Connatre l'anatomie de l'auricule gauche Dr Ciobotaru Vlad Unit - - PowerPoint PPT Presentation

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

• Grant/Research Support
• Consulting Fees/Honoraria
• Major Stock Shareholder/Equity
• Royalty Income
• Ownership/Founder
• Intellectual Property Rights
• Other Financial Benefit
• Boston Scientific, Philips, AG2RFoundation, Region Occitanie, BRL
• Philips,
• none
• none
• 3DHeartModeling
• 3DHeartModeling
• none

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

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

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)

Data from FLAAC registry: 57% thromboembolic events reduction but caution to serious complications in some patients

7.2% > 2devices 96% successful after 1 procedure 2.3% two procedures 7.2% procedure-related Serious Adverse Events

LAAC should be made on an individual basis and integrate a preprocedural assessment of risk/benefice ratio

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

Shape, Depth, Diameter of the neck Ellipticity, Orientation of LAA ostium LAA position Pulmonary Ridge preeminence, LA volume, Size of interatrial Fossa Angle from fossa to LAA ostium

Procedural risk depends on:

Inter atrial Puncture site Shape of Catheter Catheter alignment Prothesis type and shape

Anatomical Factors Procedural Factors Manufacturers’ recommendations are based only on the LAA neck diameter.

A.LAA gram (RAO 350/caudal 110) showing small LAA with prominent pectinate muscles. Note: position of distal marker

• f the delivery catheter (DC)

Shape:

B.LAA gram (RAO 350/caudal 110)

• f the anterior lobe showing

prominent pectinate muscles. Note: distal marker of DC

• D. Prominent pectinate muscles,

depth 13 mm

• A. Small, shallow LAA
• B. Small, shallow LAA
• C. Small, shallow LAA

A B

Small LAA With Protruding Pectinate Muscles

Watchman Device Implantation

• A. Watchman device (24 mm) deployed, all

LAA lobes covered, compression was good (26%), no leakage, tug test was good, mild protrusion to LA

• B. Watchman device

appeared deformed by pectinate muscles

• C. Tug test was satisfactory.

Protrusion < 4.2 mm

A B C 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

Auricule bilobé avec ridge interne proéminent

Shape: bilobed

24x31mm 16x18mm

Shape: bilobed

Amulet 25 Couvrir l’ostium avec un disc plus large avec une surcompression du lobe

In situ

Shape: bilobed

Pulmonary Ridge preeminence:

Long distance between IVC outlet and IAS, Short distance between IAS and LAA

• rifice, 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

Angle from fossa to LAA ostium:

In situ: misalignment Simulation Optimal Off axis Off-axis simulation

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 SIMULATION DE PONCTION ANTERO-INFERIEURE post ant inf ant inf Exemple de ridge prononcé avec un LAA orienté vers l’arrière post ant inf

Inter atrial Puncture site Shape of Catheter & Catheter alignment

3D Printing simulation accurately predicts procedures risks

VCS VCI AVANT ARR SCHEMATISATION DES SITES DE PONCTION TRANSSEPTALE INF-POST et INF-ANT ANT-INF POST-INF SUP-POST MED-INF Ao vci vcs TEE35° vcs TEE90° TEE110° TEE10° Mi

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:* RECHMPL17_0230 Brief Title:* Use lay language. Left Atrial Appendage Occlusion Guided by 3D printing Acronym: LAA-Print registry Official Title:* National Longitudinal Registry for Mid-Term Clinical Outcome And Procedure Efficacy Evaluation In Using A Novel Preprocedural Planning Method For Left Atrial Appendage Occlusion Guided By 3D Printing Study Type:* Observational Interventional Expanded access Official Title:* National Longitudinal Registry for Mid-Term Clinical Outcome And Procedure Efficacy Evaluation In Using A Novel Preprocedural Planning Method For Left Atrial Appendage Occlusion Guided By 3D Printing

Clinical aim:

to predict the risk of procedural complications to Improve Safety: by decreasing operating time and complications

ClinicalTrials.gov ID: NCT03330210

Study Start: Jan 18th, 2018

• ngoing

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
• Clinique Arnaud Tzank – Saint Laurent du Var (06) – Dr Alain Mihoubi
• CHU Grenoble – Grenoble (38) – Pr Pascal Defaye, Dr Peggy Jacon
• CH Henri Mondor – Créteil (94) – Dr Julien Ternacle ; Dr Annabelle Nguyen Pr Teiger
• CHU Bordeaux – Bordeaux (33) – Dr Xavier Iriart ; Dr Reda Jakamy Pr Thambo
• Hopital Marie Lannelongue – Le Plessis Robinson (92) – Dr Sébastien Hascoet
• 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

Grants : AG2RFondation Region Occitanie BRL, Philips, Boston Scientific,

Operative Prospective Risk Score for LAAC

The puncture site of the thin inter atrial septum of the fossa ovalis: The alignment of the catheter with the LAA axis: Deployment of the prosthesis:

Standard: posteroinferior: 1pt Another site (anteroinferior): 2pt Optimal alignment: 1pt 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 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 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

Nb of patients N=200 Operative Predicted Low risk N=104 Operative Predicted Moderate risk N=59 Operative Predicted High Risk N=37 P High risk vs low risk Failure 12 (32%) <0,05 Recaptures>2 3 (3%) 5 (10%) 7 (19%) <0,05 Prosthesis ≥2 1 (1%) 6 (2%) 8 (21%) <0,05 Inappropriate implantation 7 (10%) 11 (30%) <0,05 SAEs 5 (8%) 10 (27%) <0,05 Pericardial effusion>10mm Pericardiocentesis 4(4%) 1 3(5%) 2 4(11%) 2 Haemorrhage (≥2points) 2 8 Coronary syndrome 4 Time (intraLA) min 21±7 28±13 58±25 <0,05

Anatomical Factors associated with operative predicted high risk group were: retroversion (50% of cases), elliptical LAA ostium (41%), flat chicken wing shape(58%), reduced depth (38%), double ostium (20%).

Logistic regression- Primary end point Source DDL Khi² (Wald) Pr > Wald Khi² (LR) Pr > LR Max Diameter 1 0,445 0,505 0,437 0,509 Depth 1 1,007 0,316 0,976 0,323 Depth/diameter 1 0,886 0,346 0,851 0,356 Volume 1 0,004 0,949 0,004 0,949 Risk score 2 25,022 < 0,0001 65,324 < 0,0001 Shape 4 3,820 0,431 4,072 0,396 LAA Orientation (retroversion) 1 0,030 0,863 0,030 0,863 Ellipticity 1 1,157 0,282 1,194 0,275

Predictive parameter for occurrence of a primary end point*

Primary end point: Safety combined criteria including : SAEs, (tamponade, bleeding, transfusion, coronary syndrome, renal impairment),

• r failed procedure,
• r inappropriate implantation: large leak>5mm or important bulging ,
• r Excessive time > 50min (from transseptal puncture to prosthesis implantation)

Results

Take Home Messages

• LAA has a complex, highly heterogeneous anatomy
• the role of multi modality imaging (TOE and CT) in left atrial

appendage planning

• step-by-step approch
• Ponction/Alignement/Shape
• device size to use for that specific patient but also what catheter

to use for that patient's specific anatomy

• anatomical feasibility of the LAAO procedure (caution to identify

high risk group)

• Value of 3-D volume rendering simulation or 3D Printing in

complexes cases

Conclusion The key of a better treatment is anticipation

Merci de votre attention