Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study.

OBJECTIVES: The aim of this study was to evaluate the long-term (3-year) safety and effectiveness of endovascular baroreflex amplification (EVBA) from both the European and American CALM-FIM cohorts. BACKGROUND: The CALM-FIM study demonstrated that EVBA in patients with resistant hypertension significantly lowered blood pressure (BP) with an acceptable safety profile during 6-month follow-up. METHODS: The CALM-FIM studies were prospective, nonrandomized, first-in-human studies that enrolled patients with resistant hypertension (office systolic BP ≥160 mm Hg and mean 24-hour ambulatory BP ≥130/80 mm Hg despite a stable regimen of ≥3 antihypertensive medications, including a diuretic agent). The incidence of (serious) adverse events and changes in BP, heart rate, and prescribed antihypertensive medication up to 3 years after implantation were determined. RESULTS: The Mobius device was implanted in 47 patients (30 in Europe, 17 in the United States; mean age 54 years, 23 women). Five serious adverse events (hypotension, n = 2; hypertension, n = 1; vascular access complications, n = 2) and 2 transient ischemic attacks occurred within 30 days postprocedure. Two strokes and 1 transient ischemic attack occurred more than 2 years postimplantation. Mean office BP at baseline was 181 ± 17/107 ± 16 mm Hg and decreased by 25/12 mm Hg (95% CI: 17-33/8-17 mm Hg) at 6 months and 30/12 mm Hg (95% CI: 21-38/8-17 mm Hg) at 3 years. Mean 24-hour ambulatory BP at baseline was 166 ± 16/98 ± 15 mm Hg and decreased by 20/11 mm Hg (95% CI: 14-25/8-15 mm Hg) at 6 months. CONCLUSIONS: EVBA with the MobiusHD was effective in reducing BP at 3-year follow-up and appears to have an acceptable safety profile in patients with uncomplicated implantation, although data from randomized sham-controlled trials are needed to further evaluate the risk-benefit profile. (Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM_EUR], NCT01911897; Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM_US], NCT01831895).

Stroke Incidence and Outcome Disparity in Rural Regions of Southern West Virginia.

INTRODUCTION: West Virginia has the highest incidence of obesity, smoking, and diabetes within the United States, placing its population at higher risk of stroke. In addition to these endemic risk factors, Appalachia faces various socioeconomic and health care access challenges that could negatively impact stroke incidence and outcomes. At present, there are limited data regarding geographic variables on stroke outcomes in rural Appalachia. We set out to quantify Appalachian geographic patterns of stroke incidence and outcomes. METHODS: This is a retrospective analysis of all patients hospitalized with a diagnosis of stroke in West Virginia's largest tertiary hospital. During the study (2000-2018), 14,488 patients were analyzed, with an emphasis on those who died from stroke (n = 1022). We first used institutional ICD-9/10 data alongside demographics information and chart reviews to evaluate disease patterns while also exploring emerging hot spot pattern changes over time; we then exploited an emerging time series analysis using temporal trends to assess differing instances of stroke occurrence regionally with hot spots defined as higher than expected incidences of stroke and stroke death. RESULTS: Data analysis revealed several hot spots of increasing stroke and mortality rates, many of which achieved statistically significant variance compared to expected norms (P = 0.001). Moreover, this study revealed high-risk zones in rural West Virginia wherein the incidence and mortality rates of stroke are suggestively higher and less resistance to economic change than urban centers. CONCLUSIONS: Stroke incidence and mortality were found to be higher than expected in many areas of rural West Virginia. The higher stroke risk populations correlate with area that may be impacted by socioeconomic factors and limited access to primary care. These high-risk areas may therefore benefit from investments in infrastructure, patient education, and unrestricted primary care.

Sex Differences in Case Fatality Rate of COVID-19: Insights From a Multinational Registry.

OBJECTIVES: To confirm whether a relationship exists between male sex and coronavirus disease 2019 (COVID-19) mortality and whether this relationship is age dependent. PATIENTS AND METHODS: We queried the COVID-19 Research Network, a multinational database using the TriNetX network, to identify patients with confirmed COVID-19 infection. The main end point of the study was all-cause mortality. RESULTS: A total of 14,712 patients were included, of whom 6387 (43%) were men. Men were older (mean age, 55.0±17.7 years vs 51.1±17.9 years; P<.001) and had a higher prevalence of hypertension, diabetes, coronary disease, obstructive pulmonary disease, nicotine dependence, and heart failure but a lower prevalence of obesity. Before propensity score matching (PSM), all-cause mortality rate was 8.8% in men and 4.3% in women (odds ratio, 2.15; 95% CI, 1.87 to 2.46; P<.001) at a median follow-up duration of 34 and 32 days, respectively. In the Kaplan-Meier survival analysis, the cumulative probability of survival was significantly lower in men than in women (73% vs 86%; log-rank, P<.001). After PSM, all-cause mortality remained significantly higher in men than in women (8.13% vs 4.60%; odds ratio, 1.81; 95% CI, 1.55 to 2.11; P<.001). In the Kaplan-Meier survival analysis, the cumulative probability of survival remained significantly lower in men than in women (74% vs 86%; log-rank, P<.001). The cumulative probability of survival remained significantly lower in propensity score-matched men than in women after excluding patients younger than 50 years and those who were taking angiotensin-converting enzyme inhibitor or angiotensin receptor blocker medications on admission. CONCLUSION: Among patients with COVID-19 infection, men had a significantly higher mortality than did women, and this difference was not completely explained by the higher prevalence of comorbidities in men.

Device profile of the MobiusHD EVBA system for the treatment of resistant hypertension: overview of its mechanism of action, safety and efficacy.

INTRODUCTION: Early promising results of renal nerve denervation awakened interest in developing medical device alternatives for patients with resistant hypertension. The subsequent sham-controlled renal nerve denervation randomized trials were disappointing leading researchers and innovators to explore alternative device and trial designs to address this significant unmet need. We describe the innovation process leading to the first endovascular carotid baroreflex amplification device currently undergoing clinical trials in the United States and Europe. AREAS COVERED: We provide a brief overview of carotid baroreceptor physiology and then couple this knowledge with the fundamental principles of strain pattern changes that led to the proposed innovation. The mechanism of blood pressure reduction via enhancing innate physiologic carotid sinus baroreceptor signaling through changes in pulsatile focal carotid bulb strain is described alongside preclinical testing and early clinical results. EXPERT OPINION: The collective data to date suggest endovascular carotid baroreflex amplification may be an innovative alternative for resistant hypertension patients. However, well-controlled studies will be needed to assess efficacy, safety, durability, and risk: benefit of this permanent intravascular carotid implant. SUBJECT CODES: high blood pressure, hypertension, treatment, physiology.

New Preoperative Spinal Cord Ischemia Risk Stratification Model for Patients Undergoing Thoracic Endovascular Aortic Repair.

PURPOSE: Our objective was to determine significant predictors of spinal cord ischemia (SCI) following Thoracic Endovascular Aortic Repair (TEVAR) and to further develop a simple and clinically orientated risk score model. METHODS: A retrospective review of data from the Society of Vascular Surgery/Vascular Quality Initiative national data set was performed for all patients undergoing TEVAR from January, 2014 to June 2018. Preoperative demographics, procedure-related variables, and clinical details related to SCI were examined. A SCI risk score was developed utilizing a multivariable logistic regression model. RESULTS: For the 7889 patients in the final analysis who underwent TEVAR during the study period, the mean age was 67.6 ± 13.9, range 18 to 90 years, and the majority was male (65%). Postoperative outcomes included stroke (3.0%), myocardial infarction (2.9%), inhospital mortality (5.4%), transient SCI (1.5%), and permanent SCI (2.1%). Nearly half of the overall cases were performed in high volume centers. Predictors of increased risk for SCI included age by decade (odds ratio [OR]: 1.2), celiac coverage (OR: 1.5), current smoker (OR: 1.6), dialysis (OR: 1.9), 3 or more aortic implanted devices (OR: 1.7), emergent or urgent surgery (OR: 1.5), adjunct aorta-related procedure (OR: 2.5), adjunct not related (OR: 2.6), total estimated length of aortic device (19-31 cm, OR: 1.9 and ≥32 cm, OR: 3.0), ASA class 4 or 5 (OR: 1.6), and procedure time ≥154 minutes (OR: 1.8). Two predictors decreased the risk of SCI, cases from high-volume centers (OR: 0.6) and eGFR ≥ 60 (OR: 0.6). To evaluate the risk score model, probabilities of SCI from the original regression, raw score, and raw score categories resulted in area under the curve statistics of 0.792, 0.786, and 0.738, respectively. CONCLUSIONS: Spinal cord ischemia remains one of the most feared complications of TEVAR. Incidence of SCI in this large series of patients with TEVAR was 3.6% with nearly 60% being permanent. The proposed model provides an assessment tool to guide clinical decisions, patient consent process, risk-assessment, and procedural strategy.

A rare cause of stroke after transcatheter aortic valve replacement: Retained foreign body.

The field of transcatheter aortic valve replacement (TAVR) has matured significantly with the outcome and durability data now supporting use in lower-risk patients. We present a preventable complication from early in our experience (5 years ago) that illustrates the importance of heart team communication and cautious multidiscipline cross-pollination during the formative years of a program. An 87-year old female developed confusion, slurred speech and left upper extremity weakness 1 day following TAVR with inconclusive findings on carotid artery duplex and transthoracic echocardiography. Subsequent CT-scan disclosed a linear, ring-like, structure in the ascending aorta. The foreign body (FB) was radiolucent and successfully snared via tactile sensation and anatomic landmarks informed by the CT. The extricated FB was the valvuloplasty balloon guard (BG) that was inadvertently introduced into the patient via ascending aortic large sheath access. The failure mode was traced back to the first time use of a new balloon system and unrecognized BG by the surgical physician and technician components of the Heart Team who took the lead role in device insertion due to the open chest access. Subsequently, the heart team made changes to mitigate similar future complications by sharing multidiscipline responsibility for all procedural steps and ensuring the use of all new adjuvant devices are preceded by a procedural pause and team consensus regarding device preparation and use. Additionally, the manufacturer addition of a radiopaque marker or flair on the valvuloplasty BG may be warranted.

Increasing incidence of IV-drug use associated endocarditis in southern West Virginia and potential economic impact.

BACKGROUND: The opioid crisis has disproportionally affected Appalachia. One of the potentially lethal and costly complications associated with IV drug use is infective endocarditis (IE). The goal of this study was to assess the trend and costs of substance abuse associated IE admissions in Southern West Virginia. METHODS: This is a retrospective analysis of cost, incidence, and geographic patterns of all patients admitted over the last decade with concomitant drug abuse (cocaine, amphetamine, sedative, and other/mixed drug abuse) and IE in the largest tertiary care center for Southern West Virginia. A time series model was used to investigate the effect of drug use on the incidence of IE. RESULTS: A total of 462 patients were hospitalized with IE and concomitant illicit drug use. IE cases increased from 26 admissions in 2008 to 66 in 2015. Patterns of increases in mixed drug use (DRG most often associated with IV drug use in our center) mirrored increases in IE (P = 0.001). From 2008 to 2015, the total hospital charges were $17 306 464 on 462 cases of illicit drug associated IE. Only a fraction of the billed fees (22%) was collected ($3 829 701). CONCLUSIONS: The number of patients hospitalized with IE has dramatically increased over the last decade in a pattern that mirrors the increase in mixed drug use. The majority of payers were from underfunded state programs or private pay and thus, only 22% of the hospital charges were paid, leaving a hospital deficit of over $13 476 763 during the study period.

The history of proximal carotid protection and flow reversal to prevent stent angioplasty embolization.

Innovation in medicine is often driven by the observations of imaginative physicians who are blessed with insatiable curiosity, coupled with the inability to accept technical boundaries, the status quo of patient care, or the acceptance of procedural morbidity. Few examples illustrate this truism better than the physician-originated clinical research that transformed the safety of carotid stent angioplasty over the last 2 decades. Initial clinical application of carotid stenting suggested that proximal protection may be a better approach to prevent embolic stroke during the angioplasty procedure. The history of how this innovation was developed is particularly relevant as vascular surgeons adopt new endovascular therapies. It has been more than 15 years since Dr Juan Parodi put together a multidisciplinary team of scientists and clinicians to test the "proximal protection" hypothesis. The goal of this overview was to provide Dr Parodi team's perspective on the development of the proximal protection and flow reversal concept to minimize plaque embolization during carotid stent angioplasty procedures.

Endovascular Baroreflex Amplification for Resistant Hypertension.

PURPOSE OF REVIEW: Most hypertension devices have been designed to interrupt or modify the sympathetic nervous system, which seems to be unbalanced in hypertension. Carotid baroreceptors play a pivotal role in maintaining adrenergic balance via a direct feedback interface and would be an exceptional target for intervention. The purpose of this review is to define the role of the baroreceptor in hypertension, to examine device-based therapies targeting the baroreflex and to explore future promises of endovascular baroreflex amplification (EBA). RECENT FINDINGS: In the last two decades, two therapeutic strategies targeting the carotid baroreceptor have evolved: baroreflex activation therapy (BAT) and EBA. Both therapies enhance baroreceptor activity, either directly by electrical stimulation or indirectly by changing the geometric shape of the carotid sinus and increasing pulsatile wall strain. By showing a significant, sympathetic inhibition-mediated effect on blood pressure, BAT has laid the foundation for baroreflex-targeting therapies for resistant hypertension. EBA is a less invasive therapy with promising first-in-man study results. Ongoing randomized sham-controlled trials are needed to better understand efficacy, durability, and long-term safety and define phenotypes that may most benefit from this treatment.

Appropriate Use of Venous Imaging and Analysis of the D-Dimer/Clinical Probability Testing Paradigm in the Diagnosis and Location of Deep Venous Thrombosis.

BACKGROUND: The D-dimer (DD) level combined with the pretest Wells criteria probability (WCP) score can safely exclude deep venous thrombosis (DVT). The objective of this study was to examine the correlation between DD results alongside WCP score with findings on venous duplex ultrasound (VDU). The hypothesis is that VDU remains overutilized in low-risk patients with negative DD and that higher DD levels may correlate with thrombus burden and location. METHODS: Patients who presented to a high-volume tertiary care center with lower limb swelling with or without associated pain were retrospectively examined through June and July for 4 consecutive years (2012 to 2015). After calculating WCP, patients were divided into low-, moderate-, and high-risk categories. Electronic DD results utilizing enzyme linked immunosorbent assay, WCP data, and VDU analysis data were merged and analyzed based on receiver operator characteristic curve to determine the DD cutoff point for each WCP. Abnormal DD with an average value ≥ 0.6 mg/L fibrinogen equivalent units (FEUs) was correlated to positive DVT to differentiate proximal DVT (above popliteal vein) from distal DVT (below popliteal vein). RESULTS: Data of 1,909 patients were analyzed, and 239 (12.5%) patients were excluded secondary to serial repeat visits or follow-ups, surveillance screens, and if they had a previous history of DVT. The average age was 62.1 ± 16.3 years with more women (55.7%) and the majority presented with limb pain and edema (87%). DD studies were ordered and completed in 202 patients and correlated with all positive and negative DVT patients (100% sensitivity and negative predictive value, with specificity and positive predictive value of 14.9% and 15.9%, respectively). Twenty-six of 202 patients had DD that were in the normal range 0.1-0.59 mg/L (FEU), all of which were negative for DVT (100% sensitive). Fifty one of 202 patients had DD values of 0.6-1.2 mg/L FEU, of which only 3 DVTs were recorded, and all of them were distal DVTs. In addition, 685 patients with WCP <1 and negative DD were sent for VDU. Thus, 762 patients had an unnecessary immediate VDU (Wells ≤1 and -DD) study during their initial presentation. Potential charge savings for VDU for all patients are 762 × $1,557 = $1,186,434 and DD for all patients are 762 × $182 = $138,684, with total potential savings of $1,047,750 (USD 2016). CONCLUSIONS: This study suggests that DD is still underutilized, and DD in conjunction with WCP could significantly reduce the number of unnecessary immediate VDUs. Higher value of DD (>1.2 mg/L FEU) may raise concern for proximal DVT. Concern on cost-effectiveness exists and raises the demand for a proposed algorithm to be followed.

The Impact of the Drug Epidemic on the Incidence of Sepsis in West Virginia.

Introduction Drug abuse and overdoses are on the rise in West Virginia. Multiple socioeconomic and prescription-prescribing practices influenced this shift. The shifting burden of intravenous drug use to more rural areas has created unique challenges for patient access (medical attention, addiction education, rehabilitation), as well as created an avalanche of additional costs for hospital networks. Methods We analyzed sepsis cases from 2006 to 2015 to investigate whether different types of drug use have increased the odds of developing sepsis as compared to other forms of drug use. To investigate this aspect, the authors examined this relationship by using a logistical regression and a time series analysis of the total cases of drug use and infections. Results The initial analysis investigated the association between drug use and the number of sepsis cases at Charleston Area Medical Center from 2006 to 2015 using a time series analysis. Results suggest that there are similar relationships between sepsis and sedative usage (p=0.016) and sepsis by mixed/other drug (p= 0.020) use. For logistic regression (n=2284), the infection models of sepsis/skin, endocarditis/skin infection, and osteomyelitis/skin infection showed several exposures significantly increased the risk of different infections. A drug user with a positive urine test for opiates is 80.8 percent more likely to develop sepsis as compared to skin infections (p=0.001). The use of sedatives also significantly increased the odds of developing sepsis by 83.2 percent (p=0.002). Conclusion Sepsis left untreated will result in a high mortality rate. As illicit drug use increases, sepsis cases will increase. Further research is needed to understand the continued relationship between drug use and the incidence of sepsis. Based on the current evidence, sepsis appears to be slightly affected by drug use and seems to be influenced by sedatives and opiates but only at a marginal level.

Issues related to renal artery angioplasty and stenting.

Renal artery stenosis may play a significant role in the pathogenesis of secondary hypertension, renal dysfunction, and flash pulmonary edema. Currently correction of renal arterial inflow stenosis is reserved for resistant hypertension patients who have failed maximal medical therapy, have worsening renal function and/or unexplained proximal congestive failure. With the recent advances in minimally invasive percutaneous stent placement techniques, open surgical revascularization has been largely replaced by renal artery stenting. The potential benefit of revascularization seemed intuitive; however, the initial enthusiasm and rise in the number of percutaneous interventions have been tempered by many subsequent negative randomized clinical trials that failed to prove the proposed benefits of the percutaneous intervention. The negative randomized trial results have fallen under scrutiny due to trial design concerns and inconsistent outcomes of these studies compared to pivotal trials undertaken under US Food and Drug Administration scrutiny. Treatment of atherosclerotic renal artery occlusive disease has become one of the most debatable topics in the field of vascular disease. The results from recent randomized clinical trials of renal artery stenting have basically limited the utilization of the procedure in many centers, but not every clinical scenario was covered in those trials. There are potential areas for improvement focusing mainly on procedural details and patient selection with respect to catheter based treatment of atherosclerotic renal artery stenosis. We believe, limiting patient selection, enrollment criteria and outcomes measured functioned to reduce the benefit of renal artery stenosis stenting by not enrolling patients likely to benefit. Future studies incorporating potential procedural improvements and that include patients more likely to benefit from renal stenting than were included in ASTRAL and CORAL are needed to more carefully examine specific patient subgroups so that "the baby is not thrown out with the bath water." We also discuss several other concerns related to renal artery stenting which include diagnostic, procedure, indication, and reimbursement issues.

Evidence-based medicine and contemporary certification: Analysis of the American Board of Vascular Medicine endovascular board examination.

Since 2005, the American Board of Vascular Medicine (ABVM) endovascular examination has been used to certify vascular practitioners. Annual rigorous review has confirmed it is psychometrically valid and reliable. However, the evidence basis underlying the examination items has not been studied systematically. The aim of this study was to adjudicate class of recommendation (COR) and level of evidence (LOE) for the 2015 ABVM endovascular examination and establish an additional feedback mechanism for examination improvement based on contemporary evidence-based guidelines. We performed a pooled consensus process to classify each of the 110 items in the 2015 ABVM endovascular examination by COR and LOE as detailed in the current guideline statements. We added additional categories for items that were not eligible for assignment using traditional current evidence-based metrics: 'COR X', cannot be determined, not applicable, or simple recognition; and 'LOE X', cannot be determined or not applicable. COR classifications were assigned in the following proportion: Class I=15%, Class II=40%, Class III=3%, COR X=42%. LOE classifications were assigned in the following proportion: Level A=12%, Level B=34%, Level C=32%, LOE X=22%. Our analysis showed that nearly half of the 2015 ABVM endovascular examination items were supported by strong scientific evidence or fact-based knowledge. COR and LOE analysis yielded notably different results. Use of alternate classification schema may be powerful tools for improving certification exams in healthcare.

Clinical Outcome of Carotid Artery Stenting According to Provider Specialty and Volume.

BACKGROUND: Several studies have demonstrated better outcomes for carotid endarterectomy with high-volume hospitals and providers. However, only a few studies have reported on the impact of operator specialty/volume on the perioperative outcome of carotid artery stenting (CAS). This study will analyze the correlation of CAS outcomes and provider specialty and volume. METHODS: Prospectively collected data of CAS procedures done at our institution during a 10-year period were analyzed. Major adverse events (MAEs; 30-day stroke, myocardial infarction, and death) were compared according to provider specialty (vascular surgeons [VSs], interventional cardiologists [ICs], interventional radiologists [IRs], interventional vascular medicine [IVM]), and volume (≥5 CAS/year vs. <5 CAS/year). RESULTS: Four hundred fourteen CAS procedures (44% for symptomatic indications) were analyzed. Demographics/clinical characteristics were somewhat similar between specialties. MAE rates were not significantly different between various specialties: 3.1% for IC, 6.3% for VS, 7.1% for IR, 6.7% for IVM (P = 0.3121; 6.3% for VS and 3.8% for others combined, P = 0.2469). When physicians with <5 CAS/year were excluded: the MAE rates were 3.1% for IC, 4.7% for VS, and 6.7% for IVM (P = 0.5633). When VS alone were compared with others, and physicians with <5 CAS/year were excluded, the MAE rates were 4.7% for VS vs. 3.6% for non-VS (P = 0.5958). The MAE rates for low-volume providers, regardless of their specialty, were 9.5% vs. 4% for high-volume providers (P = 0.1002). Logistic regression analysis showed that the odds ratio of MAE was 0.4 (0.15-1.1, P = 0.0674) for high-volume providers, while the odds ratio for VS was 1.3 (0.45-3.954, P = 0.5969). CONCLUSIONS: Perioperative MAE rates for CAS were similar between various providers, regardless of specialties, particularly for vascular surgeons with similar volume to nonvascular surgeons. Low-volume providers had higher MAE rates.

Validation of subclavian duplex velocity criteria to grade severity of subclavian artery stenosis.

BACKGROUND: Validation of subclavian duplex ultrasound velocity criteria (SDUS VC) to grade the severity of subclavian artery stenosis has not been established or systematically studied. Currently, there is a paucity of published literature and lack of practitioner consensus for how subclavian duplex velocity findings should be interpreted in patients with subclavian artery stenosis. OBJECTIVE: The objective of the present study was to validate SDUS measurements using subclavian conventional or computed tomography angiogram (subclavian angiogram [SA])-derived measurements. Secondary objectives included measuring the correlation between SDUS peak systolic velocities and SA measurements, and to determine the optimal cutoff value for predicting significant stenosis (>70%). METHODS: This is a retrospective review of all patients with suspected subclavian artery stenosis and a convenience sample of carotid artery patients who underwent SDUS and SA from May 1999 to July 2013. SA reference vessel and intralesion minimal lumen diameters were measured and compared with SDUS velocities obtained within 3 months of the imaging study. Percent stenosis was calculated using the North American Symptomatic Carotid Endarterectomy Trial method for detecting stenosis in a sufficiently large cohort. Receiver operating characteristic curves was generated for SDUS VC to predict >70% stenosis. Velocity cutoff points were determined with equal weighting of sensitivity and specificity. RESULTS: We examined 268 arteries for 177 patients. The majority of the arteries were for female patients (52.5%) with a mean age of 66.7 ± 11.1 years. Twenty-three arteries had retrograde vertebral artery flow and excluded from further analysis. For the remaining 245 arteries, the average peak systolic velocity was 212.6 ± 110.7 cm/s, with a range of 45-626 cm/s. Average stenosis was 25.8% ± 28.2%, with a range of 0% to 100%. Following receiver operating characteristic analysis, we found a cutoff value of >240 cm/s to be most predictive of >70%. Area under the curve was 0.94 with 95% confidence intervals of 0.91 to 0.97. The sensitivity and specificity for predicting >70% stenosis was 90.9 and 82.5%, respectively. CONCLUSIONS: In patients with known or suspected disease involving the great vessels, a subclavian artery flow velocity exceeding 240 cm/s seems to be predictive of significant subclavian stenosis. Thus, we propose new SDUS VC, for predicting subclavian artery stenosis. However, because of the use of a convenience sample, it is possible that the current proposed cutoff point might need to be adjusted for other populations.

Avoiding collateral damage in the war on hypertension.

When performed by experienced clinicians, renal nerve denervation (RND) can be done with very low risk of complication and/or acute renal injury Renal function seems to remain unchanged in this small series over 3 years More studies are needed to establish the role of renal biomarkers in assessment of acute renal injury in this setting and larger series of RND in azotemic patients should be done before the procedure indications can be expanded.

Validation of venous duplex ultrasound imaging in determining iliac vein stenosis after standard treatment of active chronic venous ulcers.

OBJECTIVE: Chronic venous ulcer (CVU) is a potentially debilitating condition that remains the most common etiology for leg ulcers. The condition has significant associated costs and effect on patient quality of life. That truncal reflux can be worsened by iliac vein occlusive disease is well known. However, there has not been systematic investigation of venous duplex ultrasound (VDUS) criteria to correlate common femoral vein (CFV) reflux with iliac vein stenosis. We sought to correlate VDUS criteria for predicting iliac vein stenosis and to investigate venous outflow factors associated with CVU recurrence. METHODS: We conducted a systematic retrospective review of a consecutive series of 36 patients who received standard therapies, including compression therapy along with ablation of incompetent great saphenous veins for treating CVU, but in whom the treatment failed. Elevated CVF reflux was considered as reflux duration (RD) measured by VDUS to last >1 second. A receiver operator characteristic curve analysis was performed to determine the optimal CFV threshold value to predict 50% iliac vein stenosis measured by intravascular ultrasound. RESULTS: The 36 patients presented with 54 CVUs on 38 limbs. The median (25th-75th quartiles) age was 61.2 (57.6-68.8) years, body mass index was 36.8 (25.2-52.3) kg/m(2), CFV RD was 2.7 (1.6-3.5) seconds, ulcer diameter was 4.2 (3.0-4.0) cm, and ulcer depth was 2.5 (2.0-3.0) mm. The optimal cutoff RD value was >2.5 seconds by receiver operator characteristic curve analysis, with an area under the curve of 0.77 (P = .001). CVUs associated with an RD >2.5 seconds had significantly more iliac vein stenosis >50% by intravascular ultrasound (24 of 30; 80%) than those with an RD <2.5 seconds (6 of 24; 25%; P < .001). Likewise, >50% stenosis for those above and below an RD >1 second was 61.4% vs 30%, respectively (P = .089). Significantly less recurrence of CVU was found for patients taking pentoxifylline (43.6% vs 80.0%; P = .031) and those with stents placed (40.0% vs 70.8%; P = .031). A nonsignificant trend was found for iliac vein interrogation (44.4% vs 72.2%; P = .082). CONCLUSIONS: This study highlights the utility of VDUS in diagnosing iliac vein stenosis with 2.5 seconds to predict ≥50% iliac vein stenosis. Stent placement and pentoxifylline were associated with ulcer healing and reduced risk of venous ulcer recurrence.

Novel Risk Score Model for Prediction of Survival Following Elective Endovascular Abdominal Aortic Aneurysm Repair.

OBJECTIVE: The purpose of this study was to identify significant predictors of long-term mortality after elective endovascular abdominal aortic aneurysm repair (EVAR). METHODS: We included all cases with elective EVAR based on a national data set from the Society for Vascular Surgery Patient Safety Organization. Clinical and anatomic variables were analyzed with a Kaplan-Meier and Cox-regression model to determine predictors of mortality and develop a score equation to categorize patients into low, medium, and high long-term mortality risk. RESULTS: A total of 5678 patients with EVAR were included with an average age of 73.6 ± 8.2 years. The majority were male (81.6%) with a history of smoking (86.1%). There were 3 deaths within 30 days (0.1%). Several factors were associated with poor survival: unstable angina (hazard ratio [HR], 2.8; P = .008), dialysis (HR, 3.7; P < .001), estimated glomerular filtration rate (eGFR) <30 (HR, 1.7; P = .044), eGFR 30 to 59 (HR, 1.4; P = .002), age >80 (HR, 3.2; P < .001), age 75 to 79 (HR, 2.2; P < .001), chronic obstructive pulmonary disease on oxygen (HR, 3.3; P < .001), aortic diameter >5.8 cm (HR, 1.2; P = .043), and high risk for surgery (HR, 1.4; P = .043). Preoperative aspirin use and body mass index 25 to 35 were both found to be protective (HR, 0.78; P = .017 and HR, 0.8; P = .024, respectively). With our scoring model, 5- and 10-year survival rates for patients with low, medium, and high risk were 89.2%, 80.7%, and 64.1% and 77.2%, 60.1%, and 40.1%, respectively (P < .001). CONCLUSION: Ten-year survival following EVAR in patients with a high-risk score utilizing the model provided was 40.1%. Patients with multiple comorbidities at risk for decreased long-term survival can be identified with our model, which is more applicable for high-volume contemporary institutions.