Our aim was to describe our experience with infrapopliteal endovascular procedures performed in diabetic patients with ischemic ulcers and critical ischemia (CLI). A retrospective study of 101 procedures was performed. Our cohort was divided into groups according to the number of tibial vessels attempted and the number of patent tibial vessels achieved to the foot. An angiosome anatomical classification of ulcers were used to describe the local perfusion obtained after revascularization. Ischemic ulcer healing and limb salvage rates were measured. Ischemic ulcer healing at 12 months and limb salvage at 24 months was similar between a single revascularization and multiple revascularization attempts. The group in whom none patent tibial vessel to the foot was obtained presented lower healing and limb salvage rates. No differences were observed between obtaining a single patent tibial vessel versus more than one tibial vessel. Indirect revascularization of the ulcer through arterial-arterial connections provided similar results than those obtained after direct revascularization via its specific angiosome tibial artery. Our results suggest that, in CLI diabetic patients with ischemic ulcers that undergo infrapopliteal endovascular procedures, better results are expected if at least one patent vessel is obtained and flow is restored to the local ischemic area of the foot.
Critical limb ischemia (CLI) mainly affects elderly patients with important comorbidities and significant diffuse multilevel vascular lesions [
In tibial vein bypass planning, it has been generally accepted that the decision of which tibial outflow vessel should be treated must be taken according to angiographic considerations of the target distal vessel quality, since better patency rates are expected if less diseased runoff artery is used for distal anastomosis. However, the endovascular approach offers the possibility of treating more than one tibial vessel. In addition, data shown in several recent reports suggest that improved clinical outcomes could be achieved when blood flow is directed to the local ischemic area of the foot through its specific source tibial artery using and angiosome anatomical model [
Our aim is to analyze the clinical and hemodynamic results of infrapopliteal endovascular procedures applied to CLI diabetic patients with ischemic ulcers according to the number of tibial vessels attempted for revascularization, the number of tibial arteries finally achieved to the foot and the local perfusion of the ischemic ulcer obtained after revascularization in order to describe the usefulness of these recent techniques in new reperfusion strategies.
We carried out a retrospective study of consecutive primary infrapopliteal endoluminal techniques performed at our Vascular Surgery Department for CLI and ischemic ulcers in diabetic patients over a ten-year period (January 1999–December 2009). All patients with end-stage renal disease were excluded from the analysis since this specific condition is associated with worst outcomes due to the extensive arterial calcification found in these subjects. During this period, endovascular procedures were progressively implemented as the first treatment option for CLI whenever technically feasible. The clinical diagnosis of CLI was confirmed by objective documentation of severe hemodynamic compromise according to TASC (TransAtlantic InterSociety Concensus) criteria [
Demographic details, atherosclerosis risk factors, basal and postoperative hemodynamic data, and TASC classification for the worse lesion treated were entered in our database. Femoropopliteal lesions were classified using the TASC-II criteria [
Our cohort was divided in groups according to the number of tibial vessels attempted for treatment, the number of patent tibial vessels finally achieved to the foot and the local perfusion of the ischemic ulcer obtained after revascularization. Thus, the infrapopliteal interventions were classified as “single revascularization” if only one tibial vessel was treated and “multiple revascularization” if more than one infrapopliteal vessel was attempted for revascularization.
We considered that a patent tibial vessel was finally achieved if lesion recanalization was successful and morphological result of the procedure on target lesion was optimal (without dissections and/or without residual stenosis >30%). Endovascular treatment of the peroneal artery also required at least one patent distal peroneal branch to the foot to consider the artery successfully revascularizated. Those procedures in which none patent tibial arteries were obtained were classified as “runoff 0 group.” Interventions in which a single outflow vessel to the foot was obtained with an optimal morphological result were classified as “runoff 1 group.” Procedures in which more than one outflow tibial artery was achieved were classified as “runoff >1 group.”
Local perfusion of the ischemic ulcer obtained after revascularization was analyzed according to an angiosome model. Taylor and Palmer introduced this anatomical concept in 1987, widely used in modern plastic surgery, which is defined as 3-dimensional block of tissue supplied by a specific source artery and drained by a specific vein [
Angiosomes of the foot. Calcaneal branch (1); medial plantar branch (2); and lateral plantar branch (3) of the posterior tibial artery; dorsalis pedis angiosome (4); anterior branch (5) and calcaneal branch (6) of the peroneal artery.
The analysis according to the postoperative ischemic ulcer local perfusion was only performed in those procedures in which at least one patent tibial vessel was obtained. We excluded the “runoff 0” interventions in order to evaluate the influence of foot vessels patency on our cohort results. Preoperative and intraoperative angiographies were reviewed and procedures were classified using an angiosome anatomical model as ‘‘direct revascularization’’ (DR) if at least one feeding vessel supplied the injured angiosome and as ‘‘indirect revascularization’’ (IR) if it fed an unrelated angiosome. Indirect revascularization was subdivided into IR ‘‘through collaterals’’ (IRc) and ‘‘without collaterals’’ depending on the presence of collateral vessels to the affected angiosome (pedal arch and distal peroneal branches). The ulcer-angiosome and angiogram-angiosome assignment were done in a blinded fashion. Revascularization of digit ulcers by the ‘‘dorsalis pedis’’ or the plantar artery was considered as DR. The same exception was applied in heel ulcers perfused by the plantar artery or the calcaneal branch of the peroneal artery.
All patients were called for follow-up at 1 month, 3 months, and then every 6 months after the procedure was performed. Patency was assessed by ABI in all cases. Color duplex scanning was performed in those patients with noncompressible ABI, with stent implants or those who required complex endovascular revascularization procedures. Patients who showed clinical worsening or those with a drop in ABI >0.15 were initially assessed by color duplex scanning. Echographic restenosis was defined as the finding of a peak systolic velocity ratio >2.5 in the target lesion and only symptomatic restenosis were treated. Lower limbs angiography was performed prior to reintervention. Reinterventions were classified as major (conversion to bypass, thrombectomy, thrombolysis, or major surgical procedure) and minor (new endovascular procedure without the need for thrombectomy or thrombolysis).
The main objectives of the study were ischemic ulcer healing at 12 months and limb salvage at 24 months. Foot tissue lesions were considered as infected according to the CDC/NHSN surveillance definition of health care-associated infection criteria [
The results of our cohort were also analyzed according to the definition of the different Objective Performance Goals proposed by the Society for Vascular Surgery for evaluating catheter-based treatment of CLI [
Freedom from any MALE or perioperative death (freedom from MALE+POD), amputation-free survival, and overall survival at 24 months were calculated to discriminate between limb-specific results and survival-related results as CLI patients use to develop multiple adverse events that can greatly influence the revascularization outcomes and patients survival. Freedom from any reintervention or amputation (freedom from RAO) and freedom from restenosis, any reintervention or amputation (freedom from RAS), were measured as estimators of hemodynamic failure [
All the previously mentioned endpoints were compared according to the number of tibial vessels attempted for revascularization, the number of tibial vessels finally achieved to the foot, and the local perfusion of the ischemic ulcer obtained after revascularization.
One hundred and one primary infrapopliteal endovascular procedures performed in 92 diabetic patients with ischemic ulcers between January 1999 and December 2009 were retrospectively followed. All the revascularizated ischemic ulcers were limited to the foot. Most of the procedures were performed between 2005 and 2009 (74 (73%) endovascular techniques) and only 8 (8%) between 1999 and 2000. Median follow-up was 19 (9–38) months and 11 (10.8%) patients were lost. Demographic characteristics, comorbidities, ischemic ulcer description, and basal hemodynamic data are described in Table
Basal characteristics of the subjects included.
Basal characteristics |
|
---|---|
Age (years) | 72 (64–77) |
Males | 62 (61.4%) |
Smoking history | 75 (74.3%) |
Dyslipidemia | 33 (32.7%) |
Hypertension | 73 (72.3%) |
Ischemic heart disease | 30 (29.7%) |
Chronic obstructive pulmonary disease | 6 (5.9%) |
Stroke | 20 (19.8%) |
Preoperative ABI* | 0.54 (0.40–0.67) |
Noncompressible ABI* | 54 (53.5%) |
Infected ulcers | 37 (36.6%) |
Injured angiosome | |
Dorsalis pedis angiosome | 79 (78.2%) |
Medial plantar branch angiosome | 54 (53.5%) |
Lateral plantar branch angiosome | 26 (25.7%) |
Posterior tibial a. calcaneal angiosome | 11 (10.9%) |
Peroneal a. calcaneal angiosome | 9 (8.9%) |
Peroneal a. anterior angiosome | 2 (2.0%) |
*ABI: ankle-brachial index.
The TASC-II classification of the worst lesion treated was TASC-D in 79.2% surgeries. In 56 (55.4%) endovascular procedures the tibial intervention was combined with a femoro-popliteal angioplasty. Stents were used selectively in 9 (8.9%) procedures. Seven (6.8%) stents were implanted in the femoro-popliteal sector and 2 (1.9%) in the tibial sector. Multiple revascularization of the tibial sector was attempted in 52 (51.5%) interventions and single revascularization in 49 (48.5%). In 16 (15.8%) procedures a direct line of blood flow to the foot was not achieved (runoff 0 group). A single patent tibial vessel was obtained in 64 (63.4%) interventions (runoff 1 group) and more than one in 21 (20.8%) procedures (runoff >1 group). After excluding the runoff 0 group, DR of the ischemic ulcer was achieved in 46 (54.1%) procedures, IR “through collaterals” in 22 (25.9%) and IR “without collaterals” in 17 (20%) interventions (Table
TASC-II classification for the worst lesion treated and perioperative data of the subjects included.
Perioperative data |
|
---|---|
TASC-B | 6 (5.9%) |
TASC-C | 15 (14.9%) |
TASC-D | 80 (79.2%) |
Combined treatment* | 56 (55.4%) |
Debridement | 11 (10.9%) |
Minor amputation | 28 (27.7%) |
Multiple revascularization | 52 (51.5%) |
Runoff 0 | 16 (15.8%) |
Runoff 1 | 64 (63.4%) |
Runoff > 1 | 21 (20.8%) |
DR# | 46 (54.1%) |
IR† “through collaterals” | 22 (25.9%) |
IR† “without collaterals” | 17 (20.0%) |
Postoperative ABI& | 0.84 (0.69–0.93) |
MACE+ at 30 days | 3 (3.0%) |
MALE |
3 (3.0%) |
Major amputation at 30 days | 2 (2.0%) |
*Combined treatment: combined treatment of the femoropopliteal and the infrapopliteal sector; #DR: direct revascularization; †IR: indirect revascularization; &ABI: ankle-brachial index; +MACE: major adverse cardiovascular event;
The incidence of MACE, MALE, and major amputation at 30 days was 3%, 3%, and 2%, respectively. Ischemic ulcer healing at 12 months was 55.0% and limb salvage at 24 months was 74.9%. Freedom from MALE+POD at 24 months was 64.8%. We recorded an amputation-free survival rate of 63.3% after 2 years of follow-up. Overall survival at 24 months was 76.9%. Freedom from RAS and freedom from RAO at 24 months were 37.6% and 58.9%, respectively.
A multiple tibial revascularization attempt was more frequently performed in males and in patients with smoking history (Table
Basal characteristics according to the number of tibial vessels attempted for revascularization.
Basal characteristics | SR# ( |
MR† ( |
|
---|---|---|---|
Age (years) | 72 (66–80) | 72 (63–76) | 0.39 |
Males | 24 (48.9%) | 38 (73.0%) |
|
Smoking history | 30 (61.2%) | 45 (86.5%) |
|
Dyslipidemia | 18 (36.7%) | 15 (28.8%) | 0.39 |
Hypertension | 36 (73.5%) | 37 (71.2%) | 0.79 |
Ischemic heart disease | 15 (30.6%) | 15 (28.8%) | 0.84 |
Chronic obstructive pulmonary disease | 3 (6.1%) | 3 (5.8%) | 0.94 |
Stroke | 10 (10.4%) | 10 (19.2%) | 0.88 |
Preoperative ABI* | 0.54 (0.44–0.68) | 0.54 (0.35–0.67) | 0.55 |
Noncompressible ABI* | 24 (49.0%) | 30 (57.7%) | 0.38 |
Infected ulcers | 17 (34.7%) | 20 (38.5%) | 0.69 |
Injured angiosome | |||
Dorsalis pedis angiosome | 40 (81.6%) | 39 (75.0%) | 0.42 |
Medial plantar branch angiosome | 25 (51.0%) | 29 (55.8%) | 0.63 |
Lateral plantar branch angiosome | 15 (30.6%) | 11 (21.2%) | 0.27 |
Posterior tibial a. calcaneal angiosome | 6 (12.2%) | 5 (9.6%) | 0.67 |
Peroneal a. calcaneal angiosome | 4 (8.2%) | 5 (9.6%) | 0.53 |
Peroneal a. anterior angiosome | 0 (0%) | 2 (2.0%) | 0.49 |
*ABI: ankle-brachial index; #SR: single revascularization; †MR: multiple revascularization.
TASC-II classification for the worst lesion treated and perioperative data according to the number of tibial vessels attempted for revascularization.
Perioperative data | SR+ ( |
MR |
|
---|---|---|---|
TASC-B | 4 (8.2%) | 2 (3.8%) | 0.35 |
TASC-C | 7 (14.3%) | 8 (15.4%) | 0.87 |
TASC-D | 38 (77.6%) | 42 (80.8%) | 0.69 |
Combined treatment* | 32 (65.3%) | 24 (46.2%) |
|
Debridement | 6 (12.2%) | 5 (9.6%) | 0.67 |
Minor amputation | 14 (28.6%) | 14 (26.9%) | 0.85 |
Runoff 0 | 10 (20.4%) | 6 (11.5%) | 0.22 |
Runoff 1 | 36 (73.5%) | 28 (53.8%) |
|
Runoff > 1 | 3 (6.1%) | 18 (34.6%) |
|
Postoperative ABI# | 0.90 (0.67–0.94) | 0.83 (0.68–0.92) | 0.86 |
MACE† at 30 days | 2 (4.1%) | 1 (1.9%) | 0.61 |
MALE& at 30 days | 1 (2.0%) | 2 (3.8%) | 0.59 |
Major amputation at 30 days | 0 (0%) | 2 (3.8%) | 0.49 |
*Combined treatment: combined treatment of the femoropopliteal and the infrapopliteal sector; #ABI: ankle-brachial index; †MACE: major adverse cardiovascular events; &MALE: major adverse limb events; +SR: single revascularization;
The incidence of MACE (4.1% versus 1.9%
Ischemic ulcer healing rate at 12 months was 50.6% in the single revascularization group and 58.8% in the multiple revascularization group
Ischemic ulcer healing at 12 months (a) and limb salvage at 24 months according to number of tibial vessels attempted for endovascular treatment. SR: single revascularization (Blue line); MR: multiple revascularization (red line). The standard error was <10% for the data shown.
Freedom from MALE-POD at 24 months was 62.1% in the single revascularization group and 71.3% in the multiple revascularization group
Freedom from RAS at 24 months was 24% in the single revascularization group and 43% in the multiple revascularization group
Smoking history, ischemic heart disease, and previous strokes were more prevalent in runoff >1 group patients (Table
Basal characteristics according to the patent tibial vessels achieved to the foot.
Basal characteristics |
|
|||||
---|---|---|---|---|---|---|
Runoff 0 ( |
Runoff 1 ( |
Runoff > 1 ( |
Runoff > 1 versus runoff 1 | Runoff > 1 versus runoff 0 | Runoff 1 versus runoff 0 | |
Age (years) | 74 (59–79) | 72 (64–77) | 70 (63–75) | 0.46 | 0.57 | 0.87 |
Males | 12 (75.0%) | 35 (54.7%) | 15 (71.4%) | 0.17 | 0.80 | 0.14 |
Smoking history | 13 (81.3%) | 43 (67.2%) | 19 (90.5%) |
|
0.41 | 0.36 |
Dyslipidemia | 7 (43.8%) | 19 (29.7%) | 7 (33.3%) | 0.75 | 0.51 | 0.28 |
Hypertension | 10 (62.5%) | 48 (75.0%) | 15 (71.4%) | 0.74 | 0.56 | 0.31 |
Ischemic heart disease | 4 (25.0%) | 16 (25.0%) | 10 (47.6%) |
|
0.16 | 0.19 |
Chronic obstructive pulmonary disease | 0 (0%) | 6 (9.4%) | 0 (0%) | 0.32 | n.a | 0.34 |
Stroke | 2 (12.5%) | 10 (15.6%) | 8 (38.1%) |
|
|
0.55 |
Preoperative ABI* | 0.46 (0.35–0.56) | 0.55 (0.43–0.68) | 0.61 (0.37–0.65) | 0.55 | 0.28 | 0.21 |
Noncompressible ABI* | 10 (62.5%) | 31 (48.4%) | 13 (61.9%) | 0.28 | 0.97 | 0.31 |
Infected ulcers | 5 (31.3%) | 24 (37.5%) | 8 (38.1%) | 0.96 | 0.66 | 0.64 |
Injured angiosome | ||||||
Dorsalis pedis angiosome | 14 (87.5%) | 51 (79.7%) | 14 (66.7%) | 0.22 | 0.24 | 0.72 |
Medial plantar branch angiosome | 9 (56.3%) | 32 (50.0%) | 13 (61.9%) | 0.34 | 0.72 | 0.65 |
Lateral plantar branch angiosome | 4 (25.0%) | 18 (28.1%) | 4 (19.0%) | 0.56 | 0.70 | 0.53 |
Posterior tibial a. calcaneal angiosome | 1 (6.3%) | 6 (9.4%) | 4 (19.0%) | 0.25 | 0.36 | 0.57 |
Peroneal a. calcaneal angiosome | 1 (6.3%) | 4 (6.3%) | 4 (19.0%) | 0.09 | 0.36 | 0.68 |
Peroneal a. anterior angiosome | 0 (0%) | 2 (3.1%) | 0 (0%) | 0.56 | n.a | 0.63 |
*ABI: ankle-brachial index.
TASC-II classification for the worst lesion treated and perioperative data according to the patent tibial vessels achieved to the foot.
Perioperative data |
|
|||||
---|---|---|---|---|---|---|
Runoff 0 ( |
Runoff 1 ( |
Runoff > 1 ( |
Runoff > 1 versus runoff 1 | Runoff > 1 versus runoff 0 | Runoff 1 versus runoff 0 | |
TASC-B | 0 (0%) | 5 (7.8%) | 1 (4.8%) | 0.63 | 0.37 | 0.57 |
TASC-C | 4 (25.0%) | 9 (14.1%) | 2 (9.5%) | 0.72 | 0.20 | 0.28 |
TASC-D | 12 (75.0%) | 50 (78.1%) | 18 (85.7%) | 0.54 | 0.43 | 0.74 |
Combined treatment* | 9 (56.3%) | 25 (39.1%) | 11 (52.4%) | 0.28 | 0.81 | 0.21 |
Multiple revascularization | 6 (11.5%) | 28 (53.8%) | 18 (34.6%) |
|
|
0.65 |
Debridement | 3 (18.8%) | 6 (9.4%) | 2 (9.5%) | 0.98 | 0.63 | 0.37 |
Minor amputation | 6 (37.5%) | 19 (29.7%) | 3 (14.3%) | 0.25 | 0.13 | 0.54 |
Postoperative ABI# | 0.52 (0.57–0.66) | 0.88 (0.73–0.93) | 0.90 (0.77–0.97) | 0.54 |
|
|
MACE† at 30 days | 0 (0%) | 3 (4.7%) | 0 (0%) | 0.57 | n.a | 0.50 |
MALE& at 30 days | 1 (4.8%) | 2 (3.1%) | 0 (0%) | 0.57 | 0.56 | 0.63 |
Major amputation at 30 days | 1 (4.8%) | 1 (1.6%) | 0 (0%) | 0.43 | 0.56 | 0.80 |
*Combined treatment: combined treatment of the femoropopliteal and the infrapopliteal sector; #ABI: ankle-brachial index; †MACE: major adverse cardiovascular event; &MALE: major adverse limb event.
The incidence of MACE, MALE, and major amputation at 30 days was similar between runoff 0 group, runoff 1 group, and runoff >1 group (Table
Ischemic ulcer healing rate at 12 months was much lower in the runoff 0 group when it was compared with healing rates of the runoff 1 group (14.3% versus 60.3%
Ischemic ulcer healing at 12 months (a) and limb salvage at 24 months according to number of patent tibial vessels achieved to the foot. Runoff 0 = none patent tibial vessel achieved (blue line); Runoff 1 = one patent tibial vessel achieved (red line); Runoff >1 = more than one patent tibial vessel achieved (black line). The standard error was >10% for the data shown in dashed lines.
Freedom from MALE+POD at 24 months was lower in the runoff 0 group when it was compared to the runoff 1 group (25.0% versus 74.9%
Amputation-free survival at 24 months was lower in runoff 0 group than in runoff 1 group (43.8% versus 64.3%
Overall survival at 24 months was 84.4% in runoff 0 group, 72.9% in runoff 1 group and 83.6% in runoff >1 group and no statistical differences were observed (runoff >1 versus runoff 1
Freedom from RAS at 24 months was lower in the runoff 0 group when it was compared with runoff 1 group (18.8% versus 42.8%
Freedom from RAO at 24 months in the runoff 0 group was lower than the rates obtained in the runoff 1 group (25.0% versus 66.5%
Eighty-five procedures were analyzed after excluding 16 interventions in which no patent tibial artery to the foot was obtained. The results of these “runoff 0” interventions have been shown above.
Basal characteristics of the patients included are shown in Table
Basal characteristics according to the local perfusion of the ischemic ulcer.
Basal characteristics |
|
|||||
---|---|---|---|---|---|---|
DR# ( |
IR† “through collaterals” ( |
IR† “without collaterals” ( |
DR# versus IR† “through collaterals” | DR# versus IR† “without collaterals” | IR# “through collaterals versus IR† “without collaterals” | |
Age (years) | 72 (63–78) | 72 (68–75) | 69 (63–77) | 0.94 | 0.99 | 0.60 |
Males | 30 (65.2%) | 11 (50.0%) | 9 (52.9%) | 0.23 | 0.37 | 0.85 |
Smoking history | 36 (78.3%) | 15 (68.2%) | 11 (64.7%) | 0.36 | 0.27 | 0.81 |
Dyslipidemia | 13 (28.3%) | 9 (40.9%) | 4 (23.5%) | 0.29 | 0.70 | 0.25 |
Hypertension | 31 (67.4%) | 18 (81.8%) | 14 (82.4%) | 0.26 | 0.35 | 0.96 |
Ischemic heart disease | 17 (36.9%) | 5 (22.7%) | 4 (23.5%) | 0.24 | 0.31 | 0.95 |
Chronic obstructive pulmonary disease | 3 (6.5%) | 2 (9.1%) | 1 (5.9%) | 0.65 | 0.92 | 0.70 |
Stroke | 9 (19.6%) | 6 (27.3%) | 3 (17.3%) | 0.47 | 0.86 | 0.70 |
Preoperative ABI* | 0.50 (0.41–0.68) | 0.60 (0.48–0.74) | 0.64 (0.32–0.67) | 0.30 | 0.79 | 0.48 |
Noncompressible ABI* | 25 (54.3%) | 9 (40.9%) | 7 (41.2%) | 0.30 | 0.75 | 0.26 |
Infected ulcers | 6 (35.3%) | 8 (36.4%) | 18 (39.1%) | 0.82 | 0.78 | 0.94 |
Injured angiosome | ||||||
Dorsalis pedis angiosome | 37 (80.4%) | 16 (72.7%) | 12 (70.6%) | 0.47 | 0.40 | 0.88 |
Medial plantar branch angiosome | 24 (52.2%) | 11 (50.0%) | 10 (58.8%) | 0.86 | 0.63 | 0.58 |
Lateral plantar branch angiosome | 10 (21.7%) | 9 (40.9%) | 3 (17.6%) | 0.09 | 0.51 | 0.16 |
Posterior tibial a. calcaneal angiosome | 5 (10.9%) | 2 (9.1%) | 3 (17.6%) | 0.59 | 0.67 | 0.63 |
Peroneal a. calcaneal angiosome | 5 (10.9%) | 1 (4.5%) | 2 (11.8%) | 0.65 | 0.61 | 0.57 |
Peroneal a. anterior angiosome | 2 (4.3%) | 0 (0%) | 0 (0%) | 0.45 | 0.53 | n.a |
*ABI: ankle-brachial index; #DR: direct revascularization; †IR: indirect revascularization.
TASC-II classification for the worst lesion treated and perioperative data according to the local perfusion of the ischemic ulcer.
Perioperative data |
|
|||||
---|---|---|---|---|---|---|
DR+ ( |
IR |
IR |
DR+ versus IR “through collaterals” | DR+ versus IR |
IR |
|
TASC-B | 3 (6.5%) | 3 (13.6%) | 0 (0%) | 0.38 | 0.55 | 0.24 |
TASC-C | 4 (8.7%) | 3 (13.6%) | 4 (23.5%) | 0.67 | 0.19 | 0.67 |
TASC-D | 39 (84.8%) | 16 (72.7%) | 13 (76.5%) | 0.23 | 0.46 | 0.79 |
Combined treatment* | 20 (43.5%) | 7 (31.8%) | 3 (17.6%) |
|
|
0.46 |
Debridement | 4 (8.7%) | 2 (9.1%) | 2 (11.8%) | 0.95 | 0.65 | 0.78 |
Minor amputation | 12 (26.1%) | 7 (31.8%) | 3 (17.6%) | 0.62 | 0.74 | 0.46 |
Multiple revascularization | 31 (67.4%) | 8 (36.4%) | 7 (41.2%) |
|
|
0.75 |
Runoff 1 | 28 (60.9%) | 20 (90.9%) | 16 (94.1%) |
|
|
0.70 |
Runoff > 1 | 18 (39.1%) | 2 (9.1%) | 1 (5.9%) |
|
|
0.70 |
Postoperative ABI# | 0.85 (0.70–0.95) | 0.91 (0.82–0.95) | 0.80 (0.65–0.91) | 0.30 | 0.79 | 0.48 |
MACE† at 30 days | 1 (2.2%) | 2 (9.1%) | 0 (0%) | 0.24 | 0.54 | 0.49 |
MALE& at 30 days | 1 (2.2%) | 1 (4.5%) | 1 (5.9%) | 0.54 | 0.47 | 0.85 |
Major amputation at 30 days | 1 (2.2%) | 1 (4.5%) | 0 (0%) | 0.54 | 0.73 | 0.37 |
*Combined treatment: combined treatment of the femoropopliteal and the infrapopliteal sector; #ABI: ankle-brachial index; †MACE: major adverse cardiovascular event; &MALE: major adverse limb event; +DR: direct revascularization;
The incidence of MACE, MALE, and major amputation at 30 days was similar between DR, IR “through collaterals,” and IR “without collaterals” groups (Table
Ischemic ulcer healing at 12 months was lower in IR “without collaterals” group when it was compared with DR (7.1% versus 66.0%
Ischemic ulcer healing at 12 months (a) and limb salvage at 24 months according to an angiosome classification of the ulcers. IR: indirect revascularization without collaterals (blue line); IRc: indirect revascularization through collateral vessels (black line); DR: direct revascularization (red line). The standard error was >10% for the data shown in dashed lines.
Freedom from MALE+POD at 24 months was lower in IR “without collaterals” group when it was compared with DR (45.9% versus 80.9%
Amputation-free survival at 24 months was 67.5% in the DR group, 73.3% in the IR “through collaterals” group, and 61.9% in IR “without collaterals” group, and no statistical differences were observed (DR versus IR “through collaterals”
There was a tendency towards a lower freedom from RAS rate at 24 months in the IR “without collaterals” group when it was compared with DR group (22.5% versus 53.0%
Freedom from RAO at 24 months was lower in the IR “without collaterals” group than in DR group (38.5% versus 74.0%
The care of reperfused ischemic ulcers is a major postoperative problem due to the slow tissue healing time and the frequent need for associated techniques on the ischemic wound. Delayed healing is especially important in patients with diabetes mellitus. This disease produces a number of complex biomechanical, neuropathogenic, and immunogenic foot disorders, which are able to reduce the capacity of tissue regeneration [
One of the main advantages of the endovascular treatment is the possibility to “navigate” through the patient’s infragenicular vascular anatomy. Endoluminal techniques offer the chance of treating more than one tibial vessel and this strategy could be associated with better clinical outcomes due to a better hypothetical hemodynamic improvement. According to Faglia et al., the risk of major amputation could increase up to eight times for each obstructed crural artery with alarming proportions in those procedures in which all three crural arteries were occluded [
On the other hand, the success of revascularization, although essential to ensure limb salvage, does not completely reduce the risk of delayed ischemic ulcer healing and major amputation. A healing failure rate and limb loss of around 15% have been reported in patients with pedal tissue loss and successful tibial vein bypasses [
Therefore, according to these results, the depleted choke collateral network seems not to be able to successfully reperfuse foot ischemic wounds in CLI diabetic patients. However, blood flow restoration to the ulcer through patent arterial-arterial connections like pedal arch or distal peroneal branches provided similar results to those obtained after reperfusion of the ulcer through its specific tibial artery in our cohort. The influence of these collateral vessels on distal revascularization results has been widely discussed with contradictory conclusions. Berceli et al. in a retrospective cohort of pedal distal bypasses performed for heel ulcerations described a tendency towards a higher ulcer healing rate in those with a patent pedal arch though no statistical differences were recorded [
This study has some limitations. It is a retrospective analysis; therefore the groups compared are not homologous, as they were not randomly assigned, situation that prevents from firm conclusions. We could not assess the size of the wounds and the different local treatment applied to the ischemic ulcer. Toe pressure was not routinely measured in those patients with noncompressible ABI. Therefore, hemodynamic data should be interpreted with caution. Most of the procedures were performed during the last 5 years of follow-up. This imbalance could be explained by our learning curve and the progressive technical improvement that experience the endovascular techniques in last years making this type of treatment more accessible for patients with CLI. As a result, the procedures indication may be varied over the years as we covered a wide enrollment period. The number of cases of some of the analyzed groups was small due to the limited sample size obtained following our inclusion criteria. This limitation explains why standard errors of some of the Kaplan-Meier curves exceeded the 10% standard error.
With these limitations in mind, our results suggest that obtaining a direct line of blood flow to the foot during a infrapopliteal endovascular procedure performed in diabetics for CLI and tissue loss is mandatory to achieve ischemic ulcer healing and limb salvage. A multiple endovascular revascularization attempt seems secure, although this strategy does not improve the revascularization results. Clinical outcomes are subject to the restoration of blood flow to the local ischemic and are independent of the number of patent tibial vessels obtained after revascularization. In this context, the restoration of blood flow to the ischemic ulcer through a medium or large size collateral vessel could provide similar results in terms of ulcer healing and limb salvage rates to those obtained via its specific source tibial artery. Therefore, a careful study of the foot collateral vessels anatomy should be done before an endovascular infrapopliteal procedure is performed.
According to the data draw in this study we suggest a distal endovascular planning in three steps. First, it is mandatory to obtain a direct straight line to the foot through the easier-to-treat tibial artery, even if the injured angiosome is not anatomically fed because this circumstance improves the results of the revascularization significantly. Second, if in the first step we did not achieve blood flow to the ulcer it is advisable to attempt the revascularization of another tibial vessel specifically related to the ulcer or indirectly-related through collateral vessels. Third, if it is not possible to obtain a direct line to the foot, a distal vein bypass has to be considered if feasible.
The authors declare that there is no conflict of interests regarding the publication of this paper.