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1.
Eur Heart J Suppl ; 26(Suppl 1): i6-i10, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38867865

RESUMEN

The COAPT 5-year data demonstrate that compared with medical treatment transcatheter edge-to-edge repair (TEER) with the MitraClip in symptomatic patients with Grade 3+/Grade 4+ secondary mitral regurgitation (SMR) reduced by nearly half the annualized hospitalization risk (33 vs. 57%), by almost 30% the death rate (57 vs. 67%) and achieved significant and durable SMR reduction in 95% of patients. Control patients who crossed over to TEER at 2 years had better prognosis, but nearly half of them died before reaching crossover eligibility. Death or hospitalization for heart failure (HHF) occurred in 73.6% of TEER patients and 91.5% of controls within 5 years, pointing to a need for further study to address left ventricle (LV) dysfunction, the underlying cause of patient's disease. MTRA-FR targeted SMR using the same device and did not improve the composite endpoint of all-cause mortality or HHF at 12 months. Possible reasons for the discrepancy include enrolment of patients with more severe MR and less-advanced LV disease (dilation/dysfunction), less-procedural complications, and higher success in reducing MR in COAPT compared with MITRA-FR. Thus, the ideal patient for MitraClip treatment would be one with severe MR, but with no too severe LV dilation/dysfunction, which is what differentiates COAPT patients from those in MITRA-FR.

2.
Clin Infect Dis ; 75(4): 638-646, 2022 09 10.
Artículo en Inglés | MEDLINE | ID: mdl-34894124

RESUMEN

BACKGROUND: Infective endocarditis (IE) following transcatheter aortic valve replacement (TAVR) has been associated with a dismal prognosis. However, scarce data exist on IE perivalvular extension (PEE) in such patients. METHODS: This multicenter study included 579 patients who had the diagnosis of definite IE at a median of 171 (53-421) days following TAVR. PEE was defined as the presence of an intracardiac abscess, pseudoaneurysm, or fistula. RESULTS: A total of 105 patients (18.1%) were diagnosed with PEE (perivalvular abscess, pseudoaneurysm, fistula, or a combination in 87, 7, 7, and 4 patients, respectively). A history of chronic kidney disease (adjusted odds ratio [ORadj], 2.08; 95% confidence interval [CI]: 1.27-3.41; P = .003) and IE secondary to coagulase-negative staphylococci (ORadj, 2.71; 95% CI: 1.57-4.69; P < .001) were associated with an increased risk of PEE. Surgery was performed at index IE episode in 34 patients (32.4%) with PEE (vs 15.2% in patients without PEE, P < .001). In-hospital and 2-year mortality rates among PEE-IE patients were 36.5% and 69.4%, respectively. Factors independently associated with an increased mortality were the occurrence of other complications (stroke post-TAVR, acute renal failure, septic shock) and the lack of surgery at index IE hospitalization (padj < 0.05 for all). CONCLUSIONS: PEE occurred in about one-fifth of IE post-TAVR patients, with the presence of coagulase-negative staphylococci and chronic kidney disease determining an increased risk. Patients with PEE-IE exhibited high early and late mortality rates, and surgery during IE hospitalization seemed to be associated with better outcomes.


Asunto(s)
Aneurisma Falso , Endocarditis Bacteriana , Endocarditis , Insuficiencia Renal Crónica , Reemplazo de la Válvula Aórtica Transcatéter , Absceso , Aneurisma Falso/complicaciones , Aneurisma Falso/cirugía , Coagulasa , Endocarditis/epidemiología , Endocarditis/etiología , Endocarditis/cirugía , Endocarditis Bacteriana/epidemiología , Endocarditis Bacteriana/etiología , Endocarditis Bacteriana/cirugía , Humanos , Insuficiencia Renal Crónica/complicaciones , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos
3.
Catheter Cardiovasc Interv ; 100(3): 451-460, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35644994

RESUMEN

BACKGROUND: Mitral-valve transcatheter edge-to-edge repair (MV-TEER) is recommended in patients with severe functional mitral regurgitation (FMR) and in those with degenerative mitral regurgitation (DMR) not eligible to traditional surgery. Patients with a history of previous cardiac surgery are considered at high risk for surgical reintervention, but data are lacking regarding procedural and clinical outcomes. OBJECTIVE: aim of this study was to assess the efficacy and clinical results of MV-TEER in patients with previous cardiac surgery enrolled in the "multicentre Italian Society of Interventional Cardiology registry of transcatheter treatment of mitral valve regurgitation" (GIOTTO). METHODS: Patients with previous coronary artery bypass grafting (CABG), surgical aortic valve replacement (AVR), or mitral valve repair (MVR) were included. Those with multiple or combined previous cardiac surgeries were excluded. Clinical follow-up was performed at 30 days, 1 year, and 2 years. The primary endpoint was a composite of death or rehospitalization at 1- and 2-year follow-ups. RESULTS: A total of 330 patients enrolled in the GIOTTO registry were considered (CABG 77.9%, AVR 14.2%, and MVR 7.9%). Most patients showed FMR (66.9%), moderate reduction of left ventricular (LV) ejection fraction, and signs of LV dilation. Procedural and device successes were 94.8% and 97%. At 1 and 2 years, the composite endpoint occurred are 29.1% and 52.4%, respectively. The composite outcome rates were similar across the three subgroups of previous cardiac surgery (p = 0.928) and between the FMR and DMR subgroups (p = 0.850) at 2 years. In a multivariate analysis, residual mitral regurgitation (rMR) ≥2+ was the main predictor of adverse events at 1 year (hazard ratio: 1.54 [95% confidence interval, CI: 1.00-2.38]; p = 0.050). This association was confirmed at 2 years of Kaplan-Meier analysis (p = 0.001). CONCLUSIONS: MV-TEER is effective in these patients, regardless of the subtype of previous cardiac surgery and the MR etiology. An rMR ≥2+ is independently associated with adverse outcomes at 1-year follow-up.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Cateterismo Cardíaco , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/etiología , Insuficiencia de la Válvula Mitral/cirugía , Resultado del Tratamiento
5.
Artículo en Inglés | MEDLINE | ID: mdl-36525378

RESUMEN

OBJECTIVES: To explore the long-term clinical outcomes following intravascular lithotripsy (IVL) in calcified coronary lesions from a real-world population. BACKGROUND: IVL is a relatively new but promising modality for treating coronary calcified lesions, but there is a dearth of long-term outcome data from real-world patients. METHODS: This was a multicenter, observational study in which we enrolled all patients treated with IVL from November 2018 to February 2021 from eight centers in Europe and the United Kingdom. Procedural success, complications, and clinical outcomes (cardiac death, target vessel myocardial infarction [TVMI], target lesion revascularization [TLR], and MACE [major adverse cardiac events, the composite of cardiac death, TVMI, and TLR]) were assessed. RESULTS: In total, 273 patients with a mean age of 72 ± 9.1 years were treated with IVL. Major comorbidities included diabetes mellitus (n = 110, 40%) and chronic kidney disease (n = 45, 16%). Acute coronary syndrome accounted for 48% (n = 132) of patients, while 52% (n = 141) had stable angina. De novo lesions and in-stent restenosis accounted for 79% and 21% of cases, respectively. Intravascular imaging was used in 33% (n = 90) of patients. An upfront IVL strategy was adopted in 34% (n = 92), while the rest were bailout procedures. Adjuvant rotational atherectomy ("RotaTripsy") was required in 11% (n = 31) of cases. The procedural success was 99%. During a median follow-up of 687 days (interquartile range: 549-787), cardiac death occurred in 5% (n = 14), TVMI in 3% (n = 8), TLR in 6% (n = 16), and MACE rate was 11% (n = 30). CONCLUSION: This is the largest multicenter registry with a long-term follow-up showing the remarkably high procedural success of IVL use in calcified coronary lesions with low rates of hard endpoints and MACE.

6.
Nutr Metab Cardiovasc Dis ; 32(3): 586-595, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-35109998

RESUMEN

BACKGROUND AND AIMS: The aim of the present study is to evaluate whether advanced coronary atherosclerosis analysis by CCTA may improve prognostic stratification among diabetic patients at high cardiovascular risk (CV risk). METHODS AND RESULTS: The study population consisted of 265 consecutive diabetic patients at high CV risk who underwent CCTA for suspected CAD between January 2011 and December 2016. For every patients both traditional and advanced, qualitative and quantitative coronary plaque analysis were performed. The occurrence of cardiac death, ACS, and non-urgent revascularization were recorded at follow-up. Among the 265 patients enrolled, 21 were lost to follow-up, whereas 244 (92%) had a complete follow-up (mean 45 ± 22 months) and were classified at high (n = 67) or very high cardiovascular risk (n = 177), according to ESC Guidelines. A total of 63 events were recorded (3 Cardiac Death, 3 NSTEMI, 8 unstable angina, 36 late non-urgent revascularization and 13 non-cardiac death) in 57 different patients. Elevated fibro-fatty plaque volume was the only predictor of events over age, gender and traditional risk factor when ACS and MACE were considered as end-points [HR (95% CI) 6.01 (1.65-21.87), p = 0.006 and 3.46 (2.00-5.97); p < 0.001]. CONCLUSION: The present study confirms the prognostic role of advance coronary atherosclerosis evaluation beyond risk factors and stenosis severity, even in diabetics. Despite the very high cardiovascular risk of study population, a not negligible portion (23%) of patients exhibited totally normal coronaries.


Asunto(s)
Enfermedad de la Arteria Coronaria , Diabetes Mellitus , Placa Aterosclerótica , Angiografía por Tomografía Computarizada , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Diabetes Mellitus/diagnóstico , Estudios de Seguimiento , Humanos , Placa Aterosclerótica/diagnóstico por imagen , Placa Aterosclerótica/terapia , Valor Predictivo de las Pruebas , Pronóstico , Medición de Riesgo , Factores de Riesgo
7.
Eur Heart J Suppl ; 24(Suppl I): I16-I21, 2022 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-36380798

RESUMEN

Transcatheter mitral valve replacement (TMVR) is a novel therapeutic option for patients with severe mitral regurgitation (MR) at high or prohibitive surgical risk. Most TMVR technologies under investigation use either a trans-apical or a trans-septal approach via dedicated multistep anchoring systems. Transcatheter mitral valve replacement offers several potential advantages over transcatheter repair, notably a greater and more sustained MR reduction. At the same time, significant engineering challenges and potential disadvantages must be acknowledged. Preclinical and clinical studies have shown promising results, demonstrating TMVR feasibility. Nevertheless, further development, testing, and trials are needed before considering TMVR as a definitive therapeutic option for MR in a wide range of anatomical scenarios.

8.
J Card Surg ; 37(7): 1887-1893, 2022 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35249231

RESUMEN

AIMS: In the clinical practice a noteworthy proportion of severe symptomatic aortic stenosis patients presents with low-flow low-gradients features, these having reported a less favorable prognosis even when surgically or transcatheter treated. METHODS AND RESULTS: We retrospectively analyzed the prospectively collected data on 1051 consecutive patients undergone balloon-expandable transcatheter aortic valve replacement at our Institution from January 2008 to January 2020. We divided the population according with a mean aortic gradient (MAG) < or ≥40 mmHg and we performed a propensity-matched analysis based on the Society of Thoracic Surgery Score and age, obtaining two homogeneous groups of 314 patients each (Groups A and B, respectively). We then analyzed the outcomes of the two groups by implementing adjusted Cox models adjusted for significant clinical differences between the two groups, such as sex, ejection fraction, comorbidities and other variables not included in the propensity-matched analysis. The only variable associated with both cardiovascular and all-cause events was an ejection fraction ≤35%. Finally, a sensitivity analysis found that an ejection fraction ≤35% was associated with an increase cardiovascular and all-cause mortality only in patients with an indexed end-diastolic volume >97 ml/m2 (p = .0438 and .3363, respectively). CONCLUSIONS: In our series a MAG <40 mmHg was not found to be per se an independent risk factor for cardiac and all-cause mortality after transcatheter aortic valve replacement. The ejection fraction was found to be an independent risk factor only in the context of enlarged left ventricular dimensions.


Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Humanos , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , Volumen Sistólico , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del Tratamiento , Función Ventricular Izquierda
9.
Catheter Cardiovasc Interv ; 97(5): E676-E679, 2021 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-32744772

RESUMEN

The development and progressive enlargement over time of multiple saccular coronary artery aneurysms (CAA) after implantation of everolimus-eluting stent and bioresorbable vascular scaffolds (BVS) have been reported. CAA was successfully excluded by two overlapped covered stents expanded inside a long metallic drug-eluting stent to avoid dislodgment at the overlap point. Optical coherence tomography (OCT) was repeatedly performed to monitor CAA expansion and to guide treatment through precise measurement of aneurysm length and vessel size at the landing zone. At 10-month follow-up, coronary computed tomography angiography showed persistent CAA exclusion. To the best of our knowledge, this is the first report of this technique to exclude a long CCA segment.


Asunto(s)
Implantes Absorbibles , Aneurisma Coronario , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Aneurisma Coronario/diagnóstico por imagen , Aneurisma Coronario/etiología , Aneurisma Coronario/cirugía , Angiografía Coronaria , Humanos , Masculino , Persona de Mediana Edad , Nigeria , Intervención Coronaria Percutánea/efectos adversos , Stents , Andamios del Tejido , Tomografía de Coherencia Óptica , Resultado del Tratamiento
10.
Eur Heart J Suppl ; 23(Suppl E): E19-E24, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-35233210

RESUMEN

Tricuspid regurgitation (TR) is common in patients with left-sided valvular heart disease and is independently associated with increased mortality and morbidity because it leads to right-sided heart failure and recurrent hospitalization. The prognostic benefit of isolated TR surgical repair or replacement is unclear and medical treatment of decompensated right heart failure alone does not prevent the progression of the disease. Recently, minimal invasive catheter-based techniques have emerged as a feasible and effective option for TR treatment in selected high-risk patients who would clinically benefit from tricuspid valve repair. We provide an overview of the current state of transcatheter TR treatment using the edge-to-edge technique.

11.
Cardiovasc Diabetol ; 19(1): 183, 2020 10 20.
Artículo en Inglés | MEDLINE | ID: mdl-33081810

RESUMEN

BACKGROUND: High-sensitivity C-reactive protein (hs-CRP) elevation frequently occurs in acute myocardial infarction (AMI) and is associated with adverse outcomes. Since diabetes mellitus (DM) is characterized by an underlying chronic inflammation, hs-CRP may have a different prognostic power in AMI patients with and without DM. METHODS: We prospectively included 2064 AMI patients; hs-CRP was measured at hospital admission. Patients were grouped according to hs-CRP quartiles and DM status. The primary endpoint was a composite of in-hospital mortality, cardiogenic shock, and acute pulmonary edema. Two-year all-cause mortality was the secondary endpoint. RESULTS: Twenty-six percent (n = 548) of patients had DM and they had higher hs-CRP levels than non-DM patients (5.32 vs. 3.24 mg/L; P < 0.0001). The primary endpoint incidence in the overall population (7%, 9%, 13%, 22%; P for trend < 0.0001), in DM (14%, 9%, 21%, 27%; P = 0.0001), and non-DM (5%, 8%, 10%, 19%; P < 0.0001) patients increased in parallel with hs-CRP quartiles. The adjusted risk of the primary endpoint increased in parallel with hs-CRP quartiles in DM and non-DM patients but this relationship was less evident in DM patients. In the overall population, the adjusted OR of the primary endpoint associated with an hs-CRP value ≥ 2 mg/L was 2.10 (95% CI 1.46-3.00). For the same risk, hs-CRP was 7 and 2 mg/L in patients with and without DM. A similar behavior was observed for the secondary endpoint when the HR associated with an hs-CRP value ≥ 2 mg/L found in the overall population was 2.25 (95% CI 1.57-3.22). For the same risk, hs-CRP was 8 and 1.5 mg/L in DM and non-DM patients. CONCLUSIONS: This study shows that hs-CRP predicts in-hospital outcome and two-year mortality in AMI patients with and without DM. However, in DM patients, the same risk of developing events as in non-DM patients is associated to higher hs-CRP levels.


Asunto(s)
Proteína C-Reactiva/análisis , Diabetes Mellitus/sangre , Mediadores de Inflamación/sangre , Infarto del Miocardio sin Elevación del ST/sangre , Admisión del Paciente , Infarto del Miocardio con Elevación del ST/sangre , Anciano , Anciano de 80 o más Años , Biomarcadores/sangre , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/mortalidad , Femenino , Mortalidad Hospitalaria , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Infarto del Miocardio sin Elevación del ST/diagnóstico , Infarto del Miocardio sin Elevación del ST/mortalidad , Valor Predictivo de las Pruebas , Pronóstico , Estudios Prospectivos , Edema Pulmonar/sangre , Edema Pulmonar/mortalidad , Medición de Riesgo , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/mortalidad , Choque Cardiogénico/sangre , Choque Cardiogénico/mortalidad , Regulación hacia Arriba
12.
Curr Atheroscler Rep ; 22(7): 29, 2020 06 10.
Artículo en Inglés | MEDLINE | ID: mdl-32524266

RESUMEN

Transcatheter interventions for structural heart disease (SHD) now represent an effective alternative to surgery in selected patients. A clear premise is that delay in or neglect of treating patients in need of SHD intervention is associated with unavoidable morbidity and mortality because many of them have life-threatening conditions. However, the recent outbreak of coronavirus-associated disease-2019 (COVID-19) is placing an unprecedented strain on patients, physicians and world healthcare systems that resulted in deferral of elective and semi-elective procedures, such as SHD, and delay in the treatment of patients with acute coronary syndrome (ACS). We hereby present the case for a focused resumption of transcatheter SHD interventions in selected centers, in order to preserve patient safety and avoid that death rate will extend far beyond that directly associated with COVID-19. A similar approach should be applied to the invasive management of ACS. Indeed, a proactive and vigilant stance on managing SHD and ACS is crucial, especially in the context of the COVID-19 pandemic, when the risk of overlooking severely sick patients or postponing life-saving treatments is high. If such corrective measures are not put into effect, we may expect in the near future an excess of avoidable fatalities indirectly due to COVID-19 but truly caused by cardiovascular diseases, as well as an exceedingly large number of patients with severe heart failure leading to shorter life expectancy, reduced quality of life and increased healthcare cost.


Asunto(s)
Síndrome Coronario Agudo/terapia , Betacoronavirus , Infecciones por Coronavirus/epidemiología , Manejo de la Enfermedad , Cardiopatías/terapia , Pandemias , Neumonía Viral/epidemiología , Síndrome Coronario Agudo/epidemiología , COVID-19 , Comorbilidad , Cardiopatías/epidemiología , Humanos , SARS-CoV-2
13.
Eur Heart J Suppl ; 22(Suppl L): L15-L18, 2020 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-33654462

RESUMEN

In the last two decades, several studies and widespread clinical use demonstrated that coronary computed tomography angiography (CCTA) is an appropriate method for the non-invasive assessment of patients with suspected stable coronary artery disease (CAD) and low-to-intermediate pretest likelihood of CAD. Moreover, a growing body of literature is showing that CCTA may have also a clinical role in patients with high pretest likelihood of CAD, known CAD and complex and diffuse disease. Particularly, the SYNTAX II trial demonstrated the feasibility of planning interventional and surgical coronary procedures with CCTA thanks to its ability to combine, in a single method, precise stenosis quantification, accurate plaque characterization, functional assessment with fractional flow reserve derived from standard acquired CCTA datasets, and selection of the revascularization modality for any individual patient and of the vessels that need to be revascularized. More recently, the SYNTAX III Revolution trial showed, in patients with three-vessel CAD with or without left main involvement, that treatment decision-making between percutaneous coronary intervention and coronary artery bypass grafting based on CCTA only has an almost perfect agreement with the treatment decision derived from invasive coronary angiography (ICA). The high degree of correlation between CCTA and ICA suggests the potential feasibility of treatment decision-making based solely on non-invasive imaging and clinical information. New research prospects have opened up for the future to demonstrate the true feasibility and safety of this innovative approach in the clinical arena.

14.
Catheter Cardiovasc Interv ; 93(1): E1-E7, 2019 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-30286520

RESUMEN

BACKGROUND: There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year-performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial. METHODS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure. RESULTS: Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia-driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for "bail out" stent. CONCLUSION: At three-year follow-up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).


Asunto(s)
Implantes Absorbibles , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Enfermedad de la Arteria Coronaria/terapia , Everolimus/administración & dosificación , Intervención Coronaria Percutánea/instrumentación , Anciano , Fármacos Cardiovasculares/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Trombosis Coronaria/epidemiología , Everolimus/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Estudios Prospectivos , Diseño de Prótesis , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
15.
Eur Heart J ; 39(41): 3689-3698, 2018 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-30312411

RESUMEN

Aims: Coronary computed tomography angiography (CTA) has emerged as a non-invasive diagnostic method for patients with suspected coronary artery disease, but its usefulness in patients with complex coronary artery disease remains to be investigated. The present study sought to determine the agreement between separate heart teams on treatment decision-making based on either coronary CTA or conventional angiography. Methods and results: Separate heart teams composed of an interventional cardiologist, a cardiac surgeon, and a radiologist were randomized to assess the coronary artery disease with either coronary CTA or conventional angiography in patients with de novo left main or three-vessel coronary artery disease. Each heart team, blinded for the other imaging modality, quantified the anatomical complexity using the SYNTAX score and integrated clinical information using the SYNTAX Score II to provide a treatment recommendations based on mortality prediction at 4 years: coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or equipoise between CABG and PCI. The primary endpoint was the agreement between heart teams on the revascularization strategy. The secondary endpoint was the impact of fractional flow reserve derived from coronary CTA (FFRCT) on treatment decision and procedural planning. Overall, 223 patients were included. A treatment recommendation of CABG was made in 28% of the cases with coronary CTA and in 26% with conventional angiography. The agreement concerning treatment decision between coronary CTA and conventional angiography was high (Cohen's kappa 0.82, 95% confidence interval 0.74-0.91). The heart teams agreed on the coronary segments to be revascularized in 80% of the cases. FFRCT was available for 869/1108 lesions (196/223 patients). Fractional flow reserve derived from coronary CTA changed the treatment decision in 7% of the patients. Conclusion: In patients with left main or three-vessel coronary artery disease, a heart team treatment decision-making based on coronary CTA showed high agreement with the decision derived from conventional coronary angiography suggesting the potential feasibility of a treatment decision-making and planning based solely on this non-invasive imaging modality and clinical information. Trial registration number: NCT02813473.


Asunto(s)
Toma de Decisiones Clínicas/métodos , Angiografía por Tomografía Computarizada , Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Vasos Coronarios , Anciano , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea
16.
Catheter Cardiovasc Interv ; 91(7): 1202-1209, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29024452

RESUMEN

BACKGROUND: Preclinical data showed that overlapping (OVP) scaffolds might result in delayed healing and strut coverage compared to nonOVP scaffold segments. Furthermore, OVP in patients could result in increased periprocedure myocardial infarction (MI) rate secondary to side branch occlusion; however, little is known whether this may have an impact on long-term clinical outcomes. METHODS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. In this study, we compared the immediate and 2-year clinical outcomes of patients with OVP scaffolds (n = 115) to those of patients with nonOVP scaffolds (n = 697). The primary objective was the comparison of major adverse cardiac event (MACE) (cardiac death, MI and ischemic-driven target lesion revascularization [TLR]) and scaffold thrombosis (ST) rates up to 2 years. RESULTS: Baseline clinical and angiographic characteristics were comparable between cohorts except for longer lesions in the OVP patients as expected (16.7 ± 7.3 vs. 11.6 ± 4.4 mm, P < 0.0001), higher lesion complexity (B2) and numerically smaller vessel size. In-hospital, there was a marked increase in MACE in the OVP cohort (7.0 vs. 0.9%, P = 0.002), exclusively driven by a higher rate of periprocedure MI (7.0 vs. 0.9%, P = 0.002). Long-term MACE did not significantly differ between groups (10.4% in the OVP cohort vs. 6.6% in the no-OVP group, P = 0.1) with comparable rates of cardiac death (0.9 vs. 1.2%, P = 1.0) and ischemia-driven TLR (1.7 vs. 2.5%, P = 1.0). Cumulative incidence of MI was higher in the OVP cohort (7.8 vs. 3.0%, P = 0.02). Of note, the rate of MI between hospital discharge and 2-year follow-up was lower in the OVP cohort (0.8 vs. 2.1%, P = 0.04). Cumulative incidence of definite/probable ST was relatively low and comparable between groups (1.8 vs. 1.5%, P = 0.7). CONCLUSIONS: In this low-to-moderate complex population treated with the ABSORB scaffold the OVP group showed a higher incidence of periprocedure MI with no immediate or long-term increase in cardiac death, TLR or ST.


Asunto(s)
Implantes Absorbibles , Enfermedad de la Arteria Coronaria/cirugía , Intervención Coronaria Percutánea/instrumentación , Anciano , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Trombosis Coronaria/etiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
17.
Catheter Cardiovasc Interv ; 91(3): 387-395, 2018 02 15.
Artículo en Inglés | MEDLINE | ID: mdl-28471086

RESUMEN

OBJECTIVES: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. METHODS: The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups. CONCLUSION: In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc.


Asunto(s)
Implantes Absorbibles , Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/cirugía , Diabetes Mellitus , Stents Liberadores de Fármacos , Everolimus/administración & dosificación , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/mortalidad , Femenino , Humanos , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Masculino , Persona de Mediana Edad , Puntaje de Propensión , Diseño de Prótesis , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
18.
Circ Res ; 119(12): 1339-1346, 2016 Dec 09.
Artículo en Inglés | MEDLINE | ID: mdl-27799252

RESUMEN

RATIONALE: In contrast to cardiomyocyte necrosis, which can be quantified by cardiac troponin, functional cardiomyocyte impairment, including mitochondrial dysfunction, has escaped clinical recognition in acute myocardial infarction (AMI) patients. OBJECTIVE: To investigate the diagnostic accuracy for AMI and prognostic prediction of in-hospital mortality of cytochrome c. METHODS AND RESULTS: We prospectively assessed cytochrome c serum levels at hospital presentation in 2 cohorts: a diagnostic cohort of patients presenting with suspected AMI and a prognostic cohort of definite AMI patients. Diagnostic accuracy for AMI was the primary diagnostic end point, and prognostic prediction of in-hospital mortality was the primary prognostic end point. Serum cytochrome c had no diagnostic utility for AMI (area under the receiver-operating characteristics curve 0.51; 95% confidence intervals 0.44-0.58; P=0.76). Among 753 AMI patients in the prognostic cohort, cytochrome c was detectable in 280 (37%) patients. These patients had higher in-hospital mortality than patients with nondetectable cytochrome c (6% versus 1%; P<0.001). This result was mainly driven by the high mortality rate observed in ST-segment-elevation AMI patients with detectable cytochrome c, as compared with those with nondetectable cytochrome c (11% versus 1%; P<0.001). At multivariable analysis, cytochrome c remained a significant independent predictor of in-hospital mortality (odds ratio 3.0; 95% confidence interval 1.9-5.7; P<0.001), even after adjustment for major clinical confounders (odds ratio 4.01; 95% confidence interval 1.20-13.38; P=0.02). CONCLUSIONS: Cytochrome c serum concentrations do not have diagnostic but substantial prognostic utility in AMI.


Asunto(s)
Citocromos c/sangre , Infarto del Miocardio/sangre , Infarto del Miocardio/diagnóstico , Anciano , Anciano de 80 o más Años , Biomarcadores/sangre , Estudios de Cohortes , Femenino , Mortalidad Hospitalaria/tendencias , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/mortalidad , Admisión del Paciente/tendencias , Pronóstico , Estudios Prospectivos
19.
Eur Radiol ; 28(4): 1383-1392, 2018 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-29164383

RESUMEN

OBJECTIVES: To evaluate image quality, coronary evaluability and radiation exposure of coronary CT angiography (CCTA) performed with whole-heart coverage cardiac-CT in patients with atrial fibrillation (AF). MATERIALS AND METHODS: We prospectively enrolled 164 patients with AF who underwent a clinically indicated CCTA with a 16-cm z-axis coverage scanner. In all patients CCTA was performed using prospective ECG-triggering with targeted RR interval. We evaluated image quality, coronary evaluability and effective dose (ED). Patients were divided in two subgroups based on heart rate (HR) during imaging. Group 1: 64 patients with low HR (<75 bpm), group 2: 100 patients with high HR (≥75 bpm). Written informed consent was obtained from all patients and the institutional ethics committee approved the study protocol. RESULTS: In a segment-based analysis, coronary evaluability was 98.4 % (2,577/2,620 segments) in the whole population, without significant differences between groups (1,013/1,024 (98.9 %) and 1,565/1,596 (98.1 %), for groups 1 and 2, respectively, p=0.15). Mean ED was similar in both groups (3.8±1.9 mSv and 3.9±2.1 mSv in groups 1 and 2, respectively, p=0.75) CONCLUSIONS: The whole-heart-coverage scanner could evaluate coronary arteries with high image quality and without increase in radiation exposure in AF patients, even in the high HR group. KEY POINTS: • Last-generation CT scanner improves coronary artery assessment in AF patients. • The new CT scanner enables low radiation exposure in AF patients. • Diagnostic ICA maybe avoided in AF patients with suspected CAD. • Whole-heart coverage CT scanner enables low radiation exposure in AF patients.


Asunto(s)
Algoritmos , Fibrilación Atrial/diagnóstico por imagen , Angiografía por Tomografía Computarizada/métodos , Angiografía Coronaria/métodos , Procesamiento de Imagen Asistido por Computador/métodos , Dosis de Radiación , Anciano , Artefactos , Fibrilación Atrial/fisiopatología , Angiografía por Tomografía Computarizada/instrumentación , Angiografía Coronaria/instrumentación , Femenino , Corazón/diagnóstico por imagen , Corazón/fisiopatología , Humanos , Masculino , Movimiento (Física) , Estudios Prospectivos
20.
AJR Am J Roentgenol ; 210(6): 1208-1215, 2018 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-29667891

RESUMEN

OBJECTIVE: Motion artifact can reduce the diagnostic accuracy of coronary CT angiography (CCTA) for coronary artery disease (CAD). The purpose of this study was to compare the diagnostic performance of an algorithm dedicated to correcting coronary motion artifact with the performance of standard reconstruction methods in a prospective international multicenter study. SUBJECTS AND METHODS: Patients referred for clinically indicated invasive coronary angiography (ICA) for suspected CAD prospectively underwent an investigational CCTA examination free from heart rate-lowering medications before they underwent ICA. Blinded core laboratory interpretations of motion-corrected and standard reconstructions for obstructive CAD (≥ 50% stenosis) were compared with ICA findings. Segments unevaluable owing to artifact were considered obstructive. The primary endpoint was per-subject diagnostic accuracy of the intracycle motion correction algorithm for obstructive CAD found at ICA. RESULTS: Among 230 patients who underwent CCTA with the motion correction algorithm and standard reconstruction, 92 (40.0%) had obstructive CAD on the basis of ICA findings. At a mean heart rate of 68.0 ± 11.7 beats/min, the motion correction algorithm reduced the number of nondiagnostic scans compared with standard reconstruction (20.4% vs 34.8%; p < 0.001). Diagnostic accuracy for obstructive CAD with the motion correction algorithm (62%; 95% CI, 56-68%) was not significantly different from that of standard reconstruction on a per-subject basis (59%; 95% CI, 53-66%; p = 0.28) but was superior on a per-vessel basis: 77% (95% CI, 74-80%) versus 72% (95% CI, 69-75%) (p = 0.02). The motion correction algorithm was superior in subgroups of patients with severely obstructive (≥ 70%) stenosis, heart rate ≥ 70 beats/min, and vessels in the atrioventricular groove. CONCLUSION: The motion correction algorithm studied reduces artifacts and improves diagnostic performance for obstructive CAD on a per-vessel basis and in selected subgroups on a per-subject basis.


Asunto(s)
Algoritmos , Técnicas de Imagen Sincronizada Cardíacas , Angiografía por Tomografía Computarizada , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Interpretación de Imagen Radiográfica Asistida por Computador/métodos , Anciano , Artefactos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos
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