1. Peripheral Interventions: Unmet needs!
Ralf Langhoff, MD
Center for Vascular Medicine
Berlin-Wilmersdorf
St. Gertrauden Hospital
Charité, CC11
Academic Teaching Hospitals ― Charité Berlin

2. ?

3. Medical needs!
Scientific needs!
Peripheral trials differ from cardiological trials!
Can we trust the data?
Economic needs/ristrictions!
Even if a therapy is superior - can we afford it?
Public relation/awareness needs!

4. Medical Needs
How to treat long SFA occlusions?

5. SFA loading creates risk of kinking and vessel injury

6. 3D stent geometry accommodates loading in SFA
Ideal mechanical implant would mimic rather than
resist the vessel

7. What Is the Effect of Oversizing?
In-Stent Restenosis
Response to injury?
or to radial force, to chronic outward force, to…?

8. Self-Expanding Stents Exert Chronic Outward Force
Nominal Stent
Diameter
COF
Lesion
Stent placement
After balloon post-dilatation
Lesion

9. Medical Needs How to treat long SFA occlusions?
Full metal Jacket results in ISR!
Spot-Stenting (Tack-it or Multi-Loc???)
TOBA-Trial may give an answer, if
spot stenting is the way to go

10. Are DEBs effective in long SFA lesions?
No data, yet! (Levant I &II, Thunder, Fempac, Biolux PI
Adavance PTx,…< 10 cm)
LIMITATIONS OF DEB
Up to 15 % of SFA lesions are calcified!
Calcified lesions respond better to stents!
(Combination therapy DEB with atherectomy?)
Flow-limiting dissections
Sub-optimal PTA or lesions refractory to POBA

11. Medical Needs Still in-stent-restenosis (ISR) is the main draw-back
in SFA stenting?
Open Question:
What is the optimal solution for in-stent-restenosis (ISR)?
Cryo, PCB did not show any improvement to POBA!
DEB, DES, Covered Stents with ‚good‘ results
Debulking plus DEB could be an even better solution?

12. Zilver PTX Trial FAIR Trial (ZILVER DES) (In.pact DEB) TLR @12 month
LL~8 cm

13. Reline Trial 6 month PPR LL~19 cm (covered stent, Viabahn) 6 month PPR

14. Can we improve something in our Procedure Techniques?

15. Medical Needs We do not have a strict POBA protocol!
Balloon expansion mechanism cause significant shear stress and trauma and can lead to
High dissection rate, elastic recoil and abrupt closure
During Inflation
End of Inflation
Folded balloon
Plaque
Blood vessel
Shear stress formation
Half- inflated balloon
Dissection
Inflated balloon
Before Inflation

16. Long Balloon Inflation Time Improves Outcomes
Inflation Time (sec)
p-value
30 (n = 37)
180 (n = 37)
Major dissection (grades 3 and 4) 16 5
0.010
Minor or no dissections (grades 1 and 2) 21 32
0.010
Further Interventions
Stent
Further dilation (prolonged dilation, dilation with larger diameter) 20 4 16 9 1 8
0.017
Residual stenosis (>30%) 12 5
Complication (embolization, thrombosis) 1 1
Mean ankle-brachial index (before, after intervention)
0.66, 0.87
0.65, 0.84
0.97
Zorger N, et al. J Vasc Interv Radiol Apr;13(4):355-9. 16
EU /13

17. Medical Needs Iliacs? Cobest Trial Only few open questions!
Covered Stents?
Cobest Trial

18. Medical Needs BTK ? POBA still is the mainstay!
DES in case of a PTA failure (focal lesions)!
but what about DEB (latest Medtronic RCT …)
Is this a class effect, device effect,….?
….still a lot of interesting scientific work to do
(excipient, cristalline vs. non-cristalline….)
Angiosome?

19. Angiosome

20. Amputation Free Survival and Freedom from Major Amputation
82%
49%
68%
29%
Iida et al, J Vasc Surg 2012

21. Angiosome–targeted infrapopliteal endovascular
revascularisation for treatment of diabetic foot ulcers
Overall series
84 propensity matched pairs
N=250
N=168
Söderström M, J Vasc Surg Feb 2013

22. Scientific Needs Scientific Needs Cardiology Trials: e.g.
GUSTO1, n= STEMI
COMMIT/CCS2, n= STEMI
PAOD Trials: e.g.
BASIL, n= 452
most RCTs include n~ 100
We need working groups and no vain PI‘s!

23. Economic needs/ristrictions Economic needs/ristrictions
Even if a therapy is superior, can we afford it?
In Germany a salary may be related to cost effectifness!
The DRG System is far from being fair and there is no
real interest in medical needs!

24. Economic needs/ristrictions
PR and Awareness needs!
Economic needs/ristrictions
Economic needs/ristrictions
Every patient knows the impact of coronary artery disease
but what is PAOD? Intermittent claudication?
We need a new wording!
PAOD is a ‚marker disease‘ and clearly related to an
increase in mortality rate (more than numerous cancers)!
We need support by the health care providers and
health care insurance system to become aware!
No frontiers between surgery and interventionists – there
is enough work to do and no time for competition!

25. Thank You For Your Attention!
Ralf Langhoff, MD
Center for Vascular Medicine
Berlin-Wilmersdorf
St. Gertrauden Hospital
Charité, CC11
Academic Teaching Hospitals ― Charité Berlin