Resistant Hypertension Percutaneous Renal Interventions Shaiful Azmi Yahaya, MD, FNHAM Consultant Cardiologist, Kuala Lumpur, Malaysia Your Heart‌Our Passion
Disclosure Slide I have no conflict of interest in the context of this presentation
Resistant Hypertension Definition: Blood Pressure > target goals >140/90 mmHg, despite taking 3 anti-hypertensive medications, or
requiring > 4 anti-hypertensives to control. These patients are at risk for: stroke heart disease kidney failure.
Resistant Hypertension The exact prevalence of Resistant Hypertension is unknown A few large trials have indicated that it can be relatively common, between 16-27% of study population. Control & Treatment of Hypertension is important. Current treatment options: Lifestyle modification Pharmacotherapy After ruling out secondary or reversible causes of elevated BP, the only options until recently have been to add more medications and diet regimes like DASH.
ďƒž These patients may benefit from special diagnostic and therapeutic considerations.
Percutaneous Renal Interventions 1) Renal Revascularization PTA
Pre
2) Renal Denervation RDN
Post
Percutaneous Renal Interventions 1) Renal Revascularization PTA
Pre
2) Renal Denervation RDN
Post
1) Renal Revascularization PTA • A retrospective review of patients who underwent renal artery revascularization at Institut Jantung Negara (National Heart Institute), Kuala Lumpur between October 1999 and February 2012. (n = 203) • Data at baseline and follow-up were compared using paired t-test or McNemar’s test • A p<0.05 was considered as statistical significant Age: Mean: 59.3 + 15.9 years Gender: Male: 119 (59%); Female: 84 (41%)
Associated Clinical Conditions: ď&#x201A;Ż
ď&#x201A;Ż
Percentage % of patients
Number of cases by year:
year
Number of cases by year: Initial enthusiasm with increasing number was
contributed by routine renal angiogram [with JR catheter], at end of procedure for patients with BP >160/90 mmHg and patients with multivessel disease.
As literature showed debatable results of renal
stenting, coupled by increasing number of radial procedures, enthusiasm for the ‘drive-by shooting’ of renal arteries declined and numbers decreased
Clinical disease conditions:
Percentage % of patients
Clinical Indications for Revascularization:
Renal artery PTA
Location
Lesions Total number of lesions
238
Mean, % stenosis
80 ± 13
Stents Total number of stents
251
Mean, length, (mm)
15.1 ± 2.5 (5-24)
Mean, diameter size (mm)
5.5 ± 1.2 (2.5-8)
Direct stenting
116 (46.2%)
Mean, deployment pressure
12 ± 3 (6-22)
Mean stents per patient
1.2
Procedural success
Complications
n
Dissection Perforation Stent dislodgement Vascular access Complications Death Others
4 0 0 0 0 0 3
Systolic BP [Office BP] Significant reduction in SBP p=0.02
p<0.05
155±26
155±26 144±25
p=0.023
155±26 143±22
p=0.015
155±26 148±24
147±12
Diastolic BP [Office BP] No change in DBP p=0.527
80±16
79±11
p=0.611
80±16
78±14
p=0.831
80±16
79±12
p=0.737
80±16 78±12
No. of anti-hypertensive drugs Reduction in number of antihypertensives in first 12 months p=0.074
2.8±1.2
p=0.008
2.8±1.2 2.5±1.0
p=0.013
2.8±1.2 2.4±0.9
p=0.612
2.8±1.2 2.5±0.9
2.6±0.9
Creatinine No change in serum creatinine level p=0.620
147±108 150±86
p=0.172
147±108 147±120
p=0.608
147±108 153±137
p=0.329
147±108 154±142
Cumulative survivors (freedom from Death)
Month 0 12 24 36 48 60 72
No. at risk 181 138 121 107 90 69 47
Prob. 100% 95.2% 95.2% 93.6% 93.6% 93.6% 93.6%
Event Free Survival (freedom from Death, TLR, stroke)
Month 0 12 24 36 48 60 72
No. at risk 181 136 118 104 88 67 45
Prob. 100% 92.8% 92.8% 89.5% 87.7% 87.8% 87.7%
Renal Artery Revascularization: Conclusions: Limitations: single centre, small number [n=203],
ď&#x192;&#x2DC; The debate on the value of Percutaneous Renal Artery Revascularisation continues among nephrologists and interventionalists despite recent prospective randomized trial data. ď&#x192;&#x2DC; In our single centre experience, for patients with Renal Artery stenosis, percutaneous renal revascularization in addition to medical therapy, resulted in a lower Systolic Blood Pressure and transient reduction in number of antihypertensive medications.
Renal Artery Revascularization: Conclusions: Limitations: single centre, small number [n=203],
However, Renal revascularization did not result in improvements in serum creatinine and Diastolic Blood Pressure. More “definitive” studies on the long-term outcomes are needed to answer if: renal PTA would have added benefits over medical therapy who are the appropriate patients with RAS (if not all) who will benefit.
Percutaneous Renal Interventions 1) Renal Revascularization PTA
Pre
2) Renal Denervation RDN
Post
Following results of: Symplicity HTN-1 Symplicity HTN-2: randomized 106 patients with Resistant Hypertension from 24 centres in Australia, Europe and New Zealand to either medical therapy or RDN from 2009-2010. At 6 months follow up, the mean blood pressure reduced by 32/12mmHg in patients who underwent RDN.13 No serious procedural complications occurred and renal function remained the same at follow up. Another bigger randomized trial using this system, the Symplicity HTN-3 trial had just been approved by the US FDA and is due to start soon
In May 2011, Funding from IJN foundation Started Resistant Hypertension clinic: to screen and review [referred] patients with uncontrolled hypertension. Patients were reviewed, secondary or reversible causes of elevated BP ruled out. Underwent Ambulatory BP monitoring ABPM Those with true Resistant Hypertension, meeting a set of criteria, would be offered RDN.
Renal Denervation RDN
On 14th September 2011, Institut Jantung Negara performed renal artery denervation for patients with Resistant Hypertension, using the Symplicity® Catheter system (Ardian).
The following reports the early results of the first 15 patients from our Registry, concentrating only on BP response Note that in Symplicity HTN-2, the BP reduction of 32/12mmHg was seen at 12 months follow up.
Procedure:
Access into the femoral artery Guiding catheter advanced to engage the renal artery ostium. Angiogram performed to determine the anatomical suitability. The ablation catheter introduced into the renal artery The tip positioned to achieve good contact with the artery wall. Ablation catheter
Procedure: Radiofrequency energy ablationapplied for 2 minutes. Catheter tip is repositioned at another site to achieve ideally between 4-6 ablations within each artery. A “dimple” of the artery wall can often times be seen after each ablation. The same is repeated in the contralateral artery
As there is no immediate change in BP immediate post procedure, current endpoint is achieving 4-6 “good” ablations in each artery. It is a relatively simple procedure. The total procedure time is usually less than 1 hour. As the ablation can be painful and uncomfortable, we routinely administer opioid intraprocedurally.
Baseline characteristics Number of cases
15
Mean age, years
65.6 Âą 9.5
BMI, kg/m2
29.0 Âą 3.6
Clinical data
Percentage
Clinical data
Percentage
Baseline data
ABPM - Systolic BP, mmHg - Diastolic BP. mmHg
154.8 ± 17.8 83.1 ± 14.2
BP Office - Systolic BP, mmHg - Diastolic BP. mmHg
182.5 ± 14.6 86.6 ± 9.6
eGFR
69.3 ± 16.4
Creatinine, mg/dl
93.9 ± 24.3
Procedure data
No. of ablation -Right -Left
5.1± 1.6 4.6 ± 1.5
Mean procedure time, mins
63.9 ± 13.6
Mean fluoro time, mins
17.8 ± 6.3
Mean contrast used, ml
171.5 ± 39.8
No. of medications Mean, 4.4 Âą 0.9 Median, 4 Min-Max, 3-6
No. of drugs
Medications
No. of patients
ABPM-Systolic BP
No significant change in ABPM SBP
154.8+17.8 vs.50.88+16.97,p=0.54 154.8+17.8 vs.142.7+14.1,p=0.321
154.8+17.8 vs.142.1+19.8, p=0.126 154.8+17.8 vs.140.6+15.1, p=0.088 154.8+17.8 vs.135.6+25.6, p=0.148
ABPM-Diastolic BP No change in ABPM DBP 83.1+14.2 vs.84.3+15.4,p=0.606 83.1+14.2 vs.81.1+14.4,p=0.316 83.1+14.2 vs.79.0+13.3,p=0.798
83.1+14.2 vs.83.8+20.6,p=0.824
83.1+14.2 vs.71.3+15.0,p=0.081
Office- Systolic BP Significant reduction in office SBP 182.5+14.6 vs.165.6+27.8,p=0.148
182.5+14.6 vs.172.0+17.2,p=0.061
182.5+14.6 vs.161.5+27.4,p=0.002
182.5+14.6 vs.160.1+22.0,p=0.001
182.5+14.6 vs.146.4+21.9,p=0.013
Office-Diastolic BP
No change in office DBP 86.6+9.6 vs.86.0+11.5,p=0.336
86.6+9.6 vs.81.7+11.1,p=0.133
86.6+9.6 vs.79.5+14.87,p=0.015
86.6+9.6 vs.83.8+16.2,p=0.259 86.6+9.6 vs.79.6+11.3,p=0.88
e GFR No change in eGFR 69.3+16.4 vs.56.1+23.6,p=0.436 69.3+16.4 vs.65.1+18.3,p=0.44
69.3+16.4 vs.68.6+19.7,p=0.369
Serum Creatinine No significant change in serum creatinine 93.9+24.3 vs.103.8+40.5,p=0.199
93.9+24.3 vs.97.1+27.4,p=0.360
93.9+24.3 vs.94.0+28.8,p=0.280
93.9+24.3 vs.95.0+28.0,p=0.233 93.9+24.3 vs.94.7+25.5,p=0.152
Renal Denervation: Conclusions: Limitations: single centre, small number [n=15], follow-up [12 months] ď&#x192;&#x2DC; In our experience, Catheter-based Renal Artery denervation with Radiofrequency Energy resulted in a reduction of Systolic blood pressure of Resistant Hypertension patients during short term follow up. ď&#x192;&#x2DC; We await our intermediate and longer term results.
Renal Denervation: Conclusions: Limitations: single centre, small number [n=15], follow-up [12 months] ď&#x192;&#x2DC; Catheter-based Renal Artery denervation appeared to be a safe procedure and did not result in significant change in renal function. ď&#x192;&#x2DC; Future larger trials with longer- term clinical outcomes and larger study populations with milder hypertension may expand the indications/acceptance of this procedure.
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