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Effect of the Rheos Device on long term BP control'

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Title: Effect of the Rheos Device on long term BP control'


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Refractory or Difficult to Control
Hypertension Vasilios Papademetriou.
MD Professor of Medicine Georgetown University
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BP and Risk of CHD Mortality
CHD, coronary heart disease. Multiple Risk Factor
Intervention Trial (MRFIT) n347,978 men without
previous myocardial infarction. Neaton JD et al.
In Hypertension Pathophysiology, Diagnosis, and
Management. 1995127-144.
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BP and Risk of Stroke Mortality
Multiple Risk Factor Intervention Trial (MRFIT)
n347,978 men without previous myocardial
infarction. Neaton JD et al. In Hypertension
Pathophysiology, Diagnosis, and Management.
1995127-144.
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Effect of Systolic BP and Diastolic BP on CHD
Mortality MRFIT Screenees (N316,099)
Death rateper 10,000person-years
Diastolic BP (mm Hg)
Systolic BP (mm Hg)
Men aged 35 to 57 years followed up for a mean
of 12 years. Adapted from Neaton et al. Arch
Intern Med. 199215256-64.
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Stroke and IHD Mortality vs Usual Systolic BP by
Age
Mortality(Floating Absolute Risk and 95 CI)
IHDischemic heart diseaseProspective Studies
Collaboration. Lancet. 20023601903-1913.
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High-Normal Blood Pressure and CVD Risk
Framingham Study
Men
Women
High normal 130-139/85-89 mm Hg
Normal 120-129/80-84 mm Hg
Optimal lt120/80 mm Hg
P0.01
10
Plt0.001
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Cumulative Incidence ()
6
4
2
0
0
2
4
6
8
10
12
14
0
2
4
6
8
10
12
14
Time (years)
Time (years)
Vasan et al. N Engl J Med. 20013451291-1297.
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Clinical Trials in Hypertension
Should we treat ISH in older persons?
What is the best way to treat HBP?
Should we treat DBP in older persons?
What is the goal of treatment?
Should we treat diastolic HBP?
Can we prevent hypertension?
1960s 1970s 1980s 1990-1995 1996-1999 2000 2001-2
003 2004-2008
TROPHY
HR Black, 2003.
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Treatment of Hypertension and Cardiovascular
Outcomes Placebo Controlled Trials
Combined results from hypertension treatment
trials Decrease in eventstreated compared to
controls
Percent
17 randomized, placebo-controlled treatment
trials (48,000 subjects) 14 diuretic and 3
beta blocker based trials All differences are
statistically significant.
Herbert P, Moser M, et al. Arch Intern Med.
1993153578-581. Moser M, Herbert PR. J Am Coll
Cardiol. 199627(5)1214-1218.
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Resistant or difficult to control Hypertension
  • Nationwide only 34 of pts controlled
  • Average meds used 3.5
  • 10-15 of pts with BPgt160 systolic
  • What causes resistance?

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Resistant or Refractory Hypertension
  • Hypertension ( gt140/90) despite treatment with
    three or more medicines in a sensible
    combination, in maximal doses, that include a
    diuretic
  • For ISH same definition for systolic BP gt160 mmHg

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Difficult to control Hypertension
  • Persistent elevation of blood pressure, despite
    treatment with two or three drugs, but not
    meeting the definition of Resistant
    Hypertension
  • Difficult to Control Hypertension is far more
    common than Resistant Hypertension

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Prevalence of Resistant Hypertension
  • Specialized Referral Centers 10-15
  • True Resistant HTN 2-5
  • Prevalence is higher among patients with target
    organ damage i.e renal or cardiac disease, PVD
    etc

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Potential causes of Resistance
  • Of 436 referred pts, 21 met criteria RH
  • Cause of Resistance
  • 43 suboptimal regimen
  • 14 medication intolerance
  • 11 secondary causes
  • 10 non compliance
  • 8 psychiatric causes
  • 14 other causes

Yakovlevitch et al Arch Intern Med. 1991
Sep151(9)1786-92
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Potential causes of Resistance
  • 1218 Pts studied, 141 had RH
  • 58 inappropriate regimen
  • 16 poor adherence
  • 8 physiologic causes
  • 6 office resistance
  • 5 secondary causes

Garg et al Am J Hypertens. 2005 May18(5 Pt
1)619-26
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MAJOR CAUSES OF RESISTANT HYPERTENSION
  • Inaccurate measurement of BP
  • Inadequate control of salt intake
  • Insufficient or no use of diuretics
  • secondary causes of HTN
  • Drugs or substances that raise BP
  • Inappropriate or inadequate treatment regimes
  • Poor compliance

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CAUSES OF DRUG RESITANT HYPERTENSION
  • Inaccurate measurement of BP
  • Pseudonormotension
  • Small cuff
  • White coat hypertension

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White Coat Hypertension
  • Elevated Pressure in the office and normal at
    home
  • White coat effect Elevated pressure at home,
    much higher in the office
  • Repeat home measurements
  • 24 hr ABPM in pts with no target organ damage
  • White coat hypertension is not benign.

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Prognostic Value of ABPM in Refractory
Hypertension
  • 86 pts with refractory HTN (DBP gt100 mm Hg on 3
    or more drugs for 3 visits
  • Patients divided into tertiles using ABPM DBP (LT
    lt88, MT 88-97, HT gt97 mm Hg)
  • Followed for 49 months
  • Monitored for CV events, target organ damage
  • Redon et al Hypertension 1998 31 712

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Office and ABPM Measurements
  • Low Tertile Middle T High T
  • DBP lt88 88-97 gt94
  • Office SBP 175 174 182
  • DBP 106 107 110

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Circadian 24-h BP Profile in Resistant
Hypertensives
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CV Event in Patients with Refractory Office
Hypertension




Plt.01
Office BP 175/106 174/107
182/110
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Probability of Event Free Survival In Resistant
Hypertensives by 24-h DBP Tertiles
DBP lt 88
DBP 88-97
DBP gt97
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CAUSES OF DRUG RESITANCE
  • Inadequate control of salt intake
  • Measure 24hr Na excretion
  • Goal is 100 mmol or less

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CAUSES OF DRUG RESITANT HYPERTENSION
  • Insufficient use of diuretics
  • Once daily lasix ineffective
  • Low dose thiazides ineffective
  • Thiazides not effective with cr gt2.0
  • Consider combinations HCTZ/triamt
  • Remember eplerenone / spironolactone

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Effective combinations pts controlled
VA cooperative study group
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MAJOR CAUSES OF RESISTANT HYPERTENSION
  • Inaccurate measurement of BP
  • Inadequate control of salt intake
  • Insufficient or no use of diuretics
  • secondary causes of HTN
  • Drugs or substances that raise BP
  • Inappropriate or inadequate treatment regimes
  • Poor compliance

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CAUSES OF DRUG RESITANT HYPERTENSION
  • Inability or disinclination to comply
  • Ask about adverse effects
  • Consider viagra for impotence
  • Explain consequences of htn and of treatment

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CAUSES OF DRUG RESITANT HYPERTENSION
  • Identifiable secondary or comorbid causes
  • CKD
  • Diabetes mellitus
  • Renovascular hypertension
  • Sleep apnea
  • Thyroid disease
  • Hyperaldosteronism
  • Pheochromocytoma

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Potential Causes of Resistance
  • Exogenous
  • Dietary and Life style Factors
  • Intrinsic Secondary Causes

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Potential Causes of Resistance
  • Exogenous causes
  • Sympathomimetic drugs (ephedra, cocain etc)
  • Anabolic steroids
  • Appedite suppressant
  • NSAIDS
  • Dietary and life style factors
  • Excessive alcohol use
  • High sodium diet
  • Overeating ( obesity)
  • Secondary Causes

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Drugs that may Cause Resistance
  • Drugs that regularly raise BP
  • Anabolic steroids
  • Sympathomimetic amines (midodrine)
  • Cocaine
  • Nicotine
  • Drugs that often raise BP
  • Ethanol (in excess)
  • Corticorticoids
  • Cyclosporin
  • Erythropoetin
  • Anorectics
  • NSAIAs including COX-2 inhibitors
  • 3. Drugs that occassionally raise BP
  • Caffeine
  • Phenothiazines
  • Tricyclics

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Secondary Causes
  • Renal parenchymal disease 6-8
  • Renal Artery stenosis 3-4
  • Hyperaldosteronism up to 15
  • Pheochromocytoma 0.5
  • Cushings syndrome 0.5
  • Hyper/Hypothyroidism 1-3
  • Sleep apnea up to 30
  • Coarctation of the aorta 0.1

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Renal Artery Stenosis Renovascular
hypertension A relatively common and reversible
cause of drug resistant hypertension?
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Secondary Causes
  • Renal parenchymal disease 6-8
  • Renal Artery stenosis 3-4
  • Hyperaldosteronism up to 15
  • Pheochromocytoma 0.5
  • Cushings syndrome 0.5
  • Hyper/Hypothyroidism 1-3
  • Sleep apnea up to 30
  • Coarctation of the aorta 0.1

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Primary hyperaldosteronism
  • High aldo, low PRA
  • Look for adernal mass
  • Respond to spironolactone / eplerenon
  • In many patients MRI is negative
  • Small adenomas can be found, but rarely active
  • Empiric use of spitonolactone/eplerenon

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Approach to Therapy of Resistant Hypertension
Life style changes
  • Reduce sodium intake
  • Weight reduction
  • Limit amount of alcohol
  • Regular exercise
  • Adherence to medication
  • Simplify medical regimen

54
Approach to Therapy of Resistant Hypertension
Pharmacologic Therapy
  • Add or increase the dose of diuretic
  • For GFRlt30 use loop diuretics BID
  • Use logical combinations
  • Diuretic
  • ACE/ARB
  • Beta blocker
  • Calcium blocker
  • Centrally active agents

55
Approach to Therapy of Resistant Hypertension
Additional Pharmacologic Therapy
  • Clonidine
  • Minoxidil
  • Spironolactone
  • Reserpine
  • Dual diuretic therapy (HCTZ/spironolact)
  • Dual CCB ( dihydropiridine/Non Dihydrop
  • ACE/ARB

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Our Experience
57
The Veterans Administration Medical system in the
US
  • Largest medical system in the US
  • 171 active medical centers
  • Over 5.5 million patients
  • Pioneering computerized medical records
  • Recently been characterized as one of the best
    systems in the US

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Improvement in Performance Measures in the VA
system
  • Target LDL-C
  • ACEI in pts with Heart failure
  • Beta blockers in post MI and HF
  • Hg A1C in Diabetics
  • Door to Needle time lt 90 min STEMI
  • Cardiac cath within 72 hrs in NSTEMI
  • BP lt140/90 and lt 160/100 ( Resistant)

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Reports
FOR RED - PROVIDER ANECGOG,ZOVSYTYDU SUMMARY
SEVERE HYPERTENSIVE 4 ( 24.0)
MODERATE HYPERTENSIVE 4 ( 24.0)
TOTAL 17 (100.0)
NORMOTENSIVE 9 ( 52.0) B. SEVERE
HYPERTENSIVE LAST BLOOD PRESSURE 160 SBP AND/OR
100 DBP 4-DIG NAME LAST BP DATE
HOME-PHONE 323 APPTMENTS TO SEP 1 -----
----------- ---------------- ------------
---------------------- R5726 READT,JTVDU
163/90! 07/23/00 202-574-3864 AUG 23 RED
MCPHERSON S6841 SLICR,UCESP 151/108! 12/13/99
703-289-7282 AUG 21 RED-AGARWAL Q2374
QYTC,JUXR 184/85 ! 05/18/00 540-258-1648
AUG 28 RED-HUANG V6118 VTHUP,NWXRT 160/91 !
06/21/00 301-327-2846 AUG 22 RED-AGARWAL B.
MILD HYPERTENSIVE LAST BLOOD PRESSURE 140-159
SBP AND/OR 90-99 DBP 4-DIG NAME LAST
BP DATE HOME-PHONE 323 APPTMENTS TO SEP
1 ----- ----------- ----------------
------------ ---------------------- P3901
PEAOI,APGOMP 156/88 06/23/00 703-159-7521
AUG 23 RED WRIGHT R4521 RYOUN,MIZEF 142/95
11/22/99 540-357-2582 AUG 21 RED-AGARWAL
R0309 RERS,GECW TE 151/81 04/20/00
202-456-8199 AUG 28 RED-HUANG S7807
SDASUKR,WEFH 153/82 07/11/00 301-248-0248
AUG 22 RED-AGARWAL
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Reports
Team RED LAST BP
LAST BP 140-159 LAST BP 160
Provider
Total Pts lt140,lt90 AND/OR 90-99
AND/OR 100
AFEDERTY,BILKOP 35
11 ( 31.4) 18 ( 51.4) 6 ( 17.1)

BWERTYGOM,CIOPJA 16 8 ( 50.0)
7 ( 43.8) 1 ( 6.3)

FERDVILK,BEDFURG 14 4 ( 28.6)
4 ( 28.6) 6 ( 42.9)
KWERFDEE,NIMNUM
11 4 ( 36.4) 6 ( 54.5)
1 ( 9.1)
MCASVUERD,VIGNIK 12
5 ( 41.7) 6 ( 50.0) 1 ( 8.3)

NEFGUJ,BLIGFUR 45 14 ( 31.1)
20 ( 44.4) 11 ( 24.4)
VUBU,VRALDIMOR
67 23 ( 34.3) 29 ( 43.3)
15 ( 22.4)
WINHITRU,FIJLIKI 107
33 ( 30.8) 49 ( 45.8) 25 ( 23.4)

-------- --------------
-------------- ----------
Team
sum 307 102 ( 33.2) 139 ( 45.3)
66 ( 21.5)





Team YELLOW
LAST BP LAST BP 140-159
LAST BP 160
Provider Total Pts
lt140,lt90 AND/OR 90-99 AND/OR 100

AQWERTUG,MATRYA 46 13 ( 28.3)
18 ( 39.1) 15 ( 32.6)
FREWSUM,VOBRET
15 6 ( 40.0) 5 ( 33.3)
4 ( 26.7)
HESCHI,NIKLAB 18
7 ( 38.9) 5 ( 27.8) 6 ( 33.3)

KQUIDTRE,MINMIMI 82 20 ( 24.4)
36 ( 43.9) 26 ( 31.7)
MURTYOM,BLOPPO
14 2 ( 14.3) 9 ( 64.3)
3 ( 21.4)
SWEWTTEW,CUCCI 68
32 ( 47.1) 23 ( 33.8) 13 ( 19.1)

SEQWSERT,VERGIJL 11 6 ( 54.5)
4 ( 36.4) 1 ( 9.1)

VAVUVVI,HEFREIT 21 10 ( 47.6)
6 ( 28.6) 5 ( 23.8)

-------- -------------- --------------
----------
Team sum 275
96 ( 34.9) 106 ( 38.5) 73 ( 26.5)

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Progress NoteReminder Screen
69
Select Resolution for Reminder
1. SelectReminder
2. Selectfrom Dialogsto Resolvethe Reminder
ProgressNote Text
Updatesfor PCE
70
of Patients with BPlt140/90
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Improving Hypertension VAMC Washington DC
Percent Patients
3,133
6,507
8,357
9,418
10,745
12,606
lt 140, lt 90
lt 160, lt 120
gt 160, gt 120
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The Washington VA Experience
  • Blood Pressure Control

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Washington VAImprovement of BP Control in The
VA system
  • Provider reminders
  • Provider education
  • Patient education
  • Free BP cuffs
  • Organizational Changes
  • Frequent meetings
  • Virtual consults, E-mails to providers
  • Complex hypertension clinics

74
Blood Pressure control Rates (lt140/90) at the
Washington VAMC Jan 2005 to March 2006
79
53
75
Inadequate Blood Pressure Control Remains a
Silent Killer
90
80
Awareness
70
60
50
Treatment
US Adults ()
40
30
20
Control
46 million people not at BP goal
10
0
NHANES II1976-1980
NHANES 1999-2002
NHANES III(Phase 1)1988-1991
NHANES III(Phase 2)1991-1994
Control defined as BP lt140/90 mm Hg per JNC
7 Source NHANES 1988-1994 and NHANES
1999-2000. Centers for Disease Control. MMWR.
200554(01)7-9. Fields LE, et al. Hypertens.
2004441-7.
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Patients with BP gt160/100 mmHg The Washington
VAMC, Jan2005 to March 2006
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Suggested Regimens to PMDs
  • Diuretic thiazides, lasix
  • ACEI or ARB
  • Beta Blocker
  • CCB
  • Clonidine, minoxidil, reserpine,
  • Spironolactone/eplarinone

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Prevalence of TRUE RESISTANT Hypertension
  • In our Institution is lt 2
  • Many of these patients can be controlled with a
    good multidrug regimen
  • Devices may have a role in the future.
  • WHERE ARA WE TODAY WITH DEVICES?

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Dose Response to Permanently Implanted Baroreflex
Activating System
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Rheos Feasibility TrialDRT Systolic Blood
Pressure Data
N10
unaudited
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Rheos Feasibility TrialDRT Diastolic Blood
Pressure Data
N10
unaudited
102
Rheos Feasibility Trial DRT - Heart Rate Data
N10
unaudited
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Effect of the Rheos Device on long term BP
control.
Rheos Device
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Rheos Device
  • Promising new technology
  • May help those difficult to control patients in
    combination with drug therapy
  • May be useful in non compliant patients
  • May be useful in patients intolerant to
    medication
  • ?????

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Resistant Hypertension
  • Int the population at large 10-15
  • True resistant about 2
  • Optimizing regimen can control many patients
  • Secondary causes should be searched for
  • Remember the importance of diuretics
  • Role of spironolactone/eplerinone
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