renal denerva syon
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c. Renal Denerva syon. Siren Sezer Baskent Üniversitesi Nefroloji Bilim Dalı. Hipertansiyon. c. Dünya çapında en önemli ölüm nedeni Her 3 erişkinden biri hipertansif Her 20/10 mmHg artış 10 yıllık ölüm riskini 2 katı arttırıyor - PowerPoint PPT PresentationTRANSCRIPT
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Renal Denervasyon
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Siren SezerBaskent Üniversitesi Nefroloji Bilim Dalı
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Hipertansiyon
• Dünya çapında en önemli ölüm nedeni
• Her 3 erişkinden biri hipertansif
• Her 20/10 mmHg artış 10 yıllık ölüm riskini 2 katı arttırıyor
• Dramatik olarak stroke, kalp krizi,kalp yetmezliği ve böbrek yetmezliği riskini arttırır
• Tedavi alanlarda kontrol oranı %30-50
• Şu an 1 milyar kişi hipertansif
• 2025 yılında 1.6 milyar kişi hipertansif olacak
35%tedavi alan
kontrollü
30% tedavisiz
35% tedavi alan kontrolsüz
Chobanian et al. Hypertension. 2003;42(6):1206–1252.
2
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Dirençli hipertansiyon En az 3 farklı sınıf antihipertansife (biri diüretik)
rağmen kanbasıncının 140/90 mmHg’nin altına düşürülememesi
(JNC 7)
National Health and Nutritional Examination Survey’e göre % 8.9İspanyol çalışması:ABPM ile 12.2
Lenfant C Hypertension 2003Cushman Wc, J Clin Hypertension 2002de la Sierra A,Hypertension 2011
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HipertrofiAritmiOksijen tüketimi
VasokontriksiyonAtheroskleroz
InsulinDirenci
Renal Sempatik aktivasyon santral sempatik deşarjın hedef organlarındadır
Renal AfferentSinirler
↑ Renin RAAS aktivasyonu↑ Sodium retensiyonu↓ Renal kan akımı
Uyku bozukluğu
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• Sinirler T10-L2 den çıkarlar • Sinirler arter etrafında dallanır ve
adventisya içinde yer alır within the adventitia
Böbrek Sinir anatomisi
Damarlumeni
Media
Adventitia
Renal Nerv
es
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Hayvan Hipertansiyon modellerinde RENAL DENERVASYON
Kan basıncı düşerTuz duyarlı domuzİki böbrek tek darlıkTek böbrek darlıkGenetik olarak HT ratlar
Kan basıncı önlenir veya tedavi edilirKöpek obesite modelli HTDüşük doğum ağırlıklı ratlar
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Tuz retansiyonunu azaltırSirozlu ratlarKalp yetmezliği olan ratlarAV fistulası olan köpeklerYüksek döngülü kalp yetmezliği olan köpekler
Sol ventrikül fonksiyonunu düzeltirKalp krizi sonrası ratlarda
Hayvan Hipertansiyon modellerinde RENAL DENERVASYON
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First-in-Man (AU)First-in-Man (AU)
Series of Pilot Studies(EU, US & AU)
Series of Pilot Studies(EU, US & AU)
Symplicity HTN-2Initial RCT(EU & AU)
Symplicity HTN-2Initial RCT(EU & AU)
SYMPLICITY HTN-3US Pivotal Trial (US)SYMPLICITY HTN-3US Pivotal Trial (US)
Global SYMPLICITY Registry
(Approved Regions)
Global SYMPLICITY Registry
(Approved Regions)
Expand HTN Indication(Approved Regions)
Expand HTN Indication(Approved Regions)
Post-Market Registry(US)
Post-Market Registry(US) SYMPLICITY HFSYMPLICITY HF
Symplicity HTN-1
Pilot Studies inNew Indications
(Approved Regions)
Pilot Studies inNew Indications
(Approved Regions)
Trials under way
SYMPLICITY Clinical Trial Program 5000 den fazla hasta multipl çalışmalar ve
indikasyonlar
c c
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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
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Symplicity HTN-1
*Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.)
Hypertension. 2011;57:911-917.
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Symplicity HTN-1: 1. ayda cevap vermeyenlerin takibinde cevap oranı (n=45)
58% 57%64%
82%
100%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 Month 3 Months 6 Months 12 Months 24 Months 36 Months(n=45) (n=45) (n=44) (n=39) (n=17) (n=8)
Cevap Ofis SKB≥ 10 mmHg dan fazla düşme
*Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.)
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Symplicity HTN-1: 3 yıl içinde kan basıncı düşüşü
KB değişimi(mmHg)
P<0.01 tüm ölçümlerde başlangıca göre
*Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.)
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• 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)
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Symplicity HTN-2
Symplicity HTN-2 Investigators. Lancet. 2010;376:1903-1909.
Lancet. 2010;376:1903-1909.
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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
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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
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İlk basamakDışlama kriterleri
Pseudoresisitans (ABPM ve ev ölçüm takibi)
Sekonder hipetansiyon nedenlerini araştırınYüksek tuz alımı, obstrüktif uyku apnesi, KB yülselten ilaçlar,hasta uyumsuzluluğu, ciddi obesite
İkinci basamak En az 3 veya 4’lü antihipertansif tedaviyi (diüretik ve antialdosteron içeren) ABPM tekrarlayın
Üçüncü basamak Anatomik kontraindikasyonları gözden geçirin (multipl renal arter varsa, ana renal arter çağı 4 mm az veya uzunluğu 20 mm’den kısa ise), daha önce anjioplasti veya renal stend yapıldıysa), GFR<45 ml/dak altı ise
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Vascular Medicine and Hypertension Unit the Hopital Europeen Georges Pompidu,Paris
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AÇIK NOKTALARRandomize kör çalışmalarHasta kaydında 24 saat ABPM ölçümüFarklı yöntemlerin etkinliği ve güveninirliğinin karşılaştırılmasıUzun dönem takip ve güveninirlik verisiMaliyet kar ilişkisi değelendirilmesiMerkezlerin eğitim sertifikalanması
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2014 OCAK2014 OCAKBEKLENMEYEN SONUÇBEKLENMEYEN SONUÇ
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