0.60), new-onset atrial fibrillation (OR 0.24; CI 95% 0.14-0.42 and OR 0.21; CI 95% 0.13-0.34) and major bleedings (OR 0.32; CI 95% 0.16-0.65 and OR 0.47; CI 95% 0.25-0.89). The BE prostheses reduced the risk of moderate/severe PVL at 30-day (OR 0.31; CI 95% 0.17-0.55) and of PPI both at 30-day (OR 0.51; CI 95% 0.33-0.79) and 1 year (OR 0.40; CI 95% 0.30-0.55) as compared to SE TAVI. Conclusions A TAVI strategy, independently from BE or SE prostheses, offers a midterm survival comparable to AVR. The BE prostheses are associated with a reduction of PPI and PVL compared to SE prostheses without any differences in all-cause and CV mortality during two years of follow up. PROSPERO ID CRD42020182407., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Left ventricle (LV) unloading during VenoArterial ExtraCorporeal Membrane Oxygenation (VA-ECMO) reduces the risk of LV distention, stagnation and pulmonary congestion resulting from the increased afterload. Lacking direct comparisons between unloading strategies we used network meta-analysis to indirectly compare different unloading approaches., Methods: A literature research was performed to include all studies on VA-ECMO reporting data on mechanical LV unloading. The pre-specified outcome was in-hospital death., Results: Literature search identified 389 studies: 16 were included in the analysis (3930 patients). Two strategies of mechanical LV unloading were compared: afterload reduction (IABP) and preload reduction (Impella pump, right upper pulmonary/trans-septal catheters, LV surgical vents). Any LV unloading strategy was associated with mortality reduction with overall OR = 0.54; 95% CI 0.42-0.70; p < .001. Targeting afterload was associated with reduced mortality (OR = 0.61 95% CI 0.46-0.81; p < .001; I 2  = 61%), as targeting preload (OR = 0.34 95% CI 0.21-0.55; p < .001; I 2  = 0%). Significant between group difference was observed (p = .04): to further explore this we performed a network meta-analysis. Indirect comparisons between afterload and preload reduction were estimated. Any unloading technique was confirmed better than none but preload targeting resulted better than afterload targeting., Conclusion: Any unloading strategy in VA-ECMO patients was associated with lower mortality as compared to no-unloading. Preload reduction strategies resulted superior to afterload reduction., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: MitraClip implantation has evolved as a new tool for treatment of inoperable or high-risk patients with severe functional mitral regurgitation (FMR) due to dilated cardiomyopathy (DCM). Limited data are available regarding MitraClip outcomes comparing patients with ischemic and non-ischemic DCM., Methods: From 2008 to 2016, 314 patients received MitraClip for FMR at four institutions: Brescia, Zurich and Milan. Patients were stratified according to MR aetiology in non-ischemic FMR (n = 99) and ischemic FMR (n = 215). Preoperative risk factors, operative variables and outcomes up to 2-year were evaluated. A multivariable Cox Proportional Hazards survival model with covariate adjustments was used to assess the relationship between FMR aetiology and 2-year cardiac mortality., Results: As expected, patients with ischemic FMR had significantly more risk factors and comorbidities. Overall procedural success rate was 80% and in-hospital cardiac mortality was 3% without significant differences between aetiology. Two-year overall (25% vs. 19%, p = 0.574) and cardiac (18% vs. 16%, p = 0.990) mortality rates were comparable. No differences were detected in terms of re-hospitalization rates (32%), LVAD implantation (4.5%) and mitral valve surgery (1%). LVEF ≤ 25%, LVEDV > 216 ml, NT-proBNP ≥ 10.000 pg/ml and AF were the strongest baseline predictors of 2-year cardiac mortality. Greater improvements of 6MWT and NYHA functional class were observed in patients with non-ischemic FMR., Conclusions: The ischemic or non-ischemic aetiology of DCM did not affect in-hospital and 2-year cardiac mortality after MitraClip in patients with FMR. In case of unfavorable baseline clinical condition, the indication for MitraClip should be carefully weighed in favour of conservative medical therapy alone or left ventricular assist device., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Objectives: This study sought to compare clinical outcome of polymer-free amphilimus-eluting stent (PF-AES) versus biodegradable-polymer biolimus-eluting stent (BD-BES) in "all-comer" diabetes mellitus (DM) and non-DM patients who underwent percutaneous coronary intervention., Background: The PF-AES has shown promising preliminary results in patients with DM., Methods: Data from 2 multicentre-national registries (the ASTUTE and the INSPIRE-1) were used to analyse 1776 patients stratified in non-DM and DM. A double 1:1 propensity-score matched analysis (PF-AES vs. BD-BES) was performed in each group to adjust for clinical and procedural characteristics. Primary stent-efficacy and stent-safety endpoints were 1-year target-lesion revascularization (TLR) and target-lesion failure (TLF, composed of cardiac-death, target-vessel myocardial infarction and any TLR)., Results: After propensity-score matching, 850 patients were stratified as non-DM (425 PF-AES/425 BD-BES) and 480 as DM patients (240 PF-AES/240 BD-BES). Both TLF (20 of 425 [5%] vs. 24 of 425 [6%]; P log-rank =0.527) and TLR (9 of 425 [2%] vs. 18 of 425 [4%]; P log-rank =0.079) were similar between PF-AES and BD-BES in non-DM patients. In DM, TLF (12 of 240 [5%] vs. 31 of 240 [13%]; P log-rank =0.002) and TLR (9 of 240 [4%] vs. 21 of 240 [9%]; P log-rank =0.019) were significantly lower in PF-AES compared to BD-BES. Upon multivariate analysis, the most powerful predictors of TLF were chronic kidney disease in non-DM (OR 4.24, 95% CI: 2.07-8.70, p<0.001) and stent type in DM patients (OR 2.76, 1.36-5.56, p=0.005)., Conclusions: This matched-cohort study suggests that PF-AES has better safety and efficacy profile than BD-BES in patients with DM., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Objective: To develop a neurophysiological method to explore central motor pathways to proximal and distal muscles of lower limbs., Methods: MEPs to transcranial magnetic stimulation using the double cone coil were bilaterally and simultaneously recorded from vastus medialis, tibialis anterior and flexor hallucis brevis. Voluntary facilitation was controlled using a predefined sequence of movements of constant amplitude. Compound motor action potentials elicited by maximal high voltage electrical stimulation of lumbosacral roots (root-CMAPs) were recorded from the same muscles to obtain the corresponding peripheral conduction times. We studied 28 healthy subjects and 28 multiple sclerosis (MS) patients with no or mild motor impairment., Results: The described facilitation procedure and the averaging of 5 MEPs reduced area variability to about 10%. In MS patients conduction slowing and/or MEP area reduction in at least one muscle was found in 91.7% of cases, with significant correlation with individual motor impairment., Conclusions: Combined use of stable MEPs and maximal root-CMAPs was able to detect both conduction slowing and conduction failure in central motor pathways to proximal and distal districts of lower limbs in MS patients., Significance: The proposed method provides an extensive electrophysiological mapping of central motor impairment of lower limbs in clinical application., (Copyright © 2013 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.)