Cardiovascular Diseases
Conditions
Brief summary
Left atrial appendage occlusion is being widely recommended as a treatment strategy for patients with nonvalvular AF to prevent stroke, especially those who cannot tolerate long-term oral anticoagulation or have other reasons for nonpharmacologic therapy. Currently, there are a number of guidance for left atrial appendage occlusion, such as transesophageal echocardiography, intracardiac echocardiogram, fluoroscopy, computed tomographic/computed tomographic angiography and so on. Procedures such as atrial septal puncture, device size selection and operational view are guided by different methods in various centers. Our center has developed a new approach to guidance: Cone-beam CT and cardiac computed tomographic angiography were combined by three-dimensional - three-dimensional image fusion in guiding left atrial appendage occlusion.
Detailed description
Eligible NVAF patients were recruited consecutively and received our LAAO workflow of local anesthesia, intracardiac echocardiography-guided transseptal puncture, and 3DCTA-3DCBCTF fusion-guided occluder implantation. The primary outcome was optimal occluder implantation (successful implantation with no occluder recapture and replacement). Other outcomes were procedure/fluoroscopic time, contrast agent consumption, radiation dose, and peri-procedure complications. We compared our results with existing publications of LAAO guided by 3DCTA and two-dimensional fluoroscopy (3DCTA-2DF) fusion images.
Interventions
PROCEDUREcone-beam computed tomography fusion image
Left Atrial Appendage Occlusion Under Cone-beam Computed Tomography Fusion Image Guidance
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. An age of \>18 years; 2. A CHA2DS2-VASc score of ≥2; 3. Clinical conditions allowing TEE and sedation; 4. Left ventricular ejection fraction \>30%; 5. And at least one of the following indications: (a) HAS-BLED score of ≥3; (b) intolerance to long-term OAC, and (c) stroke, transient ischemic attack, or thromboembolism even under oral anticoagulation treatment;
Exclusion criteria
1. A glomerular filtration rate of \<50 mL/min/1.73 m2; 2. The presence of a thrombus in the LA and LAA; 3. Acute myocardial infarction or unstable angina, decompensated heart failure (New York Heart Association functional class III-IV), or heart transplantation; 4. Stroke or transient ischemic attack within 30 days; 5. Very poor peripheral vessel access not allowing device delivery; 6. Moderate or massive pericardial effusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of success at first device selected | In surgery | successful occluder deployment and release with no being resized |
Countries
China
Contacts
Primary ContactJUN PU, Doctor
Outcome results
None listed