|Year : 2020 | Volume
| Issue : 2 | Page : 129-135
Comparative study of outcomes between single-vessel versus multiple-vessel infrapopliteal angioplasties in patients with chronic limb-threatening ischemia
Hemant K Chaudhari, KB Sumanthraj, Vivek Anand, Vishnu Motukuru, S Roshan Rodney, C P S Sravan, K Sivakrishna, KR Suresh
Jain Institute of Vascular Sciences, A Unit of Bhagwan Mahaveer Jain Hospital, Bengaluru, Karnataka, India
|Date of Submission||13-Sep-2019|
|Date of Acceptance||21-Oct-2019|
|Date of Web Publication||17-Jun-2020|
Dr. Hemant K Chaudhari
Jain Institute of Vascular Sciences, A Unit of Bhagwan Mahaveer Jain Hospital, Bengaluru, Karnataka
Source of Support: None, Conflict of Interest: None
Purpose: To determine whether the number of infrapopliteal arteries undergoing endovascular treatment is associated with the limb salvage and wound healing in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: This was a single-center, prospective, nonrandomized study comprising 143 CLTI patients who underwent successful infrapopliteal angioplasty without or corrected inflow femoropopliteal disease, at Jain Institute of Vascular Sciences, Bengaluru, between May 2017 and October 2018. Patients were divided into two groups, based on either a single vessel (SV group, n=91) or a multiple infrapopliteal vessels (MV group, n =52) were angioplastied. Patients with isolated femoropopliteal revascularization, femorodistal bypass, prior vascular intervention, technical failure, and lost to follow-up were excluded. Primary outcomes were limb salvage and wound healing at 6th month. Secondary outcomes were changes in ankle–brachial index (ABI), toe–brachial index (TBI), transcutaneous oxygen saturation (TcPO2), plantar arch quality (PAQ), major adverse cardiac events (MACE), and all-cause mortality at 6th month. Results: Baseline characteristics were comparable in both groups. The wound healing rate (70.12% vs. 62.79%) and limb salvage rate (93.51% vs. 90.70%) at 6th month were comparable among SV and MV groups (P = 0.88 and 0.59, respectively). The mean wound healing time was significantly better in MV group (83 ± 40 vs. 108 ± 43 days) (P = 0.003). MACE (6.59% vs. 9.80%), mortality (15.38% vs. 17.30%), PAQ [complete (31.87% vs. 36.54%), incomplete (48.35% vs. 57.69% ) and absent arch (19.78% vs. 5.76%) in SV and MV groups, respectively], and changes in ABI, TBI, and TcPO2among both groups were comparable, except TcPO2changes at 1 month which showed a significant improvement in MV group (P = 0.03). Conclusions: MV infrapopliteal angioplasties are associated with shorter wound healing time, but have no effect on limb salvage and wound healing rates at 6th month.
Keywords: Chronic limb-threatening ischemia, infrapopliteal vessel angioplasty, limb salvage rate, wound healing
|How to cite this article:|
Chaudhari HK, Sumanthraj K B, Anand V, Motukuru V, Rodney S R, Sravan C P, Sivakrishna K, Suresh K R. Comparative study of outcomes between single-vessel versus multiple-vessel infrapopliteal angioplasties in patients with chronic limb-threatening ischemia. Indian J Vasc Endovasc Surg 2020;7:129-35
|How to cite this URL:|
Chaudhari HK, Sumanthraj K B, Anand V, Motukuru V, Rodney S R, Sravan C P, Sivakrishna K, Suresh K R. Comparative study of outcomes between single-vessel versus multiple-vessel infrapopliteal angioplasties in patients with chronic limb-threatening ischemia. Indian J Vasc Endovasc Surg [serial online] 2020 [cited 2020 Jul 4];7:129-35. Available from: http://www.indjvascsurg.org/text.asp?2020/7/2/129/286909
| Introduction|| |
Infrapopliteal angioplasty has been accepted as a primary modality of revascularization in chronic limb-threatening ischemia (CLTI) patients.,,,,,, This approach offers the advantage of concomitantly treating more than one infrapopliteal vessel and may provide clinical outcomes comparable with those of bypass.,, Various possible explanation has been proposed for this, like even if restenosis/occlusion occurs in one of the infrapopliteal angioplastied vessels, continued perfusion from other vessels could help in better wound healing. Second explanation is that the multiple-vessel (MV) approach could provide greater perfusion to the foot and, therefore, could compensate for an incomplete plantar arch (IPA), improving wound healing speed and limb salvage rate. Despite these proposed potential benefit, risk of major amputation in failed endovascular interventions, risk of major adverse cardiac events (MACEs), and mortality associated with MV intervention should also be considered.
Studies have shown that at least one patent tibial artery to the foot is often needed to achieve a sufficient amount of blood flow necessary for limb salvage and wound healing,,,, but the potential benefit of treating multiple infrapopliteal arteries still remains uncertain.
Therefore, the aim of this study was to evaluate if the number of infrapopliteal arteries treated with endovascular intervention is associated with increased limb salvage rate and wound healing.
| Materials and Methods|| |
The study was previously approved by the local ethical and scientific committee of research and reported as per the STROBE guidelines. Written informed consent was obtained from all patients.
This is a single-center, prospective, observational, nonrandomized, double-arm, comparative, open-ended study comprising 143 CLTI patients with tissue loss who underwent successful infrapopliteal angioplasty without or corrected inflow from May 1, 2017, to October 31, 2018 (18 months) at Jain Institute of Vascular Sciences (JIVAS), a Unit of Bhagwan Mahaveer Jain Hospital, Bengaluru, and were followed up at 1st, 3rd, and 6th months.
- Rutherford Class 5 and 6
- Single or multiple occlusive infrapopliteal vessel lesions
- In-flow vessel (superficial femoral artery and popliteal artery) free from flow-limiting lesion or in-flow lesion correction with bypass or endovascular intervention during index procedure.
- Prior vascular intervention in target limb
- Technical/hemodynamic failure
- Aortoiliac occlusive disease.
Patient selection and methodology
During the study period, 256 patients were admitted in JIVAS with CLTI who underwent infrainguinal revascularization. Among these, 73 patients who required revascularization of isolated femoropopliteal segment (endovascular/open) and other infrainguinal surgery (femorodistal bypass), were excluded from study. The remaining 183 patients underwent infrapopliteal angioplasty ± inflow correction (if any inflow lesion). Among these, 19 patients were lost to follow-up, 13 patient's procedures were technically/hemodynamically unsuccessful, and eight patients had a history of previous vascular intervention in target lower limb, so were excluded from the study. Thus, finally 143 patient were analyzed, who were divided into single-vessel group (SV group) (n = 91) and multiple vessel (MV group) (n = 52) depending on whether one or more than one infrapopliteal vessel underwent successful angioplasty, respectively. Twenty-three patients who died during follow-up (14 in SV group and 9 in MV group) were not available for analysis at 6th month, so excluded for all limb outcome analysis (wound healing and limb salvage) and thus all limb outcomes were calculated for the remaining 120 patients (77 in SV group and 43 in MV group) [Figure 1].
|Figure 1: Patient selection flowchart. CLTI: Chronic limb-threatening ischemia, SV: Single vessel, MV: Multiple vessel|
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In all patients, demographics; history of tobacco use; comorbidities; overall clinical severity based on Rutherford –Becker class and Wound Ischemia foot Infection (WIfI) stage; ulcer/gangrene location were recorded at time of presentation. Pre-operative, postoperative and follow up: 1st, 3rd and 6th month ankle brachial index (ABI); toe brachial index (TBI); trans-cutaneous oxygen saturation (TcPO2) - supine and foot down; any postoperative major adverse cardiac events (MACE) and mortality were recorded prospectively.
. Baseline laboratory investigation and preoperative imaging in the form of arterial duplex/magnetic resonance/computed tomography angiography were recorded in all patients.
Ulcer locations were documented as toe, plantar, foot dorsum, heel, or ankle ulcer. If ulcer was involving multiple areas of foot, it was counted separately in both locations.
Once inflow to the infrapopliteal segment was corrected (if any inflow lesion), standard wire and catheter techniques were used for plain infrapopliteal balloon angioplasty (balloon diameter ranging from 1.5 mm to 3.5 mm). On table completion, digital subtraction angiogram was done in all patients to record the final result and quality of plantar arch. Postprocedure pulse/Doppler signal status was noted, and the ABI/TBI and TcPO2 were done within 48 h postprocedure.
All patients were started on single antiplatelet preoperatively and were changed to dual antiplatelets postoperatively which were continued for a period of 1 month (3 months in case of femoropopliteal stenting).
All procedures were performed by three different consultant vascular surgeons along with vascular fellow. The number of infrapopliteal vessels treated was at the discretion of treating surgeon. The choice of the first artery to treat was based on an analysis of two factors: the easiest artery technically to cross (shorter stenosis/occlusion, less calcified, proximal segment, stenosis preferable to occlusion) and the presence of adequate distal outflow (better distal runoff forming plantar arch). Deliberate angiosome-based revascularization was not performed. MV interventions were defined as interventions on infrapopliteal vessels in parallel, rather than in series. Tibial peroneal trunk (TPT) was considered as an extension of the peroneal and posterior tibial artery (PTA) and dorsalis pedis artery (DPA) as extension of anterior tibial artery (ATA). For example, an angioplasty of the TPT and peroneal vessels would be categorized as a SV intervention, while an angioplasty of the TPT and the ATA/DPA would be categorized as MV.
All patients underwent periprocedural debridement/minor amputation depending on infection status. Patients were followed up daily or alternate days initially depending on wound status. Postprocedure surveillance includes clinical examination and ABI, TBI, and TcPO2(supine and foot down) at 1st, 3rd, and 6th months of follow-up. Postoperative standard wound care was provided as per JIVAS protocol. All patients were made aware about foot care and appropriate foot wear given. The time of wound healing, limb loss, MACE, and mortality were recorded.
The primary outcomes were limb salvage and wound healing rate at 6th month. The secondary outcomes include changes in ABI, TBI, and TcPO2, plantar arch quality (PAQ), MACE, and all-cause mortality rate at 6th month.
Wound healing was defined as complete epithelialization of the tissue defect by secondary intention or tertiary intention., Wound healing time was defined as the number of days taken for complete wound healing after revascularization.
Limb salvage was defined as freedom from major amputation (below or above knee).,
Hemodynamic success was defined as increase in ABI >0.15 and TBI >0.10 or increase in pulse volume recording (PVR) amplitude >50%.,
Procedural technical success is obtaining one straight in-line flow to the foot without any flow-limiting dissection, with <30% residual stenosis of the target vessel being angioplastied. Technical success in MV interventions was defined as successful revascularization of at least two infrapopliteal vessels.,
All-cause mortality was defined as death due to cardiac or any noncardiac cause.
The plantar arches were classified as complete(CPA), incomplete(IPA) and absent plantar arch (APA). CPA was defined as presence of both, DPA and at least one plantar artery, with the communication of these arteries through the deep plantar artery or lateral tarsal artery. IPA was defined as presence of one pedal artery but no plantar arch. APA  was defined as no identifiable pedal artery, with only side branches detectable in the foot.
It was performed using SPSS software (version 20.0; IBM Corp, Armonk, NY, USA). Descriptive statistics were evaluated in terms of frequencies, percentages, or mean ± standard deviations. Categorical variables were evaluated by Fisher's exact test or Chi-square test. Continuous variables were compared using the unpaired t-test. P < 0.05 was considered to indicate a statistically significant difference. Kaplan–Meier analysis was used to estimate cumulative wound healing and limb salvage rate.
| Results|| |
A total of 143 patients underwent successful infrapopliteal angioplasty: 91 in SV and 52 in MV groups. Technical and hemodynamic success rate was 92.89%.
Majority of patients were male (75.82% vs. 82.69%, P = 0.34). Most common comorbidities were diabetes mellitus (89.01% vs. 96.15%, P = 0.21) and hypertension (65.93% vs. 65.38%, P = 0.94), followed by ischemic heart disease (45.05% vs. 40.38%, P = 0.58) in both groups. Almost half of the patients had history of tobacco use (47.25% vs. 50%, P = 0.75). The most common site of ulcer location was toes followed by plantar and heel ulcer (81.23% vs. 76.92%, 25.27% vs. 32.69%, and 23.08% vs. 26.92%) (P = 0.53, 0.34, and 0.64, respectively). Majority of patients were in Rutherford–Becker Class VI (80.22% vs. 86.54%, P = 0.34). Wound, ischemia, and foot infection (WIfI) stage distribution was comparable among both groups, with most patients were in Stage IV (57.14% vs. 57.69%, P = 0.62). Overall, there were no significant baseline characteristic differences between two groups [Table 1].
|Table 1: Baseline characteristics of patients undergoing single-vessel and multiple-vessel infrapopliteal angioplasties|
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Both groups are equal in terms of inflow correction of superficial femoral artery/popliteal steno-occlusive lesions (56.04% vs. 44.23%). The most common modality for inflow correction was endovascular intervention (angioplasty/stenting) (49.45% vs. 42.31%, P = 0.41), followed by open repair (femoropopliteal bypass) (6.59% vs. 1.92%, P = 0.42). There is a significant difference between two groups with respective targeted infrapopliteal vessels. ATA (42.86% vs. 84.6%), PTA (32.97% vs. 65.38%), and peroneal (19.78% vs. 69.23%) were predominantly treated in MV group as compared with SV group (P < 0.001). TPT angioplasties were comparable among two groups [Table 2].
|Table 2: Procedural details of patients undergoing single-vessel and multiple-vessel infrapopliteal angioplasties|
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Limb salvage rate at the end of 6 months in SV group was 93.51% (72/77), whereas in MV group, it was 90.70% (39/43), but this observed difference was not statistically significant (P = 0.59) [Figure 2].
|Figure 2: Limb salvage rate (6 months) in single- and multiple-vessel groups|
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Complete wound healing rate at 6th month was comparable among two groups, 70.12% (54/77) in SV group and 62.79% (27/43) in MV group (P = 0.88) [Figure 3]. The mean wound healing time was significantly better in MV group as compared with SV (108 ± 43 days vs. 83 ± 40 days) (P = 0.003) [Table 3].
|Figure 3: Wound healing rate (6 months) in single- and multiple-vessel angioplasty groups|
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Preoperative, postoperative, follow-up 1st, 3rd, and 6th month ABI and TBI showed no significant differences between the two study groups. Both supine and foot down TcPO2 at 1 month showed significant improvement in MV group as compared to SV group (supine TcPO2 37.58 ± 8.03 vs. 33.21 ± 7.58, P = 0.03 and foot down TcPO2 49.58 ± 10.05 vs. 43.98 ± 8.06, P = 0.03, respectively). Preoperative, postoperative, and follow-up at 3rd and 6th month supine and foot down TcPO2 showed no significant difference between two groups [Table 4].
|Table 4: Ankle-brachial index, toe-brachial index, and transcutaneous oxygen saturation (supine and foot down changes) in single- and multiple-vessel infrapopliteal angioplasty groups|
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Considering the effect on PAQ, complete, incomplete, and APA was observed in 31.87% (29/91), 48.35% (44/91), and 19.78% (18/91) of the patients in SV group and 36.54% (19/52), 57.69% (30/52), and 5.76% (3/52) of the patients in MV group, respectively, which was statistically not significant (P = 0.07) [Table 5].
|Table 5: Effect of single- and multiple-vessel intervention on plantar arch quality|
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Over 6 months, MACEs occurred in 6.59% (6/91) in SV group and 9.80% (5/52) in MV group, which was comparable among two groups (P = 0.86). Mortality from all causes was observed in 15.38% (14/91) and 17.30% (9/52) of the patients in SV and MV groups, respectively. Although the all-cause mortality was high among MV group, this observed difference was not statistically significant (P = 0.57) [Table 6].
|Table 6: Major adverse cardiac events and all-cause mortality in single- and multiple-vessel infrapopliteal angioplasty groups|
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| Discussion|| |
In this prospective study, we have compared outcomes of single infrapopliteal vessel angioplasty with that of multiple infrapopliteal vessel angioplasties. We found that limb salvage and wound healing rate between two groups were comparable, whereas wound healing time was significantly less in MV as compared with SV infrapopliteal angioplasty. Secondary objective of the study showed significant improvement in 1 month TcPO2 in MV group, whereas other secondary parameters such as ABI, TBI, and TcPO2-preoperative, postoperative, 3rd and 6th month; PAQ; MACE, and mortality were equally matched in SV and MV groups.
In our study, there was no significant difference in baseline characteristics among two groups. Darling et al., Biagioni et al., Kobayashi et al., and de Athayde Soares et al. also reported similar findings.
In our study, there was no significant difference in 6-month limb salvage rate between SV and MV groups (93.51% vs. 90.70%) (P = 0.59). de Athayde Soares et al. (89.3% vs. 93.8%) (P = 0.595) and Kobayashi et al. (85.6% vs. 93.9%) (P = 0.18) also noticed the same finding in their study. This implies that limb salvage is not affected by the number of infrapopliteal vessels angioplastied.
All major amputations were due to nonsalvageable foot either due to extensive tissue loss or extensive infection, so, in all amputation patients, wounds were considered to be not healed. In the present study, complete wound healing rate over 6 month, between SV and MV groups, was comparable (70.12% vs. 62.79%) (P = 0.88). Although this observed difference was not statistically significant, Kaplan–Meier curve of wound healing indicates that wound healing was better in MV group compared to SV group for initial 4 months, but from 4 to 6 months, wound healing rate was better in SV group as compared with MV group. Like our study, Darling et al. also did not found any significant difference in 6-month wound healing rate (37% vs. 41%) (P = 0.13). Biagioni et al., in their study, reported better 1-year wound healing rate in MV group (33.60% vs. 63.90%) (P = 0.006). Kobayashi et al. also showed better 1-year wound healing rate in MV group as compared to SV group (87% vs. 79%, P = 0.003). In our study, wound healing rate is better in SV group (though the difference is not statistically significant), possible explanation for this is, more number of diabetes patients (96.15% vs. 89.01%) and more number of patients with Rutherford Class 6 (large wound burden) (86.54% vs. 80.22%) in MV group as compared to SV group ; though these parameters were not statistically significant among two group, they might have contributed for lower wound healing rate in MV group.
The present study showed that the mean wound healing time was better in MV group (83 ± 40 days) as compared with SV group (108 ± 43 days) (P = 0.003). Kobayashi et al. in their study found similar results (83 days vs. 142 days) (P = 0.01). This shorter wound healing time in MV group might be because MV approach could provide greater perfusion to the foot, and therefore, improving wound healing speed and MV approach could also provide continuing healing of the wound, because the perfusion from the other vessel could compensate, even if restenosis occurs in one vessel.
Complete, incomplete, and APA was achieved equally in SV (31.87%, 48.35%, and 19.78%) and MV groups (36.54%, 57.69%, and 5.76%), respectively (P = 0.07). de Athayde Soares et al. also, in their study, found that complete, incomplete, and APA was achieved in 38.9%, 38.9%, and 22.2% in SV group and 27%, 54%, and 19% in MV group (P = 0.29, P = 0.29, and P = 0.52), respectively.
Preoperative, postoperative, and follow-up 1st, 3rd, and 6th month ABI and TBI were comparable among the two groups, implying that MV angioplasties do not give the desired advantage. Kobayashi et al., in their study, found comparable preoperative ABI and TBI among SV and MV group with no significant difference postoperatively.
Both supine and foot down TcPO2 at 1 month showed significant improvement in MV group as compared to SV group (supine TcPO2 37.58 ± 8.03 vs. 33.21 ± 7.58, P = 0.03 and foot down TcPO2 49.58 ± 10.05 vs. 43.98 ± 8.06, P = 0.03, respectively). Rest preoperative, postoperative, 3rd and 6th month (supine and foot down TcPO2) showed no significant difference between two groups. This indicates that MV angioplasties have advantage of improving tissue oxygen saturation probably by providing greater perfusion to the foot, effect of which is maximum at 1 month and it wears off by 3rd month follow-up. Kobayashi et al., in their study, found no significant difference between preoperative and postoperative TcPO2. None of the other studies considered TcPO2 at follow-up.
MACEs over 6 months occurred in 6.59% in SV group and 9.80% in MV group, but this observed difference is not statistically significant (P = 0.86), indicating that targeting more than one vessel might not increase risk of MACE.
Six-month mortality from all causes occurred in 15.38% and 17.30% of the patients in SV and MV groups, respectively; this observed difference was not statistically significant (P = 0.57). de Athayde Soares et al., in their study, found lower perioperative mortality in SV group as compared with MV group (4.2% vs. 16.2%) (P = 0.039).
First, the sample size of the present study was relatively small and this is single-center study. Second, selection of number of infrapopliteal vessel for angioplasty is at operator's discretion; though we tried to reduce this bias by selecting 3 independent vascular surgeons, selection bias cannot be excluded completely. Third, risk of renal impairment with the use of a greater contrast volume, extended procedure time, and radiation exposure which can differ in two groups, were not taken into consideration. Fourth, collateral circulation which may affect outcomes was not taken into consideration.
| Conclusions|| |
From this study, we conclude that multiple infrapopliteal vessel angioplasties may result in shorter time to wound healing, but have no effect on wound healing rate and limb salvage rate.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]