Therapeutic Advances in Cardiovascular Disease最新文献

COVID-19 is said to be a pandemic that does not distinguish between skin color or ethnic origin. However, data in many parts of the world, especially in the United States, begin to show that there is a sector of society suffering a more significant impact from this pandemic. The Black population is more vulnerable than the White population to infection and death by COVID-19, with hypertension and diabetes mellitus as probable predisposing factors. Over time, multiple disparities have been observed between the health of Black and White populations, associated mainly with socioeconomic inequalities. However, some mechanisms and pathophysiological susceptibilities begin to be elucidated that are related directly to the higher prevalence of multiple diseases in the Black population, including infection and death by COVID-19. Plasma vitamin D levels and evolutionary adaptations of the renin-angiotensin-aldosterone system (RAAS) in Black people differ considerably from those of other races. The role of these factors in the development and progression of hypertension and multiple lung diseases, among them SARS-CoV-2 infection, is well established. In this sense, the present review attempts to elucidate the link between vitamin D and RAAS ethnic disparities and susceptibility to infection and death by COVID-19 in Black people, and suggests possible mechanisms for this susceptibility.

Background: The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies.

Methods: A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness.

Results: Reported NI trials, with the most frequently chosen clinical endpoint of major adverse cardiac events (MACE), had NI margins ranging from 1.66% to 5.00%, resulting in patient populations of 400-1500 per treatment group. Clinical study endpoints comprising of MACE complemented with rates of bleeding complications and stent thrombosis (ST) are suggested to conduct a statistically and clinically meaningful NI trial. Study designs with surrogate endpoints amenable to intrapatient randomizations, are a very attractive option to reduce the number of necessary patients by about half. Comparative clinical endpoint studies with MACE and ST/bleeding rates to study a shortened dual antiplatelet therapy (DAPT) in coronary stent trials are feasible, whereas ST as the sole primary endpoint is not useful.

Conclusions: Expanded composite clinical endpoints (MACE complemented by ST and bleeding rates and intrapatient randomization for selected surrogate endpoints) may be suitable tools to meet future needs in device approval, recertification and reimbursement.

Introduction: Thyroid hormone (TH) has an essential role on the functional capability of cardiac muscle with its gene modulation and induction of vasodilatory effects. There is considerable evidence to suggest the role of TH in patients with acute coronary syndrome, but less is known about its prognostic role in heart failure (HF) patients. We aim to evaluate the association between subclinical hypothyroid state (SCHS) and event rates including 30-day all-cause and HF readmission in patients with an index hospitalization for acute HF syndrome (AHFS).

Methodology: A retrospective chart review analysis of 2335 patients admitted with the diagnosis of AHFS between 1 January 2007 and 31 December 2017 was conducted. SCHS was defined as thyroid-stimulating hormone (TSH) level >4.50 mIU/L with a normal thyroxine (T₄) level. Patients with pre-existing thyroid disease or receiving thyroid replacement therapy were excluded. HF with preserved ejection fraction (HFpEF) was defined as left ventricular ejection fraction (LVEF) >40% and HF with reduced ejection fraction (HFrEF) was defined as having LVEF ⩽40%. Percentage of 30-day, 3-month and 6-month all-cause readmission and mortality rates were calculated in both cohorts of AHFS (HFpEF and HFrEF) with and without SCHS.

Results: The mean age of the 2335 AHFS population was 65 (±14.8) years. Of the 2335 patients admitted with AHFS, 1228 (52.6%) patients were found to have HFrEF and 1107 (47.4%) with HFpEF. There were 170 (7.3%) patients with AHFS found to have SCHS. There were more males than females (54% versus 46%). The percentage of hospital readmission within 30 days was higher for patients with SCHS compared with those without SCHS in the HFrEF group (42% versus 30%, p = 0.001). Hospital readmission within 30 days for patients with SCHS compared with those without SCHS in the HFpEF group did not differ (36.5% versus 31%, p = 0.47). Additionally, all-cause mortality was higher among patients with SCHS compared with patients without SCHS in the HFrEF group (18.7% versus 7.0%, p < 0.001). All-cause mortality was found similar in both arms of the HFpEF group (9.5% versus 7.7%, p = 0.73).

Conclusion: During an index hospital admission for AHFS, SCHS was an independent predictor of readmission in 30 days in patients with HFrEF but not in patients with HFpEF. Additionally, it was related to adverse outcome such as all-cause mortality in HFrEF patients but not in HFpEF patients. Further studies regarding the concept of tissue thyroid and the potential for a therapeutic target are warranted.

Aim: To evaluate inter-core laboratory variability of quantitative coronary angiography (QCA) parameters in comparison with intra-core laboratory variability in a randomized controlled trial evaluating drug-eluting stents.

Methods: A total of 50 patients with 62 coronary lesions were analyzed by four analysis experts belonging to an Angiographic Core Laboratory (ACL: 1 expert) and a Cardiovascular Imaging Core Laboratory (CICL: 3 experts). QCA was based on the same standard operating procedure, but selections of projection and cine frames were at the discretion of each analyst. Inter- and intra-core laboratory variabilities were evaluated by accuracy, precision, Bland Altman analysis, and coefficient of variation.

Results: Pre-MLD (minimal lumen diameter) was significantly smaller in results from ACL than those from all CICL experts. Number of analyzed projections did not affect pre-MLD results. Acute gain was larger in ACL than in CICL2. No significant difference was observed in late loss and loss index between inter-core laboratories. Agreement between core labs in the Bland-Altman analysis for each QCA parameter was as follows (mean difference, 95% limits of agreement): pre-MLD (-0.32, -0.74 to 0.10), stent MLD (0.08, -0.28 to 0.44), acute gain (0.22, -0.44 to 0.88), and late loss (-0.07, -0.69 to 0.55). Agreement between analysts in CICL (mean difference, 95% limits of agreement) was: pre MLD (-0.03, -0.37 to 0.31), stent MLD (0.15, -0.15 to 0.45), acute gain (0.05, -0.45 to 0.55), and late loss (0.04, -0.52 to 0.60). The widest limits of agreement among three analyses were shown in both analyses. Width of limited agreement in the intra-core laboratory analysis tended to be smaller than the inter-core laboratory analysis with these parameters. Coefficient of variation tended to be larger in lesion length (LL), acute gain, late loss, and loss index in inter- and in intra- core laboratory comparisons.

Conclusion: Inter-core laboratory QCA variability in late loss and loss index analysis could be similar to intra-core laboratory variability, but more strict alignment between core laboratories would be necessary for initial procedural data analysis.

Background: Endovascular therapy for acute lower limb ischemia (ALLI) has developed and demonstrated safety and efficacy. The purpose of this study was to assess clinical outcomes in patients treated for ALLI with conventional endovascular or surgical revascularization.

Method: This study was a retrospective single-center review. Consecutive patients with ALLI treated with conventional endovascular revascularization (ER) without thrombolytic agent or surgical revascularization (SR) between 2008 and 2014 were investigated. The 1 year and 3 year amputation rate and mortality rate were assessed by time-to-event methods, including Kaplan-Meier estimation.

Result: A total of 64 limbs in 62 patients with ALLI due to thromboembolism or thrombosis of a native artery, bypass graft, or previous stented vessel were included. The majority of limbs (90.9%) presented with Rutherford clinical categories 1 to 2 ischemia. Technical success rate was 95.5% in ER and 92.9% in SR group (p = 0.547). Overall amputation rates were 9.1% in ER versus 9.5% in SR after 1 year (p = 0.971) and 9.1% in ER versus 11.9% in SR after 3 year (p = 0.742). Overall mortality rates were 15% in ER versus 7.1% in SR after 1 year (p = 0.491) and 15% in ER versus 11.2% in SR after 3 year (p = 0.878).

Conclusion: Endovascular or surgical revascularization of ALLI resulted in comparable outcomes in limb salvage and mortality rate at 1 year and 3 year. Conventional endovascular therapy without thrombolytic agent such as stenting, balloon angioplasty, or catheter-directed thrombosuction may be considered as a treatment option for ALLI.

Background: Little is known about the extent to which routine care management of peripheral arterial disease (PAD) and intermittent claudication (IC) align with best practice recommendations on exercise therapy. We conducted a scoping review to examine the published literature on the availability and workings of exercise therapy in the routine management of patients with PAD and IC, and the attitude and practice of health professionals and patients.

Methods: A systematic search was conducted in February 2018. The Cumulative Index of Nursing and Allied Health Literature, Ovid MEDLINE, Allied and Complementary Medicine Database, ScienceDirect, Web of Science and the Directory of Open Access Repositories were searched. Hand searching of reference lists of identified studies was also performed. Inclusion criteria were based on study aim, and included studies that reported on the perceptions, practices, and workings of routine exercise programs for patients with IC, their availability, access, and perceived barriers.

Results: Eight studies met the eligibility criteria and were included in the review. Studies conducted within Europe were included. Findings indicated that vascular surgeons in parts of Europe generally recognize supervised exercise therapy as a best practice treatment for IC, but do not often refer their patients for supervised exercise therapy due to the unavailability of, or lack of access to supervised exercise therapy programs. Available supervised exercise therapy programs do not implement best practice recommendations, and in the majority, patients only undergo one session per week. Some challenges were cited as the cause of the suboptimal program implementation. These included issues related to patients' engagement and adherence as well as resource constraints.

Conclusion: There is a dearth of published research on exercise therapy in the routine management of PAD and IC. Available data from a few countries within Europe indicated that supervised exercise is underutilized despite health professionals recognizing the benefits. Research is needed to understand how to improve the availability, access, uptake, and adherence to the best exercise recommendations in the routine management of people with PAD and IC.

Background: Recombinant factor VIIa (rFVIIa) (Novoseven®) is utilized for the reversal of anticoagulation-associated bleeding and refractory bleeding in cardiac surgery. In August 2015, rFVIIa was transferred from the blood bank to the pharmacy at New York University (NYU) Langone Health. Concordantly, an off-label dosing guideline was developed. The objective of this study was to describe utilization and cost of rFVIIa and assess compliance to our dosing guideline.

Methods: We performed a retrospective, observational review of rFVIIa administrations post-implementation of an off-label dosing guideline. All patients who received rFVIIa between September 2015 and June 2017 were evaluated. For each rFVIIa administration, anticoagulation and laboratory values, indications for use, dosing, ordering and administration times, concomitant blood products, and adverse events were collected. Adverse events included venous thromboembolism, stroke, myocardial infarction, and death due to systemic embolism and mortality. The primary endpoint was the utilization of rFVIIa in accordance with the off-label dosing guideline. Secondary endpoints included hemostatic efficacy of rFVIIa, adverse events, blood products administered, and cost-effectiveness of rFVIIa transition to pharmacy.

Results: A total of 63 patients [pediatric (n = 6), adult (n = 57)] received rFVIIa, with the majority of use for refractory bleeding after cardiac surgery. The utilization of rVIIa decreased after development of the off-label dosing guideline and transition from blood bank to pharmacy. The total incidence of thromboembolic events within 30 days was 19.6%; 17.6% arterial and 2% venous; 70% of patients with an adverse event were over 70 years of age. Use of rFVIIa reduced the median number of units of blood products administered.

Conclusion: Administration of rFVIIa for cardiac surgery appears to be effective for hemostasis. Transitioning rFVIIa from the blood bank to pharmacy and implementation of a dosing guideline appears to have reduced utilization. Patients receiving rFVIIa should be monitored for thromboembolic events. Elderly patients may be at higher risk for thromboembolic events.

Ivabradine is a pure heart-rate lowering drug that is nowadays used, accordingly to the last ESC Guidelines, to reduce mortality and heart failure (HF) hospitalization in patients with HF with reduced ejection fraction and in symptomatic patiens with inappropriate sinus tachycardia. Moreover, interesting effect of ivabradine on endothelial and myocardial function and on oxidative stress and inflamation pathways are progressively emerging. The aim of this paper is to highlight newer evidences about ivabradine effect (and consequently possible future application of the drug) in pathological settings different from guidelines-based clinical practice.

Background: Despite the complexity of SYNTAX score (SS), guidelines recommend this tool to help choosing between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in patients with left main of three-vessel coronary artery disease. The aim of this study was to compare the inter-observer variation in SS performed by clinical cardiologists (CC), interventional cardiologists (IC), and cardiac surgeons (CS).

Methods: Seven coronary angiographies from patients with left main and/or three-vessel disease chosen by a heart team were analyzed by 10 CC, 10 IC and 10 CS. SS was calculated via SYNTAX website.

Results: Kappa concordance was very low between CC and CS (k = 0.176), moderate between CS and IC (k = 0.563), and moderate between CC and IC (0.553). There was a statistically significant difference between CC, who classified more cases as low complexity (70%), and CS, who classified more cases as moderate complexity (80%) (p = 0.041).

Conclusion: Concordance between SS analyzed by CC, CS and IC is low. The usefulness of SS in decision-making of revascularization strategy is undeniable and evidence supports its use. However, this study highlights the importance of well-trained professionals on calculating the SS. It could avoid misclassification of borderline cases.