Pulmonary Hypertension Registry of Kerala, India (PRO-KERALA): One-year outcomes.

BACKGROUND: Short term outcomes of patients with pulmonary hypertension are not available from low and middle-income countries including India. METHODS: We conducted a prospective study of 2003 patients with pulmonary hypertension, from 50 centres (PROKERALA) in Kerala, who were followed up for one year. Pulmonary hypertension (PH) was mainly diagnosed on the basis of Doppler echocardiography. The primary outcome was a composite end-point of all-cause death and hospital admission for heart failure. All cause hospitalisation events constituted the secondary outcome. RESULTS: Mean age of study population was 56 ± 16 years. Group 1 and Group 2 PH categories constituted 21.2% and 59% of the study population, respectively. Nearly two-thirds (65%) of the study participants had functional class II symptoms. 31% of Group 1 PH patients were on specific vasodilator drugs.In total, 83 patients (4.1%) died during the one-year follow-up period. Further, 1235 re-hospitalisation events (61.7%) were reported. In the multivariate model, baseline NYHA class III/IV (OR 1.87, 95% C.I. 1.35-2.56), use of calcium channel blockers (OR 0.18, 95% C.I. 0.04-0.77), vasodilator therapy (OR 0.5, 95% C.I. 0.28-0.87) and antiplatelet agents (OR 1.80, 95% C.I. 1.29-2.51) were associated with primary composite outcome at one-year (p < 0.05). CONCLUSION: In the PROKERALA registry, annual mortality rate was 4%. More than half of the patients reported re-hospitalisation events on follow up. Uptake of guideline directed therapies were suboptimal in the study population. Quality improvement programmes to improve guideline directed therapy may improve clinical outcomes of PH patients in India.

Associations between preoperative anaemia and hospital costs following major abdominal surgery: cohort study.

BACKGROUND: Determining the cost-effectiveness and sustainability of patient blood management programmes relies on quantifying the economic burden of preoperative anaemia. This retrospective cohort study aimed to evaluate the hospital costs attributable to preoperative anaemia in patients undergoing major abdominal surgery. METHODS: Patients who underwent major abdominal surgery between 2010 and 2018 were included. The association between preoperative patient haemoglobin (Hb) concentration and hospital costs was evaluated by curve estimation based on the least-square method. The in-hospital cost of index admission was calculated using an activity-based costing methodology. Multivariable regression analysis and propensity score matching were used to estimate the effects of Hb concentration on variables related directly to hospital costs. RESULTS: A total of 1286 patients were included. The median overall cost was US $18 476 (i.q.r.13 784-27 880), and 568 patients (44.2 per cent) had a Hb level below 13.0 g/dl. Patients with a preoperative Hb level below 9.0 g/dl had total hospital costs that were 50.6 (95 per cent c.i. 14.1 to 98.9) per cent higher than those for patients with a preoperative Hb level of 9.0-13.0 g/dl (P < 0.001), 72.5 (30.6 to 128.0) per cent higher than costs for patients with a Hb concentration of 13.1-15.0 g/dl (P < 0.001), and 62.4 (21.8 to 116.7) per cent higher than those for patients with a Hb level greater than 15.0 g/dl (P < 0.001). Multivariable general linear modelling showed that packed red blood cell (PRBC) transfusions were a principal cost driver in patients with a Hb concentration below 9.0 g/dl. CONCLUSION: Patients with the lowest Hb concentration incurred the highest hospital costs, which were strongly associated with increased PRBC transfusions. Costs and possible complications may be decreased by treating preoperative anaemia, particularly more severe anaemia.

One-year clinical outcome of patients with nonvalvular atrial fibrillation: Insights from KERALA-AF registry.

BACKGROUND: We report patient characteristics, treatment pattern and one-year clinical outcome of nonvalvular atrial fibrillation (NVAF) from Kerala, India. This cohort forms part of Kerala Atrial Fibrillation (KERALA-AF) registry which is an ongoing large prospective study. METHODS: KERALA-AF registry collected data of adults with previously or newly diagnosed atrial fibrillation (AF) during April 2016 to April 2017. A total of 3421 patients were recruited from 53 hospitals across Kerala state. We analysed one-year follow-up outcome of 2507 patients with NVAF. RESULTS: Mean age at recruitment was 67.2 years (range 18-98) and 54.8% were males. Main co-morbidities were hypertension (61.2%), hyperlipidaemia (46.2%) and diabetes mellitus (37.2%). Major co-existing diseases were chronic kidney disease (42.1%), coronary artery disease (41.6%), and chronic heart failure (26.4%). Mean CHA2DS2-VASc score was 3.18 (SD ± 1.7) and HAS-BLED score, 1.84 (SD ± 1.3). At baseline, use of oral anticoagulants (OAC) was 38.6% and antiplatelets 32.7%. On one-month follow-up use of OAC increased to 65.8% and antiplatelets to 48.3%. One-year all-cause mortality was 16.48 and hospitalization 20.65 per 100 person years. The main causes of death were cardiovascular (75.0%), stroke (13.1%) and others (11.9%). The major causes of hospitalizations were acute coronary syndrome (35.0%), followed by arrhythmia (29.5%) and heart failure (8.4%). CONCLUSIONS: Despite high risk profile of patients in this registry, use of OAC was suboptimal, whereas antiplatelets were used in nearly half of patients. A relatively high rate of annual mortality and hospitalization was observed in patients with NVAF in Kerala AF Registry.

Pulmonary hypertension registry of Kerala, India (PRO-KERALA) - Clinical characteristics and practice patterns.

BACKGROUND: Epidemiological data on pulmonary hypertension (PH) are scarce from developing countries including India. METHODS: We established a multi-center registry of PH, the PRO-KERALA registry, in Kerala, India. Fifty hospitals enrolled consecutive adult (>18 years) patients for one year. Echocardiographic criteria (right ventricular systolic pressure - RVSP > 50 mmHg) or invasively obtained mean pulmonary artery pressure > 25 mmHg was the criteria for entry. RESULTS: There were 2003 patients (52% Women, mean age 56 ±â€¯16.1 years) enrolled. The mean RVSP was 68.2 (SD = 17.9) mmHg. Majority of the study participants (59%) belonged to group 2 of the WHO Nice Classification 2013 (PH secondary to left heart disease). One-fifth (21.2%) belonged to group 1, while 13.3%, 3.8% and 2.4% of the study population belonged to groups 3, 4 and 5 respectively. More than a quarter (27%) reported PH due to left heart disease with valvular disease etiology; while 20.7% had coronary artery disease. The other common etiological factors were chronic obstructive pulmonary disease (10.6%), congenital heart disease (14.6%), idiopathic pulmonary hypertension (5.8%), and chronic thromboembolic pulmonary hypertension (3.8%). Only one of two patients with pulmonary artery hypertension was receiving PH specific therapies. The use of combination therapy was negligible and PH-specific therapies were prescribed off-label to a small proportion of patients too. CONCLUSION: PRO-KERALA is the first PH registry from South Asia and the second largest globally. Left heart diseases attribute to three fifths of patients with PH. Utilization rates of PH specific drug therapies are remarkably lower than the Western population.

Angiographic predictors of success in antegrade approach of Chronic Total Occlusion interventions in a South Indian population in the contemporary era.

Chronic Total Occlusion (CTO) intervention is a challenging area in interventional cardiology. Presently about 70% of CTO interventions are successful. MATERIALS AND METHODS: This was a single center prospective study of a cohort of all patients undergoing percutaneous coronary intervention (PCI) as elective or adhoc procedure for CTO from August 2014 to June 2015. Only antegrade CTO interventions were included. In all patients the following data were recorded. RESULTS: A total of 210 (8.9% of total PCI (2353) during the study period) CTO patients were followed up. The mean age was 56.54±8.9. In the study sixty nine patients (32.9%) presented with chronic stable angina and rest of the patients had history of acute coronary syndrome of which 22.9% (n=48) had unstable angina (UA) or non ST elevation myocardial infarction (NSTEMI) and 44.2% (n=93) had ST Elevation Myocardial Infarction (STEMI). In those with history of ACS, 64.78% (n=92) had ACS during the previous year and remaining 35.22% (n=49) had ACS prior to that. Single vessel CTO was seen in 89.5% (n=188) and two vessel CTO in 10.5% (n=22). LAD was involved in 36.7% (n=77), RCA in 48.1% (n=101), and LCX in 15.2% (n=32). Procedural success in the first attempt was 68.1% (n=143), which increased to 71.42% (n=150) after the second attempt. CTO interventions were more frequently successful when the calcium was absent or minimal (p-0.05), CTO length was <10mm (p<0.01) and good distal reformation (p<0.01).

Geographical variation in the clinical presentation of endomyocardial fibrosis in India?

OBJECTIVES: To compare the clinical presentation, clinical profile and survival of two groups of endomyocardial fibrosis patients. METHODS: The study was a prospective cohort study, or a prospective case series, comparing all consecutive echocardiographically proven patients with endomyocardial fibrosis seen in Medical College Trivandrum with the patients seen in Medical College Hospital, Alappuzha(Alleppey) (or TD Medical College). In all patients the clinical details like age, sex, type of endomyocardial fibrosis, the presence of anaemia, eosinophilia, neutrophilia and type of rhythm(Sinus or atrial fibrillation) etc were compared by both simple X2 and by Kaplan Meier survival curves. RESULTS: The mean age and the sex distribution was same in both places Briefly the incidence of biventricular endomyocardial fibrosis was more from Trivandrum than Alleppey, 64.9% vs 14.3% (p<0.0.001), the incidence of atrial fibrillation was more in Trivandrum 44.2% vs 16.3%. (p<0.001)The overall survival of Trivandrum patients was poorer (p<0.0001). The six year survival was 61% in the Trivandrum population whereas it was 91.5% in the Alleppey population. CONCLUSIONS: These differences may have been due to the better nutrition of the Alleppey patients due to a higher exposure to fish compared to the Trivandrum population. Better nutrition would protect against Magnesium deficiency and prevent the absorption of Cerium in the patients from Alleppey, compared to those from Trivandrum.

Population access to reperfusion services for ST-segment elevation myocardial infarction in Kerala, India.

BACKGROUND: Population access to timely reperfusion is a decisive factor in determining the success and acceptability of any regional system of ST-segment elevation myocardial infarction (STEMI) care. We sought to determine the proportion of population of the southern Indian state of Kerala having timely access to STEMI reperfusion. METHODS: We identified the STEMI reperfusion facilities available at all acute-care hospitals, in Kerala, by conducting a cross-sectional survey. We mapped the geographical catchment areas of these hospitals using historical travel speeds and appropriate Geospatial Information Systems (GIS) analyses. Subsequently, using block level population data, we estimated the proportion of the population residing within these geographies. RESULTS: We estimated that 23.33 million people, forming 69.84% of the state population, resided in the green zone (within half-hour travel distance of a percutaneous coronary intervention [PCI]-capable hospital), which covered 47.94% of the geographical area of the state. Outside this green zone, 21.87% of the state population resided within 1hr travel distance of a thrombolysis-capable hospital. Finally, 8.28% of the state population resided in the red zone, where access to any reperfusion-capable hospital took >1hr, which covered 22.15% of the geographical area of the state. CONCLUSIONS: A majority of the population of Kerala had timely access to PCI-capable hospitals. GIS-based mapping of Indian states, in terms of access to STEMI reperfusion, may help devise protocols to achieve seamless transfer of patients to reperfusion-capable hospitals. Such regionalization of STEMI care would enhance organizational synergies to achieve better access to reperfusion, especially in remote areas.

Sofosbuvir plus ribavirin in treatment-naïve patients with chronic hepatitis C virus genotype 1 or 3 infection in India.

Until 2014, pegylated interferon plus ribavirin was the recommended standard of care for the treatment of chronic hepatitis C virus (HCV) infection in India. This open-label phase 3b study, conducted across 14 sites in India between 31 March 2014 and 30 November 2015, evaluated the efficacy and safety of sofosbuvir plus ribavirin therapy among treatment-naïve patients with chronic genotype 1 or 3 HCV infection. A total of 117 patients with genotype 1 or 3 HCV infection were randomized 1:1 to receive sofosbuvir 400 mg and weight-based ribavirin (1000 or 1200 mg) daily for 16 or 24 weeks. Among those with genotype 1 infection, the primary efficacy endpoint of sustained virologic response at 12 weeks post-treatment (SVR12) was reported in 90% (95% confidence intervals [CI], 73-98) and 96% (95% CI, 82-100) of patients following 16 and 24 weeks of treatment, respectively. For patients with genotype 3 infection, SVR12 rates were 100% (95% CI, 88-100) and 93% (95% CI, 78-99) after 16 and 24 weeks of therapy, respectively. Adverse events, most of which were mild or moderate in severity, occurred in 69% and 57% of patients receiving 16 and 24 weeks of treatment, respectively. The most common treatment-emergent adverse events were asthenia, headache and cough. Only one patient in the 24-week group discontinued treatment with sofosbuvir during this study. Overall, sofosbuvir plus ribavirin therapy achieved SVR12 rates ≥90% and was well tolerated among treatment-naïve patients with chronic genotype 1 or 3 HCV infection in India.

Rheumatic Heart Disease in Kerala: A Vanishing Entity? An Echo Doppler Study in 5-15-Years-Old School Children.

Background. Early detection of subclinical rheumatic heart disease by use of echocardiography warrants timely implementation of secondary antibiotic prophylaxis and thereby prevents or retards its related complications. Objectives. The objective of this epidemiological study was to determine prevalence of RHD by echocardiography using World Heart Federation criteria in randomly selected school children of Trivandrum. Methods. This was a population-based cross-sectional screening study carried out in Trivandrum. A total of 2060 school children, 5-15 years, were randomly selected from five government and two private (aided) schools. All enrolled children were screened for RHD according to standard clinical and WHF criteria of echocardiography. Results. Echocardiographic examinations confirmed RHD in 5 children out of 146 clinically suspected cases. Thus, clinical prevalence was found to be 2.4 per 1000. According to WHF criteria of echocardiography, 12 children (12/2060) were diagnosed with RHD corresponding to echocardiographic prevalence of 5.83 cases per 1000. As per criteria, 6 children were diagnosed with definite RHD and 6 with borderline RHD. Conclusions. The results of the current study demonstrate that echocardiography is more sensitive and feasible in detecting clinically silent RHD. Our study, the largest school survey of south India till date, points towards declining prevalence of RHD (5.83/1000 cases) using WHF criteria in Kerala.

Preoperative assessment of retrorectal tumours.

BACKGROUND: Retrorectal tumours present diagnostic and surgical challenges. This study aimed to identify whether preoperative imaging and/or biopsy provide diagnostic accuracy. METHODS: A consecutive series of patients who had undergone excision of a retrorectal tumour were identified from a database (2002-2013). Details of patient demographics, preoperative presentation, imaging, biopsy, surgical procedure, and gross and microscopic pathology were reviewed. Preoperative imaging and/or biopsies were compared with eventual pathology findings. RESULTS: In total, 76 patients were identified, all of whom had undergone preoperative cross-sectional imaging whereas only 22 had preoperative biopsy. Imaging correctly discriminated benign from malignant tumours in 72 of the 76 patients (specificity 97 per cent, sensitivity 88 per cent, positive predictive value 88 per cent and negative predictive value 97 per cent). The corresponding values for preoperative biopsy (benign versus malignant) were 100, 83, 100 and 93 per cent. None of the four patients who were assessed incorrectly as having benign or malignant disease on imaging would have undergone an alternative procedure had this been known before surgery. Preoperative biopsy did not significantly influence patient management, and the absence of preoperative biopsy had no detrimental effect; a definitive preoperative histological diagnosis would not have influenced subsequent management. CONCLUSION: Preoperative imaging was accurate in the assessment of retrorectal tumours, whereas biopsy did not add to the surgical strategy.

Primary melanoma of the cochlea with cerebellopontine extension and leptomeningeal spread.

BACKGROUND: Less than 1 per cent of tumours occurring in the region encompassing the internal auditory canal and the cerebellopontine angle are malignant. Primary central nervous system melanomas arising from this region are exceptionally rare and are often initially misdiagnosed as acoustic neuromas. METHODS: We present a 71-year-old man with acute vestibular disturbance and unilateral hearing loss. Magnetic resonance imaging demonstrated a mass, thought to be a cochlear nerve schwannoma, involving the cochlea and the internal auditory canal. At surgery, a pigmented mass adherent to the facial nerve was visualised, and the observed histopathology was consistent with a malignant melanoma. No extracranial site for the primary tumour was found, suggestive of a primary central nervous system melanoma. RESULTS: Despite surgical resection and adjuvant radiotherapy, the patient re-presented with extensive leptomeningeal disease 16 months later. CONCLUSION: Malignant tumours in the internal auditory canal and cerebellopontine angle region are rare. Early diagnosis and management are aided by recognition of characteristic factors such as a history of prior malignancy, atypical magnetic resonance imaging findings and accelerated audiovestibular symptoms. Despite the presented patient's outcome, total surgical resection with post-operative radiotherapy remains the recommended treatment.

Ocular complications in children with nephrotic syndrome on long term oral steroids.

OBJECTIVES: To estimate the burden of ocular complications like posterior subcapsular cataract (PSCC) and raised intra ocular pressure (IOP) in children with nephrotic syndrome on long term steroid therapy and to assess the correlation of cumulative dosage and duration of consumption of steroids with these ocular complications. METHODS: Children between 4-18 y with nephrotic syndrome, who received steroids for at least six months, were included in this cross sectional study. Demographic, clinical and treatment details were obtained from case records. Detailed ocular evaluation was performed to detect PSCC and to measure IOP. RESULTS: One hundred and eighteen children were screened and 82 with a median (IQR=Interquartile range) follow up of 4.2 y (2.4, 6.3 y) were included in the final analysis. The median (IQR) age of children was 9.3 y (6, 12.5 y) at recruitment. The proportion of children with PSCC and raised IOP were 22/82 (26.8 %) and 9/82 (10.97 %) respectively. PSCC was associated with older age (p = 0.009). The median cumulative dose of steroids in those with and without cataract was 338.4 mg/kg and 343.2 mg/kg respectively (p = 0.58). The median duration of steroid theraphy was 58 wk and 59 wk in the two groups respectively (p = 0.73). Of children with PSCC, 9 (42.8 %) had mild diminution of vision. CONCLUSIONS: One in 4 and 1 in 9 children with nephrotic syndrome in the present study had PSCC and raised IOP respectively. Cumulative dose and duration of steroid therapy were not significantly associated with PSCC or raised IOP. The present study emphasizes the need for regular ocular evaluation and also to explore additional factors in causation of steroid induced ocular complications.

Gender differences on risk factors of non-communicable diseases--a community based cross-sectional study in central Nepal.

BACKGROUND: Non-communicable diseases are the leading causes of death globally, killing more people each year than all other causes combined. As many other developing countries, Nepal is also facing double burden of diseases. The aim of present study was to assess gender wise differences on prevalence of risk factors of non-communicable diseases. METHODS: This was a community based cross sectional study which was based on WHO's STEP approach for surveillance risk factors of non-communicable diseases among males and females. Multi-staged sampling technique was used to get required study sample. Descriptive and inferential statistics were applied to compare the risk factors between two genders. RESULTS: More than two-fifth of male and one-fifth of female respondents were currently using tobacco. The proportion of current alcohol users was found higher among the male respondents (28.6%) than their female counterparts (13.6%) (P<0.001). Only 35 (5.3%) of males and 13 (2.3%) of females were found consuming adequate (≥5 serving) intake of fruits per day. Study revealed that hypertension was slightly higher in male 165 (24.8%) than their female counterparts 111 (19.3%) but differences between two genders were statistically not significant. CONCLUSIONS: The findings of present study suggest that there is high prevalence of risk factors of non-communicable diseases among both sexes in central Nepal. The finding emphasises the need for a focused national strategies targeting to tackle this modern epidemic of non-communicable diseases by incorporating primordial prevention activities to all adult population irrespective to gender.

Clinical profile and outcome of chronic pancreatitis in children.

OBJECTIVE: To evaluate the etiology, presentation, complications and management of chronic pancreatitis in children. DESIGN: Retrospective chart review. SETTING: Gastroenterology department at Christian Medical College and Hospital, Vellore, India between January 2005 and December 2010. PARTICIPANTS: 99 Children (>18 yrs) diagnosed with chronic pancreatitis based on clinical and imaging features. MAIN OUTCOME MEASURES: Etiology, clinical presentation, complications and management of chronic pancreatitis in children. RESULTS: Of 3887 children who attended the Gastroenterology department, 99(2.5%) had chronic pancreatitis, of which 60 (60.6%) were males. In 95(95.9%) patients no definite cause was detected and they were labeled as Idiopathic chronic pancreatitis. All patients had abdominal pain, while 9(9.1%) had diabetes mellitus. Of the 22 children tested for stool fat, 10(45.5%) had steatorrhea. Pancreatic calcification was seen in 69 (69.7%). 68 (71.6%) patients with idiopathic chronic pancreatitis had calcification. Calcific idiopathic chronic pancreatitis was more frequent in males (67.6% vs. 48.1%, P=0.07), and was more commonly associated with diabetes mellitus (13.2% vs. none, P=0.047) and steatorrhea (61.5% vs. 16.7%, P=0.069). Pseudocyst (17.1%) and ascites (9.1%) were the most common complications. All children were treated with pancreatic enzyme supplements for pain relief. 57 patients were followed up. With enzyme supplementation, pain relief was present in 32 (56.1%) patients. Of those who did not improve, 10 underwent endotherapy and 15 underwent surgery. Follow up of 8 patients who underwent endotherapy, showed that 5 (62.5%) had relief. Follow up of 11 patients who underwent surgery showed that only 3 (27%) had pain relief. There was no death. CONCLUSIONS: Idiopathic chronic pancreatitis is the predominant form of chronic pancreatitis in children and adolescents. It can present with or without calcification. The calcific variety is an aggressive disease characterized by early morphological and functional damage to the pancreas.

Partial anterior sacrectomy with nerve preservation to treat locally advanced rectal cancer.

AIM: Most studies that have reported outcomes after composite abdomino-sacral resection for locally advanced/recurrent rectal cancer have involved resections below the S2/3 disc space. Involvement of the sacrum above this level is uncommon and, until recently, was considered a contraindication to resection. METHOD: We report here a surgical technique to deal with high sacral involvement with an anterior approach and maintenance of sacropelvic stability. RESULTS: The operative findings confirmed a locally perforated rectal cancer with an associated abscess cavity and direct invasion into S2. Given the likelihood that a complete dislocation of the sacrum would cause significant neurological damage and pelvic instability without oncological benefit, we opted for a partial high anterior sacrectomy with nerve preservation. The patient made an uncomplicated recovery without neurological deficit and was able to walk with the aid of crutches from postoperative day 3. CONCLUSION: While a high sacral transection is appropriate for some patients with locally advanced/recurrent rectal cancer, operative decisions and options should be tailored to each individual.

Contrasting approaches to end of life and palliative care in end stage kidney disease.

With increased numbers of the elderly, including nursing home patients, being accepted for end-stage kidney disease (ESKD) management, there is heightened interest and focus on end of life decisions, advanced care planning and directives, withdrawal from dialysis and palliative care in this setting. Despite this, care at the individual patient level can vary greatly. Here, we present two contrasting cases to highlight the importance of early and ongoing involvement of palliative care in patients with ESKD. In the first case, a high quality of life was preserved before the patient died with dignity, with early interdisciplinary palliative care involvement. In the second case there was a long protracted period of poor quality of life prior to death. This was associated with resistance to the involvement of palliative care, mainly from the family. Addressing end of life care issues early in the chronic kidney disease (CKD) trajectory and ensuring patients, their families and health care providers are well informed, may contribute to a better outcome for the patient and their family.