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Purpose: The study was designed to evaluate whether an educational intervention to train the health center (HC) staff to optimize care for sexual and gender minority (SGM) patients could improve documentation of sexual orientation and gender identity (SOGI) and increase preventive screenings. Methods: Twelve HCs were matched and randomized to either receive a tailored, multicomponent educational intervention or a 1-hour prerecorded webinar. Documentation of SGM status and clinical testing was measured through analysis of data that HCs report annually. Nonparametric statistics were used to assess associations between baseline HC characteristics and outcome measures. Results: The HCs were geographically, racially, and ethnically diverse. In all but one HC, <10% of the patients were identified as SGM. Intervention HCs underwent between 3 and 10 trainings, which were highly acceptable. In 2018, 9 of 12 HCs documented SO and 11 of 12 documented GI for at least 50% of their patients. Five of 6 intervention HCs increased SO documentation by 2020, compared to 3 of 6 control HCs (nonsignificant, NS). Five intervention HCs increased GI documentation, although generally by less than 10%, compared to 2 of the controls (NS). Intervention HCs tended to increase documentation of preventive services more than control HCs, but the changes were NS. Conclusions: An educational intervention designed to train the HC staff to provide culturally responsive services for SGM patients was found to be acceptable, with favorable, but nonsignificant changes. Further refinement of the intervention using a larger sample of HCs might demonstrate the effectiveness of this approach. Clinical trial registration #: NCT03554785.

Atrial functional mitral regurgitation (aFMR) has a peculiar pathophysiology that may have distinctive outcomes. We investigated the impact of transcatheter edge-to-edge repair in aFMR compared with other FMR etiologies. The GIOTTO (GIse registry Of Transcatheter treatment of MR) is a multicenter, prospective study enrolling patients with symptomatic MR treated with MitraClip up to 2020. We categorized patients with FMR as aFMR, ischemic FMR (iFMR), and nonischemic ventricular FMR (niFMR). The clinical end points were defined according to the Mitral Valve Academic Research Consortium. Of 1,153 patients, 6% had aFMR, 47% iFMR, and 47% niFMR. Patients with aFMR were older, mostly women, and had a higher atrial fibrillation rate. They had better left ventricular ejection fraction and smaller left ventricular volumes, with no difference in mitral effective regurgitant orifice area. The acute device and procedural success rates were similar among the groups. At the longest available follow-up (median 478 days, interquartile range 91 to 741 days), the rate of MR ≥2+ was similar among the groups. Patients with aFMR had a lower rate of cardiovascular death and heart failure than patients with iFMR (hazard ratio [HR] 0.43, p = 0.02) and niFMR (HR 0.45, p = 0.03). The aFMR etiology remained independently associated with the composite outcome, together with postprocedural MR ≤1+ (HR 0.63, p <0.01) and peripheral arteriopathy (HR 1.82, p = 0.003). The results of this GIOTTO subanalysis suggested that aFMR is less prevalent and associated with better outcomes compared with other causes of FMR treated by transcatheter edge-to-edge repair. Postprocedural MR >1+, peripheral vasculopathy, non-aFMR were independent predictors of worse outcomes., Competing Interests: Declaration of Competing Interest Drs. Giuseppe Tarantini, Bedogni, Grasso, Paolo Denti (PD), Tamburino, Petroni, Montorfano declared speaker fees from Abbott Vascular. The remaining authors have no competing interest to declare., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: In the context of primary mitral regurgitation (PMR), the selection of patients for transcatheter edge-to-edge repair (TEER) does not include a systematic assessment of PMR-associated cardiac remodelling., Aims: We aimed to investigate the epidemiology and prognostic significance of different phenotypes of extra-mitral valve (MV) cardiac involvement in a large series of patients with PMR referred for TEER., Methods: The study included 654 patients from the multicentre Italian GIOTTO registry, stratified into groups according to extra-mitral valve (MV) cardiac involvement. The primary endpoint was all-cause death at 2-year follow-up., Results: Patients with no cardiac involvement (NI; n=58), left heart involvement (LHI; n=343) and right heart involvement (RHI; n=253) were analysed. Acute technical success was achieved in 98% of patients. Kaplan-Meier curve analysis revealed significantly worse survival in patients with LHI and RHI (p=0.041). On multivariate Cox regression analysis, extra-MV cardiac involvement, haemoglobin level and technical success were independent predictors of the primary endpoint occurrence., Conclusions: Grading cardiac involvement may help refine risk stratification, since at least 1 group of extra-MV cardiac involvement represents in itself a negative predictor of midterm outcome.

Background: In the first report from the MitraBridge registry, MitraClip as a bridge to heart transplantation (HTx) proved to be at 1-year an effective treatment strategy for 119 patients with advanced heart failure (HF) who were potential candidates for HTx. We aimed to determine if benefits of MitraClip procedure as a bridge-to-transplant persist up to 2-years., Methods: By the end of the enrollment period, a total of 153 advanced HF patients (median age 59 years, left ventricular ejection fraction 26.9 ± 7.7%) with significant secondary mitral regurgitation, who were potential candidates for HTx and were treated with MitraClip as a bridge-to-transplant strategy, were included in the MitraBridge registry. The primary endpoint was the 2-year composite adverse events rate of all-cause death, first hospitalization for HF, urgent HTx or LVAD implantation., Results: Procedural success was achieved in 89.5% of cases. Thirty-day mortality was 0%. At 2-year, Kaplan-Meier estimates of freedom from primary endpoint was 47%. Through 24 months, the annualized rate of HF rehospitalization per patient-year was 44%. After an overall median follow-up time of 26 (9-52) months, elective HTx was successfully performed in 30 cases (21%), 19 patients (13.5%) maintained or obtained the eligibility for transplant, and 32 patients (22.5%) no longer had an indication for HTx because of significant clinical improvement., Conclusions: After 2-years of follow-up, the use of MitraClip as a bridge-to-transplant was confirmed as an effective strategy, allowing elective HTx or eligibility for transplant in one third of patients, and no more need for transplantation in 22.5% of cases., Competing Interests: Declaration of Competing Interest A.S. has served as a consultant and received consulting fees from NeoChord Inc.; R.E.L. received speaker fees from Abbott, Boston and Edwards; M.A. received speaker fees from Abbott Vascular and Medtronic; P.G. has been a proctor for Abbot; N.M.V.M. received research grant support from Abbott Vascular, Biotronik, Medtronik, Boston Scientific, Edwards Lifesciences, Daiichi Sankyo, Abiomed en PulseCath BV; F.S. received consultancy and lecture's fees from Abbott and Edwards., (Copyright © 2023 Elsevier B.V. All rights reserved.)

This study aimed to compare the peri-procedural success and complication rate within a large registry of intra-cardiac echocardiography (ICE)- vs. transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) procedures with a Watchmann FLX device. Data from 772 LAAO procedures, performed at 26 Italian centers, were reviewed. Technical success was considered as the final implant of a Watchmann FLX device in LAA; the absence of pericardial tamponade, peri-procedural stroke and/or systemic embolism, major bleeding and device embolization during the procedure was defined as a procedural success. One-year stroke and major bleeding rates were evaluated as outcome. ICE-guided LAA occlusion was performed in 149 patients, while TEE was used in 623 patients. Baseline characteristics were similar between the ICE and TEE groups. The technical success was 100% in both groups. Procedural success was also extremely high (98.5%), and was comparable between ICE (98.7%) and TEE (98.5%). ICE was associated with a slightly longer procedural time (73 ± 31 vs. 61.9 ± 36 min, p = 0.042) and shorter hospital stay (5.3 ± 4 vs. 5.8 ± 6 days, p = 0.028) compared to the TEE group. At one year, stroke and major bleeding rates did not differ between the ICE and TEE groups. A Watchmann FLX device showed high technical and procedural success rate, and ICE guidance does not appear inferior to TEE.

Purpose of Review: Immunoglobulin G4-related diseases (IgG4-RDs) are immune-mediated fibroinflammatory multisystemic conditions identified by the presence of tumefactive lesions with a rich infiltrate of IgG4-positive plasma cells, and often by a high IgG4 serum concentration. IgG-RDs have a prevalence of at least 1 case every 100,000 persons, and they are mostly diagnosed after age 50, with a male to female ratio of about 3:1. IgG4-RD pathophysiology is still uncertain: it has been proposed that both genetic predisposition and chronic environmental exposures may play a role by triggering abnormal immune activation that perpetuates the disease. The purpose of this review is to summarize the evidences supporting the hypothesis that certain environmental/occupational exposures can trigger IgG4-RDs, focusing on the possible role of asbestos in an emerging IgG4-RD called idiopathic retroperitoneal fibrosis (IRF)., Recent Findings: Although some studies suggested a relationship between tobacco smoking and IgG4-RD risk, occupational exposures seem to have the most interesting effects. Positive history of blue-collar work increases the risk of developing an IgG4-RD, and mineral dusts and asbestos were the most strongly associated industrial compounds. Asbestos has been found to be a risk factor for IRF years before its classification as IgG4-RD, and later in two large case-control studies. In the most recent one, conducted on 90 patients and 270 controls, asbestos exposure conferred an increased IRF risk, quantified by odds ratios from 2.46 to 7.07. Further structured studies including serum IgG4 evaluation should be conducted to clarify the effect of asbestos on patients with confirmed diagnosis of IgG4-related IRF. Environmental exposures, especially of occupational origin, appear to play a role in the development of different types of IgG-RDs. In particular, although first suggested very recently, the relationship between asbestos and IRF deserves to be explored in more structured studies, especially because of the biological plausibility of the role of asbestos in IRF pathogenesis., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Despite the growing experience with MitraClip in the broad spectrum of mitral regurgitation (MR), limited data are available regarding the independent prognostic role on survival of different mitral regurgitation etiology subtypes. We sought to evaluate the impact of flail leaflet etiology in a large series of patients with primary MR (PMR) who underwent MitraClip treatment. The study included 588 patients with significant PMR from the multicenter GIOTTO (Italian Society of Interventional Cardiology [GIse] registry Of Transcatheter treatment of mitral valve regurgitaTiOn), stratified into 2 groups according to MR etiology: flail + (n = 300) and flail - (n = 288). The primary end point was a composite of cardiac death and first rehospitalization for heart failure (HF). To account for the baseline differences, patients were propensity score-matched 1:1. Flail leaflet etiology was present in about a half of the patients. Acute technical success was achieved in 98% of the overall cohort, with no significant differences between the study groups (p = 0.789). At the 2-year Kaplan-Meier analysis, the primary end point occurred in 13% of flail + patients compared with 23% in flail - (p = 0.009). The flail + group presented lower rates of both cardiac death and rehospitalization for HF, whereas a similar overall death rate was observed between the groups. A multivariate Cox regression analysis identified flail leaflet etiology as an independent predictor of favorable outcome in terms of the primary end point (hazard ratio 0.141, 95% confidence interval 0.049 to 0.401, p <0.001). After propensity score matching, flail + patients had confirmed lower rates of cardiac mortality and rehospitalization for HF but similar rates of overall death. In conclusion, flail leaflet-related etiology was common in patients with PMR who underwent MitraClip treatment and was an independent predictor of midterm favorable clinical outcomes., Competing Interests: Declaration of Competing Interest Drs. Grasso, Adamo, Denti, Giordano, Bartorelli, Montorfano, Petronio, Tamburino, and Bedogni received consultation and speakers fees from Abbott Vascular outside the submitted work. The remaining authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives. To assess the performance of US federally qualified health centers (FQHCs) after 6 years of required sexual orientation and gender identity (SOGI) data reporting and update estimated proportions of sexual and gender minorities cared for at FQHCs. Methods. We conducted secondary analyses of data reported to the 2020 and 2021 Uniform Data System from 1297 FQHCs caring for nearly 30 000 000 patients annually. We used multivariable logistic regression to explore FQHC-level and patient-level factors associated with SOGI data completeness. Results. SOGI data were missing for 29.1% and 24.0% of patients, respectively. Among patients with reported SOGI data, 3.5% identified as sexual minorities and 1.5% identified as gender minorities. Southern FQHCs and those caring for more low-income and Black patients were more likely to have above-average SOGI data completeness. Larger FQHCs were more likely to have below-average SOGI data completeness. Conclusions. Substantial increases in SOGI data completeness at FQHCs over 6 years reflect the success of reporting mandates. Future research is needed to identify other patient-level and FQHC-level factors contributing to residual levels of SOGI data missingness. ( Am J Public Health. 2023;113(8):883-892. https://doi.org/10.2105/AJPH.2023.307323).

Background: The relationship between high postprocedural mean gradient (ppMG) and clinical events following mitral valve transcatheter edge-to-edge repair (MV-TEER) in patients with degenerative mitral regurgitation (DMR) is still debated., Aim: The purpose of this study was to evaluate the effect of elevated ppMG after MV-TEER on clinical events in patients with DMR at 1-year follow-up., Methods: The study included 371 patients with DMR treated with MV-TEER enrolled in the "Multi-center Italian Society of Interventional Cardiology (GISE) registry of trans-catheter treatment of mitral valve regurgitation" (GIOTTO) registry. Patients were stratified in tertiles according to ppMG. Primary endpoint was a composite of all-cause death and hospitalization due to heart failure at 1-year follow-up., Results: Patients were stratified as follows: 187 with a ppMG ≤ 3 mmHg, 77 with a ppMG > 3/=4 mmHg, and 107 with a ppMG > 4 mmHg. Clinical follow-up was available in all subjects. At multivariate analysis, neither a ppMG > 4 mmHg nor a ppMG ≥ 5 mmHg were independently associated with the outcome. Notably, the risk of elevated residual MR (rMR > 2+) was significantly higher in patients belonging to the highest tertile of ppMG (p = 0.009). The association of ppMG > 4 mmHg and rMR ≥ 2+ was strongly and independently associated with adverse events (hazard ratio: 1.98; 95% confidence interval: [1.10-3.58])., Conclusions: In a real-world cohort of patients suffering DMR and treated with MV-TEER, isolated ppMG was not associated with the outcome at 1-year follow-up. A high proportion of patients showed both elevated ppMG and rMR and their combination appeared to be a strong predictor of adverse events., (© 2023 Wiley Periodicals LLC.)

Background: Concomitant mitral transcatheter edge-to-edge repair (M-TEER) and left atrial appendage closure (LAAC) showed to be a feasible approach to optimize the treatment of patients eligible for both procedures, but mid-term outcomes are unclear., Methods: We retrospectively analyzed consecutive patients undergoing M-TEER and enrolled in the local prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) registry. We compared patients undergoing isolated M-TEER ( n = 58, 58.5%) with those undergoing concomitant M-TEER and LAAC ( n = 41, 41.5%) from January 2018 to December 2022. The primary endpoint was a composite of all-cause death, stroke or systemic embolism, hospitalization for heart failure, and bleeding at 1 year. The co-primary endpoint was procedural success., Results: The primary endpoint was similar between patients undergoing concomitant M-TEER+LAAC or isolated M-TEER (Kaplan Meier (KM) estimates 36.6% vs. 44.8%; p log-rank = 0.75). Procedural success was also similar (92.7% vs. 94.8%; p = 0.69). At 1- year, minor bleeds were lower in patients undergoing concomitant M-TEER and LAAC (KM estimates 0.0% vs. 18.9%; p log-rank < 0.01)., Conclusion: In patients with concomitant MR and AF and eligible for M-TEER and LAAC treatment, a combined approach of M-TEER and LAAC was as safe as an M-TEER-alone strategy and associated with lower minor bleeding at 1 year.

Purpose: This study identified barriers and facilitators associated with providing culturally responsive care for sexual and gender minority (SGM) patients at federally qualified health centers (FQHCs) in the United States, from the perspective of clinical leadership. Methods: Between July and December 2018, 23 semistructured, in-depth qualitative interviews were held with clinical leaders representing six FQHCs residing in rural and urban settings. Stakeholders included Chief Executive Officer, Executive Director, Chief Medical Officer, Medical Director, Clinic Site Director, and Nurse Manager positions. Interview transcripts were analyzed using inductive thematic analysis. Results: Barriers included personnel factors related to lack of training and fear, competing priorities, and environments that focused on treating all patients similarly. Facilitators included established partnerships with external organizations, staff with prior SGM training and knowledge, and active initiatives in clinic settings targeting SGM care. Conclusions: Clinical leadership expressed strong support for evolving their FQHCs into organizations that provide culturally responsive care for their SGM patients. FQHC staff across all levels of clinical care would benefit from regularly occurring training sessions on culturally responsive care for SGM patients. To ensure sustainability, improve staff buy-in, and mitigate the impact of staff turnover, improving culturally competent care for SGM patients should be a shared goal and responsibility for leadership, medical providers, and administrative staff. CTN Registration: NCT03554785.

Describe health of transgender women (TW) with HIV vs. cisgender men and women (CM, CW) in a U.S. HIV care cohort. Data were from Centers for AIDS Research Network of Integrated Clinical Systems (CNICS), 2005-2022. TW were identified using clinical data/identity measures. PWH (n = 1285) were included in analyses (275 TW, 547 CM, 463 CW). Cross-sectional multivariable analyses compared HIV outcomes/co-morbidities between TW/CM and TW/CW, and adjusted odds ratios (aOR) and 95% confidence intervals (95% CI) were estimated. TW had poorer adherence (> 90% adherent; aOR 0.57; 95%CI 0.38, 0.87) and were more likely to miss ≥ 3 visits in the past year than CM (aOR 1.50, 95%CI 1.06, 2.10); indicated more anxiety compared to both CM and CW (p ≤ 0.001, p = 0.02); hepatitis C infection (p = 0.03) and past-year/lifetime substance treatment (p = 0.004/p = 0.001) compared to CM; and substance use relative to CW. TW with HIV differed in HIV clinical outcomes and co-morbidities from CM and CW., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Percutaneous left atrial appendage occlusion (LAAO) presents many technical complex features, and it is often performed under the intraprocedural surveillance of a product specialist (PS). Our aim is to assess whether LAAO is equally safe and effective when performed in high-volume centers without PS support., Methods: Intraprocedural results and long-term outcome were retrospectively assessed in 247 patients who underwent LAAO without intraprocedural PS monitoring between January 2013 and January 2022 at three different hospitals. This cohort was then matched to a population who underwent LAAO with PS surveillance. The primary end point was all-cause mortality at 1 year. The secondary end point was a composite of cardiovascular mortality plus nonfatal ischemic stroke occurrence at 1 year., Results: Of the 247 study patients, procedural success was achieved in 243 patients (98.4%), with only 1 (0.4%) intraprocedural death. After matching, we did not identify any significant difference between the two groups in terms of procedural time (70 ± 19 min vs. 81 ± 30 min, p  = 0.106), procedural success (98.4% vs. 96.7%, p  = 0.242), and procedure-related ischemic stroke (0.8% vs. 1.2%, p  = 0.653). Compared to the matched cohort, a significant higher dosage of contrast was used during procedures without specialist supervision (98 ± 19 vs. 43 ± 21, p  < 0.001), but this was not associated with a higher postprocedural acute kidney injury occurrence (0.8% vs. 0.4%, p  = 0.56). At 1 year, the primary and the secondary endpoints occurred in 21 (9%) and 11 (4%) of our cohort, respectively. Kaplan-Meier curves showed no significant difference in both primary ( p  = 0.85) and secondary ( p  = 0.74) endpoint occurrence according to intraprocedural PS monitoring., Conclusions: Our results show that LAAO, despite the absence of intraprocedural PS monitoring, remains a long-term safe and effective procedure, when performed in high-volume centers., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Margonato, Rizza, Ingallina, Preda, Ancona, Belli, Godino, Agricola, Della Bella, Grasso, Contarini and Mazzone.)

The effects of postural training on postural stability and vestibulospinal reflexes (VSRs) were investigated in normal subjects. A period (23 minutes) of repeated episodes (n = 10, 50 seconds) of unipedal stance elicited a progressive reduction of the area covered by centre of pressure (CoP) displacement, of average CoP displacement along the X and Y axes and of CoP velocity observed in this challenging postural task. All these changes were correlated to each other with the only exception of those in X and Y CoP displacement. Moreover, they were larger in the subjects showing higher initial instability in unipedal stance, suggesting that they were triggered by the modulation of sensory afferents signalling body sway. No changes in bipedal stance occurred soon and 1 hour after this period of postural training, while a reduction of CoP displacement was apparent after 24 hours, possibly due to a beneficial effect of overnight sleep on postural learning. The same period of postural training also reduced the CoP displacement elicited by electrical vestibular stimulation (EVS) along the X axis up to 24 hours following the training end. No significant changes in postural parameters of bipedal stance and VSRs could be observed in control experiments where subjects were tested at identical time points without performing the postural training. Therefore, postural training led to a stricter control of CoP displacement, possibly acting through the cerebellum by enhancing feedforward mechanisms of postural stability and by depressing the VSR, the most important reflex mechanism involved in balance maintenance under challenging conditions., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Grasso et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: To adapt and validate an algorithm to ascertain transgender and gender diverse (TGD) patients within electronic health record (EHR) data., Methods: Using a previously unvalidated algorithm of identifying TGD persons within administrative claims data in a multistep, hierarchical process, we validated this algorithm in an EHR data set with self-reported gender identity., Results: Within an EHR data set of 52 746 adults with self-reported gender identity (gold standard) a previously unvalidated algorithm to identify TGD persons via TGD-related diagnosis and procedure codes, and gender-affirming hormone therapy prescription data had a sensitivity of 87.3% (95% confidence interval [CI] 86.4-88.2), specificity of 98.7% (95% CI 98.6-98.8), positive predictive value (PPV) of 88.7% (95% CI 87.9-89.4), and negative predictive value (NPV) of 98.5% (95% CI 98.4-98.6). The area under the curve (AUC) was 0.930 (95% CI 0.925-0.935). Steps to further categorize patients as presumably TGD men versus women based on prescription data performed well: sensitivity of 97.6%, specificity of 92.7%, PPV of 93.2%, and NPV of 97.4%. The AUC was 0.95 (95% CI 0.94-0.96)., Conclusions: In the absence of self-reported gender identity data, an algorithm to identify TGD patients in administrative data using TGD-related diagnosis and procedure codes, and gender-affirming hormone prescriptions performs well., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Transgender and gender diverse (TGD) individuals experience more severe psychological distress and may be at higher risk for suicide compared to cisgender individuals. The existing literature largely consists of small-sample studies that do not assess subgroup differences., Objective: To examine rates of self-reported suicidal ideation among four TGD groups compared to cisgender individuals., Design: Data were extracted from the electronic health records of patients receiving primary care at a community health center specializing in sexual and gender minority health. A logistic regression was used to examine the relationship between sociodemographic variables and the presence of current suicidal ideation., Participants: 29,988 patients receiving care at a community health center in Northeastern US between 2015 and 2018., Main Measures: Demographic questionnaire, 9-item Patient Health Questionnaire KEY RESULTS: Younger age, sexual and gender minority identity, and public/grants-based insurance were associated with significantly higher odds of suicidal ideation. Relative to cisgender men, transgender men (OR=2.08; 95% CI=1.29-3.36; p=.003), transgender women (OR=3.08; 95% CI=2.05-4.63; p<.001), nonbinary (NB) individuals assigned male at birth (AMAB; OR=3.55; 95% CI=1.86-6.77; p<001), and NB individuals assigned female at birth (AFAB; OR=2.49; 95% CI=1.52-4.07; p<001) all endorsed significantly higher odds of current suicidal ideation, controlling for age, race, ethnicity, sexual orientation, and insurance status. Larger proportions of transgender women (23.6%) and NB AMAB individuals (26.7%) reported suicidal ideation not only compared to cisgender men (6.1%) and women (6.6%), but also compared to transgender men (17.4%; χ 2 [5, n=25,959]=906.454, p<0.001)., Conclusions: TGD patients were at significantly increased risk of suicidal ideation, even after accounting for age, race, ethnicity, sexual orientation, and insurance status. Findings suggest distinct risk profiles by assigned sex at birth. Consistent assessment of and intervention for suicidal ideation should be prioritized in settings that serve TGD patients., (© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Introduction: The Watchman FLX is a novel device for transcatheter left atrial appendage occlusion (LAAO) specifically designed to improve procedural performance in more complex anatomies with a better safety profile. Recently, small prospective non-randomized studies have shown good procedural success and safety compared with previous experiences. Results from large multicenter registries are needed to confirm the safety and efficacy of the Watchman FLX device in a real-world setting., Methods: Italian FLX registry is a retrospective, non-randomized, multicentric study across 25 investigational centers in Italy including consecutive patients undergoing LAAO with the Watchman FLX between March 2019 and September 2021 (N = 772). The primary efficacy outcome was the technical success of the LAAO procedure (peri-device flow ≤ 5 mm) as assessed by intra-procedural imaging. The peri-procedural safety outcome was defined as the occurrence of one of the following events within 7 days after the procedure or by hospital discharge: death, stroke, transient ischemic attack, major extracranial bleeding (BARC type 3 or 5), pericardial effusion with tamponade or device embolization., Results: A total of 772 patients were enrolled. The mean age was 76 ± 8 with a mean CHA2DS2-VASc score of 4.1 ± 1.4 and a mean HAS-BLED score of 3.7 ± 1.1. Technical success was achieved in 772 (100%) patients with the first device implanted in 760 (98.4%) patients. A peri-procedural safety outcome event occurred in 21 patients (2.7%) with major extracranial bleeding being the most common (1.7%). No device embolization occurred. At discharge 459 patients (59.4%) were treated with dual antiplatelet therapy (DAPT)., Conclusions: The Italian FLX registry represents the largest multicenter retrospective real-world study reporting periprocedural outcome of LAAO with the Watchman FLX device, resulting in a procedural success rate of 100% and a low incidence of peri-procedural major adverse events (2.7%)., Competing Interests: PM, SB and CT have been consultant for Abbott and Boston Scientific Inc. PP is proctor for Cardia and Boston Scientific Inc. CT has received lecture and proctor fees from and for Boston Scientific Inc and Abbott Medical. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Berti, De Caterina, Grasso, Casu, Giacchi, Pagnotta, Maremmani, Mazzone, Limite, Tomassini, Greco, Romeo, Caramanno, Fassini, Geraci, Chiarito, Tondo, Tamburino and Contarini.)

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.

Aim: Patients with severe mitral regurgitation (MR) and acute heart failure (HF) have refractory symptoms without adequate response to medical therapy. The objective of this analysis was to assess the impact of the MitraClip device in acutely ill HF patients, characterized by NYHA Class IV at baseline, in a real-world, contemporary setting., Methods and Results: EXPAND was a prospective, multicenter, international study enrolling patients with MR who consented to receive the MitraClip System at 57 sites globally. The study outcomes included acute procedural success (APS), quality of life, heart failure hospitalizations (HFH), and all-cause mortality. The study population comprised 1,041 patients, with 118 patients having baseline NYHA Class IV, and 922 having baseline NYHA Class I/II/III. NYHA Class IV patients had a significantly higher rate of baseline co-morbidities and secondary MR aetiology compared with NYHA Class I/II/III patients. APS was achieved in 92.4% of NYHA Class IV patients and significant improvement in MR grade to ≤Mild (1+) in 90.7% of subjects at 30 days and 92.9% at 1 year was observed. 1-year-mortality was higher in the NYHA Class IV subjects compared with the NYHA Class I/II/III subjects (29.2% vs. 17.7%, P < 0.01). Significant improvement in functional capacity assessed by NYHA Functional Class and Quality of Life assessed through KCCQ score was observed. At 1 year, 72.6% of NYHA Class IV subjects improved to NYHA Class I/II and ΔKCCQ was 31.2 (24.1, 38.3) compared with baseline., Conclusion: In the prospective, real-world EXPAND study, MitraClip in patients with severe MR and NYHA Class IV was found to be safe and effective in treating MR, and significantly improving QoL and long-term clinical outcomes., (© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Ripened cheeses, such as pecorino, are susceptible to mites and molds contamination on the crust area that must be removed before the product can be marketed. This study investigates the effectiveness of gaseous ozone treatment in the control of microbiological and mite growth without negatively affecting product quality., Results: Cheese samples were treated with gaseous ozone at 200 and 300 ppb for 8 h per day (overnight) for 150 days in storage rooms under controlled conditions (12 °C and 85% relative humidity). The results showed that ozone at 200 ppb limits the growth of mites starting from 25 days of storage and significantly reduced bacteria, molds, and yeasts counts starting from 75 days of storage. Concerning the physicochemical and qualitative parameters evaluated during ripening (weight loss, moisture content, dry weight, ash, fat, protein, total nitrogen, color, non-destructive firmness), no significant differences were shown between the control samples and ozone treatment at 200 ppb. Sensory analysis (consumer test) also showed no specific defects with the ozone-treated samples. It was observed that the ozone treatment at 300 ppb had limited microbiological growth and no alteration of sensory aspects but did not have the same positive impact on some aspects of overall quality, compared with ozone treatment at 200 ppb., Conclusion: The use of gaseous ozone treatments during ripening of pecorino cheese can potentially offer an excellent solution for the control of mite growth, while preserving the quality and sensory characteristics of the product. For this reason, this technique could be very useful for commercial purposes. © 2022 Society of Chemical Industry., (© 2022 Society of Chemical Industry.)

Background: The third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system was introduced to assist in leaflet grasping with the longer clip arms of MitraClip XTR and to improve ease of use with the modified delivery catheter., Objectives: The EXPAND study evaluated contemporary real-world outcomes in subjects with mitral regurgitation (MR) treated with the third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system., Methods: EXPAND is a prospective, multicenter, international, single-arm study that enrolled patients with primary MR and secondary MR at 57 centers. Follow-up was conducted through 12 months. Echocardiograms were analyzed by an echocardiographic core laboratories. Study outcomes included: MR severity, functional capacity measured by New York Heart Association functional class, quality of life measured by Kansas City Cardiomyopathy Questionnaire, heart failure hospitalizations, all-cause mortality., Results: 1,041 patients were enrolled from April 2018 through March 2019, of which 50.5% had primary or mixed etiology. Implant success was 98.9%; 1.5 ± 0.6 clips were implanted per subject. Significant MR reduction from baseline (≥MR 3+: 56.0%) to 30 days (≤MR 1+:88.8%) was maintained through 1 year (MR ≤1+: 89.2%). A total of 84.5% and 93.0% of subjects in primary MR and secondary MR, respectively, had ≤1+ MR at 1 year. Significant improvements were observed in clinical outcomes (New York Heart Association functional class I/II in 80.3%, +21.6 improvement in Kansas City Cardiomyopathy Questionnaire score) at 1 year. All-cause mortality and heart failure hospitalizations at 1 year were 14.9% and 18.9%, respectively, which was significantly lower than previous studies., Conclusions: The study demonstrates treatment with the third-generation system resulted in substantial reduction of MR in a contemporary real-world practice, compared with the results of earlier EVEREST and COAPT trials.(The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices [EXPAND]; NCT03502811)., Competing Interests: Funding Support and Author Disclosures The EXPAND study was funded and sponsored by Abbott. Dr Kar has received grants and institutional research support from Abbott, Boston Scientific, and Edwards Lifesciences; has received consulting fees/honoraria from Abbott, Boston Scientific, W.L. Gore, and Medtronic; served as a steering committee member of the TRILUMINATE study (Abbott); and served as national principal investigator of the EXPAND study and the REPAIR MR study for Abbott. Dr von Bardeleben has served in unpaid trial activities for Abbott, Edwards Lifesciences, and University of Göttingen (IIT); and has served on an advisory or Speakers Bureau for Abbott Cardiovascular, Bioventrix, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and Neochord. Prof Rottbauer has received consulting fees/speaker honoraria from Abbott, Bayer Healthcare, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, and Medtronic; and is a member of the steering committee of the EXPAND G4 study for Abbott and Encourage AF study for Daiichi Sankyo. Dr Mahoney has served as proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; has been a consultant for Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific; and has received research support from Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific. Dr Price has received consulting fees from AstraZeneca, Chiesi USA, Medtronic, Boston Scientific, Abbott, and WL Gore outside of the submitted work. Dr Grasso has served as a proctor for Abbott and Boston Scientific; and has received speaker fees from Edwards Lifesciences. Dr Williams has received research funding from Abbott, Medtronic, BSC, and Edwards Lifesciences. Prof Lurz has served as a consultant and received institutional fees and research grants from Abbott, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr Ahmed has served as a proctor and advisor, and received consulting fees and research grants from Abbott, Edwards Lifesciences, and Medtronic. Prof Hausleiter has received research support from Abbott Vascular and Edwards Lifesciences. Dr Chehab has received study grants and consulting fees from Abbott, Edwards Lifesciences, and Biotronics. Dr Zamorano has received speaker honoraria from Pfizer, Amgen, and Daiichi Sankyo; and research grants from Abbott and Edwards Lifesciences. Dr Asch’s work as director of an academic core laboratory is paid by institutional research grants (MedStar Health) from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Neovasc, Ancora Heart, Livanova, MVRx, InnovHeart, Polares Medical, and Aria CV. Prof Maisano has received grant and/or institutional research support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, and Terumo; and has received consulting fees, personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, and Cardiovalve; has received royalty income/IP rights from Edwards Lifesciences; and is a shareholder (including share options) of Cardiogard, Magenta, SwissVortex, Transseptalsolutions, Occlufit, 4Tech, and Perifect., (Copyright © 2023. Published by Elsevier Inc.)

Aims: Mitral valve transcatheter edge-to-edge repair is a guideline-recommended treatment option for patients with secondary mitral regurgitation (SMR). The purpose of this analysis was to report contemporary real-world outcomes in SMR patients treated with third-generation MitraClip systems., Methods and Results: EXPAND is a prospective, multicentre, international, single-arm study with 1041 patients treated for mitral regurgitation (MR) with MitraClip NTR/XTR, with 30-day and 1-year follow-up. All echocardiograms were analysed by an independent echocardiographic core lab. Study outcomes included procedural outcomes, durability of MR reduction, and major adverse events including all-cause mortality and heart failure hospitalizations (HFH). A subgroup of 413 symptomatic patients (age 74.7 ± 10.1 years, 58% male) with severe SMR were included. MR reduction to MR ≤ 1+ and MR ≤ 2+ was achieved in 93.0% and 98.5% of patients, respectively, which was sustained at 1-year follow-up. All-cause mortality was 17.7% at 1-year- follow-up, and the combined endpoint of all-cause mortality or first HFH occurred in 34% of patients. This combined endpoint was significantly less frequently observed in MR ≤ 1+ patients (Kaplan-Maier estimates: 29.7% vs. 69.6% for MR ≤ 1+ vs. MR  ≥ 2 +; p < 0.0001). New York Heart Association (NYHA) functional class improved significantly from baseline (NYHA ≤ II: 17%) to 1-year follow-up (NYHA ≤ II: 78%) (p < 0.0001). While MR reduction was comparable between NTR-only vs. XTR-only treated patients, less XTR clips were required for achieving MR reduction., Conclusions: Under real-world conditions, optimal sustained MR reduction to MR ≤ 1+ was achieved in a high percentage of patients with third-generation MitraClip, which translated into symptomatic improvement and low event rates. These results appear to be comparable with recent randomized clinical trials., (© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Up to half of real-world patients with secondary mitral regurgitation who underwent transcatheter edge-to-edge repair (TEER) do not meet the highly selective COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) criteria. No randomized trials or standardized and validated tools exist to evaluate the risk: benefit ratio of TEER in this specific population. We sought to derive and externally validate a clinical risk score to predict the risk of death or heart failure (HF) hospitalization for COAPT-ineligible patients who underwent TEER (CITE score). The study population consisted of patients with secondary mitral regurgitation having at least 1 exclusion criterion of the COAPT trial. The derivation cohort included 489 patients from the GIOTTO (GIse registry of Transcatheter treatment of Mitral Valve regurgitaTiOn) registry. Cox proportional hazards regression was used to identify predictors of 2-year death/HF hospitalization and develop a numerical risk score. The predictive performance was assessed in the derivation cohort and validated in 268 patients from the MiZüBr (Milan-Zürich-Brescia) registry. The CITE score (hemodynamic instability, left ventricular impairment, New York Heart Association class III/IV, peripheral artery disease, atrial fibrillation, brain natriuretic peptide, and hemoglobin) showed a c-index for 2-year death or HF hospitalization of 0.70 (95% confidence interval [CI] 0.67 to 0.73) in the derivation cohort, and 0.68 (95% CI 0.64 to 0.73) in the validation cohort. A cutoff of <12 points was selected to identify patients at lower risk of adverse outcomes, hazard ratio of 0.35 (95% CI 0.26 to 0.46). In conclusion, the CITE score is a simple 7-item tool for the prediction of death or HF hospitalization at 2 years after TEER in COAPT-ineligible patients. The score may support clinical decision-making by identifying those patients who, even if excluded from clinical trials, can still benefit from TEER., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: To propose an approach for semantic and functional data harmonization related to sex and gender constructs in electronic health records (EHRs) and other clinical systems for implementors, as outlined in the National Academies of Sciences, Engineering, and Medicine (NASEM) report Measuring Sex, Gender Identity, and Sexual Orientation and the Health Level 7 (HL7) Gender Harmony Project (GHP) product brief "Gender Harmony-Modeling Sex and Gender Representation, Release 1.", Materials and Methods: Authors from both publications contributed to a plan for data harmonization based upon fundamental principles in informatics, including privacy, openness, access, legitimate infringement, least intrusive alternatives, and accountability., Results: We propose construct entities and value sets that best align with both publications to allow the implementation of EHR data elements on gender identity, recorded sex or gender, and sex for clinical use in the United States. We include usability- and interoperability-focused reasoning for each of these decisions, as well as suggestions for cross-tabulation for populations., Discussion and Conclusion: Both publications agree on core approaches to conceptualization and measurement of sex- and gender-related constructs. However, some clarifications could improve our ability to assess gender modality, alignment (or lack thereof) between gender identity and assigned gender at birth, and address both individual-level and population-level health inequities. By bridging the GHP and NASEM recommendations, we provide a path forward for implementation of sex- and gender-related EHR elements. Suggestions for implementation of gender identity, recorded sex or gender, and sex for clinical use are provided, along with semantic and functional justifications., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

The mortality rate of hospitalized COVID-19 patients differed strongly between the first three pandemic waves. Nevertheless, their long-term survival has been poorly assessed. The aim of this study was to compare the clinical characteristics and mortality rates of 825 patients with coronavirus disease 2019 (COVID-19) infection who were hospitalized at the Alessandria hub hospital, in Northern Italy, during the first fifty days of the first three pandemic waves. Each subject was followed in terms of vital status for six months from the date of hospital admission or until deceased. Patients admitted during the three waves differed in age ( p = 0.03), disease severity ( p < 0.0001), Charlson comorbidity index ( p = 0.0002), oxygen therapy ( p = 0.002), and invasive mechanical ventilation ( p < 0.0001). By the end of follow-up, 309 deaths (38.7%) were observed, of which 186 occurred during hub hospitalization (22.5%). Deaths were distributed differently among the waves ( p < 0.0001), resulting in being higher amongst those subjects admitted during the first wave. The COVID-19 infection was reported as the main cause of death and patients with a higher mortality risk were those aged ≥65 years [adjusted HR = 3.40 (95% CI 2.20-5.24)], with a higher disease severity [adjusted HR = 1.87 (95%CI 1.43-2.45)], and those requiring oxygen therapy [adjusted HR = 2.30 (95%CI 1.61-3.30)]. In conclusion, COVID-19 patients admitted to our hub hospital during the second and the third waves had a lower risk of long-term mortality than those admitted during the first. Older age, more severe disease, and the need for oxygen therapy were among the strongest risk factors for poor prognosis.

Purpose: This study was conducted to characterize documentation of sexual orientation and gender identity (SOGI) and provision of screening and preventive services in a diverse sample of community health centers (CHCs). Methods: Twelve CHCs provided data submitted to the Health Resources and Services Administration (HRSA) in 2018 from their Uniform Data System (UDS) reports. Prevalence of SOGI documentation, screenings, and preventive services were calculated. Sociodemographic correlates of documentation were analyzed using Fisher's exact test and Wilcoxon rank sum/Mann-Whitney U test. Results: Patient data recording sexual orientation (SO) were missing in 2%-93% of UDS reports from the 12 CHCs, and gender identity (GI) data were missing from 0% to 96% of UDS reports. CHCs were most likely to report body mass index and tobacco screening and least likely to report hepatitis A or B vaccination, independent of SO or GI. Transgender females were less likely to have mammography documented than cisgender females. Transgender males were less likely to have anal Pap tests, be vaccinated for hepatitis B, or be referred for risky alcohol use compared to cisgender males. Patients who identified as "another gender" were less likely to be referred for risky alcohol use, undergo mammography or anal Pap testing, or receive hepatitis A vaccination than cisgender people. Individuals who did not disclose their GI were less likely to be vaccinated for hepatitis A or B than cisgender people. Conclusion: SOGI status was often not documented by a diverse array of CHCs. However, when SOGI status was documented, we saw evidence of disparities in preventive interventions and referrals, particularly for transgender patients. Clinical trial registration number: NCT03554785.

Despite being highly effective in reducing residual mitral regurgitation and improving outcomes, mitral valve transcatheter edge-to-edge repair (MV-TEER) may be associated with high postprocedural residual mitral gradient (rMG). Conflicting results have been reported regarding the relation between rMG and adverse events. This study aimed to evaluate the predictors and the impact of elevated rMG after MV-TEER on clinical events in patients with functional mitral regurgitation (FMR) at 2 years follow-up. We selected a cohort of 864 patients with FMR who were treated with MV-TEER enrolled in the multicentre Italian Society of Interventional Cardiology (GISE) registry of transcatheter treatment of mitral valve regurgitation (GIOTTO). Patients were stratified into tertiles according to rMG. The primary clinical end point was a composite of all-cause death and hospitalization because of heart failure at 2-year follow-up. Overall, 269 patients (31.5%) with an rMG &lt;3 mm Hg, 259 (30.3%) with an rMG ≥3/&lt;4 mm Hg, and 326 (38.2%) with an rMG ≥4 mm Hg were considered. At multivariate logistic regression, ischemic FMR etiology, baseline MG, and the number of implanted clips were independent predictors of an rMG ≥4 mm Hg. Clinical follow-up was available in 570 patients (63.2%). Patients with an rMG ≥4 mm Hg experienced higher rates of the composite end point than patients of the other tertiles (51.1%, vs 42.3% vs 40.8% log-rank test: p = 0.033). In multivariate Cox's regression, both rMG ≥4 mm Hg (hazard ratio 1.54, 95% confidence interval 1.14 to 2.08) and residual mitral regurgitation ≥2+ (hazard ratio 1.36, 95% confidence interval 1.01 to 1.83) were independent predictors of adverse events at 2-year follow-up. In conclusion, we demonstrated that real-world patients who underwent MV-TEER who show an rMG ≥4 mm Hg are at higher risk of death or hospitalization because of heart failure during a 2-year follow-up. Further studies will be needed to confirm our results., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Aim: Randomized controlled trials comparing the use of the MitraClip device in addition to guideline directed medical therapy (GDMT) to GDMT alone in patients with secondary mitral regurgitation (MR) have shown conflicting results. However, if these differences could be due to the underlying MR aetiology is still unknown. Therefore, we aimed to evaluate if the effects of percutaneous edge-to-edge repair with MitraClip implantation could differ in patients with ischaemic (I-MR) and non-ischaemic mitral regurgitation (NI-MR)., Methods and Results: PubMed, Embase, BioMed Central, and the Cochrane Central Register of Controlled Trials were searched for all studies including patients with secondary MR treated with the MitraClip device. Data were pooled using a random-effects model. Primary endpoint was the composite of all-cause death and heart failure-related hospitalization. Secondary endpoints were the single components of the primary endpoint, New York Heart Association functional Classes III and IV, and mitral valve re-intervention. Seven studies enrolling 2501 patients were included. Patients with I-MR compared with patients with NI-MR had a similar risk of the primary endpoint (odds ratio: 1.17; 95% confidence interval: 0.93 to 1.46; I 2 : 0%). The risk of all-cause death was increased in patients with I-MR (odds ratio: 1.31; 95% confidence interval: 1.07 to 1.62; I 2 : 0%), while no differences were observed between the two groups in terms of the other secondary endpoints., Conclusions: The risk of mortality after MitraClip implantation is lower in patients with NI-MR than in those with I-MR. No absolute differences in the risk of heart failure related hospitalization were observed between groups., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Testicular germ cell tumors (TGCT), histologically classified as seminomas and nonseminomas, are believed to arise from primordial gonocytes, with the maturation process blocked when they are subjected to DNA methylation reprogramming. SNPs in DNA methylation machinery and folate-dependent one-carbon metabolism genes have been postulated to influence the proper establishment of DNA methylation., Methods: In this pathway-focused investigation, we evaluated the association between 273 selected tag SNPs from 28 DNA methylation-related genes and TGCT risk. We carried out association analysis at individual SNP and gene-based level using summary statistics from the Genome Wide Association Study meta-analysis recently conducted by the international Testicular Cancer Consortium on 10,156 TGCT cases and 179,683 controls., Results: In individual SNP analyses, seven SNPs, four mapping within MTHFR, were associated with TGCT risk after correction for multiple testing (q ≤ 0.05). Queries of public databases showed that three of these SNPs were associated with MTHFR changes in enzymatic activity (rs1801133) or expression level in testis tissue (rs12121543, rs1476413). Gene-based analyses revealed MTHFR (q = 8.4 × 10-4), methyl-CpG-binding protein 2 (MECP2; q = 2 × 10-3), and ZBTB4 (q = 0.03) as the top TGCT-associated genes. Stratifying by tumor histology, four MTHFR SNPs were associated with seminoma. In gene-based analysis MTHFR was associated with risk of seminoma (q = 2.8 × 10-4), but not with nonseminomatous tumors (q = 0.22)., Conclusions: Genetic variants within MTHFR, potentially having an impact on the DNA methylation pattern, are associated with TGCT risk., Impact: This finding suggests that TGCT pathogenesis could be associated with the folate cycle status, and this relation could be partly due to hereditary factors., (©2022 American Association for Cancer Research.)

Background: Mitral-valve transcatheter edge-to-edge repair (MV-TEER) is recommended in patients with severe functional mitral regurgitation (FMR) and in those with degenerative mitral regurgitation (DMR) not eligible to traditional surgery. Patients with a history of previous cardiac surgery are considered at high risk for surgical reintervention, but data are lacking regarding procedural and clinical outcomes., Objective: aim of this study was to assess the efficacy and clinical results of MV-TEER in patients with previous cardiac surgery enrolled in the "multicentre Italian Society of Interventional Cardiology registry of transcatheter treatment of mitral valve regurgitation" (GIOTTO)., Methods: Patients with previous coronary artery bypass grafting (CABG), surgical aortic valve replacement (AVR), or mitral valve repair (MVR) were included. Those with multiple or combined previous cardiac surgeries were excluded. Clinical follow-up was performed at 30 days, 1 year, and 2 years. The primary endpoint was a composite of death or rehospitalization at 1- and 2-year follow-ups., Results: A total of 330 patients enrolled in the GIOTTO registry were considered (CABG 77.9%, AVR 14.2%, and MVR 7.9%). Most patients showed FMR (66.9%), moderate reduction of left ventricular (LV) ejection fraction, and signs of LV dilation. Procedural and device successes were 94.8% and 97%. At 1 and 2 years, the composite endpoint occurred are 29.1% and 52.4%, respectively. The composite outcome rates were similar across the three subgroups of previous cardiac surgery (p = 0.928) and between the FMR and DMR subgroups (p = 0.850) at 2 years. In a multivariate analysis, residual mitral regurgitation (rMR) ≥2+ was the main predictor of adverse events at 1 year (hazard ratio: 1.54 [95% confidence interval, CI: 1.00-2.38]; p = 0.050). This association was confirmed at 2 years of Kaplan-Meier analysis (p = 0.001)., Conclusions: MV-TEER is effective in these patients, regardless of the subtype of previous cardiac surgery and the MR etiology. An rMR ≥2+ is independently associated with adverse outcomes at 1-year follow-up., (© 2022 Wiley Periodicals LLC.)

Introduction: The Watchman-FLX left atrial appendage closure (LAAC) device presents innovative features: higher conformability, reduced length, closed distal "flex-ball" during deployment, and flattened surface. We report our real-world experience with the Watchman-FLX device in two centers with consolidated LAAC expertise., Methods: We enrolled 200 consecutive Watchman-FLX patients (2019-2021) in a nonrandomized double-center registry; procedural data and follow-up for midterm clinical outcomes were collected. A control group of 100 patients treated with first-generation Watchman (2.5) was included., Results: According to mean CHAD 2 DS 2 -VASc (5 ± 1.40) and HAS-BLED (3.8 ± 1.01) scores, the population included in this study was at high risk: 29% had a previous stroke and 56.5% a bleeding event. Main LAAC indications were symptomatic hemorrhage (39.5%), need for triple antithrombotic therapy (39%), gastrointestinal bleeding (32%), and oral anticoagulation intolerance (18%). Transesophageal echocardiography guidance was followed in 93% of cases (48% in general anesthesia and 45% under conscious sedation). Repositioning an FLX device was required in 20% of cases and no complication occurred. In 96% of patients, the first selected device was delivered, while in 4% a device size change was required after the first choice (7% with Watchman 2.5). Peridevice leaks (<5 mm) were found postimplant in two cases (1%). Overall, the procedural success rate was 99.5%. One patient's procedure was unsuccessful (0.5%), due to left atrial appendage (LAA) anatomy; differently, the mean failure rate with Watchman 2.5 was 2%. No device embolization was reported. Complications (8.5%) were mainly related to the access site (3%); major bleedings (1%), and in-hospital death (0.5%) rarely occurred. After a follow-up of 272 ± 173 days, 2.3% of cases experienced a non-device-related stroke and 0.6% fatal bleeding., Conclusion: Our registry showed a high procedural success rate of the Watchman-FLX in a high-risk population. According to our experience, the main advantages include easy implanting and repositioning, absence of embolization, good LAA sealing, and low rate of complications in the follow-up period., (© 2022 Wiley Periodicals LLC.)

Background: Data on outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves (BEVs) or self-expandable valves (SEVs) as well as the impact of center valve preference on these outcomes are limited., Objectives: The aim of this study was to compare outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference., Methods: In a multicenter registry (n = 17), 13 centers exhibited valve preference (66.6%-90% of volume) and were included. Outcomes were compared between BEVs and SEVs stratified by center valve preference., Results: In total, 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs) were included. The mean age was 81 years, and the mean Society of Thoracic Surgeons score was 5.2. Baseline characteristics were similar between BEVs and SEVs. Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [P < 0.001] and 12.7% vs 10.0% [P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [P < 0.001] and 2.2% vs 1.4% [P = 0.162]; HR: 2.08; P for interaction < 0.01). Aortic regurgitation greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [P < 0.001] and 3.4% vs 3.7% [P = 0.504], respectively). Two-year mortality was higher with SEVs at BEV-dominant centers but not at SEV-dominant centers (21.9% vs 16.9% [P = 0.021] and 16.8% vs 16.5% [P = 0.642], respectively; HR: 1.20; P for interaction = 0.032)., Conclusions: Periprocedural outcomes, aortic regurgitation greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers. Outcomes are similar regardless of valve type at SEV-dominant centers. The present results stress the need to account for this factor when comparing BEV and SEV outcomes. (The Aortic+Mitral Transcatheter [AMTRAC] Valve Registry; NCT04031274)., Competing Interests: Funding Support and Author Disclosures Dr Van Miegham has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi-Sankyo; and has received advisory fees from Abbott, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi-Sankyo. Dr Barbanti has received consulting fees from Edwards Lifesciences. Dr Grasso is a proctor for Abbott Vascular. Dr De Backer has received research grants and consulting fees from Abbott and Boston Scientific. Dr Andreas is a proctor for Abbott and Edwards Lifesciences; and has received advisory board fees from Medtronic. Dr Estévez-Loureiro is a consultant for Abbott Vascular and Boston Scientific. Dr Nombela-Franco has received consulting fees from Edwards Lifesciences; and is a proctor for Abbott. Dr Søndergaard has received consulting fees and/or institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. Dr Amat-Santos is a proctor for Boston Scientific. Dr Finkelstein is a proctor for Edwards Lifesciences and Medtronic; and has received consulting fees from Edwards Lifesciences and Medtronic. 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. Published by Elsevier Inc. All rights reserved.)

The systematic documentation of sexual orientation and gender identity data in electronic health records can improve patient-centered care and help to identify and address health disparities affecting sexual and gender minority populations. Although there are existing guidelines for sexual orientation and gender identity data among adult patients, there are not yet standard recommendations for pediatric patients. In this article, we discuss methods that pediatric primary care organizations can use to collect and document sexual orientation and gender identity information with children and adolescents in electronic health records. These recommendations take into consideration children's developmental stages, the role of caregivers, and the need to protect the privacy of this information. We also focus on the current limitations of electronic health records in capturing the nuances of sexual and gender minority identities and make suggestions for addressing these limitations., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Inflammation has been hypothesized to play a role in the development and progression of breast cancer and might differently impact breast cancer risk among pre and postmenopausal women. We performed a nested case-control study to examine whether pre-diagnostic circulating concentrations of adiponectin, leptin, c-reactive protein (CRP), tumour necrosis factor-α, interferon-γ and 6 interleukins were associated with breast cancer risk, overall and by menopausal status., Methods: Pre-diagnostic levels of inflammatory biomarkers were measured in plasma from 1558 case-control pairs from the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. We used conditional logistic regression to estimate the odds ratios (ORs) of breast cancer at blood collection, per one standard deviation increase in biomarker concentration., Results: Cases were diagnosed at a mean age of 61.4 years on average 8.6 years after blood collection. No statistically significant association was observed between inflammatory markers and breast cancer risk overall. In premenopausal women, borderline significant inverse associations were observed for leptin, leptin-to-adiponectin ratio and CRP [OR= 0.89 (0.77-1.03), OR= 0.88 (0.76-1.01) and OR= 0.87 (0.75-1.01), respectively] while positive associations were observed among postmenopausal women [OR= 1.16 (1.05-1.29), OR= 1.11 (1.01-1.23), OR= 1.10 (0.99-1.22), respectively]. Adjustment for BMI strengthened the estimates in premenopausal women [leptin: OR = 0.83 (0.68-1.00), leptin-to-adiponectin ratio: OR = 0.80 (0.66-0.97), CRP: OR = 0.85 (0.72-1.00)] but attenuated the estimates in postmenopausal women [leptin: OR = 1.09 (0.96-1.24), leptin-to-adiponectin ratio: OR = 1.02 (0.89-1.16), CRP: OR = 1.04 (0.92-1.16)]., Conclusions: Associations between CRP, leptin and leptin-to-adiponectin ratio with breast cancer risk may represent the dual effect of obesity by menopausal status although this deserves further investigation., (© 2022. The Author(s).)

Purpose: This article characterizes a telehealth program implemented during the COVID-19 pandemic for transgender and gender diverse (TGD) patients at Fenway Health, a federally qualified health center in Boston, Massachusetts, specializing in gender and sexual minority health care. Telehealth is well positioned to meet TGD patients' health needs by allowing them to conveniently and safely engage in care., Methods: The COVID-19 pandemic has presented the opportunity to reimagine the way that Fenway Health provides care, by pivoting almost completely to a virtual model in response to this public health emergency. From March through August 2020, TGD patients ( n =3189) from 24 U.S. states utilized our telehealth medical and behavioral health (BH) services., Results: Fenway Health cared for close to as many unique TGD patients during this 6-month period via telehealth as it did via in-person services during calendar year 2019 (3794 medical patients in 2019 vs. 3033 in March through August 2020 [95%]; 946 BH patients in 2019 vs. 911 in March through August 2020 [96%]). TGD patients who utilized telehealth had a similar demographic profile as those who used in-person services., Conclusion: Fenway Health quickly pivoted to telehealth during the COVID-19 pandemic enabling gender-affirming care for TGD communities. By increasing access to clinicians trained in gender-affirming care, telehealth helps ensure that TGD patients regardless of geographic location can access crucial health services. Given the dearth of gender-affirming health care services across the United States, permanently removing state licensure requirements and payment parity for telehealth could ensure access to more gender-responsive care across state lines., Competing Interests: No competing financial interests exist., (Copyright 2022, Mary Ann Liebert, Inc., publishers.)

Background: Procedural success after transcatheter edge-to-edge mitral valve repair (TEER) is defined as a reduction of mitral regurgitation (MR) degree to

Background: Although Moral Distress (MD) is a matter of concern within the Pediatric Intensive Care Unit (PICU), there is no validated Italian instrument for measuring the phenomenon in nurses and physicians who care for pediatric patients in Intensive Care. The authors of the Italian Moral Distress Scale-Revised (Italian MDS-R), validated for the adult setting, in 2017, invited further research to evaluate the generalizability of the scale to clinicians working in other fields. Our study aims to reduce this knowledge gap by developing and validating the pediatric version of the Italian MDS-R., Methods: We evaluated the new instrument for construct validity, then we administered it in a multicenter, web-based survey that involved healthcare providers of three PICUs and three adult ICUs admitting children in northern, central, and southern Italy. Finally, we tested it for internal consistency, confirmatory factorial validity, convergent validity, and differences between groups analysis., Results: The 14-item, three-factor model best fit the data. The scale showed good reliability (a = 0.87). Still, it did not correlate with the Emotional Exhaustion and Depersonalization sub-scales of the Maslach Burnout Inventory (MBI) or with the 2-item Connor-Davidson Resilience Scale (CD-RISC 2) or the Satisfaction with Life Scale (SWLS). A mild correlation was found between the Italian Pediatric MDS-R score and intention to resign from the job. No correlation was found between MD and years of experience. Females, nurses, and clinicians who cared for COVID-19 patients had a higher MD score., Conclusions: The Italian Pediatric MDS-R is a valid and reliable instrument for measuring MD among Italian health workers who care for critically ill children. Further research would be helpful in better investigating its applicability to the heterogeneous scenario of Italian Pediatric Critical Care Medicine.

Background: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing., Aims: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old., Methods: All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups., Results: Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715)., Conclusions: Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. ((ClinicalTrials.gov: NCT04031274).

Background: Risk stratification for transcatheter edge-to-edge mitral valve repair (TEER) is paramount in the decision-making process for treating severe mitral regurgitation (MR)., Objectives: This study sought to create and validate a user-friendly score (MitraScore) to predict the risk of mortality in patients undergoing TEER., Methods: The derivation cohort was based on a multicentric international registry that included 1,119 patients referred for TEER between 2012 and 2020. Score discrimination was assessed using Harrell's c-statistic, and the calibration was evaluated with the Gronnesby and Borgan goodness-of-fit test. An external validation was carried out in 725 patients from the GIOTTO registry., Results: After multivariate analysis, we identified 8 independent predictors of mortality during the follow-up (2.1 ± 1.8 years): age ≥75 years, anemia, glomerular filtrate rate <60 mL/min/1.73 m 2 , left ventricular ejection fraction <40%, peripheral artery disease, chronic obstructive pulmonary disease, high diuretic dose, and no therapy with renin-angiotensin system inhibitors. The MitraScore was derived by assigning 1 point to each independent predictor. The c-statistic was 0.70. Per each point of the MitraScore, the relative risk of mortality increased by 55% (HR: 1.55; 95% CI: 1.44-1.67; P < 0.001). The discrimination and calibration for mortality prediction was better than those of EuroSCORE II (c-statistic 0.61) or Society of Thoracic Surgeons score (c-statistic 0.57). The MitraScore maintained adequate performance in the validation cohort (c-statistic 0.66). The score was also predictive for heart failure rehospitalization and was correlated with the probability of clinical improvement., Conclusions: The MitraScore is a simple prediction algorithm for the prediction of follow-up mortality in patients treated with TEER., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: A-FMR is considered a specific sub-type of secondary MR in patients with atrial fibrillation (AF) and preserved left ventricle ejection fraction (LVEF). Aim of the study was to investigate the acute and mid-term outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) with the MitraClip in atrial functional mitral regurgitation (A-FMR)., Methods: The study included patients with A-FMR and concomitant AF who underwent to the MitraClip at 7 Italian Centers. Aim of the study was to assess the safety, efficacy and mid-term cardiovascular outcomes., Results: After reviewing 1153 patients with FMR treated with TMVr from 2009 to 2021, 87 patients (median age 81 years, 61% female) with A-FMR were identified. Technical success was achieved in 97%, 30-day device success in 83% and 30-day procedural success in 80%. All-cause death at 30-day was 5%. Estimated two-year freedom from all-cause death and cardiac death was 60% and 77%, respectively, whereas freedom from all-cause death/heart failure hospitalization was 55%. Residual MR ≤ 2+ was encountered in 89% (n = 47/53) and improvement in NYHA class I/II in 79% (n = 48/61). Post-procedural MR ≥ 2+ (HR 5.400, CI 1.371-21.268) and inter-commissural annular diameter ≥ 35 mm (HR 4.159, CI 1.057-16.363) were independent predictors of all-cause death/heart failure hospitalization during the follow-up. Positive reverse remodeling of left atrium and mitral annular dimensions occurred after TMVr during the follow-up., Conclusions: MitraClip resulted to be a safe and effective option to treat A-FMR in elderly patients., (Copyright © 2021 Elsevier B.V. All rights reserved.)

The application of anti-hail nets is a practice that has been employed for a long time on different fruit and vegetable cultivations and in different fields of the world. In this work, we checked the effects of shading with white anti-hail nets on the post-harvest quality of "Soreli" kiwifruit collected at two different °Brix (7-8 and 8-9) from vineyards of two different ages (8 and 9 years) and stored at 1 °C for 90 days. It was observed that during the storage, the firmness and color parameters (L*, a*, b*, and Chroma) and the SSC content were generally higher in kiwifruit samples harvested in open field than in those under the nets. Regarding the bioactive compounds, the open field samples showed higher values in total flavonoids content during storage, and the content of carotenoids and chlorophylls in fruits grown in open fields was higher from 30-45 days up to the end of the storage. In contrast, the polyphenols and ascorbic acid values of fruits in open fields and under the nets showed a similar evolution of the values from 45 to 60 days. In general, the early and late harvest time based on the °Brix values and the different ages of the kiwifruit plants under the nets did not affect the quality parameters.

Tobacco use remains the leading cause of preventable disease and death in the US. The number of tobacco products has grown over the past decade. E-cigarette use has increased rapidly in recent years, but patterns and correlates of use have not been thoroughly assessed. We examined relationships among demographic factors, e-cigarette and conventional cigarette use in a large sample (N = 12,409) of adult patients at a community health center in the Northeastern US. Overall, 13% (N = 1675) of the sample reported ever using e-cigarettes. In logistic regression models, ever having used e-cigarettes was associated with younger age (ages 18-25; OR = 3.5, p < 0.001). Being transgender (OR = 1.8, p < 0.001), bisexual (OR = 1.5, p < 0.001), un-partnered (OR = 1.5, p < 0.001), having a lower income (OR = 1.6, p < 0.001) or a high BMI (OR = 1.4, p = 0.009) were associated with increased odds of use, whereas being a woman (OR = 0.7, p < 0.001) or Black/African American (OR = 0.7, p = 0.007) were associated with lower odds of use. Of the participants who reported e-cigarette use, a majority also endorsed current or former use of conventional cigarettes. Individuals who formerly used conventional cigarettes were nearly three times more likely to report daily e-cigarette use than current users. Among primary care patients at a community health center, e-cigarette use was reported by a sizeable portion of the sample. Overall, odds of use were higher in certain patient populations, and individuals who formally used cigarettes were more likely to report e-cigarette use than individuals who currently smoke, suggesting that e-cigarettes may be functioning as a cessation aid or a strategy to reduce conventional cigarette use., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: Accurate representation of clinical sex and gender identity in interoperable clinical systems is a major challenge for organizations intent on improving outcomes for sex- and gender-marginalized people. Improved data collection has been hindered by the historical approach that presumed a single, often binary, datum was sufficient. We describe the Health Level Seven International (HL7) Gender Harmony logical model that proposes an improved approach., Materials and Methods: The proposed solution was developed via an American National Standards Institute (ANSI)-certified collaborative balloted process. As an HL7 Informative Document, it is an HL7 International-balloted consensus on the subject of representing sex and representing gender in clinical systems based on work of the gender harmony project led by the HL7 Vocabulary Work Group., Results: The Gender Harmony Model is a logical model that provides a standardized approach that is both backwards-compatible and an improvement to the meaningful capture of gender identity, recorded sex or recorded gender, a sex for clinical use, the name to use, and pronouns that are affirmative and inclusive of gender-marginalized people., Conclusion: Most clinical systems and current standards in health care do not meaningfully address, nor do they consistently represent, sex and gender diversity, which has impeded interoperability and led to suboptimal health care. The Gender Harmony Project was formed to create more inclusive health information exchange standards to enable a safer, higher-quality, and embracing healthcare experience. The Gender Harmony Model provides the informative guidance for standards developers to implement a more thorough technical design that improves the narrow binary design used in many legacy clinical systems., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Medical Informatics Association.)

Objectives. To examine the relationship between city-level structural stigma pertaining to sexual orientation and gender identity (SOGI) and completeness of patient SOGI data collection at US federally qualified health centers (FQHCs). Methods. We used the Human Rights Campaign's Municipal Equality Index to quantify city-level structural stigma against sexual and gender minority people in 506 US cities across 49 states. We ascertained the completeness of SOGI data collection at FQHCs from the 2018 Uniform Data System, which describes FQHC patient demographics and service utilization. We included FQHCs in cities captured by the structural stigma index in multinomial generalized linear mixed models to examine the relationship between city-level structural stigma and SOGI data completeness. Results. FQHCs in cities with more protective sexual orientation nondiscrimination policies reported more complete patient sexual orientation data (adjusted odds ratio [AOR] = 1.6; 95% confidence interval [CI] = 1.2, 2.1). This association was also found for gender identity nondiscrimination policies and gender identity data collection (AOR = 1.7; 95% CI = 1.3, 2.2). Conclusions. Municipal sexual and gender minority nondiscrimination laws are associated with social and municipal environments that facilitate patient SOGI data collection.( Am J Public Health . 2021;111(11):2059-2063. https://doi.org/10.2105/AJPH.2021.306414).

Objectives: To investigate how the changes of left ventricle ejection fraction (LVEF) between admission and discharge affected the long-term outcome in patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation., Background: An acute impairment of LVEF after surgical repair of mitral regurgitation, known as afterload mismatch, has been associated with increased all-cause mortality. Afterload mismatch after percutaneous edge-to-edge mitral valve repair has been postulated to be a transient phenomenon., Methods: This study is based on a single-center, retrospective, observational registry of patients who underwent percutaneous edge-to-edge mitral valve repair with the MitraClip (Abbot Vascular) system for the treatment of symptomatic, moderate-to-severe mitral regurgitation. We included data on 399 patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation. Expert echocardiographers assessed LVEF before the procedure and at discharge. The patients were divided into three groups according to the difference of periprocedural LVEF measurements: unchanged ( n = 318), improved ( n = 40), and decreased ( n = 41) LVEF., Results: The median follow-up time was 2.0 years. When adjusted for gender, NYHA class and estimated glomerular filtration rate, decreased postprocedural LVEF was associated with an increased risk of death (adjusted HR 2.05, 95% CI 1.26-3.34) and increased postprocedural LVEF with a reduced risk of death (adjusted HR 0.47, 95% CI 0.24-0.91) compared to unchanged LVEF. Conclusion: Among patients who underwent percutaneous edge-to-edge mitral valve repair, decreased postprocedural LVEF was associated with increased mortality, while improved LVEF was associated with lower mortality compared to unchanged LVEF.