PULMONARY ARTERY DENERVATION FOR TREATMENT OF PULMONARY ARTERIAL HYPERTENSION: RESULTS FROM A CONTROLLED BEFORE AND AFTER STUDY—PADN 2 STUDY Shao-Liang Chen, MD, FACC

Disclosure I, Shao-Liang Chen, has nothing to disclosure

Background: surgical denervation Juratsch CE, et al. Chest 1980;77;

Background: percutaneou denervation Chen SL, et al. Eurointervention 2013 March PADN at PA bifurcation, followed by PADN PADN at distal PA, followed by PADN

Background: PADN-1 FIM study Chen SL, et al. JACC 2013;61: patients unresponsive to medication enrolled between March and May patient excluded: (+) adenosine test 21 patients PADN group(N=13) Control group(N=8) 3-month follow-up: 6MWT, echo, Hemodynamic measurements: post, 24h,1w,3-m

Primary endpoint Primary endpoint: Δ6-minute walk distance (6MWD) at 6- month follow-up between PADN and Medication groups Definition: Δ6MWD =6MWD-6-month minus 6MWD-baseline

Secondary endpoints Hemodynamic variables: mean and systolic pulmonary arterial pressure pulmonary vessel resistance RV function (Tei) PAH-related events, repeat hospitalization

Definition of PAH-related events 1.the worsening of PAH, 2.the initiation of treatment with the intravenous or subcutaneous injection of drugs, 3.lung transplantation, 4.atrial septostomy 5.all-cause death

Calculation of sample size Patient sample size: Δ6MWD =+60 m after PADN treatment Δ6MWD= +15 m after the medication treatment A total of 24 patients were required 15% of additional sample (uncertainty), finally N=28 patients To achieve 2-sided p-value<0.05, 80% power

Study flow chart Target drugs= 5’-PDE Prostacyclin ET-receptor antagonists

Baseline clinical characteristics

Medication treatment

Comparison of measurements

In conclusion PADN treatment was associated with significant improvement of 6MWD and less PAH-related event Further RCT was required to show the benefit of PADN in reducing mortality in patients with IPAH, secondary PAH and PH from LHD

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