Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease.

BACKGROUND: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy. METHODS: Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis. RESULTS: A total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]). CONCLUSIONS: In this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).

High ankle-brachial index participants experienced similar long-term mortality as peripheral artery disease in a national sample of community-dwelling adults.

BACKGROUND: Only a few small studies have shown the association between high ankle-brachial pressure index (ABI >1.4) and adverse cardiovascular (CV) events and mortality. Although there is abundant literature depicting the association between ABI and overall systemic atherosclerosis, it typically focuses on low ABI. Furthermore, historically, many studies focusing on peripheral artery disease have excluded high ABI participants. We aimed to study the mortality outcomes of persons with high ABI in the National Health and Nutrition Examination Survey (NHANES). METHODS: We obtained ABI from participants aged ≥40 years for survey years 1999 to 2004. We defined low a ABI as ≤0.9, normal ABI as 0.9 to 1.4, and high ABI as >1.4 or if the ankle pressures were >245 mm Hg. Demographics, various comorbidities, and laboratory test results were obtained at the time of the survey interview. Multivariable adjusted hazard ratios (HRs) along with 95% confidence intervals (CIs) were calculated for CV and all-cause mortality via Cox proportional hazards regression. Mortality was linked to all NHANES participants for follow-up through December 31, 2019, by the Centers for Disease Control and Prevention. RESULTS: We identified 7639 NHANES participants with available ABI. Of these, 6787 (89%) had a normal ABI, 646 (8%) had a low ABI, and 206 (3%) had elevated ABI. Of participants with high ABI, 50% were men, 15% were African Americans, 10% were current smokers, 56% had hypertension, 33% had diabetes, 15% had chronic kidney disease (CKD), and 18% had concomitant coronary artery disease (CAD). Diabetes (odds ratio [OR], 2.4; 95% CI, 1.7-3.2), CAD (OR, 1.6; 95% CI, 1.0-2.4), and CKD (OR, 1.5; 95% CI, 1.0-2.3) at baseline were associated with having a high ABI, respectively. A high ABI was associated independently with elevated CV (HR, 2.6; 95% CI, 2.1-3.1; P < .0001) and all-cause mortality (HR, 2.5; 95% CI, 2.2-2.8; P < .0001) after adjusting for covariates, including diabetes, CKD, CAD, current smoking, cancer, and hypertension. CONCLUSIONS: A high ABI is associated with an elevated CV and all-cause mortality, similar to patients with PAD. High ABI participants should receive the same attention and aggressive medical therapies as patients with PAD.

Outcomes of peripheral artery disease and polyvascular disease in patients with end-stage kidney disease.

OBJECTIVE: Patients with peripheral artery disease (PAD) and end-stage kidney disease are a high-risk population, and concomitant atherosclerosis in coronary arteries (CAD) or cerebral arteries (CVD) is common. The aim of the study was to assess long-term outcomes of PAD and the impact of coexistent CAD and CVD on outcomes. METHODS: The United States Renal Data System was used to identify patients with PAD within 6 months of incident dialysis. Four groups were formed: PAD alone, PAD with CAD, PAD with CVD, and PAD with CAD and CVD. PAD-specific outcomes (chronic limb-threatening ischemia, major amputation, percutaneous/surgical revascularization, and their composite, defined as major adverse limb events [MALE]) as well as all-cause mortality, myocardial infarction, and stroke were studied. RESULTS: The study included 106,567 patients (mean age, 71.2 years; 40.8% female) with a median follow-up of 546 days (interquartile range, 214-1096 days). Most patients had PAD and CAD (49.8%), 25.8% had PAD alone, and 19.2% had all three territories involved. MALE rate in patients with PAD was 22.3% and 35.0% at 1 and 3 years, respectively. In comparison to PAD alone, the coexistence of both CAD and CVD (ie, polyvascular disease) was associated with a higher adjusted rates of all-cause mortality (hazard ratio [HR], 1.28; 95% confidence interval [CI], 1.24-1.31), myocardial infarction (HR, 1.78; 95% CI, 1.69-1.88), stroke (HR, 1.66; 95% CI, 1.52,1.80), and MALE (HR, 1.07; 95% CI, 1.04-1.11). CONCLUSIONS: Patients with end-stage kidney disease have a high burden of PAD with poor long-term outcomes, which worsen, in an incremental fashion, with the involvement of each additional diseased arterial bed.

Impact of preexisting coronary artery and peripheral artery disease on outcomes in diabetic patients after kidney transplant.

BACKGROUND: Atherosclerotic cardiovascular disease is highly prevalent in patients with end-stage kidney disease (ESKD). Kidney transplant (KT) improves patient survival and cardiovascular outcomes. The impact of preexisting coronary artery disease (CAD) and peripheral artery disease (PAD) on posttransplant outcomes remains unclear. METHODS: This is a retrospective study utilizing the United States Renal Data System. Adult diabetic dialysis patients who underwent first KT between 2006 and 2017 were included. The study population was divided into four cohorts based on presence of CAD/PAD: (1) polyvascular disease (CAD + PAD); (2) CAD without PAD; (3) PAD without CAD; (4) no CAD or PAD (reference cohort). The primary outcome was 3-year all-cause mortality. Secondary outcomes were incidence of posttransplant myocardial infarction (MI), cerebrovascular accidents (CVA), and graft failure. RESULTS: The study population included 19,329 patients with 64.4% men, mean age 55.4 years, and median dialysis duration of 2.8 years. Atherosclerotic cardiovascular disease was present in 28% of patients. The median follow up was 3 years. All-cause mortality and incidence of posttransplant MI were higher with CAD and highest in patients with polyvascular disease. The cohort with polyvascular disease had twofold higher all-cause mortality (16.7%, adjusted hazard ratio (aHR) 1.5, p < 0.0001) and a fourfold higher incidence of MI (12.7%, aHR 3.3, p < 0.0001) compared to the reference cohort (8.0% and 3.1%, respectively). There was a higher incidence of posttransplant CVA in the cohort with PAD (3.4%, aHR 1.5, p = 0.01) compared to the reference cohort (2.0%). The cohorts had no difference in graft failure rates. CONCLUSIONS: Preexisting CAD and/or PAD result in worse posttransplant survival and cardiovascular outcomes in patients with diabetes mellitus and ESKD without a reduction in graft survival.

Comparison of the effectiveness and safety of 2 aspirin doses in secondary prevention of cardiovascular outcomes in patients with chronic kidney disease: A subgroup analysis of ADAPTABLE.

BACKGROUND: Among patients with established cardiovascular disease, the ADAPTABLE trial found no significant differences in cardiovascular events and bleeding rates between 81 mg and 325 mg of aspirin (ASA) daily. In this secondary analysis from the ADAPTABLE trial, we studied the effectiveness and safety of ASA dosing in patients with a history of chronic kidney disease (CKD). METHODS: ADAPTABLE participants were stratified based on the presence or absence of CKD, defined using ICD-9/10-CM codes. Within the CKD group, we compared outcomes between patients taking ASA 81 mg and 325 mg. The primary effectiveness outcome was defined as a composite of all cause death, myocardial infarction, or stroke and the primary safety outcome was hospitalization for major bleeding. Adjusted Cox proportional hazard models were utilized to report differences between the groups. RESULTS: After excluding 414 (2.7%) patients due to missing medical history, a total of 14,662 patients were included from the ADAPTABLE cohort, of whom 2,648 (18%) patients had CKD. Patients with CKD were older (median age 69.4 vs 67.1 years; P < .0001) and less likely to be white (71.5% vs 81.7%; P < .0001) when compared to those without CKD. At a median follow-up of 26.2 months, CKD was associated with an increased risk of both the primary effectiveness outcome (adjusted HR 1.79 [1.57, 2.05] P < .001 and the primary safety outcome (adjusted HR 4.64 (2.98, 7.21), P < .001 and P < .05, respectively) regardless of ASA dose. There was no significant difference in effectiveness (adjusted HR 1.01 95% CI 0.82, 1.23; P = .95) or safety (adjusted HR 0.93; 95% CI 0.52, 1.64; P = .79) between ASA groups. CONCLUSIONS: Patients with CKD were more likely than those without CKD to have adverse cardiovascular events or death and were also more likely to have major bleeding requiring hospitalization. However, there was no association between ASA dose and study outcomes among these patients with CKD.

Outcomes among patients with peripheral artery disease in the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study.

BACKGROUND: We aimed to understand the effects of aspirin dose on outcomes in patients with peripheral artery disease (PAD) as well as their participation in a pragmatic randomized controlled trial. METHODS: In a subanalysis of the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study, we compared aspirin doses (81 vs 325 mg) among participants with PAD and study participation metrics in patients with and without PAD. The primary outcome composite was all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke. RESULTS: Among 14,662 participants enrolled in ADAPTABLE with PAD status available, 3493 (23.8%) had PAD. Participants with PAD were more likely to experience the primary composite (13.76% vs 5.31%, p < 0.001), all-cause mortality (7.55% vs 3.01%, p < 0.001), myocardial infarction (5.71% vs 2.09%, p < 0.001), stroke (2.45% vs 0.86%, p < 0.001), and major bleeding (1.19% vs 0.44%, p < 0.001). A higher aspirin dose did not reduce the primary outcome in patients with PAD (13.68% vs 13.84% in 81 mg and 325 mg groups; OR 1.05, 95% CI 0.88-1.25). Participants with PAD were less likely to enroll via email (33.0% vs 41.9%, p < 0.0001), less likely to choose internet follow-up (79.2% vs 89.5%, p < 0.0001), and were more likely to change their aspirin doses (39.7% vs 30.7%, p < 0.0001). CONCLUSIONS: ADAPTABLE participants with PAD did not benefit from a higher dose of aspirin and participated in the study differently from those without PAD. These results reinforce the need for additional PAD-specific research and suggest that different trial strategies may be needed for optimal engagement of patients with PAD. (ClinicalTrials.gov Identifier: NCT02697916).

Orthostatic variation of pulmonary artery pressure in ambulatory heart failure patients.

AIM: To study effect of change in position (supine and standing) on pulmonary artery pressure (PAP) in ambulatory heart failure (HF) patients. METHODS: Seventeen patients with CardioMEMS® sensor and stable heart failure were consented and included in this single center study. Supine and standing measurements were obtained with at least 5 min interval between the two positions. These measurements included PAP readings utilizing the manufacturer handheld interrogator obtaining 10 s data in addition to the systemic blood pressure and heart rate recordings. RESULTS: Mean supine and standing readings and their difference (Δ) were as follows respectively: Systolic PAP were 33.4 (± 11.19), 23.6 (± 10) and Δ was 9.9 mmHg (p = 0.0001), diastolic PAP were 14.2 (± 5.6), 7.9 (± 5.7) and Δ was 6.3 mmHg (p = 0.0001) and mean PAP were 21.8 (± 7.8), 14 (± 7.2) and Δ was 7.4 mmHg (p = 0.0001) while the systemic blood pressure did not vary significantly. CONCLUSION: There is orthostatic variation of PAP in ambulatory HF patients demonstrating a mean decline with standing in diastolic PAP by 6.3 mmHg, systolic PAP by 9.9 mmHg and mean PAP by 7.4 mmHg in absence of significant orthostatic variation in systemic blood pressure or heart rate. These findings have significant clinical implications and inform that PAP in each patient should always be measured in the same position. Since initial readings at the time of implant were taken in supine position, it may be best to use supine position or to obtain a baseline standing PAP reading if standing PAP is planned on being used.

In-hospital Outcomes of Patients with Septic Shock and Underlying Chronic Atrial Fibrillation: A Propensity Matched Analysis from A National Dataset.

INTRODUCTION: Atrial fibrillation (AF) is one of the most common arrhythmias among hospitalized patients. Among patients admitted with septic shock (SS), the new occurrence of atrial fibrillation has been associated with an increase in intensive care unit (ICU) length of stay and in-hospital mortality. This is partially related to further reduction in cardiac output and thus worsening organ perfusion due to atrial fibrillation. However, there is a paucity of research on the outcomes of patients who have underlying chronic AF (UCAF) and then develop SS. This study aimed to identify the clinical characteristics and outcomes of patients with UCAF admitted with SS compared to patients with SS without UCAF. METHODS: This study was a retrospective analysis of the 2016 and 2017 Nationwide Readmission Database. ICD-10 codes were used to identify patients with SS, and these patients were stratified into those with and without UCAF. Propensity matching analyses were performed to compare clinical outcomes and in-hospital mortality between the two groups. RESULTS: A total of 353,422 patients with hospitalization for SS were identified, 5.8% (n = 20,772) of whom had UCAF. After 2:1 propensity matching, 20,719 patients were identified as having SS with UCAF, and 41,438 patients were identified as having SS without UCAF. Patients with SS and UCAF had a higher incidence of ischemic stroke [2.5% versus 2.2%, p = 0.012], length of stay [11.5 days versus 10.9 days, p < 0.001], mean total charges [$154,094 versus $144,037, p < 0.001] compared to those with SS without UCAF. In-hospital mortality was high in both groups, but was slightly higher among those with SS and UCAF than those with SS and no UCAF [34.4% versus 34.1%, p = 0.049]. CONCLUSIONS: This study identified UCAF as an adverse prognosticator for clinical outcomes. Patients with SS and UCAF need to be identified as a higher risk category of SS who will require more intensive management.

Outcomes in Patients With Chronic Kidney Disease and End-stage Renal Disease and Durable Left Ventricular Assist Device: Insights From the United States Renal Data System Database.

BACKGROUND: There is paucity of data regarding durable left ventricular assist device (LVAD) outcomes in patients with chronic kidney disease (CKD) stages 3-5 and CKD stage 5 on dialysis (end-stage renal disease [ESRD]). METHODS AND RESULTS: We conducted a retrospective study of Medicare beneficiaries with ESRD and a 5% sample of patients with CKD with an LVAD (2006-2018) to determine 1-year outcomes using the United States Renal Data System database. The LVAD implantation, comorbidities, and outcomes were identified using appropriate International Classification of Diseases, 9th and 10th edition codes. We identified 496 patients with CKD and 95 patients with ESRD who underwent LVAD implantation. The patients with ESRD were younger (59 years vs 66 years; P < .001), had more Blacks (40% vs 24.6%, P = .009), compared with the CKD group. The 1-year mortality (49.5% vs 30.9%, P < .001) and index mortality (27.4% vs 16.7%, P = .014) rates were higher for patients with ESRD. A subgroup analysis showed significantly higher mortality in ESRD vs CKD 3 (49.5% vs 30.2%, adjusted P = .009), but no significant difference in mortality between stage 3 vs 4/5 (30.2% vs 30.8%, adjusted P = .941). There was no significant difference in secondary outcomes (bleeding, stroke, and sepsis/infection) during follow-up between the 2 groups. CONCLUSIONS: Patients with ESRD undergoing LVAD implantation had significantly higher index and 1-year mortality rates compared with patients with CKD.

Impact of Underlying Congestive Heart Failure on In-Hospital Outcomes in Patients with Septic Shock.

Purpose: Septic shock (SS) manifests with profound circulatory and cellular metabolism abnormalities and has a high in-hospital mortality (25%-50%). Congestive heart failure (CHF) patients have underlying circulatory dysfunction and compromised cardiac reserve that may place them at increased risk if they develop sepsis. Outcomes in patients with CHF who are admitted with SS have not been well studied. Materials and Method: Retrospective cross sectional secondary analysis of the Nationwide Readmission Database (NRD) for 2016 and 2017. ICD-10 codes were used to identify patients with SS during hospitalization, and then the cohort was dichotomized into those with and without an underlying diagnosis of CHF. Results: Propensity match analyses were performed to evaluate in-hospital mortality and clinical cardiovascular outcomes in the 2 groups. Cardiogenic shock patients were excluded from the study. A total of 578,629 patients with hospitalization for SS were identified, of whom 19.1% had a coexisting diagnosis of CHF. After propensity matching, 81,699 individuals were included in the comparative groups of SS with CHF and SS with no CHF. In-hospital mortality (35.28% vs 32.50%, P < .001), incidence of ischemic stroke (2.71% vs 2.53%, P = .0032), and acute kidney injury (69.9% vs 63.9%, P = .001) were significantly higher in patients with SS and CHF when compared to those with SS and no CHF. Conclusions: This study identified CHF as a strong adverse prognosticator for inpatient mortality and several major adverse clinical outcomes. Study findings suggest the need for further investigation into these findings' mechanisms to improve outcomes in patients with SS and underlying CHF.

Nationwide study of six-month readmissions in critical limb ischemia: Predictors and impact of revascularization strategies.

OBJECTIVE: There is a paucity of data regarding six-month readmissions in critical limb ischemia patients and the influence of management strategy during index-admission [endovascular, surgical, hybrid procedure, medical therapy, and amputation]. We aimed to investigate the incidence, predictors, and impact of management strategies on six-month readmission in patients with critical limb ischemia. METHODS: A secondary analysis of the Nationwide Readmissions Database (2016-2017) was conducted. Propensity score matching was performed for subgroup analysis. RESULTS: We identified 50,058 patients with primary diagnosis of critical limb ischemia. Six-month all-cause and critical limb ischemia-related readmission rate was 52.36% and 10.86%, respectively. The risk of all-cause readmission was lower with amputation but was similar among other subgroups. Patients receiving surgical [HR 0.62, CI(0.48-0.79), p < 0.001] and hybrid procedure [HR 0.65 (0.46-0.93), p = 0.02] had lower risk of unplanned critical limb ischemia-related readmission compared to endovascular, though the risk of unplanned revascularization/amputation during readmission was similar between the three strategies. The risk of non-critical limb ischemia-related readmission was higher with surgical [HR 1.13, CI(1.04-1.23), p = 0.003] and hybrid procedure [HR 1.17, CI(1.08-1.28), p < 0.001], driven by increased procedure-related/wound complications. Eventhough endovascular patients were older with more severe critical limb ischemia presentation, a lower proportion received home-health or placement upon discharge from index-admission. This could account for higher readmission without higher repeat revascularization in endovascular group. CONCLUSION: The risk of critical limb ischemia and non-critical limb ischemia-related readmission differ according to the management strategy. Significant differences in discharge disposition exist depending on revascularization strategy. Study findings identify opportunities for reducing readmissions by focusing on nonprocedural aspects like wound-care, discharge planning and placement.

A PILOT STUDY on the Clinical and Functional Outcomes of an Improvised Technique of Core-cut Fistulectomy for Fistula-in-ano.

BACKGROUND: Anal fistulae are difficult to treat entities and minimally invasive procedures are evolving with promises. Our improvised technique is a simple and easy day-care procedure for simple fistulae. AIM: To evaluate the outcomes of a technical modification in the procedure of core-cut fistulectomy in simple cryptoglandular fistula-in-ano. METHODS: 47 patients of fistula-in-ano presenting to the out-patient of the General Surgery department at All India Institute of Medical Sciences, Bhopal, from November 2018 to March 2020 were selected. A complete history, physical examination followed by relevant investigations were meticulously performed and recorded. They were operated using an improvised core-cut technique, under a pudendal nerve block. Patients were kept on follow-up for a minimum of 6 months period to note the outcome of the surgery. RESULTS: The mean age was 37 ± 13.17 years with a male: female ratio of 5.1:1. The most common clinical presentation was perianal discharge in 96% of patients followed by pain and pruritus ani in 45% and 32%, respectively. 93.62% were inter-sphincteric, and 6.38% were trans-sphincteric. Extra-sphincteric and supra-levator fistulae were excluded from the study. The mean operative time was 17 ± 10.19 minutes. The mean healing time was 19.21 ± 5.99 days. The success rate of this novel technique of core-cut was calculated to be 89.37%. The rate of recurrence was calculated to be 10.63% (5 out of 47 patients). None of our patients developed incontinence. CONCLUSION: Our pilot study results for simple fistulae-in-ano had less morbidity, postoperative pain, better wound healing, patient satisfaction, and compliance with low risk of recurrence, and no incontinence. It could hence be recommended for larger groups and more complicated fistulae in the future.

Warfarin versus direct oral anticoagulants for treating left ventricular thrombus: a systematic review and meta-analysis.

BACKGROUND: Left ventricular thrombus (LVT) is not uncommon and pose a risk of systemic embolism, which can be mitigated by adequate anticoagulation. Direct oral anticoagulants (DOACs) are increasingly being used as alternatives to warfarin for anticoagulation, but their efficacy and safety profile has been debated. We aim to compare the therapeutic efficacy and safety of DOACs versus warfarin for the treatment of LVT. METHODOLOGY: We systematically searched PubMed/Medline, Google Scholar, Cochrane library, and LILCAS databases from inception to 14th August 2020 to identify relevant studies comparing warfarin and DOACs for LVT treatment and used the pooled data extracted from retrieved studies to perform a meta-analysis. RESULTS: We report pooled data on 1955 patients from 8 studies, with a mean age of 61 years and 59.7 years in warfarin and DOACs group, respectively. The pooled odds ratio for thrombus resolution was 1.11 (95% CI 0.51-2.39) on comparing warfarin to DOAC, but it did not reach a statistical significance (p = 0.76). The pooled risk ratio (RR) of stroke or systemic embolization and bleeding in patients treated with warfarin vs DOACs was 1.04 (95% CI 0.64-1.68; p = 0.85), and 1.15 (95% CI 0.62-2.13; p = 0.57), respectively; with an overall RR of 1.09 (95% CI 0.70-1.70; p = 0.48) for mortality. CONCLUSIONS: DOACs appears to be non-inferior or at least as effective as warfarin in the treatment of left ventricular thrombus without any statistical difference in stroke or bleeding complications.

Clinician engagement in the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial.

BACKGROUND: ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) is a pragmatic clinical trial examining high-dose versus low-dose aspirin among patients with cardiovascular disease. ADAPTABLE is leveraging novel approaches for clinical trial conduct to expedite study completion and reduce costs. One pivotal aspect of the trial conduct is maximizing clinician engagement. METHODS/RESULTS: Clinician engagement can be diminished by barriers including time limitations, insufficient research infrastructure, lack of research training, inadequate compensation for research activities, and clinician beliefs. We used several key approaches to boost clinician engagement such as empowering clinician champions, including a variety of clinicians, nurses and advanced practice providers, periodic newsletters and coordinated team celebrations, and deploying novel technological solutions. Specifically, some centers generated electronic health records-based best practice advisories and research dashboards. Future large pragmatic trials will benefit from standardization of the various clinician engagement strategies especially studies leveraging electronic health records-based approaches like research dashboards. Financial or academic "credit" for clinician engagement in clinical research may boost participation rates in clinical studies. CONCLUSION: Maximizing clinician engagement is important for the success of clinical trials; the strategies employed in the ADAPTABLE trial may serve as a template for future pragmatic studies.

Safety and efficacy study of the wound care 360° SiteSeal® vascular closure device in percutaneous cardiac catheterization procedures.

OBJECTIVES: Vascular access site complications after percutaneous transfemoral cardiovascular procedures remain a common cause of morbidity and mortality. We evaluated the SiteSeal® VCD for achieving hemostasis following diagnostic cardiac catheterization. METHODS: We conducted a prospective case control single center study to assess the safety and efficacy of SiteSeal® VCD compared to standard manual compression following diagnostic cardiac catheterization. Forty patients were enrolled in study to receive either SiteSeal® device or manual compression (20 in each group). RESULTS: Patients in the SiteSeal® group achieved hemostasis in a significantly shorter time (4 ± 2.4 vs. 19 ± 2.4 min, P < 0.001), had shorter time from hemostasis to ambulation (95 ± 44 vs. 388 ± 63 min, P < 0.001) and significantly earlier device deployment to discharge time compared to the manual compression group (4.7 ± 1.1 vs. 8.9 ± 4.8 h, P = 0.001). There was one non-major bleeding event in the SiteSeal® group which occurred >24 h after discharge from the hospital and was managed conservatively. In the remaining device patients, there was no clinical or Doppler ultrasound evidence of major or minor vascular complication with good overall patient comfort at discharge, 7 days and 30 days follow-up. CONCLUSIONS: In this first clinical experience, the SiteSeal® VCD achieved safe and efficient hemostasis, allowed for earlier ambulation and faster discharge compared to manual compression.

Cardiac rehabilitation in patients with peripheral arterial disease after revascularization.

OBJECTIVES: To evaluate safety, feasibility, and benefit of cardiac rehabilitation (CR) in patients with peripheral arterial disease (PAD) who undergo revascularization. METHODS: We conducted a prospective, non-randomized, pilot study to assess the feasibility, safety, and benefit of CR in PAD patients after revascularization compared to standard of care (controls). CR feasibility was assessed by the ability to complete 36 sessions. Safety was defined as the absence of adverse cardiovascular events during CR. Quality of life (QoL) assessment was performed using SF-36 form (Medical Outcomes Study 36-Item Short-Form Health Survey) and PAD-specific quality of life questionnaire (VascuQOL6). Other endpoints included incidence of claudication during 6-minute walk test (6MWT), mean distance, and number of laps walked. All outcome data were collected before and after CR completion. Standard statistical tests were used for comparisons. RESULTS: This study enrolled 20 subjects (CR group = 10). Mean age was 60.70 (±7.13) and 63.1 (±9.17) years in CR and controls, respectively (p-value > 0.05). Fifty percent and 60% were female in CR and control group, respectively. All subjects completed 36 CR sessions without adverse events. The increase in mean distance walked during 6MWT was higher in the CR group compared to control group (63.7 m vs. 10.5 m, p = 0.043). Change in mean number of laps walked was higher in the CR group (3.5 vs. -1.1; p < 0.01). Scores on 6 of 8 scales of SF-36 and VascuQOL6 were higher in the CR group, though not statistically significant. CONCLUSION: CR is safe, feasible, and improves walking ability in ambulatory patients with PAD after arterial revascularization.

Vascular complications associated with percutaneous left ventricular assist device placement: A 10-year US perspective.

BACKGROUND: Over the last decade, there has been a significant increase in the use of percutaneous left ventricular assist devices(p-LVADs). p-LVADs are being increasingly used during complex coronary interventions and for acute cardiogenic shock. These large bore percutaneous devices have a higher risk of vascular complications. We examined the vascular complication rates from the use of p-LVAD in a national database. METHODS: We conducted a secondary analysis of the National In-patient Sample (NIS) dataset from 2005 till 2015. We used the ICD-9-CM procedure codes 37.68 and 37.62 for p-LVAD placement regardless of indications. We investigated common vascular complications, defining them by the validated ICD 9 CM codes. χ2 test and t test were used for categorical and continuous variables, respectively for comparison. RESULTS: A total of 31,263 p-LVAD placements were identified during the period studied. A majority of patients were male (72.68%) and 64.44% were white. The overall incidence of vascular complications was 13.53%, out of which 56% required surgical treatment. Acute limb thromboembolism and bleeding requiring transfusion accounted for 27.6% and 21.8% of all vascular complications. Occurrence of a vascular complication was associated with significantly higher in-hospital mortality (37.77% vs. 29.95%, p < .001), length of stay (22.7 vs. 12.2 days, p < .001) and cost of hospitalization ($ 161,923 vs. $ 95,547, p < .001). CONCLUSIONS: There is a high incidence of vascular complications with p-LVAD placement including need for vascular surgery. These complications are associated with a higher in-hospital, LOS and hospitalization costs. These findings should be factored into the decision-making for p-LVAD placement.

Impact of short term oral steroid use for intravenous contrast media hypersensitivity prophylaxis in diabetic patients undergoing nonemergent coronary angiography or interventions.

OBJECTIVES: Oral steroids are routinely administered in the United States for prophylaxis of iodinated contrast media hypersensitivity (ICMH). We studied the impact of short-term steroid use in diabetic patients with ICMH undergoing nonemergent coronary angiography. METHODS: We retrospectively analyzed records of diabetic patients with and without ICMH who underwent nonemergent coronary angiography at our center. Primary study endpoint was 30-day major adverse cardiac events (MACE) and secondary endpoints were pre- and postprocedure fasting blood glucose (FBG), highest in hospital blood glucose, pre- and postprocedure systolic blood pressure (SBP), and use of intravenous insulin and antihypertensive medications. RESULTS: A total of 88 diabetics with ICMH (study group) and 76 diabetics without ICMH (control group) undergoing angiography were enrolled. Demographics and hemoglobin A1c values were similar in both groups. Preprocedural FBG was significantly higher in the study group. The study group had significantly higher post angiography FBG (239.93 + 96.88 mg/dl vs. 156.6 + 59.88 mg/dl) and greater use of intravenous (IV) insulin (67.27% vs. 32.43%). Further, those who received steroids had significantly higher systolic SBP postprocedure (146.16 + 25.35 mmHg vs. 130.8 + 21.59 mmHg), a higher incidence of severe hypertension and use of IV antihypertensive medications (80.95% vs. 19.05%) periprocedurally. There were no differences in 30-day MACE between groups. CONCLUSION: Short-term steroid use for ICMH results in a significant increase in surrogate markers for adverse clinical events after coronary procedures. Study findings highlight the need for better periprocedural management of these patients and to limit steroid prophylaxis to those with only true ICMH.

Direct oral anticoagulant use in left ventricular thrombus.

Left ventricular thrombus (LVT) is associated with a significant risk of ischemic stroke (IS) and peripheral embolization. Societal guidelines recommend the use of warfarin, with direct oral anticoagulants (DOACs) only for patients unable to tolerate warfarin. We studied the natural history of LVT with anticoagulation (AC) with emphasis on comparing warfarin and DOAC use. In this single center study, we identified patients with a confirmed LVT. Type and duration of anticoagulation, INR levels and clinical outcomes (bleeding, ischemic stroke or peripheral embolization, and thrombus resolution) were recorded. LVT was confirmed in a total of 110 patients. Mean age was 59 + 14 years. 79% were men. Underlying etiology was chronic ischemic cardiomyopathy in 58%, non-ischemic cardiomyopathy in 23%. AC was started in 96 (87%) patients. At 1 year follow up, 11 patients (10%) had a stroke while on any AC (2 had hemorrhagic stroke and 9 had IS). Of those with IS, 7 were on warfarin (71% of those had subtherapeutic INR) and 2 patients on DOACs had IS. The 1-year risk of any stroke was 15% in warfarin group (12% risk of ischemic stroke) compared to 6% in the DOACs group (p = 0.33). 37 (63%) patients on warfarin and 18 (53%) on DOACs had resolution of thrombus (p = 0.85). One-year risk of stroke with LVT is high (10%) even with AC. Most patients IS on warfarin had subtherapeutic INR. There was no statistical difference in stroke risk or rate of thrombus resolution between warfarin and DOACs treated patients.

Seclusion: A Patient Perspective.

The appropriate treatment of mentally unwell, aggressive patients has challenged psychiatry for centuries. Seclusion is practiced worldwide, but concerns remain regarding its appropriateness and lack of alternatives. Patients generally report seclusion as a negative experience, though there is a paucity of literature exploring this in detail. This investigation was a service evaluation appraising inpatients' perspective of processes occurring before (information, communication), during (review, care), and after (debrief, reflection) seclusion in a psychiatric intensive care unit (PICU). In this phenomenological study, qualitative data were gathered using a questionnaire in a structured interview. All patients had been nursed in seclusion during admission to a male PICU at South London and the Maudsley NHS Foundation Trust. Ten patients were interviewed over 4 months. The central theme was perceived lack of communication in the patient-professional relationship, which manifested itself as (i) violence against patients, (ii) lack of psychological support, and (iii) the need for alternatives. Such feedback from patients queries whether national guidelines are appropriate and/or being adhered to. Healthcare practitioners have a responsibility to challenge accepted practice to continually improve the standard of patient-centred care. Utilising patient perspectives can be a powerful driver of change towards more humane treatment of vulnerable patients.