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OBJECTIVE: To review the current literature and establish a consensual recommendation on duplex ultrasound (DUS) surveillance after endovascular treatment of the femoropopliteal tract. METHODS: This systematic review conducted literature searches on DUS surveillance after endovascular treatment of the femoropopliteal tract, and event rates. The primary end point was primary assisted patency. Secondary end points were primary patency, secondary patency, and limb salvage for double-armed studies, and sensitivity and specificity of DUS compared with other surveillance methods for single-armed studies. PubMed, Embase, and the Cochrane Library were searched. A systematic review was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement. Articles were eligible if they compared DUS surveillance others surveillance methods. Prospective, large cohort studies reporting on long-term events after endovascular treatment were also included. RESULTS: The initial search resulted in five studies. Only one double-armed non-randomized study compared DUS surveillance with ankle-brachial index (ABI) follow-up after femoropopliteal stenting. The DUS group demonstrated improved primary assisted patency (84% versus 76% at 12 months and 68% versus 38% at 36 months, p=.008) and limb salvage (97% versus 83% at 12 months and 90% versus 50% at 36 months, p<.001) compared with ABI follow-up. In one single-armed study, DUS surveillance showed a high sensitivity (91%) and specificity (100%) in detecting restenosis. ABI and clinical follow-up demonstrated a low sensitivity (55%-67% and 52%-64%, respectively) but reasonable specificity (80%-85% and 82%-88%, respectively) in detecting restenosis. CONCLUSION: The scarce available evidence suggests a clinical benefit of DUS surveillance after endovascular treatment of the femoropopliteal tract.
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OBJECTIVE: Current guidelines do not recommend the use of antibiotics to treat clinically uninfected ulcers. However, physicians continue to prescribe antibiotics for clinically uninfected ulcers with the rationale 'better to be safe than sorry'. Yet, antibiotic resistance is increasing, side-effects are common and treatment costs are rising. Evidence is needed to identify whether antibiotic treatment for clinically uninfected ulcers can be justified or we should stop prescribing them. The aim of this study was to evaluate whether antibiotic treatment in cases of clinically uninfected ulcers improved ulcer healing compared to treatment without antibiotics. METHOD: Consecutive patients treated in the outpatient clinic for clinically uninfected diabetic foot ulcer both in 2015 and in 2017 were retrospectively analysed. Primary outcome was ulcer healing at one year. Secondary outcomes were limb salvage, freedom from any amputation, amputation-free survival (AFS) and survival. RESULTS: A total of 102 ulcers of 91 patients were included for final analyses. The non-antibiotics and antibiotics groups both consisted of 51 ulcers. Ulcer healing at one year was 77.3% in the non-antibiotics group and 74.7% in the antibiotics group (p=0.158). No difference was found for limb salvage (93.8% versus 95.9%, respectively; p=0.661), freedom from any amputation (85.6% versus 85.6%, respectively; p=1.000), AFS (85.4% versus 79.1%, respectively; p=0.460) or survival (89.6% versus 83.7%, respectively; p=0.426). CONCLUSION: In this study, no benefits of antibiotic treatment over non-antibiotic treatment for clinically uninfected ulcers were identified. The findings of this study emphasise the recommendation of current guidelines to not treat clinically uninfected ulcer with antibiotics.
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Diabetes Mellitus , Pie Diabético , Humanos , Pie Diabético/tratamiento farmacológico , Antibacterianos/uso terapéutico , Cicatrización de Heridas , Estudios Retrospectivos , Recuperación del Miembro , Diabetes Mellitus/tratamiento farmacológicoRESUMEN
Endovascular revascularization is the preferred treatment for peripheral arterial disease. Restenosis often occurs as a response to procedure-induced arterial damage. Reducing vascular injury during endovascular revascularization may improve its success rate. This study developed and validated an ex vivo flow model using porcine iliac arteries, obtained from a local abattoir. Twenty arteries (of 10 pigs) were equally allocated to two groups: a mock-treated control group and an endovascular intervention group. Arteries of both groups were perfused with porcine blood for 9 min, including 3 min of balloon angioplasty in the intervention group. Vessel injury was assessed by calculating the presence of endothelial cell denudation, vasomotor function, and histopathological analysis. MR imaging displayed balloon positioning and inflation. Endothelial cell staining showed 76% of denudation after ballooning compared to 6% in the control group (p < 0.001). This was confirmed by histopathological analysis, showing a significantly reduced endothelial nuclei count after ballooning compared to the controls (median: 22 vs. 37 nuclei/mm, p = 0.022). In the intervention group, vasoconstriction and endothelium-dependent relaxation were significantly reduced (p < 0.05).We present an ex vivo flow model to test the effects of endovascular therapy on the vessel's wall morphology, endothelial denudation, and endothelial-dependent vasomotor function under physiological conditions. Additionally, it allows the future testing of human arterial tissue.
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Angioplastia Coronaria con Balón , Angioplastia de Balón , Humanos , Porcinos , Animales , Angioplastia Coronaria con Balón/métodos , Angioplastia de Balón/efectos adversos , Imagen por Resonancia Magnética , Vasoconstricción/fisiología , Arteria Ilíaca/diagnóstico por imagen , Arteria Ilíaca/cirugíaRESUMEN
CLINICAL IMPACT: After percutaneous deep venous arterialization (pDVA), the created arteriovenous circuit needs time to develop. Postprocedural care in patients after pDVA is essential in order to create optimal conditions for maturation of the circuit, and thus save the limb. However, current literature mainly focusses on the procedure itself, making postprocedural care an underexposed topic. Therefore, this study presents an overview of the available literature of postprocedural care of pDVA patients and provides recommendations based on expert opinion when current knowledge is limited.
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BACKGROUND: Chronic limb-threatening ischemia (CLTI) is known for its high rates of major amputation and mortality. Conventional revascularization techniques often fail in CLTI patients due to the heavily diseased arteries. Foot vein arterialization (FVA) has been proposed as an alternative technique to provide arterial blood to the foot by using the disease-free venous bed. OBJECTIVES: This systematic review and meta-analysis aimed to determine outcomes of surgical FVA (sFVA) and percutaneous FVA (pFVA) at 6 and 12 months post-procedure. DATA SOURCES: PubMed, Scopus, Web of Science, and the Cochrane Library databases were searched to identify papers reporting clinical outcomes of sFVA and pFVA published between January 1966 and March 2023. METHODS: Databases were searched for eligible studies. A meta-analysis was performed to evaluate the limb salvage rate, overall survival rate, and wound healing rate at 6 and 12 months. RESULTS: A total of 27 studies were included, with 753 patients and 793 limbs. Of the included studies, 16 analyzed the sFVA technique and 11 the pFVA technique. Of the included patients, 86.3% were Rutherford 5/6 in the sFVA group versus 98.4% in the pFVA group. The pooled limb salvage rate at 6 and 12 months was 78.1% and 74.1% in the sFVA group and 81.7% and 78.6% in the pFVA group, respectively. Wound healing rates were not reported in the sFVA group. In the pFVA group, the pooled wound healing rates were 48.1% and 64.5% at 6 and 12 months, respectively. CONCLUSION: This study showed promising results after FVA among a large population of CLTI patients. In high-risk patients, pFVA is a feasible option with favorable limb salvage and wound healing rates.
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Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.
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Enfermedad de la Arteria Coronaria , Everolimus , Enfermedad Arterial Periférica , Implantes Absorbibles , Anciano , Everolimus/administración & dosificación , Humanos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/diagnóstico por imagen , Diseño de Prótesis , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
The fluoropolymer-coated, paclitaxel-eluting Eluvia stent has shown promising results for the endovascular treatment of femoropopliteal artery lesions in patients with claudication. The aim of the current study was to evaluate efficacy and safety outcomes of the Eluvia stent for the treatment of long femoropopliteal lesions in Asian patients. This is a single-center, retrospective study. The primary endpoint was primary patency at 1 year. Secondary outcomes were 30-days complication rate, technical success, 1-year freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, amputation-free survival (AFS), wound healing, and clinical improvement. A total of 64 patients with 67 femoropopliteal lesions were included; 78% suffered from diabetes and 84% had chronic limb-threatening ischemia (CLTI). Of those with ischemic wounds, 79% did not have run-off to the foot. Mean lesion length was 193 ± 128 mm and 52% were severely calcified. Primary patency at 1 year was 84% in the overall cohort and 91% in patients with complete lesion coverage with the Eluvia stent. Technical success was achieved in 100% of the cases and 30-day complications occurred in six patients. Twelve-month freedom from CD-TLR, limb salvage, survival, and AFS were 92%, 93%, 85%, and 80%, respectively. In 80% of patients, complete wound healing was experienced and 84% had clinical improvement after 1 year. The Eluvia stent showed promising 12-month patency and clinical results for femoropopliteal treatment in this CLTI-dominant patient population with severely calcified, long lesions. Patient numbers were, however, small; larger trials are required to validate these findings. Aneurysmal change seen in some cases also needs further investigation.
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Stents Liberadores de Fármacos , Paclitaxel , Enfermedad Arterial Periférica , Isquemia Crónica que Amenaza las Extremidades , Arteria Femoral/diagnóstico por imagen , Humanos , Recuperación del Miembro , Paclitaxel/efectos adversos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Estudios Retrospectivos , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
Purpose: To evaluate the midterm results of patients suffering from no-option chronic limb-threatening ischemia (CLTI) treated with a dedicated system for percutaneous deep venous arterialization (pDVA). Materials and Methods: Thirty-two consecutive CLTI patients (mean age 67±14 years; 20 men) treated with pDVA using the Limflow device at 4 centers between 11 July 2014 and 11 June 2018 were retrospectively analyzed. Of all patients, 21 (66%) had diabetes, 8 (25%) were on immunosuppression, 4 (16%) had dialysis-dependent renal failure, 9 (28%) had Rutherford category 6 ischemia, and 25 (78%) were deemed at high risk of amputation. The primary outcome was amputation-free survival (AFS) at 6 months. Secondary outcomes were wound healing, limb salvage, and survival at 6, 12, and 24 months. Results: Technical success was achieved in 31 patients (96.9%). The median follow-up was 34 months (range 16-63). At 6, 12, and 24 months, estimates were 83.9%, 71.0%, and 67.2% for AFS, 86.8%, 79.8% and 79.8% for limb salvage, and 36.6%, 68.2%, and 72.7% for complete wound healing, respectively. Median time to complete wound healing was 4.9 months (range 0.5-15). The DVA circuit occluded during follow-up in 21 patients; the median time to occlusion was 2.6 months. Reintervention for occlusion was performed in 17 patients: 16 because of unhealed wounds and 1 for a newly developed ulcer. Conclusion: This study represents the largest population of patients with no-option CLTI treated with pDVA using the LimFlow device with midterm results. In this complex group of patients, pDVA using the LimFlow device has been shown to be feasible, with a high technical success rate and AFS at 6 up to 24 months coupled with wound healing. In selected patients with no-option CLTI, pDVA could be a recommended treatment to prevent amputation and heal wounds.
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Procedimientos Endovasculares/instrumentación , Isquemia/cirugía , Enfermedades Vasculares Periféricas/cirugía , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Enfermedad Crónica , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Isquemia/diagnóstico por imagen , Isquemia/fisiopatología , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Enfermedades Vasculares Periféricas/diagnóstico por imagen , Enfermedades Vasculares Periféricas/fisiopatología , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción Vascular , Cicatrización de HeridasRESUMEN
OBJECTIVE: The aim was to review and analyse the literature on clinical outcomes of drug coated balloon (DCB) vs. standard percutaneous transluminal angioplasty (PTA) for the treatment of infrapopliteal arterial disease. METHODS: This is a systematic review and meta-analysis. The MEDLINE, EMBASE and Cochrane Database of Systematic Reviews were searched for studies published between January 2008 and November 2018. Two authors independently performed the search, study selection, assessment of methodological quality and data extraction. Studies were eligible when reporting PTA and DCB outcomes in infrapopliteal arteries, published in English, human studies, and full text was available. Methodological quality was determined by MINORS and Cochrane risk of bias tool. GRADE methodology was used to rate the evidence for observed outcomes. The primary outcome was the 12 month limb salvage rate. Secondary outcomes were 12 month survival, amputation free survival (AFS), restenosis, and target lesion revascularisation (TLR) rates. Inclusion criteria for pooling data were randomised controlled trials and comparative studies with 12 month outcomes. RESULTS: Ten studies representing 1593 patients met the inclusion criteria. The quality was assessed as moderate or low. Data from five studies were pooled, and 12 month outcomes for DCB vs. PTA were limb salvage rate, 94.0% vs. 95.7% (odds ratio (OR), 0.92; 95% confidence interval (CI), 0.39-2.21); and survival rate, 89.8% vs. 92.9% (OR 0.69; 95% CI 0.39-1.21). Data from four studies were pooled, and 12 month outcomes for PTA vs. DCB were restenosis rate, 62.0% vs. 32.9% (OR 2.87; 95% CI 0.83-9.92); and TLR rate, 27.8% vs. 14.0% (OR 2.76; 95% CI 0.90-8.48). Pooled data from two studies showed 12 month AFS rate for DCB vs. PTA; 82.5% vs. 88.7% (OR 0.79; 95% CI 0.23-2.75). No statistically significant differences were found. CONCLUSION: Based on this systematic review and meta-analysis no significant differences in limb salvage, survival, restenosis, TLR, and AFS rates were found when DCB angioplasty was compared with standard PTA.
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Angioplastia de Balón/instrumentación , Materiales Biocompatibles Revestidos , Recuperación del Miembro/métodos , Enfermedad Arterial Periférica/cirugía , Amputación Quirúrgica/estadística & datos numéricos , Angioplastia de Balón/métodos , Stents Liberadores de Fármacos , Arteria Femoral/cirugía , Humanos , Recuperación del Miembro/instrumentación , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/mortalidad , Arteria Poplítea/cirugía , Análisis de Supervivencia , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Guidelines recommend routine patching after carotid endarterectomy (CEA) on the basis of a lower restenosis rate and presumed lower procedural stroke rate than with primary repair. Underlying evidence is based on studies performed decades ago with perioperative care that significantly differed from current standards. Recent studies raise doubt about routine patching and have suggested that a more selective approach to patch closure (PAC) might be noninferior for procedural safety and long-term stroke prevention. The objective was to review the literature on the procedural safety and perioperative stroke prevention of PAC compared with primary closure (PRC) after CEA. METHODS: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases were searched from January 1966 to September 2017. Two authors independently performed the search, study selection, assessment of methodologic quality, and data extraction. Articles were eligible if they compared PAC and PRC after CEA, were published in English, included human studies, and had a full text available. Methodologic quality for nonrandomized studies was assessed using the Methodological Index for Non-Randomized Studies score; randomized controlled trials were assessed using Grading of Recommendations Assessment, Development, and Evaluation. Nonrandomized studies with a score ≤15 were excluded. The primary outcome measure was 30-day stroke risk. Secondary outcome measures were long-term restenosis (>50%) and postoperative bleeding. RESULTS: Twenty-nine articles met the inclusion criteria, 9 randomized studies and 20 nonrandomized studies, for a total of 12,696 patients and 13,219 CEAs. Overall 30-day stroke risk was higher in the PRC group (odds ratio [OR], 1.9; 95% confidence interval [CI], 1.2-2.9). After exclusion of nonrandomized studies, this difference was not statistically significant anymore (OR, 1.8; 95% CI, 0.8-3.9). The restenosis rate was higher after PRC (OR, 2.2; 95% CI, 1.4-3.4). There were no differences in bleeding complications. Methodologic quality of the nonrandomized studies was moderate, and seven were excluded. Quality of the evidence according to Grading of Recommendations Assessment, Development, and Evaluation was moderate for restenosis, 30-day stroke, and bleeding. CONCLUSIONS: In this systematic review, on the basis of moderate-quality evidence, perioperative stroke rate was lower after PAC compared with PRC. The rate of restenosis was higher after PRC, although the clinical significance of this finding in terms of long-term stroke prevention remained unclear.
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Angioplastia/instrumentación , Enfermedades de las Arterias Carótidas/cirugía , Endarterectomía Carotidea , Técnicas de Cierre de Heridas , Adulto , Anciano , Anciano de 80 o más Años , Angioplastia/efectos adversos , Angioplastia/mortalidad , Enfermedades de las Arterias Carótidas/complicaciones , Enfermedades de las Arterias Carótidas/mortalidad , Endarterectomía Carotidea/efectos adversos , Endarterectomía Carotidea/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Hemorragia Posoperatoria/etiología , Recurrencia , Medición de Riesgo , Factores de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Factores de Tiempo , Resultado del Tratamiento , Técnicas de Cierre de Heridas/efectos adversos , Técnicas de Cierre de Heridas/mortalidadRESUMEN
PURPOSE: To evaluate the safety and effectiveness of below-the-ankle (BTA) angioplasty and to assess whether additional BTA angioplasty after below-the-knee (BTK) angioplasty would improve clinical outcomes in patients with critical limb ischemia. MATERIALS AND METHODS: Two authors independently performed the search, study selection, assessment of methodological quality, and data extraction for this systematic review and meta-analysis. MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched. Articles were eligible if it was reported that BTA angioplasty was performed and if the articles were published in English and had the full text available. Methodological quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS) score. The primary outcome was 12-month limb salvage rate. Secondary outcomes were 12-month amputation-free survival, technical success, complications, survival, and freedom from reintervention. RESULTS: Ten articles met the inclusion criteria, reporting a total of 478 patients with BTA angioplasty performed in 524 legs. Three of the 10 included studies compared BTK angioplasty only to BTK angioplasty and additional BTA angioplasty. The pooled 12-month limb salvage rate was 92% (95% confidence interval [CI], 0.88-0.96). No statistically significant difference was found in limb salvage when additional BTA angioplasty was compared to BTK angioplasty only (odds ratio [OR], 1.23; 95% CI, 0.61-2.49). The pooled 12-month amputation-free survival was 78% (95% CI, 0.69-0.87). No statistically significant difference was found in amputation-free survival rate when additional BTA angioplasty was compared to BTK angioplasty only (OR, 1.58; 95% CI, 0.95-2.64). The methodological quality of the studies included was moderate, according to the MINORS score. CONCLUSIONS: This systematic review and meta-analysis showed that additional BTA angioplasty is a safe and feasible procedure, with a 92% pooled proportion of limb salvage at 12 months.
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Angioplastia , Tobillo/irrigación sanguínea , Isquemia/terapia , Enfermedad Arterial Periférica/terapia , Anciano , Amputación Quirúrgica , Angioplastia/efectos adversos , Enfermedad Crítica , Femenino , Humanos , Isquemia/diagnóstico por imagen , Isquemia/fisiopatología , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Supervivencia sin Progresión , Flujo Sanguíneo Regional , Retratamiento , Factores de Riesgo , Factores de TiempoRESUMEN
OBJECTIVE: To investigate and compare the outcomes of the available treatment modalities for anterior accessory saphenous vein (AASV) incompetence. METHODS: A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Studies reporting the outcomes of patients who were treated for primary AASV incompetence were included. The methodologic quality of the articles was assessed using the Methodological Index for Non-Randomized Studies (MINORS). A random-effects model was used to estimate anatomic success, defined as AASV occlusion. The secondary outcomes were pain during and after treatment, venous clinical severity score, quality of life, esthetic result, time to return to daily activities, and complications. RESULTS: The search identified 860 articles, of which 16 met the inclusion criteria. A total of 609 AASVs were reported. The included studies were of poor or moderate quality according to MINORS score. The pooled anatomic success rates were 91.8% after endovenous laser ablation and radiofrequency ablation (EVLA, RFA, 11 studies), 93.6% after cyanoacrylate closure (3 studies), and 79.8% after sclerotherapy (2 studies). The non-pooled anatomic success rate was 97.9% after phlebectomy and 82% after CHIVA. Paresthesia was seen after EVLA in 0.7% of patients (6 studies). Phlebitis was seen in 2.6% of patients after RFA (2 studies), 27% after sclerotherapy (1 study), and 12% after the phlebectomy (1 study). Deep venous thrombosis and skin burn did not occur. CONCLUSION: Treatment of AASV incompetence is safe and effective. Despite limited evidence, occlusion of the AASV can be achieved with endovenous thermal ablation and cyanoacrylate. There does not appear to be a benefit of EVLA compared to RFA regarding treatment efficacy. Phlebectomy shows promising results if the saphenofemoral junction is competent. Lower results are seen after sclerotherapy and CHIVA. However, studies with sufficient sample sizes of solely treatment of AASV incompetence are needed to draw firm conclusions.
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Terapia por Láser , Várices , Insuficiencia Venosa , Humanos , Terapia por Láser/métodos , Calidad de Vida , Vena Safena/cirugía , Escleroterapia/métodos , Resultado del Tratamiento , Várices/terapia , Insuficiencia Venosa/cirugíaRESUMEN
OBJECTIVE: In the present study, we reviewed and analyzed the currently available data on the Flebogrif device (Balton, Warsaw, Poland) to define its role in the global varicose vein treatment devices market. METHODS: A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Studies were eligible if they had included patients treated using the Flebogrif for saphenous vein incompetence, had been reported in English, and had the full text available. The methodologic quality of the studies was assessed using the methodologic index for nonrandomized studies (MINORS) score. A random effects model was used to estimate the primary outcome of anatomic success, defined as the occlusion rate of the treated vein. The estimates are reported with the 95% confidence intervals (CIs). The secondary outcomes were clinical success, complication rate, pain during and after the procedure, and time to return to work. RESULTS: Five articles met the inclusion criteria, reporting 348 procedures in 392 patients. Four studies reported the 3-month anatomic success, and three studies reported the 12-month anatomic success. The pooled 3-month anatomic success rate was 95.6% (95% CI, 93.2%-98.0%). The 12-month anatomic success rate was 93.2% (95% CI, 90.3%-96.1%). The only major complication reported within 3 months was deep vein thrombosis, which developed in 0.3% of the patients. The minor complications of thrombophlebitis and hyperpigmentation had occurred in 13.3% to 14.5% and 3.3% to 10.0% of patients, respectively, within 3 months. The methodologic quality of the included studies was moderate. CONCLUSIONS: Mechanochemical ablation using the Flebogrif device is a safe and well-tolerated procedure for the treatment of saphenous vein insufficiency. However, well-designed studies of sufficient sample size and follow-up are required to compare the effectiveness with other endovenous treatment modalities and define the definitive role of the Flebogrif device.
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Técnicas de Ablación/instrumentación , Catéteres , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/métodos , Várices/terapia , Terapia Combinada , HumanosRESUMEN
Percutaneous deep venous arterialization (pDVA) is a promising treatment option in patients with chronic limb-threatening ischemia. Stenosis and occlusions, which are the Achilles' heel of every revascularization procedure, can be treated when detected early. However, frequent monitoring after pDVA is required because when stenosis or occlusions develop is unknown. Therefore, patients currently need to visit the hospital every 2 weeks for surveillance, which can be burdensome. Accordingly, we aimed to develop a model that can predict future stenosis or occlusions in patients after pDVA to be able to create tailor-made follow-up protocols. The data set included 343 peak systolic velocity and 335 volume flow measurements of 23 patients. A stenosis or occlusion developed in 17 patients, and 6 patients remained lesion-free. A statistically significant increase in the risk of stenosis or occlusion was found when duplex ultrasound values decreased 20% within 1 month. The prediction model was also able to estimate a patient-specific risk of future stenosis or occlusions. This is promising for the possibility of reducing the frequency of follow-up visits for low-risk patients and increasing the frequency for high-risk patients. These observations are the starting point for individual surveillance programs in post-pDVA patients. Future studies with a larger cohort are necessary for validation of this model.
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INTRODUCTION: Different types of bioresorbable vascular scaffolds (BVSs) have been developed and used in below-the-knee (BTK) arterial diseases. This is the first study reviewing and analyzing the literature on BVS treatment for BTK arterial disease. EVIDENCE ACQUISITION: MEDLINE, Embase, and Cochrane were searched for studies published until October 21, 2019. The search, study selection, quality assessment, and data extraction were performed by 2 authors independently. Articles that studied the treatment of BTK arterial disease by using BVSs were eligible. Exclusion criteria were studies with a variant design (e.g. case reports <5 patients), non-BTK indications for BVS use, and nonhuman studies. Primary endpoint was 12-month primary patency. Secondary endpoints were 12-month freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, and amputation-free survival (AFS). Study quality was assessed by the Methodological Index for Non-randomized Studies score. EVIDENCE SYNTHESIS: Five studies representing 155 patients with 160 treated limbs met the inclusion criteria. Pooled 12-month primary patency per limb was 90% (143/160; 95% confidence interval [CI]: 0.84-0.95), freedom from CD-TLR 96% (124/130; 95% CI: 0.91-0.99), limb salvage rate 97% (156/160; 95% CI: 0.94-1.00), survival rate 90% (112/125; 95% CI: 0.82-0.96), and AFS rate 89% (110/125; 95% CI: 0.81-0.94). Subgroup analyses of included Absorb BVS studies showed similar results. All studies were assessed as moderate quality. CONCLUSIONS: This meta-analysis of case series showed good 12-month patency and clinical results with BVSs for BTK arterial disease, even in patients with multimorbidity and short but complex lesions. These results encourage a revival of this scaffold.
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Implantes Absorbibles , Enfermedad Arterial Periférica , Humanos , Recuperación del Miembro , Enfermedad Arterial Periférica/cirugía , Arteria Poplítea/cirugía , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
Severely calcified lesions continue to plague endovascular interventions by negatively affecting the acute and long-term results. A new technique was developed to allow balloon crossing or to treat persistent recoil. In the direct extravascular calcium interruption arterial procedure technique, an artery forceps is percutaneously introduced to modify the plaque after conventional techniques have failed. In this initial experience, the direct extravascular calcium interruption arterial procedure technique was successful as a bailout option in patients in whom balloon crossing was impossible or recoil was untreatable even with high-pressure balloons.
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BACKGROUND: To evaluate the safety, feasibility and effectiveness of high-pressure, noncompliant balloon angioplasty in the management of long infrapopliteal calcified lesions. METHODS: Consecutive patients, presenting with chronic limb-threatening ischemia (CLTI) and long (>100 mm) calcified infrapopliteal lesions who were treated with a high pressure, noncompliant balloon (JADE, OrbusNeich, Hong Kong) between January 2016 and July 2016 were retrospectively analyzed. Angioplasty was performed by inflating the balloon to a pressure of 22 to 24 atm for 90 seconds. Primary outcome was technical success. Secondary outcomes were procedure-related complications, limb salvage, amputation-free survival (AFS), wound healing, overall survival, freedom from clinically driven target lesion reintervention (CD-TLR), and resolution of CLTI at 2 and 3 years. RESULTS: Overall, 23 lesions in 21 limbs of 20 patients were treated. All patients had tissue loss (Rutherford 5 or 6). The mean lesion length was 374.8 mm. Of all lesions, 56.5% were occlusions, 91.3% were classified as TransAtlantic Inter-Society Consensus (TASC) C and D lesions, and 78.3% had severe calcification classification. Of all lesions, 52.2% extended into the below-the-ankle arteries. Technical success was achieved in 22 lesions (95.7%). There were no procedure-related complications. No bailout stenting was required. At 2 and 3 years, limb salvage was 84.7% and 78.7%, AFS was 71.4% and 56.1%, wound healing was 81.0% and 85.7%, overall survival was 75.0% and 64.3% and freedom from CD-TLR was 77.6% and 63.5%, respectively. Resolution of CLTI without TLR was 81.0% at 2 and 3 years. CONCLUSIONS: This study is the first to analyze safety and feasibility of a high-pressure, noncompliant balloon for long, calcified infrapopliteal and inframalleolar lesions.
Asunto(s)
Angioplastia de Balón , Enfermedad Arterial Periférica , Angioplastia de Balón/efectos adversos , Humanos , Isquemia , Recuperación del Miembro , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/diagnóstico por imagen , Estudios Retrospectivos , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
Percutaneous deep venous arterialization (pDVA) is a developing technique for limb salvage in patients with chronic limb-threatening ischemia by creating an arteriovenous (AV) circuit. After pDVA, patency of the AV circuit is evaluated using duplex ultrasound (DUS) imaging. Peak systolic velocity (PSV) and volume flow (VF) values for maintaining a patent AV circuit are undefined; therefore, guidance about when a reintervention should be performed is lacking. The objective of this study was to interpret post-pDVA PSV and VF values in relation to AV circuit preservation. This was performed by analyzing DUS results of 22 post-pDVA patients. A total of 670 PSV and 623 VF measurements were collected. A PSV value of ≤55 cm/s and a VF value of ≤195 mL/min were found predictive for failure. The reliability of PSV and VF measurements in patent AV-circuits was good (intraclass correlation coefficient; PSV, 0.85; VF, 0.88). In conclusion, this study is the first to analyze DUS measurements in post-pDVA patients and showed that DUS can be used to anticipate for failure. The thresholds found can be used to help interpret DUS measurements in post-pDVA patients. More research in a larger patient population is needed to prospectively validate these thresholds.
RESUMEN
BACKGROUND: Recent studies showed no reduction in major amputation rates after introduction of a multidisciplinary team (MDT) approach for the treatment of diabetic foot ulcer. The efficacy of MDTs in the current standard of care is being questioned. This retrospective single-center study evaluated the efficacy of an outpatient MDT approach on limb salvage and ulcer healing in treating diabetic foot ulcers. METHODS: Patients with a diabetic foot ulcer treated before (2015) and after (2017) implementation of an MDT in a single center were compared. The MDT met weekly and consisted of a vascular surgeon, physiatrist, internist, shoe technician, wound care nurse, nurse practitioner, cast technician, and podiatrist. The primary outcome was limb salvage at 1 year. Secondary outcomes were ulcer healing, amputation-free survival, freedom from any amputation, and overall survival. Multivariable Cox regression models were used to assess predictors for major amputation. RESULTS: A vascular surgeon treated 104 patients with 148 ulcers in 2015, and the multidisciplinary team treated 133 patients with 188 ulcers in 2017. Limb salvage (90.9% vs. 95.5%, P=0.050), freedom from any amputation (56.5% vs. 78.0%, P<0.001), and ulcer healing (48.3% vs. 69.2%, P<0.001) were significantly lower in the non-MDT group than in the MDT group. Amputation-free survival and overall survival did not differ significantly between the groups. Predictors for major amputation were University of Texas Wound Classification 3D (hazard ratio, 2.8; 95% confidence interval, 1.17-6.45) and being treated in the non-MDT group (hazard ratio, 3.7; 95% confidence interval, 1.25-11.08). CONCLUSIONS: This retrospective study found an MDT dedicated to diabetic foot care was highly effective in increasing limb salvage and ulcer healing. We advise that such an MDT is an integrated part of the patient's chain-based care.