Renal Denervation for Resistant Hypertension

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1 : Renal Denervation for Resistant Hypertension ???? 2013.6.13.
2 : (1)28.4% (2)()11.1% (3)7.2% (4)6.1% (5)6% (6)4.5% (7)4.1% (8)3.2% (9)3.2% (10)2.8% 2013.06.
3 : 2013.06.
4 : Hypertension Epidemiology Single largest contributor to death worldwide Every 20/10 mmHg increase in BP correlates with a doubling of 10-year cardiovascular mortality Dramatically increases risk of stroke, heart attack, heart failure, & kidney failure Only half of all treated hypertensives are controlled to established BP targets High prevalence: Affects 1 in 3 adults 1B people worldwide 1.6 B by 2025 35% Treated & Controlled 30% Untreated 35% Treated but Uncontrolled Chobanian et al. Hypertension.  2003;42(6):1206–1252. 4 c
5 : Definition of Resistant Hypertension Uncontrolled Hypertension Includes all patients who lack BP control on treatment, including those on inadequate treatment regimens, those with poor adherence, those with undetected secondary hypertension, as well as those with treatment resistance Resistant Hypertension BP that remains above goal in spite of compliance with optimal doses of 3 antihypertensive medications if difficult classes; ideally, 1 of the 3 agents should be a diuretic. The treatment plan must include attention to lifestyle measures Includes those patients who achieve BP control but require 4 antihypertensive agents to do so. (controlled resistant hypertension)
6 : Resistant Hypertension (Circulation. 2008;117:e510-e526.)
7 : Pseudo-resistance Poor Blood Pressure Technique Inaccurate measurement Two of the most common mistakes measuring BP before letting the patient sit quietly use of too small a cuff Poor Adherence a major cause of lack of BP control White-Coat Effect Common, a prevalence of 20%-30% in patients with resistant hypertension as in the more general hypertensive population less severe target organ damage, less cardiovascular risk compared with persistent hypertension during ambulatory monitoring (Circulation. 2008;117:e510-e526.)
8 : Resistant Hypertension (Circulation. 2008;117:e510-e526.)
9 : Resistant Hypertension (Circulation. 2008;117:e510-e526.)
10 : Resistant Hypertension Diagnostic and Treatment Recommendations (Circulation. 2008;117:e510-e526.)
11 : , Santorini, Greece.
12 : Pathophysiology of Hypertension
13 : Sympathetic Nerve Activity Sympathetic nerve activity can only be measured directly through difficult and invasive techniques such as muscle sympathetic nerve activity(MSNA) SNS activity is usually measured indirectly by measuring the physiologic responses that result Heart rate Pulse waves Sweat gland activity Galvanic skin response Thermography
14 : Measuring SNS Activity Pulse plethysmography (recorded from the finger) can indicate the relative activity of the SNS As SNS activity decreases, Y height, and X/Y height increases Purdy R, et al, “Suboccipital dermatomyotomic stimulation and digital blood flow” JAOA, Vol 96, No.5 May 1996, 285-289.
15 : Measuring SNS Activity This study looked at sympathetic response to touch and gentle suboccipital manipulation With simple touch (placebo manipulation), we see a significant reduction of SNS activity, evidenced by increases in increased pulse height and X/Y ratio Baseline Touch
16 : Splanchnicectomy, Sympathectomy
17 : Strategies for treatment of Resistant Hypertension
18 : Carotid Baroreceptor Stimulation Carotid baroreceptors physiologically modulate autonomic tone, by inhibiting sympathetic cardiovascular drive and stimulating vagal influences on the heart This homeostatic function is impaired in hypertension, leading to marked vasoconstriction and tachycardia. Preliminary studies in experimental animals have been conducted to try to restore the baroreceptor function.  able to lower BP as well as reduce circulating levels of norepinephrine Recently the implantation of a permanent bilateral perivascular carotid sinus pulse generator for carotid baroreceptor stimulation has been made feasible in patients with resistant hypertension. the stimulation procedure caused sustained BP reduction (31/14 mmHg) coupled with consistent sympathoinhibition, without any major side effects.
19 : Renal Denervation
20 : Hypertrophy Arrhythmia Oxygen Consumption Vasoconstriction Atherosclerosis Insulin Resistance Renal Sympathetic Activation: Afferent Nerves Kidney as Origin of Central Sympathetic Drive Renal Afferent Nerves Renin Release RAAS activation Sodium Retention Renal Blood Flow Sleep Disturbances 20
21 : Renal Denervation
23 : Renal Nerve Anatomy Allows a Catheter-Based Approach 23 Renal artery access via standard interventional technique 4-6 two-minute treatments per artery Proprietary RF generator Automated Low power Built-in safety algorithms Spacing of e.g. 5 mm.
24 : First-in-Man (AU) Series of Pilot Studies (EU, US & AU) Symplicity HTN-2 Initial RCT (EU & AU) SYMPLICITY HTN-3 US Pivotal Trial (US) Global SYMPLICITY Registry (Approved Regions) Expand HTN Indication (Approved Regions) Post-Market Registry (US) SYMPLICITY HF Symplicity HTN-1 Pilot Studies in New Indications (Approved Regions) Trials under way SYMPLICITY Clinical Trial Program follows over 5000 patients across multiple indications c
25 : Initial Cohort – Reported in the Lancet, 2009: First-in-man, non-randomized Cohort of 45 patients with resistant HTN (SBP =160 mmHg on =3 anti-HTN drugs, including a diuretic; eGFR = 45 mL/min) - 12-month data \ Expanded Cohort* – This Report (Symplicity HTN-1): Expanded cohort of patients (n=153) 36-month follow-up Lancet. 2009;373:1275-1281 25 Symplicity HTN-1 *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.) Hypertension. 2011;57:911-917.
26 : Baseline Patient Characteristics (n=153) 26 Symplicity HTN-1 Investigators. Hypertension. 2011;57:911-917.
27 : Brief Procedure with a Low Complication rate (n=153) 38 minute median procedure time Average of 4 ablations per artery Intravenous narcotics & sedatives used to manage pain during delivery of RF energy No catheter or generator malfunctions No major complications Minor complications 4/153: 1 renal artery dissection during catheter delivery (prior to RF energy), no sequelae 3 access site complications, treated without further sequelae 27 Symplicity HTN-1 Investigators. Hypertension. 2011;57:911-917.
28 : Symplicity HTN-1: BP Reductions through 3 years BP change (mmHg) P<0.01 for from BL for all time points *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.)
29 : Symplicity HTN-1: Percentage Responders Over Time Responder was defined as an office SBP reduction = 10 mmHg *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.)
30 : Symplicity HTN-1: Response Rate Among Non-responders at 1 Month (n=45) Responder was defined as an office SBP reduction = 10 mmHg *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.)
31 : Symplicity HTN-1: Chronic Safety Out to 3 Years One progression of a pre-existing stenosis unrelated to RF treatment (stented without further sequelae) One new moderate stenosis which was not haemodynamically relevant and no treatment 3 deaths within the follow-up period; all unrelated to the device or therapy No hypotensive events that required hospitalization There were no observed changes in mean electrolytes or eGFR *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.)
32 : Conclusions from Symplicity HTN-1 The magnitude of clinical response is significant and sustained through 3 years Increasing responder rates indicate: no loss of treatment effect out to 36 months BP non-response at 6 months does not predict failure to respond at 12 months or later The treatment effect was consistent across subgroups (age, diabetes status, and baseline renal function) No late adverse events were seen *Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.)
33 : Purpose: To demonstrate the effectiveness of catheter-based renal denervation for reducing blood pressure in patients with uncontrolled hypertension in a prospective, randomized, controlled, clinical trial Patients: 106 patients randomized 1:1 to treatment with renal denervation vs. control Clinical Sites: 24 centers in Europe, Australia, & New Zealand (67% were designated hypertension centers of excellence) 33 Symplicity HTN-2 Symplicity HTN-2 Investigators. Lancet. 2010;376:1903-1909. Lancet. 2010;376:1903-1909.
34 : Participating Centers Europe & Australia/NZ PI: Prof. Murray Esler Symplicity HTN-2 Investigators. Lancet. 2010;376:1903-1909.
35 : Symplicity HTN-2 Trial Inclusion Criteria: Office SBP = 160 mmHg (= 150 mmHg with type II diabetes mellitus) Stable drug regimen of 3+ more anti-HTN medications Age 18-85 years Exclusion Criteria: Haemodynamically or anatomically significant renal artery abnormalities or prior renal artery intervention eGFR < 45 mL/min/1.73m2 (MDRD formula) Type 1 diabetes mellitus Contraindication to MRI Stenotic valvular heart disease for which reduction of BP would be hazardous MI, unstable angina, or CVA in the prior 6 months Symplicity HTN-2 Investigators. Lancet. 2010;376:1903-1909. Treatment-resistant HTN population BL OBP 178/97 mmHg 49 RDN, 51 Control Age 58 years BMI 31 kg/m² 40% with Diabetes eGFR 77* Avg # meds 5.2 RDN and Control groups generally well-matched *MDRD, ml/min/1.73m2 c
36 : Assessed for Eligibility (n=190) Excluded During Screening, Prior to Randomisation (n=84) BP < 160 at Baseline Visit (after 2-weeks of medication compliance confirmation) (n=36; 19%) Ineligible anatomy (n=30; 16%) Declined participation (n=10; 5%) Other exclusion criteria discovered after consent (n=8; 4%) Randomised (n=106) Allocated to RDN n=52 Treated n=49 Analysable 6-month Primary End-Point Screening Allocated to Control n=54 Control n=51 Analysable 12-month Post- Randomisation 12-month post-RDN n=47 Per protocol, 6-mo Post-RDN (Crossover) n=35 Not-per-protocol*, 6-mo Post-RDN (Crossover) n=9 * Crossed-over with ineligible BP (<160 mmHg) Symplicity HTN-2: Patient disposition Crossover n=46 2 LTFU
37 : RDN and Control Populations Well-matched, Severe Treatment Resistant Hypertensives * n = 42 for RDN and n = 43 for Control. Wilcoxon rank-sum test for two independent samples used for between-group comparisons of UACR. † n = 39 for RDN and n = 42 for Control. Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Esler, M.)
38 : Symplicity HTN-2: Procedural Safety One renal artery dissection from injection of contrast into renal artery wall during dye angiography. The lesion was stented without further consequences One hospitalization prolonged in a crossover patient due to hypotension following the RDN procedure. IV fluids administered, anti-hypertensive medications decreased and patient discharge without further incident No radiofrequency-related renal artery stenosis or aneurysm occurred in either Randomised group Minor adverse events (full cohort) 1 femoral artery pseudoaneurysm treated with manual compression 1 post-procedural drop in BP resulting in a reduction in medication 1 urinary tract infection 1 prolonged hospitalisation for evaluation of paraesthesias 1 back pain treated with pain medications and resolved after 1 month Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Esler, M.)
39 : Symplicity HTN-2: Primary Endpoint and Latest Follow-up from Baseline to 6 Months (mmHg) Primary Endpoint: 84% of RDN patients had =10 mmHg reduction in SBP 10% of RDN patients had no reduction in SBP Systolic Diastolic Systolic Diastolic Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Esler, M.) RDN (n= 47) from Baseline to 12 Months (mmHg) Systolic Diastolic Primary Endpoint (6M post Randomisation) Latest Follow-up (12M post Randomisation) Latest Follow-up: Control crossover (n = 35): -24/-8 mmHg (Analysis on patients with SBP = 160 mmHg at 6 M) p <0.01 for from baseline p <0.01 for difference between RDN and Control
40 : Symplicity HTN-2: Medication Changes at 6 and 12 Months Post-Renal Denervation Physicians were allowed to make changes to medications Once the 6 month primary endpoint was reached* *Further analysis of Medications is ongoing
41 : Symplicity HTN-2: Renal Function Results Symplicity HTN-2 Investigators. The Lancet. 2010. RDN N=47 Crossover N=35 Treated at Randomisation Treated after 6-mo follow-up
42 : Symplicity HTN-2: Lancet Conclusions Catheter-based renal denervation, done in a multicentre, randomised trial in patients with treatment-resistant essential hypertension, resulted in significant reductions in BP. The magnitude of BP reduction can be predicted to affect the development of hypertension-related diseases and mortality The technique was applied without major complications. This therapeutic innovation, based on the described neural pathophysiology of essential hypertension, affirms the crucial relevance of renal nerves in the maintenance of BP in patients with hypertension. Catheter-based renal denervation is beneficial for patients with treatment-resistant essential hypertension. 42 Symplicity HTN-2 Investigators. Lancet. 2010;376:1903-1909.
43 : The Future is Bright for RDN Initial data derived from first generation catheter. Multi polar catheters may increase efficacy and reduce duration of procedure. Currently denervation is assumed at the end of the procedure. The ability to confirm denervation at the end of the procedure will improve efficacy.
44 : The Future is Bright for RDN Every major catheter company will have a RDN system. Other modes of ablation (ultrasound,cryo) will be developed. Indications for RDN will expand.
45 : The End


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