Determination of Treatment Efficacy after Revascularization of Intermittent Claudication Patients by Physical Function Assessment.

PURPOSE: There have been few reports examining changes in physical activity (PA) after revascularization of lower extremities from the perspective of physical function at discharge. The purpose of this study was to clarify the effects of physical function before discharge on the amount of PA after discharge in patients who underwent revascularization. METHODS: The subjects were 34 Fontaine class II patients admitted for elective surgical revascularization or endovascular treatment at two hospitals from September 2017 to October 2019. Triaxial accelerometers were used to measure changes in sedentary behavior (SB) before admission and 1 month after discharge. Multiple regression analysis was performed on the 6-min walking distance (6MWD) at the time of discharge and the change in SB 1 month after discharge; the cutoff value was calculated from the receiver operating characteristic (ROC) curve. RESULTS: SB 1 month after discharge significantly decreased in the decreased SB group compared to the increased SB group (575.5 [400-745.2] vs. 649.5 [453.8-809.2], p <0.01). ROC curve was plotted with SB increase/decrease as the dependent variable and 6MWD at discharge as the independent variable; the cutoff value was 357.5 m. CONCLUSION: 6MWD measurement at discharge may help predict changes in SB after discharge.

Index atherectomy peripheral vascular interventions performed for claudication are associated with more reinterventions than nonatherectomy interventions.

OBJECTIVE: Despite limited evidence supporting atherectomy alone over stenting/angioplasty as the index peripheral vascular intervention (PVI), the use of atherectomy has rapidly increased in recent years. We previously identified a wide distribution of atherectomy practice patterns among US physicians. The aim of this study was to investigate the association of index atherectomy with reintervention. METHODS: We used 100% Medicare fee-for-service claims to identify all beneficiaries who underwent elective first-time femoropopliteal PVI for claudication between January 1, 2019, and December 31, 2019. Subsequent PVI reinterventions were examined through June 30, 2021. Kaplan-Meier curves were used to compare rates of PVI reinterventions for patients who received index atherectomy versus nonatherectomy procedures. Reintervention rates were also described for physicians by their overall atherectomy use (by quartile). A hierarchical Cox proportional hazard model was used to evaluate patient and physician-level characteristics associated with reinterventions. RESULTS: A total of 15,246 patients underwent an index PVI for claudication in 2019, of which 59.7% were atherectomy. After a median of 603 days (interquartile range, 77-784 days) of follow-up, 41.2% of patients underwent a PVI reintervention, including 48.9% of patients who underwent index atherectomy versus 29.8% of patients who underwent index nonatherectomy (P < .001). Patients treated by high physician users of atherectomy (quartile 4) received more reinterventions than patients treated by standard physician users (quartiles 1-3) (56.8% vs 39.6%; P < .001). After adjustment, patient factors association with PVI reintervention included receipt of index atherectomy (adjusted hazard ratio [aHR], 1.33; 95% confidence interval [CI], 1.21-1.46), Black race (vs White; aHR; 1.18; 95% CI, 1.03-1.34), diabetes (aHR, 1.13; 95% CI, 1.07-1.21), and urban residence (aHR, 1.11; 95% CI, 1.01-1.22). Physician factors associated with reintervention included male sex (aHR, 1.52; 95% CI, 1.12-2.04), high-volume PVI practices (aHR, 1.23; 95% CI, 1.10-1.37), and physicians with a high use of index atherectomy (aHR, 1.49; 95% CI, 1.27-1.74). Vascular surgeons had a lower risk of PVI reintervention than cardiologists (vs vascular; aHR, 1.22; 95% CI, 1.09-1.38), radiologists (aHR, 1.55; 95% CI, 1.31-1.83), and other specialties (aHR, 1.59; 95% CI, 1.20-2.11). The location of services delivered was not associated with reintervention (P > .05). CONCLUSIONS: The use of atherectomy as an index PVI for claudication is associated with higher PVI reintervention rates compared with nonatherectomy procedures. Similarly, high physician users of atherectomy perform more PVI reinterventions than their peers. The appropriateness of using atherectomy for initial treatment of claudication needs critical reevaluation.

Use of Atherectomy During Index Peripheral Vascular Interventions.

OBJECTIVES: The aim of this study was to describe physician practice patterns and examine physician-level factors associated with the use of atherectomy during index revascularization for patients with femoropopliteal peripheral artery disease. BACKGROUND: There are minimal data to support the routine use of atherectomy over angioplasty and/or stenting for the endovascular treatment of peripheral artery disease. METHODS: Medicare fee-for-service claims (January 1 to December 31, 2019) were used to identify all beneficiaries undergoing elective first-time femoropopliteal peripheral vascular intervention (PVI) for claudication or chronic limb-threatening ischemia. Hierarchical logistic regression was used to evaluate patient- and physician-level characteristics associated with atherectomy. RESULTS: A total of 58,552 patients underwent index femoropopliteal PVI by 1,627 physicians. There was a wide distribution of physician practice patterns in the use of atherectomy, ranging from 0% to 100% (median 55.1%). Independent characteristics associated with atherectomy included treatment for claudication (vs. chronic limb-threatening ischemia; odds ratio [OR]: 1.51), patient diabetes (OR: 1.09), physician male sex (OR: 2.08), less time in practice (OR: 1.41 to 2.72), nonvascular surgery specialties (OR: 2.78 to 5.71), physicians with high volumes of femoropopliteal PVI (OR: 1.67 to 3.51), and physicians working primarily at ambulatory surgery centers or office-based laboratories (OR: 2.19 to 7.97) (p ≤ 0.03 for all). Overall, $266.8 million was reimbursed by Medicare for index femoropopliteal PVI in 2019. Of this, $240.6 million (90.2%) was reimbursed for atherectomy, which constituted 53.8% of cases. CONCLUSIONS: There is a wide distribution of physician practice patterns for the use of atherectomy during index PVI. There is a critical need for professional guidelines outlining the appropriate use of atherectomy in order to prevent overutilization of this technology, particularly in high-reimbursement settings.

Quantifying the risk-adjusted hospital costs of postoperative complications after lower extremity bypass in patients with claudication.

OBJECTIVE: Increasing evidence has shown that the risks associated with surgical revascularization for intermittent claudication outweigh the benefits. The aim of our study was to quantify the cost of care associated with perioperative complications after elective lower extremity bypass (LEB) in patients presenting with intermittent claudication. METHODS: All patients undergoing first-time LEB for claudication in the Healthcare Database (2009-2015) were included. The primary outcome was in-hospital postoperative complications, including major adverse limb events (MALE), major adverse cardiac events (MACE), acute kidney injury, and wound complications. The overall crude hospital costs are reported, and a generalized linear model with log link and inverse Gaussian distribution was used to calculate the predicted hospital costs for specific complications. RESULTS: Overall, 7154 patients had undergone elective LEB for claudication during the study period. The median age was 66 years (interquartile range, 59-73 years), 67.5% were male, and 75.3% were white. Two thirds of patients (61.2%) had Medicare insurance, followed by private insurance (26.9%), Medicaid (7.7%), and other insurance (4.2%). In-hospital complications occurred in 8.5% of patients, including acute kidney injury in 3.0%, MALE in 2.8%, wound complications in 2.3%, and MACE in 1.0%. The overall median crude hospital cost was $11,783 (interquartile range, $8911-$15,767) per patient. The incremental increase in cost associated with a postoperative complication was significant, ranging from $6183 (95% confidence interval, $4604-$7762) for MALE to $10,485 (95% confidence interval, $6529-$14,441) for MACE after risk adjustment. CONCLUSIONS: Postoperative complications after elective LEB for claudication are not uncommon and increase the in-hospital costs by 46% to 78% depending on the complication. Surgical revascularization for claudication should be used sparingly in carefully selected patients.

Trends and perioperative outcomes of patients with human immunodeficiency virus (HIV) undergoing lower extremity revascularization.

The development of highly active antiretroviral therapy (HAART) has significantly improved the life expectancy of patients with human immunodeficiency virus (HIV), but has led to the rise of chronic conditions including peripheral artery disease (PAD). However, trends and outcomes among patients with HIV undergoing lower extremity revascularization are poorly characterized. The aim of this study was to investigate the trends and perioperative outcomes of lower extremity revascularization among patients with HIV and PAD in a national database. The National Inpatient Sample (NIS) was reviewed between 2003 and 2014. All hospital admissions with a diagnosis of PAD undergoing lower extremity revascularization were stratified based on HIV status. Outcomes were assessed using propensity score matching and multivariable regression. Among all patients undergoing lower extremity revascularization for PAD, there was a significant increase in the proportion of patients with HIV from 0.21% in 2003 to 0.52% in 2014 (p < 0.01). Patients with HIV were more likely to be younger, male, and have fewer comorbidities, including coronary artery disease and diabetes, at the time of intervention compared to patients without HIV. With propensity score matching and multivariable regression, HIV status was associated with increased total hospital costs, but not length of stay, major amputation, or mortality. Patients with HIV with PAD who undergo revascularization are younger with fewer comorbidities, but have increased hospital costs compared to those without HIV. Lower extremity revascularization for PAD is safe for patients with HIV without increased risk of in-hospital major amputation or mortality, and continues to increase each year.

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.

Cost-effectiveness of revascularization in patients with intermittent claudication.

BACKGROUND: Revascularization is a treatment option for patients with intermittent claudication. However, there is a lack of evidence to support its long-term benefits and cost-effectiveness. The aim of this study was to compare the cost-effectiveness of revascularization and best medical therapy (BMT) with that of BMT alone. METHODS: Data were used from the IRONIC (Invasive Revascularization Or Not in Intermittent Claudication) RCT where consecutive patients with mild-to-severe intermittent claudication owing to aortoiliac or femoropopliteal disease were allocated to either BMT alone (including a structured, non-supervised exercise programme) or to revascularization together with BMT. Inpatient and outpatient costs were obtained prospectively over 24 months of follow-up. Mean improvement in quality-adjusted life-years (QALYs) was calculated based on responses to the EuroQol Five Dimensions EQ-5D-3 L™ questionnaire. Cost-effectiveness was assessed as the cost per QALY gained. RESULTS: A total of 158 patients were randomized, 79 to each group. The mean cost per patient in the BMT group was €1901, whereas it was €8280 in the group treated with revascularization in addition to BMT, with a cost difference of €6379 (95 per cent c.i. €4229 to 8728) per patient. Revascularization in addition to BMT resulted in a mean gain in QALYs of 0·16 (95 per cent c.i. 0·06 to 0·24) per patient, giving an incremental cost-effectiveness ratio of €42 881 per QALY. CONCLUSION: The costs associated with revascularization together with BMT in patients with intermittent claudication were about four times higher than those of BMT alone. The incremental cost-effectiveness ratio of revascularization was within the accepted threshold for public willingness to pay according to the Swedish National Guidelines, but exceeded that of the UK National Institute for Health and Care Excellence guidelines.

High Reintervention and Amputation Rates After Outpatient Atherectomy for Claudication.

Outpatient use of atherectomy for peripheral arterial disease has grown rapidly and outcomes are poorly understood. We analyzed outcomes of atherectomy done for claudication, comparing office and hospital outpatient settings. Analysis of Medicare Part B claims data was performed for incident femoral-popliteal or tibial-peroneal atherectomy from 2012 to 2014. Longitudinal analysis assessed services 18 months before, during, and up to 18 months after the incident peripheral vascular intervention (PVI). Differences between office-based and hospital outpatient-based settings were assessed using χ2 and Fisher exact tests. Comparing procedure settings, significant differences in race (femoral-popliteal: P = .04, tibial-peroneal: P = .001), chronic renal failure (femoral-popliteal: P = .002), and hypertension (femoral-popliteal: P = .01, tibial-peroneal: P = .006) were found. Nine hundred twenty-four patients undergoing femoral-popliteal atherectomy were analyzed (262 office based, 662 hospital outpatient based); 42.7% of office-based and 36.9% of hospital outpatient-based femoral-popliteal atherectomy patients had repeat PVI within 18 months ( P = .10). Major amputation was performed in 2.3% and 3.2% of patients in office and hospital outpatient settings, respectively ( P = .47). Four hundred twenty-three patients undergoing tibial-peroneal atherectomy were analyzed (202 office based, 221 hospital outpatient based); 46.5% of office-based and 38.9% of hospital outpatient-based tibial-peroneal atherectomy patients had repeat PVI within 1 year ( P = .11). Major amputation was performed in 5.0% and 8.1% of patients in office and hospital outpatient settings, respectively ( P = .19). Our study demonstrates higher than expected rates of major amputation for patients undergoing peripheral arterial atherectomy with regard to previously reported rates. Further studies may be required to prove the efficacy and safety of atherectomy for occlusive disease in the femoral-popliteal and tibial-peroneal segments to ensure outcomes are not worse than the natural history of medically managed claudicants.

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.

Directional Atherectomy Is Associated with Better Long-Term Efficiency Compared with Angioplasty for Common Femoral Artery Occlusive Disease in Rutherford 2-4 Patients.

BACKGROUND: Despite increased interest in treating common femoral artery (CFA) with endovascular technology, there are little data regarding the long-term outcomes of different endovascular treatment modalities. We report the results after endovascular therapy of symptomatic obstructions of the CFA in a single center. METHODS: We retrospectively reviewed the records of consecutive patients with eligible CFA lesions who were treated with endovascular methods between 2011 and 2013. The preoperative demographic operative details and postoperative outcomes were compared and statistically analyzed. RESULTS: Ninety patients with CFA lesions were treated, and 76 (84.4%) completed a follow-up. Claudication was present in 62 of 76 (81.6%) patients, and stenosis was present in 60 of 76 (78.9%) patients. Angioplasty was performed in 45 patients, and atherectomy was performed in 31 patients. There was no significant difference in the preoperative demographic data, procedure time, contrast administration, or length of hospital stay between the 2 groups. In-hospital treatment costs were significantly higher in the atherectomy group (69,822 RenMinBi Yuan vs. 49,078 RenMinBi Yuan; P = 0.043). During the 4-year primary patency, for whole group or bifurcated/claudicant subgroup, all patients within the atherectomy group were significantly better than those in the angioplasty group. CONCLUSIONS: Atherectomy may be a better alternative to angioplasty for CFA atherosclerotic obstructions lesions. Compared with angioplasty, atherectomy seems to have better results in bifurcated lesions or claudicant patients. In diabetic patients, no superiority was found on either patency or improvement in walking distance.

Cost-effectiveness of superficial femoral artery endovascular interventions in the UK and Germany: a modelling study.

OBJECTIVES: To assess the lifetime costs and cost-effectiveness of 5 endovascular interventions to treat superficial femoral arterial disease. DESIGN: A model-based health economic evaluation. An existing decision analytical model was used, with updated effectiveness data taken from the literature, and updated costs based on purchasing prices. SETTING: UK and German healthcare perspectives were considered. PARTICIPANTS: Patients with intermittent claudication of the femoropopliteal arteries eligible for endovascular treatment. METHODS: UK and German healthcare perspectives were considered, as were different strategies for re-intervention. INTERVENTIONS: Percutaneous transluminal angioplasty (PTA) with bail-out bare metal stenting (assumed to represent the existing standard of care, and 4 alternatives: primary bare metal stents, drug-eluting stents, drug-eluting balloons (DEBs) and biomimetic stents). PRIMARY OUTCOME MEASURES: The incremental cost-effectiveness ratio between 2 treatments, defined as the incremental costs divided by the incremental quality-adjusted life years (QALYs). RESULTS: Use of a biomimetic stent, BioMimics 3D, was always estimated to dominate the other interventions, having lower lifetime costs and greater effectiveness, as measured by QALYs. Of the remaining interventions, DEBs were always the most effective, and PTA the least effective. There was uncertainty in the cost-effectiveness results, with key drivers being the costs and effectiveness of the biomimetic stent along with the costs of DEBs. CONCLUSIONS: All 4 of the alternatives to PTA were more effective, with the biomimetic stent being the most cost-effective. As there was uncertainty in the results, and all of the interventions have different mechanisms of action, all 4 may be considered to be alternatives to PTA.

Indication for Lower Extremity Revascularization and Hospital Profiling of Readmissions.

BACKGROUND: Surgical readmissions are common, costly, and the focus of national quality improvement efforts. Given the relatively high readmission rates among vascular patients, pay-for-performance initiatives such as Medicare's Hospital Readmissions Reduction Program (HRRP) have targeted vascular surgery for increased scrutiny in the near future. Yet, the extent to which institutional case mix influences hospital profiling remains unexplored. We sought to evaluate whether higher readmission rates in vascular surgery are a reflection of worse performance or of treating sicker patients. METHODS: This retrospective observational cohort study of the national Medicare population includes 479,047 beneficiaries undergoing lower extremity revascularization (LER) in 1,701 hospitals from 2005 to 2009. We employed hierarchical logistic regression to mimic Center for Medicare and Medicaid Services methodology accounting for age, gender, preexisting comorbidities, and differences in hospital operative volume. We estimated 30-day risk-standardized readmission rates (RSRR) for each hospital when including (1) all LER patients; (2) claudicants; or (3) high-risk patients (rest pain, ulceration, or tissue loss). We stratified hospitals into quintiles based on overall RSRR for all LERs and examined differences in RSRR for claudicants and high-risk patients between and within quintiles. Next, we evaluated differences in case mix (the proportion of claudicants and high-risk patients treated) across quintiles. Finally, we simulated differences in the receipt of penalties before and after adjusting for hospital case mix. RESULTS: Readmission rates varied widely by indication: 7.3% (claudicants) vs. 19.5% (high risk). Even after adjusting for patient demographics, length of stay, and discharge destination, high-risk patients were significantly more likely to be readmitted (odds ratio 1.76, 95% confidence interval 1.71-1.81). The Best hospitals (top quintile) under the HRRP treated a much lower proportion of high-risk patients compared with the Worst hospitals (bottom quintile) (20% vs. 56%, P < 0.001). In the absence of case-mix adjustment, we observed a stepwise increase in the proportion of hospitals penalized as the proportion of high-risk patients treated increased (35-60%, P < 0.001). However, after case-mix adjustment, there were no differences between quintiles in the proportion of hospitalized penalized (50-46%, P = 0.30). CONCLUSION: Our findings suggest that the differences in readmission rates following LER are largely driven by hospital case mix rather than true differences in quality.

Analysis of Internet information on the controversial X-Stop device.

BACKGROUND CONTEXT: The Internet is frequently used by patients to aid in medical decision making. Multiple studies display the Internet's ineffectiveness in presenting high-quality information regarding surgical procedures and devices. With recent reports of unacceptably high complication rates and poor outcomes with the X-Stop device, it is important that online information is comprehensive and accurate. This study is the first to examine Internet information on the controversial X-Stop. PURPOSE: To determine how accurately public information over the Internet portrays the existing primary literature on the X-Stop, how extensively the X-Stop is characterized online, and how patient decision making could foreseeably be affected. STUDY DESIGN: This cross-sectional study analyzed publicly available Internet information, including videos on the web site YouTube regarding the X-Stop device. PATIENT SAMPLE: No patients were involved in this study. OUTCOME MEASURES: No specific outcome measures were used. METHODS: Search engines Google, Yahoo, and Bing were used to identify 105 web sites providing information on the X-Stop. Videos on the web site YouTube were included. Web sites were categorized based on the authorship. Each site was analyzed for the provision of appropriate patient inclusion and exclusion criteria, surgical and nonsurgical treatment alternatives, purported benefits, common complications, peer-reviewed literature citations, and descriptions/diagrams of the procedure. Data were evaluated for each authorship subgroup and the entire group of sites. RESULTS: Forty-three percent of sites were authored by a private medical group, 4% by an academic medical group, 16% by an insurance company, 9% by a biomedical industry, 10% by news sources, and 19% by other. Thirty-one percent of web sites and 11% of sites authored by private medical groups contained references to peer-reviewed literature. Fifty-six percent of web sites reported patient inclusion criteria, whereas 33% reported exclusion criteria. Benefits and complications were reported within 91% and 23% of sites, respectively. Surgical and nonsurgical treatment options were mentioned within 59% and 61% of web sites, respectively. CONCLUSIONS: Our study demonstrates the Internet's ineffectiveness in reporting quality information on the X-Stop. Information was often incomplete and potentially misleading. Significant controversy exists within primary literature regarding the safety and efficacy of the X-Stop. Yet, publicly available Internet information largely provided misinformation and did not reflect any such controversy. This raises the concern that such information lends itself more toward patient recruitment than patient education. Medical professionals need to know how this may affect their patients' decision making.

Preoperative duplex vein mapping (DVM) reduces costs in patients undergoing infrainguinal bypass surgery: results of a prospective randomised study.

OBJECTIVES: Surgical site infections (SSIs) after bypass procedures provoke major costs. The aim of this prospective randomised trial was to assess if preoperative duplex vein mapping (DVM) reduces costs generated by SSI. MATERIALS/METHODS: Patients undergoing primary infrainguinal bypass were randomised to DVM of the ipsilateral greater saphenous vein (group A) or none (group B). Costs were calculated by the hospital's accounting department. RESULTS: From December 2009 to April 2011, 130 patients (65 each group) were enrolled. Both cohorts were equal regarding demographics, risk factors and costs for primary bypass surgery, respectively. SSIs were classified minor (A: n = 13 vs. B: n = 13, P = n.s.) and major (A: n = 1 vs. B: n = 12, P = .0154). Preoperative DVM was the only significant factor to prevent major SSI (P = .011). Theatre costs for SSI: A: 537 € versus B 6553 € (P = .16). Recovery room/intensive care unit (ICU) costs for SSI: A: 0 € versus B: 8016 € (P = .22). Surgical ward costs for SSI: A: 2823 € versus B: 22 386 € (P = .011). Costs for outpatient visits due to SSI: A: 6265 € versus B: 12 831 € (P = .67). Total costs of patients without SSI: 8177 € versus major SSI: 10 963 € (P < .001). CONCLUSION: DVM significantly reduces costs generated by re-admission in patients suffering from major SSI.

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.

Influence of use of a vascular closure device on incidence and surgical management of access site complications after percutaneous interventions.

AIM: The study aimed to evaluate vascular access site complications (ASCs) after percutaneous interventions (PIs) in our institution for changes in annual incidence and surgical management after increased usage of a vascular closure device (VCD; in all cases: Angioseal™). MATERIAL AND METHODS: All patients who underwent repair of arterial pseudo-aneurysms or access site stenosis/occlusion leading to leg ischaemia (LI) or new-onset disabling claudication (CI) after PIs between 2001 and 2008 were included. Annual rates of procedures and methods of repair of ASC were evaluated. RESULTS: After a total of 58 453 PIs, 352 patients (0.6%) were operated on for: pseudo-aneurysms (n = 300; 0.51%); and local stenosis/occlusion leading to LI/CI (n = 52; 0.09%). Numbers increased significantly with more widespread VCD use: group A (2001-2004: 2860 VCDs; 28 284 PIs; 10.1%): n = 132 (0.47%); and group B (2005-2008: 11,660 VCDs; 30,169 PIs; 38.6%): n = 220 (0.73%) (p < 0.001). In contrast to similar rates of pseudo-aneurysms (group A: n = 124; 0.44%; group B: n = 176; 0.58%; not significant), a significant increase of operations for local stenoses/occlusions was seen with widespread VCD use: n = 8 versus n = 44 (p < 0.001). CONCLUSIONS: In the era of VCDs, complications are rare. However, use of these devices is not without complications, and may require complex reconstructions.