Percutaneous coronary intervention with a drug-eluting stent is the most common mode of revascularization for coronary artery disease. However, restenosis rates remain high. Non-stent-based local ...drug delivery by a drug-coated balloon (DCB) has been investigated, as it leaves no metallic mesh. A DCB consists of a semicompliant balloon coated with antiproliferative agents encapsulated in a polymer matrix, which is released into the wall after inflation and contact with the intima. DCB have demonstrated effectiveness in treating in-stent restenosis. Clinical studies using DCB in de novo coronary artery disease have shown mixed results, with a major benefit in small-vessel disease. Differences in study results are not only due to variations in DCB technology but also to disparity in procedural approach, "leave nothing behind" or "combination therapy," and vessel size. This review focuses on the available evidence from randomized trials and proposes a design for future clinical trials.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
There are a limited number of donor hearts available for transplantation every year, and an even lower number of these hearts actually undergo transplantation. One of the barriers to utilizing donor ...hearts is the inferior outcomes associated with prolonged ischemic times. There have been increasing attempts to develop alternative techniques for prolonged storage to raise the number of heart transplants while maintaining acceptable outcomes. One such new technology utilizes continuous ex vivo perfusion of the donor heart with oxygenated blood and allows for prolonged storage and preservation times. The TransMedics Organ Care System (OCS) Heart (TransMedics; Andover, MA) claims to optimize the condition of the donor organs by preserving them in a warm, functioning environment. On April 6, 2021, the United States Food and Drug Administration convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to provide guidance on the TransMedics OCS Heart System's application for premarket approval. This application was subsequently approved on September 7, 2021. We provide an overview of the meeting, including the results of the clinical trials that were presented.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
BACKGROUND:The HEART Pathway (history, ECG, age, risk factors, and initial troponin) is an accelerated diagnostic protocol designed to identify low-risk emergency department patients with chest pain ...for early discharge without stress testing or angiography. The objective of this study was to determine whether implementation of the HEART Pathway is safe (30-day death and myocardial infarction rate <1% in low-risk patients) and effective (reduces 30-day hospitalizations) in emergency department patients with possible acute coronary syndrome.
METHODS:A prospective pre-post study was conducted at 3 US sites among 8474 adult emergency department patients with possible acute coronary syndrome. Patients included were ≥21 years old, investigated for possible acute coronary syndrome, and had no evidence of ST-segment–elevation myocardial infarction on ECG. Accrual occurred for 12 months before and after HEART Pathway implementation from November 2013 to January 2016. The HEART Pathway accelerated diagnostic protocol was integrated into the electronic health record at each site as an interactive clinical decision support tool. After accelerated diagnostic protocol integration, ED providers prospectively used the HEART Pathway to identify patients with possible acute coronary syndrome as low risk (appropriate for early discharge without stress testing or angiography) or non-low risk (appropriate for further in-hospital evaluation). The primary safety and effectiveness outcomes, death, and myocardial infarction (MI) and hospitalization rates at 30 days were determined from health records, insurance claims, and death index data.
RESULTS:Preimplementation and postimplementation cohorts included 3713 and 4761 patients, respectively. The HEART Pathway identified 30.7% as low risk; 0.4% of these patients experienced death or MI within 30 days. Hospitalization at 30 days was reduced by 6% in the postimplementation versus preimplementation cohort (55.6% versus 61.6%; adjusted odds ratio, 0.79; 95% CI, 0.71–0.87). During the index visit, more MIs were detected in the postimplementation cohort (6.6% versus 5.7%; adjusted odds ratio, 1.36; 95% CI, 1.12–1.65). Rates of death or MI during follow-up were similar (1.1% versus 1.3%; adjusted odds ratio, 0.88; 95% CI, 0.58–1.33).
CONCLUSIONS:HEART Pathway implementation was associated with decreased hospitalizations, increased identification of index visit MIs, and a very low death and MI rate among low-risk patients. These findings support use of the HEART Pathway to identify low-risk patients who can be safely discharged without stress testing or angiography.
CLINICAL TRIAL REGISTRATION:URLhttp://www.clinicaltrials.gov. Unique identifierNCT02056964.
Targeting inflammation in atherosclerosis: overview, strategy and directions Waksman, Ron; Merdler, Ilan; Case, Brian C ...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,
2024-Jan-01, Volume:
20, Issue:
1
Journal Article
Peer reviewed
Atherosclerosis is a chronic condition characterised by the build-up of plaque in the inner lining of the blood vessels and it is the main underlying cause of cardiovascular disease. The development ...of atherosclerosis is associated with the accumulation of cholesterol and inflammation. Although effective therapies exist to lower low-density lipoprotein cholesterol (LDL-C) levels, some patients still experience cardiovascular events due to persistent inflammation, known as residual inflammatory risk (RIR). Researchers have conducted laboratory and animal studies to investigate the measurement and targeting of the inflammatory cascade associated with atherosclerosis, which have yielded promising results. In addition to guideline-directed lifestyle modifications and optimal medical therapy focusing on reducing LDL-C levels, pharmacological interventions targeting inflammation may provide further assistance in preventing future cardiac events. This review aims to explain the mechanisms of inflammation in atherosclerosis, identifies potential biomarkers, discusses available therapeutic options and their strengths and limitations, highlights future advancements, and summarises notable clinical studies. Finally, an evaluation and management algorithm for addressing RIR is presented.
The coronavirus disease 2019 (COVID-19) pandemic has greatly impacted the US healthcare system. Cardiac involvement in COVID-19 is common and manifested by troponin and natriuretic peptide elevation ...and tends to have a worse prognosis. We analyzed patients who presented to the MedStar Health system (11 hospitals in Washington, DC, and Maryland) with either an ST-elevation myocardial infarction or non-ST-elevation myocardial infarction early in the pandemic (March 1, 2020 to June 30, 2020) using the International Classification of Diseases, Tenth Revision. Patients’ clinical course and outcomes, including in-hospital mortality, were compared on the basis of the results of COVID-19 status (positive or negative). The cohort included 1533 patients admitted with an acute myocardial infarction (AMI), of whom 86 had confirmed severe acute respiratory syndrome coronavirus 2 infection, during the study period. COVID-19-positive patients were older and non-White and had more co-morbidities. Furthermore, inflammatory markers and N-terminal-proB-type-natriuretic peptide were higher in COVID-19-positive AMI patients. Only 20.0% (17) of COVID-19-positive patients underwent coronary angiography. In-hospital mortality was significantly higher in AMI patients with concomitant COVID-19-positive status (27.9%) than in patients without COVID-19 during the same period (3.7%; p < 0.001). Patients with AMI and COVID-19 tended to be older, with more co-morbidities, when compared to those with an AMI and without COVID-19. In conclusion, myocardial infarction with concomitant COVID-19 was associated with increased in-hospital mortality. Efforts should be focused on the early recognition, evaluation, and treatment of these patients.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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