Connaître l'anatomie de l'auricule gauche Dr Ciobotaru Vlad Unité d’exploration des cardiopathies valvulaires et structurelles Hôpital Privé Les Franciscaines, Nîmes CEO 3DHeartModeling
Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company • Grant/Research Support • Boston Scientific, Philips, AG2RFoundation, Region Occitanie, BRL • Consulting Fees/Honoraria • Philips, • Major Stock Shareholder/Equity • none • Royalty Income • none • Ownership/Founder • 3DHeartModeling • Intellectual Property Rights • 3DHeartModeling • Other Financial Benefit • none
Backgroud: LAA closure One third of patients at moderate/high risk of stroke fail to receive OAC Alternative to OAC treatment is mandatory 2 randomized trials and registries from expert centers: favorable outcome and low morbidity for 2 devices 2016 ESC Guidelines for AF: class IIb in patients with CI to OAC
3D TEE method of landing zone measurements In an ideal world
Data from FLAAC registry: 57% thromboembolic events reduction but caution to serious complications in some patients LAAC should be made on an individual basis and integrate a preprocedural assessment of risk/benefice ratio 7.2% > 2devices 96% successful after 1 procedure 2.3% two procedures 7.2% procedure-related Serious Adverse Events Percutaneous Left Atrial Appendage Closure Is a Reasonable Option for Patients With Atrial Fibrillation at High Risk for Cerebrovascular Events, Volume: 11, Issue: 3, DOI: (10.1161/CIRCINTERVENTIONS.117.005841)
US FDA Manufacturer and User Facility Device Experience (MAUDE) database TCT 2019 Of nearly 3,000 adverse events reported to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database, 2015-2018 Watchman device • 42% involved pericardial effusion, ( Pericardiocentesis 62% ; Open-heart surgery 16.9% ) • 11% thrombus, • 5.7% cerebrovascular accident, and • 5% device embolization. • There were also about 211 deaths Awareness of, and preparation for, the management of procedural complications can increase patient safety and improve the risk-benefit ratio for LAA closure. Further improvements in the technology and refinements in the implanting techniques should be focused at preventing this dreaded complication
Inappropriate implantations
TOE and CT : multiple plane analysis X Iriart, V Ciobotaru Arch Cardiovasc Dis. 2018 Jun Korsholm K and col JACC Cardiovasc Interv. 2019 Oct 23
Manufacturers’ recommendations are based only on the LAA neck diameter . Procedural risk depends on: Anatomical Factors Procedural Factors Shape, Inter atrial Puncture site Depth, Shape of Catheter Diameter of the neck Catheter alignment Ellipticity, Prothesis type and shape Orientation of LAA ostium LAA position Pulmonary Ridge preeminence, LA volume, Size of interatrial Fossa Angle from fossa to LAA ostium
Shape: A Small LAA With Protruding Pectinate Muscles A. LAA gram (RAO 35 0 /caudal 11 0 ) showing small LAA with prominent pectinate muscles. Note : position of distal marker of the delivery catheter (DC) B A. Small, shallow LAA B. Small, shallow LAA B. LAA gram (RAO 35 0 /caudal 11 0 ) of the anterior lobe showing prominent pectinate muscles. D. Prominent pectinate muscles, Note: distal marker of DC C. Small, shallow LAA depth 13 mm
Watchman Device Implantation C B A Protrusion < 4.2 mm A. Watchman device (24 mm) deployed, all B. Watchman device C. Tug test was satisfactory. LAA lobes covered, compression was appeared deformed by good (26%), no leakage, tug test was pectinate muscles good, mild protrusion to LA Immediately after release, Watchman device was embolized to the LA – LV - aorta
Depth + Ellipticity:
Depth + Ellipticity:
Depth+shape:
Depth+shape:
Retro-Orientation of a small LAA
Shape: bilobed Auricule bilobé avec ridge interne proéminent 24x31mm 16x18mm
Shape: bilobed
Shape: bilobed In situ Amulet 25 Couvrir l’ostium avec un disc plus large avec une surcompression du lobe
Pulmonary Ridge preeminence :
Angle from fossa to LAA ostium : Long distance between IVC outlet and IAS, Short distance between IAS and LAA orifice, and higher angle between IAS and LAA orifice normal vectors might be good predictors for incomplete LAA occlusion JACC March 21, 2017 Volume 69, Issue 11
Inter atrial Puncture site Shape of Catheter & Catheter alignment In situ: misalignment Off axis Simulation Off-axis simulation Optimal 3D printing guide the transseptal puncture Ciobotaru V; EuroIntervention. 2018 Jun 20;14(2):176-184
Inter atrial Puncture site Shape of Catheter & Catheter alignment SIMULATION DE PONCTION POSTERO-INFERIEURE post ant Exemple de ridge prononcé avec un LAA orienté vers l’arrière inf post ant inf ant inf SIMULATION DE PONCTION ANTERO-INFERIEURE
3D Printing simulation accurately predicts procedures risks
SCHEMATISATION DES SITES DE PONCTION TRANSSEPTALE INF-POST et INF-ANT VCS Ao ARR TEE35° AVANT TEE10° Mi MED-INF TEE110° VCI ANT-INF TEE90° POST-INF vcs SUP-POST vcs vci
Retro-Orientation of LAA, large ostium
Korsholm K and col JACC Cardiovasc Interv. 2019 Oct 23
Clinical Impact of 3D Printing Sizing
LAA-Print French Registry: recruited 250 patients in 16 centres Unique Protocol ID: * ClinicalTrials.gov ID: NCT03330210 RECHMPL17_0230 Use lay language. Brief Title: * Left Atrial Appendage Occlusion Guided by 3D printing Acronym: LAA-Print registry National Longitudinal Registry for Mid-Term Clinical Outcome And Procedure Efficacy Evaluation In Using A Novel Official Title: * Preprocedural Planning Method For Left Atrial Appendage Occlusion Guided By 3D Printing Study Start: Jan 18th, 2018 Observational Study Type: * Interventional ongoing Expanded access to predict the risk of procedural complications National Longitudinal Registry for Mid-Term Clinical Outcome And Procedure Efficacy Evaluation In Using A Novel Clinical to Improve Safety: by decreasing operating time and Official Title: * Preprocedural Planning Method For Left Atrial Appendage complications aim : Occlusion Guided By 3D Printing
Thanks to Hôpital Privé les Franciscaines :- Nîmes (30) - Dr Penelope Pujadas Clinique Pasteur – Toulouse (31) – Dr Nicolas Combe Polyclinique les fleurs – Ollioules (83)- Dr Philippe Commeau Hopital privé Clairval – Marseille (13) – Dr Edouard Cheneau Grants : Clinique Arnaud Tzank – Saint Laurent du Var (06) – Dr Alain Mihoubi CHU Grenoble – Grenoble (38) – Pr Pascal Defaye, Dr Peggy Jacon AG2RFondation CH Henri Mondor – Créteil (94) – Dr Julien Ternacle ; Dr Annabelle Nguyen Pr Teiger Region Occitanie CHU Bordeaux – Bordeaux (33) – Dr Xavier Iriart ; Dr Reda Jakamy Pr Thambo BRL, Philips, Hopital Marie Lannelongue – Le Plessis Robinson (92) – Dr Sébastien Hascoet Boston Scientific, Hopital européen de Marseille – Marseille (13) – Dr Sébastien Armero CHU HEGP – Paris (75) – Dr Eloi Marijon Centre Cardiologique du Nord – Saint Denis (93) – Dr Antoine Lepillier CHU Rangueil – Toulouse (31) – Pr Elbaz Meyer Hopital de la Timone – Marseille (13) – Dr Bonnet CHU Poitiers – Poitiers (86) – Dr Bruno Degrand ; Dr Sébastien Levesque CHU Amiens – Amiens (80) – Pr Jean Sylvain Hermida CHU Brest – Brest (29) – Pr Jacques Mansourati CHU Dijon – Dilon (21) – Pr Lorgis ; Dr Buffet ; Dr Richard
Operative Prospective Risk Score for LAAC The puncture site of the thin inter Standard: posteroinferior: 1pt atrial septum of the fossa ovalis: Another site (anteroinferior): 2pt Optimal alignment: 1pt The alignment of the catheter Misalignment but resolved with a maximal rotation of the catheter (torq): 2pt Important misalignment despite a torq movement inducing a deformation of the model 3pt with the LAA axis: Optimal seal: stable, adequate compression, no bulging, nor leaks, nor obliquity, covering all LAA lobes 1pt Sub-optimal deployment: large gap, bulging or obliquity, over-compressed: 2pt Deployment of the prosthesis: Instable when tug test or prosthesis eject: 3pt TOTAL OPERATIVE RISK SCORE Low if the global Score=3, Moderate risk if the global score: 4 or 5, High risk if the global score ≥ 6 or if one item is scored 3
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