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How to Perform Renal Denervation A/Prof Michael Nguyen Director Cardiac Catheterization Laboratory Fremantle Hospital Western Australia 2 2 Overview • Equipment and lab setup • Assessing renal anatomy • Intra-procedural patient management and monitoring • Symplicity Catheter delivery and RF ablation • Post-procedural care • RF Generator messages 3 Equipment and Lab Setup 4 Symplicity ® Renal Denervation System™ LBL027 Rev. E 5 5 Equipment Set-up • Symplicity Catheter and Generator • Dispersive electrode (Ground pad) – sent with Symplicity Catheter • Foot pedal • 6 Fr renal guide catheter (45-55cm) (RDN-D1/RDC-1 or IMA/LIMA) and introducer sheath • Guidewires • Tuohy (RHV) • Non-ionic contrast (dilute to 50:50) • Heparinized saline flush bag • Radiopaque ruler (optional) Common medications to have available: • Heparin • Fentanyl / Morphine or similar • Midazolam (Dormicum, Versed) or similar • Nitroglycerine • Atropine 6 Manifold Setup Dilute to 50:50 Monitor IA pressures via groin sheath sidearm Pressure Transducer or 7 Generator and Dispersive Electrode • Generator – Plug in RF generator and turn on switch on back panel – Verify system beeps and all displays momentarily illuminate – Press Continue • Dispersive Electrode (Ground Pad) – Place on the thigh or other non-bony area out of the angiogram field (shave if necessary for good contact) Model G2 Front Panel 8 Symplicity Catheter • Remove cover, then remove catheter from packaging tray, handle end first. • Pass cable connector outside sterile field and connect to generator 9 Catheter Tip Features Flexible Tip (self-orienting) 5mm 12mm Deflectable Shaft 10 Catheter Handle Features Shaft & electrode can rotate independent from handle body • Handle rotator has tactile “click” every 45° • Dot on rotator gives relative rotational reference Deflect tip by pulling lever towards back of handle Straighten tip by pushing lever towards front of handle [...]... pedal (or RF button) once to activate catheter – Do not inject contrast during active treatment (alters impedance) • Generator will automatically control RF energy delivery: – Continuously monitors temperature and impedance – Automatically shuts off after 2 min or when either impedance or temperature exceed program limits – To manually stop RF delivery, depress foot pedal or press RF button once 27 27... to superior or inferior hemisphere – Fully deflect tip to optimize electrode apposition to the vessel wall – May not need to use handle lever to deflect tip in tortuous anatomy or proximal locations 23 Wall Contact Sufficient Wall Contact Excessive Wall Contact (avoid distending vessel wall with electrode) 24 Example Treatment Sites Distal locations in straight vessels may require more deflection to. .. such as dual renal arteries or beyond significant renal artery branch points 32 Post-Procedural Care 33 Post-Procedure Care • Manage femoral access site per standard protocol – Be attentive to preventing groin access complications • Be attentive to radiocontrast nephropathy prophylaxis per hospital policy (hydrate well) 34 RF Generator Messages Note: This section only applies to G2 generator software... deflected • Deliver Symplicity Catheter through the renal guide catheter Use the catheter shaft (not handle) to position catheter within vessel 22 Position electrode ≥5mm proximal to renal bifurcation Positioning Catheter • With electrode advanced to most distal treatment site, use handle lever to deflect catheter tip against vessel wall and retract to most distal treatment site • Good wall contact is... sterile saline • Perform renal artery angiogram (cine) of treated artery • Confirm ACT > 250 sec • Repeat entire procedure on opposite renal artery 29 Areas to Avoid • Avoid placing the electrode at the ostium of small branch arteries, such as those perfusing the adrenal glands • Avoid treating in very distal segments of the renal artery, in particular, segments beyondsignificant renal artery branch...Assessing Renal Anatomy 11 Renal Angiogram Eligible Anatomy: • Absence of flow limiting obstructions • Diameter ≥ 4mm in targeted area • Absence of prior renal angioplasty, indwelling renal stents, 12 or aortic graphs Renal Angiogram • Limit contrast dye exposure – 50/50 dilution of contrast and use of DSA or biplane... quality of respiration and oxygenation – Monitor respiratory rate and pulse oximetry 18 18 Symplicity Catheter Delivery and RF Ablation 19 Targeting Renal Nerves • Nerves arise from T10-L2 • The nerves arborize around the artery and primarily lie within the adventitia Vessel Lumen Media Adventitia 20 20 Renal Nerves Targeting Renal Nerves • Always Treat distal to proximal • Do not re-cross previously treated... • Changing from AP to oblique and cranial views can provide optimal assessment of artery length AP projection ~20% LAO projection 14 Guide Catheter Selection Typical: RDN-D1 or RDC-1 Alternate: IMA or LIMA • Once suitable anatomy is confirmed, upsize to 6Fr (or larger) introducer and guide • Consider guide shape based on renal anatomy 15 Intra-Procedural Patient Management and Monitoring 16 Patient... require more deflection to achieve vessel wall contact Unable to confirm adequate contact visually (may need to rely on impedance to assess for sufficient wall contact) Because of added guide catheter support, proximal locations may require less deflection to achieve 25 vessel wall contact Optimizing Treatment Sites: Impedance • Impedance may be used to confirm stable wall contact: – Higher impedance may... Messages Note: This section only applies to G2 generator software version 1.02.01 and beyond 35 Basic and Advanced Settings • Per the Generator User Manual, using softkeys, it is possible to toggle between Basic and Advanced displays • During RF ON, in addition to time and temperature, the advanced display also displays Power and % Impedance drop • Generally, bigger impedance drops indicate better delivery