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  1. Article: Rarely Encountered Gram-Negative Rods and Lung Transplant Recipients: A Narrative Review.

    Farfour, Eric / Roux, Antoine / Sage, Edouard / Revillet, Hélène / Vasse, Marc / Vallée, Alexandre

    Microorganisms

    2023  Volume 11, Issue 6

    Abstract: The respiratory tract of lung transplant recipients (LTR) is likely to be colonized with non-fermentative Gram-negative rods. As a consequence of the improvements in molecular sequencing and taxonomy, an increasing number of bacterial species have been ... ...

    Abstract The respiratory tract of lung transplant recipients (LTR) is likely to be colonized with non-fermentative Gram-negative rods. As a consequence of the improvements in molecular sequencing and taxonomy, an increasing number of bacterial species have been described. We performed a review of the literature of bacterial infections in LTR involving non-fermentative Gram-negative rods with exclusion of
    Language English
    Publishing date 2023-05-31
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2720891-6
    ISSN 2076-2607
    ISSN 2076-2607
    DOI 10.3390/microorganisms11061468
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Successful management of donor-acquired fat embolism after lung transplantation.

    Glorion, Matthieu / Sarsam, Matthieu / de Wolf, Julien / Sage, Edouard

    Interactive cardiovascular and thoracic surgery

    2021  Volume 33, Issue 1, Page(s) 158–160

    Abstract: Fat embolism is a serious complication in patients with multiple traumatic injuries. It is often asymptomatic during the first hours of resuscitation, thus remains underdiagnosed in patients who progress to brain death. Lung transplantation issued from ... ...

    Abstract Fat embolism is a serious complication in patients with multiple traumatic injuries. It is often asymptomatic during the first hours of resuscitation, thus remains underdiagnosed in patients who progress to brain death. Lung transplantation issued from such grafts can lead to severe lung primary graft dysfunction, the management of which is deemed difficult. Herein, we report a successful management of donor-acquired fat embolism syndrome after lung transplant in a 22 years old woman for cystic fibrosis. Fat embolism was suspected because of the donor's traumatic injuries and confirmed by histopathological analysis. An immediate postoperative primary graft dysfunction was successfully managed with veno-arterial extracorporeal membrane oxygenation. The patient is alive 31 months after surgery.
    MeSH term(s) Adult ; Embolism, Fat/diagnostic imaging ; Embolism, Fat/etiology ; Female ; Humans ; Lung Transplantation/adverse effects ; Primary Graft Dysfunction/etiology ; Primary Graft Dysfunction/therapy ; Pulmonary Embolism ; Tissue Donors ; Young Adult
    Language English
    Publishing date 2021-02-12
    Publishing country England
    Document type Journal Article
    ZDB-ID 2095298-3
    ISSN 1569-9285 ; 1569-9293
    ISSN (online) 1569-9285
    ISSN 1569-9293
    DOI 10.1093/icvts/ivab051
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Bronchial artery embolization for hemoptysis in adult patients with cystic fibrosis: a single-center retrospective study.

    Roussel, Alexandre / Sage, Edouard / Roux, Antoine / Guth, Axel / Mellot, François / Gravel, Guillaume

    Acta radiologica (Stockholm, Sweden : 1987)

    2022  Volume 64, Issue 4, Page(s) 1381–1389

    Abstract: Background: Hemoptysis is a severe complication of cystic fibrosis (CF) for which bronchial artery embolization (BAE) is an efficient primary therapeutic option. However, recurrence is more frequent than for other etiologies of hemoptysis.: Purpose: ... ...

    Abstract Background: Hemoptysis is a severe complication of cystic fibrosis (CF) for which bronchial artery embolization (BAE) is an efficient primary therapeutic option. However, recurrence is more frequent than for other etiologies of hemoptysis.
    Purpose: To assess the safety and efficacy of BAE in patients with CF and hemoptysis and predictive factors for recurrent hemoptysis.
    Material and methods: This retrospective study reviewed all adult patients with CF treated by BAE for hemoptysis in our center from 2004 to 2021. The primary endpoint was the recurrence of hemoptysis after bronchial artery embolization. Secondary endpoints were overall survival and complications. We introduced the vascular burden (VB) defined as the sum of all bronchial artery diameters measured on pre-procedural enhanced computed tomography (CT) scans.
    Results: A total of 48 BAE were performed in 31 patients. A total of 19 recurrences occurred with a median recurrence-free survival of 3.9 years. In univariate analyzes, percentage of unembolized VB (%UVB) (hazard ratio [HR] = 1.034, 95% confidence interval [CI=1.016-1.052;
    Conclusion: When possible, unilateral BAE seems sufficient in patients with CF with hemoptysis even in such a diffuse disease involving both lungs. The efficiency of BAE could be improved by thoroughly targeting all arteries vascularizing the bleeding lung.
    MeSH term(s) Humans ; Adult ; Cystic Fibrosis/complications ; Hemoptysis/therapy ; Bronchial Arteries ; Embolization, Therapeutic/methods ; Retrospective Studies ; Treatment Outcome ; Male ; Female ; Middle Aged
    Language English
    Publishing date 2022-09-14
    Publishing country England
    Document type Journal Article
    ZDB-ID 105-3
    ISSN 1600-0455 ; 0284-1851 ; 0349-652X
    ISSN (online) 1600-0455
    ISSN 0284-1851 ; 0349-652X
    DOI 10.1177/02841851221126833
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Complementary Therapy Learning in the Setting of Lung Transplantation: A Single-Center Observational Study of Appropriation and Efficacy.

    Michel-Cherqui, Mireille / Fessler, Julien / Szekely, Barbara / Glorion, Matthieu / Sage, Edouard / Fischler, Marc / Vallée, Alexandre / Le Guen, Morgan

    Journal of clinical medicine

    2023  Volume 12, Issue 5

    Abstract: Transplanted patients could benefit from complementary techniques. This prospective single-center, open study, performed in a tertiary university hospital, evaluates the appropriation and efficacy of a toolbox-kit of complementary techniques. Self- ... ...

    Abstract Transplanted patients could benefit from complementary techniques. This prospective single-center, open study, performed in a tertiary university hospital, evaluates the appropriation and efficacy of a toolbox-kit of complementary techniques. Self-hypnosis, sophrology, relaxation, holistic gymnastics, and transcutaneous electric nerve stimulation (TENS) were taught to adult patients scheduled for double-lung transplantation. Patients were asked to use them before and after transplantation, as needed. The primary outcome was appropriation of each technique within the first three postoperative months. Secondary outcomes included efficacy on pain, anxiety, stress, sleep, and quality-of-life. Among the 80 patients included from May 2017 to September 2020, 59 were evaluated at the 4th postoperative month. Over the 4359 sessions performed, the most frequent technique used before surgery was relaxation. After transplantation, the techniques most frequently used were relaxation and TENS. TENS was the best technique in terms of autonomy, usability, adaptation, and compliance. Self-appropriation of relaxation was the easiest, while self-appropriation of holistic gymnastics was difficult but appreciated by patients. In conclusion: the appropriation by patients of complementary therapies such as mind-body therapies, TENS and holistic gymnastics is feasible in lung transplantation. Even after a short training session, patients regularly practiced these therapies, mainly TENS and relaxation.
    Language English
    Publishing date 2023-02-21
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2662592-1
    ISSN 2077-0383
    ISSN 2077-0383
    DOI 10.3390/jcm12051722
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  5. Article ; Online: The Inhibition of the Membrane-Bound Transcription Factor Site-1 Protease (MBTP1) Alleviates the p.Phe508del-Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Defects in Cystic Fibrosis Cells.

    Santinelli, Raphaël / Benz, Nathalie / Guellec, Julie / Quinquis, Fabien / Kocas, Ervin / Thomas, Johan / Montier, Tristan / Ka, Chandran / Luczka-Majérus, Emilie / Sage, Edouard / Férec, Claude / Coraux, Christelle / Trouvé, Pascal

    Cells

    2024  Volume 13, Issue 2

    Abstract: Cystic Fibrosis (CF) is present due to mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene, the most frequent variant being p.phe508del. The CFTR protein is a chloride (Cl-) channel which is defective and almost absent of ... ...

    Abstract Cystic Fibrosis (CF) is present due to mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene, the most frequent variant being p.phe508del. The CFTR protein is a chloride (Cl-) channel which is defective and almost absent of cell membranes when the p.Phe508del mutation is present. The p.Phe508del-CFTR protein is retained in the endoplasmic reticulum (ER) and together with inflammation and infection triggers the Unfolded Protein Response (UPR). During the UPR, the Activating Transcription Factor 6 (ATF6) is activated with cleavage and then decreases the expression of p.Phe508del-CFTR. We have previously shown that the inhibition of the activation of ATF6 alleviates the p.Phe508del-CFTR defects in cells overexpressing the mutated protein. In the present paper, our aim was to inhibit the cleavage of ATF6, and thus its activation in a human bronchial cell line with endogenous p.Phe508del-CFTR expression and in bronchial cells from patients, to be more relevant to CF. This was achieved by inhibiting the protease MBTP1 which is responsible for the cleavage of ATF6. We show here that this inhibition leads to increased mRNA and p.Phe508del-CFTR expression and, consequently, to increased Cl-efflux. We also explain the mechanisms linked to these increases with the modulation of genes when MBTP1 is inhibited. Indeed, RT-qPCR assays show that genes such as HSPA1B, CEBPB, VIMP, PFND2, MAPK8, XBP1, INSIG1, and CALR are modulated. In conclusion, we show that the inhibition of MBTP1 has a beneficial effect in relevant models to CF and that this is due to the modulation of genes involved in the disease.
    MeSH term(s) Humans ; Cystic Fibrosis Transmembrane Conductance Regulator/genetics ; Cystic Fibrosis/genetics ; Transcription Factors ; Serine Endopeptidases ; Proprotein Convertases
    Chemical Substances Cystic Fibrosis Transmembrane Conductance Regulator (126880-72-6) ; Transcription Factors ; membrane-bound transcription factor peptidase, site 1 (EC 3.4.21.112) ; Serine Endopeptidases (EC 3.4.21.-) ; CFTR protein, human ; Proprotein Convertases (EC 3.4.21.-)
    Language English
    Publishing date 2024-01-18
    Publishing country Switzerland
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2661518-6
    ISSN 2073-4409 ; 2073-4409
    ISSN (online) 2073-4409
    ISSN 2073-4409
    DOI 10.3390/cells13020185
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  6. Article ; Online: Short-term consequences of F508del-CFTR thermal instability on CFTR-dependent transepithelial currents in human airway epithelial cells.

    Froux, Lionel / Coraux, Christelle / Sage, Edouard / Becq, Frédéric

    Scientific reports

    2019  Volume 9, Issue 1, Page(s) 13729

    Abstract: Loss-of-function mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) channel in human airway epithelial cells are responsible for Cystic Fibrosis. A deleterious impact of physiological temperature on CFTR plasma membrane ... ...

    Abstract Loss-of-function mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) channel in human airway epithelial cells are responsible for Cystic Fibrosis. A deleterious impact of physiological temperature on CFTR plasma membrane expression, residence and channel activity is characteristic of the most common and severe CF mutation, F508del. Using primary human F508del-airway epithelial cells and CF bronchial epithelial CFBE41o- cell lines expressing F508del- or WT-CFTR, we examined the effects of temperature (29 °C-39 °C) on the amplitude and stability of short-circuit CFTR-dependent currents over time and the efficiency of pharmacological strategies to stably restore F508del-CFTR function. We show that F508del-CFTR functional instability at 37 °C is not prevented by low temperature or VX-809 correction, genistein and VX-770 potentiators, nor by the combination VX-809/VX-770. Moreover, F508del-CFTR-dependent currents 30 minutes after CFTR activation at 37 °C did not significantly differ whether a potentiator was used or not. We demonstrate that F508del-CFTR function loss is aggravated at temperatures above 37 °C while limited by a small decrease of temperature and show that the more F508del-CFTR is stimulated, the faster the current loss happens. Our study highlights the existence of a temperature-dependent process inhibiting the function of F508del-CFTR, possibly explaining the low efficacy of pharmacological drugs in clinic.
    MeSH term(s) Bronchi/metabolism ; Cell Line ; Cystic Fibrosis/genetics ; Cystic Fibrosis/metabolism ; Cystic Fibrosis Transmembrane Conductance Regulator/genetics ; Cystic Fibrosis Transmembrane Conductance Regulator/metabolism ; Epithelial Cells/metabolism ; Humans ; Mutation/genetics ; Thermal Conductivity
    Chemical Substances CFTR protein, human ; Cystic Fibrosis Transmembrane Conductance Regulator (126880-72-6)
    Language English
    Publishing date 2019-09-24
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2615211-3
    ISSN 2045-2322 ; 2045-2322
    ISSN (online) 2045-2322
    ISSN 2045-2322
    DOI 10.1038/s41598-019-50066-7
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  7. Article ; Online: Trans-arterial embolization for hemoptysis in lung transplant recipients.

    Gravel, Guillaume / Sage, Edouard / Cuquemelle, Elise / Roussel, Alexandre / Roux, Antoine / Glorion, Matthieu / Parquin, François / Mellot, François / Picard, Clément

    Respiratory medicine and research

    2022  Volume 82, Page(s) 100941

    Abstract: Introduction: Hemoptysis isn't rare in lung transplant recipients (LTR). Yet, trans-arterial embolization (TAE) in LTR has been rarely reported in the literature. The aim of the study was to present the feasibility and outcomes of TAE for hemoptysis in ... ...

    Abstract Introduction: Hemoptysis isn't rare in lung transplant recipients (LTR). Yet, trans-arterial embolization (TAE) in LTR has been rarely reported in the literature. The aim of the study was to present the feasibility and outcomes of TAE for hemoptysis in LTR.
    Materials and methods: Retrospective study of all LTR who underwent TAE for hemoptysis in our single institution between 2005 and 2020.
    Results: A total of 787 patients underwent lung transplantation between 2005 and 2020. Fifteen LTR underwent 21 TAE for hemoptysis in a median delay of 42 days after LT. TAE was performed within a year after LT in 13 patients (86.7%) with 12 of those patients having concomitant severe ischemic airway injury with necrosis and anastomotic dehiscence. Bronchoscopy confirmed bronchial anastomoses has being the source of the bleeding in 11 LTR (84.6%). Restoration of bronchial vascularization was highlighted in 13 patients (87%). Despite TAE, bronchial anastomosis healing was observed in all surviving patients with anastomotic dehiscence in a median delay of 43 days.
    Conclusion: In our experience, hemoptysis requiring TAE in LTR was rare, frequently occurring in the first weeks after LT, and seemed associated with anastomotic ischemia and dehiscence. Bleeding mainly originated from ischemic bronchial anastomosis through the restoration of the bronchial artery circulation. Our results suggest that bronchial arteriography should be routinely proposed in such patients in the event of hemoptysis.
    MeSH term(s) Humans ; Hemoptysis/etiology ; Hemoptysis/therapy ; Retrospective Studies ; Transplant Recipients ; Treatment Outcome ; Lung
    Language English
    Publishing date 2022-07-28
    Publishing country France
    Document type Journal Article
    ISSN 2590-0412
    ISSN (online) 2590-0412
    DOI 10.1016/j.resmer.2022.100941
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  8. Article ; Online: The rescue of F508del-CFTR by elexacaftor/tezacaftor/ivacaftor (Trikafta) in human airway epithelial cells is underestimated due to the presence of ivacaftor.

    Becq, Frédéric / Mirval, Sandra / Carrez, Thomas / Lévêque, Manuella / Billet, Arnaud / Coraux, Christelle / Sage, Edouard / Cantereau, Anne

    The European respiratory journal

    2022  Volume 59, Issue 2

    Abstract: Trikafta, currently the leading therapeutic in cystic fibrosis (CF), has demonstrated a real clinical benefit. This treatment is the triple combination therapy of two folding correctors elexacaftor/tezacaftor (VX445/VX661) plus the gating potentiator ... ...

    Abstract Trikafta, currently the leading therapeutic in cystic fibrosis (CF), has demonstrated a real clinical benefit. This treatment is the triple combination therapy of two folding correctors elexacaftor/tezacaftor (VX445/VX661) plus the gating potentiator ivacaftor (VX770). In this study, our aim was to compare the properties of F508del-CFTR in cells treated with either lumacaftor (VX809), tezacaftor, elexacaftor, elexacaftor/tezacaftor with or without ivacaftor. We studied F508del-CFTR function, maturation and membrane localisation by Ussing chamber and whole-cell patch-clamp recordings, Western blot and immunolocalisation experiments. With human primary airway epithelial cells and the cell lines CFBE and BHK expressing F508del, we found that, whereas the combination elexacaftor/tezacaftor/ivacaftor was efficient in rescuing F508del-CFTR abnormal maturation, apical membrane location and function, the presence of ivacaftor limits these effects. The basal F508del-CFTR short-circuit current was significantly increased by elexacaftor/tezacaftor/ivacaftor and elexacaftor/tezacaftor compared to other correctors and nontreated cells, an effect dependent on ivacaftor and cAMP. These results suggest that the level of the basal F508del-CFTR current might be a marker for correction efficacy in CF cells. When cells were treated with ivacaftor combined to any correctors, the F508del-CFTR current was unresponsive to the subsequently acute addition of ivacaftor, unlike the CFTR (cystic fibrosis transmembrane conductance regulator) potentiators genistein and Cact-A1 which increased elexacaftor/tezacaftor/ivacaftor and elexacaftor/tezacaftor-corrected F508del-CFTR currents. These findings show that ivacaftor reduces the correction efficacy of Trikafta. Thus, combining elexacaftor/tezacaftor with a different potentiator might improve the therapeutic efficacy for treating CF patients.
    MeSH term(s) Aminophenols ; Benzodioxoles ; Cystic Fibrosis Transmembrane Conductance Regulator/genetics ; Cystic Fibrosis Transmembrane Conductance Regulator/metabolism ; Drug Combinations ; Epithelial Cells/metabolism ; Humans ; Indoles ; Mutation ; Pyrazoles ; Pyridines ; Pyrrolidines ; Quinolines ; Quinolones
    Chemical Substances Aminophenols ; Benzodioxoles ; CFTR protein, human ; Drug Combinations ; Indoles ; Pyrazoles ; Pyridines ; Pyrrolidines ; Quinolines ; Quinolones ; elexacaftor, ivacaftor, tezacaftor drug combination ; tezacaftor ; Cystic Fibrosis Transmembrane Conductance Regulator (126880-72-6) ; ivacaftor (1Y740ILL1Z) ; elexacaftor (RRN67GMB0V)
    Language English
    Publishing date 2022-02-24
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 639359-7
    ISSN 1399-3003 ; 0903-1936
    ISSN (online) 1399-3003
    ISSN 0903-1936
    DOI 10.1183/13993003.00671-2021
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Feasibility and Usefulness of Self-Hypnosis in Patients Undergoing Double-Lung Transplantation During the Pre- and Postoperative Periods: A Randomized Study.

    Michel-Cherqui, Mireille / Szekely, Barbara / Fessler, Julien / Glorion, Matthieu / Sage, Edouard / Le Guen, Morgan / Trichereau, Julie / Vallée, Alexandre / Fischler, Marc

    Journal of cardiothoracic and vascular anesthesia

    2022  Volume 36, Issue 8 Pt A, Page(s) 2490–2499

    Abstract: Objective: Hypnosis can reduce pain and anxiety in surgical patients. This study aimed to demonstrate that implementing self-hypnosis in the setting of lung transplantation could improve patients' pain and quality of life.: Design: A randomized, ... ...

    Abstract Objective: Hypnosis can reduce pain and anxiety in surgical patients. This study aimed to demonstrate that implementing self-hypnosis in the setting of lung transplantation could improve patients' pain and quality of life.
    Design: A randomized, single-center study.
    Setting: Foch University Hospital, Suresnes, France.
    Participants: The participants were patients aged 15 years or older who needed a double-lung transplant. Patients were excluded if they participated in only 1 learning self-hypnosis session before transplantation.
    Interventions: Patients were included at the time of their final evaluation before inscription on the waiting list. They were taught self-hypnosis at this time and were asked to perform it by themselves before and after transplantation, as frequently as possible.
    Measurements and main results: The main outcome of the study was self-reported pain 1 month after lung transplantation. Secondary outcomes were self-reported pain, anxiety, coping, catastrophism, and self-reported quality of life evaluated at their registration, 7 days and 1 and 4 months after the transplantation. Seventy-eight patients were included, but only 28 patients in the control group and 33 in the self-hypnosis group were evaluated at the fourth postoperative month. Practice of self-hypnosis was high before transplantation (76.6%), lower after, from 32.3% in the intensive care unit to 51.6% during the last 3 months of the study. Group-time interactions were not statistically significant whatever the concerned outcome, especially pain score at 1 month (p = 0.16).
    Conclusion: Implementation of self-hypnosis is possible, but the study failed to demonstrate an improvement in patients' experience, perhaps due to the variable compliance with the technique.
    MeSH term(s) Adolescent ; Adult ; Feasibility Studies ; Humans ; Hypnosis/methods ; Lung Transplantation/adverse effects ; Pain, Postoperative/etiology ; Pain, Postoperative/prevention & control ; Quality of Life
    Language English
    Publishing date 2022-01-21
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1067317-9
    ISSN 1532-8422 ; 1053-0770
    ISSN (online) 1532-8422
    ISSN 1053-0770
    DOI 10.1053/j.jvca.2022.01.027
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  10. Article ; Online: Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial.

    Messika, Jonathan / Eloy, Philippine / Boulate, David / Charvet, Aude / Fessler, Julien / Jougon, Jacques / Lacoste, Philippe / Mercier, Olaf / Portran, Philippe / Roze, Hadrien / Sage, Edouard / Thes, Jacques / Tronc, Francois / Vourc'h, Mickael / Montravers, Philippe / Castier, Yves / Mal, Herve / Mordant, Pierre

    BMJ open

    2024  Volume 14, Issue 3, Page(s) e077770

    Abstract: Introduction: Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used as intraoperative support for LTx, despite no precise ... ...

    Abstract Introduction: Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used as intraoperative support for LTx, despite no precise guidelines for its initiation. We aim to evaluate two strategies of VA-ECMO initiation in the perioperative period in patients with obstructive or restrictive lung disease requiring bilateral LTx. In the control 'on-demand' arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental 'systematic' arm, VA-ECMO will be pre-emptively initiated. We hypothesise a 'systematic' strategy will increase the number of ventilatory-free days at day 28.
    Methods and analysis: We designed a multicentre randomised controlled trial in parallel groups. Adult patients with obstructive or restrictive lung disease requiring bilateral LTx, without a formal indication for pre-emptive VA-ECMO before LTx, will be included. Patients with preoperative pulmonary hypertension with haemodynamic collapse, ECMO as a bridge to transplantation, severe hypoxaemia or hypercarbia will be secondarily excluded. In the systematic group, VA-ECMO will be systematically implanted before the first pulmonary artery cross-clamp. In the on-demand group, VA-ECMO will be implanted intraoperatively if haemodynamic or respiratory indices meet preplanned criteria. Non-inclusion, secondary exclusion and VA-ECMO initiation criteria were validated by a Delphi process among investigators. Postoperative weaning of ECMO and mechanical ventilation will be managed according to best practice guidelines. The number of ventilator-free days at 28 days (primary endpoint) will be compared between the two groups in the intention-to-treat population. Secondary endpoints encompass organ failure occurrence, day 28, day 90 and year 1 vital status, and adverse events.
    Ethics and dissemination: The sponsor is the Assistance Publique-Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.
    Trial registration number: NCT05664204.
    MeSH term(s) Adult ; Humans ; Extracorporeal Membrane Oxygenation ; Quality of Life ; Lung Transplantation ; Morbidity ; Hypertension, Pulmonary/therapy ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic
    Language English
    Publishing date 2024-03-05
    Publishing country England
    Document type Clinical Trial Protocol ; Journal Article
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2023-077770
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