Optimal timing of influenza vaccination among patients with acute myocardial infarction - Findings from the IAMI trial.

Influenza vaccination reduces the risk of adverse cardiovascular events.The IAMI trial randomly assigned 2571 patients with acute myocardial infarction (AMI) to receive influenza vaccine or saline placebo during their index hospital admission. It was conducted at 30 centers in 8 countries from October 1, 2016 to March 1, 2020. In this post-hoc exploratory sub-study, we compare the trial outcomes in patients receiving early season vaccination (n = 1188) and late season vaccination (n = 1344).The primary endpoint wasthe composite of all-cause death, myocardial infarction (MI), or stent thrombosis at 12 months. Thecumulative incidence of the primary and key secondary endpoints by randomized treatment and early or late vaccination was estimated using the Kaplan-Meier method. In the early vaccinated group, the primary composite endpoint occurred in 36 participants (6.0%) assigned to influenza vaccine and 49 (8.4%) assigned to placebo (HR 0.69; 95% CI 0.45 to 1.07), compared to 31 participants (4.7%) assigned to influenza vaccine and 42 (6.2%) assigned to placebo (HR 0.74; 95% CI 0.47 to 1.18) in the late vaccinated group (P = 0.848 for interaction on HR scale at 1 year). We observed similar estimates for the key secondary endpoints of all-cause death and CV death. There was no statistically significant difference in vaccine effectiveness against adverse cardiovascular events by timing of vaccination. The effect of vaccination on all-cause death at one year was more pronounced in the group receiving early vaccination (HR 0.50; 95% CI, 0.29 to 0.86) compared late vaccination group (HR 0.75; 35% CI, 0.40 to 1.40) but there was no statistically significant difference between these groups (Interaction P = 0.335). In conclusion,there is insufficient evidence from the trial to establish whether there is a difference in efficacy between early and late vaccinationbut regardless of vaccination timing we strongly recommend influenza vaccination in all patients with cardiovascular diseases.

Clinical impact of influenza vaccination after ST- and non-ST-segment elevation myocardial infarction - insights from the IAMI trial.

BACKGROUND: Influenza vaccination early after myocardial infarction (MI) improves prognosis but vaccine effectiveness may differ dependent on type of MI. METHODS: A total of 2,571 participants were prospectively enrolled in the Influenza vaccination after myocardial infarction (IAMI) trial and randomly assigned to receive in-hospital inactivated influenza vaccine or saline placebo. The trial was conducted at 30 centers in eight countries from October 1, 2016 to March 1, 2020. Here we report vaccine effectiveness in the 2,467 participants with ST-segment elevation MI (STEMI, n = 1,348) or non-ST-segment elevation MI (NSTEMI, n = 1,119). The primary endpoint was the composite of all-cause death, MI, or stent thrombosis at 12 months. Cumulative incidence of the primary and key secondary endpoints by randomized treatment and NSTEMI/STEMI was estimated using the Kaplan-Meier method. Treatment effects were evaluated with formal interaction testing to assess for effect modification. RESULTS: Baseline risk was higher in participants with NSTEMI. In the NSTEMI group the primary endpoint occurred in 6.5% of participants assigned to influenza vaccine and 10.5% assigned to placebo (hazard ratio [HR], 0.60; 95% CI, 0.39-0.91), compared to 4.1% assigned to influenza vaccine and 4.5% assigned to placebo in the STEMI group (HR, 0.90; 95% CI, 0.54-1.50, P = .237 for interaction). Similar findings were seen for the key secondary endpoints of all-cause death and cardiovascular death. The Kaplan-Meier risk difference in all-cause death at one year was more pronounced in participants with NSTEMI (NSTEMI: HR, 0.47; 95% CI 0.28-0.80, STEMI: HR, 0.86; 95% CI, 0.43-1.70, interaction P = .028). CONCLUSIONS: The beneficial effect of influenza vaccination on adverse cardiovascular events may be enhanced in patients with NSTEMI compared to those with STEMI.

Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.

BACKGROUND: Observational and small, randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. METHODS: We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI; 99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary end point was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary end points: all-cause death, cardiovascular death, MI, and stent thrombosis. RESULTS: Because of the COVID-19 pandemic, the data safety and monitoring board recommended to halt the trial before attaining the prespecified sample size. Between October 1, 2016, and March 1, 2020, 2571 participants were randomized at 30 centers across 8 countries. Participants assigned to influenza vaccine totaled 1290 and individuals assigned to placebo equaled 1281; of these, 2532 received the study treatment (1272 influenza vaccine and 1260 placebo) and were included in the modified intention to treat analysis. Over the 12-month follow-up, the primary outcome occurred in 67 participants (5.3%) assigned influenza vaccine and 91 participants (7.2%) assigned placebo (hazard ratio, 0.72 [95% CI, 0.52-0.99]; P=0.040). Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59 [95% CI, 0.39-0.89]; P=0.010), rates of cardiovascular death were 2.7% and 4.5%, (hazard ratio, 0.59 [95% CI, 0.39-0.90]; P=0.014), and rates of MI were 2.0% and 2.4% (hazard ratio, 0.86 [95% CI, 0.50-1.46]; P=0.57) in the influenza vaccine and placebo groups, respectively. CONCLUSIONS: Influenza vaccination early after an MI or in high-risk coronary heart disease resulted in a lower risk of a composite of all-cause death, MI, or stent thrombosis, and a lower risk of all-cause death and cardiovascular death, as well, at 12 months compared with placebo. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02831608.

Evaluation of a portable assembly catheter simulator using a 3D-printed heart model for percutaneous transvenous mitral commissurotomy in developing countries: Catheter simulator for PTMC.

AIMS: We developed a catheter simulator for percutaneous transvenous mitral commissurotomy (PTMC) based on the data from a patient with mitral valve stenosis. The simulator has the following characteristics: 1) the simulator is portable and easy to assemble and disassemble, 2) the cardiac portion is created using a 3D-printer, based on patient computed tomography data, 3) the simulator uses a foot-operated water pump to create pulsatile flow, and 4) the fossa ovalis in the atrial septum of the heart model is made of a thin polyurethane membrane and is interchangeable. We aimed to assess the effectiveness of this novel simulator for training in PTMC using the Inoue balloon in developing countries. METHODS AND RESULTS: We used this simulator for training in the National Institute of Cardiovascular Diseases in Bangladesh (13 physicians), and in Kenyatta National Hospital in Kenya (11 physicians). The effectiveness of training was evaluated by questionnaire and the procedure time in simulation. The questionnaire obtained from the trainees showed that the model scored 4.7±0.5 for realism, utility of pulsatile flow scored 4.7±0.5, simulator utility scored 4.9±0.3, and the effect of training on PTMC performance scored 4.9±0.5. The procedure time in simulation was shortened from 30.0±12.6 min (first time), to 23.4±11.9 min (second time) and to 20.4 ± 11.1 min (third time) (p<0.01). CONCLUSIONS: The novel portable assembly catheter simulator using a 3D-printed heart model for PTMC received positive comments and improved the skills of trainees.

Unprotected left main percutaneous coronary intervention in a 108-year-old patient.

With the increase in life expectancy, the proportion of very elderly people is increasing. Coronary artery disease (CAD) is an important cause of mortality and morbidity in this age group, for which myocardial revascularization is often indicated. Percutaneous coronary intervention (PCI) in the very elderly bears the inherent risks of complications and mortality, but the potential benefits may outweigh these risks. A number of observational studies, registries, and few randomized controlled trials have shown the safety and feasibility of PCI in octogenarians and nonagenarians. However, PCI is only rarely done in centenarians; so, the outcome of percutaneous coronary revascularization in this age group is largely unknown. PCI in a centenarian with complex CAD is described here; the patient presented with unstable angina despite optimum medical therapy, and surgery was declined. Good angiographic success was followed by non-cardiac complications, which were managed with a multidisciplinary approach.

Recurrent Deep Vein Thrombosis due to Thrombophilia.

Deep vein thrombosis (DVT) is a common condition that is often under-diagnosed. Acquired or hereditary defects of coagulation or a combination of these defects may facilitate the development of DVT. Recurrent DVT, a positive family history or unusual presentation may warrant investigation for hereditary thrombophilia. Investigations are best when conducted at least one month after completion of a course of anticoagulant therapy. Most patients are managed with heparin in the acute stage overlapped by warfarin. The case presented here describes a 40-year old man undergoing three episodes of DVT. Investigations revealed protein C and protein S deficiency. Protein C, protein S and antithrombin deficiency either singly or in combination, are relatively common causes of hereditary thrombophilia. The case presented here serves as a reminder of the need to look into the underlying cause of venous thromboembolism.

A young male with familial hypercholesterolemia.

A nine-year-old Bangladeshi male with a body mass index 16.5 kg/m(2) presented with progressive tuberous xanthomata on both auricles, elbows, gluteal regions and legs since birth. His father, paternal and maternal grandfather had xanthelasma, however, the siblings had none. Examination of the cardiovascular system was otherwise normal. Laboratory investigations were performed on several occasions since he was 4 years of age and revealed extreme dyslipidaemia with very high total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), apolipoprotein B (Apo-B) and lipoprotein(a), and low apolipoprotein-A (Apo-A) levels. Repeated combination of lipid lowering agents with cholestyramine, atorvastatin and ezetimibe were virtually ineffective in improving the lipid profiles. Supplementation therapy with niacin also had no effect. In view of the unavailability in Bangladesh of lipid apheresis, the cornerstone of therapy, the management of the case becomes complicated.

Embolized stent in the coronary circulation "without riding the wire" and its novel management strategy.

We report a unique technique for retrieval of a coronary stent, embolized during percutaneous coronary intervention (PCI), using conventional angioplasty wires and angioplasty balloon catheters. In this case, the stent embolized into the distal left main and proximal left circumflex arteries. As the guide catheter and percutaneous coronary angioplasty (PTCA) wire were withdrawn from the coronary arteries, the stent was freely floating in the coronary circulation "without riding the wire". It was managed by re-entry of the Intermediate PTCA wire through the stent with the help of an over-the-wire balloon and was successfully deployed across the lesion. Stent embolization, although a very rare event, may lead to devastating consequences. This technique has been demonstrated for the first time and employs readily available tools that are familiar to all operators.

Electrocardiographic prediction of left anterior descending coronary artery occlusion site in acute anterior myocardial infarction.

The complications, therapy and prognosis are significantly determined by the exact location of occlusion site in left anterior descending (LAD) coronary artery in anterior acute myocardial infarction (AMI). This study assessed the role of Electrocardiogram (ECG) as a predictor of coronary artery occlusion site in anterior AMI. Sixty two patients of anterior AMI were divided into two groups according to the occlusion site in relation to first septal and first diagonal branches, proximal--group A and distal--group B. Their initial ECG were analyzed and interpreted. The number of patients having ST elevation in leads aVR and aVL (> or = 0.5 mm) were significantly higher in proximal group compared to distal ones (42.3% vs 2.8% and 73.1% vs 22.2%; p < 0.001). Similarly the number of patients having ST depression in inferior leads, II (> or = 1 mm), III (> or = 1 mm) and aVF (> or = 1 mm) were also significantly higher in proximal group (84.6% vs 22.2%, 88.5% vs 33.3% and 84.6% vs 22.2%; p < 0.001). The sensitivity of ST depression in inferior leads II (> or = 1 mm), III (> or = 1 mm) and aVF (> or = 1 mm) to predict the proximal lesion were 85.0%, 88.0% and 85.0% respectively, whereas specificity were 78.0%, 67.0% and 78.0% respectively. The ST elevation in a VR had 42.0% sensitivity and 97.0% specificity to predict proximal lesion. Similarly ST elevation in aVL (> or = 0.5 mm) had 73% sensitivity and 78% specificity. In anterior AMI, ST elevation in aVR, aVL and ST depression in inferior leads can predict the occlusion site in LAD proximal to first diagonal and first septal branch.