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BRACHYTHERAPY IN INSTENT RESTENOSIS PSCC Experience (One-year follow-up)
Dr. Saad Al Kasab, FRCP, FACC, FCCP
Senior Consultant Interventional Cardiologist
Prince Sultan Cardiac Center
Vascular Brachytherapy
Vascular Brachytherapy (VBT):  New therapy utilizing radiation in the vasculature (coronary or peripheral arteries) intended to inhibit restenosis.

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Results:  Vascular brachytherapy significantly inhibited neointimal formation after balloon injury1
Control
Treated
1 Waksman, et al. Circulation, 1995.;91:1533-1539.
Emory University – Atlanta, Georgia USA
Animal Trials with Novoste? System Post PTCA
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Results:  Vascular brachytherapy significantly inhibited neointimal formation adjunctive to stent implantation1
Control
Treated
1 Waksman, et al. Circulation, 1995;92: 1383-1386.
Animal Trials with Novoste? System Post Stent
Emory University – Atlanta, Georgia USA
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  I   Basics of Radiation II    Restenosis definition III   Clinical Trials of Radiotherapy IV   Long-Term Effect of Brachytherapy for        coronary artery disease.

I  Basics of Radiation
Main Index
Radiation Review
1
2
3
4
Types of Radiation                 
Alpha
Beta
Gamma & X-rays
Neutrons
 2 neutrons + 2 protons 
 2 positive charges 
 Short range in tissue
 Electron
 Travels max. 1cm in tissue
 Positive or negative charge
 Uncharged particle
 Photons
 Electromagnetic radiation
 Long range, very penetrating 
Radiation Choices for VBT
Beta  (electrons)                
 Deeply penetrating, delivers
   significant dose to normal tissue

 Dwell times of 12-15 minutes

 Requires shielded room
 Clinicians and staff must leave
  during treatment
 Auxiliary shielding required for
  patient

Gamma  (photons)
 Short, finite (<1 cm) range
 Rapid deposit of energy in
   tissue ( 2.5 - 4 minutes)
 Minimal shielding requirements
  (shielded by 1-2 cm of plastic)
 Clinician remains in room
   during treatment

*Radiation for Restenosis, Diamond & Vessely, JVIR, ‘98
Radiation: Biological effects
Direct effect: DNA damage - interact with tissue electron to produce fast recoil electron which directly affect ionization of DNA I.e. radiation induce single or double strand DNA, breakage ? to cause lethal chromosomal aberration.
Indirect effect:
70% of cells are water
Water molecules are ionized / excited
Result:  H2O + H2O + ? OH + H3O+
                                       
  (Free radial - seeks an electron for stability )
OH + OH ? H2O2

(Hydrogen peroxide is a powerful oxidizing agent)
OH and H202 cause molecular damage in the DNA
 Consists of two components:
 Transfer Device
  containing Radiation
  Source Train

 Delivery Catheter
The Beta-Cath? System
MT-180-02  05/01
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Usable life    Single use


Outer diameter   5 French (Old) -  3.5 French (New)

Catheter Type   ?-Rail? Delivery Catheter
      rapid-exchange type catheter       (25 cm distal rail length)

Wire requirements  <0.014” (0.36mm) steerable guidewire   
      
Delivery Catheter
MT-180-02  05/01
Three Causes of Restenosis
Recoil - Immediate loss of lumen diameter.

Remodeling - Gradual vascular contraction caused by cell growth outside artery wall.

Hyperplasia - Cell growth in lining of arterial wall.
Clinical Experience at Prince Sultan Cardiac Center (One-year follow-up)

     
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35 patients
37 procedures
Sex   - 33 males
         -   2 females
Age range  - 38 - 75
                  ? 59 year
RISK FACTORS
Smoking - 11
D.M.       - 12    -  10 non-insulin dependent
                          -  2  insulin dependent
Hypertension    -  12
 Renal dysfunction -  1
Previous MI      -  12 
CLINICAL DATA


Angina       Stable            U.A.
  24               17                  7
No symptoms  - 10 pts  - positive stress test
CARDIAC CATH DATA
A) Vessels involved:
LAD         Cx          RCA         Diagonal
 23             2             11               1
No. of diseased vessels: Single    Two    3-vessel
                                             25          6             4
No. of treated vessels: Single vessel    Two-vessel
                                             33 pts                   2 pts          
CARDIAC CATH DATA
   1)  All patient has restenosed Bare metal stent    except two patients:
one patient has Drug-eluting stent (Taxus)
one patient has Drug-coated stent (Dexa)

2)  One patient has Gamma radiation to     stented RCA
CARDIAC CATH DATA
B) Vessels involved:
Ref diameter 2.5 - 4.0 mm mean 3.1 mm
Diameter of stenosis (mm) 0 - 0.9 ? 0.7
Diameter of

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