Single-Center Experience of 100 Consecutive Percutaneous Patent Ductus Arteriosus Closures in Infants ≤1000 Grams
2021; Lippincott Williams & Wilkins; Volume: 14; Issue: 6 Linguagem: Inglês
10.1161/circinterventions.121.010600
ISSN1941-7632
AutoresRanjit Philip, Neil Tailor, Jason N. Johnson, Leah Apalodimas, Jorden Cunningham, Judy Hoy, B. Rush Waller, Shyam Sathanandam,
Tópico(s)Tracheal and airway disorders
ResumoHomeCirculation: Cardiovascular InterventionsVol. 14, No. 6Single-Center Experience of 100 Consecutive Percutaneous Patent Ductus Arteriosus Closures in Infants ≤1000 Grams Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessLetterPDF/EPUBSingle-Center Experience of 100 Consecutive Percutaneous Patent Ductus Arteriosus Closures in Infants ≤1000 Grams Ranjit Philip, MD Neil Tailor, MD Jason N. Johnson, MD, MHS Leah Apalodimas, MSN, APN, CCRN, CPNP-AC/PC Jorden Cunningham, PhD Judy Hoy, RN, BSN B. Rush Waller III, MD Shyam SathanandamMD Ranjit PhilipRanjit Philip Correspondence to: Ranjit Philip, MD, 848 Adams Avenue, Memphis, TN 38103. Email E-mail Address: [email protected] https://orcid.org/0000-0003-3748-0215 University of Tennessee Health Science Centre, LeBonheur Children's Hospital, Memphis. , Neil TailorNeil Tailor University of Tennessee Health Science Centre, LeBonheur Children's Hospital, Memphis. , Jason N. JohnsonJason N. Johnson https://orcid.org/0000-0003-0712-1123 University of Tennessee Health Science Centre, LeBonheur Children's Hospital, Memphis. , Leah ApalodimasLeah Apalodimas https://orcid.org/0000-0002-0970-4325 University of Tennessee Health Science Centre, LeBonheur Children's Hospital, Memphis. , Jorden CunninghamJorden Cunningham https://orcid.org/0000-0003-2171-7353 University of Tennessee Health Science Centre, LeBonheur Children's Hospital, Memphis. , Judy HoyJudy Hoy https://orcid.org/0000-0002-6306-2183 University of Tennessee Health Science Centre, LeBonheur Children's Hospital, Memphis. , B. Rush Waller IIIB. Rush Waller III https://orcid.org/0000-0003-4340-2248 University of Tennessee Health Science Centre, LeBonheur Children's Hospital, Memphis. , Shyam SathanandamShyam Sathanandam https://orcid.org/0000-0001-8639-0852 University of Tennessee Health Science Centre, LeBonheur Children's Hospital, Memphis. Originally published7 Jun 2021https://doi.org/10.1161/CIRCINTERVENTIONS.121.010600Circulation: Cardiovascular Interventions. 2021;14:e010600Premature infants weighing ≤1000 g, are considered high risk for any procedure. Many of these infants endure the effects of a patent ductus arteriosus (PDA).1 Advances in device technology has extended the application of transcatheter PDA closure to small infants.2 We describe the lessons learned from a large, single-center experience in 100 consecutive infants weighing ≤1000 g between June2015 and March2020.This study was approved by University of Tennessee IRB. Data will be made available upon request. All procedures were performed in the cath-lab using a femoral vein only approach under fluoroscopic and echocardiographic guidance (Table). The median age and weight were 24.3 days (range: 9–50 days) and 821.4 g (range: 540–1000 g), respectively. The median gestational age was 24.4weeks (range: 22–28weeks). The Amplatzer Vascular Plug-II (n=3), the Microvascular Plug, (MVP, n=27), and the Amplatzer Piccolo Occluder (APO, n=70) were used. The success rate was 100%, defined as the proportion of infants in whom a device was implanted irrespective of the outcome. At latest follow-up (median 2.5 years), the survival rate was 91%. There were 3 major and 3 minor adverse events (AE). Mortality and reinterventions were considered major AE. Events that did not lead to hemodynamic compromise were considered minor.Table. Description of the Characteristics of the Patients, PDA, and ProcedurePatient characteristicsPDA characteristicsProcedure characteristicsGestational age, weeksMinimal PDA diameter, mmProcedure age, d Mean±SD24.4±1.4 Mean±SD3.17±0.78 Mean±SD24.3±10.8 Range22–28 Range(1.6–5.0) Range(9–50)Birth weight, gLargest PDA diameter, mmProcedure weight, g Mean±SD681.6±148.0 Mean±SD4.24±0.59 Mean±SD821.4±119.1 Range(400–910) Range(3.0–6.4) Range(540–1000)Ventilator dependent94%PDA length, mmOut of NICU time, min*History of pulmonary hemorrhage9% Mean±SD10.74±1.54 Mean±SD88.0±28.5 Range(6.0–14.5) Range(49–161)History of NEC stage IIB and III21%Device usedProcedure time, min† 4 mm AVP-II‡2 Mean±SD28±22 6 mm AVP-II§1 Range(8–61) MVP-5Q∥24History of IVH grade III and IV29% MVP-7Q3Fluoroscopy time, min 03–02 Piccolo15 Mean±SD4.99±3.19 04–02 Piccolo48 Range(1.2–24)History of sepsis25% 04–04 Piccolo¶1Radiation dose, mGy 05–02 Piccolo3 Mean±SD4.08±3.77Inotropic support4% 05–04 Piccolo#3 Range(1.0–18.5)Previous COXI treatment95%No. of infants in whom more than one device was attempted5Procedure performed on high frequency ventilator12%Renal impairment12%Concomitant balloon pulmonary valvuloplasty during PDA closure6%AVP indicates Amplatzer Vascular Plug; COX, cyclo-oxygenase; ICV, inferior vena cava; IVH, intraventricular hemorrhage; LPA, left pulmonary artery; MVP Microvascular Plug; NEC, Necrotizing Enterocolitis; NICU, neonatal intensive care unit; and PDA, patent ductus arteriosus.* Out of NICU time is the time from when the infant is disconnected from the ventilator in the NICU to the time the infant is placed back on the ventilator upon return.† Procedure time is the time from when the physician scrubs in, to the time the physician scrubs out.‡ Complications noted in both patients (IVC laceration and pericardial effusion).§ Device was snared and retrieved secondary to LPA stenosis—PDA spontaneously closed.∥ One patient initially had MVP-5Q implanted that was snared and retrieved and closed using a 04–02 Piccolo. This patient is included in that row.¶ Aortic arch stenosis noted 1-week postprocedure that was treated with stent implantation.# Aortic arch stenosis noted 1-week postprocedure that was treated with stent implantation.The Amplatzer Vascular Plug-II was used in the first 3 infants, all of whom experienced AEs. The very first infant developed left pulmonary artery stenosis requiring device retrieval. The second infant (840 g) had inadvertent laceration of the inferior vena cava due to a guidewire-sheath/dilator size mismatch leading to mortality. The third infant (900 g) developed a medium-sized hemorrhagic pericardial effusion secondary to a glide-wire perforation requiring drain placement. Subsequent to these AEs, the use of Amplatzer Vascular Plug-II and glide-wires were abandoned. The MVP, which requires no catheter exchange was then used exclusively. There was one AE with the MVP. A 740 g infant developed moderate left pulmonary artery stenosis immediately after releasing the MVP-5Q requiring retrieval and subsequent closure with a 04-02 APO.There were 2 aortic arch obstructions with the APO—a 760 g infant with multi-organ failure on high frequency ventilator and a 13-days old, 22-weeks' gestation, 560 g infant. In both cases, the APO was implanted completely within the PDA (intraductal). However, a week later, with signs of NEC and renal failure, respectively, aortic arch stenosis secondary to protrusion of the device was diagnosed. Both required stenting of the aorta from a carotid approach. The first infant died 14 days poststenting secondary to respiratory failure. The second infant, now at 9 months, has not required reinterventions.Currently, this series represents the largest cohort in infants weighing ≤1000 g. This experience serves as a guide for operators to be successful and avoid AEs in these highly fragile infants. Procedural modifications have been previously described.3 However, few other subtilities are worth discussing that are unique for infants under a kilogram. It is important for operators to gain experience with this procedure in >1000 g infants before venturing into the sub-1 kg cohort. The majority of AEs were early in the experience, particularly with the Amplatzer Vascular Plug-II which is less suited than the MVP or the APO for infants ≤1000 g.4Intraductal positioning of the device is necessary to avoid stenosis of the aorta or the left pulmonary artery. If this is impossible, choosing a smaller size device could help as was the case in 4 infants in this series. Device embolization is less likely than in larger infants. However, even if the device is intraductal, it can be extruded out when the duct constricts around it as described in the 2 patients with aortic arch stenosis. There were 2 other occasions where the device was extruded towards the aorta without arch obstruction requiring no interventions. In all these instances, the 4 mm length APO was used, as opposed to the more commonly used 2 mm length device. It may be prudent to use the shortest length device to avoid this complication.The device must be oriented co-axial to the long axis of the PDA. The smaller/younger the infant, the longer the PDA. It is usually hockey-stick shaped.5 Positioning the device within the shaft of the hockey-stick rather than the blade is ideal (10–4 orientation on the clock dial by lateral fluoroscopy). Delivery systems are relatively stiff and tend to pull the device towards the left pulmonary artery especially if one waits long to release the device. It is best to pack the device inside the PDA rather than unsheathing the delivery catheter over the device. Delivery systems must be removed immediately after device release to prevent inadvertent injury by the blunt tip of these equipment. After device release, angiograms via delivery catheters must be avoided. Further assessment can be accomplished by echocardiography.Transcatheter PDA closure is feasible in infants ≤1000 g. However, it will find its way into the algorithm for PDA management in premature infants only if the procedure is safe. A regimented approach is necessary for success.Sources of FundingNone.Disclosures Dr Sathanandam is a Proctor/Consultant Abbott. Dr Johnson is a Consultant Abbott. The other authors report no conflicts.FootnotesFor Sources of Funding and Disclosures, see page 643.Correspondence to: Ranjit Philip, MD, 848 Adams Avenue, Memphis, TN 38103. Email [email protected]eduReferences1. Backes CH, Cheatham SL, Deyo GM, Leopold S, Ball MK, Smith CV, Garg V, Holzer RJ, Cheatham JP, Berman DP. Percutaneous patent ductus arteriosus (PDA) closure in very preterm infants: feasibility and complications.J Am Heart Assoc. 2016; 5:e002923. doi: 10.1161/JAHA.115.002923LinkGoogle Scholar2. Sathanandam SK, Gutfinger D, O'Brien L, Forbes TJ, Gillespie MJ, Berman DP, Armstrong AK, Shahanavaz S, Jones TK, Morray BH, et al.. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams.Catheter Cardiovasc Interv. 2020; 96:1266–1276. doi: 10.1002/ccd.28973CrossrefMedlineGoogle Scholar3. Sathanandam S, Balduf K, Chilakala S, Washington K, Allen K, Knott-Craig C, Rush Waller B, Philip R. Role of Transcatheter patent ductus arteriosus closure in extremely low birth weight infants.Catheter Cardiovasc Interv. 2019; 93:89–96. doi: 10.1002/ccd.27808CrossrefMedlineGoogle Scholar4. Sathanandam S, Justino H, Waller BR, Radtke W, Qureshi AM. Initial clinical experience with the Medtronic Micro Vascular Plug™ in transcatheter occlusion of PDAs in extremely premature infants.Catheter Cardiovasc Interv. 2017; 89:1051–1058. doi: 10.1002/ccd.26878CrossrefMedlineGoogle Scholar5. Philip R, Waller BR, Agrawal V, Wright D, Arevalo A, Zurakowski D, Sathanandam S. Morphologic characterization of the patent ductus arteriosus in the premature infant and the choice of transcatheter occlusion device.Catheter Cardiovasc Interv. 2016; 87:310–317. doi: 10.1002/ccd.26287CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails June 2021Vol 14, Issue 6Article InformationMetrics Download: 58 © 2021 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.121.010600PMID: 34092088 Originally publishedJune 7, 2021 Keywordsechocardiographyfluoroscopypreterm infantspulmonary arterypatent ductus arteriosusPDF download SubjectsClinical StudiesComplicationsCongenital Heart DiseaseMortality/Survival
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