barorezeptorstimulation oder renale denervierung zur ... · suspend enrollment in the three...
TRANSCRIPT
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Barorezeptorstimulation oder renale
Denervierung zur Behandlung der
(resistenten) HypertonieJoachim Beige
Klinikum St. Georg (Abt. Nephrologie / KfH Nierenzentrum)
Leipzig
www.sanktgeorg.de/nephro.html
(Interessenkonflikt: Studienvergütungen [Klinikum St. Georg] und Sprecherhonorare
von CVRx)
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2
HTN-3 Results
Bhat, Bakris et. al. N Engl J Med 2014; 370:1393-1401
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3
EditorialFranz H. Messerli and Sripal Bangalore
April 10, 2014 F.H. Messerli and S. Bangalore
… the medical community has been enamored with this procedure. Resistant
hypertension evolved into a fashionable diagnosis …
Patients whose blood pressure is above their average … will be… enrolled.
Blood-pressure measurements are prone to be lower regardless of whether there
was an intervention.
… time has come to turn the page on renal denervation for hypertension but by all
means, let's not close the book.
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Häufigkeit in Deutschland / Leipzig
Ca. 20% der Bevölkerung (16 Mio/100.00)*
11 Mio /69.000 diagnostiziert Dunkelziffer 5 Mio / 31.000
9 Mio / 56.000 unter Therapie 2 Mio / 12.000 ohne Therapie
Ca. 4 / 25.000 Mio ausreichend therapiert
Ca. 5 Mio / 31.000 nicht ausreichend therapiert
*Yoon S et al.: NCHS Data Brief. 2012 Oct;(107):1-8;#Barochinger J et al. Clin Exp Hypertens. 2012 Nov 13.
Ca. 0,4 Mio / 2.500 „Therapy – resistant“#
schwere Hypertonie„schwer zu therapierende Hypertonie“
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Schwere Hypertonie
Hypertension. 2008;51:1403-1419
>= 140/90 mmHg unter
>= 3 optimal dosierten Antihypertensiva
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Jung et al, Journal of Hypertension 2013, 31:766–774
Percentage of prescribed drugs taken by nonadherent patients
40 of 76 patients (53%) were nonadherent !
30% had complete and 70% had
incomplete adherence
85% of the latter had taken less than 50%
of drugs prescribed
Incompliance !
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N= 38327
Selbst bei SBP > 170mmHg: nur in 50% der Fälle wurde Therapie intensiviert
Therapie-Intensivierung trotz SBP > 140mmHg nur in < 1/3 der Arztbesuche
Circulation. 2008;117:2884-2892
Die Docs sind Teil des Problems !!!
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Ann Intern Med. 2008;148(8):578-586
15 459 patients with uncontrolled hypertension who made 70 557 visits
Effect of Unrelated Comorbid Conditions on
Hypertension Management
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• 5 442 410 patients
• 140 126 resistant
hypertension and
≥4 antihypert. Agents
• ACEI or ARB (96.2%)
• Diuretics (93.2%)
• Calcium channel
blockers (83.6%)
• ß-blockers (80.0%)
Hypertension. 2011;58:1008-1013
Wie sind Patienten mit resistenter Hypertonie und
>4 Medikamenten behandelt ?
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Am J Hypertens 2003;16:925–930
PA, n=34
Non-PA, n=42
Effect of Low-Dose Spironolactone on Resistant
Hypertension
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The American Journal of Medicine (2012) 125, 1229.e1-1229.e10
BP baseline
164 / 95 mmHg
Chlorthalidon vs. Hydrochlorothiazid (n=609)
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Minoxidil
BMJ, 1977, 2, 667-669
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Minoxidil
BMJ, 1977, 2, 667-669
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OSAS in resistant hypertension
N=125,
resistant hypertension (Brasil)
Hypertension. 2011;58:811-817
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St.Georg gGmbH / Klinik für Kardiologie, Angiologie, Internistische Intensivmedizin / M. Heuer / Renale Denervierung 5
Pathophysiologischer Hintergrund
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Dank an Dr. G. Hennig, Klinik f. Gefässchirurgie, Klinikum St. Georg
Operativer Situs
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Kidneys
↓ HR ↑ Vasodilation
↓ Stiffness
↑ Natriuresis
↓ Renin
secretion
Carotid Baroreceptor Stimulation
Heart Vessels
Brain
Autonomic Nervous SystemInhibited Sympathetic Activity
Enhanced Parasympathetic Activity
Baroreflex Activation Therapie (BAT)
Moduliert das autonome Nervensystem
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27
Muskel Sympathikusaktiviät
nach 3 Monaten Hochdruckschrittmacher
Time [mins]
0
50
100
150
200
250
0
50
100
150
0 9 18 27 36 45
AB
P [
mm
Hg
]M
SN
A [
%]
ONOFF ONOFF OFF
57 yo maleMSNA after 3 months of continuous therapy
Heusser et al. Hypertension 2010
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Proprietary and Confidential Information of CVRx, Inc.
neo (neu, Studie) vs Rheos („alt“)
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20 mg Minoxidil
25 mg Aldactone
25 mg HCT
300 mg Aliskiren
320 mg Candesartan
20 mg Amlodipin
95 mg Metoprolol
8 mg Doxazosin
50 mg Citalopram
Nach Barorezeptor-Stimulation
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RR 200/120, nach Aggregat
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RR 160/95, nach Adrenalektomie
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10 mg Minoxidil
25 mg Aldactone
12,5 mg HCT
150 mg Aliskiren
160 mg Candesartan
20 mg Amlodipin
95 mg Metoprolol
8 mg Doxazosin
Nach Adrenalektomie
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Fallbericht Hämodialysepatientin, 38J., multiple
Med. – Unverträglichkeiten, LvH, ABDM Tagesmittel
190/122
Intraoperativer Response
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0,9 mg Moxonidin
10 mg Ramipril
25 mg HCT
20 mg Lercanidipin
5 mg Bisoprolol
150 mg Ebrantil
500 mg Furosemid
Fallbericht Hämodialysepatientin, 38J., multiple
Med. – Unverträglichkeiten, LvH, ABDM Tagesmittel
190/122
Device Aktivierung Tag + 16
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Kroon et al: J Am Coll Cardiol. 2010 Oct 5;56(15):1254-8
4-Jahres Ergebnisse Rheo Debut StudieDiastolic*
(Baseline= 111 ± 20 mmHg)
-18-21-22
Systolic*
(Baseline = 193 ± 36 mmHg)
-36
-40
-38
-30
-20
-50
-10
Ch
an
ge
in m
mH
g o
r B
PM
-40
Anti-hypertensive
Medications
Baseline
(n=45)5.0 1.3
1 year -0.2 0.3
2 years
(n=17)-0.7 0.4
3 years -0.8 0.4
4 years** -1.6 0.5
2 years
3 years
1 year
4 years
0
-53
-30
* P < 0.01
** p = 0.02
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Bisognano et al: J Am Coll Cardiol. 59, (5), 31 Jan 2012, P.541
Doppelblinde, Placebo-kontrollierte Studie (n=265)
N=164 N=78
N=170 N=80
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Barostim neo trial
Hoppe, Beige et al.: JASH (2012) 1–7 DBP HR 45
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Alle klinischen Studien BAT
Studientitel Design n Endpunkt Senkung
(mmHg ± SD)
Rheos Pivotal Doppel-Blind, randomisiert,
Sham-kontrolliert
265 BPtrue 35/15;
10% nonresponder
Rheos Debut Offen, prospektiv 45 BPtrue 21/12
XR-1 Offen, prospektiv 30 BPtrue 26/12
XR-1 und Rheos Offen, prospektiv,
Einzelzentrum
16 BPtrue 52±17 / 26±14
Beige et al.: Nieren- und Hochdruckkrankheiten, Nov. 2012; 41/11, 464-71
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Beige et al.: Nieren- und Hochdruckkrankheiten, Nov. 2012; 41/11, 464-71
Leipziger Erfahrung Hochdruckschrittmacher
BP
baselin
e (
mm
Hg
)
-100
-90
-80
-70
-60
-50
-40
-30
-20
-10
00
50
100
150
200
250
300
BP
delt
a 6
M (
mm
Hg
)
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Beige et al.: Nieren- und Hochdruckkrankheiten, Nov. 2012; 41/11, 464-71
Leipziger Erfahrung Hochdruckschrittmacher
Dialysepatienten
BP
baselin
e (
mm
Hg
)
-90
-80
-70
-60
-50
-40
-30
-20
-10
00
50
100
150
200
250
300
BP
delt
a 6
M (
mm
Hg
)
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Borisenko, Beige et al.: JASH, 2013
BAT Kosten pro QUALY (Registerdaten)
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Chronic Baroreceptor Activation Enhances Survival
in Dogs With Pacing-Induced Heart Failure
Zucker, Rossing A et al.: Hypertension. 2007 Nov;50(5):904-10
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Chronic Baroreceptor Activation Enhances Survival
in Dogs With Pacing-Induced Heart Failure
Zucker, Rossing A et al.: Hypertension. 2007 Nov;50(5):904-10
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Chronic Baroreceptor Activation Enhances Survival
in Dogs With Pacing-Induced Heart Failure
Zucker, Rossing A et al.: Hypertension. 2007 Nov;50(5):904-10
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Krum et al. Lancet. 2009 Apr 11;373(9671):1275-81.
Renale Denervation (Simplicity 1)
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St.Georg gGmbH / Klinik für Kardiologie, Angiologie, Internistische Intensivmedizin / M. Heuer / Renale Denervierung 10
Grundlagen der endovaskulären Prozedur
-> gemeinsam mit Schmerzfasern
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St.Georg gGmbH / Klinik für Kardiologie, Angiologie, Internistische Intensivmedizin / M. Heuer / Renale Denervierung 11
Grundlagen der endovaskulären Prozedur
Nervenhistologie (Schweine-Modell) 6 Monate nach RDN:
Clin Res Cardiol. 2011
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Symplicity HTN-2 Investigators. Lancet. 2010;376:1903-1909.
Renale Denervation (Simplicity 2)
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Baseline: 178/97mmHg, 5.2 med.
Symplicity HTN-2 Investigators. Lancet. 2010;376:1903-1909.
Catheter-based Renal Sympathetic
Denervation for resistant Hypertension Simplicity 2
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66
RNA and MSNA in Difficult-to-Control Hypertensive
PatientsSys BP, MSNA and HR before and after RND
Brinkmann, Heusser, Tank et al. Hypertension. 2012;60:00-00.
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67
A Controlled Trial of Renal Denervation for
Resistant Hypertension (HTN-3)
Bhat, Bakris et. al. N Engl J Med 2014; 370:1393-1401
Clin. Cardiol. 2012.
N=535
N=171
N=364
N=1441
N=171
N=353
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68
HTN-3 Population
Bhat, Bakris et. al. N Engl J Med 2014; 370:1393-1401
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69
HTN-3 Safety
Bhat, Bakris et. al. N Engl J Med 2014; 370:1393-1401
N=535 N=535
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70
HTN-3 Safety
Bhat, Bakris et. al. N Engl J Med 2014; 370:1393-1401
N=535 N=535
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71
HTN-3 Results
Bhat, Bakris et. al. N Engl J Med 2014; 370:1393-1401
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72
Online Appendix
Bhat, Bakris et. al. N Engl J Med 2014; 370:1393-1401
RND Sham
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73
HTN-3 Results / Supp. Appendix
Bhat, Bakris et. al. N Engl J Med 2014; 370:1393-1401
The average office, home, and ambulatory systolic blood pressure drops for the
first renal denervation procedures of all operators
were close to or slightly higher
than the overall average for the study.
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74
Medtronic
http://www.ptca.org/news/2014/0109_MEDTRONIC_SYMPLICITY.html
accessed at June 4th 2014
Suspend enrollment in the three countries where renal denervation hypertension
trials are being conducted for regulatory approvals
Continue to ensure patient access to the Symplicity technology at the discretion of
their physicians in markets where it is approved
Continue the Global SYMPLICITY post-market surveillance registry and renal
denervation studies evaluating other non-hypertension indications
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http://clinicaltrials.gov/ct2/results/map?term=renal+denervation&recr=Open&no_unk=Y
Accessed at June4th, 2014
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Totgesagte leben länger …
http://clinicaltrials.gov/ct2/results/map?term=renal+denervation&recr=Open&no_unk=Y
Accessed at June4th, 2014
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St.Georg gGmbH / Klinik für Kardiologie, Angiologie, Internistische Intensivmedizin / M. Heuer / Renale Denervierung 21
Weiterentwicklung: Multielektroden-Devices
EnligHTN-System (St.Jude)
• Simultane Ablation in Vorbereitung
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Krum et al. Lancet. 2009 Apr 11;373(9671):1275-81.