Randomized trial of an oblique versus standard fluoroscopic-guided micropuncture technique for femoral arterial access: The Micropuncture-CFA trial.

BACKGROUND: The anterior-posterior fluoroscopic guidance (the AP technique) is a standard method for common femoral artery (CFA) access, but the rate of CFA access with ultrasound vs. the AP technique was not significantly different. We have shown an oblique fluoroscopic guidance (the oblique technique) with a micropuncture needle (MPN) resulted in CFA access in 100 % of patients. The outcome of the oblique vs. AP technique is unknown. We compared the utilities of the oblique vs. AP technique for CFA access with a MPN in patients undergoing coronary procedures. METHODS: A total of 200 patients were randomized to the oblique vs. AP technique. Using the oblique technique, a MPN was advanced to the mid pubis in the 20° ipsilateral right-or left anterior oblique view with fluoroscopic guidance and the CFA was punctured. In the AP technique, a MPN was advanced to the mid femoral head in the AP view with fluoroscopic guidance and the CFA was punctured. The primary endpoint was the rate of successful access to the CFA. RESULTS: The rates of first pass and CFA access were higher with the oblique vs. AP technique (82 % vs. 61 %, and 94 % vs. 81 %, respectively; P < 0.01). The number of needle punctures was lower with the oblique vs. AP technique (1.1 ± 0.39 vs. 1.4 ± 0.78, respectively; P < 0.01). In high CFA bifurcations, the rate of CFA access was higher with the oblique vs. AP technique (76 % vs. 52 %, respectively; P < 0.01). Vascular complications were lower with the oblique vs. AP technique (1 % vs. 7 %, respectively; P < 0.05). CONCLUSIONS: Our data suggest that the oblique technique, compared with the AP technique, significantly increased the rates of first pass and access to the CFA, and decreased the number of punctures and vascular complication. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03955653.

Impact of Body Mass Index on the Association of Ankle-Brachial Index With All-Cause and Cardiovascular Mortality: Results from the National Health and Nutrition Examination Survey.

OBJECTIVE: To assess the influence of body-mass index (BMI) on the association of ankle-brachial index (ABI) with mortality. PATIENTS AND METHODS: We conducted a prospective study of National Health and Nutrition Examination Survey participants enrolled from January 1, 1999 to December 31, 2002 with BMI and ABI data available. ABI categories were <0.9 (low), 0.9 to 1.3 (reference), and >1.3 (high). BMI categories were <30 kg/m2 (nonobese) and ≥30 kg/m2 (obese). Cardiovascular (CV) and all-cause mortality were assessed by National Death Index records. Cox proportional-hazards models and Kaplan-Meier survival estimates were used to compare groups. RESULTS: In total, 4614 subjects were included, with mean age 56±12 years and BMI 28±6 kg/m2. Median follow-up was 10.3 years (interquartile range [IQR]: 9.3 to 11.4 years). Low and high ABI were present in 7% and 8%, respectively. After adjustment, low ABI was associated with increased all-cause and CV mortality in nonobese (hazard ratio [HR] 1.5, 95% CI, 1.1-2.1 for all-cause and 3.0 [1.8-5.1] for CV mortality) and obese individuals (1.8 [1.2-2.7] and 2.5 [1.2-5.6], respectively) compared with reference. High ABI was associated with increased CV mortality in nonobese (2.2 [1.1-4.5]) but not obese patients; it was not associated with all-cause mortality overall or when stratified by BMI. CONCLUSION: In a US cohort, weight influenced the prognostic significance of high ABI. This may be related to technical factors reducing compressibility of the calf arteries in obese persons compared with those who are nonobese.

Etiology of gastrointestinal bleeding in patients on dual antiplatelet therapy.

OBJECTIVE: Dual antiplatelet therapy (DAPT) is associated with an increased risk of gastrointestinal (GI) bleeding and is thought to cause upper gastrointestinal bleeding (UGIB). However, recent reports indicate that the incidence of lower gastrointestinal bleeding (LGIB) in patients on DAPT may be increasing. We aimed to compare the endoscopic findings and etiology of GI bleeding between patients on DAPT compared with those not on DAPT. METHODS: This was a retrospective, single-center, case-control study. Cases were 114 consecutive patients admitted with a first episode of GI bleeding while on DAPT who underwent detailed GI evaluation. We chose 114 controls who had GIB but were not on DAPT. RESULTS: There was no significant difference in the incidence of UGIB or LGIB between the two groups (UGIB: 53.5% vs 51.3% and LGIB: 46.5% vs 48.7%, P = 0.10) or within groups (DAPT: 53.5% vs 46.5%, P = 0.30 and controls: 51.3% vs 48.7%, P = 0.80). Although the DAPT group had a lower prevalence of the usual UGIB risk factors, it had a higher likelihood of bleeding from varices or upper GI inflammation [odds ratio (OR) 3.54, 95% confidence interval (CI) 0.14-92.3; OR 13.98, 95% CI 1.40-140.36]. No etiology of bleeding was identified in a higher percentage of patients on DAPT than those who were not (22.8% vs 5.3%). CONCLUSION: In patients with GI bleeding, the incidences of UGIB and LGIB are similar irrespective of their DAPT use.

Association of QT interval with mortality by kidney function: results from the National Health and Nutrition Examination Survey (NHANES).

Objective: Prolonged QT interval predisposes to ventricular arrhythmias and sudden cardiac death. However, the association between QT interval and mortality by the level of pre-existing kidney function has not been investigated. Methods: We followed 6565 participants from the National Health and Nutrition Examination Survey III for a median of 13.3 years. Sample divided according to corrected QT (QTc) interval was as follows: normal (QTc <450 ms for men and <460 ms for women) or prolonged. It was further categorised as follows: (1) no chronic kidney disease (CKD), that is, albumin to creatinine ratio (ACR) <30 mg/g and estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2; (2) CKD by eGFR only (eGFR <60 mL/min/1.73 m2, ACR <30 mg/g); (3) CKD by ACR only (ACR >30 mg/g, eGFR >60 mL/min/1.73 m2) and (4) CKD by both. Cox proportional hazards models were used. Results: CKD group had prolonged QTc than those without CKD (20.5%vs12.9%, p<0.0001). Both prolonged QTc and CKD are independently associated with increased risk of mortality. When combined, risk of mortality is higher in those with CKD by eGFR with prolonged QTc than normal QTc (HR 2.6 (1.7-3.9) and 3.1 (1.7-5.4) vs 1.4 (1.1-1.7) and 1.7 (1.3-2.1) for all-cause and CV mortality). There is no significant difference in risk in those with CKD by ACR when QTc is prolonged. There is significant improvement in risk prediction for all-cause and CV mortality when QTc is added to CKD beyond established CV risk factors (net reclassification index p<0.00001). Conclusion: A screening ECG in those with CKD may help in finer risk stratification and may be considered.

Association Between Coronary Artery Disease and MicroRNA: Literature Review and Clinical Perspective.

BACKGROUND: Until recently, circulating micro-RNAs (miRNAs) have attracted major interest as novel biomarkers for the early diagnosis of coronary artery disease (CAD). This review article summarizes the available evidence on the correlation of micro-RNAs with both the clinical and subclinical coronary artery disease and highlights the necessity for exploring miRNAs as a potential diagnostic and prognostic biomarker of early CAD in an adult population. METHODS: A systematic literature analysis and retrieval online systems Public/Publisher MEDLINE/ Excerpta Medica Database /Medical Literature Analysis and Retrieval System Online,(PUBMED/EMBASE/MEDLINE) search were conducted for relevant information. Search was limited to the articles published in English language and conducted on humans, January 2000 onwards. We excluded studies of heart surgery, coronary artery bypass grafting (CABG), angioplasty and heart transplant. Eighteen studies met the inclusion criteria. RESULTS: Seven out of 18 studies were multivariate, i.e. adjusted for age, gender, body mass index (BMI), smoking, hypertension, diabetes, and blood lipid profiles, while the remaining twelve studies were univariate analysis. Different sources of miRNAs were used, i.e. plasma/serum, microparticles, whole blood, platelets, blood mononuclear intimal and endothelial progenitor cells were investigated. Fourteen out of 18 studies showed up-regulation of different miRNA in CAD patients and in vulnerable plaque disease. Four out of 18 studies showed both the up-regulation and down-regulation of miRNA in the population, while only three studies showed down-regulation of miRNA. Various sources and types of miRNA were used in each study. CONCLUSION: This review gives an extensive overview of up-regulation and down-regulation of miRNA in CAD and non-CAD patients. The pattern of miRNA regulation with respect to CAD/non-CAD study subjects varies across individual studies and different parameters, which could be the possible reason for this aberrancy. We suggest further trials be conducted in future for highlighting the role of miRNA in CAD, which may improve both the diagnostic and therapeutic approaches to stratifying CAD burden in the general population.

Association of corrected QT interval with body mass index, and the impact of this association on mortality: Results from the Third National Health and Nutrition Examination Survey.

BACKGROUND: Both QT interval and body mass index (BMI) are independently associated with mortality. Those with higher BMI have longer QT, although evidence is inconsistent. The joint association of QT and BMI with mortality merits investigation. OBJECTIVE: To examine the association of QT with BMI, and to examine the joint association of QT and BMI with all-cause and cardiovascular mortality. METHODS: We followed 4036 participants from NHANES III for a median of 14.7 years. Weighted sample was divided into 4 categories by BMI as: 18.5-24.9, 25-29.9, 30-34.9 and ≥35, and 2 categories by corrected QT interval (QTc) as: normal (<450ms in males, <460ms in females) or prolonged. Cox proportional hazards models were used with adjustment for demographic characteristics and cardiovascular risk factors. RESULTS: QTc was longer among those with higher BMI (mean QTc: 424.7, 425.8, 430.9 and 437.8 respectively for BMI 18.5-24.9, 25-29.9, 30-34.9 and ≥35, p-trend: <0.001). Overall, longer QTc or higher BMI were associated with increased all-cause and cardiovascular mortality risk compared to mean QTc or mean BMI, respectively. When combined, cardiovascular mortality was significantly increased among obese individuals with prolonged QTc [hazard ratio (95% CI): 3.1 (1.2-8.0) and 4.8 (1.2-19.9) but not when QTc was normal [1.0 (0.5-2.0) and 1.4 (0.8-2.8)] for BMI 30-34.9 and ≥35, respectively compared to BMI 18.5-24.9 and normal QTc. Similar (although not statistically significant) findings were observed for all-cause mortality. Risk prediction for both all-cause and cardiovascular mortality improved when QTc was added to the adjusted model with BMI (net reclassification index 0.14, p=0.01 and 0.14, p<0.0001 for all-cause and cardiovascular mortality, respectively). CONCLUSION: Individuals with higher BMI have a significantly longer QTc. BMI is associated with increased all-cause and cardiovascular mortality risk when QTc is prolonged but not when QTc is normal. These novel observations suggest that QTc should be factored into risk stratification of obese individuals with a screening electrocardiogram. This may help stratify individuals into lower risk categories when QTc is normal.

Collective impact of conventional cardiovascular risk factors and coronary calcium score on clinical outcomes with or without statin therapy: The St Francis Heart Study.

BACKGROUND AND AIMS: The efficacy of statin therapy remains unknown in patients eligible for statin therapy with and without elevated coronary calcium score (CAC). The study sought to evaluate how cardiovascular risk factors, expressed in terms of statin eligibility for primary prevention, and CAC modify clinical outcomes with and without statin therapy. METHODS: We conducted a post-hoc analysis of the St. Francis Heart Study treatment trial, a double-blind, placebo-controlled randomized controlled trial of atorvastatin (20 mg), vitamin C (1 g), and vitamin E (1000 U) daily, versus placebos in 990 asymptomatic individuals with CAC ≥ 80th percentile for age and gender. Primary cardiovascular outcomes included non-fatal myocardial infarction or coronary death, coronary revascularization, stroke, and peripheral arterial revascularization. We further stratified the treatment and placebo groups by eligibility (eligible when statin indicated) for statin therapy based on 2013 ACC/AHA guidelines and based on CAC categories. RESULTS: After a median follow-up of 4.8 years, cardiovascular events had occurred in 3.9% of the statin treated but not eligible, 4.6% of the untreated and not eligible, 8.9% of the treated and eligible and 13.4% of the untreated and eligible groups, respectively (p<0.001). Low CAC (<100) occurred infrequently in statin eligible subjects (≤4%) and was associated with low 10-year event rate (<1 per 100 person-years). In contrast, high CAC (>300) occurred frequently in more than 35% of the statin not eligible subjects and was associated with a high 10-year event rate (≥17 per 100 person-years). Risk prediction improved significantly when both clinical risk profile and CAC score were combined (net reclassification index p = 0.002). CONCLUSIONS: Under the current statin treatment guidelines a small number of statin eligible subjects with low CAC might not benefit from statin therapy within 5 years. However, the statin not eligible subjects with high CAC have high event rate attributing to loss of opportunity for effective primary prevention.

Cardiovascular and Mortality Outcomes in the Elderly With Impaired Cardiac and Pulmonary Function: The Cardiovascular Health Study (CHS).

BACKGROUND: Impaired pulmonary function (IPF) and left ventricular systolic dysfunction (LVSD) are prevalent in the elderly and are associated with significant morbidity and mortality. The main objectives of this study were to examine the relative impact and joint association of IPF and LVSD with heart failure, cardiovascular mortality and all-cause mortality, and their impact on risk classification using a continuous net reclassification index. METHODS AND RESULTS: We followed 2342 adults without prevalent cardiovascular disease (mean age, 76 years) from the Cardiovascular Health Study for a median of 12.6 years. LVSD was defined as LV ejection fraction <55%. IPF was defined as: forced expiratory volume in 1 second:forced vital capacity <70%, and predicted forced expiratory volume in 1 second <80%. Outcomes included heart failure hospitalization, cardiovascular mortality, all-cause mortality, and composite outcome. LVSD was detected in 128 subjects (6%), IPF in 441 (19%) and both in 38 (2%). Compared to those without LVSD or IPF, there was a significantly increased cardiovascular risk for groups of LVSD only, IPF only, and LVSD plus IPF, adjusted hazard ratio (95% CI) 2.1 (1.5-3.0), 1.7 (1.4-2.1), and 3.2 (2.0-5.1) for HF; 1.8 (1.2-2.6), 1.4 (1.1-1.8), and 2.8 (1.7-4.7) for cardiovascular mortality; 1.3 (1.0-1.8), 1.7 (1.4-1.9), and 2.1 (1.5-3.0) for all-cause mortality, and 1.6 (1.3-2.1), 1.7 (1.5-1.9), and 2.4 (1.7-3.3) for composite outcome, respectively. Risk classification improved significantly for all outcomes when IPF was added to the adjusted model with LVSD or LVSD to IPF. CONCLUSIONS: While risk of cardiovascular outcomes was the highest among elderly with both LVSD and IPF, risk was comparable between subjects with IPF alone and those with LVSD alone. This observation, combined with improved risk classification by adding IPF to LVSD or LVSD to IPF, underscore the importance of comprehensive heart and lung evaluation in cardiovascular outcome assessment.