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1. Achievement of Meaningful Clinical Outcomes Is Unaffected by Capsulotomy Type During Arthroscopic Treatment of Femoroacetabular Impingement Syndrome: Results From the Multicenter Arthroscopic Study of the Hip (MASH) Study Group.

Author

Parvaresh, Kevin, Rasio, Jonathan P., Martin, RobRoy L., Kivlan, Benjamin R., Carreira, Dominic, Christoforetti, John J., Harris, Joshua D., Matsuda, Dean K., Salvo, John, Wolff, Andrew B., and Nho, Shane J.

Subjects
*FEMORACETABULAR impingement, *RESEARCH, *ACHIEVEMENT, *ARTHROSCOPY, *MULTIPLE regression analysis, *HEALTH outcome assessment, *MEDICAL cooperation, *RETROSPECTIVE studies, *SURGERY, *PATIENTS, *SEX distribution, *T-test (Statistics), *DESCRIPTIVE statistics, *CHI-squared test, *BODY mass index, *DATA analysis software, *LONGITUDINAL method
Abstract

Background: Capsule management has emerged as an important topic in the field of hip arthroscopy. The 2 most popular techniques are interportal capsulotomy and T-type capsulotomy, but few studies have compared outcomes between these 2 techniques. Purpose: To compare 2-year (±2 months) patient-reported outcomes (PROs) between patients who underwent interportal versus T-type capsulotomy during arthroscopic labral repair for femoroacetabular impingement syndrome (FAIS). Study Design: Cohort study; Level of evidence, 3. Methods: A retrospective review of a large multicenter registry of patients undergoing arthroscopic hip preservation surgery for FAIS was performed. Data from 9 surgeons across 9 sites between January 2014 and February 2018 were included in the study. Baseline demographic data, preoperative PROs, and minimum 2-year postoperative PROs including Hip Outcome Score–Activities of Daily Living (HOS-ADL), HOS–Sports Subscale (HOS-SS), modified Harris Hip Score, and International Hip Outcome Tool–12 (iHOT-12) were recorded. Patients were divided into 2 groups based on whether interportal or T-type capsulotomy was performed according to the senior surgeon's preference and training, and all capsulotomies were then routinely repaired. The 2 groups were matched 1:1 by age, sex, and body mass index (BMI). Achievement of minimal clinically important difference (MCID), Patient Acceptable Symptomatic State (PASS), and substantial clinical benefit (SCB) was compared for the HOS-ADL, HOS-SS, and iHOT-12 between the 2 groups. Results: The final analysis included 658 of 1483 eligible patients with a mean ± SD age of 32.6 ± 11.6 years and BMI of 24.0 ± 3.7; of these, 329 patients were treated via interportal capsulotomy, and 329 patients were treated via T-type capsulotomy. Female patients comprised 66.3% of the study population. Capsulotomy type was not a predictor of 2-year postoperative PROs on multivariate linear regression analysis when adjusted for covariates. Chi-square analysis showed no statistical difference in achievement of MCID, PASS, and SCB between the interportal and T-type groups for HOS-ADL (80.3%, 75.8%, 52.7% and 77.1%, 71.7%, 53.6%, respectively; P >.01 for all), HOS-SS (83.6%, 72.5%, 51.5% and 81.7%, 68.4%, 49.2%, respectively; P >.01 for all), and iHOT-12 (87.5%, 72.0%, 50.5% and 80.0%, 64.7%, 45.6%, respectively; P >.01 for all). Conclusion: Arthroscopic management of FAIS resulted in significant clinical improvement that was independent of capsulotomy type when the capsulotomy included repair. [ABSTRACT FROM AUTHOR]

Published
2021
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2. Retinopathy of prematurity and neurodevelopmental outcomes in preterm infants: A systematic review and meta-analysis

Author

Shivashankar Diggikar, Puvaneswari Gurumoorthy, Paula Trif, Diana Mudura, N. Karthik Nagesh, Radu Galis, Anand Vinekar, and Boris W. Kramer

Subjects
BIRTH-WEIGHT INFANTS, cerebral palsy, FACTOR-I, BEVACIZUMAB, INTERNATIONAL CLASSIFICATION, AGE, anti-VEGF, ENDOTHELIAL GROWTH-FACTOR, 2-YEAR OUTCOMES, Pediatrics, Perinatology and Child Health, 28TH WEEK, retinopathy of prematurity, behavioural issues, LASER, ranibizumab, preterm, CHILDREN BORN
Abstract

BackgroundRetinopathy of prematurity (ROP) and abnormal brain development share similar risk factors and mechanisms. There has been contrasting evidence on the association of ROP with adverse neurodevelopmental outcomes.ObjectiveWe analysed the association between ROP at levels of severity and treatment with all neurodevelopmental outcomes until adolescence.Data sourceWe followed PRISMA guidelines and searched Medline and Embase between 1 August 1990 and 31 March 2022.Study selection and participantsRandomised or quasi-randomised clinical trials and observational studies on preterm infants (Data extraction and synthesisWe included studies on ROP and any neurocognitive or neuropsychiatric outcomes.OutcomesThe primary outcomes were as follows: cognitive composite scores evaluated between the ages of 18 and 48 months by the Bayley Scales of Infant and Toddler Development (BSID) or equivalent; neurodevelopmental impairment (NDI; moderate to severe NDI or severe NDI), cerebral palsy, cognitive impairment; and neuropsychiatric or behavioural problems. The secondary outcomes were as follows: motor and language composite scores evaluated between the ages of 18 and 48 months by BSID or equivalent; motor/language impairment; and moderate/severe NDI as defined by the authors.ResultsIn preterm infants, “any ROP” was associated with an increased risk of cognitive impairment or intellectual disability [n = 83,506; odds ratio (OR): 2.56; 95% CI: 1.40–4.69; p = 0.002], cerebral palsy (n = 3,706; OR: 2.26; 95% CI: 1.72–2.96; p n = 81,439; OR: 2.45; 95% CI: 1.03–5.83; p = 0.04), or NDI as defined by authors (n = 1,930; OR: 3.83; 95% CI: 1.61–9.12; p = 0.002). Type 1 or severe ROP increased the risk of cerebral palsy (OR: 2.19; 95% CI: 1.23–3.88; p = 0.07), cognitive impairment or intellectual disability (n = 5,167; OR: 3.56; 95% CI: 2.6–4.86; p n = 5,500; OR: 2.76; 95% CI: 2.11–3.60; p p = 0.04], but not for cerebral palsy (aOR: 1.29; 95% CI: 0.65–2.56; p = 0.45). All outcomes were adjudged with a “very low” certainty of evidence.Conclusion and relevanceInfants with “any ROP” had higher risks of cognitive impairment or intellectual disability, cerebral palsy, and behavioural problems. Anti-VEGF treatment increased the risk of moderate cognitive impairment. These results support the association of ROP and anti-VEGF treatment with adverse neurodevelopmental outcomes.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/, identifier: CRD42022326009.

Published
2023
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3. Retinopathy of prematurity and neurodevelopmental outcomes in preterm infants: A systematic review and meta-analysis

Subjects
BIRTH-WEIGHT INFANTS, cerebral palsy, FACTOR-I, BEVACIZUMAB, INTERNATIONAL CLASSIFICATION, AGE, anti-VEGF, ENDOTHELIAL GROWTH-FACTOR, 2-YEAR OUTCOMES, 28TH WEEK, retinopathy of prematurity, behavioural issues, LASER, ranibizumab, preterm, CHILDREN BORN
Abstract

BackgroundRetinopathy of prematurity (ROP) and abnormal brain development share similar risk factors and mechanisms. There has been contrasting evidence on the association of ROP with adverse neurodevelopmental outcomes.ObjectiveWe analysed the association between ROP at levels of severity and treatment with all neurodevelopmental outcomes until adolescence.Data sourceWe followed PRISMA guidelines and searched Medline and Embase between 1 August 1990 and 31 March 2022.Study selection and participantsRandomised or quasi-randomised clinical trials and observational studies on preterm infants (

Published
2023

4. Aortic valve replacement vs. balloon-expandable and self-expandable transcatheter implantation:A network meta-analysis

Author

D'Ascenzo, Fabrizio, Bruno, Francesco, Baldetti, Luca, De Filippo, Ovidio, Marengo, Giorgio, Breviario, Susanna, Melillo, Francesco, Thyregod, Hans Gustav Horsted, Thiele, Holger, Sondergaard, Lars, Popma, Jeffrey J., Kodali, Susheel, Franchin, Luca, Annaratone, Margherita, Marruncheddu, Laura, Gallone, Guglielmo, Crimi, Gabriele, La Torre, Michele, Rinaldi, Mauro, Omede, Pierluigi, Conrotto, Federico, Salizzoni, Stefano, De Ferrari, Gaetano Maria, D'Ascenzo, Fabrizio, Bruno, Francesco, Baldetti, Luca, De Filippo, Ovidio, Marengo, Giorgio, Breviario, Susanna, Melillo, Francesco, Thyregod, Hans Gustav Horsted, Thiele, Holger, Sondergaard, Lars, Popma, Jeffrey J., Kodali, Susheel, Franchin, Luca, Annaratone, Margherita, Marruncheddu, Laura, Gallone, Guglielmo, Crimi, Gabriele, La Torre, Michele, Rinaldi, Mauro, Omede, Pierluigi, Conrotto, Federico, Salizzoni, Stefano, and De Ferrari, Gaetano Maria

Abstract

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

Published
2021

5. In vivo evaluation of a pro-healing polydopamine coated stent through an in-stent restenosis rat model

Author

Mickaël Maton, Adrien Hertault, Blandine Maurel, Feng Chai, Jonathan Sobocinski, Joel Lyskawa, Nicolas Blanchemain, Patrice Woisel, Médicaments et biomatériaux à libération contrôlée: mécanismes et optimisation - Advanced Drug Delivery Systems - U 1008 (MBLC - ADDS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre hospitalier [Valenciennes, Nord], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Unité Matériaux et Transformations - UMR 8207 (UMET), Centrale Lille-Institut de Chimie du CNRS (INC)-Université de Lille-Centre National de la Recherche Scientifique (CNRS)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Génétique des maladies multifactorielles (GMM), Université de Lille, Droit et Santé-Centre National de la Recherche Scientifique (CNRS), Plateforme Ressources Experimentales, D.H.U.R.E, University of Lille, INTERREG 2 Sea program (IMODE), and French Society of Vascular Surgery (SCV)

Subjects
Neointima, p38 mitogen-activated protein kinases, medicine.medical_treatment, proliferation, polymer, [SDV]Life Sciences [q-bio], Biomedical Engineering, 2-year outcomes, Pharmacology, paclitaxel, Western blot, Restenosis, In vivo, medicine, General Materials Science, cardiovascular diseases, titanium, medicine.diagnostic_test, Chemistry, Stent, bare-metal, equipment and supplies, medicine.disease, In vitro, quinone-rich polydopamine, Endothelial stem cell, immobilization, endothelial-cell, everolimus-eluting stents
Abstract

Drug-eluting stents have demonstrated efficiency in in-stent restenosis (ISR) but induced a risk of late acute thrombosis by delaying strut re-endothelialization. Polydopamine (PDA), a biocompatible polymer inspired from adhesive proteins of mussels, has been reported to promote endothelial cell (EC) proliferation while limiting SMC proliferation in vitro, thus suggesting the pro-healing potential. This study aimed at evaluating in vivo the impact of the pro-healing PDA-coated stent on ISR and on the quality of the strut re-endothelialization in a rat model. PDA-coated stents demonstrated a significant reduction in ISR in vivo compared to bare metal stents (ratio neointima/media = 0.48 (±0.26) versus 0.83 (±0.42), p < 0.001). Western blot analyses identified a trend towards an increased activation of p38 MAPK phosphorylation and its anti-proliferative effects on vascular SMC that could explain the results observed in morphological analyses. This bioinspired and biocompatible polydopamine layer could intrinsically limit ISR. In addition, according to its latent reactivity, PDA offers the possibility to immobilize some relevant drugs on the PDA-functionalized stent to provide potential synergistic effects.

Published
2021

6. Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients The FRANCE-2 Registry

Author

Gilard, Martine, Eltchaninoff, Hélène, Donzeau-Gouge, Patrick, Chevreul, Karine, Fajadet, Jean, Leprince, Pascal, Leguerrier, Alain, Lievre, Michel, Prat, Alain, Teiger, Emmanuel, Lefèvre, Thierry, Tchetche, Didier, Carrie, Didier, Himbert, Dominique, Albat, Bernard, Cribier, Alain, Sudre, Arnaud, Blanchard, Didier, Rioufol, Gilles, Collet, Frederic, Houel, Remi, dos Santos, Pierre, Meneveau, Nicolas, Ghostine, Said, Manigold, Thibaut, Guyon, Philippe, Grisoli, Dominique, Le Breton, Hervé, Delpine, Stephane, Didier, Romain, Favereau, Xavier, Souteyrand, Geraud, Ohlmann, Patrick, Doisy, Vincent, Grollier, Gilles, Gommeaux, Antoine, Claudel, Jean-Philippe, Bourlon, Francois, Bertrand, Bernard, Laskar, Marc, Iung, Bernard, Optimisation des régulations physiologiques (ORPHY (EA 4324)), Université de Brest (UBO)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Service de cardiologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Nouvelles Cibles Pharmacologiques de la Protection Endothéliale et de l'Insuffisance Cardiaque (EnVI), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Cardiovasculaire Paris Sud (ICPS), APHP URC-Eco Ile de Frabce, Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris]-Université Paris Diderot - Paris 7 (UPD7), Clinique Pasteur, Clinique Pasteur [Toulouse], Service de chirurgie cardiaque et thoracique [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Service de chirurgie thoracique cardiaque et vasculaire [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Département de physiologie (CHU Henri Mondor), Hôpital Henri Mondor, Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service de cardiologie, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service de cardiologie [Toulouse], Hôpital de Rangueil, CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Institut de médecine moléculaire de Rangueil (I2MR), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-IFR150-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut des Maladies Métaboliques et Cardiovasculaires (I2MC), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Diderot - Paris 7 (UPD7)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Service de chirurgie thoracique et cardio-vasculaire, Hôpital Arnaud de Villeneuve-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université Montpellier 1 (UM1)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Pôle Cardiologie Interventionnelle / Coro-scanner / IRM Cardiaque, Clinique Saint Gatien, Hôpital Cardiovasculaire Louis Pradel, Hospices Civils de Lyon (HCL), Université Bordeaux Segalen - Bordeaux 2, Université de Franche-Comté (UFC), Service de cardiologie et maladies vasculaires, Service de cardiologie et de pathologie vasculaire [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Service de Chirurgie Thoracique et Vasculaire - Médecine vasculaire [CHU Limoges], CHU Limoges, Equipe de Recherche Médicale Appliquée (ERMA), Université de Limoges (UNILIM)-CHU Limoges-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503), CHU de Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), FRANCE-2 registry, Edwards Lifesciences, Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service de Chirurgie cardiaque et thoracique [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de chirurgie thoracique cardiaque et vasculaire [Rennes] = Thoracic and Cardiovascular Surgery [Rennes], CHU Pontchaillou [Rennes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve-Université de Montpellier (UM), Université Bourgogne Franche-Comté [COMUE] (UBFC), Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503)-Université de Limoges (UNILIM)-CHU Limoges, Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service Cardiologie [CHU Toulouse], Pôle Cardiovasculaire et Métabolique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université de Toulouse (UT)-Université de Toulouse (UT)- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
corevalve, predictors, [SDV]Life Sciences [q-bio], permanent pacemaker implantation, stenosis, impact, 2-year outcomes, survival, mortality, long-term outcomes, late clinical-outcomes
Abstract

International audience; BACKGROUND Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. OBJECTIVES This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. METHODS The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. RESULTS A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade >= 2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in < 2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. CONCLUSIONS The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time. (J Am Coll Cardiol 2016; 68: 1637-47) (C) 2016 by the American College of Cardiology Foundation.

Published
2016

7. Association Between Transcatheter Aortic Valve Replacement and Subsequent Infective Endocarditis and In-Hospital Death

Author

Marina Urena, Hervé Le Breton, Ugolino Livi, Susheel Kodali, Alec Vahanian, Maria Cristina Ferreira, Francesco Giannini, Luca Testa, Dominique Himbert, Alexandre Abizaid, Asim N. Cheema, Josep Rodés-Cabau, Juan C. Castillo, Francesco Rosato, Vicenç Serra, Vinicius Esteves, Won-Keun Kim, Fabio Sandoli de Brito, Guglielmo Mario Actis Dato, Henrique Barbosa Ribeiro, Vincent Auffret, Azeem Latib, Thomas Pilgrim, Julio Andrea, José Armando Mangione, Marco Barbanti, Marcos Antonio Marino, Alberto San Roman, Oliver Husser, Luis Nombela-Franco, Rishi Puri, Harindra C. Wijeysundera, Didier Tchetche, John G. Webb, Claudia Fiorina, Luiz A. Carvalho, Hélène Eltchaninoff, Nikolaj Ihlemann, Valter Correa Lima, Howard C. Herrmann, John Lisko, Axel Linke, Ander Regueiro, Pedro A. Lemos, Jean Bernard Masson, Mohamed Abdel-Wahab, Lars Søndergaard, David Messika-Zeitoun, Enrique Gutiérrez-Ibañes, Stamatios Lerakis, Costanza Pellegrini, Raj Makkar, Jan Malte Sinning, Antonio J. Muñoz-García, Norman Mangner, Eric Durand, Antonio L. Bartorelli, Antonio Miceli, Stefan Stortecky, Ignacio J. Amat-Santos, Martin B. Leon, Samir R. Kapadia, Thomas Walther, Hasan Jilaihawi, Fabian Nietlispach, Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Université Laval, Service de cardiologie et maladies vasculaires, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Service de cardiologie [CHU Rouen], Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU), Nouvelles Cibles Pharmacologiques de la Protection Endothéliale et de l'Insuffisance Cardiaque (EnVI), CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de cardiologie, Université Paris Diderot - Paris 7 (UPD7)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC-IT Rennes, Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Fundacion Alfonso Martin Escudero, Madrid, Spain, Université Laval [Québec] (ULaval), Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], CHU Pontchaillou [Rennes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), and Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, medicine.medical_treatment, 2-year outcomes, 030204 cardiovascular system & hematology, 0302 clinical medicine, Valve replacement, Risk Factors, Interquartile range, Odds Ratio, implantation, Hospital Mortality, Registries, 030212 general & internal medicine, multicenter registry, Endocarditis, Medicine (all), Incidence (epidemiology), Mortality rate, Hazard ratio, Age Factors, Bacterial, regurgitation, Aged, Endocarditis, Bacterial, Female, Follow-Up Studies, Heart Failure, Humans, Sex Factors, Staphylococcal Infections, Staphylococcus aureus, Transcatheter Aortic Valve Replacement, Treatment Outcome, General Medicine, 3. Good health, Infective endocarditis, impact, [SDV.IB]Life Sciences [q-bio]/Bioengineering, metaanalysis, medicine.medical_specialty, prevalence, 03 medical and health sciences, early surgery, medicine, business.industry, Odds ratio, medicine.disease, Surgery, predictors, business
Abstract

International audience; IMPORTANCE Limited data exist on clinical characteristics and outcomes of patients who had infective endocarditis after undergoing transcatheter aortic valve replacement (TAVR). OBJECTIVE To determine the associated factors, clinical characteristics, and outcomes of patients who had infective endocarditis after TAVR. DESIGN, SETTING, AND PARTICIPANTS The Infectious Endocarditis after TAVR International Registry included patients with definite infective endocarditis after TAVR from 47 centers from Europe, North America, and South America between June 2005 and October 2015. EXPOSURE Transcatheter aortic valve replacement for incidence of infective endocarditis and infective endocarditis for in-hospital mortality. MAIN OUTCOMES AND MEASURES Infective endocarditis and in-hospital mortality after infective endocarditis. RESULTS A total of 250 cases of infective endocarditis occurred in 20 006 patients after TAVR (incidence, 1.1% per person-year; 95% Cl, 1.1%44%; median age, 80 years; 64% men). Median time from TAVR to infective endocarditis was 5.3 months (interquartile range [IQR], 1.5-13.4 months). The characteristics associated with higher risk of progressing to infective endocarditis after TAVR was younger age (78.9 years vs 81.8 years; hazard ratio [HR], 0.97 per year; 95% CI, 0.94-0.99), male sex (62.0% vs 49.7%; HR, 1.69; 95% C1,1.13-2.52), diabetes mellitus (41.7% vs 30.0%; HR, 1.52; 95% Cl, 1.02-2.29), and moderate to severe aortic regurgitation (22.4% vs 14.7%; HR, 2.05; 95% Cl, 1.28-3.28). Health care-associated infective endocarditis was present in 52.8% (95% Cl, 46.6%-59.0%) of patients. Enterococci species and Staphylococcus aureus were the most frequently isolated microorganisms (24.6%; 95% Cl, 19.1%-30.1% and 23.3%; 95% Cl, 17.9%-28.7%, respectively). The in-hospital mortality rate was 36% (95% Cl, 30.0%-41.9%; 90 deaths; 160 survivors), and surgery was performed in 14.8% (95% Cl, 10.4%-19.2%) of patients during the infective endocarditis episode. In-hospital mortality was associated with a higher logistic EuroSCORE (23.1% vs 18.6%; odds ratio [OR], 1.03 per 1% increase; 95% C1,1.00-1.05), heart failure (59.3% vs 23.7%; OR, 3.36; 95% Cl, 1.74-6.45), and acute kidney injury (67.4% vs 31.6%; OR, 2.70; 95% C1,1.42-5.11). The 2-year mortality rate was 66.7% (95% Cl, 59.0%-74.2%; 132 deaths; 115 survivors). CONCLUSIONS AND RELEVANCE Among patients undergoing TAVR, younger age, male sex, history of diabetes mellitus, and moderate to severe residual aortic regurgitation were significantly associated with an increased risk of infective endocarditis. Patients who developed endocarditis had high rates of in-hospital mortality and 2-year mortality.

Published
2016

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