Renal Sympathetic Denervation for HTN
Contents
1. EE SAMSUNG MEDICAL CENTER P wevicat center P wevicat center FCM AA e 20901 2 03 19 14 31 38 3 201 2 03 21 63 363 3 72 erent T z gt 1 201 2 03 19 ta 31 32 201 2 03 19 21 95656557 L TARA ri x 44 k CE T lt gt g x gt so gt gt Pt aks u ma u a DR FGAT 5 ped E Symplcity newest data sets oldest gt AL 240 309 308 310 314 m m F H 4 Imax 49 7 56 7 58 0 53 7 36 7 Pmax 8 0 8 0 8 0 8 0 0 0 Pend 8 0 8 0 8 0 8 0 0 t 120 120 120 120 0 Code 50 NORM NORM NORM USER EXIT mlu _ EE SAMSUNG MEDICAL CENTER P wevicat center EE SAMSUNG MEDICAL CENTER Symplicity HIN Overview Design Multicenter 19 sites in Europe Australia and the United States nonrandomized open label proof of concept study Population 153 patients with treatment resistant hypertension Treatment Endovascular catheter based renal denervation using the Symplicity renal denervation system plus baseline antihypertensive medications Duration 36 months assessments at 1 3 6 12 18 24 and 36 months Outcome Measures Primary efficacy measure change in office blood pressure BP Primary safety measures based on physical examination basic blood chemistries and anatomic2. Vasoconstriction A Heart rate Atherosclerosis 7 Fiera De 5 G3bN Nerves 00 V f Renin Release gt RAAS activation Pressure p 1 Sodium Retention 4 1 Renal Blood Flow Kidney function SAMSUNG MEDICAL CENTER Renal Denervation A New Therapeutic Approach e Recently renal denervation using a novel approach percutaneous catheter based radiofrequency ablation was shown to significantly reduce BP in patients with resistant hypertension The procedure was found to be simple and safe with minimal procedure related adverse events Catheter based renal denervation could represent a significant advance in the management of resistant hypertension 1 Schlaich MP et al Hypertension 2009 54 1195 2001 2 Symplicity HTN 2 Investigators Lancet 2010 376 1903 1909 3 Symplicity HTN 1 Investigators Hypertension 2011 57 911 917 Ma P SAMSUNG MEDICAL CENTER Symplicity catheter and generator Dispersive electrode ground pad sent with Symplicity catheter 6 French sheath 6 French renal guide catheter 45 55 cm RDN D1 RDC 1 or IMA LIMA Guidewire 0 014 non hydrophilic Tuohy RHV Non tonic contrast dilute to 50 50 Heparinized saline flush bag pressurized Radiopaque ruler P MEDICAL CENTER Symplicity Symplicity catheter 0 108Cm e 1 3mm 0 051 inch Deflectable Shaft
3. Heparinized Saline Pressure Transducer or Stopcock Dilute to 50 50 Control Syringe Monitor Intra arterial IA pressures via groin sheath sidearm EIS TT 6F RDC 1 or LIMA Side Arm Adapter Symplicity Catheter RHV SAMSUNG MEDICAL CENTER Medications e Common medications to have available for procedure Midazolam eg dormicum Versed or similar Fentanyl morphine or similar Nitroglycerine Atropine P MEDICAL CENTER Renal Angiogram Absence of flow limiting obstructions Diameter gt 4 mm in targeted area Absence of prior renal angioplasty indwelling renal stents or aortic graphs P SAMSUNG MEDICAL CENTER Targeting Re Adventitia Renal Nerves P MEDICAL CENTER Targeting Renal Ner Always treat distal to proximal Do not re cross previously treated site 4 6 focal treatments 120 seconds per treatment gt 5 mm between locations Stable unique locations Circumferential coverage e Common strategy dependent on renal anatomy Distal Inferior and inferolateral locations Proximal Superior and superolateral locations If positioning is unstable avoid purely lateral treatments possible electrode movement with respiration Favor stable wall contact over circumferential treatment e PULL ROTATE ASSESS new location and prior treatment site with cine just prior to each trea
4. as a SBP reduction of lt 10mmHg ai SAMSUNG MEDICAL CENTER MAE S Ti Renal denervation 15 significantly reduce BP in patients with resistant hypertension The procedure was found to be simple and safe with minimal procedure related adverse events Office BP reduced by 17 4 8 4 mmHg at 6 month follow up In SMO P MEDICAL CENTER
5. 0 74 45 6 2 ox 120 120 84 38 7 Check Status Messages Code 25 22 20 _ SAMSUNG SAMSUNG MEDICAL CENTER End of Treat ssaging RE OFF RE OFF ENERGY SUCCESSFULLY DELIVERED A 50 AFTER 120 sec ENSURE PROPER ELECTRODE CONTACT FOR NEXT TREATMENT PRESS FOOT SWITCH TWO TIMES TO CONTINUE Energy successtully delivered Strive for improved electrode message will automatically clear contact on subsequent treatments after electrode in firm contact with and stable against vessel wall ai SAMSUNG MEDICAL CENTER M Check Status Messages The proprietary generator algorithm will occasionally stop RF delivery if certain temperature and or impedance thresholds are crossed n these cases some messaging will be displayed to guide users on how to proceed Check status messages can be cleared by pressing the foot switch twice within 3 seconds or by pressing the continue softkey on the generator P MEDICAL CENTER Status Messages Commonh tricountered gt Generator messages commonly encountered and related action steps Message Image treatment site Electrode mav have moved Ensure proper electrode contact Ensure proper electrode contact for next treatment High Impedance check catheter position and or connections Check Status Action Code Wait approximately one minute and image prior treatment site as increased 22a 22b 24a vessel
6. Renal Sympathetic Denervation for HTN k j w i Se Young Department of CardioVascular Center Samsung Medical Center er Worldwide Prevalence_o Hypertensterris Increasing In 2000 972 million Prevalence of Hypertension by World Region 26 of the adult population had hypertension 2000 2025 e By year 2025 1 56 billion 29 are projected to have hypertension Most of the expected increase will be in economically developing regions 05 Sa 0 20 40 60 80 100 120 140 160 180 Number of People With Hypertension millions Kearney PM et al Lancet 2005 365 217 223 ai SAMSUNG MEDICAL CENTER JNC 7 Classification of Blooc Pressure LeveTs Systolic Diastolic BP Classification mm Hg mm Hg Normal lt 120 and lt 80 Pre hypertension 120 139 or 80 89 Stage 1 Hypertension 140 159 or 90 99 Stage 2 Hypertension gt 160 Or gt 100 JNC 7 The Seventh Report of the Joint National Committee on Prevention Detection Evalu ation and Treatment of High BP Chobanian AV et al Hypertension 2003 42 1206 1252 P MEDICAL CENTER 2007 ESH ESC Classification 0 Levels Systolic BP Classification mm Hg Optimal 120 Normal 120 129 High Normal 130 139 Grade 1 Hypertension 140 159 Grade 2 Hypertension 160 Grade 3 Hypertension gt 180 and and or and or and or and or and or M Di
7. Z0 17mm Ph Eo SAMSUNG a j h t ERU D 249p b smt SAMSUNG MEDICAL CENTER Symplicity Catreter Tip Fea 5 mm 12 mm Flexible 6 self orienting Shaft SAMSUNG MEDICAL CENTER Symplicity Catheter Fandle eatures Deflect tip by Straighten tip by pulling lever pushing lever towards back towards front of handle of handle Shaft and electrode can rotate independently from handle body sHandle rotator has tactile click every 45 degrees Dot on rotator gives relative rotational reference SAMSUNG SAMSUNG MEDICAL CENTER Generator V Back Panel Front Panel Power ACPower Grounding Volume Switch Connector Stud Adjust Display RF button 1 00 Symplicity ARDIAN RON e Ln STATUS CONTINUE B FAULTS Soft key Indicator 3X Dispersive Light 3X electrode Extension connector Foot switch cable catheter connector connector LBL042 A Model G2 SAMSUNG MEDICAL CENTER e Key Guide Selection Criteria Takeoff angle of renal arteries Engagement at ostium to prevent deep seating of guide catheter Soft tip at engagement with both active and balanced support 6tr 45 55Cm Medtronic Sherpa RDN D1 ks ii 2 a N Medtronic Sherpa IMA KN P MEDICAL CENTER Contrast
8. and chronic procedural safety a composite cardiovascular endpoint occurrence of 210 mm Hg SBP reductions achievement of target SBP change in 24 hour ambulatory BP and change in home BP Symplicity HTN 2 Investigators Lancet 2010 376 1903 1909 i P SAMSUNG MEDICAL CENTER Symplicity HTN 2 Trial 6 Month Offiee BP Primary Endpoint 10 0 10 20 30 40 50 6 Mean Office BP Change mm Hg 32 12 1 O Symplicity Renal Denervation Group n 49 m SBP DBP Control Group n 51 33 11 mm Hg differ ence between Sym plicity renal denerv ation and control gr oups P lt 0 0001 for SBP and DBP 84 of patients in the renal denervation group had gt 10 mm Hg reduction in SBP e 10 of patients In the renal denervation group had no reduction in SBP P SAMSUNG MEDICAL CENTER SMC Result n Demographics Mean age SD years 52 6 13 Gender female 20 Comorbidities diabetes mellitus 25 7 Coronary artery disease 19 2 Hyperlipidemia 54 3 Mean eGFR SD mL min 1 73m 78 1 16 796 BP Diuretic 77 1 ACE ARB 94 3 Beta blocker 74 3 Calcium channel blocker 77 1 Spironolactone 14 3 dii S EU cturt SMC data n Change in blood pressure mmHg p Systolic 8 17 4 20 1M n 30 3M n 21 6M n 19 1 Month Non responder 8 30 26 6 defined
9. assessment of renal vasculature P MEDICAL CENTER 1 Symplicity HTN 1 Signi ained B C Pressure Reductions to at Least 3 10 0 2 10 9 p 20 Systolic oP Diastolic c 2 30 U 31 40 6mo 1 year 2 years 3 years n 144 n 132 n 105 n 34 SAMSUNG MEDICAL CENTER Symplicity HTN 1 This CrHtce DIN 100 90 80 70 60 50 40 30 20 10 0 da 94 82 82 80 74 71 71 69 1mo 3mo 6mo 9mo 12mo 18mo 24mo 30mo 36mo n 143 n 148 n 144 n 96 n 132 n 108 n 105 n 44 n 34 Responder was defined as an office SBP reduction 210 mmHg ELTE SAMSUNG MEDICAL CENTER Symplicity HIN Overview Design Multicenter 24 sites in Europe Australia and New Zealand prospective randomized controlled study e Population 106 patients with treatment resistant hypertension e Treatment Intervention group endovascular catheter based renal denervation with the Symplicity renal denervation system plus baseline antihypertensive medications Control group baseline antihypertensive medications alone e Duration 6 months for the primary endpoint with follow up to 3 years e Outcome Measures Primary endpoint between group changes in average office SBP from baseline to 6 months Secondary endpoints acute
10. astolic mm Hg lt 80 80 84 85 89 SUL SS 100 109 2110 2007 ESH ESC 2007 Hypertension Practice Guidelines of the European Society of Hypertension ESH and European Society of Cardiology ESC Mancia G et al Fur Heart 6 P MEDICAL CENTER Even Small Reductionsin BP _ Reduce Risk ef V Mortality gt 10 reduction in risk 2 mm Hg decrease of stroke mortality in mean office SBP 7 reduction in risk of ischemic heart disease mortality SBP systolic blood pressure Lewington 5 et al Lancet 2002 360 1903 1913 SAMSUNG MEDICAL CENTER Cardiovascular Mortality Risk Doubles With Each 20 10 mra tg Increase in BP 8x 2 CV Mortality Risk 115 75 135 85 155 95 175 105 SBP DBP mm Hg CV cardiovascular SBP systolic blood pressure DBP diastolic blood pressure In individuals aged 40 to 69 years 10 year study period starting at BP 115 75 mm Hg Lewington S et al Zancet 2002 360 1903 1913 SAMSUNG MEDICAL CENTER Drugs Work But Not as You May Ihi ell as Current approach failing 35 Physician inertia Treated but Patient compliance Uncontrolled Resistant HTN Renal denervation RDN potentially a complance independent therapy P MEDICAL CENTER Renal Sympathetic Nerve Activity Kidney as Origin of Central Sympathetic e 1 Contractility
11. reactivity such as spasm may be encountered When imaging vessel be aware electrode may have moved during treatment 22b 24b Strive for improved electrode contact on subsequent treatments 23 24c Electrode in firm contact with and stable against vessel wall Treatment was completed strive for improved electrode contact on subsequent 50 treatments K Electrode in firm contact with and stable against vessel wall Ensure no excessive tissue catheter electrode contact ie vessel distension 20 6 Ensure catheter is not positioned in guide a branch or small artery Reposition catheter electrode if necessary and attempt to restart treatment Check catheter and dispersive electrode connections Replace catheter and or dispersive electrode as needed Additional detail sometimes provided but these portions of the message drive action For more detail and other check status messages consult Generator User Manual SAMSUNG MEDICAL CENTER Procedure 7 w MEDICAL CENTER MEDICAL CENTER gt O 53 4 3 0 2 A cm 2 1 9030503 7 t a o Ele 2012 03 19 M 1 90565203 219565650772 201 2 03 a 30 8568772 SAMSUNG MEDICAL CENTER s Masa ni newest data sets oldest 6309 38 310 314 0 Leu MEM Max i Sympiiciy Pmx 8 0 8 0 8 0 80 0
12. tment Treat Distal to Proximal gt 5mm Spacing _ SAMSUNG SAMSUNG MEDICAL CENTER Optimizing W it Excessive Wall Contact avoid distending vessel wall with electrode Sufficient Wall Contact ai SAMSUNG MEDICAL CENTER Angiographic Appearance 655 1221 1916 Pre Procedure 1 Month Follow Up M t N Increased vessel reactivity such as spasm may be encountered when treating in areas with reduced blood flow such as dual renal arteries or beyond significant renal artery branch points MEDICAL CENTER Basic anq Ad 5 Per the Generator User Manual using softkeys it is possible to toggle between Basic and Advanced displays e During RF ON in addition to time and temperature the advanced display also displays Power and Impedance drop e Generally bigger impedance drops indicate better delivery of energy Basic Setting Advanced Setting RF ON RE ON ag 12 57 C 120s 37 C EY 15 2130 SAMSUNG SAMSUNG MEDICAL CENTER Using a softkey It Is possible to view a summary of the last 5 treatments performed lt newest data sets oldest gt Starting Impedance 70 285 3 398 317 291 96 Impedance Drop 002008 11 22 17 9 25 Max t Tmax 48 59 64 65 5 e Power Watts Pmax 7 9 9 0 9 0 6 2 9 0 End Power Watts Pend 5 0 8
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