Angiosome concept myth or truth? Does it make a real difference in real world cases?

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Angiosome concept myth or truth? Does it make a real difference in real world cases? Osamu Iida, MD, FACC Kansai Rosai Hospital Amagasaki, Hyogo, Japan

Disclosure Speaker name:... I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) X I do not have any potential conflict of interest

Different comorbidities in CLI but almost comparable amputation-free survival Key baseline characteristics OLIVE PRVENT III CIRCULASE BASIL CRITISH EVT BSX+Drug Drug EVT/BSX EVT BSX Age>80 yrs 26% 18% 18% 26% Male 65% 65% 79% 66% 63% 68% DM 71% 62% 51% 39% 48% 48% Hemodialysis 52% 10% 5% Tissue loss 88% 74% 69% 75% 78% 73% Isolated BTK lesions 41% One-year AFS 74% 74.0% - 79.9% 75% 72% Despite heterogeneity characteristics, 1-year AFS reveals around 75%. But, it is clinically difficult to simply compare to each study. Circ Cardiovasc Interv. 2013;6:68-76. J Vasc Surg 2006;43:742-51. J Vasc Surg 2006;43:752-9. Lancet 2005;366:1925-34. J Vasc Surg. 2015;62:965-973.

Angiosome concept is important? Despite an aggressive approach for revascularization, amputation rates of up to 20% can occur despite a patent bypass in patients with CLI and tissue loss. Ischemic ulcer Revascularization Major amputation This has led to the proposal of an angiosome-based revascularization strategy (where the specific artery perfusing the corresponding diseased territory is revascularized). Sumpio BE et al. J Vasc Surg 2013;58:814 826.

74 years, Male, tissue loss at heel (R6) DM, ESRD on HD Severe stenosis presnted at ATA to DPA Poor flow to the calcaneal region was observed. (from DPA-pedal arch)

74 years, Male, tissue loss at heel (R6) DM, ESRD on HD Angioplasty for ATA-DPA Poor flow to calcaneal region despite ATA-DPA revascularization (1-straight line)

74 years, Male, tissue loss at heel (R6) DM, ESRD on HD Angioplasty for ATA-DPA 1-straight line Major amputation (BK amputaion)

Angiosomes of the lower extremity Angiosome is an anatomical concept, defined as the blood supply from a main, secondary or distributing artery to a specific tissue area. Shishehbor MH, et al. Circ Cardiovasc Interv. 2014;7:642-644.

Biancari F. Eur J Vasc Endovasc Surg. 2014;47:517-522. Meta-analysis of angiosome concept Forest plot for effectiveness in wound healing Forest plot for effectiveness in limb salvage

2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity PAD: Executive Summary

2017 ESC Guidelines on the Diagnosis and Treatment of PAD, in collaboration with the ESVS 1) The decision of revascularization should also consider the angiosome concept, targeting the ischaemic tissues. 2) The angiosome model should not be used as an absolute strategy for interventions on patients with CLTI. 3) Further, well-structured prospective studies are needed to assess the value of the angiosome concept.

Why angiosome is clinically important? -1) Know limitations of BTK angioplasty- Repeat EVT @ 1 year Restenosis @ 3 months 40% 70% Iida O, et al. Eur J Vasc Endovasc Surg. 2012;44:425-31. Early Recoil @ 15 min. 97% Baumann F, et al. J Endovasc Ther. 2014;21:44-51. We should consider endovascular revascularization as absolute strategy providing blood flow efficiently because of presence of limitations of BTK angioplasty.

Why angiosome is clinically important? -2) Impact of angiosome differs from studies - Publication Country Limbs (Pts) Outcomes DM ESRD Alexandrescu, 2008 Retro 124 (98) Wound Healing 124 (100%) 27 (22%) Iida, 2010 Retro 203 (177) Limb Salvage 120 (68%) 96 (54%) Alexandrescu, 2011 Retro 232 (208) WH, LS, Mortality 232 (100%) 42 (18%) Blanes Orti, 2011 Retro 34 (32) Wound Healing 27 (73%) 13 (35%) Iida, 2012 Retro 369 (329) LS, Mortality 172 (73%) 149 (63%) Soderstrom, 2013 Retro 250 (226) Wound Healing 250 (100%) 39 (16%) Fossaceca, 2013 Retro 201 (201) WH, LS 201 (100%) 15 (7.4%) Acin, 2014 Retro 101 (92) WH, LS, Mortality 101 (100%) 0 (0%) More effective, Less effective Angiosome-guided angioplasty is more or less effective depending on the patient characteristics. Bunte MC, et al. Interv Cardiol Clin. 2017;6:271-277.

Association of cardiovascular risk factors with pattern of lower limb atherosclerosis Diehm N et al. Eur J Vasc Endovasc Surg. 2006:31;59 63.

Renal insufficiency is independently associated with a distal distribution pattern Diffuse severe calcification: (A) along the SFA; (B) occlusion of the distal ATA and proximal PA and complete occlusion of the PTA; and (C) occlusion of the plantar and dorsal arterial arches at the foot level. Wasmuth S et al. Eur J Vasc Endovasc Surg. 2010;39:591-596.

Diseased A-A (Artery-Artery) connection attributable to presence of DM and dialysis A-A connection from PA (peroneal artery) 1. Communicating branch to PTA 2. Calcaneal branch to PTA 3. Perforating branch to ATA Pedal arch ATA PTA

Discrepancy from theory to practice We should seek determinants of patients with CLI who derive the most clinical benefit from direct revascularization (DR). Indirect revascularization Limb salvage In clinical practice, moderate limb salvage rates (68-76%) were obtained by indirect revascularization (IR) in earlier studies. However, it remains unclear which patients derive the most clinical benefit from direct revascularization (DR).

Worse limb prognosis for IR vs. DR only in patients with CLI complicated with wound infection and DM (N=718) CLI complicated with both wound infection and DM, when IR has a poorer outcome. Indirect EVT & CRP 3 mg/dl DM n Hazard ratio for MALE - - 159 1.00 (Ref) - 443 0.88 [0.67, 1.15] - 21 1.05 [0.54, 2.04] 95 2.17 [1.54, 3.06]** Iida O, et al. Eur J Vasc Endovasc Surg. 2013;46:575-582.

CC: rt dorsalis gangrene Rutherford 6, W3I3FI2 * Severe wound infection PMH: HTN, DM, Aortic valve stenosis (AS) ADL: Ambulatory Skin perfusion pressure Dorsal 17mmHg Plantar 30mmHg Case: 97 yrs, female

Isolated Below-the-knee Lesion

US-guided Puncture for DPA System Guiding Sheath: Parent Plus 4.5Fr, 55cm Guide Wire: Cruise 0.014, 235cm Gladius 0.014, 200cm Back-up Catheter: Prominent 1.8/2.6Fr, 110cm Corsair PV 2.6Fr, 135cm EVT Balloon: Coyote MR 2.0*220mm Ultraverse 3.0*300mm

Bidirectional Wiring for ATA System Guiding Sheath: Parent Plus 4.5Fr, 55cm Guide Wire: Cruise 0.014, 235cm Gladius 0.014, 200cm Back-up Catheter: Prominent 1.8/2.6Fr, 110cm Corsair PV 2.6Fr, 135cm EVT Balloon: Coyote MR 2.0*220mm Ultraverse 3.0*300mm

Rendezvous Technique System Guiding Sheath: Parent Plus 4.5Fr, 55cm Guide Wire: Cruise 0.014, 235cm Gladius 0.014, 200cm Back-up Catheter: Prominent 1.8/2.6Fr, 110cm Corsair PV 2.6Fr, 135cm EVT Balloon: Coyote MR 2.0*220mm Ultraverse 3.0*300mm

Balloon Angioplasty for BTA System Guiding Sheath: Parent Plus 4.5Fr, 55cm Guide Wire: Cruise 0.014, 235cm Gladius 0.014, 200cm Back-up Catheter: Prominent 1.8/2.6Fr, 110cm Corsair PV 2.6Fr, 135cm EVT Balloon: Coyote MR 2.0*220mm Ultraverse 3.0*300mm

Final Angiography BTK BTA

After revascularization

The angiosome-oriented revascularization for CLI patients without concurrent wound infection and DM AFS Freedom from MALE There was no significant difference in terms of AFS and freedom from MALE for patients without concurrent wound infection and DM. Iida O, et al. J Endovasc Ther. 2014;21:607-615.

The angiosome-oriented revascularization for CLI patients without concurrent wound infection and DM Propensity matching Iida O, et al. J Endovasc Ther. 2014;21:607-615.

Angiosome Targeted PTA is More Important in patients with diabetes Direct PTA Direct PTA Indirect PTA with collaterals Indirect PTA with collaterals Indirect PTA Indirect PTA with no collaterals with no collaterals p = 0.004 p 0.001 In diabetic patients, indirect endovascular revascularization leads to the poorest wound healing and leg salvage rates. Endovascular procedures should be targeted according to the angiosome concept. Špillerová K, et al. Eur J Vasc Endovasc Surg. 2017;53:567-575.

CC: rt 1 st digit gangrene Rutherford 5, W1I2FI0] *wound infection (-) PMH: HTN, ESRD in dialysis Cerebral infarction (CI) *Diabetes mellitus (-) ADL: wheel chair Skin perfusion pressure Dorsal 21mmHg Plantar 31mmHg Case: 83 yrs, female

Isolated Below-the-knee Lesion

Angioplasty for Dorsal System Guiding Sheath: Parent Plus 3Fr, 55cm Guide Wire: Cruise 0.014, 175cm Gladius 0.014, 235cm Back-up Catheter: Prominent 1.8/2.6Fr, 110cm EVT Balloon: JADE 2.5*120mm ULTRAVERSE 3.0*300mm

Final Angiography BTK BTA

Why angiosome is clinically important? -3) Aggressive wound care by angiosome Tx- Pre angioplasty POD 21 days Skin perfusion pressure Dorsalis pedis side 21mmHg 75mmHg Plantar side 31mmHg 39mmHg

Think about the Angiosome Concept Angiosome Concept DM With Infection Necessity Non-DM DM With Infection Without infection The angiosome concept always result in better wound healing Non-DM Without infection Less necessity Based on our analysis and experience, revascularization for woundrelated artery is best way to achieve better clinical outcomes.

Angiosome concept myth or truth? Does it make a real difference in real world cases? Osamu Iida, MD, FACC Kansai Rosai Hospital Amagasaki, Hyogo, Japan