Renal fractional flow reserve and hypertension response after renal artery stenting

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1 Renal fractional flow reserve and hypertension response after renal artery stenting Jacek Kadziela,Adam Witkowski, Andrzej Januszewicz, Aleksander Prejbisz, Ilona Michałowska, Krzysztof Cedro, Magdalena Januszewicz, Elżbieta Florczak, Łukasz Kalińczuk, Bożena Norwa-Otto, Ewa Warchoł, Witold Rużyłło. Institute of Cardiology, Warsaw, Poland Warsaw Medical University, Warsaw, Poland

2 This pilot study was supported by grant 2P05B02530 from Polish Ministry of Science and Higher Education. ClinicalTrials.gov identifier: NCT Conflict of interest: NONE

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6 How can we improve the qualification for renal artery stenting? potential PREDICTORS?

7 Fractional Flow Reserve - FAME study: N=1005 pts If FFR<0.8 = PERFORM PCI absolute difference in MACE-free survival FFR-guided Angio-guided 30 days 2.9% 90 days 3.8% 180 days 4.9% 360 days 5.3%

8 FFR<0.8 FFR 0.8 OFFICE BP!

9 62 pts OFFICE BP!

10 FFR <0.8 significant RAS?

11 Pd/Pa <0.9

12 Pd/Pa <0.9 significant RAS?

13 The aim The aim of the study was to determine potential relationship between resting translesional pressures ratio (Pd/Pa ratio), renal fractional flow reserve (rffr) and hypertension response assessed with ambulatory blood pressure monitoring (ABPM ) after renal revascularization.

14 STUDY PROTOCOL Moderate unilateral RAS in Dupplex/angioCT N=44 OUT : Renal arteriography with hemodynamic assesment N=44 OUT: pts with RAS<60% in angio (N=9) If RAS 60% Renal artery stenting N=35 1pt- restenosis and DES 1pt- consent withdrawal 6month Follow-up N=33 analysed

15 Renal arteriography - Standard technique (femoral approach) - QCA analysis (performed by the operator blinded to hemodynamic data) : Minimal lumen diameter (MLD) - measured at the most tight lesion segment and compared to the Reference lumen diameter (RLD) measured at the nearest normal (preferably proximal) artery segment. %Diameter stenosis (DS%):DS=1-(MLD/RLD)*100.

16 Hemodynamic assessment Pressure wire PW5 (Radi, Sweden) Papaverine 30mg given i.a. TSPG- translesional systolic pressure gradient Pd/Pa ratio rffr (during maximal hyperemia)

17 Hemodynamic assessment

18 Blood pressure assessment ABPM 24 ambulatory blood pressure recording (ABPM) before the procedure and after 6 months using a SpaceLabs or (Ambulatory Monitoring, Redmond, Washington, USA). ABPM readings were obtained every 15 min during the day (6:00 22:00 h) and every 30 min during the night (22:00 6:00 h).

19 Baseline characteristics Age (years) 64.0 ± 9.3 Males (%) 48.6 Diabetes mellitus (%) 22.7 Hypercholesterolemia (%) 82.9 GFR (ml/min) 71.4 ± 22.5 Diameter stenosis (%), 71.0 ± 12.5 Minimal lumen diameter (mm) 1.7 ± 0.7 Lesion length (mm) 11.5 ± 3.4 TSPG at rest (mmhg) 42.4 ± 26.2 TSPG at hyperemia (mmhg) 56.1± 20.8

20 Anti-HTN treatment Number of anti-htn medications 3.8 ± 1.3 Number of DDD* 4.9 ± 2.9 % patients on drug class: ACEi/ARB 82% Beta-adrenergic blocker 89% Calcium channel blocker 73% Diuretic 66% Alpha-1 adrenergic blocker 25% Other 11% *DDD- defined daily doses, according to the WHO criteria

21 Anti-HT treatment - DDD Pd/Pa <0.9 Pd/Pa 0.9 p Baseline 4.8 ± ± 2.3 ns 6months 4.5 ± ± 2.4 ns change -0.6 ± ± 1.7 ns

22 RESULTS Hemodynamic assessment Pd/Pa ratio 55,6 44,4 Pd/Pa< ± 0.12 Pd/Pa mg papaverine i.a rffr 0.75± ,8 42,2 rffr<0.8 rffr 0.8

23 Pd/Pa ratio r-pearson correlation Pd/Pa ratio/tspg Pd/Pa ratio/ MLD Pd/Pa ratio / DS R=-0.91 R=0.60 R=-0.63 P<0.001 p<0.001 p<0.001

24 rffr r-pearson correlation rffr / TSPG rffr / MLD rffr / DS R=-0.88 R=0.66 R=-0.70 P<0.001 p<0.001 p<0.001

25 Variable Cut-off Value ROC - analysis Sensivity(%) Specifity(%) PPV(%) NPV(%) Accuracy (%) Pd/Pa ratio < rffr < Delta RI < PSV (cm/s) > RAR >

26 RENAL STENTING Mean 14.7±2.5mm of stent length under pressure of 12.4 ± 3.3 atmosphere was implanted. The stent length moderately correlated both with Pd/Pa (r=-0.46, p<0.01), and rffr (r=-0.47,p<0.01). No complications

27 Systolic BP (mmhg) Systolic BP changes Pd/Pa abnormal vs normal 160 Baseline 6 months follow-up Pd/Pa <0.9 Pd/Pa 0.9 Mean delta Pd/Pa <0.9 Pd/Pa 0.9 p 24-hours -2.6 ± ± 9.4 ns daytime 0.7 ± ± 10.1 <0.05 night-time -3.9 ± ± 16.1 ns

28 Diastolic BP (mmhg) Diastolic BP changes Pd/Pa abnormal vs normal 80 Baseline 6 months follow-up Mean delta Pd/Pa <0.9 Pd/Pa 0.9 p Pd/Pa <0.9 Pd/Pa hours -1.2 ± ± 7.7 ns daytime -1.3 ± ± 6.9 <0.05 night-time -1.5 ± ±9.9 ns

29 Systolic BP (mmhg) Systolic BP changes rffr abnormal vs normal 160 Baseline 6 months follow-up rffr <0.8 rffr 0.8 Mean delta rffr<0.8 rffr 0.8 p 24-hours 0.3± ± 11.7 ns daytime 5.0± ± 15.5 ns night-time -2.8± ± 14.0 ns

30 Diastolic BP (mmhg) Diastolic BP changes rffr abnormal vs normal 80 Baseline 6 months follow-up rffr <0.8 rffr 0.8 Mean delta rffr <0.8 rffr 0.8 p 24-hours 0.7 ± ± 7.1 ns daytime 1.7 ± ± 9.0 ns night-time -1.3 ± ± 8.8 ns

31 CONCLUSION In our study, physiological assessment of renal artery stenosis using Pd/Pa ratio and papaverine-induced renal FFR did not predict hypertension response after renal artery stenting assessed with 24 hours ABPM

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