Technique of the VenaSeal System
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1 Technique of the VenaSeal System
2 Indication & Contraindications VenaSeal Indication: The Sapheon VenaSeal System is intended for the permantent, complete, endovascular adhesive closure of the great saphenous vein (GSV) and associated varicosities in the treatment of venous eflux disease. Contraindication: Not intended for use in patients with the following conditions: Previous hypersensitivity reactions to SCA Acute superficial thrombophlebitis Phlebitis migrans Acute sepsis 2
3 Patient Preparation and VenaSeal VenaSeal Kit: 1 x VenaSeal Adhesive 5ml 1 x Sapheon VenaSeal Catheter System 1 x 7 Fr, 80,3 cm Introducer 1 x 5 Fr, 86,1 cm Dilator 1 x 5 Fr, 91,8 cm Catheter 1 x Vena Seal System Dispenser Gun/0.09 ml per application 2 x 14 Gauge, 3.8 cm Sapheon VenaSeal Dispencer Tips 2 x 3 ml Syringes 1 x (0.889 mm) 180cm, J- Wire Guidewire System Set Up 3
4 OR Tabel Set Up 1 x Sapheon VenaSeal Kit + 5 ml Syringe local Anesthesia + 20 ml sterile water + vein access needle + sterile swab + blade Picture from Sanja Schuller-Petrovic - Vienna 4
5 Pre-Op Patient set up Identify and check: Saphenofemoral junction Aneurysmal and tortuous segments Large branches and perforators Potential access sites
6 Leg Preparation for treatment Prep patient s leg as used as for other endoluminal vein procedures like RF / Laser / Steam Picture from Sanja Schuller-Petrovic - Vienna
7 Vein Access Vein access with percutaneously technique and under ultrasound guidance. Small amount of local anesthesia.
8 After Vein Access placement of J-Guide wire J-tip wire threaded through access needle; needle is removed, leaving wire in place and place guidewire tip caudal to the SFJ. Guidewire placement Picture from Prof. Dr. T. Pröbstle, Mannheim
9 Vena Seal Catheter System Preparation Picture from Prof. Dr. T. Pröbstle, Mannheim Use the over the wire technique and place the 7 Fr introducer/dilator from the VenaSeal System over the guidewire to the SFJ
10 Vena Seal Catheter System Preparation Picture from Prof. Dr. T. Pröbstle, Mannheim Remove the J-gudiewire and the dialtor and flush the indroducer through the luer injection port with sterile saline using a flush syringe and leave the saline syringe in place.
11 Vena Seal Catheter System Preparation SFJ 5 cm Under real-time ultrasound guidance, position the introducer tip 5cm caudal from the SFJ
12 Vena Seal Catheter System Preparation Picture from Prof. Dr. T. Pröbstle, Mannheim Picture from Prof. Dr. T. Pröbstle, Mannheim Attach the Sapheon VenaSeal dispensing tip to the 3 ml syringe, and extract the Sapheon VenaSeal Adhesive (SCA) from its vial into the 3 ml syringe. Remove all Adhesive from the vial and use if needed the second syringe.
13 Vena Seal Catheter System Preparation Attach adhesive-filled syringe to catheter and peril catheter
14 Vena Seal Catheter System Preparation Remove the VenaSeal dispensing tip from the syringe and contect/lock the 3 ml syringe into the dispenser gun
15 Vena Seal Catheter System Preparation Picture from Sanja Schuller-Petrovic - Vienna Pre fill the VenaSeal catheter with the adhesive (SCA) till the SCA will reach the laser mark at the tip of the VenaSeal catheter.
16 Vena Seal Catheter System Preparation Remove the saline filled flushing syringe from the introducer and insert the primed catheter (SCA) into the introducer and advance the catheter until its tip has reached the tip of the introducer.(see mark at distal end of catheter) Be careful catheter will kink easily!
17 Final Tip Position Tip 5 cm from SFJ 5 cm Holding the catheter in place, pull the catheter back onto catheter and look the introducer to the catheter with the spin-look mechanism. This will expose the catheter tip positioning it 5 cm caudal to the SFJ.
18 Proprietary Catheter The VSCS Delivery Catheter has micro-lumens which are filled with air. Under ultrasound imaging, the air has reflective properties providing a distinct recognition pattern.
19 Head down Position Position patient in Head down (light Trendelenburg) position 15º 0º
20 Treatment
21 VenaSeal Procedure + Compression 1 Picture from Prof. Dr. T. Pröbstle, Mannheim Using the transverse ultrasound plane, position the ultrasound transducer just 2-3 cm cephalad (direction to head) to the catheter tip and apply pressure to compress the GSV near the SFJ.
22 VenaSeal Procedure + Compression 2 3 Picture from Prof. Dr. T. Pröbstle, Mannheim While applying compression, deliver 0.09 ml of SCA in the vein by depressing the trigger of the VenSeal System dispenser gun once and hold the trigger for 3 seconds! Immediately pull back the introducer for 1cm and deliver another 0.09 ml of SCA by holding the dispencer gun trigger for another 3 seconds. Follow to the second injection immediately (within 3 seconds) pull back the introducer for 3 cm.
23 VenaSeal Procedure + Compression 4 Picture from Prof. Dr. T. Pröbstle, Mannheim Probe transverse + 2 fingertips compression Following these two initial injections, immediately (within 3 seconds) pull back the connected introducer and catheter 3 cm and hold the transverse compression with the ultrasound transducer for 3 minutes. During the compression time, utilize a hand caudal to the transducer to add light compression
24 VenaSeal Procedure + Compression 1 Picture from Prof. Dr. T. Pröbstle, Mannheim After compression time locate the catheter tip under ultrasound guidance and confirm the tip position. Apply compression on the vein cephalic to the catheter tip with the ultrasound probe in transverse position.
25 Following Treatment Segments 2 3 Picture from Prof. Dr. T. Pröbstle, Mannheim Deliver another 0.09 ml of SCA by holding the dispencer gun trigger for another 3 seconds. Follow to the injection immediately (within 3 seconds) pull back the introducer for 3 cm.
26 VenaSeal Procedure + Compression 4 Picture from Prof. Dr. T. Pröbstle, Mannheim Probe transverse + 2 fingertips compression Following each injections, immediately (within 3 seconds) pull back the connected introducer /catheter 3 cm and hold the transverse compression with the ultrasound transducer for 30 seconds. During the compression time, utilize a hand caudal to the transducer to add light compression
27 Repeat step 1-4 to treat the entire length of the target vein segment till 5 cm before the access site. compression cephalic to the catheter tip Deliver 0.09 ml SCA by holding the dispenser gun trigger for another 3 seconds. pull back the introducer / catheter for 3 cm. Probe transverse + 2 fingertips compression
28 Final VenaSeal segment After the final SCA injection, remove the dispenser system and hold hand pressure as long as necessary to close the wound and achieve hemostasis.
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