Early experience with the Micro Plug Set for preterm patent ductus arteriosus closure

Abstract

Objectives: We intend to describe early experience using a new, commercially available Micro Plug Set for preterm neonate and infant transcatheter patent ductus arteriosus (PDA) occlusion. Background: Transcatheter PDA occlusion in premature neonates and small infants is safe and effective. The procedure is early in its evolution. Methods: Procedural and short-term outcomes of preterm neonates and infants undergoing transcatheter PDA occlusion with a new, commercially available device were reviewed. Results: Eight preterm neonates and infants born at median 27 weeks gestation (23-36 weeks) underwent transcatheter PDA device closure with the Micro Plug Set. The device is short (2.5 mm) with a range of diameters (3, 4, 5, 6 mm) and delivered through a microcatheter. Procedures were performed at median 41 days of age (12-88 days) and at 1690 g (760-3,310 g). Transvenous PDA device occlusion was performed with fluoroscopic and echocardiography guidance. All procedures were successful with complete PDA occlusion. There were no procedural or short-term adverse events. Conclusions: Preterm neonate and infant transcatheter PDA device closure with a new, commercially available short and microcatheter delivered device (Micro Plug Set) was safe and effective in a small, early series of patients. K E Y W O R D S cardiac catheterization, congenital heart disease, patent ductus arteriosus, premature neonate, preterm infant, vascular occlusion 1 | INTRODUCTION Hemodynamically significant persistent patent ductus arteriosus (PDA) is a common diagnosis among preterm infants that can complicate their postnatal course. Medical, surgical, or transcatheter ductal closure improves outcomes and simplifies clinical management. Transcatheter management is becoming an increasingly accepted practice that has been proven safe and effective. 1-15 Similar to transcatheter management of older PDA patients 16 and other structural heart lesions (atrial septal defect, transcatheter pulmonary valve, transcatheter aortic valve replacement), there is rapid device evolution early in clinical translation. 17-19 Early on, devices traditionally used for transcatheter PDA device closure in older patients were adapted for use in preterm infants, such as, detachable coils, 1-4

Institutional Trend in Device Selection for Transcatheter PDA Closure in Premature Infants

“…Overall, these results demonstrate a favorable safety and efficacy profile for the procedure using any of the devices and are consistent with previous reports [ 9 – 11 , 13 – 15 , 17 ]. We note that in our cohort, embolization occurred after deploying and releasing the MVP device and the Piccolo device, but not the Micro Plug device.…”

“…The operators posit that the relative softness of the microcatheter during delivery, which creates less distortion of the anatomy, offers more precision when positioning the device, leading to a reduced incidence of embolization. Our group previously reported successful use of the Micro Plug device off-label for percutaneous closure of PDA in premature infants in a small cohort of 8 patients [ 17 ]. This report provides additional evidence of the safety and efficacy of using the device for this indication and shows that it compares favorably to the purpose-built Piccolo device and MVP device.…”

“…We compare the safety and efficacy between device types and demonstrate an evolution in device selection over time, with the Micro Plug device emerging as the preferred device for our institution. This paper also serves as an additional report of successful use of the Micro Plug device in a larger number of patients than the original report ( n = 8) by our group [ 17 ].…”

“…Advances in technique and the proliferation of available devices have led to success with transcatheter management of PDA even in very small premature infants, and transcatheter closure is an increasingly accepted practice [4,[6][7][8][9][10][11][12][13][14][15][16]. In the last several years, success has been reported using the Medtronic Micro Vascular Plug "MVP" (Medtronic, Minneapolis, MN) [9,11], the purpose-built Amplatzer Piccolo Occluder "Piccolo" (Abbot, Santa Clara, CA) [12][13][14][15], and the Micro Plug Set "Micro Plug" (KA Medical, Minneapolis, MN) [17]. No studies to date have compared the safety or clinical merits of these different devices.…”

Utility of Follow-Up Echocardiograms in Uncomplicated PDA Device Closures Performed After Infancy

“…A patent ductus arteriosus (PDA) represents one of the most common cardiovascular conditions observed in approximately 1 in 2000 term births, accounting for 5-10% of all congenital heart disease [1]. Usual treatment of a hemodynamically significant PDA during infancy has been via pharmacological, surgical, or transcatheter closure depending on the clinical situation [2][3][4][5][6][7]. In addition, PDAs may also be first diagnosed when patients are older [8].…”