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Endovascular therapy - device based review
 

Endovascular therapy - device based review

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  • Dox and epi but pinocytosis not as good in epi as per al mufasti
  • Dox and epi but pinocytosis not as good in epi as per al mufasti
  • Dox and epi but pinocytosis not as good in epi as per al mufasti

Endovascular therapy - device based review Endovascular therapy - device based review Presentation Transcript

  • Justin McWilliams, MDDepartment of Interventional Radiology University of California – Los Angeles
  •  Part I – Background  Peripheral arterial occlusive disease  Tried and true: surgery and angioplasty Part II – Device-based review  Nitinol stents  Stent-grafts  Atherectomy devices  Specialized balloons  Crossing devices Part III – What to use, when?  A somewhat evidence-based approach Part IV – A look forward
  • Background
  •  The arteries of the leg are difficult to treat  Frequent chronic total occlusion  Extensive calcification  Dynamic forces with movement  High degree of elastic recoil Few well-studied treatments  Bypass surgery (too invasive!)  Angioplasty (poor durability!) Multiple new minimally-invasive technologies have been introduced, but evidence is scarce  Few RCTs to show superiority to established techniques  No comparative trials between new techniques
  • Primary patency in claudicants 1 0.9 0.8Cumulative patency 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 0 1 2 3 4 5 Years Autologous vein Synthetic graft Angioplasty (stenosis) Angioplasty (occlusion) 1
  • Primary patency in CLI 1 0.9 0.8Cumulative patency 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 0 0 1 2 3 4 5 Years Autologous vein Synthetic graft Angioplasty (stenosis) Angioplasty (occlusion) 1
  •  Stainless steel stents Simpson AtheroCath Auth Rotablator Neodymium:YAG laser
  •  Stainless steel stents  Improved immediate technical success  No benefit in long-term patency Simpson AtheroCath  34% 1-year patency (inferior to PTA)  Ineffective in long or occluded lesions Auth Rotablator  31-61% 1-year patency, 12-19% 2-year patency  Frequent thrombosis, spasm, embolization A wood-burning 1985 Yugo… proving that different is not always better. Neodymium:YAG lasers  Thermal energy led to vessel wall damage  High incidence of thrombosis and spasm 2-7
  •  Stent-grafts Cryoplasty Cutting balloons Drug-eluting balloons
  •  Stainless steel stents Nitinol stents! Simpson AtheroCath Silverhawk! Auth Rotablator Diamondback! Neodymium-YAG laser Cool-tip excimer laser!
  • Nitinol stents
  • Examples of stainless steel stents. Clockwise:Gianturco Z stent; Palmaz; Wallstent. Examples of latest-generation Nitinol stents. Clockwise fromExamples of first-generation Nitinol stents. Top upper left: Conformexx; SMART Control; Lifestent; Protégéto bottom: Intracoil; Symphony; Memotherm. Everflex; Zilver.
  •  More flexible Improved radial strength Ability to recover from crushing Reduced foreshortening
  • First author Year Structure # and type of Lesion Outcome Comments patients characteristicsDuda 2005 RCT 57 claudicants or TASC B-C Favorable. Primary patency 89/80/67/59% at 1/2/3/4(SIROCCO II) (vs. DES) rest pain 8 cm No years. SMART stent. 66% occlusions difference from DES.Krankenberg 2007 RCT 244 claudicants TASC A No Primary patency 68% (stent) vs. 61%(FAST) (vs. PTA) 4.5 cm difference. (PTA) at 1 year. Stent fracture rate 12%. No difference in PTA versus stent for 30% occlusions short stenoses; likely advantage of stent over PTA for short occlusions. Bard Luminexx 3 stent.Schillinger 2007 RCT 104 patients TASC A-B Favorable. Primary patency 63/51% (stent) vs.(Vienna (vs. PTA) 90% claudicants ~10 cm Better 37/26% (PTA) at 1/2 years. BetterABSOLUTE) 35% occlusions than PTA. clinical outcomes for stent group at 6 months, tendency for better outcomes at 2 years. Dynalink or Absolute stent.Katzen 2010 RCT 230 claudicants TASC A-B Favorable. Primary patency 81% (stent) vs. 37%(RESILIENT) (vs. PTA) 7 cm Better (PTA) at 1 year. (80% vs 60%). 1-year 15% occlusions than PTA. clinical success 72 vs. 32%. 3.8% stent fracture rate. 2 year freedom from TLR 78% vs. 42%. Lifestent.Dake (Zilver IP RCT (vs. 479 patients, TASC A-B Favorable. 0.9% fracture rate at 1 year.PTX) PTA and mostly 5.5 cm Better DES) claudicants 30% occlusions than PTA but inferior to DES. 8-13
  • First author Year Structure # and type Lesion Outcome Comments of patients characteristicsLugmayr 2002 Prospective 44 TASC A-B Favorable Primary patency 87/85/76% at 1/2/3 single center claudicants 3.5 cm years. Secondary patency 91/91/87%. registry 41% occlusions Symphony stent.Mewissen 2004 Retrospective 122 patients TASC B-C Favorable Primary patency 76/60% at 1/2 years. ~12 cm SMART stent. 14% occlusionsFerreira 2007 Retrospective 59 patients, TASC C-D Favorable Primary patency 90/78/74/69% at 1/2/3/4 85% 19 cm years. claudicants Zilver stent.Zeller (FACT) 2008 Multicenter 110 patients TASC A-B Favorable Primary patency 77% at 1 year. registry <10 cm Conformexx stent.Dosluoglu 2008 Retrospective 127 patients, TASC C-D Favorable - Primary patency 83/80/74% at 1/2/3 (stent vs. CLI and No years for TASC C. 54/28% at 1/2 years synthetic AK claudicants difference for TASC D. AK bypass 81/75/65% at bypass) from surgical 1/2/3 years. bypass SMART stent.Bosiers 2009 Prospective 151 patients TASC B-C Favorable Primary patency 72% at 1 year. 8%(DURABILITY) multicenter ~10 cm fracture rate. registry 40% occlusions Protégé Everflex stent. 14-19
  • Primary patency of latest generation Nitinol stents 100 90 80Primary patency (%) 70 Mewissen 60 Dosluoglu 50 Duda Ferreira 40 Dake 30 Zeller Katzen 20 Bosiers 10 0 1 2 3 4 Years
  •  The role of primary stenting in the SFA is uncertain Not all stents are created equal  Nitinol better suited to SFA than stainless steel  Different Nitinol stent designs have yielded different results Stent re-stenosis is a significant problem The latest generation of Nitinol stents have shown promising early and mid-term results, even in extensive disease Applications  Bail-out for dissection or suboptimal angioplasty  Possible primary role in moderate-length stenoses and occlusions
  • Stent-grafts
  •  0.035” wire compatible  7F or 8F sheath  5-8 mm diameters ePTFE lining over Nitinol skeleton  Prevents tissue ingrowth  Extremely flexible  Lengthens and foreshortens easily
  • Initial angiogram in a 64-year- A Crosser device was used to A 6 mm x 15 cm Viabahn wasold male claudicant pass through the CTO deployed. Final angiographydemonstrates a 12-cm chronic intraluminally. The lesion was demonstrates excellent flowtotal occlusion of the left SFA. then pre-dilated. with no residual stenosis.
  • First author Year Structure # and type Lesion Outcome Comments of patients characteristicsMcQuade 2010 Prospective 100 limbs, TASC A-D Favorable. Primary patency 72 and 59% at 1 and 4 randomized 72% 25 cm No difference years. Secondary patency 83 and 74%. No difference in ABI or limb salvage. (vs. AK claudicants from surgical synthetic bypass bypass)Saxon 2003 Prospective 28 TASC B-C Favorable. 93% clinical success for Viabahn; 46% randomized claudicants 7 cm Better than for angioplasty. 87% primary patency at (vs. PTA) 10% occlusions PTA 2 years for Viabahn; 23% for PTA.Ansel IP Prospective 148 18 cm No difference Primary patency 53% for Viabahn, 58%(VIBRANT) randomized from stent for Zilver at 1 year. Secondary patency (vs. Zilver 93 vs. 98%. stent) 20-22
  • First author Year Structure # and type Lesion Outcome Comments of patients characteristicsJahnke 2003 Single center 52 TASC B-C Favorable Primary patency 78% at 1 year, 74% at 2 registry claudicants 8.5 cm years. 83% occlusionsFischer 2006 Retrospective 57 10.7 cm Favorable in Primary patency 67/57/45, secondary claudicants 87% occlusions optimal patency 81/80/69% at 1/3/5 years. With conditions optimal conditions (no heavy calcification, no popliteal obstruction, no complete SFA occlusion, minimum 1 vessel distal runoff, adequate antiplatelet therapy), primary patency was 80/71/62% at 1/3/5 years.Saxon 2007 Single center 87 limbs TASC C and D Favorable Primary patency 76% at 1 year, 55% at 4 registry claudicants 14 cm years. Secondary patency 93/79%. and CLI 42% occlusions Patency independent of lesion length, or stenosis vs occlusion. 5 mm devices had worse patency. Clinical success in 88% at mean 28 months.Farraj 2009 Prospective 32 TASC D Favorable Primary patency 80% at 1 year. 3% single center claudicants 15 cm subacute thrombosis; 7% restenosis; registry 10% silent occlusion. 23-26
  • Primary patency of Viabahn endoprosthesis 100 90 80Primary patency (%) 70 Kedora 60 Saxon 2003 50 Jahnke 40 Fischer Saxon 2007 30 Farraj 20 Ansel 10 0 1 2 3 4 5 Years
  •  Patency rates appear independent of lesion length and lesion type in some studies (but VIBRANT suggests otherwise)  Comparable to above-knee synthetic bypass, superior to PTA Flexibility and ability to shorten and lengthen make it well-suited to SFA  No fractures have been reported Covering collaterals may increase risk of limb threat if re- thrombosis occurs (uncertain) Applications  Bail-out for perforation or vessel rupture  Chronic total occlusions  TASC C and D who can’t have surgery  In-stent restenosis
  • Directional atherectomy
  •  0.014” compatible monorail catheter  Multiple sizes for vessels 2-7 mm  6F or 7F sheath Concave shaped carbide cutting blade spins at 8000 rpm  Shaves off plaque as catheter is advanced Long nose cone for plaque collection
  • After wire placement, advance Slowly advance catheter under Deactivate catheter, whichSilverhawk to near edge of lesion fluoroscopy (1-2 mm/sec) until end straightens it and re-sheaths theand activate catheter. The cutting of lesion is reached. Ribbons of cutting blade. Withdraw theblade will be exposed and pressed plaque will be shaved off and stored catheter to the near edge of theagainst the plaque. in the nose cone. lesion, rotate it 90 degrees, and repeat. Empty nose cone as needed.
  • First Year Structure # and type of Lesion Outcome Commentsauthor patients characteristics RamaiahNo prospective randomized trials 2006 Observational 601 patients, 70% ~5 cm Favorable Stand-alone treatment in 73%. Freedom from TLR 80% at 1 year (primary(TALON) multicenter claudicants, above patency not reported). Worse outcomes  Contradictory dataZeller 2004 registry Prospective and below knee 84 patients, above De novo: 4.3 cm Favorable with longer lesions. Stand-alone treatment in 35%, 59% low single center knee. 1/3 each de Restenotic: 10.5 cm pressure PTA, 6% stent. 1-year primary registry novo, restenotic, In-stent: 13.1 cm patency was 84/54/54% for de in-stent restenosis 8% occlusions novo/restenotic/in-stent restenosis. Secondary patency was 100/93/91%.McKinsey 2008 Prospective 275 patients, 63% TASC A-D Favorable Stand-alone in 65%, 24% adjunctive single center CLI, above and ~8 cm PTA, 8% stent. Primary patency 62/46% registry below knee. 39% occlusions at 1/2 years. Secondary patency 80/72%. 88% limb salvage for CLI at 18 months. 1-year primary patency by TASC class: A-71 B-70 C-56 D-54%.Biskup 2008 Retrospective 35 patients, 74% TASC A-D Equivocal 1-year primary patency 68%, secondary CLI, above and 9.4 cm patency 73%. Limb salvage 74% at 6 below knee months.Chung 2008 Retrospective 19 patients, above TASC A-C Unfavorab Primary patency 10% at one year. 74% knee le limb salvage.Keeling 2007 Prospective 60 patients, 67% TASC A-D. Equivocal Stand-alone treatment in 76%. 1-year single center CLI, above knee. 9 cm primary patency 62%, secondary registry patency 76%. Limb salvage 86% at 1 year for CLI. 7% embolization rate. 27-32
  •  Plaque debulking without barotrauma  More effective debulking compared to laser or rotational atherectomy  May reduce recurrent intimal hyperplasia (not proven) Technical success >95% in most series  Learning curve first 15-25 cases  Adjunctive PTA needed in 25-50%  Stent needed in <10% Low reported complication rate with proper use  Similar to other endovascular techniques  But… Use of filterwire with SilverHawk demonstrated plaque embolization in all cases (0.5-10 mm shavings) 33,60
  • Pros Cons • Expensive• Decreases reliance on stents • Limited calcium efficacy • Time-consuming with long• Reduces barotrauma; may occlusions (15-90 minutes) decrease dissection rate and • Not effective in thrombus intimal hyperplasia • Possible embolization risk • Multiple devices if upsizing• Safer treatment of problem required areas (CFA, popliteal, branch points, etc.) • No proof of superiority over established methods
  •  Role in SFA treatment is uncertain  Ability to remove plaque is attractive  Avoids implantable devices  Apparent good results in complex lesions and limb salvage  No RCTs to demonstrate relative effectiveness Possible applications  Branch points (CFA and trifurcation)  In-stent restenosis  Infrapopliteal lesions in CLI  Eccentric SFA/popliteal lesions
  • Laser atherectomy
  •  Turbo-Elite excimer laser  0.9 – 2.5 mm diameters; 4F-8F sheath  “Cold-tipped”  Bursts of 308-nm UV energy ablate plaque and thrombus photochemically  Shallow tissue penetration = less tissue damage Chronic total occlusions can be crossed with step-by-step technique  Converts occlusion to stenosis, possibly making PTA more effective and durable Once the lesion is recanalized, angioplasty is used to enlarge the channel (if needed)  May reduce need for stenting
  •  Laser is “forward-firing”: the lumen created is only slightly larger than the catheter itself  Relatively small volume of plaque ablated  Insufficient to fully recanalize larger vessels (SFA) TURBO-Booster deflects the catheter tip, thereby enlarging the lumen created  Functions as a directional atherectomy catheter  May reduce need for adjunctive angioplasty
  • Diffuse, severe in-stent Following 4 passes of Following adjunctive Doppler ultrasound 6 months later demonstratesrestenosis 1 year after TURBO-Booster excimer cryoplasty, an excellent continued patency. The patient is asymptomatic.placement of a Nitinol laser, the lumen is much angiographic result isSFA stent. The patient improved. Mild stenosis/ achieved.presented with irregularity remains.recurrent claudication.
  • First author Year Structure # and type of Lesion Outcome Comments patients characteristicsVisona 1998 Single center 78 claudicants, 7.2 cm Equivocal 83% adjunctive PTA. 8% early registry above knee 100% occlusions thrombosis. Primary patency 47/40% at 1/2 years. Poor results in longer (>10 cm) lesions and poor run-off.Steinkamp 2002 Single center 312 claudicants, 1-10 cm Favorable 100% adjunctive PTA and/or stent. 4% registry above knee occlusions perforation. Primary patency 75/62/49% at 1/2/3 years.Bosiers 2005 Multicenter 48 CLI, above Unknown; severe Favorable 86% adjunctive PTA and/or stent. 90%(LACI registry and below knee diffuse disease limb salvage at 6 months.Belgium)Laird (LACI) 2005 Multicenter 145 CLI, above TASC C-D Favorable 96% adjunctive PTA, 45% stent. 92% registry and below knee 16 cm limb salvage at 6 months. 69% 92% occlusions improved Rutherford category. Primary patency 93% at 6 months.Stoner 2007 Retrospective 40 patients, 65% TASC B-C Equivocal 75% adjunctive PTA, 14% stent. Primary CLI. Above and 45% occlusions patency 44% at 1 year. 55% limb below knee. salvage in CLI. 33% complication rate in 1st month.Dave 2009 Prospective, 65 claudicants. 5.5 cm Equivocal 77% adjunctive PTA, 23% stent. Primary(CELLO, not multicenter 16% occlusions patency 54% at 1 year. 78% freedomyet published) trial from TLR. TURBO-Booster. 34-39
  • Pros Cons• Can cross and debulk • Relatively small lumen lesion with one device created• Facilitates angioplasty at • Expensive lower pressures, perhaps lowering dissection rate • Rarely stand-alone• Good limb salvage rate • Unimpressive patency in CLI rate in claudicants
  •  No randomized controlled trials Expensive, particularly given that adjunctive PTA and/or stent is almost always needed Occasional perforation and distal embolization Possible applications  Limb salvage in CLI  Long, complex occlusions that are refractory to other treatments  In-stent restenosis
  • Orbital atherectomy
  •  0.014” compatible catheter  0.014” compatible catheter  6F or 7F sheath  8F sheath Eccentrically-mounted crown  Cutting tip 2.1 mm with blades  Crown sizes 1.25-2.25 mm down, 3.0 mm with blades up  Lumen diameter can be increased by increasing orbital speed  2.25 mm crown at max RPM – 4  Control pod allows for mm lumen created simultaneous saline infusion and plaque/debris aspiration Rotation of crown “sands” down the plaque  99% of particles are <5 microns
  • 40-42
  • 40-42
  • First author Year Structure # and type of Lesion Outcome Comments patients characterist icsSafian (OASIS) 2009 Multicenter 124 patients, 3 cm Favorable? Stand-alone in 58%. Adjunctive PTA in registry 68% claudicants, 12% 39%, stent in 3%. 78% clinical below knee only occlusions improvement at 6 months. Low complication rate. Patency unknown. Diamondback 360.Wissgott 2008 Single 23 claudicants, 2.6 cm Favorable? Stand-alone in 30%. Adjunctive PTA in center at or above knee 26% 61%, stent in 9%. 92% primary patency registry occlusions at 6 months. Pathway.Zeller 2009 Multicenter 172 patients, 3.5 cm, 31% Favorable Stand-alone in 33%. Adjunctive PTA in(PATHWAY prospective claudicants and occlusions 57%, stent in 7%. 1-year primaryPVD) trial CLI, above or patency 62% (duplex). Rutherford class below knee 3.0 (baseline), 1.5 (1 year). 1% MAE. 40-42
  •  Diamondback 360  Similar mode of action to Rotablator (which did not improve results of PTA)  Effective in calcified lesions  Multiple devices needed for upsizing  Distal slow-flow/spasm possible; hemolysis  Limited data set; reasonable safety and efficacy Pathway Jetstream G2  Similar mode of action to TEC atherectomy device (which did not improve results of PTA)  Active aspiration and front-end cutting  2 sizes in 1 device  Minimal distal embolization  Prospective trial showed angiographic and clinical success and safety Uncertain role in PAD treatment at present  Further study is awaited
  •  Possible roles  Stent avoidance  No stent zones  Long diffuse non-occlusive disease  Stent promotion/expansion  Densely calcified areas  Preparation for biologic restenosis solutions
  • Cutting balloons
  •  0.014” or 0.018” wire compatible balloon catheter  6F or 7F sheath  Monorail or OTW 4 microsurgical blades mounted longitudinally on the balloon In vitro advantages over PTA  Decreases inflammatory response  Decreases endothelial damage  Decreases proliferative response  Achieves larger lumen areas 43-45
  • First author Year Structure # and type Lesion Outcome Comments of patients characteristicsCanaud 2008 Single 128, 86% CLI <10 cm Favorable Primary patency 75% at 1 and 2 years center 10% occlusions for fem-pop lesions. 4% dissection rate. registryAmighi 2008 RCT vs. 43, 80% 2.5 cm Unfavorable Primary patency 68% at 6 months for PTA claudicants 25% occlusions PTA; 38% for CBA. 73% clinical patency for PTA, 38% for CBA.Dick 2008 RCT vs. 40, 76% In-stent restenosis No Primary patency 27% for CBA, 35% for PTA claudicants 8 cm difference PTA at 6 months. No difference in ABI 10% occlusions or walking distance. No difference in laboratory parameters of inflammation. 46-48
  •  In vitro advantages have not been demonstrated in vivo  Appears equivalent or even inferior to PTA No definite role in PAD treatment at present  Possible application in fibrotic/calcified lesions resistant to conventional PTA
  • Cryoplasty
  •  0.014” or 0.035” wire compatible balloon catheters  0.035”: 6F-8F sheath, SFA/popliteal use  0.014”: 4F-6F sheath, below knee use Nitrous oxide used for balloon inflation  Dilates and cools vessel wall to -10° C simultaneously  Induces apoptosis in the smooth muscle cells that contribute to restenosis  Alters plaque response May result in less dissection, less elastic recoil, and less re-stenosis compared to conventional PTA 49-51
  • First Year Structure # and type of Lesion Outcome Commentsauthor patients characteristicsFava 2004 Single center 15 claudicants 6.5 cm Favorable? Only 9/15 had 1-year angiographic registry 33% occlusions follow-up (8 were patent); 2 late occlusions were not studiedLaird 2005, Single center 102 claudicants 4.5 cm Favorable? Primary patency 70% at 9 months. 2006 registry 15% occlusions Clinical patency 82% at 9 months, 75% at 3 years. 7% dissection rate.Samson 2006, Single center 64, 80% 4 cm Favorable, Early results: 82% 1-year patency. 2008 registry claudicants 0% occlusions then Later results: Primary patency 57/49% at 1/2 years. Less effective in calcified unfavorable lesions. 8% dissection rate.Korteweg 2008 Single center 32 claudicants Half TASC A, half Equivocal 67% 1-year primary patency in TASC A. registry TASC B-C 32% 1-year primary patency in TASC B- C. No ABI improvement over baseline at 1 year.Banerjee 2009 Retrospective 27 patients, 39 14 cm Favorable 72% stand-alone; 29% stent. 67% lesions, 80% 33% occlusions primary patency at 1 year. claudicants 18% in-stentDas (BTK 2009 Prospective 108 patients, Infrapopliteal Favorable Adjunctive stent placement in 3%. LimbCHILL) trial CLI. Below salvage rate 85% at 1 year. Freedom knee only from TLR 79% at 1 year.Jahnke 2009 Prospective 77 patients, Popliteal only; No advantage 29% treatment success for cryo, 52% for(COLD, in randomized 77% claudicants stenosis or (early results) PTA. 9-month patency 76% for cryo,progress) trial (vs. PTA) occlusion 63% for PTA. 37% dissection rate with cryo, 26% for PTA. 52-60
  •  Fava 2004: 83% patency at 18 months Laird 2006: 75% patency at 3 years Samson 2006: 82% patency at 1 year Analysis of studies shows:  Incomplete follow-up  Subjective outcome measures (“clinical patency”)  Non-standard definition of restenosis 52,53,55,69
  •  Samson re-evaluated cryoplasty in 2008  Often fails in heavily calcified lesions  Low patency rates (43% at 1 year, 51% at 2 years)  Adds ~$1700 to cost of procedure  Technique is no longer used in his practice Recent cryoplasty trial for restenosis was abandoned  All 12 patients developed restenosis within 1 year In vivo, no difference from PTA in release of adhesion molecules, growth factors, and cytokines Recent review of cryoplasty concludes that there is no evidence of any benefit over conventional PTA 56,61,67,68
  •  In vitro advantages have not been demonstrated in vivo  Safe and feasible, with low dissection rate, but no evidence of benefit over PTA  Expected advantage in restenotic lesions has not been seen No definite role in PAD treatment at present
  • Drug eluting balloons
  •  Studies in swine demonstrate sustained inhibition of smooth muscle proliferation after short exposure of tissue to paclitaxel Control Coated balloon allows more even delivery of drug to the lesion than a drug-eluting stent Cypher (sirolimus- eluting stent) Early effectiveness demonstrated in coronary circulation Paccocath (paclitaxel- coated balloon) 70,71
  • First Year Structure # and type Lesion Outcome Commentsauthor of patients characteristicsWerk 2008 RCT 87 patients, TASC A-D DEB better Primary patency 81% for DEB vs. 53%(FEMPAC) claudicants 6 cm for PTA at 6 months. Freedom from TLR 87% for DEB vs. and CLI 16% occlusions 50% for PTA at 2 years. Paclitaxel-coated balloon.Tepe 2008 RCT 154 patients, 7.4 cm DEB better Primary patency 78/68% at 1/2 years for(THUNDER) claudicants 27% occlusions DEB, 42/41% for PTA. and CLI 36% restenotic Freedom from TLR 85% for DEB vs. lesions 48% for PTA at 2 years. Paclitaxel-coated balloon. 72,73
  •  Promising technology  Superiority to PTA demonstrated in small RCTs  Effective in de novo and restenotic lesions  Avoids device implantation (except in cases of dissection or residual stenosis) Await FDA approval (2011?) and larger RCTs
  • Specialized crossing devices
  •  Wire passage across CTO is a requisite step to recanalization About 20% of SFA CTOs are resistant to conventional crossing techniques  Fibrous cap  Heavy calcification  Long lesions  Subintimal wire passage with unsuccessful re-entry
  •  6 French sheath, 0.039” crossing profile Catheter jaws create blunt microdissection through the occlusion Micro guide catheter is advanced over the device to allow distal wire placement
  •  5 French sheath, 0.014” wire compatible Low-amplitude, high-velocity microvibration pulverizes the CTO, creating a channel The elastic arterial wall is resistant to the vibration, allowing the catheter to remain selectively intraluminal Advance Pull Activate Advance catheter guidewire catheter guidewire over back into and gently into distal guidewire catheter advance lumen to CTO lumen www.flowcardia.com
  • Outback Pioneer 6 French sheath, 0.014” wire  7 French sheath, 0.014” wire compatible compatible Use “L” and “T” markers to  Intravascular ultrasound allows orient re-entry cannula toward orientation of re-entry cannula true lumen under fluoroscopy toward true lumen 22 gauge nitinol cannula  Nitinol needle extends into true deploys into true lumen, followed by wire lumen, followed by wire passage passage
  • Chronic total occlusion of SFA. Outback catheter advanced to Needle deployed and wireLesion crossed subintimally, but site of reconstitution. passed, followed by angioplastywire would not re-enter. Inset: L marker of Outback is and stent placement. turned in the direction of desired puncture.
  • First author Year Structure # and type of Lesion Outcome Comments patients characteristicsMossop 2006 Prospective 44 patients, iliac 9.5 cm Favorable 91% technical success. 22 minutes(Frontrunner) trial and SFA average crossing time. Lumen re-entry catheter necessary in 35% of successful occlusions crossings. No complications related to device. Prototype version used.Gandini 2009 Retrospective 12 patients, 26 cm Favorable 75% technical success. 4 minute(Crosser) SFA, SFA-pop catheter activation time to cross. or SFA-distal Failures usually due to extensive occlusions calcification. No complications.Steinkamp 2002 Prospective 312 patents, 7.5 cm Favorable 92% technical success. 3% had(Spectranetics trial SFA occlusions eccentric calcified plaque that could notlaser) be debulked; 4% perforation rate.Beschorner 2009 Retrospective 61 patients, SFA 20 cm Favorable 88% technical success. 55% of(Outback) occlusions procedures required pre-dilation of subintimal space in order to deliver the catheter. One death related to delayed femoral bleeding from extensive puncture attempts.Jacobs 2006 Retrospective 20 patients, iliac 9.5 cm Favorable 100% technical success. <10 minutes to(Pioneer) and SFA achieve re-entry. Bleeding at occlusions recanalization site in 18%, but did not appear to be at the site of needle deployment. 62-65
  •  Frontrunner  Difficult to use and takes the longest.  35% of crossings are extraluminal (really only 55% success rate!)  Too large for below-the-knee use. Crosser  Easy to use  Success rate 64-75% Excimer laser  >90% success rate  Can cross and debulk with one device  Occasional perforation Outback and Pioneer  Both are very effective for true lumen re-entry  Outback favored (smaller sheath size, no IVUS needed)
  • What to use, when?
  •  Poor study design in the endovascular literature makes it difficult to apply the existing evidence to individual patient scenarios  Small sample sizes  Patient heterogeneity  Lesion heterogeneity
  •  Of all the novel endovascular devices, only three have demonstrated superiority to PTA in randomized controlled trials  Nitinol stents – not all trials have shown benefit!  Stent-grafts – only two small RCTs!  Drug-eluting balloons – not available in USA!
  •  Conventional angioplasty remains the treatment of choice for short lesions Moderate-length stenoses and occlusions may be best treated with nitinol stents or stent-grafts Long, complex occlusions may be best treated with stent-grafts or bypass surgery (or subintimal angioplasty!) Drug-eluting balloons and atherectomy devices may reduce our reliance on implantable devices, but further research is needed
  • A look forward
  • Trial name Year Structure # and type of Lesion Outcome Comments patients characteristicsSUPER UK, 2005-2008 RCT 150, 120, 120 5-14.5 cm ? SMART stent vs. PTASIT-UP,DURAVESTZILVER PTX 2005-? RCT 480 <14 cm ? Paclitaxel-eluting Zilver stent vs. PTAVIBRANT 2005-2010 RCT 150 >8 cm ? Viabahn vs. bare nitinol stentSUPER SL 2005-2008 RCT 200 5-22 cm ? Cordis SMART stent vs. Bard Luminexx stentMASCOT 2008-2009 Prospective, 50 >5 cm ? AngioSculpt scoring balloon non-randomized catheter trialDEFINITIVE 2009-2010 Prospective, 800, above and TASC A-D, <20 ? Silverhawk atherectomyLE non-randomized below knee cm trialATHERO 2006-? Prospective 100 claudicants <10 cm ? Cryoplasty vs. Silverhawk randomized trial
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  • Conservative Surgical Bypass • Medical management • Considerable morbidity • Exercise therapy • Need autologous vein (ideally) • Often insufficient on its own • 5-year patency 39-74% Treatment of PAD Amputation Endovascular • Last resort • Minimally invasive• Limb salvage is preferable whenever possible • High technical success rate • 5-year patency (angioplasty)12-68%
  • Pros Cons• Extremely flexible (no • Expensive (3-4x cost of fractures) bare stent)• Good patency even in • Larger sheath TASC C-D lesions • Possible collateral loss • Occasional acute thrombosis
  •  Endovascular treatment of peripheral arterial occlusive disease is rapidly becoming first-line, regardless of disease severity The explosion of new devices over the last 10 years has raised more questions than answers The next 10 years should bring much- needed clarity to PAD treatment