Ashok Thakkar

A first-in-man study of sirolimus-eluting, biodegradable polymer coated cobalt chromium stent in real life patients.

INTRODUCTION Despite considerable benefits associated with current drug-eluting stents, continued attention to the safety, efficacy, and deliverability of available drug-eluting stent has led to the development of newer stent. METHODS This study was a single-centre, prospective, non-randomized, first-in-man study which included clinical follow-up data was collected at 1, 8 and 12 months after the procedure. The study included 105 patients with de novo native coronary artery lesions including multi-vessel disease treated with Supralimus-Core® stent. Repeat angiography was performed 8 months post-stent implantation. RESULTS At quantitative coronary angiography 8-month luminal late loss was 0.39 ± 0.33 mm in-stent and 0.33 ± 0.35 mm in-segment. The incidence of any major adverse cardiac event at 30 days, 8 months and 12 months was 1 (1%), 6 (6%) and 7 (7%) respectively. CONCLUSION This study demonstrates that the Supralimus-Core® SES is a safe and effective treatment for patients with obstructive coronary artery disease. ClinicalTrials.gov ID: NCT00811616.

Prognosis of Left Ventricular Systolic Dysfunction in Septic Shock Patients

INTRODUCTION The prognosis of myocardial dysfunction in critically ill patients with sepsis and its association with mortality is controversial. We aim to determine the significance of left ventricular systolic dysfunction in septic shock patients and their associated outcome. MATERIALS AND METHODS A prospective, single center, observational study was carried out at an intensive care unit of a tertiary care hospital. A total of 66 patients diagnosed with septic shock were enrolled in the study from September 2010 to June 2012. The 2D echocardiography was performed for all the patients. Ejection fraction <50% was the diagnosing parameter for the patients with systolic dysfunction in septic shock. Acute Physiology and Chronic Health Evaluation III (APACHE III) score was calculated. RESULTS The mean age of patients were found to be 53.71 ± 16.76 years. The mortality rate was found to be 48.48% and among them 43.75% patients had ejection fraction <50%. Non-survivors exhibited significantly lower mean blood pressure (74.19 ± 10.28 versus 80.59 ± 11.31; p = 0.008), lower ejection fraction (52.59 ± 16.37 versus 62.56 ± 8.31; p = 0.029) and higher APACHE III score (89.34 ± 15.41 versus 70.65 ± 13.27; p <0.001). The receiver operating characteristic curves APACHE III score (area under curve = 0.830) and ejection fraction (area under curve = 0.656) were used to predict the mortality in septic patients. CONCLUSION Low ejection fraction, a marker to measure left ventricular systolic dysfunction is a predictor of mortality in septic shock patients. However, more research is needed to confirm the findings.

Successful Transradial Percutaneous Coronary Intervention in a Patient with Dextrocardia and Situs Inversus

Dextrocardia with situs inversus is a rare clinical entity with an estimated incidence ranges from 1 in 8000 to 1 in10,000. Percutaneous intervention in patient with dextrocardia and situs inversus is clinically challenging due to abnormal orientation of coronary geometry and the intervention requires appropriate use of guiding catheters, engagement technique, appropriate radiological angles as well as views. In this case-report, we describe percutaneous intervention with stenting in 48-year-old male patient with dextrocardia and situs inversus. We successfully deployed drug-eluting stents in right coronary artery and left circumflex artery.

Systemic exposure of sirolimus after coronary stent implantation in patients with de novo coronary lesions: Supralimus-Core® pharmacokinetic study

OBJECTIVES This study was conducted to assess the systemic drug release and distribution of sirolimus-eluting coronary stents. METHODS Twenty patients with coronary artery disease (CAD) were treated with 1, 2, or 3 a newly designed metallic stents. Blood samples were drawn at 14 time points to determine the pharmacokinetic of sirolimus. Whole blood concentrations of sirolimus were determined by using a sensitive validated high-performance liquid chromatography mass spectrometry/mass spectrometry method. RESULTS Minimal measurable blood levels were detectable at 7 days. Across all dose levels, individual T(max) values ranged from 1.00 hour and 12.00 hours; individual C(max) ranged from 0.73 ng/mL and 4.13 ng/mL. CONCLUSION This study confirms the limited exposure of the systemic circulation of the eluted drug with the use of the Supralimus-Core® Sirolimus-Eluting Coronary Stent System (Sahajanand Medical Technologies Pvt. Ltd., Surat, India). In this study, sirolimus concentration in systemic circulation is to be safe, well-tolerated and short-lived.

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.

A case of type I variant Kounis syndrome with Samter-Beer triad.

Kounis syndrome is defined as the coexistence of acute coronary syndromes with situations associated with allergy or hypersensitivity, as well as anaphylactic or anaphylactoid reactions, to a variety of medical conditions, environmental and medication exposures. We report a case of Kounis-Zavras syndrome type I variant in the setting of aspirin-induced asthma, or the Samter-Beer triad of asthma, nasal polyps and aspirin allergy. When there is a young individual with no predisposing factors of atherosclerosis and apparent coronary lesion, with or without electrocardiography and biochemical markers of infarction, the possibility of Kounis syndrome should be kept in mind.

In vivo assessment of stent recoil of biodegradable polymer-coated cobalt-chromium sirolimus-eluting coronary stent system.

INTRODUCTION Immediate and acute stent recoil has been observed following balloon deflation in normal and diseased coronary arteries, and the degree varies by stent design. METHODS A total of 19 patients, who underwent elective stent implantation for single de novo native coronary artery lesions, were enrolled: all patients treated with the biodegradable polymer-coated sirolimus-eluting cobalt-chromium coronary stent system (Supralimus-Core(®)). The immediate, acute and cumulative stent recoil was assessed by quantitative coronary angiography. The cumulative stent recoil was measured at 24 h of stent implantation. RESULTS The absolute late loss due to recoil was found 0.08 ± 0.19 mm for Immediate Stent Recoil (ISR), 0.05 ± 0.21 mm for Acute Stent Recoil (ASR) and 0.11 ± 0.25 mm for Cumulative Stent Recoil (CSR) respectively. CONCLUSIONS In vivo acute stent recoil of the Supralimus-Core(®) has higher radial strength compared to other available standard drug-eluting stents.

Clinical Outcomes from Unselected “Real-World” Patients with Long Coronary Lesion Receiving 40 mm Biodegradable Polymer Coated Sirolimus-Eluting Stent

Background. Long lesions being implanted with drug-eluting stents (DES) are associated with relatively high restenosis rates and higher incidences of adverse events. Objectives. We aimed to examine the safety and efficacy of the long (40 mm) biodegradable polymer coated Indolimus sirolimus-eluting stent (SES) in real-world patients with long coronary lesions. Methods. This study was observational, nonrandomized, retrospective, and carried out in real-world patients. A total of 258 patients were enrolled for the treatment of long coronary lesions, with 40 mm Indolimus. The primary endpoints in the study were incidence of major adverse cardiac events (MACE), a miscellany of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) or target vessel revascularization (TVR), and stent thrombosis (ST) up to 6-month follow-up. Results. The study population included higher proportion of males (74.4%) and average age was 53.2 ± 11.0 years. A total of 278 lesions were intervened successfully with 280 stents. The observed MACE at 6-month follow-up was 2.0%, which included 0.8% cardiac death and 1.2% MI. There were no TLR or TVR and ST observed during 6-month follow-up. Conclusions. The long (40 mm) Indolimus stent demonstrated low MACE rate and was proven to be safe and effective treatment for long lesions in “real-world” patients.

Development and Evaluation of Drug Eluting Stent Having Biphasic Release From a Single Layer of Biodegradable Polymer

In stent restenosis is the major disadvantage of percutaneous transluminal angioplasty. To overcome this limitation, drug eluting stents were introduced. We have developed novel sirolimus eluting stent using biocompatible and biodegradable polymer matrix. Developed stent have biphasic release profile for sirolimus from a single layer of polymer matrix, having blend of slow and fast degrading polymers. Coating integrity of coated stents were evaluated after crimping and postexpansion with the help of scanning electron microscopy while thickness of coated stent was measured using destructive test method. This shows that drug-polymers bilayer was uniformly coated with the average thickness of 5.2lms. There was no deformation after crimping and expansion of the stent. We have also measured in vitro and in vivo release profiles of sirolimus from stents which shows biphasic release characteristics, i.e., initial burst period followed by sustained release. In vitro release profile is well correlated with in vivo release in blood and arterial tissues. Developed stents showed good efficacy and safety in porcine coronary artery model. [DOI: 10.1115/1.4023414]

Small-for-gestational-age versus appropriate-for-gestational-age: Comparison of cord blood lipid profile & insulin levels in term newborns (SAGA-ACT study).

Background & objectives: The genesis of atherosclerotic lesions, a major cardiovascular risk factor starts in the early stage of life. If the premature development of cardiovascular risk factors can be anticipated during childhood, cardiovascular events can be prevented effectively by taking appropriate measures. This study was carried out to assess the role of in utero malnutrition in cardiovascular disease development by comparing cord blood lipid profiles and serum insulin levels between small-for-gestational-age (SGA) and appropriate-for-gestational-age (AGA) term newborns. Methods: Consecutive full-term infants who were born between June 20 and August 19, 2013, at the Obstetric Unit of a Hospital at Secunderabad, India, were enrolled in this study. Participating newborns were divided into SGA group (n = 51; test group) and AGA group (n = 52; control group) based on their gestational age and body weight. Cord blood lipid profile and insulin levels were compared between these two groups. Results: As compared to the newborns in AGA group, SGA group of newborns had significantly (P<0.01) higher levels of cholesterol, triglyceride and low-density lipoprotein. No difference was observed between the groups for high-density lipoprotein and insulin levels. Mild and moderate anaemia was observed among mothers of both groups, while severe anaemia was seen in mothers of SGA group only. Interpretation & conclusions: SGA newborns exhibited elevated lipid profiles as compared to AGA newborns. Hence, SGA newborns should be closely monitored for cardiovascular morbidities during childhood, adolescence and early adult life.