Barostimulaatio ja renaalinen denervaatio

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1 Barostimulaatio ja renaalinen denervaatio Daniel Gordin, Dos, ol HYKS Vatsakeskus, Nefrologia FinnDiane Tutkimus, Folkhälsanin tutkimuskeskus, Helsingin yliopisto Valtakunnallinen hypertensiopäivä Messukeskus, Helsinki Folkhälsan Research Center Helsinki University Central Hospital the FinnDiane Study

2 Outline 1) Refractory hypertension 2) Renal denervation (RDN) 3) Baroreflex activation therapy (BAT)

3 Outline 1) Refractory hypertension 2) Renal denervation (RDN) 3) Baroreflex activation therapy (BAT)

4 1) Refractory hypertension If 3 antihypertensive agents from at least 3 different classes including a diuretic à fails to lower SBP and DBP values to <140 and 90 mmhg, respectively. maximal dosage 10 (15%) of patients with hypertension age, obesity, diabetes mellitus, sleep apnea, and chronic kidney disease increase the risk Mancia G et al. European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). ESH/ESC Guidelines for the management of arterial hypertension. J Hypertens 2013

5 Spironolactone à fourth-line drug? RCT: A+C+D + 12 weeks of each treatment Mean egfr 92 ml/min Williams B et al. Lancet 2015

6 Williams B et al. Lancet 2015

7 K and Creatinine increase? K None of these was clinically serious or led to withdrawals from the trial. Williams B et al. Lancet 2015

8 Pharmalogic pipeline

9 Pharmalogic pipeline Empty?

10 Pharmalogic pipeline Empty? Endothelin antagonists Vasopeptidase inhibitors Aldosterone synthase inhibitors Guanylatecyclase stimulators and activators

11 Sympathetic neural mechanisms of blood pressure RDN vs BAT Victor RG. Nat Rev Cardiol 2015

12 Outline 1) Resistant hypertension 2) Renal denervation (RDN) 3) Baroreflex activation therapy (BAT)

13 2) Renal denervation (RDN)

14 3-year report of the Symplicity HTN-1 study 106 patients randomized 1:1 to treatment with renal denervation vs. control Krum H et al. Lancet 2013

15 Renal Denervation Reduces LV Hypertrophy Brandt MC et al. JACC 2012

16 Baroreflex sensitivity (BRS) by standardized tests from continuous arterial BP (Finapres) Zuern CS et al. JACC 2013

17 Baroreflex sensitivity (BRS) by standardized tests from continuous arterial BP (Finapres) Zuern CS et al. JACC 2013

18 à Impaired cardiac BRS identifies patients with resistant hypertension who respond to RDN. Baroreflex sensitivity (BRS) by standardized tests from continuous arterial BP (Finapres) Zuern CS et al. JACC 2013

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20 The Symplicity HTN-3 Trial Bhatt DL et al. NEJM 2014

21 HTN-3: Areas of Investigation Heterogeneity of US Operator Experience Patient Demographics Catheter Design Medication Changes or Adherence? Trial Conduct Hawthorne Effect Individuals modify behavior in response to their awareness of being observed Placebo Effect Regression to Mean Extreme variables tend to move closer to average

22 RDN - What next? Renal nerve stimulation prior to RDN à Increases BP à After RDN the BP rise is blunted à Multicenter study to come Gal P et al. J Hum Hypertens 2015

23 RDN - What next? Transcatheter perivascular alcohol denervation Neural system in adventitia affected à No damage to the intima-media

24 Outline 1) Resistant hypertension 2) Renal denervation (RDN) 3) Baroreflex activation therapy (BAT)

25 Rheos Hypertension Pivotal Trial Design Trial Hypothesis: Baroreflex Activation Therapy is Safe and Effective for the Treatment of Resistant Hypertension Prospective randomized double-blind trial 322 patients at 49 sites 590 roll-in patients / 265 randomized (2:1) Implant Randomization 6-Month Blinded Evaluation Period 6-Month Blinded Evaluation Period Long-Term Follow-Up N = 181 N = 84 Group A Device ON Group B Device OFF Group A Device ON Group B Device ON Bisognano et al. J Am Coll Cardiol 2011 (months)

26 Rheos Hypertension Pivotal Trial Design Co-primary endpoints 1. Short Term Acute Response (10mm Hg drop between groups 0 vs 6 mo) 2. Long Term Sustained Response (10mm Hg drop between groups 0 vs 12 mo in responder at 6 mo) 3. Short Term Procedural Adverse Events (within 30 d of implant) 4. Short Term Hypertension Therapy Adverse Events (30 d to 6 mo of implant) 5. Long Term Device Adverse Events (30 d to 12 mo) Implant Randomization 6-Month Blinded Evaluation Period 6-Month Blinded Evaluation Period Long-Term Follow-Up N = 181 N = 84 Group A Device ON Group B Device OFF Group A Device ON Group B Device ON (months) Bisognano et al. J Am Coll Cardiol 2011

27 Rheos Hypertension Pivotal Trial Design 3 out of 5 endpoints were met 1. Short Term Acute Response (10mm Hg drop between groups 0 vs 6 mo) 2. Long Term Sustained Response (10mm Hg drop between groups 0 vs 12 mo in responders at 6 mo) 3. Short Term Procedural Adverse Events (within 30 d of implant) 4. Short Term Hypertension Therapy Adverse Events (30 d to 6 mo of implant) 5. Long Term Device Adverse Events (30 d to 12 mo) Implant Randomization 6-Month Blinded Evaluation Period 6-Month Blinded Evaluation Period Long-Term Follow-Up N = 181 N = 84 Group A Device ON Group B Device OFF Group A Device ON Group B Device ON (months) Bisognano et al. J Am Coll Cardiol 2011

28 Rheos Hypertension Pivotal Trial Design Bisognano et al. J Am Coll Cardiol 2011

29 2 nd Generation Platform 1 st Generation 2 nd Generation

30 Barostim neo Improved Technology Platform Procedural Improvements Single electrode (vs. two multi-pronged electrodes) Patient positioning Shorter procedure time and hospital stay (1 hour and 1 day vs. 3 hours and 2 days) Substantially improved safety profile Product Improvements Significantly smaller lead design Longer battery life Percent Free from Complication 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 2nd Generation neo +4x improvement 1st Generation Rheos Months from Implant Rheos (1 st Generation) Next-generation Barostim neo 30

31 Barostim neo Demonstrates Equivalent Efficacy Unilateral Barostim neo Efficacy Results - single-arm, open-label study of patients with resistant hypertension Change in BP & HR (mmhg & bpm) Change in BP (mmhg) Systolic (Baseline = 172 ± 20 mmhg) * * Diastolic (Baseline = 100 ± 14 mmhg) * * Heart Rate (Baseline = 75 ± 14 bpm) SBP DBP HR Month 3 Month 6 N = 30 p-value <.001 Hoppe U et al. J Am Soc Hypertens 2012

32 Complications 2 nd generation device (Barostim Neo) Hoppe U et al. J Am Soc Hypertens 2012

33 Complications 2 nd generation device (Barostim Neo) Comparable to a cardiac pacemaker Hoppe U et al. J Am Soc Hypertens 2012

34 Baroreflex activation therapy improves Arterial Stiffness AIx and aortic PWV decreased in a singe-arm study Wallbach M et al. J Hypertens 2015

35 Acute on/off effects and chronic blood pressure reduction after long-term BAT Aim: To assess BP alterations after device activation (4-6 min) and deactivation (4-6 min) 17 patients in a open-lable single arm evaluation Evidence of tolerance to BAT? Halbach M et al. J Hypertens 2015

36 Acute on/off effects and chronic blood pressure reduction after long-term BAT Halbach M et al. J Hypertens 2015

37 Acute on/off effects and chronic blood pressure reduction after long-term BAT Halbach M et al. J Hypertens 2015

38 BAT for the treatment of systolic heart failure 146 subjects randomly assigned to best medical treatment (BMT) or BMT + BAT Endpoints: Changes in NYHA functional class, quality-of-life score, and 6- minute hall walk distance Abraham WT et al. JACC Heart Fail 2015

39 BAT for the treatment of systolic heart failure Positive result for changes in NYHA functional class, quality-of-life score, and 6-minute hall walk distance and Pro-BNP Abraham WT et al. JACC Heart Fail 2015

40 BAT for the treatment of systolic heart failure Positive result for changes in NYHA functional class, quality-of-life score, and 6-minute hall walk distance and Pro-BNP Effects more pronounced in patients not treated with cardiac resynchronization therapy Abraham WT et al. JACC Heart Fail 2015

41 European Society of Hypertension/European Society of Cardiology (ESH/ESC) Mancia G et al. European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). ESH/ESC Guidelines for the management of arterial hypertension. J Hypertens 2013

42 European Society of Hypertension/European Society of Cardiology (ESH/ESC) Carotid baroreceptor stimulation is mentioned as one of the options to treat resistant hypertension Mancia G et al. European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). ESH/ESC Guidelines for the management of arterial hypertension. J Hypertens 2013

43 European Society of Hypertension/European Society of Cardiology (ESH/ESC) Carotid baroreceptor stimulation is mentioned as one of the options to treat resistant hypertension But Prospective, randomized trials to test the hypothesis are warranted Mancia G et al. European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). ESH/ESC Guidelines for the management of arterial hypertension. J Hypertens 2013

44 The Nordic BAT Study Dr Gordin Ass Prof Albäck Dr Vikatmaa Prof Groop Ass Prof Tikkanen Prof Kjeldsen Dr Fadl Elmula Prof Andersson Prof Kahan Prof Viigimaa Prof Hecht Olsen Ass Prof Gottsäter Dr Björses Dr Elf Ass Prof Malina

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