RESUMEN
OBJECTIVE: Nutritional status plays a complex role in the pathophysiology and outcomes of chronic limb threatening ischaemia (CLTI). Undernutrition may be a modifiable risk factor. Given the variability in nutritional status concepts in CLTI outcomes studies, a systematic review examining the association between undernutrition and outcomes in patients with CLTI was conducted. DATA SOURCES: A systematic literature search of nine databases (Allied and Complementary Medicine Database [AMED], CINAHL Complete, Cochrane Library, Google Scholar, Ovid Medline, Ovid Embase, PubMed, Scopus, and Web of Science Core Collection databases) was conducted up to 23 May 2023. REVIEW METHODS: Inclusion criteria were randomised controlled trials, cohort studies, and case-control studies of patients with CLTI conducted after 1982 that reported the effect size for a nutritional status measure and the outcomes of death, amputation, or a composite of the two. Two reviewers independently performed screening, data extraction, and quality assessment, with a third independent reviewer resolving conflicts. RESULTS: A total of 6 818 citations were screened, with 49 observational studies (31 from Japan) included in the review. The mean patient age ranged 56.0 - 86.9 years. Most included patients were undergoing revascularisation. Unidimensional indicators of undernutrition (including low serum albumin, low body mass index, and zinc deficiency) as well as multidimensional measures (such as nutritional screening tool scores indicating undernutrition) were found to be associated with a statistically significant increased risk of death, amputation, and composite events in most studies. Effect sizes of the association were generally larger when multidimensional nutritional screening tools were used. However, the quality of evidence was poor and certainty of evidence was very low. CONCLUSION: Undernutrition is consistently associated with an increased risk of death and amputation in patients with CLTI, regardless of the measure used. Broader efforts to understand the framework of nutritional status and validation of nutritional screening tools in CLTI populations are needed.
RESUMEN
BACKGROUND: The present study investigated the outcomes and possible predictive factors of autologous bone marrow cells (BMCs) therapy in patients with "no-option" critical limb ischaemia (CLI). It was focused on exploring the clinical background and prior statin and renin-angiotensin system (RAS)-acting agents pharmacotherapy related to the therapeutic efficacy of BMCs treatment. METHODS: In the present study, we reviewed thirty-three patients (mean age 64.9 ± 10 years; 31 males) with advanced CLI after failed or impossible revascularisation, who were treated with 40 mL of autologous BMCs by local intramuscular application. Patients with limb salvage and wound healing (N = 22) were considered as responders to BMCs therapy, and patients with limb salvage and complete ischemic wound healing (N = 13) were defined as super-responders. Logistic regression models were used to screen and identify the prognostic factors, and a receiver operating characteristics (ROC) curve, a linear regression, and a survival curve were drawn to determine the predictive accuracy, the correlation between the candidate predictors, and the risk of major amputation. RESULTS: Based on the univariate regression analysis, baseline C-reactive protein (CRP) and transcutaneous oxygen pressure (TcPO2) values were identified as prognostic factors of the responders, while CRP value, ankle-brachial index (ABI), and bone marrow-derived mononuclear cells (BM-MNCs) concentration were identified as prognostic factors of the super-responders. An area under the ROC curve of 0.768 indicated good discrimination for CRP > 8.1 mg/L before transplantation as a predictive factor for negative clinical response. Linear regression analysis revealed a significant dependence between the levels of baseline CRP and the concentration of BM-MNCs in transplanted bone marrow. Patients taking atorvastatin before BMCs treatment (N = 22) had significantly improved TcPO2 and reduced pain scale after BMCs transplant, compared to the non-atorvastatin group. Statin treatment was associated with reduced risk for major amputation. However, the difference was not statistically significant. Statin use was also associated with a significantly higher concentration of BM-MNCs in the transplanted bone marrow compared to patients without statin treatment. Patients treated with RAS-acting agents (N = 20) had significantly reduced pain scale after BMCs transplant, compared to the non-RAS-acting agents group. Similar results, reduced pain scale and improved TcPO2, were achieved in patients treated with atorvastatin and RAS-acting agents (N = 17) before BMCs treatment. Results of the Spearman correlation showed a significant positive correlation between CLI regression, responders, and previous therapy before BMCs transplant with RAS-acting agents alone or with atorvastatin. CONCLUSIONS: CRP and TcPO2 were prognostic factors of the responders, while CRP value, ABI, and BM-MNCs concentration were identified as predictive factors of the super-responders. Atorvastatin treatment was associated with a significantly increased concentration of BM-MNCs in bone marrow concentrate and higher TcPO2 and lower pain scale after BMCs treatment in CLI patients. Similarly, reduced pain scales and improved TcPO2 were achieved in patients treated with atorvastatin and RAS-acting agents before BMCs treatment. Positive correlations between responders and previous treatment before BMCs transplant with RAS-acting agents alone or with atorvastatin were significant.
RESUMEN
BACKGROUND: Chronic limb-threatening ischemia (CLTI) is the end-stage of peripheral arterial disease (PAD) posing a high risk for limb loss and mortality. This study aims to evaluate and list possible predictors of major adverse limb events (MALEs) in CLTI patients with tissue loss. METHODS: This retrospective study included all Rutherford-Becker stage 5 or 6 patients who required foot debridement and revascularization in our department from January 2016 to December 2018. The limbs were classified according to the TASC II, GLASS and WiFI grading systems. The primary composite outcome was MALEs at 2 years. The secondary outcomes included all-cause mortality, primary patency, freedom from reintervention, and major amputation. Kaplan-Meier estimates were used to determine the event rates, and Cox proportional hazards model with the index MALE as a time-dependent covariate was used to search for MALEs predictors. RESULTS: Of 241 included patients, 19 underwent open surgeries (7.9 %) 207 had endovascular interventions (85.9 %) and 15 required a hybrid approach (6.2 %). On univariate analysis, patients who experienced MALEs (n = 111) more often required hemodialysis (25 vs 15; p = .02), presented with more complex lesions (TASC D on femoropopliteal (p = .05) or below the knee (BTK) arteries (p = .006) with increasing infra-inguinal GLASS Stage (p < .0001)), a history of index limb open (p = .009) or endovascular (p = .049) revascularization, an occluded tibial artery (p = .002 for the posterior tibial and p = .052 for the anterior tibial), or a "desert foot" (p = .02). The CRP level was also higher at admission (p = .001). Technical success of BTK revascularization significantly reduced MALEs (p < .0001) along with the number of patent BTK vessels (p = .0007). Independent predictors of MALEs included hemodialysis (HR = 2.00; 95%CI: 1.14 to 3.39), pulsatile arterial pressure (HR = 1.01; 95%CI: 1.00 to 1.03) and the infra-inguinal GLASS Stage (HR = 2.50; 95%CI: 1.17 to 5.82). We could not correlate our results with the WiFI scores for amputation risk and revascularization benefit. CONCLUSION: For patients with CLTI at the stage of trophic disorders, with or without a history of index limb revascularization, the GLASS successfully predicted MALEs. Hemodialysis and high pulsatile arterial pressure increased the risk of MALEs. The WiFI score did not demonstrate its interest in this subgroup of patients.
Asunto(s)
Amputación Quirúrgica , Enfermedad Crítica , Recuperación del Miembro , Enfermedad Arterial Periférica , Humanos , Masculino , Estudios Retrospectivos , Anciano , Factores de Riesgo , Femenino , Factores de Tiempo , Medición de Riesgo , Persona de Mediana Edad , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/mortalidad , Anciano de 80 o más Años , Isquemia Crónica que Amenaza las Extremidades/cirugía , Extremidad Inferior/irrigación sanguínea , Grado de Desobstrucción Vascular , Procedimientos Endovasculares/efectos adversos , Desbridamiento , Resultado del Tratamiento , Isquemia/fisiopatología , Isquemia/terapia , Isquemia/diagnóstico , Isquemia/mortalidad , Supervivencia sin ProgresiónRESUMEN
Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this guideline the IWGDF, the European Society for Vascular Surgery and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development, and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.
Asunto(s)
Diabetes Mellitus , Pie Diabético , Úlcera del Pie , Enfermedad Arterial Periférica , Humanos , Pie Diabético/diagnóstico , Pie Diabético/etiología , Pie Diabético/prevención & control , Gangrena , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/diagnóstico , Extremidad InferiorRESUMEN
OBJECTIVES: To evaluate the impact of the ultrasound-guided popliteal sciatic nerve block (PSNB) for pain management during endovascular treatment of chronic limb-threatening ischemia (CLTI). MATERIAL AND METHODS: From November 2020 to January 2022, 111 CLTI patients that underwent endovascular procedures were prospectively enrolled in this prospective single-arm interventional study. Ultrasound-guided PSNB was used for procedural pain control. Pain intensity was evaluated throughout the procedure (baseline, 10 min after the block, pain peak, and at the end of the procedure) with the visual analog scale (VAS). RESULTS: Forty-six patients underwent above-the-knee revascularization (ATK), 20/111 below-the-knee (BTK) revascularization, 20/111 to both ATK and BTK revascularization. In 25 cases, no endovascular option was feasible at diagnostic angiography. The PSNB was effective in 96% of patients, with no need for further pain management with a statistically significant reduction (p < 0.0001) in the mean value of the VAS from 7.86 ± 1.81 (pre-procedural) to 2.04 ± 2.20 after 10 min from the block and up to 0.74 ± 1.43 at the end of the procedure (mean time 43 min). Only 1 complication related to the popliteal sciatic nerve block was registered (a temporary foot drop, completely resolved within 48 h). The time necessary to perform the block ranged between 4 and 10 min. CONCLUSION: Ultrasound-guided PSNB is a feasible and effective method to manage patients with rest pain and increase comfort and compliance during endovascular procedures. CLINICAL RELEVANCE STATEMENT: An ultrasound-guided popliteal sciatic nerve block is a safe, feasible, and effective technique to manage pain during endovascular treatment of chronic limb-threatening ischemia, especially in frail patients with multiple comorbidities who are poor candidates for deep sedoanalgesia or general anesthesia. KEY POINTS: Endovascular treatment of CTLI may require long revascularization sessions in patients with high levels of pain at rest, which could be exacerbated during the revascularization procedure. The PSNB is routinely used for anesthesia and analgesia during foot and ankle surgery, but the experience with lower limb revascularization procedures is very limited and not included in any international guideline. Ultrasound-guided PSNB is a feasible and effective regional anesthesia technique to relieve procedural and resting pain. Because of its safety and availability, every interventional radiologist should know how to perform this type of loco-regional anesthesia.
Asunto(s)
Anestesia de Conducción , Bloqueo Nervioso , Dolor Asociado a Procedimientos Médicos , Humanos , Manejo del Dolor , Isquemia Crónica que Amenaza las Extremidades , Bloqueo Nervioso/métodos , Dolor Asociado a Procedimientos Médicos/complicaciones , Estudios Prospectivos , Nervio Ciático/diagnóstico por imagen , Ultrasonografía Intervencional/métodos , Anestesia de Conducción/efectos adversos , Dolor/etiologíaRESUMEN
The current study aimed to evaluate the effectiveness of peripheral blood mononuclear cell (PB-MNC) therapy as adjuvant treatment for patients with diabetic foot ulcers (DFUs) and no-option critical limb ischaemia (NO-CLI). The study is a prospective, noncontrolled, observational study including patients with neuro-ischaemic DFUs and NO-CLI who had unsuccessful revascularization below the ankle (BTA) and persistence of foot ischaemia defined by TcPO2 values less than 30 mmHg. All patients received three cycles of PB-MNC therapy administered through a "below-the-ankle approach" in the affected foot along the wound-related artery according to the angiosome theory. The primary outcome measures were healing, major amputation, and survival after 1 year of follow-up. The secondary outcome measures were the evaluation of tissue perfusion by TcPO2 and foot pain defined by the numerical rating scale (NRS). Fifty-five patients were included. They were aged >70 years old and the majority were male and affected by type 2 diabetes with a long diabetes duration (>20 years); the majority of DFUs were infected and nearly 90% were assessed as gangrene. Overall, 69.1% of patients healed and survived, 3.6% healed and deceased, 10.9% did not heal and deceased, and 16.4% had a major amputation. At baseline and after PB-MNC therapy, the TcPO2 values were 17 ± 11 and 41 ± 12 mmHg, respectively (p < 0.0001), while the pain values (NRS) were 6.8 ± 1.7 vs. 2.8 ± 1.7, respectively (p < 0.0001). Any adverse event was recorded during the PB-MNC therapy. Adjuvant PB-MNC therapy seems to promote good outcomes in patients with NO-CLI and neuro-ischaemic DFUs.
RESUMEN
We evaluated the use of autologus bone marrow stem cells transplantation in patients with critical limb ischaemia (CLI) not eligible for revascularization. Eighty consecutive patients candidate to amputation were enrolled in a single-centre retrospective study. The primary endpoint was defined as the amputation-free rate from stem cells transplantation. Secondary endpoints were the evaluation of transcutaneous oximetry and its predictive potential for probability of amputation and the evaluation of rest pain. Ankle brachial index, transcutaneous oxygen (TcpO2) and radiological imaging were performed at the enrolment and during the follow-up times. All patients were treated with auto transplant of bone marrow stem cells. Two patients died due to acute renal and acute respiratory failures. 19 patients were amputated from the thigh or leg. In total, 59 of 80 patients intended to thigh amputation saved the limb, preserving the plantar support. TcpO2 was found a predictive metric with an AUC equal to .763, and a threshold for a risk of amputation of 10% and 5% at the values ≤22.7 and ≤26.9 mmHg, respectively. Auto transplant of bone marrow stem cells seems to be a safe and an efficient option for CLI not eligible to revascularizzation.
RESUMEN
Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.
RESUMEN
Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.
RESUMEN
OBJECTIVES: Cell therapy has had satisfactory safety and efficacy outcomes for no-option critical limb ischaemia (NO-CLI) patients. In the current study, we aimed to compare the image quality of ischaemic lower limb blood vessels shown on volumetric CT-based time maximum intensity projection CT perfusion (t-MIP CTP) versus single-phase CTA (sCTA). We also tried to quantify the blood flow of the ischaemic lower extremity based on the t-MIP technique, not only to precisely show the dynamic change in blood flow from before to after cell therapy but also to detect any relationship between this change and patient prognosis. METHODS: A total of 31 patients with thromboangiitis obliterans (TAO)-induced NO-CLI who had been referred from the department of vascular surgery to undergo autologous stem cell transplantation into a single limb from January 2020 to March 2021 were prospectively enrolled in this study. Preoperative sCTA or t-MIP CTP and postoperative 1-month t-MIP CTP were performed in all patients. Clinical outcomes, including the 1-month ankle-brachial index (ABI) and 3-month CLI status, were also analysed. Image quality, including objective scores (attenuation, signal-to-noise ratio [SNR] and contrast-to-noise ratio [CNR]), subjective scores and collateral scores, was compared between preoperative sCTA and t-MIP CTP. Vascular volume was calculated as the total volume (mL) of lower limb arteries within the scanning range. All images and calculations were performed by 2 separate radiologists. Receiver operating characteristic curves were drawn to reveal the sensitivity and specificity of vascular volume and ABI in predicting prognosis. RESULTS: Both sCTA and t-MIP CTP images exhibited good quality for diagnosis. t-MIP CTP images showed significantly higher attenuation, SNR and CNR in all arterial segments (popliteal artery, anterior tibial artery, posterior tibial artery and peroneal artery). In subjective and collateral score evaluations, t-MIP CTP images were also significantly better than sCTA images (both p < .05). At 1 month after transplantation, both vascular volume and ABI showed significant improvement (both p < .01). At 3 months after transplantation, 38.71% of patients (12/31) achieved CLI relief (Rutherford class < 4). Through the receiver operating characteristic (ROC) curve, the 1-month vascular volume increase ratio showed better ability to predict the 3-month prognosis (radiologist 1: AUC, 0.757; sensitivity, 0.750; specificity, 0.840; radiologist 2: AUC, 0.803; sensitivity, 0.500; specificity, 1.000) than the 1-month ABI increase ratio (AUC, 0.607; sensitivity, 0.230; specificity, 0.820) or 1-month ABI (AUC, 0.410; sensitivity, 0.080; specificity, 0.580). CONCLUSION: t-MIP CTP showed significantly higher-quality images of ischaemic limb vascularity than sCTA. t-MIP CTP can reveal the anatomical information of collaterals more accurately, which is of great importance for NO-CLI patients undergoing cell transplantation. The 1-month vascular volume increase ratio can predict the 3-month prognosis more precisely on this basis.
RESUMEN
We evaluated the impact of COVID-19 restriction on the angioplasty service and outcome of chronic limb-threatening ischaemia (CLTI) patients undergoing lower-limb angioplasty in a UK secondary care setting. Consecutive patients were analysed retrospectively. Pre-COVID-19 (08/2018-02/2020), 106 CLTI patients (91% Fontaine 4; 60% diabetes mellitus) and during COVID-19 (03/2020-07/2021) 94 patients were treated (86% Fontaine 4; 66% diabetes mellitus). While the average monthly number of patients treated did not change, the proportion of day cases significantly increased (53% to 80%), and hospitalised patients decreased. Patients treated in ≤14/5 days after referral significantly increased to 64/63%. Kaplan-Meier survival analysis (30-day/1-year) showed that neither wound healing nor mortality were significantly changed during COVID-19. In day cases, 1-year but not 30-day major amputations significantly increased, and clinically driven target-lesion revascularisation decreased during COVID-19. One-year mortality was significantly worse in hospitalised compared to day cases (14% vs. 43%) at similar wound healing rates (83% vs. 84%). The most frequent known cause of death was infectious disease (64%), while cardiovascular (21%) was less frequent. Despite COVID-19 restrictions, a safe and effective angioplasty service was maintained while shortening waiting times. Very high mortality rates in hospitalised patients may indicate that CLTI patients need to be referred and treated more aggressively earlier.
RESUMEN
The current literature strongly supports the use of supervised exercise therapy (SET) as the first-line treatment for symptomatic peripheral arterial disease (PAD) such as intermittent claudication (IC). However, this form of treatment remains underutilised in clinical practice. The home-based exercise therapy (HBET), in which patients must conduct themselves unsupervised is generally less effective than SET in terms of improving functional walking capacity. Nevertheless, it may be a useful alternative where SET is unavailable. The objective of this systematic review is to determine the effectiveness of HBET in reducing symptoms of IC in patients with PAD. Studies eligible for inclusion in this systematic review were parallel-group randomised controlled trials (RCTs) published in the English language that compared the effect of HBET to a comparator arm (SET or no exercise/attention control) in adults with PAD and IC. Studies were eligible if outcome measures were available at baseline and at 12 weeks of follow-up or more. The electronic databases PubMed, Google Scholar, and the Cochrane Library were searched from the earliest records up to January 2021. The Cochrane Collaboration risk of bias tool for RCTs (RoB 2) was used to assess the risk of bias in individual studies, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) classification system was used to appraise the quality of evidence for each outcome across all studies. The primary investigator independently collected, pooled, and analysed the data. The data was then entered into the ReviewManager 5 (RevMan 5) software, and a meta-analysis was performed by using a fixed or random effects model depending on the presence or absence of statistical heterogeneity. The review author identified seven RCTs involving a total of 754 patients which were included in this study. Overall, the risk of bias in the included studies was moderate. Even though the results were variable, this analysis supported the ability of HBET to improve functional walking capacity and self-reported quality of life (QoL) to an extent. This review shows that a home-based exercise intervention with regular professional support and encouragement is beneficial in improving functional walking capacity as well as some aspects of QoL in patients with PAD and IC when compared to no exercise. However, when HBET is compared to hospital-based supervised exercise intervention, SET yields greater benefits.
RESUMEN
BACKGROUND: Recently, increased risk of amputation under sodium glucose cotransporter-2 inhibitors has been debated. Similar concerns have been raised with other "traditional" diuretics, more particularly in patients with or at risk of lower extremity arterial disease (LEAD). AIM: To collect all available data on any potential risk of amputation associated with diuretics in patients with or at risk of LEAD. Additionally, we looked for other limb-related events in these patients. METHODS: We searched in PubMed, Embase and Scopus databases up to February 2021 for references, using peripheral or lower extremity arterial disease, diuretics and amputation keywords, excluding case reports, experimental animal studies and non-English reports. RESULTS: Among the 1376 hits identified in the databases, six studies were finally included in this review, including one cross-sectional and five longitudinal studies (total of 47,612 participants). One study was limited to thiazide diuretics, one focused on loop diuretics and the remainder mixed all diuretics. All studies reported a significant association between diuretic use and amputation risk in patients with or at high risk of LEAD. Despite some limitations in several studies, the meta-analysis showed an increased risk of amputation associated with diuretics (odds ratio: 1.75, 95% confidence interval: 1.53-1.99; P<0.001). Beyond amputation, patients with or at risk of LEAD under diuretics appeared to be at increased risk of other lower limb events, mostly in the presence of other comorbidities, including diabetes. CONCLUSIONS: Although the amount of data in the literature is scarce, this first systematic review and meta-analysis favours an increased risk of amputation in patients with or at risk of LEAD under diuretics. Further prospective studies must be conducted to provide a better understanding of the mechanisms. Meanwhile, the use of diuretics in these patients should be parsimonious, considering alternatives whenever possible.
Asunto(s)
Diuréticos , Enfermedad Arterial Periférica , Humanos , Diuréticos/efectos adversos , Estudios Transversales , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/complicaciones , Extremidad Inferior , Amputación Quirúrgica , Factores de RiesgoRESUMEN
PURPOSE: To describe a crossing technique of stenotic/occluded and tortuous highly calcific ankle vessels during complex percutaneous limb salvage intervention in diabetic patients with ischaemic foot ulcers (Rutherford 5 and 6). TECHNIQUE: We propose a simple technique to achieve "straightening" of the tortuous vessel and allow safe devices passage into the foot arteries, Patients were asked to hold their foot in plantar or dorsal flexion, accordingly to the treated artery. If unable to do so, an equipe member executed the manoeuvre on their behalf. RESULTS: The technique was applied in 148 cases, with a success rate of 81% (120/148). No complications related to the manoeuvre were observed. CONCLUSION: Crossing of tortuous distal crural vessels can be challenging in diabetic patients; in our experience, this technique can be a useful tool to obtain a successful recanalization in complex procedures with high risk of failure.
Asunto(s)
Tobillo , Isquemia , Humanos , Tobillo/irrigación sanguínea , Isquemia/diagnóstico por imagen , Isquemia/cirugía , Pie , Pierna/irrigación sanguínea , Arterias , Recuperación del Miembro , Resultado del Tratamiento , Estudios RetrospectivosRESUMEN
OBJECTIVES: Foot ulceration associated with diabetic foot disease (DFD) and chronic limb-threatening ischaemia (CLTI) presents a complex clinical challenge and failure to heal the wound imposes a significant risk of major limb amputation (MLA). In attempt to accelerate wound healing rates and decrease MLA, tissue engineering research into bio-engineered scaffolds and skin substitutes has become a growing area of interest. Advanced wound therapies such as fetal bovine acellular dermal matrix (FBADM) may have success in the treatment of difficult to heal chronic foot ulcers. The FBADM traps and binds the patients' own epithelial cells to rebuild the dermis layer of the skin. Previous studies have suggested that wounds treated with FBADM had a faster healing rate than wounds managed with conventional dressings. However, these studies excluded foot wounds with chronic exposed bone or tendon, active infection, gangrene, or osteomyelitis and patients with uncontrolled blood glucose levels were excluded. The aim of this study was to assess the efficacy of FBADM for patients admitted to hospital acutely with severe foot ulceration secondary to DFD and CLTI. METHODS: Between February 2020 and December 2021, inpatients admitted acutely at a single tertiary centre with a severe non-healing foot ulcer and had a wound suitable for application of a FBADM after primary debridement were included in the study. A severe non-healing foot wound was defined as a Society for Vascular Surgery Wound, Ischaemia, and foot Infection (WIfI) stage of 3 or 4. Participants were prospectively followed up at regular intervals at a multidisciplinary high-risk diabetic foot clinic until June 2022. The primary endpoint was time to wound closure. The secondary endpoints were number of applications of FBADM, readmission rate and amputation-free survival. RESULTS: There were 22 patients included in the study with a median age of 71 (50-87) years and 15 were male. Five patients had a WIfI stage of 3 and 17 had a WIfI score of 4. Overall, 14 patients required revascularisation procedures (6 open surgery,8 endovascular intervention). A total of 18 patients achieved complete wound healing with a median time to wound healing of 178 (28-397) days. Two patients underwent a MLA and two patients died prior to complete wound healing. The median length of stay was 16.5 (5-115) days, and 4 patients were readmitted to hospital within 12 months. CONCLUSION: FBADM may be a useful adjunct in the acute setting of complex DFD and CLTI ulceration to assist with wound healing. Future comparative prospective studies are required to further validate these preliminary findings.
RESUMEN
OBJECTIVE: Demonstrate that simplified ERICVA (Valladolid Critical Limb Ischaemia Risk Scale) is useful in predicting amputation in chronic limb-threatening ischemia (CLI) after one year of revascularization. METHODS: A retrospective cohort study was performed. We analyzed the medical records of 93 patients over the age of 35 with the diagnosis of CLI who were treated in the Department of Internal Medicine, Orthopedics or in the Cardiovascular Surgery Unit of the Víctor Lazarte Echegaray Hospital and the High Complexity Virgen de La Puerta Hospital during the period 2015-2018. The simplified ERICVA score was determined in patients before surgical and endovascular revascularization. We included 31 patients who scored 2 or more points in the exposed group and 62 patients who scored less than 2 points in the group not exposed to amputation risk. The collected data was analyzed with the statistical program SPSS where the Relative Risk and significance was obtained with Pearson's Chi-square. The multivariate analysis was also carried out in order to obtain the adjusted relative risk. RESULTS: It was identified that the simplified ERICVA score greater than or equal to 2 points was more frequent in those who underwent amputation (90.3%) compared to patients who did not undergo amputation (4.8%), increasing the risk of amputation in those patients with CLI who underwent revascularization (RR: 18.67, P<0.001). It was also possible to identify that within the group of patients that showed a high risk of amputation according to the ERICVA scale, they had a higher risk of major amputation (RR: 9.32, P<0.001) as opposed to the risk of minor amputation (RR: 1, 89, P=0.193). Among the items of the simplified ERICVA scale, the preoperative neutrophil-lymphocyte ratio and hematocrit were significantly higher in the group of amputated patients (P<0.001). In addition, it was possible to identify that the score greater than or equal to 2 was independently associated with the risk of amputation in patients revascularized with CLI (RR: 13.5, P<0.001). CONCLUSION: In our patient population, the simplified ERICVA scale is useful in predicting major and minor amputation in critical limb ischemia after revascularization. The present data showed that the patients who had a simplified ERICVA score greater than or equal to 2 had a higher risk of major amputation compared to the risk of minor amputation. However, it is important to highlight that the impact on the prediction of minor amputation is greater because in some circumstances major amputation can appear as a complication of CLI.
Asunto(s)
Procedimientos Endovasculares , Enfermedad Arterial Periférica , Amputación Quirúrgica , Isquemia Crónica que Amenaza las Extremidades , Procedimientos Endovasculares/efectos adversos , Humanos , Isquemia/diagnóstico , Isquemia/cirugía , Recuperación del Miembro , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/cirugía , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Isquemia Crónica que Amenaza las Extremidades , Calidad de Vida , Humanos , Amputación Quirúrgica , Procedimientos Quirúrgicos Vasculares , Tratamiento Conservador , Estudios Observacionales como AsuntoRESUMEN
Background: Patients with acute limb ischaemia (ALI) present with acute symptoms, requiring prompt diagnosis and expedited treatment to preserve the viability of the affected ischaemic tissue. Case summary: We present an 83-year-old female patient with upper ALI due to thrombotic occlusion of the left brachial artery. Concomitantly, the patient had a first diagnosis of atrial fibrillation and was not on treatment with oral anticoagulation. Transfemoral thrombectomy using a 6F Rotarex® catheter resulted in removal of the thrombus from the brachial artery. However, significant amounts of debris embolized distally, causing occlusion of both the radial and ulnar arteries. The debris was successfully removed after puncture of the distal radial artery and retrograde thrombus aspiration using a 5F Envoy catheter. This manoeuver led to flow restoration in both the radial and ulnar arteries and to complete resolution of ischaemic symptoms of the patient. Discussion: Interventionists may consider distal radial puncture not only as an access site for coronary angiography but also as an option for the endovascular management of ALI in cases of cardiac embolism, as described herein or in cases of thrombotic complications during routine catheterization and percutaneous coronary intervention. Herein, we describe the case of an 83-year-old patient, who presented with acute upper limb ischaemia. Due to embolization of thrombotic debris during Rotarex® catheter thrombectomy, flow further diminished in the ulnar and radial arteries. The last hope for successful interventional treatment was thrombectomy from distally after retrograde puncture of the distal radial artery. This unique manoeuver led to flow restoration and complete recovery of the patient without the need for open surgery.
RESUMEN
Purpose: The effect of chronic limb threatening ischemia (CLTI) on advanced cardiac disease, which requires surgical treatment, has rarely been reported. The purpose of this study was to review the outcomes of cardiac surgery in patients with CLTI and determine the risk factors, with a particular focus on the severity of CLTI. Patients: The baseline characteristics and outcomes of 33 patients who were treated for CLTI and underwent cardiac surgery were retrospectively analyzed. The states of CLTI were evaluated based on the Wound, Ischemia, and foot Infection (WIfI) classification system, and 33 patients were divided into the low-WIfI group (stages 1-2, n = 13) and high-WIfI group (stages 3-4, n = 20). Results: The in-hospital mortality rate was 0% in low-WIfI group and 35% in high-WIfI group (p = 0.027). Postoperative complications, particularly severe infections, occurred more frequently among high-WIfI group than low-WIfI group (70.0% vs. 23.1%, p < 0.01). Multivariable analysis identified foot infection grade as a WIfI classification factor and lower albumin levels as factors significantly associated with postoperative complications. The 1-year and 2-year survival rates were 84.6% and 67.7% in low-WIfI group and 45% and 28.1% in high-WIfI group, respectively (p = 0.011). Conclusions: Cardiac surgery in patients with high WIfI stage was an extremely high-risk procedure. In such patients, lowering the WIfI stage by lower extremity revascularization and/or debridement of diseased parts prior to cardiac surgery can be considered.
RESUMEN
OBJECTIVE: Great efforts have been made to choose between bypass surgery and angioplasty as the first choice for revascularisation in chronic limb threatening ischaemia (CLTI). Endovascular therapy predominates despite limited evidence for its advantages. The purpose of this observational cohort study was to investigate outcomes after open and endovascular infrapopliteal revascularisation in extensive infrainguinal arterial disease. METHODS: The medical records of 1 427 patients who underwent infrainguinal revascularisation exclusively for CLTI in the period January 2014 to February 2019 were reviewed. After detailed analysis, only infrapopliteal revascularisations classified as GLASS stage II or III were considered, resulting in 326 procedures. In total, 127 patients underwent endovascular therapy and 199 patients underwent bypass graft surgery (BGS). The primary endpoints included amputation free survival (AFS) and overall survival (OS). Secondary endpoints included the analyses of multiple factors related to long term AFS. RESULTS: Regarding the primary endpoint, AFS was 75.2% and 65.2% at one and three years, respectively. OS at one and three years was 91.2% and 83.1%, respectively. In the univariable analysis, the hazard of the combined endpoint of major amputation or death was higher after bypass surgery than after endovascular therapy (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.13 - 2.89; p = .013). After either revascularisation method, TASC II femoropopliteal D was associated with a higher risk of amputation or death (HR 1.69, 95% CI 1.10 - 2.58; p = .015). Multivariable Cox regression analysis revealed no association between the variables analysed for AFS. CONCLUSION: Patients with CLTI submitted to infrapopliteal revascularisation and classified as GLASS II and III had satisfactory AFS and OS rates after an individualised team conference decision. Furthermore, the revascularisation modality (endovascular or open) did not influence the AFS results.