The Effect of Clinical Care Location on Clinical Outcomes After Peripheral Vascular Intervention in Medicare Beneficiaries.

OBJECTIVES: Modifications in reimbursement rates by Medicare in 2008 have led to peripheral vascular interventions (PVI) being performed more commonly in outpatient and office-based clinics. The objective of this study was to determine the effects of this shift in clinical care setting on clinical outcomes after PVI. BACKGROUND: Modifications in reimbursement have led to peripheral vascular intervention (PVI) being more commonly performed in outpatient hospital settings and office-based clinics. METHODS: Using a 100% national sample of Medicare beneficiaries from 2010 to 2012, we examined 30-day and 1-year rates of all-cause mortality, major lower extremity amputation, repeat revascularization, and all-cause hospitalization by clinical care location of index PVI. RESULTS: A total of 218,858 Medicare beneficiaries underwent an index PVI between 2010 and 2012. Index PVIs performed in inpatient settings were associated with higher 1-year rates of all-cause mortality (23.6% vs. 10.4% and 11.7%; p < 0.001), major lower extremity amputation (10.1% vs. 3.7% and 3.5%; p < 0.001), and all-cause repeat hospitalization (63.3% vs. 48.5% and 48.0%; p < 0.001), but lower rates of repeat revascularization (25.1% vs. 26.9% vs. 38.6%; p < 0.001) when compared with outpatient hospital settings and office-based clinics, respectively. After adjustment for potential confounders, patients treated in office-based clinics remained more likely than patients in inpatient hospital settings to require repeat revascularization within 1 year across all specialties. There was also a statistically significant interaction effect between location of index revascularization and geographic region on the occurrence of all-cause hospitalization, repeat revascularization, and lower extremity amputation. CONCLUSIONS: Index PVI performed in office-based settings was associated with a higher hazard of repeat revascularization when compared with other settings. Differences in clinical outcomes across treatment settings and geographic regions suggest that inconsistent application of PVI may exist and highlights the need for studies to determine optimal delivery of PVI in clinical practice.

Cost-Effectiveness Analysis of the Use of a Prophylactic Antibiotic for Patients Undergoing Lower Limb Amputation due to Diabetes or Vascular Illness in Colombia.

BACKGROUND: The use of a prophylactic antibiotic in an amputation surgery is a key element for the successful recovery of the patient. We aim to determine, from the perspective of the Colombian health system, the cost-effectiveness of administering a prophylactic antibiotic among patients undergoing lower limb amputation due to diabetes or vascular illness in Colombia. METHODS: A decision tree was constructed to compare the use and nonuse of a prophylactic antibiotic. The probabilities of transition were obtained from studies identified from a systematic review of the clinical literature. The chosen health outcome was reduction in mortality due to prevention of infection. The costs were measured by expert consensus using the standard case methodology, and the resource valuation was carried out using national-level pricing manuals. Deterministic sensitivity, scenarios, and probabilistic analyses were conducted. RESULTS: In the base case, the use of a prophylactic antibiotic compared with nonuse was a dominant strategy. This result was consistent when considering different types of medications and when modifying most of the variables in the model. The use of a prophylactic antibiotic ceases to be dominant when the probability of infection is greater than 48%. CONCLUSIONS: The administration of a prophylactic antibiotic was a dominant strategy, which is a conclusion that holds in most cases examined; therefore, it is unlikely that the uncertainty around the estimation of costs and benefits change the results. We recommend creating policies oriented toward promoting the use of a prophylactic antibiotic during amputation surgery in Colombia.

Rates and Outcomes of Parathyroidectomy for Secondary Hyperparathyroidism in the United States.

BACKGROUND AND OBJECTIVES: Secondary hyperparathyroidism is common among patients with ESRD. Although medical therapy for secondary hyperparathyroidism has changed dramatically over the last decade, rates of parathyroidectomy for secondary hyperparathyroidism across the United States population are unknown. We examined temporal trends in rates of parathyroidectomy, in-hospital mortality, length of hospital stay, and costs of hospitalization. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Using the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample, a representative national database on hospital stay regardless of age and payer in the United States, we identified parathyroidectomies for secondary hyperparathyroidism from 2002 to 2011. Data from the US Renal Data System reports were used to calculate the rate of parathyroidectomy. RESULTS: We identified 32,971 parathyroidectomies for secondary hyperparathyroidism between 2002 and 2011. The overall rate of parathyroidectomy was approximately 5.4/1000 patients (95% confidence interval [95% CI], 5.0/1000 to 6.0/1000). The rate decreased from 2003 (7.9/1000 patients; 95% CI, 6.2/1000 to 9.6/1000), reached a nadir in 2005 (3.3/1000 patients; 95% CI, 2.6/1000 to 4.0/1000), increased again through 2006 (5.4/1000 patients; 95% CI, 4.4/1000 to 6.4/1000), and remained stable since that time. Rates of in-hospital mortality decreased from 1.7% (95% CI, 0.8% to 2.6%) in 2002 to 0.8% (95% CI, 0.1% to 1.6%) in 2011 (P for trend <0.001). In-hospital mortality rates were significantly higher in patients with heart failure (odds ratio [OR], 4.23; 95% CI, 2.59 to 6.91) and peripheral vascular disease (OR, 4.59; 95% CI, 2.75 to 7.65) and lower among patients with prior kidney transplantation (OR, 0.20; 95% CI, 0.06 to 0.65). CONCLUSIONS: Despite the use of multiple medical therapies, rates of parathyroidectomy of secondary hyperparathyroidism have not declined in recent years.

Volume-outcome relationship for peripheral endovascular interventions: a review of existing literature.

The incidence and prevalence of peripheral vascular disease has been increasing. When coexistent with coronary artery disease (CAD), it has shown to predict higher mortality along with poorer quality-of-life consequently leading to a marked increase in healthcare costs. Broadly, there has been an increase in utilization of endovascular techniques in the management of peripheral vascular diseases. An inverse relation between volume and outcomes has been noted in these procedures. Additionally, improved resource utilization has also been noted with higher hospital and operator volumes. This has led to proposals to regionalize these procedures to high volume hospitals. There have also been calls to introduce the idea of having a set threshold of procedures for providers. This review presents an overview of published literature on the volume-outcome relationship affecting the outcomes of peripheral endovascular procedures.

Intravascular Ultrasound in Lower Extremity Peripheral Vascular Interventions: Variation in Utilization and Impact on In-Hospital Outcomes From the Nationwide Inpatient Sample (2006-2011).

PURPOSE: To examine the impact of intravascular ultrasound (IVUS) utilization during lower limb endovascular interventions as regards postprocedural complications and amputation. METHODS: The study cohort was derived from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample database between the years 2006 and 2011. Peripheral endovascular interventions were identified using appropriate ICD-9 procedure codes. Two-level hierarchical multivariate mixed models were created. The co-primary outcomes were in-hospital mortality and amputation; the secondary outcome was postprocedural complications. Model results are given as the odds ratio (OR) and 95% confidence interval (CI). Hospitalization costs were also assessed. RESULTS: Overall, among the 92,714 patients extracted from the database during the observation period, IVUS was used in 1299 (1.4%) patients. IVUS utilization during lower extremity peripheral vascular procedures was independently predictive of a lower rate of postprocedural complications (OR 0.80, 95% CI 0.66 to 0.99, p=0.037) as well as lower amputation rates (OR 0.59, 95% CI 0.45 to 0.77, p<0.001) without any significant impact on in-hospital mortality. Multivariate analysis also revealed IVUS utilization to be predictive of a nonsignificant increase in hospitalization costs ($1333, 95% CI -$167 to +$2833, p=0.082). CONCLUSION: IVUS use during lower limb endovascular interventions is predictive of lower postprocedural complication and amputation rates with a nonsignificant increase in hospitalization costs.

Effect of physical activity assessment on prognostication for peripheral artery disease and mortality.

OBJECTIVE: To examine whether a simple question about the performance of regular vigorous activity is associated with peripheral artery disease (PAD) and mortality. METHODS: A total of 1288 individuals undergoing nonemergency coronary angiography were assessed for participation in regular vigorous activity by questionnaire. Data on demographic characteristics, ankle-brachial indexes, and cardiovascular outcomes were prospectively collected. RESULTS: Compared with those who denied participation in regular vigorous activity, those who reported participation were less likely to have PAD (odds ratio, 0.58; 95% CI, 0.39-0.86), had higher ankle-brachial indexes, had better Walking Impairment Questionnaire scores (P<.001), and experienced reduced all-cause mortality rates (hazard ratio, 0.48; 95% CI, 0.31-0.74). When added to the Framingham Risk Score, the response improved the net reclassification index for all-cause (32.6%) and cardiovascular (32.0%) mortality. CONCLUSION: Among at-risk individuals, regular vigorous activity is associated with decreased PAD and all-cause mortality. Simple and readily available, a single yes/no query about participation in regular vigorous exercise could be used to improve risk stratification.

A practical index to predict 30-day mortality after major amputation.

BACKGROUND: Patients at risk of mortality after amputation have not been well identified. We sought to devise a clinical index predicting 30-day mortality after amputation that would allow stratification of intensity of postoperative care. METHODS: The National Surgical Quality Improvement Program (NSQIP) database (2005-2009) was analyzed for patients who had above- or below-knee amputations. An additive risk index was created based on logistic regression that examined patient demographics, comorbidities, and operative characteristics. A threshold score for clinical action was identified as the score at which the gain in certainty was maximized. The primary outcome measure was 30-day mortality. RESULTS: Among 9244 patients analyzed, there were 744 deaths (8.1%) at 30 days, with 280 occurring after hospital discharge (37.9%). The final index includes 11 components with a total score range of 0-13: age (60-79 or ≥80 years), history of congestive heart failure, chronic obstructive pulmonary disease, or major cardiac surgery, using steroid medications, having dependent functional status, dyspnea, being on dialysis, having impaired sensorium, or preoperative sepsis. This index has a c-statistic of 0.7391, and the score at which clinical action should be taken is ≥5. The observed probability of 30-day mortality increased from 1.06% at a score of 1 to 10% at 5 and 38.5% at a score of 10. CONCLUSIONS: More than one-third of deaths within 30 days of major amputation occur after discharge from acute care. A novel index to predict 30-day mortality after major amputation is described. Patients receiving a score ≥5 face a substantial risk of mortality and should be held in the hospital longer or, if discharged, receive closer postoperative follow-up.

Lower-extremity endovascular interventions for Medicare beneficiaries: comparative effectiveness as a function of provider specialty.

PURPOSE: Lower-extremity endovascular interventions are increasingly being performed by vascular surgeons (VSs) and interventional cardiologists (ICs) in addition to interventional radiologists (IRs). Regardless of specialty, well trained, experienced, and dedicated operators are expected to offer the best outcomes. To examine specialty-specific trends, outcomes of percutaneous lower-extremity revascularizations in Medicare beneficiaries were compared according to physician specialty types providing the service. MATERIALS AND METHODS: Medicare Standard Analytical Files that contain longitudinal data of all services (physician, inpatient, outpatient) provided to a 5% sample of Medicare beneficiaries were studied. All claims for percutaneous angioplasty, atherectomy, and stent implantation of lower-extremity arteries during the years 2005­2007 were extracted, and the following outcomes were assessed: mortality, transfusion, intensive care unit (ICU) use, length of stay, and subsequent revascularization or amputation. Outcomes were compared by using regression models adjusted for age, sex, race, emergency department admission, and comorbid conditions. RESULTS: Most outcomes were significantly worse if the service was provided by vascular surgeons compared with other vascular specialists. The in-hospital mortality rate for procedures performed by VSs was 19% higher than for those performed by others, but this difference was not significant (P =.351). Adjusted average 1-year procedure costs were significantly lower for IRs ($17,640) than for VSs ($19,012) or ICs ($19,096). CONCLUSIONS: Medicare data show that endovascular lower-extremity revascularization by vascular surgeons results in more transfusion and ICU use, longer hospital stay, more repeat revascularization procedures or amputations, and higher costs compared with procedures performed by interventional radiologists.

Socioeconomic position is not associated with 30-day or 1-year mortality in demographically diverse vascular surgery patients.

OBJECTIVES: Disparities in outcomes after surgical procedures have been attributed to race, sex, use of private insurance, and socioeconomic position (SEP). The purpose of this study was to determine the impact of SEP on mortality after lower-extremity bypass (LEB) surgery in a diverse patient population with extremes of SEP. DESIGN: Analysis of an electronic medical database. SETTING: A tertiary care hospital in a demographically diverse section of a large metropolitan area. PARTICIPANTS: Six hundred nine (158 white men, 156 nonwhite men, 100 white women, and 195 non-white women) patients undergoing infrarenal lower-extremity arterial bypass surgery from July 1, 2002, to December 31, 2007. MEASUREMENTS AND RESULTS: SEP was estimated using data from the 2000 US Census. The effects of race, sex, various comorbidities, the Revised Cardiac Risk Index, American Society of Anesthesiologists physical status, use of private insurance, indication for bypass surgery, and SEP on all-cause mortality was analyzed. SEP differed significantly among the 4 race-sex groups, with white men having the highest position (mean = 2.38) and non-white men having the lowest position (mean = -3.02). There was no statistically significant association in 30-day mortality among race-sex groups or with SEP. One-year mortality differed significantly between men and women for the entire cohort (13.7% and 24.1%, respectively; p < 0.01) but not among race groups or SEP. CONCLUSIONS: Disparities in SEP are not associated with short- or long-term mortality after LEB surgery. Other comorbid risk factors are more important when determining outcomes and should be the focus of interventions to improve outcomes.

An assessment of the concentration-related prognostic value of cardiac troponin I following acute coronary syndrome.

In 2004 the British Cardiac Society redefined myocardial infarction by cardiac troponin I (cTnI) concentration: ≤ 0.06 µg/L (unstable angina), >0.06 to < 0.5 µg/L (myocardial necrosis), and ≥ 0.5 µg/L (myocardial infarction). We investigated the effects of this classification on all-cause mortality in 1,285 patients from the Evaluation of the Methods and Management of Acute Coronary Events (EMMACE)-2 registry. There were 528 deaths (6.6-year all-cause mortality 41.1%). Survival was greatest in the cTnI ≤ 0.06-µg/L subgroup at 30 days (p = 0.005), 6 months (p = 0.015), 1 year (p = 0.002), and 6.6 years (p = 0.045). After adjustment there was no significant difference in survival between the cTnI >0.06- to < 0.5-µg/L and ≥ 0.5-µg/L subgroups. Increased mortality (hazard ratio, 95% confidence interval) was associated with ages 70 to 80 years (2.58, 1.17 to 3.91) and >80 years (3.30, 3.50 to 5.06), peripheral vascular disease (1.50, 1.16 to 1.94), heart failure (1.36, 1.05 to 1.83), diabetes mellitus (1.68, 1.36 to 2.07), severe left ventricular systolic dysfunction (1.50, 1.00 to 2.21), and creatinine per 10 µmol/L (1.65, 1.02 to 1.08), whereas ages 50 to 60 years (0.55, 0.32 to 0.96), ß blockers (0.53, 0.44 to 0.64), aspirin (0.80 0.65 to 0.99), angiotensin-converting enzyme inhibitors (0.67, 0.56 to 0.80), statins (0.73, 0.59 to 0.90), and revascularization (0.33, 0.12 to 0.92) were associated with a lower risk of death. In conclusion, although quantitative evaluation of cTnI concentration in patients with acute coronary syndrome with cTnI > 0.06 µg/L was associated with no added prognostic information, the dichotomization of patients by cTnI status ("positive" and "negative") facilitates acute coronary syndrome risk stratification.

Evaluating preventable adverse safety events after elective lower extremity procedures.

BACKGROUND: Improving patient safety has become a national priority. Patient safety indicators (PSIs) are validated tools to identify potentially preventable adverse events. No studies currently exist for evaluating lower extremity (LE) vascular procedures and the occurrence of PSIs. METHODS: The Nationwide Inpatient Sample (2003-2007) was queried for elective LE angioplasty (endo) and bypass (open). PSIs appropriate to surgery were analyzed by χ(2) and logistic regression analyses. RESULTS: A total of 226,501 LE interventions (104,491 endo; 122,010 open) were evaluated. The rate of developing any PSI was 7.74% (open) and 8.51% (endo), P < .0001. In the latter group, PSI9 (postoperative hemorrhage or hematoma) with the rate 4.74% was a predominant indicator that was associated with an almost three times greater likelihood of death in this group. PSI predictors included advanced age (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.55-1.75 for oldest vs youngest patients), females (OR, 1.18; 95% CI, 1.13-1.22), blacks (OR, 1.10; 95% CI, 1.04-1.17), congestive heart failure (OR, 1.83; 95% CI, 1.72-1.96), diabetes mellitus (OR, 1.20; 95% CI, 1.12-1.28), renal failure (OR, 2.31; 95% CI, 2.14-2.50), hospital teaching status (OR, 1.21; 95% CI, 1.17-1.26), and larger hospitals (OR, 1.11; 95% CI, 1.05-1.17). PSI occurrence was associated with increased cost ($28,387 vs $13,278; P < .0001). CONCLUSIONS: Endovascular procedures were found to have lower mortality rates overall, but were found to have a greater number of safety events occur primarily due to bleeding complications in women and the elderly. PSIs were associated with advanced age, black race, and comorbidities. Adverse events added significant cost, occurred more frequently in teaching and large hospitals, and future organizational analysis may improve safety and reduce cost.

Sequential compression biomechanical device in patients with critical limb ischemia and nonreconstructible peripheral vascular disease.

OBJECTIVES: Critical limb ischemia (CLI) patients who are unsuitable for intervention face the dire prospect of primary amputation. Sequential compression biomechanical device (SCBD) therapy provides a limb salvage option for these patients. This study assessed the outcome of SCBD in severe CLI patients who otherwise would face an amputation. Primary end points were limb salvage and 30-day mortality. Secondary end points were hemodynamic outcomes (increase in popliteal artery flow and toe pressure), ulcer healing, quality-adjusted time without symptoms of disease or toxicity of treatment (Q-TwiST), and cost-effectiveness. METHODS: From 2004 to 2009, we assessed 4538 patients with peripheral vascular disease (PVD). Of these, 707 had CLI, 518 underwent intervention, and 189 were not suitable for any intervention. A total of 171 patients joined the SCBD program for 3 months. RESULTS: All patients were Rutherford category ≥4. Median follow-up was 13 months. Mean toe pressure increased from 39.9 to 55.42 mm Hg, with a mean difference in toe pressure of 15.49 mm Hg (P = .0001). Mean popliteal flow increased from 35.44 to 55.91 cm/s, with mean difference in popliteal flow of 20.47 cm/s (P < .0001). Mortality at 30 days was 0.6%. Median amputation-free survival was 18 months. Limb salvage at 3.5 years was 94%. Freedom from major adverse clinical events (MACE) at 4.5 years was 62.5%. We treated 171 patients with SCBD at a cost of €681,948, with an estimated median per-patient cost of treatment with SCBD of €3988. CONCLUSION: SCBD therapy is a cost-effective and clinically efficacious solution in CLI patients with no option of revascularization. It provides adequate limb salvage and ameliorated amputation-free survival while providing relief of rest pain without any intervention.

Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis.

BACKGROUND: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that survival in patients with severe lower limb ischemia (rest pain, tissue loss) who survived postintervention for >2 years after initial randomization to bypass surgery (BSX) vs balloon angioplasty (BAP) was associated with an improvement in subsequent amputation-free and overall survival of about 6 and 7 months, respectively. We now compare the effect on hospital costs and health-related quality of life (HRQOL) of the BSX-first and BAP-first revascularization strategies using a within-trial cost-effectiveness analysis. METHODS: We measured HRQOL using the Vascular Quality of Life Questionnaire (VascuQol), the Short Form 36 (SF-36), and the EuroQol (EQ-5D) health outcome measure up to 3 years from randomization. Hospital use was measured and valued using United Kingdom National Health Service hospital costs over 3 years. Analysis was by intention-to-treat. Incremental cost-effectiveness ratios were estimated for cost per quality-adjusted life-year (QALY) gained. Uncertainty was assessed using nonparametric bootstrapping of incremental costs and incremental effects. RESULTS: No significant differences in HRQOL emerged when the two treatment strategies were compared. During the first year from randomization, the mean cost of inpatient hospital treatment in patients allocated to BSX ($34,378) was estimated to be about $8469 (95% confidence interval, $2,417-$14,522) greater than that of patients allocated to BAP ($25,909). Owing to increased costs subsequently incurred by the BAP patients, this difference decreased at the end of follow-up to $5521 ($45,322 for BSX vs $39,801 for BAP) and was no longer significant. The incremental cost-effectiveness ratio of a BSX-first strategy was $184,492 per QALY gained. The probability that BSX was more cost-effective than BAP was relatively low given the similar distributions in HRQOL, survival, and hospital costs. CONCLUSIONS: Adopting a BSX-first strategy for patients with severe limb ischemia does result in a modest increase in hospital costs, with a small positive but insignificant gain in disease-specific and generic HRQOL. However, the real-world choice between BSX-first and BAP-first revascularization strategies for severe limb ischemia due to infrainguinal disease cannot depend on costs alone and will require a more comprehensive consideration of individual patient preferences conditioned by expectations of survival and other health outcomes.

The Viborg Vascular (VIVA) screening trial of 65-74 year old men in the central region of Denmark: study protocol.

BACKGROUND: Screening for abdominal aortic aneurysm (AAA) of men aged 65-74 years reduces the AAA-related mortality and is generally considered cost effective. Despite of this only a few national health care services have implemented permanent programs. Around 10% of men in this group have peripheral arterial disease (PAD) defined by an ankle brachial systolic blood pressure index (ABI) below 0.9 resulting in an increased mortality-rate of 25-30%. In addition well-documented health benefits may be achieved through primary prophylaxis by initiating systematic cholesterol-lowering, smoking cessation, low-dose acetylsalicylic acid (aspirins), exercise, a healthy diet and blood-pressure control altogether reducing the increased risks for cardiovascular disease by at least 20-25%. The benefits of combining screening for AAA and PAD seem evident; yet they remain to be established. The objective of this study is to assess the efficacy and the cost-effectiveness of a combined screening program for AAA, PAD and hypertension. METHODS: The Viborg Vascular (VIVA) screening trial is a randomized, clinically controlled study designed to evaluate the benefits of vascular screening and modern vascular prophylaxis in a population of 50,000 men aged 65-74 years. Enrolment started October 2008 and is expected to stop in October 2010. The primary outcome is all-cause mortality. The secondary outcomes are cardiovascular mortality, AAA-related mortality, hospital services related to cardiovascular conditions, prevalence of AAA, PAD and potentially undiagnosed hypertension, health-related quality of life and cost effectiveness. Data analysis by intention to treat. RESULTS: Major follow-up will be performed at 3, 5 and 10 years and final study result after 15 years. TRIAL REGISTRATION: ClinicalTrials.gov NCT00662480.

Preoperative functional status predicts perioperative outcomes after infrainguinal bypass surgery.

OBJECTIVE: Infrainguinal surgical bypass (BPG) is a durable method for lower extremity revascularization, but is accompanied by significant 30-day morbidity and mortality (MM). The goal of this study is to relate preoperative functional status, a defined metric in the National Surgical Quality Improvement Program (NSQIP) database, to perioperative MM. METHODS: Between January 1, 2005 and December 31, 2007, all patients who underwent BPG from the NSQIP private sector database were reviewed. The primary end-point was 30-day MM. Patients were stratified by preoperative functional status: independent (IND) vs dependent (DEP). Associated patient demographic/clinical data were analyzed using univariate and multivariate methods. Composite odds ratios were constructed with clusters of high-risk comorbidities. RESULTS: There were 5639 BPG patients (4600 [81.6%] IND and 1039 [18.4%]) DEP. DEP patients were significantly older (71.6 +/- 11.8 vs 66.8 +/- 11.8 years; P < .0001), had more chronic obstructive pulmonary disease (COPD) (16.7% vs 11.4%; P < .0001), diabetes (54.2% vs 40.7%; P < .0001), dialysis dependence (16.4% vs 5.6%; P < .0001), and critical limb ischemia (64.6% vs 44.0%; P < .0001). DEP patients had a higher incidence of death (6.1% vs 1.5%; P < .0001) and major complications (30.3% vs 14.2%; P < .0001). DEP was an independent predictor of major complications (odds ratio [OR]: 2.0; 95% confidence interval [CI]: [1.7-2.4]; P < .0001) major systemic complications (2.5 [1.9-3.2]; P < .0001), major operative site complications (1.6 [1.4-1.9]; P < .0001) and death (2.3[1.6-3.4]; P < .0001). The combination of DEP with emergency surgery, Cr > 1.8, or rest pain increased the odds of major complications by five, seven, or 11-fold, respectively. The combination of DEP with hemodialysis, emergency surgery, or age > or = 80 years increased the odds of death by 13, 38, or 87-fold, respectively. CONCLUSION: Preoperative DEP is significantly correlated with all adverse 30-day outcomes in BPG patients. Furthermore, when combined in high-risk composites with specific preoperative clinical variables, DEP is associated with prohibitive MM, thereby identifying patient cohorts that may be unsuitable for BPG.

Prediction rule for cardiovascular events and mortality in peripheral arterial disease patients: data from the prospective Second Manifestations of ARTerial disease (SMART) cohort study.

BACKGROUND: Patients with peripheral arterial disease (PAD) are at high risk of secondary cardiovascular death and events such as myocardial infarction or stroke. To minimize this elevated risk, cardiovascular risk factors should be treated in all PAD patients. Secondary risk management may benefit from a prediction tool to identify PAD patients at the highest risk who could be referred for an additional extensive workup. Stratifying PAD patients according to their risk of secondary events could aid in achieving optimal therapy compliance. To this end we developed a prediction model for secondary cardiovascular events in PAD patients. METHODS: The model was developed using data from 800 PAD patients who participated in the Second Manifestations of ARTerial disease (SMART) cohort study. From the baseline characteristics, 13 candidate predictors were selected for the model development. Missing values were imputed by means of single regression imputation. Continuous predictors were truncated and transformed where necessary, followed by model reduction by means of backward stepwise selection. To correct for over-fitting, a bootstrapping technique was applied. Finally, a score chart was created that divides patients in four risk categories that have been linked to the risk of a cardiovascular event during 1- and 5-year follow-up. RESULTS: During a mean follow-up of 4.7 years, 120 events occurred (27% nonfatal myocardial infarction, 21% nonfatal stroke, and 52% mortality from vascular causes), corresponding to a 1- and 5-year cumulative incidence of 3.1% and 13.2%, respectively. Important predictors for the secondary risk of a cardiovascular event are age, history of symptomatic cardiovascular disease, systolic blood pressure, high-density lipoprotein cholesterol, smoking behavior, ankle-brachial pressure index, and creatinine level. The risk of a cardiovascular event in a patient as predicted by the model was 0% to 10% and 1% to 28% for the four risk categories at 1- and 5-year follow-up, respectively. The discriminating capacity of the prediction model, indicated by the c statistic, was 0.76 (95% confidence interval, 0.71-0.80). CONCLUSION: A prediction model can be used to predict secondary cardiovascular risk in PAD patients. We propose such a prediction model to allow for the identification of PAD patients at the highest risk of a cardiovascular event or cardiovascular death, which may be a viable tool in vascular secondary health care practice.