BVS Expand: Single Center Registry

BVS-STEMI-First •  Sept 2012: BVS in real world patients, excl STEMI

Disease Severity Sym

ptom

Sev

erity

Syntax Trial

DES Vs Surgery Courage Trial

Stents Vs Meds

Absorb A Absorb B

Absorb Extend Absorb II

Absorb III/IV

BVS Expand

BVS STEMI

•  Dec 15th 2012: BVS in STEMI, Apposition by OCT

0

50

100

150

200

250

300

350

Total

STEMI

Expand

330

236

94

Enrollment curves of the ABSORB Expand and ABSORB STEMI-FIRST studies

In the same period, 2152 PCI were performed. (15.3%) >600

Scaffolds

375

256

119

1-4-14

Till Oct 2013 All (N=200, L=275) MVD 77 (38.5%) Bif, SB >1.5 80 / 275 (29.1%) Total Occlusion 33 / 275 (12.0%) CTO 16 / 275 (5.8) B2 or higher 113(41.1%)

Calcification 126/ 275 (45.8%)

Lesion Length 25.41 ± 13.52 mm

Range 5.32, 80.01 mm

Overlap 88 / 275 (32.0%) Total scaffolds 390 Scaffolds per procedure

1.95

Failure to deliver 7 (3.7%) Device succes 269 / 274 (98.2)

Patient and Procedural characteristics

Procedural characteristics Procedural characteristics (SB > 2.0 mm) Bifurcation lesions (L=54)LAD 38 (70,4%)Involvement of both SB and MV (Medina 111, 101, 011) 15 (27.8%)1 Scaffold Technique 51 (94.4%)T-stenting 1 (1.8%)Culotte 1 (1.8%)TAP 1 (1.8%)MV pre-dilatation 44 (81.4%)MV post-dilatation 26 (44.4%)SB pre-dilatation 6 (11.1%)SB dilatation post MV Scaffolding 18 (33.3%)Kissing balloon 3 (5.6%)Proximal optimization technique 26 (44.4%)Final MV TIMI flow <3 1 (1.8%)Side-branch Timi flow <3 3 (5.6%)Failure to rewire the SB 0 (0%)Failure to dilate SB 1 (1.8%)Composite of “side branch trouble” 5 (9.3%)

JMRL/KW 4231633

CLS 3.5 Pilot 50. Ryujin 1.25x10 Miracle3

Two scaffolds for bifurcation

Final result

*

#

$

BVS Absorb™ 2,5 x 18mm*

BVS Absorb™ 3,0 x 28mm#

BVS Absorb™ 2,5 x 18mm$

A B C D

a b c d

distal Proximal

OCT final LCX

St. Jude Medical C7™ Dragonfly™

LCX

MO

MO

JMRL/KW 4231633

BVS Absorb in CTO and bifurcation: Culotte technique

OCT Final LCX

Intage Realia™ Cybernet systems™, Japan Flythrough Carina with MO

JMRL/KW 4231633

BVS Absorb in CTO and bifurcation: Culotte technique

ACS-LR at 142 days: Edge restenosis

Incomplete lesion coverage. A. Note a proximal edge dissection (white arrow). C. Angiogram at event shows a contrast deficit at the proximal edge of the scaffold, extending within the scaffold. OCT shows the presence of occlusive edge restenosis (D) and restenosis within the scaffold with layered pattern (E), without luminal thrombus. 2653265 7-5-2013

Treated with DES

Late TLR/ST: Restenosis

Figure 5. Late BVS thrombosis 112 days post-implantation and malapposition Implantation of a 3.5x28mm BVS in an ostial LAD lesion (A), with suspected underexpansion by angiography (B). C. Angiogram at event after thrombus aspiration. OCT reveals sites with malapposed struts with thrombus (D; arrows) and occlusive restenosis with underexpansion (minimal scaffold diameter:2.71mm) (E). 0100219 25-jan-2013

Treated with Promus

Day 288: restenosis DES -> CABG

Acute ST after pPCI

Figure 2. Acute thrombosis 2 hours after BVS implantation due to incomplete lesion coverage. A. Pre procedural and B. post-procedural angiogram at baseline. Note the mild haziness at the proximal edge post-procedure (arrow). C. Angiogram at event after thrombus aspiration. Presence of red and white thrombus at the proximal segment of the scaffold (D) and at the proximal edge segment (E) extending beyond 5mm. The thrombus is overlying a thin cap fibroatheroma, with possible rupture (arrow). Histology of thrombus aspirates (F-G) demonstrates platelet-rich thrombus. 8433321??

Treated with BVS

BVS: Restoration of Pulsatility in the Porcine Coronary Model

Target lesion failure in EMC registries  BVS-EXPAND and STEMI > 443 patients: 17 TLR

Acute <24 hours

Subacute <30 days

Late <6 months

Late: >6 months

DAPT interruption

POBA + IIbIIIa

Underexpantion POBA BVS/DES Undersizing/ malapposition

• POBA, max 0.5 mm >Nominal • BMS/DES > 4 mm

?? BVS/DES

Geographical miss

Dissection: BVS bailout

Edge restenosis: BVS/DES

Neointima hyperplasia

-- DEB DES

Strut fracture • POBA, max 0.5 mm >Nominal • BMS/DES > 4 mm

DES DES

BVS failure treatment.

 Depending on mechanism.

 Multiple factors frequently present.

  Invasive imaging recommendend

 POBA, BMS, BVS, DES possible