RESUMEN
OBJECTIVE: The Coherex-EU Study evaluated the safety and efficacy of PFO closure utilizing novel in-tunnel PFO closure devices. BACKGROUND: Transcatheter closure of patent foramen ovale (PFO) followed the development of transcatheter closure devices designed to patch atrial septal defects (ASDs). The Coherex FlatStent™ and FlatStent™ EF devices were designed specifically to treat PFO anatomy. METHODS: A total of 95 patients with a clinical indication for PFO closure were enrolled in a prospective, multicenter first in man study at six clinical sites. Thirty-six patients received the first-generation FlatStent study device, and 57 patients received the second-generation FlatStent EF study device, which was modified based on clinical experience during the first 38 cases. Two patients enrolled to receive the first generation did not receive a device. RESULTS: At 6 months post-procedure, 45% (17/38) of the intention-to-treat (ITT) cohort receiving the first-generation FlatStent device had complete closure, 26% (10/38) had a trivial residual shunt, and 29% (11/38) had a moderate to large residual shunt. In the ITT cohort receiving the second-generation FlatStent EF device, 76% (43/57) had complete closure, 12% (7/57) had a trivial shunt, and 12% had a moderate to large shunt. Five major adverse events occurred, all without sequelae. CONCLUSION: This initial study of the Coherex FlatStent/FlatStent EF PFO Closure System demonstrated the potential for in-tunnel PFO closure. The in-tunnel Coherex FlatStent EF may offer an alternative to septal repair devices for PFO closure in appropriately selected patients; however, further investigation will be necessary to establish the best use of this device.
Asunto(s)
Cateterismo Cardíaco/métodos , Procedimientos Quirúrgicos Cardíacos/métodos , Foramen Oval Permeable/cirugía , Dispositivo Oclusor Septal , Stents , Adolescente , Adulto , Anciano , Ecocardiografía , Femenino , Estudios de Seguimiento , Foramen Oval Permeable/diagnóstico , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Resultado del Tratamiento , Adulto JovenRESUMEN
Peripheral intravenous therapy is an established therapy with known complications and failures. The burden of the cost of unsuccessful short peripheral catheter (SPC) placement and maintenance is not always clearly identified. This often-obscured cost of poor quality needs to be defined and addressed. The scope of the problem is defined here, and a metric that can be applied to measure the magnitude of the problem and identify targets for focused improvement initiatives that would improve the quality of infusion therapy using SPCs is proposed.