Role of Speckle Tracking Echocardiography to Predict Left Ventricular Dysfunction Post Mitral Valve Replacement Surgery for Severe Mitral Regurgitation.

Background: Despite improvement in the surgical procedure and strictly following the guidelines for mitral valve replacement (MVR), left ventricular dysfunction still occurs. Novel echocardiographic indices can predict development of LV (left ventricle) dysfunction post MVR. LV-GLS (global longitudinal strain) derived from speckle tracking echocardiography, has been proposed as a novel measure to better depict latent LV dysfunction. Methods: A total of 100 patients with severe MR (mitral regurgitation) planned for MVR were included. Speckle tracking echocardiography was performed at baseline and at follow up post MVR. ROC (Receiver operating characteristics) curve was plotted to derive the cutoff value of LV-GLS for prediction of LV dysfunction post MVR. Univariate and multi variate regression was analyzed to predict the independent predictors of LV dysfunction after MVR. Results: LV-GLS was decreased from baseline data (-19.9 vs. -17.7) in patients with LVEF <50% after MVR compared to patients with LVEF≥ 50%. Baseline value of LVESD (35.36 mm vs. 28.23 mm) and LVEDD (49.33 mm vs. 45.10 mm) were significantly higher in patients with LVEF<50% compared to LVEF ≥50% at 3 months follow up. A cutoff value of GLS -19% with sensitivity of 80.3% and specificity of 75.7% was associated in patients with LV dysfunction after MVR. In multivariate regression model GLS < -19% (OR = 21.8, CI:6.61-82.4, P=<0.001) was an independent predictor of LV dysfunction post MVR. Conclusion: A GLS value of less than -19% was demonstrated as an independent predictor of short term LV dysfunction after mitral valve surgery, LVESD ≥40 mm was also verified additional parameter to predict the LV dysfunction post MVR.

Assessment of the impact of heart failure on household economic well-being: a protocol.

Background: Heart failure (HF), which is an emerging public health issue, adversely affects the strained health system in India. The adverse impact of HF on the economic well-being has been narrated in various anecdotal reports from India, with affected individuals and their dependents pushed into the vicious cycle of poverty. There is limited research quantifying how HF impacts the economic well-being of households from low- and middle-income countries. Methods: We describe the methods of a detailed economic impact assessment of HF at the household level in India. The study will be initiated across 20 hospitals in India, which are part of the National heart Failure Registry (NHFR). The selected centres represent different regions in India, stratified based on the prevailing stages of epidemiological transition levels (ETLs). We will collect data from 1800 patients with acute decompensated HF and within 6-15 months follow-up from the time of initial admission. The data that we intend to collect will consist of a) household healthcare expenditure including out-of-pocket expenditure, b) financing mechanisms used by households and (c) the impoverishing effects of health expenditures including distress financing and catastrophic health expenditure. Trained staff at each centre will collect data by using a validated and structured interview schedule. The study will have 80% power to detect an 8% difference in the proportion of households experiencing catastrophic health expenditures between two ETL groups.  After considering a non-response rate of 5%, the target sample size is approximately 600 patients from each group and the total sample size is 1800 patients. Potential Impact: Our study will provide information on catastrophic health spending, distress financing and household expenditure in heart failure patients. Our findings will help policy makers in understanding the micro-economic impact of HF in India and aid in allocation of appropriate resources for prevention and control of HF.

Coexistent coronary artery disease in Indian patients undergoing permanent pacemaker implantation (PPI) for symptomatic bradyarrhythmia.

BACKGROUND: The cause-effect of conduction disturbance in chronic lesion of coronary arteries is complicated. This study was designed to evaluate coexistent CAD in patients with symptomatic bradyarrhythmia to find common anatomic basis for conduction disturbances and its relationship to conventional coronary risk factors. METHODS: In this prospective observational study, 929 patients who admitted for symptomatic bradyarrhythmia requiring permanent pacemaker implantation were included. All included patients underwent coronary angiography and were divided into groups based on angiographic findings. Association between conduction disturbances and these groups were analyzed. RESULTS: A total of 929 patients with mean age of 63.1 years were included in our study. We found age ≥50 years, male sex, presence of diabetes and hypertension as statistically significant predictors of abnormal coronary angiography. Obstructive CAD (≥50% stenosis) was found in 34.4% patients. Prevalence of single vessel disease, double vessel disease and triple vessel disease was 15.3%, 10.2% and 8.9% respectively. Severe coronary obstruction (≥90% obstruction) was found in 16.25% patients. Revascularization was advised in three fourth of cases of obstructive CAD. Approximately two third of patients didn't have significant obstruction in coronaries supplying the conduction system. Type 4 was the commonest anatomy in obstructive CAD. SA Nodal artery was found more diseased in patients of SSS with p value of 0.01. CONCLUSION: Obstructive CAD was found in one third of patients undergoing PPI. Age ≥50 years, male sex, diabetes and hypertension were found significantly correlated with presence of CAD and may act as important markers for the judgment of further coronary evaluation.

Diagnostic Accuracy of Computed Tomography Angiography as Compared to Conventional Angiography in Patients Undergoing Noncoronary Cardiac Surgery.

OBJECTIVE: To compare the diagnostic accuracy of multi-slice computed tomography (MSCT) angiography with conventional angiography in patients undergoing major noncoronary cardiac surgeries. MATERIALS AND METHODS: We studied fifty major noncoronary cardiac surgery patients scheduled for invasive coronary angiography, 29 (58%) female and 21 (42%) male. Inclusion criteria of the study were age of the patients ≥40 years, having low or intermediate probability of coronary artery disease (CAD), left ventricular ejection fraction (LVEF) >35%, and patient giving informed consent for undergoing MSCT and conventional coronary angiography. The patients with LVEF <35%, high pretest probability of CAD, and hemodynamically unstable were excluded from the study. RESULTS: The diagnostic accuracy of CT coronary angiography was evaluated regarding true positive, true negative values. The overall sensitivity and specificity of CT angiography technique was 100% (95% confidence interval [CI]: 39.76%-100%) and 91.30% (95% CI: 79.21%-97.58%). The positive (50%; 95% CI: 15.70%-84.30%) and negative predictive values (100%; 95% CI: 91.59%-100%) of CT angiography were also fairly high in these patients. CONCLUSION: Our study suggests that this non-invasive technique may improve perioperative risk stratification in patients undegoing non-cardiac surgery.

Novel indexes for diagnosing metabolic syndrome in apparently healthy Gujarati Asian Indians: a cross-sectional study.

BACKGROUND: We aimed to compare the diagnostic accuracy of four novel indexes-triglyceride/high-density lipoprotein cholesterol (TG/HDL-C) ratio, weight height ratio (WHtR), lipid accumulation product (LAP) and visceral adiposity index (VAI) with conventional components of metabolic syndrome (MetS) in order to identify a single index for the diagnosis of MetS in Gujarati Indian population. METHODS: This observational and cross sectional study involved a total of 3329 healthy adults of 18-79 years of age. Demographic and clinical data such as body mass index, waist circumference, blood pressure were measured along with the levels of lipids and fasting blood glucose. RESULTS: The overall prevalence of MetS was 34.32%, which was almost double in older individuals (45.5% vs. 20.8%) and slightly higher in males (37% vs. 31.2%). In comparison to individual components of MetS, three novel indexes-VAI, LAP and TG/HDL-C ratio showed superior diagnostic efficacy yielding an area under curve of 0.856, 0.821 and 0.821 respectively. The optimal cut-offs for VAI, LAP and TG/HDL Ratios for male, females, young and old population are (79.71, 88.12, 75.42, 87.4), (35.62, 34.73, 35.88, 34.7) and (2.249, 3.16, 2.49, 2.79) respectively. The diagnostic effectiveness of novel markers was unaffected by the age and gender of an individual. However, the efficacy of WHtR was comparable with the other conventional markers. CONCLUSION: Three novel markers-LAP, VAI and TG/HDL-C ratio could be effectively used as a single 'Surrogate marker' for screening of asymptomatic Gujarati Asian Indians with MetS.

AGE-Related Differences of Novel Atherosclerotic Risk Factors and Angiographic Profile Among Gujarati Acute Coronary Syndrome Patients.

CONTEXT: Although numerous risk factors have been established to predict the development of acute coronary syndrome (ACS), the risk factor profile may be different between the younger and older individuals. AIM: To analyse the frequency and pattern of atherogenic risk factors and angiographic profiles in age-stratified Gujarati patients with ACS. MATERIALS AND METHODS: ACS patients undergoing coronary angiography at U.N. Mehta Institute of Cardiology and Research, Gujarat, India between January 2008 and December 2012 were classified in to two age groups with 40y as cut-off. Patients were assessed for conventional risk factors (diabetes mellitus, dyslipidaemia, hypertension, smoking, obesity), novel risk factors (high sensitivity C-reactive protein, lipoprotein (a), homocysteine), and angiographic profiles.The statistical difference between two age groups was determined by Student's t-test for continuous variables and Chi-square or Fisher's exact test for categorical variables. RESULTS: A total of 200 patients, 100 patients ≤40 y of age and 100 patients >40 y of age, were evaluated. Older patients had higher frequency of hypertension (32 vs. 16%, p=0.008), while family history of coronary artery disease was more common among younger patients (19 vs. 9%, p=0.041). The incidence of diabetes, dyslipidaemia, smoking and tobacco chewing did not vary significantly between the two groups. Total cholesterol and low-density lipoprotein cholesterol levels were significantly higher in the younger group (p<0.05). Lipoprotein (a), homocysteine and high-sensitivity C reactive protein levels were comparable between two age groups. Multi-vessel coronary artery disease was more common among older group. The most commonly affected coronary artery was the left anterior descending artery among younger patients (44%) and the left circumflex artery among older patients (38.1%). CONCLUSION: Young patients with ACS had different atherosclerotic risk profile and less extensive coronary artery disease as compared to older counterparts. Emphasis should be given on diagnosis and management of major modifiable risk factors.

Study of Effectiveness and Safety of Percutaneous Balloon Mitral Valvulotomy for Treatment of Pregnant Patients with Severe Mitral Stenosis.

INTRODUCTION: In pregnant women mitral stenosis is the commonest cardiac valvular lesion. When it is present in majorly severe condition it leads to maternal and fetal morbidity and mortality. In mitral stenosis pregnancy can lead to development of heart failure. AIM: To evaluate the safety and efficacy of balloon mitral valvulotomy (BMV) in pregnant females with severe mitral stenosis. MATERIALS AND METHODS: A total of 30 pregnant patients who underwent BMV were included in the study from July 2011 to November 2013. Clinical follow-up during pregnancy was done every 3 months until delivery and after delivery. The mean follow up time after BMV was 6.72±0.56 months. RESULTS: From the 30 pregnant females 14 (46.67%) and 16 (53.3%) patients underwent BMV during the third and second trimester of pregnancy respectively. The mean mitral valve area was 0.85+0.16 cm(2) before BMV that increased to 1.60+0.27 cm(2) (p<0.0001) immediately after BMV. Peak and mean diastolic gradients had decreased significantly within 48 hours after the procedure (p<0.001) but remained very much unchanged at 6.72 month period of follow-up. Two patients had an increase in mitral regurgitation by 2 grades. CONCLUSION: During pregnancy BMV technique is safe and effective in patients with severe mitral stenosis. This results in marked symptomatic relief along with long term maternal and fetal outcomes.

Novel atherosclerotic risk factors and angiographic profile of young Gujarati patients with acute coronary syndrome.

OBJECTIVES: In this study we aimed to analyse the frequency of atherosclerotic risk factors with focus to novel risk factors for coronary artery disease and angiographic profile in young (≤ 40 years) acute coronary syndrome (ACS) patient with healthy controls in Gujarat, India. METHODS: Between January 2008 and December 2012, 109 consecutive young patients aged ≤ 40 years old, diagnosed to have ACS were included in the study. All ACS patients underwent diagnostic coronary angiography. An equivalent age and sex matched population without coronary disease with similar risk factors without tobacco considered a control group. All angiographic patients were evaluated for conventional risk factors for coronary artery disease like diabetes mellitus, hypertension, smoking, obesity as well as novel atherogenic risk factors like high sensitivity C-reactive protein (Hs-CRP), Lipoprotein(a) [LP(a)], homocysteine, apolipoprotein A1 (ApoA1) and B (ApoB). RESULT: In a study group, out of 109 young patients, 90 (82.6%) patients were presented to our hospital as ST-segment elevation myocardial infarction (STEMI), 10 (9.2%) presented as known non-ST-elevation myocardial infarction (NSTEMI) and 9 (8.3%) presented as unstable angina (UA). Serum cholesterol, triglycerides, LDL, LP(a) and lipid tetrad index were significantly higher in the study group whereas the HDL levels significantly lower as compared to the control group. CONCLUSION: A quite common risk factors of premature CAD are smoking, high Hs-CRP, high LP(a), hyperhomocysteinaemia and positive family history in the young ACS. Most common presentation of ACS in young was STEMI. On angiography, single vessel involvement was the most common finding.

First-in-human evaluation of the novel BioMime sirolimus-eluting coronary stent with bioabsorbable polymer for the treatment of single de novo lesions located in native coronary vessels - results from the meriT-1 trial.

AIMS: We report the initial human evaluation of the novel BioMimeTM sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 µm) and a biodegradable polymer for the treatment of de novo coronary lesions. METHODS AND RESULTS: The meriT-1 trial was a prospective, non-randomised, single-arm, single-centre, first-in-human evaluation of the safety, feasibility and performance of the BioMime SES. Lesion criteria included non-occlusive stenosis ≤ 19 mm in length located in native coronary vessels. Clinical follow-up (FU) was performed at 1, 8 and 12 months; all patients were assigned for angiographic FU at eight months. A total of 30 patients (30 lesions) were enrolled between March 2009 and February 2010. Mean age was 49.9 years, 30% were diabetics, and 36.7% had previous myocardial infarction (MI). Baseline median [25%, 75% interquartile range] lesion length, reference diameter and % diameter stenosis were 15.51 mm [12.74, 20.27], 2.94 mm [2.71, 3.34], and 80.5% [67.0%, 90.7%], respectively. Overall, there was one stent implanted per lesion and procedural success was 100%. At eight-month angiographic FU (26/30), median in-stent late lumen loss was 0.15 mm [0.09, 0.33]; also, there were no cases of binary restenosis within the treated segment. Clinical FU at 12 months (100%) demonstrated absence of MACE (cardiac death, MI and target lesion revascularisation) and stent thrombosis (ST). CONCLUSIONS: The novel BioMime SES demonstrated excellent performance in single coronary lesions including high procedural success and efficacy, as demonstrated by the relatively low late lumen loss (a surrogate of neointimal hyperplasia) at eight-month angiographic FU. Overall, there were no safety concerns in this preliminary evaluation including absence of MACE or ST up to 12 months.

Response of blood pressure after percutaneous transluminal renal artery angioplasty and stenting.

AIM: To evaluate the short and intermediate term outcome of percutaneous transluminal renal artery angioplasty (PTRA) and stenting particularly on blood pressure (BP) control and renal function and to evaluate predictors of poor BP response after successful PTRA and stenting. METHODS: We conducted a prospective analysis of all patients who underwent PTRA and stenting in our institute between August 2010 to September 2012. A total number of 86 patients were underwent PTRA and renal stenting. Selective angiography was done to confirm at least 70% angiographic stenosis. The predilatation done except few cases with critical stenosis, direct stenting was done in the rest of cases. All patients received aspirin 325 mg orally, and clopidogrel 300 mg orally within 24 h before the procedure. Heparin was used as the procedural anticoagulant agent. Optimal results with TIMI-III flow obtained in all cases. Following stent placement, aspirin 150 mg orally once daily was continued for a minimum of 12 mo and clopidogrel 75 mg orally once daily for at least 4 wk. The clinical, radiological, electrocardiography, echocardiography and treatment data of all patients were recorded. The BP measurement, serum creatinine and glomerular filtration rate (GFR) were recorded before the procedure and 1 and 6 mo after PTRA. RESULTS: A total of 86 patients were included in the study. The mean age of study population was 55.87 ± 11.85 years old and 67 (77.9%) of patients were male. There was a significant reduction in both systolic and diastolic BP at 1 mo after the procedure: 170.15 ± 20.10 mmHg vs 146.60 ± 17.32 mmHg and 98.38 ± 10.55 mmHg vs 89.88 ± 9.22 mmHg respectively (P = 0.0000). The reduction in BP was constant throughout the follow-up period and was evident 6 mo after the procedure: 144.23 ± 18.19 and 88.26 ± 9.79 mmHg respectively (P = 0.0000). However, no improvement in renal function was observed at any time during the follow-up period. After multivariate analysis, we found male sex, low GFR (< 60 mL/min) and higher baseline mean BP as a poor predictors of successful outcome on BP response after PTRA and stenting. CONCLUSION: The PTRA and stenting can be considered as an effective therapeutic intervention for improving BP control with minimal effect on renal function. The male sex, higher baseline BP and low GFR are associated with poor BP response after successful PTRA and stenting.

First-in-human evaluation of the novel BioMime sirolimuselutingcoronary stent with bioabsorbable polymer for thetreatment of single de novo lesions located in nativecoronary vessels - results from the meriT-1 trial

We report the initial human evaluation of the novel BioMimeTM sirolimus-eluting stent (SES) (MerilLife Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymerfor the treatment of de novo coronary lesions.Methods and results: The meriT-1 trial was a prospective, non-randomised, single-arm, single-centre,first-in-human evaluation of the safety, feasibility and performance of the BioMime SES. Lesion criteriaincluded non-occlusive stenosis ≤19 mm in length located in native coronary vessels. Clinical follow-up (FU)was performed at 1, 8 and 12 months; all patients were assigned for angiographic FU at eight months. A totalof 30 patients (30 lesions) were enrolled between March 2009 and February 2010. Mean age was 49.9 years,30% were diabetics, and 36.7% had previous myocardial infarction (MI). Baseline median [25%, 75% interquartilerange] lesion length, reference diameter and % diameter stenosis were 15.51 mm [12.74, 20.27],2.94 mm [2.71, 3.34], and 80.5% [67.0%, 90.7%], respectively. Overall, there was one stent implanted perlesion and procedural success was 100%. At eight-month angiographic FU (26/30), median in-stent latelumen loss was 0.15 mm [0.09, 0.33]; also, there were no cases of binary restenosis within the treated segment.Clinical FU at 12 months (100%) demonstrated absence of MACE (cardiac death, MI and target lesionrevascularisation) and stent thrombosis (ST).Conclusions: The novel BioMime SES demonstrated excellent performance in single coronary lesionsincluding high procedural success and efficacy, as demonstrated by the relatively low late lumen loss (a surrogateof neointimal hyperplasia) at eight-month angiographic FU. Overall, there were no safety concerns inthis preliminary evaluation including absence of MACE or ST up to 12 months.

Biodegradable-polymer-based, sirolimus-eluting Supralimus stent: 6-month angiographic and 30-month clinical follow-up results from the series I prospective study.

AIMS: There have been recent concerns regarding the long-term safety of the first generation of drug-eluting stents, which utilised a permanent polymer coating for drug delivery. SERIES I is a prospective, non-randomised, first-in-man open label study with the biodegradable polymer-based Supralimus sirolimus eluting stent (Sahajanand Medical Technologies Pvt. Ltd, India) for the treatment of patients with coronary artery lesions. METHODS AND RESULTS: One hundred patients were treated with 126 Supralimus stents (mean lesion length 10.5 +/- 4.3 mm, mean reference vessel diameter 2.66 +/- 0.62 mm). The pre-specified primary endpoint was angiographic binary in-stent restenosis at six months. Secondary endpoints were device-orientated major adverse clinical events (MACE; defined as a composite of cardiac death, nonfatal myocardial infarction [Q-wave and Non-Q wave], or clinically-justified target vessel revascularisation) at 30 days, nine months and 30 months. Angiographic follow-up in a pre-specified subgroup of 60 patients at six months showed binary angiographic restenosis rates of 0% (in-stent) and 1.7% (in-segment). The in-stent late loss was 0.09 +/- 0.37 mm. MACE rates were 0% after one month, 6% at 9-month follow-up and 7% after 30 months follow-up. CONCLUSIONS: The biodegradable-polymer-based sirolimus-eluting stent (Supralimus) is effective in inhibiting neointimal hyperplasia.