Safety and effectiveness of the novel Myval Octacor transcatheter heart valve in severe, symptomatic aortic valve stenosis - A real-world Indian experience (The OCTACOR India Study).

PURPOSE: To evaluate the safety and effectiveness of the novel, next-generation Myval Octacor - Transcatheter Heart Valve (THV) in patients with severe, symptomatic, native aortic stenosis (AS). METHODS: This multicenter, real-world observational registry included 123 patients with severe symptomatic AS, across 16 Indian centers who underwent treatment with the novel Myval Octacor THV. Study endpoints included all-cause mortality, all stroke, acute kidney injury (AKI), major vascular complications, moderate or severe paravalvular leakage (PVL) and new permanent pacemaker implantation (PPI) until 30 days follow-up. RESULTS: Of the 123 patients (average age 70.07 ± 8.33 years), 37.4 % (n = 46) were female and 39.84 % presented with bicuspid valves. The technical success rate of the procedure was 100 % and the device success rate at 30 days was 98.4 %. At 30 days (n = 123) after the procedure, the overall mortality was 1.6 %. AKI occurred in 1.6 % of patients and there was no incidence of stroke, bleeding (types 3 and 4), and major vascular complications. In an analysis of 31 patients whose echocardiographic parameters were available across all timepoints, there were significant improvements in the mean pressure gradient (54.31 ± 18.19 mmHg vs. 10.42 ± 4.24 mmHg; p < 0.0001) and effective orifice area (0.66 ± 0.21 cm2 vs. 1.80 ± 0.44 cm2; p < 0.0001) from baseline to the 30-day follow-up. None of the patients experienced severe PVL, while moderate PVL was observed in two patients (1.6 %). CONCLUSIONS: Early outcomes of the next-generation, novel Myval Octacor THV proved its safety and effectiveness in the treatment of severe AS.

Impact of COVID-19 on heart failure hospitalization and outcome in India - A cardiological society of India study (CSI-HF in COVID 19 times study - "The COVID C-HF study").

OBJECTIVES: The presentation and outcomes of acute decompensated heart failure (ADHF) during COVID times (June 2020 to Dec 2020) were compared with the historical control during the same period in 2019. METHODS: Data of 4806 consecutive patients of acute HF admitted in 22 centres in the country were collected during this period. The admission patterns, aetiology, outcomes, prescription of guideline-directed medical therapy (GDMT) and interventions were analysed in this retrospective study. RESULTS: Admissions for acute heart failure during the pandemic period in 2020 decreased by 20% compared to the corresponding six-month period in 2019, with numbers dropping from 2675 to 2131. However, no difference in the epidemiology was seen. The mean age of presentation in 2019 was 61.75 (±13.7) years, and 59.97 (±14.6) years in 2020. There was a significant decrease in the mean age of presentation (p = 0.001). Also. the proportion of male patients decreased significantly from 68.67% to 65.84% (p = 0.037). The in-hospital mortality for acute heart failure did not differ significantly between 2019 and 2020 (4.19% and 4.,97%) respectively (p = 0.19). The proportion of patients with HFrEF did not change in 2020 compared to 2019 (76.82% vs 75.74%, respectively). The average duration of hospital stay was 6.5 days. CONCLUSION: The outcomes of ADHF patients admitted during the Covid pandemic did not differ significantly. The length of hospital stay remained the same. The study highlighted the sub-optimal use of GDMT, though slightly improving over the last few years.

COVID-19 infected ST-Elevation myocardial infarction in India (COSTA INDIA).

OBJECTIVE: To find out differences in the presentation, management and outcomes of COVID-19 infected STEMI patients compared to age and sex-matched non-infected STEMI patients treated during the same period. METHODS: This was a retrospective multicentre observational registry in which we collected data of COVID-19 positive STEMI patients from selected tertiary care hospitals across India. For every COVID-19 positive STEMI patient, two age and sex-matched COVID-19 negative STEMI patients were enrolled as control. The primary endpoint was a composite of in-hospital mortality, re-infarction, heart failure, and stroke. RESULTS: 410 COVID-19 positive STEMI cases were compared with 799 COVID-19 negative STEMI cases. The composite of death/reinfarction/stroke/heart failure was significantly higher among the COVID-19 positive STEMI patients compared with COVID-19 negative STEMI cases (27.1% vs 20.7% p value = 0.01); though mortality rate did not differ significantly (8.0% vs 5.8% p value = 0.13). Significantly lower proportion of COVID-19 positive STEMI patients received reperfusion treatment and primary PCI (60.7% vs 71.1% p value=< 0.001 and 15.4% vs 23.4% p value = 0.001 respectively). Rate of systematic early PCI (pharmaco-invasive treatment) was significantly lower in the COVID-19 positive group compared with COVID-19 negative group. There was no difference in the prevalence of high thrombus burden (14.5% and 12.0% p value = 0.55 among COVID-19 positive and negative patients respectively) CONCLUSIONS: In this large registry of STEMI patients, we did not find significant excess in in-hospital mortality among COVID-19 co-infected patients compared with non-infected patients despite lower rate of primary PCI and reperfusion treatment, though composite of in-hospital mortality, re-infarction, stroke and heart failure was higher.

Sural Sensory Nerve Action Potential: A Study in Healthy Indian Subjects at Tertiary Care Center of North-West India.

Objectives: This study was done to obtain the reference data for the sural SNAP amplitude and latency at distances of 14, 12, and 10 cm from the active recording electrode in Indian healthy subjects for different age groups. Material and Methods: Two hundred forty-four healthy subjects (18-80 years) were included in this cross-sectional study. Subjects were divided into six groups according to age. Sural SNAP was recorded antidromically stimulating at three sites (14, 12, and 10 cm from the recording electrode). The quantitative variables were expressed as Mean ± SD/Median (IQR) and compared using t test/ANOVA. Transformed data for amplitude were analyzed with the use of paired t test. P < 0.05 was considered statistically significant. SPSS version 20.0 software was used for statistical analysis. Results: Mean age of included subjects was 43.28 years. Maximum leg girth was at 14 cm. Analysis showed a significant difference in the leg girth at all three sites (P < 0.001). Sural SNAP latency at each stimulating site was compared in different age groups, no significant difference was found between groups (P = 0.19). Maximum amplitude was in the 18-30-years age group and amplitude was minimum in the 71-80-years age group (4.34 and 2.79, respectively). The difference in the amplitude recorded in the different age groups was found to be statistically different (P < 0.001). The difference in the amplitude recorded at each site was found to be statistically different (P < 0.001). Conclusion: This is the first study with a large sample size (244 subjects) to provide age-stratified reference data for SNAP in the Indian population by using three sites of stimulation at distances of 14, 12, and 10 cm from the recording electrode. This study shows that sural SNAP amplitude varies with the age of the subject and distance from stimulation.

Clinical Characteristics, Etiology, Recanalization Rates and Neurological Outcomes in CVT: A Prospective Cohort Study.

Background: Recanalization rates in cerebral venous thrombosis (CVT) and its effect on neurological outcome have been debated worldwide and are inadequately addressed in studies from India. Our objective was to study the clinical profile of CVT and determine recanalization rates with its predictors and its effect on outcome. Methods: A prospective single centre cohort study on 101 patients with radiologically confirmed acute CVT between October 2018 and June 2021 was conducted. Anticoagulation was given for 3-12 months or lifelong for thrombophilias. Recanalization status of vessels was assessed between 3-6 months and at 12 months after ictus. Outcome was defined as favorable (mRS 0-1) or unfavorable. Patients with atleast one CT/MR venogram on follow up were included. Results: Of the 101 enrolled patients, 83 completed study protocol. Mean age of patients was 34.2 ± 11.7 years. Clinical characteristics included headache (75.9%),seizure (66.2%), altered mentation(20.4%) with clustering of cases during summers. Transverse- sigmoid sinuses were predominantly involved (66.2 %) followed by superior sagittal sinus (SSS,65.0%).Commonest etiologies were thrombophilia (27.7%) and postpartum state (15.6%). Complete recanalization was achieved in 67.4%, partial in 26.5% and no recanalization in 6.02% at end of 12 months. Recanalization rates improved from 83.09% between 3-6 months to 93.9 % at 12 months. Median time to last follow-up was 12months and at last follow up 95.1% had favorable mRS with recurrence in two patients with raised factor VIII levels. Conclusion: Recanalization occurred in more than 90% of CVT patients. Isolated superior sagittal sinus thrombosis and age <50 years were predictors of complete recanalization. Most patients, except few achieved a favorable mRS.

Comparison of Clinical and Radiological Features of Aquaporin4 (AQP-4) Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) and Anti Myelin Oligodendrocyte Glycoprotein (Anti-MOG) Syndrome-Our Experience from Northwest India.

Background: More and more cases of myelin oligodendrocyte glycoprotein (MOG) antibody are being diagnosed with the availability of laboratory tests helping us to know the differing patterns from AQP-4 antibody disease and we need to understand the natural course, treatment, and prognosis in a better way. Objectives: Neuromyelitis optica spectrum disorder (NMOSD) and anti-MOG syndromes are immune-mediated inflammatory demyelinating conditions of the central nervous system (CNS) that mainly involve the optic nerves and the spinal cord. We conducted this study to compare demographic, clinical, laboratory, and radiological features of AQP-4 antibody and MOG antibody positive patients. Methods: A single-centre retrospective observational study from a large tertiary care university centre of Northwest India conducted during 2019--2021. We screened all patients presenting with acute CNS demyelinating attacks and recruited total 47 patients of which 25 were positive for AQP4 antibody and 22 were positive for MOG antibody. No patient tested positive for both antibodies. Data were collected using a standardized format including demographic, clinical, laboratory, and neuroimaging data. Results: In our study, total 47 patients were included, amongst which 25 patients were AQP4 antibody and 22 patients were MOG antibody positive. Though there was no gender preponderance, pediatric patients were more frequently affected in MOG antibody positive group. In AQP-4 antibody positive patients, myelitis was most common presenting clinical feature followed by optic neuritis (ON), simultaneous ON with myelitis, and brainstem syndrome. In MOG antibody positive group, myelitis was the commonest phenotype followed by ON, brainstem syndrome, and cerebral syndrome. The neuroimaging revealed involvement of medulla mainly area postrema, cervicodorsal spinal cord and extension of cervical lesion up to brainstem more commonly in AQP4 antibody group, on the other hand involvement of upper brainstem (midbrain and pons), cortex, and conus was more common in MOG antibody group. Conclusion: We have made an attempt to find differentiating features in AQP-4 vs. MOG antibody positive cases but they were of no statistically significance value as the numbers were small. Further larger studies may prove helpful in planning better strategies in two groups.

Isolated Acute Cerebrovascular Involvement in COVID-19 without Fever and Respiratory Symptoms: An Indian Perspective.

BACKGROUND: Stroke in COVID-19 has been reported in critically ill patients globally. Stroke as a singular manifestation of COVID-19 in absence of typical symptoms (fever, cough and dyspnea) is under- recognized. OBJECTIVE: Comparative study of clinical and laboratory parameters of COVID-19 stroke patients without typical symptoms at onset with stroke cases without COVID-19 infection. METHODS: 28consecutive stroke patients, eight with coronavirus infection and twenty without COVID-19 admitted to neurology department of a tertiary care centre of North West India between 20 June,2020 and 19 July,2020 were enrolled in this retrospective study. RESULTS: COVID-19 patients had higher frequency of seizures (4[50%]) vs 2[10%];p= 0.03)and altered mental status(6[75%] vs 6[30%] p= 0.04). Severity of ischemic stroke(NIHSS >20, 3[75 %] vs 2[18%])and mortality(p=0.04)despite comparable vascular risk factors for stroke between the two groups was higher in COVID-19 patients. Three out of four COVID-19 young strokes died. Two females with COVID-19 did not develop any typical symptoms, six males(75%) developed fever with dyspnea after a mean delay of 2.7 days(Standard deviation 1.7) from stroke onset. All six patients who developed fever subsequently expired. Inflammatory markers (neutrophil to lymphocyte ratio;p<0.001and ESR: p<0.001), transaminases(p=0.038) and creatinine (p=0.009) were significantly elevated in COVID-19 patients. CONCLUSION: Isolated cerebrovascular involvement can be a presentation of COVID-19.Stroke severity and mortality is higher in COVID-19 with young strokes being no exemption. Development of fever was associated with clinical worsening. COVID-19 pandemic is far from over in India, such atypical presentations need to be recognized early and warrant stringent diagnostic protocols.

Myelitis: A Rare Presentation of Epstein Barr Virus.

EBV associated nervous system complications includes encephalitis, meningitis, cerebellitis, polyradiculomyelitis, transverse myelitis, cranial and peripheral neuropathies, and psychiatric abnormalities are usually more commonly seen in immunocompromised patients and rarely in immunocompetent patients. Here we are reporting a 13 years old boy developed headache, malaise, sore throat and low back pain with radiation to both lower limbs. Next day he felt numbness below umbilicus followed by acute onset weakness in both lower limbs and urinary retention. Motor exam revealed proximal muscle power MRC grade 4/5 and distal power 1/5 in right lower limb and proximal power 4-/5 and distal power 0/5 in left lower limb with normal power in both upper limbs. Deep tendon reflexes were bilaterally normal except absent ankle reflexes. Both plantars were mute. All the modalities of sensation including pain, touch, temperature, joint position and vibration were impaired below umbilicus. Routine investigations were normal. The magnetic resonance imaging (MRI) of thoracic spine showed intramedullary lesion in conus, which was iso-hyperintense on T1-weighted and hyperintense on T2- weighted images extending from D12thoracic vertebral level to L1 with cord expansion (Figures 1, 2). The MRI features were suggestive of conus myelitis. Cerebrospinal fluid (CSF) analysis revealed increased protein, normal cells, glucose and Chloride. CSF Polymerase chain reaction (PCR) was positive for Epstein Barr virus . The clinical and imaging findings were consistent with the diagnosis of myelitis and responded well to steroid plus acyclovir treatment. The clinicians should be aware of such uncommon etiology of a common disease.

Guillain-barre Syndrome in Indian Population: A Retrospective Study.

OBJECTIVES: To study clinical characteristics of various forms of Guillain-Barre syndrome in Indian adults. MATERIAL AND METHODS: The epidemiological, clinical, cerebrospinal fluid and electrophysiological data of 65 patients of Guillain-Barre syndrome (GBS) were reviewed in a retrospective study. RESULTS: Analysis of age distribution disclosed a high incidence (36.92%) in young adults between 18 to 29 years of age. Seasonal preponderance in winter and summer was found. Preceding events were identified in 22 (33.84%) cases. Motor weakness, areflexia, and facial weakness were the most common clinical features. Cerebrospinal fluid albuminocytological dissociation was present in 80% of patients. Utilising clinical and electrophysiological data, these 65 patients with Guillain-Barre syndrome were subclassified as acute demyelinating polyradiculoneuropathy 17 (26.15%), axonal form 17 (26.15%), Fisher's syndrome 2 (3.07%)and ataxic variant 1(1.53). The remaining 28 (43.07%) patients were unclassified. 9(13.8%) patients had recurrent GBS. Only 5 (7.7%) patients required mechanical ventilation. Follow up available on 47 patients disclosed that all of them recovered satisfactorily. No patient was persistently disabled and no mortality occurred during hospitalization. CONCLUSIONS: GBS in Indian population from northwest India showed peculiar age, seasonal distribution and high frequency of both AIDP and axonal subtypes. Both, axonal and demyelinating subtypes shared common clinical features and had good prognosis.

Clinical Outcomes of Novel Long-Tapered Sirolimus-Eluting Coronary Stent System in Real-World Patients With Long Diffused De Novo Coronary Lesions.

BACKGROUND: When coronary lesions involve segments > 48 mm, the only treatment possibility is stent overlapping which is associated with higher neointimal proliferation that lead to more restenosis. Furthermore, tapering of coronary arteries is a major challenge observed with long diffuse coronary lesions. This study attempted to assess the safety and performance of world's first commercialised long-tapered (60 mm) sirolimus-eluting coronary stent (SES) system for the treatment of long diffused de novo coronary lesions in real world scenario. METHODS: This was a retrospective, non-randomised, multicentre study which included 362 consecutive patients implanted with long-tapered BioMime™ Morph SES system for the treatment of long diffused de novo coronary lesions. Safety endpoint was major adverse cardiac events (MACE), which was defined as composite of cardiac death, myocardial infarction (MI) and ischemic-driven target lesion revascularization (ID-TLR), at 12-month follow-up. RESULTS: Out of 362 patients included, 170 (47.0%) were diabetic and 159 (43.9%) were hypertensive. The mean age of all patients was 61.09 ± 9.04 years. A total of 625 lesions were identified; out of which 402 lesions were intervened successfully using BioMime Morph. The cumulative incidence of MACE was 7 (2.0%) at 12-month follow-up which included four (1.1%) cardiac deaths, one (0.3%) case of MI and two (0.6%) ID-TLR. Acute stent thrombosis was reported in one (0.3%) patient. CONCLUSIONS: The present study confirms the safety and performance of BioMime Morph, and hence, can be considered as a treatment of choice for long diffused tapered de novo coronary lesions in routine clinical practice.

Tumefactive demyelinating lesions (TDLs): A case series of clinicoradiological features.

OBJECTIVE: Diagnosis of tumefactive demyelination lesions (TDLs) is challenging to neurophysician, neuroradiologist or neurosurgeon. Our objective in this study was to analyze clinicoradiological features of TDLs. PATIENTS AND METHOD: A retrospective analysis with prospective follow-up of 11 cases of TDLs was performed. Study was conducted in the neurology department of a tertiary care centre of North-West India from August 2014 to March 2017. MRI of brain and cervical spine with contrast, visual evoked potential, oligoclonal bands, serum anti-AQP4 antibody and MRS performed in most of the patients. RESULTS: Mean age of tumefactive demyelinating lesions was 19.63 years (10-41) with male preponderance (M: F=1.4) and one of the patients was in a pediatric age group. Relapsing and demyelinating courses of disease, seizure and incomplete ring enhancement were found in 6 out of 11(54.5%), 4 out of 11 (36.3%) 3 out of 11(27.2) respectively. OCBs were positive in 4 out of 5 patients (80%). CONCLUSION: Recognition of atypical presentation or clinicoradiological features would aid in diagnosis along with visual evoked potential, oligoclonal bands and responsiveness to steroids may obviate the need for invasive procedure like brain biopsy.

One-year outcomes of a BioMime™ Sirolimus-Eluting Coronary Stent System with a biodegradable polymer in all-comers coronary artery disease patients: The meriT-3 study.

OBJECTIVES: The aim of the merit-3 study was to determine the safety and performance of the BioMime Sirolimus-Eluting Coronary Stent System (SES) in all-comer patients with coronary artery disease (CAD) in one-year clinical follow-up period. METHODS: The meriT-3 was a multi-centre, observational, post-marketing study conducted in 1161 patients with CAD who were implanted with BioMime SES at 15 sites in India. The primary endpoint was major adverse cardiac event (MACE) at one year defined as the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Clinical follow-up was performed at 1, 6, and 12 months. Major adverse cardiac event occurred at 30 days and subsequently at 6 months and at long-term follow-up of 1 year was analyzed. RESULTS: MACE observed at 1 and 6 months follow-up was 16 (1.38%) and 21 (1.83%) respectively. Cumulative 1 year MACE was 26 (2.35%) with 16 (1.39%) all cause death, 4 (0.35%) MI and 6 (0.52%) TLR. In addition, ST was observed in 1 (0.09%) patient. CONCLUSIONS: The present study suggests that the BioMime SES is safe and effective in a "real-world", all-comers CAD patients, indicating low rates of MACE. CTRI ACKNOWLEDGEMENT NO: REF/2016/07/011808.