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G.Biamino University Leipzig – Heart Center Clinical and Interventional Angiology The Upsurge in Renal Revascularisation: Cosmetic or Clinically Relevant ? Nothing to disclose

The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

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Page 1: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

G.Biamino

University Leipzig – Heart CenterClinical and Interventional Angiology

The Upsurge in Renal Revascularisation:

Cosmetic or Clinically Relevant ?

Nothing to disclose

Page 2: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

The Upsurge in Renal Revascularisation:

Cosmetic or Clinically Relevant ?

Nothing is clear about the incidence of renal artery stenoses

Page 3: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery Stenosis at Time of Coronary Arteriography

Prospective cohort of 297hypertensive patients who underwent coronary angiography between (July 1998-March 1999)

All patients underwent screening abdominal aortography

Mean Age 64.9 + 10 yearsMean Blood Pressure

142.8 + 22.5/79.6 + 11.4 mmHg

Mayo Clin Proc 2002;77:309-16

Page 4: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery Stenosis At Time of Coronary Arteriography

0%

10%

20%

30%

40%

50%

60%

0 25 25-49 50-70 >70

53

13 15 127

Maximal Renal Artery Stenosis %

Patie

nts

%

Mayo Clin Proc 2002;77:309-16

Page 5: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Prevalence of Renal Stenosis in Patients with CHD

19 % of patients (101/534) referredfor coronary angiography withrefractory hypertension (> 140/90on two drugs) had RAS >70%.

Khosla et al., Cath.Card.Interv. 2003, 58:400-03

Page 6: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Prevalence of Renal Stenosisin Patients with CHD

In a cohort of 500 consecutivepatients showing a relevant coronary disease

20 % had an undetected renalstenosisin half of these cases thestenosis was consideredcritical

8%

P.Rubino et al., Cardiovascular Clinic, Mercogliano (AV)

Page 7: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Approx. < 10% of RASWomen 15-50 yearsUnknown etiologyDistal locationTypical anatomySeldom ischemic nephropathyRarely progression to occlusionPlain balloon angioplasty therapy of choice to cure hypertension

Safian&Textor, N Engl J Med 2001;344:431

Renal Artery Stenosis and Fibromuscular Dysplasia -

What are the Facts?

Post PTA

Page 8: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Atherosclerotic Renal Artery Stenosis-What are the Facts?

Two facts have to be considered consolidate:

Etiology: as expression of a generalized atherosclerotic disease

Location:> 90 % of the

sclerotic lesions involve the origin of the renal artery

Page 9: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Atherosclerotic Renal Artery Stenosis--What are the Facts?

More common than previously recognized

Progressive disorder

Associated with Coronary Artery Diseaseand/or PAODMay cause“flash” pulmonary edema orunstable angina pectorisCauses “difficult-to-control” hypertension

Leads to progressive renal insufficiency

Page 10: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Atherosclerotic Renal Artery Stenosis--What are the Facts?

Greco and Breyer: Semin Nephrol 1996

Literature extremely inconsistent :3 – 16 %

In case of stenoses

> 75% in 39%

a progression to occlusion

Has been observed within 2 years after the diagnosis

Page 11: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Atherosclerotic Renal Artery Stenosis--What are the Facts?

POOR DATA ON

IncidencePrevalenceProgression

Page 12: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

The first PTRA, 07.12.77The first PTRA, 07.12.77

RASbeforePTRA

4 monthsAfter PTRA

Page 13: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Subtotal Stenosis of the left Renal ArterySubtotal Stenosis of the left Renal Artery

Andreas Grüntzig , Jan. 1978

Page 14: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Instruments for the first PTRA, 1977Instruments for the first PTRA, 1977

8 F guiding cath.

4 F ballooncath. 5/20mm, no end-hole

With permission of Prof. Felix Mahler

Page 15: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

PTRAPTRAPTRA PTRA/StentPTRA/StentPTRA/Stent

Number ofNumberNumber ofofpatientspatientspatients 424242 434343

PrimaryPrimaryPrimarysuccess ratesuccesssuccess raterate 57%57%57%

PrimaryPrimaryPrimarypatency ratepatency ratepatency rate 29%29%29%

RestenosisRestenosisRestenosisrateraterate 48%48%48%

88%88%

75%75%

14%14%

Percutaneous Angioplasty of the Renal ArteryResults of a Randomised Study

STENTING vs PTA

Van den Van den VenVen et al.: et al.: LancetLancet 1999; 2821999; 282--286286

Page 16: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Stenting ofStenting of the RASthe RAS

70

75

80

85

90

95

100

discharge 6months 12months 24month 36months

primarysecondary

(%)

Kaplan-Meier-curve: n = 364

Th. Zeller, 2002

Page 17: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Technical Improvement :The Coronary Technique

Do we need PROTECTION DEVICES ???

Page 18: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery StentingOstial stenosis of right renal artery

55726, P01-0446

Page 19: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery StentingOstial stenosis of right renal artery

55726, P01-0446

Page 20: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery StentingOstial stenosis of right renal artery

55726, P01-0446

Page 21: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery StentingOstial stenosis of right renal artery

55726, P01-0446

Page 22: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

LET`S DO IT !!INDICATION ???

What is the Problem Today ?

•Primary Success Rate

~100%

•Restenosis Rate < 10%

•Complications rare

Page 23: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Potential Indication for Renal Artery Revascularization

Refractory/Resistant HypertensionChronic Renal Insufficiency

Recurrent „ Flash“ Pulmonary Edema

Need for Use of ACE InhibitorsUnilateral Renal Artery Stenosis

FEW DATA

NO DATA

Page 24: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery StenosisClinical Manifastation

Renal artery stenosis

Hypertension

Chronic renal failure

Renal artery stenosis and hypertension

Renal artery stenosis, hypertension,and chronicrenal failure

Renal artery stenosis and chronic renal failure

R.Safian, St.TextorN.Engl.J.Med.6,2001

Page 25: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Results of Renal Artery Angioplasty/ Stenting in Hypertensives

Accumulate data from 8 authors 349 patients with mean follow up 11 months

Hypertension:UnchangedImprovedCure

Palmaz JVIR 1998;9:539-430

44%

56%

10%

Page 26: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Meta-Analysis: PTRA vs Medicine in Hypertension and RAS

Am J Med 2003;114:44-50

Page 27: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery Stenting Blood Pressure - Bad Krozingen Data

129

144

89102

7379

020406080

100120140160

pre post 6 m 12 m 24 m 36 m 48 m 60 m

BPsBPmBPd

p < 0.0001

Zeller et al. Cath Cardiovasc Intervent 2003

144

10279

129

8973

Page 28: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery Stenting Blood Pressure - Bad Krozingen Data

3,06

1,17

2,78

1,15

2,61

1,2

2,61

1,18

2,6

1,22

2,59

1,31

2,73

1,06

2,39

1,17

00,5

11,5

22,5

33,5

44,5

prä post 6 M 12 M 24 M 36 M 48 M 60 M

SDn med

1,171,15 1,2 1,18 1,22 1,31 1,06

1,17

Zeller et al. Cath Cardiovasc Intervent 2003

3,062,39

Page 29: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Interventional vs. Best MedicalTherapy

in Hypertension

COST EFFECTIVE

STAR - study: answer in 5- 7- years !!

Page 30: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Is Renal Artery PTA & Stenting Effective Treatment for Ischemic Nephropathy and Renal Vascular

Hypertension?

WHAT IS IMPROVEMENT ???

Page 31: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Endovascular Treatment in Ischemic Nephropathy

Challenging for 2 main reasons:

-Relatively poor reported resultswith stent revascularization

-No investigations available which reliably predict a therapeutic response to revascularization

(Doppler assessment of vascular may have a role)

Sos, ISET 2004

Page 32: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

0

0,5

1

1,5

2

2,5

prä post 6 M 12 M 24 M 36 M 48 M

RI<0.70.7-0.8RI>0.8

Renal Artery Stenting Renal Function- Bad Krozingen Data

Serum creatinine (mg%) and RI

Zeller et al. Cath Cardiovasc Intervent 2003

Page 33: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal ArteryStenting

Renal Dysfunction

Zeller et al., Circulation2003;108:2244-2249

Zeller et al., J EndovascTher

2004, in press

0

0,2

0,4

0,6

0,8

1

1,2

1,4

1,6

1,8

2

Baseline 6 Months 12 Months

CREATIN

INE (m

g/l)

* #

* p <0.01, # p =0.005

1,45 1,39

0

0,5

1

1,5

2

2,5

pre 33 mo

SDcrea

[mg/dL]

Page 34: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Endovascular Treatment of RAS in Ischemic Nephropathy

CURED

IMPROVED

UNCHANGED

DETERIORATED ??

Page 35: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery StentingRenal Dysfunction

Serum CreatinineConcentrationDecrease >10%: 34%Unchanged (+ 10%): 39%Increase > 10%: 27%

Zeller et al., J Endovasc Ther 2004, in press

Mean follow-up 34 + 20 months

Page 36: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery Stenting in CRI

Matsumoto, A. Presented at ISET, Miami, Florida January 2003

0

5

10

15

20

25

30

35

40

Improved Stabilized Worsened

Perc

ent C

hang

e

Impact on Renal Function

Page 37: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Acute Deterioration in Renal Function after Angioplasty/ Stenting

Incidence of 10-20% in patientswith ischemic nephropathy

Possible etiologies:

-iodinated contrast nephropathy

-procedure related arterial trauma(e.g. dissection)

-cholesterol atheroembolization

Sos, ISET 2004

Page 38: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

99 000 procedures,in 2003 (WW)

• US : 60 000• EU : 30 000• ROW: 10 000

Renal Artery Angioplasty

With permission of Bernard de BruyneSan Diego, April, 2004

•No reliable noninvasive tests to assess the functional severity of the renal stenosis

•1/3 improves, 1/3 unchanged, 1/3 further deterioration (BP + Renal function)

• No reliable noninvasive testing to predict which patient might benefit from renal artery stenting

•Very little is known on pathophysiology of renal artery stenosis revascularisation.

Page 39: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Question of the day :IS THIS LESION RELEVANT ?

AT LEAST TRY TO MEASURE THE PRESSURE GRADIENTBEFORE YOU IMPLANT A STENT !!!!!!

Page 40: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

74-year-old man with severe AHTDiffuse coronary atherosclerosis

RightRight Upper Upper RenalRenal ArteryArtery

With permission of Bernard de Bruyne

Page 41: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

What is a “significant” gradient ?

• Which difference in pressure?

• Which pressure: mean, systolic, diastolic?

• Resting gradient or hyperemicgradient?

• Pressure gradient orresistance?

With permission of Bernard de Bruyne

Page 42: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Artery Hemodynamics and RenalArtery Stenosis Angioplastyfor Cardiac Interventionalists

Conclusions1. We know very little about it

2. Let’s apply sound physiology (and common sense) to

• better understand what we are doing

• select patients in whom renalstenting makes sense

With permission of Bernard de Bruyne

Page 43: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

How can we prevent an excess of

!!! WE NEED EVIDENCE BASED DATA !!!

OCULO-STENOTIC REFLEXES IN RAS??

Page 44: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Renal Stenosis Severity vs

Renal Blood Flow and Renal Perfusion Pressure

May A. G. et al Surgery, 1963

FLOW PRESSURE

Page 45: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Coronary Circulation Renal Circulation

Local adaptation ONLY Local AND systemic adaptation

In case of stenosis:

• Pao increases

• Pd remains normal

• Flow tends to decrease

In case of stenosis:

• Pao remains normal

• Pd decreases

• Flow remains constant

The heart keeps the flow constantat the cost of the pressure

Kidneys keep the pressure constantat the cost of the flow

Coronary and Renal Autoregulation

With permission of Bernard de Bruyne

Page 46: The Upsurge in Renal Revascularisation: Cosmetic … › pdf › pdf › 050902_lec3.pdfrenal failure Renal artery stenosis and chronic renal failure R.Safian, St.Textor N.Engl.J.Med.6,2001

Catheter Positions

ReninSamplingIn the RightRenal Vein

ReninSamplingIn the LeftRenal Vein

ReninSamplingIn the LeftRenal Artery

Distal RenalPressure(RadiPressureWire,Pd)

Proximal RenalPressure(Pa)

With permission of Bernard de Bruyne