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
Congenital coronary artery fistula is a rare malformation that may involve any or all coronary artery branches and any cardiac chamber. Elective closure of coronary artery fistula by surgery or percutaneous transcatheter technique is generally accepted in the presence of symptoms. Controversies exist in the management of asymptomatic patients. We report a case of successful percutaneous transcatheter device closure of an aneurysmally dilated coronary fistula, originating from the circumflex artery and draining into the coronary sinus, through the persistent left superior vena cava. Persistent left superior vena cava facilitated the easier closure of the fistula, with short procedural and fluoroscopy times.
