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1.
Am Heart J ; 275: 96-104, 2024 Jun 09.
Artículo en Inglés | MEDLINE | ID: mdl-38862073

RESUMEN

AIMS: The REGENERATE-COBRA trial (NCT05711849) will assess the safety and efficacy of an intracoronary infusion of autologous bone marrow-derived mononuclear cells in refractory angina patients with no revascularization options who are symptomatic despite optimal medical and device therapy. METHODS: REGENERATE-COBRA is a single site, blinded, randomized, sham-controlled, Phase II clinical trial enrolling 110 refractory angina patients with no revascularization options who are symptomatic despite optimal medical and device therapy. Patients will be randomized to either autologous bone marrow derived-mononuclear cells or a sham procedure. Patients in the cell-treated arm will undergo a bone marrow aspiration and an intracoronary infusion of autologous bone marrow derived-mononuclear cells. Patients in the control arm will undergo a sham bone marrow aspiration and a sham intracoronary infusion. The trial's primary endpoint is an improvement in Canadian Cardiovascular Society (CCS) angina class by 2 classes between baseline and 6 months. Secondary endpoints include change in: CCS class at 12 months, myocardial ischemic burden (as measured by perfusion imaging) at 6 months, quality of life at 6 and 12 months (as measured by EQ-5D-5L, EQ-5D-VAS and Seattle Angina Questionnaire), angina frequency at 6 and 12 months, total exercise time (as measured by a modified Bruce protocol) and major adverse cardiovascular events at 6 and 12 months. CONCLUSIONS: This is the first trial to assess the safety and efficacy of an intracoronary infusion of autologous bone marrow-derived unfractionated mononuclear cells in symptomatic refractory angina patients who have exhausted conventional therapeutic options.

2.
Eur Heart J ; 45(27): 2380-2391, 2024 Jul 12.
Artículo en Inglés | MEDLINE | ID: mdl-38805681

RESUMEN

BACKGROUND AND AIMS: A routine invasive strategy is recommended in the management of higher risk patients with non-ST-elevation acute coronary syndromes (NSTE-ACSs). However, patients with previous coronary artery bypass graft (CABG) surgery were excluded from key trials that informed these guidelines. Thus, the benefit of a routine invasive strategy is less certain in this specific subgroup. METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted. A comprehensive search was performed of PubMed, EMBASE, Cochrane, and ClinicalTrials.gov. Eligible studies were RCTs of routine invasive vs. a conservative or selective invasive strategy in patients presenting with NSTE-ACS that included patients with previous CABG. Summary data were collected from the authors of each trial if not previously published. Outcomes assessed were all-cause mortality, cardiac mortality, myocardial infarction, and cardiac-related hospitalization. Using a random-effects model, risk ratios (RRs) with 95% confidence intervals (CIs) were calculated. RESULTS: Summary data were obtained from 11 RCTs, including previously unpublished subgroup outcomes of nine trials, comprising 897 patients with previous CABG (477 routine invasive, 420 conservative/selective invasive) followed up for a weighted mean of 2.0 (range 0.5-10) years. A routine invasive strategy did not reduce all-cause mortality (RR 1.12, 95% CI 0.97-1.29), cardiac mortality (RR 1.05, 95% CI 0.70-1.58), myocardial infarction (RR 0.90, 95% CI 0.65-1.23), or cardiac-related hospitalization (RR 1.05, 95% CI 0.78-1.40). CONCLUSIONS: This is the first meta-analysis assessing the effect of a routine invasive strategy in patients with prior CABG who present with NSTE-ACS. The results confirm the under-representation of this patient group in RCTs of invasive management in NSTE-ACS and suggest that there is no benefit to a routine invasive strategy compared to a conservative approach with regard to major adverse cardiac events. These findings should be validated in an adequately powered RCT.


Asunto(s)
Síndrome Coronario Agudo , Tratamiento Conservador , Puente de Arteria Coronaria , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Síndrome Coronario Agudo/terapia , Síndrome Coronario Agudo/cirugía , Tratamiento Conservador/métodos , Infarto del Miocardio sin Elevación del ST/cirugía , Infarto del Miocardio sin Elevación del ST/terapia , Infarto del Miocardio sin Elevación del ST/mortalidad , Intervención Coronaria Percutánea/métodos
4.
J Cardiovasc Comput Tomogr ; 18(3): 291-296, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38462389

RESUMEN

BACKGROUND: Computed tomography cardiac angiography (CTCA) is recommended for the evaluation of patients with prior coronary artery bypass graft (CABG) surgery. The BYPASS-CTCA study demonstrated that CTCA prior to invasive coronary angiography (ICA) in CABG patients leads to significant reductions in procedure time and contrast-induced nephropathy (CIN), alongside improved patient satisfaction. However, whether CTCA information was used to facilitate selective graft cannulation at ICA was not protocol mandated. In this post-hoc analysis we investigated the influence of CTCA facilitated selective graft assessment on angiographic parameters and study endpoints. METHODS: BYPASS-CTCA was a randomized controlled trial in which patients with previous CABG referred for ICA were randomized to undergo CTCA prior to ICA, or ICA alone. In this post-hoc analysis we assessed the impact of selective ICA (grafts not invasively cannulated based on the CTCA result) following CTCA versus non-selective ICA (imaging all grafts irrespective of CTCA findings). The primary endpoints were ICA procedural duration, incidence of CIN, and patient satisfaction post-ICA. Secondary endpoints included the incidence of procedural complications and 1-year major adverse cardiac events. RESULTS: In the CTCA cohort (n â€‹= â€‹343), 214 (62.4%) patients had selective coronary angiography performed, whereas 129 (37.6%) patients had non-selective ICA. Procedure times were significantly reduced in the selective CTCA â€‹+ â€‹ICA group compared to the non-selective CTCA â€‹+ â€‹ICA group (-5.82min, 95% CI -7.99 to -3.65, p â€‹< â€‹0.001) along with reduction of CIN (1.5% vs 5.8%, OR 0.26, 95% CI 0.10 to 0.98). No difference was seen in patient satisfaction with the ICA, however procedural complications (0.9% vs 4.7%, OR 0.21, 95% CI 0.09-0.87) and 1-year major adverse cardiac events (13.1% vs 20.9%, HR 0.55, 95% CI 0.32-0.96) were significantly lower in the selective group. CONCLUSIONS: In patients with prior CABG, CTCA guided selective angiographic assessment of bypass grafts is associated with improved procedural parameters, lower complication rates and better 12-month outcomes. Taken in addition to the main findings of the BYPASS-CTCA trial, these results suggest a synergistic approach between CTCA and ICA should be considered in this patient group. REGISTRATION: ClinicalTrials.gov, NCT03736018.


Asunto(s)
Angiografía por Tomografía Computarizada , Angiografía Coronaria , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria , Valor Predictivo de las Pruebas , Humanos , Femenino , Masculino , Persona de Mediana Edad , Anciano , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Resultado del Tratamiento , Puente de Arteria Coronaria/efectos adversos , Factores de Tiempo , Factores de Riesgo , Satisfacción del Paciente , Vasos Coronarios/diagnóstico por imagen , Enfermedades Renales/diagnóstico por imagen , Tempo Operativo , Medios de Contraste/administración & dosificación , Medios de Contraste/efectos adversos
5.
Eur Heart J ; 45(18): 1647-1658, 2024 May 13.
Artículo en Inglés | MEDLINE | ID: mdl-38513060

RESUMEN

BACKGROUND AND AIMS: Contrast-induced nephropathy (CIN), also known as contrast-associated acute kidney injury (CA-AKI) underlies a significant proportion of the morbidity and mortality following coronary angiographic procedures in high-risk patients and remains a significant unmet need. In pre-clinical studies inorganic nitrate, which is chemically reduced in vivo to nitric oxide, is renoprotective but this observation is yet to be translated clinically. In this study, the efficacy of inorganic nitrate in the prevention of CIN in high-risk patients presenting with acute coronary syndromes (ACS) is reported. METHODS: NITRATE-CIN is a double-blind, randomized, single-centre, placebo-controlled trial assessing efficacy of inorganic nitrate in CIN prevention in at-risk patients presenting with ACS. Patients were randomized 1:1 to once daily potassium nitrate (12 mmol) or placebo (potassium chloride) capsules for 5 days. The primary endpoint was CIN (KDIGO criteria). Secondary outcomes included kidney function [estimated glomerular filtration rate (eGFR)] at 3 months, rates of procedural myocardial infarction, and major adverse cardiac events (MACE) at 12 months. This study is registered with ClinicalTrials.gov: NCT03627130. RESULTS: Over 3 years, 640 patients were randomized with a median follow-up of 1.0 years, 319 received inorganic nitrate with 321 received placebo. The mean age of trial participants was 71.0 years, with 73.3% male and 75.2% Caucasian; 45.9% had diabetes, 56.0% had chronic kidney disease (eGFR <60 mL/min) and the mean Mehran score of the population was 10. Inorganic nitrate treatment significantly reduced CIN rates (9.1%) vs. placebo (30.5%, P < .001). This difference persisted after adjustment for baseline creatinine and diabetes status (odds ratio 0.21, 95% confidence interval 0.13-0.34). Secondary outcomes were improved with inorganic nitrate, with lower rates of procedural myocardial infarction (2.7% vs. 12.5%, P = .003), improved 3-month renal function (between-group change in eGFR 5.17, 95% CI 2.94-7.39) and reduced 1-year MACE (9.1% vs. 18.1%, P = .001) vs. placebo. CONCLUSIONS: In patients at risk of renal injury undergoing coronary angiography for ACS, a short (5 day) course of once-daily inorganic nitrate reduced CIN, improved kidney outcomes at 3 months, and MACE events at 1 year compared to placebo.


Asunto(s)
Síndrome Coronario Agudo , Lesión Renal Aguda , Medios de Contraste , Angiografía Coronaria , Nitratos , Humanos , Angiografía Coronaria/efectos adversos , Angiografía Coronaria/métodos , Medios de Contraste/efectos adversos , Masculino , Femenino , Método Doble Ciego , Nitratos/administración & dosificación , Nitratos/uso terapéutico , Lesión Renal Aguda/inducido químicamente , Lesión Renal Aguda/prevención & control , Anciano , Persona de Mediana Edad , Tasa de Filtración Glomerular/efectos de los fármacos , Compuestos de Potasio/administración & dosificación , Compuestos de Potasio/uso terapéutico
6.
NEJM Evid ; 3(2): EVIDoa2300286, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38320489

RESUMEN

BACKGROUND: In patients with acute myocardial infarction (MI), therapies that could further reduce the risk of adverse cardiovascular and metabolic outcomes are needed. METHODS: In this international registry-based, randomized, double-blind trial, patients without prior diabetes or chronic heart failure, presenting with acute MI and impaired left ventricular systolic function, were randomly assigned 10 mg of dapagliflozin or placebo, given once daily. The primary outcome was the hierarchical composite of death, hospitalization for heart failure, nonfatal MI, atrial fibrillation/flutter, type 2 diabetes mellitus, New York Heart Association Functional Classification at the last visit, and body weight decrease of 5% or greater at the last visit using the win ratio analysis method. The key secondary outcome was the same hierarchical composite excluding the body weight component. RESULTS: We enrolled 4017 patients of whom 2019 were assigned to dapagliflozin and 1998 to placebo. The analysis of the primary hierarchical composite outcome resulted in significantly more wins for dapagliflozin than for placebo (win ratio, 1.34; 95% confidence interval [CI], 1.20 to 1.50; P<0.001). The win ratio outcome, which was adopted in a change of analysis during trial performance because of low event accrual, was mainly driven by the added cardiometabolic outcomes. The composite of time to cardiovascular death/hospitalization for heart failure occurred in 50/2019 (2.5%) patients assigned to dapagliflozin and 52/1998 (2.6%) patients assigned to placebo (hazard ratio, 0.95; 95% CI, 0.64 to 1.40). The rates of other cardiovascular events were low, with differences between the groups not reaching nominal statistical significance. No safety concerns were identified. CONCLUSIONS: In patients with acute MI as noted above, after approximately 1 year of treatment with dapagliflozin there were significant benefits with regard to improvement in cardiometabolic outcomes but no impact on the composite of cardiovascular death or hospitalization for heart failure compared with placebo. (Funded by AstraZeneca; ClinicalTrial.gov number, NCT04564742.)


Asunto(s)
Compuestos de Bencidrilo , Diabetes Mellitus Tipo 2 , Glucósidos , Insuficiencia Cardíaca , Infarto del Miocardio , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Infarto del Miocardio/tratamiento farmacológico
7.
Circulation ; 148(18): 1371-1380, 2023 10 31.
Artículo en Inglés | MEDLINE | ID: mdl-37772419

RESUMEN

BACKGROUND: Patients with previous coronary artery bypass grafting often require invasive coronary angiography (ICA). However, for these patients, the procedure is technically more challenging and has a higher risk of complications. Observational studies suggest that computed tomography cardiac angiography (CTCA) may facilitate ICA in this group, but this has not been tested in a randomized controlled trial. METHODS: This study was a single-center, open-label randomized controlled trial assessing the benefit of adjunctive CTCA in patients with previous coronary artery bypass grafting referred for ICA. Patients were randomized 1:1 to undergo CTCA before ICA or ICA alone. The co-primary end points were procedural duration of the ICA (defined as the interval between local anesthesia administration for obtaining vascular access and removal of the last catheter), patient satisfaction after ICA using a validated questionnaire, and the incidence of contrast-induced nephropathy. Linear regression was used for procedural duration and patient satisfaction score; contrast-induced nephropathy was analyzed using logistic regression. We applied the Bonferroni correction, with P<0.017 considered significant and 98.33% CIs presented. Secondary end points included incidence of procedural complications and 1-year major adverse cardiac events. RESULTS: Over 3 years, 688 patients were randomized with a median follow-up of 1.0 years. The mean age was 69.8±10.4 years, 108 (15.7%) were women, 402 (58.4%) were White, and there was a high burden of comorbidity (85.3% hypertension and 53.8% diabetes). The median time from coronary artery bypass grafting to angiography was 12.0 years, and there were a median of 3 (interquartile range, 2 to 3) grafts per participant. Procedure duration of the ICA was significantly shorter in the CTCA+ICA group (CTCA+ICA, 18.6±9.5 minutes versus ICA alone, 39.5±16.9 minutes [98.33% CI, -23.5 to -18.4]; P<0.001), alongside improved mean ICA satisfaction scores (1=very good to 5=very poor; -1.1 difference [98.33% CI, -1.2 to -0.9]; P<0.001), and reduced incidence of contrast-induced nephropathy (3.4% versus 27.9%; odds ratio, 0.09 [98.33% CI, 0.04-0.2]; P<0.001). Procedural complications (2.3% versus 10.8%; odds ratio, 0.2 [95% CI, 0.1-0.4]; P<0.001) and 1-year major adverse cardiac events (16.0% versus 29.4%; hazard ratio, 0.4 [95% CI, 0.3-0.6]; P<0.001) were also lower in the CTCA+ICA group. CONCLUSIONS: For patients with previous coronary artery bypass grafting, CTCA before ICA leads to reductions in procedure time and contrast-induced nephropathy, with improved patient satisfaction. CTCA before ICA should be considered in this group of patients. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03736018.


Asunto(s)
Angiografía por Tomografía Computarizada , Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Angiografía Coronaria/efectos adversos , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Puente de Arteria Coronaria
9.
Am J Cardiovasc Dis ; 13(3): 168-176, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37469533

RESUMEN

OBJECTIVE: To assess the safety and effectiveness of a novel pathway of deferrred invasive angiography in low-risk NSTEMI patients with concurrent COVID-19 infections; contrary to current UK guidelines recommending invasive coronary angiography in NSTEMI patients within 72 hours. METHODS: This was a single-centre, observational study of all NSTEMI patients referred for inpatient coronary angiography at Barts Heart Centre, between March 2020 and June 2022. Demographic, procedural and outcome data were collected as part of a national cardiac audit. RESULTS: 201 COVID positive NSTEMI patients were referred for angiography at Barts Heart Centre. 10 patients died from COVID related respiratory complications prior to angiography. Therefore, 191 patients underwent deferred angiography (median time 16 days from COVID diagnosis). The median GRACE score was 128 (IQR 86-153). Troponin levels were significantly elevated on initial COVID diagnosis compared to time of their procedure. 73% patients had a culprit lesion identified. 61.2% receiving PCI. Patients were followed-up for a median of 363 days (IQR 120-485 days) with MACE rates of 7.3%. This is comparable to the MACE event for NSTEMI patients (n=4529) without COVID at our institution treated during the same time-period (8.1%). CONCLUSION: This study demonstrates the safety and effectiveness of deferred coronary angiography on a COVID-Recovered pathway after a period of medical management for patients presenting with NSTEMI and concurrent COVID-19 infection. There was no adverse signal associated with the wait for angiography with similar MACE rates to the non-deferred NSTEMI cohort without COVID-19.

10.
J Am Coll Cardiol ; 81(25): 2406-2416, 2023 06 27.
Artículo en Inglés | MEDLINE | ID: mdl-37344042

RESUMEN

BACKGROUND: It has been previously reported during the first COVID-19 outbreak that patients presenting with ST-segment elevation myocardial infarction (STEMI) and concurrent COVID-19 infection have increased thrombus burden and poorer outcomes. To date, there have been no reports comparing the outcomes of COVID-19-positive STEMI patients across all waves of the pandemic. OBJECTIVES: This study compared the baseline demographic, procedural, and angiographic characteristics alongside the clinical outcomes of patients presenting with STEMI and concurrent COVID-19 infection across the COVID-19 pandemic in the United Kingdom. METHODS: This was a single-center, observational study of 1,269 consecutive patients admitted with confirmed STEMI treated with percutaneous coronary intervention (between January 3, 2020 and October 3, 2022). COVID-19-positive patients were split into 3 groups based upon the time course of the pandemic, and a comparison was made between waves. RESULTS: A total of 154 COVID-19-positive patients with STEMI were included in the present analysis and were compared with 1,115 COVID-19-negative patients. Early during the pandemic (wave 1), STEMI patients presenting with concurrent COVID-19 infection had high rates of cardiac arrest, evidence of increased thrombus burden, bigger infarcts, and worse outcomes. However, by wave 3, no differences existed in outcomes between COVID-19-positive and -negative patients, with significant differences compared with earlier COVID-19-positive patients. Poor outcomes later in the study period were predominantly in unvaccinated individuals. CONCLUSIONS: Significant changes have occurred in the clinical characteristics, angiographic features, and outcomes of STEMI patients with COVID-19 infection treated by primary percutaneous coronary intervention during the course of the pandemic. Importantly, outcomes of recent waves and in vaccinated individuals are no different to a non-COVID-19 population.


Asunto(s)
COVID-19 , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Trombosis , Humanos , COVID-19/epidemiología , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/epidemiología , Infarto del Miocardio con Elevación del ST/terapia , Pandemias , Trombosis/diagnóstico por imagen , Trombosis/epidemiología , Trombosis/etiología , Reino Unido/epidemiología , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento
11.
ESC Heart Fail ; 10(4): 2664-2671, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37190883

RESUMEN

AIMS: The DCM Support trial (NCT03572660) uses a percutaneous circulatory support device (Impella CP, Abiomed, Danvers, MA, USA) to improve the safety of an intracoronary cell infusion procedure in patients with dilated cardiomyopathy (DCM) and a severely reduced left ventricular ejection fraction (LVEF). METHODS AND RESULTS: DCM Support is a single-site, single-arm Phase II trial enrolling 20 symptomatic DCM patients with an LVEF ≤ 35% despite optimal medical and device therapy. After 5 days of granulocyte colony-stimulating factor therapy and a subsequent bone marrow aspiration, patients undergo an intracoronary infusion of autologous bone-marrow-derived mononuclear cells. The Impella CP device is used to provide haemodynamic support during the infusion procedure. The trial's primary endpoint is change in LVEF from baseline at 3 months. Secondary efficacy endpoints are change in LVEF from baseline at 12 months, and change in exercise capacity, New York Heart Association class, quality of life, and N-terminal pro-B-type natriuretic peptide levels from baseline at 3 and 12 months. Safety endpoints include procedural safety and major adverse cardiac events at 3 and 12 months. CONCLUSIONS: This is the first trial to assess the safety and efficacy of cytokine and autologous intracoronary cell therapy with a procedural circulatory support device for patients with severe left ventricular impairment. This novel combination may allow us to target a patient population most at need of this therapy.


Asunto(s)
Cardiomiopatía Dilatada , Humanos , Cardiomiopatía Dilatada/complicaciones , Cardiomiopatía Dilatada/terapia , Volumen Sistólico , Función Ventricular Izquierda , Calidad de Vida , Resultado del Tratamiento , Tratamiento Basado en Trasplante de Células y Tejidos
12.
Am J Cardiovasc Dis ; 13(2): 32-42, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37213314

RESUMEN

Recently, there has been growing interest in the early discharge strategy for low-risk patients who have undergone primary percutaneous coronary intervention (PCI) to treat ST-segment elevation myocardial infarction (STEMI). So far findings have suggested there are multiple advantages of shorter hospital stays, including that it could be a safe way to be more cost- and resource-efficient, reduce cases of hospital-acquired infection and boost patient satisfaction. However, there are remaining concerns surrounding safety, patient education, adequate follow-up and the generalisability of the findings from current studies which are mostly small-scale. By assessing the current research, we describe the advantages, disadvantages and challenges of early hospital discharge for STEMI and discuss the factors that determine if a patient can be considered low risk. If it is feasible to safely employ a strategy like this, the implications for healthcare systems worldwide could be extremely beneficial, particularly in lower-income economies and when we consider the detrimental impacts of the recent COVID-19 pandemic on healthcare systems.

13.
Am Heart J Plus ; 30: 100301, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38510922

RESUMEN

Background: Drug eluting balloons (DEB) are a feasible method of rapid delivery of drug to a coronary vessel wall. Their efficacy has been established for the treatment of in-stent restenosis and small vessel disease but there is limited data for their use in bifurcation lesions. Objective: The aim of this study was to assess the effectiveness of provisional upfront side-branch DEB use in bifurcation lesions compared to a simple balloon (POBA) or upfront 2 stent bifurcation strategy. Methods: We conducted an observational study of 625 patients undergoing PCI to bifurcation lesions. All the patients had a DES deployed in the main vessel (MV). Decision on revascularization option for the side branch (SB) was made by the operator. The primary endpoint was target vessel failure. Secondary endpoints were target vessel myocardial infarction and all-cause mortality. Results: 311 patients had upfront DEB to the SB whilst the remaining were treated with either DES (188) or POBA (126). Baseline characteristics were similar aside from history of previous MI, which were higher in patients treated with DES or POBA, p = 0.009 whereas patients with previous CABG were likely to undergo DEB treatment (p = 0.004). TVF was more likely to occur in the POBA group (7.5 %) compared to the DEB (3.3 %) and DES (3.3 %) groups (p = 0.0019). There was no significant difference in TV-MI (p = 0.62) or death (p = 0.98) between the groups. Conclusion: This study suggests that provisional bifurcation stenting with upfront Sirolimus DEB use in the SB is an effective treatment for non-LMS bifurcation PCI.

14.
Regen Med ; 17(12): 891-903, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-36226504

RESUMEN

Aims: Given the logistical issues surrounding intramyocardial cell delivery, we sought to address the efficacy of the simpler, more accessible intracoronary route by re-evaluating REGENERATE-DCM and REGENERATE-IHD (autologous cell therapy trials for heart failure; n = 150). Methods: A retrospective statistical analysis was performed on the trials' combined data. The following end points were evaluated: left ventricular ejection fraction (LVEF), N-terminal pro brain natriuretic peptide concentration (NT-proBNP), New York Heart Association class (NYHA) and quality of life. Results: This demonstrated a new efficacy signal for intracoronary delivery, with significant benefits to: LVEF (3.7%; p = 0.01), NT-proBNP (median -76 pg/ml; p = 0.04), NYHA class (48% patients; p = 0.01) and quality of life (12 ± 19; p = 0.006). The improvements in LVEF, NYHA and quality of life scores remained significant compared to the control group. Conclusion: The efficacy and logistical simplicity of intracoronary delivery should be taken into consideration for future trials.


Trials of cell therapy for heart failure have not clearly identified the best method to deliver the cells to the heart. A small proportion of these studies have used the intracoronary method (which infuses the cells into the heart's arteries) as it was thought to be less effective. However, this is the simplest method and uses widely accessible techniques and equipment. By combining data from two previous heart failure trials, we sought to look for an efficacy signal for the intracoronary method in a larger sample size. We found that the intracoronary route demonstrated improvements in patients' heart function and symptoms. Although it may require a larger number of patients to show efficacy, this signal, alongside the intracoronary route's relative simplicity, should be taken into consideration when future trials of cell therapy for heart failure are planned.


Asunto(s)
Insuficiencia Cardíaca , Función Ventricular Izquierda , Humanos , Volumen Sistólico , Calidad de Vida , Estudios Retrospectivos , Insuficiencia Cardíaca/terapia
15.
Front Cardiovasc Med ; 9: 1002508, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36172585

RESUMEN

Introduction: This is the first reported case of a patient with dilated cardiomyopathy (DCM) and severely impaired left ventricular function to receive a combined treatment of granulocyte colony-stimulating factor therapy and an intracoronary delivery of autologous bone marrow-derived mononuclear cells with percutaneous circulatory assistance (the Impella CP device; Abiomed, Danvers, MA). Main symptoms and outcome: Three months post-treatment, the gentleman in his early 70s demonstrated an improvement in left ventricular ejection fraction (13-17%) and a reduction in New York Heart Association class from III to class I. There was also an improvement in his 6-minute walk test (147-357 meters), N-terminal pro-brain natriuretic peptide level (14,099-7,129 ng/l) and quality of life scores. There were no safety concerns during the treatment or follow-up. Conclusion: This case report suggests combined cell and cytokine therapy with adjunctive circulatory support could be a safe and promising treatment for patients with DCM and severely reduced ejection fraction.

16.
Eur J Intern Med ; 105: 69-76, 2022 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-35999094

RESUMEN

BACKGROUND: The characteristics and outcome of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive patients with ST-Elevation Myocardial Infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) are still poorly known. METHODS: The PANDEMIC study was an investigator-initiated, collaborative, individual patient data (IPD) meta-analysis of registry-based studies. MEDLINE, ScienceDirect, Web of Sciences, and SCOPUS were searched to identify all registry-based studies describing the characteristics and outcome of SARS-CoV-2-positive STEMI patients undergoing PPCI. The control group consisted of SARS-CoV-2-negative STEMI patients undergoing PPCI in the same time period from the ISACS-STEMI COVID 19 registry. The primary outcome was in-hospital mortality; the secondary outcome was postprocedural reperfusion assessed by TIMI flow. RESULTS: Of 8 registry-based studies identified, IPD were obtained from 6 studies including 941 SARS-CoV-2-positive patients; the control group included 2005 SARS-CoV-2-negative patients. SARS-CoV-2-positive patients showed a significantly higher in-hospital mortality (p < 0.001) and worse postprocedural TIMI flow (<3, p < 0.001) compared with SARS-CoV-2-negative subjects. The increased risk for SARS-CoV-2-positive patients was significantly higher in males compared to females for both the primary (pinteraction = 0.001) and secondary outcome (pinteraction = 0.023). In SARS-CoV-2-positive patients, age ≥ 75 years (OR = 5.72; 95%CI: 1.77-18.5), impaired postprocedural TIMI flow (OR = 11.72; 95%CI: 2.64-52.10), and cardiogenic shock at presentation (OR = 11.02; 95%CI: 2.84-42.80) were independent predictors of mortality. CONCLUSIONS: In STEMI patients undergoing PPCI, SARS-CoV-2 positivity is independently associated with impaired reperfusion and with a higher risk of in-hospital mortality, especially among male patients. Age ≥ 75 years, cardiogenic shock, and impaired postprocedural TIMI flow independently predict mortality in this high-risk population.


Asunto(s)
COVID-19 , Infarto del Miocardio , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Femenino , Humanos , Masculino , Anciano , Infarto del Miocardio con Elevación del ST/cirugía , SARS-CoV-2 , Choque Cardiogénico/etiología , Intervención Coronaria Percutánea/efectos adversos , Sistema de Registros , Angioplastia , Resultado del Tratamiento
17.
Am J Cardiol ; 177: 1-6, 2022 08 15.
Artículo en Inglés | MEDLINE | ID: mdl-35732552

RESUMEN

Emergency percutaneous coronary intervention of the left main (LM ePCI) coronary artery necessitated by acute coronary syndrome is associated with a high risk of mortality. However, optimal treatment strategies and related outcomes remain undefined in this group. We undertook a multi-center, retrospective, observational cohort study of consecutive patients requiring LM ePCI between 2011 and 2018 and reported the coronary anatomy, treatment strategies, outcomes, and predictors of mortality. A total of 116 consecutive cases were included. Patients were predominantly male (85%) with a median age of 68.0 years; 12 patients (10%) had previous coronary artery bypass grafting. ST-elevation was noted in 76 (66%); 30 (26%) presented with an out-of-hospital cardiac arrest (OOHCA) and 47 (41%) with cardiogenic shock. The most frequent pattern of disease was Medina 1,1,1, seen in 59 patients (51%). The commonest revascularization strategy was provisional stenting (95 cases, 82%) with improved or thrombolysis in myocardial infarction 3 flow seen in 85 cases (73%). All-cause mortality was 35% at 30 days, rising to 58% at 5 years. Adverse predictors of 30-day mortality included presentation with cardiogenic shock (p = 0.018) and OOHCA (p = 0.020), whereas improved flow and/or thrombolysis in myocardial infarction 3 flow in both circumflex and left anterior descending artery afforded a better prognosis (p = 0.028). In conclusion, patients who underwent LM ePCI are a high-risk subgroup and commonly present with cardiogenic shock and OOHCA. Provisional stenting appears to be the preferred option with the successful restoration of coronary flow in most cases despite complex anatomy. High 30-day mortality is driven by the presence of cardiogenic shock, OOHCA, and failure to restore or improve coronary flow.


Asunto(s)
Infarto del Miocardio , Intervención Coronaria Percutánea , Anciano , Vasos Coronarios , Femenino , Humanos , Masculino , Intervención Coronaria Percutánea/efectos adversos , Estudios Retrospectivos , Choque Cardiogénico/terapia , Resultado del Tratamiento
19.
Cardiovasc Revasc Med ; 43: 13-17, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-35534348

RESUMEN

BACKGROUND: Patients with aortic stenosis (AS) are susceptible to myocardial ischemia and often present acutely, making it challenging to differentiate between a type 1 NSTEMI and acute decompensated aortic stenosis. This study aims to evaluate the diagnostic accuracy of Troponin T (TnT) (>5 fold above the upper limit of normal), ischemic ECG and angina, to predict a type 1 non-ST elevation myocardial infarction (NSTEMI) and obstructive coronary artery disease (CAD) among patients with severe AS and acute presentations. METHODS: Patients with severe AS and acute symptoms: angina (Canadian Cardiovascular Society Class 3/4), dyspnea (New York Heart Association 4) and/or syncope were included. The endpoints were a type 1 NSTEMI defined by the presence of a coronary thrombus or > 90% stenosis and obstructive CAD defined as >70% stenosis, by computed tomography (CT) and/or invasive coronary angiography (ICA). RESULTS: Out of 273 patients, 6.2% had a type 1 NSTEMI. Positive TnT, ischemic ECG and angina demonstrated negative predictive values of 95%, 94% and 97% respectively and positive predictive values of 12%, 9% and 13% respectively. Specificity increased with all three metrics (95%), whilst sensitivity and positive predictive value reduced (18% and 19% respectively). 39.2% of patients had obstructive CAD. Positive TnT, ischemic ECG and angina demonstrated sensitivity of 64%, 34% and 41% respectively and specificity of 57%, 77% and 77% respectively. CONCLUSIONS: Angina, ischemic ECG and positive TnT are common among patients with AS presenting acutely and often not associated with a type 1 NSTEMI. These metrics, if positive, cannot reliably differentiate between a type 1 NSTEMI and acute decompensated AS. Coronary imaging using either CT or ICA is necessary to make a definitive diagnosis of a type 1 NSTEMI in patients with severe AS.


Asunto(s)
Estenosis de la Válvula Aórtica , Enfermedad de la Arteria Coronaria , Infarto del Miocardio , Infarto del Miocardio sin Elevación del ST , Angina de Pecho/diagnóstico , Angina de Pecho/etiología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Canadá , Constricción Patológica , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico , Humanos , Infarto del Miocardio/diagnóstico , Infarto del Miocardio sin Elevación del ST/diagnóstico por imagen , Troponina T
20.
J Am Coll Cardiol ; 79(12): 1141-1151, 2022 03 29.
Artículo en Inglés | MEDLINE | ID: mdl-35331408

RESUMEN

BACKGROUND: Patients with previous coronary artery bypass graft (CABG) surgery typically have complex coronary disease and remain at high risk of adverse events. Quantitative myocardial perfusion indices predict outcomes in native vessel disease, but their prognostic performance in patients with prior CABG is unknown. OBJECTIVES: In this study, we sought to evaluate whether global stress myocardial blood flow (MBF) and perfusion reserve (MPR) derived from perfusion mapping cardiac magnetic resonance (CMR) independently predict adverse outcomes in patients with prior CABG. METHODS: This was a retrospective analysis of consecutive patients with prior CABG referred for adenosine stress perfusion CMR. Perfusion mapping was performed in-line with automated quantification of MBF. The primary outcome was a composite of all-cause mortality and major adverse cardiovascular events defined as nonfatal myocardial infarction and unplanned revascularization. Associations were evaluated with the use of Cox proportional hazards models after adjusting for comorbidities and CMR parameters. RESULTS: A total of 341 patients (median age 67 years, 86% male) were included. Over a median follow-up of 638 days (IQR: 367-976 days), 81 patients (24%) reached the primary outcome. Both stress MBF and MPR independently predicted outcomes after adjusting for known prognostic factors (regional ischemia, infarction). The adjusted hazard ratio (HR) for 1 mL/g/min of decrease in stress MBF was 2.56 (95% CI: 1.45-4.35) and for 1 unit of decrease in MPR was 1.61 (95% CI: 1.08-2.38). CONCLUSIONS: Global stress MBF and MPR derived from perfusion CMR independently predict adverse outcomes in patients with previous CABG. This effect is independent from the presence of regional ischemia on visual assessment and the extent of previous infarction.


Asunto(s)
Enfermedad de la Arteria Coronaria , Imagen de Perfusión Miocárdica , Anciano , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Circulación Coronaria/fisiología , Femenino , Humanos , Infarto , Isquemia , Masculino , Perfusión , Valor Predictivo de las Pruebas , Estudios Retrospectivos
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