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Integrative Journal of Diabetes and Kidney Diseases [JDKD] Volume 2020 Issue 01 May 04, 2020 Int j diabetes & kidney dis, Volume 01(01): 1–7, 2020 Introduction Peripheral Arterial Disease (PAD) is a disorder of progressive stenosis and/or occlusion in the arteries of the upper and lower extremities. It is estimated that >200 million people worldwide have some degree of PAD [1]. It affects the lower limbs more commonly and is characterized by claudication or Critical Limb Ischaemia (CLI). Initial therapy starts with lifestyle modification such as smoking cessation, exercise programmes and healthier diets. Risk factor control is also imperative such as the use of statins, antiplatelets and blood glucose control, in Retrograde Revascularisation in Patients with Critical Limb Ischaemia and Diabetic Foot Aimen Gmati*, Terri-Ann Russell, Badri Vijaynagar, Hazel Chon, Robert Hicks, Sreevalsan Kappadath, Gabor Libertiny, Avtar Brar, Vijay Bahal, Ganesh Alluvada, Davis omas, and Maher Hamish Department of Vascular and Endovascular Surgery, Northampton General Hospital NHS Trust, UK Received: April 25, 2020; Accepted: May 01, 2020; Published: May 04, 2020 R-Infotext Citation: Gmati A, Terri-Ann R, Vijaynagar B, Chon H, Hicks R, et al. (2020) Retrograde Revascularisation in Patients with Critical Limb Ischaemia and Diabetic Foot. Int j diabetes & kidney dis 01(01): 1–7. Abstract e primary objective of this study was to assess the immediate success rate of the retrograde approach for arterial revascularization in patients with critical limb ischaemia, with a particular focus on the outcomes of diabetic patients. A prospective cohort study was performed between May 2019 – February 2020 to assess the success rate of using the retrograde approach in patients with critical limb ischaemia. e patients either had a failed previous attempt at antegrade angioplasty or first- time angioplasty, with non-invasive imaging showing a patent pedal/tibial or popliteal artery. e access vessels used were the popliteal, posterior tibial, anterior tibial artery and the dorsalis pedis. 21 patients with critical limb ischaemia had retrograde angioplasty performed. 48% (10/21) patients were known to have diabetes mellitus. In the total cohort, 57% (12/21) underwent secondary angioplasty having failed a previous attempt at antegrade. In the diabetic group, 60% (6/10) were attempting retrograde as a secondary procedure. Four had popliteal access (19%), eight had posterior tibial access (38%), seven had anterior tibial access (33%), and two cases (10%) used dorsalis pedis as the access vessel. In 16/21 (76%) patients, there was successful revascularisation with excellent results. In the diabetic group, there was a 70% (7/10) success rate. All access sites were controlled with pressure only. Patients were sat up directly post-procedure and mobilised within one hour. No use of closing devices and access sheaths were pushed to a maximum of 6Fr in some cases. ere were no peri-procedural complications and no access complications. is cohort showed that retrograde access is a suitable option for patients whom have initially failed antegrade. In a specific group of patients, the retrograde approach could be considered to be a primary access site with minimal complications. With early mobilisation and no closing devices, this approach could save time, money and resources. Keywords: Peripheral Arterial Disease (PAD); Peripheral Vascular Disease (PVD) Critical Limb Ischaemia (CLI); Angioplasty; Arterial Revascularisation; Retrograde Access; Diabetic foot. Research Article

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Page 1: Retrograde Revascularisation in Patients with Critical ... · Department of Vascular and Endovascular Surgery, Northampton General Hospital NHS Trust, UK Received: April 25, 2020;

Integrative Journal of Diabetes and Kidney Diseases [JDKD]

Volume 2020 Issue 01

May 04, 2020 Int j diabetes & kidney dis, Volume 01(01): 1–7, 2020

Introduction

Peripheral Arterial Disease (PAD) is a disorder of progressive stenosis and/or occlusion in the arteries of the upper and lower extremities. It is estimated that >200 million people worldwide have some degree of PAD [1]. It affects the lower limbs more commonly and is

characterized by claudication or Critical Limb Ischaemia (CLI).

Initial therapy starts with lifestyle modification such as smoking cessation, exercise programmes and healthier diets. Risk factor control is also imperative such as the use of statins, antiplatelets and blood glucose control, in

Retrograde Revascularisation in Patients with Critical Limb Ischaemia and Diabetic FootAimen Gmati*, Terri-Ann Russell, Badri Vijaynagar, Hazel Chon, Robert Hicks, Sreevalsan Kappadath, Gabor Libertiny, Avtar Brar, Vijay Bahal, Ganesh Alluvada, Davis Thomas, and Maher Hamish

Department of Vascular and Endovascular Surgery, Northampton General Hospital NHS Trust, UK

Received: April 25, 2020; Accepted: May 01, 2020; Published: May 04, 2020

R-Infotext Citation: Gmati A, Terri-Ann R, Vijaynagar B, Chon H, Hicks R, et al. (2020) Retrograde Revascularisation in Patients with Critical Limb Ischaemia and Diabetic Foot. Int j diabetes & kidney dis 01(01): 1–7.

Abstract

The primary objective of this study was to assess the immediate success rate of the retrograde approach for arterial revascularization in patients with critical limb ischaemia, with a particular focus on the outcomes of diabetic patients.

A prospective cohort study was performed between May 2019 – February 2020 to assess the success rate of using the retrograde approach in patients with critical limb ischaemia. The patients either had a failed previous attempt at antegrade angioplasty or first-time angioplasty, with non-invasive imaging showing a patent pedal/tibial or popliteal artery. The access vessels used were the popliteal, posterior tibial, anterior tibial artery and the dorsalis pedis.

21 patients with critical limb ischaemia had retrograde angioplasty performed. 48% (10/21) patients were known to have diabetes mellitus. In the total cohort, 57% (12/21) underwent secondary angioplasty having failed a previous attempt at antegrade. In the diabetic group, 60% (6/10) were attempting retrograde as a secondary procedure. Four had popliteal access (19%), eight had posterior tibial access (38%), seven had anterior tibial access (33%), and two cases (10%) used dorsalis pedis as the access vessel. In 16/21 (76%) patients, there was successful revascularisation with excellent results. In the diabetic group, there was a 70% (7/10) success rate. All access sites were controlled with pressure only. Patients were sat up directly post-procedure and mobilised within one hour. No use of closing devices and access sheaths were pushed to a maximum of 6Fr in some cases. There were no peri-procedural complications and no access complications.

This cohort showed that retrograde access is a suitable option for patients whom have initially failed antegrade. In a specific group of patients, the retrograde approach could be considered to be a primary access site with minimal complications. With early mobilisation and no closing devices, this approach could save time, money and resources.

Keywords: Peripheral Arterial Disease (PAD); Peripheral Vascular Disease (PVD) Critical Limb Ischaemia (CLI); Angioplasty; Arterial Revascularisation; Retrograde Access; Diabetic foot.

Research Article

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May 04, 2020 Int j diabetes & kidney dis, Volume 01(01): 2–7, 2020

diabetic patients. Along with best medical therapy some patients may need further intervention to treat symptoms whether via endovascular, surgical interventions or hybrid procedures.

Use of endovascular options such as angioplasty and/or stenting are increasing worldwide, which is also evident in the UK. In the three years between 2014–2016, 13,886 lower limb procedures were submitted to the National Vascular Registry (case ascertainment around 60%). In the following years between 2016–2018, the NVR reports a substantial increase to 22,109 procedures. However, this is only the data submitted to the registry. With the low case ascertainment rates and the variation between NHS trusts, the true figure is estimated to be three times this amount [2].

In approximately 15–20% of patients with infra-inguinal arterial occlusive lesions the lesion cannot be crossed using antegrade vascular access from the common femoral artery as is conventionally used [3]. A viable option for these patients would be retrograde pedal/tibial access. Despite it being first described approximately 20 years ago, retrograde pedal/tibial access is still extremely under-utilized [4]. For those who do use this technique, it is thought to be best reserved for patients with CLI who fail initial antegrade angioplasty.

The primary objective of this study was to assess the immediate success rate of the retrograde approach for arterial revascularization in patients with critical limb ischaemia, with a focus on the outcomes of diabetic patients.

The secondary objective was to identify the scope for utilising the retrograde approach as first line management, or whether it should be reserved for use as an adjunct to the antegrade approach.

Material and Methods

This is a prospective study analysing the use of retrograde pedal access for infra-inguinal peripheral arterial disease during the period of May 2019 to February 2020 in patients who had critical limb ischaemia. The inclusion criteria were that the patients had a failed previous attempt at antegrade angioplasty or it was thought that antegrade angioplasty would be more difficult than retrograde

access and had non-invasive vascular imaging confirming a patent distal vessel. The approach itself was decided at the time by the interventionist doing the procedure.

Arterial cannulation was performed using a micro-puncture introducer (COOK), 4Fr sheath (up to 6Fr), Stiff TERUMO or V18 Guidewire, and Glide Catheter (NAVICROSS or CXI). All access was ultrasound guided. All cannulation was done using a 0.18 wire and a cocktail of 3000 units of unfractionated heparin, 200 micrograms GTN and 2.5 mg of verapamil as a prophylaxis for intra-arterial spasms.

Results and Discussion

There were a total of 21 cases of retrograde access during the time period observed, of which 18 were male and 3 females. The mean patient age was 70 years. 48% were known diabetics (10/21) and 71% (15/21) were known to have hypertension or have ischaemic cardiovascular disease (see Fig. 1). All patients had a degree of CLI presenting either with rest pain or tissue loss with or without superimposed infection.

When looking at the vascularity of these patients – all presented with SFA/popliteal and/or other multi-level occlusive disease. Antegrade angioplasty had initially failed 57% of the cohort (12/21) leading to the use of retrograde approach as secondary angioplasty. In 43% patients (9/21), this technique was used as the primary mode of access.

In the total cohort 57% (12/21) patients underwent secondary angioplasty having failed a previous attempt at antegrade angioplasty. In the group of patients with diabetes, 60% (6/10) were attempting retrograde as a secondary procedure (see Figure 1).

Four (19%) had popliteal access, eight (38%) had posterior tibial access, seven (33%) had anterior tibial access, and two (10%) cases used the dorsalis pedis as the primary access vessel (see Figure 2).

In 16/21 (76%) patients, there was successful revascularisation with excellent immediate results. In the diabetic group, there was a 70% (7/10) success rate.

In terms of the recovery period; patients were sat up directly post-procedure and mobilised within one hour.

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Figure 1: patient demographics including gender, risk factors/co-morbidities and type of angioplasty.

Figure 2: chart showing proportion of arterial access sites used.

This is compared to the femoral antegrade approach when patients need to be supine for two hours and bedrest for two hours, or 1 hour/1 hour if a closing device is used.

Access sheaths up to a maximum of 6Fr were used in some below-the-knee cases. There were no uses of closing devices and any reported peri-procedural or access complications. Patients were followed up clinically and with regular duplex scanning.

In another case, a 70 year old known vasculopath with chronic kidney disease stage 4 (on haemodialysis) was admitted with diabetic foot sepsis and gangrenous 2nd and 3rd toes (see Figure 5). Most notably, the patient had untreated diabetes with an HbA1c > 100mmol/mol (>11.5%) on admission.

Published data on retrograde endovascular procedures is relatively far and few. There are few reports on small

case series and individualised case reports of the retrograde technique being used, mostly with patients who fail antegrade angioplasty.

One paper presented six cases in which retrograde pedal access was used in patients with critical limb ischaemia who failed conventional antegrade angioplasty [5]. In four patients the posterior tibial artery was used, and in two patients the dorsalis pedis was the artery of choice. All cases showed successful recanalisation, with no major complications peri-procedurally.

In 2010, a case series of 273 patients with critical limb ischaemia who had retrograde intervention performed was presented at the VEITH symposium [6]. There was anterior tibial access in 54%, posterior tibial in 45%, and peroneal artery in 1%. Immediate success was noted in 96% of cases.

Another study presented 13 cases of failed antegrade angioplasty of tibial vessels [7]. 11 patients had access through posterior tibial and two patients had access through the dorsalis pedis artery. In 11/13 (85%) there was successful reopening of the tibial vessel.

A 2008 article in the Journal of Endovascular Therapy reported retrograde access being performed in 51 cases. All the patients had previously failed antegrade revascularisation of at least one tibial artery. The success rate in this cohort was around 86% with 44/51 patients having a successful angioplasty. It was reported that in one case there was dorsalis pedis artery occlusion at the access site, requiring surgical thrombectomy [8].

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Figure 3: these images are of a primary angioplasty that was accessed via the posterior tibial artery. The sheaths were upsized to 6Fr and two stents were successfully deployed. Left: duplex showing long occluded right SFA. Middle left: occluded right SFA pre-angioplasty. Middle right: gradual ballooning of the vessel. Right: SFA post-angioplasty showing successful recanalisation of the artery.

Figure 4: Follow-up duplex scan of the same patient at 3 months shows the vessel has remained patent.

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Figure 5: Images showing this patient’s diabetic foot disease on presentation pre-procedure.

Figure 6: Pre-angioplasty images showing an occluded right SFA and popliteal artery. After failing primary antegrade angioplasty, it was deemed that the foot was not salvageable and a below-knee amputation would be required. Secondary retrograde angioplasty was attempted as a last-resort.

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Figure 7: Post-angioplasty images showing access from the right ATA, just below the knee joint on the proximal lateral side. An 018 wire was passed into the popliteal artery; the sheath was upsized to 5Fr and the track was dilated to 5mm. After crossing the lesion, gradual ballooning, and deployment of two stents, there was recanalisation of the SFA and effective revascularisation of the foot. This patient had very narrowly avoided a BKA.

In a 2013 paper that reviewed the technical details on retrograde angioplasty, the author reports that when looking at the published data, the technique is safe and feasible [9]. However, there should be great selectivity in which patients receive this mode of treatment. He reports that retrograde access should be reserved for limb salvage in critical limb ischaemia patients who have no open surgical options. This lack of other options generally is due to high operative risk or lack of appropriate bypass conduits.

The retrograde approach presents us with both advantages and disadvantages to the procedure. The success rate in this cohort of 76% is very similar to reported effective outcomes when using conventional antegrade approach. In the 12 cases that underwent secondary angioplasty, following an initial failed antegrade approach, 10 of them were successful using the retrograde fashion – giving a success rate of 83%. For patients who

have more advanced disease, this may be the last effective strategy before an amputation is considered.

It is clearly an excellent technique for patients who cannot lie flat, crucial to some patients with critical limb ischaemia. It can serve as an alternative to the up-and-over access, which itself is a very demanding approach for any endovascular interventionist.

This approach is generally thought to be more comfortable and convenient for patients; in recovery time (less bedrest time in retrograde approach than femoral antegrade) and in early patient mobilisation. There were no reported complications from the access sites and no closing devices were needed for the retrograde approach.

Ultimately, with the amalgamation of all of these factors, it can be extrapolated that we can achieve a higher rate of case turnover in the interventional radiology suite. This could lead to a reduction in time, money spent on scarce resources used per case.

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Naturally, there are also disadvantages to this particular technique. One of which is that only the access vessel itself can have any intervention below-the-knee. Other BTK vessels cannot be crossed due to anatomical difficulties of managing the microcatheter. In the BTK vessels the sheath size upper limit can be taken to a maximum of 6Fr. As with any new skill, there will be a learning curve for both the interventionist and the vascular lab staff. This requires a level of patience and allowing the whole team to adapt to this novel technique. However, with a multi-disciplinary approach the technique can be safely implemented in more vascular service institutions.

There were some limitations faced when looking at the results of the study. As discussed, the technique is still much underused and so the sample cohort size is fairly small. There is also a short follow-up period with the study only being conducted within the last one year. It is however, continually growing, where a database is beginning to form at this institution for further evaluation of the procedure and follow-up of existing patients.

There were some practical limitations to this work – the popliteal approach requires patients to be prone for convenient access to the vessel. This can make positioning difficult peri-procedurally which may be more inconvenient for patients. Both antegrade and retrograde access may need with the wire snared to allow crossing of the lesion. Albeit, this has only happened in very few cases in this study, but as the population size grows we can expect to see more cases requiring the use of top and bottom access.

Conclusion

This cohort showed that retrograde access is a suitable, and sometimes, limb-saving option for patients whom initially have failed antegrade access. In a particular group of patients, it can be considered to be a primary access site, especially for those with extensive proximal disease.

These patients need to be continually followed-up to derive the long term patency rates of vessels reopened using the retrograde approach. Further research needs to be implemented in establishing links between the types of patients that suit retrograde access as the primary mode of angioplasty.

Acknowledgement

Special thanks to the above named authors, Interventional Radiology Department at Northampton General Hospital, and Northamptonshire Vascular Services.

References1. Shu J, Santulli G (2018) Update on peripheral artery

disease: Epidemiology and evidence-based facts. Atherosclerosis 275: 379–381. [View]

2. The Royal College of Surgeons of England (2019) 2019 Annual Report, National Vascular Registry.

3. El-Sayed, Hosam F (2013) Methodist DeBakey cardiovascular journal 2: 73–8.

4. Lyer SS et al. (1990) Catheterization and Cardiovascular Diagnosis 20: 251–3.

5. Botti C, Ansel G, Silver M, Barker B, South S (2003) Percutaneous Retrograde Tibial Access in Limb Salvage. Journal of Endovascular Therapy 10: 614–618.

6. Walker C (2010) Durability of PTAs using pedal artery approaches. 37th Annual VEITH Symposium; November 18th 2010; New York City, NY 2010.

7. Rogers R, Dattilo P, Garcia J, Tsai T, Casserly I (2011) Retrograde approach to recanalization of complex tibial disease. Catheterization and Cardiovascular Interventions 77: 915–925. [View]

8. Montero-Baker M, Schmidt A, Bräunlich S, Ulrich M, Thieme M, et al. (2008) Retrograde Approach for Complex Popliteal and Tibioperoneal Occlusions. Journal of Endovascular Therapy 15: 594–604. [View]

9. El-Sayed H (2013) Retrograde Pedal/Tibial Artery Access for Treatment of Infragenicular Arterial Occlusive Disease. Methodist DeBakey Cardiovascular Journal 9: 73–78. [View]

*Corresponding author: Aimen Gmati, Foundation Year 2 Doctor, Northampton General Hospital NHS Trust, UK, Address: Apartment 39, 61 Watkin Road, Leicester, LE2 7HZ, UK; Mobile: +44 7551702032; Email: [email protected]