Late bleeding events in TAVI patients receiving vitamin K antagonists or direct oral anticoagulants.

INTRODUCTION AND OBJECTIVES: The optimal chronic antithrombotic regimen for patients with atrial fibrillation undergoing transcatheter aortic valve implantation (TAVI) remains uncertain. Our aim was to compare the incidence of late bleeding events between patients on direct oral anticoagulants (DOACs) and those on vitamin-K antagonists (VKA). METHODS: This single-center observational study included TAVI patients requiring oral anticoagulation at discharge between 2015 and 2021. The primary endpoint was any clinically significant bleeding event. Secondary endpoints were stroke, heart failure, and all-cause mortality. RESULTS: A total of 702 TAVI procedures were performed, with 297 patients requiring oral anticoagulation at discharge. Among them, 206 (69.4%) received VKA and 91 (30.6%) received DOAC. Baseline clinical, procedural and in-hospital characteristics did not significantly differ between groups, except for better renal function among DOAC patients. The median length of follow-up was 2.8 years. The risk of bleeding events was higher in patients receiving DOACs than in those receiving VKA (HR, 2.27; 95%CI, 1.21-4.26; incidence of 9.7 and 4.2 events per 100 patient-years of follow-up for DOAC and VKA patients, respectively). There were no statistically significant differences in the rates of stroke (HR, 1.28; 95%CI, 0.4-4.3), heart failure hospitalization (HR, 0.92; 95%CI, 0.46-1.86), or all-cause mortality (HR, 1.02; 95%CI, 0.68-1.55). CONCLUSIONS: In older patients undergoing TAVI and receiving anticoagulant therapy for atrial fibrillation, the use of DOAC was associated with a higher risk of late bleeding events than VKA.

Long-term outcomes comparison of mitral valve repair or replacement for secondary mitral valve regurgitation. An updated systematic review and reconstructed time-to-event study-level meta-analysis.

BACKGROUND AND AIM: The ideal surgical intervention for secondary mitral regurgitation (SMR), a disease of the left ventricle not the mitral valve itself, is still debated. We performed an updated systematic review and study-level meta-analysis investigating mitral valve repair (MVr) versus mitral valve replacement (MVR) for adult patients with SMR, with or without coronary artery disease (CAD). METHODS: PubMed, CENTRAL and EMBASE were searched for studies comparing MVr versus MVR. Randomized trial or observational studies were considered eligible. Primary endpoint was long-term mortality for any cause. Kaplan-Meier survival curves were reconstructed and compared with Cox linear regression. Landmark analysis and time-varying hazard ratio (HR) were analyzed. Sensitivity analyses included meta-regression and separate sub-analysis. A random effects model was used. RESULTS: Twenty-three studies (MVr=3,727 and MVR=2,839) were included. One study was a randomized trial, and 19 studies were adjusted. The mean weighted follow-up was 3.7±2.8 years. MVR was associated with significative greater late mortality (HR=1.26; 95 % CI, 1.14-1.39; P<0.0001) at 10-year follow-up. There was a time-varying trend showing an increased risk of mortality in the first 2 years after MVR (HR=1.38; 95 % CI, 1.21-1.56; P<0.0001), after which this difference dissipated (HR=0.94; 95 % CI, 0.81-1.09; P=0.41). Separate sub-analyses showed comparable long-term mortality in patients with concomitant coronary surgery ≥90 %, left ventricle ejection fraction ≤40 %, and sub-valvular apparatus preservation rate of 100 %. CONCLUSIONS: Compared to repair, MVR is associated with higher probability of mortality in the first 2 years following surgery, after which the two procedures showed comparable late mortality rate.

Resultados tras 5 años de cirugía o abordaje percutáneo en coronariopatía grave. Metanálisis de ensayos aleatorizados con reconstrucción del tiempo hasta el evento / Results beyond 5-years of surgery or percutaneous approach in severe coronary disease. Reconstructed time-to-event meta-analysis of randomized trials

Introducción y objetivos: Existe controversia sobre la mejor estrategia de revascularización en la enfermedad coronaria avanzada, incluidas la enfermedad del tronco coronario y la enfermedad multivaso. Varios metanálisis han comparado resultados a 5 años, pero no hay resultados después del quinto año. Se realizaron una revisión sistemática y un metanálisis de ensayos clínicos aleatorizados para comparar los resultados después del quinto año entre la cirugía de revascularización coronaria (CABG) y la intervención coronaria percutánea (ICP) con stents farmacoactivos.MétodosSe analizaron los ensayos clínicos publicados entre 2010 y 2023. El objetivo primario fue la mortalidad por cualquier causa. Las bases de datos originales se reconstruyeron a partir de las curvas de Kaplan-Meier simulando un metanálisis individual. Se realizaron comparaciones en ciertos puntos de corte (5 y 10 años). Se calculó la diferencia del tiempo medio de supervivencia restringida. Se aplicó el modelo de efectos aleatorios y de DerSimonian-Laird.ResultadosSe analizó a 5.180 pacientes. Durante los 10 años de seguimiento, las ICP muestran una mayor incidencia de mortalidad (HR=1,19; IC95%, 1,04-1,32; p=0,008). La ICP muestra un mayor riesgo de mortalidad a 5 años (HR=1,2; IC95%, 1,06-1,53; p=0,008), mientras que no hubo diferencias de 5 a 10 años (HR=1,03; IC95%, 0,84-1,26; p=0,76). La esperanza de vida de los pacientes sometidos a CABG fue ligeramente mayor (2,4 meses más).ConclusionesEntre los pacientes con enfermedad coronaria avanzada, incluidas la enfermedad del tronco coronario y la enfermedad multivaso, hubo mayor mortalidad tras una ICP que tras la CABG a los 10 años de seguimiento. En concreto, la ICP tiene mayor mortalidad durante los primeros 5 años y un riesgo comparable de 5 a 10 años. (AU)

Introduction and objectives: There is controversy about the optimal revascularization strategy in severe coronary artery disease (CAD), including left main disease and/or multivessel disease. Several meta-analyses have analyzed the results at 5-year follow-up but there are no results after the fifth year. We conducted a systematic review and meta-analysis of randomized clinical trials, comparing results after the fifth year, between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) using drug-eluting stents in patients with severe CAD.MethodsWe analyzed all clinical trials between January 2010 and January 2023. The primary endpoint was all-cause mortality. The databases of the original articles were reconstructed from Kaplan-Meier curves, simulating an individual-level meta-analysis. Comparisons were made at certain cutoff points (5 and 10 years). The 10-year restricted median survival time difference between CABG and PCI was calculated. The random effects model and the DerSimonian-Laird method were applied.ResultsThe meta-analysis included 5180 patients. During the 10-year follow-up, PCI showed a higher overall incidence of all-cause mortality (HR, 1.19; 95%CI, 1.04-1.32; P=.008)]. PCI showed an increased risk of all-cause mortality within 5 years (HR, 1.2; 95%CI, 1.06-1.53; P=.008), while no differences in the 5–10-year period were revealed (HR, 1.03; 95%CI, 0.84-1.26; P=.76). Life expectancy of CABG patients was slightly higher than that of PCI patients (2.4 months more).ConclusionsIn patients with severe CAD, including left main disease and/or multivessel disease, there was higher a incidence of all-cause mortality after PCI compared with CABG at 10 years of follow-up. Specifically, PCI has higher mortality during the first 5 years and comparable risk beyond 5 years. (AU)

The Association of Desert Dust with the Risk of Acute Coronary Syndrome in Subjects of a Younger Age.

Objectives: Recently, desert dust in Europe has been recognized as a cardiovascular health problem. In Spain, desert dust inflows in recent years have been associated with worsening air quality. The present study examines whether desert dust events are related to the incidence of acute coronary syndrome (ACS) in patients under 55 years of age. Methods: Data from 2416 consecutive patients admitted to a tertiary hospital due to ACS were prospectively analyzed. A case-crossover time-stratified design using Poisson conditional regression models was applied to estimate the impact of desert dust events involving particulate matter concentrations of an aerodynamic diameter <10 µm (PM10) on the incidence of ACS in patients under 55 years of age. Results: Desert dust intrusion on days 0 to 5 before ACS onset showed no significant association with the incidence of ACS in patients under 55 years of age. The incidence rate ratios of PM10 concentrations 1, 2, 3, 3, 4, and 5 days before ACS onset (for changes of 10 µg/m3) were 1.02 (95% CI 0.97-1.1; p = 0.41), 1.01 (95% CI 0.96-1.07; p = 0.66), 0.99 (95% CI 0.94-1.05; p = 0.78), 0.96 (95% CI 0.9-1.02; p = 0.18), and 0.97 (95% CI 0.91-1.04; p = 0.41). Conclusions: Our findings suggest that desert dust is unlikely to be related to the incidence of ACS in patients under 55 years of age.

Hemodynamic performance of self-expandable transcatheter aortic valve replacement systems during valve deployment.

OBJECTIVES: Little is known about valve hemodynamic performance during the Evolut and Neo deployment course. We aimed to evaluate transvalvular mean and peak-to-peak gradients over several intraprocedural timepoints during TAVR with Evolut PRO+ (Medtronic) and Neo (Boston Scientific) systems. METHODS: This was single-center pilot sub-study from the SavvyWire EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI) trial. Participants received either the Evolut PRO+ or Neo for native valve severe aortic stenosis and the SavvyWire (OpSens Medical) was used for device delivery, pacing, and continuous left ventricular and aortic pressure measurements. For the Evolut, evaluation was done for baseline, two-thirds of valve deployment (still recapturable), 90% of valve deployment (no longer recapturable), and post-deployment hemodynamics. For the Neo, analysis was done at baseline, after the first step (top-crown deployment), and at final status. RESULTS: Nineteen patients were included (Evolut = 15; Neo = 4). There were no statistically significant changes in peak-to-peak gradients (44 mm Hg [IQR:33-69] vs 43 mm Hg [IQR:26-62], P = .41) between baseline and two-thirds of valve deployment in the Evolut patients. There was a significant decrease in mean (40 mm Hg [IQR:32-54] vs 14 mm Hg [IQR:10-18], P less than .001) and peak-to-peak (43 mmHg [IQRS:26-62] vs 9 mm Hg [IQR:8-13], P less than .001) transvalvular gradients between two-thirds and 90% of valve deployment for Evolut. Neo patients exhibited a decrease in transvalvular gradients after top-crown deployment (42.5 mm Hg baseline vs 13 mm Hg). CONCLUSIONS: Transvalvular gradients did not vary between the point of "no-recapture" compared to baseline values in patients receiving the Evolut, whereas a significant reduction in transvalvular gradients was observed when the valve was deployed at 90% and fully deployed. The Neo valve was slightly obstructive after the first step of deployment.

The Alignment of the Tibial Component in Total Knee Arthroplasty: Is a Technology-Assisted System Better Than Conventional Instrumentation?

Background Technologies such as navigation and robotics are aimed at improving tibial alignment in total knee arthroplasties (TKA) and eliminating the errors resulting from the use of manual instrumentation. Methods This prospective study analyzed 130 arthroplasties in order to determine whether navigation can improve the frontal mechanical axis of the tibia and whether the postoperative angulation of this axis differs from the preoperative one. The mean patient age was 71.8 years, and the mean BMI was 31.17. Eighty-six patients were female. The same cemented TKA model and the same imageless navigation system were used in all cases. Results The mean postoperative tibial angle following implantation was 87.65°, without any statistically significant differences with respect to the previous angulation. However, navigation was seen to result in a nearly neutral tibial axis, a larger number of cases (41.5%-60.8% {p = 0.002}) aligned within the safe zone (90° ± 3°), a smaller number of outliers, and a clustering of values around the mean. Conclusions Navigation improves the frontal positioning of the tibial component in total knee arthroplasties but does not offer any advantages as compared with conventional instrumentation.

Self-expanding TAVI using the cusp overlap technique versus the traditional technique: electrocardiogram changes and 1-year cardiovascular outcomes.

INTRODUCTION AND OBJECTIVES: Transcatheter aortic valve implantation (TAVI) using the cusp overlap technique (COT) has shown a lower pacemaker implantation rate at 30 days. The objective of this study was to compare electrocardiogram changes and clinical outcomes between COT and the traditional technique (TT) at 1 year of follow-up. METHODS: Observational, retrospective, nonrandomized study of consecutive patients undergoing TAVI between January 2015 and January 2021. Patients were matched using a propensity score and the TT was compared with COT. The primary endpoints were electrocardiogram changes and a combined endpoint including pacemaker implantation, hospitalization, or cardiovascular death at 1 year. RESULTS: We included 254 patients. After propensity score matching, 184 patients (92 per group) remained. There were no statistically significant differences in baseline characteristics. At 1 year, COT patients showed a significant reduction in new onset left bundle branch block (49% vs 27%, P=.002) and less P wave (13.1±21.0 msec vs 5.47±12.5 msec; P=.003) and QRS prolongation (29.77±27.0 msec vs 16.38±25.4 msec, P <.001). COT was associated with a significant reduction in the occurrence of the primary endpoint (SHR, 0.39 [IC95%, 0.21-0.76]; P=.005). CONCLUSIONS: At 1 year of follow-up, COT reduced the incidence of new onset left bundle branch block and diminished QRS and P wave widening compared with the TT. COT was also associated with a statistically significant reduction in the occurrence of the combined primary cardiovascular endpoint.

Very Long-term Outcome of Bilateral Internal Thoracic Artery in Diabetic Patients: A Systematic Review and Reconstructed Time-To-Event Meta-analysis.

The benefits of single (SITA) and bilateral internal thoracic arteries (BITA) in diabetics undergoing coronary bypass grafting (CABG) are conflicting. We undertook a study-level meta-analysis to compare early and long-term outcomes of both CABG configurations. PubMed, CENTRAL, and EMBASE were searched for studies comparing BITA versus SITA for isolated CABG surgery in diabetics. Randomized trials or observational studies were considered eligible for the analysis. Kaplan-Meier curves of long-term survival were reconstructed and compared with Cox linear regression; incidence rate ratios (IRR) with 95% confidence intervals (CI) for long-term survival were calculated. Landmark analysis and time-varying hazard ratio (HR) were analyzed. Odds ratios (OR) were extracted for early mortality, postoperative stroke, deep sternal wound infection (DSWI), and myocardial infarction (MI). A random effects meta-analysis was performed. Sensitivity analyses included leave-one-out-analyses and meta-regression. Thirteen studies (7332 patients) were included. Overall, at 20-year follow-up, BITA was associated with higher survival (HR = 0.77; 95% CI, 0.71-0.84; P < 0.0001). Time-varying HR and landmark analysis reported BITA was associated with a higher rate of 10-year survival (HR = 0.75, 95% CI 0.68-0.82, P < 0.0001), while from 10 to 20-year follow-up no difference was revealed (HR = 0.99, 95% CI 0.82-1.19, P = 0.93). There was no increase in early mortality, postoperative MI, stroke, or DSWI between the groups. At meta-regression, the higher the age, the higher the long-term overall survival in patients with BITA. In diabetics, the BITA approach is associated with improved 10-year survival with no increase in early mortality, MI, stroke, or DSWI. In the 10-20-year timeframe, BITA and SITA showed comparable survival.

IAMCEST en mujeres. Recuperación de la expectativa de vida tras la intervención coronaria percutánea / STEMI in women. Life expectancy recovery after primary percutaneous coronary intervention

Introducción y objetivos: La mortalidad tras un infarto agudo de miocardio con elevación del segmento ST (IAMCEST) sigue siendo alta a pesar de los avances médicos. Las mujeres están poco representadas en los estudios, lo que limita el conocimiento sobre su tratamiento y su pronóstico. Se desconoce si las mujeres tratadas con intervención coronaria percutánea (ICP) primaria recuperan una esperanza de vida similar a una población de referencia. El objetivo del estudio es determinar si las mujeres sometidas a ICP primaria recuperan una supervivencia similar a la población general de iguales edad y región. Métodos: Se incluyeron todos los IAMCEST desde enero de 2014 a octubre de 2021. Se emparejó la muestra con una población de referencia de iguales edad y región, obtenida del Instituto Nacional de Estadística. Se determinaron las supervivencias observada y esperada y el exceso de mortalidad (EM) mediante el método Ederer II. Se repitió el análisis para mujeres de edad ≤ 65 y> 65 años. Resultados: Se reclutó a 2.194 personas; 528 casos eran mujeres (23,9%). Entre las mujeres que sobrevivieron los primeros 30 días, los EM del 1.er, el 5.o y el 7.o año fueron del 1,6% (IC95%, 0,3-4), el 4,7% (IC95%, 0,3-10,1) y el 7,21% (IC95%, 0,5-15,1) respectivamente. Conclusiones: Las mujeres con un IAMCEST tratadas con ICP primaria que sobreviven al evento agudo reducen significativamente su EM y presentan una esperanza de vida similar a la de la población de referencia de iguales edad y región.(AU)

Introduction and objectives: Despite medical advances, mortality after ST-elevation myocardial infarction (STEMI) remains high. Women are often underrepresented in trials and registries, limiting knowledge of their management and prognosis. It is unknown whether life expectancy in women of all ages treated with primary percutaneous coronary intervention (PPCI) is similar to that in a reference population free of the disease. The main objective of this study was to determine whether life expectancy in women undergoing PPCI and surviving the main event returns to a similar level to that in the general population of the same age and region. Methods: We included all patients diagnosed with STEMI from January 2014 to October 2021. We matched women to a reference population of the same age and region from the National Institute of Statistics to determine observed survival, expected survival, and excess mortality (EM) using the Ederer II method. We repeated the analysis in women aged ≤ 65 and> 65 years. Results: A total of 2194 patients were recruited, of whom 528 were women (23.9%). In women surviving the first 30 days, EM at 1, 5 and 7 years was 1.6% (95%CI, 0.3-4), 4.7% (95%CI, 0.3-10.1), and 7.2% (95%CI, 0.5-15.1), respectively. Conclusions: EM was reduced in women with STEMI who were treated with PPCI and who survived the main event. However, life expectancy remained lower than that in a reference population of the same age and region.(AU)

Urinary catheterization of patients with acute heart failure in a hospital emergency department: a factor associated with prognosis. / El sondaje vesical de los pacientes con insuficiencia cardiaca aguda en un servicio de urgencias hospitalario se asocia al pronóstico.

OBJECTIVES: To analyze whether urinary catheterization in a hospital emergency department (ED) affects short-term prognosis in patients with acute heart failure (AHF). MATERIAL AND METHODS: We prospectively recorded baseline and other clinical data in a consecutive cohort of ED patients treated for AHF. Crude and adjusted associations were calculated between catheterization and a primary composite outcome (30-day readmission for AHF and/or death) and secondary outcomes (in-hospital mortality, urinary tract infection [UTI], and duration of hospital stay.). RESULTS: Nine hundred ninety-one patients were admitted for AHF. The mean (SD) age was 66 (10.5) years; 71% were women. Catheterization was required for 29.2% in the ED. The primary composite outcome was observed in 7.7% of the patients who were not catheterized and 12.8% of the catheterized patients (P = .02). In-hospital mortality occurred in 5.9% and 9.7% of non-catheterized and catheterized patients, respectively (P = .04), and UTIs occurred in 19.1% and 26.6% (P = .01). Twelve of the non-catheterized patients (1.7%) were readmitted for AHF (vs 11 (3.8%) of the catheterized patients (P = .06), and there were no differences between the groups in hospital stay (11 vs 10.9 days, P = .78). In the adjusted analysis of associations between catheterization and the primary outcome the odds and hazard ratios (OR and HR, respectively) were OR, 1.7 (95% CI, 1.1-2.7) (P = .02) and HR, 1.6 (95% CI, 1.1-2.5) (P = .03). For secondary outcomes, significant associations emerged between catheterization and UTIs (OR, 1.8 [95% CI, 1.1-2.2]; P = .008) and readmission for AHF (OR, 2.9 [95% CI, 1.2-7.3]; P = .02). CONCLUSION: Routine insertion of a urinary catheter in patients with AHF in the ED is associated with worse 30-day clinical outcomes.

OBJETIVO: Analizar si el sondaje vesical (SV) rutinario en un servicio de urgencias hospitalario (SUH) de pacientes diagnosticados de insuficiencia cardiaca aguda (ICA) está asociado con la evolución a corto plazo. METODO: Se recogieron prospectivamente datos basales y clínicos de una cohorte de pacientes consecutivos que ingresaron por ICA. Se analizó la asociación cruda y ajustada del SV con el evento combinado de muerte o reingreso por insuficiencia cardiaca a 30 días (objetivo primario), así como mortalidad intrahospitalaria, infección del tracto urinario (ITU) y estancia hospitalaria (objetivos secundarios). RESULTADOS: Se incluyeron 991 pacientes hospitalizados por ICA, la edad media fue de 66 años (DE 10,5) y el 71% fueron mujeres. Un 29,2% de los pacientes requirieron SV en el SUH. El evento combinado fue del 7,7% para el grupo no SV y 12,8% para grupo SV (p = 0,02); mortalidad intrahospitalaria fue del 5,9% en el grupo no SV y 9,7% en el grupo SV (p = 0,04); se diagnosticó ITU en el 19,1% de pacientes en el grupo no SV y en el 26,6% en el grupo SV (p = 0,01). A 30 días, 12 pacientes (1,7%) reingresaron por insuficiencia cardiaca en el grupo no SV versus 11 (3,8%) pacientes en el grupo SV (p = 0,06). No hubo diferencias en la estancia hospitalaria (11 versus 10,9 días); p = 0,78). En el análisis ajustado, el SV se asoció con el objetivo primario; [OR = 1,7 (IC 95%: 1,1-2,7; p = 0,02); HR = 1,6 (IC 95%: 1,1-2,5; p = 0,03)]; con la ITU (OR = 1,8; IC 95%: 1,1­2,2; p = 0,008) y con el reingreso por insuficiencia cardiaca (OR = 2,9; IC 95%: 1,2-7,3; p = 0,02). CONCLUSIONES: La inserción rutinaria del SV en el SUH en pacientes con ICA se asoció a peores resultados clínicos a los 30 días.

Results beyond 5-years of surgery or percutaneous approach in severe coronary disease. Reconstructed time-to-event meta-analysis of randomized trials.

INTRODUCTION AND OBJECTIVES: There is controversy about the optimal revascularization strategy in severe coronary artery disease (CAD), including left main disease and/or multivessel disease. Several meta-analyses have analyzed the results at 5-year follow-up but there are no results after the fifth year. We conducted a systematic review and meta-analysis of randomized clinical trials, comparing results after the fifth year, between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) using drug-eluting stents in patients with severe CAD. METHODS: We analyzed all clinical trials between January 2010 and January 2023. The primary endpoint was all-cause mortality. The databases of the original articles were reconstructed from Kaplan-Meier curves, simulating an individual-level meta-analysis. Comparisons were made at certain cutoff points (5 and 10 years). The 10-year restricted median survival time difference between CABG and PCI was calculated. The random effects model and the DerSimonian-Laird method were applied. RESULTS: The meta-analysis included 5180 patients. During the 10-year follow-up, PCI showed a higher overall incidence of all-cause mortality (HR, 1.19; 95%CI, 1.04-1.32; P=.008)]. PCI showed an increased risk of all-cause mortality within 5 years (HR, 1.2; 95%CI, 1.06-1.53; P=.008), while no differences in the 5-10-year period were revealed (HR, 1.03; 95%CI, 0.84-1.26; P=.76). Life expectancy of CABG patients was slightly higher than that of PCI patients (2.4 months more). CONCLUSIONS: In patients with severe CAD, including left main disease and/or multivessel disease, there was higher a incidence of all-cause mortality after PCI compared with CABG at 10 years of follow-up. Specifically, PCI has higher mortality during the first 5 years and comparable risk beyond 5 years.

Effects of MIdazolam versus MOrphine in acute cardiogenic pulmonary edema and chronic obstructive pulmonary disease: An analysis of MIMO trial.

AIMS: Chronic obstructive pulmonary disease (COPD) is an important comorbidity in heart failure. The MIMO trial showed that patients with acute cardiogenic pulmonary edema (ACPE) treated with midazolam had fewer serious adverse events than those treated with morphine. In this post hoc analysis, we examined whether the presence/ absence of COPD modifies the reduced risk of midazolam over morphine. METHODS: Patients >18 years old clinically diagnosed with ACPE and with dyspnea and anxiety were randomized (1:1) at emergency department arrival to receive either intravenous midazolam or morphine. In this post hoc analysis, we calculated the relative risk (RR) of serious adverse events in patients with and without COPD. Calculating the CochranMantel-Haenszel interaction test, we evaluated if COPD modified the reduced risk of serious adverse events in the midazolam arm compared to morphine. RESULTS: Overall, 25 (22.5%) of the 111 patients randomized had a history of COPD. Patients with COPD were more commonly men with a history of previous episodes of heart failure, than participants without COPD. In the COPD group, the RR for the incidence of serious adverse events in the midazolam versus morphine arm was 0.36 (95%CI, 0.1-1.46). In the group without COPD, the RR was 0.44 (95%CI, 0.22-0.91). The presence of COPD did not modify the reduced risk of serious adverse events in the midazolam arm compared to morphine (p for interaction =0.79). CONCLUSIONS: The reduced risk of serious adverse events in the midazolam group compared with morphine is similar in patients with and without COPD.

Rationale and Design of the Impact of Air Pollution Due to DESERT Dust in Patients with HEART Failure (DESERT HEART).

AIMS: The main objective of this study is to determine whether exposure to Saharan dust causes airway inflammation and oxidative stress in patients with stable chronic heart failure (HF) and a left ventricular ejection fraction of less than 40%. METHODS: A longitudinal study design is used, involving the inclusion of 40 patients with stable chronic HF and a left ventricular ejection fraction of less than 40%. Four sputum samplings will be taken from each patient, with one sampling taken each week over four consecutive weeks. The sputum samples will be used to analyze the degree of inflammation and oxidative stress. Air quality monitoring stations will be used to analyze the particulate matter (PM) exposure of each patient. The intrusion of desert dust will be identified using meteorological models. There will be 160 scheduled samplings in 40 patients with chronic HF. Mixed regression models will be used to assess the influence of the concentrations of PM (from the episodes of desert dust) upon the airway inflammation and oxidative stress markers. CONCLUSION: The results of this study will test the hypothesis that exposure to high concentrations of Saharan dust affects the normal function of the respiratory epithelium due to the imbalance between the production of free radicals and antioxidant enzymes, thus causing increased pulmonary inflammation and oxidative stress in patients with HF that in turn may facilitate decompensations of their background disease condition.

Current status of transcatheter mitral valve replacement: systematic review and meta-analysis.

Introduction: Mitral Regurgitation (MR) has a strong impact on quality of life and on mid-term survival. Transcatheter mitral valve replacement (TMVR) is rapidly expanding and a growing number of studies have been published recently. Methods: A systematic review of studies reporting on clinical data for patients with symptomatic severe MR undergoing TMVR was performed. Early- and mid-term outcomes (clinical and echocardiographic) were evaluated. Overall weighted means and rates were calculated. Risk ratios or mean differences were calculated for pre- and post-procedural comparisons. Results: A total of 12 studies and 347 patients who underwent TMVR with devices clinically available or under clinical evaluation were included. Thirty-day mortality, stroke and major bleeding rates were 8.4%, 2.6%, and 15.6%, respectively. Pooled random-effects demonstrated a significant reduction of ≥ grade 3+ MR (RR: 0.05; 95% CI: 0.02-0.11; p < 0.001) and in the rates of patients in NYHA class 3-4 after the intervention (RR: 0.27; 95% CI: 0.22-0.34; p < 0.001). Additionally, the pooled fixed-effect mean difference for quality of life based on the KCCQ score yielded an improvement in 12.9 points (95% CI:7.4-18.4, p < 0.001), and exercise capacity improved by a pooled fixed-effect mean difference of 56.8 meters in the 6-minute walk test (95% CI 32.2-81.3, p < 0.001). Conclusions: Among 12 studies and 347 patients comprising the updated evidence with current TMVR systems there was a statistically significant reduction in ≥ grade 3+ MR and in the number of patients exhibiting poor functional class (NYHA 3 or 4) after the intervention. Overall rate of major bleeding was the main shortcoming of this technique.

STEMI in women. Life expectancy recovery after primary percutaneous coronary intervention.

INTRODUCTION AND OBJECTIVES: Despite medical advances, mortality after ST-elevation myocardial infarction (STEMI) remains high. Women are often underrepresented in trials and registries, limiting knowledge of their management and prognosis. It is unknown whether life expectancy in women of all ages treated with primary percutaneous coronary intervention (PPCI) is similar to that in a reference population free of the disease. The main objective of this study was to determine whether life expectancy in women undergoing PPCI and surviving the main event returns to a similar level to that in the general population of the same age and region. METHODS: We included all patients diagnosed with STEMI from January 2014 to October 2021. We matched women to a reference population of the same age and region from the National Institute of Statistics to determine observed survival, expected survival, and excess mortality (EM) using the Ederer II method. We repeated the analysis in women aged ≤ 65 and> 65 years. RESULTS: A total of 2194 patients were recruited, of whom 528 were women (23.9%). In women surviving the first 30 days, EM at 1, 5 and 7 years was 1.6% (95%CI, 0.3-4), 4.7% (95%CI, 0.3-10.1), and 7.2% (95%CI, 0.5-15.1), respectively. CONCLUSIONS: EM was reduced in women with STEMI who were treated with PPCI and who survived the main event. However, life expectancy remained lower than that in a reference population of the same age and region.

Resultados a corto y medio plazo de la reparación transcatéter de la válvula tricúspide: revisión sistemática y metanálisis de estudios observacionales / Early and mid-term outcomes of transcatheter tricuspid valve repair: systematic review and meta-analysis of observational studies

Introducción y objetivos La insuficiencia tricuspídea (IT) se asocia con un peor pronóstico si no se corrige. Se han publicado recientemente numerosos estudios sobre reparación transcatéter de la válvula tricúspide (RTT) Métodos Se llevó a cabo una revisión sistemática de estudios que publican datos clínicos de pacientes con IT significativa sometidos a RTT. Se evaluaron objetivos clínicos y ecocardiográficos a corto y medio plazo. Las razones de riesgo (RR) y las diferencias de medias (DM) se obtuvieron de la comparación de datos previos y posteriores a la intervención. Se hizo también un análisis de sensibilidad según el abordaje principal (reparación borde a borde frente a anuloplastia) Resultados Se incluyeron 19 estudios (todos observacionales o ensayos de un solo grupo) con un total de 991 pacientes sometidos a RTT sola. Las tasas de mortalidad e ictus a 30 días fueron del 2,8 y el 0,2% respectivamente. El análisis agrupado de efectos aleatorios mostró una reducción significativa de IT (RR=0,33; IC95%, 0,26-0,42; p <0,001), vena contracta (DM, 5,9mm; IC95%, 4-7,9; p <0,001), diámetro telediastólico del ventrículo derecho (DM, 3,5mm; IC95%, 2,5-4,5; p <0,001) y clase funcional de la NYHA 3 o 4 (RR=0,32; IC95%, 0,27-0,37; p <0,001) a los 30 días. Las complicaciones hemorrágicas y la IT residual al menos grave fueron numéricamente superiores en el grupo de anuloplastia percutánea en comparación con el grupo de reparación borde a borde (hemorragias, el 13,3 y el 2,8%; IT residual, el 40,4 y el 27,9%) Conclusiones En los 991 pacientes que formaron parte de la experiencia inicial de RTT, tras la intervención se observó una reducción estadísticamente significativa del grado de IT grave o peor, una mala clase funcional (NYHA 3-4), la anchura de la vena contracta y el diámetro telediastólico del ventrículo derecho. Hasta ahora, el abordaje con reparación borde a borde parece tener un mejor perfil de seguridad (AU)

Introduction and objectives Severe tricuspid regurgitation (TR) is associated with poor prognosis when left untreated, and a growing number of studies on transcatheter tricuspid valve repair (TTVr) have been published over the last few months. Methods We performed a comprehensive systematic review of published literature providing clinical data on TTVr for patients with significant TR. Early and mid-term clinical and echocardiographic outcomes were evaluated. Risk ratios (RR) or mean differences (MD) were obtained when comparing pre- and postprocedural data. A sensitivity analysis was also performed according to the main approach for repair (edge-to-edge vs annuloplasty). Results A total of 19 studies (all observational or single-arm trials) and 991 patients who underwent isolated TTVr were included. Thirty-day mortality and stroke rates were 2.8% and 0.2%, respectively. Pooled random-effects resulted in a significant reduction of ≥ severe TR (RR, 0.33; 95%CI, 0.26-0.42; P<.001), vena contracta width (MD, 5.9mm; 95%CI, 4-7.9; P <.001), right ventricular end-diastolic diameter (MD, 3.5mm; 95%CI, 2.5-4.5; P <.001), and New York Heart Association (NYHA) class III or IV at last follow-up (RR, 0.32; 95%CI, 0.27-0.37; P <.001). Bleeding complications and residual ≥ severe TR were numerically higher in the annuloplasty-like group compared with edge-to-edge repair (13.3% vs 3.8% for bleeding and 40.4% vs 27.9% for residual severe TR). Conclusions Among 991 patients comprising the early experience for several TTVr devices, there was a statistically significant reduction in ≥ severe TR, NYHA class III-IV, vena contracta width and right ventricular end-diastolic diameter after TTVr. Thus far, the edge-to-edge approach seems to be associated with a better safety profile (AU)

Long-Term Outcomes Comparison Between Surgical and Percutaneous Coronary Revascularization in Patients With Multivessel Coronary Disease or Left Main Disease: A Systematic Review and Study Level Meta-Analysis of Randomized Trials.

Recent randomized trials comparing coronary artery bypass graft (CABG) with percutaneous coronary intervention (PCI) utilizing drug-eluting stents in patients with left main disease (LMD) and/or multivessel disease (MVD), reported conflicting results. We performed a study level meta-analysis comparing the 2 interventions for the treatment of LMD or MVD. Using electronic databases, we retrieved 6 trials, between January, 2010 and December, 2022. Five-years Kaplan-Meier curves of endpoints where reconstructed. Comparisons were made by cox-linear regression frailty model and by landmark analysis. A random-effect method was applied. A total of 8269 patients were included and randomly assigned to CABG (n = 4135) or PCI (n = 4134). During 5-years follow-up, PCI showed a higher incidence of all-cause mortality (hazard ratio [HR] 1.28; 95% confidence interval [CI], 1.11-1.47; P < 0.0001]), myocardial infarction (HR 1.84; 95% CI, 1.54-2.19; P < 0.0001) and repeat coronary revascularization (HR 1.96; 95% CI, 1.72-2.24; P < 0.0001). There was no long-term difference between the 2 interventions for cardiovascular death (P = 0.14) and stroke (P = 0.20), although the incidence of stroke was higher with CABG within 30-days from intervention (P < 0.0001). PCI was associated with an increased risk for composite endpoints (P < 0.0001) and major cerebral and cardiovascular events. (P < 0.0001). In conclusion, at 5-year follow-up, in patients with LMD and/or MVD there was a significant higher incidence of all-cause mortality, myocardial infarction and repeat revascularization with PCI compared to CABG. The incidence of stroke was higher with CABG during the postprocedural period, but no difference was found during 5-years follow-up. Longer follow-up is mandatory to better define outcome difference between the 2 interventions.

Midazolam versus morphine in acute cardiogenic pulmonary edema patients with and without atrial fibrillation: findings from the MIMO trial.

BACKGROUND AND IMPORTANCE: The MIMO clinical trial showed that patients with acute cardiogenic pulmonary edema (ACPE) treated with midazolam had fewer serious adverse events than those treated with morphine. Atrial fibrillation (AF) is a common comorbidity in heart failure and affects patient's outcome. OBJECTIVE: The primary endpoint of this substudy is to know if AF modified the reduced risk of serious adverse events in the midazolam arm compared to morphine. The first secondary endpoint is to know if AF modified the reduced risk of serious adverse events or death at 30 days in the midazolam arm. The second secondary objective of this substudy is to analyze whether AF modified the reduced risk of midazolam against morphine on the total number of serious adverse events per patient. DESIGN: We conducted a secondary analysis of the MIMO trial. Patients more than 18 years old clinically diagnosed with ACPE and with dyspnea and anxiety were randomized (1:1) at emergency department arrival to receive either intravenous midazolam or morphine. OUTCOME MEASURES AND ANALYSIS: In this post hoc analysis, we calculated the relative risk (RR) of serious adverse events in patients with and without AF. Calculating the Cochran-Mantel-Haenszel interaction test, we evaluated if AF modified the reduced risk of serious adverse events in the midazolam arm compared to morphine. MAIN RESULTS: One hundred eleven patients (median = 78.9 years; IQR, 72.3-83.7; women, 52.2%) were randomized in the MIMO trial, 55 to receive midazolam and 56 to morphine. All randomized patients received the assigned drug and there were no losses to follow-up. Forty-four patients (39.6%) had AF. In the AF group, the RR for the incidence of serious adverse events in the midazolam versus morphine arm was 0.42 (95% CI, 0.14-1.3). In the group without AF, the RR was 0.46 (95% CI, 0.21-1). The presence of AF did not modify the reduced risk of serious adverse events in the midazolam arm compared with morphine ( P for interaction = 0.88). CONCLUSION: This post hoc analysis of the MIMO trial suggests that the reduced risk of serious adverse events in the midazolam group compared to morphine is similar in patients with and without AF.

Effects of midazolam vs morphine in patients with acute pulmonary edema with left ventricular systolic dysfunction: a secondary analysis of data from the MIMO trial. / Efectos del midazolam frente a la morfina en pacientes con edema agudo de pulmón con disfunción sistólica ventricular izquierda: un análisis secundario del ensayo MIMO.

OBJECTIVES: The midazolam vs morphine (MIMO) trial showed that patients treated with midazolam had fewer serious adverse events than those treated with morphine. In many patients with acute pulmonary edema, the left ventricular ejection fraction (LVEF) is preserved, at 50% or higher. We aimed to determine whether left ventricular (LV) systolic dysfunction (D), defined by an LVEF of less than 50%, modifies the protective effect of midazolam vs morphine. MATERIAL AND METHODS: The MIMO trial randomized 111 patients with acute pulmonary edema to receive intravenous midazolam in 1-mg doses to a maximum of 3 mg (n = 55) or morphine in 2- to 4-mg doses to a maximum of 8 mg (n= 56). We calculated the relative risk (RR) for a serious adverse event in patients with and without systolic LVD. RESULTS: LVEF was preserved in 84 (75.7%) of the patients with acute pulmonary edema. In patients with systolic LVD, 4 patients (26.9%) in the midazolam arm vs 6 (50%) in the morphine arm developed serious adverse events (RR, 0.53; 95% CI, 0.2-1.4). In patients without systolic LVD, 6 patients (15%) in the midazolam arm vs 18 (40.9%) in the morphine arm experienced such events (RR, 0.37; 95% CI, 0.16-0.83). The presence of systolic LVD did not modify the protective effect of midazolam on serious adverse effects (P=.57). CONCLUSION: The effect of midazolam vs morphine in protecting against the development of serious adverse events or death is similar in patients with and without systolic LVD.

OBJETIVO: El ensayo clínico MIMO demostró que los pacientes con edema agudo de pulmón (EAP) tratados con midazolam tenían menos eventos adversos graves (EAG) que los tratados con morfina. Muchos pacientes con EAP tienen fracción de eyección del ventrículo izquierdo (FEVI) preservada ($ 50%). El objetivo fue conocer si la disfunción sistólica ventricular izquierda (DSVI) (fracción eyección ventrículo izquierdo 50%) modifica el efecto protector del midazolam frente a la morfina. METODO: El estudio MIMO asignó al azar 111 pacientes con EAP a tratamiento con midazolam (dosis de 1 mg intravenosa, hasta una dosis máxima de 3 mg, n = 55) o morfina (dosis de 2-4 mg, hasta una dosis máxima de 8 mg, n = 56). Se calculó el riesgo relativo (RR) de padecer un EAG en pacientes con y sin DSVI. RESULTADOS: La FEVI preservada estuvo presente en 84 (75,7%) pacientes con EAP. En el grupo con DSVI, 4 pacientes (26,9%) en el brazo midazolam frente a 6 (50%) en el brazo morfina presentaron EAG (RR = 0,53; IC 95: 0,2-1,4). En el grupo sin DSVI 6 pacientes (15%) del brazo midazolam frente a 18 (40,9%) del brazo morfina presentaron EAG (RR = 0,37; IC 95: 0,16-0,83). La DSVI no modificó el efecto protector del midazolam en la aparición de EAG con respecto a la morfina (p = 0,57). CONCLUSIONES: En pacientes con EAP el efecto protector del midazolam sobre la morfina en la aparición de EAG y EAG o muerte fue similar en pacientes con y sin DSVI.