Date JANUARY 2012

Renal denervation therapy: The 1st Malaysia experience

INSTITUT JANTUNG NEGARA DR. ROBAAYAH ZAMBAHARI DR. AZLAN HUSSEIN DR. SHAIFUL AZMI YAHAYA

Catheter-based treatment for renal symphatetic denervation

Treatment using the Symplicity Catheter

Transcatheter renal denervation trials: Chronology

The burden of hypertension in Malaysia

• The prevalence of hypertension in Malaysians aged 30 years and above was 42.6% in 2006

• 4.8 million individuals with hypertension in Malaysia• 3rd National health and morbidity survey in 2006

revealed 2/3 of individuals in Malaysia with hypertension were unaware that they have hypertension

• Only 26% of Malaysian patients achieved blood pressure control while on treatment

Source: MOH/P/PAK/158/Malaysia clinical practice guidelines for the management of hypertension 2008 (3rd edition)

Transcathether renal denervation for the treatment of resistant hypertension: The first

IJN experience

• Setting up resistant hypertension clinic• IJN (Malaysian National Heart Institute) is the first centre in

Asia to perform the renal denervation on the 11th September 2010.

• Performed using the Symplicity Cathether system (Ardian Medtronic)

• Presence of a proctor- Dr. Justin Davies (Interventional cardiologist and Walport clinical lecturer at Imperial College, London)

IJN resistant hypertension clinic website and facebook page

Methods• Patients referred to IJN resistant hypertension

clinic• Stratified based on inclusion and exclusion

criteria• Medication compliance assessment• Ambulatory blood pressure

monitoring/investigations• Screening for secondary hypertension• Consented for renal denervation therapy• Follow up

Inclusion criterias

• Based on the SYMPLICITY-HTN 2 trial• Systolic BP of more than 160 mmHg based on

average 3 office BP reading previously measured (more than 150 mmHg for type 2 DM)

• Patient is adhering to a stable 3 or more antihypertensive medications

• Patient is 18-85 years of age

Exclusion criterias• Renal artery abnormalities ( Renal artery stenosis,

diameter less than 4mm or 20mm in length)• EGFR of less than (45ml/min/1.73m2) based on MDRD

calculation criteria• Type 1 diabetes mellitus• Recent MI, Unstable angina and CVA within the last 6

months or scheduled or planned surgery in the next 6 months

• Haemodynamically significant valvular heart disease• Pregnant, nursing or planning to be pregnant

Patient group

Period between August 2010 – January 2012

Patient Age distribution

Ethnic group and sex

Cardiovascular risk factors

Antihypertensive medications

N= 39Resistant Hypertension=25White coat HTN=14

*4 patients excluded

Classes of anti hypertensive medications

Average baseline office BP based on 3 previous outpatient clinic visits

prior to referral

Ambulatory BP results pre procedurePatient is on 4

antihypertensive medications

Results

• Blood pressure changes from baseline and at follow up (2 weeks, 1 month, 3 month, 6 month and 12 month)

• Acute procedural safety and chronic procedural safety

• EGFR and renal profile at 2 weeks, 1 month and 3 month follow up

• Fasting sugar and HBAIC at 6 month follow up• Composite cardiovascular endpoints (MACE)

Procedural analysis

EGFR at follow up post procedure

EGFR is preserved of at least more than 45 mls/min/1.73m2 during follow up

Transient drop in one of the patient

On average, the EGFR did not show any significant change

Results of ABPM at follow up: Average 24 hour ABPM

Results: Systolic BP (max)

Result: Diastolic BP (max)

Result: Mean BP

Results: Average 24 hour Systolic difference at F/U

Result: Average 24 hour Diastolic difference at F/U

•Average office-based BP in the renal-denervation group was reduced 32/12 mm Hg (average baseline 178/96 mm Hg) six months after the ablation

•Between-group differences in BP at six months were 33/11 mm Hg (p<0.0001)

•Of the patients in the ablation arm, 84% had a 10-mm-Hg or greater drop in SBP vs 35% of controls (p<0.0001)

•There did not appear to be any adverse events:

Imaging of renal arteries for damage showed no evidence of renal artery stenosis or aneurysmal dilatation during the six-month follow-up . There were no changes in renal function, even in those with mild to moderate renal failure

SYMPLICITY HTN-2: Results

Conclusions

• Percutaneous catheter-based theraputic renal denervation is safe and simple

• Symplicity 2 study has shown that there is BP lowering benefit with no significant decline in renal function

• Longer follow up is necessary to observe further response to BP stabilization in our small cohort