RESUMEN
This study aimed to evaluate the long-term clinical outcomes of drug-coated drug (DCB) angioplasty for long femoropopliteal lesions in older patients with chronic limb-threatening ischemia (CLTI). In this multi-center retrospective study, we enrolled 119 patients with CLTI due to Trans-Atlantic Inter-Society Consensus (TASCII) C/D femoropopliteal lesions who underwent DCB angioplasty. A total of 119 patients with 122 limbs (TASCII Câ =â 67, 54.9%; TASCII Dâ =â 55, 45.1%) were enrolled. At 36-month follow-up, primary patency, assisted primary patency, secondary patency, and freedom from target lesion revascularization were 47.3%, 49.8%, 59.5%, and 62.7%, respectively, and there was a significant improvement over baseline in Rutherford class (Pâ <â .001) and ankle-brachial index measurements (Pâ <â .001). Complex target lesions (Pâ =â .017) and 1 stenosis-free outflow vessel (Pâ =â .001) were risk predictors of freedom from clinically driven target lesion revascularization. Complex target lesions (Pâ =â .044), diabetes (Pâ =â .007), and 1 stenosis-free outflow vessel (Pâ =â .003) were risk predictors of restenosis. At 2 months, the ulcer healing rate was 96.3% (26/27). At 36 months, the limb salvage and survival rates were 85.8% and 83.3%, respectively. DCB angioplasty were safe and effective for older patients with CLTI attributable to femoropopliteal TASCII C/D lesions.
Asunto(s)
Angioplastia de Balón , Arteria Femoral , Arteria Poplítea , Humanos , Masculino , Femenino , Estudios Retrospectivos , Anciano , Angioplastia de Balón/métodos , Arteria Poplítea/diagnóstico por imagen , Anciano de 80 o más Años , Resultado del Tratamiento , Isquemia Crónica que Amenaza las Extremidades/terapia , Enfermedad Arterial Periférica/terapia , Grado de Desobstrucción Vascular , Materiales Biocompatibles Revestidos , Persona de Mediana EdadRESUMEN
The rate of vascular recanalizations in CLTI is increasing worldwide. Safety and efficacy of surgical versus endovascular treatment in CLTI patients was investigated in 2 prospective randomized trials with contrasting results. The BEST-CLI trial randomized 1830 patients with CLTI, the Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL-2) trial included 345 patients with CLTI. Best-CLI evaluated outcome events as the primary endpoint, which includes major reinterventions in addition to major amputations and death. Only half of the CLTI patients received a crural intervention or surgery. There were no differences in major amputations or death. After a median follow-up (FU) of 2,7 years, the surgery group showed significantly better results compared to the endovascular group, due to fewer re-interventions. BASIL-2 used amputation-free survival as the primary outcome and only included patients with lower leg lesions. After a median FU of 40 months, endovascular therapy was found to be superior. The extremely high mortality rate was remarkable in both studies. The BEST-CLI study represents CLTI patients only to a limited degree, whereas the BASIL-2 study presents the treatment of CLTI patients with below-the-knee-lesions quite well. Both studies confirm that patients with CLTI should be treated in specialized centers that offer both crural surgery and endovascular therapy. Cardiovascular risk factor management must play a more important role in reducing the high mortality associated with CLTI.
Asunto(s)
Amputación Quirúrgica , Humanos , Isquemia Crónica que Amenaza las Extremidades/cirugía , Isquemia Crónica que Amenaza las Extremidades/terapia , Isquemia/terapia , Procedimientos Endovasculares/métodos , Masculino , Resultado del Tratamiento , Anciano , Femenino , Persona de Mediana EdadRESUMEN
Chronic limb threatening ischemia (CLTI) poses a significant treatment challenge for vascular surgeons, interventionalists, podiatrists, and associated medical specialists. The evidence for what constitutes appropriate care is rapidly evolving and new treatment options are in constant development. This review examines the current guidelines for CLTI care, as well as reported outcomes for multiple care strategies in this patient population, including revascularization and medical optimization. We performed a literature review of the PubMed database, reviewing articles that reported outcomes for CLTI care between 2000 and 2023, and described these outcomes as they relate to the current state of CLTI treatment. Significant data are still forthcoming regarding CLTI care, but widespread adoption of appropriate CLTI care is essential for the treatment of this vulnerable population.
Asunto(s)
Isquemia Crónica que Amenaza las Extremidades , Humanos , Resultado del Tratamiento , Factores de Riesgo , Isquemia Crónica que Amenaza las Extremidades/terapia , Procedimientos Quirúrgicos Vasculares/normas , Procedimientos Quirúrgicos Vasculares/efectos adversos , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/fisiopatología , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/normas , Medicina Basada en la Evidencia/normas , Guías de Práctica Clínica como Asunto , Isquemia/terapia , Isquemia/diagnóstico , Isquemia/fisiopatología , Recuperación del Miembro , Enfermedad CrónicaAsunto(s)
Angioplastia de Balón , Isquemia , Humanos , Isquemia/terapia , Isquemia/diagnóstico por imagen , Angioplastia de Balón/métodos , Isquemia Crónica que Amenaza las Extremidades/terapia , Isquemia Crónica que Amenaza las Extremidades/diagnóstico por imagen , Materiales Biocompatibles Revestidos , Enfermedad CrónicaRESUMEN
Peripheral artery disease (PAD) is the lower limb manifestation of systemic atherosclerotic disease. PAD may initially present with symptoms of intermittent claudication, whilst chronic limb-threatening ischaemia (CLTI), the end stage of PAD, presents with rest pain and/or tissue loss. PAD is an age-related condition present in over 10% of those aged ≥65 in high-income countries. Guidelines regarding definition, diagnosis and staging of PAD and CLTI have been updated to reflect the changing patterns and presentations of disease given the increasing prevalence of diabetes. Recent research has changed guidelines on optimal medical therapy, with low-dose anticoagulant plus aspirin recommended in some patients. Recently published randomised trials highlight where bypass-first or endovascular-first approaches may be optimal in infra-inguinal disease. New techniques in endovascular surgery have increased minimally invasive options for ever more complex disease. Increasing recognition has been given to the complexity of patients with CLTI where a high prevalence of both frailty and cognitive impairment are present and a significant burden of multi-morbidity and polypharmacy. Despite advances in minimally invasive revascularisation techniques and reduction in amputation incidence, survival remains poor for many with CLTI. Shared decision-making is essential, and conservative management is often appropriate for older patients. There is emerging evidence of the benefit of specialist geriatric team input in the perioperative management of older patients undergoing surgery for CLTI. Recent UK guidelines now recommend screening for frailty, cognitive impairment and delirium in older vascular surgery patients as well as recommending all vascular surgery services have support and input from specialist geriatrics teams.
Asunto(s)
Enfermedad Arterial Periférica , Humanos , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/epidemiología , Anciano , Procedimientos Endovasculares/métodos , Factores de Riesgo , Isquemia Crónica que Amenaza las Extremidades/epidemiología , Isquemia Crónica que Amenaza las Extremidades/terapia , Isquemia Crónica que Amenaza las Extremidades/diagnóstico , Isquemia Crónica que Amenaza las Extremidades/cirugía , Procedimientos Quirúrgicos Vasculares , Factores de Edad , Guías de Práctica Clínica como AsuntoRESUMEN
Systemic sclerosis (SSc) is a collagen disease with immune abnormalities, vasculopathy, and fibrosis. Ca blockers and prostaglandins are used to treat peripheral circulatory disturbances. Chronic limb-threatening ischemia (CLTI) is a disease characterized by extremity ulcers, necrosis, and pain due to limb ischemia. Since only a few patients present with coexistence of CLTI and SSc, the treatment outcomes of revascularization in these cases are unknown. In this study, we evaluated the clinical characteristics and treatment outcomes of seven patients with CLTI and SSc, and 35 patients with uncomplicated CLTI who were hospitalized from 2012 to 2022. A higher proportion of patients with uncomplicated CLTI had diabetes and male. There were no significant differences in the age at which ischemic ulceration occurred, other comorbidities, or in treatments, including antimicrobial agents, revascularization and amputation, improvement of pain, and the survival time from ulcer onset between the two subgroups. EVT or amputation was performed in six or two of the seven patients with CLTI and SSc, respectively. Among those who underwent EVT, 33% (2/6) achieved epithelialization and 67% (4/6) experienced pain relief. These results suggest that the revascularization in cases with CLTI and SSc should consider factors such as infection and general condition, since revascularization improve the pain of these patients.
Asunto(s)
Isquemia Crónica que Amenaza las Extremidades , Esclerodermia Sistémica , Humanos , Masculino , Femenino , Esclerodermia Sistémica/complicaciones , Esclerodermia Sistémica/terapia , Anciano , Persona de Mediana Edad , Resultado del Tratamiento , Isquemia Crónica que Amenaza las Extremidades/cirugía , Isquemia Crónica que Amenaza las Extremidades/complicaciones , Isquemia Crónica que Amenaza las Extremidades/etiología , Isquemia Crónica que Amenaza las Extremidades/diagnóstico , Isquemia Crónica que Amenaza las Extremidades/terapia , Amputación Quirúrgica/estadística & datos numéricos , Procedimientos Endovasculares , Estudios Retrospectivos , Isquemia/etiología , Isquemia/terapia , Isquemia/diagnóstico , Anciano de 80 o más Años , AdultoRESUMEN
Chronic limb threatening ischemia (CLTI) is the most severe manifestation of peripheral arterial disease and represents a particularly high-risk subgroup of patients. As such, efforts to better understand this complex patient population through well-designed clinical research studies are critical to improving CLTI care. Prospective randomized clinical trials (RCTs) remain the gold standard in clinical research, but these trials are resource-intensive and have highly selective patient populations, which limit their feasibility and generalizability. Alternatively, retrospective studies are less expensive than RCTs, have a larger sample size, and are more generalizable owing to a broader patient population. Health care administrative data provide rich sources of information that may be used for research purposes and are increasingly being used for the study of vascular surgery conditions, including CLTI. Although administrative data are collected for billing purposes, they may be leveraged to study a broad range of topics in vascular surgery including those related to health care delivery, epidemiology, health disparities, and outcomes. This review provides an overview of administrative data available for CLTI research, the strengths and limitations of these data sources, current areas of investigation, and future opportunities for further study with the goal of improving outcomes in this high-risk population.
Asunto(s)
Isquemia Crónica que Amenaza las Extremidades , Enfermedad Arterial Periférica , Humanos , Resultado del Tratamiento , Isquemia Crónica que Amenaza las Extremidades/cirugía , Isquemia Crónica que Amenaza las Extremidades/terapia , Isquemia Crónica que Amenaza las Extremidades/epidemiología , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico , Bases de Datos Factuales , Factores de Riesgo , Procedimientos Quirúrgicos Vasculares , Reclamos Administrativos en el Cuidado de la Salud , Isquemia/terapia , Isquemia/diagnóstico , Isquemia/epidemiología , Enfermedad CrónicaRESUMEN
The physical consequences of peripheral artery disease (PAD) are well established; however, the impact of comorbid mental health disorders such as depression and anxiety are not well understood. The impact of psychological stress is not only associated with worse perioperative morbidity and mortality but also with a physiologic cascade that accelerates plaque formation. Increasing screening to identify and subsequently treat comorbid mental health disorders is an integral next step in improving outcomes in PAD management. Failure to adequately address social and psychological impact on PAD patients will further widen the gap in disparities faced by high-risk and disenfranchised populations. Integration of mental health professionals, addiction specialists, and community navigators into multidisciplinary care teams can bolster support for PAD patients and improve outcomes.
Asunto(s)
Salud Mental , Enfermedad Arterial Periférica , Humanos , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/fisiopatología , Factores de Riesgo , Resultado del Tratamiento , Comorbilidad , Isquemia Crónica que Amenaza las Extremidades/terapia , Isquemia Crónica que Amenaza las Extremidades/diagnóstico , Isquemia Crónica que Amenaza las Extremidades/psicología , Enfermedad Crítica , Isquemia/terapia , Isquemia/diagnóstico , Isquemia/fisiopatología , Medición de Riesgo , Disparidades en Atención de Salud , Procedimientos Quirúrgicos Vasculares , Estrés Psicológico/diagnóstico , Estrés Psicológico/terapia , Estrés Psicológico/epidemiología , Trastornos Mentales/terapia , Trastornos Mentales/diagnóstico , Trastornos Mentales/epidemiología , Trastornos Mentales/psicologíaRESUMEN
Multidisciplinary teams are necessary to treat complex patients with chronic limb-threatening ischemia (CLTI). The need for adequate wound care and control of comorbid conditions cannot be accomplished by the vascular specialist alone. Numerous specialties have a role in this group to include surgical podiatrists, orthopedic surgery, plastic and reconstructive surgery endocrinology, and wound care. However, the vascular specialist must drive this team as the patients are usually referred to them and numerous studies have shown a direct correlation between major amputations and the lack of vascular involvement. Creating these teams is unique in each community and must consider practice patterns that are relevant in the local region. CLTI is a challenging disease to manage, and multidisciplinary teams have demonstrated an ability to improve outcomes and deliver superior care to this patient population.
Asunto(s)
Amputación Quirúrgica , Isquemia Crónica que Amenaza las Extremidades , Recuperación del Miembro , Grupo de Atención al Paciente , Procedimientos Quirúrgicos Vasculares , Humanos , Resultado del Tratamiento , Isquemia Crónica que Amenaza las Extremidades/cirugía , Isquemia Crónica que Amenaza las Extremidades/terapia , Comunicación Interdisciplinaria , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico , Prestación Integrada de Atención de Salud/organización & administración , Factores de Riesgo , Isquemia/terapia , Isquemia/fisiopatología , Isquemia/cirugía , Isquemia/diagnóstico , Isquemia/diagnóstico por imagen , Conducta Cooperativa , Enfermedad CrónicaRESUMEN
BACKGROUND: To assess the quality of clinical practice guidelines (CPGs) for chronic limb-threatening ischemia (CLTI) using the Appraisal of Guidelines for Research and Evaluation II instrument. METHODS: A systematic review of Medline, Embase, and online CPG databases was carried out. Four CPGs on CLTI were identified: Global Vascular Guidelines (GVG), European Society of Cardiology (ESC), American College of Cardiology, and National Institute for Health and Care Excellence guidelines on lower limb peripheral arterial disease. Two independent appraisers analyzed the 4 CPGs using the Appraisal of Guidelines for Research and Evaluation II instrument. CPGs were ranked across 6 domains with 23 items that ranged from 1 (strongly disagree) to 7 (strongly agree). A scaled domain score was calculated as a percentage of the maximum possible score achievable. A domain score of ≥50% and an overall average domain score of ≥80% reflected a CPG of adequate quality recommended for use. RESULTS: GVG had the highest overall score (82.9%), as an average of all domains, and ESC had the lowest score (50.2%). GVG and National Institute for Health and Care Excellence guidelines had all domains scoring >50%, while American College of Cardiology had 5 and ESC had 3. Two domains, rigor of development and applicability, scored the lowest among the CPGs. There was a lack of detail in describing systematic methods used in the literature review, how guidelines were formulated with minimal bias, and the planned procedure for updating the guidelines. Implications of guideline application and monitoring of outcomes after implementations were not explicitly discussed. CONCLUSIONS: The GVG guideline published in 2019 discussing CLTI is assessed to be of high quality and recommended for use. This review helps to improve clinical decision-making and quality of future CPGs for CLTI.
Asunto(s)
Isquemia Crónica que Amenaza las Extremidades , Indicadores de Calidad de la Atención de Salud , Humanos , Enfermedad Crónica , Isquemia Crónica que Amenaza las Extremidades/terapia , Isquemia Crónica que Amenaza las Extremidades/diagnóstico , Medicina Basada en la Evidencia/normas , Isquemia/terapia , Isquemia/diagnóstico , Isquemia/fisiopatología , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico , Guías de Práctica Clínica como Asunto/normas , Indicadores de Calidad de la Atención de Salud/normas , Resultado del TratamientoRESUMEN
BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. RESULTS: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).
Asunto(s)
Isquemia Crónica que Amenaza las Extremidades , Recuperación del Miembro , Procedimientos Quirúrgicos Vasculares , Humanos , Isquemia Crónica que Amenaza las Extremidades/cirugía , Isquemia Crónica que Amenaza las Extremidades/terapia , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos , Recuperación del Miembro/efectos adversos , Recuperación del Miembro/métodos , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento , Procedimientos Quirúrgicos Vasculares/efectos adversos , Procedimientos Quirúrgicos Vasculares/métodos , Vena Safena/trasplanteRESUMEN
BACKGROUND: To set therapeutic benchmarks, in 2009 the Society for Vascular Surgery defined objective performance goals (OPG) for treatment of patients with chronic limb threatening ischemia (CLTI) with either open surgical bypass or endovascular intervention. The goal of these OPGs are to set standards of care from a revascularization standpoint and to provide performance benchmarks for 1 year patency rates for new endovascular therapies. While OPGs are useful in this regard, a critical decision point in the treatment of patients with CLTI is determining when revascularization is necessary. There is little guidance in the comprehensive treatment of this patient population, especially in the nonoperative cohort. Guidelines are needed for the CLTI patient population as a whole and not just those revascularized, and our aim was to assess whether CLTI OPGs could be attained with nonoperative management alone. METHODS: Our cohort included patients with an incident diagnosis of CLTI (by hemodynamic and symptomatic criteria) at our institution from 2013-2017. The primary outcome measured was mortality. Secondary outcomes were limb loss and failure of amputation-free survival. Descriptive statistics were used to define the 2 groups - patients undergoing primary revascularization and patients undergoing primary wound management. The risk difference in outcomes between the 2 groups was estimated using collaborative-targeted maximum likelihood estimation. RESULTS: Our cohort included 349 incident CLTI patients; 60% male, 51% white, mean age 63 +/- 13 years, 20% Rutherford 4, and 80% Rutherford 5. Most patients (277, 79%) underwent primary revascularization, and 72 (21%) were treated with wound care alone. Demographics and presenting characteristics were similar between groups. Although the revascularized patients were more likely to have femoropopliteal disease (72% vs. 36%), both groups had a high rate of infrapopliteal disease (62% vs. 57%). Not surprisingly, the patients in the revascularization group were less likely to have congestive heart failure (34% vs. 42%), complicated diabetes (52% vs. 79%), obesity (19% vs. 33%), and end stage renal disease (14% vs. 28%). In the wound care group, 2-year outcomes were 65% survival, 51% amputation free survival, 19% major limb amputation, and 17% major adverse cardiac event. The wound care cohort had a 13% greater risk of death at 2 years; however, the risk of limb loss at 2 years was 12% less in the wound care cohort. CONCLUSIONS: A comprehensive set treatment goals and expected amputation free survival outcomes can guide revascularization, but also assure that appropriate outcomes are achieved for patients treated without revascularization. The 2-year outcomes achieved in this cohort provide an estimate of outcomes for nonrevascularized CLTI patients. Although multi-center or prospective studies are needed, we demonstrate that equal, even improved, limb salvage rates are possible.
Asunto(s)
Isquemia Crónica que Amenaza las Extremidades/cirugía , Úlcera de la Pierna/terapia , Procedimientos Quirúrgicos Vasculares/normas , Adulto , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica/estadística & datos numéricos , Benchmarking , Isquemia Crónica que Amenaza las Extremidades/complicaciones , Isquemia Crónica que Amenaza las Extremidades/terapia , Estudios de Cohortes , Femenino , Humanos , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Sociedades Médicas , Cicatrización de HeridasRESUMEN
OBJECTIVE: Our institution's multidisciplinary Prevention of Amputation in Veterans Everywhere (PAVE) program allocates veterans with critical limb threatening ischemia (CLTI) to immediate revascularization, conservative care, primary amputation, or palliative limb care according to previously reported criteria. These four groups align with the approaches outlined by the global guidelines for the management of CLTI. In the present study, we have delineated the natural history of the palliative limb care group of patients and quantified the procedural risks and outcomes. METHODS: Veterans prospectively enrolled into the palliative limb cohort of our PAVE program from January 2005 to January 2020 were analyzed. The primary outcome was mortality. The secondary outcomes included overall and limb-related readmissions, limb loss, and wound healing. The clinical frailty scale (CFS) score was calculated, and the 5-year expected mortality was estimated using the Veterans Affairs Quality Enhancement Research Initiative tool. Regression analysis was performed to establish associations among the following variables: mortality, wound, ischemia, and foot infection (WIfI) score, CFS score, overall admissions, and limb-related admissions. RESULTS: The PAVE program enrolled 1158 limbs during 15 years. Of the 1158 limbs, 157 (13.5%) in 145 patients were allocated to the palliative limb care group. The overall mortality of the group was 88.2% (median interval, 3.5 months; range, 0-91 months). Of the 128 patients who had died, 64 (50%) had died within 3 months of enrollment. The predicted 5-year mortality for the group was 66%. The average CFS score for the group was 6.2, denoting persons moderately to severely frail. Using the CFS score, 106 patients were considered frail and 39 were considered not frail. No differences were found in mortality between the frail and nonfrail patients. However, a statistically significant difference was found in early (<3 months) mortality (56.2% vs 37.5%; P = .032). The 30-day limb-related readmission rate was 4.7%. Eventual major amputation was necessary for 18 limbs (11.5%). Wound healing occurred in 30 patients (20.6%). Regression analysis demonstrated no association between the CFS score and mortality (r = 0.55; P = .159) or between the WIfI score and mortality (r = 0.0165; P = .98). However, a significant association was found between the WIfI score and limb-related admissions (r = 0.97; P < .001). CONCLUSIONS: Frail patients with CLTI had high early mortality and a low risk of limb-related complications. They also had a low incidence of deferred primary amputation or limb-related readmissions. In our cohort, the vast majority of patients had died within a few months of enrollment without requiring an amputation. A comprehensive approach to the treatment of CLTI patients should include a palliative limb care option because a significant proportion of these patients will have limited survival and can potentially avoid unnecessary surgery and major amputation.
Asunto(s)
Isquemia Crónica que Amenaza las Extremidades/terapia , Anciano Frágil , Fragilidad/diagnóstico , Recuperación del Miembro , Cuidados Paliativos , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Isquemia Crónica que Amenaza las Extremidades/diagnóstico , Isquemia Crónica que Amenaza las Extremidades/mortalidad , Isquemia Crónica que Amenaza las Extremidades/fisiopatología , Femenino , Fragilidad/mortalidad , Fragilidad/fisiopatología , Estado Funcional , Humanos , Recuperación del Miembro/efectos adversos , Recuperación del Miembro/mortalidad , Masculino , Persona de Mediana Edad , Readmisión del Paciente , Recuperación de la Función , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Veteranos , Cicatrización de HeridasRESUMEN
OBJECTIVE: Combined suprainguinal and infrainguinal revascularization is sometimes necessary in the treatment of patients with chronic limb-threatening ischemia (CLTI). However, data on outcomes of concomitant revascularization procedures are lacking. We studied the outcomes of patients with CLTI who underwent suprainguinal bypass (SIB) alone, SIB with concomitant infrainguinal bypass (IIB), and SIB with concomitant infrainguinal peripheral endovascular intervention (IIPVI). METHODS: We reviewed all patients in the Vascular Quality Initiative with CLTI who underwent SIB from January 2010 to June 2020. Logistic regression, Kaplan-Meier survival estimates, log-rank tests, and Cox regression were used to analyze outcomes. Outcomes were 30-day mortality, perioperative myocardial infarction, perioperative major amputation, 1-year amputation-free survival, and 5-year survival. RESULTS: Of 8037 patients included, 81.3% (n = 6537) underwent SIB alone, 9.7% (n = 783) underwent SIB+IIB, and 8.9% (n = 717) underwent SIB+IIPVI. The indication for surgery was rest pain in 5040 (62.5%) and tissue loss in 3031 (37.6%). There were no significant differences in 30-day mortality and perioperative myocardial infarction rates. However, there was 2.8-fold increased odds of perioperative major amputation in both SIB+IIPVI (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.30-5.88; P = .008) and SIB+IIB (OR, 2.79; 95% CI, 1.38-5.54; P = .004) among patients with rest pain as compared with SIB alone. Comparing SIB+IIPVI with SIB alone, there were no significant differences in 1-year freedom from amputation and amputation-free survival. SIB+IIPVI was associated with a 27% increased risk of 5-year mortality (hazard ratio [HR], 1.27; 95% CI, 1.03-1.55; P = .035). Compared with SIB alone, SIB+IIB was associated with 97% increased risk of 1-year major amputation among patients with rest pain (HR, 1.97; 95% CI, 1.06-3.69; P = .033), but a 47% decreased risk of 1-year major amputation or death for patients with tissue loss (HR, 0.53; 95% CI, 0.37-0.78; P = .001). SIB+IIPVI, compared with SIB+IIB, was associated with a two-fold increased risk of 1-year major amputation or death (HR, 2.04; 95% CI, 1.04-2.23), P = .003) and a 52% increased risk of 5-year mortality (HR,1.52; 95% CI, 1.04-2.24; P = .032) among patients with tissue loss. CONCLUSIONS: This study shows that SIB with concomitant infrainguinal revascularization in patients with rest pain is associated with an increased risk of amputation, whereas SIB+IIB in patients with tissue loss is associated with decreased risk of amputation or death. SIB+IIB outperformed SIB+IIPVI in patients with tissue loss. SIB with infrainguinal revascularization should be limited in patients with rest pain in line with current guidelines, but SIB+IIB may be preferred in patients with tissue loss.
Asunto(s)
Isquemia Crónica que Amenaza las Extremidades/terapia , Procedimientos Endovasculares , Injerto Vascular , Anciano , Amputación Quirúrgica , Canadá , Isquemia Crónica que Amenaza las Extremidades/diagnóstico por imagen , Isquemia Crónica que Amenaza las Extremidades/mortalidad , Isquemia Crónica que Amenaza las Extremidades/fisiopatología , Bases de Datos Factuales , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Supervivencia sin Progresión , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Estados Unidos , Injerto Vascular/efectos adversos , Injerto Vascular/mortalidad , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Chronic limb-threatening ischemia (CLTI), which presents with ischemic rest pain, ulceration, or gangrene, is a complex form of peripheral artery disease that can cause mortality and amputation. C-reactive protein (CRP), an inflammatory marker, indicates vascular inflammation resulting from the cytokine-dependent inflammatory process in the arterial wall, and arterial atherosclerosis resulting from the inflammation. Lower albumin levels are also associated with peripheral artery disease. We investigated the association between CRP/Albumin ratio (CAR) and long-term mortality in patients with CLTI. METHODS: A total of 172 patients who underwent endovascular treatment (EVT) for below the knee (BTK) lesions were enrolled in this study. Patients with acute infection requiring antibiotic therapy, chronic inflammatory disease, end-stage liver disease, malignancy were excluded from the study. Besides, patients with pre-follow-up intervention to the same vascular bed were also excluded from the study. The primary endpoint of the study was all-cause mortality. Patients were divided into 2 groups according to mortality. RESULTS: A total of 70 patients (40.6%) died during 32 ± 21 months of follow-up in the present study. The major amputation rate was 21.5%. The mortality (+) group was older and had higher rates of congestive heart failure, chronic kidney disease, history of stroke, and CRP levels. Moreover, statin and ACE inhibitor/angiotensin receptor blocker (ACE/ARB) use, GFR, and albumin levels were lower in the mortality (+) group. CAR was significantly higher in the mortality (+) group when comparing both groups (3.25 [1.46 - 7.86] vs. 9.75 [4.5 - 17.71], P < 0.001). CAR, congestive heart failure, chronic kidney disease, history of stroke, ACE/ARB, or statin use were independent predictors of all-cause mortality in multivariable Cox regression analysis. CONCLUSIONS: CAR was associated with mortality in CLTI patients undergoing EVT for BTK lesions. CAR may be a simple method to help patient selection, assessment, and intervention strategy for EVT and may improve patient outcomes.
Asunto(s)
Albúminas , Proteína C-Reactiva , Isquemia Crónica que Amenaza las Extremidades , Procedimientos Endovasculares , Insuficiencia Cardíaca , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Insuficiencia Renal Crónica , Accidente Cerebrovascular , Albúminas/química , Amputación Quirúrgica/efectos adversos , Antagonistas de Receptores de Angiotensina , Inhibidores de la Enzima Convertidora de Angiotensina , Proteína C-Reactiva/química , Isquemia Crónica que Amenaza las Extremidades/complicaciones , Isquemia Crónica que Amenaza las Extremidades/terapia , Procedimientos Endovasculares/efectos adversos , Femenino , Insuficiencia Cardíaca/etiología , Humanos , Inflamación/etiología , Isquemia/diagnóstico por imagen , Isquemia/cirugía , Recuperación del Miembro/efectos adversos , Masculino , Mortalidad , Enfermedad Arterial Periférica/terapia , Sistema de Registros , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/terapia , Estudios Retrospectivos , Factores de Riesgo , Accidente Cerebrovascular/etiología , Resultado del TratamientoAsunto(s)
Isquemia Crónica que Amenaza las Extremidades/etiología , Isquemia Crónica que Amenaza las Extremidades/terapia , Fragilidad/complicaciones , Fragilidad/diagnóstico , Desnutrición/complicaciones , Estado Nutricional , Isquemia Crónica que Amenaza las Extremidades/diagnóstico , Humanos , Desnutrición/diagnóstico , Desnutrición/prevención & control , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: Venous arterialization is an upcoming and novel alternative in chronic limb threatening ischemia (CLTI) patients in the absence of standard revascularization options. The aim of this study is to systematically review and analyze outcomes of venous arterialization. METHODS: A systematic literature search was performed in 5 databases using the PRISMA methodology. Inclusion criteria were English language original research papers on CLTI patients treated with venous arterialization. EXCLUSION CRITERIA: absence of CLTI due to atherosclerosis, duplicate study or reporting of patients, meeting abstract only. Quality and risk of bias were evaluated. Meta-analysis was performed using random effects model on articles that have a sample size of equal or greater than 10. RESULTS: Twelve studies included 442 patients that underwent treatment for 445 limbs (374 patients and 377 limbs underwent venous arterialization while remainder underwent traditional bypass and served as control subjects). Average age was 66 [18 studies, range 37 -91 years], 68% were male [271/366, 15 studies] and 67% diabetic [271/406, 16 studies]). Most limbs (88%, 352/398, 16 studies) had tissue loss. Pooled 30-day mortality was 3.7% (95%-confidence interval [CI] 0.8 -6.6%), 30-day morbidity was 15.5% (95%-CI 3.2 -27.8%), 30-day major adverse cardiovascular event was 5.2% (95%-CI 1.7 -8.6%) and 30-day major adverse limb event was 16.7% (95%-CI 1.5 -31.9%). Pooled 1-year limb-salvage rate was 79.0% (95%-CI 68.7 -90.7) and 1-year survival rate was 85.7% (95%-CI 76.2 -96.4). Studies quality varied significantly across studies. CONCLUSION: Venous arterialization has an acceptable a 1-year limb salvage rate of 79%, however, this is based on low levels of evidence. More randomized controlled trials or high-quality cohort studies are needed to further define the effectiveness of this procedure for CLTI.
Asunto(s)
Isquemia Crónica que Amenaza las Extremidades , Procedimientos Endovasculares , Enfermedad Arterial Periférica , Adulto , Anciano , Anciano de 80 o más Años , Isquemia Crónica que Amenaza las Extremidades/complicaciones , Isquemia Crónica que Amenaza las Extremidades/terapia , Humanos , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Factores de Riesgo , Resultado del TratamientoRESUMEN
Critical limb ischemia (CLI) is the most severe clinical manifestation of peripheral arterial disease, which causes many amputations and deaths. Conventional treatment strategies for CLI (e.g., stent implantation and vascular surgery) bring surgical risk, which are not suitable for each patient. Extracellular vesicles (EVs) can be a potential solution for CLI. Herein, vascular endothelial growth factor (VEGF; i.e., a crucial molecule related to angiogenesis) and transcription factor EB (TFEB; i.e., a pivotal regulator of autophagy) are chosen as the target gene to improve the bioactivity of EVs derived from endothelial cells. The VEGF/TFEB-engineered EVs (Engineered-EVs) are fabricated by genetically engineering the parent cells, and their versatile functions are confirmed using three cell models (human umbilical vein endothelial cells, myoblast, and monocytes). Injectable thermal-responsive hydrogel are then combined with Engineered-EVs to combat CLI. These results reveal that the hydrogel can enhance the stability of Engineered-EVs in vivo and release EVs at different temperatures. Moreover, the results of animal studies indicate that Engineered-EV/Hydrogel can significantly improve neovascularization, attenuate muscle injury, and recover limb function after CLI. Finally, mechanistic studies shed light on the therapeutic effect of Engineered-EV/Hydrogel due to the activated VEGF/VEGFR pathway and autophagy-lysosomal pathway.
Asunto(s)
Factores de Transcripción Básicos con Cremalleras de Leucinas y Motivos Hélice-Asa-Hélice/uso terapéutico , Isquemia Crónica que Amenaza las Extremidades , Vesículas Extracelulares , Hidrogeles , Factor A de Crecimiento Endotelial Vascular/uso terapéutico , Animales , Factores de Transcripción Básicos con Cremalleras de Leucinas y Motivos Hélice-Asa-Hélice/metabolismo , Isquemia Crónica que Amenaza las Extremidades/terapia , Sistemas de Liberación de Medicamentos , Vesículas Extracelulares/metabolismo , Células Endoteliales de la Vena Umbilical Humana/metabolismo , Humanos , Hidrogeles/farmacología , Isquemia/terapia , Factor A de Crecimiento Endotelial Vascular/metabolismoRESUMEN
Background The optimal treatment strategy for patients with chronic limb-threatening ischemia (CLTI) is often unclear. Frailty has emerged as an important factor that can identify patients at greater risk of poor outcomes and guide treatment selection, but few studies have explored its utility among the CLTI population. We examine the association of a health record-based frailty measure with treatment choice and long-term outcomes among patients hospitalized with CLTI. Methods and Results We included patients aged >65 years hospitalized with CLTI in the Medicare Provider Analysis and Review data set between October 1, 2009 and September 30, 2015. The primary exposure was frailty, defined by the Claims-based Frailty Indicator. Baseline frailty status and revascularization choice were examined using logistic regression. Cox proportional hazards regression was used to determine the association between frailty and death or amputation, stratifying by treatment strategy. Of 85 060 patients, 35 484 (42%) were classified as frail. Frail patients had lower likelihood of revascularization (adjusted odds ratio [OR], 0.78; 95% CI, 0.75â0.82). Among those revascularized, frailty was associated with lower likelihood of surgical versus endovascular treatment (adjusted OR, 0.76; CI, 0.72â0.81). Frail patients experienced increased risk of amputation or death, regardless of revascularization status (revascularized: adjusted hazard ratio [HR], 1.34; CI, 1.30â1.38; non-revascularized: adjusted HR, 1.22; CI, 1.17â1.27). Among those revascularized, frailty was independently associated with amputation or death irrespective of revascularization strategy (surgical: adjusted HR, 1.36; CI, 1.31â1.42; endovascular: aHR, 1.29; CI, 1.243â1.35). Conclusions Among patients hospitalized with CLTI, frailty is an important independent predictor of revascularization strategy and longitudinal adverse outcomes.