Caracterización de los pacientes con enfermedades vasculares periféricas fallecidos en un período de cuatro años / Characterization of patients with peripheral vascular diseases who died in a period of four years

Introducción: Las enfermedades vasculares periféricas constituyen un problema de salud en el ámbito mundial por resultar causa importante de discapacidad y de invalidez. Objetivo: Caracterizar a los pacientes con enfermedades vasculares periféricas fallecidos en un período de cuatro años. Método: Se realizó un estudio descriptivo y analítico en los pacientes fallecidos entre enero de 2015 y diciembre de 2018. Se estudiaron variables sociodemográficas y clínicas. Se estimaron las frecuencias absolutas y relativas, así como la tasa de mortalidad. Se identificó la asociación entre las variables con la causa directa de muerte. Resultados: El 42,7 por ciento de los diabéticos fallecieron; de estos, el 57,5 por ciento estaban descompensados. La hipertensión arterial, el tabaquismo y la diabetes mellitus fueron los factores de riesgo más frecuentes. La tasa de mortalidad total resultó 0,171/1000 ingresos. Como enfermedades arteriales más frecuente aparecieron los AAA (28,1 por ciento ) y la angiopatía diabética (25 por ciento ); y, como parte de esta última, el pie (25,7 por ciento ). La aneurismectomía con injerto por sustitución representó la cirugía revascularizadora más realizada (58,8 por ciento ). El shock hipovolémico y el tromboembolismo pulmonar predominaron como complicaciones posquirúrgicas (15,7 por ciento ). El shock séptico (31,6 por ciento ) y la bronconeumonía bacteriana (25,7 por ciento) fueron las causas directas de muerte. Conclusiones: Se logró caracterizar a los pacientes con enfermedades vasculares periféricas fallecidos en los últimos cuatro años, por lo que estimaron la tasa de prevalencia y la tendencia anual de la mortalidad en el Instituto Nacional de Angiología y Cirugía Vascular en ese período; asimismo, las variables asociadas a las causas directas de muerte(AU)

Introduction: Peripheral vascular diseases are a global health problem because they are a major cause of disability. Objective: Characterize patients with peripheral vascular diseases who died over a period of four years. Method: A descriptive and analytical study was conducted in patients who died between January 2015 and December 2018. Socio-demographic and clinical variables were studied. Absolute and relative frequencies were estimated, as well as the mortality rate. The association between the variables with the direct cause of death was identified. Results: 42.7 percent of diabetic patients died; of these, 57.5 percent were decompensated. High blood pressure, smoking and diabetes mellitus were the most frequent risk factors. The total mortality rate was 0.171/1000 admissions. The most frequent arterial diseases were AAA (28.1 percent) and diabetic angiopathy (25 percent); and, as part of the latter, foot angiopathy (25.7 percent). Aneurysmectomy with graft substitution represented the most performed revascularizing surgery (58.8 percent). Hypovolemic shock and pulmonary thromboembolism predominated as post-surgical complications (15.7 percent). Septic shock (31.6 percent) and bacterial bronchopneumonia (25.7 percent) were the direct causes of death. Conclusions: It was possible to characterize patients with peripheral vascular diseases who died in the last four years, so they estimated the prevalence rate and the annual trend of mortality at the National Institute of Angiology and Vascular Surgery in that period; also, the variables associated with direct causes of death(AU)

Pre-operative Neutrophil to Lymphocyte Ratio is Associated With 30 Day Death or Amputation After Revascularisation for Acute Limb Ischaemia.

OBJECTIVE: Inflammation is an early feature of acute limb ischaemia (ALI), hence the potential prognostic significance of inflammatory biomarkers. This study aimed to assess the value of pre-operative inflammatory biomarkers, specifically the neutrophil to lymphocyte ratio (NLR) and the platelet to lymphocyte ratio (PLR), for predicting an adverse outcome after revascularisation for ALI. METHODS: All patients submitted to lower limb revascularisation for Rutherford IIa or IIb ALI at the authors' institution between 2009 and 2019 were screened retrospectively. Pre-operative NLR and PLR were analysed, along with other known prognostic factors. Primary outcome was the composite endpoint of 30 day death or amputation. RESULTS: A total of 345 patients were included, 84 of whom suffered the primary outcome (24.3%). The median follow up was 23.1 months (3.1 - 52.2). Higher age (OR 1.05 per year increase, 95% CI 1.01 - 1.09), diabetes (OR 2.63, 95% CI 1.14 - 6.06), Rutherford grade IIb vs. IIa (OR 5.51, 95% CI 2.11 - 14.42), higher NLR (OR 1.28 per unit increase, 95% CI 1.12 - 1.47), and fasciotomy need (OR 3.44, 95% CI 1.14 - 10.34) were independently associated with 30 day death or amputation, whereas pre-operative statin or anticoagulant medication were associated with a risk reduction (OR 0.23, 95% CI 0.53 - 0.96 and OR 0.20, 95% CI 0.05 - 0.84, respectively). PLR did not show an independent effect on this population. Pre-operative NLR presented a good discriminative ability (AUC 0.86, 95% CI 0.82 - 0.90). A cut off NLR level ≥ 5.4 demonstrated a 90.5% sensitivity and 73.6% specificity for 30 day death or amputation. Kaplan-Meier analysis showed that patients with pre-operative NLR ≥ 5.4 had significantly lower 30 day, six month and one year amputation free survival when compared with those with NLR < 5.4 (64.8 ± 4.0%, 44.1 ± 4.1%, and 37.5 ± 4.1% vs. 98.5 ± 0.9%, 91.9 ± 2.0%, and 85.9 ± 2.5%, log rank p < .001). CONCLUSION: In this study, higher pre-operative NLR was associated with 30 day death or amputation following intervention for Rutherford grade IIa or IIb ALI. NLR potentially stands as a simple, widely available and inexpensive biomarker that can refine decision making and possibly contribute to ALI morbidity and mortality reduction.

Peripheral Vascular Disease and Kidney Transplant Outcomes: Rethinking an Important Ongoing Complication.

Peripheral vascular disease (PVD) is highly prevalent in patients on the waiting list for kidney transplantation (KT) and after transplantation and is associated with impaired transplant outcomes. Multiple traditional and nontraditional risk factors, as well as uremia- and transplant-related factors, affect 2 processes that can coexist, atherosclerosis and arteriosclerosis, leading to PVD. Some pathogenic mechanisms, such as inflammation-related endothelial dysfunction, mineral metabolism disorders, lipid alterations, or diabetic status, may contribute to the development and progression of PVD. Early detection of PVD before and after KT, better understanding of the mechanisms of vascular damage, and application of suitable therapeutic approaches could all minimize the impact of PVD on transplant outcomes. This review focuses on the following issues: (1) definition, epidemiological data, diagnosis, risk factors, and pathogenic mechanisms in KT candidates and recipients; (2) adverse clinical consequences and outcomes; and (3) classical and new therapeutic approaches.

A meta-analysis of mortality after minor amputation among patients with diabetes and/or peripheral vascular disease.

OBJECTIVE: Foot complications in patients with diabetes or peripheral artery disease (PAD) are serious events in the life of these patients that often lead to amputations and mortality. No evidence synthesis has been reported on the mortality rates after minor lower extremity amputation; thus, a quantitative evidence synthesis was needed. METHODS: A systematic literature search was performed to identify studies that had reported the survival or mortality rates after a minor LEA. The studies were required to include one or more of the following primary outcomes: mortality rate at 30 days, 1 year, 3 years, 5 years, 6 to 7 years, or 8 to 9 years. The secondary outcomes were the mortality rates according to the anatomic location of the amputation in the foot and the independent risk factors for mortality. RESULTS: A total of 28 studies with 17,325 subjects fulfilled the inclusion criteria. The meta-analytical results of the mortality rates were as follows: 3.5% at 1 month, 20% at 1 year, 28% at 3 years, 44.1% at 5 years, 51.3% at 6 to 7 years, and 58.5% at 8 to 9 years. From these studies of diabetic patients, age was the most consistent independent risk factor, followed by chronic kidney disease, PAD, and coronary artery disease. One study of patients with PAD had reported diabetes as an independent risk factor for mortality. The subgroup analysis of the four studies reporting the outcomes of patients with PAD showed greater 3- and 5-year mortality rates compared with the overall and "diabetic" results. CONCLUSIONS: Mortality after minor amputation for patients with diabetes and/or PAD was found to be very high. Compared with the reported cancer data, survival was worse than that for many cancers. Just as in the case of major amputations, minor amputations should be considered a pivotal event in the life of these patients.

Outcomes for Angioplasty and Bypass Lower Limb Revascularisation Procedures for Limb Salvage in England: Findings From the Getting It Right First Time Programme.

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.

Chelation therapy for atherosclerotic cardiovascular disease.

BACKGROUND: Chelation therapy is promoted and practiced around the world as a form of alternative medicine in the treatment of atherosclerotic cardiovascular disease. It has been suggested as a safe, relatively inexpensive, non-surgical method of restoring blood flow in atherosclerotic vessels. However, there is currently limited high-quality, adequately-powered research informing evidence-based medicine on the topic, specifically regarding clinical outcomes. Due to this limited evidence, the benefit of chelation therapy remains controversial at present. This is an update of a review first published in 2002. OBJECTIVES: To assess the effects of ethylene diamine tetra-acetic acid (EDTA) chelation therapy versus placebo or no treatment on clinical outcomes among people with atherosclerotic cardiovascular disease. SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 6 August 2019. We searched the bibliographies of the studies retrieved by the literature searches for further trials. SELECTION CRITERIA: We included studies if they were randomised controlled trials of EDTA chelation therapy versus placebo or no treatment in participants with atherosclerotic cardiovascular disease. The main outcome measures we considered include all-cause or cause-specific mortality, non-fatal cardiovascular events, direct or indirect measurement of disease severity, and subjective measures of improvement or adverse events. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed trial quality using standard Cochrane procedures. A third author considered any unresolved issues, and we discussed any discrepancies until a consensus was reached. We contacted study authors for additional information. MAIN RESULTS: We included five studies with a total of 1993 randomised participants. Three studies enrolled participants with peripheral vascular disease and two studies included participants with coronary artery disease, one of which specifically recruited people who had had a myocardial infarction. The number of participants in each study varied widely (from 10 to 1708 participants), but all studies compared EDTA chelation to a placebo. Risk of bias for the included studies was generally moderate to low, but one study had high risk of bias because the study investigators broke their randomisation code halfway through the study and rolled the placebo participants over to active treatment. Certainty of the evidence, as assessed by GRADE, was generally low to very low, which was mostly due to a paucity of data in each outcome's meta-analysis. This limited our ability to draw any strong conclusions. We also had concerns about one study's risk of bias regarding blinding and outcome assessment that may have biased the results. Two studies with coronary artery disease participants reported no evidence of a difference in all-cause mortality between chelation therapy and placebo (risk ratio (RR) 0.97, 95% CI 0.73 to 1.28; 1792 participants; low-certainty). One study with coronary artery disease participants reported no evidence of a difference in coronary heart disease deaths between chelation therapy and placebo (RR 1.02, 95% CI 0.70 to 1.48; 1708 participants; very low-certainty). Two studies with coronary artery disease participants reported no evidence of a difference in myocardial infarction (RR 0.81, 95% CI 0.57 to 1.14; 1792 participants; moderate-certainty), angina (RR 0.95, 95% CI 0.55 to 1.67; 1792 participants; very low-certainty), and coronary revascularisation (RR 0.46, 95% CI 0.07 to 3.25; 1792 participants). Two studies (one with coronary artery disease participants and one with peripheral vascular disease participants) reported no evidence of a difference in stroke (RR 0.88, 95% CI 0.40 to 1.92; 1867 participants; low-certainty). Ankle-brachial pressure index (ABPI; also known as ankle brachial index) was measured in three studies, all including participants with peripheral vascular disease; two studies found no evidence of a difference in the treatment groups after three months after treatment (mean difference (MD) 0.02, 95% CI -0.03 to 0.06; 181 participants; low-certainty). A third study reported an improvement in ABPI in the EDTA chelation group, but this study was at high risk of bias. Meta-analysis of maximum and pain-free walking distances three months after treatment included participants with peripheral vascular disease and showed no evidence of a difference between the treatment groups (MD -31.46, 95% CI -87.63 to 24.71; 165 participants; 2 studies; low-certainty). Quality of life outcomes were reported by two studies that included participants with coronary artery disease, but we were unable to pool the data due to different methods of reporting and varied criteria. However, there did not appear to be any major differences between the treatment groups. None of the included studies reported on vascular deaths. Overall, there was no evidence of major or minor adverse events associated with EDTA chelation treatment. AUTHORS' CONCLUSIONS: There is currently insufficient evidence to determine the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes of people with atherosclerotic cardiovascular disease. More high-quality, randomised controlled trials are needed that assess the effects of chelation therapy on longevity and quality of life among people with atherosclerotic cardiovascular disease.

Impact of cognitive impairment and systemic vascular comorbidities on risk of all-cause and cardiovascular mortality: National Health and Nutrition Examination Survey 1999 to 2002.

OBJECTIVES: To evaluate impacts of cognitive impairment and systemic vascular comorbidities on hazards of all-cause and cardiovascular mortality in a representative United States population. METHODS: Subjects aged ≥60 years from two waves of National Health and Nutrition Examination Survey were analyzed. Cognitive function was evaluated by Digit Symbol Substitution Test. Systemic vascular comorbidities included diabetes mellitus (DM), chronic kidney disease (CKD), high blood pressure (HBP) and hypotension. Hazards of all-cause and cardiovascular mortality were estimated with Cox proportional hazard regression models. RESULTS: After a median follow-up of 9.83 years, 937 (35.6%) and 247 (8.6%) deaths caused by all causes and cardiovascular diseases, respectively. After adjusting for confounders, cognitive impairment predicted a higher risk of all-cause mortality (Hazard Ratios (HR), 2.00; 95% confidence interval (CI), 1.62-2.46) and cardiovascular mortality (HR, 1.79; 95% CI, 1.27-2.53). Risk of all-cause mortality was further increased among those with cognitive impairment concomitant with DM (HR, 2.24; 95% CI, 1.61-3.13), CKD (HR, 2.56; 95% CI, 1.77-3.67), HBP (HR, 2.57; 95% CI, 1.73-3.84) or hypotension (HR, 2.38; 95% CI, 1.78-3.18). Co-presence of cognitive impairment with DM (HR, 2.30; 95% CI, 1.25-4.26), CKD (HR, 2.56; 95% CI, 1.35-4.88), HBP (HR, 4.65; 95% CI, 2.28-9.46) or hypotension (HR, 2.69; 95% CI, 1.67-4.31) also posed a significant higher risk of cardiovascular mortality than participants with neither condition. INTERPRETATION: Cognitive impairment concomitant with other systemic vascular comorbidities predicted further increased risks of mortality. More extensive assessments and management of cognitive function and systemic vascular comorbidities are warranted.

Effects of simultaneous pancreas-kidney transplantation and kidney transplantation alone on the outcome of peripheral vascular diseases.

BACKGROUND: The effects of Simultaneous Pancreas Kidney Transplantation (SPKT) on Peripheral Vascular Disease (PVD) warrants additional study and more target focus, since little is known about the mid- and long-term effects on the progression of PVD after transplantation. METHODS: 101 SPKT and 26 Kidney Transplantation Alone (KTA) recipients with insulin-dependent diabetes mellitus (IDDM) were retrospectively evaluated with regard to graft and metabolic outcome. Special subgroup analysis was directed towards the development and progression of peripheral vascular complications (PVC) (amputation, ischemic ulceration, lower extremity angioplasty/ bypass surgery) after transplantation. RESULTS: The 10-year patient survival was significantly higher in the SPKT group (SPKT: 82% versus KTA 40%; P < 0.001). KTA recipients had a higher prevalence of atherosclerotic risk factors, including coronary artery disease (P < 0.001), higher serum triglyceride levels (P = 0.049), higher systolic (P = 0.03) and diastolic (P = 0.02) blood pressure levels. The incidence of PVD before transplantation was comparable between both groups (P = 0.114). Risk factor adjusted multivariate analysis revealed that patients with SPKT had a significant lower amount (32%) of PVCs (32 PVCs in 21 out of 101 SPKT; P < 0.001) when compared to the KTA patients who developed a significant increase in PVCs to 69% of cases (18 PVCs in 11 out of 26 KTA; P < 0.001). In line mean values of HbA1c (P < 0.01) and serum triglycerides (P < 0.01) were significantly lower in patients with SPKT > 8 years after transplantation. CONCLUSION: SPKT favorably slows down development and progression of PVD by maintaining a superior metabolic vascular risk profile in patients with IDDM1.

Stenting for Inferior Vena Cava Stenosis After Liver Transplant.

OBJECTIVE. A case series analysis and meta-analysis were performed to assess the efficacy of stenting for inferior vena cava (IVC) stenosis after liver transplant; a secondary analysis assessed demographic factors as potential predictors of all-cause mortality. MATERIALS AND METHODS. Liver transplant recipients treated for symptomatic IVC stenosis at a major medical center from 1996 to 2017 were assessed. The main medical databases were searched for studies evaluating stenting in liver transplant recipients with IVC stenosis. Cox proportional hazards regression analysis was used to determine predictors of survival (age, sex, reason for transplant, stent size and number, publication year). Univariate and multivariable models were constructed. Because patients in the case series and meta-analysis had similar demographics and outcomes, the results were pooled. RESULTS. The case series included 40 patients (31 treated with stents; nine, without stents). Meta-analysis of 5277 records identified 17 eligible studies involving 73 patients. Stenting was effective in resolving the gradient in 100% of patients and in relieving symptoms in 85% of patients. Primary stent patency at latest follow-up (median, 556 days) was seen in 113 of 118 stents (96%; some patients had multiple stents). Reason for transplant was the only significant predictor of all-cause mortality; patients with hepatocellular carcinoma had a higher hazard of death than those undergoing transplant for other reasons (hazard ratio = 3.23; 95% CI, 1.40-7.42; p = 0.006). CONCLUSION. Stenting for IVC stenosis after liver transplant is clinically effective and durable, with 96% of stents showing long-term patency and 85% of patients experiencing symptom relief.

Mortalidad a largo plazo asociada al uso de dispositivos liberadores de paclitaxel en el tratamiento del paciente con enfermedad arterial periférica (informe de situación, junio de 2019) / Long term mortality signal associated to treatment with paclitaxel-eluting devices in peripheral arterial disease (status report, June 2019

Se resumen a continuación las principales reacciones y eventos de interés que se han venido produciendo en la comunidad vascular internacional desde el pasado mes de diciembre de 2018, cuando se publicó el metaanálisis de Konstantinos Katsanos, hasta junio de 2019. Este estudio, que ha sido severamente criticado, identifica la falta de fiabilidad de los resultados comunicados por la industria. A la luz de los datos hasta ahora expuestos, la SEACV hace una serie de recomendaciones basadas en la información disponible hasta ahora sobre los balones y stent farmacoactivos con paclitaxel que están en la misma línea que los organismos internacionales

This paper summarizes the main reactions and events of interest that have been occurring in the international vascular community since last December 2018, when the meta-analysis by Konstantinos Katsanos was published. This study, which has been severely criticized, identifies the unreliability of the results reported by the industry. In light of the data presented so far, the SEACV makes a series of recommendations about the paclitaxel-eluting balloons and stents based on the information available until now which are in line with international organizations

Bleeding Complications in Lower-Extremity Peripheral Vascular Interventions: Insights From the NCDR PVI Registry.

OBJECTIVES: This study sought to assess periprocedural bleeding complications in lower-extremity peripheral vascular interventions (PVIs). BACKGROUND: Few studies have examined the incidence, predictors, or outcomes of periprocedural bleeding after lower-extremity PVI. METHODS: The study examined patients undergoing PVI at 76 hospitals in the National Cardiovascular Data Registry PVI registry from 2014 to 2016. Post-PVI major bleeding was defined as any overt bleeding with a hemoglobin (Hb) drop of ≥3 g/dl, any Hb decline of ≥4 g/dl, or blood transfusion in patients with pre-procedure Hb >8 g/dl within 72 h of their procedure. Hierarchical multivariable logistic regression was used to identify factors independently associated with post-PVI bleeding. The study also examined adjusted in-hospital mortality among patients with or without major bleeding complications. RESULTS: Among 18,289 PVI procedures, major bleeding occurred in 744 (4.10%). Patient characteristics independently associated with bleeding included age, female sex, heart failure, pre-procedural hemoglobin <12 g/dl, nonelective PVI, and critical limb ischemia on presentation. Procedural characteristics associated with bleeding included nonfemoral vascular access, use of thrombolytic therapy, PVI of the aortoiliac segment, and multilesion interventions, whereas use of closure devices was associated with less bleeding. All-cause in-hospital mortality was higher in patients who experienced bleeding than in those who did not (6.60% vs. 0.30%; p < 0.001; adjusted hazard ratio: 10.9; 95% confidence interval: 6.9 to 17.0). CONCLUSIONS: Major bleeding occurred in 4.10% of lower-extremity PVI procedures and was associated with several patient and procedural characteristics, as well as in-hospital mortality. These insights can be incorporated into strategies to reduce periprocedural bleeding after PVI.

Racial differences and mortality risk in patients with heart failure and hyponatremia.

BACKGROUND: Hyponatremia is a well-established poor prognostic marker in patients with heart failure. Whether the mortality risk is comparable among different races of patients with heart failure and hyponatremia is unknown. MATERIALS AND METHODS: Consecutive patients admitted with acute decompensated heart failure and an admission sodium level<135 mEq/L from 1/1/2001 through 12/31/10 were identified. Patients were divided into four groups based on self-reported race: white, African American, Hispanic and other. African Americans were used as the reference group for statistical analysis. The primary outcome was all-cause mortality. RESULTS: We included 4,343 patients, from which 1,356 (31%) identified as white, 1,248 (29%) as African American, 780 (18%) as Hispanic and 959 (22%) as other. During a median follow-up of 23 months, a total of 2,384 patients died: 678 were African American, 820 were white, 298 were Hispanic and 588 were other. After adjusting for baseline demographics, comorbidities and medication use, Hispanic patients had a 45% less risk of death as compared to African Americans (HR .55, CI .48-.64, p<0.05). There was no difference in mortality between white and African American patients (HR 1.04, CI .92-1.2, p = 0.79). CONCLUSION: Hispanic patients admitted for heart failure and who were hyponatremic on admission had an independent lower risk of mortality compared to other groups. These findings may be due to the disparate activity of the renin-angiotensin-aldosterone system among various racial groups. This observational study is hypothesis generating and suggests that treatment of patients with heart failure and hyponatremia should perhaps be focused more on renin-angiotensin-aldosterone system reduction in certain racial groups, yet less in others.

A systematic review and meta-analysis of bivalirudin application in peripheral endovascular procedures.

OBJECTIVE: The direct thrombin inhibitor bivalirudin (BIV) was shown to be superior to unfractionated heparin (UFH) in percutaneous coronary interventions for reducing procedural blood loss. The aim of this study was to compare outcome profiles of BIV and UFH in peripheral endovascular procedures (PEPs) by synthesizing the currently available data. METHODS: Following the PRISMA statement, we conducted a comprehensive literature search using Medline, Cochrane CENTRAL, PubMed, EMBASE, CINAHL Google scholar, and clinicaltrials.gov. We recruited randomized, controlled trials and well-conducted observational studies that compared UFH and BIV in PEPs requiring anticoagulation, excluding endovascular cardiac procedures and coronary interventions. Random-effects meta-analyses were conducted to compare the outcome profiles of these two agents. RESULTS: Thirteen articles containing 14 studies involving a total of 21,057 patients were enrolled. Of these, 2 were randomized controlled trials, 2 were prospective cohort studies, and 10 were retrospective studies. There were no significant differences between BIV and UFH in terms of procedural success rates, major and minor perioperative bleeding, transfusion, perioperative transient ischemic attack, or hemorrhagic strokes. However, compared with UFH, BIV had significantly lower odds ratios (OR) of perioperative mortality (OR, 0.58; 95% confidence interval [CI], 0.40-0.86), major adverse cardiovascular events (OR, 0.65; 95% CI, 0.51-0.83), net adverse clinical events (OR, 0.75; 95% CI, 0.63-0.88), perioperative myocardial infarction (OR, 0.73; 95% CI, 0.55-0.98), major vascular complications (OR, 0.59; 95% CI, 0.39-0.91), and minor vascular complications (OR, 0.58; 95% CI, 0.40-0.84). CONCLUSIONS: Compared with UFH, PEPs using BIV had comparable procedural success rates and odds of perioperative transient ischemic attack and hemorrhagic stroke. However, procedures with BIV had a lower but nonsignificant odds of perioperative bleeding and transfusion. Depending on the procedures conducted, the patients who received BIV will have reduced or comparable odds of perioperative mortality, myocardial infarction, major adverse cardiovascular events, net adverse clinical events, and major and minor vascular complications. Therefore, BIV may be chosen solely as an alternative procedural anticoagulant to UFH for PEPs.

Outcomes in patients with peripheral vascular disease following percutaneous coronary intervention.

OBJECTIVES: To evaluate the clinical characteristics and outcomes of patients with peripheral vascular disease (PVD) undergoing percutaneous coronary intervention (PCI) in a contemporary setting, and to determine whether use of drug-eluting stents (DESs) improves outcomes. BACKGROUND: PVD was an independent risk factor for adverse outcomes following PCI in the bare-metal stent (BMS) era. It is not known whether outcomes in these patients have improved with advances in interventional techniques and stent technology, as they have for the general population. METHODS: Eighteen thousand three hundred and eighty patients undergoing PCI from an Australian registry between 2005 and 2013 were studied. Clinical and procedural data, 30-day and 12-month outcomes were compared in those with and without a reported history of PVD. Outcomes were also compared between patients with PVD who received DES and those who received BMS. Long-term mortality was compared using Australian National Death Index (NDI) linkage. RESULTS: Patients with PVD (n = 1,251, 6.8%) were older and had more prevalent diabetes, hypertension, cerebrovascular disease, heart failure, renal impairment, ostial lesions, left main, and multi-vessel disease (p < 0.001). Patients with PVD had significantly higher rates of major adverse cardiovascular events (MACEs) compared with those without PVD, in-hospital (5.7% vs. 4.1%, p < 0.008), at 30-days (8.6% vs. 5.8%, p < 0.001) and at 12-months (24.6% vs. 13.2%, p < 0.001). At 4.9 ± 2.6 years follow-up, there was significantly greater mortality in the PVD group. PVD patients who received DES experienced significantly less MACE than PVD patients treated with BMS at 30-days (4.8 vs. 10.1%, p < 0.001) and 12-months (19.4 vs. 26.4%, p < 0.005). CONCLUSIONS: PVD is an independent predictor of adverse outcomes in patients undergoing PCI. PVD patient who received DES had improved outcomes compared with those receiving BMS.

Analysis of patient factors associated with 30-day mortality after tracheostomy.

OBJECTIVE: Mortality has been reported to be 22% to 45% in patients with a tracheostomy. To better counsel patients and families, we aimed to determine the effect of body mass index (BMI), socioeconomic status (SES), and the 17 conditions of the Charlson comorbidity index (CCI) on 30-day survival posttracheostomy. METHODS: This retrospective cohort study identified adult patients enrolled from our institution in the Global Tracheostomy Collaborative database from March 2014 to June 2015. Data collected included age, BMI, residential zip code, and comorbidities. Cox proportionate univariate and multivariate analyses were used to measure the impact of BMI, SES, and CCI variables with 30-day posttracheostomy survival. We used geocoding as a surrogate for patients' SES. We used Deyo's modification of the CCI, which utilized International Classification of Diseases, 9th Revision, codes to identify comorbidities. RESULTS: Of 326 tracheostomies identified, the 30-day mortality rate was 15.6%. No significant differences were noted in BMI or in any of the SES categories between survivors and nonsurvivors. CCI was significantly higher in the 30-day mortality group. Congestive heart failure (hazard ratio [HR] = 2.39), severe liver disease (HR = 3.15), and peripheral vascular disease (HR = 2.62) were found to significantly impact 30-day survival. CONCLUSION: Higher CCI and specifically severe liver disease, congestive heart failure, and peripheral vascular disease were associated with increased 30-day mortality posttracheostomy. No association was found between BMI or SES and 30-day survival. This study identified three comorbidities that independently affect mortality in tracheostomy patients, which should be discussed with patients and families before tracheostomy. LEVEL OF EVIDENCE: 3 Laryngoscope, 129:847-851, 2019.

Initiating haemodialysis twice-weekly as part of an incremental programme may protect residual kidney function.

BACKGROUND: Initiating twice-weekly haemodialysis (2×HD) in patients who retain significant residual kidney function (RKF) may have benefits. We aimed to determine differences between patients initiated on twice- and thrice-weekly regimes, with respect to loss of kidney function, survival and other safety parameters. METHODS: We conducted a single-centre retrospective study of patients initiating dialysis with a residual urea clearance (KRU) of ≥3 mL/min, over a 20-year period. Patients who had 2×HD for ≥3 months during the 12 months following initiation of 2×HD were identified for comparison with those dialysed thrice-weekly (3×HD). RESULTS: The 2×HD group consisted of 154 patients, and the 3×HD group 411 patients. The 2×HD patients were younger (59 ± 15 versus 62 ± 15 years: P = 0.014) and weighed less (70 ± 16 versus 80 ± 18 kg: P < 0.001). More were females (34% versus 27%: P = 0.004). Fewer had diabetes (25% versus 34%: P = 0.04) and peripheral vascular disease (PVD) (13% versus 23%: P = 0.008). Baseline KRU was similar in both groups (5.3 ± 2.4 for 2 × HD versus 5.1 ± 2.8 mL/min for 3 × HD: P = 0.507). In a mixed effects model correcting for between-group differences in comorbidities and demographics, 3×HD was associated with increased rate of loss of KRU and separation of KRU. In separate mixed effects models, group (2×HD versus 3×HD) was not associated with differences in serum potassium or phosphate, and the groups did not differ with respect to total standard Kt/V. Survival, adjusted for age, gender, weight, baseline KRU and comorbidity (prevalence of diabetes, cardiac disease, PVD and malignancy) was greater in the 2×HD group (hazard ratio 0.755: P = 0.044). In sub-analyses, the survival benefit was confined to women, and those of less than median bodyweight. CONCLUSION: 2×HD initiation as part of an incremental programme with regular monthly monitoring of KRU was safe and associated with a reduced rate of loss of RKF early after dialysis initiation and improved survival. Randomized controlled trials of this approach are indicated.

A systematic review of isolated radial artery harvesting as a conduit for lower limb bypass grafting.

BACKGROUND: Whilst autologous vein conduits have been heralded as the first-line approach for patients undergoing lower limb bypass grafting procedures, patients with peripheral arterial occlusive disease may have exhausted venous options given prior use for cardiac surgery, varicose vein surgery, or lower limb revascularization. Hence, the use of a radial artery graft may serve as a viable alternative. METHODS: The systematic review was performed in accordance to the Preferred Reporting Items for Systematic Review and Meta-analysis guidelines. An electronic search was performed on the following databases: Medline (via PubMed); EMBASE; Cochrane library to search for relevant publications. A narrative analysis was conducted. RESULTS: Four publications were included in this review including two retrospective cohort studies, one case series, and one case report, with a total of 43 patients. The most common indication for lower limb bypass grafting was critical limb ischemia, and the radial artery was chosen as graft conduit, most commonly due to the absence of suitable arm or leg vein. There was one case of 30-day mortality and 11 reinterventions. CONCLUSION: Despite the encouraging results, the paucity of high-quality studies prevents the establishment of any firm conclusion. This warrants the need for appropriately conducted randomized controlled trials to compare the radial artery graft to autologous vein grafts and prosthetic grafts for lower limb bypass grafting.