ABSTRACT
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.
Subject(s)
Aortic Valve Stenosis , Aortic Valve , Heart Valve Prosthesis , Prosthesis Design , Registries , Severity of Illness Index , Transcatheter Aortic Valve Replacement , Humans , Female , Male , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Treatment Outcome , Aged , India , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/mortality , Time Factors , Aged, 80 and over , Middle Aged , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve/physiopathology , Risk Factors , Recovery of Function , Postoperative Complications , Retrospective Studies , HemodynamicsABSTRACT
Total anomalous systemic venous drainage is an extremely rare congenital heart defect. In this study we describe an 11-year-old girl who presented with a history of fatigue and central cyanosis that she had had since early childhood with unremarkable precordial examination results. Investigations revealed left heterotaxy with all systemic venous drainage to the left-sided atrium with non-compaction of the left ventricle.