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Objective: Bleeding is frequent during transcatheter aortic valve implantation (TAVI), especially when performed through a transapical approach (TA), and is associated with a worse prognosis. The present study aims to test the implication of red blood cell (RBC) transfusion and the optimal transfusion strategy in this context. Methods: Among 11,265 participants in the multicenter TRITAVI (Transfusion Requirements in Transcatheter Aortic Valve Implantation) registry, 548 patients (4.9%) who received TA-TAVI at 19 European centers were included. One-to-one propensity score matching was performed to reduce treatment selection bias and potential confounding among transfused versus non-transfused patients. The primary endpoint of the study was the 30-day occurrence of all-cause mortality. Results: 209 patients (38 %) received RBC transfusions. The primary endpoint occurred in 47 (8.6 %) patients. Propensity score matching identified 188 pairs of patients with and without RBC transfusion. In the propensity score-matched analysis, RBC transfusion was associated with increased 30-day mortality (HR 3.35, 95 % CI 1.51 - 7.39; p = 0.002). At multivariable cox regression analysis, RBC transfusion was an independent predictor of 30-day mortality (HR 3.07, 95 % CI 1.01-9.41, p = 0.048), as well as baseline ejection fraction (HR 0.96, 95 % CI 0.92-0.99, p = 0.043), and acute kidney injury (HR 3.95, 95 % CI 1.11-14.05, p = 0.034). Conclusions: RBC transfusion is an independent predictor of short-term mortality in patients undergoing TA-TAVI, regardless of major bleeding.Clinical trial registration: https://www.clinicaltrials.gov Unique identifier: NCT03740425.
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BACKGROUND: Dialysis is a rare but serious complication after transcatheter aortic valve replacement. We analyzed the large multicenter TRITAVI (transfusion requirements in transcatheter aortic valve implantation) registry in order to develop and validate a clinical score assessing this risk. METHODS AND RESULTS: A total of 10 071 consecutive patients were enrolled in 19 European centers. Patients were randomly assigned (2:1) to a derivation and validation cohort. Two scores were developed, 1 including only preprocedural variables (TRITAVIpre) and 1 also including procedural variables (TRITAVIpost). In the 6714 patients of the derivation cohort (age 82±6 years, 48% men), preprocedural factors independently associated with dialysis and included in the TRITAVIpre score were male sex, diabetes, prior coronary artery bypass graft, anemia, nonfemoral access, and creatinine clearance <30 mL/min per m2. Additional independent predictors among procedural features were volume of contrast, need for transfusion, and major vascular complications. Both scores showed a good discrimination power for identifying risk for dialysis with C-statistic 0.78 for TRITAVIpre and C-statistic 0.88 for TRITAVIpost score. Need for dialysis increased from the lowest to the highest of 3 risk score groups (from 0.3% to 3.9% for TRITAVIpre score and from 0.1% to 6.2% for TRITAVIpost score). Analysis of the 3357 patients of the validation cohort (age 82±7 years, 48% men) confirmed the good discrimination power of both scores (C-statistic 0.80 for TRITAVIpre and 0.81 for TRITAVIpost score). Need for dialysis was associated with a significant increase in 1-year mortality (from 6.9% to 54.4%; P=0.0001). CONCLUSIONS: A simple preprocedural clinical score can help predict the risk of dialysis after transcatheter aortic valve replacement.
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Estenosis de la Válvula Aórtica , Diabetes Mellitus , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Sistema de Registros , Diálisis Renal , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Estudios Multicéntricos como AsuntoRESUMEN
AIMS: This study aimed to determine whether any change occurred over time in level of evidence (LoE) of therapeutic interventions supporting heart failure (HF) and other European Society of Cardiology guideline recommendations. METHODS AND RESULTS: We selected topics with at least three documents released between 2008 and April 2022. Classes of recommendations (CoR) and supporting LoE related to therapeutic interventions within each document were collected and compared over time. A total of 1822 recommendations from 18 documents on 6 topics [median number per document = 112, 867 (48%) CoR I] were included in the analysis. There was a trend towards a reduction over time in the percentage of CoR I in HF (46-36-34%), non-ST elevation myocardial infarction (NSTEMI; 78-58-54%), and pulmonary embolism (PE; 65-50-39%) guidelines, with a decrease in the total number of recommendations for HF only. Percentage of CoR I was stable over time around 40% for valvular heart disease (VHD) and atrial fibrillation (AF), and around 60% for cardiovascular prevention (CVP), with an increase in the total number of recommendations for VHD and CVP and a decrease for AF. Among CoR I, 319 (37%) were supported by LoE A, with a decrease over time for HF (56-46-42%), an increase for NSTEMI (29-38-48%) and AF (28-31-36%), a bimodal distribution for PE and CVP, and a lack for VHD. CONCLUSIONS: LoE supporting therapeutic recommendations in contemporary European guidelines is generally low. Physicians should be aware of these limitations, and scientific societies promote a greater understanding of their significance and drive future research directions.
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AIMS: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have been evaluated in phase 3 randomized-controlled trials (RCTs) that enrolled individuals with heart failure and preserved ejection fraction (HFpEF) based on detailed clinical, biochemical, and echocardiographic criteria (hereafter HF-RCTs), and in cardiovascular outcomes trials (CVOTs) in diabetic patients, in which the diagnosis of HFpEF relied on medical history. METHODS AND RESULTS: We performed a study-level meta-analysis of the efficacy of SGLT2i across different definitions of HFpEF. Three HF-RCTs (EMPEROR-Preserved, DELIVER, and SOLOIST-WHF) and four CVOTs (EMPA-REG OUTCOME, DECLARE-TIMI 58, VERTIS-CV, and SCORED) were included, for a total of 14â034 patients. SGLT2i reduced the risk of cardiovascular death or heart failure hospitalization (HFH) in all RCTs pooled together [risk ratio 0.75, 95% confidence interval (95% CI) 0.63-0.89, NNT 19], in HF-RCTs (risk ratio 0.71, 95% CI 0.52-0.97, NNT 13), and in CVOTs (risk ratio 0.78, 95% CI 0.60-0.99, NNT 26). SGLT2i also decreased the risk of HFH in all RCTs (risk ratio 0.81, 95% CI 0.73-0.90, NNT 45), in HF-RCTs (risk ratio 0.81, 95% CI 0.72-0.93, NNT 37), and in CVOTs (risk ratio 0.78, 95% CI 0.61-0.99, NNT 46). By contrast, SGLT2i were not superior to placebo for cardiovascular death or all-cause death in all RCTs, HF-RCTs, or CVOTs. Results were comparable after excluding one RCT at a time. Meta-regression analysis confirmed that the type of RCT (HF-RCT vs. CVOT) did not influence the SGLT2i effect. CONCLUSIONS: In RCTs, SGLT2i improved the outcomes of patients with HFpEF regardless of how the latter was diagnosed.
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Diabetes Mellitus Tipo 2 , Insuficiencia Cardíaca , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/inducido químicamente , Inhibidores del Cotransportador de Sodio-Glucosa 2/efectos adversos , Volumen SistólicoRESUMEN
OBJECTIVE: Acute kidney injury (AKI) may complicate transcatheter aortic valve replacement (TAVR) and could be linked to atheroembolization associated with catheter manipulation in the supra-renal (SR) aorta. We sought to determine the impact of SR aortic atheroma burden (SR-AAB) and composition, as well as of the aortic valve calcium score (AV-CS), measured at pre-operative multislice computed tomography (PO-MSCT), on AKI-TAVR. METHODS: All TAVR-patients 3 January-2018 to December-2020 were included. A three-dimensional analysis of PO-MSCT was performed, calculating percentage SR-AAB (%SR-AAB) as [(absolute SR-AAB volume)*100/vessel volume]. Types of plaque were defined according to Hounsfield unit (HU) intensity ranges. Calcified plaque was subcategorized into 3 strata: low- (351-700 HU), mid- (701-1000 HU), and highcalcium (>1000 HU, termed 1 K-plaque). RESULTS: The study population included 222 patients [mean age 83.3 ± 5.7 years, 95 (42.8%) males], AKI-TAVR occurred in 67/222 (30.2%). Absolute SR-AAB (41.3 ± 16.4 cm3 vs. 32.5 ± 10.7 cm3,p < 0.001) and %SR-AAB (17.6 ± 5.1% vs. 13.9 ± 4.3%,p < 0.001) were significantly higher in patients developing AKI-TAVR. Patients who developed AKI-TAVR had higher midcalcium (6.9 ± 3.8% vs. 4.2 ± 3.5%,p < 0.001) and 1 K-plaque (5.4 ± 3.7% vs. 2.4 ± 2.4%,p < 0.001) with no difference in AV-CS (p = 0.691). Adjusted multivariable logistic regression analysis showed that %SR-AAB [OR (x%increase): 1.12, 95%CI: 1.04-1.22,p = 0.006] and %SR-calcified plaque [OR (x%increase): 5.60, 95%CI: 2.50-13.36,p < 0.001] were associated with AKI-TAVR. Finally, 3-knots spline analyses identified %SR-AAB >15.0% and %SR-calcified plaque >7.0% as optimal thresholds to predict an increased risk of AKI-TAVR. CONCLUSIONS: Suprarenal aortic atheroma, when highly calcified, is associated with AKI-TAVR. Perioperative-MSCT assessment of aortic atherosclerosis may help in identification of patients at high-risk for AKI-TAVR, who could benefit from higher peri-operative surveillance.
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Lesión Renal Aguda , Estenosis de la Válvula Aórtica , Placa Aterosclerótica , Reemplazo de la Válvula Aórtica Transcatéter , Masculino , Humanos , Anciano , Anciano de 80 o más Años , Femenino , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Placa Aterosclerótica/complicaciones , Calcio , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Factores de Riesgo , Resultado del Tratamiento , Estudios Retrospectivos , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/epidemiología , Lesión Renal Aguda/etiología , Válvula Aórtica/cirugía , Tomografía Computarizada Multidetector , Aorta/cirugíaRESUMEN
BACKGROUND: The well-known COVID-19 pandemic totally transformed people's lives, paving the way to various psychopathological symptoms. In particular, patients may experience a short- and long-term decreasing in their wellbeing. In this vein, the aim of this paper was to assess the COVID-19 patients' psychopathological profile (post-traumatic stress disorder, distress, anxiety and depression symptoms), detecting possible differences linked to the ventilatory treatments. METHODS: Outpatients who recovered from COVID-19 were asked to provide socio-demographic and clinical information, and to complete a brief psychological screening evaluation (Impact of Event Scale-Revised [IES-R], Depression Anxiety Stress Scale [DASS-21]). RESULTS: Overall, after informed consent, 163 Italian patients took part in this research. Of them, 31.9% did not undergo any ventilatory therapy, 27.6% undertook oxygen therapy, 28.2% underwent noninvasive mechanical ventilation, and 12.3% received invasive mechanical ventilation. Although no statistically significant differences were revealed among patients stratified by spontaneous breathing or ventilatory therapies, they reported statistically significant more depression (4.5+5.2 vs. 3.5+3.2; P=0.017) and anxiety (4.3+4.5 vs. 2.4+2.6; P<0.00001) symptoms than normative groups. Moreover, patients experiencing COVID-19 disease as a trauma, complained statistically significant higher levels of depression, anxiety and stress symptoms than who did not describe a clinically relevant traumatic experience (P<0.001). CONCLUSIONS: Thus, this study suggests to healthcare professionals to consider COVID-19 experience as a potential real trauma for patients, and underlines the necessity to define patients' psychopathological profile in order to propose tailored and effective preventive and supportive psychological interventions.
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COVID-19 , Trastornos por Estrés Postraumático , Humanos , Trastornos por Estrés Postraumático/psicología , Depresión/diagnóstico , Estudios de Seguimiento , Pandemias/prevención & control , Pacientes Ambulatorios , Ansiedad/psicologíaRESUMEN
BACKGROUND: The COVID-19 pandemic severely impacted global health. The aim of this study was to compare predictors of symptoms-to-emergency-call timing delay in acute coronary syndrome (ACS) and their impact on mortality before and during the COVID-19 outbreak. METHODS: We collected sociodemographic, clinical data, procedural features, preadmission and intra-hospital outcomes of consecutive patients admitted for ACS in seventeen Italian centers from March to April 2018, 2019, and 2020. RESULTS: In 2020, a 32.92% reduction in ACS admissions was observed compared to 2018 and 2019. Unstable angina, typical and atypical symptoms, and intermittent angina were identified as significant predictors of symptoms-to-emergency-call timing delay before and during the COVID-19 pandemic (P<0.005 for all the items). Differently from 2018-2019, during the pandemic, hypertension and dyspnea (P=0.002 versus P=0.490 and P=0.001 vs. P=0.761 for 2018-2019 and 2020, respectively) did not result as predictors of delay in symptoms-to-emergency-call timing. Among these predictors, only the atypical symptoms (HR 3.36; 95% CI: 1.172-9.667, P=0.024) in 2020 and the dyspnea (HR 2.64; 95% CI: 1.345-5.190, P=0.005) in 2018-2019 resulted significantly associated with higher mortality. Finally, the family attendance at the onset of the symptoms resulted in a reduction in symptoms-to-emergency-call timing (in 2020 P<0.001; CI: -1710.73; -493.19) and in a trend of reduced mortality (HR 0.31; 95% CI: 0.089-1.079, P=0.066) in 2020. CONCLUSIONS: During the COVID-19 outbreak, atypical symptoms and family attendance at ACS onset were identified, respectively, as adverse and favorable predictors of symptoms-to-emergency-call timing delay and mortality.
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Síndrome Coronario Agudo , COVID-19 , Humanos , COVID-19/epidemiología , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/epidemiología , Pandemias , Angina Inestable/epidemiología , Disnea/epidemiologíaRESUMEN
Echocardiographic evaluation of left ventricular ejection fraction (LVEF) provides important information regarding both myocardial function and prognosis. This parameter presents various limitations and does not allow early detection of myocardial dysfunction. LVEF may be related to hemodynamic load, geometric assumptions, to image quality, and it does not reflect myocardial contractility. It has been hypothesized that speckle tracking echocardiography (STE) may allow overcoming such limits. STE through the measurement of strain and strain rate, which detect myocardial deformation, allows earlier identification of myocardial dysfunction in different settings both in presence of systolic and diastolic dysfunction, helps to predict left ventricular remodeling after acute myocardial infarction (AMI), and helps to decide the timing of surgery in asymptomatic severe valvular heart disease which is still a problematic issue. Increasingly interest regards the role of STE for the assessment of cardiomyopathies, myocarditis, and pulmonary hypertension. STE may be applied to the evaluation of systolic and diastolic dysfunction. STE is useful in all conditions in which cardiac dysfunction is not still overt, but a subclinical involvement is undoubtedly present such as in presence of cardiovascular risk factors and in cardio-oncology at earlier stages. It has been confirmed its role in predicting left ventricular remodeling after AMI which represents an important prognostic datum and in deciding the timing of surgery in asymptomatic valvular diseases. STE is an important tool to detect myocardial impairment even at earlier stages. 3DSTE and layer-specific strain represent promising fields of clinical application of STE.
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Cardiomiopatías , Infarto del Miocardio , Disfunción Ventricular Izquierda , Humanos , Función Ventricular Izquierda , Volumen Sistólico , Disfunción Ventricular Izquierda/diagnóstico por imagen , Remodelación Ventricular , Ecocardiografía/efectos adversos , Ecocardiografía/métodos , Infarto del Miocardio/diagnóstico por imagenRESUMEN
Background Acute kidney injury (AKI) after transcatheter aortic valve replacement (TAVR) is associated with increased mortality. However, it is controversial whether AKI affects prognosis per se, being linked to baseline chronic kidney disease (CKD) and bleeding complications. The aim of this study was to disentangle, applying mediation analysis, the association between AKI and clinical outcome, considering CKD and bleedings. Methods and Results Consecutive patients undergoing TAVR were prospectively enrolled at 5 high-volume centers in Italy. AKI was defined according to Valve Academic Research Consortium-3 consensus, whereas bleeding with Bleeding Academic Research Consortium. Primary outcome was all-cause mortality after 1-year follow-up. Among 2621 patients undergoing TAVR, AKI occurrence was associated with 1-year mortality. This association of AKI with the primary end points remained significant after adjusting for baseline risk estimators, either Society of Thoracic Surgeons score (hazard ratio [HR], 2.78 [95% CI, 1.95-3.80], P<0.001) or EuroSCORE-II (HR, 1.85 [95% CI, 1.35-2.56], P<0.001). Both AKI and CKD significantly and independently affected primary outcome (HR, 3.06 [95% CI, 2.01-4.64], P<0.001 and HR, 1.82 [95% CI 1.27-2.65], P<0.01, respectively). The estimated proportion of the total effect of CKD mediated via AKI was, on average, 15%, 95% CI, 4%-29%, P<0.001. The significant effect of Bleeding Academic Research Consortium 2-5 bleedings on the primary outcome was not mediated by AKI. Conclusions AKI occurs in 1 out of 6 patients and significantly mediates one fifth of the effect of baseline CKD on all-cause mortality after TAVR. Our analysis supports a systematic effort to prevent AKI during TAVR, which may potentially translate into improved patients' 1-year survival.
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Lesión Renal Aguda , Estenosis de la Válvula Aórtica , Insuficiencia Renal Crónica , Reemplazo de la Válvula Aórtica Transcatéter , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/epidemiología , Lesión Renal Aguda/etiología , Válvula Aórtica/cirugía , Humanos , Pronóstico , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/epidemiología , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: The COVID-19 pandemic increased the complexity of the clinical management and pharmacological treatment of patients presenting with an Acute Coronary Syndrome (ACS). AIM: to explore the incidence and prognostic impact of in-hospital bleeding in patients presenting with ACS before and during the COVID-19 pandemic. METHODS: We evaluated in-hospital Thrombolysis In Myocardial Infarction (TIMI) major and minor bleeding among 2851 patients with ACS from 17 Italian centers during the first wave of the COVID-19 pandemic (i.e., March-April 2020) and in the same period in the previous two years. RESULTS: The incidence of in-hospital TIMI major and minor bleeding was similar before and during the COVID-19 pandemic. TIMI major or minor bleeding was associated with a significant threefold increase in all-cause mortality, with a similar prognostic impact before and during the COVID-19 pandemic. CONCLUSIONS: the incidence and clinical impact of in-hospital bleeding in ACS patients was similar before and during the COVID-19 pandemic. We confirmed a significant and sizable negative prognostic impact of in-hospital bleeding in ACS patients.
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BACKGROUND: Following the availability of new drugs for chronic heart failure (HF) with reduced ejection fraction (HFrEF), we sought to provide an updated and comparative synthesis of the evidence on HFrEF pharmacotherapy efficacy. METHODS: We performed a Bayesian network meta-analysis of phase 2 and 3 randomized controlled trials (RCTs) of medical therapy in HFrEF patient cohorts with more than 90% of the participants with left ventricular ejection fraction less than 45% and all-cause mortality reported. RESULTS: Sixty-nine RCTs, accounting for 91,741 subjects, were evaluated. The step-wise introduction of new drugs progressively decreased the risk of all-cause death, up to reaching a random-effects hazard ratio (HR) of 0.43 (95% credible intervals [CrI] 0.27-0.63) with beta blockers (BB), angiotensin-converting enzyme inhibitors (ACEi), and mineralocorticoid receptor antagonist (MRA) versus placebo. The risk was further reduced by adding sodium-glucose cotransporter-2 inhibitors (SGLT2i; HR 0.38, 95% CrI 0.22-0.60), ivabradine (HR 0.39, 95% CrI 0.21-0.64), or vericiguat (HR 0.40, 95% CrI 0.22-0.65) to neurohormonal inhibitors, and by angiotensin receptor-neprilysin inhibitor (ARNI), BB, and MRA (HR 0.36, 95% CrI 0.20-0.60). In a sensitivity analysis considering the ARNI and non-ARNI subgroups of SGLT2i RCTs, the combination SGLT2i + ARNI + BB + MRA was associated with the lowest HR (0.28, 95% CrI 0.16-0.45 vs. 0.40, 95% CrI 0.24-0.60 for SGLT2i + BB + ACEi + MRA). Consistent results were obtained in sensitivity analyses and by calculating surface under the cumulative ranking area, as well as for cardiovascular mortality (information available for 56 RCTs), HF hospitalization (45 RCTs), and all-cause hospitalization (26 RCTs). CONCLUSIONS: Combination medical therapy including neurohormonal inhibitors and newer drugs, especially ARNI and SGLT2i, confers the maximum benefit with regard to HFrEF prognosis.
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Insuficiencia Cardíaca , Disfunción Ventricular Izquierda , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Humanos , Metaanálisis en Red , Volumen SistólicoRESUMEN
AIMS: We assessed the efficacy of the drugs developed after neurohormonal inhibition (NEUi) in patients with heart failure (HF) with reduced ejection fraction (HFrEF) and concomitant chronic kidney disease (CKD). METHODS AND RESULTS: The literature was systematically searched for phase 3 randomized controlled trials (RCTs) involving ≥90% patients with left ventricular ejection fraction <45%, of whom <30% were acutely decompensated, and with published information about the subgroup of estimated glomerular filtration rate <60 mL/min/1.73 m2. Six RCTs were included in a study-level network meta-analysis evaluating the effect of NEUi, ivabradine, angiotensin receptor-neprilysin inhibitor (ARNI), sodium-glucose cotransporter-2 inhibitors (SGLT2i), vericiguat, and omecamtiv mecarbil (OM) on a composite outcome of cardiovascular death or hospitalization for HF. In a fixed-effects model, SGLT2i [hazard ratio (HR) 0.78, 95% credible interval (CrI) 0.69-0.89], ARNI (HR 0.79, 95% CrI 0.69-0.90), and ivabradine (HR 0.82, 95% CrI 0.69-0.98) decreased the risk of the composite outcome vs. NEUi, whereas OM did not (HR 0.98, 95% CrI 0.89-1.10). A trend for improved outcome was also found for vericiguat (HR 0.90, 95% CrI 0.80-1.00). In indirect comparisons, both SLGT2i (HR 0.80, 95% CrI 0.68-0.94) and ARNI (HR 0.80, 95% CrI 0.68-0.95) reduced the risk vs. OM; furthermore, there was a trend for a greater benefit of SGLT2i vs. vericiguat (HR 0.88, 95% CrI 0.73-1.00) and ivabradine vs. OM (HR 0.84, 95% CrI 0.68-1.00). Results were comparable in a random-effects model and in sensitivity analyses. Surface under the cumulative ranking area scores were 81.8%, 80.8%, 68.9%, 44.2%, 16.6%, and 7.8% for SGLT2i, ARNI, ivabradine, vericiguat, OM, and NEUi, respectively. CONCLUSION: Expanding pharmacotherapy beyond NEUi improves outcomes in HFrEF with CKD.
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Insuficiencia Cardíaca Sistólica , Insuficiencia Renal Crónica , Disfunción Ventricular Izquierda , Humanos , Ivabradina , Metaanálisis en Red , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/tratamiento farmacológico , Volumen Sistólico , Ensayos Clínicos Fase III como Asunto , Ensayos Clínicos Controlados Aleatorios como AsuntoAsunto(s)
COVID-19/complicaciones , Ecocardiografía/métodos , Cardiopatías/complicaciones , Cardiopatías/diagnóstico por imagen , Corazón/diagnóstico por imagen , Hospitalización , Sistemas de Atención de Punto , Anciano , COVID-19/diagnóstico por imagen , COVID-19/mortalidad , Femenino , Cardiopatías/mortalidad , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Sistemas de Atención de Punto/estadística & datos numéricos , Pronóstico , Medición de Riesgo , SARS-CoV-2 , Índice de Severidad de la Enfermedad , Centros de Atención TerciariaRESUMEN
AIMS: To compare the safety and efficacy of very short (≤3 months), short (6 months), standard (12 months), and extended (>12 months) dual antiplatelet therapy (DAPT), and of subsequent monotherapies, after coronary drug-eluting stent (DES) implantation. METHODS AND RESULTS: Twenty-two randomized control trials (n = 110 059 patients/year) were selected and included in a Bayesian network meta-analysis. The primary efficacy endpoint (PEP) was a composite of cardiac death, myocardial infarction (MI), and stent thrombosis (ST), with each of the components of the PEP being a secondary efficacy endpoint. The primary safety endpoint was major bleeding rate. Compared to standard, we found a lower rate of MI [odds ratio (OR) 0.56, 95% confidence interval (CI) 0.44-0.77] in extended, a lower rate of major bleeding (OR 0.61, 95% CI 0.39-0.87) in very short, and a lower rate of any bleeding (OR 0.61, 95% CI 0.38-0.90) in short DAPT. All DAPT durations were comparable regarding the secondary efficacy endpoints. Very short DAPT followed by P2Y12 inhibition was the treatment of choice to reduce both major bleeding and MI. In the ACS subgroup, extended DAPT (as compared to standard) reduced PEP and ST rates (but not MIs). CONCLUSION: The efficacy of short and very short is comparable with that of standard DAPT after DES implantation, whereas extended DAPT reduces MI rate. Very short DAPT is associated with lower haemorrhagic events and, followed by a P2Y12 inhibitor monotherapy, should be preferred in order to pursue a trade-off between major bleeding and ischaemic events.
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Stents Liberadores de Fármacos , Terapia Antiplaquetaria Doble , Duración de la Terapia , Teorema de Bayes , Terapia Antiplaquetaria Doble/efectos adversos , Terapia Antiplaquetaria Doble/métodos , Humanos , Metaanálisis en Red , Inhibidores de Agregación Plaquetaria/efectos adversos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Therapeutic approaches based on gene silencing technologies represent a new opportunity to manage hypercholesterolemia. Inclisiran is a small interfering RNA that targets proprotein convertase subtilisin/kexin type 9 (PCSK9) mRNA. Clinical studies have demonstrated that inclisiran is effective, safe, and well-tolerated in reducing low-density lipoprotein cholesterol (LDL-C) in patients with familial hypercholesterolemia, atherosclerotic cardiovascular disease, and atherosclerotic cardiovascular disease risk equivalents. A meta-analysis of phase 3 trials demonstrated a 51% reduction in LDL-C levels at 18 months as compared with placebo. Adverse event incidence was found to be comparable in individuals treated with inclisiran and those receiving placebo, though the reactions at the site of injection were more common in patients receiving inclisiran as compared with those receiving placebo. The recommended inclisiran dose is 284 mg administered as a subcutaneous injection to be repeated after three months with a subsequent 6-month maintenance regimen. Overall, since the pharmacological efficacy of inclisiran in LDL-C reduction is comparable to that of monoclonal antibodies against PCSK9, the longer effect duration and the favorable safety profile may favor this newer approach for hypercholesterolemia management.
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BACKGROUND: Long-term effects of Coronavirus Disease of 2019 (COVID-19) are of utmost relevance. We aimed to determine: 1) the functional capacity of COVID-19 survivors by cardiopulmonary exercise testing (CPET); 2) the characteristics associated with cardiopulmonary exercise testing (CPET) performance; 3) the safety and tolerability of CPET. METHODS: We prospectively enrolled consecutive patients with laboratory-confirmed COVID-19 from Azienda Sanitaria Locale 3, Genoa. Three months after hospital discharge a complete clinical evaluation, trans-thoracic echocardiography, CPET, pulmonary function tests, and dominant leg extension (DLE) maximal strength measurement were performed. RESULTS: From the 225 patients discharged alive from March to November 2020, we excluded 12 incomplete/missing cases and 13 unable to perform CPET, leading to a final cohort of 200. Median percent-predicted peak oxygen uptake (%pVO2) was 88% (78.3-103.1). Ninety-nine (49.5%) patients had %pVO2 below, whereas 101 (50.5%) above the 85% predicted value. Among the 99 patients with reduced %pVO2, 61 (61%) had a normal anaerobic threshold: of these, 9(14.8%) had respiratory, 21(34.4%) cardiac, and 31(50.8%) non-cardiopulmonary reasons for exercise limitation. Inerestingly, 80% of patients experienced at least one disabling symtpom, not related to %pVO2 or functional capacity. Multivariate linear regression showed percent-predicted forced expiratory volume in one-second(ß = 5.29,p = 0.023), percent-predicted diffusing capacity of lungs for carbon monoxide(ß = 6.31,p = 0.001), and DLE maximal strength(ß = 14.09,p = 0.008) to be independently associated with pVO2. No adverse event was reported during or after CPET, and no involved health professional developed COVID-19. CONCLUSIONS: At three months after discharge, about 1/3rd of COVID-19 survivors show functional limitations, mainly explained by muscular impairment, calling for future research to identify patients at higher risk of long-term effects that may benefit from careful surveillance and targeted rehabilitation.
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COVID-19 , Prueba de Esfuerzo , Ecocardiografía , Tolerancia al Ejercicio , Estudios de Seguimiento , Humanos , Consumo de Oxígeno , SARS-CoV-2RESUMEN
AIMS: Acute kidney injury (AKI) may complicate transcatheter aortic valve replacement (TAVR) leading to higher mortality. The relationship between AKI, obesity, and mortality, however, is controversial. We sought to investigate the impact of body habitus on the prognostic value of AKI in TAVR. METHODS: Among the 645 patients who underwent successful TAVR in a single high-volume centre, we retrospectively evaluated the association between AKI-TAVR and 30-day, 6-month, and 1-year mortality, and whether this relationship was affected by BMI. AKI was defined according to the Valve Academic Research Consortium-2 criteria. Patients were categorized into three groups by BMI: low-to-normal weight (<25âkg/m2), overweight (25-30âkg/m2), obese (>30.0âkg/m2). RESULTS: Three-hundred and twenty-four (50.2%) patients were low-to-normal weight, 223 (34.6%) overweight, and 98 (15.2%) obese. AKI occurred in 141 (21.9%), similarly across BMI groups. Thirty-day, 6-month, and 1-year mortality rates were 2.2, 3.7, and 7.9%, without differences across BMI groups. Among patients who developed AKI-TAVR, 30-day (8.7 vs. 2.0 vs. 0.0%), 6-month (13.0 vs. 6.1 vs. 4.3%), and 1-year (20.3 vs. 12.2 vs. 4.3%) mortality showed a decreasing trend across increasing BMI categories (all Pâ<â0.05); the same trend was not observed for patients without AKI-TAVR. In multivariate models, AKI was associated with 30-day [odds ratio (OR): 2.46, 95% confidence interval (CI): 1.70-8.67], 6-month (OR: 2.75, 95% CI: 1.32-7.59), and 1-year mortality (OR: 1.84, 95% CI: 1.22-3.71, all Pâ<â0.05). The interaction between AKI and BMI, when added to the models, was consistently significant (all Pâ<â0.05). CONCLUSION: Higher BMI is associated with better survival in TAVR patients who develop AKI.
Asunto(s)
Lesión Renal Aguda , Estenosis de la Válvula Aórtica , Obesidad/epidemiología , Complicaciones Posoperatorias , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/etiología , Lesión Renal Aguda/mortalidad , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/epidemiología , Estenosis de la Válvula Aórtica/cirugía , Índice de Masa Corporal , Comorbilidad , Femenino , Humanos , Italia/epidemiología , Masculino , Evaluación de Procesos y Resultados en Atención de Salud , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/mortalidad , Pronóstico , Medición de Riesgo , Factores de Riesgo , Análisis de Supervivencia , Reemplazo de la Válvula Aórtica Transcatéter/métodosRESUMEN
BACKGROUND: Increases in cardiac troponin (cTn) in coronavirus disease 2019 (COVID-19) have been associated with worse prognosis. Nonetheless, data about the significance of cTn in elderly subjects with COVID-19 are lacking. METHODS: From a registry of consecutive patients with COVID-19 admitted to a hub hospital in Italy from 25/02/2020 to 03/07/2020, we selected those ≥ 60 year-old and with cTnI measured within three days from the molecular diagnosis of SARS-CoV-2 infection. When available, a second cTnI value within 48 h was also extracted. The relationship between increased cTnI and all-cause in-hospital mortality was evaluated by a Cox regression model and restricted cubic spline functions with three knots. RESULTS: Of 343 included patients (median age: 75.0 (68.0-83.0) years, 34.7% men), 88 (25.7%) had cTnI above the upper-reference limit (0.046 µg/L). Patients with increased cTnI had more comorbidities, greater impaired respiratory exchange and higher inflammatory markers on admission than those with normal cTnI. Furthermore, they died more (73.9%vs. 37.3%, P < 0.001) over 15 (6-25) days of hospitalization. The association of elevated cTnI with mortality was confirmed by the adjusted Cox regression model (HR = 1.61, 95%CI: 1.06-2.52, P = 0.039) and was linear until 0.3 µg/L, with a subsequent plateau. Of 191 (55.7%) patients with a second cTnI measurement, 49 (25.7%) had an increasing trend, which was not associated with mortality (univariate HR = 1.39, 95%CI: 0.87-2.22, P = 0.265). CONCLUSIONS: In elderly COVID-19 patients, an initial increase in cTn is common and predicts a higher risk of death. Serial cTn testing may not confer additional prognostic information.