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1. Association between pulmonary artery pulsatility and mortality after implantation of left ventricular assist device

Author

Ali Akamkam, Vincent Galand, Marie Jungling, Clément Delmas, Camille Dambrin, Mathieu Pernot, Michel Kindo, Philippe Gaudard, Philippe Rouviere, Thomas Senage, Olivier Chavanon, Marylou Para, Vlad Gariboldi, Matteo Pozzi, Pierre‐Yves Litzler, Gerard Babatasi, Olivier Bouchot, Costin Radu, Thierry Bourguignon, Nicolas D'Ostrevy, Ramzi Abi Akar, Fabrice Vanhuyse, Maïra Gaillard, Gilles Chatelier, Audrey Fels, Erwan Flecher, and Julien Guihaire

Subjects
Left ventricular assist device, Haemodynamics, Circulatory assist devices, Ventricle, right, Heart failure, Database, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Abstract Aims Right ventricular failure after left ventricular assist device (LVAD) implantation is a major concern that remains challenging to predict. We sought to investigate the relationship between preoperative pulmonary artery pulsatility index (PAPi) and mortality after LVAD implantation. Methods and results A retrospective analysis of the ASSIST‐ICD multicentre registry allowed the assessment of PAPi before LVAD according to the formula [(systolic pulmonary artery pressure − diastolic pulmonary artery pressure)/central venous pressure]. The primary endpoint was survival at 3 months, according to the threshold value of PAPi determined by the receiver operating characteristic (ROC) curve. A multivariate analysis including demographic, echographic, haemodynamic, and biological variables was performed to identify predictive factors for 2 year mortality. One hundred seventeen patients were included from 2007 to 2021. The mean age was 58.45 years (±13.16), with 15.4% of women (sex ratio 5.5). A total of 53.4% were implanted as bridge to transplant and 43.1% as destination therapy. Post‐operative right ventricular failure was observed in 57 patients (48.7%), with no significant difference between survivors and non‐survivors at 1 month (odds ratio 1.59, P = 0.30). The median PAPi for the whole study population was 2.83 [interquartile range 1.63–4.69]. The threshold value of PAPi determined by the ROC curve was 2.84. Patients with PAPi ≥ 2.84 had a higher survival rate at 3 months [PAPi

Published
2024
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2. Characteristics and outcome of ambulatory heart failure patients receiving a left ventricular assist device

Author

Guillaume Baudry, Nicolas Nesseler, Erwan Flecher, André Vincentelli, Céline Goeminne, Clément Delmas, Jean Porterie, Karine Nubret, Mathieu Pernot, Michel Kindo, Tam Hoang Minh, Philippe Rouvière, Philippe Gaudard, Magali Michel, Thomas Senage, Aude Boignard, Olivier Chavanon, Marylou Para, Constance Verdonk, Edeline Pelcé, Vlad Gariboldi, Frederic Anselme, Pierre‐Yves Litzler, Katrien Blanchart, Gerard Babatasi, Marie Bielefeld, Olivier Bouchot, David Hamon, Nicolas Lellouche, Xavier Bailleul, Thibaud Genet, Romain Eschalier, Nicolas d'Ostrevy, Marie‐Cécile Bories, Ramzi Abi Akar, Hugues Blangy, Fabrice Vanhuyse, Jean François Obadia, Vincent Galand, and Matteo Pozzi

Subjects
Advanced heart failure, Heart failure medications, Mechanical circulatory support, Left ventricular assist device, Outcome measures, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Abstract Aims Despite regularly updated guidelines, there is still a delay in referral of advanced heart failure patients to mechanical circulatory support and transplant centres. We aimed to analyse characteristics and outcome of non‐inotrope‐dependent patients implanted with a left ventricular assist device (LVAD). Methods and results The ASSIST‐ICD registry collected LVAD data in 19 centres in France between February 2006 and December 2016. We used data of patients in Interagency Registry for Mechanically Assisted Circulatory Support Classes 4–7. The primary endpoint was survival analysis. Predictors of mortality were searched with multivariable analyses. A total of 303 patients (mean age 61.0 ± 9.9 years, male sex 86.8%) were included in the present analysis. Ischaemic cardiomyopathy was the leading heart failure aetiology (64%), and bridge to transplantation was the main implantation strategy (56.1%). The overall likelihood of being alive while on LVAD support or having a transplant at 1, 2, 3, and 5 years was 66%, 61.7%, 58.7%, and 55.1%, respectively. Age [hazard ratio (HR) 1.03, 95% confidence interval (CI) 1.00–1.05; P = 0.02], a concomitant procedure (HR 2.32, 95% CI 1.52–3.53; P

Published
2021
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3. Effect of Moderate Hypothermia vs Normothermia on 30-Day Mortality in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Clinical Trial

Author

Bruno, Levy, Nicolas, Girerd, Julien, Amour, Emmanuel, Besnier, Nicolas, Nesseler, Julie, Helms, Clément, Delmas, Romain, Sonneville, Catherine, Guidon, Bertrand, Rozec, Helène, David, David, Bougon, Oussama, Chaouch, Oulehri, Walid, Dupont, Hervé, Nicolas, Belin, Lucie, Gaide-Chevronnay, Patrick, Rossignol, Antoine, Kimmoun, Kevin, Duarte, Arthur S, Slutsky, Daniel, Brodie, Jean-Luc, Fellahi, Alexandre, Ouattara, Alain, Combes, Michel, Kindo, Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Service de Réanimation Médicale [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu [Nancy], Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy] (INI-CRCT), French-Clinical Research Infrastructure Network - F-CRIN [Paris] (Cardiovascular & Renal Clinical Trialists - CRCT ), Centre d'investigation clinique plurithématique Pierre Drouin [Nancy] (CIC-P), Centre d'investigation clinique [Nancy] (CIC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Hôpital Privé Jacques Cartier [Massy], Endothélium, valvulopathies et insuffisance cardiaque (EnVI), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Rouen, Normandie Université (NU), CHU Pontchaillou [Rennes], Nutrition, Métabolismes et Cancer (NuMeCan), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Les Hôpitaux Universitaires de Strasbourg (HUS), Nouvel Hôpital Civil de Strasbourg, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Marseille, Centre hospitalier universitaire de Nantes (CHU Nantes), unité de recherche de l'institut du thorax UMR1087 UMR6291 (ITX), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Arnaud de Villeneuve [CHRU Montpellier], Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Université Paris Descartes - Paris 5 (UPD5), CHU Amiens-Picardie, Service de Réanimation médicale [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre Hospitalier Universitaire [Grenoble] (CHU), Keenan Research Centre of the Li Ka Shing Knowledge Institute [Toronto], University of Toronto, Columbia University [New York], Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL), Biologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases, Université de Bordeaux (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), CHU Bordeaux [Bordeaux], Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), 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)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut de cardiologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), The trial was sponsored and conducted by the Direction de la Recherche Clinique, CHU Nancy, with a grant from the French Ministry of Health., HYPO-ECMO Trial Group and the International ECMO Network (ECMONet): Mathieu Mattei MD, Carine Thivillier MD, Thomas Auchet MD, Pierrre Perez MD, Caroline Fritz MD, Pablo Maureira MD, PhD, Maxime Hubert MD, Yihua Liu MD, PhD, Ferhat Meziani MD, PhD, Hamid Merdji MD, Alexandra Monnier MD, Raphaël Clere-Jehl MD, Ania Nieszkowska MD, Marc Pineton MD, Juliette Chommeloux MD, Guillaume Hékimian MD, Guillaume Lebreton MD, Astrid Quessard MD, Julien Imbault MD, Alain Rémy MD, Mathieu Pernot MD, Pierre Joseph MD, Giovanni Scollo MD, Matteo Pozzi MD, PhD, Étienne Escudier MD, Michel Muller MD, Didier Dorez MD, Michel Sirodot MD, Fabien Doguet MD, Vincent Scherrer MD, Chadi Aludaat MD, Michael Bernasinski MD, Elie Zogheib MD, PhD, Thierry Caus MD, PhD, Philippe Bizouarn MD, PhD, Mickael Vourc'h MD, PhD, Jean-Christian Roussel MD, PhD, Thomas Senage MD, PhD, Erwan Flecher MD, PhD, Jean-Philippe Verhoye MD, PhD, Antoine Roisne MD, Sébastien Biedermann MD, Fanny Vardon-Bounes MD, PhD, Laure Crognier MD, Jean Porterie MD, Pascal Colson MD, PhD, Philippe Gaudard MD, PhD, Philippe Rouviere MD, Lila Bouadma MD, PhD, Fabrice Sinnah MD, PhD, Patrick Nataf MD, PhD, Marylou Para MD, Pauline Dureau MD, Nima Djavidi MD, Adrien Bouglé MD, PhD, Pascal Leprince MD, PhD, Géraldine Dessertaine MD, Michel Durand MD, Pierre Albaladejo MD, Cecile Martin MD, François Belon MD, Gael Piton MD, PhD, Hadrien Winiszewski MD, Andrea Perroti MD, David Tonon MD, Bernard Cholley MD, PhD, Diane Zlotnik MD, Paul Achouh MD, PhD, Hélène Nougue MD, PhD, Olivier Collange MD, PhD, Paul Michel Mertes MD, PhD, Michel Kindo MD, PhD, and Jonchère, Laurent

Subjects
Male, Time Factors, [SDV]Life Sciences [q-bio], Shock, Cardiogenic, Hemorrhage, General Medicine, Middle Aged, Respiration, Artificial, Body Temperature, [SDV] Life Sciences [q-bio], Renal Replacement Therapy, Stroke, Extracorporeal Membrane Oxygenation, Hypothermia, Induced, Sepsis, Confidence Intervals, Intubation, Intratracheal, Heart Transplantation, Humans, Female, France, Heart-Assist Devices, Erythrocyte Transfusion, Original Investigation
Abstract

ImportanceThe optimal approach to the use of venoarterial extracorporeal membrane oxygenation (ECMO) during cardiogenic shock is uncertain.ObjectiveTo determine whether early use of moderate hypothermia (33-34 °C) compared with strict normothermia (36-37 °C) improves mortality in patients with cardiogenic shock receiving venoarterial ECMO.Design, Setting, and ParticipantsRandomized clinical trial of patients (who were eligible if they had been endotracheally intubated and were receiving venoarterial ECMO for cardiogenic shock for InterventionsEarly moderate hypothermia (33-34 °C; n = 168) for 24 hours or strict normothermia (36-37 °C; n = 166).Main Outcomes and MeasuresThe primary outcome was mortality at 30 days. There were 31 secondary outcomes including mortality at days 7, 60, and 180; a composite outcome of death, heart transplant, escalation to left ventricular assist device implantation, or stroke at days 30, 60, and 180; and days without requiring a ventilator or kidney replacement therapy at days 30, 60, and 180. Adverse events included rates of severe bleeding, sepsis, and number of units of packed red blood cells transfused during venoarterial ECMO.ResultsAmong the 374 patients who were randomized, 334 completed the trial (mean age, 58 [SD, 12] years; 24% women) and were included in the primary analysis. At 30 days, 71 patients (42%) in the moderate hypothermia group had died vs 84 patients (51%) in the normothermia group (adjusted odds ratio, 0.71 [95% CI, 0.45 to 1.13], P = .15; risk difference, −8.3% [95% CI, −16.3% to −0.3%]). For the composite outcome of death, heart transplant, escalation to left ventricular assist device implantation, or stroke at day 30, the adjusted odds ratio was 0.57 (95% CI, 0.36 to 0.90; P = .02) for the moderate hypothermia group compared with the normothermia group and the risk difference was −12.7% (95% CI, −22.3% to −3.2%). Of the 31 secondary outcomes, 30 were inconclusive. The incidence of moderate or severe bleeding was 41% in the moderate hypothermia group vs 42% in the normothermia group. The incidence of infections was 52% in both groups. The incidence of bacteremia was 20% in the moderate hypothermia group vs 30% in the normothermia group.Conclusions and RelevanceIn this randomized clinical trial involving patients with refractory cardiogenic shock treated with venoarterial ECMO, early application of moderate hypothermia for 24 hours did not significantly increase survival compared with normothermia. However, because the 95% CI was wide and included a potentially important effect size, these findings should be considered inconclusive.Trial RegistrationClinicalTrials.gov Identifier: NCT02754193

Published
2022

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