ASD DEVICES

COMPLICATIONS OF ASD DEVICE CLOSURE(8.6%)

Massimo Chessa et al JACC Vol. 39, No. 6, 2002March 20, 2002:1061–5

3.5% Incidence Of Device Embolisation-90% To PA2.5%incidence Of ArrhythmiasDevice Malfunction <=1% CasesPericardial Effusion <0.1 Cases Surgery 2-3%Thrombosis And Embolism <0.1%Local Complications <=1.0%

ASD DEVICES

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

Advantages- Largest experience worldwide- Very easy to use- Retrievable until release- All sizes up to 40mm

• Disadvantages- Erosion and tamponade (very rare,0.1%)

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

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

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

Cocoon device

• Self-Expanding Platinum-Coated Nitinol Devices

• Coating helps to Prevent Nickel Release

CLAMSHELL DEVICE

• WITHDRAWN BECAUSE OF STRESS FRACTURES

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

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

OCCLUTECH FIGULLA OCCLUDER

• Tips of the mesh wires broughttogether in one hub at the right atrialend• 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 withAmplatzer for similar sizes

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

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

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 developmentStatus: currently in pre-clinical studies

THANK YOU