CATHETERIZATION PROTOCOL Prepared by Matthew Crystal ( )

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1 CATHETERIZATION PROTOCOL Prepared by Matthew Crystal ( ) Cath Procedure Diagnosis: Hospitalization Requirement Blood on hold Cath Lab Fontan Yes (CCU after completion) Yes (as per OR protocols) Pre-cath requirements: 1. Ultrasound with Doppler to assess patency of neck and groin vessels (bilaterally). 2. Cardiac MRI/CT (MRI preferred) to assess anatomy and distance from SVC/RA junction to IVC/diaphragm and (IVC diameter for stent sizing). a. Should have been seen recently in clinic with CXR, ECG, CBC, sat, and echocardiogram as pre-op studies. 3. Once all data is completed and reviewed, patients should be presented at afternoon Cardio-Surgical conference. Bookings include a post-cath CCU bed, and available CVsurgeon. 4. Once presented to conference (and all studies done) then a cath requisition should be completed. Dr. Benson will obtain research consent for all patients (prior to or in pre-cath clinic). 5. Start ASA 81mg po od 1-2 weeks prior to catheterization and continue up until day of cath Cardiac Catheterization: Access: All access will be obtained prior to catheterization. 6 Fr. sheaths placed in the RFV, LFV and RIJV/LIJV 5 Fr. sheath placed in the RFA/LFA Catheters: Arterial access will take a 5 Fr. Marker Pigtail Venous access will be a 6 Fr. Gensini via the IJV, 6 Fr. Gensini or Berman Angio in femoral vein, 5 Fr. Marker Pigtail in other femoral vein Hemodynamic data: Start with usual pre-fontan study (refer to Pre-Fontan Diagnostic Cardiac Catheterizatioon protocol in cath manual for details) Angiography: Glenn anastamosis/hemi-fontan with pulmonary angiography +/- selective PA injections. Low IVC injection to delineate IVC anatomy/junction with RA.

2 Right atriogram to assess anastamosis location with PAs, ventricular function, patency of outflow tract (aorta/neo-aorta), aortic arch. Procedure: 1. Once pre-fontan assessment complete and patient deemed appropriate candidate for Fontan completion, remove catheter from RFV and insert.035 Amplatz exchange wire. Remove 6Fr. sheath and exchange for 6Fr. long sheath. 2. Insert 15mm Amplatz snare into IJV (Gensini) and position superior to RA/PA perforation site. 3. Insert either Chiba transeptal needle (or in certain instances a RF perforation catheter may be employed) in the long sheath and position inferior to the RA/PA anastamosis site. 4. Once in appropriate position perforate the roof of the RA and advance into the PA/Hemi- Fontan. (image 1) 5. Pass the exchange wire into the PA/SVC and snare the end of the wire from above in order to externalize the exchange wire. 6. Once the wire is stabilized, the 6Fr. long sheath is exchanged for a 12Fr. long sheath and is advanced into the SVC. (image 2) 7. Once in good position, dilation of the RA-PA connection is require prior to stent implantation. 8. Start with coronary balloon to dilate the goretex patch at the roof of the RA. Increase the dilating balloon size until the 12 Fr. sheath can be advanced into the SVC. 9. With the sheath in good position a CP covered stent* mounted on a 16mm Z-Med II balloon is inserted into the sheath. (image 3) 10. Once in good position from the RA/PA junction through the atrium into the RA/IVC junction the balloon is inflated and the stent deployed. The ends of the stent are flared to anchor above and below the atrium and to avoid obstruction of flow in the hepatic veins or the pulmonary arteries. 11. To ensure appropriate anchoring at the inferior end, a second covered stent is opened and the covering removed (now uncovered) and is deployed from the middle of the first stent through the IVC/RA junction to a deeper portion of the IVC (intrahepatic). (image 4) 12. Once all stents are in good position the hemodynamics and angiography is repeated to assess obstruction to flow in the hepatic veins, conduit/stent, PAs, pulmonary veins. 13. The patient is then extubated in the cath lab and transferred to the CCCU for observation. *Stent selection is based on the measurement from the middle of the PA above the roof of the RA to the RA/IVC junction just superior to the hepatic vein insertion. Once this measurement is obtained, reference to the chart supplied by the company outlines specifically which stent gives the appropriate distance when inflated to a diameter of 16mm. This is typically the stent length 5-10mm longer than the actual distance required.

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5 Post-Cath Lab Fontan Protocol (Minimum Requirement): CCU: Extubation in the cath lab (if clinically appropriate) or transfer to CCU intubated. CXR 2 views on arrival in CCU Echocardiogram for Stent flow Observation for minimum 48 hours Medications: Cefazolin 40mg/kg IV in cath lab and repeat 2 nd dose 8 hours later Heparin infusion therapeutic levels for 24 hours ASA 81mg po continued/started the morning after the cath Plavix 1mg/kg/day po the morning after the cath (continue for 3 months) Discontinue heparin 4 hours after oral antiplatelet drugs given 4D: Close observation for pleural effusions Echo prior to discharge (flow study) Vessel U/S (neck, groin) prior to discharge if possible (or as outpatient at clinical follow-up) Observation for minimum 24 hours Follow-up: 1-2 weeks post-discharge with Dr. Benson (ECG, CXR, Echo [assessment as above]) 3 month, 6 month and 1 year follow-up with Dr. Benson/primary cardiologist - ECG, echo, CXR at all appointments - Holter monitor at 6 months - MRI at 6 months (unless contraindicated) Post-cath lab Fontan catheterization at months or earlier if clinically required (diagnostic study with Dr. Benson) References: 1. Hausdorf, Gerd; Schneider, Martin; Konertz, Wolfgang. Surgical preconditioning and completion of total cavopulmonary connection by interventional cardiac catheterisation: a new concept. Heart 1996;75(4): Klima, Uwe; Peters, Tina; Peuster, Matthias; Hausdorf, Gerd; Peuster. A Novel Technique for Establishin Total Cavopulmonary Connection: From Surgical Preconditioning to Interventional Completion. JTCVS Nov 2000;120(5): Sidiropoulos, A; Ritter, J; Schneider, M; Konertz, W. Fontan modification for subsequent nonsurgical Fontan completion. EJCTS 1998;13: Galantowicz,M; Cheatham, JP. Fontan completion without surgery. Sem Thorac Cardiovasc Surg 2004;7: Crystal, MA; Yoo, S-J; Mikailian, H; Benson, LN. Catheter-Based Completion of the Fontan Circuit: A Nonsurgical Approach. Circulation 2006;114:e5-e6.