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.

Esophageal complications following aluminium phosphide ingestion: an emerging issue among survivors of poisoning.

Aluminium phosphide ingestion is the most common agricultural poisoning in suburban and rural India and with a high mortality rate. Among survivors of acute poisoning there are recent sporadic reports of esophageal complications such as esophageal strictures and tracheo-esophageal fistula. The present study was carried out to determine the incidence, natural history, and treatment outcome of local esophageal complications in survivors of aluminium phosphide poisoning with complaints of dysphagia. All confirmed cases of poisoning with aluminium phosphide ingestion were admitted in Hamidia Hospital, Gandhi Medical College, Bhopal, Madhya Pradesh, India, from October 2007 to October 2008. Survivors with complaints of dysphagia underwent a barium study and upper gastrointestinal endoscopy to determine site and nature of esophageal complications. All cases of strictures were treated with fluoroscopy-guided Savary-Gilliard bougie dilation, and patients with tracheo-esophageal fistula underwent surgery. Of 104 confirmed cases, 31 survived. Ten survivors with dysphagia were found to have single short-segment esophageal stricture and two patients with odynophagia and swallow-cough sequence had tracheo-esophageal fistula. All cases of esophageal strictures responded successfully to Savary-Gilliard dilation in six to ten sessions without any major complications. Patients with tracheo-esophageal fistula were treated successfully via surgery. Nearly one-third of survivors of aluminium phosphide ingestion developed esophageal complications. Hence, we conclude that all survivors of aluminium phosphide poisoning must undergo barium swallow and endoscopic examination for early detection of esophageal complications. Prevention of esophageal complications after aluminium phosphide ingestion needs to be given adequate attention because tracheo-esophageal fistula and esophageal stricture are associated with high morbidity. When one finds esophageal stricture or fistula, the possibility of aluminium phosphide ingestion should always be considered.