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European Heart Journal May 2022The prevalence of chronic limb-threatening ischaemia (CLTI) is increasing and available data often derive from cohorts with various selection criteria. In the present...
AIMS
The prevalence of chronic limb-threatening ischaemia (CLTI) is increasing and available data often derive from cohorts with various selection criteria. In the present study, we included CLTI patients and studied sex-related differences in their risk profile, vascular procedures, and long-term outcome.
METHODS AND RESULTS
We analysed 199 953 unselected patients of the largest public health insurance in Germany (AOK: Local healthcare funds), hospitalized between 2010 and 2017 for a main diagnosis of CLTI. A baseline period of 2 years before index hospitalization to assess comorbidities and previous procedures, and a follow-up period until 2018 were included. Female CLTI patients were older (median 81.4 vs. 73.8 years in males; P < 0.001) and more often diagnosed with hypertension, atrial fibrillation, chronic heart failure, and chronic kidney disease. Male patients suffered more frequently from diabetes mellitus, dyslipidaemia, smoking, cerebrovascular disease, and chronic coronary syndrome (all P < 0.001). Within hospitalized CLTI patients, females represent the minority (43% vs. 57%; P < 0.001) and during index hospitalization, women underwent less frequently diagnostic angiographies (67 vs. 70%) and revascularization procedures (61 vs. 65%; both P < 0.001). Moreover, women received less frequently guideline-recommended drugs like statins (35 vs. 43%) and antithrombotic therapy (48 vs. 53%; both P < 0.001) at baseline. Interestingly, after including age and comorbidities in a Cox regression analysis, female sex was associated with increased overall-survival (OS) [hazard ratio (HR) 0.95; 95% confidence interval (CI) 0.94-0.96] and amputation-free survival (AFS) (HR 0.84; 95% CI 0.83-0.85; both P < 0.001).
CONCLUSION
Female patients with CLTI were older, underwent less often vascular procedures, and received less frequently guideline-recommended medication. Nevertheless, female sex was independently associated with better OS and AFS during follow-up.
Topics: Amputation, Surgical; Chronic Disease; Chronic Limb-Threatening Ischemia; Female; Humans; Ischemia; Male; Peripheral Arterial Disease; Progression-Free Survival; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome
PubMed: 35134893
DOI: 10.1093/eurheartj/ehac016 -
Stem Cells Translational Medicine May 2022Although satisfying outcomes have been demonstrated in terms of autologous stem cell transplantation in the treatment of angiitis-induced critical limb ischemia (AICLI),...
Although satisfying outcomes have been demonstrated in terms of autologous stem cell transplantation in the treatment of angiitis-induced critical limb ischemia (AICLI), few studies have systematically reported the recurrence conditions. In the current study, we aimed to investigate recurrence conditions of a relatively large AICLI cohort in our center during a long-term follow-up period. From May 2009 to August 2020, 181 patients with AICLI received peripheral blood mononuclear cells (PBMNCs) or purified CD34+ cells (PCCs) transplantation. The main outcomes included recurrence and new lesions. Patient demographic data, ischemic limb characteristics, interventional characteristics, etc., were identified and analyzed. A logistic multivariable regression was performed to identify the independent risk factors for recurrence by a stepwise selection of variables. One hundred forty-eight patients were enrolled in this study. The mean follow-up period was 62.3 ± 37.4 months (range 12-144 months). The 5- and 10-year recurrence-free rates were 88.5% (95% confidence interval [CI] 3.1%-82.6%) and 71.7% (95% CI 7.6%-58.2%), respectively. The 5- and 10-year new lesion-free rates were 93.2% (95% CI 2.2%-89.0%) and 91.7% (95% CI 2.7%-86.6%), respectively. The finding of multiple limbs involved (OR 1.322 95% CI 1.123-12.549, P = .036) and ischemia relief period ≥5 months (OR 3.367 95% CI 1.112-10.192, P = .032) were demonstrated to be independent risk factors for recurrence in patients with AICLI who underwent cell transplantation. For patients with AICLI who responded to cell transplantation, the durability of this therapy was satisfactory, with 5- and 10-year recurrence-free rates of 88.5% and 71.7%, respectively. Multiple limbs involved at admission and ischemia relief period ≥5 months were demonstrated to be independent risk factors for recurrence after transplantation.
Topics: Chronic Limb-Threatening Ischemia; Hematopoietic Stem Cell Transplantation; Humans; Ischemia; Leukocytes, Mononuclear; Transplantation, Autologous; Treatment Outcome; Vasculitis
PubMed: 35446404
DOI: 10.1093/stcltm/szac017 -
International Journal of Environmental... Jan 2023Critical ischemia of the lower limbs refers to the last stages of peripheral arterial disease. It is characterized by resting discomfort or trophic disorders such as...
BACKGROUND
Critical ischemia of the lower limbs refers to the last stages of peripheral arterial disease. It is characterized by resting discomfort or trophic disorders such as ulceration, skin necrosis, or gangrene in the lower limbs. Critical ischemia corresponds to Leriche-Fontaine (LF) stages III-IV and Rutherford stages 4-6. The purpose of this study was to observe the patency and postoperative complications of patients who have had infra-inguinal surgical revascularization and compare the results based on the kind of graft utilized.
METHODS
The present study was designed as an observational retrospective cohort study, including all patients from 2018 to 2019 diagnosed with severe ischemia of the lower limbs who were hospitalized at the Vascular Surgery Clinic of the County Emergency Clinical Hospital of Targu Mures.
RESULTS
Patients with a polytetrafluoroethylene (PTFE) graft had a higher incidence of chronic obstructive pulmonary disease ( = 0.01), stage III LF (70.41% vs. 55.29%), = 0.03), and a lower incidence of stage IV LF (29.95% vs. 44.71%, = 0.03). As for complications, the PTFE group showed a lower incidence of bypass thrombosis (29.59% vs. 44.71%; = 0.03) and graft infection (9.18% vs. 21.18%; = 0.02), but no statistical significance in the event of bleeding ( = 0.40). Regarding the outcomes, no statistical significance was seen for below-the-knee amputations or death. However, the PTFE group had a lower incidence of above-the-knee amputations (11.22% vs. 24.71%; = 0.01). At multivariate analysis, the PTFE graft is an independent predictor of primary patency at 6, 12, and 24 months (OR: 2.15, = 0.02; OR: 1.84, = 0.04; and OR: 1.89, = 0.03), as well as a protective factor against bypass thrombosis (OR: 0.52; = 0.03), graft infection (OR: 0.37; = 0.02), and above-the-knee amputation (OR: 0.38; = 0.01).; Conclusions: According to this study's findings, there were minor differences regarding the long-term patency, bypass thrombosis, graft infections, and above-the-knee amputations. In addition, the PTFE graft group had a higher incidence of primary patency at 6, 12, and 24 months, as well as a lower incidence of bypass thrombosis, graft infection, and above-the-knee amputations.
Topics: Humans; Polyethylene Terephthalates; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Chronic Limb-Threatening Ischemia; Femoral Artery; Retrospective Studies; Vascular Patency; Ischemia; Postoperative Complications; Polytetrafluoroethylene; Treatment Outcome
PubMed: 36673997
DOI: 10.3390/ijerph20021235 -
European Journal of Vascular and... Dec 2022To assess the comparative effectiveness and temporal changes in quality of life (QoL) outcomes after revascularisation, major lower extremity amputation (MLEA), and... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To assess the comparative effectiveness and temporal changes in quality of life (QoL) outcomes after revascularisation, major lower extremity amputation (MLEA), and conservative management (CM) in chronic limb threatening ischaemia (CLTI).
DATA SOURCES
MEDLINE, Embase, PsycINFO, CINAHL, and Web of Science.
REVIEW METHODS
A systematic review and meta-analysis were performed on QoL measured by any QoL instrument in adult patients with CLTI after open surgery (OS), endovascular intervention (EVI), MLEA, or CM. Randomised controlled trials and prospective observational studies published in any language between 1 January 1990 and 21 May 2021 were included. There was a pre-specified measurement time point of six months. Random effects meta-analysis was conducted on total scores for each QoL instrument. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations approach (PROSPERO registration: CRD42021253953).
RESULTS
Fifty-five studies with 8 909 patients were included. There was significant heterogeneity in the methods used to measure QoL, and the study characteristics. In particular, 14 different QoL instruments were used with various combinations of disease specific and generic instruments within each study. A narrative summary is therefore presented. Comparative effectiveness data showed there was reasonable certainty that QoL was similar between OS and EVI at six months. Temporal outcomes suggested small to moderate improvements in QOL six months after OS and EVI compared with baseline. Limited data indicated that QoL can be maintained or slightly improved after MLEA or CM. Treatment effects were overestimated owing to small study effects, selective non-reporting, attrition, and survivorship bias.
CONCLUSION
QoL after OS and EVI appears to be similar. Revascularisation may provide modest QoL benefits, while MLEA or CM can maintain QoL. However, certainty of evidence is generally low or very low, and interpretation is hampered by significant heterogeneity. There is a need for a CLTI specific QoL instrument and methodological standardisation in QoL studies.
Topics: Humans; Quality of Life; Chronic Limb-Threatening Ischemia; Amputation, Surgical; Vascular Surgical Procedures; Conservative Treatment; Observational Studies as Topic
PubMed: 35952907
DOI: 10.1016/j.ejvs.2022.07.051 -
International Journal of Molecular... Feb 2021Peripheral artery disease (PAD) is a manifestation of atherosclerosis, which may affect arteries of the lower extremities. The most dangerous PAD complication is chronic... (Review)
Review
Peripheral artery disease (PAD) is a manifestation of atherosclerosis, which may affect arteries of the lower extremities. The most dangerous PAD complication is chronic limb-threatening ischemia (CLTI). Without revascularization, CLTI often causes limb loss. However, neither open surgical revascularization nor endovascular treatment (EVT) ensure long-term success and freedom from restenosis and revascularization failure. In recent years, EVT has gained growing acceptance among all vascular specialties, becoming the primary approach of revascularization in patients with CLTI. In clinical practice, different clinical outcomes after EVT in patients with similar comorbidities undergoing the same procedure (in terms of revascularization technique and localization of the disease) cause unsolved issues that need to be addressed. Nowadays, risk management of revascularization failure is one of the major challenges in the vascular field. The aim of this literature review is to identify potential predictors for lower extremity endovascular revascularization outcomes and possible prevention strategies.
Topics: Endovascular Procedures; Humans; Ischemia; Lower Extremity; Outcome Assessment, Health Care; Peripheral Arterial Disease; Postoperative Complications; Risk Assessment; Risk Factors
PubMed: 33670461
DOI: 10.3390/ijms22042002 -
Stem Cell Research & Therapy Mar 2022Patients with AICLI constitute a considerable proportion of NO-CLI patients and cannot be treated with surgical or endovascular treatment. Although cell therapy has... (Randomized Controlled Trial)
Randomized Controlled Trial
The peripheral blood mononuclear cells versus purified CD34 cells transplantation in patients with angiitis-induced critical limb ischemia trial: 5-year outcomes and return to work analysis-a randomized single-blinded non-inferiority trial.
BACKGROUNDS
Patients with AICLI constitute a considerable proportion of NO-CLI patients and cannot be treated with surgical or endovascular treatment. Although cell therapy has shown satisfactory results in treating AICLI, research comparing the efficacy of treatment with the 2 kinds of cell products is rare. The aim of this study was to report the 5-year outcomes of a randomized single-blinded noninferiority trial (Number: NCT02089828) on peripheral blood mononuclear cells (PBMNCs) and purified CD34 cells (PCCs) transplantation for treating angiitis-induced critical limb ischemia (AICLI).
METHODS
A randomized single-blinded non-inferiority trial (Number: NCT02089828) was performed. Fifty patients were randomized 1:1 to the PBMNCs and PCCs groups. Efficacy outcomes, safety outcomes and patients' work conditions were analyzed. The primary efficacy outcomes included major amputation and total amputation over 60 months.
RESULTS
During the 60-month follow-up, 1 patient was lost to follow-up, 1 died, and 2 underwent major amputation. The major amputation-free survival rate (MAFS) was 92.0% (95% confidence interval [CI] 82.0%-100.0%) in the PBMNCs group and 91.7% (95% CI 81.3%-100.0%) in the PCCs group (P = 0.980). Compared with the PCCs group, the PBMNCs group had a significantly higher 5-year new lesion-free survival rate (100.0% vs. 83.3% [95% CI 69.7-99.7%], P = 0.039). All patients lost their ability to work before transplantation, and the 5-year cumulative return to work (RTW) rates were 88.0% in the PBMNCs group and 76.0% in the PCCs group (P = 0.085).
CONCLUSION
The long-term follow-up outcomes of this trial not only demonstrated similar efficacy and safety for the 2 types of autoimplants but also showed a satisfactory cumulative RTW rate in AICLI patients who underwent cell transplantation.
TRIAL REGISTRATION
ClinicalTrials.gov, number NCT02089828. Registered 14 March 2014, https://clinicaltrials.gov/ct2/show/record/NCT02089828 .
Topics: Cell Transplantation; Chronic Limb-Threatening Ischemia; Humans; Ischemia; Leukocytes, Mononuclear; Return to Work; Treatment Outcome; Vasculitis
PubMed: 35313967
DOI: 10.1186/s13287-022-02804-4 -
Stem Cell Research & Therapy Jul 2022Peripheral arterial disease is atherosclerotic occlusive disease of the lower extremity arteries and afflicts hundreds of millions of individuals worldwide. Its most... (Review)
Review
Peripheral arterial disease is atherosclerotic occlusive disease of the lower extremity arteries and afflicts hundreds of millions of individuals worldwide. Its most severe manifestation is chronic limb-threatening ischemia (Petersen et al. (Science 300(5622):1140-2, 2003)), which is associated with severe pain at rest in the limbs, which progresses to necrosis, limb amputation, and/or death of the patient. Consequently, the care of these patients is considered a financial burden for both patients and health systems. Multidisciplinary endeavors are required to address this refractory disease and to find definitive solutions that lead to improved living conditions. Revascularization is the cornerstone of therapy for preventing limb amputation, and both open vascular surgery and endovascular therapy play a key role in the treatment of patients with CLI. Around one-third of these patients are not candidates for conventional surgical treatment, however, leading to higher amputation rates (approaching 20-25% at one year) with high morbidity and lower quality of life. Advances in regenerative medicine have enabled the development of cell-based therapies that promote the formation of new blood vessels. Particularly, mesenchymal stem cells (MSCs) have emerged as an attractive therapeutic agent in various diseases, including CLI, due to their role in tissue regeneration and immunomodulation. This review discusses the characteristics of MSCs, as well as their regenerative properties and their action mechanisms on CLI.
Topics: Chronic Limb-Threatening Ischemia; Humans; Ischemia; Limb Salvage; Lower Extremity; Mesenchymal Stem Cells; Quality of Life; Risk Factors; Treatment Outcome
PubMed: 35883198
DOI: 10.1186/s13287-022-03043-3 -
Journal of Diabetes Research 2021Management of neuropathic pain in people with diabetes has been widely investigated. However, little attention was paid to address ischemic-related pain in patients with... (Review)
Review
Management of neuropathic pain in people with diabetes has been widely investigated. However, little attention was paid to address ischemic-related pain in patients with diabetes mellitus who suffered from chronic limb-threatening ischemia (CLTI), the end stage of lower extremity arterial disease (LEAD). Pain management has a tremendous influence on patients' quality of life and prognosis. Poor management of this type of pain owing to the lack of full understanding undermines patients' physical and mental quality of life, which often results in a grim prognosis, such as depression, myocardial infarction, lower limb amputation, and even mortality. In the present article, we review the current strategy in the pain management of diabetes-related CLTI. The endovascular therapy, pharmacological therapies, and other optional methods could be selected following comprehensive assessments to mitigate ischemic-related pain, in line with our current clinical practice. It is very important for clinicians and patients to strengthen the understanding and build intervention strategy in ischemic pain management and possible adverse consequence.
Topics: Chronic Disease; Diabetes Mellitus; Humans; Ischemia; Pain Management; Peripheral Arterial Disease; Quality of Life; Risk Factors; Treatment Outcome
PubMed: 34046505
DOI: 10.1155/2021/6699292 -
VASA. Zeitschrift Fur Gefasskrankheiten Jul 2023
Topics: Humans; Chronic Limb-Threatening Ischemia; Treatment Outcome; Risk Factors; Endovascular Procedures; Ischemia; Limb Salvage; Peripheral Arterial Disease; Retrospective Studies; Chronic Disease
PubMed: 37394924
DOI: 10.1024/0301-1526/a001078 -
Cardiovascular Journal of AfricaThromboangitis obliteransis (TAO) is a nonatherosclerotic, inflammatory, occlusive arteritis that affects small and medium-sized arteries, veins and nerves. A large...
OBJECTIVES
Thromboangitis obliteransis (TAO) is a nonatherosclerotic, inflammatory, occlusive arteritis that affects small and medium-sized arteries, veins and nerves. A large proportion of patients with TAO suffer from claudication, and the ultimate condition is gangrene and limb loss if there is no treatment or the cessation of smoking. Endovascular revascularisations are performed frequently and provide acceptable results in patients who are not suitable for surgery. In this study, we aimed to show our clinical experience in patients with TAO who were treated with endovascular revascularisation.
METHODS
Between January 2014 and March 2020, 18 patients with lower-extremity critical limb ischaemia (CLI) underwent endovascular treatment (ET). Technical details and clinical success at follow up were documented.
RESULTS
This study included 18 patients with lower-extremity TAO who presented with CLI and were treated with ET. The mean age of the patients was 38.8 ± 7.3 years. Fifty per cent of patients had pain at rest, 33.7% had minor tissue loss and non-healing ulcers, and 16.7% had major tissue loss on admission. The majority of lesions were located in the peroneal and tibial arteries ( = 13, 72.27percnt;). Two (11.1%) patients had distal superficial femoral artery occlusion concomitant with popliteal artery (PA) lesions, and three (16.7%) had PA occlusion concomitant with peroneal and tibial artery lesions. Re-establishment of antegrade flow in at least one vessel was achieved in 15 (83.3%) patients. Balloon angioplasty was performed in all patients. Plain old balloon angioplasty (POBA) was used in nine (60%) patients and drug-eluting balloon (DEB) angioplasty in six (40%). The mean duration of follow up in 15 patient who had undergone successful ET was 21.5 ± 8.1 months. The primary CLI-free rate at 12 and 24 months was 80% (66.7% in all patients). Secondary CLI-free rates at six, 12 and 24 months were 100, 93.3 and 53.3%, respectively. Patients who were active smokers during their follow up had a higher frequency of out-patient clinic consultations ( = 0.03).
CONCLUSION
Controversy has continued on the role of ET in the treatment of TAO. This study shows that ET of TAO had promising primary and secondary patency rates with high technical success and limb-salvage rates.
Topics: Humans; Adult; Middle Aged; Thromboangiitis Obliterans; Chronic Limb-Threatening Ischemia; Treatment Outcome; Popliteal Artery; Angioplasty, Balloon; Limb Salvage; Peripheral Arterial Disease; Ischemia; Vascular Patency
PubMed: 35789369
DOI: 10.5830/CVJA-2022-018