Bifurcation stenting with BVS

Maciej Lesiak Department of Cardiology

University Hospital in Poznan, Poland

Breaking the limits or just breaking the struts?

Disclosure

Speaker’s name: Maciej Lesiak

I have the following potential conflicts of interest to this

presentation:

Research contracts

Consulting: Abbott Vascular

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

Background

• BVS is a promising technology (vessel reparative therapy)

• Scaffolds have not been tested in bifurcation lesions so far

• Is coronary artery bifurcation an important limitation in the use of BVS?

2.0 mm balloon 8 ATM

Strut crossing

2.5 mm balloon 8 ATM

BVS 3.0x18 mm, test in the air

connector

The importance of the crossing point location

Kissing with two NC balloons 3.0 & 2.5 @ 8 ATM

Test in the air

3.0

2.5

BVS 3.0 x 18 mm

3.88 mm

Kissing with two NC balloons (3.0 & 2.5 mm) @ 8 ATM

BVS 3.0x18 mm Silicone tube, lumen 3.0 mm

No ruptured links

3.0

NC 2.5

BVS 3.0 x 18 mm NC 3.0 BVS 3.0 x 18 mm

3.52 mm

Poznan Bifurcation BVS Registry

• Consecutive bifurcation cases treated with BVS

• Informed consent

• Any indication to PCI (stable or ACS)

• Any Medina type

• No excessive calcium & tortuosity

Inclusion / exclusion criteria

Prospective, single-centre clinical registry

Baseline characteristics N = 43

Age (years) 62± 11

Male gender 33 (77%)

Diabetes mellitus 14 (32.6%)

Hypertension 33 (76.7%)

Smoking 20 (46.5%)

Previous MI 22 (52.4%)

LV Ejection Fraction (%) 51 ± 11

Previous revascularization 24 (55,8%)

Peripheral vascular disease 4 (9.3%)

Chronic Kidney Disease (eGFR<60) 6 (14.0%)

Indication for PCI

Stable angina 33 (76.7%)

Unstable angina / NSTEMI 7 (16.5%)

STEMI 3 (7.0%)

Total population

Vessel / Lesion characteristics N = 43

Bifurcation location

LM/LAD, LM/LCx 7 (16.3%)

LAD/DIA 25 (58.1%)

LCX/OM 9 (20.9%)

RCA (PL/PDA) 2 (4.7%)

True bifurcation lesion: 1,1,1 / 1,0,1 / 0,1,1 20 (46.5%)

Ostial SB only (0,0,1) 8 (18.6%)

Type B2+C 36 (83.7%)

Calcification (moderate/heavy) 10 (27%)

Thrombus (angio) 4 (9.3%)

CTO 7 (16.3%)

Vessel / lesion

Procedure characteristics N = 43

Radial approach 30 (70%)

6 F Guiding catheter 43 (100%)

Simple technique (one stent) 37 (86%)

Provisional T stenting 30 (70%)

Systematic T stenting 4 (9%)

TAP technique 1 (3%)

SB ostial stenting 8 (19%)

Pre dilatation 42(98%)

Strut opening 13 (35%)

Final Kissing / snuggle 13 (30%)

FK MB balloon diameter 3.0 ± 0.2 mm

FK SB balloon diameter 2.4 ± 0.2 mm

Results

Vessel / Lesion characteristics N = 43

Main Vessel

Reference vessel diameter prox. 3.2 ± 0.7 mm

Reference vessel diameter dist. 2.7 ± 1.0 mm

Lesion length (mm) 11.8 ± 8.8 mm

Diameter stenosis (%) 72 ± 27 %

Side Branch

Reference vessel diameter 2.4 ± 0.5 mm

Lesion length 5.1 ± 5.4 mm

Diameter stenosis 39.6 ± 31.4 %

Angles

Proximal bifurcation angle (angle A) 140 ± 40 degrees

Distal bifurcation angle (angle B) 54± 30 degrees

Bifurcation angle < 50 degrees 26 (60.5%)

Results

Procedure characteristics N = 43

MB Stent diameter 3.1 ± 0.2 mm

MB Stent length 21 ± 4.6 mm

SB Stent diameter 2.8 ± 0.4 mm

SB Stent length 21 ± 4.4 mm

Additional stenting

MB / SB 3 / 0

Scaffold/procedure success 43 / 42*

Fluoroscopy time 10.9 ± 6.7 min

Contrast use 145 ± 57 ml

IVUS / OCT 13 (30%)

Results

*One case of SB dissection during wire re-cross, slow flow, CKMB

In hospital Discharge-30 days

Death 0 1 (fatal stroke)

Cardiac death 0 0

Myocardial infarction 2 0

Q MI 0 0

Non-Q MI 2* 0

Stroke 0 1

Stent thrombosis (any as of ARC) 0 0

Target vessel failure 0 0

Clinical outcomes

*One case of SB dissection during wire re-cross, slow flow, CKMB

One case of septal branch closure with CKMB

n=43 Discharge – end of FU

All cause death 1

Cardiac death 0

Myocardial infarction 0

Target lesion revascularization 0

Target vessel revascularization 0

Stent thrombosis (any as of ARC) 0

Target vessel failure 0

Follow-up

Median observation time 134 days (3 – 366)

Mean observation time 140 ± 98 days

Baseline characteristics and angiography

49YO man, stable angina class 3. Anterior MI & PCI of LAD in 2013

6 F Guide, femoral approach

Target vessel

Wired vessel

Pre-dilatation, NC 2.5x15 mm 12 ATM BVS 2.5x18 mm, 16 ATM

After BVS implantation

Proximal BVS implant.

3.0x18, 16 ATM

Kissing (snuggle) @ 8 ATM SB 2.5x15

mm / MB 2.75x15

Final result

OCT

SB ostium

OCT

OCT

Baseline characteristics and angiography

60 YO woman, stable angina class 2

6 F Guide, femoral approach

Target vessel

Direct BVS 3.0x18 mm, 16 ATM After implantation

POT, NC 3.25x12 mm 18 ATM

Rewiring distal strut

Strut crossing NC 2.5x12, 10 ATM

SB wire

BVS 2.5x18 through BVS 3.0 struts

SB BVS positioning

TAP

BVS TAP

SB BVS position Implantation:

SB BVS 2.5x18 mm, 14 ATM

BVS implantation

MB balloon 3.25x12 inflation, 4 ATM Kissing: SB BVS 2.5x18 mm, 8

ATM / MB 3.25x12, 8 ATM

IInd POT: NC 3.25x12 mm, 18 ATM

Final result

Final result

OCT

Pullback from diagonal branch Pullback from LAD

OCT

Pullback from diagonal branch Pullback from LAD

DIA LAD

Neo-carina

LAD

Breaking the limits or breaking

the struts?