Association Between Mental Health Burden, Clinical Presentation, and Outcomes in Individuals With Symptomatic Peripheral Artery Disease: A Scientific Statement From the American Heart Association.

Along with the rising burden of peripheral artery disease (PAD), mental health concerns are increasingly being recognized as a comorbidity to address in the chronic disease management of symptomatic PAD. Apart from a high prevalence of comorbid mental health conditions, the role of pain and changing health behaviors and the broader impacts of illness and adaptation to living with PAD require specialized behavioral health expertise. This scientific statement builds a case that this expertise should be integrated within the multidisciplinary PAD team. Furthermore, areas such as cognitive dysfunction and palliative care are highlighted as needing psychological interventions. Although much of the evidence of the efficacy of psychological and psychotropic interventions has been extrapolated from other cardiovascular populations, evidence for the role of psychological interventions for behavior change, for example, uptake of exercise regimens, is increasingly being accrued within PAD. Areas for behavioral health needs and interactions with PAD treatment are discussed, including the use of opioids, depression management, anxiety and stress reduction interventions, the use of benzodiazepines and antidepressants, smoking cessation, rehabilitation trajectories after amputation, and the role of cognitive decline for PAD treatment and outcomes. A case summary highlights the stigma around mental health and vascular disease and the fragmentation of care. This scientific statement provides remarks for building a road map for integrated behavioral PAD care and potential solutions to overcome these barriers. Instrumental to reaching these changes are interprofessional advocacy efforts and initiatives that help break down the stigma around mental health and promote evidence-based collaborative, nonhierarchical, and multidisciplinary PAD care.

Contributions of Systolic and Diastolic Blood Pressures to Cardiovascular Outcomes in the ALLHAT Study.

BACKGROUND: SBP and DBP have important associations with cardiovascular events, but are seldom considered simultaneously. OBJECTIVES: This study sought to simultaneously analyze systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements on the associated risk of a primary composite outcome of all-cause mortality, myocardial infarction (MI), congestive heart failure (CHF), or stroke. METHODS: This study analyzed ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) data, which randomized adults to chlorthalidone, amlodipine, or lisinopril. The authors evaluated the simultaneous association of repeated SBP and DBP measurements on the primary composite outcome, and each outcome using proportional hazards regression. The authors report hazard ratios using a "heat map" to represent high and low risk according to SBP and DBP combinations. RESULTS: During a median follow-up of 4.4 years (interquartile range: 3.6-5.4 years), 33,357 participants experienced 2,636 MIs, 866 CHF events, 936 strokes, and 3,700 deaths; 8,138 patients (24.4%) had at least 1 event. For the composite outcome, all-cause mortality, MI, and CHF, a U-shaped association was observed with SBP and DBP, but the SBP and DBP associated with the lowest hazards differed for each outcome. For example, SBP/DBP of 140-155/70-80 mm Hg was associated with the lowest HR for all-cause mortality, compared with 110-120/85-90 mm Hg for MI and 125-135/70-75 mm Hg for CHF. In contrast, the association of SBP and stroke was linear. CONCLUSIONS: The risk pattern of SBP and DBP differs by clinical outcomes, and the SBP and DBP associated with the lowest risk. Our results suggest individualization of blood pressure targets may depend in part on the cardiovascular event for which the patient is most at risk.

Analysis of Medicare Payments and Patient Outcomes With Pre-Operative Imaging for Carotid Endarterectomy.

OBJECTIVE: The use of radiographic evaluation of carotid disease may vary, and current guidelines do not strongly recommend the use of cross-sectional imaging (CSI) prior to surgical intervention. We sought to describe the trends in preoperative carotid imaging and evaluate the associated clinical outcomes and Medicare payments for patients undergoing carotid endarterectomy (CEA) for asymptomatic carotid disease. METHODS: We used a 20% Medicare sample from 2006 to 2014 identifying patients undergoing CEA for asymptomatic disease. We evaluated preoperative carotid ultrasound and CSI use: CT or MRI of the neck prior to CEA. We calculated average payments of each study from the carrier file and revenue center file. Imaging payments included both the professional component (PC) and the technical component (TC). Claims with a reimbursement of $0 and studies where payment for both the TC and PC could not be identified were excluded from the overall calculation to determine average payment per study. Inpatient reimbursements according to DRG 37-39 were calculated. We compared hospital length of stay (LOS), in hospital stroke, carotid re-exploration, and mortality according to CSI use. RESULTS: A total of 58,993 CEAs were identified with pre-operative carotid imaging. The average age was 74.8 ± 7.5 years, and 56.0% were men. A total of 19,678 (33%) patients had ultrasound alone with an average of (2.4 ± 1.9) exams prior to CEA. A total of 39,315 patients underwent CSI prior to CEA with 2.5 ± 2.1 ultrasounds, 0.95 ± 0.86 neck CTs and 0.47 ± 0.7 MRIs per patient. The average payment for ultrasound was $140 ± 40, $282 ± 94 for CT and $410 ± 146 for MRI. The average inpatient reimbursements were $7,413 ± 4,215 for patients without CSI compared with $7,792 ± 3,921 for patients with CSI, P < 0.001. The average LOS during CEA admission was 2.5 ± 3.7days. Patients with CSI had a slightly lower percentage of patients being discharged by postoperative day 2 compared with ultrasound alone (88.9% vs. 91.5%, respectively, P < 0.001). The overall in-hospital stroke rate was 0.38% and carotid re-exploration rate was 1.0% and there was no statistical significant difference between groups. Median follow-up was 3.9 years, and mortality at 8 years was 50% and did not statistically differ between groups. CONCLUSIONS: Our analysis found preoperative imaging to include CSI in nearly two-thirds of patients prior to CEA for asymptomatic disease. As imaging and inpatient payments were higher with patients with CSI further work is needed to understand when CSI is appropriate prior to surgical intervention to appropriately allocate healthcare resources.

Cost-effectiveness analysis of ankle-brachial index screening in patients with coronary artery disease to optimize medical management.

INTRODUCTION: Screening for peripheral artery disease (PAD) with the ankle-brachial index (ABI) test is currently not recommended in the general population; however, previous studies advocate screening in high-risk populations. Although providers may be hesitant to prescribe low-dose rivaroxaban to patients with coronary artery disease (CAD) alone, given the reduction in cardiovascular events and death associated with rivaroxaban, screening for PAD with the ABI test and accordingly prescribing rivaroxaban may provide additional benefits. We sought to describe the cost-effectiveness of screening for PAD in patients with CAD to optimize this high-risk populations' medical management. METHODS: We used a Markov model to evaluate the ABI test in patients with CAD. We assumed that all patients screened would be candidates for low-dose rivaroxaban. We assessed the cost of ABI screening at $100 per patient and added additional charges for physician visits ($100) and rivaroxaban cost ($470 per month). We used a 30-day cycle and performed analysis over 35 years. We evaluated quality-adjusted life years (QALYs) from previous studies and determined the incremental cost-effectiveness ratio (ICER) according to our model. We performed a deterministic and probabilistic sensitivity analyses of variables with uncertainty and reported them in a Tornado diagram showing the variables with the greatest effect on the ICER. RESULTS: Our model estimates decision costs to screen or not screen at $94,953 and $82,553, respectively. The QALYs gained from screening was 0.060, generating an ICER of $207,491 per QALY. Factors most influential on the ICER were the reduction in all-cause mortality associated with rivaroxaban and the prohibitively high cost of rivaroxaban. If rivaroxaban cost less than $95 per month, this would make screening cost-effective based on a willingness to pay threshold of $50,000 per QALY. CONCLUSIONS: According to our model, screening patients with CAD for PAD to start low-dose rivaroxaban is not currently cost-effective due to insufficient reduction in all-cause mortality and high medication costs. Nevertheless, vascular surgeons have a unique opportunity to prescribe or advocate for low-dose rivaroxaban in patients with PAD to improve cardiovascular outcomes.

Mid-Term Survival after Thoracic Endovascular Aortic Repair by Indication in the Medicare Population.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) is indicated for treatment of aneurysms, dissections, and traumatic injury. We describe mid-term mortality and reintervention rates in Medicare beneficiaries undergoing TEVAR. STUDY DESIGN: Patients who underwent TEVAR between 2006 and 2014 were identified by CPT codes in a 20% Medicare sample. Indication for aortic repair (aneurysm, dissection, trauma) was ascertained via ICD-9 codes. Follow-up was evaluated until 2015. Kaplan-Meier survival analysis and Cox regression were used to compare mortality, with reintervention and mortality rates expressed as a composite outcome in a hazard ratio with 95% confidence interval (hazard ratio [HR] 95% CI). RESULTS: There were 3,095 patients who underwent TEVAR during the study period: 1,465 (47%) for aneurysm, 1,448 (47%) for dissection, and 182 (5.9%) for trauma. Mean patient age was 74.4 years, and 44.5% were female. Median follow-up was 2.7 years. The overall 30-day, 1-year, and 5-year, and 8-year survival rates were 93%, 78%, 49%, and 33%, respectively. Thirty-day mortality was highest in traumatic indications, but overall mortality was highest in patients undergoing TEVAR for aneurysm. Freedom from combined reintervention and mortality at 30 days, 1 year, 5 years, and 8 years was 89%, 73%, 43%, and 29%, respectively. Reintervention was highest in patients undergoing TEVAR for dissection (12.8%), followed by aneurysm (10.0%) and trauma (5.5%). Advanced age (HR 1.03 per year, 95% CI 1.02-1.03), congestive heart failure (CHF) (HR 1.48, 95% CI 1.33-1.65), dementia (HR 1.40, 95% CI 1.14-1.28), and rupture (HR 1.38, 95% CI 1.24-1.54) were associated with mortality. CONCLUSIONS: Midterm survival is lower in patients who undergo TEVAR for dissection and aneurysm compared with trauma. Aneurysmal disease, advanced age, CHF, dementia, and aortic rupture are associated with mortality and reintervention in TEVAR.

Comparison of mid-term graft patency in common femoral versus superficial femoral artery inflow for infra-geniculate bypass in the vascular quality initiative.

OBJECTIVES: The superficial femoral artery can be used as inflow for infra-geniculate bypass, but progressive proximal occlusive disease may affect graft durability. We sought to evaluate the effect of superficial femoral artery versus common femoral artery inflow on infra-geniculate bypass patency within a large contemporary multicenter registry. METHODS: The vascular quality initiative was queried from 2013 to 2019 to identify patients with >30-day patency follow-up, Rutherford chronic limb ischemia stage 1-6, and an infra-geniculate bypass, excluding those with prior ipsilateral bypass. The cohort was stratified by inflow vessel, with primary, primary-assisted, and secondary patency serving as the primary outcome variables. Multivariate Cox-proportional hazard models and radius-based propensity-score matching were performed to reduce treatment-selection bias due to clinical covariates. RESULTS: A total of 11,190 bypass procedures were performed (8378 common femoral artery inflow, 2812 superficial femoral artery) on 10,110 patients, with a mean follow-up of 12.8 months (range 1-98). Patients receiving superficial femoral artery inflow bypasses were more commonly male (p = 0.002), obese (p < 0.0001) and had chronic, limb threatening ischemia (p < 0.0001), whereas those with common femoral artery inflow were older (p < 0.0004), and had higher baseline comorbidities including smoking (p < 0.0001), coronary disease (p < 0.0001), and pulmonary disease (p < 0.0001). On life-table analysis, there was no significant difference in three year estimated primary (32.1 vs 30.1%, p = 0.928), primary assisted (60.5 vs 65.8%, p = 0.191), or secondary patency (62.5 vs 66.7%, p = 0.139) between superficial femoral artery and common femoral artery inflow groups, respectively. A multivariate Cox model found no significant association between inflow vessel and primary patency (0.96 [0.88-1.04], HR [95%CI]), primary-assisted (1.07 [0.95-1.20], HR [95%CI]), or secondary patency (1.08 [0.96-1.22]). In a propensity-matched cohort (n = 11,151), there were small but statistically significant differences in primary, primary-assisted, and secondary patency at latest follow-up (non-time-to-event data) between groups. The largest difference was observed when evaluating secondary patency, with common femoral artery inflow having a marginally higher secondary patency of 88.1% compared to 85.6% for those with superficial femoral artery inflow at latest follow-up (p = 0.009). CONCLUSIONS: Within the vascular quality initiative, there is no significant difference in life-table determined three-year primary, primary-assisted, and secondary patency between infra-geniculate bypasses using common femoral artery inflow compared to superficial femoral artery inflow. Small, statistically significant differences exist in primary, primary-assisted, and secondary patency favoring common femoral artery inflow after propensity score matching. Long-term follow-up data are required in the vascular quality initiative to better evaluate bypass graft durability as this study was limited by a mean follow-up of one year.

Initial financial impact of office-based laboratories on Medicare payments for percutaneous interventions for peripheral artery disease.

OBJECTIVE: Percutaneous interventions for peripheral artery disease (PAD) are transitioning away from hospital-based settings to office-based laboratories (OBLs). Those in favor of OBL use reference lower hospitalization rates and high efficiency; however, critics claim financial incentives may lead to multiple procedures and higher atherectomy use. We sought to determine how Medicare payments are affected by OBL use. METHODS: We identified physicians performing percutaneous interventions for PAD from 2006 to 2013 in a 20% Medicare sample. Physicians performing a majority of interventions at OBLs were classified as high OBL users; control physicians performed interventions at hospital-based settings. The primary outcomes were total Medicare payments at 30 days and 1 year. Generalized log-gamma regression models were used to evaluate factors influencing payments reported as a percentage change and 95% confidence interval (95% CI). A secondary analysis was performed of physicians who transitioned from hospital-based settings to OBLs, "switch physicians." A multivariate model with difference-in-differences regression was used to evaluate the effects of transitioning to OBLs. RESULTS: A total of 89 high OBL users performed percutaneous interventions on 887 patients, and 3715 control physicians treated 54,213 patients during the time period. Payments for patients treated by high OBL users were significantly higher compared with control physicians at 30 days ($4465), 90 days ($8925), and 1 year ($27,436). Major factors increasing payments at 1 year were treatment by a high OBL user (49%; 95% CI, 42%-56%), hospital admissions (127%; 95% CI, 123%-131%), repeated lower extremity procedures (41%; 95% CI, 39%-43%), and lower extremity wound (20%; 95% CI,18%-22%). Factors decreasing payments at 1 year were living in a rural setting (8%; 95% CI, 7%-9%) and dementia (5%; 95% CI, 3%-7%). Analysis of 292 switch physicians identified 3888 patients treated before OBLs (pre-switch) and 3246 after OBLs (post-switch). Transitioning to OBLs was associated with higher payments at 30 days and 90 days, and this increase was higher compared with control physicians. CONCLUSIONS: These findings highlight that OBL use for PAD interventions significantly influences Medicare payments, and its widespread adaptation should be made with caution. The main factors driving payments were hospitalization admissions, repeated lower extremity procedures, and wound status. Further work is needed to evaluate the appropriate use of OBLs to optimize patient outcomes and resource allocations.

Incidence and Risk Factors for Deep Vein Thrombosis after Radiofrequency and Laser Ablation of the Lower Extremity Veins.

BACKGROUND: The rates of thromboembolic complications such as deep vein thrombosis (DVT) after venous ablation procedures for symptomatic superficial venous insufficiency are controversial. We sought to describe the risk factors for and incidence of DVT after radiofrequency ablation (RFA) and laser ablation (LA). METHODS: We queried the Truven Health Marketscan Database from 2007-16 for patients who underwent RFA or LA and had a follow-up duplex ultrasound within 30 days of the ablation procedure. The primary outcome was DVT at 7 and 30 days identified by International Classification of Diseases-9 and International Classification of Diseases-10 codes. Multivariable regression was used to evaluate the patient and procedural variables associated with a DVT at 30 days, expressed as odds ratios (ORs) with a 95% confidence interval (95% CI). Patients and procedures with a previous DVT diagnosis were excluded. RESULTS: A total of 256,999 patients underwent 433,286 ablation procedures: 192,195 (44.4%) RFA and 241,091 LA. Of these, 8,203 (1.9%) had a newly diagnosed DVT within 7 days and 13,347 (3.1%) within 30 days of the procedure. The incidence of DVT decreased over the study period. LA (2.8%) demonstrated a lower incidence of DVT at 30 days compared with RFA (3.4%), P < 0.001. On multivariable regression, LA (OR, 0.82; 95% CI 0.80-0.85) was again associated with a decreased risk for 30-day DVT, as was female gender (OR, 0.74; 95% CI, 0.71-0.77), and sclerotherapy performed on the same day (OR, 0.91; 95% CI, 0.85-0.98). A diagnosis of peripheral artery disease (OR, 1.23; 95% CI, 1.16-1.31) and concomitant stab phlebectomy (OR, 1.43; 95% CI, 1.37-1.49) was associated with an increased risk of DVT within 30 days. CONCLUSIONS: The incidence of newly diagnosed DVT within 30 days of an ablation procedure was 3.2%. The risk for DVT decreased in recent years, and LA was associated with an 18% decreased risk compared with RFA.

Preprocedural Cross-Sectional Imaging Prior to Percutaneous Peripheral Arterial Disease Interventions.

Preprocedural cross-sectional imaging (PCSI) for peripheral artery disease (PAD) may vary due to patient complexity, anatomical disease burden, and physician preference. The objective of this study was to determine the utility of PCSI prior to percutaneous vascular interventions (PVIs) for PAD. Patients receiving first time lower extremity angiograms from 2013 to 2015 at a single institution were evaluated for PCSI performed within 180 days, defined as computed tomography angiography (CTA) or magnetic resonance angiography (MRA) evaluating abdominal to pedal vasculature. The primary outcome was technical success defined as improving the target outflow vessels to <30% stenosis. Of the 346 patients who underwent lower extremity angiograms, 158 (45.7%) patients had PCSI, including 150 patients had CTA and 8 patients had MRA. Of these, 48% were ordered by the referring provider (84% at an outside institution). Preprocedural cross-sectional imaging was performed at a median of 26 days (interquartile range: 9-53) prior to the procedure. The analysis of the institution's 5 vascular surgeons identified PCSI rates ranging from 31% to 70%. On multivariate analysis, chronic kidney disease (odds ratio [OR] = 0.35; 95% confidence interval [CI]: 0.17-0.73) was associated with less PSCI usage, and inpatient/emergency department evaluation (OR = 3.20; 95% CI: 1.58-6.50) and aortoiliac disease (OR = 2.78; 95% CI: 1.46-5.29) were associated with higher usage. After excluding 31 diagnostic procedures, technical success was not statistically significant with PSCI (91.3%) compared to without PCSI (85.6%), P = .11. When analyzing 89 femoral-popliteal occlusions, technical success was higher with PCSI (88%) compared to procedures without (69%) P = .026. Our analysis demonstrates that routine ordering of PCSI may not be warranted when considering technical success of PVI; however, PCSI may be helpful in treatment planning. Further studies are needed to confirm these findings in another practice setting, with more prescriptive use of PCSI to improve procedural success, and thereby improve the value of PCSI.

Endovascular Neck Stabilization Before EVAR for Infrarenal Aortic Aneurysm in Chronic Aortic Dissection.

BACKGROUND: Endovascular treatment of infrarenal abdominal aortic aneurysm (AAA) with proximal chronic aortic dissection is challenging as a false and true lumen at the level of the infra-renal neck does not allow a sufficient landing zone. We describe staged endovascular neck stabilization prior to standard endovascular aortic repair (EVAR) for AAA with chronic aortic dissection. TECHNIQUE: To create a stable proximal neck (PN) by closing entry tears, thereby resulting in total false lumen thrombosis (FLT) prior to standard EVAR. Case 1 false lumen fenestrations were present at the descending aorta, the right renal artery orifice and PN. After closing the entry tear by thoracic EVAR, an aortic cuff was placed in the true lumen of the PN and renal stenting for the right renal artery was performed. After 2 months, total FLT was achieved, and EVAR was performed. Case 2 false lumen fenestrations were present at the descending, super celiac aorta and PN. After closing the entry by TEVAR, aortic cuffs were placed at infrarenal aorta to close residual entries. After 1 month of achieving total FLT, EVAR was performed. Both cases had no type 1 endoleak during follow-up. CONCLUSION: The endovascular neck stabilization is a useful treatment option that facilitates standard EVAR for AAA in chronic aortic dissection.

Impact of office-based laboratories on physician practice patterns and outcomes after percutaneous vascular interventions for peripheral artery disease.

BACKGROUND: Percutaneous vascular interventions (PVIs) for peripheral artery disease have shifted from hospital-based facilities to office-based laboratories (OBLs). The transition to OBLs is due to a variety of factors such as technology advancement, increased efficiency, and financial incentives. We evaluated the impact of physicians switching to OBLs use from hospital-based facilities on procedure volume, procedure type, and patient outcomes. METHODS: We identified patients with PVI for lower extremity peripheral artery disease from 2006 to 2013 in a 20% Medicare sample and identified physicians who transitioned from predominantly hospital-based facilities to OBLs (switch physicians) and compared them with those who did not use OBLs (control physicians). The main outcomes investigated were average number of PVIs at 30 days and 1 year and atherectomy usage. Patient outcomes included above-ankle amputation, major adverse limb events, and death. We used a difference-in-difference model to control for time effects in a multivariate regression model, reported as an odds ratio (OR) and 95% confidence interval (CI). RESULTS: The cohort comprised 292 switch physicians, who treated 7134 patients (3888 before OBL use and 3246 after transitioning to OBLs), and 3715 control physicians treating 54,213 patients (36,327 in the preperiod and 17,886 in the postperiod). Switch and control physicians both treated more patients with lower extremity wounds during the study period; however, this increase was greater for control physician (0.7% vs 5.5%, P < .001). On average, patients treated by switch physicians had 0.05 (95% CI, 0.03-0.07; P < .001) underwent more PVIs within 30 days and 0.12 more PVIs (95% CI, 0.08-0.16; P < .001) within 1 year of the initial revascularization procedure after the physician transitioned to an OBL. Similarly, patients treated by switch physicians underwent 0.02 (95% CI, 0.01-0.03; P = .002) more atherectomy procedures at 30 days and 0.03 (95% CI, 0.01-0.05; P = .008) more atherectomy procedures at 1 year. Transitioning to OBLs was also associated with a decreased risk in above-ankle amputation at 30 days (OR, 0.58; 95% CI, 0.38-0.97; P = .009) and 1 year (OR, 0.75; 95% CI, 0.60-0.95; P = .01). However, no statistical difference was observed for major adverse limb events and mortality rates at 30 days and 1 year because patients treated by switch and control physicians experienced similar decreases. CONCLUSIONS: Transitioning to OBLs was associated higher 30-day and 1-year PVI rates and atherectomy rates. Although transitioning to OBLs was associated with lower rates of above-ankle amputations, switch physicians treated a lower number of patients with lower extremity wounds.

Forearm loop arteriovenous grafts preserve and may create new upper arm access sites.

INTRODUCTION: This study evaluated the mid-term patency of forearm loop arteriovenous grafts and the dilation of previously inadequate upper arm basilic and cephalic veins after failed forearm loop arteriovenous graft. METHODS: All access procedures from September 2009 to December 2015 were reviewed. Vein mapping measurements were used to determine whether there was "adequate" upper arm cephalic and/or basilic vein, defined as ⩾3 mm by duplex ultrasound, at the time of forearm loop arteriovenous graft creation. Outcomes of forearm loop arteriovenous graft were compared with upper arm arteriovenous fistula, and primary and cumulative patencies were evaluated. RESULTS: Thirty-eight forearm loop arteriovenous grafts and 278 upper arm arteriovenous fistulas were created. In the forearm loop arteriovenous graft cohort, nine were inserted with adequate upper arm vein, group A, and 29 were inserted with inadequate upper arm vein, group B. Cumulative patency was lower for forearm loop arteriovenous graft compared with upper arm arteriovenous fistula at 6 months, 1 year, and 2 years (67% vs 91%, 61% vs 85%, and 49% vs 80%, respectively, P < .01). Comparison of group A forearm loop arteriovenous graft and upper arm arteriovenous fistula did not show a statistical difference in cumulative patency at 6 months, 1 year, and 2 years (P = .80, .62, and .70, respectively). Of group B with failed forearm loop arteriovenous graft, 36% became candidates for upper arm arteriovenous fistula with dilation of ipsilateral upper arm cephalic or basilic vein to ⩾3 mm. CONCLUSION: In this study, forearm loop arteriovenous graft with adequate upper arm vein did not show a statistical difference in mid-term patencies compared with upper arm arteriovenous fistula. For those forearm loop arteriovenous grafts with inadequate upper arm vein, approximately one-third of patients became candidates for upper arm arteriovenous fistula demonstrating the benefits forearm loop arteriovenous graft.

Association of opioid use and peripheral artery disease.

BACKGROUND: Prescription opioids account for 40% of all U.S. opioid overdose deaths, and national efforts have intensified to reduce opioid prescriptions. Little is known about the relationship between peripheral artery disease (PAD) and high-risk opioid use. The objectives of this study were to evaluate this relationship and to assess the impact of PAD treatment on opiate use. METHODS: In this retrospective cohort study, the Truven Health MarketScan database (Truven Health Analytics, Ann Arbor, Mich), a deidentified national private insurance claims database, was queried to identify patients with PAD (two or more International Classification of Diseases, Ninth Revision diagnosis codes of PAD ≥2 months apart, with at least 2 years of continuous enrollment) from 2007 to 2015. Critical limb ischemia (CLI) was defined as the presence of rest pain, ulcers, or gangrene. The primary outcome was high opioid use, defined as two or more opioid prescriptions within a 1-year period. Multivariable analysis was used to determine risk factors for high opioid use. RESULTS: A total of 178,880 patients met the inclusion criteria, 35% of whom had CLI. Mean ± standard deviation follow-up time was 5.3 ± 2.1 years. An average of 24.7% of patients met the high opioid use criteria in any given calendar year, with a small but significant decline in high opioid use after 2010 (P < .01). During years of high opioid use, 5.9 ± 5.5 yearly prescriptions were filled. A new diagnosis of PAD increased high opioid use (21.7% before diagnosis vs 27.3% after diagnosis; P < .001). A diagnosis of CLI was also associated with increased high opioid use (25.4% before diagnosis vs 34.5% after diagnosis; P < .001). Multivariable analysis identified back pain (odds ratio [OR], 1.89; 95% confidence interval [CI], 1.84-1.93; P < .001) and illicit drug use (OR, 1.87; 95% CI, 1.72-2.03; P < .001) as the highest predictors of high opioid use. A diagnosis of CLI was also associated with higher risk (OR, 1.61; 95% CI, 1.57-1.64; P < .001). A total of 43,443 PAD patients (24.3%) underwent 80,816 PAD-related procedures. After exclusion of periprocedural opioid prescriptions (4.9% of all opioid prescriptions), the yearly percentage of high opioid users increased from 25.8% before treatment to 29.6% after treatment (P < .001). CONCLUSIONS: Patients with PAD are at increased risk for high opioid use, with nearly one-quarter meeting described criteria. CLI and treatment for PAD additionally increase high opioid use. In addition to heightened awareness and active opioid management, our findings warrant further investigation into underlying causes and deterrents of high-risk opioid use.

Metformin prescription status and abdominal aortic aneurysm disease progression in the U.S. veteran population.

BACKGROUND: Identification of a safe and effective medical therapy for abdominal aortic aneurysm (AAA) disease remains a significant unmet medical need. Recent small cohort studies indicate that metformin, the world's most commonly prescribed oral hypoglycemic agent, may limit AAA enlargement. We sought to validate these preliminary observations in a larger cohort. METHODS: All patients with asymptomatic AAA disease managed in the Veterans Affairs Health Care System between 2003 and 2013 were identified by International Classification of Diseases, Ninth Revision codes. Those with a concomitant diagnosis of diabetes mellitus who also received two or more abdominal imaging studies (computed tomography, magnetic resonance imaging, or ultrasound) documenting the presence and size of an AAA, separated by at least 1 year, were included for review. Maximal AAA diameters were determined from radiologic reports. Further data acquisition was censored after surgical AAA repair, when performed. Comorbidities, active smoking status, and outpatient medication records (within 6 months of AAA diagnosis) were also queried. Yearly AAA enlargement rates, as a function of metformin treatment status, were compared using two statistical models expressed in millimeters per year: a multivariate linear regression (model 1) and a multivariate mixed-effects model with random intercept and random slope (model 2). RESULTS: A total of 13,834 patients with 58,833 radiographic records were included in the analysis, with radiology imaging follow-up of 4.2 ± 2.6 years (mean ± standard deviation). The average age of the patients at AAA diagnosis was 69.8 ± 7.8 years, and 39.7% had a metformin prescription within ±6 months of AAA. The mean growth rate for AAAs in the entire cohort was 1.4 ± 2.0 mm/y by model 1 analysis and 1.3 ± 1.6 mm/y by model 2 analysis. The unadjusted mean rate of AAA growth was 1.2 ± 1.9 mm/y for patients prescribed metformin compared with 1.5 ± 2.2 mm/y for those without (P < .001), a 20% decrease. This effect remained significant when adjusted for variables relevant on AAA progression: metformin prescription was associated with a reduction in yearly AAA growth rate of -0.23 mm (95% confidence interval, -0.35 to -0.16; P < .001) by model 1 analysis and 0.20 mm/y (95% confidence interval, -0.26 to -0.14; P < .001) by model 2 analysis. A subset analysis of 7462 patients with baseline AAA size of 35 to 49 mm showed a similar inhibitory effect (1.4 ± 2.0 mm/y to 1.7 ± 2.2 mm/y; P < .001). Patients' factors associated with an increased yearly AAA growth rate were baseline AAA size, metastatic solid tumors, active smoking, chronic obstructive pulmonary disease, and chronic renal disease. Factors associated with decreased yearly AAA growth rates included prescriptions for angiotensin II type 1 receptor blockers or sulfonylureas and the presence of diabetes-related complications. CONCLUSIONS: In a nationwide analysis of diabetic Veterans Affairs patients, prescription for metformin was associated with decreased AAA enlargement. These findings provide further support for the conduct of prospective clinical trials to test the ability of metformin to limit progression of early AAA disease.

Episode-based cost reduction for endovascular aneurysm repair.

OBJECTIVE: Effective strategies to reduce costs associated with endovascular aneurysm repair (EVAR) remain elusive for many medical centers. In this study, targeted interventions to reduce inpatient EVAR costs were identified and implemented. METHODS: From June 2015 to February 2016, we analyzed the EVAR practice at a high-volume academic medical center to identify, to rank, and ultimately to reduce procedure-related costs. In this analysis, per-patient direct costs to the hospital were compared before (September 2013-May 2015) and after (March 2016-January 2017) interventions were implemented. Improvement efforts concentrated on three categories that accounted for a majority of costs: implants, rooming costs, and computed tomography scans performed during the index hospitalization. RESULTS: Costs were compared between 141 EVAR procedures before implementation (PRE period) and 47 EVAR procedures after implementation (POST period). Based on data obtained through the Society for Vascular Surgery EVAR Cost Demonstration Project, it was determined that implantable device costs were higher than those at peer institutions. New purchasing strategies were implemented, resulting in a 30.8% decrease in per-case device costs between the PRE and POST periods. Care pathways were modified to reduce use of and costs for computed tomography scans obtained during the index hospitalization. Compared with baseline, per-case imaging costs decreased by 92.9% (P < .001), including a 99.0% (P = .001) reduction in postprocessing costs. Care pathways were also implemented to reduce preprocedural rooming for patients traveling long distances the day before surgery, resulting in a 50% decrease in utilization rate (35.4% PRE to 17.0% POST; P = .021), without having a significant impact on median postprocedural length of stay (PRE, 2 days [interquartile range, 1-11 days]; POST, 2 days [1-7 days]; P = .185). Medication costs also decreased by 38.2% (P < .001) as a hospital-wide effort. CONCLUSIONS: Excessive costs associated with EVAR threaten the sustainability of these procedures in health care organizations. Targeted cost reduction efforts can effectively reduce expenses without compromising quality or limiting patients' access.

Arteriovenous Fistula and Graft Construction in Patients with Implantable Cardiac Devices: Does Side Matter?

BACKGROUND: Limited reports have documented the effect cardiac implantable electronic devices (CIEDs) have on arteriovenous (AV) access patency. Current recommendations suggest placing the access on the contralateral side of the CIEDs, as there is concern for increased central venous stenosis and access failure. The goal of this study is to review our single-center AV access patency rates for dialysis patients with an ipsilateral or contralateral side CIED. METHODS: A retrospective review was performed from 2008 to 2016 at a single institution identifying all patients who have received a CIED and the diagnosis of end-stage renal disease (ESRD). Medical records were queried to identify each patient's dialysis access and whether it was ipsilateral or contralateral to the CIED. Primary outcomes of study were primary and secondary patency rates. RESULTS: A total of 44 patients were identified to have ESRD and CIED. Of these patients, 28 patients with fistulas or grafts (13 ipsilateral and 15 contralateral) had follow-up with regards to their AV access. There were 3 primary failures in both groups. For patients who had the CIED placed after already starting the dialysis, patency was based on when the cardiac device was implanted. Primary patency for ipsilateral and contralateral access was 20.2 and 22.2 months, respectively. With secondary interventions, ipsilateral and contralateral mean patency was 39 and 48.8 months, respectively. Six-month and 1-year primary patency for arteriovenous fistula or arteriovenous graft on patients with ipsilateral access was 69.2% and 53.8%, respectively. Ipsilateral 1-year cumulative patency was 39 months. CONCLUSIONS: CIED may lead to stenosis or occlusion to one's AV access; however, primary assisted and secondary patency rates are still acceptable at 6 months and 1 year compared to Kidney Disease Outcomes Quality Initiative guidelines. Despite a CIED, a surgeon's algorithm should not lead to the abandonment of an ipsilateral access if the central venous system is patent.

Association of Blood Pressure Measurements With Peripheral Artery Disease Events.

BACKGROUND: Current guidelines recommend treating hypertension in patients with peripheral artery disease (PAD) to reduce the risk of cardiac events and stroke, but the effect of reducing blood pressure on lower extremity PAD events is largely unknown. We investigated the association of blood pressure with lower extremity PAD events using data from the ALLHAT trial (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial). METHODS: ALLHAT investigated the effect of different antihypertensive medication classes (chlorthalidone, amlodipine, lisinopril, or doxazosin) on cardiovascular events. With the use of these data, the primary outcome in our analysis was time to first lower extremity PAD event, defined as PAD-related hospitalization, procedures, medical treatment, or PAD-related death. Given the availability of longitudinal standardized blood pressure measurements, we analyzed systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse pressure as time-varying categorical variables (reference categories 120-129 mm Hg for SBP, 70-79 mm Hg for DBP, and 45-54 mm Hg for pulse pressure) in separate models. We used extended Cox regression with death as a competing risk to calculate the association of each blood pressure component with PAD events, and report the results as subdistribution hazard ratios and 95% CIs. RESULTS: The present analysis included 33 357 patients with an average age of 67.4 years, 53.1% men, 59.7% white race, and 36.2% with diabetes mellitus. The median baseline blood pressure was 146/84 mm Hg. Participants were followed for a median of 4.3 (interquartile range, 3.6-5.3) years, during which time 1489 (4.5%) had a lower extremity PAD event, and 4148 (12.4%) died. In models adjusted for demographic and clinical characteristics, SBP <120 mm Hg was associated with a 26% (CI, 5%-52%; P=0.015) higher hazard and SBP≥160 mm Hg was associated with a 21% (CI, 0%-48%; P=0.050) higher hazard for a PAD event, in comparison with SBP 120 to 129 mm Hg. In contrast, lower, but not higher, DBP was associated with a higher hazard of PAD events: for DBP <60 mm Hg (hazard ratio, 1.72; CI, 1.38-2.16). Pulse pressure had a U-shaped association with PAD events. CONCLUSIONS: In this reanalysis of data from ALLHAT, we found a higher rate of lower extremity PAD events with higher and lower SBP and pulse pressure and with lower DBP. Given the recent revised blood pressure guidelines advocating lower SBP targets for overall cardiovascular risk reduction, further refinement of optimal blood pressure targets specific to PAD is needed. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00000542.

Mycotic Renal Artery Aneurysm Presenting as Critical Limb Ischemia in Culture-Negative Endocarditis.

Mycotic renal artery aneurysms are rare and can be difficult to diagnose. Classic symptoms such as hematuria, hypertension, or abdominal pain can be vague or nonexistent. We report a case of a 53-year-old woman with a history of intravenous drug abuse presenting with critical limb ischemia, in which CT angiography identified a mycotic renal aneurysm. This aneurysm tripled in size from 0.46 cm to 1.65 cm in a 3-week interval. Echocardiography demonstrated aortic valve vegetations leading to a diagnosis of culture-negative endocarditis. The patient underwent primary resection and repair of the aneurysm, aortic valve replacement, and left below-knee amputation after bilateral common iliac and left superficial femoral artery stenting. At 1-year follow-up, her serum creatinine is stable and repaired artery remains patent.

Stabilization of the Abdominal Aorta During the Cardiac Cycle with the Sac-Anchoring Nellix Device.

The Nellix device uses polymer-filled endobags to stabilize the abdominal aortic aneurysm (AAA) sac which is described as endovascular aneurysm sealing (EVAS). We analyzed cardiac-gated computed tomography angiography scans of repaired AAA with EVAS in 4 patients to evaluate the geometry and cardiac pulsatility-induced deformation. Graft translation and aortic curvature changes were found to be minimal during the cardiac cycle. The mean ± standard deviation changes in renal-aorta angles (1.0 ± 0.9°) were less than the changes in the superior mesenteric artery-aorta angle (4.0 ± 2.1°) (P < 0.01), during the cardiac cycle, demonstrating greater stabilization of the visceral branches closer to the device. These findings confirm stabilization of the abdominal aorta during the cardiac cycle using EVAS.