Cardiovascular disease due to novel coronavirus and the search for investigational therapies.

Objective: The primary purpose of the study was to investigate and to summarize the registered trials that listed COVID-19 as the primary condition. Methods: We performed a search on ClinicalTrials.gov using the independent search terms COVID-19, SARS, and SARS-CoV-2 and then downloaded the data file on March 23, 2020. All trials were downloaded to a csv file and searched for appropriateness. Results: Of 124 registered trials, 56 (45.2%) were listed as recruiting. The majority (85 [68.5%]) were classified as interventional, 37 (29.8%) as observational, and one (0.8%) each as either expanded access: individual patients|treatment investigational new drug/protocol or expanded access: intermediate-size population|treatment investigational new drug/protocol. There were 67 (54.0%) trials that listed drug as the type of study. Immunologic and antiviral trials were the most common, representing approximately 30% and 21%, respectively. When immunologic and antiviral drugs were used alone or in combination, they represented 41.9% and 34.4%, respectively. Antimalarial agents are represented in 7.5% of trials. Approximately 14% of trials involved traditional Chinese medicine. The study agents used solely or in combination represented approximately 80% of therapeutic approaches to COVID-19. Conclusions: There was a large and quick response on ClinicalTrials.gov to the COVID-19 outbreak. Many of the registered trials are currently recruiting new patients, whereas some will begin in the near future. Specific potential experimental therapies, including dosing and monitoring, might be found by reviewing content. Within ClinicalTrials.gov, patients, family members, health care professionals, and researchers can search and find ongoing and future trials for COVID-19.

Results of Telehealth Electronic Monitoring for Post Discharge Complications and Surgical Site Infections following Arterial Revascularization with Groin Incision.

BACKGROUND: Post-surgical discharge complications result in increased hospital readmissions, cost, and patient dissatisfaction. Telehealth technology to monitor patients, especially those in geographically isolated areas, may reduce post-operative complications and improve health and financial outcomes. The primary objective of this study was to compare outcomes between patients who received TeleHealth Electronic Monitoring (THEM) and those with routine discharge instructions and no monitoring, Standard Of Care (SOC). METHODS: This is a prospective randomized study of vascular surgery patients with infrainguinal incisions. THEM patients received a tablet and home monitoring devices that transmitted information to care managers. Monitoring tools included image capture, weight scales, blood pressure cuffs, thermometers, and oxygen saturation monitors. Care managers used the TeleMed 2020 Enform™ platform to review alerts, real-time patient data, and dialogue with the care team. RESULTS: Eighty patients were screened and 30 enrolled, of which 16 (53.3%) were randomized to the THEM group and 14 (46.7%) to the control group. Average age and body mass index for THEM and control patients were similar (62.5 ± 7.2 vs. 65.7 ± 7.3, P = 0.234; and 27.7 ± 4.3 vs. 29.1 7.1, P = 0.487), respectively. There was a similar number of male participants in each group (THEM 62.5% vs. SOC 42.9%, P = 0.464). There were no significant differences in wound or 30-day readmissions (THEM 6.3% vs. SOC 7.1%, P = 1.000). Interestingly, 30-day infection rates indicated that care managers identified marginally more superficial wound problems in the THEM group (31.3% vs. 7.1%, P = 0.175). Both groups reported an increase in short-form-8 physical summary scores, but was more pronounced in THEM patients (P = 0.076). THEM patients reported a significantly greater improvement in quality of life on 3 of the short-form-8 quality subscales (physical function, role-physical, and role-emotional; THEM delta 7.5 versus Control delta 1.1; THEM delta 8.7 versus Control delta 1.1; and THEM delta 6.3 versus Control delta -0.5; all P < 0.05). THEM patients reported trends for higher satisfaction in terms of general satisfaction, technical quality, and accessibility for Patient Satisfaction Questionnaire-18 survey questions (4.2 vs. 3.7, P = 0.072; 4.5 vs. 4.1, P = 0.081; and 4.2 vs. 3.8, P = 0.063), respectively. CONCLUSIONS: THEM was technically feasible and provided some benefit to patients in geographically disparate areas. THEM was associated with increased patient satisfaction. Additional findings suggested that THEM patients embraced telehealth technology and took advantage of increased access to healthcare professionals. Telehealth successfully merged remotely generated information with care manager interaction. Presently, a larger study, preferably multi-center, is warranted and under consideration.

Comparative study of clinical outcome of endovascular aortic aneurysms repair in large diameter aortic necks (>31 mm) versus smaller necks.

BACKGROUND: This study compares short-term (30 days) and intermediate term (3 years) clinical outcomes in patients with large (≥31 mm) versus small aortic neck diameters (≤28 and ≤31 mm). METHODS: Prospectively collected data from 741 patients who underwent endovascular aortic aneurysm repair were analyzed. Some surgeons have reported the threshold for a large aortic neck for endovascular aortic aneurysm repair to be 28 mm, whereas for others it is 31 mm. Therefore, we classified aortic neck diameter into less than or equal to 28 versus greater than 28 mm; and less than or equal to 31 versus greater than 31 mm. Logistic regression and Kaplan-Meier analyses were used to compare outcomes. RESULTS: There were 688 patients who had a defined aortic neck diameter: 592 with less than or equal to 28 mm, 96 with greater than 28 mm, 655 with less than or equal to 31 mm, and 33 with greater than 31 mm. The mean follow-up was 25.2 months for less than or equal to 31 mm versus 31.8 months for greater than 31 mm. Clinical characteristics were similar in all groups, except that there were more patients outside the instructions for use in the greater than 31 mm versus less than or equal to 31 mm group (94% vs 44%; P < .0001). There was a significant increase in early type I endoleak for patients with an aortic neck diameter of greater than 31 versus less than or equal to 31 mm (9 [27%] vs 74 [11%]; P = .01); late type I endoleaks (4 [14%] vs 18 [3%]; P = .01); sac expansion (5 [17%] vs 28 [5%]; P = .01); late intervention (5 [17%] vs 23 [4%]; P = .01); and death (9 [31%] vs 48 [8%]; P < .0001). There were no differences in outcomes between the patients with greater than 28 mm aortic neck diameters and the less than or equal to 28 mm diameters. Freedom from late type I endoleak at 1, 2, and 3 years were 96%, 88%, and 88% for patients with a neck diameter of greater than 31 mm versus 97%, 97%, and 97% for a diameter less than or equal to 31 mm (P = .19). The rate of freedom from sac expansion for patients with a diameter greater than 31 mm was 88%, 81%, and 81% at 1, 2, and 3 years versus 99%, 97%, and 92% for a diameter less than or equal to 31 mm (P = .02). Freedom from late intervention for 1, 2, and 3 years for patients with a diameter greater than 31 mm were 91%, 91%, and 91% versus 99%, 97%, and 96% for those with a diameter less than or equal to 31 mm. Survival rates at 1, 2, and 3 years for a diameter greater than 31 mm were 83%, 74%, and 68% versus 96%, 92%, and 90% for a diameter less than or equal to 31 mm (P < .001). Multivariate logistic regression analysis showed that patients with a diameter greater than 31 mm had an odds ratio of 6.1 (95% confidence interval [CI], 2.2-16.8) for mortality, 4.7 (95% CI, 1.4-15.5) for sac expansion, and 4.9 (95% CI, 1.4-17.4) for late type I endoleak. CONCLUSIONS: Patients with large aortic neck diameters (>31 mm) had higher rates of early and late type I endoleak, sac expansion, late intervention, and mortality.

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.

Telehealth electronic monitoring to reduce postdischarge complications and surgical site infections after arterial revascularization with groin incision.

It is intuitive that postdischarge surgical complications are associated with increased patient dissatisfaction, and are directly associated with an increase in medical expenditures. It is also easy to make the connection that many post-hospital discharge surgical complications, including surgical site infections (SSIs), could be influenced or exacerbated by patient comorbidities. The authors of a recent study reported that female gender, obesity, diabetes, smoking, hypertension, coronary artery disease, critical limb ischemia, chronic obstructive pulmonary disease, dyspnea, and neurologic disease were significant predictors of SSIs after vascular reconstruction was performed. The main concern for optimal patient care, especially in geographically isolated areas of West Virginia, is to have early, expeditious, and prompt diagnosis of complications and SSI. This adjunct to existing approaches could lead to improved outcomes and patient satisfaction, minimizing third-party interventions and decreasing the total cost of care. It seems reasonable to believe that monitoring using telehealth technology and managing the general health care of patients after a hospital vascular intervention will improve overall health and reduce 30-day readmissions and SSIs.

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.

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.

Compliance of postendovascular aortic aneurysm repair imaging surveillance.

OBJECTIVE: Imaging surveillance after endovascular aortic aneurysm repair (EVAR) is critical. In this study we analyzed compliance with imaging surveillance after EVAR and its effect on clinical outcomes. METHODS: Retrospective analysis of prospectively collected data of 565 EVAR patients (August 2001-November 2013), who were followed using duplex ultrasound and/or computed tomography angiography. Patients were considered noncompliant (NC) if they did not have any follow-up imaging for 2 years and/or missed their first post-EVAR imaging over 6 months. A Kaplan-Meier analysis was used to compare compliance rates in EVAR patients with hostile neck (HN) vs favorable neck (FN) anatomy (according to instructions for use). A multivariate analysis was also done to correlate compliance and comorbidities. RESULTS: Forty-three percent were compliant (7% had no follow-up imaging) and 57% were NC. The mean follow-up for compliant patients was 25.4 months (0-119 months) vs 31.4 months for NC (0-140 months). The mean number of imaging was 3.5 for compliant vs 2.6 for NC (P < .0001). Sixty-four percent were NC for HN patients vs 50% for FN patients (P = .0007). The rates of compliance at 1, 2, 3, 4, and 5 years for all patients were 78%, 63%, 55%, 45%, and 32%; and 84%, 68%, 61%, 54%, and 40% for FN patients; and 73%, 57%, 48%, 37%, and 25% for HN patients (P = .009). The NC rate for patients with late endoleak and/or sac expansion was 58% vs 54% for patients with no endoleak (P = .51). The NC rate for patients with late reintervention was 70% vs 53% for patients with no reintervention (P = .1254). Univariate and multivariate analyses showed that patients with peripheral arterial disease had an odds ratio of 1.9 (P = .0331), patients with carotid disease had an odds ratio of 2 (P = .0305), and HN patients had an odds ratio of 1.8 (P = .0007) for NC. Age and residential locations were not factors in compliance. CONCLUSIONS: Overall, compliance of imaging surveillance after EVAR was low, particularly in HN EVAR patients, and additional studies are needed to determine if strict post-EVAR surveillance is necessary, and its effect on long-term clinical outcome.

Iliac Vein Interrogation Augments Venous Ulcer Healing in Patients Who Have Failed Standard Compression Therapy along with Pathological Venous Closure.

BACKGROUND: Treatment of venous ulcers is demanding for patients, as well as clinicians, and the investigation of underlying venous hypertension is the cornerstone of therapy. We propose that occult iliac vein stenosis should be ruled out by iliac vein interrogation (IVI) in patients with advanced venous stasis. METHODS: We conducted a systematic retrospective analysis of a consecutive series of patients who presented with CEAP (clinical, etiological, anatomical, and pathophysiological) 6 venous disease. All patients had great saphenous vein ablation, compressive treatment, wound care (including Unna boot compression), and perforator closure using ablation therapy. Iliac vein stenosis was defined as ≥50% stenosis in cross-sectional surface area on intravascular ultrasound. Primary outcomes include time of venous ulcer healing and/or measurable change in the Venous Clinical Severity Score. RESULTS: Twenty-two patients with CEAP 6 venous disease met the inclusion criteria (active ulcers >1.5 cm in diameter). The average age and body mass index were 62.2 ± 9.2 years and 41.7 ± 16.7, respectively. The majority were female (72.7%) with common comorbidities, such as hyperlipidemia (54.5%), hypertension (36.4%), and diabetes mellitus (27.3%). Twenty-nine ulcers with an average diameter of 3.4 ± 1.9 cm and a depth of 2.2 ± 0.5 mm were treated. The majority of the ulcers occurred on the left limb (n = 17, 58.6%). Average perforator venous reflux was 3.6 ± 0.8 sec, while common femoral reflux was 1.8 ± 1.6. The majority (n = 19, 64.5%) of the perforator veins were located at the base of the ulcer, while the remainder (n = 10, 34.5%) were within 2 cm from the base. Of the 13 patients who underwent IVI, 8 patients (61.5%) had stenosis >50% that was corrected with iliac vein angioplasty and stenting (IVAS). There was a strong trend toward shorter healing time in the IVI group (7.9 ± 9.5 weeks) than for patients in the no iliac vein interrogation (NIVI) group (20.2 ± 15.3 weeks, P = 0.055). The final VCCS score was not significantly different (IVI = 7.9 ± 9.5 vs. NIVI = 10.0 ± 6.5, P = 0.578). However, compared with the NIVI group, the healing time for patients who actually received IVAS was marginally lower (5.8 ± 3.6 weeks, P = 0.075) and final VCCS was significantly lower (2.4 ± 2.9, P = 0.031). Veins that received IVI and IVAS remained patent and the associated ulcers were healed (100%). CONCLUSION: The small sample size and retrospective design limit the strength of the conclusions but the findings suggest that further studies are needed to define the exact role of IVI including angioplasty/stenting for patients with chronic venous ulcers.

Prospective randomized double-blinded trial comparing 2 anti-MRSA agents with supplemental coverage of cefazolin before lower extremity revascularization.

OBJECTIVE: To compare with antibiotics with methicillin-resistant microbial coverage in a prospective fashion. BACKGROUND: Current antibiotic prophylaxis for vascular procedures includes a first generation cephalosporin. No changes in recommendations have occurred despite changes in reports of incidence of MRSA related surgical site infections. Does supplemental anti-MRSA prophylactic coverage provide a significant reduction in Gram-positive or MRSA infections? METHODS: Single center prospective double blinded randomized study of patients undergoing lower extremity vascular procedures from 2011 to 2014. One hundred seventy-eight (178) patients were evaluated at 90 days for surgical site infection. Infections were categorized as early infections less than 30 days of the index procedure and late after 90 days. RESULTS: Early vascular surgical site infection occurred in 7(8.24%) of patients in the Vancomycin arm, and 11 (11.83%) in the Daptomycin arm (P = 0.43). Gram-positive related infections and MRSA infections occurred in 1(1.18%)/0(0%) of Vancomycin patients and 9 (9.68%)/1 (1.08%) of Daptomycin patients, respectively (P < 0.02 and P = 1.00). Readmissions related to surgical site infections occurred in 4(4.71%) in the Vancomycin group and 11 (11.8%) in the Daptomycin group (P = 0.11). Patients undergoing operative exploration occurred in 5 (5.88%) in the Vancomycin group and 10 (10.75%) of the Daptomycin group (P = 0.17). Late infections were reported in 3 patients, 2 of which were in the combined Daptomycin group. Median hospital charges related to readmissions due to a surgical site infection was $50,823 in the combination Vancomycin arm and $110,920 in the combination Daptomycin group; however, no statistical significance was appreciated (P = 0.11). CONCLUSIONS: Vancomycin supplemental prophylaxis seems to reduce the incidence of Gram-positive infection compared with adding supplemental Daptomycin prophylaxis. The Incidence of MRSA-related surgical site infections is low with the addition of either anti-MRSA agents compared with historical incidence of MRSA-related infection.

Update on intervention versus medical therapy for atherosclerotic renal artery stenosis.

Atherosclerotic renal artery stenosis is known to be one of the most common causes of secondary hypertension, and early nonrandomized studies suggested that renal artery stenting (RASt) improved outcomes. The vascular community embraced this less invasive treatment alternative to surgery, and RASt increased in popularity during the late 1990s. However, recent randomized studies have failed to show a benefit regarding blood pressure or renal function when RASt was compared with best medical therapy, creating significant concerns about procedural efficacy. In the wake of these randomized trial results, hypertension and renal disease experts along with vascular interventional specialists now struggle with how to best manage atherosclerotic renal artery stenosis. This review objectively analyzes the current literature and highlights each trial's design weaknesses and strengths. We have provided our recommendations for contemporary treatment guidelines based on our interpretation of the available empirical data.

The effect of chronic renal insufficiency by use of glomerular filtration rate versus serum creatinine level on late clinical outcome of carotid endarterectomy.

BACKGROUND: Several studies have reported mixed results after carotid endarterectomy (CEA) in patients with chronic renal insufficiency (CRI), and we previously reported the perioperative outcome in patients with CRI by use of serum creatinine (Cr) level and glomerular filtration rate (GFR). However, only a few of these studies used GFR by the Modification of Diet in Renal Disease equation in their analysis of long-term outcome. METHODS: During the study period, 1000 CEAs (926 patients) were analyzed; 940 of these CEAs had Cr levels and 925 had GFR data. Patients were classified into normal (GFR ≥60 mL/min/1.73 m(2) or Cr <1.5 mg/dL), moderate CRI (GFR ≥30-59 or Cr ≥1.5-2.9), and severe CRI (GFR <30 or Cr ≥3). RESULTS: At a mean follow-up of 34.5 months and a median of 34 months (range, 1-53 months), combined stroke and death rates for Cr levels (867 patients) were 9%, 18%, and 44% for Cr <1.5, ≥1.5 to 2.9, and ≥3 (P = .0001) in contrast to 8%, 14%, and 26% for GFR (854 patients) of >60, ≥30 to 59, and <30, respectively (P = .0003). Combined stroke and death rates for asymptomatic patients were 8%, 17%, and 44% (P = .0001) for patients with Cr levels of <1.5, ≥1.5 to 2.9, and ≥3, respectively, vs 7%, 13%, and 24% for a GFR of ≥60, ≥30 to 59, and <30 (P = .0063). By Kaplan-Meier analysis, stroke-free survival rates at 1 year, 2 years, and 3 years were 97%, 94%, and 92% for Cr <1.5; 92%, 85%, and 81% for Cr ≥1.5 to 2.9; and 56%, 56%, and 56% for Cr ≥3 (P < .0001); vs 98%, 95%, and 93% for a GFR ≥60; 93%, 90%, and 86% for a GFR of ≥30 to 59; and 86%, 77%, and 73% for a GFR <30 (P < .0001). These rates for asymptomatic patients at 1 year, 2 years, and 3 years were 97%, 95%, and 93% for Cr <1.5; 94%, 87%, and 82% for Cr ≥1.5 to 2.9; and 56%, 56%, and 56% for Cr ≥3 (P < .0001); vs 98%, 95%, and 94% for a GFR ≥60; 95%, 91%, and 86% for a GFR of ≥30 to 59; and 84%, 80%, and 75% for a GFR <30 (P = .0026). A univariate regression analysis for asymptomatic patients showed that the hazard ratio (HR) of stroke and death was 6.5 (P = .0003) for a Cr ≥3 and 3.1 for a GFR <30 (P = .0089). A multivariate analysis showed that Cr ≥3 had an HR of stroke and death of 4.7 (P = .008), and GFR <30 had an HR of 2.2 (P = .097). CONCLUSIONS: Patients with severe CRI had higher rates of combined stroke/death. Therefore, CEA for these patients (particularly in asymptomatic patients) must be considered with caution.

Anatomic and clinical predictors of reintervention after subclavian artery stenting.

OBJECTIVE: This study was conducted to determine long-term predictors of target lesion reintervention (TLR) after subclavian artery stenting (SAS). METHODS: This was a single-center retrospective review of patients with symptomatic atherosclerotic subclavian artery disease who underwent SAS between January 1999 and December 2013. Repeat intervention was only performed in patients with recurrent symptoms and ≥70% in-stent restenosis (ISR). TLR was defined as need for a repeat percutaneous intervention involving a previously stented area. Freedom from events (ISR and TLR) was analyzed using Kaplan-Meier curves. Cox regression analysis was used to determine the significant predictors of TLR and ISR. RESULTS: Index procedures were performed on 139 arteries in 138 patients (69.6% female). Patients were an average age of 64.5 years, with major comorbidities of hypertension (80.4%), hyperlipidemia (72.5%), and tobacco use (60.1%). Also performed during the study period were 24 TLR procedures, resulting 166 SAS interventions attempted for patients with subclavian atherosclerotic disease during a 15-year span. Of 166 procedures, 163 (98.2%) were treated successfully. Stents were placed in all but two index arteries. The main indications for SAS were subclavian steal syndrome (48.9%), arm claudication (21.6%), and coronary steal syndrome (28.8%). The average preprocedure stenosis was 87.2% ± 11.2%. For index procedures (139 arteries), duplex follow-up was available for 134 arteries (96.4%), with an overall ISR rate of 18.7% (25 of 134). Primary patency for the index procedures was 84.7% at 10 years. The overall TLR rate for the index procedures was 12.7% (17 cases). Seven patients required more than one secondary procedure. For all cases, the freedom from ISR was 91%, 77%, and 68% at 1, 5, and 10 years, respectively, and freedom from TLR was 94%, 85%, and 82% at 1, 5, and 10 years, respectively. Multivariate analysis showed the significant predictors of ISR were smoking/chronic obstructive pulmonary disease (hazard ratio [HR], 3.2; P = .001), age by decade (HR, 0.5; P < .001), discharged with statin therapy (HR, 0.3; P = .001), vessel diameter ≤7 mm (HR, 2.3; P = .028), and right-sided intervention (HR, 0.3; P = .040). The sole significant predictor of TLR was age by decade (HR, 0.6; P = .008). CONCLUSIONS: SAS has a high primary success and durability with satisfactory outcomes well beyond 10 years. ISR was more likely to develop in patients who were smokers with chronic obstructive disease or had a baseline vessel size of ≤7 mm. Younger age could be an independent risk factor for secondary intervention.

Long-term Comparative Outcomes of Carotid Artery Stenting Following Previous Carotid Endarterectomy vs De Novo Lesions.

PURPOSE: To report the long-term outcomes of patients who underwent carotid artery stenting (CAS) for de novo carotid stenosis vs patients treated for restenosis after carotid endarterectomy (CEA). METHODS: A retrospective review was conducted of all 385 patients (mean age 68.6±9.6 years; 231 men) who underwent 435 CAS procedures at a large tertiary care center between January 1999 and December 2013. For analysis, patients were stratified based on their lesion type [de novo (dn) vs post-CEA restenosis (res)] and subclassified by symptoms status [symptomatic (Sx) or asymptomatic (Asx)], creating 4 groups: (1) CAS-dn Asx, (2) CAS-dn Sx, (3) CAS-res Asx, and (4) CAS-res Sx. For the CAS-res group, the mean elapsed time from CEA to CAS was 72.4±63.6 months. Outcomes included target vessel reintervention (TVR) and in-stent restenosis (ISR), the latter defined by a carotid duplex ultrasound velocity >275 cm/s. RESULTS: The main indication for initial carotid angiography with possible revascularization was severe carotid stenosis (≥70%-99% on duplex) in both CAS-dn and CAS-res groups (83.6% vs 83.7%, p=0.999). There were no significant differences in the percentage of patients with postintervention residual stenosis (<30%; 100% each arm) or complications between CAS-res vs CAS-dn: in-hospital stroke (1.4% vs 1.8%, respectively), myocardial infarction (0.9% vs 0%), or death (0.9% vs 0%). Mean follow-up was 62.4±45.6 months (median 53.5, range 1-180). Average clinical/TVR follow-up was greater for the CAS-res group (71.9±48.6 months) compared with 53.3±40.5 months for the CAS-dn group (p<0.001). Across the 4 study groups, there were no differences in freedom from ISR (p=0.174) or TVR (p=0.856). Multivariate analysis found peripheral vascular disease (PVD) as the sole ISR independent predictor [hazard ratio (HR) 1.92, 95% confidence interval (CI) 1.03 to 3.62, p=0.041], while significant predictors for TVR were age <65 years at the time of the procedure (HR 2.55, 95% CI 1.05 to 6.18, p=0.039) and PVD (HR 2.46, 95% CI 1.03 to 5.87, p=0.043). CONCLUSION: The current study suggests that CAS is a feasible and durable therapeutic option for recurrent restenosis after CEA. Long-term outcomes were similar for patients treated for de novo lesions or post-CEA restenosis. Age and PVD appear to influence long-term CAS durability.

Appropriate use of D-dimer testing can minimize over-utilization of venous duplex ultrasound in a contemporary high-volume hospital.

BACKGROUND: The sensitivity of d-dimer (DD) in detecting deep venous thrombosis (DVT) is remarkably high; however, many institutions send patients immediately for a venous duplex ultrasound (VDU). This study was designed to examine the appropriate utilization of DD and VDU in a high-volume hospital. METHODS: A retrospective study was conducted on consecutive patients who presented to a high-volume emergency department (ED) with lower extremity limb swelling/pain over a 30-day period, who were sent for VDU during an evaluation for DVT. VDU data were merged with electronic DD laboratory results. The enzyme-linked immunosorbent assay method was used to provide DD values and thresholds. Values above 0.60 mg/fibrinogen equivalent unit (FEU) were considered abnormal. RESULTS: We reviewed the medical records of 517 ED patients in the month of June 2013. After applying the Wells criteria, 157 patients (30.4%) were excluded because of a history of DVT or pulmonary embolism, having been screened for shortness of breath, or sent for surveillance-leaving 360 for analysis. The average age was 59.3 ± 16.5 years with more women (210, 58.3%) and the majority reported limb pain or swelling (73.9%). DD was performed on 51 patients with an average value of 3.6 ± 5.4 mg/FEU, of which 43 (84.3%) were positive. DD identified all positive and negative DVT patients (100% sensitivity and negative predictive value), but also included 40 false positives (16.7% specificity). On the other hand, 309 patients were sent directly to VDU without DD; of those, 43 (13.9%) were positive for DVT. However, 266 (86.1%) patients were negative for DVT by VDU without DD and these were deemed improper by our current study protocol. Potential charge savings were calculated as VDU for all (360 × $1000 = $360,000), DD for all (360 × $145 = $52,200), and VDU for both true and false positives (estimated to be about 25% of the cases; 90 × $1000 = $90,000); this equals a charge savings of $217,800 and would avoid unnecessary VDUs. CONCLUSIONS: Based on the results of our study, we suggest that the DD test be utilized during the initial work-up for patients with limb swelling/pain in the emergency room. Appropriate utilization of DD, as well as other clinical criteria, may limit the over-utilization and added cost of VDU, without a negative impact on patient care. The results of DD tests should be utilized to limit the number of patients sent for VDU to only those patients with a positive DD or other significant underlying concerns.