The imprecision of measuring activated clotting time (ACT) from the guiding catheter during percutaneous coronary interventions.

BACKGROUND: Finding the balance between the reduction in ischemic events and bleeding complications is crucial for the success of percutaneous coronary intervention (PCI). The activated clotting time (ACT) is used routinely worldwide to monitor and titrate anticoagulation therapy with unfractionated heparin (UFH) during the procedure. OBJECTIVES: We aimed to test the accuracy of ACT measurements from the guiding catheter compared to the arterial access sheath. METHODS: Patients undergoing PCI with UFH therapy were prospectively enrolled. Blood samples were drawn from the coronary guide catheter and the arterial access sheath. ACT values were determined in the same ACT machine, and potential interactions with clinical variables were analyzed. RESULTS: The study included 331 patients with post PCI ACT measurements. The mean ACT value of the catheter samples was statistically higher than the arterial access sample [294 ± 77 s Vs. 250 ± 60 s, p < 0.001]. The mean difference between the guiding catheter and the arterial line sheath samples was 43 ± 27 s (P < 0.001). We found that in 101/331 [30 %] patients the ACT from the guiding catheter was above 250 s, while from the access sheath it was below 250 s. Notably, in 40/331 [12 %] the ACT from the guiding catheter was above 200 s, while from the access sheath it was below 200 s. CONCLUSIONS: Large proportion of patient may be considered to have therapeutic ACT if measured from guide catheter during PCI, while the corresponding ACT from arterial sheath is subtherapeutic. This difference may have clinical and safety significance.

Catheter ablation of atrioventricular nodal reentrant tachycardia, when AVNRT presented as a fetus or infant.

BACKGROUND: Atrioventricular nodal reentrant tachycardia (AVNRT) does not commonly present during infancy. Although relative safety of catheter ablation of AVNRT has been demonstrated in pediatrics, this procedure is rarely indicated in children <15 kg. METHODS: Retrospective review of seven cases of AVNRT that presented in children younger than 1 year of age and required catheter ablation for definitive management. Electrophysiology (EP) study was planned with two or three catheters. Area of ablation determined by voltage mapping, propagation sinus wave collision and slow pathway potential location. Ablation performed with cryothermal energy. No fluoroscopy was used. RESULTS: Presentation ranged from 36 weeks of gestation to 11 months of age. Two presented in fetal life and two in the neonatal period. The median age of ablation was 20 months (range 17-31 months). The median weight at ablation was 11.4 kg (range 8.9-14.9 kg). Median follow-up time was 16 months. All had typical AVNRT. The median tachycardia cycle length was 216 ms. 100% successful rate using cryoablation. No complications. No recurrence of tachycardia during the follow-up period. CONCLUSION: Slow AV nodal pathway cryoablation may be safely performed, with good short and medium-term outcomes in patients under 15 kg.

Adaptation and Validation of the Falls Efficacy Scale-International (FES-I) in Community-Dwelling Older Mexican Adults.

The objective of this study was to evaluate the reliability and validity of the FES-I scale in community-dwelling older Mexican adults. Participants were 222 older adults, with a mean age of 70 years; 75% were women who completed a sociodemographic data sheet, a Spanish version of the FES-I scale, intended to explore measures of depression, quality of life, and instrumental activities of daily living. Discriminant validity was demonstrated for all items on the FES-I scale and when groups of older adults were compared according to age. Evidence of internal consistency was found in all the items of the FES-I scale (α = .91) and convergent and divergent validity of the FES-I scale with measures of depression and quality of life, except instrumental activities of daily living. The Confirmatory Factor Analysis shows that the FES-I scale partially retains its two-factor measurement properties since five items were removed from the model to fit the data. The FES-I scale is a valid and reliable measure for clinical evaluations of fear of falls in older Mexican adults in the community.

Harms of third- and fourth-generation combined oral contraceptives in premenopausal women: A systematic review and meta-analysis.

We assessed the available evidence regarding adverse effects on surrogate and patient-important health outcomes of third- and fourth-generation combined oral contraceptives among premenopausal women. We performed a systematic review and meta-analysis including randomized controlled trials and observational studies comparing third- and fourth-generation combined oral contraceptives with other generation contraceptives or placebo. Studies that enrolled women aged 15 to 50 years, with at least three cycles of intervention and 6 months of follow-up were included. A total of 33 studies comprising 629,783 women were included. Low-density lipoprotein cholesterol levels were significantly lower in fourth-generation oral contraceptives (mean differences (MD): -0.24 mmol/L; [95% CI -0.39 to -0.08]), while total cholesterol was significantly increased in levonorgestrel users when compared to third-generation oral contraceptives (MD: 0.27 mmol/L; [95% CI 0.04 to 0.50]). A decreased arterial thrombosis incidence was shown in fourth-generation oral contraceptive users, as compared to levonorgestrel (incidence rate ratio (IRR): 0.41; [95% CI 0.19 to 0.86]). No difference was found in the occurrence of deep venous thrombosis between fourth-generation oral contraceptives and levonorgestrel users (IRR: 0.91; [95% CI 0.66 to 1.27]; p = 0.60; I2 = 0%). Regarding the remaining outcomes, data were heterogeneous and showed no clear difference. In premenopausal women, the use of third- and fourth-generation oral contraceptives is associated with an improved lipid profile and lower risk of arterial thrombosis. Data were inconclusive regarding the rest of outcomes assessed. This review was registered in PROSPERO with CRD42020211133.

Clinical Use of CathPCI Registry Risk Score and Its Validation to Predict Long-Term Mortality.

Risk models to estimate percutaneous coronary intervention (PCI) mortality have limited value in complex high-risk patients. However, it was improved by a recently developed bedside model to predict in-hospital mortality using data from the American College of Cardiology CathPCI Registry that included 706,263 patients. The median risk-standardized in-hospital mortality rate was 1.9%. In an attempt to validate this model in patients admitted because of acute coronary ischemia to predict in-hospital, 30-day, and 1-year mortality, we applied the proposed risk score to the study population of the Acute Coronary Syndrome Israeli Survey (ACSIS). This study was conducted for 2 months in 2018 and included all patients admitted to 25 coronary care units and cardiology departments in Israel. The ACSIS included 1,155 patients admitted because of acute myocardial infarction and who underwent PCI. In-hospital, 30-day, and 1-year mortality were 2.3%, 3.1%, and 6.2%, respectively. The CathPCI risk score yielded an area under the receiver operating characteristic curve of 0.96 (95% confidence interval [CI] 0.94 to 0.99) for in-hospital mortality; 0.96 (95% CI 0.94 to 0.98) for the 30-day mortality, and 0.88 (95% CI 0.83 to 0.93) for the 1-year mortality. The current model also included frail patients, and those with aortic stenosis, refractory shock, and after cardiac arrest. In conclusion, the CathPCI Registry risk score was validated using data from the ACSIS. Because the ACSIS population comprised patients with acute ischemia including those with high-risk features this model demonstrates a wider scope of application compared with previous ones. In addition, the model seems to be suitable to predict also the 30-day and 1-year mortality.

Coronary stent failure: role of a blended approach with drug-coated balloons for complex lesions.

The management of coronary artery disease by means of percutaneous approach have been focused initially to overcome the recoil and acute occlusion after vessel ballooning; therefore, to develop and improve metallic stent platforms, and later drug-eluting technologies. Contemporarily, the necessity emerged to optimize interventional procedures using functional physiologic tests and intravascular imaging guidance, but still stent failures, especially in the complex lesion setting, continue to be not negligible. This comprehensive review is focused on the technology of drug-coated balloons as a tool to treat coronary artery disease without the need for metal implantation but still eluting antirestenotic drugs such as paclitaxel or sirolimus. We delve into these technologies, the drugs, the technical aspects of the deployment and the most updated evidence also proposing a dedicated interventional algorithm. There is solid data to support the use of drug-coated balloons in patients with in-stent restenosis and de-novo small coronary artery disease but also new evidence with promising results from recent studies indicate the feasibility of this approach in complex coronary interventions, bifurcation lesions and larger coronary vessels. In this state-of-the-art review, we also propose a blended approach based on the combination of drug-eluting stents and drug-coated balloons, keeping in mind the necessity to reduce the total stent length in order to reduce the long-term risk of complications.

Predictors, Outcomes and Impact of Mechanical Circulatory Support of Patients With Mechanical Complications After Acute Myocardial Infarction.

BACKGROUND: Despite early and currently effective epicardial coronary recanalization, the mortality rate after mechanical complication (MC) remains high, especially in cardiogenic shock. There is an increase in the use of mechanical circulatory support in patients with cardiogenic shock and MC, however, evidence is still scarce and most studies exclude patients with mechanical complications. METHODS: Using the National Inpatient Sample database from 2015 to 2018 to identify patients with AMI, we aimed to determine the predictors and outcomes of patients with MC, subtypes and the use of MCS. RESULTS: We identified 2,427,315 patients with AMI; 2345 (0.1 %) developed MC and of them 1320 (56.3 %) received MCS. Regarding subtypes, 960 (40.9 %) had ventricular septal rupture (VSR), 540 (23.0 %) papillary muscle rupture (PMR), 530 (22.6 %) pseudoaneurysm, and 315 (13.4 %) free wall rupture (FWR). Mortality was 12 times higher (OR: 11.663, CI: 10.582-12.855, p < 0.001) in patients with MC compared to patients without MC (49.7 % vs. 4.6 %, p < 0.001) and all subtypes of MC showed a significant increase in mortality. The use of MCS was associated with decreased mortality in PMR (46.2 % to 34.8 %, p = 0.009) and pseudoaneurysm (64.7 % to 42.1 %, p < 0.001), however, with higher mortality in VSR. CONCLUSIONS: The incidence of MC after an AMI is very low, nonetheless the in-hospital mortality rate remains very high. It tends to occur more in older patients and with fewer comorbidities. The subtype with the highest frequency and highest mortality was VSR. The use of mechanical circulatory support was associated with better survival in PMR and pseudoaneurysm, but not overall survival.

Efectos del aislamiento social en el estado cognitivo de personas mayores de 65 años durante la pandemia SARS-CoV-2: estudio comparativo longitudinal / Effects of social isolation on the cognitive status of people over 65 years of age during the SARS-CoV-2 pandemic: A longitudinal comparative study

Introduction The SARS-CoV-2 pandemic has affected the entire population, especially vulnerable people with risk factors, such as people over 65 years. Globally and nationally, health protection measures were established to reduce transmission and the impact of the disease on the healthcare system, such as using face masks, hand washing, and social distancing, among others. This led to restrictions on activities outside the home, which affected the cognitive sphere of the population, especially people over 65 years of age. Objective To demonstrate that social isolation causes changes in the cognitive status of people over 65 years of age. Methods A longitudinal study was conducted from 2019 to 2020, with the participation of 37 older adults in a parish club of support activities who voluntarily agreed to participate by signing the informed consent form. The Folstein Mini-Mental State Examination was administered to all of them at two points in the study: before the pandemic and after six months of strict social isolation established as a control measure for the SARS-CoV-2 pandemic. We looked for cognitive status differences during this period and studied qualitative-quantitative sociodemographic variables. Results The club members were older people, predominantly women. Mean age of the participants was 75.4 years; 89.2% had little schooling (less than ten years of formal education). Identified prevalent diseases were arterial hypertension and type-2 diabetes mellitus. In the first evaluation, six out of thirty-seven participants had slight cognitive deficits (16.2%), all females; there were no cases of cognitive impairment; the rest had normal cognitive status (31 out of 37, or 83.8%). After the second evaluation (at the end of strict isolation due to the pandemic), we observed that 11 (29.7%) participants had slight cognitive deficits (ten female and one male), which represents an increase of 13.5%. In addition, four participants (10.8%) showed mild cognitive impairment, all females. Such changes were statistically significant (p-value < 0.05). We conclude that social isolation due to the SARS-CoV-2 pandemic was related to changes in the cognitive status of the elderly.

Introducción La pandemia por SARS-CoV-2, ha afectado a toda la población, especialmente a personas vulnerables y con factores de riesgo, como las personas mayores de 65 años. A nivel mundial y nacional se establecieron medidas de protección sanitaria como medio para reducir la transmisión y el impacto de la enfermedad en el sistema de salud como uso de mascarilla, lavado de manos, distanciamiento social, entre otros. Esto generó restricciones en las actividades fuera del hogar, lo que afectó el aspecto cognitivo de la población, especialmente a las personas mayores de 65 años. Objetivo Demostrar que el aislamiento social genera cambios en el estado cognitivo de las personas mayores de 65 años. Metodología Se realizó un estudio longitudinal en el periodo de 2019 a 2020, con la participación de 37 personas mayores pertenecientes a un club parroquial de actividades de apoyo, quienes aceptaron participar voluntariamente mediante firma del consentimiento informado. A todos se les aplicó el en dos momentos del estudio: previo a la pandemia y al cabo de seis meses del aislamiento social estricto establecido como medida de control de la pandemia por SARS- CoV-2. En dicho período se buscaron diferencias en el estado cognitivo y también se estudiaron variables sociodemográficas cuali-cuantitativas. Resultados Los integrantes del club son personas mayores, predominantemente mujeres. El promedio de edad de los participantes fue de 75,4 años; el 89,2% tenía escolaridad baja (menos de 10 años de educación). Las enfermedades prevalentes identificadas fueron: hipertensión arterial y diabetes mellitus tipo-2. En la primera evaluación se observó que 6 de 37 participantes presentaron ligero déficit cognitivo (16,2%), todas de sexo femenino; no hubo casos con deterioro cognitivo; los demás tuvieron estado cognitivo normal (31 de 37, es decir 83,8%). Tras la segunda evaluación (al finalizar el aislamiento estricto por la pandemia), se observó que 11 (29,7%) personas registraron ligero déficit cognitivo (10 mujeres y 1 hombre), lo que implica un incremento de 13,5%. Además, se identificaron cuatro casos (10,8%) de los participantes que presentaron deterioro cognitivo leve, todas fueron de sexo femenino. Tales cambios fueron estadísticamente significativos (valor p < 0,05). Se concluye que el aislamiento por la pandemia de SARS-CoV-2 está relacionado con cambios en el estado cognitivo de las personas mayores.

Effects of social isolation on the cognitive status of people over 65 years of age during the SARS-CoV-2 pandemic: A longitudinal comparative study. / Efectos del aislamiento social en el estado cognitivo de personas mayores de 65 años durante la pandemia SARS-CoV-2: estudio comparativo longitudinal.

Introduction: The SARS-CoV-2 pandemic has affected the entire population, especially vulnerable people with risk factors, such as people over 65 years. Globally and nationally, health protection measures were established to reduce transmission and the impact of the disease on the healthcare system, such as using face masks, hand washing, and social distancing, among others. This led to restrictions on activities outside the home, which affected the cognitive sphere of the population, especially people over 65 years of age. Objective: To demonstrate that social isolation causes changes in the cognitive status of people over 65 years of age. Methods: A longitudinal study was conducted from 2019 to 2020, with the participation of 37 older adults in a parish club of support activities who voluntarily agreed to participate by signing the informed consent form. The Folstein Mini-Mental State Examination was administered to all of them at two points in the study: before the pandemic and after six months of strict social isolation established as a control measure for the SARS-CoV-2 pandemic. We looked for cognitive status differences during this period and studied qualitative-quantitative sociodemographic variables. Results: The club members were older people, predominantly women. Mean age of the participants was 75.4 years; 89.2% had little schooling (less than ten years of formal education). Identified prevalent diseases were arterial hypertension and type-2 diabetes mellitus. In the first evaluation, six out of thirty-seven participants had slight cognitive deficits (16.2%), all females; there were no cases of cognitive impairment; the rest had normal cognitive status (31 out of 37, or 83.8%). After the second evaluation (at the end of strict isolation due to the pandemic), we observed that 11 (29.7%) participants had slight cognitive deficits (ten female and one male), which represents an increase of 13.5%. In addition, four participants (10.8%) showed mild cognitive impairment, all females. Such changes were statistically significant (p-value < 0.05). We conclude that social isolation due to the SARS-CoV-2 pandemic was related to changes in the cognitive status of the elderly.

Introducción: La pandemia por SARS-CoV-2, ha afectado a toda la población, especialmente a personas vulnerables y con factores de riesgo, como las personas mayores de 65 años. A nivel mundial y nacional se establecieron medidas de protección sanitaria como medio para reducir la transmisión y el impacto de la enfermedad en el sistema de salud como uso de mascarilla, lavado de manos, distanciamiento social, entre otros. Esto generó restricciones en las actividades fuera del hogar, lo que afectó el aspecto cognitivo de la población, especialmente a las personas mayores de 65 años. Objetivo: Demostrar que el aislamiento social genera cambios en el estado cognitivo de las personas mayores de 65 años. Metodología: Se realizó un estudio longitudinal en el periodo de 2019 a 2020, con la participación de 37 personas mayores pertenecientes a un club parroquial de actividades de apoyo, quienes aceptaron participar voluntariamente mediante firma del consentimiento informado. A todos se les aplicó el en dos momentos del estudio: previo a la pandemia y al cabo de seis meses del aislamiento social estricto establecido como medida de control de la pandemia por SARS- CoV-2. En dicho período se buscaron diferencias en el estado cognitivo y también se estudiaron variables sociodemográficas cuali-cuantitativas. Resultados: Los integrantes del club son personas mayores, predominantemente mujeres. El promedio de edad de los participantes fue de 75,4 años; el 89,2% tenía escolaridad baja (menos de 10 años de educación). Las enfermedades prevalentes identificadas fueron: hipertensión arterial y diabetes mellitus tipo-2. En la primera evaluación se observó que 6 de 37 participantes presentaron ligero déficit cognitivo (16,2%), todas de sexo femenino; no hubo casos con deterioro cognitivo; los demás tuvieron estado cognitivo normal (31 de 37, es decir 83,8%). Tras la segunda evaluación (al finalizar el aislamiento estricto por la pandemia), se observó que 11 (29,7%) personas registraron ligero déficit cognitivo (10 mujeres y 1 hombre), lo que implica un incremento de 13,5%. Además, se identificaron cuatro casos (10,8%) de los participantes que presentaron deterioro cognitivo leve, todas fueron de sexo femenino. Tales cambios fueron estadísticamente significativos (valor p < 0,05). Se concluye que el aislamiento por la pandemia de SARS-CoV-2 está relacionado con cambios en el estado cognitivo de las personas mayores.

Risk of ionizing radiation in pregnancy: just a myth or a real concern?

There are natural concerns regarding the risks posed to the foetus by ionizing radiation exposure during pregnancy. Therefore, many female physicians select to avoid working in an environment associated with ionizing radiation exposure like the catheterization laboratory and even exclude training as electrophysiology, interventional cardiologists, or radiologists. For those already working in this field, pregnancy involves usually a 1-year interruption (pregnancy and maternity leave) to their careers, leading at times to delays in the decision to become pregnant. This review describes the low added risk of malformation/cancer in the offspring, highlight gaps in our understanding, discuss several common wrong beliefs, and recommend how to further decrease radiation dose, especially during pregnancy.

HOMA-IR as a predictor of Health Outcomes in Patients with Metabolic Risk Factors: A Systematic Review and Meta-analysis.

INTRODUCTION: There exists clinical interest in the following question: Is there an association between HOMA-IR and the risk of developing metabolic diseases? AIMS: Assessing the association between high values of HOMA-IR with the incidence of T2DM, MACE, essential hypertension, dyslipidemia, NASH, and cancer in healthy participants and participants with a component of metabolic syndrome. METHODS: Databases were searched by an experienced librarian to find eligible studies. Observational cohort studies enrolling healthy adults and adults with metabolic syndrome components that evaluated HOMA as a marker of IR were considered for inclusion. Eligibility assessment, data extraction and risk of bias assessment were performed independently and in duplicate. Baseline characteristics of patients, cutoff values of HOMA-IR to predict metabolic events were extracted independently and in duplicate. RESULTS: 38 studies (215,878 participants) proved eligible. A higher HOMA-IR value had a significant effect on the risk of developing T2DM (HR 1.87; CI 1.40-2.49), presenting non-fatal MACE (HR 1.46; CI 1.08-1.97) and hypertension (HR 1.35; CI 1.15-1.59). No association was found regarding cancer mortality and fatal MACE with higher HOMA-IR values, there was not enough information to carry out a meta-analysis to establish an association between higher values of HOMA with cancer incidence, dyslipidemia, and NASH. CONCLUSIONS: High values of HOMA were associated with an increased risk of diabetes, hypertension, and non-fatal MACE; yet, not for cardiovascular or cancer mortality. More research is needed to determine the value of the HOMA index in metabolic and cardiovascular outcomes. PROSPERO REGISTRATION NUMBER: CRD42020187645.

Pediatric Micra leadless pacemaker implantation via internal jugular and femoral veins: experience with 11 patients.

In pediatrics, conventional transvenous and epicardial pacemaker systems carry complications, such as lead distortion due to growth and activity, in addition to lead and pocket complications. A retrospective review of pediatric leadless pacing at the University of Minnesota Masonic Children's Hospital (MN, USA) from 2018 through 2021 was performed. Diagnoses, rationale for pacing, demographics, pacing thresholds and longevity of devices were recorded. Twelve leadless pacemaker insertions and one removal were performed successfully in patients weighing 19-90 kg. Six patients had Micra implantation via the internal jugular vein without surgical cut-down. Up to 3 years of follow-up were noted, with median follow-up of 22 months. No late complications occurred. Leadless pacemaker implantation and early retrieval were feasible in pediatric patients.

Pacemaker placement has been the standard of care for patients when the top and bottom chambers of the heart are not communicating electrically. Patients can either be born with this, or it can happen after heart surgery. Traditional pacemaker technique involves placing wires (leads) through veins to the heart and surgically implanting a generator in the body. This carries a risk of complications, mainly lead dislocation and fracture with growth and activity. The Micra leadless pacemaker mitigates this risk and can be implanted into the muscle of the right ventricle. There are currently only small case series and reports in the literature on Micra pacemaker implantation in pediatric patients with congenital heart disease. We implanted 12 such devices in 11 pediatric patients weighing 19­90 kg. Six of these implantations were deployed using the internal jugular vein and were successful. One patient had a pericardial effusion at the time of implantation. Overall, leadless pacemaker implantation in the pediatric population with congenital heart disease is feasible, but further data are needed to assess long-term safety.

Conduction System Pacing in Pediatrics and Congenital Heart Disease, a Single Center Series of 24 Patients.

His-bundle pacing has demonstrated feasibility in numerous adult studies to reverse and prevent pacing-induced cardiomyopathy, however, is met with higher capture thresholds with deployment sheaths designed for adults with his-bundles in the typical location. To describe 24 pediatric and adult congenital patients post-physiologic pacing. Patients at the University of Minnesota Masonic Children's Hospital with congenital complete heart block or congenital heart disease and atrioventricular block presented for pacemaker placement between November 2019 and January 2021. Twenty-four patients had attempted his-bundle placement using either Medtronic's C315 or C308 sheaths and 3830 leads except for 3 patients who had Boston Scientific's His system with the Shape 3 sheath and 7842 leads. Twenty-four total patients underwent physiologic pacing (23 his-bundle, 13 female, 11 male) with median age of 14 years (range 8-39 years) with median weight of 51 kg (range 21.2-81 kg) with five right-sided implants performed. Twelve patients had congenital heart disease including atrioventricular canal defects, tetralogy of Fallot, and ventricular septal defect repairs (nine patients with ventricular septal defect repairs). Twelve patients had selective His-bundle pacing (six with congenital heart disease). Median threshold to capture was 0.5 V at 0.4 ms (range 0.4 to 1.1 V at 0.4 ms), impedance 570 ohms (range 456-1140 ohms), and sensing median of 9.7 mV (range 1.5-13.8 mV if present). The median follow-up time was 610 days (range 240-760 days). No complications occurred peri-procedurally or during follow-up. His-bundle pacing is feasible in pediatric and congenital heart disease patients.

Drug-coated balloon for the management of coronary chronic total occlusions.

There is a higher rate of successful recanalization of patients with coronary chronic total occlusions, nevertheless, the rate of patients referred for revascularization remains low. In addition, there is a greater need to improve long-term outcomes of chronic total occlusions after percutaneous coronary intervention, and although the implantation of new-generation drug-eluting stents has been optimized with coronary imaging guidance, the rate of stenting failure remains a major issue and long-term vessel patency could be improved. We reviewed clinical data regarding the benefit of treating chronic total occlusions and the use of drug-coated balloons as an alternative therapeutic modality in this setting. Although clinical data is limited, the initial evidence and the daily clinical practice point towards a synergistic hybrid treatment strategy based on the combination of drug-coated balloons plus drug-eluting stents, reducing the total stent length and maintaining the scaffolding properties of stents where it is mandatory. Additionally, drug-coated balloons allow natural enlargement of the open vessel after percutaneous coronary intervention (PCI), which is a major limitation of stents in chronic total occlusion (CTO).

Trends of sources of clinical research funding from 1990 to 2020: a meta-epidemiological study.

Evidence has raised concerns regarding the association between funding sources and doubtful data. Our main outcome was to analyze trends on funding sources in articles published from 1990 to 2020 in the more influential journals of internal and general medicine. In this meta-epidemiological study, we included peer-reviewed studies from the 10 highest impact journals in general and internal medicine published between January 1990 and February 2020 based on published original research according to the 2018 InCites Journal of Citation Reports, these consisted of the following: The New England Journal of Medicine, The Lancet, JAMA, BMJ, JAMA Internal Medicine, Annals of Internal Medicine, PLOS Medicine, Cachexia, BMC Medicine, and Mayo Clinic Proceedings Two reviewers working in duplicate extracted data regarding year of publication, study design, and sources of funding. In total, 496 articles were found; of these, 311 (62.7%) were observational studies, 167 (33.7%) were experimental, and 16 (3.2%) were secondary analyses. Percentages of grant sources through the years were predominantly from government (60%), industry (23.83%), and non-governmental (16.06%) organizations. The percentage of industry subsidies tended to decrease, but this was not significant in a linear regression model (r=0.02, p≥0.05). Government and non-government funding sources showed a trend to decrease in the same univariate analysis with both significant associations (r=0.21, p≤0.001 and r=0.10, p≤0.001, respectively). The main funding source in medical research has consistently been government aid. Despite previous reported data, no association was found between the source of funding and statistically significant results favoring study authors' hypothesis.

Efficacy and Safety of a Dedicated Left Atrial Appendage Occlusion Protocol.

OBJECTIVES: The aim of this study is to present a dedicated left atrial appendage closure protocol, which could be of great interest in the approach of frail patients. BACKGROUND: Left atrial appendage (LAA) occlusion emerged as a promising therapeutic tool for stroke prevention, as most of the atrial fibrillation (AF) related strokes result from LAA thromboembolism, with an important residual risk even for anticoagulated patients. As an internationally recognized and scientifically-based protocol for the patients with higher comorbidities has not yet been defined for this procedure in terms of anaesthesia use or post procedural antithrombotic therapy and follow-up, we developed a dedicated protocol that could be applied in frail patients. In this study we describe the mid-term outcome of our strategy. METHODS: We enrolled 32 patients that underwent percutaneous LAA occlusion under transesophageal echocardiogram guidance, using only superficial sedation. A dedicated anti-thrombotic regimen was chosen for all patients, taking into consideration their bleeding and thrombotic risk profile. All patients routinely performed echocardiography after 3 months follow-up. RESULTS: Procedural success was achieved in all cases, except for one, due to extreme angulation of the LAA neck, while one patient required general anaesthesia. Only 9.4% of the patients, having previous stroke and still at high risk for cardio-embolic events, continued anticoagulation, while 31.2% discontinued any anti-thombotic drug. While no in-hospital complication was encountered, we found one asymptomatic device-thrombosis, managed by 30 days anticoagulation. No deaths, strokes or major bleedings occurred during an average 10.3 months of follow-up. CONCLUSIONS: A tailored post-implantation anti-thrombotic regimen and the avoidance of general anaesthesia can be a safe and effective strategy for the usually frail patients requiring percutaneous LAAO.

Balloon aortic valvuloplasty review: the revenge during COVID-19 outbreak?

Aortic stenosis is a highly prevalent cardiac valvular disease in adult population and increases with age. After symptoms onset in severe aortic stenosis, the prognosis begins to decline; however, new studies demonstrate an increased risk of death in patients with moderate disease. Although majority of patients with severe aortic stenosis are treated electively with surgical or transcatheter aortic valve replacement, not all patients are candidates for the interventions. Balloon aortic valvuloplasty can be used successfully as a bridge to definitive treatment or as palliative therapy in patients who are not candidates for either procedure. In this paper, we discuss and justify the current indications and contraindications for balloon aortic valvuloplasty. Additionally, the step-by-step procedure technique and most frequent complications are described. Moreover, we presented the safety and feasibility of balloon aortic valvuloplasty in 33 consecutive patients on a waiting list for transcatheter aortic valve replacement at 3 expert Italian centers during the first and second waves of COVID-19, when clinical priorities focused on hospitalized patients with pneumonia. The procedural success in this cohort of patients was achieved in 31 patients (94%). Out of the 33 patients enrolled, 15 underwent TAVR within 5±2 months from the valvuloplasty, and at 6-month follow-up a total of 2 patients died for end-stage heart failure.