Search

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.)

Purpose: To evaluate reliability, accuracy, and agreement of simple visual estimation (SVE) in determining the degree of peripheral arterial stenosis compared with calibrated measurements., Materials and Methods: In 2 sessions, 23 interventionists with a wide range of experience and subspecialty training reviewed 42 angiographic images of lower extremity and carotid arteries (21 iliofemoral arteries and 21 carotid arteries). An independent physician measured all lesions using manual calipers. Intrarater and interrater reliability were assessed by intraclass correlation. A ± 5% error was considered the threshold for accuracy, and weighted κ statistics were computed to assess agreement with respect to the degree of stenosis (< 50%, nonsignificant; 50%-80%, significant; > 80%, severe)., Results: Intrarater reliability of SVE was 0.99, and interrater reliability was 0.83. Accuracy varied from 52.8% for images of severe stenosis to 26.5% and 18.1% for significant and nonsignificant stenosis, respectively (P < .001). Agreement between SVE and caliper with regard to degree of stenosis was good (weighted κ 0.56) overall with correct classification ranging from 92.6% for severe stenosis to 53.4% and 68.2% for significant and nonsignificant stenosis, respectively (P < .001). Misclassification of nonsignificant and significant stenosis was more frequent for carotid arteries than for lower extremities., Conclusions: Despite high reliability, SVE of peripheral arterial stenosis has limited accuracy in determining the exact degree of stenosis. Although severe stenosis is readily identified by SVE, arterial stenosis of < 80% is frequently overestimated, especially for carotid arteries, and should be confirmed by caliper assessment., (Copyright © 2015 SIR. Published by Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to test the radioprotection efficacy and comfort of newer bilayer barium sulphate-bismuth oxide composite (XPF) caps in an interventional cardiology setting., Methods and Results: Operators were randomly assigned to wear standard fabric (n=59), 0.3 mm (n=74), or 0.5 mm (n=64) lead-equivalent XPF caps. Radiation doses were measured by using dosimeters placed outside and underneath the caps. Wearing comfort was assessed at the end of each measurement on a visual analogue scale (VAS) (0-100, with 100 indicating optimal comfort). Procedural data did not differ between the XPF and standard groups. Mean standard, XPF 0.3 mm, and XPF 0.5 mm cap weights were 12.5 g, 118.4 g, and 123.7 g, respectively. VAS comfort ratings of the standard and XPF caps did not differ significantly (p=0.272). The mean radiation protection was 12.0%, 95% CI: 4.9-19.1% (standard caps, n=35), 91.5%, 95% CI: 87.4-95.6% (XPF 0.3 mm caps, n=45) and 97.1%, 95% CI: 92.5-100% (XPF 0.5 mm caps, n=44) (p≤0.001 for all group comparisons). Using the XPF caps, a cumulative total radiation dose reduction by almost factor 10 was evident (272 procedures, 22,310 μSv outside the XPF caps, 2,770 μSv inside the caps)., Conclusions: Lightweight XPF caps show comparable comfort to standard fabric caps, but provide substantial radiation protection during fluoroscopy-guided cardiac interventions.

Background: Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure., Objectives: This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group)., Methods: Eligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed., Results: The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (-15.5 ± 24.1 mm Hg vs. -18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by -32.9 ± 28.1 mm Hg at 6 months, but this response regressed to -21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg., Conclusions: These data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Uncontrolled hypertension, whether due to drug resistance or poor adherence and persistence, remains a problem in many patients. The ROX coupler is a novel technology designed to reduce arterial blood pressure consequent to the predicted physical effects of reducing vascular resistance and improving arterial compliance. This article describes the technical aspects of the device and implantation procedure, results from a preclinical study, patient selection criteria, and potential complications of this therapy for uncontrolled hypertension., Background: The coupler is a self-expanding, stent-like device that exploits the mechanical effects of the creation of a low-resistance, high-compliance venous segment to the central arterial tree, and can be implanted in a standard catheterization laboratory under fluoroscopic guidance., Methods: Preclinical studies were conducted in sheep with acute or chronic hypertension. The devices were implanted in the aorta for up to 12 months. The anastomoses were evaluated for patency, healing, conformation into the artery and vein, and complications., Results: Deployment of the anastomotic device in ovine aortas for up to 12 months showed optimal anastomotic patency in all animals with proper healing and conformation of the device into the artery and the vein. There was no significant residual mural thrombus and minimal to moderate intimal thickening at the vein outflow, consistent with expected arterialization., Conclusions: A novel arteriovenous coupler for percutaneous placement in the iliac vasculature is under clinical investigation as a potential treatment modality for selected patients with uncontrolled hypertension. Initial results from patients with uncontrolled hypertension are expected in Autumn 2014., (© 2014 Wiley Periodicals, Inc.)

Aims: The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal denervation (RDN), but did not meet its primary efficacy endpoint. Prior RDN studies have demonstrated significant and durable reductions in blood pressure. This analysis investigated factors that may help explain these disparate results., Methods and Results: Patients with resistant hypertension were randomized 2 : 1 to RDN (n = 364) or sham (n = 171). The primary endpoint was the difference in office systolic blood pressure (SBP) change at 6 months. A multivariable analysis identified predictors of SBP change. Additional analyses examined the influence of medication changes, results in selected subgroups and procedural factors. Between randomization and the 6-month endpoint, 39% of patients underwent medication changes. Predictors of office SBP reduction at 6 months were baseline office SBP ≥ 180 mmHg, aldosterone antagonist use, and non-use of vasodilators; number of ablations was a predictor in the RDN group. Non-African-American patients receiving RDN had a significantly greater change in office SBP than those receiving sham; -15.2 ± 23.5 vs. -8.6 ± 24.8 mmHg, respectively (P = 0.012). Greater reductions in office and ambulatory SBP, and heart rate were observed with a higher number of ablations and energy delivery in a four-quadrant pattern., Conclusions: Post hoc analyses, although derived from limited patient cohorts, reveal several potential confounding factors that may partially explain the unexpected blood pressure responses in both the sham control and RDN groups. These hypothesis-generating data further inform the design of subsequent research to evaluate the potential role of RDN in the treatment of resistant hypertension. CLINICALTRIALS.GOV IDENTIFIER: NCT01418261., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Tandem atherosclerotic lesions of the carotid bifurcation and the ipsilateral proximal common carotid artery (CCA) or innominate arteries (IA) can be challenging to treat. A surgical approach may treat the lesion at the carotid bifurcation, but proximal CCA or IA lesions require a major surgical exposure. An endovascular approach is challenging as well since anatomic variations, such as a type III aortic arch, can render navigation very difficult. We report our experience in the hybrid surgical and endovascular treatment of complex proximal CCA and IA lesions. Eleven patients who underwent hybrid procedures with surgical exposure (with or without endarterectomy) of the carotid artery and retrograde endovascular intervention of a proximal lesion were included in the study. The mean percentage of stenosis was 81%. Seven patients underwent a carotid endarterectomy (CEA), and 4 patients underwent only a surgical cutdown for retrograde endovascular access of the IA or left CCA. All procedures were technically successful. Eight patients had no symptoms within 30 days of the procedure. The hybrid retrograde endovascular approach through carotid exposure with or without CEA appears to be effective and safe in selected patients who have a high-risk complex anatomy of tandem lesions.

Background: Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring (ABPM) to assess the efficacy of the procedure., Objectives: SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) was a prospective, blinded, randomized, sham-controlled trial. The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements 6 months post-randomization., Methods: Patients with resistant hypertension were randomized 2:1 to renal denervation or sham control. Patients were on a stable antihypertensive regimen including maximally tolerated doses of at least 3 drugs including a diuretic before randomization. The powered secondary efficacy endpoint was a change in mean 24-h ambulatory systolic blood pressure (SBP). Nondipper to dipper (nighttime blood pressure [BP] 10% to 20% lower than daytime BP) conversion was calculated at 6 months., Results: The 24-h ambulatory SBP changed -6.8 ± 15.1 mm Hg in the denervation group and -4.8 ± 17.3 mm Hg in the sham group: difference of -2.0 mm Hg (95% confidence interval [CI]: -5.0 to 1.1; p = 0.98 with a 2 mm Hg superiority margin). The daytime ambulatory SBP change difference between groups was -1.1 (95% CI: -4.3 to 2.2; p = 0.52). The nocturnal ambulatory SBP change difference between groups was -3.3 (95 CI: -6.7 to 0.1; p = 0.06). The percent of nondippers converted to dippers was 21.2% in the denervation group and 15.0% in the sham group (95% CI: -3.8% to 16.2%; p = 0.30). Change in 24-h heart rate was -1.4 ± 7.4 in the denervation group and -1.3 ± 7.3 in the sham group; (95% CI: -1.5 to 1.4; p = 0.94)., Conclusions: This trial did not demonstrate a benefit of renal artery denervation on reduction in ambulatory BP in either the 24-h or day and night periods compared with sham (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension., Methods: We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months., Results: A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P=0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups., Conclusions: This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. (Funded by Medtronic; SYMPLICITY HTN-3 ClinicalTrials.gov number, NCT01418261.).

Purpose: To test whether newer bilayer barium sulfate-bismuth oxide composite (XPF) thyroid collars (TCs) provide superior radiation protection and comfort during fluoroscopy-guided interventions compared with standard 0.5-mm lead-equivalent TCs., Materials and Methods: Institutional review board approval and written informed consent were obtained for this HIPAA-compliant study, and 144 fluoroscopy-guided vascular interventions were included at one center between October 2011 and July 2012, with up to two operators randomly assigned to wear XPF (n = 135) or standard 0.5-mm lead-equivalent (n = 121) TCs. Radiation doses were measured by using dosimeters placed outside and underneath the TCs. Wearing comfort was assessed at the end of each procedure on a visual analog scale (0-100, with 100 indicating optimal comfort). Adjusted differences in comfort and radiation dose reductions were calculated by using a mixed logistic regression model and the common method of inverse variance weighting, respectively., Results: Patient (height, weight, and body mass index) and procedure (type and duration of intervention, operator, fluoroscopy time, dose-area product, and air kerma) data did not differ between the XPF and standard groups. Comfort was assessed in all 256 measurements. On average, the XPF TCs were 47.6% lighter than the standard TCs (mean weight ± standard deviation, 133 g ± 14 vs 254 g ± 44; P < .001) and had a significantly higher likelihood of a high level of comfort (visual analog scale >90; odds ratio, 7.6; 95% confidence interval: 3.0, 19.2; P < .001). Radiation dose reduction provided by the TCs was analyzed in 117 data sets (60 in the XPF group, 57 in the standard group). The mean radiation dose reductions (ie, radiation protection) provided by XPF and standard TCs were 90.7% and 72.4%, with an adjusted mean difference of 17.9% (95% confidence interval: 7.7%, 28.1%; P < .001) favoring XPF., Conclusion: XPF TCs are a lightweight alternative to standard 0.5-mm lead-equivalent TCs and provide superior radiation protection during fluoroscopy-guided interventions., (© RSNA, 2013.)

Despite increasing numbers of endovascular interventions to treat arterial and venous disease, scant level 1 evidence is available regarding the role of antithrombotic and antiplatelet therapy in patients undergoing these procedures. The current practice in this regard is heterogeneous and has mainly been driven by data from coronary artery disease and percutaneous coronary intervention. This article discusses the role of antithrombotic and antiplatelet agents for endovascular intervention., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objective: Radiation exposure to interventionalists is increasing. The currently available standard radiation protection devices are heavy and do not protect the head of the operator. The aim of this study was to evaluate the effectiveness and comfort of caps and thyroid collars made of a disposable, light-weight, lead-free material (XPF) for occupational radiation protection in a clinical setting., Subjects and Methods: Up to two interventional operators were randomized to wear a XPF or standard 0.5-mm lead-equivalent thyroid collars in 60 consecutive endovascular procedures requiring fluoroscopy. Simultaneously a XPF cap was worn by all operators. Radiation doses were measured using dosimeters placed outside and underneath the caps and thyroid collars. Wearing comfort was assessed at the end of each procedure on a visual analog scale (0-100 [100 = optimal])., Results: Patient and procedure data did not differ between the XPF and standard protection groups. The cumulative radiation dose measured outside the cap was 15,700 μSv and outside the thyroid collars 21,240 μSv. Measured radiation attenuation provided by the XPF caps (n = 70), XPF thyroid collars (n = 40), and standard thyroid collars (n = 38) was 85.4% ± 25.6%, 79.7% ± 25.8% and 71.9% ± 34.2%, respectively (mean difference XPF vs standard thyroid collars, 7.8% [95% CI, -5.9% to 21.6%]; p = 0.258). The median XPF cap weight was 144 g (interquartile range, 128-170 g), and the XPF thyroid collars were 27% lighter than the standard thyroid collars (p < 0.0001). Operators rated the comfort of all devices as high (mean scores for XPF caps and XPF thyroid collars 83.4 ± 12.7 (SD) and 88.5 ± 14.6, respectively; mean scores for standard thyroid collars 89.6 ± 9.9) (p = 0.648)., Conclusion: Light-weight disposable caps and thyroid collars made of XPF were assessed as being comfortable to wear, and they provide radiation protection similar to that of standard 0.5-mm lead-equivalent thyroid collars.

Objective: There is growing evidence supporting the use of coronary CT angiography (CTA) to triage patients in the emergency department (ED) with acute chest pain and low risk of acute coronary syndrome (ACS). We hypothesized that coronary CTA can guide early management and safely discharge patients by introducing a dedicated patient management protocol., Subjects and Methods: We conducted a prospective cohort study in three EDs of a large health care system (> 1300 beds). Five hundred twenty-nine patients (mean age, 52.1 years; 56% women) with chest pain, negative cardiac enzyme results, normal or nondiagnostic ECG findings, and a thrombolysis in myocardial infarction (TIMI) risk score of 2 or less were admitted and underwent CTA. A new dedicated chest pain triage protocol (levels 1-5) was implemented. On the basis of CTA findings, patients were stratified into one of the following four groups: 0, low (negative CTA findings); 1, mild (1-49% stenosis); 2, moderate (50-69% stenosis); or 3, severe (≥ 70% stenosis) risk of ACS. Outcome measures included major adverse cardiac events (MACEs) during the first 30 days after CTA, downstream testing results, and length of stay (LOS). LOS was compared before and after implementation of our chest pain triage protocol., Results: Three hundred seventeen patients (59.9%) with negative CTA findings and 151 (28.5%) with mild stenosis were discharged from the ED with a very low downstream testing rate and a very low MACE rate (negative predictive value = 99.8%). Twenty-five patients (4.7%) had moderate stenosis (n = 17 undergoing further testing). Thirty-six patients (6.8%) had stenosis of 70% or greater by CTA (n = 34 positive by invasive angiography or SPECT-myocardial perfusion imaging). The sensitivity of CTA was 94%. The rate of MACEs in patients with stenosis of 70% or greater (8.3%) was significantly higher (p < 0.001) than in patients with negative CTA findings (0%) or those with mild stenosis (0.2%). A 51% decrease in LOS-from 28.8 to 14.0 hours--was noted after implementation of the dedicated chest pain protocol (p < 0.001)., Conclusion: Chest pain patients with negative or mild nonobstructive CTA findings can be safely discharged from the ED without further testing. Implementation of a dedicated chest pain triage protocol is critical for the success of a coronary CTA program.