Renal Denervation in Hypertension...Renal Denervation in Hypertension - The Story Told With...
Transcript of Renal Denervation in Hypertension...Renal Denervation in Hypertension - The Story Told With...
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Renal Denervation in Hypertension - The Story Told With Skepticism -
Prof. Sverre E. Kjeldsen, MD, Dr. Med., FAHA, FESC Department of Cardiology
Oslo University Hospital, Oslo, Norway, Division of Cardiovascular Medicine, University of Michigan,
Ann Arbor, Michigan Past-President of European Society of Hypertension
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Arterial Plasma Noradrenaline During Mental Stress Predicts Future BP
Resting SBP at 18-Year Follow-Up
SB
P (m
m H
g)
Arterial noradrenaline tertile at baseline during mental stress test
P=.004
Flaa A et al. Hypertension. 2008;32:336-341.
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Dr. Reginald H. Smithwick
Oslo RDN study
Sympathectomy: An Early Surgical Precedent
1952
Photo of Dr. Smithwick reproduced with permission from JAMA.
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Rate
of sp
illove
r of n
oradre
nalin
efro
m the
kidn
eys t
o plas
ma (n
g/min)
0
100
200
300
400
NormalBP
20-39 40-59 60-79
EssentialHypertension
**
*
Increased Spillover of Noradrenaline into the Renal Veins in Essential Hypertension
M. Esler, G. Lambert, G. Jennings. J. Hypertension 1990; 8:S53-57 (updated)
15 patients
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• Standard interventional technique • 4-6 two-minute treatments per artery • Proprietary RF Generator
− Automated − Low-power − Built-in safety algorithms
Renal Nerve Anatomy Allows a Catheter-Based Approach
6
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CONFIDENTIAL Version Date: 28JUN2011
• Nerves arise from T10-L2 • The nerves arborize around the artery
and primarily lie within the adventitia
Renal Nerve Anatomy
Vessel Lumen
Media
Adventitia
Renal Nerves
7 7
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8
Baseline Patient Characteristics (n=153)
Symplicity HTN-1 Investigators. Hypertension. 2011;57:911-917.
Demographics Age (years) 57 ± 11 Gender (% female) 39% Race (% non-Caucasian) 5%
Co-morbidities Diabetes Mellitus II (%) 31% CAD (%) 22% Hyperlipidemia (%) 68% eGFR (mL/min/1.73m2) 83 ± 20
Blood Pressure Baseline Office BP (mmHg) 175/98 ± 17/15 Number of anti-HTN meds (mean) 5.1 ± 1.4
Diuretic (%) 95% Aldosterone blocker(%) 22% ACE/ARB (%) 91% Direct Renin Inhibitor 14% Beta-blocker (%) 82% Calcium channel blocker (%) 75%
Centrally acting sympatholytic (%) 33% Vasodilator (%) 19%
Alpha-1 blocker 19%
● Upper age range ● No ambulatory BP ● No evidence of drug adherence
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Symplicity HTN-2 Trial: Office BP Reduction
P≤0.005 for changes in SBP and DBP at all time points between Symplicity RDN and control groups; error bars represent 95% CIs. Symplicity HTN-2 Investigators (Esler M et al.) Lancet. 2010;376:1903-1909.
Total n=106 (intervention group n=52, control group n=54)
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When Stringent Definitions are Used, 7.6% to 18% of Patients Have True Treatment-Resistant Hypertension
• Spanish ABPM Monitoring Registry definition:1
– Use of 3 antihypertensive drugs (with 1 diuretic)
– Clinic BP ≥140 and/or ≥90 mm Hg – Daytime BP ≥130 and/or ≥80 mm Hg
• Pierdomenico et al definition:2
– Use of triple therapy – Clinic BP ≥140 or ≥90 mm Hg
at ≥2 visits – Daytime BP ≥135 or ≥85 mm Hg
• Both studies excluded patients at BP target being treated with ≥4 drugs1,2
– True prevalence of treatment-resistant hypertension may therefore be somewhat higher
Large prescription registry in Israel suggests prevalence of 1-2 % only
ABPM=ambulatory blood pressure monitoring; BP=blood pressure. 1. de la Sierra A et al. Hypertension. 2011;57:898-902; 2. Pierdomenico SD et al. Am J Hypertens. 2005;18:1422-1428.
7.6%
18%
Spanish ABPM Monitoring Registry1
(N=8295)
Italy: Pierdomenico et al2
(N=742)
Pat
ient
s (%
) 1-2 % ?
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Ray W. Gifford: Hypertension 1988 Proceedings From Course at the Cleveland Clinic in
October 1987:
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Ray W. Gifford: Hypertension 1988
Gifford RW. Hypertension 1988; 11 (Suppl. II): 101-5.
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Eskås et al. Blood Pressure, 2016; in press
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How Many Patients Are Actually Adherent to Their Antihypertensive Medication?
A quantitative analysis based on serum drug levels in patients taking free combination multidrug therapy*
Patie
nts (
%)
Fully Compliant With Treatment
No Drugs Detectable in
Serum
N=84 Number of antihypertensives: 5.0±1.2
34.5%
65.5%
34.5%
Poor drug adherence in apparent treatment resistant hypertension makes these patients wide open for Hawthorne effect: Patients start taking their prescribed medication when getting attention with subsequent fall in BP
Fulfilled Criteria for
Nonadherence *All patients except 3 were taking agents as free combinations. Ceral J et al. Hypertens Res. 2011;34:87-90.
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The Hawthorne Effect
People change their behaviour when being under observation
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Fractions (%) of apparent treatment resistant HT patients detected to be non-adherent by therapeutic drug monitoring
(TDM) or direct observed treatment (DOT)
Ceral et al. 2011 N=84 TDM, blod 65.5 % Jung et al. 2013 N=76 TDM, urin 53.0 % Strauch et al. 2013 N=163 TDM, blod 47.0 % Strauch et al. 2013 N=176 TDM, blod 19.0 %
Fadl Elmula et al. 2013 and 2014 N=83 DOT + 24t ABM 29.3 %
Brinker et al. 2014 N=56 TDM, blod 54.0 %
Tomaszewski et al. 2014 N=208 TDM, urin 25.0 % Florczak et al. 2015 N=36 TDM, blod 86.1 %
Hameed et al 2015 N=50 DOT + 24t ABM 50.0 %
Eskås PA, Heimark S et. al. Blood Press 2016; 25: in press.
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Therapeutic Drug Monitoring Facilitates BP Control in Resistant Hypertension
17 Brinker S, Kaplan NH et al. JACC 2014; 63: 834-5.
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18
170 mmHg
137 mmHg
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Drug Compliance or Adherence
Written patients’ reports, home BP Electronic pill boxes
Blood measurements of drugs Urine measurements of drugs
Prescription registries Witnessed intake of drugs
(directly observed therapy = DOT)
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Methods 2 Inclusion criteria Exclusion criteria Office SBP >140mmHg (measured per guidelines) Daytime ambulatory SBP >135mm/Hg (after witnessed intake of anti-hypertensiv drugs prior to ABPM) Age 18-80 years At minimum, 3 antihypertensive medications must meet one of them must be a diuretic.
Hemodynamically or anatomically significant renal artery abnormalities or stenosis (>50%) or prior renal artery intervention eGFR < 45 mL/min/1.73m² (MDRD formula) Alb/creat ratio > 50 mg/mmol Type 1 diabetes mellitus Known alcohol/drug abuse MI, unstable angina, or CVA in the prior 6 months Known secondary cause of hypertension Known chronic serious disease
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Witnessed Intake of Antihypertensive Drugs
• Patients were asked to bring their prescribed medication to the clinical visit • Medication was documented and administered by the investigator and swallowed by the patient under continuous observation
• Patients were then continuously under the observation by the investigator
Methods 3
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Flow Chart of Oslo RND – First Part Open Design
Fadl Elmula F et al. Hypertension 2013;62:526-532
Copyright © American Heart Association, Inc. All rights reserved.
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Office mean systolic and diastolic blood pressures at baseline and 1, 3, and 6 months after renal denervation (n=6).
Fadl Elmula F et al. Hypertension 2013;62:526-532
Copyright © American Heart Association, Inc. All rights reserved.
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Daytime ambulatory mean systolic and diastolic blood pressures at baseline and 3 and 6 months after renal denervation (n=6).
Fadl Elmula F et al. Hypertension 2013;62:526-532
Copyright © American Heart Association, Inc. All rights reserved.
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F. Elmula et al. Hypertension 2014;63:991-999.
Control Methods: Integrated Non-Invasive Hemodynamic Management Using the HOTMAN® System to guide improvement and adjustment of drug treatment
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Methods: Integrated Non-Invasive Hemodynamic Management Using the HOTMAN® System
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Methods: Integrated Non-Invasive Hemodynamic Management Using the HOTMAN® System
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Clinical Case 2 (of 53) Hemodynamic Measurements at Baseline
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Clinical Case 2 (of 53) 24h ABPM at Baseline and 6 Month Follow-up
Baseline 6 Month
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The Oslo RDN Study Inclusion criteria Exclusion criteria Average SBP ≥140mmHg (measured per guidelines) 24 hour average ABPM SBP >135mm/Hg (witnessed intake of all meds prior to AMBP) Age 18-80 years At minimum, 3 antihypertensive medications must meet one of them must be a diureticum.
Hemodynamically or anatomically significant renal artery abnormalities or stenosis (>50%) or prior renal artery intervention eGFR < 45 mL/min/1.73m2 (MDRD formula) Alb/creat ratio > 50 mg/mmol Type 1 diabetes mellitus Known alcohol/drug abuse MI, unstable angina, or CVA in the prior 6 months Known secondary cause of hypertension Known chronic serious disease
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F. Elmula et al. Hypertension 2014
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Change in The Mean Ambulatory Daytime BP after Witnessed Intake of Antihypertensive
Drugs (n=13)
164
130
102
81
60
80
100
120
140
160
180
Referral BPs BPs after witnessed drugs intake
Ambu
lato
ry B
lood
Pre
ssur
e, m
mH
g Amb. daytime SBP
Amb. daytime DBP
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Office BPs at 3 and 6 months
F. Elmula et al. Hypertension 2014;63: 991-999.
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Individual office BPs at 3 and 6 months
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Daytime Ambulatory BPs at 3 and 6 months
F. Elmula et al. Hypertension 2014;63: 991-999.
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Individual daytime ambulatory BPs at 3 and 6 months
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F. Elmula et al. Hypertension 2014;63: 991-999.
Online March 3, 2014
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For Full Details, Please Go to WWW.NEJM.ORG
Bhatt DL, Kandzari DE, O’Neill WW, et al...Bakris GL. N Engl J Med 2014
Online March 31, 2014
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Effect of RDN on 6 Months Office SBP
FEM Fadl Elmula et al. Blood Press 2015; 24: 263-274
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Effect of RDN on 6 Months 24-hour BP
FEM Fadl Elmula et al. Blood Press 2015; 24: 263-274
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Effect of RDN on 6 Months eGFR
FEM Fadl Elmula et al. Blood Press 2015; 24: 263-274
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Persu A, Jin Y, Fadl Elmula FEM, Renkin J, Høieggen A, Kjeldsen SE, Staessen JA 2014
Incident Renal Artery Stenosis Following RDN
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+ Symplicity HTN-2 - Oslo RDN - Symplicity HTN-3 - Prague-15 - French Dener-HTN - Symplicity Flex
The current evidence is AGAINST renal denervation