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1.
Medicine (Baltimore) ; 103(36): e38788, 2024 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-39252230

RESUMO

INTRODUCTION: Sinus of Valsalva aneurysm (SOVA), a rare cardiac malformation, is usually congenital and rarely acquired and most commonly occurring in the right coronary sinus. The clinical presentation of patients with SOVA varies. It is usually asymptomatic when it has not ruptured, and when it compresses neighboring structures or ruptures, it can lead to heart failure or shock, at which point urgent surgical intervention is usually required. Rupture of the sinus of Valsalva aneurysm (RSOVA) during pregnancy is really hard to come by, especially if the clinical presentations resemble that of an acute myocardial infarction. This report describes a pregnant woman with severe chest pain and hypotension with aVR and V1 ST-segment elevation due to RSOVA. PATIENT CONCERNS: Effects of RSOVA on the fetus, disease survival, and prognosis. DIAGNOSIS: RSOVA. INTERVENTIONS: Open SOVA repair. OUTCOMES: The patient's blood pressure returned to normal range and clinical symptoms disappeared after the surgery. After 3 months of follow-up, the patient was hemodynamically stable without chest discomfort, and an echocardiogram showed a normal aortic sinus. CONCLUSION: Progressive aneurysm dilatation or rupture has a poor prognosis. A thorough history and physical examination are fundamental, with echocardiography being the initial diagnostic tool of choice, and other ancillary tests (e.g., computed tomography) being used to complement and confirm the diagnosis. Surgery remains the current treatment of choice for patients with RSOVA, while the continuation of pregnancy in pregnant patients with RSOVA remains a case-by-case measure.


Assuntos
Complicações Cardiovasculares na Gravidez , Choque Cardiogênico , Seio Aórtico , Humanos , Gravidez , Feminino , Complicações Cardiovasculares na Gravidez/diagnóstico , Adulto , Choque Cardiogênico/etiologia , Choque Cardiogênico/diagnóstico , Seio Aórtico/diagnóstico por imagem , Seio Coronário/anormalidades , Ruptura Aórtica/diagnóstico , Ruptura Aórtica/complicações , Ruptura Aórtica/cirurgia , Aneurisma Aórtico/complicações , Aneurisma Aórtico/diagnóstico , Aneurisma Aórtico/cirurgia , Eletrocardiografia , Ecocardiografia
2.
Ann Cardiol Angeiol (Paris) ; 73(4): 101785, 2024 Sep.
Artigo em Francês | MEDLINE | ID: mdl-39146699

RESUMO

Coronary sinus reducer implantation is a percutaneous technique creating a narrowing in the coronary sinus through the implantation of an hourglass-shaped endoprosthesis. It is proposed to reduce symptoms in patients suffering from refractory angina pectoris. This innovative treatment is experiencing a major craze among interventional cardiologists. It is associated with very high procedural success rates. Complications are rare and include coronary sinus dissection or perforation and migration of the device. This review exposes the device implantation technique, the potential anatomical difficulties, the tips and tricks to overcome challenging situations. It also focuses on the prevention and management of potential complications.


Assuntos
Seio Coronário , Humanos , Angina Pectoris/terapia , Angina Pectoris/prevenção & controle , Angina Pectoris/etiologia , Complicações Pós-Operatórias/prevenção & controle
3.
Echocardiography ; 41(8): e15866, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-39189809

RESUMO

A 15-year-old male patient presented with a 3-year history of recurrent dizziness and headaches and was initially diagnosed with patent foramen ovale. A transcatheter closure procedure was planned and conducted under general anesthesia, utilizing ultrasound guidance through the femoral vein. Preadmission echocardiography confirmed the presence of a patent foramen ovale. However, further investigation with transesophageal echocardiography (TEE) performed under general anesthesia, revealed that the observed atrial septal anomaly was not a patent foramen ovale. Instead, real-time TEE identified it as the left atrial opening of the coronary vein. Subsequent detailed TEE tracking confirmed a rare case of coronary sinus ostium atresia with left atrial reflux of the coronary vein, leading to a significant revision of the initial diagnosis and planned treatment.


Assuntos
Seio Coronário , Erros de Diagnóstico , Forame Oval Patente , Humanos , Masculino , Forame Oval Patente/diagnóstico por imagem , Forame Oval Patente/complicações , Forame Oval Patente/diagnóstico , Seio Coronário/anormalidades , Seio Coronário/diagnóstico por imagem , Adolescente , Diagnóstico Diferencial , Ecocardiografia Transesofagiana/métodos , Anomalias dos Vasos Coronários/diagnóstico , Anomalias dos Vasos Coronários/diagnóstico por imagem
4.
Radiol Cardiothorac Imaging ; 6(4): e230407, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-39023372

RESUMO

Purpose To investigate the association between the anomalous aortic origin of the right coronary artery (R-AAOCA) from the left coronary sinus with interarterial course (IAC) found at coronary CT angiography and sudden cardiac death using a large data set from five university hospitals. Materials and Methods From a total of 89 314 CCTA scans (January 2009 to December 2016) that were retrospectively collected, 316 patients with R-AAOCA from the left sinus with IAC were retrospectively collected. After excluding patients with less than 2 years of follow-up, patients who had already undergone cardiovascular surgery or intervention, and patients with arrhythmia or heart failure before undergoing coronary CT angiography, 224 patients were analyzed. Follow-up was terminated upon the occurrence of major adverse cardiovascular events (MACE). Logistic regression was used to identify clinical and radiologic information as independent predictors of MACE. Results The period prevalence of R-AAOCA from the left sinus with IAC was 0.354%. The mean age was 62.03 years, with a male-to-female ratio of 182:134. During follow-up, 19 of 224 patients (8.5%) experienced MACE, but none had sudden cardiac death. Of these cases, only seven (3.13%) were suspected of being due to R-AAOCA from the left sinus with IAC and all of them had unstable angina. Coronary artery disease was significantly associated with MACE (P < .001), while no significant correlation was observed with radiologic features. Conclusion Sudden cardiac death was not associated with R-AAOCA from the left sinus with IAC found at coronary CT angiography. The occurrence of MACE was low, with coronary artery disease being the sole significant predictor of a patient's prognosis. Keywords: Anomalous Aortic Origin of the Right Coronary Artery, Left Coronary Sinus with Interarterial Course, Coronary CT Angiography, Sudden Cardiac Death Supplemental material is available for this article. © RSNA, 2024.


Assuntos
Angiografia por Tomografia Computadorizada , Angiografia Coronária , Anomalias dos Vasos Coronários , Morte Súbita Cardíaca , Humanos , Masculino , Anomalias dos Vasos Coronários/diagnóstico por imagem , Anomalias dos Vasos Coronários/mortalidade , Anomalias dos Vasos Coronários/complicações , Morte Súbita Cardíaca/etiologia , Morte Súbita Cardíaca/epidemiologia , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Idoso , Seio Coronário/anormalidades , Seio Coronário/diagnóstico por imagem
5.
Artigo em Inglês | MEDLINE | ID: mdl-38967498

RESUMO

In this case report, we describe the surgical treatment of a right coronary sinus aneurysm. A 69-year-old male patient was screened because of palpitations. He was finally diagnosed with an aneurysm of the sinus of Valsalva of the right coronary cusp. According to current aortic guidelines, surgical reconstruction was proposed. The patient underwent a cardiac operation through a median sternotomy under routine cardiopulmonary bypass. After aortic cross-clamping, the aorta was opened and the connection between the aorta and the aneurysm was clearly visualized, underneath the ostium of the right coronary artery. After excision of the right coronary button and the remaining right coronary sinus wall, this sinus was reconstructed with a Dacron graft, with subsequent coronary reimplantation. The postoperative course was uneventful. The patient was discharged on postoperative day 7. A complete sinus reconstruction was preferred over local patching of the defect because of the proximity of the aneurysm sac to the right coronary artery and the fragile, thin aortic tissue just underneath the coronary ostium.


Assuntos
Seio Coronário , Humanos , Masculino , Idoso , Seio Coronário/cirurgia , Seio Aórtico/cirurgia , Aneurisma Coronário/cirurgia , Aneurisma Coronário/diagnóstico , Implante de Prótese Vascular/métodos , Resultado do Tratamento , Ponte Cardiopulmonar/métodos
6.
Future Cardiol ; 20(5-6): 281-286, 2024 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-38975696

RESUMO

One of the most common complications of tricuspid valve replacement is atrioventricular block (AVB), often requiring permanent pacing. The endocardial pacemaker lead, placed in the right ventricle, may sometimes interfere with the implanted prosthesis, causing its early dysfunction and the need for alternative sites of pacing. To the best of our knowledge, we present the first case of a successful combined percutaneous procedure consisting of the implantation of two leads in the coronary sinus for univentricular bifocal pacing and a transcatheter tricuspid valve-in-valve implantation in a young patient with severe dysfunction of the tricuspid bioprosthesis, requiring permanent pacing for a postsurgical complete atrioventricular block.


Tricuspid valve replacement with surgery can often lead to cardiac rhythm disorders requiring a permanent pacemaker. This device may occasionally damage the tricuspid prosthesis. We present the first case of a combined procedure of tricuspid valve replacement and device implantation distant from the prosthesis without the need for a surgical approach in a young patient with severe tricuspid prosthesis malfunctioning and permanent pacing.


Assuntos
Cateterismo Cardíaco , Estimulação Cardíaca Artificial , Seio Coronário , Implante de Prótese de Valva Cardíaca , Valva Tricúspide , Humanos , Valva Tricúspide/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Seio Coronário/cirurgia , Cateterismo Cardíaco/métodos , Estimulação Cardíaca Artificial/métodos , Bloqueio Atrioventricular/terapia , Bloqueio Atrioventricular/etiologia , Bioprótese , Próteses Valvulares Cardíacas , Insuficiência da Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/diagnóstico , Marca-Passo Artificial , Feminino , Masculino , Adulto
7.
Adv Exp Med Biol ; 1441: 145-153, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38884709

RESUMO

The development of the inflow tract is undoubtedly one of the most complex remodeling events in the formation of the four-chambered heart. It involves the creation of two separate atrial chambers, the formation of an atrial/atrioventricular (AV) septal complex, the incorporation of the caval veins and coronary sinus into the right atrium, and the remodeling events that result in pulmonary venous return draining into the left atrium. In these processes, the atrioventricular mesenchymal complex, consisting of the major atrioventricular (AV) cushions, the mesenchymal cap on the primary atrial septum (pAS), and the dorsal mesenchymal protrusion (DMP), plays a crucial role.


Assuntos
Átrios do Coração , Animais , Humanos , Seio Coronário/embriologia , Seio Coronário/anormalidades , Coração/embriologia , Mesoderma/embriologia , Veias Pulmonares/anormalidades
8.
Vasc Health Risk Manag ; 20: 245-250, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38859874

RESUMO

Guidewire loss is a rare complication of central venous catheterization. A 65-year-old male was hospitalized in a high-dependency unit for exacerbation of chronic obstructive pulmonary disease, pneumonia, erythrocytosis, and clinical signs of heart failure. Upon admission, after an unsuccessful right jugular approach, a left jugular central venous catheter was placed. The next day, chest radiography revealed the catheter located in the left parasternal region, with suspected retention of the guidewire, visually confirmed by the presence of its proximal end inside the catheter. The left parasternal location of the catheter and the typical projection of the guidewire in the coronary sinus, later confirmed by echocardiography, raised suspicion of a persistent left superior vena cava (PLSVC). Agitated saline injected into the left antecubital vein confirmed bubble entry from the coronary sinus into the right atrium. After clamping the guidewire, the catheter was carefully retrieved along with the guidewire without any complications. This is the first reported case of guidewire retention in PLSVC and coronary sinus. It underscores the potential causes of guidewire loss and advocates preventive measures to avoid this potentially fatal complication.


Assuntos
Cateterismo Venoso Central , Cateteres Venosos Centrais , Seio Coronário , Remoção de Dispositivo , Veia Cava Superior Esquerda Persistente , Humanos , Masculino , Idoso , Seio Coronário/anormalidades , Seio Coronário/diagnóstico por imagem , Cateterismo Venoso Central/instrumentação , Cateterismo Venoso Central/efeitos adversos , Veia Cava Superior Esquerda Persistente/complicações , Veia Cava Superior Esquerda Persistente/diagnóstico por imagem , Veia Cava Superior Esquerda Persistente/terapia , Resultado do Tratamento , Cateteres de Demora , Veia Cava Superior/anormalidades , Veia Cava Superior/diagnóstico por imagem , Flebografia
9.
Ann Hematol ; 103(7): 2557-2560, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38748259

RESUMO

Primary cardiac lymphomas (PCLs) are a rare clinical entity, in which treatment guidelines remain to be established. Rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (R-EPOCH) has been proposed, given that it involves a continuous infusion of anthracycline, reducing the risk of a cardiotoxicity and therefore the theoretical risk of perforation. However, the literature on this method of treatment is scarce. Herein, we present a unique case of a 75-year-old male, diagnosed with primary cardiac diffuse large B-cell lymphoma (DLBCL) with relatively unusual involvement of the coronary sinus, treated first with one cycle of R-EPOCH, followed by three cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) to reduce said risk. To our knowledge, this is one of two cases, in which a patient with PCL was treated this way.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica , Seio Coronário , Ciclofosfamida , Doxorrubicina , Etoposídeo , Neoplasias Cardíacas , Linfoma Difuso de Grandes Células B , Prednisona , Rituximab , Vincristina , Humanos , Linfoma Difuso de Grandes Células B/tratamento farmacológico , Linfoma Difuso de Grandes Células B/patologia , Masculino , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Vincristina/administração & dosagem , Vincristina/uso terapêutico , Ciclofosfamida/administração & dosagem , Ciclofosfamida/uso terapêutico , Prednisona/uso terapêutico , Prednisona/administração & dosagem , Rituximab/administração & dosagem , Rituximab/uso terapêutico , Doxorrubicina/uso terapêutico , Doxorrubicina/administração & dosagem , Seio Coronário/diagnóstico por imagem , Neoplasias Cardíacas/tratamento farmacológico , Neoplasias Cardíacas/patologia , Etoposídeo/administração & dosagem , Etoposídeo/uso terapêutico
11.
J Cardiovasc Electrophysiol ; 35(7): 1440-1449, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38757370

RESUMO

INTRODUCTION: The accuracy of surface ECG algorithms for predicting the origin of outflow tract ventricular arrhythmias (OT-VAs) might be questioned. Intracardiac electrograms recorded at anatomic landmarks could provide new predictive insights. We aim to evaluate the efficacy of a novel criterion utilizing the activation pattern of the coronary sinus (CS) in localizing OT-VAs, including VAs originating from the right ventricular outflow tract (RVOT), endocardial left ventricular outflow tract (Endo-LVOT), and epicardial left ventricular outflow tract (Epi-LVOT). METHODS: We measured the ventricular activation time of the mitral annulus (MA) from the onset of the earliest QRS complex of VAs to the initial deflection over the isoelectric line at local signals, namely the QRS-MA interval. The activation at 3 and 12 o'clock of the MA was recorded as the QRS-MA3 and QRS-MA12 intervals, respectively. Their predictive values were compared to previous ECG algorithms. RESULTS: A total of 68 patients with OT-VAs were enrolled (51 for development and 17 for validation). From early to late, the ventricular activation sequences at MA12 were as follows: Epi-LVOT, Endo-LVOT, and RVOT. In LBBB morphology OT-VAs, the QRS-MA12 interval was significantly earlier for LVOT origins than RVOT origins. In the combined cohort of development and validation cohort, a cut-off value of ≤10 ms predicted the LVOT origin with a sensitivity of 100% and specificity of 78%. The QRS-MA12 interval ≤ -24 ms additionally predicted epicardial LVOT sites of origin. CONCLUSIONS: The QRS-MA interval could accurately differentiate the OT-VAs localization.


Assuntos
Potenciais de Ação , Seio Coronário , Eletrocardiografia , Frequência Cardíaca , Valor Preditivo dos Testes , Humanos , Seio Coronário/fisiopatologia , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Algoritmos , Técnicas Eletrofisiológicas Cardíacas , Reprodutibilidade dos Testes , Fatores de Tempo , Taquicardia Ventricular/fisiopatologia , Taquicardia Ventricular/diagnóstico , Arritmias Cardíacas/fisiopatologia , Arritmias Cardíacas/diagnóstico , Adulto , Diagnóstico Diferencial
12.
Int J Cardiovasc Imaging ; 40(5): 1159-1160, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38703291

RESUMO

Unroofed sinus is categorized into four subtypes. Types I and II represent complete unroofing with or without an LSVC, respectively [1]. Types III and IV are partial unroofing involving the mid-CS (type III) or near the LA appendage and left superior pulmonary vein (type IV) [1]. CT has advantages over echocardiography in detection of this anomaly (illustrated in this case) as well as in precise delineation of defect and associated findings (presence or absence of LSVC). Short axis reconstructions at the level of CS are helpful in diagnosis. Considerations for repair include location of CS defect, presence of LSVC and other abnormalities as well as comorbidity risks [2].


Assuntos
Seio Coronário , Valor Preditivo dos Testes , Humanos , Angiografia por Tomografia Computadorizada , Angiografia Coronária , Seio Coronário/anormalidades , Seio Coronário/diagnóstico por imagem , Seio Coronário/fisiopatologia , Anomalias dos Vasos Coronários/diagnóstico por imagem , Flebografia/métodos , Veia Cava Superior/anormalidades , Veia Cava Superior/diagnóstico por imagem
14.
Circ Arrhythm Electrophysiol ; 17(6): e012486, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38690652

RESUMO

BACKGROUND: 12,13-dihydroxy-9Z-octadecenoic acid (12,13-diHOME) has shown potential in protecting against heart disease, but its relationship with atrial fibrillation (AF) remains unknown. METHODS: Coronary sinus (CS) and femoral vein blood samplings were synchronously collected from AF and non-AF subjects (paroxysmal supraventricular tachycardia or idiopathic premature ventricular complexes) who underwent catheter ablation. First, untargeted metabolomic profiling was performed in a discovery cohort (including 12 AF and 12 non-AF subjects) to identify the most promising CS or femoral vein metabolite. Then, the selected metabolite was further measured in a validation cohort (including 119 AF and 103 non-AF subjects) to confirm its relationship with left atrium remodeling and 1-year postablation recurrence of AF. Finally, the biological function of the selected metabolite was validated in a rapid-paced cultured HL-1 atrial cardiomyocytes model. RESULTS: Metabolomic analysis identified CS 12,13-diHOME as the most pronounced change metabolite correlated with left atrium remodeling in the discovery cohort. In the validation cohort, CS 12,13-diHOME was significantly lower in patients with AF than non-AF controls (84.32±20.13 versus 96.24±23.56 pg/mL; P<0.01), and associated with worse structural, functional, and electrical remodeling of left atrium. Multivariable regression analyses further demonstrated that decreased CS 12,13-diHOME was an independent predictor of 1-year postablation recurrence of AF (odds ratio, 0.754 [95% CI, 0.648-0.920]; P=0.005). Biological function validations showed that 12,13-diHOME treatment significantly protect the cell viability, improved the expression of MHC (myosin heavy chain) and Cav1.2 (L-type calcium channel α1c), and attenuated mitochondrial damage in the rapid-paced cultured HL-1 cardiomyocytes model. CONCLUSIONS: CS metabolite 12,13-diHOME is decreased in patients with AF and can serve as a novel biomarker for left atrium remodeling.


Assuntos
Fibrilação Atrial , Remodelamento Atrial , Biomarcadores , Ablação por Cateter , Seio Coronário , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/cirurgia , Fibrilação Atrial/metabolismo , Fibrilação Atrial/diagnóstico , Humanos , Masculino , Feminino , Biomarcadores/sangue , Biomarcadores/metabolismo , Pessoa de Meia-Idade , Seio Coronário/metabolismo , Seio Coronário/fisiopatologia , Metabolômica , Miócitos Cardíacos/metabolismo , Miócitos Cardíacos/patologia , Animais , Idoso , Estudos de Casos e Controles , Recidiva , Função do Átrio Esquerdo , Átrios do Coração/fisiopatologia , Átrios do Coração/metabolismo , Valor Preditivo dos Testes
15.
Eur J Heart Fail ; 26(4): 1065-1077, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38606485

RESUMO

AIMS: Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients. METHODS AND RESULTS: Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population. CONCLUSIONS: In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial.


Assuntos
Seio Coronário , Estudos de Viabilidade , Átrios do Coração , Insuficiência Cardíaca , Volume Sistólico , Humanos , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/cirurgia , Insuficiência Cardíaca/terapia , Feminino , Masculino , Volume Sistólico/fisiologia , Idoso , Átrios do Coração/fisiopatologia , Átrios do Coração/diagnóstico por imagem , Seio Coronário/fisiopatologia , Resultado do Tratamento , Pessoa de Meia-Idade , Ecocardiografia/métodos , Qualidade de Vida , Cateterismo Cardíaco/métodos , Estudos Prospectivos , Função Ventricular Esquerda/fisiologia , Seguimentos , Hemodinâmica/fisiologia
17.
Lancet ; 403(10436): 1543-1553, 2024 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-38604209

RESUMO

BACKGROUND: The coronary sinus reducer (CSR) is proposed to reduce angina in patients with stable coronary artery disease by improving myocardial perfusion. We aimed to measure its efficacy, compared with placebo, on myocardial ischaemia reduction and symptom improvement. METHODS: ORBITA-COSMIC was a double-blind, randomised, placebo-controlled trial conducted at six UK hospitals. Patients aged 18 years or older with angina, stable coronary artery disease, ischaemia, and no further options for treatment were eligible. All patients completed a quantitative adenosine-stress perfusion cardiac magnetic resonance scan, symptom and quality-of-life questionnaires, and a treadmill exercise test before entering a 2-week symptom assessment phase, in which patients reported their angina symptoms using a smartphone application (ORBITA-app). Patients were randomly assigned (1:1) to receive either CSR or placebo. Both participants and investigators were masked to study assignment. After the CSR implantation or placebo procedure, patients entered a 6-month blinded follow-up phase in which they reported their daily symptoms in the ORBITA-app. At 6 months, all assessments were repeated. The primary outcome was myocardial blood flow in segments designated ischaemic at enrolment during the adenosine-stress perfusion cardiac magnetic resonance scan. The primary symptom outcome was the number of daily angina episodes. Analysis was done by intention-to-treat and followed Bayesian methodology. The study is registered with ClinicalTrials.gov, NCT04892537, and completed. FINDINGS: Between May 26, 2021, and June 28, 2023, 61 patients were enrolled, of whom 51 (44 [86%] male; seven [14%] female) were randomly assigned to either the CSR group (n=25) or the placebo group (n=26). Of these, 50 patients were included in the intention-to-treat analysis (24 in the CSR group and 26 in the placebo group). 454 (57%) of 800 imaged cardiac segments were ischaemic at enrolment, with a median stress myocardial blood flow of 1·08 mL/min per g (IQR 0·77-1·41). Myocardial blood flow in ischaemic segments did not improve with CSR compared with placebo (difference 0·06 mL/min per g [95% CrI -0·09 to 0·20]; Pr(Benefit)=78·8%). The number of daily angina episodes was reduced with CSR compared with placebo (OR 1·40 [95% CrI 1·08 to 1·83]; Pr(Benefit)=99·4%). There were two CSR embolisation events in the CSR group, and no acute coronary syndrome events or deaths in either group. INTERPRETATION: ORBITA-COSMIC found no evidence that the CSR improved transmural myocardial perfusion, but the CSR did improve angina compared with placebo. These findings provide evidence for the use of CSR as a further antianginal option for patients with stable coronary artery disease. FUNDING: Medical Research Council, Imperial College Healthcare Charity, National Institute for Health and Care Research Imperial Biomedical Research Centre, St Mary's Coronary Flow Trust, British Heart Foundation.


Assuntos
Angina Estável , Doença da Artéria Coronariana , Seio Coronário , Intervenção Coronária Percutânea , Humanos , Masculino , Feminino , Doença da Artéria Coronariana/terapia , Angina Estável/tratamento farmacológico , Seio Coronário/diagnóstico por imagem , Teorema de Bayes , Resultado do Tratamento , Intervenção Coronária Percutânea/efeitos adversos , Método Duplo-Cego , Isquemia , Adenosina
18.
Circ Cardiovasc Interv ; 17(4): e013675, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38626079

RESUMO

BACKGROUND: Primary percutaneous coronary intervention (pPCI) has improved clinical outcomes in patients with ST-segment-elevation myocardial infarction. However, as many as 50% of patients still have suboptimal myocardial reperfusion and experience extensive myocardial necrosis. The PiCSO-AMI-I trial (Pressure-Controlled Intermittent Coronary Sinus Occlusion-Acute Myocardial Infarction-I) evaluated whether PiCSO therapy can further reduce myocardial infarct size (IS) in patients undergoing pPCI. METHODS: Patients with anterior ST-segment-elevation myocardial infarction and Thrombolysis in Myocardial Infarction flow 0-1 were randomized at 16 European centers to PiCSO-assisted pPCI or conventional pPCI. The PiCSO Impulse Catheter (8Fr balloon-tipped catheter) was inserted via femoral venous access after antegrade flow restoration of the culprit vessel and before proceeding with stenting. The primary end point was the difference in IS (expressed as a percentage of left ventricular mass) at 5 days by cardiac magnetic resonance. Secondary end points were the extent of microvascular obstruction and intramyocardial hemorrhage at 5 days and IS at 6 months. RESULTS: Among 145 randomized patients, 72 received PiCSO-assisted pPCI and 73 conventional pPCI. No differences were observed in IS at 5 days (27.2%±12.4% versus 28.3%±11.45%; P=0.59) and 6 months (19.2%±10.1% versus 18.8%±7.7%; P=0.83), nor were differences between PiCSO-treated and control patients noted in terms of the occurrence of microvascular obstruction (67.2% versus 64.6%; P=0.85) or intramyocardial hemorrhage (55.7% versus 60%; P=0.72). The study was prematurely discontinued by the sponsor with no further clinical follow-up beyond 6 months. However, up to 6 months of PiCSO use appeared safe with no device-related adverse events. CONCLUSIONS: In this prematurely discontinued randomized trial, PiCSO therapy as an adjunct to pPCI did not reduce IS when compared with conventional pPCI in patients with anterior ST-segment-elevation myocardial infarction. PiCSO use was associated with increased procedural time and contrast but no increase in adverse events up to 6 months. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03625869.


Assuntos
Seio Coronário , Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Seio Coronário/diagnóstico por imagem , Circulação Coronária , Resultado do Tratamento , Estudos Prospectivos , Infarto do Miocárdio/etiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Infarto do Miocárdio com Supradesnível do Segmento ST/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Hemorragia/etiologia
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