This document summarizes various devices used to close atrial septal defects (ASDs), including their designs, sizes, advantages, and disadvantages. The most commonly used device is the Amplatzer Septal Occluder, which has a double disc design and is self-expanding. Other devices discussed include the Gore HELEX, Lifetech/Cera, Figulla, Cardioseal/Starflex, and newer bioabsorbable options like the Biotrek. Complication rates of ASD device closure are generally low, below 10%, with embolization and arrhythmias being the most common issues. Larger trials have shown the Amplatzer to be very effective and easy

1. ASD DEVICES

2. COMPLICATIONS OF ASD DEVICE CLOSURE(8.6%)
3.5% Incidence Of Device Embolisation-90% To PA
2.5%incidence Of Arrhythmias
Device Malfunction <=1% Cases
Pericardial Effusion <0.1 Cases
Surgery 2-3%
Thrombosis And Embolism <0.1%
Local Complications <=1.0%
Massimo Chessa et al JACC Vol. 39, No. 6, 2002March 20, 2002:1061–5

3. ASD DEVICES

4. AMPLATZER SEPTAL OCCLUDER
 Self-expandable
 Double disc
 Nitinol wire mesh 0.004” - 0.008”
 Polyester fabric fills the waist and discs
 Sizes: 4-40 mm(waist diameter)
 Waist length 3-4 mm
 LA disc exceeds waist by 12-16 mm
 RA disc exceeds waist by 8-10 mm

5. Advantages
- Largest experience worldwide
- Very easy to use
- Retrievable until release
- All sizes up to 40mm
• Disadvantages
- Erosion and tamponade (very rare,0.1%)

6. GORE HELEX Septal Occluder
 Two discs formed by one
continuous wire in the
shape of a spiral
 15- 35 mm sizes available
 ePTFE patch attached to
the wire

7. Advantages:
•Preloaded in catheter
•Soft and atraumatic
•No long sheath required, so reduced risk of air embolism
•Safety chord - retrievable at any stage of the procedure, even
after release
•Metal mostly covered, so no thrombus formation/erosion
experienced
Disadvantages:
•Difficult to teach
•Device embolizations ?more frequent than with other devices
•Residual shunts more frequent (but no embolic events)
•Wire fractures – rare
•Defects up to 20 – 22 mm

8. LIFETECH /CERA DEVICES
Sizes 6 mm to 40 mm
Need 8 Fr to 14 Fr sheaths
Available with a kink-resistant delivery Sheath
Nitinol ,Polyester, Pure Stainless Steel tip,
ePTFE membrane

9. Cocoon device
• Self-Expanding Platinum-Coated Nitinol
Devices
• Coating helps to Prevent Nickel Release

10. CLAMSHELL DEVICE
• WITHDRAWN BECAUSE OF STRESS FRACTURES

11. CARDIOSEAL/STARFLEX SEPTAL REPAIR IMPLANT
•Modified version of the Clamshell
device
•2 square Dacron patches mounted
between four steel arms To
Facilitate Device Centering
•STARFlex has additional
microsprings attached to device
arms

12. Advantages:
•Long experience (1996)
•Easy to use (premounted version)
•Device arms are flexible and can bend independently from
each other
Disadvantages:
•Difficult to retrieve when right disc is opened
•Wire fractures (in larger defects and devices)
•Thrombus formation
•New onset of atrial fibrillation
•Maximum defect of 20 – 22 mm

13. OCCLUTECH FIGULLA OCCLUDER
• Tips of the mesh wires brought
together in one hub at the right atrial
end
• Reduced material in the left atrium
• Flat low profile of the left atrial disc
• No hub or edges on left atrial disc
• Easy to use and retrievable
• Sizes: 6 – 36 mm in 3 mm increments
• Larger sheath compared with
Amplatzer for similar sizes

14. FIGULLA FLEX ASD AND PFO OCCLUDERS
• Available from 6 mm to 40 mm size
• Retrievable and safe
• System allows a tilt of 45 degrees using a biopsy forceps
delivery method
• Therefore much better when used in challenging cases

15. BIOSTAR IMPLANT
• STARFlex® self—centering
• Cardioseal framework
• Bioresorbable collagen derived
from the submucosa derived from
the intestine
• Improved “biological” edge to
edge seal matrix gradually
remodeled and replaced with host
tissue

16. BIOTREK BIOABSORBABLE
SEPTAL REPAIR
• Polymer:
– novel bioabsorbable polymer (P4HB)
– absorbs as a non-inflammatory natural metabolite
• Design:
– conforms to wide range of defect morphologies
– easy to use - repositionable and radiopaque
• Implant/Tissue Interface:
incorporates biological response modifiers to regulate
thromboresistance and endothelialization
• Newest development
Status: currently in pre-clinical studies

17. THANK YOU