Année 2017/2018
Thèse
Pour le
DOCTORAT EN MEDECINE
Diplôme d’État par
Julien NAËL
Né le 3 Avril 1989 à Saint-Lô (50)
Expérience tourangelle de l’approche minimaliste dans le remplacement valvu- laire aortique percutané.
Présentée et soutenue publiquement le Lundi 22 Octobre devant un jury composé de :
Président du Jury : Professeur Dominique BABUTY, Cardiologie, PU, Faculté de Médecine - Tours
Membres du Jury :
Professeur Denis ANGOULVANT, Cardiologie, PU, Faculté de Médecine – Tours Professeur Laurent FAUCHIER, Cardiologie, PU, Faculté de Médecine – Tours Docteur Bernard DESVEAUX, Cardiologie, PH, CHU – Tours
Directeur de thèse : Docteur Christophe SAINT ETIENNE, Cardiologie, PH, CHU - Tours
Abstract:
Tours’local experience of minimalist approach in transcatheter aortic valve im- plantation
Background: In trans-aortic valve implantation (TAVI) procedure, trans-femoral ac- cess is associated with better outcomes. Moreover, some recent studies show that lo- cal anaesthesia may be used during the procedure instead of general anaesthesia. Mi- nimalist approach, associating both transfemoral access and local anaesthesia, is in development but its safety and efficiency remain uncertain.
Aims: To assess the safety and the efficiency of minimalist approach in TAVI.
Methods: From January 2016 to December 2017, 368 TAVI were performed in the University Hospital Center of Tours for patients suffering from a symptomatic aortic stenosis. Patients who benefited from a minimalist approach were studied retrospec- tively. Initial characteristics, procedure’s data, results and outcomes were compared to surgical TAVI and to patients from the 2015 France TAVI register.
Results: 294 patients were included in the minimalist approach, 27 in the surgical one and 4283 were included in the France TAVI register. No significant difference was shown on one-month mortality compared to the surgical approach (3.4% vs 0%, P = 0.34) and to France TAVI register (3.3%, P = 0.96). Minimalist approach was as- sociated with lower length of hospital stay (6 ± 0.4 vs 7,9 ± 1.7 days, P = 0.028) and with lower length of stay in intensive care (1.1 ± 0.2 vs 2.1 ± 0.6 days, P = 0.04) compared to surgical approach. Less infections (0.7% vs 7%, P = 0.0027), less trans- fusions (1% vs 11%, P = 0.0002) and less hospitalizations in Critical Care Unit (1.4%
vs 59%, P < 0.0001) were recorded compared to surgical approach. Less tampon- nades (0% vs 1,9%, P = 0.018), less grade III or IV aortic regurgitations (2% vs 8.7%, P = 0.0001) were described compared to France TAVI register. However, more patients benefited from a permanent pacemaker compared to France TAVI (26% vs 18.4%, P = 0.005) in our cohort.
Conclusion: Minimalist approach doesn’t seem to impact mortality and is associated with a shorter length of hospital stay and with better results compared to surgical ap- proach and to France TAVI register.
Key words : Aortic stenosis, Transcatheter aortic valve replacement, minimalist ap-
proach, mortality, efficiency
Resumé :
Expérience tourangelle de l’approche minimaliste dans le remplacement valvu- laire aortique percutané.
Contexte : La voie d’abord transfémorale percutanée est associée à de meilleurs ré- sultats lorsqu’elle est possible et de récentes études concluent à la faisabilité de la procédure de remplacement valvulaire aortique percutané (TAVI) sous anesthésie lo- cale. La stratégie minimaliste associant un accès transfémoral sous anesthésie locale est en cours de développement mais sa sécurité et son efficacité reste inconnue.
Objectifs : Evaluer l’efficacité et la sécurité de l’approche minimaliste dans les TAVI.
Méthodes : Entre Janvier 2016 et Décembre 2017, 368 personnes présentant un ré- trécissement aortique aortique serré symptomatique ont bénéficié d’un TAVI. Parmis ces patients, nous avons étudiés rétrospectivement les patients qui ont bénéficié d’une approche minimaliste. Les caractéristiques initiales, les données de procédure et les résultats ont été comparés avec les TAVI chirurgicaux et les patients inclus dans le registre France TAVI en 2015.
Résultats : Il y avait 294 patients dans la cohorte minimaliste, 27 TAVI chirurgicaux et 4283 patients inclus dans France TAVI. Il n’y avait pas de différence significative sur la mortalité à un mois comparés aux TAVI chirurgicaux (3.4% vs 0%, P = 0.34) et au registre France TAVI (3.3%, P = 0.96). Les TAVI minimalistes étaient associés à une durée d’hospitalisation plus courte (6 ± 0.4 vs 7,9 ± 1.7 jours, P = 0.028) ainsi qu’un séjour plus court en soins intensifs (1.1 ± 0.2 vs 2.1 ± 0.6 jours, P = 0.04) que les TAVI chirurgicaux. Il y avait moins d’infections (0.7% vs 7%, P = 0.0027), moins de transfusions (1% vs 11%, P = 0.0002) et moins d’hospitalisations en réanimation (1.4% vs 59%, P < 0.0001) chez les TAVI minimalistes. Comparés au registre France TAVI, les patients de la cohorte minimaliste ont présenté moins de tamponnades (0%
vs 1,9%, P = 0.018), moins de de fuites aortiques grade III ou IV (2% vs 8.7%, P = 0.0001) mais d’avantage ont été implantés d’un stimulateur cardiaque après la procé- dure (26% vs 18.4%, P = 0.005).
Conclusion : L’approche minimaliste dans les TAVI n’a pas d’effet délétère sur la mortalité est associé à une durée d’hospitalisation plus courte et de meilleurs résultats comparés aux TAVI chirurgicaux et aux patients inclus dans le registre France TAVI.
Mots clés : Rétrécissement aortique, remplacement valvulaire aortique percutané,
approche minimaliste, mortalité, efficacité.
Faculté de Médecine – 10, boulevard Tonnellé – CS 73223 – 37032 TOURS Cedex 1 – Tél : 02.47.36.66.00 – www.med.univ-tours.fr 1 01/09/2018 / 5 UNIVERSITE DE TOURS
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ASSESSEURS
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********
DOYENS HONORAIRES Pr Emile ARON (†) – 1962-1966 Directeur de l’Ecole de Médecine - 1947-1962
Pr Georges DESBUQUOIS (†) - 1966-1972 Pr André GOUAZE - 1972-1994 Pr Jean-Claude ROLLAND – 1994-2004
Pr Dominique PERROTIN – 2004-2014 PROFESSEURS EMERITES
Pr Daniel ALISON Pr Philippe ARBEILLE Pr Catherine BARTHELEMY
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Pr Alain GOUDEAU Pr Noël HUTEN Pr Olivier LE FLOCH Pr Yvon LEBRANCHU Pr Elisabeth LECA Pr Anne-MarieLEHR-DRYLEWICZ
Pr Gérard LORETTE Pr Roland QUENTIN Pr Alain ROBIER
PrElieSALIBA
PROFESSEURS HONORAIRES
P.ANTHONIOZ –A.AUDURIER –A.AUTRET –P.BAGROS –P.BARDOS –J.L.BAULIEU –C.BERGER –JC.BESNARD – P. BEUTTER – P. BONNET – M. BROCHIER – P. BURDIN – L. CASTELLANI – B. CHARBONNIER –P. CHOUTET – T.
CONSTANS –C.COUET -J.P.FAUCHIER –F.FETISSOF –J.FUSCIARDI –P.GAILLARD –G.GINIES –A.GOUAZE –J.L.
GUILMOT –M. JAN –J.P. LAMAGNERE –F. LAMISSE –Y.LANSON –J.LAUGIER –P. LECOMTE –E.LEMARIE –G.
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SAINDELLE –J.J.SANTINI –D.SAUVAGE –D.SIRINELLI –B.TOUMIEUX –J.WEILL
PROFESSEURS DES UNIVERSITES - PRATICIENS HOSPITALIERS ANDRES Christian ... Biochimie et biologie moléculaire ANGOULVANT Denis ... Cardiologie
AUPART Michel ... Chirurgie thoracique et cardiovasculaire BABUTY Dominique ... Cardiologie
BALLON Nicolas ... Psychiatrie ; addictologie BARILLOT Isabelle ... Cancérologie ; radiothérapie BARON Christophe ... Immunologie
BEJAN-ANGOULVANT Théodora ... Pharmacologie clinique BERNARD Anne ... Cardiologie
BERNARD Louis ... Maladies infectieuses et maladies tropicales BLANCHARD-LAUMONNIER Emmanuelle .... Biologie cellulaire
BLASCO Hélène ... Biochimie et biologie moléculaire BODY Gilles ... Gynécologie et obstétrique BONNET-BRILHAULT Frédérique ... Physiologie
BRILHAULT Jean ... Chirurgie orthopédique et traumatologique BRUNEREAU Laurent ... Radiologie et imagerie médicale
BRUYERE Franck ... Urologie BUCHLER Matthias ... Néphrologie
CALAIS Gilles ... Cancérologie, radiothérapie CAMUS Vincent ... Psychiatrie d’adultes CHANDENIER Jacques ... Parasitologie, mycologie COLOMBAT Philippe ... Hématologie, transfusion CORCIA Philippe ... Neurologie
COTTIER Jean-Philippe ... Radiologie et imagerie médicale DE TOFFOL Bertrand ... Neurologie
DEQUIN Pierre-François... Thérapeutique
DESOUBEAUX Guillaume... Parasitologie et mycologie DESTRIEUX Christophe ... Anatomie
DIOT Patrice ... Pneumologie
DU BOUEXIC de PINIEUX Gonzague ... Anatomie & cytologie pathologiques DUCLUZEAU Pierre-Henri ... Endocrinologie, diabétologie, et nutrition DUMONT Pascal ... Chirurgie thoracique et cardiovasculaire EL HAGE Wissam ... Psychiatrie adultes
EHRMANN Stephan ... Réanimation FAUCHIER Laurent ... Cardiologie
FAVARD Luc ... Chirurgie orthopédique et traumatologique FOUGERE Bertrand ... Gériatrie
FOUQUET Bernard ... Médecine physique et de réadaptation FRANCOIS Patrick ... Neurochirurgie
FROMONT-HANKARD Gaëlle ... Anatomie & cytologie pathologiques GAUDY-GRAFFIN Catherine ... Bactériologie-virologie, hygiène hospitalière GOGA Dominique ... Chirurgie maxillo-faciale et stomatologie GOUPILLE Philippe ... Rhumatologie
GRUEL Yves ... Hématologie, transfusion
GUERIF Fabrice ... Biologie et médecine du développement et de la reproduction GUYETANT Serge ... Anatomie et cytologie pathologiques
GYAN Emmanuel ... Hématologie, transfusion HAILLOT Olivier ... Urologie
HALIMI Jean-Michel ... Thérapeutique HANKARD Régis... Pédiatrie
HERAULT Olivier ... Hématologie, transfusion HERBRETEAU Denis ... Radiologie et imagerie médicale HOURIOUX Christophe ... Biologie cellulaire
LABARTHE François ... Pédiatrie
LAFFON Marc ... Anesthésiologie et réanimation chirurgicale, médecine d’urgence LARDY Hubert ... Chirurgie infantile
LARIBI Saïd ... Médecine d’urgence LARTIGUE Marie-Frédérique ... Bactériologie-virologie
LAURE Boris ... Chirurgie maxillo-faciale et stomatologie LECOMTE Thierry ... Gastroentérologie, hépatologie
LESCANNE Emmanuel ... Oto-rhino-laryngologie LINASSIER Claude ... Cancérologie, radiothérapie MACHET Laurent ... Dermato-vénéréologie MAILLOT François ... Médecine interne MARCHAND-ADAM Sylvain ... Pneumologie
Faculté de Médecine – 10, boulevard Tonnellé – CS 73223 – 37032 TOURS Cedex 1 – Tél : 02.47.36.66.00 – www.med.univ-tours.fr 3 MARRET Henri ... Gynécologie-obstétrique
MARUANI Annabel ... Dermatologie-vénéréologie
MEREGHETTI Laurent ... Bactériologie-virologie ; hygiène hospitalière MORINIERE Sylvain ... Oto-rhino-laryngologie
MOUSSATA Driffa ... Gastro-entérologie MULLEMAN Denis ... Rhumatologie ODENT Thierry ... Chirurgie infantile OUAISSI Mehdi ... Chirurgie digestive OULDAMER Lobna ... Gynécologie-obstétrique
PAGES Jean-Christophe ... Biochimie et biologie moléculaire
PAINTAUD Gilles ... Pharmacologie fondamentale, pharmacologie clinique PATAT Frédéric ... Biophysique et médecine nucléaire
PERROTIN Dominique ... Réanimation médicale, médecine d’urgence PERROTIN Franck ... Gynécologie-obstétrique
PISELLA Pierre-Jean ... Ophtalmologie PLANTIER Laurent ... Physiologie
REMERAND Francis ... Anesthésiologie et réanimation, médecine d’urgence ROINGEARD Philippe ... Biologie cellulaire
ROSSET Philippe ... Chirurgie orthopédique et traumatologique RUSCH Emmanuel ... Epidémiologie, économie de la santé et prévention SAINT-MARTIN Pauline ... Médecine légale et droit de la santé
SALAME Ephrem ... Chirurgie digestive
SAMIMI Mahtab ... Dermatologie-vénéréologie
SANTIAGO-RIBEIRO Maria ... Biophysique et médecine nucléaire THOMAS-CASTELNAU Pierre ... Pédiatrie
TOUTAIN Annick ... Génétique
VAILLANT Loïc ... Dermato-vénéréologie VELUT Stéphane ... Anatomie
VOURC’H Patrick ... Biochimie et biologie moléculaire WATIER Hervé ... Immunologie
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PROFESSEURS ASSOCIES
MALLET Donatien ... Soins palliatifs POTIER Alain ... Médecine Générale ROBERT Jean ... Médecine Générale
MAITRES DE CONFERENCES DES UNIVERSITES - PRATICIENS HOSPITALIERS
BAKHOS David ... Physiologie BARBIER Louise... Chirurgie digestive
BERHOUET Julien ... Chirurgie orthopédique et traumatologique
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CAILLE Agnès ... Biostat., informatique médical et technologies de communication CLEMENTY Nicolas ... Cardiologie
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FAVRAIS Géraldine ... Pédiatrie
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GOUILLEUX Valérie... Immunologie GUILLON Antoine ... Réanimation
GUILLON-GRAMMATICO Leslie ... Epidémiologie, économie de la santé et prévention HOARAU Cyrille ... Immunologie
IVANES Fabrice ... Physiologie
LE GUELLEC Chantal ... Pharmacologie fondamentale, pharmacologie clinique MACHET Marie-Christine ... Anatomie et cytologie pathologiques
MOREL Baptiste ... Radiologie pédiatrique
PIVER Éric ... Biochimie et biologie moléculaire
REROLLE Camille ... Médecine légale
ROUMY Jérôme ... Biophysique et médecine nucléaire SAUTENET Bénédicte ... Néphrologie
TERNANT David ... Pharmacologie fondamentale, pharmacologie clinique ZEMMOURA Ilyess ... Neurochirurgie
MAITRES DE CONFERENCES DES UNIVERSITES
AGUILLON-HERNANDEZ Nadia ... Neurosciences BOREL Stéphanie ... Orthophonie DIBAO-DINA Clarisse ... Médecine Générale
MONJAUZE Cécile ... Sciences du langage - orthophonie PATIENT Romuald... Biologie cellulaire
RENOUX-JACQUET Cécile ... Médecine Générale
MAITRES DE CONFERENCES ASSOCIES
RUIZ Christophe ... Médecine Générale SAMKO Boris ... Médecine Générale
CHERCHEURS INSERM - CNRS - INRA
BOUAKAZ Ayache ... Directeur de Recherche INSERM – UMR INSERM 1253 CHALON Sylvie ... Directeur de Recherche INSERM – UMR INSERM 1253 COURTY Yves ... Chargé de Recherche CNRS – UMR INSERM 1100 DE ROCQUIGNY Hugues ... Chargé de Recherche INSERM – UMR INSERM 1259 ESCOFFRE Jean-Michel ... Chargé de Recherche INSERM – UMR INSERM 1253 GILOT Philippe ... Chargé de Recherche INRA – UMR INRA 1282 GOUILLEUX Fabrice ... Directeur de Recherche CNRS – UMR CNRS 7001 GOMOT Marie ... Chargée de Recherche INSERM – UMR INSERM 1253 HEUZE-VOURCH Nathalie ... Chargée de Recherche INSERM – UMR INSERM 1100 KORKMAZ Brice ... Chargé de Recherche INSERM – UMR INSERM 1100 LAUMONNIER Frédéric ... Chargé de Recherche INSERM - UMR INSERM 1253 LE PAPE Alain ... Directeur de Recherche CNRS – UMR INSERM 1100 MAZURIER Frédéric ... Directeur de Recherche INSERM – UMR CNRS 7001 MEUNIER Jean-Christophe ... Chargé de Recherche INSERM – UMR INSERM 1259 PAGET Christophe ... Chargé de Recherche INSERM – UMR INSERM 1100 RAOUL William ... Chargé de Recherche INSERM – UMR CNRS 7001 SI TAHAR Mustapha ... Directeur de Recherche INSERM – UMR INSERM 1100 WARDAK Claire ... Chargée de Recherche INSERM – UMR INSERM 1253
CHARGES D’ENSEIGNEMENT Pour l’Ecole d’Orthophonie
DELORE Claire ... Orthophoniste GOUIN Jean-Marie ... Praticien Hospitalier PERRIER Danièle ... Orthophoniste Pour l’Ecole d’Orthoptie
LALA Emmanuelle ... Praticien Hospitalier MAJZOUB Samuel... Praticien Hospitalier Pour l’Ethique Médicale
BIRMELE Béatrice ... Praticien Hospitalier
SERMENT D’HIPPOCRATE
E n présence des Maîtres de cette Faculté, de mes chers condisciples
et selon la tradition d’Hippocrate,
je promets et je jure d’être fidèle aux lois de l’honneur et de la probité dans l’exercice de la Médecine.
Je donnerai mes soins gratuits à l’indigent,
et n’exigerai jamais un salaire au-dessus de mon travail.
Admis dans l’intérieur des maisons, mes yeux ne verront pas ce qui s’y passe, ma langue taira
les secrets qui me seront confiés et mon état ne servira pas à corrompre les mœurs ni à favoriser le crime.
Respectueux et reconnaissant envers mes Maîtres, je rendrai à leurs enfants
l’instruction que j’ai reçue de leurs pères.
Que les hommes m’accordent leur estime si je suis fidèle à mes promesses.
Que je sois couvert d’opprobre et méprisé de mes confrères
si j’y manque.
Remerciements :
A Monsieur le Professeur Dominique Babuty :
Merci de me faire l’honneur de présider le jury de cette thèse. Veuillez trouver ici l’expres- sion de mes sincères remerciements et de mon profond respect.
A Monsieur le Professeur Denis Angoulvant :
Vous avez montré un intérêt au sujet de cette thèse, et vous me faites l’honneur de juger ce travail. Veuillez trouver ici l’expression de mes sincères remerciements.
A Monsieur le Professeur Laurent Fauchier :
Je vous remercie, pour l’implication que vous avez eu lors de ma formation passée. Merci d’avoir accepté de participer au jury de cette thèse. Veuillez trouver ici l’expression de mes sincères remerciements et de mon profond respect.
A Monsieur le Docteur Bernard Desveaux :
Merci d’abord d’avoir accepté de juger ce travail et faire partie du jury. Je n’oublierai ja- mais la passion dont tu as fais preuve afin de faire de nous de bons cardiologues. Merci d’avoir tou- jours été là pour nous et comme l’a exprimé un grand réalisateur italien en intitulant l’un de ses très beaux films : « nous t’avons tant aimé ».
A Monsieur le Docteur Christophe Saint-Etienne
Je te remercie pour la pédagogie dont tu as fais preuve et de m’avoir fait aimer la cardiologie interventionelle bien que je n’ai pas choisi cette voie. Merci pour ta confiance, ta disponibilité et d’avoir accepté de diriger cette thèse.
Table des matières
1 ABBREVIATIONS 2 INTRODUCTION
3 MATERIAL AND METHODS 3.1 Study
3.2 Patients 3.3 Procedure 3.4 Data 3.5 Endpoints 3.6 Statistics 4 RESULTS
4.1 Comparisons with Surgical TAVR 4.1.1 Baseline characteristics 4.1.2 Procedure’s characteristics 4.1.3 Outcomes
4.2 Comparisons with France TAVI registry 4.2.1 Baseline characteristics
4.2.2 Procedure’s characteristics 4.2.3 Outcomes
5 DISCUSSION
6 CONCLUSION
7 REFERENCES
8 FIGURES
9 TABLE
1 ABBREVIATIONS
BARC : Bleeding Academic Research Consortium CCU : Critical Care Unit
EPE : Electrophysiologic Exploration ESC : European Society of Cardiology ICCU : Intensive Cardiac Care Unit NYHA : New York Heart Association PPM : Permanent Pacemaker
SAVR : Surgical Aortic Valve Replacement STS : Society of Thoracic Surgeons
TAVI : Transcatheter Aortic Valve Implantation TEE : Trans-Esophageal Echography
TTE : Trans-Thoracic Echocardiography
VARC-2 : Valve Academic Research Consortium 2
2 INTRODUCTION
Aortic stenosis is a valvulopathy defined by the narrowing of the valvular aortic area.
The prevalence of moderate or severe AS was age-dependent from a low of 0.02% in subjects aged 18–44 years to a high of 2.8% in patients aged ≥ 75 years
1. Thererfore it is the most common valvuopathy in our developed countries
The main cause of aortic stenosis is the valvular degeneration, so called Möncke- berg’s disease. The valve looks remodelled and calcified. Other less common aetiolo- gies, are the congenital heart disease known as biscupid aortic valve and rheumatic causes
2-3.
Asymptomatic for a long time, patients progressively developed : dyspnea, chest pain and even lipothymie or syncope most of the time during physical exertion Trans-tho- racic echography (TTE) is the best non-invasive test for the diagnosis. European guidelines define that aortic stenosis is severe when the transvalvular aortic gradient is superior to 40 mmHg, the maximum aortic systolic velocity is above 4 m/s and/or the aortic valvular area is under 1 cm
2or 0,6 cm
2/m
2 4(Figure 1).
Surgical aortic valvular replacement (SAVR) is the historic treatment fore severe symptomatic aortic stenosis. However, this approach remains associated with poor outcomes when performed on high risk or contra-indicated patients (open heart surgery, endotracheal ventilation, stay in intensive care unit
5). Since 2002 Tran- scatheter Aortic Valve Implantation (TAVI) has been developed to offer an alternative for these patient
6. In the PARTNER-I trial, patients with severe aortic stenosis who where not suitable candidates for surgery, TAVI, has compared with standard therapy significantly reduced the rates of death from any cause
7. It appears now as the gold standard treatment for all patients with a high surgical risk
5-7. More recent studies highlight that TAVI is a reasonable alternative to SAVR among the intermediate risk population
8. European society of cardiology’s (ESC) guidelines, from 2017, recom- mend TAVI rather than SAVR in patients with an Euroscore II > 4% after discussion in Heart Team and in the absence of contraindications
4(Figure 2).
Different anatomical accesses (transfemoral, transcarotid, subclavian, direct aortic,
transapical) have been developped to enable TAVI procedure in almost a majority of
patients with aortic stenosis. Choice of the access depends on caliber and calcifica- tions of the femoral artery. Indeed, femoral approach, by its lower complication risk, is the first choice
9. In Partner II study, transfemoral approach is associated with a mortality rate reduced twice compared to transapical and direct aortic approaches among high-risk populations
10.
At first, TAVI required a general anaesthesia in order to implant the valve and to per- form Trans-Esophageal Echography control (TEE). However, local anaesthesia, with similar results, is associated with better surgical outcomes and a reduction of hospital costs
11-14.
Valves’ design and deployment technics are in constant progression. Medtronic Corevalve EvolutR is a partially recapturable valve such as allowed the reduction of expansion complications and post-procedure aortic regurgitations. Furthermore, shealth diameter’s reduction and arterial closure technic’s improvement reduced the outcome of vascular complications. In PARTNER I-B cohort, vascular complications were estimated to 16.2% with Edwards Sapien valve in 2010
7. Forward study, pub- lished in 2017, finds a rate of major vascular complications of 6.5% with the Corevalve EvolutR valve
15.
Technical evolutions associated with a greater expertise acquired by the intervention- al cardiologists reduced the procedure duration, hospital length of stay and improved patients’ tolerance. Thus TAVI is a more standardized and predictable procedure re- sulting in an earlier patient’s discharge and in a reduction of medical costs
16-17.
With these new elements, a « minimalist » approach has been chosen by some cardio-
logic centres. The vascular access is only made by the femoral artery after a local
anesthesia and a minimalist analgesia. The valve’s position control is made after the
deployment by a TTE. The procedure usually takes place in the cath lab, easier to ac-
cess than the hybrid room. Babaliaros and al. have described a minimalist approach,
with minimal morbidity and mortality and equivalent effectiveness compared with
standard approach, using local anesthesia, minimal conscious sedation and fully per-
cutaneous access site, where anesthesiologist were not needed. Furthemore, studies
have demonstrated feasibility and safety of the femoral artery access under local anesthesia
18-23.Disadvantages of this technic are both the lack of local guidance by TEE and a harder surgical conversion in case of severe issues. New TTE machines, with better perfor- mances, allow to avoid TOE control to verify the good position of the valve and the lack of aortic regurgitation.
Currently, only a few studies have compared outcomes between surgical and percuta- neous access
24. Moreover, safety, efficacy and outcomes of the minimalist approach remains unclear.
Therefore, we conducted a retrospective study in our center based on our local exper-
iment of minimalist approach, in order to assess safety and efficacy of this technic.
3 MATERIAL AND METHODS
3.1 Study
Our study was a monocentric one, lead in the cardiology department of Tours’Uni- versity Hospital Center from January the first 2016 to December the 31th 2017.
In a first time, we compared initial characteristics, procedure datas and patients’ out- comes from our cohort of TAVI with minimalist approach to a cohort composed of patients who benefited from TAVI with a surgical approach. In a second time, our co- hort was compared to the French national observational registrer, FRANCE TAVI, lead by the French Society of Cardiology. This register includes all the patients who underwent a TAVI during the year 2015.
3.2 Patients
Inclusion criteria were : a severe aortic stenosis confirmed by a trans thoracic echocardiography including a mean gradient above 40 mmHg, a maximal systolic peak speed > 4 m/s, an aortic area < 1 cm
2(ou < 0,6 cm
2/m
2) in patients complaining from a dyspnea estimated as II or above in New York Heart Association’s classifica- tion and who underwent a TAVI by minimalist approach. Itself defined by : a proce- dure lead under local anesthesia by percutaneous femoral access, without the pres- ence of an anaesthesiologist, without a systematically pre-implant balloon valvulo- plasty, with a systematically angiographic control and an echocardiographic control on demand.
Exclusion criteria were : patients who underwent another arterial access, a general
anesthesia a surgical femoral access or a systematically predilatation.
3.3 Procedure
Either balloon-expandable SAPIEN 3 (Edwards Lifescience, Irvine, CA, USA) or auto-expandable valve COREVALVE EVOLUT R (Medtronic, Inc., Minneapolis, MN, USA) were implanted.
All procedures were lead either in a hybrid room or in the cath lab. The procedure was performed by at least two cardiologists assisted by two nurses and one radio ma- nipulator (one of them dedicated to the valve’s setting).
Arterial access was chosen according to arterial diameter, aortic calcifications and ar- terial tortuosity highlighted by an aortic tomodensitometry.
Local anesthesia at the ponction site was realized by 2% Lidocaine and MEOPA was used in case of severe anxiety. Patients were washed, prepared by the paramedics to obtain the most rigorous sterility according to the local guidance.
Either fluoroscopic or femoral ultrasounds guidance were used to guide the femoral ponction. Control TTE was realized by a cardiologist trained in echocardiography with a VIVID S6 (General Electric, Boston, MA, USA).
Two PROGLIDE arterial closures (Abbott, Chicago, IL, USA) were used.
At the beginning of the study, all patients were transferred after the procedure to the intensive cardiac care unit (ICCU) for a minimum of 24-hour monitoring according to the usual guidelines. Then, some patients, meeting strict standards (no catheco- lamines support, no vascular damages, low risk of conductive disorder), were trans- ferred to our conventional cardiological department under telemetric monitoring. A hospitalization in a Critical Care Unit were sometimes needed by some patients due to a severe complication or to a kidney failure requiring dialysis after the procedure.
A doppler of the scarpa was performed twenty four hours after the procedure and be-
fore the first raising. A echocardiography was performed before discharge and 30
days after.
3.4 Data
Data were collected retrospectively from patients’ computerized medical files using the hospital software. The data were prospectively collected in the database all along patients’ stay.
Procedure’s success rates and complications were evaluated according to Valve Academic Research Consortium 2 (VARC-2) and Bleeding Academic Research Consortium (BARC) for hemorrhagic ones
25-26.
3.5 Endpoints
The principal end-point was one-month mortality.
Secondary end-points were : in-hospital mortality, one-year mortality, length of ICU stay, total length of stay, existence of aortic regurgitation, of valve migration during the procedure, of vascular or haemorragic complications at the femoral site, of trans- fusions, of aortic annulus’rupture, aortic dissection, tamponnade, stroke, the need for a pacemaker implantation and occurence of infection.
3.6 Statistics
Data were described as median or mean for quantitative variables, and frequency and percentage for qualitative variables. All statistical tests were two-tailed with a signifi- cance threshold of 0.05. Analyses were performed with Excel (Microsoft, Redmond, WA, USA). In univariate analysis, quantitative variables were compared using Chi2 test and qualitative variables were compared using Student test.
Data collection and analyses were conducted in accordance with the French national
guidelines : under the French law, retrospective study using data from medical chart
require only a declaration to the Commission nationale Informatique et Libertés. The
hospital’s computerized database was declared at this commission. There is no re-
quirement of a declaration to an ethic committee.
4 RESULTS
4.1 Comparisons with Surgical TAVI 4.1.1 Baseline characteristics :
From January, the first of 2016 to December, the thirty one of 2017, 365 trans-aor- tic valvular replacement have been performed in the University Hospital Center of Tours, including 294 by minimalist approach. Flow chart is described in figure 3.
By the same time, twenty-six surgical TAVI were performed : 12 transcarotid, 1 transapical, 1 subclavian and 12 trans-aortic.
Main patients’ characteristics are shown in table 1. Mean age was 84 ± 0.7 year-old and 151 patients (51%) were men, compared to 80 ± 2.7 year-old with 20 men (74%) in the surgical cohort (P = 0,001). Euroscore II was similar between the two groups (5.4 ± 0.5 vs 7.8 ± 3.6, P = 0.20) . So was the STS score (5.3 ± 0.6 vs 4.9 ± 1.2, P = 0.67). No difference was shown in initial patients’ characteristics except for the peripheral arterial disease(6.8% vs 41%, P < 0.0001) and the history of sur- gical TAVI (2.7% vs 15%, P = 0,001).
4.1.2 Procedure’s characteristics :
Procedure’s characteristics are described in Table 2. 179 Corevalves EvolutR (61%)
et 114 Sapien 3 (39%) were implanted in the minimalist group compared to 14 Co-
revalves EvolutR (52%) and 13 Sapien 3 (48%) in the surgical TAVI. General
anaesthesia was used in 13 procedures (48%) in the surgical group. No significant
difference were shown for the others procedure characteristics..
4.1.3 Outcomes :
Patients’ outcomes are shown in table 3. In-hospital mortality rate was 1.7% in the minimalist group compared to 0% in the surgical one(P = 0.50). One-month mor- tality rate was 3.4% compared to 0%, (P = 0.34), one-year mortality rate 11% vs 11%, (P = 0.93). Four patients (1.4%) in the minimalist groupe compared to sixteen patients (59%) in the surgical one required a hospitalization in a critical care unit (P
< 0.0001). Patients from the minimalist group remained hospitalized 6 ± 0,4 days versus 7,9 ± 1.7 days (P = 0.028) in the surgical one. Median length of stay in ICU of minimalist group was 1.1 ± 0.2 days compared to 2.1 ± 0.6 days in the control group (P = 0.04). Less infections were described in the minimalist group (0.7% vs 7%, P = 0.0027). Transfusion was less often needed in the minimalist group (1% vs 11%, P = 0.0002) compared to the surgical approach. No significant difference was seen for valve migration, at least medium aortic regurgitation, vascular complica- tions, strokes and the need for a pace-maker implantation.
4.2 Comparisons with France TAVI registry 4.2.1 Baseline characteristics :
From January, the first to December the thirty one of 2015, 4293 patients were in- cluded in the France TAVI register. Mean age was 83 ± 7.3 years old and 2122 pa- tients (49%) were male. Patients’ main characteristics are described in Table 1.
51 % patients of the minimalist cohort suffered from a NYHA III or IV dyspnea compared to 63% in the France TAVI cohort (P = 0.015).
Signifiant differences were described between the groups for peripheral arteriopa-
thy (6.8% vs 21%, P < 0.0001) and for medical history of coronary artery bypass
grafting (4.4% vs 9.9%, P = 0.003).
4.2.2 Procedure’s characteristics :
Procedure’s characteristics are shown in Table 2.
In France TAVI, 3015 valves SAPIEN 3 were implanted (70% vs 39%, P <
0.0001). So were 1230 Corevalve (28% vs 61%, P < 0.0001).
47 % of procedures required a general anaesthesia. In 83% of cases, a trans-femoral access was chosen and in 27%, a trans-oesophageal US was needed in order to control the valve deployment. No significant differences were shown between France TAVI and our minimalist cohort for device failure, two valves implanted or more and surgical conversion.
4.2.3 Outcomes :
Outcomes are described in Table 3.
One-month mortality was 3.3% in France TAVI compared to 3.4% in our minimal- ist cohort (P = 0.96).
47% of patients from the minimalist cohort et 28% from patients of France TAVI remained hospitalised from 1 to 5 days (P < 0.0001), Respectively, 40% and 45%
stayed at the hospital from 6 to 9 days (P = 0.21) and 14% and 26% more than 10 days (P < 0.0001).
No tamponnade was described in our cohort compared to 1.9% in France TAVI re-
gister (P = 0.018). 2% of at least mild aortic regurgitation were observed at one
month in our cohort compared to 8.7% in France TAVI (P = 0.0001). Respectively,
26% compared to 18.4% of patients required the implantation of a permanent pa-
cemaker (P = 0.005). No significant differences were described for aortic ruptures,
aortic dissections, valve migration and stroke incidence.
5 DISCUSSION
To our knowledge, our study was the first one to evaluate safety and efficiency of a wholly minimal approach in trans aortic valvular implantation. Feasibility and safety of the minimalist approach have been compared to TAVI driven under a surgical ap- proach and to a national cohort including all TAVI performed in France whatever the approach was.
No deleterious effects were shown for the minimalist approach compared to the sur- gical one and to the France TAVI cohort regarding the primary end-point which was mortality at one-month.
No significant difference was demonstrated on in-hospital, one-month and one-year mortalities between minimalist and surgical approach. In our surgical cohort, the ac- cess was mostly a transcarotid one, explaining why the mortality rate was so low compared to the surgical approach in PARTNER II. Indeed, in PARTNER II, the ac- cesses were only transaortic and transapical with a 23 % mortality.
Moreover, no significant difference was shown on mortality at one-month between our cohort and France TAVI.
However, minimalist approach was associated with a shorter length of hospital stay and with fewer admissions in Critical Care compared to the surgical TAVI. The usual length of stay in Intensive Care for patients with minimalist approach was right above 24-hour for a closer surveillance after procedure and 4 % patients were directly orien- ted to the conventional ward.
Compared to France TAVI, length of hospital stay was shorter in the minimalist group and almost a half of our cohort stayed in the hospital less than five days. By reducing the hospital length of stay, we may hope a reduction of hospital costs. Its impact could be study in a second time.
Moreover, minimalist approach was associated with a reduction of complication rates related to vascular access : less hemorrhagic events were recorded compared to the surgical group with a lower transfusion rate.
At the beginning of the minimalist approach, femoral access was obtained by fluoro-
vascular complications. Closer studies of this technic with a larger cohort of patients would be helpful in order to access the benefits of echographic guidance in TAVI.
Then, in the minimalist approach, infections were less often recorded than in the sur- gical cohort.
Compared to France TAVI cohort, less tamponnades were observed. This may be ex- plained by an experience gathered through the years by interventional cardiologists and valve deployment technics which improved reducing the risk of aortic annulus’s rupture. In 2015, temporary transvenous cardiac pacing catheters were used with a higher risk of tamponnade while ballooned temporary cardiac pacing with balloon- tipped pacing catheters were used in our entire cohort.
Moreover, less aortic regurgitations were described in our cohort, especially medium to severe ones, compared to France TAVI. In 2015, the launching of Corevalve EVO- LUT R can explain this difference. This valve is, indeed, a recatchable one. It can be positioned again in an optimal way if needed by the interventional cardiologists in order to reduce aortic regurgitations after the procedure. The exact number of Core- valve EVOLUT R implanted in 2015 in France TAVI is not known. However, its ge- neralisation dated from the end of 2015 while in our minimalist cohort, 61% of our patients benefited from a Corevalve EVOULT R.
Furthermore, the implantation of an auto-extensible valve was associated in some studies with a higher risk of ranking conductive disorder requiring a permanent pa- cemaker (PPM)
25. Thus, more PPM were implanted in our cohort in a significative way compared to France TAVI (61% vs 28%). Nowadays, no recommendations have been made concerning the indication of a PPM implantation after a trans-aortic val- vular implantation. In our cohort, when a ranking conductive disorder appeared in the following of the procedure, a electrophysiologic exploration (EPE) was systematical- ly conducted in order to search a atrioventricular block. This systematization of EPE may explain the higher rate of PPM implanted in our cohort
26.
General anaesthesia allows to obtain a stability at the moment of the valve deploy-
ment and a TOE control. Theoretically, the combination of these two technics should
reduce the risk of aortic regurgitation. But, in France TAVI, only 27% of patients be-
nefited from a TOE at the deployment time and less aortic regurgitations have been described in our minimalist approach.
At the beginning of our experiment, systematic predilatations were made. They were secondarily stopped and excluded from our definition of minimalist approach. In 2016 and 2017, 88% of procedures underwent under local anaesthesia and with a transfemoral access.
The very low rate of procedure failure (1,0%) in our cohort underlines the efficiency of the minimalist approach and its feasibility by a transfemoral access in a large pro- portion even with a rate of 6.8 % of peripheral artery disease in our cohort.
With a low number of patients included, our study lacked of strength to demonstrate a reduction of mortality with the minimalist approach compared to the surgical ap- proach and to France TAVI register. Moreover, our study was a monocentric retros- pective one reducing its applicability.
We chose to compare our results to France TAVI, a national register, lead by the French Society of Cardiology which inventories all patients benefiting from a TAVI in France. This register includes all TAVI even TAVI realised by a minimalist ap- proach implying a new bias. This strategy was hardly used in 2015. Indeed, in France TAVI, 47 % of procedure underwent under general anaesthesia and 17% of vascular accesses were different from a transferral access used in the minimalist approach.
A larger resort of the minimalist approach should be evaluated in a second time. No- wadays, other teams, preferentially use, like ours, minimalist approach with convin- cing results.
6 CONCLUSION
The minimalist approach has no deleterious impact on mortality and is associated
with shorter length of hospital stay and better results compared to surgical approach
and to France TAVI register.
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8 Figures
Figure 1. ESC guidelines for assessment of aortic stenosis
Figure 2. ESC guidelines for management of aortic stenosis
9 Tables
Vu, le Directeur de Thèse
Vu, le Doyen
De la Faculté de Médecine de Tours Tours, le
NAËL Julien
36 pages, 3 figures, 3 tableaux Résumé :
Contexte : La voie d’abord transfémorale percutanée est associée à de meilleurs résultats lors- qu’elle est possible et de récentes études concluent à la faisabilité de la procédure de remplacement valvulaire aortique percutané (TAVI) sous anesthésie locale. La stratégie minimaliste associant un accès transfémoral sous anesthésie locale est en cours de développement mais sa sécurité et son ef- ficacité reste inconnue.
Objectif : Evaluer l’efficacité et la sécurité de l’approche minimaliste dans les TAVI.
Méthodes : Entre Janvier 2016 et Décembre 2017, 368 personnes présentant un rétrécissement aor- tique aortique serré symptomatique ont bénéficié d’un TAVI au CHU de Tours. Parmi ces patients, nous avons étudiés rétrospectivement les patients qui ont bénéficié d’une approche minimaliste. Les caractéristiques initiales, les données de procédure et les résultats ont été comparés aux TAVI chi- rurgicaux et aux patients inclus dans le registre France TAVI en 2015.
Résultats : Il y avait 294 patients inclus dans la cohorte minimaliste, 27 TAVI chirurgicaux et 4293 patients inclus dans France TAVI. Il n’y avait pas de différence significative sur la mortalité à un mois comparée aux TAVI chirurgicaux (3.4% vs 0%, P = 0.34) et au registre France TAVI (3.3%, P
= 0.96). Les TAVI minimalistes étaient associés à une durée d’hospitalisation plus courte (6 ± 0.4 vs 7,9 ± 1.7 jours, P = 0.028) ainsi qu’un séjour plus court en soins intensifs (1.1 ± 0.2 vs 2.1 ± 0.6 jours, P = 0.04) que les TAVI chirurgicaux. Il y avait également moins d’infections (0.7% vs 7%, P
= 0.0027), moins de transfusions (1% vs 11%, P = 0.0002) et moins d’hospitalisations en réanima- tion (1.4% vs 59%, P < 0.0001) chez les TAVI minimalistes. Comparés au registre France TAVI, les patients de la cohorte minimaliste ont présenté moins de tamponnades (0% vs 1,9%, P = 0.018), moins de de fuites aortiques grade III ou IV (2% vs 8.7%, P = 0.0001) mais d’avantage ont été im- plantés d’un stimulateur cardiaque après la procédure (26% vs 18.4%, P = 0.005).
Conclusion : L’approche minimaliste dans les TAVI n’a pas d’impact sur la mortalité et est associé à une durée d’hospitalisation plus courte et de meilleurs résultats comparés aux TAVI chirurgicaux et aux patients inclus dans le registre France TAVI.
Mots clés : Rétrécissement aortique, TAVI, approche minimaliste, mortalité, efficacité.
Jury :
Président du Jury : Professeur Dominique BABUTY
Directeur de thèse : Docteur Christophe SAINT ETIENNE Membres du Jury : Professeur Denis ANGOULVANT
Professeur Laurent FAUCHIER Docteur Bernard DESVEAUX Date de soutenance : Lundi 22 Octobre
