Left Atrial Appendage Occlusion Guided by 3D Printing

Study Overview
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Brief Summary
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Left atrial appendage closure (LAAC) was approved by the ESC guidelines as a stroke prevention alternative to warfarin for patients with nonvalvular atrial fibrillation in patients at high risk of bleeding (IIbB). Although the overall LAAC benefice, in term of prevention of stroke or embolisme and decresing the anticoagulant-related risk of bleeding is already demonstrated, however the procedure success and safety, critically depends on understanding LAA anatomy and adequate pre-procedure planning. 3D-printed patient-specific adaptive and flexible LA models have demonstrated in a previous study an improving in LAAO device sizing, a better pre-procedural planning of the optimal trans-septal puncture site, by incorporating all anatomical variations and an improuving patient outcomes by reducing procedure time and number of prostheses employed per patient. This technique is now used in several surgical centers in France and large prospective evaluation of the practice is necessary.

Detailed Description
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The 3D printing has modified the LAAC practices with a preoperative time allowing an optimal preparation of the prosthesis. This technique is now used in several surgical centers and prospective evaluation of the practice is necessary. The objective of our research is to demonstrate the reduction of the operating time and number of prosthesis used per procedure when prior LAAC simulation testing and sizing is made on a 3D printed model. It is therefore a longitudinal research to monitor professional practices for the evaluation of a new preoperative approach. Procedures guided by 3Dprinted models will be compared (intention to treat population) in term of procedural parameters (procedure time, success rate, number of prosthesis per procedure) and procedural complication with prior Watchman study: post-FDA Approval US experience and national registries data. A second analysis (per protocol population) will be performed to compare patients with an informative utilization guided by 3D printed to those of the post-FDA Approval US experience and national registries.

Official Title
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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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: 3D printing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non valvular AF adressed for LAAC procedure Exclusion Criteria: opposition from patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 3D printing|Manufacturing and use of a model printed in 3D|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operating time | mesure of operating time to Day 0 (J0) | During 1 day | 
| number of protheses | decrease number of prothèses to Day 0 (J0) | During 1 day | 
| Implantation success rate | increase implantation success rate at Day 0 (J0) | During 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of periprosthetic leak | decrease number of periprosthetic leak at Day 0 (J0) | During 1 day | 
| anasthesia time | decrease of anasthesia time at Day 0 (J0) | During 1 day | 
| time of scopy | decrease time of scopy at Day 0 (J0) | During 1 day | 
| irradiation dose | decrease of irradiation dose (mGy.cm2) at Day 0 (J0) | 1 day | 
| Days of Hospitalisation | discharge and decrease of hospitalisation days | During 1 day | 
| number of recapture | decrease number of recapture at Day 0 (J0) | During 1 day | 
| number of off-axis prostheses | decrease number of off-axis prosthèses at Day 0 (J0) | During 1 day | 
| number of embolized prostheses | decrease number of embolized prosthèses at Day 0 (J0) | During 1 day | 
| Effective complete occlusion of the auricle | increase rate of Effective complete occlusion of the auricle | 3 months | 
| Effective complete occlusion of the auricle | increase rate of Effective complete occlusion of the auricle | 6 months | 
| prosthesis trombosis | rate of prosthesis trombosis | 12 months | 
| procedural complications | analysis of complications (Stroke, transient ischaemic attack, peripheral embolism, Pericardial effusion and tamponade Bleeding, Life threatening, major and minor, Acces related complications, Renal or hepatic acute failure) | during procedure and within 30 days | 
| complication | analysis of complications (Stroke, transient ischaemic attack, peripheral embolism, Pericardial effusion and tamponade Bleeding, Life threatening, major and minor, Acces related complications, Renal or hepatic acute failure) at 6 and 12 months | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LAAC, 3D printing, Procedure success, Procedure-related complications