Sharad Jain

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.

Prevalence and Predictors of Metabolic Syndrome in Young Asymptomatic Gujarati Population

Background. Metabolic syndrome is a cluster of risk factors leading to the development of atherosclerotic cardiovascular diseases. We aimed to evaluate the prevalence of metabolic syndrome (MS) and its predictors in young and apparently healthy Gujarati individuals. Methods. This population based cross-sectional study involved a total of 1500 healthy adults of 20–40 years of age. Demographic details and clinical data such as body mass index (BMI), waist circumference (WC), and blood pressure were measured along with the estimations of lipoprotein (a), total cholesterol (TC), triglyceride (TG), total lipid, LDL/HDL ratio, TC/HDL ratio, and fasting blood glucose (FBS). Results. Overall in young Gujarati population (20–40 years) prevalence rates of MS were 16.0% (male: 21.5%; female: 10.8%) where the metabolic abnormalities increased with advanced age as 9.56% of the young population (20–30 years) had MS, in contrast to the 24.57% in the old (31–40 years). Odds ratio analysis had indicated BMI (1.120; 95% CI: 1.077–1.163; P < 0.0001) as the strongest risk factor for MS closely followed by advancing age (1.100; 95% CI: 1.061–1.139; P < 0.0001) levels. Conclusion. Prevalence of metabolic syndrome in young Gujarati population reinforces the need for early life style intervention and awareness programs in this ethnic group.

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.

Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry

Objectives To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 µm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis. Setting Multicentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. Participants 995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months’ follow-up. Interventions Percutaneous coronary intervention with Supraflex SES, Primary and secondary outcome measures The primary endpoint—the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))—was analysed during 12 months. Results At 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 (1.8%) cardiac deaths, 16 (1.6%) MI, 7 (0.7%) TLR and 2 (0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1%), with a mean neointimal thickness of 0.13±0.06 µm. Conclusions The FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up.

Evaluation of prosthetic valve dysfunction by three-dimensional echocardiography

Background: Three-dimensional (3D) echocardiography (echo) and transesophageal echo images enable visualization of valvular anatomy from unique orientations with improved spatial relationships not previously seen with two-dimensional (2D) echo. Materials and Methods: Patients who fulfilled the criteria had undergone detailed evaluation of prosthetic valve dysfunction. Prosthetic valve dysfunction patients with stable hemodynamic were included and 3D echo findings were compared with 2D echo. Results: A total of 10 males and 25 females were evaluated in the study. Two females and one male had bioprosthetic, three males and two females had tilting disc valve, while 21 females and six males had bileaflet mechanical valve. 3D echo had shown abnormal motion of leaflets in seven male and 21 female patients compared to 2D echo. Abnormal valvular calcification was demonstrated in a total of 23 patients on 3D echo. Valve sewing-ring integrity and motion were found abnormal in two male and two female patients in 3D echo. Prosthetic valve dehiscence and thrombus were better seen in five and 15 patients, respectively, on 3D echo. On 3D echo, pannus was better seen in one male and two females. 3D echo defined exact site and size of vegetation better than 2D echo in two female patients. Conclusions: Real-time 3D imaging allows clinically useful visualization of prosthetic valve components such as leaflets, rings, and struts of all prosthetic valves, irrespective of position. “En face” view of the valve has proven useful in the assessment of prosthetic valve endocarditis, paravalvular regurgitation, and prosthesis dysfunction. 3D echo imaging plays an important role in device closure.

Acute Myeloid Leukemia with Intracardiac Thrombus Presenting as Acute Limb Ischemia

A 50-year-old female presented to our emergency department with complaints of acute onset pain in left lower limb for last 5 days. Her previous history was unremarkable. Physical examination revealed a pulse rate of 90 per minute, blood pressure of 120/76 mm Hg and normal jugular venous pulse. The left lower limb was cold and pale. Her left femoral, left popliteal, left dorsalis pedis and left posterior tibial arterial pulsations were absent. All other arterial pulsations were normally present. Cardiac and respiratory examinations were within normal limits. Electrocardiogram was within normal limits with normal sinus rhythm. A diagnosis of acute limb ischemia was made and an emergency computed tomographic angiography of infra renal aorta with both the lower limbs was done. There was a partial filling defect of the aorta just before the bifurcation along with complete thrombotic occlusion of the left common iliac artery with distal reformation by collateral from the arteries of the contralateral limb (Fig. 1). Two dimensional echocardiography showed a large (2.0 × 3.0 cm) mobile thrombus at the apico-septal region of the left ventricle along with normal ejection fraction of 60% (Fig. 2A, Supplementary movie 1). The three dimensional (3D) nature of the thrombus was better appreciated on transthoracic 3D echocardiography (Fig. 2B, Supplementary movie 2). Hematologic studies revealed anemia, with hemoglobin level of 10 g/dL, thrombocytopenia (30 platelets/nL) and leucocytocis (240 white blood cells/nL). Peripheral smear showed 95% blast cells which were peroxidase negative (Fig. 3). Bone marrow aspiration confirmed the diagnosis of acute myeloid leukemia (French American British type M2). Aortic with left ileo-femoral thromboembolectomy was done to salvage the limb. Intra venous heparin therapy was started for left ventricular thrombus. Patient was transferred to the oncology department where induction phase of chemotherapy was started according to acute myeloid leukemia management protocol. Fig. 1 Computed tomographic angiography of aorta with both lower limb. There is a partially occluding thrombus at the lower aorta just before the bifurcation along with complete thrombotic occlusion of the left common iliac artery from the origin. A: The left ... Fig. 2 Transthoracic echocardiography. A: Two dimensional echocardiography in apical four chamber view (A) showing normal sized LV with a 2.0 × 3.0 cm thrombus at the apico-septal region. B: The three dimensional (3D) structure of the thrombus is better ... Fig. 3 Peripheral blood smear at 400 × magnification (A) and 1000 × magnification (B) using Wright stain. A: There are plenty of blast in the peripheral smear which can be identified by hyperchromatic nuclei with a raised nucleus/cytoplasm ratio. ... Patients with acute leukemia are at an increased risk of both thrombosis as well as bleeding. Severe haemorrhagic complications are seen in acute promyelocytic leukemiausually secondary to disseminated intravascular coagulation. Thrombotic complications are rarely reported. There are very few reports of acute limb ischemia due to large artery occlusion in acute myeloid leukemia.1) None of the previously reported cases had left ventricular thrombus. To our knowledge, this is the first report of acute myeloid leukemia having left ventricular thrombus and left lower limb thromboembolism on presentation. The pathology of coagulopathy in acute leukemia is complex. It is determined by an interplay between various procoagulant factors (like tissue factor, cancer procoagulant factor, prothrombotic cytokines) and anticoagulant and fibrinolytic factors released or expressed by the leukemic cells.2) Due to scarcity of occurrence of thrombotic complications in acute myeloid leukemia, no large scale studies are available for guiding management of this complication. Thrombolytic and anticoagulation therapy is not without risk as patient are also at increased risk of bleeding due to simultaneous occurrence of thrombocytopenia and disseminated intravascular coagulation. Prompt diagnosis of underlying leukemia and initiation of appropriate anti leukemia treatment are keys to reducing overall morbidity and mortality.

Comparison of Clinical Outcomes Following Single versus Multivessel Percutaneous Coronary Intervention Using Biodegradable Polymer Coated Sirolimus-Eluting Stent in an All-comers Patient Population.

BACKGROUND Drug-eluting stents (DES) have been shown to reduce the rate of acute complications and the need for subsequent revascularization in cases where single-vessels are treated. The performance of DES in patients with multivessel disease and complex lesions, however, remains controversial. This study assessed and compared clinical outcomes following single vs. multivessel percutaneous coronary intervention (PCI), using the Supraflex sirolimus-eluting stent (SES), in an all-comers patient population. METHODS We conducted retrospective, multicenter, all-comers, observational study of 995 patients, who underwent either single-vessel PCI (n=769 patients; group-I) or multivessel PCI (n=226 patients; group-II), treated with the biodegradable polymer coated Supraflex SES, between July-2013 and May-2014 at nine different centers in India. Pre-specified primary endpoint, rate of major adverse cardiac events (MACE) [defined as composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and non-target lesion target vessel revascularization (non-TL TVR)], was analyzed during 12 months after the post-index procedure. We also analyzed the incidence of stent thrombosis (ST) as a safety endpoint during the follow-up period, as defined by the Academic Research Consortium (ARC). RESULTS Of the whole study group, 1,242 lesions were treated in 995 patients (mean age 61.6±10.8 years; 80.0% male) with average stent length of 26.8±9.3 mm. Multivessel PCI patients were older, had a higher prevalence of arterial hypertension, were smoker, had a family history of coronary artery disease, previous stroke and previous PCI compared to single-vessel PCI patients. Follow-up was available in 99.0% (761/769) of patients with single-vessel intervention and 96.9% (219/226) of patients with multivessel intervention at the end of 12 months. In-hospital MACE was similar for both the groups [group-I, 3 (0.4%) vs. group-II, 1 (0.4%); p=1.000]. The observed MACE for group-I and group-II, at 30 days, 6 and 12 months follow-up were 9 (1.2%) vs. 2 (0.9%); p=1.000, 15 (2.0%) vs. 7 (3.2%); p=0.302 and 24 (3.2%) vs. 12 (5.5%); p=0.109, respectively. The cumulative incidence curves for MACE showed no significant differences between the two groups, at the end of 12 months (p=0.109). CONCLUSION Our study shows that use of the Supraflex SES in single and multivessel coronary artery disease produces good clinical outcomes during 12 months of follow-up with a low rate of revascularization, despite complex lesion morphology.

Accessory pancreatic lobe with gastric duplication cyst: diagnostic challenges of a rare congenital anomaly.

Reports of combined congenital abnormalities of gastric duplication cysts and accessory pancreatic lobes are rarely reported. Patients with such anomalies may require appropriate surgical intervention tailored to the individual patient for complete cure. A multimodality diagnostic approach using ultrasonography, CT and MRI is useful for appreciation of the relevant anatomy of the congenital abnormality and for proper surgical planning. We present a case of a gastric duplication cyst with accessory pancreatic lobe and ectopic pancreatic rest in a 5-year-old child presenting with symptoms of recurrent pancreatitis.