MEET /06/2013 SESSION : RENAL AND VISCERAL

Transcription

1 MEET /06/2013 SESSION : RENAL AND VISCERAL AFTER 35 YEARS, WHAT ARE THE INDICATIONS AND RESULTS OF PTRA IN PATIENTS WITH RI OR RVH? THOMAS SOS, MD NYPH CORNELL New York, NY

2 THOMAS SOS, MD NYPH CORNELL New York, NY Potential conflicts of interest Royalties AngioDynamics, Inc Cook, Inc

3 COURTESY OF FRED KELLER, DOTTER INSTITUTE

4 RENAL ARTERY STENOSIS, HYPERTENSION and RENAL INSUFFICIENCY RENAL ARTERY STENOSIS ISCHEMIC NEPHROPATHY RENAL VASCULAR HYPERTENSION RENAL VASCULAR HYPERTENSION and ISCHEMIC NEPHRO- PATHY RENAL INSUFFICIENCY HYPERTENSIVE NEPHROPATHY HYPER TENSION

5 RENAL ARTERY STENOSIS ASSESSING SIGNIFICANCE CLINICAL BP RENAL FUNCTION ANATOMIC DIAMETER STENOSIS 70% (~90% XA) (USUALLY EYEBALL MEASUREMENT) HEMODYNAMIC/PHYSIOLOGIC 10% MEAN ARTERIAL PRESSURE GRADIENT??? DUPLEX ULTRASOUND

6 INTER-OBSERVER VARIABILITY IN THE ANGIOGRAPHIC ASSESSMENT OF RENAL ARTERY STENOSIS. Brigit C. van Jaarsvelda, Herman Pietermanb, Lucas C. van Dijkb, Andries J. van Seijenc, Pieta Krijnend, Frans H.M. Derkxa, Arie J. Man in't Velda, Maarten A.D.H. Schalekampa, on behalf of the DRASTIC study group Journal of Hypertension. 17(12): , December 1999.

7 CRITICAL STENOSIS IN PATIENTS WITH ATHEROSCLEROTIC RENOVASCULAR DISEASE APPEARS TO BE 80% OR GREATER O RVR RVR NL

8 ASSESSMENT OF RENAL ARTERY STENOSIS SEVERITY BY PRESSURE GRADIENT (Pd/Pa) and RENIN PRODUCTION PERCENT INCREASE IN RENIN Pa=AORTIC PRESSURE Pd=RENAL ARTERY PRESSURE DISTAL TO STENOSIS >10% MEAN ARTERIAL PRESSURE GRADIENT STENOTIC KIDNEY NON STENOTIC KIDNEY AORTA DEGREE of STENOSIS by PRESSURE GRADIENT (Pd/Pa) DE BRUYNE B, et al, Journal of the American College of Cardiology Volume 48, Issue 9, 7 November 2006, Pages

9 PTRA for FMD, 45 yo F 1986 PRE 1986 POST COURTESY OF FRED KELLER, DOTTER INSTITUTE

10 BP RESULTS of PTRA FMD AUTHOR PTS. 1º SUCC. CURED IMPR. F/U Mos n n (%) n (%) n (%) MEAN (RANGE) SOS (87) 16 (59) 9 (33) 16 (4-40) TEGTMEYER (100) 10 (37) 17 (83) NA (2-51) GEYSKES (100) 10 (48) 10 (48) NA (12-48) MARTIN, L (100) 5 (25) 12 (60) 16 (3-36) MARTIN, E 11 8 (73) 5 (63) 1 (13) 13 (NA) GRIM 10 9 (90) 5 (56) 4 (44) 10 (1-14) TOTAL (93) 51(46) 53(47)

11 77 y.o. WOMAN BILAT RA DISEASE, HYPERTENSION, CRI, SJӦGREN S HYPERTENSION x 15 yrs SCr mg/dl BILAT RAS LEFT RENAL ATROPHY Dx by US CHF PE x2 ACUTE ACCEL BP SEVERE R RAS R RENAL A L RA OCCL STENT Dx by MRA

12 77 y.o. WOMAN ILAT RA DISEASE, HYPERTENSION, CRI, SJӦGREN S PRE INTERVENTION Gad MRA 10cm 4.5cm

13 # 2: LIMIT CONTRAST OMNIFLUSH for AORTOGRAM 1/3 DILUTE I, cc/sec

14 # 9: COMPLETION AORTOGRAM 1/3 DILUTE I, 5 7 cc/sec

15 STAR STUDY 2009 Bax, L. et. al. Ann Intern Med 2009;150: ARTERIOGRAM: 64 (NO GRADIENTS MEASURED) NO POSSIBLE BENEFIT: 18 NO STENT: 18 <50% RAS: 12 OTHER: 6 DOUBTFUL BENEFIT: % RAS: 22 DEATHS: 2 (?! 3) WITHIN 30 DAYS: 2 WITHIN 60 DAYS: 1 (POST ANGIO GROIN INFECTION WITHIN 30 DAYS) > RECONSTRUCTIVE SURGERY > RENAL AND CARDIAC FAILURE > DEATH AT 60 DAYS

16 Revascularization versus Medical Therapy for Renal-Artery Stenosis The ASTRAL Investigators NEJM 361: November 12, 2009 Number 20 TRIAL DESIGN LIMITATIONS PATIENT SELECTION - PATIENTS WERE ELIGIBLE TO PARTICIPATE IF THEY HAD SUBSTANTIAL ANATOMICAL ATHEROSCLEROTIC STENOSIS IN AT LEAST ONE RENAL ARTERY THAT WAS CONSIDERED POTENTIALLY SUITABLE FOR ENDOVASCULAR REVASCULARIZATION AND IF THE PATIENT'S DOCTOR WAS UNCERTAIN THAT THE PATIENT WOULD DEFINITELY HAVE A WORTHWHILE CLINICAL BENEFIT FROM REVASCULARIZATION

17 RENAL ARTERY STENTING OSTIAL ATHEROMA FIRST AUTHOR YEAR PATIENTS BILATE RAL % RENAL DYSFUN CTION % RENAL FUNCTION RESPONSE, % HYPERTENSION RESPONSE, % PERI-OP COMPLICATIONS % IMPROVED UNCHANGED WORSENED CURED IMPROVED FAILED DEATH MORBIDITY BURKET FIRST LEDERMAN AUTHOR 2000 YEAR PATIENTS 300 BILATE RAL 41 % 29 RENAL DYSFUN CTION 37 % 43 RENAL FUNCTION RESPONSE, % HYPERTENSION RESPONSE, % PERI-OP COMPLICATIONS <1 % 2 BUSH IMPROVED UNCHANGED WORSENED CURED IMPROVED FAILED DEATH MORBIDITY ROCHA- SINGH KENNEDY 2002 MEAN GILL ZELLER HEY ZELLER <1 NOLAN KAYSHAP HOLDEN CORRIERE EDWARDS ML and CORRIERE MA, JVS 2009;50:

18 ASTRAL and STAR WHAT HAVE WE LEARNED? UNFORTUNATELY, THE RESULTS PROBABLY DO REPRESENT REAL WORLD EXPERIENCE ABDOMINAL AORTA IS A VERY HOSTILE ENVIRONMENT FOR ENDOVASCULAR INTERVENTION OPERATOR EXPERIENCE/COMPETENCE IN LARGE MULTICENTER TRIALS VARIES WIDELY OPTIMAL MEDICAL THERAPY IS EASIER TO STANDARDIZE LARGE SINGLE CENTER STUDIES MAY PRODUCE BEST RESULTS ACHIEVABLE THE DUTCH SHOULD NOT DO TRIALS or write editorials!?

19 ASTRAL and STAR WHY STENTING FAILED vs MEDICAL RX STUDY DESIGN STATISTICAL BOTH UNDERPOWERED CLINICAL ASTRAL PATIENTS MOST LIKELY TO BENEFIT WERE EXCLUDED BY DESIGN ( NEED SURGERY or LIKELY TO NEED REVASCULARIZATION IN 6 MONTHS, VERY SEVERE STENOSES ) ANATOMIC/HEMODYNAMIC/PHYSIOLOGIC BOTH - MANY STENOSES < 70%; NO ANGIO CORELAB BOTH - NO PRESSURE GRADIENT MEASURED TECHNICAL/OPERATOR?INEXPERIENCE? BOTH - VERY FEW CASES DONE BY MOST CENTERS BOTH - HIGH COMPLICATION RATE BOTH - MEDICAL THERAPY EASIER TO STANDARDIZE and ADMINISTER

20 CORAL WHY STENTING MAY FAIL vs MEDICAL RX STUDY DESIGN STATISTICAL ADEQUATELY POWERED CLINICAL SOME PATIENTS MOST LIKELY TO BENEFIT FROM INTERVENTION MAY BE UNINTENTIONALLY EXCLUDED FROM TRIAL (PATIENT and/or MD PREFERENCE FOR INTERVENTION) ANATOMIC/HEMODYNAMIC/PHYSIOLOGIC HAS ANGIO CORELAB NO PRESSURE GRADIENT MEASURED IN MOST CASES TECHNICAL/OPERATOR?EXPERIENCE? DIFFICULT RECRUITMENT; SOLICITED OUS CENTERS CHANGES IN STUDY PROTOCOL MIDSTREAM (PRE RANDOMIZATION EVALUATION, EMBOLIC PROTECTION) MEDICAL THERAPY EASIER TO STANDARDIZE and ADMINISTER

21 RENAL ARTERY STENTING CAN WE REDUCE THE RISKS? APPROPRIATE PATIENT SELECTION REDUCE IODINATED CONTRAST METICULOUS TECHNIQUE with MINIMAL MANIPULATION? LOWER PROFILE STENTS???? EMBOLIC PROTECTION???

22 RENAL ARTERY STENOSIS WHEN TO INTERVENE WHAT HAVE WE LEARNED AFTER 35 YEARS? TREAT ONLY HEMODYNAMICALLY SIGNIFICANT STENOSES FOR: RENAL DYSFUNCTION RECENT ONSET OR PROGRESSIVE MODERATE TO SEVERE HYPERTENSION SEVERE AND/OR DRUG RESISTANT PULMONARY EDEMA RECURRENT FLASH?JEOPARDIZED RENAL PARENCHYMA?

23 PROSPECTIVE RANDOMIZED TRIALS LEVEL 1 EVIDENCE?! POOR TRIAL DESIGN POOR INCLUSION/ EXCLUSION CRITERIA INEXPERIENCED OPERATORS SLOW RECRUITMENT LEVEL 1 EVIDENCE?! POOR/ MEANING - LESS OUTCOMES EXCESSIVE COMPLICATI - ONS

24