Comparison of Clinical Profile and Outcomes of Japanese Encephalitis and Acute Encephalitis Syndrome among Rural Children.

The study compared the clinical profile and outcomes of Japanese encephalitis (JE) and acute encephalitis syndrome (AES) in children. Fifty-six consecutive children with symptoms fulfilling the WHO clinical case definition of AES from June 2018 to June 2020 were included in the study. All patients who tested positive for either serum or cerebrospinal fluid (CSF) anti-JE-IgM antibodies were JE patients (n = 24) and compared with non-JE AES cases (n = 32). Fever, seizures, and altered sensorium were the most common presenting symptoms. Low GCS, status epilepticus, meningeal irritation, raised CSF protein, and INR > 1.5 of JE children showed significant association with mortality (p value < 0.05), whereas only low GCS showed significant association in non-JE AES cases. The JE-specific mortality rate was 29%, which was less than the mortality rate of non-JE AES children at 41%. Both JE and non-JE AES children had a similar clinical profile, but only the JE children's poor clinical and laboratory parameters were associated with adverse outcomes.

Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants.

BACKGROUND: A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® and for lot-to-lot consistency. METHODS: This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil® in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. Non-inferiority of LBRV-PV to Rotasiil was proven if the lower limit two-sided 95% confidence interval (CI) of geometric mean concentration (GMC) ratio was at least 0.5. Lot-to-lot consistency was proven if 95% CI of the GMC ratios of three lots were between 0.5 and 2. Solicited reactions were collected by using diary cards. RESULTS: Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRV-PV to Rotasiil® was 1.19 (95% CI 0.96, 1.48). The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97). The IgA GMC ratios among the three LBRV-PV lots were: Lot A versus Lot B: 1.34 (1.03, 1.75); Lot A versus Lot C: 1.22 (0.93, 1.60); and Lot B versus Lot C: 0.91 (0.69, 1.19). The 95% CIs for the GMC ratios were between 0.69 and 1.75. The incidence of solicited reactions was comparable across the four arms. Only one serious adverse event of gastroenteritis event in the Rotasiil® group was causally related. CONCLUSION: The immunological non-inferiority of LBRV-PV against Rotasiil® as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil®. TRIAL REGISTRATION NUMBER: Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104].

Tensionless Purely Laparoscopic Intra-Gastric Surgery using an Innovative Mucosal Flap-Valve Mechanism: The Jategaonkar Technique.

Cooperative laparoscopic endoscopic intra-gastric surgery, with its ability to acquire advantages of both these technologies, is a recent development in the field of minimally invasive surgery. However, the pre-requisition of its multi-disciplinary approach together with several technical constraints have, plausibly, limited its widespread acceptance. The ever-increasing number of modifications being reported in today's literature largely underscores the inability of any one to be the best. We illustrate a novel, simple-to-learn, rapid and potentially cost-effective technique of intra-gastric surgery using just the routine laparoscopic instruments, and name it the 'Jategaonkar technique'. We have practised it in seven consecutive patients without any complications; and hence, recommend it for regular application. Such a method is yet to be described in the literature.

Amending Umbilical Porting in Laparoscopic Totally Extra-peritoneal Hernioplasty: A Simplified Way.

An unambiguous identification of anterior rectus sheath (ARS) is a crucial initial step required for precise umbilical porting in order to achieve successful execution of laparoscopic totally extra-peritoneal (TEP) hernioplasty. However, it is scarcely discussed in the present-day literature. Backed with the experience of 1100 cases, we present an easy and rapid technique of exposing the anterior rectus sheath with the aim to save operative time without compromising the safety. Such a method is yet to be described in the literature.

Transfemoral aortic valve-in-valve implantation with the CoreValve Evolut for small degenerated stented bioprosthesis.

Transcatheter aortic valve-in-valve implantation represents one interesting therapeutic option for high-risk surgical patients with degenerated bioprostheses. The procedure is less invasive and can be performed without thoracotomy and general anesthesia, if the femoral approach is used. Until recently, failing small bioprostheses could only be treated percutaneously by underexpanding the CoreValve (Medtronic, Inc) or Edwards Sapien valve (Edwards Lifesciences). Underexpansion of these valves might compromise the hemodynamic performance and potentially limit its durability. Herein, we report our initial experience with the 23 mm CoreValve Evolut in 4 patients with degenerated 21 mm Mitroflow valves. The CoreValve prosthesis was successfully implanted in all 4 patients, with no major complications and no mortality at 3-month follow-up exam. However, 2 of the 4 patients developed mildly elevated transvalvular gradients. Therefore, despite our promising results, caution is necessary when considering patients with small degenerated bioprostheses for a valve-in-valve procedure.

Compression, distortion and dislodgement of large caliber stents in congenital heart defects caused by cardiopulmonary resuscitation: a case series and review of the literature.

Stenting of vascular, extracardiac or lately intracardiac stenosis has become an established interventional treatment for a variety of problems in congenital or acquired heart disease. Most stent procedures are completed successfully and the long-term outcome is favorable in the majority of cases. Stent collapse or deformation is a well recognized entity in peripheral stents and can be attributed to insufficient radial force; it can also be attributed to excessive external forces, like deformation of stents in the right ventricular outflow tract, where external compression is combined with continuous movement caused by the beating heart. The protection of the thoracic cage may prove to be insufficient in extraordinary circumstances, such as chest compression in trauma or cardiopulmonary resuscitation (CPR). In this case series, we describe three patients in whom large endovascular stents were placed to treat significant stenosis of the aorta, the aortic arch or the venous system of the inferior vena cava close to the atrium. In all patients, CPR was necessary during their clinical course for various reasons; after adequate CPR, including appropriate chest compression all patients survived the initial resuscitation phase. Clinical, echocardiographic as well as radiologic re-evaluation after resuscitation revealed significant stent distortion, compression, displacement or additional vascular injury. The possibility of mechanical deformation of large endovascular stents needs to be considered and recognized when performing CPR; if CPR is successful, immediate re-evaluation of the implanted stents--if possible by biplane fluoroscopy--seems mandatory.

Delayed coronary ischemia after transfemoral aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) offers a less invasive treatment alternative to surgical aortic valve replacement for high-risk patients. Although the procedure can be performed at low risk, life-threatening complications may arise in single cases during or even months after the procedure. Here, the details are presented of two patients who underwent TAVI by a transfemoral approach with Medtronic CoreValve prostheses and suffered myocardial ischemia months later. The patients' anatomy with small aortic root, narrow sinus of Valsalva and small distance between the annulus base and coronary arteries and/or the relative oversizing of the CoreValve prosthesis with a high positioning may have contributed to this late complication. Hence, caution is mandatory in this type of patient, with exact pre-procedural planning and close follow up required.

Interventional closure of atrial septal defects in adult patients with Ebstein's anomaly.

Ebstein's anomaly is frequently associated with interatrial communications. In patients with severe tricuspid regurgitation standard treatment is the surgical repair or replacement of the tricuspid valve and patch closure of the atrial septal defect. We sought to evaluate the feasibility and short-term outcome of interventional device closure of interatrial communications in Ebstein patients with mild to moderate tricuspid regurgitation and various degrees of clinical symptoms. In this case series of 9 patients the device closure could be performed safely and 8 of 9 patients improved in their exercise capacity or clinical condition. However, the patients need to be selected carefully and appropriately for this palliative method. In those with predominant left-to-right shunting, ASD-closure reduces the volume load of the right ventricle and can be performed according to routine procedures. In those patients with cyanosis and right-to-left shunting however, test occlusion of the interatrial communication with adequate balloon size followed by careful examination of the hemodynamics at rest and under catecholamine stimulation is compulsatory to evaluate the feasibility of device closure. The tricuspid regurgitation should not exceed moderate level, the right atrial and ventricular pressure should be within normal range for an adequate time during test occlusion and the systemic blood pressure and cardiac output maintained safely.

63-year survival after Blalock-Taussig shunt operation in a patient with single ventricle, tricuspid atresia, and pulmonary stenosis.

A 63-year-old female with complex congenital heart disease underwent a classical Blalock-Taussig (B-T) shunt operation at the age of 3 years in 1948. The cardiac morphology was not amenable to further definite surgical repair in that period of time. With this palliative operation, the patient survived to the age of 63 years and now presented with exercise intolerance and significant desaturation. Cardiac catheterization with angiography revealed a severe stenosis of the B-T shunt at the pulmonary end. Balloon dilation and stent implantation could be performed successfully. Follow-up after 5 months showed a patent B-T shunt and an increase of oxygen saturation from 65% to 80% and mild improvement of pulmonary blood flow and exercise tolerance.

Successful interventional treatment of a retrosternal pseudoaneurysm of the ascending aorta with an Amplatzer Vascular Plug II.

Pseudoaneurysm of the aorta is a rare, but potentially dangerous complication after cardiac surgery, trauma or infective aortitis. Potential fatal risk of rupture with severe hemorrhage exists, so that treatment is necessary. Surgical management carries a high morbidity and mortality rate. Using an endovascular transcatheter method seems to be a promising option for treatment of aortic pseudoaneurysms. We report a case of ascending aortic pseudoaneurysm, which was diagnosed 11 years after cardiac surgery and treated successfully by implantation of an Amplatzer Vascular Plug II.

Cardiac remodeling and effects on exercise capacity after interventional closure of atrial septal defects in different adult age groups.

BACKGROUND: Interventional closure of atrial septal defects (ASD) has become a standard procedure in pediatric and adult patients. We report immediate and mid-term results in different adult age groups. METHODS: A retrospective analysis of 332 patients undergoing percutaneous ASD closure between 1998 and 2008 was performed. Beside echocardiographic and hemodynamic measurements, the NYHA functional class was assessed before and after ASD closure. The peak oxygen uptake (VO(2peak)) was available in a subgroup of 154 patients. RESULTS: The different age groups did not differ significantly in shunt volume or defect diameter, but a significant increase could be detected in mean pulmonary arterial pressure, mean left atrial pressure and pulmonary vascular resistance (PVR9 with increasing age). Right ventricular enlargement was present in all age groups, but the degree of enlargement increased with age. Transcatheter ASD closure was successful in 99.4%, major adverse events occurred in four patients (1.2%). At 3 months from closure, 123 patients reported an improvement, 7 of worsening and 163 of no change in their functional capacity. A significant increase in VO(2peak) could be registered in all subgroups after ASD closure. When classified by shunt volume no change could be detected in VO(2peak) in the patients with a Q(p):Q(s) < 2, whereas patients with a Q(p):Q(s) > 2 had a highly significant VO(2peak) increase. CONCLUSION: Patients benefit from interventional closure of hemodynamically significant ASD regardless of their age. However, the defect should be repaired as early as possible to prevent hemodynamic complications, such as the development of pulmonary hypertension and cardiac arrhythmias.

Percutaneous closure of atrial septal defects: echocardiographic and functional results in patients older than 60 years.

BACKGROUND: Percutaneous closure of atrial septal defects is well established in children and adults and has been found to improve symptoms and positively influence right-heart remodeling. The aim of this study was to evaluate the efficacy and long-term outcome in adult patients older than 60 years. METHODS AND RESULTS: The study population comprised 96 patients in the age group of 60 to 84 years. Percutaneous closure was performed effectively in all patients. Functional capacity according to New York Heart Association functional class and peak oxygen uptake (VO(2)max) in the cardiopulmonary exercise testing improved significantly after atrial septal defects closure, especially in patients with a pulmonary-to-systemic flow ratio >2. Echocardiographic measurements of the right ventricular end-diastolic diameter showed a significant decrease. No device-associated complications were observed, but in 16 patients, paroxysmal atrial fibrillation occurred after device implantation. CONCLUSIONS: Percutaneous atrial septal defects closure can be performed safely and with minimal risk even in elderly patients. They profit in terms of symptom reduction, improvement of exercise capacity, and right-heart remodeling.

Two-dimensional strain and strain rate imaging of the right ventricle in adult patients before and after percutaneous closure of atrial septal defects.

AIMS: Echocardiographic speckle tracking or two-dimensional (2D) strain analysis is a new tool to assess myocardial function. This prospective controlled study evaluates systolic right ventricular (RV) function by 2D strain in adult patients with atrial septal defect (ASD) before and 3 months after percutaneous closure. METHODS AND RESULTS: Assessment of global longitudinal strain (GLS), global longitudinal strain rate (GLSR), and regional peak systolic strain (PSS) of right ventricle was performed in 33 ASD patients. The data were compared with those from 34 age-matched adults with patent foramen ovale. Before percutaneous closure, mean GLS was significantly increased in comparison to control group, and significantly reduced after closure. Analysis of regional PSS showed significant decrease in the lateral apical, lateral mid, and septal apical segments. GLSR was not influenced by ASD closure. CONCLUSION: Two-dimensional strain appears to be helpful also for the assessment of RV function and its response to correction of volume overload.

Transcatheter closure of patent foramen ovale in patients with paradoxical embolism. Procedural and follow-up results after implantation of the Starflex occluder device with conjunctive intensified anticoagulation regimen.

BACKGROUND: Prevalence of patent foramen ovale (PFO) is higher in patients with paradoxical embolism and associated with increased risk for recurrent thromboembolic events. By percutaneous closure of PFO, surgical closure or permanent oral anticoagulation can be avoided. So far, published series included different occluder systems and various indications and regimens of postprocedural anticoagulation. The aim of the present study was to evaluate the short- and long-term results after implantation of the Starflex occluder in patients with PFO using an intensified anticoagulation regimen. METHODS AND RESULTS: 154 patients with PFO (94 men; age: 44 +/- 13 years) and >or=1 thromboembolic event were included. Other causes for embolism were excluded. PFO closure was successful in 147 patients (95.5%). All patients were treated with phenprocoumon (INR 2.5) and aspirin (100 mg/die) for 6 months. Transesophageal echocardiography (TEE) was repeated at 6 months. Mean clinical follow-up period was 26 +/- 18 months. After 6 months, five patients had a significant residual shunt, and five patients had suspected thrombus formation on the occluder. In three of these five patients, the occluder was surgically removed and foreign body reaction was noted. During follow-up, nine patients suffered from neurological events (two strokes, seven transient ischemic attacks [TIA]), though complete closure of the PFO was documented by TEE. Two patients died during follow-up; three patients had bleeding complications. CONCLUSION: Percutaneous closure of PFO in symptomatic patients by Starflex occluder represents an effective therapy with a low incidence of periinterventional complications and recurrent thromboembolism. However, thrombus formation at the occluder system may occur in some patients despite an aggressive anticoagulation regimen.