Early and Eighteen Month Clinical Outcomes of First UK Case of Percutaneous Deep Vein Arterialisation (pDVA) to Treat “No Option” Chronic Limb-Threatening Ischemia Using the Limflow System

Abstract Background: Chronic limb-threatening ischaemia (CLTI) in cases where there are no further standard treatment options for limb salvage represents the most advanced stage of peripheral arterial disease. This case represents the first UK use of the LimFlow System to perform percutaneous deep vein arterialisation (pDVA) in a “no option” CLTI patient, with outcomes out to 18 months post-procedure.Case Presentation: We present the case of a 78 year old male diabetic patient with a history of contralateral below knee amputation who presented with ischaemic rest pain and dry gangrene involving his left heel and first and second toes. Following review by the lower limb multi-disciplinary team at our institution, the patient was deemed to have no surgical or endovascular treatment options, apart from major amputation, as there was no viable target for angioplasty or bypass. He was therefore referred as a candidate for percutaneous deep vein arterialisation (pDVA) with the LimFlow System (LimFlow SA, France). After screening of the patient according to the indications for use, the pDVA procedure was successfully performed resulting in complete resolution of ischaemic rest pain immediately following the procedure, and adequate revascularisation of the foot. The subject went on to have minor amputation of the first, second and third toes 2 months post initial procedure with further secondary angioplasty procedures to optimise the flow throughout the arterialised circuit up to 4 months after the initial procedure. He underwent elective completion transmetatarsal amputation at 13 months post index procedure. The surgical wounds post minor amputation and the heel wound showed continued healing progress, especially after secondary optimisation of the pDVA outflow, with tissue epithelialisation by 6 months and complete healing by 18 months post index procedure.Conclusions: This case report demonstrates the clinical outcomes of a technically-successful LimFlow pDVA including both limb salvage and wound healing at 18 months.

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Early and eighteen month clinical outcomes of first UK case of percutaneous deep vein arterialisation (pDVA) to treat “no option” chronic limb-threatening ischemia using the LimFlow system

CVIR Endovascular ◽

10.1186/s42155-021-00252-4 ◽

2021 ◽

Vol 4 (1) ◽

Author(s):

Symeon Lechareas ◽

Kaji Sritharan ◽

R. G. Mc Williams

Keyword(s):

Wound Healing ◽

Clinical Outcomes ◽

Limb Salvage ◽

Treatment Options ◽

Complete Healing ◽

Rest Pain ◽

Index Procedure ◽

Minor Amputation ◽

Initial Procedure ◽

Deep Vein

Abstract Background Chronic limb-threatening ischaemia (CLTI) in cases where there are no further standard treatment options for limb salvage represents the most advanced stage of peripheral arterial disease. For these “no-option” CLTI patients, an experimental treatment of foot vein arterialisation (FVA) was first described in 1912, however, it was never widely adopted as outcomes varied significantly most likely due to the complexity of the surgical intervention and lack of standardisation. In recent years there have been significant developments in performing FVA fully percutaneously and standardising the procedure with the introduction of specific indications for patient selection, a dedicated set of devices and structured follow up. This case represents the first UK use of the dedicated LimFlow System as a standardised procedure to perform percutaneous deep vein arterialisation (pDVA) in a “no option” CLTI patient according to the latest treatment recommendations in the literature, with outcomes out to 18 months post-procedure. Case presentation We present the case of a 78 year old male diabetic patient with a history of contralateral below knee amputation who presented with ischaemic rest pain and dry gangrene involving his left heel and first and second toes. Following review by the lower limb multi-disciplinary team at our institution, the patient was deemed to have no surgical or endovascular treatment options, apart from major amputation, as there was no suitable target for either angioplasty or bypass. He was therefore referred as a candidate for percutaneous deep vein arterialisation (pDVA) with the LimFlow System (LimFlow SA, France). After screening of the patient according to the indications for use, the pDVA procedure was successfully performed resulting in complete resolution of ischaemic rest pain immediately following the procedure, and adequate revascularisation of the foot. Following the index procedure, the subject went on to have minor amputation of the first, second and third toes 2 months post initial procedure with further secondary angioplasty procedures to optimise the flow throughout the arterialised circuit up to 4 months after the initial procedure. He underwent elective completion transmetatarsal amputation at 13 months post index procedure. The surgical wounds post minor amputation and the heel wound showed continued healing, especially after secondary optimisation of the pDVA outflow, with tissue epithelialisation by 6 months and complete healing by 18 months after the index procedure. Conclusions This case report demonstrates the clinical outcomes of a technically-successful standardised pDVA procedure with the LimFlow system including both limb salvage and wound healing at 18 months. It also highlights the importance of close clinical and radiological surveillance post-index procedure and the requirement for re-interventions to optimise wound healing.

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Pedal bypass with deep venous arterialization: the therapeutic option in critical limb ischemia and unreconstructable distal arteries

Vascular ◽

10.1258/vasc.2010.oa0278 ◽

2011 ◽

Vol 19 (6) ◽

pp. 313-319 ◽

Cited By ~ 16

Author(s):

Pramook Mutirangura ◽

Chanean Ruangsetakit ◽

Chumpol Wongwanit ◽

Nuttawut Sermsathanasawadi ◽

Khamin Chinsakchai

Keyword(s):

Limb Salvage ◽

Critical Limb Ischemia ◽

Therapeutic Option ◽

Limb Ischemia ◽

Graft Patency ◽

Major Amputation ◽

Complete Healing ◽

Rest Pain ◽

Ischemic Ulcer ◽

Distal Artery

Heavily calcified and severely stenotic distal arteries defined as unreconstructable, precludes the possibility of revascularization, resulting in major amputation in patients with critical limb ischemia. However, providing blood supply to the ischemic foot through the venous system instead of the arterial system may improve the circulation adequately for the healing process in the vascular compromised distal tissue. This study aimed to assess the safety and efficacy of pedal bypass with deep venous arterialization, one of the possible procedures to improve the circulation through the venous system in critically ischemic limbs and unreconstructable distal arteries. Twenty-six patients with critical limb ischemia and an unreconstructable distal artery of the lower extremities were included for the surgical procedure. Arterial bypass with distal anastomosis at the paramalleolar deep vein was carried out through a composite graft combined with adequate destruction of valve competency in the distal vein. The primary endpoint was complete healing of ischemic ulcer with amelioration of rest pain within six months. The secondary endpoints were the outcomes of survival, limb salvage and primary graft patency rate at six-month intervals to 24 months. Nineteen patients (73.1%) had complete healing of ischemic ulcer and disappearance of rest pain within six months. Six patients (23.1%) underwent major amputation. Perioperative mortality was 3.8%. After 24 months of follow-up study, the survival rate was 87.5%, whereas the limb salvage and graft patency rates were 76.02 and 49.17%, respectively. Pedal bypass with deep venous arterialization may be another therapeutic option to enhance the healing of ischemic ulcer and limb salvageability in patients with critical limb ischemia and unreconstructable distal artery.

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Treprostinil Sodium (Remodulin), a Prostacyclin Analog, in the Treatment of Critical Limb Ischemia: Open-Label Study

Vascular ◽

10.2310/6670.2006.00028 ◽

2006 ◽

Vol 14 (3) ◽

pp. 142-148 ◽

Cited By ~ 7

Author(s):

Scott Berman ◽

Rhonda Quick ◽

Pam Yoder ◽

Sonia Voigt ◽

Deborah Strootman ◽

...

Keyword(s):

Wound Healing ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Arterial Disease ◽

Complete Healing ◽

Rest Pain ◽

Open Label ◽

Serious Adverse Events ◽

Peripheral Arterial ◽

Prostacyclin Analog

The purpose of this study was to assess the safety of continuous subcutaneous therapy with treprostinil sodium (Remodulin), a prostacyclin analog, and its effect on ischemic rest pain and ischemic wound healing in subjects with critical limb ischemia (CLI) and no planned revascularization procedure. This was a 12-week, open-label, single-center pilot study enrolling 10 subjects (mean age 82.4 years) with Fontaine stage III to IV (Rutherford class 4–6) peripheral arterial disease and ankle brachial indices less than 0.55. The primary end point was safety, and the secondary end points were the effects of treatment on ischemic rest pain, limb salvage, and wound healing. There was a 62% reduction in mean worst rest pain and a 57% reduction in mean average rest pain at week 12, with most subjects using less pain medication. Three subjects experienced complete healing of their wounds. No subject developed a new wound during the trial. Treprostinil was generally well tolerated. Subcutaneous infusion-site pain was the most frequently reported side effect, with one subject withdrawing from the study as a result. Jaw pain was reported by two subjects. One subject experienced two serious adverse events considered unrelated to treprostinil (cholecystitis and congestive heart failure). This study demonstrates that chronic, continuous subcutaneous treprostinil is safe and can be useful in the treatment of ischemic pain and wounds in subjects with CLI. Future controlled studies are needed to evaluate these effects and determine appropriate patient selection.

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Abstract 14816: Twelve-month Outcomes of Stenting versus Standard Balloon Angioplasty for the Below-the-Knee Arterial Disease Patients Underwent Percutaneous Transluminal Angioplasty

Circulation ◽

10.1161/circ.132.suppl_3.14816 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Seung Woon Rha ◽

Byoung Geol Choi ◽

Se Yeon Choi ◽

Jae Kyeong Byun ◽

Jin Oh Na ◽

...

Keyword(s):

Clinical Outcomes ◽

Limb Salvage ◽

Balloon Angioplasty ◽

Percutaneous Transluminal Angioplasty ◽

Arterial Disease ◽

Transluminal Angioplasty ◽

Below The Knee ◽

Procedural Success ◽

Percutaneous Transluminal ◽

Similar Incidence

Background: Although percutaneous transluminal angioplasty (PTA) is considered as an effective treatment strategy in patients (pts) with critical limb ischemia (CLI), below-the-knee (BTK) lesions with CLI is particularly challenging. This study sought to compare the 12-month outcomes following stenting versus standard plain old balloon angioplasty (POBA) alone in BTK lesions. Method: This study consisted of 339 consecutive lower extremity arterial disease pts (394 limbs, 1026 lesions included 716 BTK lesions) with BTK lesions from Sep 2004 to Dec 2013. All the enrolled pts were treated by stenting (bare metal stents, primary or provisional, 78 limbs in 73 pts) or POBA (316 limbs in 266 pts) with PTA. Procedural success, complications and clinical outcomes were compared between the two groups up to 12 months. To adjust potential confounders, a propensity score matched (PSM) analysis was performed using the logistic regression model. Results: After PSM analysis, 2 propensity-matched groups (56 pairs in pts, n= 112; 61 pairs in limbs, n=122, C-statistic=0.808) were generated, and the baseline & angiographic characteristics of the two groups were balanced. Procedural success, complication incidences were similar between the two groups. Six to 9-month CT or angiographic follow-up, there were similar incidence of binary restenosis, primary, and secondary patency. At 12 months, there were similar incidence of individual hard endpoints including mortality, myocardial infarction, limb salvage, and any extremity amputations except the target lesion and extremity revascularization. Repeat PTA incidence was higher in the stenting group than POBA group (table). Conclusion: Although the repeat PTA risk was increased with BTK stenting, other major individual clinical outcomes and limb salvage rates were similar between the POBA and stenting for the BTK lesions.

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Phlegmasia cerulea dolens – an uncommon but alarming manifestation of deep vein thrombosis

VASA ◽

10.1024/0301-1526/a000894 ◽

2020 ◽

Vol 49 (5) ◽

pp. 422-426

Author(s):

Manuela Nickler ◽

Sebastian Haubitz ◽

Adriana Méndez ◽

Martin Gissler ◽

Peter Stierli ◽

...

Keyword(s):

Clinical Presentation ◽

Treatment Options ◽

Bleeding Risk ◽

Venous Intervention ◽

Aggressive Treatment ◽

Vein Thrombosis ◽

Prompt Treatment ◽

Surgical Thrombectomy ◽

Deep Vein ◽

Phlegmasia Cerulea Dolens

Summary: In phlegmasia cerulea dolens (PCD), immediate diagnosis and prompt treatment is crucial for limb salvage. Aggressive treatment options including venous intervention, thrombolysis and/or surgical thrombectomy should be considered. Due to the lack of data, the most appropriate intervention depends upon etiology of PCD, clinical presentation and patient’s bleeding risk.

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Surgical and endovascular hybrid approach in peripheral arterial disease of the lower limbs

VASA ◽

10.1024/0301-1526/a000561 ◽

2016 ◽

Vol 45 (5) ◽

pp. 417-422 ◽

Cited By ~ 7

Author(s):

Anouk Grandjean ◽

Katia Iglesias ◽

Céline Dubuis ◽

Sébastien Déglise ◽

Jean-Marc Corpataux ◽

...

Keyword(s):

Mortality Rate ◽

Peripheral Arterial Disease ◽

Limb Salvage ◽

Hybrid Approach ◽

Arterial Disease ◽

Early Mortality ◽

Secondary Patency ◽

Limb Salvage Rate ◽

Peripheral Arterial ◽

Salvage Rate

Abstract. Background: Multilevel peripheral arterial disease is frequently observed in patients with intermittent claudication or critical limb ischemia. This report evaluates the efficacy of one-stage hybrid revascularization in patients with multilevel arterial peripheral disease. Patients and methods: A retrospective analysis of a prospective database included all consecutive patients treated by a hybrid approach for a multilevel arterial peripheral disease. The primary outcome was the patency rate at 6 months and 1 year. Secondary outcomes were early and midterm complication rate, limb salvage and mortality rate. Statistical analysis, including a Kaplan-Meier estimate and univariate and multivariate Cox regression analyses were carried out with the primary, primary assisted and secondary patency, comparing the impact of various risk factors in pre- and post-operative treatments. Results: 64 patients were included in the study, with a mean follow-up time of 428 days (range: 4 − 1140). The technical success rate was 100 %. The primary, primary assisted and secondary patency rates at 1 year were 39 %, 66 % and 81 %, respectively. The limb-salvage rate was 94 %. The early mortality rate was 3.1 %. Early and midterm complication rates were 15.4 % and 6.4 %, respectively. The early mortality rate was 3.1 %. Conclusions: The hybrid approach is a major alternative in the treatment of peripheral arterial disease in multilevel disease and comorbid patients, with low complication and mortality rates and a high limb-salvage rate.

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Outcomes after Emergency Admission with a Diabetic Foot Attack Indicate a High Rate of Healing and Limb Salvage But Increased Mortality: 18-Month Follow-up Study

Experimental and Clinical Endocrinology & Diabetes ◽

10.1055/a-1322-4811 ◽

2020 ◽

Author(s):

Erika Vainieri ◽

Raju Ahluwalia ◽

Hani Slim ◽

Daina Walton ◽

Chris Manu ◽

...

Keyword(s):

Limb Salvage ◽

Diabetic Foot ◽

Emergency Admission ◽

Arterial Disease ◽

Major Amputation ◽

Outcome Data ◽

High Rate ◽

Free Survival ◽

Peripheral Arterial

Abstract Aim The diabetic foot attack (DFA) is perhaps the most devastating form of diabetic foot infection, presenting with rapidly progressive skin and tissue necrosis, threatening both limb and life. However, clinical outcome data in this specific group of patients are not available. Methods Analysis of 106 consecutive patients who underwent emergency hospitalisation for DFA (TEXAS Grade 3B or 3D and Infectious Diseases Society of America (IDSA) Class 4 criteria). Outcomes evaluated were: 1) Healing 2) major amputation 3) death 4) not healed. The first outcome reached in one of these four categories over the follow-up period (18.4±3.6 months) was considered. We also estimated amputation free survival. Results Overall, 57.5% (n=61) healed, 5.6% (n=6) underwent major amputation, 23.5% (n=25) died without healing and 13.2% (n=14) were alive without healing. Predictive factors associated with outcomes were: Healing (age<60, p=0.0017; no Peripheral arterial disease (PAD) p= 0.002; not on dialysis p=0.006); major amputation (CRP>100 mg/L, p=0.001; gram+ve organisms, p=0.0013; dialysis, p= 0.001), and for death (age>60, p= 0.0001; gram+ve organisms p=0.004; presence of PAD, p=0.0032; CRP, p=0.034). The major amputation free survival was 71% during the first 12 months from admission, however it had reduced to 55.4% by the end of the follow-up period. Conclusions In a unique population of hospitalised individuals with DFA, we report excellent healing and limb salvage rates using a dedicated protocol in a multidisciplinary setting. An additional novel finding was the concerning observation that such an admission was associated with high 18-month mortality, almost all of which was after discharge from hospital.

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Comparison of Clinical Outcomes With Drug Coated Balloons Versus Plain Balloon Angioplasty In Chronic Limb-Threatening Ischemia

Vascular and Endovascular Surgery ◽

10.1177/15385744211022598 ◽

2021 ◽

pp. 153857442110225

Author(s):

Joel Mathew John ◽

Vimalin Samuel ◽

Dheepak Selvaraj ◽

Prabhu Premkumar ◽

Albert A Kota ◽

...

Keyword(s):

Clinical Outcomes ◽

Interventional Procedure ◽

Tertiary Care ◽

Arterial Disease ◽

Multivariable Logistic Regression Analysis ◽

Tertiary Care Centre ◽

Chi Square ◽

Exact Test ◽

Institutional Review ◽

Chi Square Test

Objective: The use of drug coated balloon (DCB) for angioplasty has shown superior efficacy against plain balloons for treating complex infrainguinal arterial disease. We report and compare the clinical outcomes following application of DCB(Paclitaxel) and plain angioplasty (POBA) in our tertiary care centre. Methods: A retrospective, single centre analysis of 301 patients with chronic limb-threatening ischemia involving the infrainguinal segment was conducted between September 2014 and September 2018, after approval from the Institutional review board. We analyzed clinical outcomes by measuring postoperative ABI improvement, restenosis requiring reintervention procedure, minor and major amputations at the end of 18 months. . To find the association between the group variables (POBA and DCB) and other risk variables, Chi-square test/Fisher’s exact test was used. Multivariable logistic regression analysis was used. Results: Patients who underwent treatment with plain balloon (POBA) and DCB(Paclitaxel) angioplasty were 246(81.7%) and 55(18.3%) respectively. Our study group was predominantly male (Male: Female = 6.7:1), most patients were more than 50 years of age (n = 251, 83.4%). Smoking (n = 199, 66.1%) and diabetes (n = 210, 69.8%) were the most common atherosclerotic risk factors. Postoperative Ankle Brachial Pressure Index (ABI) improvement were similar in both groups (POBA = 57.7%; DCB = 69.8%; p = 0.103). Minor and major amputations following POBA were 26% and 22%; and DCB were 12.7% and 16.4% respectively. Re-stenosis requiring a re-interventional procedure within 18 months was 15%, (n = 37) following POBA; and 12.7% (n = 7) following DCB (p = 0.661). Conclusions: This retrospective study shows similar clinical limb related outcomes following POBA and DCB at 18 months. However, our comparative analysis between the POBA and DCB groups was totally unadjusted and not adjusted for common confounders such as age and sex. Hence, for one to draw definitive conclusions leading to changes in clinical practice; a randomized, prospective study with a larger patient cohort is needed.

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