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.

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.

Achieving a popliteal venous access for renal replacement therapy in critically ill COVID-19 patient in prone position.

This patient is a 67-year-old man who initially presented to our facility with acute respiratory failure secondary to COVID-19. Soon after arrival at our facility, the patient decompensated, developing severe acute respiratory distress syndrome requiring intubation and prone positioning to maintain adequate oxygenation. During the next few days, acute kidney injury with oliguria and severe volume overload developed. The vascular surgery service was consulted to obtain central venous access for emergent continuous renal replacement therapy. On examination, the patient was sedated and paralyzed in a rotating prone-positioning bed. He could not be positioned supine without immediately becoming hypoxic and decompensating. A 50-cm Permcath (Medtronic, Santa Rosa, Calif) was inserted through the left popliteal vein. This case report outlines a possible challenging scenario that the vascular interventionist may encounter in dealing with COVID-19 patients with respiratory compromise in the prone position.

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.

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.

Hybrid Treatment of Extracranial Carotid Artery Disease.

OBJECTIVE: High-degree stenosis of both innominate (IA) or left common carotid artery (CCA) and carotid bifurcation is uncommon but still represents a significant challenge to interventionists in many aspects including techniques, timing, and priority. There are several strategies for intervention that have been reported in the literature. A well-described, less-invasive strategy for extracranial tandem carotid lesions is concomitant carotid endarterectomy (CEA) with retrograde carotid angioplasty and stenting (CAS). In this study, we examine intermediate-term outcomes of this hybrid procedure and review other described treatments. METHODS: Electronic medical records of all patients who underwent hybrid (ostial CAS and CEA) procedures in a tertiary center over the last 10 years were reviewed. High-degree stenosis of the IA or CCA was defined according to North American Symptomatic Carotid Endarterectomy Trial criteria. RESULTS: A total of 6 patients were identified. The population included 4 males and 2 females with a median age of 65 years. Five patients were symptomatic and all had stenosis >75% by angiography. Five of the patients underwent left CEA with proximal stenting and one patient underwent right-sided CEA with proximal stenting. Combined 30-day mortality and stroke rate was 0%. No restenosis, stroke, heart attack, or death occurred during a follow-up range of 1 to 36 months (mean 12.8 months, median 7.8 months). CONCLUSION: The combined CEA with retrograde stenting for tandem extracranial lesion procedure is safe and feasible, with adequate intermediate-term outcomes consistent with the recent literature.

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.