Risk for surgical interventions following endovascular aneurysm repair with Endologix AFX or AFX2 Endovascular AAA Systems compared with other devices.

OBJECTIVE: To evaluate the risk for 90-day returns to care and long-term subsequent surgical interventions after primary endovascular aneurysm repair (EVAR) with an Endologix AFX Endovascular AAA System compared with three other high-volume endograft devices. METHODS: We conducted a matched cohort study using data from Kaiser Permanente's Endovascular Stent Graft Registry. Patients aged ≥18 years who underwent primary EVAR for AAA in the health care system from January 1, 2011, to December 31, 2017, comprised the eligible study sample. The treatment group included patients who received an Endologix AFX or AFX2 device (n = 470). Patients who received one of three other high-volume endograft devices used within the health care system comprised the eligible comparison group (n = 2122). These patients were 2:1 propensity score matched without replacement to patients who received an Endologix device based on a number of patient and procedural characteristics. After the application of matching, conditional logistic regression was used to evaluate the likelihood for 90-day emergency department visit and readmission. Cause-specific Cox regression was used to evaluate the long-term risk of endoleak, graft revision, secondary reintervention (not including revision), conversion to open repair, and rupture during follow-up. Cox proportional hazards regression was used to evaluate the risk of mortality (overall and aneurysm related). RESULTS: The final matched study sample included 470 patients who received an Endologix AFX or AFX2 device and 940 patients who received a different high-volume device. compared with the other devices, AFX/AFX2 had a higher risk for type III endoleak (hazard ratio [HR], 38.79; 95% confidence interval [CI], 14.51-103.67), revision surgery >1 year after the primary EVAR (HR, 4.50; 95% CI, 3.10-6.54), rupture (HR, 6.52; 95% CI, 1.73-24.63), and aneurysm-related mortality (HR, 2.43; 95% CI, 1.32-4.47) was observed with the use of AFX/AFX2. CONCLUSIONS: In our matched cohort study, patients who received an Endologix AFX System during their primary EVAR had a higher risk for several adverse longitudinal outcomes, as well as aneurysm-related mortality, when compared with patients who received other high-volume devices. Patients who have received these devices should be monitored closely after EVAR.

Decreasing trends in reintervention and readmission after endovascular aneurysm repair in a multiregional implant registry.

OBJECTIVE: As endovascular aortic aneurysm repair (EVAR) matures into its third decade, measures such as long-term reintervention and readmission have become a focus of quality improvement efforts. Within a large United States integrated health care system, we describe time trends in the rates of long-term reinterventions utilization measures. METHODS: Data from a United States multiregional EVAR registry was used to perform a descriptive study of 3891 adults who underwent conventional infrarenal EVAR for infrarenal abdominal aortic aneurysm between 2010 and 2019. Three-year follow-up was 96.7%. Outcomes included 1-, 3-, and 5-year graft revision (defined as a procedure involving placement of a new endograft component), secondary interventions (defined as a procedure necessary for maintenance of EVAR integrity [eg, coil embolization and balloon angioplasty/stenting]), conversion to open, interventions for type II endoleaks alone, and 90-day readmission. Crude cause-specific reintervention probabilities were calculated by operative year using the Aalen-Johansen estimator, with death as a competing risk and December 31, 2020 as the study end date. RESULTS: Excluding interventions for type II endoleak alone, 1-year secondary intervention incidence decreased from 5.9% for EVARs in 2010 to 2.0% in 2019 (P < .001) and 3-year incidence decreased from 7.2% to 3.6% from 2010 to 2017 (P = .03). The 3-year incidences of graft revision (mean incidence, 3.4%) and conversion to open remained fairly stable (mean incidence, 0.6%) over time. The 3-year incidence of interventions for type II endoleak alone also decreased from 3.4% in 2010 to 0.7% in 2017 (P = .01). Ninety-day readmission rates decreased from 19.3% for index EVAR in 2010 to 9.2% in 2019 (P = .03). CONCLUSIONS: Comprehensive data from a multiregional health care system demonstrates decreasing long-term secondary intervention and readmission rates over time in patients undergoing EVAR. These trends are not explained by evolving management of type II endoleaks and suggest improving graft durability, patient selection, or surgical technique. Further study is needed to define implant and anatomic predictors of different types of long-term reintervention.

Midterm outcomes for 605 patients receiving Endologix AFX or AFX2 Endovascular AAA Systems in an integrated healthcare system.

BACKGROUND: Endologix issued important safety updates for the AFX Endovascular AAA System in 2016 and 2018 owing to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up. We describe the midterm outcomes for a large cohort of patients who received an Endologix AFX or AFX2 device. STUDY DESIGN: Data from an integrated healthcare system's implant registry, which prospectively monitors all patients after endovascular aortic repair, was used for this descriptive study. Patients undergoing endovascular aortic repair with three AFX System variations (Strata [AFX-S], Duraply [AFX-D], and AFX2 with Duraply [AFX2]) were identified (2011-2017). Crude cumulative event probabilities for endoleak (types I and III), major reintervention, conversion to open, rupture, and mortality (aneurysm related and all cause) were estimated. RESULTS: Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the cohort was 3.9 (interquartile range, 2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent reintervention or conversion, and mortality was 8.8% (95% confidence interval [CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8% (95% CI, 6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI, 4.8-13.0), 10.6% (95% CI, 6.9-16.1), and 9.7% (95% CI, 6.3-14.7); for AFX2, they were 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-37.7), and 21.2% (95% CI, 10.7-39.4). CONCLUSIONS: The midterm outcomes of a large U.S. patient cohort with an Endologix AFX or AFX2 System demonstrate a concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to prevent device-related adverse events.

Survival and Reintervention Risk by Patient Age and Preoperative Abdominal Aortic Aneurysm Diameter after Endovascular Aneurysm Repair.

BACKGROUND: Endovascular aneurysm repair (EVAR) has become the standard of care for abdominal aortic aneurysm (AAA), but questions remain regarding the benefit in high-risk and elderly patients. The purpose of this study was to examine the effect of age, preoperative AAA diameter, and their interaction on survival and reintervention rates after EVAR. METHODS: Our integrated health system's AAA endograft registry was used to identify patients who underwent elective EVAR between 2010 and 2014. Of interest was the effect of patient age at the time of surgery (≤80 vs. >80 years old), preoperative AAA diameter (≤5.5 cm vs. >5.5 cm), and their interaction. Primary endpoints were all-cause mortality and reintervention. Between-within mixed-effects Cox models with propensity score weights were fit. RESULTS: Of 1,967 patients undergoing EVAR, unadjusted rates for survival at 4 years after EVAR was 76.1%, and reintervention-free rate was 86.0%. For mortality, there was insufficient evidence for an interaction between age and AAA size (P = 0.309). Patient age >80 years was associated with 2.53-fold higher mortality risk (hazard ratios [HR] = 2.53; 95% confidence intervals [CI], 1.73-3.70; P < 0.001), whereas AAA > 5.5 cm was associated with 1.75-fold higher mortality risk (HR = 1.75; 95% CI, 1.26-2.45; P = 0.001). For reintervention risk, there were no significant interactions or main effects for age or AAA diameter. CONCLUSIONS: Age and AAA diameter are independent predictors of reduced survival after EVAR, but the effect is not amplified when both are present. Age >80 years or AAA size >5.5 cm did not increase the risk of reintervention. No specific AAA size, patient age, or combination thereof was identified that would contraindicate AAA repair.

The Contemporary Safety and Effectiveness of Lower Extremity Bypass Surgery and Peripheral Endovascular Interventions in the Treatment of Symptomatic Peripheral Arterial Disease.

BACKGROUND: Treatment for symptomatic peripheral artery disease includes lower extremity bypass surgery (LEB) and peripheral endovascular interventions (PVIs); however, limited comparative effectiveness data exist between the 2 therapies. We assessed the safety and effectiveness of LEB and PVI in patients with symptomatic claudication and critical limb ischemia. METHODS AND RESULTS: In a community-based clinical registry at 2 large integrated healthcare delivery systems, we compared 883 patients undergoing PVI and 975 patients undergoing LEB between January 1, 2005 and December 31, 2011. Rates of target lesion revascularization were greater for PVI than for LEB in patients presenting with claudication (12.3±2.7% and 19.0±3.5% at 1 and 3 years versus 5.2±2.4% and 8.3±3.1%, log-rank P<0.001) and critical limb ischemia (19.1±4.8% and 31.6±6.3% at 1 and 3 years versus 10.8±2.5% and 16.0±3.2%, log-rank P<0.001). However, in comparison with PVI, LEB was associated with increased rates of complications up to 30 days following the procedure (37.1% versus 11.9%, P<0.001). There were no differences in amputation rates between the 2 groups. Findings remained consistent in sensitivity analyses by using propensity methods to account for treatment selection. CONCLUSIONS: In patients with symptomatic peripheral artery disease, in comparison with LEB, PVI was associated with fewer 30-day procedural complications, higher revascularization rates at 1 and 3 years, and no difference in subsequent amputations.

Cranial nerve injury is associated with dual antiplatelet therapy use and cervical hematoma after carotid endarterectomy.

OBJECTIVE: To determine predictors of cranial nerve injury (CNI) after carotid endarterectomy (CEA). METHODS: Consecutive CEAs performed over a 5-year period were enrolled in this study. Outcomes analyzed included 30-day major adverse event rate (composite of stroke, death, and myocardial infarction), death, stroke, disabling stroke, myocardial infarction, cervical hematoma and CNI rate, reoperation, and hospital readmission at 30 days. RESULTS: There were 1258 CEAs were included in the study, 1168 (93%) were performed using an eversion technique. Patients with symptoms comprised 27% of the cohort (n = 340). At 30 days, there were no deaths, 23 major adverse events (1.8%), 11 strokes (0.9%: nine minor, two major), 12 myocardial infarctions (0.9%), 41 cervical hematomas (3.3%), 9 reoperations (0.7%) and 10 hospital readmissions (0.8%). Median duration of stay was 1 day (interquartile range, 1-2 days). CNI rate at discharge was 2.3% (n = 29). Two patients (9%) had more than one cranial nerve affected. The marginal mandibular branch of the facial nerve was most frequently involved (n = 16; 52%), followed by the hypoglossal (n = 9; 29%), the vagus (n = 4; 13%), and the spinal accessory nerve (n = 2; 6%). Horner's syndrome, consistent with an injury to the cervical sympathetic chain, occurred in 13 patients (1%) who had a true cranial nerve affected as well. The vast majority (94%) of these CNIs and all Horner's syndrome neurapraxias were transient; only the two accessory lesions persisted at their follow-up visit (median, 32 months; range, 8-72 months). Significant predictors for CNI included diabetes (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.0-6.2; P = .048), cervical hematoma (OR, 41.7; 95% CI, 13.8-125.4; P < .001), and dual antiplatelet therapy (OR, 4.4; 95% CI, 1.7-11.4; P = .002). CONCLUSIONS: CNI is predominantly a transient complication, but is associated significantly with dual antiplatelet therapy use and the occurrence of a postoperative cervical hematoma. Scrupulous attention to hemostasis might reduce the incidence of CNI.

Anatomic runoff score predicts cardiovascular outcomes in patients with lower extremity peripheral artery disease undergoing revascularization.

BACKGROUND: Although the presence, extent, and severity of obstruction in patients with lower extremity peripheral artery disease (LE PAD) affect their functional status, quality of life, and treatment, it is not known if these factors are associated with future cardiovascular events. We empirically created an anatomic runoff score (ARS) to approximate the burden of LE PAD and determined its association with clinical outcomes. METHODS: We evaluated all patients with LE PAD and bilateral angiography undergoing revascularization in a community-based clinical study. Primary clinical outcomes of interest were (1) a composite of all-cause death, myocardial infarction (MI), and stroke and (2) amputation-free survival. Cox proportional hazards models were created to identify predictors of clinical outcomes. RESULTS: We evaluated 908 patients undergoing angiography, and a total of 260 (28.0%) patients reached the composite end point (45 MI, 63 stroke, and 152 death) during the study period. Anatomic runoff score ranged from 0 to 15 (mean 4.7; SD 2.5) with higher scores indicating a higher burden of disease, and an optimal cutpoint analysis classified patients into low ARS (<5) and high ARS (≥5). The unadjusted rates of the primary composite end point and amputation-free survival were nearly 2-fold higher in patients with a high ARS when compared with patients with a low ARS. The most significant predictors of the composite end point (death/MI/stroke) were age (δ 10 years; hazard ratio [HR] 1.53; CI 1.32-1.78; P < .001), diabetes mellitus (HR 1.65; CI 1.26-2.18; P < .001), glomerular filtration rate <30 (HR 2.23; CI 1.44-3.44; P < .001), statin use (HR 0.66; CI 0.48-0.88; P < .001), and ARS (δ 2 points; HR 1.21; CI 1.08-1.35; P < .001). CONCLUSIONS: After adjustment for clinical factors, the LE PAD ARS was an independent predictor of future cardiovascular morbidity and mortality in a broadly representative patient population undergoing revascularization for symptomatic PAD. A clinically useful anatomic scoring system, if validated, may assist clinicians in risk stratification during the course of clinical decision making.

A multiregional registry experience using an electronic medical record to optimize data capture for longitudinal outcomes in endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Registries have been proven useful to assess clinical outcomes, but data entry and personnel expenses are challenging. We developed a registry to track patients undergoing endovascular aortic aneurysm repair (EVAR) in an integrated health care system, leveraging an electronic medical record (EMR) to evaluate clinical practices, device performance, surgical complications, and medium-term outcomes. This study describes the registry design, data collection, outcomes validation, and ongoing surveillance, highlighting the unique integration with the EMR. METHODS: EVARs in six geographic regions of Kaiser Permanente were entered in the registry. Cases were imported using a screening algorithm of inpatient codes applied to the EMR. Standard note templates containing data fields were used for surgeons to enter preoperative, postoperative, and operative data as part of normal workflows in the operating room and clinics. Clinical content experts reviewed cases and entered any missing data of operative details. Patient comorbidities, aneurysm characteristics, implant details, and surgical outcomes were captured. Patients entered in the registry are followed up for life, and all relevant events are captured. RESULTS: Between January 2010 and June 2013, 2112 procedures were entered in the registry. Surgeon compliance with data entry ranges from 60% to 90% by region but has steadily increased over time. Mean aneurysm size was 5.9 cm (standard deviation, 1.3). Most patients were male (84%), were hypertensive (69%), or had a smoking history (79%). The overall reintervention rate was 10.8%: conversion to open repair (0.9%), EVAR revision (2.6%), other surgical intervention (7.3%). Of the reinterventions, 27% were for endoleaks (I, 34.3%; II, 56.9%; III, 8.8%; IV and V, 0.0%), 10.5% were due to graft malfunction, 3.4% were due to infection, and 2.3% were due to rupture. CONCLUSIONS: Leveraging an EMR provides a robust platform for monitoring short-term and midterm outcomes after abdominal aortic aneurysm repair. Use of standardized templates in the EMR allows data entry as part of normal workflow, improving compliance, accuracy, and data capture using limited but expert personnel. Assessment of patient demographics, device performance, practice variation, and postoperative outcomes benefits clinical decision-making by providing complete and adjudicated event reporting. The findings from this large, community-based EVAR registry augment other studies limited to perioperative and short-term outcomes or small patient cohorts.

Mycotic popliteal aneurysm rupture secondary to Campylobacter fetus.

BACKGROUND: Mycotic aneurysms of the popliteal artery are uncommon. Popliteal aneurysms rarely rupture. The authors present the second reported case of popliteal artery rupture as a result of Campylobacter fetus infection. This report confirms the arterial destructive potential of C. fetus infection in a peripheral artery. METHODS: An 85-year-old male who had previously undergone endovascular abdominal aortic aneurysm repair in 2007 presented with positive blood cultures for C. fetus. No endocarditis was detected. No periprosthetic fluid to suggest aortic endograft infection was present. During hospitalization for sepsis, he developed acute right knee pain and swelling. A 5.2-cm popliteal aneurysm, with contained rupture, was found on ultrasound and confirmed by computed tomography and angiography. Recommendations for treatment and a literature review are provided. RESULTS: This patient was successfully managed with total excision of the aneurysm via a posterior approach with reconstruction through a medial approach using autologous saphenous vein bypass. Culture-directed antibiotic therapy (6 weeks of intravenous ertapenem) to eradicate the pathogen completed the therapy. The patient is doing well at 18- month follow-up. CONCLUSIONS: Mycotic popliteal aneurysm associated with C. fetus is a rare but potentially fatal condition. Isolating C. fetus should alert the surgeon to the peripheral arterial destructive potential of this pathogen, as manifested by acute rupture in this patient. Traditional resection through a posterior approach and revascularization through noncontaminated tissue with culture-directed therapy are the treatments of choice.

Endovascular repair of ruptured and symptomatic abdominal aortic aneurysms using a structured protocol in a community teaching hospital.

BACKGROUND: Open abdominal aortic aneurysm (AAA) repair has gradually been replaced by endovascular aneurysm repair (EVAR). The primary objective of this study is to establish baseline mortality data and compare our institutional mortality rates for ruptured AAA patients with published rates from institutions using similar approaches. METHODS: This study is a retrospective review of 49 patients treated using a structured ruptured AAA (rAAA) protocol in a community teaching hospital. Variables examined include demographics, repair type, device used, presenting systolic blood pressure, presenting glomerular filtration rate, initial hematocrit, transfusions required, and development of postoperative abdominal compartment syndrome. RESULTS: Forty-nine patients were treated using the rAAA protocol and 48 underwent repair. The 30-day mortality for rAAA and symptomatic AAA (sAAA) was 36.4% (12/33) and 20.0% (3/15), respectively, with a mean mortality of 31.2% (15/48). Mortality for rAAA treated by EVAR was 32.0% (8/25). Mortality for rAAA in the open repair group was 33% (2/6). Conversion from EVAR to open procedure (3/48) or 6% resulted in 100% mortality (P = 0.266). The development of abdominal compartment syndrome was an absolute predictor of death as mortality was 100% (P < 0.001). Other significant predictors of death include the following: (1) blood transfusion received during operation required in 10/14 deaths (71%) (P = 0.005) and (2) transfusion received anytime during hospitalization required in 12/14 deaths or 86% (P = 0.017). CONCLUSIONS: The management and endovascular repair of sAAA or rAAA can be improved at the community hospital level by the implementation of standardized protocols. Blood transfusions and development of postoperative abdominal compartment syndrome significantly increase mortality. Individual institutional knowledge of results is critical to effective process improvement and optimal patient outcomes.

Endovascular recanalization of the superior mesenteric artery in the context of mesenteric bypass graft infection.

Mesenteric prosthetic graft infection is a rare and challenging clinical scenario. A patient is described who developed recurrent abdominal pain after occlusion of an iliomesenteric prosthetic bypass. Endovascular recanalization of the native superior mesenteric artery, which had been occluded for more than 10 years, was accomplished using axillofemoral through-wire access and a steerable guiding catheter. The infected prosthetic was then explanted and his graft-enteric fistula repaired. Technical and strategic considerations are discussed.

The risk for significant creatine kinase elevation with statins.

BACKGROUND: The HMG-CoA reductase inhibitors (statins) are effective for reducing long-term cardiovascular morbidity and mortality in both primary and secondary prevention. The most serious adverse reaction is significant elevation of creatine kinase (CK) leading to rhabdomyolysis. The incidence of CK elevation is low in randomized, controlled trials. The rate may be higher in 'real-world', less controlled settings. Data on the risks of statin-associated rhabdomyolysis in 'real-world' practice settings are limited. OBJECTIVE: The aim of this study was to examine the risk for CK elevation among statin users in a clinical practice setting. Potential risk factors were identified and evaluated to quantify the risk for CK elevation with statins. METHODS: This case-control study was conducted at Kaiser Permanente Colorado. Patients with prescriptions for lovastatin or simvastatin between 1 January 1999 and 30 June 2006 were identified. Cases (n = 183), i.e. patients with a CK > or =10x the upper limit of normal (ULN) while receiving a statin during this time period, were each matched on the date of statin purchase to ten control patients (n = 1830) without CK > or =10x ULN while receiving a statin. Multivariate, conditional logistic regression was used to assess the associations between the statin, statin dose, demographic, co-morbidity, laboratory, and medication factors potentially associated with CK >or =10x ULN. RESULTS: he mean (SD) age of patients was 64.9 (11.5) years and 56.9% were male. Overall, simvastatin use was associated with a higher likelihood for CK > or =10x ULN than lovastatin (adjusted odds ratio [OR] 4.6; 95% CI 1.1, 12.4). Using simvastatin 40 mg daily as the referent, and in the absence of interacting medications, only simvastatin 80 mg was associated with a higher likelihood for CK > or =10x ULN (OR 2.7; 95% CI 1.1, 6.9). In the presence of interacting medications, all doses of simvastatin and only lovastatin 80 mg were associated with a higher likelihood for CK > or =10x ULN. CONCLUSION: In this study, simvastatin was associated with a higher likelihood for CK > or =10x ULN than lovastatin. High-dose simvastatin, in particular, appears to confer a greater risk than lower doses of either simvastatin or lovastatin.

Effect and Durability of an In-depth Training Course on Physician Communication Skills.

INTRODUCTION: Effective clinical communication skills are integral to a successful and therapeutic clinician-patient relationship and are associated with improvement in adherence, outcomes, and lower medicolegal risk. However, in stark contrast to other clinical and cognitive skills, practicing physicians generally receive little ongoing training or assessment of individual performance in communication. OBJECTIVES: To assess the effect of an in-depth physician communication course on patients' perception of clinician skill in communication. METHODS: We analyzed the effect of a 3-day dedicated course on clinical communication skills among 65 clinicians assessed by a randomized patient survey. RESULTS: Patients were significantly more satisfied with their physician on 6 specific communication skills after the physician received the Communication Skills Intensive training. The effect persisted at 12 months' follow-up. In addition to the improved patient satisfaction scores, attendees stated that they learned many practical communication skills and valued the course. CONCLUSION: Health systems looking to improve patient-reported outcome measures should consider focused training, resources, and time for practitioners to engage in a communication skills intensive course.

Amniotic Fluid Embolism: Using the Medical Staff Process to Facilitate Streamlined Care.

Amniotic fluid embolism (AFE) is a catastrophic consequence of labor and delivery that often results in maternal and neonatal death. These poor outcomes are related largely to the rarity of the event in a population overwhelmingly biased by overall good health. Despite the presence of national AFE registries, there are no published algorithmic approaches to its management, to our knowledge. The purpose of this article is to share a care pathway developed by a multidisciplinary group at a community teaching hospital. Post hoc analysis of a complicated case of AFE resulted in development of this pathway, which addresses many of the major consequences of AFE. We offer this algorithm as a template for use by any institution willing to implement a clinical pathway to treat AFE. It is accompanied by the remarkable case outcome that prompted its development.

Pharmacologic risk factor management in peripheral arterial disease: a vade mecum for vascular surgeons.

There is broad and compelling evidence for risk factor reduction to limit cardiovascular morbidity and mortality in patients with peripheral arterial disease. Indeed, vascular surgeons have placed a call to arms to ensure this takes place. Despite this fact, some wariness exists on the part of many vascular surgeons to initiate these strategies, functionally abnegating their responsibilities in this regard. The purpose of this article is to provide a simple reference to guide effective therapies for overall cardiovascular risk reduction in patients with peripheral arterial disease. Specific recommendations are made for tobacco cessation, lipid-lowering therapy, antiplatelet therapy, blood pressure control, and maintenance of normoglycemia.

Effect of a clinical pharmacy service on lipid control in patients with peripheral arterial disease.

OBJECTIVE: Our group and others have previously established that patients with peripheral artery disease (PAD) are significantly undertreated with respect to overall cardiovascular risk factor management, despite national guidelines to the contrary. In an effort to maximize risk factor control in our patients with PAD, we established a pharmacist-managed, physician-monitored algorithmic approach to the outpatient management of lipids in patients with PAD. The purpose of this study was to determine the effect of this service on lipid screening and control in patients with PAD. METHODS: We analyzed the records of patients treated at a large, group-model, not-for-profit regional managed care system serving approximately 405,000 members. An electronic medical record provided full examination, laboratory, and pharmacy data for all patients. Pharmacy data were analyzed to determine prescriptions for lipid-lowering agents. Lipid control was assessed through fasting lipid data. Patients with validated PAD and the absence of clinical coronary artery disease (CAD) were offered the service between May 2003 and September 2004 and followed up for a minimum of 6 months. RESULTS: We administratively identified 5159 active patients with a diagnosis of PAD. Of these, 1075 could be validated with a noninvasive arterial study. The exclusion of 384 patients with a diagnosis of CAD resulted in a cohort of 691 patients. Of these, 90 patients were enrolled in the lipid service (study group), and 601 received standard care. Mean follow-up was 17.1 months. Screening fasting lipid profiles were found in 95.6% (86/90) of patients in the study group and only 66.9% (402/601) of the standard care patients (P < .0001). Low-density lipoprotein cholesterol (LDL-C) control was improved in the pharmacist-managed group, with 79.1% (68/86) achieving an LDL-C of less than 100 mg/dL in comparison to the standard care group (54.8% [219/400]; P < .0001). An LDL-C value of more than 130 mg/dL was noted in 1.2% and 14.0% (56/400) in the treatment and control groups, respectively (P < .001). Statin use was present in 51.9% (312/601) of the control group patients and 84.4% (76/90) of the pharmacist-managed group (P < .001). CONCLUSIONS: Despite national consensus of PAD as a CAD equivalent, patients are currently undertreated with regard to atherosclerotic risk factor modification. Initiation of a pharmacist-managed, physician-monitored lipid service provides improved compliance with national guidelines.

Atherosclerotic risk factor control in patients with peripheral arterial disease.

BACKGROUND: The presence of peripheral arterial disease (PAD), even in the absence of overt coronary artery disease (CAD), confers the same relative risk of death from a cardiovascular cause as in patients with a previous cardiovascular event. Current guidelines recommend atherosclerotic risk factor-reduction strategies in PAD patients identical to those in patients with a recent coronary event. The purpose of this study was to determine the status of atherosclerotic risk factor control in patients with PAD. METHODS: We analyzed the records of patients treated at 2 regional clinics serving 92,940 individuals. Full examination, laboratory, and pharmacy data were available for all patients. Pharmacy data were analyzed to determine prescriptions for beta-blocker therapy, angiotensin-converting enzyme inhibitors, and lipid-lowering agents. Lipid control was assessed through fasting lipid data. Glycemic control in diabetics was evaluated by using hemoglobin A 1c levels. RESULTS: We administratively identified 2839 patients with a diagnosis of PAD. The exclusion of 1106 patients with a diagnosis of CAD or validated not to have PAD resulted in a cohort of 1733 patients. Of these, 33.1% (574/1733) were currently receiving beta-blockers, 28.9% (500/1733) were receiving an angiotensin-converting enzyme inhibitor, and 31.3% (543/1733) were receiving a statin. Most patients (92%; 1594/1733) had a recent blood pressure recorded. However, 56% (893/1594) had a systolic blood pressure of 130 mm Hg or higher, 45.5% (726/1594) had a diastolic blood pressure of 80 mm Hg or higher, and 13.6% (217/1594) had a diastolic blood pressure of 90 mm Hg or higher. Screening fasting lipid profiles were found in 62.6% (1085/1733) of patients, 56% (508/912) had a low-density lipoprotein of 100 mg/dL or higher, and 21% (187/912) had a value of more than 130 mg/dL. In patients with diabetes, a hemoglobin A 1c level of 7.0% or higher was found in 54.2% (198/365) of patients. CONCLUSIONS: Despite national consensus of PAD as a CAD equivalent, patients are currently undertreated with regard to atherosclerotic risk factor modification. Until broader recognition of this disease process exists, vascular surgeons must continue to champion medical as well as surgical treatments for these patients.

Femoral endarteritis associated with percutaneous suture closure: new technology, challenging complications.

OBJECTIVE: Use of percutaneous suture closure devices after catheter-based interventions is increasing. We recently have seen several severe femoral arterial wall infections after use of such devices. The purpose of this study was to examine the incidence, comorbid associations, and management of femoral arterial infections associated with percutaneous suture closure devices. METHODS: We retrospectively reviewed all infectious complications that occurred after 2223 consecutive cardiac catheterization procedures performed over 12 months in a university-affiliated community teaching hospital. Outcome variables included demographics, procedural details, infection, type of arterial reconstruction required, mortality, and limb loss. RESULTS: During this study, 822 patients received percutaneous suture devices. Infection developed in 6 patients (0.7%). The incidence of diabetes in the population undergoing percutaneous suture closure was 219 of 822 patients (26.6%). Three comorbid conditions, noted in multiple patients with infectious complications, included diabetes mellitus, obesity, and placement of a percutaneous suture closure device within the past 6 months. Invasive femoral endarteritis developed in 4 patients. Gram-positive cocci predominated in 4 patients. In 1 patient with polymicrobial infection catastrophic complications developed, including multiple anastomotic ruptures and hemorrhage. A new method of repair that incorporated double-thickness everted saphenous vein was used in 2 patients, and safe arterial closure was achieved. There was 1 late fatality on postoperative day 36. Limb salvage was achieved in all patients. CONCLUSIONS: Femoral endarteritis complicating percutaneous suture closure is a challenging new problem for vascular surgeons and can result in catastrophic complications. Customary techniques that use saphenous vein patch or interposition grafting are not adequate in all circumstances. Successful outcome requires operative exploration in patients with suspected infection. Removal of the percutaneous suture closure device and debridement to normal arterial wall is recommended in all patients with suspected femoral endarteritis, based on positive intraoperative Gram stains or abnormal appearance of the adjacent femoral artery. Early success with an autologous bolstered repair is reported. Caution is advised when considering the use of a percutaneous suture closure device in patients with comorbid conditions including diabetes, obesity, and previously implanted devices.