Position statement from the Indian Society of Gastroenterology, Cardiological Society of India, Indian Academy of Neurology and Vascular Society of India on gastrointestinal bleeding and endoscopic procedures in patients on antiplatelet and/or anticoagulant therapy.

Antiplatelet and/or anticoagulant agents (collectively known as antithrombotic agents) are used to reduce the risk of thromboembolic events in patients with conditions such as atrial fibrillation, acute coronary syndrome, recurrent stroke prevention, deep vein thrombosis, hypercoagulable states and endoprostheses. Antithrombotic-associated gastrointestinal (GI) bleeding is an increasing burden due to the growing population of advanced age with multiple comorbidities and the expanding indications for the use of antiplatelet agents and anticoagulants. GI bleeding in antithrombotic users is associated with an increase in short-term and long-term mortality. In addition, in recent decades, there has been an exponential increase in the use of diagnostic and therapeutic GI endoscopic procedures. Since endoscopic procedures hold an inherent risk of bleeding that depends on the type of endoscopy and patients' comorbidities, in patients already on antithrombotic therapies, the risk of procedure-related bleeding is further increased. Interrupting or modifying doses of these agents prior to any invasive procedures put these patients at increased risk of thromboembolic events. Although many international GI societies have published guidelines for the management of antithrombotic agents during an event of GI bleeding and during urgent and elective endoscopic procedures, no Indian guidelines exist that cater to Indian gastroenterologists and their patients. In this regard, the Indian Society of Gastroenterology (ISG), in association with the Cardiological Society of India (CSI), Indian Academy of Neurology (IAN) and Vascular Society of India (VSI), have developed a "Guidance Document" for the management of antithrombotic agents during an event of GI bleeding and during urgent and elective endoscopic procedures.

Clinical relevance of double-arm blood pressure measurement and prevalence of clinically important inter-arm blood pressure differences in Indian Primary Care.

Hypertension guidelines recommend measuring blood pressure (BP) in both arms at least once. However, this is seldom done due to uncertainties regarding measurement procedure and the implications of finding a clinically important inter-arm BP difference (IAD). This study aimed to provide insight into the prevalence of clinically important IADs in a large Indian primary care cohort. A number of 134678 (37% female) unselected Indian primary care participants, mean age 45.2 (SD 11.9) years, had BP measured in both arms using a standardized, triplicate, automated simultaneous measurement method (Microlife WatchBP Office Afib). On average, there were clinically minor differences in right and left arm BP values: systolic BP 134.4 vs. 134.2 mmHg (p<0.01) and diastolic BP 82.7 vs. 82.6 mmHg (p<0.01), respectively. Prevalence of significant mean systolic IAD between 10 and 15 mmHg was 7813 (5.8%). Systolic IAD ≥ 15 mmHg 2980 (2.2%) and diastolic IAD ≥ 10 mmHg 7151 (5.3%). In total, there were 7595 (5.6%) and 8548 (6.3%) participants with BP above the 140/90 mmHg threshold in only the left or right arm, respectively. Prevalence of participants with elevated BP on one arm only was highest in patients with a systolic IAD ≥ 15 mmHg; 19.1% and 13.7%, for left and right arm, respectively. This study shows that a substantial prevalence of IAD exist in Indian primary care patients. BP is above the diagnostic threshold for hypertension in one arm only for 6% of participants. These findings emphasise the importance of undertaking bilateral BP measurement in routine clinical practice. This article is protected by copyright. All rights reserved.

Clinical relevance of double-arm blood pressure measurement and prevalence of clinically important inter-arm blood pressure differences in Indian primary care.

Hypertension guidelines recommend measuring blood pressure (BP) in both arms at least once. However, this is seldom done due to uncertainties regarding measurement procedure and the implications of finding a clinically important inter-arm BP difference (IAD). This study aimed to provide insight into the prevalence of clinically important IADs in a large Indian primary care cohort. A number of 134 678 (37% female) unselected Indian primary care participants, mean age 45.2 (SD 11.9) years, had BP measured in both arms using a standardized, triplicate, automated simultaneous measurement method (Microlife WatchBP Office Afib). On average, there were clinically minor differences in right and left arm BP values: systolic BP 134.4 vs 134.2 mmHg (p < .01) and diastolic BP 82.7 vs 82.6 mmHg (p < .01), respectively. Prevalence of significant mean systolic IAD between 10 and 15 mmHg was 7,813 (5.8%). Systolic IAD ≥ 15 mmHg 2,980 (2.2%) and diastolic IAD ≥ 10 mmHg 7,151 (5.3%). In total, there were 7,595 (5.6%) and 8,548 (6.3%) participants with BP above the 140/90 mmHg threshold in only the left or right arm, respectively. Prevalence of participants with elevated BP on one arm only was highest in patients with a systolic IAD ≥ 15 mmHg; 19.1% and 13.7%, for left and right arm, respectively. This study shows that a substantial prevalence of IAD exists in Indian primary care patients. BP is above the diagnostic threshold for hypertension in one arm only for 6% of participants. These findings emphasize the importance of undertaking bilateral BP measurement in routine clinical practice.

Have the COVID-19 pandemic and lockdown affected children's mental health in the long term? A repeated cross-sectional study.

OBJECTIVE: The study aimed to evaluate the impact of the COVID-19 pandemic on levels of anxiety and depressive symptoms in children and adolescents. DESIGN: Cross-sectional surveys were carried out on the mental health of children; one survey was conducted before the COVID-19 pandemic and one into the pandemic, 15 months after the school closures and implementation of lockdown and social distancing. Demographic data and COVID-19 pandemic-related data were collected from specific parent-report and self-report questionnaires. PARTICIPANTS: Participants included children and adolescents between ages 6 and 16 years, attending a tertiary care hospital without any diagnosed major psychiatric or chronic disorder. ANALYSIS: Data were collected at two points (before the COVID-19 pandemic and during it) and compared. Levels of anxiety and depressive symptoms were compared and tested for statistically significant differences between these two points using appropriate statistical tests. Regression models were constructed to predict the factors affecting increased anxiety levels and depressive symptoms in the COVID-19 period. RESULTS: 832 and 1255 children/adolescents were included in the study during the pre-COVID-19 and COVID-19 times, respectively. The median age of the participants was 10 years (IQR=4 years). The median (IQR) Spence Children's Anxiety Scale score was 24 (12) at the pre-COVID-19 point and 31 (13) during the COVID-19 pandemic (p<0.001, r=-0.27). 11% and 16% of children reported being depressed at these two-time points, respectively (p=0.004, φc=-0.063). Regression analysis showed that many factors, including the duration of smartphone use, female gender and only child status, were associated with increased anxiety or depression levels. CONCLUSION: A large proportion of children had elevated anxiety and depressive symptoms during the pandemic relative to before the pandemic, suggesting a need for measures to engage children in healthy habits to protect children's mental health and continuous monitoring of children during such scenarios.

Serial evaluation of vascular responses after implantation of everolimus-eluting coronary stent by optical coherence tomography.

AIM: To evaluate healing response at strut-level and cross-section level after implanting an ultra-thin strut, everolimus-eluting stent with biodegradable polymer (Tetrilimus) using optical coherence tomography (OCT) at 3 and 6 months. METHODS: This was prospective, multi-centre, single-arm, and investigator-initiated study performed at seven Indian sites between January, 2017 and September, 2018. OCT evaluations were performed in 57 patients who underwent Tetrilimus stent implantation. Follow-up OCT was scheduled at 3 months for first 16 patients and at 6 months for 41 patients. Primary outcomes included degree of strut coverage, malapposition and thickness of neointimal hyperplasia (NIH) over covered struts. RESULTS: Sixty one Tetrilimus stents were implanted to treat 59 lesions in 57 patients. Paired (baseline and follow-up) OCT data was available for 12 patients and 30 patients at 3 and 6 months, respectively. At 3 months, rapid early healing was indicated by 95.48% covered struts per lesion with very low (0.11 ± 0.06 mm) NIH. At 6 months, NIH accumulation was greater (0.21 ± 0.07 mm) as compared to 3 months. 99.77% of struts per lesion were covered at 6 months. There was a very symmetrical healing as shown by very low eccentricity index. There was no difference in vascular healing between stents with small to moderate size vessels (≤3.00 mm) and large size vessels (>3.00 mm). CONCLUSION: Present study demonstrated nearly complete endothelization and low NIH accumulation at 3 and 6 months following implantation of ultra-thin strut everolimus-eluting biodegradable polymer-coated Tetrilimus stent. Moreover, though being an ultra-thin strut stent, there was no difference in vascular healing and eccentricity after implantation of the Tetrilimus stents with smaller and larger diameters.

Blood pressure and heart rate related to sex in untreated subjects: the India ABPM study.

Women are underrepresented in groups of patients seeking hypertension care in India. The present paper reports trends in office and ambulatory blood pressure measurement (OBPM, ABPM) and 24-h heart rate (HR) with sex in 14,977 subjects untreated for hypertension (aged 47.3 ± 13.9 years, males 69.4%) visiting primary care physicians. Results showed that, for systolic blood pressure (SBP), females had lower daytime ABPM (131 ± 16 vs. 133 ± 14 mm Hg, P < .001) but higher nighttime ABPM (122 ± 18 vs. 121 ± 16 mm Hg, P < .001) than males. Females had higher HR than men at daytime (80 ± 11 vs 79 ± 11.5 bpm) and nighttime (71 ± 11 vs 69 ± 11), respectively (all P < .001). Dipping percentages for SBP (7.4 ± 7.3 vs 9.3 ± 7.4%), DBP (10.1 ± 8.6 vs. 12.3 ± 8.9%), and HR (10.7 ± 7.9 vs. 12.8 ± 9.2%) were lower (P < .001) for females than for males, respectively. Females more often had isolated nighttime hypertension as compared to males (14.9%, n = 684% vs 10.6%, n = 1105; P < .001). BP patterns and HR showed clear differences in sex, particularly at nighttime. As females were more often affected by non-dipping and elevated nighttime SBP and HR than males, they should receive ABPM, at least, as frequently as men to document higher risk necessitating treatment.

Paclitaxel-eluting stents versus everolimus-eluting coronary stents in a diabetic population: two-year follow-up of the TUXEDO-India trial.

AIMS: The aim of this study was to report whether the superiority of the everolimus-eluting stent (EES) vs. the paclitaxel-eluting stent (PES) at one-year follow-up in the Taxus Element versus Xience Prime in a Diabetic Population (TUXEDO)-India trial was sustained at longer-term follow-up. METHODS AND RESULTS: One thousand eight hundred and thirty (1,830) patients with diabetes mellitus and coronary artery disease were randomised to EES vs. PES. Follow-up data up to two years were available in 1,701 (92.9%) patients. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischaemia-driven target vessel revascularisation (TVR). Treatment with EES had a lower two-year rate of TVF (4.3% vs. 6.6%, p=0.03). Of the secondary endpoints, EES significantly reduced any MI (1.6% vs. 3.5%, p=0.01), TV-MI (0.7% vs. 3.1%, p=0.0001), ST (0.4% vs. 2.2%, p=0.001), cardiac death or target vessel MI (2.9% vs. 4.8%, p=0.04) and TLR (1.9% vs. 3.7%, p=0.02), compared with PES. Between one year and two years, no significant differences in the clinical outcomes were observed (pinteraction >0.05). CONCLUSIONS: In this adequately powered trial, the benefits of EES vs. PES in a diabetic population seen at one year were maintained at two years.

Percutaneous Coronary Intervention in Patients With Insulin-Treated and Non-Insulin-Treated Diabetes Mellitus: Secondary Analysis of the TUXEDO Trial.

IMPORTANCE: Prior studies have shown that patients with insulin-treated diabetes mellitus (ITDM) have a higher risk of cardiovascular events. However, this finding is controversial, as other studies have shown that the increased risk of cardiovascular events disappears after risk adjustment. In addition, the choice of a drug-eluting stent (limus- vs taxol-eluting) in ITDM is controversial, with studies showing worse outcomes with an everolimus-eluting stent compared with a paclitaxel-eluting stent. OBJECTIVES: To assess the outcomes of patients with ITDM vs non-ITDM who underwent percutaneous coronary intervention and to assess the efficacy and safety of an everolimus-eluting stent vs a paclitaxel-eluting stent based on insulin use status. DESIGN, SETTING, AND PARTICIPANTS: A prespecified analysis was conducted of the Taxus Element vs Xience Prime in a Diabetic Population (TUXEDO) clinical trial, which enrolled 1830 patients with ITDM and non-ITDM from June 23, 2011, to March 12, 2014. Patients were randomized 1:1 to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. MAIN OUTCOMES AND MEASURES: The primary end point was target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization at 1 year after the intervention. RESULTS: Among the 1830 patients (1377 male) in the TUXEDO trial, 747 patients (40.8%) were receiving insulin (ITDM group). Compared with the 1083 patients with non-ITDM, those with ITDM had a significant increase in target vessel failure (42 [5.6%] vs 36 [3.3%]; P = .02), death or myocardial infarction (43 [5.8%] vs 35 [3.2%]; P = .009), death (26 [3.5%] vs 18 [1.7%]; P = .01), and subacute stent thrombosis (8 [1.1%] vs 3 [0.3%]; P = .03). However, in a propensity score-adjusted analysis to account for baseline differences between the 2 groups, the differences in outcomes were no longer significant. In patients with ITDM, everolimus-eluting stents reduced the rate of target vessel failure (13 of 382 [3.4%] vs 29 of 365 [7.9%]; P = .007), major adverse cardiac events (15 of 382 [3.9%] vs 30 of 365 [8.2%]; P = .01), myocardial infarction (5 of 382 [1.3%] vs 16 of 365 [4.4%]; P = .01), stent thrombosis (2 of 382 [0.5%] vs 11 of 365 [3.0%]; P = .009), target lesion revascularization (4 of 382 [1.0%] vs 19 of 365 [5.2%]; P = .001), and target vessel revascularization (4 of 382 [1.0%] vs 19 of 365 [5.2%]; P = .001) when compared with paclitaxel-eluting stents. The results largely trended in the same direction in patients with non-ITDM (P > .05 for the interaction). CONCLUSIONS AND RELEVANCE: Patients with ITDM had a significant increase in the risk of cardiovascular events in unadjusted models that was largely attenuated after propensity score adjustment. Everolimus-eluting stents reduced the rate of cardiovascular events, including stent thrombosis, when compared with paclitaxel-eluting stents in patients with ITDM. TRIAL REGISTRATION: ctri.nic.in Identifier: CTRI/2011/06/001830.

Missed Kawasaki disease in childhood presenting as myocardial infarction in adults.

Kawasaki disease (KD) is an acute, self-limited vasculitis that occurs in young children and was first described by Japanese pediatrician Tomisaku Kawasaki in 1967. Although originally thought to be a rare condition, KD has become the most common cause of acquired heart disease in the pediatric population in developed countries. The majority of patients with KD appear to have a benign prognosis, but a subset of patients with coronary artery aneurysms are at risk for ischemic events and require lifelong treatment. In the 4 decades since the initial recognition of KD, the number of patients reaching adulthood has continued to grow. Adult cardiologists will be increasingly involved in the management of these patients. Currently, there are no established guidelines for the evaluation and treatment of adult patients who have had KD. We report 4 most probable cases of KD missed in childhood and presented as acute coronary syndrome in adulthood.

Application of 2.0 mm Titanium Plates in Rigid Internal Fixation of Mandibular Angle Fractures.

PURPOSE: The present study aimed to evaluate the efficacy and stability of 2.0 mm Titanium plates in treatment of mandibular angle fractures. MATERIALS AND METHODS: A randomized, prospective study was carried out on 17 patients treated by ORIF with 2.0 mm titanium plates. Operative handling of the plate and clinical stability were qualitatively analyzed. RESULTS: The 2.0 mm plate showed good intra-operative handling and adequate clinical stability with follow up of 6 months showing good soft tissue healing. CONCLUSION: A single 2.0 mm titanium plate provides easy handling and adequate occlusal stability in the post-operative phase as compared to the traditional 2.5 mm plate without post-operative MMF. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12663-010-0128-2) contains supplementary material, which is available to authorized users.

Platelet glycoprotein IIb/IIIa inhibition using eptifibatide with primary coronary stenting for acute myocardial infarction: a 30-day follow-up study.

The results of primary coronary stenting for acute myocardial infarction (AMI) have been reported to improve significantly with the concomitant administration of platelet glycoprotein IIb/IIIa inhibitor abciximab. There are, however, no data available with the use of eptifibatide, a more cost-effective, small-molecule GP IIb/IIIa blocker with a shorter half-life. In a prospective multicenter feasibility and efficacy study, we assigned 55 consecutive patients with AMI being taken up for primary stenting to receive eptifibatide just before the procedure (two boluses of 180 microg/kg 10 min apart and a 24-hr infusion of 2 microg/kg/min). Clinical outcomes were evaluated at 30 days after the procedure. The angiographic patency of the vessel with TIMI flow rates, TIMI myocardial perfusion (TMP) grade, and corrected TIMI frame counts were assessed at the end of procedure and before hospital discharge. At 30 days, the primary endpoint, a composite of death, myocardial infarction, and urgent target vessel revascularization (TVR) was seen in 12.7% of patients. The TIMI 3 and TMP grade 3 flow, which was seen in 93% and 86% of patient, respectively, at the end of the procedure, declined to 86% and 78%, respectively (P < 0.05) before hospital discharge. Corrected TIMI frame counts also decreased from 25.7 +/- 7.2 to 22.9 +/- 6.8 (P < 0.05). There were five (9.1%) instances of subacute thrombosis (SAT) presenting as AMI, needing urgent TVR in all, within 3-5 days of the primary procedure. No excessive bleeding complication, directly attributable to the use of eptifibatide, was observed. The study was terminated prematurely because of an unacceptable SAT rate. Administration of eptifibatide along with primary stenting for AMI is associated with a high TIMI 3 and TMP grade 3 flow acutely. However, these flows decline significantly before hospital discharge and lead to a high rate of SAT. The dosage and duration of infusion of eptifibatide in this setting needs further evaluation.