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Purpose: To quantify the interobserver variability of abdominal aortic aneurysm (AAA) neck length and angulation measurements. Materials and Methods: A total of 25 consecutive patients scheduled for endovascular AAA repair underwent follow-up 64-row computed tomographic (CT) angiography in 0.625-mm collimation. AAA neck length and angulation were determined by four blinded, independent readers. AAA neck length was defined as the longitudinal distance between the first transverse CT slice directly distal to the lowermost renal artery and the first transverse CT slice that showed at least a 15% larger outer aortic wall diameter versus the diameter measured directly below the lowermost renal artery. Infrarenal AAA neck angulation was defined as the true angle between the longitudinal axis of the proximal AAA neck and the longitudinal axis of the AAA lumen as analyzed on three-dimensional CT reconstructions. Results: Mean deviation in aortic neck length determination was 32.3% and that in aortic neck angulation was 32.1%. Interobserver variability of aortic neck length and angulation measurements was considerable: in any reader combination, at least one measurement difference was outside the predefined limits of agreement. Conclusions: Assessment of the longitudinal extension and angulation of the infrarenal aortic neck is associated with substantial observer variability, even if measurement is carried out according to a standardized protocol. Further studies are mandatory to assess dedicated technical approaches to minimize variance in the determination of the longitudinal extension and angulation of the infrarenal aortic neck. [ABSTRACT FROM AUTHOR]

Purpose: To compare the safety and effectiveness of the Viabahn endoprosthesis with that of percutaneous transluminal angioplasty (PTA) alone in the treatment of symptomatic peripheral arterial disease (PAD) affecting the superficial femoral artery (SFA).Materials and Methods: From 1998 to 1999, patients with symptomatic SFA PAD were enrolled in a prospective, multicenter randomized study and underwent either PTA alone (n = 100) or PTA followed by stent-graft placement (expanded polytetrafluoroethylene/nitinol self-expanding stent-graft) (n = 97) for stenoses or occlusions of the SFA that were 13 cm long or shorter. At baseline, there were no significant differences between the PTA and stent-graft treatment groups, including chronic limb ischemia status and treated lesion length.Results: The stent-graft group had a significantly higher technical success rate (95% vs 66%, P < .0001) and 1-year primary vessel patency rate at duplex ultrasonography (65% vs 40%, P = .0003). A patency benefit was seen for lesions at least 3 cm long. At 12 months, chronic limb ischemia status was 15% further improved for the stent-graft group (P = .003). There were no significant differences between treatment groups with regard to the occurrence of early or late major adverse events.Conclusions: In this multicenter study, the patency, technical success, and clinical status results obtained with stent-grafts were superior to those obtained with PTA alone. [ABSTRACT FROM AUTHOR]

Endovascular aneurysm repair has matured significantly over the last 20 years and is becoming increasingly popular as a minimally invasive treatment option for patients with abdominal aortic aneurysms (AAA). Long-term durability of this fascinating treatment, however, is in doubt as continuing aneurysmal degeneration of the aortoiliac graft attachment zones is clearly associated with late adverse sequelae. In recent years, our growing understanding of the physiopathology of AAA formation has facilitated scrutiny of various potential drug treatment concepts. In this article we review the mechanical and biological challenges associated with endovascular treatment of infrarenal AAAs and discuss potential approaches to ongoing aneurysmal degeneration, which hampers long-term outcomes of this minimally invasive therapy. [ABSTRACT FROM AUTHOR]

Objective: Endovascular aneurysm repair (EVAR) is a widely used option for patients with suitable vascular anatomy who have a large infrarenal abdominal aortic aneurysm (AAA). Neck diameter is the primary anatomical determinant of EVAR eligibility and device durability. Doxycycline has been proposed to stabilise the proximal neck after EVAR. This study explored doxycycline mediated aortic neck stabilisation in patients with small AAA, monitored by computed tomography over two years., Methods: This was a multicentre prospective randomised clinical trial. Subjects from the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA 3 CT, NCT01756833) were included in this secondary a priori analysis. Female baseline AAA maximum transverse diameter was between 3.5 and 4.5 cm, and male was between 3.5 and 5.0 cm. Subjects were included if they completed pre-enrolment and two year follow up computed tomography (CT) imaging. Proximal aortic neck diameter was measured at the lowest renal artery, and 5, 10, and 15 mm caudal to this point; mean neck diameter was calculated from these values. Unpaired, two tailed parametric t test analysis with post hoc Bonferroni correction was used to detect differences between neck diameters in subjects treated with placebo vs. doxycycline at baseline and two years., Results: One hundred and ninety-seven subjects (171 male, 26 female) were included in the analysis. All patients, regardless of treatment arm, demonstrated larger neck diameter caudally, a slight increase in diameter at all anatomical levels over time, and greater growth caudally. There was no statistically significant difference in infrarenal neck diameter between treatment arms at any anatomical level at any time point, nor mean change in neck diameter over two years., Conclusion: Doxycycline does not demonstrate infrarenal aortic neck growth stabilisation in small AAA followed for two years by thin cut CT imaging using a standardised acquisition protocol and cannot be recommended for mitigation of growth of the aortic neck in patients with untreated small abdominal aortic aneurysms., Competing Interests: L.K. is a consultant for Alucent Biomedical. J.N.M. is a cofounder and stockholder of Vessel Wave Technologies and Aquablade. B.K. serves on the WL Gore Scientific Advisory Board. A.P., S.O., B.R., W.B., B.T.B., and S.B. have no conflicts of interest to disclose., (© 2023 The Author(s).)

Background: The SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial showed the safety but not efficacy of the Symplicity system (Medtronic, Santa Rosa, CA, USA) at 6 months follow-up in patients with treatment-resistant hypertension. This final report presents the 36-month follow-up results., Methods: SYMPLICITY HTN-3 was a single-blind, multicentre, sham-controlled, randomised clinical trial, done in 88 centres in the USA. Adults aged 18-80 years, with treatment-resistant hypertension on stable, maximally tolerated doses of three or more drugs including a diuretic, who had a seated office systolic blood pressure of 160 mm Hg or more and 24 h ambulatory systolic blood pressure of 135 mm Hg or more were randomly assigned (2:1) to receive renal artery denervation using the single electrode (Flex) catheter or a sham control. The original primary endpoint was the change in office systolic blood pressure from baseline to 6 months for the renal artery denervation group compared with the sham control group. Patients were unmasked after the primary endpoint assessment at 6 months, at which point eligible patients in the sham control group who met the inclusion criteria (office blood pressure ≥160 mm Hg, 24 h ambulatory systolic blood pressure ≥135 mm Hg, and still prescribed three or more antihypertensive medications) could cross over to receive renal artery denervation. Changes in blood pressure up to 36 months were analysed in patients in the original renal artery denervation group and sham control group, including those who underwent renal artery denervation after 6 months (crossover group) and those who did not (non-crossover group). For comparisons between the renal artery denervation and sham control groups, follow-up blood pressure values were imputed for patients in the crossover group using their most recent pre-crossover masked blood pressure value. We report long-term blood pressure changes in renal artery denervation and sham control groups, and investigate blood pressure control in both groups using time in therapeutic blood pressure range analysis. The primary safety endpoint was the incidence of all-cause mortality, end stage renal disease, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, hospitalisation for hypertensive crisis unrelated to non-adherence to medications, or new renal artery stenosis of more than 70% within 6 months. The trial is registered with ClinicalTrials.gov, NCT01418261., Findings: From Sep 29, 2011, to May 6, 2013, 1442 patients were screened, of whom 535 (37%; 210 [39%] women and 325 [61%] men; mean age 57·9 years [SD 10·7]) were randomly assigned: 364 (68%) patients received renal artery denervation (mean age 57·9 years [10·4]) and 171 (32%) received the sham control (mean age 56·2 years [11·2]). 36-month follow-up data were available for 219 patients (original renal artery denervation group), 63 patients (crossover group), and 33 patients (non-crossover group). At 36 months, the change in office systolic blood pressure was -26·4 mm Hg (SD 25·9) in the renal artery denervation group and -5·7 mm Hg (24·4) in the sham control group (adjusted treatment difference -22·1 mm Hg [95% CI -27·2 to -17·0]; p≤0·0001). The change in 24 h ambulatory systolic blood pressure at 36 months was -15·6 mm Hg (SD 20·8) in the renal artery denervation group and -0·3 mm Hg (15·1) in the sham control group (adjusted treatment difference -16·5 mm Hg [95% CI -20·5 to -12·5]; p≤0·0001). Without imputation, the renal artery denervation group spent a significantly longer time in therapeutic blood pressure range (ie, better blood pressure control) than patients in the sham control group (18% [SD 25·0] for the renal artery denervation group vs 9% [SD 18·8] for the sham control group; p≤0·0001) despite a similar medication burden, with consistent and significant results with imputation. Rates of adverse events were similar across treatment groups, with no evidence of late-emerging complications from renal artery denervation. The rate of the composite safety endpoint to 48 months, including all-cause death, new-onset end-stage renal disease, significant embolic event resulting in end-organ damage, vascular complication, renal artery re-intervention, and hypertensive emergency was 15% (54 of 352 patients) for the renal artery denervation group, 14% (13 of 96 patients) for the crossover group, and 14% (10 of 69 patients) for the non-crossover group., Interpretation: This final report of the SYMPLICITY HTN-3 trial adds to the totality of evidence supporting the safety of renal artery denervation to 36 months after the procedure. From 12 months to 36 months after the procedure, patients who were originally randomly assigned to receive renal artery denervation had larger reductions in blood pressure and better blood pressure control compared with patients who received sham control., Funding: Medtronic., Competing Interests: Declaration of interests DLB served as the co-principal investigator of SYMPLICITY HTN-3 with funding from Medtronic paid to Brigham and Women's Hospital. DLB reports acting on advisory boards for AngioWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, and Stasys; is a member of the Board of Directors of AngioWave (stock options), Boston VA Research Institute, Bristol Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), Society of Cardiovascular Patient Care, and TobeSoft; is the Inaugural Chair of the American Heart Association Quality Oversight Committee; has consulted for Broadview Ventures; is a member of Data Monitoring Committees for Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St Jude Medical, now Abbott), Boston Scientific, Cleveland Clinic, Contego Medical, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Novartis, and Population Health Research Institute; Rutgers University; honoraria from the American College of Cardiology, Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), and Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute); is a member of the RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; is a member of the AEGIS-II executive committee (funded by CSL Behring), Belvoir Publications, Canadian Medical and Surgical Knowledge Translation Research Group, Cowen and Company, Duke Clinical Research Institute, HMP Global, Journal of the American College of Cardiology, K2P, Level Ex, Medtelligence/ReachMD, MJH Life Sciences, Oakstone CME, Piper Sandler, Population Health Research Institute, Slack Publications, Society of Cardiovascular Patient Care, WebMD, and Wiley; is the deputy editor of Clinical Cardiology; the chair of NCDR-ACTION Registry Steering Committee, and VA CART Research and Publications Committee; holds a patent on sotagliflozin (patent application 17/574,977); is named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon (neither DLB nor Brigham and Women's Hospital receive any income from this patent); research funding from Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, and 89Bio; reports royalties from Elsevier for Braunwald's Heart Disease; is a site co-investigator for Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, and Vascular Solutions; is a trustee of the American College of Cardiology; and reports unfunded research from FlowCo and Takeda. MV reports research grant support from or served on advisory boards for American Regent, Amgen, AstraZeneca, Bayer, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Novartis, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; speaker engagements with AstraZeneca, Novartis, and Roche Diagnostics; and participates on clinical trial committees for studies sponsored by Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics. DEK reports institutional research or grant support from Medtronic and Ablative Solutions, and personal consulting honoraria from Medtronic. MBL reports institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has served on consulting or advisory boards for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott. SB, VD, and MF are employees of Medtronic. KR-S is a consultant for Alucent Biomedical. RRT reports grant support from the National Institutes of Health and consultant fees from Medtronic and JanssenMD; travel support from the American Society of Nephrology, North American Artery, and the National Kidney Foundation; and royalties from UpToDate. BTK is Chief Medical Executive and member of the steering committee for Medtronic Vascular. SO has received grant support from Medtronic, Merck, and Bayer; and personal fees from Medtronic, Daiichi Sankyo, and Bayer. GLB is supported by T32 National Institutes of Health grant DK07011 and is a consultant to Bayer, KBP Biosciences, Ionis, Alnylam, AstraZeneca, Quantum Genomics, Novo Nordisk, Dia Medica Therapeutics, and InREGEN; and is the Editor of the American Journal of Nephrology., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

End-stage renal disease is a prevalent medical condition causing significant problems as the majority of patients are being treated with dialysis. While dialysis provides a means to compensate for the renal impairment, arteriovenous grafts and fistulas are often complicated by neointimal hyperplasia, loss of primary patency, and graft failure. Over the last decade, stent grafts have emerged as an alternative to balloon angioplasty and bare metal stents for revascularization in the event of arteriovenous graft occlusion or stenosis. Several randomized controlled trials have investigated the efficacy of stent grafts compared with balloon angioplasty for improving the function and durability of dialysis circuits. In this review, we present a comprehensive review of clinical trials. Stent grafts appear to offer increased primary patency over balloon angioplasty in the treatment of dialysis circuit stenosis. However, there is generally no significant difference between the two treatment modalities on other clinically relevant measures like complication rates and overall survival., Competing Interests: Conflicts of Interest C.S.P. is a consultant for Cordis, Avanos, Philips Medical; is on the advisory boards for Boston Scientific, Venture Med, and Surmodics; is a speaker for Abott Medical, Bard, Sirtex, Terumo, Penumbra, Shockwave, and Cook Medical; is an investor in Cagent Medical and Integrity Spine; and CEC: Micromedex and Intact Vascular. B.J.S. is a consultant and speaker for Medtronic, Penumbra, and Philips. R.T.G. is a consultant for Medtronic, Bard, and Cordis., (Thieme. All rights reserved.)

The aim of this study was to provide a brief overview of the history the multidisciplinary team approach, highlighting the benefit to the patient with critical limb threatening ischemia in relation to health care economics. Furthermore, we provided a description of the requisites and key components, showing how to build a multidisciplinary team.

Purpose: To evaluate the impact of a versatile flexible ceiling-mounted C-arm on active table and gantry repositioning during interventions and its effect on operator discomfort, system usability, and patient safety compared with a traditional ceiling-mounted system., Materials and Methods: There were 100 IR procedures studied: 50 in a traditional IR system (standard group) and 50 with a novel multiaxis ceiling-mounted system (test group). FlexArm was capable of multiple gantry rotation points allowing increased access to the patient in addition to 236 cm of lateral x-ray detector travel. For each procedure, both the table and the gantry repositioning were measured. Patient safety, patient/equipment repositioning effort, and physical discomfort were evaluated through an operator survey., Results: Table repositioning was reduced from 42 to 16 instances per procedure (P < .001) in the test group compared with the standard group. The operators perceived less table and gantry repositioning effort (P < .0001) and decreased risks of equipment collisions, displacement of vascular access, and dislodgment of tubes/lines with the test group (P < .0001). Operator discomfort was reduced for all body areas in the test group over the standard group (P < .0001)., Conclusions: The FlexArm system geometry enhances operator ergonomics, as there was a decrease need to move the table, leading to a perceived decrease in patient risk and decrease operator physical discomfort when compared to a traditional imaging system., (Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.)

Background: The CREST-2 Registry (C2R) was approved by National Institute of Neurological Disorders and Stroke-National Institutes of Health in September 2014 with Centers for Medicare & Medicaid Services, U.S. Food and Drug Administration, and industry collaboration to enroll patients undergoing CAS. The registry credentials interventionists and promotes optimal patient selection, procedural-technique, and outcomes., Objectives: This study reports periprocedural outcomes in a cohort of carotid artery stenting (CAS) performed for asymptomatic and symptomatic carotid stenosis., Methods: Asymptomatic patients with ≥70% and symptomatic patients with ≥50% carotid stenosis, ≤80 years of age, and at standard or high risk for carotid endarterectomy are eligible for enrollment. Interventionists are credentialed by a multispecialty committee that reviews experience, lesion selection, technique, and outcomes. The primary endpoint was a composite of stroke and death (S/D) in the 30-day periprocedural period. Myocardial infarction and access-site complications were assessed as secondary outcomes., Results: As of December 2018, 187 interventionists from 98 sites in the United States performed 2,219 CAS procedures in 2,141 patients with primary atherosclerosis (78 were bilateral). The mean age of the cohort was 68 years, 65% were male, and 92% were white; 1,180 (55%) were for asymptomatic disease, and 961 (45%) were for symptomatic disease. All U.S. Food and Drug Administration-approved stents and embolic protection devices were represented. The 30-day rate of S/D was 1.4% for asymptomatic, 2.8% for symptomatic, and 2.0% for all patients., Conclusions: C2R is the first national registry for CAS cosponsored by federal and industry partners. CAS was performed by experienced operators using appropriate patient selection and optimal technique. In that setting, a broad group of interventionists achieved very low periprocedural S/D rates for asymptomatic and symptomatic patients., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this exploratory study was to compare the performance of carotid artery stenting (CAS) best practices between Intersocietal Accreditation Commission (IAC) accredited facilities and non-accredited facilities certified by the Centers for Medicare and Medicaid Services (CMS)., Methods: A random, anonymous survey was sent to CMS and IAC accredited facilities querying facility routine performance of 16 CAS procedure components found in published guidelines and utilised during clinical trials., Results: There were 28 responses (response rate=17%). Significant differences were found between the CMS and the IAC facilities for four of 16 procedure measures: determination of modified Rankin Scale score prior to stenting (p=0.012, 95% CI 20% to 80%), accurate measurement of per cent stenosis using electronic callipers (p=0.005, 95% CI 24% to 84%), confirmation of anticoagulation with activated clotting time greater than 250 s prior to crossing the lesion (p=0.03, 95% CI 7% to 69%), and comparison of facility outcomes to accepted benchmarks for stroke and death (p=0.03, 95% CI 7% to 69%). Overall, IAC facilities performed all 16 procedures more frequently (97%) than CMS facilities (66%) (p<0.001, 95% CI 24% to 36%)., Conclusions: Although the sample size was small, the results demonstrated IAC accredited facilities are more likely to follow best practices, to use quantitative tools to select appropriate patients, and quantitively measure patient-centred clinical outcomes compared with CMS certified facilities. The findings raise the question as to the value of CMS certification versus IAC accreditation as a requirement for reimbursement., Competing Interests: Competing interests: Authors MBF, ML and NM are employees of the Intersocietal Accreditation Commission. Authors DS, BK and JSM are members of the Intersocietal Accreditation Commission Carotid Stenting Board of Directors., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Few studies have compared long-term outcomes among specific treatment modalities for critical limb ischemia. The aim of this study was to compare long-term outcomes with percutaneous transluminal angioplasty (PTA), stent placement, atherectomy, or surgical bypass in patients diagnosed with critical limb ischemia., Methods: In this observational study using Medicare claims data, we identified incident cases with a primary critical limb ischemia diagnosis who received PTA, stent placement, atherectomy, or surgical bypass. We used propensity score weighting to determine the association of treatment type with all-cause mortality and major (above ankle) amputation over 4 years follow-up., Results: Among 36 860 patients (10 904 PTA; 11 295 stent placement; 4422 atherectomy; 10 239 surgical bypass), all-cause mortality over 4 years was 49.3% with atherectomy, 51.4% with surgical bypass, 53.7% with stent placement, and 54.7% with PTA (P<0.05 for all pairwise comparisons). Major amputation rates over 4 years were 6.8% with atherectomy, 7.8% with stent placement, 8.1% with PTA, and 10.8% with surgical bypass (P<0.05 for all pairwise comparison except PTA versus stent)., Conclusions: Among Medicare beneficiaries who received PTA, stent placement, atherectomy, or surgical bypass for critical limb ischemia, high mortality and major amputation rates were observed with minor differences among treatment groups. Statistically significant group differences of uncertain clinical importance were observed for several comparisons. Results from observational research may be susceptible to bias because of unmeasured confounders and, therefore, these comparative results should be interpreted with caution.

Background The optimal treatment for critical limb ischemia remains controversial owing to conflicting conclusions from previous studies. Methods and Results We obtained administrative claims on Medicare beneficiaries with initial critical limb ischemia diagnosis in 2011. Clinical outcomes and healthcare costs over 4 years were estimated among all patients and by first treatment (endovascular revascularization, surgical revascularization, or major amputation) in unmatched and propensity-score-matched samples. Among 72 199 patients with initial primary critical limb ischemia diagnosis in 2011, survival was 46% (median survival, 3.5 years) and freedom from major amputation was 87%. Among 9942 propensity-score-matched patients (8% rest pain, 26% ulcer, and 66% gangrene), survival was 38% with endovascular revascularization (median survival, 2.7 years), 40% with surgical revascularization (median survival, 2.9 years), and 23% with major amputation (median survival, 1.3 years; P<0.001 for each revascularization procedure versus major amputation). Corresponding major amputation rates were 6.5%, 9.6%, and 10.6%, respectively ( P<0.001 for all pair-wise comparisons). The cost per patient year during follow-up was $49 700, $49 200, and $55 700, respectively ( P<0.001 for each revascularization procedure versus major amputation). Conclusions Long-term survival and cost in critical limb ischemia management is comparable between revascularization techniques, with lower major amputation rates following endovascular revascularization. Primary major amputation results in shorter survival, higher risk of subsequent major amputation, and higher healthcare costs versus revascularization. Results from this observational research may be susceptible to bias because of the influence of unmeasured confounders.

Background: Evidence supporting nonstatin lipid-lowering therapy in atherosclerotic cardiovascular disease risk reduction is variable. We aim to examine nonstatin utilization and expenditures in the United States between 2002 and 2013., Methods and Results: We used the Medical Expenditure Panel Survey database to estimate national trends in nonstatin use and cost (total and out-of-pocket, adjusted to 2013 US dollars using a gross domestic product deflator) among adults 40 years or older. Nonstatin users increased from 3 million (2.5%) in 2002-2003 (20.1 million prescriptions) to 8 million (5.6%) in 2012-2013 (45.8 million prescriptions). Among adults with atherosclerotic cardiovascular disease, nonstatin use increased from 7.5% in 2002-2003 to 13.9% in 2012-2013 after peaking at 20.3% in 2006-2007. In 2012-2013, 15.9% of high-intensity statin users also used nonstatins, versus 9.7% of low/moderate-intensity users and 3.6% of statin nonusers. Nonstatin use was significantly lower among women (odds ratio 0.80; 95% confidence interval 0.75-0.86), racial/ethnic minorities (odds ratio 0.41; 95% confidence interval 0.36-0.47), and the uninsured (odds ratio 0.47; 95% confidence interval 0.40-0.56). Total nonstatin expenditures increased from $1.7 billion (out-of-pocket cost, $0.7 billion) in 2002-2003 to $7.9 billion (out-of-pocket cost $1.6 billion) in 2012-2013, as per-user nonstatin expenditure increased from $550 to $992. Nonstatin expenditure as a proportion of all lipid-lowering therapy expenditure increased 4-fold from 8% to 32%., Conclusions: Between 2002 and 2013, nonstatin use increased by 124%, resulting in a 364% increase in nonstatin-associated expenditures., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Two positive randomized trials established carotid endarterectomy (CEA) as a superior treatment to medical management alone for the treatment of asymptomatic carotid artery stenosis. However, advances in medical therapy have led to an active and spirited debate about the best treatment for asymptomatic carotid stenosis. The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis (CREST 2) trial aims to better define the best treatment for the average patient with severe asymptomatic carotid stenosis. Enrollment in the trial may be hampered by strong opinions on either side of the debate. It is important to realize that equipoise exists and that neither the old data on CEA nor the new data on optimal medical therapy provide a rigorous answer. The assumption that medical therapy has already been proven superior to revascularization procedures may hinder both enrollment in the trial and technical advancements in revascularization procedures., (© 2017 American Academy of Neurology.)

Purpose: To evaluate the impact of a new angiographic imaging technology on radiation dose during visceral embolization procedures involving both fluoroscopy and digital subtraction angiography., Material and Methods: A retrospective analysis from a single-center consecutive series of patients was performed comparing 2 angiographic imaging systems. The AlluraClarity (CIQ; Philips Healthcare, Best, the Netherlands) was used in 100 patients (n = 59 male, mean age: 70.6 years) from July 2013 to April 2014 and compared to the former AlluraXper (AX) technology used in 139 patients (n = 71 male, mean age: 70.1 years) from May 2011 to June 2013. Patients were categorized according to body mass index (BMI [kg/m 2 ])-group 1: BMI <25, group 2: BMI ≥25 and <30, and group 3: BMI ≥30. Fluoroscopy time, the total dose of iodinated contrast administered, and procedural AirKerma (Ka, r [mGy]) were obtained., Results: Mean BMI was 26.4 ± 5.0 kg/m 2 in the CIQ and 26.4 ± 7.1 kg/m 2 in the AX group ( P = .93). Fluoroscopy time and the amount of contrast media were equally distributed. Ka, r was 1342.9 mGy versus 2214.8 mGy ( P < .001, t test) when comparing CIQ to AX. Comparing CIQ to AX, BMI subgroup analysis revealed a mean Ka, r of 970.1 to 1586.1 mGy ( P = .003, t test), 1484.7 to 2170.1 mGy ( P = .02, t test), and 1848.8 to 3348.9 mGy ( P = .001, t test) in BMI groups 1, 2, and 3, respectively., Conclusion: The CIQ technology significantly reduced mean radiation dose by 39.4% for visceral embolization procedures when compared to fluoroscopy time and contrast media dose. This dose relationship was consistent across all BMI groups.

Objective: This study was conducted to determine whether β-blocker (BB) therapy is associated with abdominal aortic aneurysm (AAA) sac regression after endovascular abdominal aortic repair (EVAR)., Methods: A total of 198 patients (mean age, 76 years) who underwent EVAR were analyzed (104 in the BB group and 94 in the non-BB group). The primary end point was the incidence of AAA sac regression at 1 and 2 years., Results: Hypertension, coronary artery disease, and hyperlipidemia were more common in the BB group. The BB group was also more likely to have been prescribed an aspirin and a statin than the non-BB group. The length of proximal neck was significantly longer in the non-BB group than in the BB group. All study patients were monitored for at least 1 year after EVAR, and 2-year follow-up was available in 104 patients (52.5%). There was no statistically significant difference in the incidence of aneurysm sac regression in either group at 1 year (52.1% in the non-BB group vs 45.2% in the BB group; P = .330) and 2 years (58.5% in the non-BB group vs 64.7% in the BB group; P = .515). The difference of the change of AAA maximum diameter between two groups did not reach statistical significance at 1 year (-6.0 ± 7.0 mm in the non-BB group vs -5.5 ± 8.1 mm in the BB group; P = .644) and 2 years (-9.0 ± 10.5 mm in the non-BB group vs -9.0 ± 10.0 mm in the BB group; P = .977). BB therapy was not associated with increased odds of AAA sac regression. The effect of third-generation BBs on AAA sac regression was not significant., Conclusions: BB therapy had no effect on AAA sac regression. At the present time, there is insufficient evidence to recommend BB therapy for the purpose of AAA sac regression., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To determine whether statin therapy is associated with abdominal aortic aneurysm (AAA) sac regression after endovascular aneurysm repair (EVAR)., Materials and Methods: A total of 109 patients treated with EVAR were retrospectively analyzed (no-statin group, n = 45; statin group, n = 64). The primary endpoint was the incidence of AAA sac regression. To investigate independent predictors of AAA sac regression, regression analysis was performed. The mean age was 74 years (range, 55-90 y), and 87.2% of patients were men., Results: The no-statin group had higher rates of AAA sac regression than the statin group at 1 year (no-statin group, 66.7%; statin group, 45.3%; P = .028). The incidence of AAA sac regression increased over time in the statin group, and no statistical difference was seen between the two groups at 2 years (no-statin group, 66.7%; statin group, 57.8%; P = .350). The difference between the changes in maximum AAA diameter was significant between groups at 1 year (no-statin group vs statin group, -4.9 mm ± 5.9; P = .041), but the difference did not reach statistical significance at 2 years (no-statin group, -10.0 mm ± 10.1; statin group, -8.0 mm ± 9.6; P = .306). Statin therapy was not associated with AAA sac regression on univariate (odds ratio [OR], 0.685; 95% confidence interval [CI], 0.310-1.516; P = .351) and multivariate analyses (OR, 0.617; 95% CI, 0.215-1.772; P = .369)., Conclusions: Statin therapy had no effect on AAA sac regression at 2 years. There is insufficient evidence to recommend statin therapy for AAA sac regression., (Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.)

Objective: We investigated whether successful revascularization of total occlusion of a large lower-extremity artery is associated with improvement of left ventricular (LV) diastolic function., Background: Total occlusion of a large lower-extremity artery might affect the systemic vascular resistance and increase the afterload, because the left ventricle must work harder to eject blood into a smaller vascular bed. Chronic elevation of afterload is a cause of LV diastolic dysfunction., Methods: This is a single-center retrospective analysis of 20 patients (10 men, age 69.6 ± 12.3 years) with chronic total occlusions (CTOs) of the aorto-iliac and femoropopliteal segments who underwent a successful endovascular revascularization. Baseline and postprocedural evaluation of diastolic function was performed, and the primary endpoint was improvement in LV diastolic function, which was defined as any decrease of the baseline E/E' ratio or any increase of the baseline E' velocity after the index procedure., Results: There was a significant effect of successful revascularization on the E/A ratio (from 1.5 ± 1.1 to 1.0 ± 0.3; P=.046) because of a significant increase of A velocity (from 86.3 ± 30.4 cm/s to 98.3 ± 21.8 cm/s; P=.03). The E' velocity (from 7.4 ± 2.0 cm/s to 8.3 ± 2.3 cm/s; P=.07) did not show a significant increase, but there was a significant reduction in E/E' ratio (from 14.6 ± 3.9 to 12.4 ± 3.3; P=.02). Logistic regression analysis did not identify possible predictors of improvement in LV diastolic function., Conclusion: Our results showed that a successful revascularization was associated with improvement in the echocardiographic parameters of LV diastolic function in patients with CTO of large lower-extremity artery, and these changes may be related to the afterload reduction.

Purpose: To determine whether statin therapy is associated with reduced restenosis following nitinol stent implantation for de novo femoropopliteal artery disease., Materials and Methods: A total of 135 limbs in 135 patients (mean age, 72 y) implanted with nitinol stents in femoropopliteal occlusions were analyzed (statin arm, n = 91; nonstatin arm, n = 44). The patients were treated with one type of nitinol stent., Results: At baseline, lesions and procedural characteristics were comparable between groups, except that the statin group had more hypertension, coronary artery disease, and hyperlipidemia. There were significant differences in the incidence of binary restenosis between groups at 1 year (45.5% for nonstatin group vs 28.6% for statin group; P = .05) and 2 years (56.8% for nonstatin group vs 38.5% for statin group; P = .04). Primary patency rates at 1 year were 50.5% in the nonstatin group and 72.5% in the statin group (P = .01). Two-year target lesion revascularization rates were 54.5% in the nonstatin group and 35.2% in the statin group (P = .03). On univariate analysis, statin therapy was associated with decreased relative risk of binary restenosis at 1 year (odds ratio [OR], 0.480; 95% confidence interval [CI], 0.227-1.014; P = .050). On multivariate analysis, statin therapy did not significantly affect the odds of binary restenosis (OR, 0.415; 95% CI, 0.071-2.437; P = .330)., Conclusions: The incidence of binary restenosis was significantly lower in the statin group than in the nonstatin group following nitinol stent implantation for de novo femoropopliteal artery disease., (Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.)

Background and Purpose: Carotid artery revascularization was previously found to incrementally reduce stroke risk among patients with carotid stenosis treated with medical therapy. However, the frequency with which optimal medical therapies are used at discharge after carotid endarterectomy (CEA) and carotid artery stenting (CAS) is not known, and the influence of patient, operator, and hospital characteristics on the likelihood of prescription is poorly understood., Methods: In a retrospective cohort study of 23 112 patients undergoing CAS or CEA between January 2007 and June 2012 at US hospitals participating in the CARE registry (Carotid Artery Revascularization and Endarterectomy), we examined antiplatelet therapy and statin utilization at discharge. Hierarchical multivariable logistic regression was used in adjusted analyses., Results: Antiplatelet agents and statins were prescribed at discharge in 99% and 78%, respectively, after CAS and 93% and 75%, respectively, after CEA. After adjustment, antiplatelet therapy was more often prescribed after CAS than CEA (odds ratio 2.4 [95% confidence interval 1.68-3.45]), but statin prescription was equally likely (odds ratio 1.11 [95% confidence interval 0.84-1.49]). Operator specialty (medical>radiology/surgery) and hospital community setting (suburban>urban>rural) independently predicted antiplatelet and statin agent use at discharge, whereas hospital geographic location (Northeast>Midwest/South>West) predicted use of statins but not antiplatelet therapy at discharge., Conclusions: US antiplatelet agent and statin discharge prescription rates were suboptimal after both CAS and CEA and varied by revascularization modality, operating physician specialty, and hospital characteristics. Improved and more uniform utilization after these procedures will be critical to the success of comprehensive stroke risk reduction efforts., (© 2016 American Heart Association, Inc.)

Purpose: To assess the bleeding risk profile using the HAS-BLED score in patients with symptomatic peripheral artery disease (PAD)., Methods: A post hoc analysis was performed using data from a series of 115 consecutive patients (mean age 72.4±11.4 years; 68 men) with symptomatic PAD undergoing endovascular revascularization. The endpoint of the study was to assess bleeding risk using the 9-point HAS-BLED score, which was previously validated in cohorts of patients with and without atrial fibrillation. For the purpose of this study, the low (0-1), intermediate (2), and high-risk (≥3) scores were stratified as low/intermediate risk (HAS-BLED <3) vs high risk (HAS-BLED ≥3)., Results: The mean HAS-BLED score was 2.76±1.16; 64 (56%) patients had a HAS-BLED score ≥3.0. Patients with PAD Rutherford category 5/6 ischemia had an even higher mean HAS-BLED score (3.20±1.12). Logistic regression analysis revealed aortoiliac or femoropopliteal segment involvement, chronic kidney disease, as well as Rutherford category 5/6, to be independent risk factors associated with a HAS-BLED score ≥3., Conclusion: Patients with PAD, especially those presenting with Rutherford category 5/6 ischemic symptoms, have high HAS-BLED scores, suggesting increased risk for major bleeding. Prospective clinical validation of the HAS-BLED score in patients with PAD may help with the risk-benefit assessment when prescribing antithrombotic therapy., (© The Author(s) 2016.)

Background: Peripheral vascular interventions are increasingly preferred for the treatment of patients with symptomatic peripheral arterial disease because they are associated with similar clinical outcomes and lower morbidity than open surgical procedures. The objective of this study was to assess the comparative effectiveness of procedural anticoagulation with bivalirudin compared with unfractionated heparin in patients undergoing peripheral vascular interventions., Methods and Results: This was a retrospective, observational study using the Premier Hospital administrative database. We examined 23,934 consecutive patients undergoing lower extremity peripheral vascular interventions between January 2008 and December 2012 who were treated with either bivalirudin or unfractionated heparin. In-hospital end points included death, myocardial infarction, transfusion, stroke, amputation, and the composite end points of major adverse cardiovascular events, and net adverse clinical events. Propensity score matching was performed to control for baseline imbalances and yielded 3649 matched pairs. After propensity score matching, patients treated with bivalirudin had lower in-hospital event rates with significantly lower mortality (odds ratio, 0.40; P=0.017), need for blood product transfusion (odds ratio, 0.74; P=0.009), major adverse cardiovascular events (odds ratio, 0.64; P=0.003), and net adverse clinical events (odds ratio, 0.72; P<0.001). These associations were observed consistently across clinically relevant subgroups., Conclusions: In patients undergoing peripheral vascular interventions, procedural anticoagulation with bivalirudin may result in more favorable in-hospital outcomes compared with unfractionated heparin, the current standard of care. These observations will require prospective confirmation in a randomized, controlled trial., (© 2016 American Heart Association, Inc.)

Objectives: The aim of this study was to evaluate short- and midterm outcomes of endovascular aneurysm repair in patients with inflammatory abdominal aortic aneurysm (IAAA) focusing on changes in perianeurysmal inflammation and hydronephrosis., Methods: A retrospective study was performed considering data prospectively gathered from 1998 to 2013 in 3 centers. Patient demographics, preoperative clinical characteristics, clinical presentation, preoperative imaging measurements, procedural, and postoperative data were collected. Main outcome was to define evolution of periaortic fibrosis and hydronephrosis at computed tomography angiography (CTA) during follow-up., Results: A total of 22 patients (male n = 20; mean age 70.9 years ± 9.3) were included (mean AAA diameter: 58 mm ± 11, symptomatic: 50%, ruptured: 9.1%). Hydroureteronephrosis was preoperatively diagnosed by CTA in 6 (27.3%) cases. Median clinical follow-up was 2.2 years (range 0.1-14.5). Nine patients died during follow-up. At 1, 2, 4, and 6 years, overall survival was 85.4%, 74.3%, 56.6%, and 49.5%, respectively. Among these 13 patients with CTA follow-up, the mean AAA diameter was 56.2 mm ± 15.5, and progression of sac diameter was detected in 1 (7.7%) patient. Median maximum thickness of perianeurysmal inflammation was 5 mm (range 2-11) and decreased/remained unchanged in 92.3% of patients. Regression of hydroureteronephrosis occurred in 3 of 5 patients available for follow-up. There were no cases of de novo hydroureteronephrosis., Conclusion: Endovascular treatment of IAAA has comparable short-term outcomes with non-IAAA. During midterm follow-up, aneurysm sac progression is rare, and perianeurysmal fibrosis decreases or remains unchanged in most cases. Hydronephrosis regression can occur in some but not all instances and thus warrants close surveillance., (© The Author(s) 2016.)

Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hypertension (HTN) and cerebrovascular disease. Little is known about medication use in FMD. Clinical features and medication use were reviewed in a national FMD registry (12 US sites). Medication usage was assessed in raw and adjusted analyses. Covariates included demographic characteristics, co-morbid conditions and vascular bed involvement. A total of 874 subjects (93.6% female) were included in the analysis. Mean age was 55.6±13.1 years, 74.5% had HTN, 25.4% had a history of transient ischemic attack or stroke, and 7.5% had a history of coronary artery disease (CAD). Renal and cerebrovascular arteries were affected in 70.4% and 74.7%, respectively. Anti-platelet agents were administered to 72.9% of patients. In multivariate analyses, factors associated with a greater likelihood of anti-platelet agent use were older age (OR=1.02 per year, p=0.005), CAD (OR=3.76, p=0.015), cerebrovascular artery FMD involvement in isolation (OR=2.31, p<0.0001) or a history of previous intervention for FMD (OR=1.52, p=0.036). A greater number of anti-HTN medications was evident in isolated renal versus isolated cerebrovascular FMD patients. Factors associated with a greater number of anti-HTN medications were older age (OR=1.03 per year, p<0.0001), history of HTN (OR=24.04, p<0.0001), history of CAD (OR=2.71, p=0.0008) and a history of a previous therapeutic procedure (OR=1.72, p=0.001). In conclusion, in FMD, medication use varies based on vascular bed involvement. Isolated renal FMD patients receive more anti-HTN agents and there is greater anti-platelet agent use among patients with cerebrovascular FMD. Further studies correlating medication use in FMD with clinically meaningful patient outcomes are necessary., (© The Author(s) 2015.)

SYMPLICITY HTN-3, the first trial of renal denervation (RDN) versus sham, enrolled 26% African Americans, a prospectively stratified cohort. Although the 6-month systolic blood pressure (SBP) reduction in African Americans (AAs) was similar in the RDN group (-15.5 ± 25.4 mm Hg, n = 85 vs. -17.8 ± 29.2, n = 49, P = .641), the sham SBP response was 9.2 mm Hg greater (P = .057) in AAs than non-AAs. In multivariate analyses, sham SBP response was predicted by an interaction between AA and a complex antihypertensive regimen (at least one antihypertensive medication prescribed ≥3 times daily), while in the RDN group, SBP response was predicted by an interaction between AA race and baseline BP ≥ 180 mm Hg. AA race did not independently predict SBP response in either sham or RDN. There appears to be effect modification by race with individual-level patient characteristics in both treatment arms that affect the observed pattern of SBP responses., (Copyright © 2015 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.)

Purpose: The purpose of this study is to evaluate a new device providing real-time monitoring on radiation exposure during fluoroscopy procedures intending to reduce radiation in an interventional radiology setting., Materials and Methods: In one interventional suite, a new system providing a real-time radiation dose display and five individual wireless dosimeters were installed. The five dosimeters were worn by the attending, fellow, nurse, technician, and anesthesiologist for every procedure taking place in that suite. During the first 6-week interval the dose display was off (closed phase) and activated thereafter, for a 6-week learning phase (learning phase) and a 10-week open phase (open phase). During these phases, the staff dose and the individual dose for each procedure were recorded from the wireless dosimeter and correlated with the fluoroscopy time. Further subanalysis for dose exposure included diagnostic versus interventional as well as short (<10 min) versus long (>10 min) procedures., Results: A total of 252 procedures were performed (n = 88 closed phase, n = 50 learning phase, n = 114 open phase). The overall mean staff dose per fluoroscopic minute was 42.79 versus 19.81 µSv/min (p < 0.05) comparing the closed and open phase. Thereby, anesthesiologists were the only individuals attaining a significant dose reduction during open phase 16.9 versus 8.86 µSv/min (p < 0.05). Furthermore, a significant reduction of total staff dose was observed for short 51 % and interventional procedures 45 % (p < 0.05, for both)., Conclusion: A real-time qualitative display of radiation exposure may reduce team radiation dose. The process may take a few weeks during the learning phase but appears sustained, thereafter.

Purpose: To compare the closure of ≤ 8-F versus 9-F to 12-F femoral access using the 8-F Angio-Seal VIP device (St. Jude Medical, Inc, St. Paul, Minnesota)., Materials and Methods: In this investigator-initiated, retrospective analysis, a consecutive series of 137 patients (n = 92 male patients [67.2%]; overall mean age, 71.0 y ± 9.8) was evaluated. Common femoral artery access was performed in all patients, and either unfractionated heparin or bivalirudin was used for anticoagulation. Access site complications were defined as follows: type 0, no bleeding; type 1, no actionable bleeding; type 2, actionable bleeding., Results: The 8-F Angio-Seal VIP device was used for closure of ≤ 8-F femoral access in 76 patients (55.5%) and for 9-F to 12-F femoral access in 61 patients (44.5%). Access site complications were observed after 8-F Angio-Seal deployment in 11 patients (8.0%) (≤ 8 F, n = 5 [6.6%]; 9-12 F, n = 6 [9.8%]; P = .54). Comparing ≤ 8-F with 9-F to 12-F femoral access, type 1 complications were observed in 3 and 6 patients (P = .19) and type 2 complications were observed in 2 and 0 patients (P = .50), respectively. All type 1 complications were managed by applying external compression. Type 2 complications (n = 2 pseudoaneurysms) were treated with thrombin injection in 1 patient and secondary percutaneous intervention in 1 patient., Conclusions: Use of the 8-F Angio-Seal for the closure of > 8-F femoral access is safe and effective. Complication rates when using the 8-F Angio-Seal for closure of ≤ 8-F and 9-F to 12-F femoral access are comparable., (Copyright © 2015 SIR. Published by Elsevier Inc. All rights reserved.)

Background and Purpose: Post-hoc, we hypothesized that over the recruitment period of the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), increasing experience and improved patient selection with carotid stenting, and to a lesser extent, carotid endarterectomy would contribute to lower periprocedural event rates., Methods: Three study periods with approximately the same number of patients were defined to span recruitment. Composite and individual rates of periprocedural stroke, myocardial infarction, and death rate were calculated separately by treatment assignment (carotid stenting/carotid endarterectomy). Temporal changes in unadjusted event rates, and rates after adjustment for temporal changes in patient characteristics, were assessed., Results: For patients randomized to carotid stenting, there was no significant temporal change in the unadjusted composite rates that declined from 6.2% in the first period, to 4.9% in the second, and 4.6% in the third (P=0.28). Adjustment for patient characteristics attenuated the rates to 6.0%, 5.9%, and 5.6% (P=0.85). For carotid endarterectomy-randomized patients, both the composite and the combined stroke and death outcome decreased between periods 1 and 2 and then increased in period 3., Conclusions: The hypothesized temporal reduction of stroke+death events for carotid stenting-treated patients was not observed. Further adjustment for changes in patient characteristics between periods, including the addition of asymptomatic patients and a >50% decrease in proportion of octogenarians enrolled, resulted in practically identical rates., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732., (© 2015 American Heart Association, Inc.)