Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 9  |  Issue : 1  |  Page : 3-10

Retrograde tibiopedal access for chronic limb-threatening ischemia: A real-world experience report of 178 consecutive patients


Department of Vascular and Endovascular Surgery, Assiut University Hospitals, Assiut, Egypt

Date of Submission24-Nov-2021
Date of Acceptance17-Dec-2021
Date of Web Publication23-Mar-2022

Correspondence Address:
Mostafa Abdelmonem
Department of Vascular and Endovascular Surgery, Assiut University Hospitals, Assiut
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijves.ijves_123_21

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  Abstract 


Objective: The objective of the current study was to report single-center data concerning the efficacy, safety, and midterm outcomes of retrograde tibiopedal access, after failed antegrade attempts, for management of infrainguinal chronic total occlusions (CTOs) in patients with chronic limb-threatening ischemia (CLTI). Methods: This prospective, observational study was conducted between July 2016 and June 2019 and included 178 patients with infrainguinal CTO in whom a percutaneous tibiopedal access was attempted as a consequence of failed recanalization using an antegrade approach due to ostial lesions or failed re-entry. Results: The study reported access, crossing, and treatment success of 93.8%, 89.9%, and 88.8% of all tibiopedal access attempts, respectively. Primary, assisted primary, and secondary patency rates were 43.8% ± 3.9%, 64.2% ± 3.8%, and 71.7% ± 3.5% at 24 months, respectively. Kaplan–Meier analysis yielded an overall amputation-free survival of 71.1% ± 3.5% at 24 months. Conclusion: Retrograde tibiopedal access is an effective and safe approach as associated with high access, crossing, treatment success, and low complication rates. This approach is considered as a bailout technique during endovascular procedures in recanalization of infrainguinal CTOs, after failed antegrade attempts, in patients with CLTI.

Keywords: Access site complications, chronic limb-threatening ischemia, chronic total occlusion, retrograde access, tibiopedal access


How to cite this article:
Abdelmonem M, Shahat M, Elashry MG, Ali H. Retrograde tibiopedal access for chronic limb-threatening ischemia: A real-world experience report of 178 consecutive patients. Indian J Vasc Endovasc Surg 2022;9:3-10

How to cite this URL:
Abdelmonem M, Shahat M, Elashry MG, Ali H. Retrograde tibiopedal access for chronic limb-threatening ischemia: A real-world experience report of 178 consecutive patients. Indian J Vasc Endovasc Surg [serial online] 2022 [cited 2022 May 28];9:3-10. Available from: https://www.indjvascsurg.org/text.asp?2022/9/1/3/340498




  Introduction Top


The estimated incidence of peripheral arterial disease (PAD) in 2010 was more than 200 million people worldwide, however, the true burden of the disease is almost certainly underestimated due to extremely limited reliable epidemiologic data.[1],[2]

Severe degree of PAD which is called chronic limb-threatening ischemia (CLTI) includes a wide array of heterogeneous group of patients with different degrees of ischemia causing ischemic rest pain, impaired wound healing, tissue necrosis, and/or increased risk of amputation.[2]

The presence of widespread multilevel disease associated with long, calcified, chronic total occlusions (CTOs) which is frequently found in patients with CLTI makes endovascular revascularization which is an established approach for limb salvage very challenging.[3],[4],[5]

Moreover, in 20% of infrainguinal endovascular intervention using the antegrade, ipsilateral or contralateral femoral approach is unsuccessful in crossing CTO lesions,[6],[7],[8] with a consequent increased risk of major amputations and death.[9]

Tønnesen et al.[10] were the first one to describe retrograde access in 1988; since then, many distal access sites have been used to overcome failed antegrade recanalization, especially in patients who are poor candidates for surgical reconstruction due to anatomical or general causes.[11]

The aim of the current study was to report single-center data concerning the efficacy, safety, and midterm outcomes of retrograde tibiopedal access, after failed antegrade attempts, for management of infrainguinal CTOs in patients with CLTI.


  Methods Top


This prospective, nonrandomized, observational study was conducted between July 2016 and June 2019 in a single tertiary referral university hospital. It included all consecutive patients presenting with intermediate and advanced limb-threatening ischemia (Wound, Ischemia, and foot Infection [WIfI] stages 2–4) associated with significant perfusion deficits (WIfI ischemia grades 2–3), according to WIfI classification system,[12] due to an infrainguinal CTO in whom a percutaneous tibiopedal access was attempted as a consequence of failed recanalization using an antegrade approach. There were no specific exclusion criteria.

The Institutional Review Board approved the study protocol developed in accordance with the Declaration of Helsinki. All patients provided written informed consent for the study enrollment and planned revascularization procedure.

Patient evaluation

All patients underwent physical examination, clinical risk assessment, ankle-brachial index (ABI)/toe-brachial index measurements, and preoperative diagnostic imaging by duplex ultrasound (DUS) examination and computed tomography angiography, in order to plan the access and treatment strategy.

The anatomic pattern of arterial disease was defined according to the Global Anatomic Staging System.[2]

Calcification of target lesions was quantified according to the Peripheral Artery Calcium Scoring System[13] that stratifies calcium degree into five grades: Grade 0, no visible calcium at the target lesion site; Grade 1, unilateral calcification <5 cm long; Grade 2, unilateral calcification ≥5 cm; Grade 3, bilateral wall calcification <5 cm; and Grade 4, bilateral calcification ≥5 cm.

All patients followed the best medical treatment protocol, including statins, aspirin 75 mg/day, and they were given clopidogrel 300 mg as a loading dose the day before the procedure.

Procedure description

Patients were treated according to the standard of care at our hospital by experienced vascular surgeons. All procedures were performed under local or regional anesthesia in a hybrid operating room equipped with a digital angiographic system (Artis zee; Siemens Healthineers, Erlangen, Germany).

The antegrade approach to the target lesion was initially attempted in all patients, and was either (a) ipsilateral via the common femoral artery with insertion of a 6-Fr, 10-cm-long sheath (Prelude; Merit Medical, South Jordan, UT, USA) or (b) contralateral using 6-F, 40-cm-long crossover sheath (Balkin Up and Over; Cook Medical, Bloomington, IN, USA). After sheath insertion, 5000 IU bolus of heparin was administered intra-arterial, with an additional 2500 IU given for procedures longer than 1 h. Once re-entry into the distal true lumen was unsuccessful via an antegrade approach, attention was directed toward a retrograde tibiopedal approach guided by fluoroscopy or DUS.

Usually, an area of the target vessel that was patent and as healthy as possible was chosen to be the point of access. Leg was adequately positioned to maximize the exposure of the target vessel being accessed. For access to anterior tibial artery (ATA), dorsalis pedis artery (DPA), and peroneal artery (PA), the leg was kept in the natural anteroposterior orientation with the toes directed nearly 90° upward using a rolled-up towel stabilizing the foot at the lateral side.[14] Whereas for access to posterior tibial artery (PTA), the leg was externally rotated with abduction of the hip and slight flexion of the knee.[15]

The C-arm was then adjusted to hit the target artery in a 90° fashion. For access to the DPA, the C-arm was brought into an ipsilateral oblique (10°–15°) and cranial position. The more proximal ATA or PA required a more ipsilateral oblique (30°–40°) position, while the PTA required a contralateral oblique position (60°).[14]

Puncture was performed using a 21-gauge, 7-cm-long needle (Cook Medical), after intra-arterial administration of 200–400 μg nitroglycerin (depending on the patient's blood pressure) through the proximal sheath to minimize vasospasm of the tibial vessels.

If the needle depth in relation to the target vessel was in doubt, the C-arm was moved 90° to the original position, and contrast injection was used to investigate the depth. Subsequently, the C-arm was brought back to the original position prior to proceeding with the puncture.[14]

After successful puncture, a 0.018-inch guidewire (V-18 Control; Boston Scientific, Marlborough, MA, USA) was inserted through the needle. Then, 0.018 platform support (TrailBlazer, Medtronic Inc., Santa Rosa, CA, USA; CXI, Cook Medical) or balloon (Pacific Plus, Medtronic Inc.) catheter was advanced over the guidewire in a sheathless manner to minimize trauma to the access artery. Contrast medium was injected through the catheter to confirm intraluminal position.

Retrograde negotiation of the CTO lesion was performed, using the combination of guidewire and support/balloon catheter [Figure 1]. In the case of failure of retrograde wire crossing, one or more of the following techniques were adopted: (a) reversed CART technique in which a proximally inserted balloon was inflated in the subintimal space to disrupt the dissection membrane, then retrograde guidewire was advanced along to the deflated balloon,[14],[16] and (b) double-balloon technique in which two balloons were inserted from both directions, apposed in the subintimal space (only separated by 0.5 cm), and then simultaneously inflated. Once the dissection membrane was disrupted, guidewire was advanced from either the antegrade or retrograde direction.[7]
Figure 1: Retrograde negotiation of the chronic total occlusion lesion using the combination of a guidewire and support catheter (arrow)

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Once the guidewire has passed the CTO and entered the proximal true lumen as confirmed by contrast injection, it was snared from above through a 5-Fr Judkins right 4.0 or Bern catheter (Boston Scientific) [Figure 2] to allow externalization of the guidewire out of the antegrade sheath. Afterward, a balloon was inserted via the antegrade sheath through the occlusion to enable reversing the guidewire so that its soft tip directed downward, then balloon angioplasty and/or stenting was accomplished in the standard antegrade fashion.
Figure 2: A retrograde 0.018-inch guidewire exiting a Bern catheter and snared from above through a 5-Fr Judkins right catheter (arrow) at the level of common femoral artery

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No drug-coated balloons, atherectomy devices, or re-entry catheters were used in this study. Hemostasis of the distal puncture site was secured by manual compression for 5–10 min, inflation of a blood pressure cuff 10 mmHg more than the systolic blood pressure for 5 min, and/or prolonged low-pressure balloon inflation at the site of puncture. All patients received lifelong aspirin 75 mg/day plus clopidogrel 75 mg/day for 3 months.

Follow-up protocol

All patients underwent DUS examination the day after the procedure to detect possible access site complications. Afterward, they were scheduled for routine follow-up visits comprising both physical and DUS examinations at our outpatient clinic every 3 months for the first 2 years and yearly thereafter. A further follow-up was then tailored for each patient.

Outcome measures

Short-term outcome measures were: (a) access success, defined as the ability to gain percutaneous entry into a tibiopedal artery in the desired location with subsequent intraluminal guidewire delivery; (b) crossing success, defined as the ability to pass a guidewire through the proximal boundary of an infrainguinal CTO via a tibiopedal access; (c) treatment success, defined as residual diameter stenosis of <30% at the end of the procedure as demonstrated on completion angiography; and (d) procedural complications, defined and categorized according to SIR criteria.[17]

Long-term outcome measures were: (a) primary patency, defined as freedom from clinically driven target lesion revascularization (CD-TLR) and restenosis (DUS peak systolic velocity ratio >2.5); (b) assisted primary patency, defined as patency maintained with the use of an additional (surgical or endovascular) procedures as long as occlusion of the primary treated site has not occurred; (c) secondary patency, defined as patency obtained with the use of an additional procedure after occlusion occurs; (d) CD-TLR, defined as any re-intervention at the target lesion (s) due to symptoms or drop of ABI of ≥20% or >0.15 when compared to postprocedure baseline ABI; (e) limb salvage, limbs that required minor amputation (toe, ray, or transmetatarsal amputation) but ultimately healed were considered successful limb salvage. Whereas limbs that required major amputation (above or below knee) were considered as failed salvage; and (f) amputation free survival (AFS), defined as time until a major (above-ankle) amputation of the index limb or death from any cause.

Statistical analysis

Descriptive statistics were used, with continuous variables expressed as mean ± standard deviation and/or median and interquartile range, and categorical variables as frequency and percentage. Kaplan–Meier survival curve was used to estimate patency rates, CD-TLR, limb salvage, AFS, and reported as proportion ± standard error. P < 0.05 was considered the threshold of statistical significance. Statistical analysis was performed using SPSS 24.0 (SPSS Inc., Chicago, IL, USA) and MedCalc 16.8 (MedCalc Software, Ostend, Belgium).


  Results Top


Between July 2016 and June 2019, 1234 patients with intermediate and advanced limb-threatening ischemia underwent endovascular recanalization of an infrainguinal CTO using the conventional antegrade approach. Among them, 178 patients (178 limbs, 14.4%), including 124 males (69.7%) with a mean age of 64.1348 years, underwent attempts for retrograde tibiopedal access after failed recanalization using the antegrade approach, and those constituted our study cohort.

Forty-seven patients (26.4%) presented with rest pain, while 131 patients (73.6%) had tissue loss. Patients' demographics and clinical characteristics are summarized in [Table 1]. One hundred forty-five patients (81.5%) had de novo atherosclerotic lesions. The mean CTO lesion length was 14.7 ± 4.01 cm. Moderate-to-severe calcification was encountered in 87 patients (48.9%). Further lesion characteristics are illustrated in [Table 2].
Table 1: Demographics and clinical characteristics of the study cohort

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Table 2: Lesion characteristics

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The most common indication for retrograde approach was failure to cross the occlusion from antegrade, as encountered in 82 patients (46.1%). The PTA and the proximal ATA were the most frequent vessels utilized for retrograde access in 86 (48.3%) and 68 patients (38.2%), respectively. Fluoroscopy was used to guide the retrograde access in 115 patients (64.6%), while ultrasound guidance was used in 63 patients (35.4%) [Table 3].
Table 3: Procedural details

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Access success was obtained in 167 patients (167/178, 93.8%). The target vessel puncture was unsuccessful in 11 cases with subsequent failure of intraluminal wire delivery, and that was attributed to severe calcification at the target access site. Sheathless approach was used in all cases with insertion of either a support (124 patients, 74.3%) or balloon catheter (43 patients, 25.7%) over a 0.018-inch wire. Adjunctive maneuvers, namely reversed CART, and double-balloon techniques were required for successful wire crossing in 36 (21.6%) and 14 patients (8.3%), respectively [Table 3].

Crossing success was reported in 95.8% (160/167) of successful retrograde access cases. For the remaining 7 cases, failure was owing to an inability to traverse the occlusion (3 patients), or enter the proximal true lumen (4 patients), with a subsequent procedure abortion.

The failed 18 cases (11 failed access, 7 failed crossing) underwent either distal bypass (11 patients) in the case of good life expectancy, surgical risk, and autogenous conduit or major amputation (7 patients) if any of the former factors was not fulfilled.

The treatment applied after successful guidewire crossing and entrance into the proximal true lumen was standard balloon angioplasty in 132 patients (82.5%), while stenting was deemed necessary in 28 patients (17.5%). Treatment success was obtained in 158 (98.8%) of the 160 cases in which wire crossing was achieved [Table 3].

Hemostasis was obtained at the tibiopedal access site by manual compression in 120 patients (71.9%). Additional blood pressure cough or balloon tamponade was necessary to secure hemostasis in 42 (25.1%) and 12 patients (7.2%), respectively [Table 3].

Complications were reported in 23 patients (23/178, 12.9%), including 17 (9.5%) tibiopedal access site complications. Vessel spasm at the distal access site was the most commonly encountered complication (8 patients, 4.5%), and managed with additional intra-arterial administration of nitroglycerin. Nine patients (5.1%) had access site hematoma, including 5 cases at the femoral access site and 4 cases at the tibiopedal access site, and all were managed conservatively. One femoral pseudoaneurysm was reported, which required surgical repair. Two patients developed access site thrombosis, and were treated successfully with aspiration thrombectomy. Another two patients had access site occlusion, and underwent uneventful conventional balloon angioplasty. One small arteriovenous fistula was encountered at the distal access site; however, it was not considered clinically relevant, and required no treatment. No other adverse events were reported in the periprocedural period [Table 4].
Table 4: Procedural complications

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All patients were followed up for a mean period of 29.2 ± 4.0 months (median, 28 months; range, 24–38 months). Of patients who underwent successful recanalization using tibiopedal access, the primary, assisted primary, and secondary patency rates were 67.6% ± 3.6%, 78.%2 ± 3.1%, and 82.8% ± 2.9% at 12 months, and 43.8% ± 3.9%, 64.2% ± 3.8%, and 71.7% ± 3.5% at 24 months, respectively [Figure 3]. Freedom from CD-TLR was 72.9% ± 3.4% and 55.4% ± 3.9% at 12 and 24 months, respectively [Figure 4].
Figure 3: Kaplan–Meier analysis of primary (solid line), assisted primary (dashed line), and secondary (dotted line) patency rates of patients with successful recanalization using tibiopedal access

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Figure 4: Kaplan–Meier estimates of freedom from clinically driven target lesion revascularization of patients with successful recanalization using tibiopedal access

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During the follow-up period, 28 patients (11.2%) lost to follow-up, 12 patients (6.7%) died, and 37 patients (20.7%) underwent major amputation. Kaplan–Meier analysis yielded an overall limb salvage rate of 88.5% ± 2.4% and 77.4% ± 3.3% and AFS of 84.5% ± 2.7% and 71.1% ± 3.5% at 12 and 24 months, respectively [Figure 5].
Figure 5: Kaplan–Meier estimates of amputation-free survival of the overall study cohort

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  Discussion Top


The global prevalence of PAD has increased dramatically in the recent years, driven by the increase in life expectancy and prevalence of diabetes mellitus.[1]

When treating CTOs, the advocated “endo-first” approach, using the standard antegrade technique, may fail to cross the lesion or re-enter the distal true lumen in a considerable number of cases.[6],[7]

The retrograde approach is a relatively recent innovation in vascular surgery. In 1988, Tønnesen et al.[10] were the first to report retrograde puncture of the popliteal artery under fluoroscopy in 50 patients via skin incision made directly over the popliteal artery with the patient in prone position. Two years later, Iyer et al.[18] reported successful retrograde recanalization of an occluded PTA using a cutdown at the level of the ankle in two cases. Since then, this approach has undergone an enormous evolution, and nowadays, almost every infrainguinal arterial segment can be accessed percutaneously in retrograde fashion while the patient in supine position.[7],[19],[20]

Both fluoroscopy and DUS can be used to guide retrograde access. Fluoroscopy is preferred in obese patients, presence of leg edema, and when accessing heavily calcified or deep vessels as proximal ATA and PA. However, it typically requires complex positioning of the X-ray tube and image intensifier, and stable position of the foot to allow for an optimal adjustment of the C-arm to the course of the access arteries. On the other hand, DUS has the advantages of minimizing the contrast medium dosage and radiation exposure. However, heavily calcified vessels can cause extensive shadowing that which will make the visualization difficult. Furthermore, it requires special experience as visualization of tip of micropuncture needles (unless echogenic) is difficult.[4],[14],[21]

In a systematic review comprising 1168 below-the-knee (BTK) attempts in 19 studies, access, crossing, and treatment success were obtained in 94.0%, 86.0%, and 84.0% of all attempts, respectively.[11] This is in accordance with results of the current study that reported access, crossing, and treatment success of 93.8%, 89.9%, and 88.8% of all tibiopedal access attempts, respectively.

Considering that 14.4% (178/1234) of CLTI patients with infrainguinal CTOs treated at our institution experienced failed antegrade approach, then only 10.1% (18/178) experienced failed retrograde access/crossing, this implies that only 1.5% (18/1234) of CTO lesions cannot be endovascularly treated.

There are several proposed advantages of retrograde approach compared to the standard antegrade one that may contribute to its high success rate. First, the distal cap of CTO lesion is often soft and thin in contrast to the hard fibrotic proximal cap, thus increasing the likelihood of successful lesion crossing via the retrograde approach.[22],[23] Second, it provides more control and pushability of the wire through the occlusion due to proximity to the target lesion.[24] Third, there is less tendency of the guidewire to divert into collaterals, as they are usually pointing in a craniocaudal direction opposite to that of the wire, thus maintaining a straight path inside the main vessel.[4],[7],[25]

In the current study, Kaplan–Meier estimate of primary patency was 67.6% and 43.8% and AFS was 84.5% and 71.1% at 12 and 24 months, respectively. In a series of 579 retrograde attempts, Schmidt et al.[5] reported a primary patency rate of 36.0% and 21.5% and AFS of 78.4% and 66.6% at 12 and 24 months, respectively. These results reflect the unique study population and severity of the disease. However, without successful revascularization, the results would have been much worse.[26]

Complications were reported in 9.6% of tibiopedal access attempts, and vessel spasm was the most commonly encountered one (4.5%). Schmidt et al.[5] reported 17.7% access site complications, with vessel spasm in 14.8% of cases. On the other hand, Welling et al.[11] reported 4.1% access site complications among 1168 BTK puncture attempts, and the most common was vessel perforation (1.1%).

Given the high success and low complication rates in addition to improved experience and endovascular tools, some authors have treated infrainguinal CTOs completely via a tibiopedal access in patients whom body habitus, comorbidities, unfavorable aortoiliac anatomy, or hostile groins precluded conventional femoral access.[27],[28],[29] On the contrary, most of the published series have considered retrograde approach as bailout access after failed antegrade one.[5],[7],[19],[20],[23],[30]

Furthermore, the liberal use of retrograde approach in claudicants remains a subject of debate. Although pioneer endovascular surgeons in highly expert centers have adopted this approach in claudicants,[5],[24],[29] others have reserved it to CLTI.[19],[20],[23],[25],[30] The argument is that retrograde approach involves a rare albeit real risk of arterial disruption, a devastating complication that may have a drastic limb effect in someone who was not initially at risk.[4]

Limitations of this study are that it is a single-center, single-arm study, with moderate number of patients, and only short-term access site complications. However, the authors do believe that this study provides high-level scientific data as it includes all CLTI comers with no exclusion criteria regarding patient comorbidities or lesion characteristics, thus representing a real-world experience. Furthermore, an advantage of this single-center study is to exclude any confounding variables that may arise when patients are treated at different hospitals. Finally, the value of tracing long-term access site complications remains controversial as vessel deterioration resulting from progression of atherosclerotic PAD cannot be ruled out.


  Conclusion Top


According to this analysis of single-center data, retrograde tibiopedal access is an effective and safe approach as associated with high access, crossing, treatment success, and low complication rates. This approach adds to the armamentarium of endovascular procedures in recanalization of infrainguinal CTOs, after failed antegrade attempts, in patients with CLTI. The midterm outcomes of this study reflect the unique study population and severity of the disease.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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