TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECTS IN PAEDIATRIC PATIENTS WITH THE NIT-OCCLUD ASD-R DEVICE

Mendoza A., Herrera M.D., Montañés E., Granados M.A., Albert L., Toral B., Flores M., Caro A., Velasco J.M.

OBJECTIVE To describe our experience with the Nit-Occlud ASD-R (NOASD-R) device for percutaneous closure of ostium secundum atrial septal defects (OS ASD) in a paediatric population.

Instituto Pediátrico del Corazón, Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), Hospital Universitario 12 de Octubre, Madrid, Spain

PATIENTS 66 patients (41 female) Median age: 5 y [ICR: 3.7-9] Median weight: 19.7 Kg [ICR: 15.5-28.5]

DEFECT Mean ASD diam: 11.5±3.7 mm Multiple defects: 8 pt (12.1%) Deficient aortic rim: 19 pt (28.8%)

DEVICE/PROCEDURE Mean 2D diam / weight: 0.59±0.3 Mean device size: 14 mm [ICR: 10-16] Mean device size / 2D diameter: 1.19±0.18 Median fluoroscopic time: 7 min [ICR: 5-11.7]

SUCCESS/COMPLICATIONS Successful implantation: 65 pt (98.5%) No major complications Minor complications: 4 pt (6%)

1 SVT (resolved) 1 first-degree AV block (resolved) 1 second-degree AV block (resolved) 1 AV femoral fistula

FOLLOW-UP (27.3±15.7 months) Small pericardial effusion (resolved within 1 month): 2 pt Residual flow through the device at 24h: 20 pt (30%) Complete occlusion at last follow-up: 64 pt (97%)NO: erosion, embolization, endocarditis, neurologic events, death

CONCLUSIONS •  Closure of OS ASD with the NOASD-R device is safe and effective in the pediatric population. •  Most patients had short-term intra-device residual flow but the definitive closure rate is high. •  Implantation success is hihg with no major complications in the short and medium-term.

The Nit-Occlud® ASD-R occlusion system has been developed for the transcatheter occlusion of the atrial septal defect (ASD).

Nit-Occlud® ASD-R is the latest member of the growing pfm medical occluder family and is also manufactured from a single nitinol wire, resulting in a very low profile. The occluder consists of two discs with polyester membranes.

www.pfmmedical.com

Quality and Experience

ASD Occlusion SystemNit-Occlud® ASD-R

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Nit-Occlud® ASD-R

Nit-Occlud® ASD-R is knitted from a single nitinol wire without soldering. It consists of two discs, a distal or left one and a proximal or right one. The unique single-layer distal disc reduces the metal used in the left-atrium (LA) by around 50%, thus providing best patients benefit by reducing the thrombo-embolic risk.

BenefitsUnique single-wire knit Nit-Occlud® ASD-R is knitted from a single Nitinol wire, making protruding fixation-clamps obsolete and results in a very low profile.

Safe and simple device releaseThe occluder is pre-mounted, retriev-able, easy to position and enables a soft and tension free release.

Patented design The single-layer left atrial disc reduces the amount of metal used in the LA by around 50% and by this decreasing the thrombo-embolic risk.

Pre-attached and ready to usePre-attached to the delivery cable and ready to use. Can be easily connected to pfm medical Nit-Occlud Implantation Sheaths via a Luer connection.

Adaptive flexible designOptimal compromise between flexibility and strength. The rim of the LA disc is reinforced to facilitate implantation and to avoid pull through.

Accelerated endothelialisationThe polyester membrane facing the LA promotes accelerated endothelia-lisation.

▸ Flexible and adaptive design▸ Single-wire knit▸ No need for protruding clamps to fixe loose wire ends ▸ Very low-profile ▸ Reduction metal of around 50% in the LA

▸ LA polyester face accelerating endothelialisation▸ Pre-mounted systems and simple to release ▸ Easy to reposition and to retrieve▸ Radiopaque▸ MR conditional

Details

Detailed View

Distal disc view Lateral view Proximal disc view

A Measuring the size of the defect

Perform a transesophageal ultrasound and use a sizing ballon catheter for measuring the defect. The stent diame-ter of the device should be larger than the min. diame-ter of the defect according to the sizing table.The margins of the defect should be more than the rim of the device.

B Schematic view of Nit-Occlud ASD-R

C Position of Nit-Occlud ASD-R after implantation

LA Left atriumRA Right atriumASD d Diameter of defect

Handling

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Nit-Occlud ASD-R

Case 1 ▸ Patient: female, 3 years old, 14 kg▸ ASD measurements: ASD secundum type,

maximal diameter 13.5 mm▸ Device: ASD-R (stent 14 mm, disc 24 mm) ▸ Clinical outcome: closed

Case 2 ▸ Patient: female, 10 years old, 34 kg▸ ASD measurements: ASD secundum type,

maximal diameter 21.3 mm▸ Device: ASD-R (stent 22 mm, disc 24 mm)▸ Clinical outcome: closed

Practice

The unique single-layer distal disc of Nit-Occlud® ASD-R reduces the metal in the LA. The rim of this disc is reinforced to facilitate implantation and to avoid pull through.

Function

The implant is connected to the pusher via retaining wires. A locking wire fixes this connection. To release the implant, the locking wire has to be pulled through the loop of the retaining wires.

Due to the axial release mechanism, there is no risk of rotation of the device inside the defect during release.

Use

Locking wireRetaining wirePart of the implant

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THE DEVICE •  Single Nitinol wire •  Low profile •  Reduction metal of 50% in LA •  Premounted •  No protruding screws