1. Appropriate BVS Utilization in the Cath Lab
Ron Waksman, MD, FACC, FSCAI Professor of Medicine, (Cardiology) Georgetown University Director, Cardiovascular Research Advanced Education,
MedStar Heart & Vascular Institute, Washington DC

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Boston Scientific
Biotronik
Biosensors
Astra Zeneca
Medtronic Vascular
Abbott Vascular
Symetis
Med Alliance
LifeTech
Amgen
Grant/Research Support
Consulting Fees/Honoraria

3. Interventional Cardiology Treatment: An Historical Unmet Need
“From the very early days, interventional cardiologists have been dreaming of a transient scaffold that would disappear after the job has been done.”
European Heart Journal, 2011, doi: /eurheartj/ehr384

4. SCAFFOLD IS FULLY RESORBED WITHIN 3-4 YEARS
All scaffold polymer is resorbed within 2-3 years
Chemical analysis of preclinical specimens shows that resorption sites contain no polymer
Polymer resorbs at the same rate in animals and humans¹
Degrading polymer is replaced by provisional matrix
Pre Clinical Images
6 months
12 months
18 months
24 months
30 months
36 months
Scaffold Strut
Resorption Site
48 months
Representative photomicrographs of porcine coronary arteries implanted with Absorb BVS. Images on file with Abbott Vascular.

5. SCAFFOLD IS FULLY RESORBED
Baseline
6 Months
2 Years
5 Years
De Bruyne, B. TCT 2014
Cohort B OCT images - courtesy of RJ van Geuns, Erasmus Medical Center, Netherlands

6. Why implant a resorbable scaffold?
Possible advantages of transient BRS vs. permanent DES
Vessel angulation and curvature are anticipated to be restored by the time the scaffold loses its integrity.
Restoration of
vessel anatomy
Liberation from the permanent metal cage will facilitate restoration of vessel pulsatility and vasomotion. Compensatory expansive remodeling and/or lumen enlargement will not be restricted.
Restoration of
vessel functionality
The risk of late or very late scaffold thrombosis will
be eliminated as the foreign material (platform & coating) will be resorbed.
Restoration of low thrombogenic milieu
Complete scaffold resorption, intact endothelium with
restored vasomotion will potentially eliminate the risk of in-scaffold neoatherosclerosis.
Potential elimination of neoatherosclerosis
Vascular Restoration Therapy

7. Which patients?

8. Recomedations from the expert panel
7 experts
Publication of a consensus paper on optimal patient selection
Jean Fajadet: co-founder and course director of the EuroPCR congress – BRS expert
Michael Haude: President of the EAPCI board – Magmaris expert
Michael Joner: Expert in the pre-clinical aspect of Magmaris
Jacques Koolen: Co-founder of EuroCTO – BRS expert
Michael Lee: co-PI of BIOSOLVE-IV – BRS expert
Ralph Tölg: Part of BIOSOLVE-II – BRS expert
Ron Waksman: Associate Director, Division of Cardiology at the Washington Hospital Center – Magmaris expert

9. Patient and lesion characteristics
Patient Characteristics
Recommendation
Lesion Characteristics
Patients with long life expectancy
***
De novo lesions 
Diabetic patients **
Tortuous Vessels -
STEMI
Severe calcification
Cardiogenic Shock
In-stent restenosis
Stable angina
Reference vessel diameter less or larger than the available device sizes
NSTEMI / Unstable angina
Diffuse long lesions
Contraindications for DAPT
Chronic Total Occlusions
Target lesion located in a SVG
Ostial lesions
Patients with poor medical compliance
Bifurcations
No adequate lesion preparation
Presence of thrombus
Left main lesions
- =not recommended, **=evaluation pending, ***=recommended
J. Fajadet, M. Haude, M. Joner, J. Koolen, M. Lee, R. Tölg, R. Waksman,
Magmaris preliminary recommendation upon commercial launch,
a consensus from the expert panel on the 14th of April, EuroIntervention 2016 ;12:

10. Limitations of BVS Mechanistic Reasons
Unfavorable Lesion sub-sets
High profile – difficult to deliver, issue in small vessel or already stented vessel - require careful vessel preparation
Issues of overlap – stent positioning and limitation of vessel lumen in overlap.
Difficult to visualize – require IVUS/OCT for proper evaluation of result
Plastic stent – high chance of mal-apposition (Chance of Stent Thrombosis or BVS Recoil) – Require high pressure post dilatation
Calcific or fibrotic lesions
Tortuous lesions
Small vessels
Bifurcations
ISR

11. Technical, procedural and DAPT recommendations
Careful technique for vessel preparation and device deployment is essential, this recommendation includes:
Meticulous vessel preparation with balloon predilatation for all lesions
Precise lesion size and length assessed
Image guided implantation with OCT or IVUS at the beginning of the learning curve
Balloon postdilatation with a non-compliant balloon
DAPT duration is at the physician discretion, in stable patients it is recommended for at least 12 months post deployment with ABSORB but preferably now up to 3 years if the patient does not bleed.
J. Fajadet, M. Haude, M. Joner, J. Koolen, M. Lee, R. Tölg, R. Waksman,
Magmaris preliminary recommendation upon commercial launch,
a consensus from the expert panel on the 14th of April, EuroIntervention 2016 ;12:

12. BRS: Tips and Tricks for a successful procedure
Correct target vessel sizing at the lesion site is crucial
If uncertain about the size, use QCA, IVUS and/or OCT for quantitative lesion evaluation
QCA underestimates and IVUS overestimates vessel dimensions by about 0.25mm
Since the diameters available are 3.0mm and 3.5mm, do not implant into vessels <2.7mm or >3.7mm
1- Size the vessel properly
Non-compliant balloon, 1:1 balloon-to-artery ratio, full expansion of the balloon should be achieved.
Residual stenosis should be
< 20%, accept lesion dissection, if necessary use scoring balloon
If the lesion is very calcified, use rotablator followed by
non-compliant balloon dilatation
NB: Heavily calcified lesions are currently off-label
2- Prepare the lesion thoroughly
Inflate the implantation balloon until full and homogenous expansion, but respect the maximum rated burst pressure
Angiography of implant result (QCA)
OCT for documentation of implant result (helpful during the learning phase)
Always post-dilate with a NC balloon at high pressure (>16 atm) if OCT shows suboptimal results keeping in mind the Magmaris expansion limit of 0.6mm beyond nominal scaffold size
3- Always post-dilate with NC balloon
Optimal BRS implantation

13. Median based on pooled Absorb and Xience
Avoid Small Vessels Outcomes by QCA RVD 2.25 mm
RVD <2.25 mm
(median 2.09 mm)
RVD ≥2.25 mm
(median 2.74 mm)
TLF: Pint diff = 0.31
ST: Pint diff = 0.12
1-Year Events (%)
# Events: 31 11 2 71 30 9 3
# Risk:
241
133
238
1067
542
1058
540
Median based on pooled Absorb and Xience

14. Optimal Implantation Technique Is Imperative for Good Clinical Outcomes
Implantation Guidance Has Evolved During Enrollment in ABSORB Trials
Full PSP Was Not Used in Many Patients
2009
2010
2011
2012
2013
2014
2015
2016
ABSORB Cohort B
ABSORB EXTEND
ABSORB II
ABSORB JAPAN
ABSORB III
ABSORB CHINA
ABSORB FIRST
ABSORB IV
Study enrollment period
Guidance on technique in commercial practice
Cohort B: March 9, 2009 and November 6, 2009
EXTEND: January 11, 2010 and October 2, 2013
AII: Nov 28th, 2011, and June 4th, 2013
A-Japan: April 27th, 2013 and December 27th, 2013
A-China: July 31, 2013 and March 13, 2014
A-FIRST: January 21st 2013 and August 30th 2014
AIII: March 22, 2013 and April 3, 2014
High Pressure Post Dil
RVD  2.5mm (US: FDA IFUs)
Implantation technique advised against high pressure Post-Dil
Ellis, S., Technique in ABSORB Trials, TCT 2016.

15. Learning Curve a bvs-specific implantation strategy can improve outcomes
PREPARE THE LESION S
SIZE APPROPRIATELY P
POST-DILATE P S P
Adapted from Gori, T., EuroPCR 2015

16. Optimal Implantation technique is imperative for good clinical outcomes
Improvement over time due to patient/lesion selection and improved technique
1Hamm, C. GABI-R, EuroPCR / 2Cortese, B. RAI, EuroPCR / 3Puricell, S., et al. Bioresorbable Coronary Scaffold Thrombosis, J Am Coll Cardiol. 2016;67:921–31. / 4Gori, T. 4 Cities Registry, EuroPCR 2015.

17. WORLDWIDE ABSORB VOLUNTARY REPORTING OF THROMBOSIS BY IMPLANT DATE
Size the vessel (3Ps)
Postdil
(OUS: 4Ps)
High Pressure
Post Dil
2.5mm  RVD
(US: FDA IFUs)
2012
2013
2014
2015
2016
Implant Date
1 Data represents exponentially weighted moving average
Data dated from Aug 31, 2016

18. Current limitations of BRS technology
Mainly performance aspects:
Pushability
Trackability
Difficult to pass complex tortuous calcified vessel segments and lesions (including bifurcation lesions)
Poor visibility if at all
Need excessive lesion preparation and post-dilatation
Poor vessel size and shape conformability
Slow scaffold expansion

19. Next Generation BRS Thinner struts (overlap/2 scaffolds)
More overexpansion? (Tapering at side branch!)
Reduce scaffold thrombosis
Easier lesion crossing

20. Bioresorbable Scaffolds in Development
REVA ReZolve
ART18Z
Abbott Absorb BVS 1.1
Amaranth
Fortitude1
ELIXIR DESolve
Biotronik Magmaris
REVA Fantom
Boston
Scientific
RENUVIA
Amaranth Aptitude1
ELIXIR DESolve Cx3
ABSORB
2nd Gen
PolyCarb
PDLLA
PLLA
Mg, PLLA
SES
None
EES
MES
NES
1st Generation BRS
2nd Generation BRS
Scaffold
Drug

21. New Generation BRS: Will They Overcome Current Limitations of BRS Technology?
New generation BRS should overcome current limitations of first generation BRS
It is imperative to adhere to appropiate patients and lesionS selection to avoid BRS complications.
Once BRS overcome these limitations we should consider expanded indications
The future depends on demonstrating superiority over best in class DES in a head to head comparison in prospective randomized trials

22. Thank You for Your Attention