Renal Artery Angioplasty and Stenting Optimal Patient Selection

Disclosures n Clinical trial support: Corindus n Consulting: Corindus, Medtronic n Speakers Bureau: Medtronic,

Renal Artery Revascularization n Hypertension management n Renal function preservation n Renal artery angioplasty

Renal Fibromuscular Dysplasia: IVUS Evaluation Prasad, Mahmud et al; Cath Cardiovasc Intv 2009; 74:

Fibromuscular Dysplasia A B C D Mahmud et al; Catheter Cardiovasc Intv 2006; 67:

Uncontrolled HTN and unilateral RAS 90% stenosis Stents back to ostia 61 year old

Blood Pressure Zeller at al. Circulation 2003; 108: 2244 -9

ASPIRE 2 Study n n n N=208; multicenter 20 mm Hg systolic BP reduction

Blood Pressure Response in Unilateral Renal Artery Stenosis Mahmud et al; JACC Intv 2008;

Renal Frame Count • Control group • BP>140/90 mm. Hg; 2 meds • No

Renal Frame Count Reduction Predicts Clinical Response to Renal Stenting Mahmud et al; JACC

Baseline Renal Frame Count and Blood Pressure Reduction After Renal Stenting Naghi, Mahmud et

Renal Resistive Index: Prognostic Value Radermacher J, et al. NEJM 2001; 344: 410 -7

ASTRAL: Blood Pressure ASTRAL Investigators; NEJM 2009; 361: 1953 -62

Randomized Trials: Major Concern STAR Bax et al; Ann Intern Med 2009: 840 -48

Effects of a balloon-induced, unilateral, controlled, graded stenosis and renin production De Bruyne, B.

Fractional Flow Reserve and Clinical Response to Renal Stenting • Group I: FFR<0. 80

Representative Example of Quantitative Renal Angiography, IVUS, and TPG in a Study Patient With

Receiver-Operating Characteristic Curves of HSG, FFR, IVUS, and Diameter Stenosis for Hypertension Improvement Leesar,

Blood Pressure Response after Renal Stenting: HSG >=21 Versus <21 mm Hg Leesar, M.

Number of Antihypertensive Medications and Serum Creatinine After Renal Stenting: HSG >=21 vs <21

Bilateral renal artery stenosis and renal dysfunction 99% stenosis Stent back to ostium 74

Stenting: Salvage Renal Function N=51 patients 42 bilateral RAS Rocha-Singh et al; Cath Cardio

Renal Artery Stenosis: Clinical n Indications for treatment (clinical presentation): n n n Renovascular

n Renal Artery Stenosis: Markers of Success Anatomical features: n n Physiological measures: n

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Renal Artery Angioplasty and Stenting: Optimal Patient Selection Ehtisham Mahmud, MD, FACC Division Chief, Cardiovascular Medicine Director, Sulpizio Cardiovascular Center-Medicine University of California, San Diego

Disclosures n Clinical trial support: Corindus n Consulting: Corindus, Medtronic n Speakers Bureau: Medtronic, Abbott Vascular

Renal Artery Revascularization n Hypertension management n Renal function preservation n Renal artery angioplasty -fibromuscular dysplasia -otherwise replaced by aorto-ostial stenting n Renal stenting -predictors of response

Renal Fibromuscular Dysplasia: IVUS Evaluation Prasad, Mahmud et al; Cath Cardiovasc Intv 2009; 74: 260 -4

Fibromuscular Dysplasia A B C D Mahmud et al; Catheter Cardiovasc Intv 2006; 67: 434 -7

Uncontrolled HTN and unilateral RAS 90% stenosis Stents back to ostia 61 year old man with uncontrolled hypertension (BP 165/100 mm Hg despite 3 antihypertensives) Mahmud et al; JACC 2007; 473 -90

Blood Pressure Zeller at al. Circulation 2003; 108: 2244 -9

ASPIRE 2 Study n n n N=208; multicenter 20 mm Hg systolic BP reduction at 12 and 24 mos Stable creatinine Restenosis: 17. 4% 39% non-responders!! Rocha-Singh et al; JACC 2005; 46: 776 -783 Mahmud JACC 2005; 46: 784 -786

Blood Pressure Response in Unilateral Renal Artery Stenosis Mahmud et al; JACC Intv 2008; 1: 286 -92 Whitlow; JACC Intv 2008; 1: 293 -294

Renal Frame Count • Control group • BP>140/90 mm. Hg; 2 meds • No renal artery stenosis • Study group • BP>140/90 mm. Hg; 2 meds • Renal artery stenosis >70% Mahmud et al; JACC Intv 2008; 1: 286 -92

Renal Frame Count Reduction Predicts Clinical Response to Renal Stenting Mahmud et al; JACC Intv 2008; 1: 286 -92

Baseline Renal Frame Count and Blood Pressure Reduction After Renal Stenting Naghi, Mahmud et al; Cath Cardiovasc Intv 2015; 86: 304 -309

Renal Resistive Index: Prognostic Value Radermacher J, et al. NEJM 2001; 344: 410 -7

ASTRAL: Blood Pressure ASTRAL Investigators; NEJM 2009; 361: 1953 -62

Randomized Trials: Major Concern STAR Bax et al; Ann Intern Med 2009: 840 -48 ASTRAL Astral Invest; NEJM 2009; 361: 1953 -62

Effects of a balloon-induced, unilateral, controlled, graded stenosis and renin production De Bruyne, B. et al. J Am Coll Cardiol 2006; 48: 1851 -1855 Copyright © 2006 American College of Cardiology Foundation. Restrictions may apply.

Fractional Flow Reserve and Clinical Response to Renal Stenting • Group I: FFR<0. 80 • Group II: FFR>0. 80 • N=17 • Papaverine for dilation Mitchell et al; Catheter Cardiovasc Interv. 2007; 69(5): 685 -9

Representative Example of Quantitative Renal Angiography, IVUS, and TPG in a Study Patient With RAS Leesar, M. A. et al. J Am Coll Cardiol 2009; 53: 2363 -2371 Copyright © 2009 American College of Cardiology Foundation. Restrictions may apply.

Receiver-Operating Characteristic Curves of HSG, FFR, IVUS, and Diameter Stenosis for Hypertension Improvement Leesar, M. A. et al. J Am Coll Cardiol 2009; 53: 2363 -2371 Copyright © 2009 American College of Cardiology Foundation. Restrictions may apply.

Blood Pressure Response after Renal Stenting: HSG >=21 Versus <21 mm Hg Leesar, M. A. et al. J Am Coll Cardiol 2009; 53: 2363 -2371 Copyright © 2009 American College of Cardiology Foundation. Restrictions may apply.

Number of Antihypertensive Medications and Serum Creatinine After Renal Stenting: HSG >=21 vs <21 mm Hg Leesar, M. A. et al. J Am Coll Cardiol 2009; 53: 2363 -2371 Copyright © 2009 American College of Cardiology Foundation. Restrictions may apply.

Bilateral renal artery stenosis and renal dysfunction 99% stenosis Stent back to ostium 74 year old woman with an dysfunctional left kidney and creatinine increase from 1. 9 to 4 mg/dl over two years

Stenting: Salvage Renal Function N=51 patients 42 bilateral RAS Rocha-Singh et al; Cath Cardio Interv 2002; 57: 135 -41

Renal Artery Stenosis: Clinical n Indications for treatment (clinical presentation): n n n Renovascular hypertension (BP ≥ 140/90 mm Hg; ≥ 2 antihypertensives) especially young or new onset elderly Ambulatory BP monitoring rather than single measurement Progressive, accelerated renal insufficiency Recurrent/flash pulmonary edema Global renal ischemia

n Renal Artery Stenosis: Markers of Success Anatomical features: n n Physiological measures: n n n Kidney >8 cm Angiographic diameter stenosis >70% by QRA IVUS CSA stenosis >80% Resistive index <0. 80 Mean Pd: Pa <0. 80 (renal FFR) Hyperemic systolic gradient ≥ 21 mm Hg Increased baseline renal frame count (>30) and RBG≥ 1 Novel measures: n n Decreased RFC after renal stenting Biomarkers/New Imaging: BNP, renal penumbra