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Renovascular Disease recognition and management. Craig A. Thompson, M.D., MMSc. Cardiac and Vascular Interventional Services Dartmouth Hitchcock Medical Center Lebanon, NH. When to When not to In whom. Renovascular Disease: The Clinical Perspective. Old Medical Adage :

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renovascular disease recognition and management

Renovascular Diseaserecognition and management

Craig A. Thompson, M.D., MMSc.

Cardiac and Vascular Interventional Services

Dartmouth Hitchcock Medical Center

Lebanon, NH

slide2

When to

  • When not to
  • In whom

Renovascular Disease: The Clinical Perspective

Old Medical Adage:

“Even a monkey can do angioplasty.”

Caveat:

It takes a real doctor to decide:

  • What the diagnostic studies do and don’t say
  • What to do afterward
  • How to address this problem in the context
    • of a living, breathing patient
slide3

Progress in Renovascular Disease

  • The disease
  • Clinical diagnosis
  • Laboratory diagnosis / imaging modalities
  • Patient selection: who benefits from intervention?
  • Limiting contrast-induced nephropathy
  • Atheroembolic protection
  • Expanding the pool of eligible patients / interventions
  • Limiting restenosis
slide4

Progress in Renovascular Disease

  • The Disease
  • Clinical diagnosis
  • Laboratory diagnosis / imaging modalities
  • Patient selection: who benefits from intervention?
  • Limiting contrast-induced nephropathy
  • Atheroembolic protection
  • Expanding the pool of eligible patients / interventions
  • Limiting restenosis
etiology of renal artery stenosis
Etiology of Renal Artery Stenosis
  • Atherosclerosis
  • Fibromuscular dysplasia
  • Polyarteritis Nodosa
  • Radiation-induced
  • Takayasu’s arteritis
defining the problem
Defining the Problem
  • RAS is an important cause of secondary hypertension
  • Renovascular disease under-appreciated as cause of CRF
  • 23% of malignant hypertension is the result of renovascular causes
  • Not all patients with RAS are hypertensive as a result
natural history of renal artery stenosis
Natural History of Renal Artery Stenosis
  • Serial U/S examination of 170 patients with 295 renal arteries
  • Exclusion for congenitally absent / occluded / prior PCI / poor window
  • Referred for renal U/S for hypertension or renal insufficiency
  • Only included in study if not a candidate for immediate revascularization
  • U/S evaluation every 6 months until time of intervention
  • Duplex evaluation: Peak Systolic Velocity (PSV) in proximal, middle, and distal RA and AO
  • Yielding the RAR (Renal-to-Aortic Ratio)

Caps et al. Circulation 1998; 98:2866-2872.

natural history of renal artery stenosis1
Natural History of Renal Artery Stenosis

Caps et al. Circulation 1998; 98:2866-2872.

Role of lipid lowering and

Aggressive risk factor modification?

slide13

Progress in Renovascular Disease

  • The Disease
  • Clinical diagnosis
  • Laboratory diagnosis / imaging modalities
  • Patient selection: who benefits from intervention?
  • Limiting contrast-induced nephropathy
  • Atheroembolic protection
  • Expanding the pool of eligible patients / interventions
  • Limiting restenosis
clinical clues
Clinical Clues
  • Onset of diastolic hypertension after age 55
  • Refractory or malignant hypertension
  • Development of resistant hypertension in a previously well-controlled patient
  • Progressive increase in Creatinine, even if still “normal”
  • Presence of atherosclerotic macrovascular disease elsewhere heightens suspicion
  • Left heart failure out-of-proportion to LV dysfunction or ischemic burden
  • Clinically silent RAS
slide15

Progress in Renovascular Disease

  • The Disease
  • Clinical diagnosis
  • Laboratory diagnosis / imaging modalities
  • Patient selection: who benefits from intervention?
  • Limiting contrast-induced nephropathy
  • Atheroembolic protection
  • Expanding the pool of eligible patients / interventions
  • Limiting restenosis
slide16

Screening for Renovascular Disease

  • Clinical syndrome most important in patient selection
  • Various diagnostic modalities:
    • Serologic markers
    • Duplex ultrasound - in experienced hands can predict with great accuracy the presence or absence of significant RAS
    • Captopril renal scan - 10-25% false negative
    • MR angiography - rare false negatives / common false positives. Equipment/experience dependent
    • Contrast angiography
duplex u s for renovascular disease
Duplex U/S for Renovascular Disease

Olin et al. Ann Intern Med. 1995; 122:833-838.

  • Prospective Duplex U/S evaluation and Renal Angiography in 102 pts
  • Goal: Validate renal artery U/S as a viable non-invasive modality
  • Drawbacks:
    • Time and labor intensive
    • Technologist dependent
    • Not available
    • NPO
    • Requires a cooperative patient
slide20

Progress in Renovascular Disease

  • The Disease
  • Clinical diagnosis
  • Laboratory diagnosis / imaging modalities
  • Patient selection: who benefits from intervention?
  • Limiting contrast-induced nephropathy
  • Atheroembolic protection
  • Expanding the pool of eligible patients / interventions
  • Limiting restenosis
what are the goals of treatment for ras
What Are the Goals of Treatment for RAS?
  • Control hypertension
  • Aid in medical management
  • Prevent deterioration in renal function
    • Forestall need for dialysis
    • Defer death and disability
hypertension and ras
Hypertension and RAS

Among 152 patients with Unilateral or Bilateral RAS undergoing surgical revascularization:

  • 90% had improvement in BP control
  • Only 15% had “cure” of hypertension

Among 20 published series of PCI for atherosclerotic renal artery disease:

  • 54% had improvement in hypertension
  • 9% had “cure” of hypertension

Hansen et al. J Vasc Surg 1992;16;319-31.

chronic renal insufficiency and ras who benefits from revascularization
Chronic Renal Insufficiency and RASWho Benefits From Revascularization?

Trial of 51 patients with Creat>2.0 before revascularization with >75% Bilateral RAS:

  • 67% had improvement in renal function
  • 27% had stabilization in renal function
  • Only 6% had worsening in renal function
  • No demonstrated impact upon mortality

Novick et al. J Urol 1983; 129:907-12.

experimental data supporting stenting for preservation of renal function
Experimental Data supporting Stenting for Preservation of Renal Function
  • 61 vessels in 31 patients with “global” obstructive atherosclerotic renal disease
  • All with chronic renal insufficiency (Creat 1.5 – 4.0)
  • Stenting with non-articulated Palmaz stents
  • Follow-up Renal U/S, Serum Creat , BP measurements:

- Improvement in reciprocal slope of serum creatinine

- Improved BP control (SBP from 170±21 Pre-stent vs. 148 ±15mmHg Post-stent; p<0.001)

- Restenosis (>50%) in only 1 of 61 vessels

- Stabilization of pole-to-pole renal dimension

Watson et al. Circulation. 2000; 102:1671-1677.

dutch renal artery stenosis intervention cooperative study
Dutch Renal Artery Stenosis Intervention Cooperative Study

N Engl J Med 2000; 342:1007-14

Results:

  • BP same in both groups
  • Fewer meds (2.1 vs. 3.2) in the PTA vs. Medical group
  • Renal function similar between groups
  • Study Design:
  • 106 hypertensive patients with RAS (>50%) and Creat<2.3 mg/dl
  • PTA vs. Medical rx with follow-up of BP/meds/ renal fxn
  • at 3&12 mths
  • Shortcomings:
  • Crossover of patients from medical-to-PTA
  • No stents
  • Is 50% stenosis physiologically significant?
  • Pts with elevated creatinine excluded
  • Is the goal of renal artery revascularization improvement in BP control?
resistive index predicts fate of renal function

(

)

PSV - MEDV

=

PSV

Resistive Index Predicts Fate of Renal Function

Radermacher et al. NEJM 2001 344: 410-17

Resistive

Index

factors that predict failure
Factors That Predict Failure

Radermacher et al. NEJM 2001; 344: 410-417.

slide32

Progress in Renovascular Disease

  • The Disease
  • Clinical diagnosis
  • Laboratory diagnosis / imaging modalities
  • Patient selection: who benefits from intervention?
  • Limiting contrast-induced nephropathy
  • Atheroembolic protection
  • Expanding the pool of eligible patients / interventions
  • Limiting restenosis
slide33

HOCM may increase

cellular injury when

potentiated by hypoxemia

c/t LOCM

Useful for localization

> Anatomic definition

-Gadopentatate dimeglumine

-Renally cleared by GF

-Not nephrotoxic to

0.4mmol/kg

-Changing kV may

improve image quality

AC and hydration

reduce Creatinine >

hydration alone in CT

with CRI (2% vs 21%)

May decrease incidence

of RCN vs. historical

controls (4.7% vs 18.8%)

Options:

Contrast minimizing maneuvers

Use of low-osmolar, non-iodinated contrast

CO2 Angiography

Gadolinium contrast

Mucomyst (Acetylcysteine)

Selective DA-1 agonists

slide34

Progress in Renovascular Disease

  • The Disease
  • Clinical diagnosis
  • Laboratory diagnosis / imaging modalities
  • Patient selection: who benefits from intervention?
  • Limiting contrast-induced nephropathy
  • Atheroembolic protection
  • Expanding the pool of eligible patients / interventions
  • Limiting restenosis
guarding against atheroembolism
Guarding Against Atheroembolism
  • Meticulous “no touch” technique
  • Use of low profile, atraumatic catheters
  • Limited catheter manipulation
  • Primary stenting when feasible
  • GP 2b3a Antagonists
  • Distal protection devices
slide36

Distal Atheroembolic Protection: The Ideal

Capture all debris

Continued renal perfusion during procedure

Limitless reservoir

Atraumatic to vessel wall

Technically easy to use

Low profile

Trackable

slide37

Pathology

of Atheroembolism

  • Plaque / cholesterol
  • Endothelial cells
  • Platelet-Fibrin Thrombi
  • Calcified tissue
evolution of distal protection devices
Evolution of Distal Protection Devices
  • Initially used in the treatment of patients with coronary bypass graft disease
  • These interventions commonly plagued by angiographic “No Reflow” phenomenon
  • Cardiac enzyme leak
  • Clinical myocardial infarction
  • Long attributed to RBC lysis and platelet activation with resultant microvascular spasm
initial reports atheroembolic protection
Initial Reports: Atheroembolic Protection

“Percusurge Guardwire”

47% of patients with SVG intervention had gross, macroscopic evidence of red-yellow debris

An additional 20% of patients had evidence of microscopic debris

Carlino et al.Circulation 1999; 99: 3221-3223

safer trial
SAFER Trial
  • Randomized comparison of SVG lesions treated +/- PercuSurge Guardwire
  • Improved outcomes: 42% decrease MACE
  • Lower laboratory MI’s
  • Safe
  • High procedural success

Baim et al. Circulation 2002.

distal protection in renovascular disease an opportunity
Distal Protection in Renovascular Disease: An Opportunity
  • Most RAS caused by atheromatous disease
  • Ostial / proximal segments of disease are common
  • Kidney will tolerate longer balloon occlusion time than coronary / cerebral circulation
  • Atheroembolism has long been viewed as a major risk / complication of percutaneous intervention of the renal arteries.
slide42

FILTER

DEVICES

OCCLUSION

DEVICES

+

Preserve flow

Limit Ischemic Time

More complete capture

-

Small debris

Vascular Injury

No antegrade flow

Prolonged Ischemic Time

Vascular Injury

Shoulder Regions

slide44

OCCLUSION

DEVICES

atheroembolization protection
Atheroembolization Protection
  • Percusurge Guardwire
  • Traverse
  • Inflate
  • Intervene
  • Embolectomize
early experience distal protection in renovascular intervention
Early Experience: Distal Protection in Renovascular Intervention

Henry et al.J Endovasc Ther 2001; 8(3): 227-37.

28 patients with 32 renal arteries

29 Lesions ostial location

100% Technical success with GuardWire

Visible debris aspirated: 100% cases

Mean RA occlusion time: 6.55 min (2.29-13.21 min)

Creatinine post-procedure and at follow-up stable or improved in all cases.

Conclusion: Distal protection against atheroembolism is feasible and safe

But is it effective?

characterization of debris
Characterization of Debris

Characterize debris in carotid intervention

Can we extrapolate to renal artery intervention?

Both atheromatous

Similar patient population

Tuber et al.Circulation 2001; 104: 2791-6.

characterization of debris1
Characterization of Debris

Why did complications still occur?

What type of debris was not captured?

Tuber et al.Circulation 2001; 104: 2791-6.

characterization of debris2
Characterization of Debris

Tuber et al.Circulation 2001; 104: 2791-6.

slide50

Splenic A

RRA

LRA

CO2 Aortogram

slide51

No trans-lesional gradient

with 5F catheter

Gadolinium Renal Angiogram

R

slide52

60mmHg gradient

with 4F catheter

Gadolinium Renal Angiogram

IVUS with

87% stenosis

c/t reference

vessel

L

resist trial
RESIST Trial

Study Design: Multicenter, randomized trial of renal PTA/Stent

+/- Distal atheroembolic protection (Cordis Angioguard XP)

+/- Anti-platelet therapy with 2b 3a antagonist (Reopro)

Endpoints:

1) Renal function as measured by

- Nuclear renal scan with DTPA

- GFR estimated by Iohexol clearance

- Serum Creatinine

2) Bleeding complications

3) Microscopic assessment of atheromatous debris within the

Angioguard XP

PI: Christopher J. Cooper, M.D. Medical College of Ohio

slide55

Progress in Renovascular Disease

  • The Disease
  • Clinical diagnosis
  • Laboratory diagnosis / imaging modalities
  • Patient selection: who benefits from intervention?
  • Limiting contrast-induced nephropathy
  • Atheroembolic protection
  • Expanding the pool of eligible patients / interventions
  • Limiting restenosis
what are the benefits of pci over surgical revascularization
What are the benefits of PCI over Surgical revascularization?
  • Shortened hospital stays
  • Reduced post-procedural morbidity / mortality

(J Vasc Surg 1994; 20: 76-87)

    • Early graft failure 5%
    • Peri-operative mortality 5.6%
    • 43% of patients required aortic grafting
  • Comparable procedural success and improvement in renal function

(J Vasc Surg 1993; 18:841-52)

    • Procedural success: PTRA 83% vs. Surgery 97% (p=NS)
    • Improved or stable renal function: PTRA 83% vs. Surgery 72% (p=NS)
  • Broadens pool of patients eligible for revascularization
benefit of renal to revascularization
Benefit of Renal TO Revascularization
  • Surgical revascularization vs. Nephrectomy in 95 patients with 100 Occluded Renal Arteries.
  • All patients hypertensive
  • 88% of patients with renal dysfunction
  • Renal function, blood pressure response and survival followed after procedure.

Oskin et al. J Vasc Surg 1999. 29 (1):140-149.

study results
Study Results
  • Blood pressure improved in both groups
    • 87% with nephrectomy
    • 92% with revascularization (p=NS)
  • Only revascularized patients (49%) demonstrated improved glomerular filtration rate (GFR).
  • 9 revascularized patients were no longer dialysis-dependant
  • The absence of a nephrogram or distal reconstitution of the vessel did not preclude revascularization (done in 48% of these cases)
  • Selective renal vein renins or nuclear renal scan may be of benefit in guiding therapy
  • Renal biopsy may show hyalinization of glomeruli, tubular atrophy, and loss of cortical thickness, but is not an absolute predictor of renal recovery or failure to recover

Oskin et al. J Vasc Surg 1999. 29 (1):140-149.

renal to technical difficulties
Renal TO: Technical Difficulties
  • Occluded renal artery without collateral filling of distal vessel – still may be a surgical candidate
  • Cautious recanalization to avoid perforation
  • Acquisition of both indirect and direct evidence of intravascular position.
  • Small balloon predilatation
  • Minimize iodinated contrast as most patients have significant baseline CRI
  • Stenting a must as there is marked elastic recoil and bulky plaque prolapse
collateral circulation of the kidney
Collateral Circulation of The Kidney

A. Suprarenal Complex

B. Lumbar Complex

C. Ureteric Complex

D. Capsular Complex

selective lumbar angiogram wire position

5F Cobra

0.018” Glidewire

5F Cobra / 7F IM Guide

Selective Lumbar Angiogram: Wire Position
angioplasty and stenting
Angioplasty and Stenting

6 x 18mm Herculink Stent

6.5mm Post-dilatation

slide70

Progress in Renovascular Disease

  • The Disease
  • Clinical diagnosis
  • Laboratory diagnosis / imaging modalities
  • Patient selection: who benefits from intervention?
  • Limiting contrast-induced nephropathy
  • Atheroembolic protection
  • Expanding the pool of eligible patients / interventions
  • Limiting restenosis
slide71

Summary

  • Renovascular disease is an often-unrecognized contributor to:
    • Uncontrolled hypertension
    • Volume overload
    • Chronic and progressive renal failure
  • Existing literature allows data-driven decision making, helping clinicians to properly manage their patients with renovascular disease. However, the optimal treatment of patients with unilateral disease or “clinically silent” disease is ill defined.
  • New technologies have expanded the pool of patients eligible for percutaneous intervention, and help to limit procedural risk with renal revascularization.
  • Atheroembolic distal protection devices are likely to be a mainstay of therapy in the near future.
  • Vascular medicine allows cooperation and collaboration across departmental boundaries.