News Article | October 31, 2016
NEW YORK - October 31, 2016 - The 28th annual Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation (CRF) featured a number of first report investigations on novel stents that could become the next generation of bioresorbable stents in patients. "Bioresorbable stents have the potential to be greatly impactful in the treatment of coronary artery disease, and it is exciting to see these first report investigations of several new and novel stents advancing the technology forward," said Ajay Kirtane, MD, SM, a Co-Director of TCT. He is also Director of the Cardiac Catheterization Laboratories at NewYork-Presbyterian Hospital/Columbia University Medical Center and an Associate Professor of Medicine at Columbia University College of Physicians and Surgeons. "These results give us the first insights into their safety and efficacy, but larger randomized trials are necessary in order to establish their role in clinical practice." The FANTOM II study examined the safety and performance of native coronary artery stenting using the radiopaque desaminotyrosine polycarbonate-based sirolimus-eluting bioresorbable vascular scaffold (Fantom). The primary endpoint was the incidence of major adverse cardiac events (MACE) and late lumen loss (LLL) at six months. The prospective, multicenter trial enrolled a total of 240 patients across 28 clinical centers in eight countries. Patients were sequentially enrolled into two separate cohorts in which the only difference between them was a six-month (Cohort A) versus a nine-month angiographic assessment (Cohort B). The Cohort A group included a total of 117 patients and the Cohort B group included 123 patients. At six months, the incidence of MACE in both cohorts was 2.1% while the mean LLL in cohort A was 0.25 ± 0.40 mm. "Results of the FANTOM II trial demonstrate sustained performance and safety through six months of this novel bioresorbable scaffold," said Alexandre Abizaid, MD, PhD, Director, Interventional Cardiology at the Instituto Dante Pazzanese de Cardiologia in São Paulo, Brazil. "This preliminary clinical data indicates good acute performance, as well as enhanced device deliverability, minimal residual stenosis and acute recoil." The FANTOM II trial was funded by REVA Medical, Inc. Dr. Abizaid reported research grants and consulting fees/honoraria from Abbott Vascular, Boston Scientific, Elixir Medical, Medtronic and REVA Medical. Results from the first-in-man study of a novel thin-strut PLLA-based sirolimus-eluting bioresorbable vascular stent (MeRes100) showed that it was both safe and effective with no major adverse cardiac events (MACE) at six months. The MeRes100 is a low profile 100μm thin strut PLLA based BRS with a unique hybrid design featuring open cells at the center and closed cells at the edges resulting in improved trackability and access to side branches. It also has enhanced visibility with three circumferential radio opaque markers at each end. In this prospective, multicenter, single arm trial of MeRes100 BRS, a total of 108 patients (116 lesions) were enrolled at 16 Indian sites from May 2015 to April 2016. The primary end-point was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, ischaemia driven target lesion revascularization (ID-TLR), and ischaemia driven target vessel revascularization (ID-TVR) at six months. The secondary end-point was scaffold thrombosis at six months. The study found no MACE or stent thrombosis (ST) after the deployment of the scaffold up to six month follow-up. Quantitative coronary analysis (QCA) data at six months demonstrated very favorable in scaffold late lumen loss of 0.15±0.26mm. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) analysis showed no scaffold recoil and near complete strut coverage (99.3%) with neointima. "The innovative design of the MeRes100 scaffold developed in India addresses some of the limitations of currently available BRS. The MeRes-1 first-in-man study demonstrates that this new generation thinner strut sirolimus-eluting BRS is safe and effective at six months," said Ashok Seth, MBBS, FRCP, DSc, Chairman of the Fortis Escorts Heart Institute and Chairman of the Cardiology Council, Fortis Group of Hospitals in New Delhi, India. "These encouraging results provide the basis for further studies using wider range of length and sizes in more complex and larger patient population moving to a randomized pivotal trial against the second generation metallic Drug Eluting Stents (DES) by mid 2017." The MeRes-1 trial was funded by Meril Lifesciences, India. Dr. Seth reported receiving consulting fees/honoraria from Abbott Vascular and Meril Lifesciences. FUTURE-I was a prospective, single-center first-in-man study that sought to assess the feasibility, preliminary safety and effectiveness of a thin-strut (100-125μm) PLLA-based sirolimus-eluting bioresorbable scaffold (Firesorb BRS) in patients with single de novo coronary artery lesions. Between January and March 2016, a total of 45 patients with 45 target lesions were enrolled. After successful implantations of BRS, the 45 patients were randomized to two different follow-up cohorts in a 2:1 ratio. 30 patients in cohort 1 were required to undergo angiographic, IVUS, and OCT follow-ups at six and 24 months, respectively; and the others in cohort 2 will undergo imaging follow-ups at 12 and 36 months, respectively. The incidence of the primary endpoint, 30-day target lesion failure, was 0% with no scaffold thrombosis. At six months, the patient-oriented composite endpoint (PoCE: all death, all Ml, or any revascularization) in Cohort 1 was 3.3% (1). One patient underwent non-target vessel revascularization the day after the index procedure due to NSTEMI. The in-scaffold late loss was 0.15mm, the percentage of late recoil by IVUS was 0.76%, and the proportion of covered struts was 98.4% including 100% in seven patients by OCT, at six-month follow-up, respectively. "The six-month clinical, angiographic, IVUS, and OCT results of the FUTURE-I study demonstrated the feasibility and preliminary safety and efficacy of the thin-strut PLLA-based sirolimus-eluting Firesorb BRS in the treatment of patients with single de novo coronary lesions," said Bo Xu, MBBS, Director of Catheterization Laboratories at Fu Wai Hospital in Beijing, China. "Long-term imaging follow-up is needed to provide more information, and a pivotal randomized controlled trial (FUTURE-II) will be initiated soon." The FUTURE-I trial was funded by a research grant from MicroPort. Dr. Xu reported having no relevant conflicts of interest to disclose. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .
Kaul U.,Fortis Escorts Heart Institute |
Bangalore S.,New York University |
Seth A.,Fortis Escorts Heart Institute |
Arambam P.,Fortis Escorts Heart Institute |
And 9 more authors.
New England Journal of Medicine | Year: 2015
BACKGROUND The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents. METHODS We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up. RESULTS At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of targetvessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P = 0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxeleluting stent group than in the everolimus-eluting stent group of target-vessel failure (P = 0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P = 0.004), stent thrombosis (2.1% vs. 0.4%, P = 0.002), target-vessel revascularization (3.4% vs. 1.2%, P = 0.002), and target-lesion revascularization (3.4% vs. 1.2%, P = 0.002). CONCLUSIONS In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. © 2015 Massachusetts Medical Society.
Bhandari S.,Fortis Escorts Heart Institute |
Jain P.,Fortis Escorts Heart Institute
Journal of Association of Physicians of India | Year: 2012
Few trials have addressed the management of acute coronary syndromes (ACS) in chronic kidney disease (CKD). Hence guidelines for the management of coronary heart disease (CHD) in CKD are based on meta-analysis, subgroup analyses, small prospective studies or retrospective analyses of controlled trials and registry data. The short-term as well as long-term prognosis of ACS patients with poor renal function is worse than those with normal renal function. The risk of cardiovascular (CV) events and mortality is inversely proportional to the estimated glomerular filtration rate (eGFR). Nevertheless, CV event rates increase even in early CKD. Contrast induced nephropathy (CIN) occurs in 15% of patients following diagnostic or therapeutic invasive procedures; less than 1% of these require dialysis. While treatment of CIN is not so effective, it is predictable and can be largely prevented. Despite a higher risk of adverse outcomes, patients with moderate-severe CKD are often treated less aggressively than patients with normal renal function due to safety concerns. Patients with CKD are less likely to receive aspirin, clopidogrel, or beta blockers and are less likely to undergo reperfusion or revascularization. Conservative treatment of ACS may partially account for worse outcome in CKD. Large registry data suggests that in-hospital revascularization is associated with improved survival, irrespective of eGFR. It is not clear whether coronary artery bypass grafting (CABG) surgery or percutaneous coronary intervention (PCI) leads to better outcomes in patients suitable for either procedure. While short-term risk of CABG in CKD is high, its long-term results have been better than medical treatment or PCI in registry data. Recent data suggest no differentials in outcomes with CABG or PCI. Randomized controlled trials involving patients with renal dysfunction are needed to confirm whether aggressive treatment of ACS will improve clinical outcomes. © JAPI.
Gupta A.,Fortis Escorts Heart Institute |
Varma A.,Fortis Escorts Heart Institute
Indian Journal of Critical Care Medicine | Year: 2015
Background: Candidemia is an important nosocomial blood stream infection in critically ill patients. Although several studies have addressed candidemia, very few have reviewed the impact of Candida glabrata candidemia in Intensive Care Unit (ICU) patients. Materials and Methods: The medical records of ICU patients between 2006 and 2010 were reviewed retrospectively. The epidemiology, clinical features and mortality related risk factors among our adult ICU patients were seen. Results: Among 144 episodes of candidemia, C. glabrata (n = 26; 18.05%) was the third most common species isolated. The incidence of C. glabrata candidemia was 0.21/1000 ICU admissions. The most common risk factors were prior exposure to broad spectrum antibiotics (100%), central venous catheter (100%), mechanical ventilation (76.9%), diabetes mellitus (50%), age >65 years (46.15%). Urine (23%) was the most common source of C. glabrata candidemia. Overall in hospital 30 days mortality rate due to C. glabrata fungemia was 53.8%. Patients who were treated with fluconazole showed better outcome than patients treated with amphotericin B. Renal failure requiring hemodialysis was the significantly associated with mortality in our study. Conclusion: Candida glabrata was the 3 rd most common Candida causing candidemia in our ICUs with a incidence of 0.21/1000 ICU admissions. The outcome of ICU acquired C. glabrata candidemia was poor with 30 days mortality rate of 53.8%. Renal failure requiring hemodialysis was the only risk factor associated with mortality. Further studies are required to identify the other risk factors associated with mortality in C. glabrata candidemia.
Agrawal A.,Fortis Escorts Heart Institute
Transfusion and Apheresis Science | Year: 2014
Introduction: Pre-transfusion testing involves blood grouping (ABO and Rh) and major cross match (testing the recipient's serum/plasma against the donor's red blood cells) at 37. °C to detect IgG antibodies. In the western countries, type and screen policy is routinely followed. Aim: This study was conducted to assess implementation of type and screen policy in standalone blood banks in India and to assess compromise on blood safety, if any? Materials and methods: The study was carried out at the Standalone Blood Bank of North India during the period January 2012 to April 2012. Type and screen study was carried out in parallel to routine cross match using Column Agglutination Technology. Results: Total 354 patients were included in the study. 4 samples were positive on antibody screening. Cross match was incompatible in 1 case. No case was found with antibody screen negative but AHG cross match incompatible. Conclusion: This study concluded good safety level in high risk category patients. Type and screen policy can be implemented in Indian settings with no compromise on blood safety provided sufficient technical and infrastructural support is available at the centre. © 2014 Elsevier Ltd.
Seth A.,Fortis Escorts Heart Institute |
Sengottuvelu G.,Apollo Hospitals |
Ravisekar V.,Fortis Escorts Heart Institute
Catheterization and Cardiovascular Interventions | Year: 2014
Recent technological developments have led to the development of Absorb™ bioresorbable vascular scaffold (BVS) [Abbott Vascular, Santa Clara, USA] for percutaneous treatment of coronary artery disease by percutaneous coronary intervention (PCI). The BVS is now approved for use in many countries but experience in bifurcation lesions is limited and largely unreported and concerns still exist about its use across major side branches. We report for the first time, the successful use of the "T and Protrusion" (TAP) technique of deploying BVS into the side branch (SB) through the struts of main branch (MB) BVS to salvage a suboptimal result and threatened closure of a SB in three cases when treating bifurcation lesions with a planned single BVS strategy. The TAP technique was successful in all cases and there were no complications. All patients continue to do well at short-term follow-up. This case report provides information regarding the feasibility as well as technical and procedural insights when using BVS for bifurcation lesions. © 2014 Wiley Periodicals, Inc.
Kumar Chugh S.,Fortis Escorts Heart Institute |
Chugh S.,Fortis Escorts Heart Institute |
Chugh Y.,Manipal University India |
Rao S.V.,Duke Clinical Research Institute
Catheterization and Cardiovascular Interventions | Year: 2013
Objectives To assess feasibility and utility of imaging of both arms using ultrasound to facilitate transradial (TR) and transulnar (TU) coronary angiograms (CA) and intervention. Background Despite well recognized advantages, transradial approach (TRA) has challenges that reduce procedural success including small arterial size, anatomical variations, and anomalies of radial artery (RA). The utility of routine pre-procedural ultrasound of the arm arteries (PPUAA) in facilitating TRA has not been previously studied. Methods To determine the role of PPUAA, we performed a single center registry of consecutive patients undergoing diagnostic and interventional procedures between 2006 and 2011. All patients underwent PPUAA of the right and left radial, ulnar (UA), as well as the brachial arteries (BA) in the antecubital fossa using a linear probe. End-points assessed included the incidence and correlates of arterial sizes, vascular anomalies, procedure success, and fluoroscopy as well as ultrasound assessment times. RA occlusion rates were studied in the last 10 months of the study period. Results Complete data on radial (mean 1.9 mm (male);1.7 mm (female)) and ulnar artery size (mean 1.8 mm (male); 1.6 mm (female)) and data on brachial branching anatomy were available in 2,344 patients; 1,872 of whom underwent a TR or TU procedure. The mean time to perform bilateral PPUAA was 6.4 min ± 1.8 min. The incidence of arterial abnormalities was 9.8% in PPUAA. Procedure success was 98.7% for CA and 97.5% for percutaneous coronary intervention. Outcomes were better in this cohort compared with remaining 3,781 patients in whom PPUAA data were not available. Conclusion This single center prospective registry shows that PPUAA is feasible, requires minimum time, and provides anatomical information that may improve procedure success while reducing patient discomfort, arterial spasm, and fluoroscopy time. These findings should be confirmed in a randomized trial. Copyright © 2013 Wiley Periodicals, Inc.
Sachdeva A.,Fortis Escorts Heart Institute
Journal of Association of Physicians of India | Year: 2015
Cardiopulmonary interactions or effects of spontaneous and mechanical ventilation (MV) were first documented in the year 1733. Stephen Hales showed that the blood pressure of healthy individual fell during spontaneous inspiration and he later went on to discover the ventilator. A year later Kussmaul described pulsus paradoxus (inspiratory absence of radial pulse) in patients with tubercular pericarditis. Echocardiography can help to diagnose a wide variety of cardiovascular diseases and can guide therapeutic decisions in patients on mechanical ventilation. © 2015 Journal of The Association of Physicians of India. All Rights Reserved.
Bhatia M.,Fortis Escorts Heart Institute
Indian Heart Journal | Year: 2014
Myocarditis is an important cause of sudden death in young adults where infectious diseases, in previously healthy patients, account for the majority of cases. Cardiac MR imaging offers an extremely versatile, comprehensive and accurate tool for evaluation of morphological and functional abnormalities, pericardial effusion, myocardial tissue characterization for myocardial edema, hyperemia and capillary leak by myocardial early gadolinium enhancement and necrosis and fibrosis by late gadolinium enhancement besides enabling non invasive follow up with significant inter-observer consistency, and quantitative accuracy. © 2014, Cardiological Society of India. All rights reserved.
Iyer P.U.,Fortis Escorts Heart Institute
Indian Journal of Pediatrics | Year: 2015
Admission of infants and children with cardiac disease to the neonatal (NICU) and pediatric ICU (PICU) is ever increasing in India (30–50 % of all admissions). The commonest indication for admission to the NICU or PICU is acute deterioration of cardiac disease. This includes: acute heart failure, hypercyanotic spells, arrhythmias, pericardial tamponade and sick cardiac neonates who need urgent intervention. Other increasingly frequent indications for ICU admission include heart failure with concomitant chest infection and impending respiratory failure and, severe cyanotic heart disease with various stroke syndromes. It is thus essential that a pediatrician be comfortable with the ICU management of such children and that low cost ICU modalities be utilized in order to reach out to as many children as feasible. It is heartening that there is renewed interest in inexpensive therapies like noninvasive ventilation and therapeutic hypothermia. © 2015, Dr. K C Chaudhuri Foundation.