EBC London 2013 Provisional SB stenting strategy with kissing balloon with Absorb

Transcription

1 EBC London 2013 Provisional SB stenting strategy with kissing balloon with Absorb A. Medina Servicio de Cardiología Hospital Universitario de Gran Canaria Dr. Negrín Islas Canarias (Spain)

2 Provisional stenting has been proved to be the treatment of choice in most bifurcated coronary lesions. BVS: concern about the scaffold integrity with balloon intervention (balloon diameter mm). Our own in vitro test shows integrity of BVS (1 or 2 balloon and low pressure inflation).

3 Provisional BVS implantation Lesion located in a major bifurcation point MB 2.5 mm in diameter SB 2.25 mm in diameter SB lesion length < 10 mm 99 bifurcated coronary lesions SBA + B0 B0 B1 B2 B3 n = 12 n = 41 n = 10 n = 29 n = 1 Kissing Balloon 26 DES in the SB Two stent (elective inverted T) SMS 3 n = 6

4 B2 BVS + KB KISSING BALLOON (8 atm) 3.5 x 28 mm BVS (16 atm) FGBody temperature Facilitates SB access? 1 2 S I D E 2.5 x 15 mm (8 atm) M A I N B R A N C H F I R S T n = 8 BVS 3.5 mm (3 & 2.5 mm) Mild waist in second balloon V E S S E L F I R S T Optimal geometry of MV scaffolding 3.5 x 28 mm BVS after KB (3-2.5) 3 x 25 mm (8 atm) Mild waist in second balloon n = 5 BVS 3 mm (2.5 & 2.5 mm)

5 A paradox : Kissing balloon Larger maximum diameter and less crown stretching 3.5 mm BVS overexpanded Eccentric Concentric crown link ondulated non ondulated Kissing Oversizing 3 mm 5.5 mm 4.5 mm 4.5 mm BVS integrity 2.5 mm BVS fracture Area mm 2 Area mm 2

6 Predilation (direct BVS failed) #39# {1,1,1} 3.5 x 18 mm BVS SB 1 st MV 1 st 1 2 MV 2 nd SB 2 nd LAD 3 mm Dg 2.5 mm (8 atm) After KB inflation

7 BASELINE Dg Measurements taken before SB origin LAD MLA 3.42 mm 2 AFTER BVS BVS 3.5 mm 14 atm Dg LAD CORONARY VESSEL WALL CONTROLS EXPANSION OF BVS BVS 3.5 mm 14 atm CSA 8.75 mm 2 KB 3 & 2.5 mm 8 atm Dg CSA 9.64 mm mm 2 Area < recommended limit wire LAD KB 3 & 2.5 mm 8 atm 3.5 mm BVS: 100% expansion = 9.6 mm 2 4 mm balloon = mm 2 AFTER BVS

8 BVS & Kissing A) Balloons selection: - MB balloon 0.5 mm less than BVS diameter - SB balloon 2.5 mm BVS diameter MB balloon SB balloon 3.5 mm 3 mm 2.5 mm 3 mm 2.5 mm 2.5 mm B) Balloons inflation pressure 8 atm

9 Clinical data n=26 Age, years 59 ± 12 Male gender 22 (85) Hypertension 12 (48) Diabetes mellitus 6 (23) Hypercholesterolemia 12 (48) Current smoking 15 (60) Unstable 22 (85) Multivessel disease 8 (30) Baseline angiographic data n=26 Location of the lesion, n (%) LAD-Dg LCx-Cx RCA Type of lesion, n (%) {1,1,1} {1,1,0} {1,0,1} {0,1,1} {1,0,0} {0,1,0} {0,0,1} 17 (65) 6 (23) 3 (12) 11 (42) 6 (23) 0 (0) 5 (19) 2 (8) 2 (8) 0 (0) QCA Main vessel Side branch Lesion length, mm 21.9 ± ± 2.1 {_,_,1} 16 (61%) Left ventricular EF 63 ± 13 Data are expresed as n (%) Prox. reference diameter 2.97 ± 0.37 Distal reference diameter 2.53 ± ± 0.3 MLD, mm 1.13 ± ± 0.41 DS,% 62 ± ± 16 *BVS diameter was selected according to proximal vessel diameter

10 Baseline QCU (n =26) Baseline Dg Proximal Before SB origin After SB origin Distal MLA LAD 8,74 mm 2 2,14 mm 2 2,47 mm 2 3,96 mm 2 Main branch SB Proximal Before SB origin MLA After SB origin Distal Ostium EEL, mm ± ± ± ± ± ± 2.8 Mean diameter,mm 3.20 ± ± Lumen area, mm ± ± ± ± ± ± 1.8 Plaque area, mm ± ± ± ± ± ± 1.1 Plaque burden, % 44 ± ± ± ± ± ± 15 MLA location, n 4 (16%) 3 (12%) (46%) 2 (8%) 5 (25%) Eccentric (MLA), n (40%) *BVS diameter was selected according to proximal main branch diameter

11 After BVS implantation Area 4.67 mm2 MeanD 2.43 mm Min 2.20 Max 2.68 Area 5.23 mm2 MeanD 2.57 mm Min 2.39 Max 2.93 After SB origin Before SB origin LAD D Dg P After Kissing Δ 1.29 mm 2 Area 4.55 mm2 MeanD 2.40 mm Min 2.15 Max 2.63 Area 6.52 mm2 MeanD 2.87 mm Min 2.60 Max 3.18 LAD D Dg P

12 Procedural data BVS 2.5 mm n= 4 BVS 3 mm n= 9 BVS 3.5 mm n= 13 KB n = 26 KB n = 26 IVUS guidance, n 26 (100%) Direct BVS implantation, n 16 (62%) MB predilation after failure, n 6 (23%) Elective MB predilation, n 4 (15%) MB balloon diameter, mm 2.44 ± 0.16 MB balloon length, mm 17.7 ± 2.6 MB balloon pressure, atm 8.4 ± 2 BVS diameter, mm 3.16 ± 0.37 BVS length, mm 24 ± 8 BVS inflation pressure, atm 15.9 ± 1.9 BVS inflation time, s 72 ± 16 KISSING BALLOON DATA MB balloon diameter, mm 2.76 ± 0.30 MB balloon length, mm 16.6 ± 2.9 MB balloon pressure, atm 7.6 ± 0.9 SB balloon diameter, mm 2.39 ± 0.25 SB balloon length, mm 16 ± 3 SB balloon pressure, atm 7.7 ± 1.2

13 Changes in BVS geometry after kissing balloon Dg LAD LAD Before KB After KB p PROXIMAL BVS SEGMENT Area, mm ± ± BEFORE SB ORIGIN Area, mm 2 SI 6.70 ± ± ns AFTER SB ORIGIN Area, mm ± 1.76 SI ± ns DISTAL BVS SEGMENT Area, mm ± ± SI (BVS symmetry index) Nominal BVS expansion Maximum tolerated expansion 3 mm Ø = 7.1 mm 2 (3.5 mm Ø = 9.6 mm 2 ) 3.5 mm Ø = 9.6 mm 2 (4 mm Ø = mm 2 )

14 Major adverse cardiac events and follow-up results (KB) Primary success (one patient needed SB stenting) 100% IN HOSPITAL KB n=26 Non-Q-wave MI 1 (4%)* Death 0 Sub-acute BVS thrombosis (PAMI) 1 (4%) FOLLOW-UP (7 ± 3 months) Recurrent infarction 0 Death (all causes) 0 Need of TLR 0 BVS thrombosis 0 Total MACE 2 (8%) * troponin elevation within 48 h post-procedure of 5 ULN with either symptoms of myocardial ischemia, new ischemic ECG changes, or documented complications during the procedure Angio-CT was performed at follow-up (n = 25). No restenosis

15 T stenting after kissing: BVS (MB) & DES (SB) #97# {0,1,1} DES BVS 3 x 18 mm BVS KB inflation 2.25 x 18 mm DES

16 Conclusions Kissing balloon for bifurcated coronary lesions treated with BVS seems to be safe and feasible Kissing balloons inflation ( 8 atm) Kissing balloons selection - MB 0.5 mm less than BVS diameter - SB 2.5 mm Mid-term clinical & angio CT follow up encouraging. IVUS or OCT guidance should be used more frequently than with metallic stent. 2-3 YEARS FOLLOW-UP WILL PROVIDE A MORE DEFINITIVE ANSWER