Rationale and design of the TUXEDO-2 India study: Ultra-Thin strUt Supraflex Cruz versus XiencE in a Diabetic pOpulation with multi-vessel disease-2.

BACKGROUND: The role of percutaneous coronary interventions (PCI) in patients with diabetes mellitus and multi-vessel disease has been questioned by the results of the FREEDOM trial, which showed superiority of coronary artery bypass graft(CABG) over first generation drug-eluting stents (DES) including a reduction in mortality. In the light of safer and more efficacious stents and significantly better medical management, those results that date back to 2012 need to be revisited. TUXEDO-2 is a study designed to compare two contemporary stents in Indian diabetic patients with multi-vessel disease. AIMS: The primary objective of the TUXEDO-2 study is to compare the clinical outcomes of PCI with ultra-thin Supraflex Cruz vs Xience when combined with contemporary optimal medical therapy (OMT) in diabetic patients with multi-vessel disease. The secondary objective is to compare clinical outcomes between a pooled cohort from both arms of the study (Supraflex Cruz + Xience; PCI arm) vs CABG based on a performance goal derived from the CABG arm of the FREEDOM trial (historical cohort). The tertiary objective is a randomized comparison of ticagrelor vs prasugrel in addition to aspirin for the composite of ischemic and bleeding events. METHODS: In this prospective, open-label, multi-centre, 2 × 2 factorial, randomized, controlled study, 1,800 patients with diabetes mellitus and multi-vessel disease (inclusion criteria similar to FREEDOM trial) with indication for coronary revascularization will be randomly assigned to Supraflex Cruz or Xience stents and also to ticagrelor- or prasugrel- based antiplatelet strategies. All patients will receive guideline directed OMT and optimal PCI including image- and physiology-guided complete revascularization where feasible. The patients will be followed through five years to assess their clinical status and major clinical events. The primary endpoint is a non-inferiority comparison of target lesion failure at one-year for Supraflex Cruz vs Xience (primary objective) with an expected event rate of 11% and a non-inferiority margin of 4.5%. For PCI vs CABG (secondary objective), the primary endpoint is major adverse cardiac events (MACE), defined as a composite of all cause death, nonfatal myocardial infarction, or stroke at one-year and yearly up to five years, with a performance goal of 21.6%. For ticagrelor vs prasugrel (tertiary objective), the primary endpoint is composite of death, myocardial infarction, stroke, and major bleeding as per the Bleeding Academic Research Consortium (BARC) at one-year with expected event rate of 15% and a non-inferiority margin of 5%. CONCLUSIONS: The TUXEDO-2 study is a contemporary study involving state-of-the-art PCI combined with guideline directed OMT in a complex subset of patients with diabetes mellitus and multi-vessel disease. The trial will answer the question as to whether a biodegradable polymer coated ultra-thin Supraflex Cruz stent is an attractive option for PCI in diabetic patients with multi-vessel disease. It will also help address the question whether the results of FREEDOM trial would have been different in the current era of safer and more efficacious stents and modern medical therapy. In addition, the comparative efficacy and safety of ticagrelor vs prasugrel in addition to aspirin will be evaluated. (CTRI/2019/11/022088).

Clinical evaluation of the Hydra self-expanding transcatheter aortic valve: 6 month results from the GENESIS trial.

OBJECTIVES: To evaluate the safety and performance of the Hydra transcatheter aortic valve (THV) in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. BACKGROUND: The Hydra THV (Vascular Innovations Co. Ltd., Nonthaburi, Thailand) is a novel flexible repositionable self-expanding system with supra-annular bovine pericardial leaflets, available in three sizes, covering aortic annuli between 17 and 27 mm. METHODS: The GENESIS trial was a prospective, multi-center, single-arm, 6 month follow-up study conducted in India. The primary performance endpoint was device success defined as per VARC-II criteria at 30 days. The primary safety endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS: Forty high-risk patients (74.5 ± 6.7 years, 60% men; STS Score:5.6 ± 4.2%) were enrolled in 11 centres. Device success was achieved in 92.5%. The effective orifice area improved from 0.7 ± 0.2 to 2.3 ± 0.6 cm2 at 30 days and to 2.2 ± 0.7 cm2 at 6 months (p < .0001). Mean aortic valve gradient decreased from 53.5 ± 18.1 to 8.9 ± 4.9 mmHg at 30 days and to 7.6 ± 2.7 mmHg at 6 months (p < .0001). The rate of new permanent pacemaker implantation was 7.5% at 30 days, and no patient had more than mild paravalvular leak at 6 months. The 30 days and 6 month all-cause mortality was 10.0 and 17.5%, cardiovascular mortality 7.5 and 7.5%, device-related mortality 5.0 and 5.0%, respectively. No patients had stroke up to 6 months. CONCLUSIONS: The GENESIS trial demonstrated high efficacy of the self-expanding Hydra THV. The cardiovascular mortality rate of 7.5% may partly be explained by the inclusion of some centres with no or limited previous experience in transcatheter aortic valve implantation.

Hypertension in Young Adults in India: Perspectives and Therapeutic Options amongst Clinician's in a Cross Sectional Observational Study.

BACKGROUND: The prevalence of hypertension in the young adult population is rising in India. Increased arterial stiffness due to RAAS activation and increased sympathetic overactivity due to stress have been implicated as primary factors for the same. This study was aimed to understand the Indian clinician's perspective on approach to management of hypertension in young adults. METHODS: A cross sectional observational survey using a structured questionnaire was conducted online with 2287clinicians (cardiologists, diabetologists, consultant physicians and family physicians). RESULTS: The prevalence of hypertension was 10-30% as per opinion of 64.8% clinicians. The top three risk factors for hypertension in young were perceived to be smoking, mental stress and obesity. Around 57.4% respondents opined that both increased heart rate and systolic blood pressure were markers of sympathetic overactivity. More than 60% respondents across specialities preferred ARBs to treat hypertension in young adults. Amongst the ARBs, telmisartan was the preferred ARB by >80% respondents. Metoprolol was the preferred beta blocker by almost 64% respondents. The objective of selection of beta-blocker by majority of clinicians due to sympathetic overactivity. Telmisartan and Metoprolol single pill combination achieved the BP goal in 40-60% of patients as reported by 41.3% of the physicians. The combination therapy was well tolerated in young hypertensive patients. CONCLUSIONS: Initiation of an early and appropriate antihypertensive treatment in young population may lower the burden of cardiovascular disease in this population. ARBs and beta -blockers were the preferred class of anti-hypertensive drugs in the cohort of young hypertensive patients .

The time to reversal of complete atrioventricular block and its predictors in acute ST-segment elevation myocardial infarction.

OBJECTIVE: The purpose of this study was to determine the time to reversal of complete AV block (CAVB) in ST-segment elevation myocardial infarction (STEMI) with various modalities of treatment and to examine the factors associated with early reversal of CAVB. METHODS: We prospectively assessed the STEMI patients complicated by CAVB. The mean time to reversal of CAVB was analyzed and compared according to the treatment received. Multivariate logistic regression analysis was performed to find the predictors of mortality. RESULTS: Of 3954 patients with STEMI, CAVB was present in 146(3.7%) patients. Inferior wall myocardial infarction (IWMI) was more commonly associated with CAVB than anterior wall myocardial infarction (AWMI) (74.7% vs 25.3%). The mean time to reversal of CAVB was 25.4 ± 35.5 h. It was significantly lower with the primary percutaneous coronary intervention (PCI) compared to thrombolysis (5.21 ± 10.54 vs 12.98 ± 17.14; p = 0.0001). Predictors of early reversal of CAVB were early presentation to hospital (<6 h) from symptom onset, presence of IWMI, any revascularization done, primary PCI performed in comparison to thrombolysis, and normal serum creatinine levels. The presence of older age, broader QRS complex, cardiogenic shock/heart failure, and elevated creatinine were independent predictors of mortality. The CAVB reverted in all the alive patients except one who required permanent pacemaker implantation. CONCLUSION: CAVB is uncommon in STEMI and it recovers in a vast majority of surviving patients. The time to reversal of CAVB in STEMI is lower with primary PCI compared to thrombolysis. Outcomes are poor without revascularization in such patients.

Syndrome 'Z': A Predictor of Angiographic Severity of Coronary Artery Disease in Patients of Acute Coronary Syndrome.

BACKGROUND: Owing to the growing evidence that the pathophysiology of obstructive sleep apnoea (OSA) and metabolic syndrome (MS) overlap considerably and both adversely impact cardiovascular health, we hypothesised that the presence of OSA with MS additively and adversely affect the severity of coronary artery disease (CAD). Exploration and understanding of this may have direct implications for the development of targeted, preventive strategies for CAD. Thus, this prospective study was aimed to determine the prevalence of 'Syndrome Z' in patients of MS who present with an acute coronary event and to correlate it with the angiographic severity of CAD in these patients. METHODS: The present study was a single centre, cross sectional study conducted in a university teaching hospital. In a span of 6 months, 922 patients with acute coronary syndromes (ACS) were screened for the study. Among these, 861 patients had no evidence of MS. The remaining 61 patients who were diagnosed to have MS were then subjected to an overnight sleep study. Only 58 had good sleep data so were included for further analysis. Angiographic parameters in terms of number of vessels involved and culprit lesions were noted and correlated with presence and absence of OSA and also with its severity based on the Apnoea/Hypopnoea Index (AHI). RESULTS: The prevalence of OSA positivity in patients with MS who presented with ACS was 34.5% (n=20). Most of the patients in the OSA negative group (78.9%, n=30) had disease limited to only one vessel while in the OSA positive group only a minority (15%, n=3) of patients had their disease limited to a single vessel (p=0.001). The number of lesions in the culprit vessel was also significantly less in the OSA negative group compared to the OSA positive group. While in the OSA negative group 68.4% (n=26) patients had a solitary lesion, followed by two and three lesions in 15.8% (n=6) of the patients each, multiple lesions were more common in OSA positive patients, involving 80% of cases (45.0%, n=9 with two lesions; 35.0%, n=7 with three lesions; only 20%, n=4 had a solitary lesion). CONCLUSIONS: Prevalence of 'Syndrome Z' is high in patients having MS presenting with ACS and it correlates with the angiographic severity of CAD.

Promoter variants of TNF-α rs1800629 and IL-10 rs1800871 are independently associated with the susceptibility of coronary artery disease in north Indian.

BACKGROUND: Tumor necrosis factor-alpha (TNF-α) are considered as a pro inflammatory and interleukin-10 (IL-10) anti inflammatory have been shown to predict the risk of incident of coronary artery disease (CAD). The polymorphism at promoter of TNF-α and IL-10 has been shown to increase transcriptional activity of the gene and play a important role in patho physiology of CAD. Aim of present study is to examine the impact of the TNF-α and IL-10 variant allele on various markers of the CAD and to study its relation with circulating TNF-α and IL-10 levels. METHODS: The -308 G/A & -238 G/A of TNF-α and -1082 G/A & -819 C/T of IL-10 gene polymorphism has been studied in 301 diagnosed CAD subjects (Age 51.50 ±â€¯9.28; BMI 25.30 ±â€¯3.58) and 305 healthy controls (Age 51.57 ±â€¯9.50; BMI 24.06 ±â€¯7.26). These polymorphism of TNF-α and IL-10 were detected by real time PCR by using Taqman SNP genotyping assay. Furthermore serum TNF-alpha and IL-10 levels were also measured by ELISA. RESULTS: Allelic and genotypic frequencies did not deviate from Hardy-Weinberg equilibrium in the controls (p > 0.05). On allele contrast, significant association with susceptibility to CAD was detected with polymorphisms in TNF-α -308 G/A, that variant genotype GA + AA (dominant model) (p = 0.030: OR = 1.61: 95% CI = 1.06-2.44) and variant allele (A) (p = 0.006: OR = 1.71: 95% CI = 1.17-2.51) of TNF-α 308 G/A gene was significant highly observed in the cases as compared to control group. Furthermore, variant genotype CT + TT (dominant model) (p = 0.004: OR = 1.62: 95% CI = 1.17-2.24) and variant allele (T) (p < 0.001: OR = 1.49: 95% CI = 1.17-1.89) of IL-10 -819 C/T gene was significant highly observed in the cases as compared to control group. CONCLUSION: Our results suggest that the TNF-α G-308A polymorphism independently associated with DBP, cholesterol, triglyceride, LDL, TNF-α and IL-10 levels which may be leads to the development of coronary artery disease of North Indians.

Obstructive Sleep Apnea and Cardiovascular Events After Percutaneous Coronary Intervention.

BACKGROUND: There is a paucity of data from large cohort studies examining the prognostic significance of obstructive sleep apnea (OSA) in patients with coronary artery disease. We hypothesized that OSA predicts subsequent major adverse cardiac and cerebrovascular events (MACCEs) in patients undergoing percutaneous coronary intervention. METHODS AND RESULTS: The Sleep and Stent Study was a prospective, multicenter registry of patients successfully treated with percutaneous coronary intervention in 5 countries. Between December 2011 and April 2014, 1748 eligible patients were prospectively enrolled. The 1311 patients who completed a sleep study within 7 days of percutaneous coronary intervention formed the cohort for this analysis. Drug-eluting stents were used in 80.1% and bioresorbable vascular scaffolds in 6.3% of the patients, and OSA, defined as an apnea-hypopnea index of ≥15 events per hour, was found in 45.3%. MACCEs, a composite of cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, and unplanned revascularization, occurred in 141 patients during the median follow-up of 1.9 years (interquartile range, 0.8 years). The crude incidence of an MACCEs was higher in the OSA than the non-OSA group (3-year estimate, 18.9% versus 14.0%; p=0.001). Multivariate Cox regression analysis indicated that OSA was a predictor of MACCEs, with an adjusted hazard ratio of 1.57 (95% confidence interval, 1.10-2.24; P=0.013), independently of age, sex, ethnicity, body mass index, diabetes mellitus, and hypertension. CONCLUSIONS: OSA is independently associated with subsequent MACCEs in patients undergoing percutaneous coronary intervention. Evaluation of therapeutic approaches to mitigate OSA-associated risk is warranted. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01306526.

Effect of Ivabradine on Heart Rate and Duration of Exercise in Patients With Mild-to-Moderate Mitral Stenosis: A Randomized Comparison With Metoprolol.

BACKGROUND: Symptoms in mitral stenosis (MS) are heart rate (HR) dependent. Increase in HR reduces diastolic filling period with rise in transmitral gradient. By reducing HR, beta-blockers improve hemodynamics and relieve symptoms, but the use may be limited by side effects. The present randomized crossover study looked at comparative efficacy of ivabradine and metoprolol on symptoms, hemodynamics, and exercise parameters in patients with mild-to-moderate MS (mitral valve area, 1-2 cm) in normal sinus rhythm. MATERIAL AND METHODS: Baseline clinical assessment, treadmill stress testing, and an echocardiographic Doppler evaluation were performed to determine resting HR, total exercise duration, mean gradient across mitral valve, and mean pulmonary artery systolic pressure (PASP). Patients were then allocated to either metoprolol or ivabradine to maximal tolerated doses over 6 weeks (metoprolol: 100 mg twice a day, ivabradine: 10 mg twice a day). Reevaluation was done at the end of this period, and all drugs stopped for washout over 2 weeks. Thereafter, the 2 groups were crossed over to the other drug that was continued for another 6 weeks. Assessment was again performed at the end of this period. RESULTS: Thirty-three patients of 34 completed the protocol. Fifteen were male, mean age was 28.9 ± 6.6 years, all were in New York Heart Association class 2, and mean resting HR was 103.5 ± 7.2/min. Mean mitral valve area was 1.56 ± 0.16 cm, mean PASP was 38.1 ± 5.1 mm Hg, and mean gradient across mitral valve was 10.6 ± 1.6 mm Hg. Significant decrease in baseline and peak exercise HR was observed at the end of follow-up with both drugs. Reduction in mitral valve gradient after ivabradine (42%) and metoprolol (37%) and reduction in PASP after both ivabradine (23%) and metoprolol (27%) were to a similar extent. Significant reduction in total exercise duration after both ivabradine and metoprolol therapy was observed. One patient developed blurring of vision with ivabradine therapy but did not require discontinuation of drug. An improvement in dyspnea of one grade was observed in all the patients by treatment with both ivabradine and metoprolol. CONCLUSIONS: Both metoprolol and ivabradine reduced symptoms and improved hemodynamics significantly from baseline to a similar extent. Ivabradine thus can be used effectively and safely in patients with MS in normal sinus rhythm who are intolerant or contraindicated for beta-blocker therapy.

Isolated left ventricular diastolic collapse in pericardial tamponade: an uncommon echocardiographic finding.

A case of circumferential moderate pericardial effusion causing isolated collapse of left ventricular cavity on two-dimensional echocardiography is reported. Pericardial effusion, mostly of infective etiology, is relatively common in this part of the world. When large enough to cause tamponade, collapse of right atrium, right ventricle, and uncommonly left atrium can be seen. Left ventricular collapse is rare, both due to the larger muscle mass and higher chamber pressure.

Reliability of Fractional Flow Reserve in Non-Infarct-Related Arteries in ST-Segment Elevation Myocardial Infarction Patients Undergoing a Pharmaco-Invasive Approach.

Objectives We investigated the reproducibility of fractional flow reserve (FFR) of significant stenoses (≥70% narrowing) in the non-infarct related artery (NIRA) during the pharmaco-invasive percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) within 24 hours of thrombolysis and at a follow up of 2-3 weeks. Background STEMI with multivessel disease has worse outcomes. The benefits of FFR-directed PCI of NIRA at the time of primary PCI are yet controversial. Assessing the hemodynamic severity of the NIRA may help in deciding the management strategy of these lesions, save time, and avoid complications. Methods Thirty-one patients undergoing PCI for STEMI under a pharmaco-invasive approach were prospectively recruited. The FFR measurements in 34 stenoses (≥70% diameter stenosis) were obtained immediately after PCI of the culprit stenosis and were repeated at a mean follow-up of 17.6 ± 3.55 (14-21) days. In addition, time to thrombolysis, time from symptom onset to PCI, left ventricular ejection fraction (LVEF), quantitative coronary angiographic measurements of the non-culprit stenoses, and thrombolysis in myocardial infarction (TIMI) flow were recorded. Results There was a significant change in FFR values at follow-up as compared to baseline (0.78 ± 0.08 (0.68-0.93) to 0.77 ± 0.08 (0.67-0.93)) (p = 0.014). In four of the lesions, the FFR values differed by >0.05 at follow-up. The follow-up FFR values led to a change in the management strategy in 5 out of 31 patients (15%) of the lesions. The TIMI flow, percentage diameter stenosis, minimum lumen diameter, and LVEF did not change. There were no predictors of this change in FFR values. Conclusions During the acute phase of STEMI, the severity of non-culprit coronary artery stenoses can not be reliably assessed by FFR. The prolonged jeopardized state of myocardium in pharmaco-invasive PCI as compared to primary PCI seems to be responsible.

Three-dimensional echocardiographic delineation of an acquired aorto-left atrial fistula complicating native aortic valve endocarditis - "advantage of three dimensions".

Aorto-atrial fistulas are rare, but important complications resulting from aortic valve infective endocarditis, aortic valve surgery, or aortic dissection. We hereby report a case of a 20-year male, referred to us with infective endocarditis of the native aortic valve with severe aortic regurgitation and symptoms of heart failure. Detailed evaluation with two-dimensional and three-dimensional transthoracic echocardiography revealed aorto-left atrial fistula secondary to the involvement of the mitral-aortic intervalvular fibrosa (MAIVF) region. The patient underwent successful removal of the vegetations, closure of the defect along with aortic valve replacement, and mitral valve repair.

Giant intrapericardial lipoma: an unusual cause of dyspnoea.

The pericardial lipomas are rare benign cardiac tumors. The clinical presentation of these cardiac neoplasms varies according to the site of growth. We describe here a case of massive intrapericardial lipoma leading to severe dyspnea, its diagnostic work up and briefly review the existing literature of this uncommon disorder. The patient underwent successful surgical resection of the tumor with complete alleviation of the symptoms.

Pacemaker lead induced inferior vena caval thrombosis leading to portal hypertension.

Inferior vena caval thrombosis is an unusual complication of permanent pacemaker implantation. The clinical presentation due to thrombosis depends on the site of thrombus. We have described here a rare case of pacemaker lead associated thrombosis of inferior vena cava, its diagnostic work up and briefly reviewed the existing literature of this uncommon complication.

A tale of two in stent restenosis in same patient: Surprising findings from optical coherence tomography.

Key Clinical Message: The morphology of in-stent restenosis (ISR) in drug eluting stents varies greatly from that of bare metal stents. Optical coherence tomography (OCT) is a useful aid for identifying the nature of ISR and planning the treatment accordingly, which may be by intravascular lithotripsy, cutting balloon or Rotablator, which can be used upfront if OCT shows calcified neoatherosclerosis. Abstract: Restenosis is the decrease in the diameter of the vessel lumen after the performance of percutaneous intervention (PCI), which may or may not involve the implantation of a stent. The morphology of in-stent restenosis (ISR) in drug eluting stents (DES) vary greatly from that of bare metal stents (BMS). We present the case of a 60-years-old lady, who was a follow up case of PCI of the left anterior descending artery with DES and left circumflex artery using BMS 16 years ago. Optical coherence tomography (OCT) revealed both neoatherosclerosis and neointimal hyperplasia in both DES as well as BMS. The morphology of ISR in DES differed from that of BMS. PCI and pharmacological strategies form the main stream of management in case of neointimal hyperplasia. Detection of pattern of ISR on OCT can direct the management of a particular patient, which may be by the use of adjunct devices like intravascular lithotripsy, cutting balloon and Rotablator, which can be used upfront if OCT shows calcified neoatherosclerosis.

Rotablation-Assisted Staged Culottes Bifurcation Stenting of Left Main Chronic Total Occlusion.

Left main coronary artery chronic total occlusion is an unusual finding discovered on coronary angiography. Historically, coronary artery bypass graft has been the preferred treatment. However, recent studies have revealed the role of left main percutaneous coronary intervention in selected patients. This is a case of staged left main coronary artery chronic total occlusion percutaneous coronary intervention. (Level of Difficulty: Advanced.).

Feasibility and efficacy of delayed pharmacoinvasive therapy for ST-elevation myocardial infarction.

BACKGROUND: ST-elevation myocardial infarction (STEMI) refers to a clinical syndrome that features symptoms of myocardial ischemia with consequent ST-elevation on electrocardiography and an associated rise in cardiac biomarkers. Rapid restoration of brisk flow in the coronary vasculature is critical in reducing mortality and morbidity. In patients with STEMI who could not receive primary percutaneous coronary intervention (PCI) on time, pharmacoinvasive strategy (thrombolysis followed by timely PCI within 3-24 h of its initiation) is an effective option. AIM: To analyze the role of delayed pharmacoinvasive strategy in the window period of 24-72 h after thrombolysis. METHODS: This was a physician-initiated, single-center prospective registry between January 2017 and July 2017 which enrolled 337 acute STEMI patients with partially occluded coronary arteries. Patients received routine pharmacoinvasive therapy (PCI within 3-24 h of thrombolysis) in one group and delayed pharmacoinvasive therapy (PCI within 24-72 h of thrombolysis) in another group. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) within 30 d of the procedure. The secondary endpoints included major bleeding as defined by Bleeding Academic Research Consortium classification, angina, and dyspnea within 30 d. RESULTS: The mean age in the two groups was comparable (55.1 ± 10.1 years vs 54.2 ± 10.5 years, P = 0.426). Diabetes was present among 20.2% and 22.1% of patients in the routine and delayed groups, respectively. Smoking rate was 54.6% and 55.8% in the routine and delayed groups, respectively. Thrombolysis was initiated within 6 h of onset of symptoms in both groups (P = 0.125). The mean time from thrombolysis to PCI in the routine and delayed groups was 16.9 ± 5.3 h and 44.1 ± 14.7 h, respectively. No significant difference was found for the occurrence of measured clinical outcomes in the two groups within 30 d (8.7% vs 12.9%, P = 0.152). Univariate analysis of demographic characteristics and risk factors for patients who reported MACCE in the two groups did not demonstrate any significant correlation. Secondary endpoints such as angina, dyspnea, and major bleeding were non-significantly different between the two groups. CONCLUSION: Delayed PCI pharmacoinvasive strategy in a critical diseased but not completely occluded artery beyond 24 h in patients who have been timely thrombolyzed seems a reasonable strategy.

Optical Coherence Tomography Findings in Patients Presenting With In-Stent Restenosis: A Prospective Observational Study of Patterns of Neointimal Hyperplasia and Associated Risk Factors.

Introduction Morphological features of neointimal tissue play a pivotal role in the pathophysiology of in-stent restenosis (ISR) after percutaneous coronary intervention (PCI). This study was designed to qualitatively and quantitatively assess neointimal characteristics of lesions using optical coherence tomography (OCT) in patients presenting with ISR.  Methods This was a single-center, prospective, observational study performed at a tertiary-care center in India. Patients diagnosed with stable angina and acute coronary syndrome with post-procedural angiographically documented restenosis (>50%) were included. Results A total of 34 patients with ISR were studied. Neointimal hyperplasia was classified as (i) homogenous group (n = 18) and (ii) non-homogenous group (n = 16). Fourteen (77.8%) diabetics belonged to the homogenous group. Predominant plaque characteristics such as neoatherosclerosis, cholesterol crystals, and calcium were documented in 14 (77.8%), 12 (66.7%), and 11 (61.1%) patients in the homogenous group and 10 (62.5%), 10 (62.5%), and 9 (56.2%) patients in the non-homogenous group, respectively. Unexpanded stent struts were identified in 11 (61.1%) and 11 (68.8%) patients in the homogenous and non-homogenous groups, respectively. Mean strut thickness was 93.73 ± 31.03 µm and 83.54 ± 18.0 µm, ISR was 72.50 ± 15.93% and 65.37 ± 21.69%, the neointimal thickness was 588.06 ± 167.82 µm and 666.25 ± 218.05 µm, and neointimal hyperplasia was 54.54 ± 11.23% and 59.26 ± 8.86% in the homogenous and non-homogenous groups, respectively. Conclusion Neoatherosclerosis and stent underexpansion were predominantly observed in our study and only diabetes was found to be significantly associated with homogenous neointimal hyperplasia.

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis-A Multicentre Real-World Experience.

BACKGROUND: Bicuspid aortic valve (BAV) affects approximately 1.5% of the general population and is seen in nearly 50% of candidates for aortic valve replacement (AVR). Despite increasingly utilised transcatheter aortic valve implantation (TAVI) in aortic stenosis (AS) patients, its use among patients with severe bicuspid AS is limited as BAV is a heterogeneous disease associated with multiple and complex anatomical challenges. AIM: To investigate the one-year outcomes of TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., Vapi, India) in patients with severe bicuspid AS. METHODS AND RESULTS: We collected data from consecutive patients with bicuspid AS who underwent TAVI with the Myval THV and had at least one-year follow-up. Baseline characteristics, procedural, and 30-day echocardiographic and clinical outcomes were collected. Sixty-two patients were included in the study. The median age was 72 [66.3, 77.0] years, 45 (72.6%) were males, and the mean STS PROM score was 3.2 ± 2.2%. All TAVI procedures were performed via the transfemoral route. The median follow-up duration was 13.5 [12.2, 18.3] months; all-cause mortality was reported in 7 (11.3%) patients and cardiovascular hospitalisation in 6 (10.6%) patients. All-stroke was reported in 2 (3.2%), permanent pacemaker implantation 5 (8.3%), and myocardial infarction 1 (1.6%) patients. The echocardiographic assessment revealed a mean pressure gradient of 10 [8, 16.5] mmHg, effective orifice area 1.7 [1.4, 1.9] cm2, moderate AR in 1 (2%), mild AR in 14 (27%), and none/trace AR in 37 (71%). In total, 1 patient was diagnosed with valve thrombosis (2.1%), Stage II (moderate) haemodynamic deterioration was seen in 3 (6.4%), and stage III (severe) haemodynamic deterioration in 1 (2.1%) patient. CONCLUSIONS: TAVI with the Myval THV in selected BAV anatomy is associated with favourable one-year hemodynamic and clinical outcomes.

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.