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1.
Vasc Endovascular Surg ; 55(1): 33-38, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33030116

RESUMO

OBJECTIVES: The Society for Vascular Surgery (SVS) created Objective Performance Goals (OPGs) for critical limb ischemia (CLI) in 2009. It was previously shown that endovascular therapy for CLI was not meeting these benchmarks. The OPG for all peripheral interventions is <8% for major adverse cardiac events (MACE), <8% for major adverse limb events (MALE), and <3% for major amputation. The goal of this study is to evaluate if outcomes have improved for CLI in recent years, specifically 2015-2018. METHODS: The Targeted Vascular Module from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) was queried to identify patients who underwent endovascular intervention for critical limb ischemia from 2011-2018. Cohorts were divided into 2011-2014 and 2015-2018. Primary 30-day outcomes were MACE, MALE, and major amputation. Univariate analyses were performed using the Fisher's exact test and the Wilcoxon rank-sum test. Multivariate analysis comparing groups was performed using inverse probability weights and trend over time analysis was performed using logistic regression with year of intervention as a continuous variable. RESULTS: From 2011 to 2018, 7,168 patients underwent an endovascular intervention for CLI. 28% were classified as "OPG high anatomic risk," and 17% were classified as "OPG high clinical risk." The 2015-2018 cohort vs. the 2011-14 cohort experienced MACE in 3.3% vs. 2.7% (p = .23), MALE in 9.1% vs. 8.9% (p = 0.83), and amputation in 4.0% vs. 4.2% (p = 0.71). When only high anatomic risk patients were considered (n = 1988), MACE was experienced in 2.4% vs. 2.2% (p = 0.87), MALE by 9.5% vs. 10.6% (p = 0.47) and amputation by 5.1% vs. 6.0% (p = 0.40). When only high clinical risk patients were considered (n = 1224), MACE was experienced in 5.2% vs. 3.9% (p = 0.33), MALE by 8.0% vs. 7.4% (p = 0.74) and amputation by 3.9% vs. 3.7% (p = 0.88). Comparing 2015-2018 to the reference 2011-2014, MALE adjusted odds ratio (AOR) = 0.99, 95% CI [0.83-1.18], MACE AOR = 1.19 95% CI [0.88-1.60], and major amputation AOR = 0.91 95% CI [0.70-1.17]. There were no decreases in the trend over time for MALE (AOR per year 0.97, CI [.94-1.02], major amputation (AOR per year: 0.97, CI [0.91-1.03], nor for MACE (AOR per year: 1.05, CI [.98-1.13]). CONCLUSION: Outcomes following endovascular interventions for CLI continue to underperform when compared to OPG benchmarks for MALE and amputations. There is no decrease over time for these target outcomes. Target MACE events remain acceptable despite the increasing clinical complexity of patients being treated.


Assuntos
Benchmarking/normas , Procedimentos Endovasculares/normas , Isquemia/cirurgia , Avaliação de Processos e Resultados em Cuidados de Saúde/normas , Doença Arterial Periférica/cirurgia , Guias de Prática Clínica como Assunto/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Idoso , Idoso de 80 Anos ou mais , Amputação/normas , Estado Terminal , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Salvamento de Membro/normas , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
2.
Vascular ; 28(6): 747-755, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33045944

RESUMO

OBJECTIVES: To compare perioperative outcomes related to atherectomy with percutaneous transluminal angioplasty versus percutaneous transluminal angioplasty alone for the treatment of lower extremity chronic limb threatening ischemia using a national patient database. METHODS: Patients with chronic limb threatening ischemia treated with atherectomy and percutaneous transluminal angioplasty or percutaneous transluminal angioplasty alone from 2011 to 2016 in the National Surgical Quality Improvement Program database were identified. Primary outcomes were major adverse limb events (30-day untreated loss of patency, major reintervention, major amputation) and major adverse cardiac events (cardiac arrest, composite outcome of myocardial infarction or stroke). Secondary outcomes included 30-day mortality, length of stay, and any unplanned readmission within 30 days. Multivariate regression analyses were performed to determine independent predictors of outcome. Propensity score matched cohort analysis was performed. A p-value <0.05 was considered statistically significant. Subgroup analyses of femoropopliteal and infrapopliteal interventions were performed. RESULTS: In total, 2636 (77.2%) patients were treated with percutaneous transluminal angioplasty and 778 (22.8%) were treated with atherectomy and percutaneous transluminal angioplasty. Multivariate analyses of the unadjusted cohort revealed no significant differences in major adverse cardiac events or major adverse limb events between the two groups (p-value >0.05). Subgroup analysis of femoropopliteal interventions demonstrated a significantly decreased likelihood of untreated loss of patency in 30 days in the atherectomy group compared to the percutaneous transluminal angioplasty group (1.1% vs. 2.7%, respectively; p-value = 0.034), which persisted on propensity score matched analysis (1.1% vs. 3.1%, respectively; p-value = 0.026). CONCLUSION: Atherectomy with balloon angioplasty of femoropopliteal disease provides a significant decrease in untreated loss of patency compared to balloon angioplasty alone.


Assuntos
Angioplastia com Balão , Aterectomia , Isquemia/terapia , Doença Arterial Periférica/terapia , Idoso , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Aterectomia/efeitos adversos , Aterectomia/mortalidade , Doença Crônica , Bases de Dados Factuais , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
3.
Vasc Health Risk Manag ; 16: 271-284, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32753875

RESUMO

Introduction: Previous studies have suggested that women with chroniclimb-threatening ischemia (CLTI) may have worse outcomes than men. The aim of this study was to determine whether there are sex-related differences in outcomes of patients with CLTI undergoing endovascular treatment with current endovascular technologies. Patients and Methods: Data were derived from the LIBERTY 360 study (NCT01855412). Hazard ratios and the respective 95% confidence intervals were synthesized to examine the association between sex and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE) and major amputation/death up to 3 years of follow-up. Results: A total of 689 patients with CLTI (female: N=252 vs male: N=437) treated with any FDA approved or cleared device were included. The mean lesion length was 126.9±117.3mm and 127.4±113.3mm for the female and male patients, respectively. Although a slightly higher incidence of in-hospital mortality was observed in the female group (1.2% vs 0.0%, p=0.049), there was no difference in female vs male survival rates during follow-up. However, the risk of major amputation at 18 months was higher for the male group (male vs female: HR: 2.36; 95% CI: 1.09-5.12; p=0.030). No difference between the two groups was detected in terms of TVR or MAE during follow-up. Discussion: Data regarding sex-related disparity in outcomes after endovascular therapy of patients with CLTI are conflicting. Gender-related characteristics rather than biological sex characteristics might be the cause of these conflicting findings. Further studies are needed to evaluate the role of sex in revascularization outcomes among this high-risk population.


Assuntos
Angioplastia com Balão , Isquemia/terapia , Doença Arterial Periférica/terapia , Idoso , Idoso de 80 Anos ou mais , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Causas de Morte , Doença Crônica , Feminino , Mortalidade Hospitalar , Humanos , Isquemia/diagnóstico , Isquemia/mortalidade , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento
4.
Eur J Vasc Endovasc Surg ; 60(4): 560-566, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32778492

RESUMO

OBJECTIVE: Although high quality epidemiological data are lacking, the global increase in chronic limb threatening ischaemia may be disproportionately affecting low and LMICs. All available data for outcomes from bypass for limb salvage are from high income countries, with none from LMIC settings where the challenge is greatest. This study aimed to assess the clinical outcomes following vein lower extremity bypass for chronic limb threatening ischaemia at the University of Colombo, Sri Lanka, and to compare patients and outcomes with those described in the Society for Vascular Surgery (SVS) Objective Performance Goals (OPG) and United States National Surgical Quality Improvement Program (NSQIP). METHODS: Consecutive patients (n = 367) undergoing SVS-OPG eligible lower extremity bypass between 2015 and 2017 were studied. Thirty day major adverse cardiovascular events (MACE), major adverse limb events (MALE), deaths, and amputations are reported, along with one year overall survival, limb salvage, and amputation free survival. RESULTS: Patients at University of Colombo had more diabetes mellitus (80% vs. SVS 57% vs. NSQIP 50%, p < .001) and tissue loss (100% vs. SVS 74% vs. NSQIP 59%, p < .001). The 30 day MALE was 7.6%, which is not a statistically significant difference from the SVS (6.1%) or NSQIP (9%). The 30 day MACE was 8.2%, statistically significantly higher than NSQIP (4.2%, p < .001) but not SVS (6.2%, p = .20). At 12 months, the overall survival (82%) was within the OPG threshold, but limb salvage (81.8%) and amputation free survival (64.5%) were just outside. CONCLUSION: Outcomes following vein bypass for ischaemic necrosis at the University of Colombo, Sri Lanka, are acceptable and similar to those reported from high income countries despite greater limb threat severity and resource limitations. Further real world data from similar settings on outcomes following revascularisation are required. These data suggest that a vein bypass first strategy for advanced ischaemic necrosis is feasible and effective even in resource limited settings.


Assuntos
Isquemia/cirurgia , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/cirurgia , Enxerto Vascular , Veias/transplante , Idoso , Idoso de 80 Anos ou mais , Amputação , Doença Crônica , Bases de Dados Factuais , Estudos de Viabilidade , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Intervalo Livre de Progressão , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Sri Lanka , Fatores de Tempo , Enxerto Vascular/efeitos adversos , Enxerto Vascular/mortalidade
5.
Eur J Vasc Endovasc Surg ; 60(5): 687-695, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32778491

RESUMO

OBJECTIVE: The Global Vascular Guideline on chronic limb threatening ischaemia (CLTI) has introduced the Global Limb Anatomic Staging System (GLASS) as a new angiographic scoring system. However, the relationship between GLASS and outcomes following revascularisation has not previously been studied. METHODS: Using pre-intervention angiograms the relationship between GLASS and immediate technical failure (ITF), amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from major adverse limb events (FF-MALE) was examined in 377 patients undergoing endovascular therapy (EVT, n = 213) or bypass surgery (BS, n = 164) in the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial (randomised 1999-2004). RESULTS: There was no significant difference in GLASS between cohorts. There was a significant relationship between ITF and GLASS in EVT (I 14%, II 15%, III 28%, p = .049). GLASS was significantly related to AFS (hazard ratio [HR], 1.37; 95% CI 1.01-1.85; p = .042), LS (HR 1.96; 95 % CI 1.12-3.43; p = .018), and FF-MALE (HR 1.49; 95% CI 1.04-1.87; p = .028) in the EVT cohort. In BS patients, there was no relationship between GLASS and these outcomes. FF-MALE was significantly worse after EVT than BS in GLASS II (p = .038) and III (p = .001). Among the subgroup of patients with femoropopliteal (FP) disease (BS, n = 109 or EVT, n = 159), FF-MALE was significantly higher after BS than EVT (p < .001). The superiority of BS over EVT with increasing GLASS FP grade was greater in the analysis of patients using vein grafts. CONCLUSION: In the BASIL-1 cohort, GLASS is associated with outcomes following EVT but not BS. Although further validation in contemporary CLTI cohorts is required, GLASS seems likely be useful in shared decision making and for stratifying patients in future trials.


Assuntos
Angioplastia/efeitos adversos , Isquemia/diagnóstico , Salvamento de Membro/efeitos adversos , Doença Arterial Periférica/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Enxerto Vascular/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Amputação/estatística & dados numéricos , Feminino , Artéria Femoral/patologia , Artéria Femoral/cirurgia , Seguimentos , Humanos , Isquemia/mortalidade , Isquemia/patologia , Isquemia/cirurgia , Salvamento de Membro/métodos , Extremidade Inferior/irrigação sanguínea , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/patologia , Doença Arterial Periférica/cirurgia , Artéria Poplítea/patologia , Artéria Poplítea/cirurgia , Complicações Pós-Operatórias/etiologia , Guias de Prática Clínica como Assunto , Fatores de Risco , Índice de Gravidade de Doença , Resultado do Tratamento
6.
Eur J Vasc Endovasc Surg ; 60(4): 549-558, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32807674

RESUMO

OBJECTIVE: Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort. METHODS: A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan-Meier method and Cox regression. RESULTS: There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78-0.91), amputation or death (HR 0.87, 95% CI 0.81-0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80-0.92) were observed. CONCLUSION: In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Stents Farmacológicos , Procedimentos Endovasculares/instrumentação , Isquemia/terapia , Perna (Membro)/irrigação sanguínea , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Demandas Administrativas em Assistência à Saúde , Idoso , Idoso de 80 Anos ou mais , Amputação , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Alemanha , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Pontuação de Propensão , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
7.
Eur J Vasc Endovasc Surg ; 60(5): 711-719, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32807678

RESUMO

OBJECTIVE: The aim of this study was to investigate outcomes for lower limb revascularisation for limb salvage within the National Health Service (NHS) in England. METHODS: This was a retrospective observational study of administrative data. Data were extracted from the Hospital Episodes Statistics database for England. Data were included for a seven year period (1 April 2011-31 March 2018 inclusive) for all patients aged ≥ 18 years receiving surgery for peripheral arterial occlusive disease. Data were extracted for patient age, sex and frailty level, the NHS trusts undertaking the procedure, the technique used (angioplasty, bypass, endarterectomy, or hybrid), the mode of admission (elective or emergency), the surgical speciality, the financial year of admission, length of hospital stay during the procedure, subsequent emergency re-admission, revascularisation procedures within 30 days and subsequent amputation and mortality within one year and within five years. The primary outcome was one year amputation free survival. For analysis, data were separated into diabetic and non-diabetic patients. Multilevel modelling was used to adjust for hierarchy and observed confounding when investigating outcomes. RESULTS: Data were available for 98 109 procedures across 124 hospital trusts. For non-diabetic patients (odds ratio 1.142, 95% confidence interval 1.068-1.222), one year amputation free survival was higher for angioplasty than for bypass. For diabetic patients, there was no difference in the primary outcome. One year amputation rates, 30 day emergency re-admission rates, and length of stay were all lower for angioplasty, and 30 day revascularisation rates were lower for bypass for both diabetic and non-diabetic patients. CONCLUSION: Outcomes were generally better for angioplasty than for bypass surgery for lower limb revascularisation for both diabetic and non-diabetic patients. The findings should be interpreted with caution given the likely different clinical presentations of those selected for each procedure. Future clinical trials may provide more definitive data.


Assuntos
Angioplastia/efeitos adversos , Isquemia/cirurgia , Salvamento de Membro/efeitos adversos , Doenças Vasculares Periféricas/cirurgia , Enxerto Vascular/efeitos adversos , Demandas Administrativas em Assistência à Saúde/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Amputação/estatística & dados numéricos , Angioplastia/estatística & dados numéricos , Inglaterra/epidemiologia , Feminino , Humanos , Isquemia/mortalidade , Tempo de Internação/estatística & dados numéricos , Salvamento de Membro/métodos , Salvamento de Membro/estatística & dados numéricos , Extremidade Inferior/irrigação sanguínea , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Doenças Vasculares Periféricas/mortalidade , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Enxerto Vascular/estatística & dados numéricos
8.
J Endovasc Ther ; 27(4): 599-607, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32633651

RESUMO

Purpose: To report the outcomes of bypass grafting (BG) vs endovascular therapy (EVT) in patients with non-dialysis-dependent chronic kidney disease (CKD) and chronic limb-threatening ischemia (CLTI). Materials and Methods: The CRITISCH Registry is a prospective, national, interdisciplinary, multicenter registry evaluating the current practice of all available treatment options in 1200 consecutive CLTI patients. For the purposes of this analysis, only the 337 patients with non-dialysis-dependent CKD treated by either BG (n=86; median 78 years, 48 men) or EVT (n=251; median age 80 years, 135 men) were analyzed. The primary composite outcome was amputation-free survival (AFS); secondary outcomes were overall survival (OS) and amputation-free time (AFT). All outcomes were evaluated in Cox proportional hazards models; the results are reported as the hazard ratio (HR) and 95% confidence interval (CI). Results: The Cox regression analysis revealed a significantly greater hazard of amputation or death after BG (HR 1.78, 95% CI 1.05 to 3.03, p=0.028). The models for AFT and overall survival also suggested a higher hazard for BG, but the differences were not significant (AFT: HR 1.66, 95% CI 0.78 to 3.53, p=0.188; OS: HR 1.41, 95% CI 0.80 to 2.47, p=0.348). The absence of runoff vessels (HR 1.73, 95% CI 1.15 to 2.60, p=0.008) was associated with a decreased AFS. The likelihood of amputation was higher in male patients (HR 2.21, 95% CI 1.10 to 4.45, p=0.027) and was associated with a lack of runoff vessels (HR 1.95, 95% CI 0.96 to 3.95, p=0.065) and myocardial infarction (HR 3.74, 95% CI 1.23 to 11.35, p=0.020). Death was more likely in patients without runoff vessels (HR 1.76, 95% CI 1.11 to 2.80, p=0.016) and those with a higher risk score (HR 1.73, 95% CI 1.03 to 2.91, p=0.038). Conclusion: This analysis suggested that BG was associated with poorer AFS than EVT in patients with non-dialysis-dependent CKD and CLTI. Male sex, previous myocardial infarction, and the absence of runoff vessels were additionally identified as predictors of poorer outcomes.


Assuntos
Procedimentos Endovasculares , Isquemia/terapia , Doença Arterial Periférica/terapia , Insuficiência Renal Crônica/terapia , Enxerto Vascular , Idoso , Idoso de 80 Anos ou mais , Amputação , Doença Crônica , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Alemanha/epidemiologia , Humanos , Isquemia/diagnóstico , Isquemia/mortalidade , Salvamento de Membro , Masculino , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Estudos Prospectivos , Sistema de Registros , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/mortalidade , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Enxerto Vascular/efeitos adversos , Enxerto Vascular/mortalidade
9.
J Endovasc Ther ; 27(5): 714-725, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32618486

RESUMO

Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study (ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.


Assuntos
Angioplastia com Balão , Aterectomia , Artéria Femoral , Claudicação Intermitente/terapia , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Idoso de 80 Anos ou mais , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Angioplastia com Balão/mortalidade , Aterectomia/efeitos adversos , Aterectomia/instrumentação , Aterectomia/mortalidade , Doença Crônica , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/mortalidade , Claudicação Intermitente/fisiopatologia , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Grau de Desobstrução Vascular
10.
Eur J Vasc Endovasc Surg ; 60(2): 231-241, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32709468

RESUMO

OBJECTIVE: The aim of this systematic review and meta-analysis was to assess the clinical outcomes after revascularisation in octogenarians with chronic limb threatening ischaemia (CLTI). METHODS: This was a systematic review and meta-analysis, in which the Medline, Embase, and Cochrane Library databases were searched systematically by two independent researchers. Meta-analyses were performed to analyse one year mortality, one year major amputation, and one year amputation free survival (AFS) after revascularisation. Pooled outcome estimates were reported as percentages and odds ratio (OR) with 95% confidence intervals (CI). In addition, sensitivity and subgroup analyses were performed and the quality of evidence was determined according to the GRADE system. RESULTS: The review includes 21 observational studies with patients who were treated for CLTI. Meta-analysis of 12 studies with a total of 17 118 patients was performed. A mortality rate of 32% was found in octogenarians (95% CI 27-37%), which was significantly higher than in the non-octogenarians (17%, 95% CI 11-22%/OR 2.52, 95% CI 1.93-3.29; GRADE: "low"). No significant difference in amputation rate was found (octogenarians 15%, 95% CI 11-18%; non-octogenarians 12%, 95% CI 7-14%; GRADE: "very low"). AFS was significantly lower in the octogenarian group (OR 1.55, 95% CI 1.03-2.43; GRADE: "very low"). In a subgroup analysis differentiating between endovascular and surgical revascularisation, amputation rates were comparable. For octogenarians, those treated conservatively had a mortality rate significantly higher than those treated by revascularisation (OR 1.76, 95% CI 1.19-2.60; GRADE: "very low"). No significant difference in mortality rate was found between primary amputation and revascularisation in octogenarians (OR 0.70, 95% CI 0.24-2.03; GRADE: "very low"). CONCLUSION: In octogenarians with CLTI, a substantial one year mortality rate of 32% was found after revascularisation. The amputation rates were comparable between both age groups. However, only low quality evidence could be obtained supporting the results of this meta-analysis because only observational studies were available for inclusion.


Assuntos
Amputação/mortalidade , Isquemia/cirurgia , Doença Arterial Periférica/cirurgia , Procedimentos Cirúrgicos Vasculares/mortalidade , Idoso , Idoso de 80 Anos ou mais , Amputação/efeitos adversos , Doença Crônica , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Masculino , Estudos Observacionais como Assunto , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Intervalo Livre de Progressão , Medição de Risco , Fatores de Risco , Fatores de Tempo , Procedimentos Cirúrgicos Vasculares/efeitos adversos
11.
J Endovasc Ther ; 27(4): 647-657, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32508220

RESUMO

Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.


Assuntos
Angioplastia com Balão/instrumentação , Materiais Revestidos Biocompatíveis , Artéria Femoral , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Doença Crônica , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
12.
Ann Vasc Surg ; 69: 317-323, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32502677

RESUMO

BACKGROUND: Acute limb ischemia (ALI) is challenging to treat because of high morbidity and mortality. Endovascular-first options beginning with thrombolysis are technically feasible with similar results to open surgery. We examined our experience with thrombolysis to identify patients and target conduits that are predictive of improved outcomes. METHODS: We performed a retrospective review of our institutional database of thrombolysis cases for arterial lower extremity disease. Thrombolysis was the index procedure, and any subsequent treatment was a reintervention. Conversion to open surgery perioperatively such as thromboembolectomy or bypass was considered a technical failure. Primary outcomes included primary patency, secondary patency, amputation-free survival (AFS), and survival. Secondary outcomes included conversion to open, reintervention <30 days, and amputation <30 days. Descriptive statistics and analysis of variance were performed for preoperative and intraoperative risk factors. Kaplan-Meier estimation and Cox proportional hazard models were used for primary and secondary outcomes. RESULTS: Ninety-nine patients with ALI were treated with thrombolysis from 2007 to 2017. Thrombolysis was attempted on native artery (40%), vein bypass (7%), prosthetic bypass (33%), and stent (19%). Rutherford class distribution was 50% class 1, 41% class 2a, 5% class 2b, and 3% class 3. Technical success was 70%, characterized by an all-endovascular approach, patency at 30 days, and AFS for 30 days. Primary patency at 1- and 2-years was 31% and 22%, respectively. Secondary patency at 1- and 2-years was 39% and 27%, respectively. Overall, 30% required conversion to open surgery at the time of the index procedure, 7% reintervention <30 days, 5% mortality <30 days, and 5% major amputation <30 days. Prosthetic grafts and vein bypasses had the worst primary and secondary patency (P < 0.05). Five out of 7 vein bypasses required open conversion. Thrombolysis of native arteries was most successful maintaining primary patency (P < 0.05), secondary patency (P < 0.05), and AFS (P < 0.05). Patients who had adjunctive procedures at the time of thrombolysis had a significantly greater primary patency (P < 0.05) and secondary patency (P < 0.05) but not greater AFS. CONCLUSION: Outcomes in thrombolysis for ALI have not significantly improved 20 years after the STILE trial. Technical success and mid-term patency rates are modest at best. Thrombolysis of vein bypasses and prosthetic grafts have poor technical success and primary patency compared with native arteries. However, aggressive adjunctive interventions during thrombolysis appear to improve primary and secondary patency.


Assuntos
Oclusão de Enxerto Vascular/tratamento farmacológico , Isquemia/tratamento farmacológico , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/tratamento farmacológico , Terapia Trombolítica , Doença Aguda , Idoso , Amputação , Bases de Dados Factuais , Feminino , Oclusão de Enxerto Vascular/diagnóstico por imagem , Oclusão de Enxerto Vascular/mortalidade , Oclusão de Enxerto Vascular/fisiopatologia , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , New York , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Centros de Atenção Terciária , Terapia Trombolítica/efeitos adversos , Terapia Trombolítica/mortalidade , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
13.
Ann Vasc Surg ; 69: 298-306, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32505677

RESUMO

BACKGROUND: Patients with critical limb ischemia (CLI) who undergo major lower extremity amputation (LEA) have been associated with high one-year mortality rates. Previous western-based studies have identified risk factors that exponentiate these poor outcomes, including nonambulatory status and cardiovascular morbidity. We assessed the effect of frailty, using the modified frailty index (mFI) in a cohort undergoing major LEA for CLI to predict mortality, perioperative complications, and unplanned readmissions in a tertiary institution from Singapore. METHODS: Data on patients who had undergone major LEA from January 2016 to December 2017 were collected retrospectively. Inclusion criteria were below-knee amputations (BKAs) or above-knee amputations (AKAs) performed for peripheral arterial disease-related tissue loss or sepsis only. Patients were categorized into 3 risk groups based on the 11-variable mFI: low mFI, 0-0.27; moderate mFI, 0.36-0.54; and high mFI ≥0.63. Univariate and multivariate analysis was performed using logistic regression analysis. RESULTS: 211 patients underwent major LEA, of whom 133 (63.0%) had undergone BKA. The mean mFI was 0.41 (range 0-0.81). 84/211 (39.8%) died within 1 year after the procedure, with mortality rates of 25/65 (38.4%), 49/127 (38.6%), and 10/19 (52.6%) in the low-, moderate-, high-mFI categories, respectively. High and moderate mFI had failed to demonstrate an increased risk of mortality when compared with the low-mFI group (P > 0.05). 91/211 (43.1%) patients had perioperative complications, whereas 27/211 (12.8%) patients were readmitted within 30 days of discharge. Myocardial infarction, chronic kidney disease, and atrial fibrillation were found to be predictive of poor outcomes after major LEA. CONCLUSIONS: Frailty as measured with the mFI did not predict outcome after major LEA. This could be due to confounding effects such as high prevalence of renal dysfunction and the constancy of diabetes and peripheral vascular disease in this population that would reduce the differentiation of patients using the mFI.


Assuntos
Amputação/mortalidade , Grupo com Ancestrais do Continente Asiático , Fragilidade/diagnóstico , Avaliação Geriátrica , Isquemia/cirurgia , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/cirurgia , Idoso , Idoso de 80 Anos ou mais , Amputação/efeitos adversos , Estado Terminal , Feminino , Idoso Fragilizado , Fragilidade/etnologia , Fragilidade/mortalidade , Humanos , Isquemia/diagnóstico , Isquemia/etnologia , Isquemia/mortalidade , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/etnologia , Doença Arterial Periférica/mortalidade , Valor Preditivo dos Testes , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Singapura , Fatores de Tempo , Resultado do Tratamento
14.
J Endovasc Ther ; 27(4): 547-564, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32571125

RESUMO

Endovascular revascularization has been increasingly utilized to treat patients with chronic limb-threatening ischemia (CLTI), particularly atherosclerotic disease in the infrapopliteal arteries. Lesions of the infrapopliteal arteries are the result of 2 different etiologies: medial calcification and intimal atheromatous plaque. Although several devices are available for endovascular treatment of infrapopliteal lesions, balloon angioplasty still comprises the mainstay of therapy due to a lack of purpose-built devices. The mechanism of balloon angioplasty consists of adventitial stretching, medial necrosis, and dissection or plaque fracture. In many cases, the diffuse nature of infrapopliteal disease and plaque complexity may lead to dissection, recoil, and early restenosis. Optimal balloon angioplasty requires careful attention to assessment of vessel calcification, appropriate vessel sizing, and the use of long balloons with prolonged inflation times, as outlined in a treatment algorithm based on this systematic review. Further development of specific devices for this arterial segment are warranted, including devices for preventing recoil (eg, dedicated atherectomy devices), treating dissections (eg, tacks, stents), and preventing neointimal hyperplasia (eg, novel drug delivery techniques and drug-eluting stents). Further understanding of infrapopliteal disease, along with the development of new technologies, will help optimize the durability of endovascular interventions and ultimately improve the limb-related outcomes of patients with CLTI.


Assuntos
Algoritmos , Angioplastia com Balão , Técnicas de Apoio para a Decisão , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Angioplastia com Balão/mortalidade , Doença Crônica , Tomada de Decisão Clínica , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Seleção de Pacientes , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Recidiva , Fatores de Risco , Resultado do Tratamento , Grau de Desobstrução Vascular
15.
Ann Vasc Surg ; 69: 1-8, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32599114

RESUMO

BACKGROUND: The adverse gender disparities for women after open abdominal aortic aneurysm (AAA) repair have been well documented. The purpose of this study is to review whether these disparities extend to elective endovascular aneurysm repair (EVAR). METHODS: Nonruptured, elective AAA was identified from the American College of Surgeons' National Quality Improvement Program (NSQIP) Targeted Participant Use File for EVAR from 2012 to 2017. The primary outcome was mortality. Secondary outcomes included lower extremity ischemia requiring intervention (LEIRI) and prolonged operative time (>120 min). Multivariable logistic regression models were used to assess the risk of mortality, LEIRI, and prolonged operative time among women compared with men. RESULTS: There were 14,019 EVAR procedures captured. A total of 3,367 were included for analysis after limiting to nonruptured, elective cases for diagnosis of AAA with a Current Procedural Terminology procedure code for EVAR. Of those, 2,764 (82.1%) were performed in men and 603 (17.9%) in women. Female patients were older (median [interquartile range (IQR)] 77 years [70-82] versus 74 years [68-80], P < 0.001), more likely to smoke (35.5% versus 29.6%, P = 0.005), and less likely to have diabetes (12.4% versus 17.8%, P = 0.001). Women had slightly smaller AAA size (median [IQR] 5.4 cm [5.0-5.9] versus 5.5 cm [5.1-6.0], P < 0.001) and were more likely to have prior abdominal operations (35.3% versus 23.1%, P < 0.001). The operative time was longer among women (median 114 min. [85-150] versus 105 min. [82-140], P < 0.001). Postoperatively, mortality was higher in female patients (1.8% versus 0.9%, P = 0.036), LEIRI occurred in higher proportion among female patients (2.7% versus 1.2%, P = 0.009), and their hospital stay was also longer (median 2 days [1-3] versus 1 day [1-2] days, P < 0.001). On multivariable logistic regression analysis, hematocrit level <30 vol% versus ≥30 vol% (odds ratio (OR) 5.5, 95% confidence interval (CI) 2.1-14.5, P < 0.001) was associated with increased mortality. Although not statistically significant, there was also evidence that the odds of mortality were also greater among women (OR 2.0, 95% CI 0.98-4.2, P = 0.06). LEIRI was more likely among women (OR 2.1, 95% CI 1.2-3.9, P = 0.015) and patients with a smoking history (OR 1.8, 95% CI 1.0-3.2, P = 0.044). Finally, odds of prolonged operative time were higher among women (OR 1.4, 95% CI 1.2-1.7, P < 0.001) and patients with chronic obstructive pulmonary disease (OR 1.2, 95% CI 1.0-1.5, P = 0.033) or partial/total dependent functional status (OR 2.2, 95% CI 1.3-3.7, P = 0.003). CONCLUSIONS: Although EVAR has improved overall surgical AAA outcomes, the NSQIP data in elective EVAR demonstrate continued sex disparities in morbidity and mortality after AAA surgical repair to the detriment of female patients.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde , Isquemia/etiologia , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Implante de Prótese Vascular/mortalidade , Bases de Dados Factuais , Procedimentos Cirúrgicos Eletivos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Isquemia/mortalidade , Isquemia/terapia , Masculino , Duração da Cirurgia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
16.
J Endovasc Ther ; 27(4): 608-613, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32419595

RESUMO

PURPOSE: To determine in a chronic limb-threatening ischemia (CLTI) population who underwent endovascular therapy (EVT) how many patients would have been categorized as preferred for bypass surgery according to the Global Vascular Guidelines (GVG) and ascertain their surgical risk. MATERIALS AND METHODS: The current study analyzed 1043 CLTI patients who presented WIfI (wound, ischemia, and foot infection) stage ≥2 and underwent EVT between April 2010 and December 2017. Of these, 176 were excluded for lack of angiographic or other data, leaving 867 CLTI patients (mean age 74±10 years; 523 men) for stratification according to the GVG into bypass-preferred, indeterminate, or EVT-preferred groups. The GVG recommend bypass as the first-line treatment when the wound is severe (WIfI stage ≥3) and lesions are complex (GLASS stage III). Surgical risk was estimated using the modified PREVENT III risk score. To further stratify the bypass-preferred population according to mortality risk, a survival decision tree was constructed using recursive partitioning. RESULTS: The bypass-preferred group accounted for 55% [95% confidence interval (CI) 51% to 58%] of the overall population. The decision tree analysis extracted a low-mortality risk subgroup with a survival rate of 99% (95% CI 98% to 100%) at 1 month and 80% (95% CI 73% to 87%) at 2 years. According to the PREVENT III score, 34% (95% CI 27% to 42%) of the low mortality risk subgroup were classified as high surgical risk. CONCLUSION: A high proportion of patients undergoing EVT were considered bypass preferred based on the GVG, and the survival of these patients was not significantly different whether they were high or low surgical risk.


Assuntos
Tomada de Decisão Clínica , Procedimentos Endovasculares/normas , Isquemia/terapia , Seleção de Pacientes , Doença Arterial Periférica/terapia , Guias de Prática Clínica como Assunto/normas , Enxerto Vascular/normas , Idoso , Idoso de 80 Anos ou mais , Amputação/normas , Doença Crônica , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Fidelidade a Diretrizes/normas , Humanos , Isquemia/diagnóstico , Isquemia/mortalidade , Salvamento de Membro/normas , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Enxerto Vascular/efeitos adversos , Enxerto Vascular/mortalidade
17.
Ann Vasc Surg ; 68: 510-521, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32439522

RESUMO

BACKGROUND: The clinical effectiveness of surgical versus endovascular therapy for chronic limb-threatening ischemia (CLTI) continues to be debated, and the resources required for each therapy are unclear. METHODS: Systematic review of randomized controlled trials (RCTs) and observational studies comparing surgery with endovascular therapy for CLTI, which reported clinical effectiveness and resource utilization. Short-term and long-term clinical outcomes were examined. RESULTS: The search yielded 4,231 titles, of which 17 publications met our inclusion criteria. Five publications were all from 1 RCT, and 12 publications were observational studies. In the RCT, the surgical approach had greater resource use in the first year (total hospital days across all admissions for surgery versus angioplasty: 46.14 ± 53.87 vs. 36.35 ± 51.39; P < 0.001; also true for days in high-dependency and intensive therapy units), but differences were not statistically significant in subsequent years. All-cause mortality presented a nonsignificant difference favoring angioplasty in the first 2 years (adjusted hazard ratio [aHR], 1.27; 95% confidence interval [95% CI], 0.75-2.15), but after 2 years, it favored surgical treatment (aHR, 0.34; 95% CI, 0.17-0.71). The observational studies reported short-term effectiveness and resource utilization favoring endovascular therapy, but most differences were not statistically significant. Long-term outcomes were more mixed; in particular, mortality outcomes generally favored surgery, although concluding that cause and effect is not possible as endovascularly treated patients tended to be older and may have had a shorter life expectancy regardless of therapy. CONCLUSIONS: The clinical effectiveness and resource utilization of surgery compared with endovascular therapy for CLTI is not known with certainty and will not be known until ongoing trials report results. It is likely that findings will vary by the time horizon, where initial outcomes and utilization tend to favor endovascular interventions, but long-term outcomes favor surgical revascularization.


Assuntos
Angioplastia , Recursos em Saúde , Isquemia/terapia , Doença Arterial Periférica/terapia , Procedimentos Cirúrgicos Vasculares , Idoso , Angioplastia/efeitos adversos , Angioplastia/mortalidade , Doença Crônica , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Tempo de Internação , Masculino , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/mortalidade
18.
J Endovasc Ther ; 27(5): 739-748, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32436810

RESUMO

PURPOSE: To investigate the incidence and clinical predictors, including institutional annual case volume, of critical in-hospital complications after endovascular therapy (EVT) for peripheral artery disease (PAD). MATERIALS AND METHODS: The data were extracted from the nationwide registry of peripheral interventions in Japan [Japanese EVT (J-EVT)] between 2012 and 2017. A total of 92,224 EVT cases either for chronic limb-threatening ischemia (CLTI) or intermittent claudication were included in the analysis. The primary outcome measure was critical in-hospital complications, which were defined as a composite of urgent surgery and in-hospital death within 30 days after EVT. The institutional volume was classified into quartiles. The association of institutional volume, as well as baseline characteristics, with the critical in-hospital complications was explored using a multivariable logistic regression model with multiple imputation for missing data. Results are presented as the adjusted odds ratio (OR) with the 95% confidence intervals (CI). RESULTS: The estimated prevalence of critical in-hospital complications was 0.3% (95% CI 0.3% to 0.4%). The following 10 patient- and limb-related characteristics were identified as independent risk factors for critical in-hospital complications: (1) female sex (OR 1.75, 95% CI 1.36 to 2.25), (2) age ≥75 years (OR 1.60, 95% CI 1.06 to 2.40), (3) CLTI (OR 2.12, 95% CI 1.47 to 3.05), (4) nonambulatory status (OR 1.66, 95% CI 1.23 to 2.24), (5) regular dialysis (OR 1.35, 95% CI 1.02 to 1.77), (6) cerebrovascular disease (OR 1.76, 95% CI 1.33 to 2.33), (7) urgent revascularization (OR 5.10, 95% CI 3.64 to 7.13), (8) aortoiliac TASC II D lesion (OR 3.65, 95% CI 2.51 to 5.33), (9) femoropopliteal TASC II D lesion (OR 1.77, 95% CI 1.24 to 2.52), and (10) infrapopliteal TASC D lesion (OR 1.52, 95% CI 1.08 to 2.13). In addition, the 4th quartile of the institutional volume (≥158 cases/year), but not the 2nd or 3rd quartile, had a significantly and independently lower risk of critical in-hospital complications than the 1st quartile (OR 0.13, 95% CI 0.07 to 0.23). CONCLUSION: After EVT for symptomatic PAD, 0.3% of the population encountered critical in-hospital complications. A higher institutional volume was significantly associated with a lower risk of critical in-hospital complications.


Assuntos
Procedimentos Endovasculares/efeitos adversos , Hospitais com Alto Volume de Atendimentos , Hospitais com Baixo Volume de Atendimentos , Claudicação Intermitente/terapia , Isquemia/terapia , Doença Arterial Periférica/terapia , Carga de Trabalho , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Procedimentos Endovasculares/mortalidade , Feminino , Mortalidade Hospitalar , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/mortalidade , Claudicação Intermitente/fisiopatologia , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Indicadores de Qualidade em Assistência à Saúde , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
19.
Ann Vasc Surg ; 68: 417-425, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32428645

RESUMO

BACKGROUND: The purpose of this study was to evaluate the outcome of percutaneous transluminal angioplasty in patients with critical limb ischemia due to popliteal artery (PA) chronic total occlusions depending on the presence of a patent portion of the PA distal to the occlusive lesion-the distal landing zone (DLZ). MATERIALS AND METHODS: We retrospectively analyzed 80 patients with critical limb ischemia (all Rutherford class 5-6), who underwent percutaneous transluminal angioplasty with or without stenting for PA chronic total occlusions with no inflow disease. Baseline demographic and clinical variables, periprocedural outcome, 12-month overall survival, limb salvage, primary patency, freedom from target lesion revascularization (TLR), amputation-free survival, and freedom from major adverse limb events in DLZ versus no-DLZ lesions were assessed. RESULTS: Of all patients (43 men; mean age 70.2 y), 40 (50%) had DLZ in the PA, whereas another 40 (50%) did not (no-DLZ). Diabetes was significantly more common among DLZ patients and was found to be a risk factor for DLZ compared with no-DLZ lesions (HR 2.58; 95% CI 1.03-6.46; P = 0.04). Other demographic and clinical variables were similar between the groups. The stenting rate was 45.0% versus 42.5% in DLZ versus no-DLZ (P = 1.0). At 12 months, there was no significant difference in primary patency (64.7% vs. 51.6%; P = 0.156), overall survival (73.4% vs. 84.0%; P = 0.283), amputation-free survival (60.0% vs. 68.8%; P = 0.432), and limb salvage rate (93.6% vs. 82.2%; P = 0.126) between DLZ and no-DLZ groups, respectively. However, freedom from TLR (92.1% vs. 67.7%; P = 0.03) and major adverse limb events (80.1% vs. 41.8%; P = 0.003) was significantly higher in DLZ compared with no-DLZ lesions (92.1% vs. 67.7%; P = 0.03). CONCLUSIONS: Diabetes was found to be a significant risk factor for DLZ compared to no-DLZ lesions. Technical success and stenting rates were similar in DLZ versus no-DLZ patients. At 12 months, there was no significant difference in limb salvage, primary patency, and overall survival between the study groups. The DLZ lesions were associated with a significantly higher freedom from TLR than no-DLZ lesions.


Assuntos
Angioplastia , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Idoso de 80 Anos ou mais , Amputação , Angioplastia/efeitos adversos , Angioplastia/instrumentação , Angioplastia/mortalidade , Doença Crônica , Estado Terminal , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
20.
Ther Adv Cardiovasc Dis ; 14: 1753944720924575, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32438865

RESUMO

BACKGROUND: Endovascular therapy for acute lower limb ischemia (ALLI) has developed and demonstrated safety and efficacy. The purpose of this study was to assess clinical outcomes in patients treated for ALLI with conventional endovascular or surgical revascularization. METHOD: This study was a retrospective single-center review. Consecutive patients with ALLI treated with conventional endovascular revascularization (ER) without thrombolytic agent or surgical revascularization (SR) between 2008 and 2014 were investigated. The 1 year and 3 year amputation rate and mortality rate were assessed by time-to-event methods, including Kaplan-Meier estimation. RESULT: A total of 64 limbs in 62 patients with ALLI due to thromboembolism or thrombosis of a native artery, bypass graft, or previous stented vessel were included. The majority of limbs (90.9%) presented with Rutherford clinical categories 1 to 2 ischemia. Technical success rate was 95.5% in ER and 92.9% in SR group (p = 0.547). Overall amputation rates were 9.1% in ER versus 9.5% in SR after 1 year (p = 0.971) and 9.1% in ER versus 11.9% in SR after 3 year (p = 0.742). Overall mortality rates were 15% in ER versus 7.1% in SR after 1 year (p = 0.491) and 15% in ER versus 11.2% in SR after 3 year (p = 0.878). CONCLUSION: Endovascular or surgical revascularization of ALLI resulted in comparable outcomes in limb salvage and mortality rate at 1 year and 3 year. Conventional endovascular therapy without thrombolytic agent such as stenting, balloon angioplasty, or catheter-directed thrombosuction may be considered as a treatment option for ALLI.


Assuntos
Angioplastia com Balão , Isquemia/terapia , Extremidade Inferior/irrigação sanguínea , Trombectomia , Procedimentos Cirúrgicos Vasculares , Idoso , Idoso de 80 Anos ou mais , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Trombectomia/efeitos adversos , Trombectomia/mortalidade , Fatores de Tempo , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/mortalidade
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