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. 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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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

10.21203/rs.3.rs-387306/v1 ◽

2021 ◽

Author(s):

Symeon Lechareas ◽

Kaji Sritha ◽

RG Mc Williams

Keyword(s):

Clinical Outcomes ◽

Limb Salvage ◽

Treatment Options ◽

Arterial Disease ◽

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. 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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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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Systematic review of inframalleolar endovascular interventions and rates of limb salvage, wound healing, restenosis, rest pain, reintervention and complications

Vascular ◽

10.1177/17085381211004246 ◽

2021 ◽

pp. 170853812110042

Author(s):

M Machin ◽

HC Younan ◽

AM Guéroult ◽

S Onida ◽

J Shalhoub ◽

...

Keyword(s):

Systematic Review ◽

Wound Healing ◽

Limb Salvage ◽

Peripheral Artery Disease ◽

Critical Limb Ischaemia ◽

Rest Pain ◽

Peripheral Artery ◽

Single Study ◽

Artery Disease

Objectives Peripheral artery disease is estimated to affect 237 million individuals worldwide. Critical limb ischaemia, also known as chronic limb threatening ischaemia is a consequence of the progression of peripheral artery disease which occurs in ∼21% of patients over a five-year period. The aim of this systematic review is to assess the use of additional below-the-ankle angioplasty in comparison to the use of above-the-ankle angioplasty alone, and the subsequent rates of amputation, wound healing, restenosis, rest pain, reintervention and complications. Methods This systematic review was undertaken in accordance with PRISMA guidelines following a registered protocol (CRD42019154893). Online databases were searched using a search strategy of 20 keywords. Included articles reported the outcome for inframalleolar (pedal artery, pedal arch, plantar arteries) angioplasty with additional proximal angioplasty in comparison to proximal angioplasty alone. GRADE assessment was applied to assess the quality of the evidence. Results After screening 1089 articles, 10 articles met the inclusion criteria. Comparative performance assessment of below-the-ankle with above-the-ankle versus above-the-ankle angioplasty alone was undertaken in 3 articles, with the remaining 7 articles reporting outcomes of below-the-ankle with above-the-ankle angioplasty with no distinct comparator group. Significant decrease in major lower limb amputation at the last follow-up in the below-the-ankle group when compared with the above-the-ankle angioplasty alone group was observed in a single study (3.45% vs. 14.9%, p < 0.05). Improved wound healing rate at follow-up in the below-the-ankle group versus above-the-ankle angioplasty alone group was also reported in a single study (59.3% vs. 38.1%, p < 0.05). Subsequent rate of amputation after below-the-ankle angioplasty has been estimated as 23.5%. Conclusion To date, there is a lack of studies assessing inframalleolar interventions and their use in improving limb salvage, wound healing and symptomatology. Prospective RCTs should be undertaken with adequate participant numbers to be sufficiently powered and report clinically important end-points.

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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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Use of an advanced collagen matrix dressing on patients with complex chronic lower extremity ulcers: A case series

SAGE Open Medical Case Reports ◽

10.1177/2050313x211013684 ◽

2021 ◽

Vol 9 ◽

pp. 2050313X2110136

Author(s):

Afsaneh Alavi ◽

Jeannine Archer ◽

Patricia Coutts

Keyword(s):

Wound Healing ◽

Lower Extremity ◽

Ethylenediaminetetraacetic Acid ◽

Case Series ◽

Standard Of Care ◽

Collagen Matrix ◽

Contact Layer ◽

Complete Healing ◽

Average Decrease

The objective of this case series was to assess the wound healing effectiveness of a collagen matrix wound dressing containing partially denatured collagen, carboxymethyl cellulose, alginate and ethylenediaminetetraacetic acid in chronic lower extremity ulcers. A total of nine patients with refractory lower extremity ulcers were treated with the collagen contact layer in addition to standard of care. Wound healing progress was measured at 2, 4 and 8 weeks. An average decrease in wound size of 73% was achieved across patients at week 8, with complete healing in two patients. The intervention was easy to use and well tolerated by patients. The results of this study, although preliminary, suggest that the advanced collagen matrix dressing represents an effective and safe treatment strategy for healing refractory chronic lower extremity ulcers of varying etiologies. Further investigation is needed to evaluate efficacy in a larger randomized clinical trial with focus on cost-effectiveness and impact on patient’s quality-of-life.

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Punch Grafting for the Management of Hard-to-Heal Diabetic Foot Ulcers: A Prospective Case Series

The International Journal of Lower Extremity Wounds ◽

10.1177/15347346211031085 ◽

2021 ◽

pp. 153473462110310

Author(s):

Marta García-Madrid ◽

Irene Sanz-Corbalán ◽

Aroa Tardáguila-García ◽

Raúl J. Molines-Barroso ◽

Mateo López-Moral ◽

...

Keyword(s):

Wound Healing ◽

Clinical Outcomes ◽

Diabetic Foot ◽

Donor Site ◽

Case Series ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Wound Debridement ◽

Prospective Case Series

Punch grafting is an alternative treatment to enhance wound healing which has been associated with promising clinical outcomes in various leg and foot wound types. We aimed to evaluate the clinical outcomes of punch grafting as a treatment for hard-to-heal diabetic foot ulcers (DFUs). Six patients with chronic neuropathic or neuroischemic DFUs with more than 6 months of evolution not responding to conventional treatment were included in a prospective case series between May 2017 and December 2020. All patients were previously debrided using an ultrasound-assisted wound debridement and then, grafted with 4 to 6 mm punch from the donor site that was in all cases the anterolateral aspect of the thigh. All patients were followed up weekly until wound healing. Four (66.7%) DFUs were located in the heel, 1 (16.7%) in the dorsal aspect of the foot and 1 (16.7%) in the Achilles tendon. The median evolution time was 172 (interquartile range [IQR], 25th-75th; 44-276) weeks with a median area of 5.9 (IQR; 1.87-37.12) cm2 before grafting. Complete epithelization was achieved in 3 (50%) patients at 12 weeks follow-up period with a mean time of 5.67 ± 2.88 weeks. Two of the remaining patients achieved wound healing at 32 and 24 weeks, respectively, and 1 patient showed punch graft unsuccessful in adhering. The median time of wound healing of all patients included in the study was 9.00 (IQR; 4.00-28.00) weeks. The wound area reduction (WAR) at 4 weeks was 38.66% and WAR at 12 weeks was 88.56%. No adverse effects related to the ulcer were registered through the follow-up period. Autologous punch graft is an easy procedure that promotes healing, achieving wound closure in chronic DFUs representing an alternative of treatment for hard-to-heal DFUs in which conservative treatment has been unsuccessful.

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Prevalence and clinical outcomes of hospitalized patients with Upper-Extremity Deep Vein Thrombosis

Journal of Vascular Surgery Venous and Lymphatic Disorders ◽

10.1016/j.jvsv.2021.05.007 ◽

2021 ◽

Author(s):

Rafael S. Cires-Drouet ◽

Frederick Durham ◽

Jashank Sharma ◽

Praveen Cheeka ◽

Zachary Strumpf ◽

...

Keyword(s):

Deep Vein Thrombosis ◽

Clinical Outcomes ◽

Upper Extremity ◽

Hospitalized Patients ◽

Vein Thrombosis ◽

Deep Vein

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Treatment Patterns and Clinical Outcomes in Korean Cancer Patients With Venous Thromboembolism: A Retrospective Cohort Study

Clinical and Applied Thrombosis/Hemostasis ◽

10.1177/1076029620979575 ◽

2021 ◽

Vol 27 ◽

pp. 107602962097957

Author(s):

Soo-Mee Bang ◽

Jin-Hyoung Kang ◽

Min Hee Hong ◽

Jin-Seok Ahn ◽

So Yeon Oh ◽

...

Keyword(s):

Venous Thromboembolism ◽

Cancer Patients ◽

Clinical Outcomes ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Events ◽

Factors Associated ◽

Vein Thrombosis ◽

Medical Chart Review ◽

Deep Vein

This study assessed epidemiologic data and clinical outcomes, including venous thromboembolism (VTE) recurrence and bleeding events, in patients with cancer-associated VTE, and assessed factors associated with clinical outcomes. Data were extracted from retrospective medical-chart review of adult patients diagnosed with cancer-associated deep vein thrombosis or pulmonary embolism who received anticoagulation treatment for ≥3 months. Patients were classified by: low-molecular-weight heparin (LMWH), direct oral anticoagulants (DOACs), and other anticoagulants. First VTE recurrence and bleeding events, and factors associated with their occurrence, were assessed during the initial 6 months of treatment. Overall, 623 patients (age: 63.7 ± 11.3 years, 49.3% male) were included (119, 132, and 372 patients in LMWH, DOACs and other anticoagulants groups, respectively). The cumulative 6-month incidence of VTE recurrence was 16.6% (total), 8.3% (LMWH), 16.7% (DOACs), and 20.7% (other); respective bleeding events were 22.5%, 11.0%, 12.3%, and 30.7%). VTE recurrence and bleeding rates differed only between LMWH and other anticoagulants (HR 2.4, 95% CI: 1.2-5.0 and 3.6, 1.9-6.8, respectively). These results highlight the importance of initial VTE treatment choice for preventing VTE recurrence and bleeding events. LMWH or DOACs for ≥3 months can be considered for effective VTE management in cancer patients.

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Perspectives and experiences of patients and healthcare professionals with geriatric assessment in chronic kidney disease: a qualitative study

BMC Nephrology ◽

10.1186/s12882-020-02206-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Carlijn G. N. Voorend ◽

Noeleen C. Berkhout-Byrne ◽

Yvette Meuleman ◽

Simon P. Mooijaart ◽

Willem Jan W. Bos ◽

...

Keyword(s):

Kidney Disease ◽

Qualitative Study ◽

Clinical Outcomes ◽

Geriatric Assessment ◽

Clinical Care ◽

Treatment Options ◽

Routine Care ◽

Treatment Team ◽

Dutch Hospital ◽

Additional Support

Abstract Background Older patients with end-stage kidney disease (ESKD) often live with unidentified frailty and multimorbidity. Despite guideline recommendations, geriatric assessment is not part of standard clinical care, resulting in a missed opportunity to enhance (clinical) outcomes including quality of life in these patients. To develop routine geriatric assessment programs for patients approaching ESKD, it is crucial to understand patients’ and professionals’ experiences with and perspectives about the benefits, facilitators and barriers for geriatric assessment. Methods In this qualitative study, semi-structured focus group discussions were conducted with ESKD patients, caregivers and professionals. Participants were purposively sampled from three Dutch hospital-based study- and routine care initiatives involving geriatric assessment for (pre-)ESKD care. Transcripts were analysed inductively using thematic analysis. Results In six focus-groups, participants (n = 47) demonstrated four major themes: (1) Perceived characteristics of the older (pre)ESKD patient group. Patients and professionals recognized increased vulnerability and (cognitive) comorbidity, which is often unrelated to calendar age. Both believed that often patients are in need of additional support in various geriatric domains. (2) Experiences with geriatric assessment. Patients regarded the content and the time spent on the geriatric assessment predominantly positive. Professionals emphasized that assessment creates awareness among the whole treatment team for cognitive and social problems, shifting the focus from mainly somatic to multidimensional problems. Outcomes of geriatric assessment were observed to enhance a dialogue on suitability of treatment options, (re)adjust treatment and provide/seek additional (social) support. (3) Barriers and facilitators for implementation of geriatric assessment in routine care. Discussed barriers included lack of communication about goals and interpretation of geriatric assessment, burden for patients, illiteracy, and organizational aspects. Major facilitators are good multidisciplinary cooperation, involvement of geriatrics and multidisciplinary team meetings. (4) Desired characteristics of a suitable geriatric assessment concerned the scope and use of tests and timing of assessment. Conclusions Patients and professionals were positive about using geriatric assessment in routine nephrology care. Implementation seems achievable, once barriers are overcome and facilitators are endorsed. Geriatric assessment in routine care appears promising to improve (clinical) outcomes in patients approaching ESKD.

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