Impact of COVID-19 on heart failure hospitalization and outcome in India - A cardiological society of India study (CSI-HF in COVID 19 times study - "The COVID C-HF study").

OBJECTIVES: The presentation and outcomes of acute decompensated heart failure (ADHF) during COVID times (June 2020 to Dec 2020) were compared with the historical control during the same period in 2019. METHODS: Data of 4806 consecutive patients of acute HF admitted in 22 centres in the country were collected during this period. The admission patterns, aetiology, outcomes, prescription of guideline-directed medical therapy (GDMT) and interventions were analysed in this retrospective study. RESULTS: Admissions for acute heart failure during the pandemic period in 2020 decreased by 20% compared to the corresponding six-month period in 2019, with numbers dropping from 2675 to 2131. However, no difference in the epidemiology was seen. The mean age of presentation in 2019 was 61.75 (±13.7) years, and 59.97 (±14.6) years in 2020. There was a significant decrease in the mean age of presentation (p = 0.001). Also. the proportion of male patients decreased significantly from 68.67% to 65.84% (p = 0.037). The in-hospital mortality for acute heart failure did not differ significantly between 2019 and 2020 (4.19% and 4.,97%) respectively (p = 0.19). The proportion of patients with HFrEF did not change in 2020 compared to 2019 (76.82% vs 75.74%, respectively). The average duration of hospital stay was 6.5 days. CONCLUSION: The outcomes of ADHF patients admitted during the Covid pandemic did not differ significantly. The length of hospital stay remained the same. The study highlighted the sub-optimal use of GDMT, though slightly improving over the last few years.

COVID-19 infected ST-Elevation myocardial infarction in India (COSTA INDIA).

OBJECTIVE: To find out differences in the presentation, management and outcomes of COVID-19 infected STEMI patients compared to age and sex-matched non-infected STEMI patients treated during the same period. METHODS: This was a retrospective multicentre observational registry in which we collected data of COVID-19 positive STEMI patients from selected tertiary care hospitals across India. For every COVID-19 positive STEMI patient, two age and sex-matched COVID-19 negative STEMI patients were enrolled as control. The primary endpoint was a composite of in-hospital mortality, re-infarction, heart failure, and stroke. RESULTS: 410 COVID-19 positive STEMI cases were compared with 799 COVID-19 negative STEMI cases. The composite of death/reinfarction/stroke/heart failure was significantly higher among the COVID-19 positive STEMI patients compared with COVID-19 negative STEMI cases (27.1% vs 20.7% p value = 0.01); though mortality rate did not differ significantly (8.0% vs 5.8% p value = 0.13). Significantly lower proportion of COVID-19 positive STEMI patients received reperfusion treatment and primary PCI (60.7% vs 71.1% p value=< 0.001 and 15.4% vs 23.4% p value = 0.001 respectively). Rate of systematic early PCI (pharmaco-invasive treatment) was significantly lower in the COVID-19 positive group compared with COVID-19 negative group. There was no difference in the prevalence of high thrombus burden (14.5% and 12.0% p value = 0.55 among COVID-19 positive and negative patients respectively) CONCLUSIONS: In this large registry of STEMI patients, we did not find significant excess in in-hospital mortality among COVID-19 co-infected patients compared with non-infected patients despite lower rate of primary PCI and reperfusion treatment, though composite of in-hospital mortality, re-infarction, stroke and heart failure was higher.

Clinical Outcomes of Novel Long-Tapered Sirolimus-Eluting Coronary Stent System in Real-World Patients With Long Diffused De Novo Coronary Lesions.

BACKGROUND: When coronary lesions involve segments > 48 mm, the only treatment possibility is stent overlapping which is associated with higher neointimal proliferation that lead to more restenosis. Furthermore, tapering of coronary arteries is a major challenge observed with long diffuse coronary lesions. This study attempted to assess the safety and performance of world's first commercialised long-tapered (60 mm) sirolimus-eluting coronary stent (SES) system for the treatment of long diffused de novo coronary lesions in real world scenario. METHODS: This was a retrospective, non-randomised, multicentre study which included 362 consecutive patients implanted with long-tapered BioMime™ Morph SES system for the treatment of long diffused de novo coronary lesions. Safety endpoint was major adverse cardiac events (MACE), which was defined as composite of cardiac death, myocardial infarction (MI) and ischemic-driven target lesion revascularization (ID-TLR), at 12-month follow-up. RESULTS: Out of 362 patients included, 170 (47.0%) were diabetic and 159 (43.9%) were hypertensive. The mean age of all patients was 61.09 ± 9.04 years. A total of 625 lesions were identified; out of which 402 lesions were intervened successfully using BioMime Morph. The cumulative incidence of MACE was 7 (2.0%) at 12-month follow-up which included four (1.1%) cardiac deaths, one (0.3%) case of MI and two (0.6%) ID-TLR. Acute stent thrombosis was reported in one (0.3%) patient. CONCLUSIONS: The present study confirms the safety and performance of BioMime Morph, and hence, can be considered as a treatment of choice for long diffused tapered de novo coronary lesions in routine clinical practice.

One-year outcomes of a BioMime™ Sirolimus-Eluting Coronary Stent System with a biodegradable polymer in all-comers coronary artery disease patients: The meriT-3 study.

OBJECTIVES: The aim of the merit-3 study was to determine the safety and performance of the BioMime Sirolimus-Eluting Coronary Stent System (SES) in all-comer patients with coronary artery disease (CAD) in one-year clinical follow-up period. METHODS: The meriT-3 was a multi-centre, observational, post-marketing study conducted in 1161 patients with CAD who were implanted with BioMime SES at 15 sites in India. The primary endpoint was major adverse cardiac event (MACE) at one year defined as the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Clinical follow-up was performed at 1, 6, and 12 months. Major adverse cardiac event occurred at 30 days and subsequently at 6 months and at long-term follow-up of 1 year was analyzed. RESULTS: MACE observed at 1 and 6 months follow-up was 16 (1.38%) and 21 (1.83%) respectively. Cumulative 1 year MACE was 26 (2.35%) with 16 (1.39%) all cause death, 4 (0.35%) MI and 6 (0.52%) TLR. In addition, ST was observed in 1 (0.09%) patient. CONCLUSIONS: The present study suggests that the BioMime SES is safe and effective in a "real-world", all-comers CAD patients, indicating low rates of MACE. CTRI ACKNOWLEDGEMENT NO: REF/2016/07/011808.

Prevalence, treatments and outcomes of coronary artery disease in Indians: A systematic review.

AIM: To conduct a systematic review on the prevalence, risk factors, treatments and outcomes of Coronary Artery Disease (CAD) in Indians. METHODS AND RESULTS: We conducted a systematic review of studies in Indians with CAD from Jan 1969 to Oct 2012. Initial search yielded 3885 studies and after review 288 observational studies were included. The prevalence of CAD in urban areas was 2.5%-12.6% and in rural areas, 1.4%-4.6%. The prevalence of risk factors was: smoking (8.9-40.5%), hypertension (13.1-36.9%) and diabetes mellitus (0.2-24.0%). The median time to reach hospital after an MI was 360 min. In hospital rates of drug use were: antiplatelets 68%-97.9%, beta blockers 47.3%-65.8% and ACEIs 27.8-56.8%. CONCLUSIONS: In this first systematic review of CAD in India, prevalence of risk factors is high, treatments delayed and use of evidence based treatments variable.

Causes of failure with Szabo technique - an analysis of nine cases.

OBJECTIVE: The objective of this case series is to identify and define causes of failure of Szabo technique in rapid-exchange monorail system for ostial lesions. METHODS AND RESULTS: From March 2009 to March 2011, 42 patients with an ostial lesion were treated percutaneously at our institution using Szabo technique in a monorail stent system. All patients received unfractionated heparin during intervention. Loading dose of clopidogrel, followed by clopidogrel and aspirin was administered. In 57% of patients, drug-eluting stents were used and in 42.8% patients bare metal stents. The stent was advanced over both wires, the target wire and the anchor wire. The anchor wire, which was passed through the proximal trailing strut of the stent helps to achieve precise stenting. The procedure was considered to be successful if stent was placed precisely covering the lesion and without stent loss or anchor wire prolapsing. Of the total 42 patients, the procedure was successful in 33, while failed in 9. Majority of failures were due to wire entanglement, which was fixed successfully in 3 cases by removing and reinserting the anchor wire. Out of other three failures, in one stent dislodgment occurred, stent could not cross the lesion in one and in another anchor wire got looped and prolapsed into target vessel. CONCLUSION: This case series shows that the Szabo technique, in spite of some difficulties like wire entanglement, stent dislodgement and resistance during stent advancement, is a simple and feasible method for treating variety of ostial lesions precisely compared to conventional angioplasty.

Effect of lowering HBV DNA levels by initial antiviral therapy before adding immunomodulator on treatment of chronic hepatitis B.

BACKGROUND: Lower hepatitis B virus DNA (HBV DNA) levels are associated with better responses in chronic hepatitis B (CHB). It is unclear whether an initial phase of antiviral treatment to lower HBV DNA levels before adding immunomodulator therapy is more effective than the strategy of using immunomodulators from the beginning. AIM: The aim of the study was to compare the efficacy of lamivudine followed by pegylated-interferon (peg-IFN) therapy with placebo followed by peg-IFN therapy in HBeAg-positive CHB patients. PATIENTS AND METHODS: Sixty-three treatment-naive HBeAg-positive patients with histologically proven CHB and alanine aminotransferase (ALT) > 1.2 x upper limit of normal (ULN) received placebo for 4 wk followed by peg-IFN 1.0 mug/kg/wk for next 24 wk (group A, N = 27; age 32 +/- 11 yr; M:F = 25:2) or lamivudine 100 mg per day for 4 wk followed by peg-IFN 1.0 mug/kg/wk for next 24 wk (group B, N = 36; age 32.5 +/- 10.5 yr; M:F = 31:5). Patients were followed for next 24 wk after completion of treatment. Biochemical and virologic responses were assessed at weeks 4, 28, and 52 and analysis was done on intention-to-treat basis. RESULTS: At wk 4, mean +/- SD of log change in DNA from baseline was 0.2594 +/- 1.7873 in group A and 1.2186 +/- 1.6347 in group B, respectively (P = 0.032). At week 28, undetectable HBV DNA was seen in eight (29.6%) and 16 (44.4%) patients in groups A and B, respectively (P= 0.298). At week 28, HBeAg loss occurred in eight (29.6%) in group A and 15 (41.7%) in group B (P = 0.43). Six months posttherapy, at week 52, undetectable HBV DNA was seen in four (14.8%) and 18 (50%) in groups A and B, respectively (P = 0.028) and HBeAg loss was maintained in four (14.8%) and 14 (38.9%) (P = 0.05) patients. Normal ALT was seen in five (18.5%) and 10 (27.8%) at week 28 (P = 0.552) and five (18.5%) and 13 (36.1%) at week 52 (P = 0.159) in groups A and B, respectively. There was a significant correlation among achievement of HBeAg loss, anti-HBe appearance, and undetectable HBV DNA levels at week 28 (P = 0.008) and 52 (P < 0.001) and HBV DNA levels at week 4. CONCLUSIONS: The strategy of using an antiviral initially to decrease HBV DNA levels before adding an immunomodulatory agent leads to improved sustained virological response as compared with using immunomodulator from the start.