A health insurance claims analysis on the effect of female sex on long-term outcomes after peripheral endovascular interventions for symptomatic peripheral arterial occlusive disease.

OBJECTIVE: Several reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD. METHODS: Health insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis. RESULTS: In the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication. CONCLUSIONS: In the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies.

Lower Limb Revascularization for Peripheral Arterial Disease in 10,951 Procedures over 11 years in a Public Health System: A Descriptive Analysis of the Largest Brazilian City.

BACKGROUND: Worldwide, peripheral arterial disease (PAD) is a disease with high morbidity, affecting more than 200 million people. Our objective was to analyze the surgical treatment for PAD performed in the Unified Health System of the city of São Paulo during the last 11 years based on publicly available data. METHODS: The study was conducted with data analysis available on the TabNet platform, belonging to the DATASUS. Public data (government health system) from procedures performed in São Paulo between 2008 and 2018 were extracted. Sex, age, municipality of residence, operative technique, number of surgeries (total and per hospital), mortality during hospitalization, mean length of stay in the intensive care unit and amount paid by the government system were analyzed. RESULTS: A total of 10,951 procedures were analyzed (either for claudicants or critical ischemia-proportion unknown); 55.4% of the procedures were performed on males, and in 50.60%, the patient was older than 65 years. Approximately two-thirds of the patients undergoing these procedures had residential addresses in São Paulo. There were 363 in-hospital deaths (mortality of 3.31%). The hospital with the highest number of surgeries (n = 2,777) had lower in-hospital mortality (1.51%) than the other hospitals. A total of $20,655,272.70 was paid for all revascularizations. CONCLUSIONS: Revascularization for PAD treatment has cost the government system more than $20 million over 11 years. Endovascular surgeries were performed more often than open surgeries and resulted in shorter hospital stays and lower perioperative mortality rates.

Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions.

BACKGROUND: The Superficial Femoral Artery-Popliteal EvidencE Development Study Group developed contemporary objective performance goals (OPGs) for peripheral vascular interventions (PVI) for superficial femoral artery (SFA)-popliteal artery disease using the Registry Assessment of Peripheral Interventional Devices. METHODS: The Society for Vascular Surgery Vascular Quality Initiative PVI registry from January 2010 to October 2016 was used to develop OPGs based on SFA-popliteal procedures (n = 21,377) for intermittent claudication and critical limb ischemia (CLI). OPGs included 1-year rates for target lesion revascularization (TLR), major amputation, and 1 and 4-year survival rates. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (percutaneous transluminal angioplasty [PTA]), self-expanding stenting, atherectomy, and any treatment type. Outcomes were illustrated by unadjusted Kaplan-Meier analyses. RESULTS: Cohorts included PTA (n = 7505), stenting (n = 9217), atherectomy (n = 2510) and any treatment (n = 21,377). The mean age was 69 years, 58% were male, 79% were White, and 52% had CLI. The freedom from TLR OPGs at 1 year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at 1 year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at 1 year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8% (any treatments). The freedom from major amputation OPG at 1 year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). The 4-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments), and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). On a multivariable analysis, which included patient-level, leg-level, and lesion-level covariates, CLI was the single independent factor associated with increased TLR, amputation, and mortality. CONCLUSIONS: The Superficial Femoral Artery-Popliteal EvidencE Development OPGs define a new, contemporary benchmark for SFA-popliteal interventions using a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision-making. It is appropriate to discuss proposals intended for regulatory approval with the US Food and Drug Administration to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance.

The cost-effectiveness of intensive low-density lipoprotein cholesterol lowering in people with peripheral artery disease.

BACKGROUND: People with peripheral artery disease are at a high risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Randomized controlled trials suggest that intensive lowering of low-density lipoprotein cholesterol (LDL-C) with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors is an effective strategy to prevent these events. This study estimated the potential benefit and cost-effectiveness of administrating PCSK9 inhibitors to a cohort of participants with peripheral artery disease. METHODS: A total of 783 participants with intermittent claudication (IC; n = 582) or chronic limb-threatening ischemia (CLTI; n = 201) were prospectively recruited from three hospitals in Australia. Serum LDL-C was measured at recruitment, and the occurrence of MACE and MALE was recorded over a median (interquartile range) follow-up of 2.2 years (0.3-5.7 years). The potential benefit of administering a PCSK9 inhibitor was estimated by calculating the absolute risk reduction and numbers needed to treat (NNT) based on relative risk reductions reported in published randomized trials. The incremental cost-effectiveness ratio per quality-adjusted life year gained was estimated. RESULTS: Intensive LDL-C lowering was estimated to lead to an absolute risk reduction in MACE of 6.1% (95% confidence interval [CI], 2.0-9.3; NNT, 16) and MALE of 13.7% (95% CI, 4.3-21.5; NNT, 7) in people with CLTI compared with 3.2% (95% CI, 1.1-4.8; NNT, 32) and 5.3% (95% CI, 1.7-8.3; NNT, 19) in people with IC. The estimated incremental cost-effectiveness ratios over a 10-year period were $55,270 USD and $32,800 USD for participants with IC and CLTI, respectively. CONCLUSIONS: This analysis suggests that treatment with a PCSK9 inhibitor is likely to be cost-effective in people with CLTI.

A systematic review and meta-analysis of gender differences in long-term mortality and cardiovascular events in peripheral artery disease.

OBJECTIVE: Individual studies of peripheral artery disease (PAD) have indicated that gender discrepancies exist in the symptoms, functional status, and treatment usage. It remains uncertain whether these discrepancies result in different long-term outcomes. We examined the potential gender differences in mortality and major adverse cardiovascular events (MACE) in patients with symptomatic PAD. METHODS: The PubMed and Embase databases were searched for studies from 2000 to January 2019. After a review of 13,582 citations, 14 articles were analyzed. The reported age-adjusted hazard ratios (HRs) for gender differences in mortality and MACE were included in the meta-analysis. The mortality outcomes were stratified according to the clinical presentation and study context. RESULTS: Male gender was associated with a greater risk of all-cause mortality (HR, 1.13; 95% confidence interval [CI], 1.10-1.16; P < .001) and MACE (HR, 1.10; 95% CI, 1.06-1.14; P < .001). In a stratified analysis, male gender was associated with a higher mortality risk for patients presenting with either critical limb ischemia (HR, 1.08; 95% CI, 1.05-1.10; P < .001) or mixed clinical presentations (HR, 1.16; 95% CI, 1.11-1.21; P < .001) but not for those with intermittent claudication (HR, 1.13; 95% CI, 0.98-1.30; P = .09). Elevated mortality risk was evident after revascularization (HR, 1.11; 95% CI, 1.04-1.19; P = .003), hospitalization (HR, 1.15; 95% CI, 1.08-1.22; P < .001), and amputation (HR, 1.09; 95% CI, 1.08-1.10; P < .001), although not in outpatient clinics (HR, 1.13; 95% CI, 0.97-1.32; P = .13), in men compared with women. CONCLUSIONS: Greater mortality and MACE rates in men with PAD occurred despite other accepted gender disparities. The mechanisms underlying these gender differences in the outcomes for PAD patients require further investigation.

Elective infrainguinal lower extremity bypass for claudication is associated with high postoperative intensive care utilization.

BACKGROUND: The overall use of intensive care units (ICUs) in the United States has been steadily increasing and is associated with tremendous health care costs. We suspect that the burden of ICU utilization after elective infrainguinal lower extremity bypass (LEB) procedures is high, despite relatively low risks of complications in the immediate postoperative period. We sought to identify the burden of ICU utilization after elective LEB in patients with claudication. METHODS: We queried the Premier Healthcare Database for all adult patients undergoing first recorded elective infrainguinal LEB for claudication from 2009 to 2015. Baseline characteristics and ICU utilization on postoperative day 0 (POD 0) were identified for each patient using Premier room and board chargemaster codes. A bivariate logistic regression was performed and postestimation concordance statistics were calculated to identify predictors of postoperative ICU vs regular surgical floor admission immediately after surgery. RESULTS: There were 6010 patients who met the selection criteria, of whom 2772 (46.1%) were admitted to the ICU and 3238 (53.9%) to the regular surgical floor on POD 0. Whereas patient-level factors were responsible for minor differences found in postoperative admission to the ICU after elective LEB, hospital characteristics made up the majority of variation in admission practices. Specifically, patients undergoing elective infrainguinal LEB in rural, nonteaching, small hospitals and those in certain geographic regions were more likely to be admitted to the ICU than to the floor (all, P < .001). Patient-level factors were poorly predictive of admission to the ICU immediately postoperatively, with C statistics ranging from 0.50 to 0.53. In contrast, hospital-level factors had higher C statistics ranging from 0.51 to 0.66, with geographic location being the strongest predictor of post-LEB ICU admission. There were no significant differences in the incidence of postoperative wound complications, major adverse limb events, major adverse cardiac events, or in-hospital mortality between groups (all, P ≥ .32). The median total hospital cost was $2340 higher for ICU compared with floor admission ($13,273 [interquartile range, $10,136-$17,883] vs $10,927 [interquartile range, $8342-$14,523]; P < .001). CONCLUSIONS: Nearly half of patients are admitted to an ICU directly after elective infrainguinal LEB for claudication. This practice is associated with significantly higher hospital cost and is predominantly influenced by hospital-level rather than by patient-level factors. Perioperative morbidity and mortality were similar regardless of postoperative disposition. To minimize ICU utilization, postoperative care intensity should be determined by clinical severity of the patient rather than by hospital routine.

Higher Inpatient Mortality for Women after Intervention for Lifestyle Limiting Claudication.

BACKGROUND: Sex-related differences in outcomes have been identified in patients with peripheral artery disease (PAD). We hypothesized that women with PAD would have equivalent inpatient mortality with men after vascular intervention. METHODS: Patients with a primary diagnosis of critical limb ischemia (CLI) or lifestyle-limiting claudication (LLC) receiving endovascular (EV) or open surgical repair from 2003-2012 were identified from the Nationwide Inpatient Sample. Demographics, comorbidities, and inpatient mortality were analyzed by chi-squared tests of independence and independent-samples t-tests. Logistic regression analysis was performed to identify predictors of inpatient mortality. SPSS 24 software was used with P < 0.05 considered statistically significant. RESULTS: We identified 139,435 (59,432 women and 80,003 men) individuals meeting the aforementioned criteria. Women were older than men (71.5 years vs. 68.2, P < 0.001). There were no differences in racial distribution but women had lower rates of diabetes (38.6% vs. 39.7%, P < 0.001), chronic obstructive pulmonary disease (17.9% vs. 19.5%, P < 0.001), and coronary artery disease (38.6% vs. 47.4%, P < 0.001), while having a higher rate of hypertension (60.0% vs. 56.1%, P < 0.001). There was no sex-related difference in the rate of chronic renal failure. Women had higher inpatient mortality than men after vascular intervention (1.3% vs. 1.1%, P < 0.001). When stratified by surgical technique, women also had higher inpatient mortality after EV repair (1.0% vs. 0.8%, P < 0.05) and open repair (1.9% vs 1.3%, P < 0.001). When separated by admitting diagnosis, women with CLI had higher inpatient mortality than men after open surgery (2.3% vs. 1.9%, P < 0.05) but not after EV intervention. Women with LLC had higher inpatient mortality after both open (0.6% vs. 0.3%, P < 0.05) and EV surgery (0.3% vs. 0.1%, P < 0.05). Regression analysis revealed female sex as an independent predictor of inpatient mortality in patients with LLC (OR, 1.74; 95% CI 1.30-2.32, P < 0.001) but not CLI. CONCLUSIONS: Women had higher inpatient mortality than men after vascular intervention for PAD. Women were also older and more likely to have EV intervention than men. Subgroup analysis suggests that these sex-related differences in inpatient mortality are more pronounced in patients with LLC than with CLI. Furthermore, regression analysis shows that sex is a significant predictor for patients diagnosed with LLC but not with CLI. Treatment guidelines should include consideration of sex in their indications for revascularization, particularly for patients diagnosed with LLC.

Nationally Representative Readmission Factors in Patients with Claudication and Critical Limb Ischemia.

BACKGROUND: Hospital readmissions are associated not only with increased mortality, morbidity, and costs but also, with current health-care reform, tied to significant financial and administrative penalties. Some studies show that patients undergoing vascular surgery may have higher than average readmission rates. The recently released Nationwide Readmission Database (NRD) is the most comprehensive national source of readmission data, gathering discharge information from 22 geographically dispersed states, accounting for 51.2% of the total U.S. resident population and 49.3% of all U.S. hospitalizations. The aim of this study is to use the power of the NRD and obtain nationally representative readmission information for patients admitted with claudication or critical limb ischemia (CLI) who underwent revascularization procedures. METHODS: The NRD was queried for all patients admitted for claudication (International Classification of Diseases Ninth Revision [ICD-9] 440.21) or CLI (ICD-9 440.22-440.24) and who underwent percutaneous transluminal angioplasty, peripheral bypass, or aortofemoral bypass. Patient demographics, comorbidities, length of stay (LOS), mortality, readmission rates, and associated costs were collected. Univariable and multivariable logistic regression analysis was implemented on claudication and CLI groups on all outcomes of interest. The most common readmission diagnosis codes and diagnosis groups were also identified. RESULTS: A total of 92,769 patients were admitted for peripheral vascular disease (33,055 with claudication and 59,714 with CLI). The 30-day readmission/any readmission rate was 8.97%/21.49% and 19.26%/40.36%, for claudication and CLI, respectively. Significant differences were found for claudication and CLI, respectively, on initial cost of admission ($18,548 vs. $29,148, P < 0.001), readmission costs ($14,726 vs. $17,681 P < 0.001), LOS (4 days vs. 9 days, P < 0.001), days to readmission (73 days vs. 59 days, P < 0.001), mortality during initial admission (256 vs. 1,363, P < 0.001), and mortality during any admission (538 vs. 3,838, P < 0.001). Univariate and multivariate logistic regression analysis found that claudication, CLI, angioplasty, peripheral bypass, aortofemoral bypass, female sex, age >65, Charlson Comorbidity Index, LOS, and primary expected payer status were all significant predictors of 30-day and overall readmissions at varying degrees. The 5 most common disease readmission groups found were other vascular procedures (12.6%), amputation of lower limb except toes (6.3%), sepsis (5.4%), heart failure (4.9%) and postoperative or other device infections (4.8%). Of the abovementioned groups, the 4 most common diagnoses included "other postoperative infections," sepsis, atherosclerosis of native arteries with gangrene, and "other complications due to other vascular device, implant, or graft." CONCLUSIONS: Our results demonstrate that there is a significant difference in readmission rates, cost, and morbidity between patients admitted for claudication and CLI. Furthermore, based on regression analysis, there are multiple other clear risk factors associated with worse clinical and economic outcomes. Further study is needed to predict which patients will require increased vigilance during their hospital stay to prevent readmissions and worse outcomes. LEVEL OF EVIDENCE: Care management/epidemiological, level IV.

Sex-Based Assessment of Patient Presentation, Lesion Characteristics, and Treatment Modalities in Patients Undergoing Peripheral Vascular Intervention.

BACKGROUND: Limited evidence suggests that women and men might be treated differently for peripheral arterial disease. This analysis evaluated sex-based differences in disease presentation and its effect on treatment modality among patients who underwent endovascular treatment for peripheral arterial disease. METHODS AND RESULTS: Using national registry data from the Vascular Quality Initiative between 2010 and 2013, we examined patient, limb, and artery characteristics by sex through descriptive statistics. We studied 26 750 procedures performed in 23 820 patients to treat 30 545 limbs and 44 804 arteries. Women presented at an older age (69 versus 67 years; P<0.001) and were less often current or former smokers (72% versus 85%; P<0.001). Transatlantic Inter-Society Consensus classification was similar among men and women (Transatlantic Inter-Society Consensus C or D: 37% in men versus 37% in women; P=0.81), as was mean occlusion length (4.5 cm in men versus 4.6 cm in women; P=0.04), even after accounting for lesion location. Women more frequently underwent treatment for rest pain (11% in men versus 16% in women; P<0.001) versus claudication (59% in men versus 53% in women; P<0.001) or tissue loss (28% in men versus 27% in women; P=0.75). Treatment modality did not differ by sex but was associated with disease severity (P for trend <0.001) and lesion location (P for trend <0.001). CONCLUSIONS: Women undergo peripheral endovascular intervention for peripheral arterial disease at an older age with critical limb ischemia. Treatment modalities do not vary by sex but are determined by disease severity and site. Although there exist sex differences in presentation, these differences do not lead to differential treatment for women with peripheral arterial disease.

Exercise rehabilitation for peripheral artery disease: An exercise physiology perspective with special emphasis on the emerging trend of home-based exercise.

Peripheral artery disease (PAD) is a significant medical concern that is highly prevalent, costly, and deadly. Additionally, patients with PAD have significant impairments in functional independence and health-related quality of life due to leg symptoms and ambulatory dysfunction. Exercise therapy is a primary treatment for patients with PAD, as ambulatory outcome measures improve following a program of exercise rehabilitation. This review describes the outcomes that improve with exercise, the potential mechanisms for improved leg symptoms, key exercise program considerations for training patients with PAD with walking-based exercise, other exercise modalities that have been utilised, the use of on-site supervised exercise programs, and a major focus on historical and contemporary trials on conducting home-based, minimally supervised exercise program to treat PAD. The review concludes with recommendations for future exercise trials, with particular emphasis on reported greater details of the exercise prescription to more accurately quantify the total exercise dose of the program.

A systematic review of treatment of intermittent claudication in the lower extremities.

BACKGROUND: Peripheral arterial disease is common and is associated with significant morbidity and mortality. METHODS: We conducted a systematic review to identify randomized trials and systematic reviews of patients with intermittent claudication to evaluate surgery, endovascular therapy, and exercise therapy. Outcomes of interest were death, amputation, walking distance, quality of life, measures of blood flow, and cost. RESULTS: We included eight systematic reviews and 12 trials enrolling 1548 patients. Data on mortality and amputation and on cost-effectiveness were sparse. Compared with medical management, each of the three treatments (surgery, endovascular therapy, and exercise therapy) was associated with improved walking distance, claudication symptoms, and quality of life (high-quality evidence). Evidence supporting superiority of one of the three approaches was limited. However, blood flow parameters improved faster and better with both forms of revascularization compared with exercise or medical management (low- to moderate-quality evidence). Compared with endovascular therapy, open surgery may be associated with longer length of hospital stay and higher complication rate but resulted in more durable patency (moderate-quality evidence). CONCLUSIONS: In patients with claudication, open surgery, endovascular therapy, and exercise therapy were superior to medical management in terms of walking distance and claudication. Choice of therapy should rely on patients' values and preferences, clinical context, and availability of operative expertise.

Cost-effectiveness of cilostazol, naftidrofuryl oxalate, and pentoxifylline for the treatment of intermittent claudication in people with peripheral arterial disease.

We assessed the cost-effectiveness of cilostazol, naftidrofuryl oxalate, and pentoxifylline for intermittent claudication due to peripheral arterial disease (PAD) in adults whose symptoms continue despite a period of conventional management. A Markov decision model was developed to assess the lifetime costs and benefits of each vasoactive drug compared to no vasoactive drug and with each other. Regression analysis was undertaken to model the relationship between maximum walking distance and utility. Resource use data were sourced from the literature and sensitivity analyses were undertaken. Naftidrofuryl oxalate is more effective and less costly than cilostazol and pentoxifylline and has an estimated cost per quality-adjusted life year gained of around £6070 compared to no vasoactive drug. The analysis uses effectiveness evidence from a network meta-analysis. In contrast to previous guidelines recommending cilostazol, the analysis suggests that naftidrofuryl oxalate is the only vasoactive drug for PAD which is likely to be cost-effective.

Presentation, treatment, and outcome differences between men and women undergoing revascularization or amputation for lower extremity peripheral arterial disease.

OBJECTIVE: Prior studies have suggested treatment and outcome disparities between men and women for lower extremity peripheral arterial disease after surgical bypass. Given the recent shift toward endovascular therapy, which has increasingly been used to treat claudication, we sought to analyze sex disparities in presentation, revascularization, amputation, and inpatient mortality. METHODS: We identified individuals with intermittent claudication and critical limb ischemia (CLI) using International Classification of Diseases, Ninth Revision codes in the Nationwide Inpatient Sample from 1998 to 2009. We compared presentation at time of intervention (intermittent claudication vs CLI), procedure (open surgery vs percutaneous transluminal angioplasty or stenting vs major amputation), and in-hospital mortality for men and women. Regional and ambulatory trends were evaluated by performing a separate analysis of the State Inpatient and Ambulatory Surgery Databases from four geographically diverse states: California, Florida, Maryland, and New Jersey. RESULTS: From the Nationwide Inpatient Sample, we identified 1,797,885 patients (56% male) with intermittent claudication (26%) and CLI (74%), who underwent 1,865,999 procedures (41% open surgery, 20% percutaneous transluminal angioplasty or stenting, and 24% amputation). Women were older at the time of intervention by 3.5 years on average and more likely to present with CLI (75.9% vs 72.3%; odds ratio [OR], 1.21; 95% confidence interval [CI], 1.21-1.23; P < .01). Women were more likely to undergo endovascular procedures for both intermittent claudication (47% vs 41%; OR, 1.27; 95% CI, 1.25-1.28; P < .01) and CLI (21% vs 19%; OR, 1.14; 95% CI, 1.13-1.15; P < .01). From 1998 to 2009, major amputations declined from 18 to 11 per 100,000 in men and 16 to 7 per 100,000 in women, predating an increase in total CLI revascularization procedures that was seen starting in 2005 for both men and women. In-hospital mortality was higher in women regardless of disease severity or procedure performed even after adjusting for age and baseline comorbidities (.5% vs .2% after percutaneous transluminal angioplasty or stenting for intermittent claudication; 1.0% vs .7% after open surgery for intermittent claudication; 2.3% vs 1.6% after percutaneous transluminal angioplasty or stenting for CLI; 2.7% vs 2.2% after open surgery for CLI; P < .01 for all comparisons). CONCLUSIONS: There appears to be a preference to perform endovascular over surgical revascularization among women, who are older and have more advanced disease at presentation. Percutaneous transluminal angioplasty or stenting continues to be popular and is increasingly being performed in the outpatient setting. Amputation and in-hospital mortality rates have been declining, and women now have lower amputation but higher mortality rates than men. Recent improvements in outcomes are likely the result of a combination of improved medical management and risk factor reduction.

[Severe intermittent claudication: PGE1 treatment. A 40-week registry, efficacy and costs]. / Claudicatio intermittens severa: trattamento con PGE1. Registry, follow up (40 settimane), efficacia e costi.

AIM: Intermittent claudication (IC) in peripheral vascular disease is characterized by lower limb pain appearing on effort. Treatment with PGE1 has been successfully used to manage IC patients. This registry has evaluated safety and costs of PGE1 in the management of IC. METHODS: In this study a long-term treatment protocol (LTP), a short-term protocol (STP) and an outpatient (OP), "on-demand" treatment have been compared. A treadmill effort test has been used to evaluate walking distance. The follow up for these three protocols was 40 weeks. PGE1 treatment was associated to a risk reduction plan and to an exercise program. RESULTS: The final analysis has included 252 LTP patients, 223 STP patients and 284 OP patients (total 659 valid cases). A group of 171 comparable patients not treated with PGE1 was used for a parallel comparison. Cardiovascular mortality and morbidity has been evaluated in 731 PGE1 patients completing 24 months of follow up. All protocols have been well tolerated. No side effects were observed. The lower cost has been observed for OP patients. In the long term, mortality and morbidity were lower in patients treated with PGE1 in comparison with patients not treated with PGE1. CONCLUSION: Considering costs and results (increase in walking distance) and improvement in Karnofsky scale the STP plan appears to be better than LTP for IC patients. The OP, "on-demand" treatment offers further improvements. This last treatment plan is simpler; the plan allows better timing for exercise. The treatment can be used even in non-specialized centers.

Trends in the national outcomes and costs for claudication and limb threatening ischemia: angioplasty vs bypass graft.

PURPOSE: Debate exists as to the benefit of angioplasty vs bypass graft in the treatment of lower extremity peripheral vascular disease. The associated costs are poorly defined in the literature. We sought to determine national estimates for the costs, utilization, and outcomes of angioplasty and bypass graft for the treatment of both claudication and limb threat. METHODS: We searched the Nationwide Inpatient Sample (NIS) database (1999-2007), identifying patients who had an identifiable International Classification of Disease (ICD)-9 diagnosis code of atherosclerotic disease (claudication [440.21] or limb threat [440.22-440.24]). Of these, only patients who underwent intervention of angioplasty ± stent (percutaneous transluminal angioplasty [PTA; 39.50-39.90]), peripheral bypass graft (BPG; 39.29) or aortofemoral bypass (ABF; 39.25) were included. We compared demographics, costs, and comorbidities, as well as multivariable-adjusted outcomes of in-hospital mortality and major amputation. Additionally, we used the New Jersey State Inpatient and Ambulatory databases in order to better understand the influence of outpatient procedures on current volume and trends. RESULTS: There were 563,143 patients identified (PTA: 38%, BPG: 50%, ABF: 6%; 5.1%: multiple procedure codes). Patients who had PTA and BPG were similar in age (70.4 vs 69.5 years) but older than patients who had ABF (61.8 years, P < .01). Patients who underwent PTA were more often women (PTA: 46%, BPG: 42%, ABF: 45.2%; P < .01). Average costs for PTA increased over 60% for claudication between 2001 and 2007 ($8670 to $14,084) and limb threat ($13,903 to $23,196). For BPG, average costs increased 36% for both claudication ($9322 to $12,681) and limb threat ($16,795 to $22,910). In 2007, the average cost per procedure of PTA was higher than BPG for both claudication ($13,903 vs $12,681; P = .02) and limb threat ($23,196 vs $22,910; P = .04). The number of patients per year undergoing PTA increased threefold (15,903 to 46,138) for claudication and limb threat (6752 to 19,468). For BPG, procedures per year decreased approximately 40% for both claudication (13,625 to 9108) and limb threat (25,575 to 13,762). In-hospital mortality was similar for PTA and BPG groups for claudication (0.1% vs 0.2%; P = .04) and limb threat (2.1% vs 2.6%; P < .01). In-hospital amputation rates were significantly higher for patients who had PTA (7%) than BPG (3.9%, odds ratio [OR], 1.67 [1.49-1.85]; P < .01) or patients who underwent ABF (3.0%; OR, 2.32 [1.79, 3.03]; P < .01). CONCLUSION: PTA has altered the treatment paradigm for lower limb ischemia with an increase in costs and procedures. It is unclear if this represents an increase in patients or number of treatments per patient. Although mortality is slightly lower with PTA for all indications, amputation rates for limb-threat patients appear higher, as does the average cost. Longitudinal studies are necessary to determine the appropriateness of PTA in both claudication and limb-threat patients. The mortality benefit with PTA may be ultimately lost, and average costs elevated, if multiple interventions are performed on the same patients.

Usefulness of postexercise ankle-brachial index to predict all-cause mortality.

Peripheral arterial disease predicts future cardiovascular events and all-cause mortality. Conventional methods of assessment might underestimate its true prevalence. We sought to determine whether a postexercise ankle-brachial index (ABI), not only improved peripheral arterial disease detection, but also independently predicted death. This was an observational study of consecutive patients referred for ABI measurement before and after the fixed-grade treadmill or symptom-limited exercise component to a noninvasive vascular laboratory from January 1990 to December 2000. The subjects were classified into 2 groups. Group 1 included patients with an ABI of ≥0.85 before and after exercise, and group 2 included patients with a normal ABI at rest but <0.85 after exercise. A total of 6,292 patients underwent ABI measurements with exercise during the study period. Propensity score matching of the groups was performed to minimize observational bias. Overall mortality, as determined using the United States Social Security death index, was the end point. The 10-year mortality rate of groups 1 and 2 was 32.7% and 41.2%, respectively. An abnormal postexercise ABI result independently predicted mortality (hazard ratio 1.3, 95% confidence interval 1.07 to 1.58, p = 0.008). Additional independent predictors of mortality were age, male gender, diabetes, and hypertension. After the exclusion of patients with a history of cardiovascular events, the predictive value of an abnormal postexercise ABI remained statistically significant (hazard ratio 1.67, 95% confidence interval 1.29 to 2.17, p <0.0001). In conclusion, our results have shown that the postexercise ABI is a powerful independent predictor of all-cause mortality and provides additional risk stratification beyond the ABI at rest.

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.

Functional status as a prognostic factor for primary revascularization for critical limb ischemia.

BACKGROUND: Lower extremity arterial revascularization (LEAR) is the gold-standard for critical lower limb ischemia (CLI). The goal of this study was twofold. First, we evaluated the long-term functional status of patients undergoing primary LEAR for CLI. Second, prognostic factors of long-term functional status and survival after primary LEAR for CLI were assessed. METHODS: All primary LEAR procedures were analyzed. Patients were stratified by preoperative functional status: ambulatory (group I) vs nonambulatory (group II). Patients were followed-up after 3 and 6 years. Adverse events (AEs) were categorized according to predefined standards: minor, surgical, failed revascularization, and systemic. Associated patient demographic/clinical data were analyzed using univariate and multivariate methods. RESULTS: There were 106 LEAR patients (group I: n = 42, 40% vs group II: n = 64, 60%). Group II patients were significantly older (75 vs 62 years; P = .00), were classified ASA 3-4 more frequently (78% vs 52%; P < .02), had more cardiac disease (n = 42, 66% vs n = 10, 24%; P = .00), renal disease (n = 26, 41% vs n = 7, 17%; P = .00), diabetes (n = 36, 56% vs n = 8, 19%; P = .00), hypertension (n = 47, 73% vs n = 13, 31%; P = .00) and severe CLI (n = 42, 66% vs n = 18, 38%; P < .01). Group II patients had a higher incidence of death (65.6% vs 14.3%; P = .00), minor AEs (n = 38, 26% vs n = 10, 22%; P = .00), surgical AEs (n = 48, 33% vs n = 12, 26%; P < .02) and systemic AEs (n = 24, 86% vs n = 4, 9%; P < .02). Also more unplanned reinterventions occurred in group II (n = 148, 76% vs n = 47, 24%; P = .00). Nonambulatory status was a multivariate independent predictor of nonambulatory status after LEAR during 6 years follow-up (odds ration [OR[: 21.47; 95% confidence interval [CI]: 2.76-166.77; P = .00). Pulmonary disease (OR: 7.49; 95% CI: 2.17-25.80; P = .00), not prescribing beta-blockers (OR: 4.67; 95% CI: 1.28-17.03; P < .02), nonambulatory status (OR: 22.99; 95% CI: 6.27-84.24; P = .00), and systemic AEs (OR: 9.66; 95% CI: 1.84-50.57; P < .01) were independent predictors of death. Functional status was not improved in group II after long-term follow-up. CONCLUSION: Nonambulatory patients suffer from extensive comorbid conditions. They are accompanied with an increased occurrence of AEs, unplanned reinterventions, and poor long-term survival rates. Successful LEAR did not improve their functional status after 6 years. This emphasizes that attempts for limb salvage must be carefully considered in these patients.

Physical activity is a predictor of all-cause mortality in patients with intermittent claudication.

OBJECTIVE: We examined whether all-cause mortality was predicted by physical activity level in peripheral arterial disease (PAD) patients limited by intermittent claudication. METHODS: This retrospective, natural history follow-up study determined survival status of each patient. Patients with stable symptoms of intermittent claudication were evaluated in the Geriatrics, Research, Education, and Clinical Center at the Maryland Veterans Affairs Health Care System (MVAHCS) at Baltimore between 1994 and 2002, and were classified into a physically sedentary group (n = 299) or a physically active group (n =135), and followed in 2004 using the Social Security Death Index. RESULTS: Median follow-up was 5.33 years (range = 0.25 to 8.33 years) for the physically active group, and 5.0 years (range = 0.17 to 8.5 years) for the sedentary group. At follow-up, 108 patients (24.9%) had died, consisting of 86 (28.8%) in the sedentary group and 22 (16.3%) in the active group. Unadjusted risk of mortality was lower (P = .005) in the physically active group (hazard ratio [HR] = 0.510, 95% CI = 0.319 to 0.816). In multivariate Cox proportional hazards analysis, age (HR = 1.045, 95% CI = 1.019 to 1.072, P < 0.001), body mass index (BMI) (HR = 0.943, 95% CI = 0.902 to 0.986, P = 0.009), ankle-brachial index (ABI) (HR = 0.202, 95% CI = 0.064 to 0.632, p = 0.006), and physical activity status (HR = 0.595, 95% CI = 0.370 to 0.955, P = .031) were predictors of mortality. CONCLUSION: Patients limited by intermittent claudication who engage in any amount of weekly physical activity beyond light intensity at baseline have a lower mortality rate than their sedentary counterparts who perform either no physical activity or only light-intensity activities. The protective effect of physical activity persists even after adjusting for other predictors of mortality, which include age, ABI, and BMI.

Estimating general-population utilities using one binary-gamble question per respondent.

This study used a single binary-gamble question per health state per respondent to obtain societal preferences for the health states intermittent claudication and major amputation and compare those with Health Utilities Indices obtained from patients, to test the feasibility of this method, and to investigate whether the utility depends on the presentation of a vignette as generic vs disease-specific. A random sample of the general U.S. population (n = 1,003) was randomly divided into ten subgroups. In telephone interviews, subjects answered one binary-gamble question in a standard-gamble format for each of two health states. The risks of death varied across subgroups but not between health states. Mean utility was estimated by the area above the proportional distribution of responses indicating acceptance of the gamble. The method is based on the binary-choice method used in contingent-valuation studies of willingness to pay. The health states were alternatively described by generic and disease-specific vignettes in two subsamples. The results suggest that the binary-gamble question can be used to obtain societal preferences for health states, and that disease-specific descriptions yield lower utilities compared with generic descriptions of health states.