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Catheter-based revascularization procedures were developed as an alternative to systemic thrombolysis for patients with intermediate-high- and high-risk pulmonary embolisms. USAT IH-PE is a retrospective and prospective multicenter registry of such patients treated with ultrasound-facilitated, catheter-directed thrombolysis, whose preliminary results are presented in this study. The primary endpoint was the incidence of pulmonary hypertension (PH) at follow-up. Secondary endpoints were short- and mid-term changes in the echocardiographic parameters of right ventricle (RV) function, in-hospital and all-cause mortality, and procedure-related bleeding events. Between March 2018 and July 2023, 102 patients were included. The majority were at intermediate-high-risk PE (86%), were mostly female (57%), and had a mean age of 63.7 ± 14.5 years, and 28.4% had active cancer. Echocardiographic follow-up was available for 70 patients, and in only one, the diagnosis of PH was confirmed by right heart catheterization, resulting in an incidence of 1.43% (CI 95%, 0.036-7.7). RV echocardiographic parameters improved both at 24 h and at follow-up. In-hospital mortality was 3.9% (CI 95%, 1.08-9.74), while all-cause mortality was 11% (CI 95%, 5.4-19.2). Only 12% had bleeding complications, of whom 4.9% were BARC ≥ 3. Preliminary results from the USAT IH-PE registry showed a low incidence of PH, improvement in RV function, and a safe profile.

Background: Treatment of aortic stenosis in patients with small annuli is challenging and can result in prosthesis-patient mismatch (PPM)., Aims: We aimed to compare the forward flow haemodynamics and clinical outcomes of contemporary transcatheter valves in patients with small annuli., Methods: The TAVI-SMALL 2 international retrospective registry included 1,378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm 2 ) treated with transfemoral self-expanding (SEV; n=1,092) and balloon-expandable valves (BEV; n=286) in 16 high-volume centres between 2011 and 2020. Analyses comparing SEV versus BEV and supra-annular (SAV; n=920) versus intra-annular valves (IAV; n=458) included inverse probability of treatment weighting (IPTW). The primary endpoints were the predischarge mean aortic gradient and incidence of severe PPM. The secondary endpoint was the incidence of more than mild paravalvular leak (PVL)., Results: The predischarge mean aortic gradient was lower after SAV versus IAV (7.8±3.9 vs 12.0±5.1; p<0.001) and SEV versus BEV implantation (8.0±4.1 vs 13.6±4.7; p<0.001). Severe PPM was more common with IAV and BEV when compared to SAV and SEV implantation, respectively, (8.8% vs 3.6%; p=0.007 and 8.7% vs 4.6%; p=0.041). At multivariable logistic regression weighted by IPTW, SAV protected from severe PPM regardless of its definition. More than mild PVL occurred more often with SEV versus BEV (11.6% vs 2.6%; p<0.001)., Conclusions: In small aortic annuli, implantation of SAV and SEV was associated with a more favourable forward haemodynamic profile than after IAV and BEV implantation, respectively. More than mild PVL was more common after SEV than BEV implantation.

Background: A risk score was recently derived from the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial. However, external validation of this score is still lacking., Aims: We aimed to validate the COAPT risk score in a large multicentre population undergoing mitral transcatheter edge-to-edge repair (M-TEER) for secondary mitral regurgitation (SMR)., Methods: The Italian Society of Interventional Cardiology (GIse) Registry of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) population was stratified according to COAPT score quartiles. The performance of the COAPT score for 2-year all-cause death or heart failure (HF) hospitalisation was evaluated in the overall population and in patients with or without a COAPT-like profile., Results: Among the 1,659 patients included in the GIOTTO registry, 934 had SMR and complete data for a COAPT risk score calculation. The incidence of 2-year all-cause death or HF hospitalisation progressively increased through the COAPT score quartiles in the overall population (26.4% vs 44.5% vs 49.4% vs 59.7%; log-rank p<0.001) and COAPT-like patients (24.7% vs 32.4% vs 52.3% vs. 53.4%; log-rank p=0.004), but not in those with a non-COAPT-like profile. The COAPT risk score had poor discrimination and good calibration in the overall population, moderate discrimination and good calibration in COAPT-like patients and very poor discrimination and poor calibration in non-COAPT-like patients., Conclusions: The COAPT risk score has a poor performance in the prognostic stratification of real-world patients undergoing M-TEER. However, after application to patients with a COAPT-like profile, moderate discrimination and good calibration were observed.

Some synthetic bone graft substitutes (BGS) can trigger ectopic bone formation, which is the hallmark of osteoinduction and the most important prerequisite for the repair of large bone defects. Unfortunately, measuring or predicting BGS osteoinductive potential based on in vitro experiments is currently impossible. A recent study claimed that synthetic BGS can induce bone formation ectopically if they create a local homeostatic imbalance during their in vivo mineralization. This raised the hope that a simple cell free in vitro mineralization experiment would correlate with osteoinduction. The aim of the present study was therefore to assess the ability of a quantitative in vitro mineralization test to predict and rank the osteoinductive potential of BGS. Eight calcium phosphate BGS already tested ectopically in 9 different in vivo studies were used for that purpose. The experiment was able to identify materials that are reliably osteoinductive from those that are not, but was inaccurate in ranking the osteoinductive materials between each other. Chemical contaminants (Ca 2+ , Mg 2+ , H + , OH - , PO 4 3- ) present in some of the BGS affected the in vitro mineralization experiment results, but not in a direction that could explain the different rankings. In conclusion, this study suggests that an in vitro experiment can be used as a fast and reliable screening tool to identify osteoinductive BGS and underline the need to study ionic contaminants on calcium phosphate BGS., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Objectives: The aim of this study was to evaluate whether fulfilling COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) criteria identifies patients with better outcomes after MitraClip treatment for secondary mitral regurgitation (SMR)., Background: To date, COAPT is the only trial showing a prognostic benefit of MitraClip implantation compared with conservative management., Methods: Three hundred four patients with SMR undergoing MitraClip placement in addition to optimal medical therapy at 3 European centers were analyzed. A COAPT-like profile was defined as absence of all the following criteria: severe left ventricular impairment, moderate to severe right ventricular dysfunction, severe tricuspid regurgitation, severe pulmonary hypertension, and hemodynamic instability. Freedom from all-cause death and from a composite endpoint (cardiovascular death and heart failure hospitalization) were evaluated at 2- and 5-year follow-up., Results: A COAPT-like profile was observed in 65% of the population. Compared with non-COAPT-like patients, those fulfilling COAPT criteria had greater survival free from all-cause death and from the composite endpoint at both 2 year (75% vs. 55% and 67% vs. 47%; p < 0.001 for both) and 5-year (49% vs. 25% and 40% vs. 19%; p < 0.001 for both) follow-up. Among the non-COAPT-like patients, similar outcomes were observed in those fulfilling 1 or ≥1 criterion. Left ventricular impairment had a late impact on outcomes, while right ventricular impairment, pulmonary hypertension, and hemodynamic instability had early effects. COAPT-like profile was an independent predictor of long-term outcomes, as well as administration of neurohormonal antagonists, European System for Cardiac Operative Risk Evaluation II score, and previous heart failure hospitalization., Conclusions: A COAPT-like profile, including specific echocardiographic and clinical criteria, identifies patients with SMR who have a better prognosis after MitraClip implantation., Competing Interests: Author Disclosures Dr. Metra has received consulting fees from Abbott Vascular, Amgen, AstraZeneca, Bayer, Edwards Therapeutics, Fresenius, Vifor, and Windtree Therapeutics. Dr. Petronio is a consultant for and has received research funds from Medtronic, Abbott Vascular, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: To explore whether left ventricular reverse remodelling (LVRR) is a predictor of outcomes in patients with functional mitral regurgitation (FMR) undergoing MitraClip procedure., Methods and Results: We analysed 184 consecutive patients with FMR who underwent successful MitraClip procedure. LVRR was defined as a reduction in left ventricular end-systolic volume ≥ 10% from baseline to 6 months. LVRR was observed in 79 (42.9%) patients. Compared with non-LVRR, LVRR patients were more likely to be females, less likely to have an ischaemic aetiology of mitral regurgitation or a prior (<6 months) heart failure (HF) hospitalization, and had smaller left ventricular dimensions. New York Heart Association class improved from baseline up to 1-year follow-up in both groups. Higher rates of overall survival (87.3% vs. 75.2%, P = 0.039), freedom from HF hospitalization (77.2% vs. 60%, P = 0.020), and freedom from the composite endpoint (cardiovascular mortality or HF hospitalization) (74.7% vs. 55.2%; P = 0.012) were observed in LVRR vs. non-LVRR patients at 2-year follow-up. LVRR was associated with a significant reduction of the adjusted relative risk of mortality, HF hospitalization and composite endpoint [hazard ratio (HR) 0.44; 95% confidence interval (CI) 0.20-0.96, P = 0.040; HR 0.55; 95% CI 0.32-0.97, P = 0.038; and HR 0.54; 95% CI 0.32-0.92, P = 0.023, respectively]. Female gender, absence of diabetes, freedom from prior HF hospitalization, non-ischaemic aetiology of mitral regurgitation, and left ventricular end-diastolic diameter < 75 mm were found to be independent predictors of LVRR., Conclusions: Left ventricular reverse remodelling is associated with better long-term outcomes in patients with FMR successfully treated with MitraClip. A careful patient selection may be useful as specific baseline features predict favourable left ventricular remodelling. [Correction added on 17 January 2019, after online publication: the preceding sentence has been changed.]., (© 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.)

Aims: The aim of this study was to investigate the feasibility, safety, and efficacy of Mitraclip therapy in patients with functional mitral regurgitation (MR) and missing leaflet coaptation (MLC)., Methods and Results: Out of 62 consecutive patients with functional MR undergoing Mitraclip implantation, 22 had MLC defined as the presence of a 'gap' between two mitral leaflets or insufficient coaptation length (<2 mm), according to the EVEREST II criterion. Compared with the control group, the MLC population had a significantly higher effective regurgitant orifice area (0.67 ± 0.31 vs. 0.41 ± 0.13 cm 2 ; P = 0.019) and sphericity index (0.80 ± 0.11 vs. 0.71 ± 0.10; P = 0.003). MLC patients were treated with pharmacological/mechanical support in order to improve leaflet coaptation and to prepare the mitral valve apparatus for grasping. Implantation of >1 clip and device time were comparable in patients with and without MLC (61.9% vs. 47.5%; P = 0.284 and 101 ± 39 vs. 108 ± 69 min; P = 0.646, respectively). No significant differences were observed between the two cohorts in technical success (95.5% vs. 97.5%, P = 0.667), 30-day device success (85.7% vs. 78.9%; P = 0.525), procedural success (81.8% vs. 75%; P = 0.842), and 1-year patient success (52.9% vs. 44.1%; P = 0.261), defined according to the MVARC (Mitral Valve Academic Research Consortium) criteria. The long-term composite endpoint of cardiovascular death and heart failure hospitalization was similar in the two groups (49.9% vs. 44.4%; P = 0.348). A significant improvement of MR and NYHA functional class and a lack of reverse remodelling were observed up to 2 years in both arms., Conclusion: The Mitraclip procedure could be extended to patients with functional MR who do not fulfil the coaptation length EVEREST II criterion and who would otherwise be excluded from this treatment., (© 2016 The Authors European Journal of Heart Failure © 2016 European Society of Cardiology.)