Session 5 Below the knee arteries & limb salvage Present & future of below the knee stenting M. Bosiers K. Deloose P. Peeters 1
PRESENT Clinical perspective whom to treat CRITICAL LIMB ISCHEMIA (CLI) 0 No complaints = INDICATOR BTK-INTERVENTION 1 Claudicant >250m 2 Claudicant 100-250m 3 Claudicant <100m 4 Rest pain 5 Non-healing wounds 6 Gangre 2
Endovascular strategy Treating angiographic images = Treating patients complaints Restoring outflow 1 artery straight-line flow to foot = PRIMARY GOAL OF ANY TREATMENT EXC : Diabetics poor collateralisation PRE POST 3
Vessel selection Single spot lesions A rare example Pre-op Post-op op 4
Vessel selection Occlusion all 3 BTK vessels Which vessel to treat? Pre-op Pre-op (distal) Post-op op 5
Vessel selection Occlusion at distal popliteal: which vessel to treat? Pre-op Pre-op Post-op op Post-op op 6
BTK lesions Device selection Short focal lesion PTA BTK for CLI-patients 7
Short focal lesion PTA first Tandem lesion on Anterior Tibial Artery Pre Post Pre-op Post dilation Passeo 3.0x40 8
Short focal lesion PTA first Short occlusion distal ATA Pre-op 9
Short focal lesion PTA first Short occlusion distal ATA Pre-op Wire passage Stabilizer+ Cordis 0.014 Dilation Ultrasoft SV BSCI 2x30 Post-op op 10
Short focal lesion PTA first Short occlusion distal ATA day 6 day 45 day 75 day 15 day 60 11
Short focal lesion PTA first Suboptimal PTA outcome Flow limiting dissection Residual stenosis BAIL-OUT STENTING Balloon-expandable Bare Passive coating Active coating Self-expanding Nitinol Pre-op Dissection Stented 12
Short focal lesion PTA first Suboptimal PTA outcome 13 How How to to select the best select the best rescue rescue tools tools
BTK lesions Device selection Short focal lesion Calcified/Ostial Bail-out stenting with balloon-exp stent PTA BTK for CLI-patients 14
Short focal lesion Bail-out stenting : CALCIFIED Bare metal: Chromis Deep (Invatec) PTA Pre Pre--op op Bail-out stenting Chromis 3.5x76 Suboptimal PTA Final 15
Short focal lesion Bail-out stenting : OSTIAL Bare metal: Multilink Vision (Abbott) Pre-op Suboptimal outcome after kissing balloon Final outcome after kissing stent 16
Short focal lesion Balloon-expandable stents Bare metal: Multilink Vision (Abbott) Own experience: 12M duplex Feb - Oct 2005 50 CLI patients Rutherford 4 68% Rutherford 5 32% 62 BTK-lesions 68 Vision stents Endpoint 12-month duplex patency Lesion before direct stenting Multi-link Vision placed 17
Short focal lesion Balloon-expandable stents Bare metal: Multilink Vision (Abbott) Tibiofibular trunc 18 (29.0%) Peroneal artery 16 (25.8%) Posterior tibial artery 16 (25.8%) Popliteal artery (P3) 2 (3.2%) Anterior tibial artery 10 (16.2%) Pre-op stenosis (%) 92.7 Lesion length (mm) 21.1 Reference Ø (mm) 3.1 18
Short focal lesion Balloon-expandable stents Bare metal: Multilink Vision (Abbott) 1-year clinical outcome 81.0% 62.8% 91.5% 89.3% 19
Short focal lesion Balloon-expandable stents Dedicated CoCr stent: Chromis Deep (Invatec) Primary stenting Chromis In combination with Amphirion Deep Balloon March-November 2007 50 CLI patients (Rutherford 4-5) 58 stents Reference diameter Lesion length Diameter stenosis N of occlusions 3.1mm 52.2mm 90.6% 10 Pre-op Final Primary endpoint: 6-months duplex-based patency Secondary endpoint: 6-months limb salvage & survival rate 20
Short focal lesion Balloon-expandable stents Dedicated CoCr stent: Chromis Deep (Invatec) 6-MONTHS OUTCOME 6M PP 68.3% 6M LS 91.5% 21
Short focal lesion Balloon-expandable stents Precise placement Ostial lesions High radial force Calcified vessels Good visibility BUT THEY MIGHT BREAK 22
BTK lesions Device selection Short focal lesion Calcified/Ostial PTA BTK for CLI-patients Bail-out stenting with balloon-exp stent Bail-out stenting with self-exp stent 23
Short focal lesion Self-expanding stents Nitinol: Xpert (Abbott) Maris Deep (Invatec) Astron Pulsar (Biotronik) Advantages Crush resistancy High flexibility Optimized radial force 24
Short focal lesion Self-expanding stents Nitinol: Xpert (Abbott) Dedicated design for small vessels Do not place a large vessel stent in smaller diameters! Metal overload + Impaired flow dynamics 25
Short focal lesion Self-expanding stents Nitinol: Xpert (Abbott) Own experience May 2005 Dec 2005 Infrapopliteal lesions 47 CLI patients (Ruth 4-5) 51 limbs - 58 lesions - 67 stents Mean lesion length = 32.4 mm 53.4% occlusions Primary endpoint: 1-year angiographic patency Absence of >50% stenosis on QVA TTF 10 (17%) FA 13 (22%) PTA 11 (19%) P3 7 (12%) ATA 17 (29%) Bosiers et al. J Cardvasc Surg 2007 Aug;48(4):455-61. 26
Short focal lesion Self-expanding stents Nitinol: Xpert (Abbott) Primary patency rate (%) 100 100 80 90 60 80 40 70 20 = Angiographic control 12M PP Limb Salvage Rate (%) 100 100 80 90 76.3% 12M LS 76.3% 60 80 40 70 20 95.9% 600 0 90 180 270 360 Time (days) Number 50 at risk 050 60 23 120 180 13 240 1 300 360 1 600 0 90 180 270 360 Time (days) Number 50 at risk 50 0 60 26 120 15 180 240 1 300 1360 Bosiers et al. J Cardvasc Surg 2007 Aug;48(4):455-61. 27
Short focal lesion Self-expanding stents Nitinol: Xpert (Abbott) Own experience (extension) May 2005 Nov 2007 Infrapopliteal lesions 94 CLI patients (Ruth 4-5) 102 limbs - 111 lesions - 134 stents Mean lesion length = 33.2 mm 33.4% occlusions TTF 26 (23%) FA 20 (18%) PTA 17 (15%) P3 12 (11%) ATA 36 (32%) Endpoints 2-year duplex-derived patency & limb salvage Bosiers et al. Vascular 2008 submitted. 28
Short focal lesion Self-expanding stents Nitinol: Xpert (Abbott) 24M PP 54.4% 24M LS 90.8% Bosiers et al. Vascular 2008 submitted. 29
BTK lesions Device selection BTK for CLI-patients Short focal lesion Calcified/Ostial Bail-out stenting with balloon-exp stent PTA Bail-out stenting with self-exp stent Long diffuse lesion PTA with long low-pressure balloons Focal stenting if residual flow-limiting lesion 30
Long diffuse lesion PTA first Long diffused lesion of Posterior Tibial Artery Baseline wound status Pre-op 31
Long diffuse lesion PTA first Long diffused lesion of Posterior Tibial Artery Pre-op Dilation Passeo 2.5x120 Post-op op 32
Long diffuse lesion PTA first Dedicated wound care Wound evolution 3-months post- intervention 6-months post- intervention 33
Long diffuse lesion PTA first Distal lesion on Posterior Tibial Artery Pre-op Wound status at baseline 34
Long diffuse lesion PTA first Distal lesion on Posterior Tibial Artery Pre-op Dilation Fox SV 2.0x80 Post-op op Post-op op Post-op op 35
Long diffuse lesion PTA first Distal lesion on Posterior Tibial Artery Wound evolution 3-months post- intervention 6-months post- intervention 36
Long diffuse lesion PTA and bail-out focal stenting Long occlusion Anterior Tibial Artery Pre-op Dilation ATA Fox SV 2.5x120 (2 times) Resulting in distal flow limiting dissection 37
Long diffuse lesion PTA and bail-out focal stenting Long occlusion Anterior Tibial Artery Final flow Stenting dissected area Astron Pulsar (4.0x60) 38
FUTURE Drug eluting stents? 39
FUTURE Ongoing multicenter CRTs Achilles (Cordis XXS (Abbott Vascular) XXS Cordis) PTA vs sirolimus eluting stent PTA vs nitinol stent Destiny (Abbott Vascular) Destiny BMS vs everolimus eluting stent PADI (Boston Scientific) PADI PTA vs paclitaxel eluting stent 40
Conclusion Endovascular strategy PTA is first approach Stenting after suboptimal PTA improves outcomes Dedicated BTK stents should be used For short focal lesions, current single center studies indicate that primary BTK stenting can be a viable option, but ongoing randomized controlled trials will give the final answer 41