1. BVS Expand: First Results of Wide Clinical Applications
Robert-Jan van Geuns, MD, PhD
Associate Professor, Thoraxcenter,
Erasmus Medical Center,
Rotterdam, the Netherlands

2. Robert-Jan J.M. Van Geuns, MD, PhD
Study Supported By: Abbott Vascular

3. 5 years of Bioresorbable scaffolds
60 months
6 months
Baseline
Absorb A
Absorb B
Absorb Extend
Absorb II
Absorb III/IV
BVS Expand
Syntax Trial
DES Vs Surgery
Symptom Severity
Courage Trial
Stents Vs Meds
BVS
5 Yr
Disease Severity

4. BVS Expand: Single Center Registry
Larger diameter up to 4.0 mm
Longer length: > 32 mm
Bifurcations
Calcified lesions
ACS patients (non-STEMI)
No previous CABG or metallic stent in target vessel
Target: 300 patients
Start Sept 1st
Absorb A
Absorb B
Absorb Extend
Absorb II
Absorb III/IV
BVS Expand
Syntax Trial
DES Vs Surgery
Symptom Severity
Courage Trial
Stents Vs Meds
BVS
5 Yr
Disease Severity

5. BVS Expand: Single Center Registry
Larger diameter up to 4.0 mm (3.3 for A and 3.5 for B)
Longer length: > 32 mm
Bifurcations
Calcified lesions
ACS patients (non-STEMI)
No previous CABG or metallic stent in target vessel
Target: 300 patients
Start Sept 1st
Dec 15th
BVS-STEMI-First
Single center registry BVS in STEMI
OCT at baseline for apposition

6. BVS Expand: Single Center Registry
Objective
This monocenter, prospective, observational post market registration will evaluate the long term safety and performance of the BVS coronary stent, in routine clinical practice. Its objective is to measure the incidence of Major Adverse Cardiac Events (MACE) patients with NSTEMI, stable or unstable angina, or silent ischemia

7. Primary Endpoint
Major Adverse Cardiac Events (MACE): defined as cardiac death, re-MI, emergent bypass surgery (CABG), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 12 months post-procedure

8. Secondary Endpoints Success Rates:
Device Success: Attainment of <30% final residual stenosis of the segment of the culprit lesion covered by the BVS, by visual estimation
Procedure Success: Device success and no peri-procedural complications
Clinical success: Procedural success and no in-hospital MACE

9. BVS Expand + BVS-STEMI-First

10. Baseline characteristics
BVS-Expand
BVS-STEMI-First
All N
104 23
127
Male
75 (72%)
20 (87%)
93 (73%)
Hypertension
60 (58%)
11 (48%)
70 (50%)
Hypercholestorolemia
46 (44%)
9 (39%)
53 (42%)
Diabetes
21 (20%)
2 (9%)
22 (17%)
Smoking
55 (53%)
12 (52%)
66 (52%)
Family
41 (39%)
6 (26%)
45 (35%)
Renal failure
7 (7%)
1 (4%)
8 (6%)
Prior MI
15 (14%)
3 (13%)
17 (13%)
Prior PCI
6 (6%)
Prior CABG
1 (1%)
0 (0%)
Prior CVA
10 (10%)
9 (7%)
PAD
12 (12%)
12 (9%)
COPD
8 (8%)

11. Indications (All patients)
47% 1%
30%
22%
18%
32%
37%
13%

12. Procedural characteristics
Implantation instruction
Use online QCA
Avoid under sizing, as postdilation is limited to 0.5 mm
Proper lesion preparation = sufficient large balloon (min 2.5 mm)
Use more supportive wires
Direct stenting possible in ACS
All (N=127)
MVD
33 (26%)
Bif
26 (21%)
CTO
8 (6%)
STEMI
23 (18%)
Overlap
35 (28%)
Total scaffolds
218
Scaffolds per procedure
1.7
Failure to deliver
7 (5.5%)
Device succes
94.5%
Days since procedure
68 ± 47
Failure to deliver:
LCX:4; LAD: 1; RCA: 2
No adverse events reported.

13. Case 4: Calcified lesion (56%!)
74 year old male, 2002 PAF, Hypertension, instable angina.
Flecanaide, Furosemide, Barnidipine, Enalapril/HCT, ASA, Clopidogrel, Statin,
Calcification +
MLA 3,15 mm2 B
MLA 8,05 mm2
MLA 1,77 mm2 B b
distal b
Fem: JR 4.0, Pilot 50-Whisper ES,
Trek 3.0 x 20,
BVS 3.5 x 28
IVUS
: film Aug 2012:RG

14. Angiographic outcome Courtesy Roberto Diletti
Lesion Length: Cohort B: 9.9 mm
Extend: mm
N =36
Calcified (N=16)
Non-Calcified (N =20)
Lesion Length
21.33 ± mm
19.26 ± mm
P=0.318 RD
3.09 ± 2.55 mm
2.50 ± 0.65 mm
p=0.740
Mean Diameter
1.81 ± 0.34 mm
1.90 ± 0.56 mm
p=0.446
MLD
0.87 ± 0.39 mm
1.09 ± 0.39 mm
p=0.058
MD post
2.86 ± 0.33 mm
2.75 ± 0.46 mm
p=0.626
MLD post
2.42 ± 0.36 mm
2.36 ± 0.47 mm
Acute gain
1.59 ± 0.46 mm
1.28 ± 0.42mm
p=0.077
Acute recoil
0.16 ± 0.33 mm
0.23 ± 0.21 mm
p=0.682
Relative acute recoil
4 ± 12 %
8 ± 6%
p=0.520
Conclusion
The implantation of second generation BVS was associated with similar absolute and relative acute recoil in calcified and non-calcified coronary lesions.

15. Case 24: Bifurcation 71 year old male, Stable Angina. MVD
BVS Absorb® scaffold 3,0 x 18 mm
pre-dilatation: Abbott Trek® 2,5 x 20 mm
BVS Absorb® scaffold 3,5 x 18 mm
Pre-procedure
Film : 1-Nov-2012: RG

16. Case 24: Bifurcation Angiogram Pinched side branch Hazyness
Opening struts: Abbott Trek® 2,5 x 12 mm
POT: Trek 3.5 x 15 NC
distal
Result distal scaffold
Final result
Courtesy Jurgen Ligthart
Film : 1-Nov-2012: RG

17. Bifurcations N = 24 Sidebranches >2 mm 24 (19%)
Sidebranches treated 7
Balloon only 6
2 scaffolds (Culotte) 1

18. Case 38: ACS 56 year old male, Chest pain, AMI
CLS Catheter; Pilot 50: no success
Miracle 3 + Trek OTW 1.5 mm - Trek: 2.0
Film : RG

19. Case 38 56 year old male, Chest pain, AMI
CLS Catheter; Pilot 50: no success
Miracle 3 + Trek OTW 1.5 mm - Trek: 2.0
Film : RG

20. Case 38 56 year old male, Chest pain, AMI MLA = 7.3 mm2 BVS: 3.0 x 18
Film : RG

21. Summary
First real world experience in >120 complex procedures very positive following a strict implantation protocol
No adverse events for these cases were reported
Procedural and angiographic outcome are exciting and inline with previous data.
Deliveribility:
Flexibilty
Crossing profile/Strut thickness
Longer procedural time, more supportive wires, more predilatation.