Applicability of the OPTA Questionnaire for Patients with Stable Ischemic Heart Disease in Indian Clinical Practice: A Cross-sectional, Real-word Evidence Study.

BACKGROUND: Angina is the symptomatic form of stable ischemic heart disease (SIHD). The OPtimal Treatment of Angina (OPTA) questionnaire was developed and validated to overcome the lack of a standardized and accurate tool to assess patients' clinical conditions with SIHD. This study aimed to understand the applicability of OPTA in patients with SIHD in routine clinical practice in India. MATERIALS AND METHODS: In this cross-sectional, single-visit study, 344 patients with SIHD were enrolled. Study endpoints were physicians' agreement on the applicability of OPTA, the usefulness of OPTA in assessing degree of impairment in daily activities of patients, and its positive predictive value (PPV). RESULTS: All enrolled patients completed the study. The mean [standard deviation (SD)] age was 56.6 (10.77) years, with a majority of patients being male (69.5%) and on antianginal treatment for >1 year (80.4%). Physicians of all participating patients agreed that the OPTA questionnaire could accurately assess whether treatment received by patients was optimal (100% agreement rate). No or moderate degree of impairment of daily activities was reported by 93.9% and 73.0% of patients for one and two health-related questions, respectively. The PPV and sensitivity of the questionnaire were 88.97% [confidence interval (CI): 87.58%, 90.22%] and 39.33% (CI: 34.01%, 44.85%), respectively. CONCLUSION: The OPTA questionnaire showed good agreement regarding health status between physicians and patients and could be used to periodically assess and guide clinical judgment in the management of SIHD in India. Further assessment of the impact of various treatments temporally and in the long term may be warranted.

COVID-Inflicted Coagulopathy: Expert Consensus on Management with Novel Oral Anticoagulants in India.

Coronavirus disease 2019 (COVID-19) is a highly hypercoagulable viral infection complicated as COVID-inflicted coagulopathy (CIC), that is associated with increased risk of morbidity and mortality. International guidelines recommend low molecular weight heparin (LMWH) to treat CIC in both in-hospital and in-home settings. However, in India, using subcutaneous LMWH may not be a feasible option for a vast majority of patients under home management. Additionally, while some evidence advocates the use of novel oral anticoagulants (NOACs), in hospitalized settings, most guidelines find no role of NOACs in hospital settings. On the other hand, the resource crunch faced in recent COVID-19 pandemic in India forced physicians to treat many patients in home settings. These patients had been usually prescribed NOACs for ease of administration and adherence. Therefore, there is a need to form a consensus on the use of NOACs to manage CIC in India.

Validation of the OPtimal Treatment of Angina (OPTA) Questionnaire in Indian Patients with Chronic Stable Angina.

BACKGROUND: A rising burden of coronary artery disease (CAD) in India is a major cause of concern, with angina being the leading manifestation. Hence a questionnaire to sensitize the clinicians about stable angina management and to assist in risk stratification is imperative. OBJECTIVE: To evaluate the content and face validity of a modified questionnaire adapted from the 7-item Seattle Angina Questionnaire (SAQ). MATERIALS AND METHODS: A panel of six experts in the field of evidence-based practice reviewed and rated the modified instrument for content clarity and relevance based on the 4-point ordinal scale. Face validity was assessed based on the trichotomous rating of "disagreed", "agree" or "neutral". Items on which ≥75% of patients "disagreed" were subjected to further review and revision. RESULTS: A total of six experts and 51 patients participated in the content and face validity, respectively. As no question received a score ≤2 by two or more experts for either content clarity or relevance, no modification in the questionnaire was required post content validation. During face validation, all patients agreed that the questions correctly measured the specific area of cardiovascular health status and response options correctly captured the answers provided. Demographic and baseline data of the patients were collected. CONCLUSION: The newly developed 5-item questionnaire demonstrated content and face validity, suggesting it to be a potential instrument to improve management decision and care of angina patients in India.

Effectiveness of Olmesartan on Blood Pressure Control in Hypertensive Patients in India: A Real World, Retrospective, Observational Study from Electronic Medical Records.

BACKGROUND: Real-world data on the effectiveness of antihypertensive drugs (AHDs) in India is limited. The present study aims to provide updated evidence regarding the effectiveness of olmesartan as monotherapy or in combination with other AHDs in Indian patients with essential hypertension. METHODS: Electronic medical record data of adult patients who were diagnosed with essential hypertension (≥140/90 mmHg) and were prescribed olmesartan as mono- or add-on therapy were retrospectively analyzed. Patients were classified based on the number of AHD classes prescribed on initiation of olmesartan. Change in systolic and diastolic blood pressure (SBP and DBP) from baseline was the primary endpoint. Secondary endpoint was evaluation of proportion of patients who achieved treatment goals as per 2018 European Society of Cardiology/European Society of Hypertension guidelines. Readings were obtained before initiating olmesartan and after at least a month of therapy with olmesartan. RESULTS: Among the 459 included patients, majority were on olmesartan monotherapy or olmesartan+1AHD (91.7%). Mean (95% confidence interval [CI]) change in olmesartan monotherapy group was: SBP (-13.4 [-15.7, -11.1] mmHg) and DBP (-8.3 [-9.5, -7.1] mmHg) and mean (95% CI) change in olmesartan+1AHD group was: SBP (-11.7 [-15.1, -8.3] mmHg) and DBP (-6.6 [-8.3, -4.9] mmHg) (P<0.001 for all). SBP and DBP goals were achieved by 40.4% and 50.3% of patients on olmesartan monotherapy and by 36.1% and 46.2% of patients on olmesartan+1AHD. Among patients with comorbid diabetes, mean (95% CI) change in olmesartan monotherapy group was: SBP (-15.5 [-18.6, -12.4] mmHg) and DBP (-8.7 [-10.2, -7.2] mmHg) and mean (95% CI) change in olmesartan+1AHD group was: SBP (-13.5 [-18.3, -8.7] mmHg) and DBP (-7.6 [-9.8, -5.4] mmHg) (P<0.001 for all). SBP and DBP goals were achieved by 38.5% and 49.4% of patients on olmesartan monotherapy and by 31.7% and 42.9% of patients on olmesartan+1AHD. CONCLUSION: Olmesartan prescribed as mono- or add-on therapy during routine clinical practice significantly reduced blood pressure in Indian patients with essential hypertension as well as in patients with comorbid diabetes.

A Retrospective, Observational, EMR-Based Real-World Evidence Study to Assess the Incidence of Pedal Edema in Essential Hypertensive Patients on Amlodipine or Cilnidipine.

INTRODUCTION: Calcium channel blockers have pedal edema as one of the confining factors of treatment. A real-world study may help evident reality of the situation in regular Indian clinical practice. The aim of the study is to assess effectiveness and incidence of pedal edema in essential hypertensive patients treated with amlodipine or cilnidipine monotherapy. METHODS: Retrospective EMR data of adult essential hypertensive patients, prescribed amlodipine (n = 800) or cilnidipine (n = 800) as monotherapy, were analyzed. Incidence of pedal edema from baseline visit was analyzed in terms of dose and duration of treatment. The changes in systolic (SBP) and diastolic blood pressure (DBP) from baseline and proportion of patients achieving target BP goals were assessed. RESULTS: In amlodipine and cilnidipine groups, mean changes in SBP and DBP from baseline to end of the study period were 28.4 and 15.1 mmHg and 24.3 and 13.5 mmHg, respectively (p value <0.05). More than 50% of patients in both groups achieved BP goal at the end of the study (p value 0.266). In amlodipine group, total 23.9% reported pedal edema, while in cilnidipine, 27.6% (p value 0.0863). At the end of the study, 3.5% and 8.2% of patients remain with pedal edema, respectively, in both groups (pvalue <0.005). CONCLUSION: Amlodipine demonstrated greater BP reduction at a lower average dose, better efficacy, and tolerability in terms of pedal edema count as a lesser number of patients reported edema at the end of the study and a higher percentage of patients continued the prescribed baseline dosage regimen as compared to cilnidipine. Thus, the study established amlodipine as an effective and well-tolerated antihypertensive for Indians.

Clinical characteristics and 30-day outcomes in patients with acute decompensated heart failure: Results from Indian College of Cardiology National Heart Failure Registry (ICCNHFR).

BACKGROUND: Acute decompensated heart failure (ADHF) is a challenging medical emergency with high mortality and its prevalence is increasing in India. There is paucity of data on ADHF in the country. METHODS: Indian College of Cardiology National Heart Failure Registry (ICCNHFR) is an on-going observational registry on ADHF contributed by 22 hospitals across India; and we present the in-hospital and 30-day outcomes of ADHF patients enrolled from August 2018 to July 2019. Major objective included capturing demographics, comorbid conditions, aetiology, prescription patterns and assessing clinical outcomes. RESULTS: Of 5269 patients (mean age: 61.90 ± 13.85 years) enrolled in this study, males were predominant (67.09%). Mean duration of hospitalization was 5.74 ± 4.74 days. Ischemic heart disease was the most common (75.44%) aetiology. Abnormal electrocardiogram readings were found in most patients (89.86%). LVEF of ˂40% was found in 68.29% of patients. In-hospital mortality rates were 6.98%. The 30-day cumulative mortality was 12.35% and 30-day rehospitalization rate was 7.98%. At discharge, all guideline-based medical therapy (GDMT) were prescribed only to 24.99% of patients and 23.72% adhered to the prescription until 30 days. Older age, high serum creatinine levels and poor LVEF contributed to high mortality and rehospitalization. CONCLUSION: Patients with ADHF were younger and predominantly males. Usage of GDMT in ADHF patients was low (24.99%) and the in-hospital mortality was high. Older age, high serum creatinine levels, poor LVEF contributed for 30-day mortality and rehospitalization. This data on ADHF, could help in developing strategies to improve outcomes for HF patients in India.

Acute decompensated heart failure (ADHF) during COVID-19 pandemic-insights from South India.

AIM: This retrospective study compares admissions and outcomes due to acute decompensated heart failure (ADHF) during the COVID-19 pandemic from 25 March to 25 July 2020 with the historical patient control who were admitted during the same period in 2019. METHODS AND RESULTS: Data of the participating hospitals was collected and analysed from the ICC NHFR (Indian College of Cardiology National Heart Failure Registry) for 2019 and 2020. Total number of ADHF admissions, demographics, aetiology, co-morbid conditions and in-hospital mortality was compared and analysed. A significant decrease in the number of hospital admissions due to ADHF from 2019 to 2020 (1056 vs. 526 respectively) was noted. Incidence of admissions with <40% ejection fraction (EF) reduced in 2020 (72.4% and 80.2% in2020 and 2019)and >40% (EF) increased (27.6% and 19.8% in 2019 and 2020 respectively, p = 0.0005). Ischemic heart disease (IHD) was the most common aetiology (78.59% in 2019 and 80.98% in 2020, p = 0.268). The in-hospital mortality was numerically higher in 2020 (10%) than in 2019 (8%), but not statistically significant (p = 0.161). CONCLUSION: This study from the registry shows that the incidence of ADHF admissions during COVID-19 lockdown significantly reduced compared to the previous year. Demographic patterns remained similar but patients presenting with de-novo HF increased; IHD was the most common cause. The in-hospital mortality was numerically higher during the lockdown. The impact of lockdown perhaps led to fewer hospitalisations and this is to be factored in future strategies to address health care delivery during such crises.

One-year clinical outcome of patients with nonvalvular atrial fibrillation: Insights from KERALA-AF registry.

BACKGROUND: We report patient characteristics, treatment pattern and one-year clinical outcome of nonvalvular atrial fibrillation (NVAF) from Kerala, India. This cohort forms part of Kerala Atrial Fibrillation (KERALA-AF) registry which is an ongoing large prospective study. METHODS: KERALA-AF registry collected data of adults with previously or newly diagnosed atrial fibrillation (AF) during April 2016 to April 2017. A total of 3421 patients were recruited from 53 hospitals across Kerala state. We analysed one-year follow-up outcome of 2507 patients with NVAF. RESULTS: Mean age at recruitment was 67.2 years (range 18-98) and 54.8% were males. Main co-morbidities were hypertension (61.2%), hyperlipidaemia (46.2%) and diabetes mellitus (37.2%). Major co-existing diseases were chronic kidney disease (42.1%), coronary artery disease (41.6%), and chronic heart failure (26.4%). Mean CHA2DS2-VASc score was 3.18 (SD ± 1.7) and HAS-BLED score, 1.84 (SD ± 1.3). At baseline, use of oral anticoagulants (OAC) was 38.6% and antiplatelets 32.7%. On one-month follow-up use of OAC increased to 65.8% and antiplatelets to 48.3%. One-year all-cause mortality was 16.48 and hospitalization 20.65 per 100 person years. The main causes of death were cardiovascular (75.0%), stroke (13.1%) and others (11.9%). The major causes of hospitalizations were acute coronary syndrome (35.0%), followed by arrhythmia (29.5%) and heart failure (8.4%). CONCLUSIONS: Despite high risk profile of patients in this registry, use of OAC was suboptimal, whereas antiplatelets were used in nearly half of patients. A relatively high rate of annual mortality and hospitalization was observed in patients with NVAF in Kerala AF Registry.

Cardiological society of India document on safety measure during echo evaluation of cardiovascular disease in the time of COVID-19.

An echocardiographic investigation is one of the key modalities of diagnosis in cardiology. There has been a rising presence of cardiological comorbidities in patients positive for COVID-19. Hence, it is becoming extremely essential to look into the correct safety precautions, healthcare professionals must take while conducting an echo investigation. The decision matrix formulated for conducting an echocardiographic evaluation is based on presence or absence of cardiological comorbidity vis-à-vis positive, suspected or negative for COVID-19. The safety measures have been constructed keeping in mind the current safety precautions by WHO, CDC and MoHFW, India.

Cardiological Society of India: Document on acute MI care during COVID-19.

The unprecedented and rapidly spreading Coronavirus Disease-19 (COVID-19) pandemic has challenged public health care systems globally. Based on worldwide experience, India has initiated a nationwide lockdown to prevent the exponential surge of cases. During COVID-19, management of cardiovascular emergencies like acute Myocardial Infarction (MI) may be compromised. Cardiological Society of India (CSI) has ventured in this moment of crisis to evolve a consensus document for care of acute MI. However, this care should be individualized, based on local expertise and governmental advisories.

Intracoronary tenecteplase in STEMI with massive thrombus.

Primary percutaneous coronary intervention is the current standard of care in ST elevation myocardial infarction (STEMI). However, large thrombus is an independent predictor for stent thrombosis and major adverse cardiac events in patients undergoing primary angioplasty for STEMI. Here we report a series of STEMI patients with large thrombus burden treated successfully with low dose intracoronary thrombolysis. There was prompt and early ST resolution. There was improvement in thrombolysis in myocardial infarction (TIMI) flow and myocardial blush grade postlysis in all patients. Majority had recanalised infarct related coronary artery thus obviating the need for stenting. There was no inhospital or 1 month mortality or bleeding events. Hence intracoronary thrombolysis is an option in patients with large thrombus burden.