D.DELEANU, M.CROITORU BUCHAREST, ROMANIA

BTK Interventions ? BTK disease = claudication and CLI BTK interventions = CLI Main goal of CLI therapy = functional limb preservation 1) Revascularization 2) Extravascular Care 3) Surveillance All accesible below the knee (BTK) lesions should be treated in patient with CLI in order to save the limb!

And then the REVOLUTION started In order to open the BTK vessels it has been used:  Materials from PCI coronary procedures  Coronary stents (BMS)  Drug eluting stents (DES) and balloons(DEB)  Dedicated tools developed: cryoplasty, atherectomy, laser

New Materials Special sheaths for crossover Guiding catheters 0.014”, 0.018” OCT guidewires Special introducers for distal retrograde access Microcatheters Low profile long balloons

New technologies - How to use them ?

Pedal retrograde access Hybrid interventions Doppler-guided arterial punctures

Results BTK interventions  Technical Success % new technical developments good selection of patients/lesions good post-procedural surveillance  Limb salvage at 1 year - 80% restoring flow even in only 1 single tibial trunk  Limb salvage at 2 years – 60-86%  Long diffuse lesions – 1 year patency – only 15% !

PTA with long low profile balloons

POST PTA

Occlusive dissection

Stent implantation

COMPLICATIONS  Incidence:2-6% Puncture site complications  hematoma  a-v fistulas  pseudoaneurism PTA site complications  a-v fistulas  dissections  perforations

A wound to heal requires higher blood flow beyond the basal metabolic need In absence of wounds (or after the wounds are healed), blood flow can be suboptimal An incidental trauma triggers an immediate need of incremental blood flow Optimal revascularization (and durable patency) represents an insurance policy against multifactorial and unpredictable CLI triggers of incremental blood flow Other factors triggering sustained blood flow: suboptimal wound care, nondirect flow to the wound related artery CLI: Flow Demand

Wound healing in CLI (RCC 5&6) - 52% at 3 months - 61% at 6 months - 72% at 12 months

DES in Tibial Interventions

12 MONTHS FOLLOW-UP DES in Randomized Trials Rastan et al; EHJ 2011 Bosiers et al; JVS 2011 Scheinert et al; JACC 2013

PRIMARY PATENCY Yukon, Destiny and Achilles Trials Rastan et al; EHJ 2011 Bosiers et al; JVS 2011 Scheinert et al; JACC 2013

Rastan et al; JACC 2012

ACHILLES TRIAL – CYPHER SELECT VS PTA DES vs PTA in BTK (RCT) Lesion length 2.7 cm (DES) vs 2.7 cm (PTA) 12 m TLR = 10.0% (DES) vs 16.5% (PTA) (p=0.257) 12 m wound heal rate (WHR)= 61.7% (DES) vs 41.3% (PTA) (p=0.0628) 39% TLR49% WHR p=0.257p= Scheinert et al; JACC 2013

LIMITATIONS DES in BTK Lesion Trials Mean lesion length ranging from 15.9 to 31 mm  Longest lesions enrolled in ACHILLES (up to 10 cm) Unavailability of DES of appropriate lengh  Longest DES 46 mm Uncertainty about the performance of DES in long lesions

DEB in TIBIAL Interventions

Schmidt et al; JACC 2011

DEB in BTK lesions DEBATE BTK First published randomized trial to asses DEB vs PTA in complex CLI-diabetic population with 12-months angiographic endpoint. Liistro F et al; Circulation 2013

DEBATE BTK TRIAL – IN.PACT VS PTA DEB vs PTA in BTK (RCT) Lesion length 12.8 cm (DEB) vs 13.0 cm (PTA) 12-m TLR = 18.5% (DEB) vs 43.3% (PTA) (p=0.003) 12-m wound heal rate (WHR)= 86% (DEB) vs 67% (PTA) (p=0.01) 59% TLR28% WHR p=0.003 p=0.01 Liistro F et al; Circulation 2013

New concept: Angiosome directed Therapy… Taylor & Palmer (1987) – plastic surgery 3-D anatomic unit of tissue fed by a source artery Between angiosomes there is collateral vessels – “ rescue collateral network”.

Does the target artery matter ? Adapted from Neville et al; Ann Vasc Surg

Angiosome directed Therapy

Conclusions Patency is necessary but not sufficient for wound healing and ultimately limb salvage Durable and sustained blood flow to the wound is an insurance against the variety of concomitant factors and unpredictable triggers leading to either wound persistence, deterioration or recurrence DES in lesions with a length up to 10 cm may be the solution to achieve the necessary patency levels DEB are preferred revascularization for lesions longer than 10 cm and foot artery lesions