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The trials of interpreting clinical trials - A Bayesian perspective on colchicine following an acute coronary syndrome

http:www.cardiocirugia.sld.cu - Sáb, 06/21/2025 - 10:00

Can J Cardiol. 2025 Jun 19:S0828-282X(25)00391-5. doi: 10.1016/j.cjca.2025.06.008. Online ahead of print.

ABSTRACT

BACKGROUND: A 2022 meta-analysis concluded colchicine reduced the cardiac risk in secondary prevention. Nevertheless, a large, randomized clinical trial (RCT) continued to randomize patients to colchicine or placebo and in 2025 published findings of no benefit. Bayesian sequential analyses and hierarchical meta-analysis can assist in understanding not only the interpretation of this latest trial but also the totality of the evidence.

METHODS: A systematic review and Bayesian meta-analysis including the recent CLEAR trial results was performed. The primary outcome was major adverse cardiovascular events (MACE), a composite of death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization. Bayesian sequential analyses were performed with vague (result dominated by CLEAR), fully informative (based on all previous studies), and "focused" (considering only the largest and most similar previous trial) priors and results compared with a hierarchical meta-analysis. The probabilities of clinically meaningful results were based on > absolute 15% MACE reduction.

RESULTS: While the 2022 meta-analysis suggested a statistically significant MACE decrease with colchicine, the Bayesian reanalysis showed a 95% credible interval (95% CrI 0.26, 1.70) for the next study, justifying CLEAR continuation. The Bayesian sequential analyses using vague, all-inclusive, and focused priors showed 58%, 100% and 92% probabilities respectively of MACE decrease with colchicine. Clinically meaningful probability decreases, based on > absolute 15% reduction, were smaller, ranging between 2% to 41%.

CONCLUSIONS: Bayesian analyses offer advantages in trial design and interpretation, suggesting some benefit for colchicine in secondary cardiovascular prevention, but considerably less certainty of its clinical importance.

PMID:40543648 | DOI:10.1016/j.cjca.2025.06.008

Categorías:

A Systematic Review and Meta-Analysis of Outcome After Repeat Revascularization for Primary Carotid Artery Restenosis

http:www.cardiocirugia.sld.cu - Sáb, 06/21/2025 - 10:00

J Endovasc Ther. 2025 Jun 21:15266028251325054. doi: 10.1177/15266028251325054. Online ahead of print.

ABSTRACT

OBJECTIVE: Carotid artery restenosis can occur after both carotid artery stenting (CAS) and carotid endarterectomy (CEA). This systematic review and meta-analysis aim to determine which revascularization technique, CAS, or CEA, is superior for treating primary carotid restenosis, irrespective of the initial revascularization method used.

DESIGN: Systematic review and meta-analysis.

METHODS: MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRALs) databases were searched for eligible studies on December 19th, 2023. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was followed. Primary endpoint was the occurrence of transient ischemic attack (TIA) or any stroke. Secondary endpoints were technical success, death within 30 days, myocardial infarction (MI), local complications, cerebral hyperperfusion syndrome (CHS), cranial nerve injury (CNI), dys-/arrythmia, secondary restenosis, repeat revascularization, and long-term survival. Results were adjusted for symptomatic status and primary treatment strategy.

RESULTS: Nineteen studies comprising 10,171 procedures in 10,041 patients were included. Baseline characteristics were comparable between groups. Main findings were (1) No difference in primary outcome; however, if adjusted for symptomatic status the rate of TIA/any stroke is higher (OR: 2.05, 95% CI: 1.29-3.27, p < 0.01) after CEA compared to CAS; (2) Significant higher rate of MI (OR: 1.85, 95% CI: 1.19-2.86, p < 0.01) after CEA; (3) Besides CNI, which appears to be commonly temporary and occurred only after CEA (7.56%, 95% CI: 4.21%-13.22%), no significant differences in other secondary endpoints were observed between groups. Long-term risk of secondary restenosis was similar between CEA compared to CAS (OR: 0.98, 95% CI: 0.39-2.49, p = 0.95); (4) Correction for the index procedure did not affect conclusions.

CONCLUSION: Based on limited-quality studies, mostly retrospective and nonrandomized in design, both CAS and CEA represent feasible treatment approaches for patients with primary restenosis, with comparable primary outcome between the two groups. However, based on the obtained results, CAS appears to be preferable. Patients should be critically evaluated in a multidisciplinary team and further research is desirable.Clinical ImpactThis review expands on previous studies by incorporating a larger patient cohort and more recent literature while offering new insights into restenosis. Unlike earlier research, this study uniquely evaluates first repeat revascularization outcomes (CAS and CEA) independently of the initial procedure, suggesting that patient and plaque characteristics might be more influential than the primary technique. Sensitivity analysis confirmed this, as stratification by index procedure did not alter conclusions. Although lower TIA/stroke and mortality rates were observed in CAS-treated patients, these findings were not statistically significant in the overall group. These results may help guide clinical decision-making for optimal restenosis management.

PMID:40542821 | DOI:10.1177/15266028251325054

Categorías:

The bone-heart axis: A crucial dialogue in cardiovascular disease

Protección miocárdica - Sáb, 06/21/2025 - 10:00

Metabolism. 2025 Jun 19;170:156332. doi: 10.1016/j.metabol.2025.156332. Online ahead of print.

ABSTRACT

Cardiovascular diseases (CVDs), the leading cause of global mortality, are now understood to be profoundly influenced by the endocrine regulatory functions of the skeletal system. Emerging evidence suggests that osteocrine factors, including fibroblast growth factor-23 (FGF23), lipocalin-2 (LCN2), Dickkopf-1 (DKK1), myeloid-derived growth factor (MYDGF), osteocalcin (OCN), and sclerostin (SOST), establish bidirectional regulatory networks with the cardiovascular system, termed the "bone-heart axis". This axis regulates critical pathological processes, including mineral metabolism, vascular calcification, and myocardial energy homeostasis. Dysregulation of this crosstalk accelerates the progression of atherosclerosis (AS), heart failure (HF), and other CVDs. Therefore, current research necessitates a paradigm shift from univariate analyses to elucidating the spatiotemporal dynamics of interorgan communication, thereby facilitating the development of precision therapeutic strategies for integrated skeletal and cardiovascular protection.

PMID:40543811 | DOI:10.1016/j.metabol.2025.156332

Antithrombotic approach in percutaneous pulmonary valve implantation (PPVI): What is our standard of care? A study endorsed by the Association for European Paediatric and Congenital Cardiology

Trasplante cardíaco - Sáb, 06/21/2025 - 10:00

Arch Cardiovasc Dis. 2025 Jun 12:S1875-2136(25)00325-0. doi: 10.1016/j.acvd.2025.04.056. Online ahead of print.

ABSTRACT

BACKGROUND: Despite the widespread adoption of percutaneous pulmonary valve implantation, there remains a lack of consensus on the optimal management of peri-interventional and long-term antithrombotic therapies because of a lack of evidence.

AIM: To clarify current practices in peri/postprocedural antithrombotic strategies for percutaneous pulmonary valve implantation.

METHODS: An online survey was submitted to the Interventional Working Group of the Association for European Paediatric and Congenital Cardiology, and was completed by 76 congenital interventional cardiologists in 2023-2024.

RESULTS: Overall, 86% had standardized protocols for anticoagulation/antiaggregation. Intraprocedural heparin administration of 100IU/kg was common (83%), and postprocedural strategies mostly included acetylsalicylic acid (aspirin) (45%) or a combination of antiaggregation and anticoagulation (29%). Long-term strategies comprised antiaggregation (88%), no therapy (11%) and anticoagulation only (1%). Acetylsalicylic acid monotherapy was prescribed by 91%, whereas 9% used dual antiaggregation therapy. Dual antiaggregation therapy was continued for suspicious medical history of thrombotic complication or microthrombi for 3-6 months. Testing for acetylsalicylic acid resistance was infrequent (36%), and only if clinically indicated. When patients had pre-established anticoagulation therapy, 59% changed their strategy. Treatment changes based on valve type were rare (8%). The primary reasons for anticoagulation/antiaggregation were to increase valve longevity (26%) and for both longevity and endocarditis prophylaxis (68%). Acute valve thrombosis was reported in 11 cases.

CONCLUSIONS: The survey reveals variability in practices after percutaneous pulmonary valve implantation. Most interventional cardiologists prefer acetylsalicylic acid for postprocedural and long-term management, whereas dual antiaggregation therapy is sometimes used in specific cases. Anticoagulation is limited to pre-existing therapy cases or isolated experiences for 3 months.

PMID:40544108 | DOI:10.1016/j.acvd.2025.04.056

Categorías: Trasplante cardíaco

Antithrombotic approach in percutaneous pulmonary valve implantation (PPVI): What is our standard of care? A study endorsed by the Association for European Paediatric and Congenital Cardiology

Congenital cardiac surgery - Sáb, 06/21/2025 - 10:00

Arch Cardiovasc Dis. 2025 Jun 12:S1875-2136(25)00325-0. doi: 10.1016/j.acvd.2025.04.056. Online ahead of print.

ABSTRACT

BACKGROUND: Despite the widespread adoption of percutaneous pulmonary valve implantation, there remains a lack of consensus on the optimal management of peri-interventional and long-term antithrombotic therapies because of a lack of evidence.

AIM: To clarify current practices in peri/postprocedural antithrombotic strategies for percutaneous pulmonary valve implantation.

METHODS: An online survey was submitted to the Interventional Working Group of the Association for European Paediatric and Congenital Cardiology, and was completed by 76 congenital interventional cardiologists in 2023-2024.

RESULTS: Overall, 86% had standardized protocols for anticoagulation/antiaggregation. Intraprocedural heparin administration of 100IU/kg was common (83%), and postprocedural strategies mostly included acetylsalicylic acid (aspirin) (45%) or a combination of antiaggregation and anticoagulation (29%). Long-term strategies comprised antiaggregation (88%), no therapy (11%) and anticoagulation only (1%). Acetylsalicylic acid monotherapy was prescribed by 91%, whereas 9% used dual antiaggregation therapy. Dual antiaggregation therapy was continued for suspicious medical history of thrombotic complication or microthrombi for 3-6 months. Testing for acetylsalicylic acid resistance was infrequent (36%), and only if clinically indicated. When patients had pre-established anticoagulation therapy, 59% changed their strategy. Treatment changes based on valve type were rare (8%). The primary reasons for anticoagulation/antiaggregation were to increase valve longevity (26%) and for both longevity and endocarditis prophylaxis (68%). Acute valve thrombosis was reported in 11 cases.

CONCLUSIONS: The survey reveals variability in practices after percutaneous pulmonary valve implantation. Most interventional cardiologists prefer acetylsalicylic acid for postprocedural and long-term management, whereas dual antiaggregation therapy is sometimes used in specific cases. Anticoagulation is limited to pre-existing therapy cases or isolated experiences for 3 months.

PMID:40544108 | DOI:10.1016/j.acvd.2025.04.056

Categorías: Cirugía congénitos

Assessing the Utility of Routine Surveillance Echocardiograms After Arterial Switch Operation in Adults with Transposition of the Great Arteries

Congenital cardiac surgery - Sáb, 06/21/2025 - 10:00

J Am Soc Echocardiogr. 2025 Jun 19:S0894-7317(25)00332-3. doi: 10.1016/j.echo.2025.06.006. Online ahead of print.

ABSTRACT

BACKGROUND: Current guidelines recommend annual or biennial transthoracic echocardiograms for patients with d-transposition of the great arteries (d-TGA) who have undergone an arterial switch operation (ASO), but optimal imaging frequency is unknown. We sought to determine the utility of annual surveillance echocardiograms for asymptomatic patients.

METHODS: Clinical documentation from 2011-2023 for asymptomatic patients > 18 years old with history of d-TGA and ASO at a single large tertiary care center was reviewed to determine if routine surveillance echocardiograms resulted in changes in clinical management (ΔMGMT), categorized as procedures (surgery or catheterization) or noninvasive changes (medication changes, additional imaging, etc.). Echocardiograms obtained for symptoms or completed before age 18 were excluded from analysis. Data was evaluated with chi-square and Kruskal-Wallis tests, Kaplan-Meier analysis, and Cox proportional hazard analysis.

RESULTS: Of 416 echocardiograms from 127 patients, the median time from ASO to final echocardiogram was 22.2 years (IQR 19.1-25.7 years; range 15.2-34.1 years). Eighteen echocardiograms (4.32%) resulted in ΔMGMT for 12 patients including 8 (1.92%) medication changes, 7 (1.68%) cardiac CT or MRI studies, and 1 (0.24%) each for cardiac catheterization and surgery. A significantly larger proportion of patients with ΔMGMT underwent ASO at age >1 year compared to patients without ΔMGMT (36.36% vs 6.14%, P<0.01). Patients with a history of hypertension, arrhythmia, >2 sternotomies, or neo-aortic valve replacement had a significantly greater risk of ΔMGMT, as did those with neo-aortic root dilation >4.5cm and/or moderate or greater neo-aortic insufficiency.

CONCLUSIONS: Routine surveillance echocardiograms are low yield in asymptomatic adults up to 30 years after ASO for d-TGA, suggesting it may be reasonable to increase the time interval between routine echocardiograms without adversely impacting care. Higher risk sub-populations including those with ASO at older ages, >2 sternotomies, neo-aortic valve replacement, and/or neo-aortic valve/root pathology may benefit from continued frequent surveillance.

PMID:40543855 | DOI:10.1016/j.echo.2025.06.006

Categorías: Cirugía congénitos

Gender Disparities in Compensation of Practicing Cardiothoracic Surgeons: Analyzing the Society of Thoracic Surgeons Compensation Survey

Congenital cardiac surgery - Sáb, 06/21/2025 - 10:00

Ann Thorac Surg. 2025 Jun 19:S0003-4975(25)00530-2. doi: 10.1016/j.athoracsur.2025.05.038. Online ahead of print.

ABSTRACT

BACKGROUND: Gender-based pay disparity in compensation is widespread. In cardiothoracic surgery, women earn between 71-84% of men's salaries at comparable ranks. Limited data exist on how factors like subspecialty, practice type, and work efforts contribute to these disparities.

METHODS: The Society of Thoracic Surgeons (STS) conducted the Compensation Survey in 2023 among practicing members with at least a 0.5 full-time equivalent role. Collected data included compensation sources, predominant subspeciality of cardiothoracic surgery, work relative value units (wRVUs) generated, and demographics. Comparisons on gender-based salary across subspecialties, years of experience, and wRVUs were included.

RESULTS: Among 838 respondents, gender disparities were present in both base salary and total compensation across all subspecialties, with women earning 64-93% of men's salaries. Income disparity was greatest in cardiac surgery with 11-20 years of experience, where women earned 63-70% of men's compensation. Similarly, in thoracic surgery, women earned 59-72% of the compensation of men with 21-30 years of experience. Women with 11-20 years of experience earned less than both men and women colleagues with 6-10 years of experience. Women reported more compensation from teaching, while men reported more from call coverage.

CONCLUSIONS: Gender pay disparities exist among cardiothoracic surgeons, even when accounting for experience and productivity. Reasons for these disparities, including parenthood penalty, need to be further studied and corrections proposed.

PMID:40543696 | DOI:10.1016/j.athoracsur.2025.05.038

Categorías: Cirugía congénitos

The Removal of Intravascular Foreign Bodies by Intervention in Pediatrics

Congenital cardiac surgery - Sáb, 06/21/2025 - 10:00

J Endovasc Ther. 2025 Jun 21:15266028251344541. doi: 10.1177/15266028251344541. Online ahead of print.

ABSTRACT

INTRODUCTION: The use of intravascular catheters has become increasingly widespread in children, due to their use in diagnostic procedures (such as coronary, intracardiac, cerebral, and renal angiography, as well as pressure monitoring) and for therapeutic purposes (including angioplasties, valvuloplasties, congenital defect closure, chemotherapy, among other uses). However, they are not free from complications, which may include catheter fracture and migration within the cardiovascular system, potentially leading to vascular or cavity perforation, arrhythmias, and even death.

OBJECTIVE: To define the clinical and hemodynamic characteristics of pediatric patients undergoing catheterization for the retrieval of intravascular foreign bodies.

MATERIALS AND METHODS: A retrospective cohort study of all patients under 18 years of age who underwent endovascular extraction of foreign bodies at a cardiovascular reference center.

RESULTS: A high percentage of successful retrieval of intravascular foreign bodies was noted, with the most frequently retrieved catheter being the chemotherapy catheter, primarily located in the right atrium, between the pulmonary trunk and the right ventricle, and in the brachiocephalic vein. Few secondary complications were observed, occurring in only 2 patients.

CONCLUSION: Endovascular retrieval of foreign bodies is a highly effective procedure, and complications are relatively low in pediatrics, even during the neonatal period and in low-birth-weight cases, making it a preferable alternative to surgical extraction.Clinical ImpactBy documenting favorable outcomes across a diverse group, it encourages clinicians to adopt catheter-based approaches more confidently. The use of tools like snare loops and balloon-tipped guidewires in this population reflects procedural innovation and adaptability. Early, minimally invasive intervention may reduce morbidity and hospital stay. These findings can influence clinical decision-making and protocol development in pediatric cardiovascular care, particularly in centers equipped for interventional procedures.

PMID:40542822 | DOI:10.1177/15266028251344541

Categorías: Cirugía congénitos

Nasal Delivery of Engineered Exosomes via a Thermo-Sensitive Hydrogel Depot Reprograms Glial Cells for Spinal Cord Repair

Terapia celular - Vie, 06/20/2025 - 10:00

Adv Sci (Weinh). 2025 Sep;12(34):e04486. doi: 10.1002/advs.202504486. Epub 2025 Jun 20.

ABSTRACT

Spinal cord injury (SCI) presents formidable therapeutic challenges due to its multifaceted pathological complexity. Here, this work reports engineered macrophage-derived exosomes overexpressing GNA12 and GNA13 (G12G13MExos) that reprogram macrophages toward the M2c anti-inflammatory phenotype and astrocytes into a neuroprotective phenotype. G12G13MExos enhance astrocyte-mediated clearance of myelin debris, glutamate homeostasis, and synapse formation while fostering astrocyte-neuron crosstalk. These effects improve neuronal survival and drove neural stem cell differentiation into V2a neurons, facilitating neural circuit reconstruction. This work develops a chitosan-based thermosensitive hydrogel that functions as a "nasal exosome intelligent slow-release depot" to enable efficient and targeted exosome delivery. This delivery system bypasses hepatic and renal sequestration and overcomes the blood-spinal cord barrier, significantly enhancing therapeutic efficacy. This strategy integrates engineered exosomes with a responsive delivery platform, modulating the inflammatory microenvironment, enhancing cellular crosstalk, and promoting neural repair. This comprehensive approach offers a promising translational avenue for SCI treatment and other central nervous system disorders.

PMID:40539838 | PMC:PMC12442609 | DOI:10.1002/advs.202504486

Categorías: Terapia celular

Petri net modeling and simulation of post-transcriptional regulatory networks of human embryonic stem cell (hESC) differentiation to cardiomyocytes

Terapia celular - Vie, 06/20/2025 - 10:00

J Integr Bioinform. 2025 Jun 23;22(1):20240037. doi: 10.1515/jib-2024-0037. eCollection 2025 Mar 1.

ABSTRACT

Stem cells are capable of self-renewal and differentiation into various cell types, showing significant potential for cellular therapies and regenerative medicine, particularly in cardiovascular diseases. The differentiation to cardiomyocytes replicates the embryonic heart development, potentially supporting cardiac regeneration. Cardiomyogenesis is controlled by complex post-transcriptional regulation that affects the construction of gene regulatory networks (GRNs), such as: alternative polyadenylation (APA), length changes in untranslated regulatory regions (3'UTRs), and microRNA (miRNA) regulation. To deepen our understanding of the cardiomyogenesis process, we have modeled a GRN for each day of cardiomyocyte differentiation. Then, each GRN was automatically transformed by four transformation rules to a Petri net and simulated using the software VANESA. The Petri nets highlighted the relationship between genes and alternative isoforms, emphasizing the inhibition of miRNA on APA isoforms with varying 3'UTR lengths. Moreover, in silico simulation of miRNA knockout enabled the visualization of the consequential effects on isoform expression. Our Petri net models provide a resourceful tool and holistic perspective to investigate the functional orchestra of transcript regulation that differentiate hESCs to cardiomyocytes. Additionally, the models can be adapted to investigate post-transcriptional GRN in other biological contexts.

PMID:40538314 | PMC:PMC12327202 | DOI:10.1515/jib-2024-0037

Categorías: Terapia celular

circRNA hsa_circ_0072107 aggravates myocardial hypertrophy via its function as a competitive endogenous RNA of miR-516b-5p

Protección miocárdica - Vie, 06/20/2025 - 10:00

Mol Med Rep. 2025 Sep;32(3):232. doi: 10.3892/mmr.2025.13597. Epub 2025 Jun 20.

ABSTRACT

The present study aimed to identify differentially expressed circRNAs in hypertrophic cardiac tissues and explored the potential regulatory role and mechanism of one differentially expressed circRNA in myocardial hypertrophy. RNA sequencing was used to identify differentially expressed circRNAs in hypertrophic and control cardiac tissues. CircRNA expression levels were verified by reverse transcription‑quantitative PCR. Isoproterenol (ISO) was used to induce hypertrophy of AC16 cells. The extent of cell hypertrophy was indicated by the cell size, protein/DNA ratio and levels of B‑type natriuretic peptide (BNP) and β‑myosin heavy chain (β‑MHC). The interactions between hsa_circ_0072107 and miR‑516b‑5p, as well as between miR‑516b‑5p and zinc ring finger protein 36 (ZFP36), were confirmed through dual luciferase assays, biotinylated probe pull‑down and anti‑AGO2 RNA immunoprecipitation assays. hsa_circ_0072107 was one of the most upregulated circRNAs in hypertrophic cardiac tissues. hsa_circ_0072107 overexpression and ISO treatment increased cell size, elevated the protein/DNA ratio and increased the levels of BNP and β‑MHC in AC16 cells, indicating that hsa_circ_0072107 aggravates AC16 hypertrophy. These changes induced by ISO treatment could be blocked by the knockdown of hsa_circ_0072107. The dual‑luciferase activity assay indicated that miR‑516b‑5p can bind to hsa_circ_0072107. miR‑516b‑5p binding site mutation blocked the effect of hsa_circ_0072107. ZFP36 is a target gene of miR‑516b‑5p, which suppresses AC16 hypertrophy. hsa_circ_0072107 overexpression alleviated the effect of miR‑516b‑5p overexpression on cell hypertrophy and ZFP36 expression. hsa_circ_0072107 is up‑regulated in hypertrophic cardiac tissues and potentially promotes AC16 hypertrophy and may play its role by acting as a competitive endogenous RNA of miR‑516b‑5p. Thus, hsa_circ_0072107 may be a novel target for the treatment of myocardial hypertrophy.

PMID:40539438 | DOI:10.3892/mmr.2025.13597

Distinct morphometric features of cardiomyocytes isolated from mouse hypertrophy models: An ImageJ analysis combined with machine learning algorithms

Protección miocárdica - Vie, 06/20/2025 - 10:00

Physiol Rep. 2025 Jun;13(12):e70425. doi: 10.14814/phy2.70425.

ABSTRACT

This study aims at defining a standardized workflow based on a customized ImageJ macro combined with a machine-learning algorithm to analyze morphometric features of isolated cardiomyocytes using high-resolution/high-content photomicrographs and to identify key and specific morphological features of cardiomyocytes isolated from various murine cardiac hypertrophy models. For that purpose, we set up and optimized a Langendorff based protocol for isolating cardiomyocytes from mouse hearts. This optimized protocol yielded in a significantly high number of formaldehyde-fixed cardiomyocytes, with more than 97% of rod shaped cells. Moreover, our method allowed for reliable gene expression analysis and conservation of cell integrity through multiple freeze-thaw cycles. Next, we successfully applied our analytical workflow on formaldehyde-fixed cardiomyocytes isolated from various murine cardiac hypertrophy models and defined distinct morphological features in Angiotensin II, Isoproterenol, and age-induced hypertrophy. Taken together, our study provides an effective and standardized workflow for high-throughput morphological and molecular characterization of isolated cardiomyocytes, and could constitute a robust and reliable analytical tool to distinguish healthy versus diseased states and assess the ability of a potential therapeutic agent or strategy to reverse the situation.

PMID:40538075 | PMC:PMC12179408 | DOI:10.14814/phy2.70425

The effects of extracorporeal blood purification (oXiris) in patients with cardiogenic shock who require VA-ECMO (CLEAN ECMO): a prospective, open-label, randomized controlled pilot study

Extracorporeal circulation - Vie, 06/20/2025 - 10:00

Crit Care. 2025 Jun 20;29(1):255. doi: 10.1186/s13054-025-05495-4.

ABSTRACT

BACKGROUND: A systemic inflammatory response can contribute to poor outcomes in an advanced stage of cardiogenic shock (CS). We investigated the efficacy of extracorporeal endotoxin and cytokine adsorption using oXiris in patients with CS undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO).

METHODS: In this prospective, single-center, randomized, open-label pilot trial, 40 patients with CS who were undergoing VA-ECMO were randomly assigned to receive either oXiris for 24 h (n = 20) or usual care (n = 20). The primary endpoint was endotoxin levels at 48 h. Secondary endpoints included changes in inflammatory cytokines, vasoactive-inotropic score (VIS), ECMO weaning success, and in-hospital and 30-day mortality.

RESULTS: The median endotoxin levels at 48 h were 0.5 (IQR 0.4-1.0) in the oXiris group and 0.4 (IQR 0.2-0.5) in the control group, with no significant difference between them (P = 0.097). The oXiris group showed significant temporal reductions in GDF-15 and IL-6 levels, with IL-6 revealing significant reductions from baseline to 24 h (P = 0.020) and from baseline to 7 days (P = 0.003). VIS decreased significantly from baseline to 48 h (-13.63, 95% CI: -20.90 - -6.34, P < 0.001) and 7 days (-12.19, 95% CI: -21.0 - -3.31, P = 0.007) in the oXiris group, but intergroup differences were insignificant. ECMO weaning success, duration of ECMO support, and mortality rates were similar between the groups.

CONCLUSION: In this pilot study conducted on CS patients requiring VA-ECMO, oXiris treatment did not significantly reduce endotoxin levels or improve patient centered clinical outcomes.

TRIAL REGISTRATION: NCT05642273, registered 8 December 2022.

PMID:40542431 | PMC:PMC12181899 | DOI:10.1186/s13054-025-05495-4

Procedural characteristics and outcomes of patients undergoing Impella-assisted high-risk percutaneous coronary interventions in the IMPELLA-PL registry

http:www.cardiocirugia.sld.cu - Vie, 06/20/2025 - 10:00

Cardiovasc Revasc Med. 2025 Jun 4:S1553-8389(25)00288-X. doi: 10.1016/j.carrev.2025.06.003. Online ahead of print.

ABSTRACT

BACKGROUND: Impella is a catheter-based, continuous blood flow left ventricle assist device used in selected patients undergoing high-risk percutaneous coronary interventions (HR PCI). We aimed to evaluate outcomes in patients undergoing Impella-assisted HR-PCI and identify independent predictors of 12-month mortality.

METHODS: Consecutive HR-PCI patients enrolled in the national, multicentre, retrospective IMPELLA-PL registry (n = 253) in 20 Polish interventional cardiological centres from October 2014 until December 2021 were included in the analysis. The main endpoints were (i) procedural success defined as revascularization of all preplanned lesions, (ii) device-related complications, (iii) 12-month mortality and major adverse cardiovascular events (MACE).

RESULTS: The majority of patients presented with multivessel disease including left main (63.6 %). The median Syntax Score II was 43.0 (32.4-55.0). The procedural success was achieved in 83.0 % of patients. Device-related complications included access site bleeding (14.6 %), limb ischemia (2.4 %) and hemolysis (1.6 %). The in-hospital MACE included 1 cardiosurgical intervention (0.4 %), 12 exacerbations of heart failure (4.7 %), 11 myocardial infarctions (4.3 %), 32 cases of acute kidney injury (12.6 %), 35 inflammatory complications (13.8 %) and 32 major bleeding complications (13.4 %). In-hospital mortality rate was 8.3 %, 12-month mortality rate was 18.2 % and MACE rate post-discharge was 22.5 %. The 12-month-mortality was increased by pre-existing, atrial fibrillation (OR 3.50, 95 % CI 1.38-8.95) and chronic kidney disease (OR 2.77, 95 % CI 1.06-7.26) and decreased by Impella removal in the cath-lab (OR 0.11, 95 % CI 0.02-0.76) and RAAS inhibitor use (OR 0.26, 95 % CI 0.08-0.89).

CONCLUSIONS: Despite high anatomical complexity of coronary artery disease of patients included in the IMPELLA-PL registry, the procedural success rate was relatively high and the mortality relatively low.

PMID:40541478 | DOI:10.1016/j.carrev.2025.06.003

Categorías:

Clinical Implication of Quantitative Flow Ratio to Predict Clinical Outcomes in De Novo Coronary Lesions After Drug-Coated Balloon Angioplasty

http:www.cardiocirugia.sld.cu - Vie, 06/20/2025 - 10:00

Cardiovasc Drugs Ther. 2025 Jun 20. doi: 10.1007/s10557-025-07735-9. Online ahead of print.

ABSTRACT

PURPOSE: The association between the intra-procedure quantitative flow ratio (QFR) and clinical outcomes after drug-coated balloon (DCB) angioplasty has not been investigated. This study aimed to investigate the clinical predictive value of pre-DCB QFR, a functional assessment of lesion preparation, for clinical outcomes in de novo coronary lesions after DCB angioplasty.

METHODS: This retrospective study included 170 consecutive patients undergoing DCB angioplasty for 177 de novo coronary lesions between January 2021 and December 2022. The QFR was computed at baseline, pre-DCB, and post-DCB. The primary endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause death, cardiac death, target vessel myocardial infarction, and target lesion revascularization.

RESULTS: During 2-year follow-up, 37 patients with 38 lesions have experienced MACE. The pre-DCB QFR, measured after pre-dilation, was significantly lower in the MACE group. Receiver operator characteristic curve analysis showed the optimal pre-DCB QFR cut-off value for predicting MACE was 0.925 (area under curve = 0.782, 95% confidence interval [CI] 0.702-0.861, sensitivity = 78.9%, specificity = 74.8%, p < 0.001). A pre-DCB QFR < 0.925 was associated with a significantly higher risk of MACE compared with a value > 0.925 (46.1% vs. 7.1%, p < 0.001). In multivariable Cox regression analyses, pre-DCB QFR < 0.925 was associated with an over sixfold increased risk of MACE (hazard ratio = 7.483, 95% CI 3.363-16.653, p < 0.001).

CONCLUSION: The pre-DCB QFR was a promising predictor of unfavorable clinical outcomes in de novo coronary lesions after DCB angioplasty.

PMID:40540079 | DOI:10.1007/s10557-025-07735-9

Categorías:

Efficacy and Safety of Clopidogrel Versus Aspirin Monotherapy After Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

http:www.cardiocirugia.sld.cu - Vie, 06/20/2025 - 10:00

Cardiol Rev. 2025 Jun 20. doi: 10.1097/CRD.0000000000000971. Online ahead of print.

ABSTRACT

Dual antiplatelet therapy is a standard treatment after percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS), but the optimal monotherapy agent post-dual antiplatelet therapy remains unclear. Clopidogrel and aspirin are widely used, yet their comparative effectiveness and safety in this patient population have not been fully established. This systematic review and meta-analysis compared the efficacy and safety of clopidogrel and aspirin monotherapy following PCI in patients with ACS. A comprehensive search of PubMed, Embase, and Web of Science was conducted from inception to March 31, 2025. Randomized controlled trials (RCTs) comparing clopidogrel and aspirin monotherapy in adult ACS patients post-PCI were included. Primary outcomes were all-cause death, myocardial infarction (MI), and ischemic stroke. Secondary outcomes included target-vessel and target-lesion revascularization, cardiovascular and noncardiovascular death, and stent thrombosis. The risk of bias was assessed using the Cochrane RoB 2 tool, and the GRADE methodology was applied to evaluate the certainty of evidence. Three RCTs involving 16,056 patients (clopidogrel: 8103; aspirin: 7953) were included. Clopidogrel significantly reduced MI (risk ratio = 0.71; 95% confidence interval: 0.55-0.92; P = 0.01) and target-vessel revascularization (risk ratio = 0.77; 95% confidence interval: 0.60-0.97; P = 0.03). No significant differences were found in all-cause death, ischemic stroke, or other secondary outcomes. Sensitivity analysis suggested a potential reduction in noncardiovascular death favoring clopidogrel. Clopidogrel monotherapy after PCI may offer superior protection against MI and target-vessel revascularization compared with aspirin, with no increased risk of death or stroke.

PMID:40539811 | DOI:10.1097/CRD.0000000000000971

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Influence of Hospital Ownership on Patient Outcomes in ST-Elevation Myocardial Infarction-Induced Cardiogenic Shock Undergoing Revascularization: A Retrospective Cohort Study

http:www.cardiocirugia.sld.cu - Vie, 06/20/2025 - 10:00

Cureus. 2025 May 20;17(5):e84471. doi: 10.7759/cureus.84471. eCollection 2025 May.

ABSTRACT

Background The healthcare landscape is notably divided between investor-owned and nonprofit hospitals, raising questions about the impact of hospital ownership on patient outcomes, especially for high-stakes conditions such as cardiogenic shock resulting from ST-elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI). This study analyzed whether differences in hospital ownership are associated with variations in mortality, length of stay (LOS), and healthcare costs. Methodology We conducted a retrospective cohort study using the National Inpatient Sample (NIS) from 2016 to 2021, identifying 95,260 adult patients with STEMI-induced cardiogenic shock treated with PCI. Identification was based on validated International Classification of Diseases, Tenth Revision, Clinical Modification coding algorithms. The primary outcome was in-hospital mortality, with LOS and total hospital charges (inflation-adjusted via the Consumer Price Index) as secondary outcomes. All outcomes were assessed using multivariable regression models adjusting for patient demographics (age, sex, race/ethnicity), comorbidities, insurance type, and hospital-level factors (region, teaching status, and bed size). Regional cost variation and case mix were also accounted for. Propensity score matching was additionally performed to validate results. Results The analysis revealed no significant difference in mortality rates between investor-owned (27.22%) and nonprofit hospitals (26.93%, adjusted odds ratio (aOR) = 1.03, p = 0.60; 95% confidence interval (CI) = 0.91-1.16). Propensity score-matched analysis confirmed similar findings (aOR = 0.98, p = 0.696). Investor-owned hospitals, however, incurred significantly higher healthcare costs (average charges = $325,543 vs. $222,528; p < 0.001). The average cost difference of $103,015.50 remained statistically and systemically significant after adjustment and may reflect differences in resource utilization and/or billing practices. LOS was slightly shorter in investor-owned hospitals (6.51 vs. 7.27 days); while statistically significant (p < 0.001), this difference was not clinically meaningful after adjustment (coefficient = 0.19, p = 0.334). Key demographic and clinical predictors included age, insurance status, comorbidity index, hospital bed size, and teaching status. Racial and insurance-based disparities, particularly among Hispanic patients and Medicaid enrollees, were associated with higher costs, though not fully explained by hospital ownership. Conclusions In this national analysis, hospital ownership was not associated with differences in mortality for STEMI-induced cardiogenic shock treated with PCI, but was independently associated with substantially higher hospital charges in investor-owned hospitals. These findings demonstrate association, not causation, and highlight the need for future research into cost drivers and initiatives to promote high-value, standardized care across all hospital types.

PMID:40539141 | PMC:PMC12178224 | DOI:10.7759/cureus.84471

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Case Report: Diagnostic and therapeutic challenges in acute myocardial infarction years after aortic replacement surgery: a case of severe vascular tortuosity

http:www.cardiocirugia.sld.cu - Vie, 06/20/2025 - 10:00

Front Cardiovasc Med. 2025 Jun 5;12:1611019. doi: 10.3389/fcvm.2025.1611019. eCollection 2025.

ABSTRACT

This study delineates the diagnostic and therapeutic strategies for acute myocardial infarction occurring years after stent implantation for Stanford type A aortic dissection. Emergency coronary angiography presented substantial technical challenges attributable to the lack of recent aortic imaging data and marked tortuosity of the brachiocephalic trunk resulting from postoperative anatomical changes. Consequently, while selective left coronary angiography was successfully completed, visualization of the right coronary artery necessitated non-selective contrast administration via a pigtail catheter. This case underscores the pivotal role of preoperative aortic computed tomography angiography (CTA) in hemodynamically stable patients, as it provides essential vascular anatomical information that may circumvent procedural complexities during coronary angiography. Building upon these observations, we advocate an "aorto-coronary combined assessment" strategy for post-aortic surgery patients, integrating systematic imaging surveillance to facilitate early identification of coronary lesions. Such an approach permits the timely implementation of intensive medical therapy or elective revascularization, thereby mitigating the risk of acute cardiovascular events.

PMID:40538917 | PMC:PMC12176840 | DOI:10.3389/fcvm.2025.1611019

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Nano Astaxanthin ameliorates myocardial infarction in rats through autophagy

Protección miocárdica - Vie, 06/20/2025 - 10:00

Sci Rep. 2025 Jun 20;15(1):20195. doi: 10.1038/s41598-025-06206-3.

ABSTRACT

Acute myocardial infarction (MI), a serious manifestation of ischemic heart disease, remains the culprit for mortality among coronary heart disease patients. Astaxanthin has demonstrated the ability to alleviate inflammation-induced myocardial damage while maintaining a balance between oxidants and antioxidants. This study investigates the cardioprotective potential of astaxanthin (ASX), particularly when encapsulated in nanostructured lipid carriers (NLCs), in isoprenaline (ISO)-induced myocardial infarction in rats. The study involved 48 rats separated into 6 groups. ASX and Nano-ASX (5 mg/kg) were administrated orally for 21 days before MI induction (isoprenaline, 85 mg/kg, subcutaneously). Blood and cardiac tissue samples were taken 24 h following the last isoprenaline injection for biochemical and histopathological investigation. The findings reveal that nano-formulated ASX significantly reduces oxidative stress and cardiac injury markers, including CK-MB, Troponin-I, and LDH. Additionally, it enhances antioxidant enzyme activities (GSH, GPx, and GSH-RD) and decreases inflammatory markers (COX-2 and VEGF). The study further demonstrates that nano-ASX stimulates autophagy by upregulating critical genes such as Beclin-1, ULK1, and LC3B, which are vital for cardiac protection and repair. Histological analysis confirms these biochemical outcomes, showing reduced myocardial damage and inflammation in the nano-ASX-treated groups. This study concludes the potential of ASX nano-formulations as an advanced therapeutic approach for myocardial infarction, leveraging improved bioavailability and targeting oxidative stress, inflammation, and autophagic mechanisms.

PMID:40542058 | PMC:PMC12181253 | DOI:10.1038/s41598-025-06206-3

Protective effects of Ginkgolide B on myocardial ischemia reperfusion injury: role of the GAS6/Axl signaling pathway

Protección miocárdica - Vie, 06/20/2025 - 10:00

Chem Biol Interact. 2025 Jun 18;418:111607. doi: 10.1016/j.cbi.2025.111607. Online ahead of print.

ABSTRACT

Myocardial ischemia can induce myocardial infarction, posing a severe threat to human health. Although restoration of blood and oxygen supply alleviates tissue damage and reduces infarct size, reperfusion may trigger additional injury that exacerbates myocardial structural and functional disturbances, a phenomenon termed myocardial ischemia-reperfusion injury (MIRI). Ginkgolide B (GB), a terpenoid compound extracted from Ginkgo biloba leaves, exhibits cardiovascular protective properties. This study investigates the potential anti-MIRI effects of GB, with specific emphasis on elucidating the role of the GAS6/Axl signaling pathway in its cardioprotective mechanisms. In vivo experiments demonstrated that GB improved cardiac function and serum biochemical parameters in mice, concurrently suppressing apoptosis and mitigating oxidative stress. In vitro studies further revealed that GB protected HL-1 cardiomyocytes from hypoxia-reoxygenation (HR) injury, as evidenced by enhanced cell viability, reduced apoptosis rates, decreased ROS and LDH levels, alongside upregulated expression of GAS6, Axl, Bcl2, antioxidant-related proteins, and mitochondrial function-associated proteins. Crucially, the protective effects of GB were reversed by GAS6 knockdown or genetic ablation in the HL-1 cell HR model. Collectively, this study confirms the definitive cardioprotective efficacy of GB against MIRI and delineates the critical involvement of the GAS6/Axl signaling pathway, thereby establishing a robust theoretical foundation and scientific rationale for the clinical application of GB in MIRI management.

PMID:40541647 | DOI:10.1016/j.cbi.2025.111607

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