Cardi-O-Fix Plug Occluder

The Starway Cardi-O-Fix Plug Occluderis a self-expandable, cylinder-shaped implant device made from a Nitinol wire mesh. In order to increase its closing ability, the discs and the waist are filled with polyester fabric. The polyester fabric is securely sewn to the cylinder-shaped part by a polyester thread. Starway Cardi-O-Fix Plug Occluder has two types. Type one (PL1) has double ends (Fig.1) and type two (PL2) has single end only (Fig.2). Both types can be used for the intended patients.

D. Diameter of the Device
L. Length of the Device

Intended Use

The Starway Cardi-O-Fix Plug Occluder is a percutaneous, transcatheter£¬permanent implant device intended for the occlusion of abnormal blood vessels.

The Starway Cardi-O-Fix Plug Occluder and Cardi-O-Fix Delivery Systemare single use devices which are sterilized via ethylene oxide (EO).

Indications:

The vascular plug may be used for a wide variety of occlusions of veins or arteries depending on the patient¡¯s diagnosis and treatment plan. Reducing or eliminating blood flow to an area of the body by blocking, or occluding, a blood vessel has become an accepted treatment option for a wide range of circulatory and internal organ diseases. Vascular plug can be used for a number of indications including patients with clinical symptoms of abnormal blood vessels, such as:
-- Aortopulmonary collaterals
-- Arteriovenous malformation
-- Surgical aortopulmonary shunts
-- Anomalous venovenous connections
-- Arteriovenous fistulas
-- Peripheral vessels

Contraindications:

Patients abnormal blood vessels, but without any significant hemodynamic alteration.

General Exclusion Criteria:
1) Sepsis (local/generalized ).
2) History of repeated pulmonary infection.
3) Any type of serious infection < 1 month prior to procedure.
4) Malignancy where life expectancy is < 3 years.
5) Demonstrated intracardiac thrombi on echocardiography.
6) Inability to obtain informed consent.

Cardi-O-Fix Delivery System

Cardi-O-Fix Delivery System is designed specifically to facilitate attachment, loading, delivery and deployment of the Cardi-O-Fix ASD, VSD, PDA, PFO and Plug Occludersand it is comprised of a delivery sheath, dilator, loader, hemostasis valve and delivery cable with plastic vise. The Starway Cardi-O-FixTM Plug Occluder and Cardi-O-FixTM Delivery Systemare single use devices which are sterilized via ethylene oxide (EO).

The recommended sizes of Cardi-O-Fix Delivery System for Cardi-O-Fix Plug Occluder are 5F, 6F, 7F, 8F, 9F, 10 and 12F.
The tip of delivery sheath is 45¡ãor 180¡ã.

Fig. 1 Delivery System for VSD, PDA & Plug Occluder

Procedure:

1. A standard right heart catheterization is performed following puncture of femoral artery and femoral vein.
2. A aortography is performed to demonstrate abnormal blood vessels by passing a pigtail catheter into the aorta. Their anatomy, sizes, amount, directions are assessed.
3. A right heart catheter is introduced with the exchange wire through the abnormal blood vessel to the part to be closure, then the right heart catheter is removed together with vessel sheath. The delivery sheath is introduced over the wire and positioned in part to be closure.
4. According to the angiogram of abnormal blood vessel, a device of 2-4mm bigger than its narrowest diameter is chosen for loading.
5. The delivery cable is passed through the loader, and the occluder is screwed clockwise into the tip of the delivery cable. Screwed and unscrewed for 3-4 times, but not over-tightened when screwed on.
6. The device and the loader are immersed in saline solution as the device is pulled into the loader to remove the air. Flush via the side arm of the loader.
7. The loader is introduced into the delivery sheath, and without rotation the occluder device is advanced into the blood vessel to be closed.
8. Aortography is performed once more to confirm a correct placement or detect a residual shunt.
9. If it is misplaced, the device can be retrieved into the delivery sheath and redeployed, or replaced by another device.
10. The device is released by turning the delivery cable counterclockwise using the plastic vise, as indicated by the arrow on the delivery cable.

Complications & Solutions:

There would be several complications during or after the procedure:

1. Air embolism in coronary arteries: It may happen if air is brought into the body due to improper manipulation, in that it can get reach to coronary arteries via left atrium-left ventricle-aorta route when patient kept in supine position. Symptoms and signs of acute myocardial infarction will be shown, which need immediate treatment such as sublingual nitroglycerin, oxygen, and intravenous vasodilators. If symptoms are relieved and electrocardiogram is returned to normal in a short time, the procedure can be continued. Otherwise stop the operation.
2. Thrombosis: Usually, it is caused by improper use of anticoagulatants during or after the procedure, and should be treated symptomatically in most cases. However, thromboembolism must be differenciated from intracranial hemorrhage, especially in senior or hypertensive patients.
3. Arrhythmia: If severe arrhythmia occurs before the device released, the procedure should be stopped immediately. Retrieve the device and remove it out of the body. Then refer the patient to cardiac surgeon. If it happens after the procedure, drugs to diminish edema, protect myocardium or treat arrhythmia should be given. When necessary, temporary pacing lead should be advanced during the observation period within a few days. If arrhythmia persists and cannot be controlled by the drugs, it must be attempted to take the device out by surgery or/and implant a permenant pacemaker.
4. Device dislodgement: If it happens, the device must be taken out by interventional method or surgery at once.