Automatic Assessment of Transcatheter Aortic Valve Implantation Results on Four-Dimensional Computed Tomography Images Using Artificial Intelligence.

Transcatheter aortic valve implantation (TAVI) is a procedure to treat severe aortic stenosis. There are several clinical concerns related to potential complications after the procedure, which demand the analysis of computerized tomography (CT) scans after TAVI to assess the implant's result. This work introduces a novel, fully automatic method for the analysis of post-TAVI 4D-CT scans to characterize the prosthesis and its relationship with the patient's anatomy. The method enables measurement extraction, including prosthesis volume, center of mass, cross-sectional area (CSA) along the prosthesis axis, and CSA difference between the aortic root and prosthesis, all the variables studied throughout the cardiac cycle. The method has been implemented and evaluated with a cohort of 13 patients with five different prosthesis models, successfully extracting all the measurements from each patient in an automatic way. For Allegra patients, the mean of the obtained inner volume values ranged from 10,798.20 mm3 to 18,172.35 mm3, and CSA in the maximum diameter plane varied from 396.35 mm2 to 485.34 mm2. The implantation of this new method could provide information of the important clinical value that would contribute to the improvement of TAVI, significantly reducing the time and effort invested by clinicians in the image interpretation process.

Cardiovascular Complications in Patients Hospitalized for COVID-19: A Cohort Study in Havana, Cuba.

INTRODUCTION AND OBJECTIVE: At least one in ten patients infected with COVID develop cardiovascular complications during hospitalization, increasing the number of deaths from this cause. However, the determinants of risk are not clearly elucidated. This study aims to determine whether there is a relationship between in-hospital cardiac complications and cardiovascular history and hospital evolution. METHODS: Prospective cohort study of 373 patients with a positive diagnosis of SARS-CoV-2 admitted to an Intensive Care Unit between March and October 2021. RESULTS: Median age was 69 (IQR: 57-77), 29.2 % of patients presented cardiovascular complications: 21.2 % electrical, 5.9 % acute coronary syndrome and 1.9 % pulmonary thromboembolism. Age RR: 1.02 (95 % CI: 1.00-1.04; p = 0.020) and history of ischemic heart disease RR: 2.23 (95 % CI: 1.27-3.92; p = 0.005) were identified as independent predictors of in-hospital cardiac complications. CONCLUSIONS: Age and history of ischemic heart disease were identified as independent predictor variables of cardiovascular complications in patients admitted with severe COVID-19 involvement; being significantly associated with lower survival.

Wellens syndrome as an independent predictor of in-hospital cardiovascular complications.

INTRODUCTION: Wellens Syndrome was described for the first time in the eighties, as an equivalent pattern of a critical lesion of the anterior descending artery. Different risk factors have been associated with a worse prognosis during hospitalisation in patients with non-ST segment elevation acute coronary syndrome. However, it is unknown whether the presence of Wellens Syndrome alone contributes to an increase in in-hospital cardiovascular complications. MATERIAL AND METHOD: Analytical prospective cohort study in 141 patients with the diagnosis of acute coronary syndrome without ST segment elevation who underwent coronary angiography between 2016 and 2020. RESULTS: Wellens syndrome was diagnosed in 64 patients with a mean age of 66.31 ± 12.54, of which 21 patients had a cardiac event during hospitalisation: hemodynamic complication 14 (21.9%), refractory or recurrent angina 4 (6.3%) and Acute myocardial infarction 3 (4.7%) confirming a relative risk (RR): 4.88 (95% confidence interval (CI) 1.92-12.45) p = 0.001. CONCLUSIONS: The presence of Wellens Syndrome is independently associated with the appearance of cardiac complications during hospitalisation.Key pointsSW is now known to be a relatively frequent presentation of ACS, not addressed in depth in clinical practice guidelines for NSTEACS. This syndrome is generally caused by a severe ADA occlusion that, if not adequately treated, could evolve into a large infarction. According to the results of the different series published, the incidence of cardiovascular risk factors in SW is similar to other forms of presentation of ischaemic heart disease.At present, the exact relationship between the main cardiovascular risk factors and SW is unknown; in addition to the possible associations of this syndrome with in-hospital cardiovascular complications and its value as a predictor of the occurrence of cardiac complications, elements that are included in the results of the present study.

Stroke prevention during and after transcatheter aortic valve implantation: From cerebral protection devices to antithrombotic management.

Since its conception, transcatheter aortic valve implantation (TAVI) has undergone important improvements both in the implantation technique and in transcatheter devices, allowing an enthusiastic adoption of this therapeutic approach in a wide population of patients previously without a surgical option and managed conservatively. Nowadays, patients with severe symptomatic aortic stenosis are typically managed with TAVI, regardless of their risk to surgery, improving the prognosis of patients and thus achieving an exponential global expansion of its use. However, thromboembolic and hemorrhagic complications remain a latent concern in TAVI recipients. Both complications can appear simultaneously in the periprocedural period or during the follow-up, and when minor, they resolved without apparent sequelae, but in a relevant percentage of cases, they are devastating, overshadowing the benefit achieved with TAVI. Our review outlines the etiology and incidence of thromboembolic complications associated with TAVI, the main current strategies for their prevention, and the implications of its pharmacological management at the follow-up in a TAVI population, mostly frail and predisposed to bleeding complications.

Patients' knowledge about their involvement in clinical trials. A non-randomized controlled trial.

Background: Nowadays, good clinical practice should be established in human research. Patient's rights and autonomy must be respected above the interest of the researcher, making mandatory to raise patient's awareness on the implications of participating in a clinical study. Contrary to popular belief, this is not always the case. This means that, after signing the informed consent form, some patients have difficulties understanding their responsibilities as participants. Materials and methods: This study is a prospective, multicenter, non-randomized controlled trial comparative survey conducted on patients enrolled in a clinical trial to evaluate and improve their understanding after an educational intervention was applied to the research staff. Results: Females were underrepresented in the clinical trials performed in this study, 21.5%. Most of the participants had a low educational level (74.4%). Around 5 and 10% of the research participants were not aware they were part of a clinical study, and more 24% just trusted in the medical decision to be enrolled. After the interventional education, the following items: "given time and resolution of the patient doubts" (p-value = 0.003), "enough written information" (p-value = 0.006), "explanation of the risks of participating in the study," (p-value = 0.047) and understanding of the information provided to them showed an improvement regarding the study in which they were participating. Conclusion: The research participants understanding of their involvement in clinical trials is limited. An educational intervention on the research team can improve the process of empowerment and transit of information.

Using Bayesian Optimization and Wavelet Decomposition in GPU for Arterial Blood Pressure Estimation.

Continuous monitoring of arterial blood pressure (ABP) of patients in hospital is currently carried out in an invasive way, which could represent a risk for them. In this paper, a noninvasive methodology to optimize ABP estimators using electrocardiogram and photoplethysmography signals is proposed. For this, the XGBoost machine learning model, optimized with Bayesian techniques, is executed in a Graphics Processing Unit, which drastically reduces execution time. The methodology is evaluated using the MIMIC-III Waveform Database. Systolic and diastolic pressures are estimated with mean absolute error values of 15.85 and 11.59 mmHg, respectively, similar to those of the state of the art. The main advantage of the proposed methodology with respect to others of the current state of the art is that it allows the optimization of the estimator model to be performed automatically and more efficiently at the computational level for the data available. Clinical Relevance- This approach has the advantage of using noninvasive methods to continuously monitor patient's arterial blood pressure, reducing the risk for patients.

Contact pathway in surgical and transcatheter aortic valve replacement.

Background: Aortic valve replacement is the gold standard treatment for severe symptomatic aortic stenosis, but thrombosis of bioprosthetic valves (PVT) remains a concern. Objective: To analyze the factors involved in the contact pathway during aortic valve replacement and to assess their impact on the development of thromboembolic complications. Methods: The study was conducted in 232 consecutive patients who underwent: transcatheter aortic valve replacement (TAVR, N = 155), and surgical valve replacement (SAVR, N = 77) (MUVITAVI project). Demographic and clinical data, outcomes including a combined end point (CEP) of thrombotic events, and imaging controls were recruited. Samples were collected 24 h before and 48 h after valve replacement. FXII, FXI and (pre)kallikrein were evaluated by Western Blot and specific ELISA with nanobodies. Results: The CEP of thrombotic events was reached by 19 patients: 13 patients presented systemic embolic events and 6 patients subclinical PVT. Valve replacement did not cause FXII activation or generation of kallikrein. There was a significant reduction of FXI levels associated with the procedure, which was statistically more pronounced in SAVR than in TAVR. Cases with reductions of FXI below 80% of basal values had a lower incidence of embolic events during the procedure than patients in whom FXI increased above 150%: 2.7 vs. 16.7%; p: 0.04. Conclusion: TAVR or SAVR did not significantly activate the contact pathway. A significant reduction of FXI, was observed, particularly in SAVR, associated with lower incidence of thrombotic events. These results encourage evaluating the usefulness and safety of FXI-directed antithrombotic treatments in these patients.

Clinical Features and Long-Term Outcomes in Very Young Patients with Myocardial Infarction with Non-Obstructive Coronary Arteries.

Background: The main cause of acute coronary syndrome (ACS) is coronary artery obstruction due to atherosclerotic plaque growth or thrombus formation secondary to plaque rupture or erosion. However, there is a subgroup of patients with signs and symptoms suggestive of ACS but without relevant coronary artery obstruction on coronary angiography. This population is defined as myocardial infarction with non-obstructive coronary arteries (MINOCA). The present study analyzes the clinical features and outcomes of very young patients with a diagnosis of MINOCA. Method: Nested case-control study of ≤40-year-old patients referred for coronary angiography due to clinical suspicion of ACS. Patients were divided into three groups: patients with obstructive coronary artery disease (CAD), patients diagnosed with MINOCA, and controls with non-coronary artery disease. Results: Of 19,321 coronary angiographies performed in our center in a period of 10 years, 408 (2.1%) were in patients ≤40 years old, and MINOCA was identified in 32 (21%) patients. The cardiovascular risk factors for obstructive CAD and MINOCA were very similar. The incidence of major adverse cardiovascular events (MACE) at follow-up was significantly higher in the MINOCA (HR 4.13 (95%CI 1.22-13.89) and obstructive CAD (HR 4.59 (95%CI 1.90-10.99) patients compared to controls. Cocaine use HR 14.58 (95%CI 3.08-69.02), family history of CAD HR 6.20 (95%CI 1.40-27.43), and depression HR 5.16 (95%CI 1.06-25.24) were associated with a poor outcome in the MINOCA population. Conclusion: Very young patients with MINOCA had a poor prognosis at long-term follow-up, similar to patients with obstructive CAD. Focusing efforts on secondary prevention is essential in this population.

Coronary Artery Disease in Very Young Patients: Analysis of Risk Factors and Long-Term Follow-Up.

Coronary artery disease (CAD) is a common chronic condition in the elderly. However, the earlier CAD begins, the stronger its impact on lifestyle and costs of health and social care. The present study analyzes clinical and angiographic features and the outcome of very young patients undergoing coronary angiography due to suspected CAD, including a nested case-control study of ≤40-year-old patients referred for coronary angiography. Patients were divided into two groups: cases with significant angiographic stenosis, and controls with non-significant stenosis. Of the 19,321 coronary angiographies performed in our center in a period of 10 years, 504 (2.6%) were in patients ≤40 years. The most common cardiovascular risk factors for significant CAD were smoking (OR 2.96; 95% CI 1.65-5.37), dyslipidemia (OR 2.18; 95% CI 1.27-3.82), and family history of CAD (OR 1.95; 95% CI 1.05-3.75). The incidence of major adverse cardiovascular events (MACE) at follow-up was significantly higher in the cases compared to controls (HR 2.71; 95% CI 1.44-5.11). Three conventional coronary risk factors were directly related to the early signs of CAD. MACE in the long-term follow-up is associated to dyslipidaemia and hypertriglyceridemia. Focusing efforts for the adequate control of CAD in young patients is a priority given the high socio-medical cost that this disease entails to society.

Using Machine Learning Techniques to Predict MACE in Very Young Acute Coronary Syndrome Patients.

Coronary artery disease is a chronic disease with an increased expression in the elderly. However, different studies have shown an increased incidence in young subjects over the last decades. The prediction of major adverse cardiac events (MACE) in very young patients has a significant impact on medical decision-making following coronary angiography and the selection of treatment. Different approaches have been developed to identify patients at a higher risk of adverse outcomes after their coronary anatomy is known. This is a prognostic study of combined data from patients ≤40 years old undergoing coronary angiography (n = 492). We evaluated whether different machine learning (ML) approaches could predict MACE more effectively than traditional statistical methods using logistic regression (LR). Our most effective model for long-term follow-up (60 ± 27 months) was random forest (RF), obtaining an area under the curve (AUC) = 0.79 (95%CI 0.69-0.88), in contrast with LR, obtaining AUC = 0.66 (95%CI 0.53-0.78, p = 0.021). At 1-year follow-up, the RF test found AUC 0.80 (95%CI 0.71-0.89) vs. LR 0.50 (95%CI 0.33-0.66, p < 0.001). The results of our study support the hypothesis that ML methods can improve both the identification of MACE risk patients and the prediction vs. traditional statistical techniques even in a small sample size. The application of ML techniques to focus the efforts on the detection of MACE in very young patients after coronary angiography could help tailor upfront follow-up strategies in such young patients according to their risk of MACE and to be used for proper assignment of health resources.

Predicting TAVI paravalvular regurgitation outcomes based on numerical simulation of the aortic annulus eccentricity and perivalvular areas.

Trans-catheter aortic valve implantation (TAVI) is an increasingly adopted technique which provides a minimal invasive solution for patients who suffer from severe aortic stenosis. Some complications of the procedure could be annular rupture or paravalvular leakage, both related with adverse outcome. In TAVI with balloon expandable devices, a mismatch between those two factors leads to a conflict situation, where improving one worsens the other. The presented research proposes a methodology that uses numerical simulation to obtain certain TAVI outcomes related with aortic regurgitation due to paravalvular leakage, such as perivalvular area, aortic eccentricity or annular pressure. The application of the methodology for two patients shows the possibility of predicting those quantities. The highest stress values are distributed along the contact area. Results also show that a great deformation on the aortic annulus does not necessarily imply a higher stress; pressure can either be converted into root reshape or into root stretching. Validation of the results was done using scientific publications, clinical guidelines and clinical reports. Numerical simulation provides a suitable tool that could possibly contribute to optimize the planification procedure adjusting the mismatch between size and pressure.

Quality of life of patients undergoing conventional vs leadless pacemaker implantation: A multicenter observational study.

BACKGROUND: Leadless pacemakers (L-PM) are an emerging effective and safe technology that offer an alternative to conventional pacemakers (C-PM) for right ventricular stimulation. However, there is little information about their potential benefits for quality of life (QoL) in patients with L-PM. We compared QoL between patients with L-PM and C-PM. METHODS: The study population comprised patients undergoing single chamber pacemaker implantation from December 2016 to March 2018. The SF-36 questionnaire was used to evaluate QoL at baseline and at 6 months of followup. We also used a questionnaire consisted of 10 specific questions related to the implant procedure. RESULTS: A total of 106 patients (64 C-PM; 42 L-PM) were included. There were no differences in baseline characteristics between the groups (C-PM vs L-PM), except for age (81.5 vs 77.3 years; P = .012) and diabetes (38% vs 17%; P = .021). Baseline SF-36 scores did not differ between the groups. At 6 months followup, patients in the L-PM group scored significantly higher on physical function (63 vs 42; P < .001), physical role (64 vs 36; P = .004), and mental health (75 vs 65; P = .017), even after adjusting for covariates. Pacemaker-related discomfort and physical restrictions were significantly lower for the L-PM group. CONCLUSION: L-PM is associated with better QoL than C-PM in both physical and mental health. Patients undergoing L-PM implantation reported less procedure-related discomfort, physical restriction, and preoccupation.

Assessment of Platelet REACtivity After Transcatheter Aortic Valve Replacement: The REAC-TAVI Trial.

OBJECTIVES: The REAC-TAVI (Assessment of platelet REACtivity after Transcatheter Aortic Valve Implantation) trial enrolled patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) pre-treated with aspirin + clopidogrel, aimed to compare the efficacy of clopidogrel and ticagrelor in suppressing high platelet reactivity (HPR) after TAVI. BACKGROUND: Current recommendations support short-term use of aspirin + clopidogrel for patients with severe AS undergoing TAVR despite the lack of compelling evidence. METHODS: This was a prospective, randomized, multicenter investigation. Platelet reactivity was measured at 6 different time points with the VerifyNow assay (Accriva Diagnostics, San Diego, California). HPR was defined as (P2Y12 reaction units (PRU) ≥208. Patients with HPR before TAVR were randomized to either aspirin + ticagrelor or aspirin + clopidogrel for 3 months. Patients without HPR continued with aspirin + clopidogrel (registry cohort). The primary endpoint was non-HPR status (PRU <208) in ≥70% of patients treated with ticagrelor at 90 days post-TAVR. RESULTS: A total of 68 patients were included. Of these, 48 (71%) had HPR (PRU 273 ± 09) and were randomized to aspirin + ticagrelor (n = 24, PRU 277 ± 08) or continued with aspirin + clopidogrel (n = 24, PRU 269 ± 49). The remaining 20 patients (29%) without HPR (PRU 133 ± 12) were included in the registry. Overall, platelet reactivity across all the study time points after TAVR was lower in patients randomized to ticagrelor compared with those treated with clopidogrel, including those enrolled in the registry (p < 0.001). The primary endpoint was achieved in 100% of patients with ticagrelor compared with 21% with clopidogrel (p < 0.001). Interestingly, 33% of clopidogrel responder patients at baseline developed HPR status during the first month after TAVR. CONCLUSIONS: HPR to clopidogrel is present in a considerable number of patients with AS undergoing TAVR. Ticagrelor achieves a better and faster effect, providing sustained suppression of HPR to these patients. (Platelet Reactivity After TAVI: A Multicenter Pilot Study [REAC-TAVI]; NCT02224066).

Impact of renin-angiotensin system inhibitors on clinical outcomes and ventricular remodelling after transcatheter aortic valve implantation: rationale and design of the RASTAVI randomised multicentre study.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) as a treatment in severe aortic stenosis (AS) is an excellent alternative to conventional surgical replacement. However, long-term outcomes are not benign. Renin-angiotensin system (RAS) blockade has shown benefit in terms of adverse remodelling in severe AS and after surgical replacement. METHODS AND ANALYSIS: The RAS blockade after TAVI (RASTAVI) trial aims to detect if there is a benefit in clinical outcomes and ventricular remodelling with this therapeutic strategy following the TAVI procedure. The study has been designed as a randomised 1:1 open-label study that will be undertaken in 8 centres including 336 TAVI recipients. All patients will receive the standard treatment. The active treatment group will receive ramipril as well. Randomisation will be done before discharge, after signing informed consent. All patients will be followed up for 3 years. A cardiac magnetic resonance will be performed initially and at 1 year to assess ventricular remodelling, defined as ventricular dimensions, ejection fraction, ventricular mass and fibrosis. Recorded events will include cardiac death, admission due to heart failure and stroke. The RASTAVI Study will improve the management of patients after TAVI and may help to increase their quality of life, reduce readmissions and improve long-term survival in this scenario. ETHICS AND DISSEMINATION: All authors and local ethics committees have approved the study design. All patients will provide informed consent. Results will be published irrespective of whether the findings are positive or negative. TRIAL REGISTRATION NUMBER: NCT03201185.

Consumo intensivo de alcohol y cannabis, y prácticas sexuales de riesgo en estudiantes universitarios / Heavy episodic drinking, cannabis use and unsafe sex among university students

Objetivo: Determinar la incidencia de las prácticas sexuales de riesgo entre universitarios y su asociación con el consumo intensivo de alcohol y el consumo de cannabis. Método: Se realizó un estudio de cohortes entre 2005 y 2011 en universitarios de la Cohorte Compostela (n=517). El consumo intensivo de alcohol se midió con la tercera pregunta del Alcohol Use Disorders Identification Test (AUDIT). Las prácticas sexuales de riesgo se midieron como sexo bajo la influencia del alcohol (SBA) y sexo sin condón (SSC). Se generaron modelos de regresión logística. Resultados: Las incidencias de SBA fueron del 40,9% y 53,0%, y las de SSC del 13,7% y el 25,7%, para mujeres y hombres, respectivamente. El consumo intensivo de alcohol y el consumo de cannabis se han mostrado asociados al SBA tanto en mujeres (odds ratio [OR]=2,08, intervalo de confianza del 95% [IC95%]: 1,03-4,21); OR=2,78, IC95%:1,57-4,92) como en hombres (OR=4,74, IC95%:1,49-15,09; OR=4,37, IC95%:1,17-16,36). El consumo de cannabis en las mujeres también se mostró asociado al SSC (OR=2,96, IC95%:1,52-5,75). Las fracciones atribuibles poblacionales de SBA para el consumo intensivo de alcohol fueron del 24,7% para las mujeres y del 52,9% para los hombres. Conclusiones: El consumo intensivo de alcohol y el consumo de cannabis constituyen problemas de salud pública debido a su asociación con una variedad de problemas, incluidas las prácticas sexuales de riesgo. Nuestros resultados permiten sugerir que una importante proporción de las prácticas de sexo no seguro podrían evitarse reduciendo este patrón de consumo de alcohol (AU)

Objective: the incidence of unsafe sex among university students and its association with heavy episodic drinking (HED) and cannabis use. Method: A cohort study was carried out from 2005 to 2011 among university students of the Compostela Cohort (n=517). HED was measured using the third question of the Alcohol Use Disorders Identification Test (AUDIT). Unsafe sex was considered to be sex under the influence of alcohol (SUA) and sex without a condom (SWC). Logistic regression models were created. Results: The incidence of SUA was 40.9% for women and 53.0% for men, while the SWC incidence ranged from 13.7% for women to 25.7% for men. HED and cannabis use were associated with SUA in both women (OR=2.08, 95% CI: 1.03-4.21; OR=2.78, 95%CI: 1.57-4.92) and men (OR=4.74 (95%CI: 1.49-15.09; OR=4.37, 95%CI: 1.17- 16.36). Moreover, cannabis use in women was associated with SWC (OR=2.96, 95%CI: 1.52-5.75). The population attributable fractions of SUA for HED were 24.7% and 52.9% for women and men, respectively. Conclusions: HED and cannabis use represent a public health problem due to their association with a variety of problems, including engagement in unsafe sex. Our results suggest that a significant proportion of unsafe sex could be avoided by reducing this consumption pattern of alcohol (AU)

[Heavy episodic drinking, cannabis use and unsafe sex among university students]. / Consumo intensivo de alcohol y cannabis, y prácticas sexuales de riesgo en estudiantes universitarios.

OBJECTIVE: To determine the incidence of unsafe sex among university students and its association with heavy episodic drinking (HED) and cannabis use. METHOD: A cohort study was carried out from 2005 to 2011 among university students of the Compostela Cohort (n=517). HED was measured using the third question of the Alcohol Use Disorders Identification Test (AUDIT). Unsafe sex was considered to be sex under the influence of alcohol (SUA) and sex without a condom (SWC). Logistic regression models were created. RESULTS: The incidence of SUA was 40.9% for women and 53.0% for men, while the SWC incidence ranged from 13.7% for women to 25.7% for men. HED and cannabis use were associated with SUA in both women (OR=2.08, 95% CI: 1.03-4.21; OR=2.78, 95%CI: 1.57-4.92) and men (OR=4.74 (95%CI: 1.49-15.09; OR=4.37, 95%CI: 1.17- 16.36). Moreover, cannabis use in women was associated with SWC (OR=2.96, 95%CI: 1.52-5.75). The population attributable fractions of SUA for HED were 24.7% and 52.9% for women and men, respectively. CONCLUSIONS: HED and cannabis use represent a public health problem due to their association with a variety of problems, including engagement in unsafe sex. Our results suggest that a significant proportion of unsafe sex could be avoided by reducing this consumption pattern of alcohol.