Impact of a Multidisciplinary Service Line and Program for Transcatheter Device Closure of the Neonatal Ductus Arteriosus

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Allen Ligon, Shazia Bhombal-Kazi, Marissa Adamson, Sarah Hash, and 10 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4441381/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 28 Aug, 2024 Read the published version in Pediatric Cardiology → Version 1 posted 8 You are reading this latest preprint version Abstract Objective – Outline a quality initiative establishing an institutional service line for neonatal transcatheter device closure of the patent ductus arteriosus (TDC-PDA). Study Design – A retrospective descriptive observational study surrounding programmatic approach to TDC-PDA in premature neonates with process measure spanning education, implementation, referral, and post-procedural care. Metrics tracked pre- and post-program creation with statistical analyses performed. Results – Neonatal TDC-PDA referrals increased exponentially since program inception (n=13 in year prior; n=42 year 1; n=74 year 2), especially in patients weighing less than 1.3 kg (12.5%; 55%; 50%), and was associated with an increased procedural success rate (81%; 95%; 99%). Procedural checklist creation decreased procedural “out of isolette” time (median 93 minutes; 59; 52), and procedural-related complication or clinical sequelae (19%; 12%; 4%). Conclusion – A multidisciplinary service line and program dedicated to neonatal TDC-PDA can result in a significant increase in referrals as well as procedural efficacy and safety for this medically fragile population. Quality improvement Patent Ductus Arteriosus Transcatheter therapy prematurity neonate Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction The advent of new technologies and novel approaches to transcatheter device closure (TDC) has greatly altered the options for addressing the patent ductus arteriosus (PDA) in the preterm/neonatal population.( 1 , 2 ) These innovations allow for a less invasive, definitive PDA closure over surgical ligation with improvements in technique and short-term outcomes.( 3 – 6 ) However, altering referral patterns away from surgical ligation and towards catheter-based closure are not immediate, and treatment approach to the PDA in the neonatal community remains controversial.( 7 – 9 ) The referring neonatologist might face challenges such as data review for patient candidacy, interfacility transfer to centers with a pediatric cardiac catheterization team, distance from the patient’s family, and facility revenues both from the procedure as well as neonatal intensive care unit stay. Although a minority of programs nationally are transitioning to the bedside for TDC-PDA, most programs continue to perform neonatal TDC-PDA within the cardiac catheterization laboratory. All programs struggle with ensuring procedural efficacy as well as safety within this medically fragile population. At current state, there are limited publications outlining the practices for ensuring safety in this population to attain successful TDC-PDA.( 10 , 11 ) Further, there is a paucity of literature speaking to a protocolized, systematic institutional approach with quality-driven metrics for rapid change.( 12 ) In September of 2021, we developed a comprehensive neonatal TDC-PDA closure program within our institution to address the multidisciplinary needs of these patients and sought to track its outcomes (designated as our Smart Aim). This study aimed to evaluate the impact of the quality initiative that established an institutional service line for neonatal TDC-PDA. The quality initiative spanned the period from referral via an interdisciplinary review team through generating checklist-pathways for all team members that encompass pre-, intra-, and post-procedural care and included tracking metrics for outcomes with institutional goals. Methods Study Design, Setting, and Population- This work represents a focused paper on a quality initiative; a retrospective descriptive observational study addressing the national trend of increasing referrals for TDC-PDA and establishment of a service line to meet increased demand. A quality-driven initiative was launched in September 2021 at Children’s Healthcare of Atlanta that serves the entirety of the population in the state of Georgia. At the time, we were the only hospital in the state with the resources and capabilities for TDC-PDA in patients less than 2kg. Therefore, the catchment population includes the entirety of the state’s extreme premature neonates with a hemodynamically significant ductus admitted to neonatal intensive care units. The state has two Level IV units (one being our own institutional 50 bed unit), 29 Level III units, and 15 Level II units. Study objectives include a summative programmatic and process (quality) measure outline of the approach to TDC-PDA in premature infants. This was to encompass a streamline of referral via an interdisciplinary review team and establishing institutional protocolized pathways for pre-, intra-, and post-procedural care. Ethical Considerations- The Children’s Healthcare of Atlanta Institutional Review Board approved this quality initiative and waived the need for parental consent. The retrospective data pull was granted waiver from review board involvement and was approved for retrospective data analysis. The board also provided patient waiver of consent. This manuscript was prepared utilizing the published SQUIRE 2.0 guidelines.( 13 ) Stepwise Practice Change Implementation- Phase 1: Protocolization of Procedure . The multidisciplinary neonatal TDC-PDA team evaluated the institutional approach to TDC-PDA and outcomes for the year prior to team formation to better understand the scope. This year correlated with the advent of new transcatheter technology for neonatal TDC-PDA approval by the United States Food and Drug Administration. The institutional approach for TDC-PDA was then protocolized in its entirety to include the pre-, intra-, and post-procedural timelines ( Figs. 1 and 2 ) . This effort included input from specialists within Neonatology (all provider levels), nursing, cardiology (imaging and interventional specialists), anesthesiology, respiratory therapy, and administration. All four congenital interventional cardiologists agreed to follow these protocols for the approach to any TDC-PDA if the patient was less than 2.5kg in weight. Phase 2: Education and Criteria Outline for Referral Base. Clinical and echocardiographic criteria for neonatal TDC-PDA referral were generated and disseminated to neonatology providers and consulting cardiologists throughout the state of Georgia. The focus remained on outlining clinical and echocardiographic criteria that suggested a hemodynamically significant PDA. These criteria were disseminated throughout the cardiologists that cover the various neonatal intensive care units throughout the state. Numerous grand rounds lectures for neonatology teams around the state were performed by a team consisting of a neonatologist and interventional cardiologist. Further, the referral to the neonatal PDA program was centralized via an email listserv ( [email protected] ) which forwarded to the multidisciplinary neonatal PDA review team. This group consisted of two neonatologists, two interventional congenital cardiologists, an imaging congenital cardiology specialist, and a patient navigator (an administrative neonatal nurse). The multidisciplinary team reviewed patient information via direct phone call, meeting and/or video streaming platform(s) to ensure optimal candidacy for TDC-PDA. Once a consensus was reached regarding candidacy for the procedure, insurance/financial approval was sought by the parent institution to include transfer into and out of our center. Lastly, a “target date” for TDC-PDA was provided to the referring neonatal unit for expected transfer to allow preparation for the procedure. Repeat echocardiography to ensure candidacy was recommended within 48 hours before transfer. Phase 3: Plan-Do-Study-Act Rapid Cycling. Throughout Phase 1 and Phase 2, we performed numerous rounds of Plan-Do-Study-Act cycling to optimize procedural checklist-pathways, referral streamline, listserv adjustments, educational session content, and criteria for referral. This has continued to include a phase where we frequently adjust the program’s guidelines, based on staff feedback and experiences. Examples include transport equipment standardization, specific isolette utilization for any TDC-PDA patient, protocolization of patient preparation in the cath lab, and the like. Other steps of optimization include pathway-checklist implementation into the hospital electronic medical record and the dedication of staff (author S. Hash) to serving as patient navigator. Outcomes and Definitions- A retrospective chart review of patients undergoing transcatheter device closure of PDA from October 2020 to September 2023. This quality-driven initiative and multidisciplinary neonatal PDA review team was launched at the end of September of 2021. For statistical analyses, we performed a grouping time periods into three separate eras. Era 1 represented the year prior to program creation (October 2020 to September 2021); Era 2 being the first year after program formation (October 2021 to September 2022) and Era 3, the second year following program establishment (October 2022 to September 2023). Outcome measures included institutional referral rates for neonatal TDC-PDA, the number of procedures performed in patients weighing less than or equal to 1.3kg (institutional consensus to be the highest risk population), and finally, success rate of TDC-PDA encounter (leaving the lab with transcatheter device in place). Process measures included tracking “out of isolette” time for TDC-PDA patients. This was defined as the time in minutes the neonate is outside of a closed isolette while within the cardiac cath lab - the institutional goal less than 70 minutes total. The time includes any that the infant spends with the isolette bed-top opened – spanning patient transfer to cath lab table, anesthesia induction, preparation/positioning, access, procedural time, hemostasis, and transfer back into the isolette. Other process measures encompassed protocolized checklist compliance rate by staff (goal of > 95% adherence rate, audited every 10 encounters) and the percent of patients with noted complications or clinical sequelae within the first 24 hours following TDC-PDA. Balancing measures included any documented post-procedure hypothermia rate (defined as less than 36 degrees Celsius) as well as staff satisfaction/care survey rating regarding the TDC-PDA procedural encounter. The latter was a survey created surrounding the TDC-PDA procedural experience, modified from the National Aeronautics and Space Administration (NASA) Task Load Index with scale of 1 (very low), 2 (low), 3 (moderate), 4 (high) to 5 (very high).( 14 , 15 ) Lastly, we examined the institutional median intensive care stay measured in total days between transfer into our center and then back to referring center. Statistical Analysis - Center referrals for neonatal TDC-PDA, patient demographics, and procedural characteristics/outcomes were collected retrospectively for data analysis. Outcomes of interventions, noted complications/clinical sequelae, and staff satisfaction scoring were outlined via descriptive analyses. Era time frames pre-program creation for the first two years following program generation were tracked as defined above. Statistical analyses were performed using SPSS version 23 (IBM, NY NY). Categorical variables presented as a number/percentage and continuous variables as a median with interquartile range. We compared categorical variables using Fisher’s exact test and continuous variables via Mann-Whitney tests; clinical significance set at p < 0.05. Results During the study period, a total of 132 patients were referred to our institution for TDC-PDA with the breakdown into the defined eras as outlined in Table 1 . All outcome measure metrics demonstrated a significant increase following service line creation and practice implementation. The number of neonatal TDC-PDA referrals increased exponentially in the years since program inception (n = 42 year 1, then n = 74 year 2) relative to the comparative study period preceding (n = 16) ( Fig. 3 ) . Moreover, there was a significant increase in patients referred weighing less than or equal to 1.3 kilogram. The year prior to program inception, this cohort represented < 13% of patient encounters, then subsequently transitioned into the primary patient subset in which the program served (55% in year 1; then 50% in year 2) ( Fig. 4 ) . Procedural success of TDC-PDA increased following program creation with 81% success rate year prior to dedicated program, then 95% in year 1 and 99% in year 2. All patients with unsuccessful TDC-PDA underwent subsequent surgical ligation (3 patients in the year prior to program initiation, 2 patients in year 2, and 1 patient in year 2 of program). Table 1 Era comparison of institutional program dedicated to neonatal transcatheter device closure of the patent ductus arteriosus. Era 1, Pre-program (10/2020-09/2021) Era 2, Year 1 of Program (10/2021-09/2022) Era 3, Year 2 of Program (10/2022-09/2023) p-value Center referrals for neonatal TDC-PDA 16 42 74 < 0.01 Neonates </= 1.3 kg 2 (12.5%) 23 (55%) 37 (50%) < 0.01 Patient size, median (kg; IQR) 1.75 (1.6–1.82) 1.08 (0.9–1.2) 1.21 (0.93–1.3) 0.22 Time “out of isolette”, median (mins) 93 59 52 0.02 Successful TDC-PDA (n;%) 13 (81%) 40 (95%) 73 (99%) < 0.01 Staff satisfaction & care rating survey score (scale to 5) 2 ( 1 – 3 ) 4 ( 3 – 5 ) 5 ( 4 – 5 ) N/A Noted complications/sequelae within the first 24 hours: -Tricuspid injury by echo (now all mild by echo with no intervention) -Vascular injury -Embolized device, snared & replaced -Moderate LPA gradient (now all mild by echo with no intervention) 3 (19%) 1 1 0 1 5 (12%) 2 0 1 2 3 (4%) 1 1 1 0 N/A Median stay in TDC-PDA center (days; if referred into center for procedure) 4 ( 3 – 6 ) 3 ( 3 – 4 ) 3 ( 3 – 4 ) 0.37 -Abbreviations: TDC-PDA = transcatheter device closure of patent ductus arteriosus; LPA = left pulmonary artery; dAo = descending Aorta After implementation of the protocolized procedural checklists, we experienced a significant reduction in the “out of isolette” time process metric for TDC-PDA patients. The year prior to practice implementation, the median out of isolette time for any TDC-PDA neonate was 93 minutes which decreased to 59 minutes in year 1 then 52 minutes in year 2. The percentage of patients meeting the institutional goal (less than 70 minutes) improved significantly: 7.5% in year prior, 64.3% in year 1 then 70.3% in year 2. Checklist compliance rate (audited every 10 encounters) achieved a > 95% attainment rate since inception of the institutional checklists at the time of program initiation. The final process measure included any appreciable complication or procedural sequalae within 24 hours of TDC-PDA, which decreased throughout practice implementation is also detailed in Table 1 . Tricuspid valve injury by echo has remained ~ 5% or less throughout the center’s TDC-PDA experience, consistent with nationally published norms. No patient required any intervention for tricuspid injury; valve dysfunction continues to rate mild or less on echocardiographic follow up imaging and there have been no documented clinical sequelae. Vascular injury occurred in one patient pre-program creation to include hematoma formation and in another characterized by distal descending aortic clot (non-occlusive) formation after device embolization retrieval. The latter was treated with systemic anti-coagulation and had resolution following full treatment regimen. Both (n = 2) embolized devices occurred in patients greater than 2 kg in size and were retrieved via transcatheter methodologies and subsequently replaced with successful TDC-PDA. Those patients with left pulmonary artery gradients, which was a tracked clinical sequela rather than a complication, rated up to the moderate range by echocardiographic evaluation post-device placement. These gradients have all improved following somatic growth and never warranted any subsequent intervention, just serial monitoring by outpatient cardiology. Balancing measures included post-procedure hypothermia rate which did not demonstrate any significance throughout data collection. There were no neonates in the study cohort with documented hypothermia (less than 36 degrees Celsius) upon return to the intensive care unit from TDC-PDA. The creation of institutional procedural checklist-pathways did result in higher staff satisfaction and “care ratings” surrounding TDC-PDA encounters. Surveys were completed by 14 different individuals (n = 10 cath lab nursing personnel and n = 4 neonatal intensive care nurses) with the average care rating being 2 prior to checklist formation then a rating of 4 in year 1 and rating of 5 in year 2. The median inpatient stays in our referral-based TDC-PDA center for those patients transferred in (> 90% of patient cohort each year) remained 3 [3–4] days throughout program creation and inception. Discussion The premature neonate belongs to a medically fragile population with dedicated teams and protocols for implementation of new technology or procedures. A multidisciplinary approach to TDC-PDA has been linked to improved outcomes and the possibility of treating patients less than 1000 grams safely.( 16 – 18 ) With this quality initiative, we generated a multidisciplinary service line and program dedicated to neonatal TDC-PDA. This program has resulted in a significant referral increase as well as improved procedural efficacy, and safety. Our study adds to the literature by outlining the logistical hurdles (referral streamline, personnel comfort, minimizing procedural time in neonates, etc.) to TDC-PDA in the preterm neonate and provides some possible implementation strategies for overcoming these challenges. Although new devices and equipment are now available for TDC-PDA, the difficulty each institution now wrestles with is the safe and effective implementation within this population as well as altering referral patterns to capture suitable candidates for the procedure. It is increasingly evident that logistics surrounding the procedure may represent the most high-risk time frame for neonates undergoing TDC-PDA including transport and anesthesia considerations.( 19 , 20 ) The next horizon for our program lies within transition from procedures being performed in the cardiac catheterization laboratory to TDC-PDA at the bedside within the neonatal intensive care unit. Much akin to our institutional program establishment, the transition to bedside procedures warrants a multidisciplinary approach with new checklist-protocol generation and numerous safeguards in place. This study helps outline practice implementation methods for this population and will serve as a model for our next steps. Referral patterns for TDC-PDA remain difficult to predict, with unclear consensus from the medical literature on who represents the best candidate - there remain widely different patterns within the institutional and even provider levels. We continue to hold educational sessions throughout the nurseries in the state of Georgia outlining new TDC-PDA technology designed for preterm neonates as well as who we believe to be TDC-PDA candidates. Limitations to this study include being a retrospective single-center data review with limited study population and no comparison cohort. We recognize that procedural success rate may be reflective of the program’s emphasis on referral screening for TDC-PDA candidacy. As TDC-PDA technology continues to advance and the experience of operators grows, the community has begun to learn the limitations of the currently available technologies. Admittedly, a question that the entirety of the neonatology (and consulted cardiologist) continues to wrestle with is distinguishing what represents a hemodynamically significant PDA and when it should be eliminated. Given that new technology enables the effective closure of the PDA in small neonates less than 1000 grams safely, this criteria and timing should be a focus of the literature moving forward. Our review team maintains its own clinical and imaging (i.e., echocardiographic) guidelines for consideration of referral to assist the neonatology providers outside our healthcare system and the consulting cardiologists. Lastly, the long term follow up for preterm neonates undergoing TDC-PDA remains quite limited within our network; this program serves numerous institutional networks throughout the entirety of the state of Georgia. Outside of those few infants that continue to follow up with our cardiac outpatient team (i.e., persistent pulmonary artery gradient, etc.) or the neonatal follow up clinic in the Atlanta area, we are not privy to the long-term clinical outcomes of TDC-PDA patients. Leveraging outpatient-based clinical encounters, both in-network and out-of-network, to evaluate longer-term outcomes continues to be a focus for our program. Conclusion Building an institutional neonatal TDC-PDA service line that streamlines referrals and review can result in a significant increase in institutional referrals. A multidisciplinary team-based approach to these challenging patients is critical and can improve the success rate and safety of this procedure. Abbreviations Transcatheter device closure (TDC) Patent ductus arteriosus (PDA) Declarations Conflicts of Interest: Dr. Ligon is a proctor and education consultant for Abbott Vascular, Inc. ; Dr. Ligon is also a consultant for B. Braun Interventional Systems, Inc. No other authors have any financial relationships to disclose. Competing Interests Dr. Ligon is a proctor and education consultant for Abbott Vascular, Inc. ; Dr. Ligon is also a consultant for B. Braun Interventional Systems, Inc. No other authors have any financial relationships to disclose. Author Contribution RAL and SEG are the creators and generators of the project/manuscript. All authors have reviewed and edited the manuscript, are in agreement with its content. SBK, MA, SH, MM, and SM are major contributors to data collection and analysis. DWK, ASL, JL, KR, LT, CS, and AP are personnel with significant input on protocol generation and drivers of PDSA cycling. Acknowledgement Dr. Timothy Watson, who without his advocacy and assistance this institutional program would have never been launched. References Sathanandam SK, Gutfinger D, O'Brien L, Forbes TJ, Gillespie MJ, Berman DP et al (2020) Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients >/=700 grams. Catheter Cardiovasc Interv 96(6):1266–1276 Morray BH, Sathanandam SK, Forbes T, Gillespie M, Berman D, Armstrong AK et al (2023) 3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo Occluder for transcatheter patent ductus arteriosus closure in children >/= 700 grams. J Perinatol 43(10):1238–1244 Kuntz MT, Staffa SJ, Graham D, Faraoni D, Levy P, DiNardo J et al (2022) Trend and Outcomes for Surgical Versus Transcatheter Patent Ductus Arteriosus Closure in Neonates and Infants at US Children's Hospitals. 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Congenit Heart Dis 14(1):69–73 Additional Declarations Competing interest reported. Dr. Ligon is a proctor and education consultant for Abbott Vascular, Inc. ; Dr. Ligon is also a consultant for B. Braun Interventional Systems, Inc. No other authors have any financial relationships to disclose. Cite Share Download PDF Status: Published Journal Publication published 28 Aug, 2024 Read the published version in Pediatric Cardiology → Version 1 posted Editorial decision: Revision requested 28 Jul, 2024 Reviews received at journal 26 Jul, 2024 Reviewers agreed at journal 09 Jul, 2024 Reviewers agreed at journal 19 May, 2024 Reviewers invited by journal 19 May, 2024 Submission checks completed at journal 19 May, 2024 Editor assigned by journal 19 May, 2024 First submitted to journal 18 May, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4441381","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":307453174,"identity":"a02ad421-d127-44f0-8bf0-5ac782430269","order_by":0,"name":"R. Allen Ligon","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA0UlEQVRIiWNgGAWjYBACPmYwZWPAxpDARpwWNoiWNLgWCcJaINRhAwbitbCzX3xcUHPemI89/dmDDzX36hjYDx/dgN9hPMXGM47dNmPjeWNuOONYsQQDT1raDQJa0qR52G7bsEnksAEZCRIMEjxmRGj5dw6oJf2Z9J9/RGlhPybN23bAjE0iwUyasY04W5iNefuSjYF+MZPs7UuQbCPkF37+4w8f83yzM5zfnv5M4se3BH5+9sPH8GphYOAxQLMXv3IQYH9AWM0oGAWjYBSMbAAArkM7VcZELZUAAAAASUVORK5CYII=","orcid":"","institution":"Children's Healthcare of Atlanta","correspondingAuthor":true,"prefix":"","firstName":"R.","middleName":"Allen","lastName":"Ligon","suffix":""},{"id":307453175,"identity":"adb48e5c-894a-4ae6-9e2f-e9c57031948e","order_by":1,"name":"Shazia Bhombal-Kazi","email":"","orcid":"","institution":"Emory University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Shazia","middleName":"","lastName":"Bhombal-Kazi","suffix":""},{"id":307453176,"identity":"0e6ce46d-17e4-4d53-ba8b-130981c344bf","order_by":2,"name":"Marissa Adamson","email":"","orcid":"","institution":"Emory University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Marissa","middleName":"","lastName":"Adamson","suffix":""},{"id":307453177,"identity":"2aad1b62-4e24-4cbf-913e-b7c6f33f07cc","order_by":3,"name":"Sarah Hash","email":"","orcid":"","institution":"Children's Healthcare of Atlanta","correspondingAuthor":false,"prefix":"","firstName":"Sarah","middleName":"","lastName":"Hash","suffix":""},{"id":307453178,"identity":"5da5b5a2-459e-4221-89e6-ca2997eb25c3","order_by":4,"name":"Dennis W. Kim","email":"","orcid":"","institution":"Children's Healthcare of Atlanta","correspondingAuthor":false,"prefix":"","firstName":"Dennis","middleName":"W.","lastName":"Kim","suffix":""},{"id":307453179,"identity":"14d079d8-72d7-4245-9376-c171ca5d8e94","order_by":5,"name":"Ashley S. LeFevre","email":"","orcid":"","institution":"Emory University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Ashley","middleName":"S.","lastName":"LeFevre","suffix":""},{"id":307453180,"identity":"6be3e955-cc47-469d-8ad7-6153f6f4447d","order_by":6,"name":"Justin Long","email":"","orcid":"","institution":"Emory University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Justin","middleName":"","lastName":"Long","suffix":""},{"id":307453181,"identity":"48fb99ca-5e8b-4e95-ad08-ae20ac04fa1e","order_by":7,"name":"Sarah McLaughlin","email":"","orcid":"","institution":"Emory University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Sarah","middleName":"","lastName":"McLaughlin","suffix":""},{"id":307453182,"identity":"6b1830ab-d66e-4a24-887a-a89cae179029","order_by":8,"name":"Marcos Mills","email":"","orcid":"","institution":"Children's Healthcare of Atlanta","correspondingAuthor":false,"prefix":"","firstName":"Marcos","middleName":"","lastName":"Mills","suffix":""},{"id":307453183,"identity":"e3f49c40-49d0-4c62-ade2-70fc2ee5ba54","order_by":9,"name":"Katie Roddy","email":"","orcid":"","institution":"Emory University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Katie","middleName":"","lastName":"Roddy","suffix":""},{"id":307453184,"identity":"a977f57b-2983-4f2a-a8e8-6a5d8a0d441a","order_by":10,"name":"Lucas Tucker","email":"","orcid":"","institution":"Children's Healthcare of Atlanta","correspondingAuthor":false,"prefix":"","firstName":"Lucas","middleName":"","lastName":"Tucker","suffix":""},{"id":307453185,"identity":"c0121770-59b9-4982-9d90-071dbcad7fad","order_by":11,"name":"Cyrus Samai","email":"","orcid":"","institution":"Children's Healthcare of Atlanta","correspondingAuthor":false,"prefix":"","firstName":"Cyrus","middleName":"","lastName":"Samai","suffix":""},{"id":307453186,"identity":"3ee01872-4ff7-49c9-b77a-3cb031276ea8","order_by":12,"name":"Anthony Piazza","email":"","orcid":"","institution":"Emory University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Anthony","middleName":"","lastName":"Piazza","suffix":""},{"id":307453188,"identity":"768e108a-fa7a-45bf-a933-f1db12a34bb1","order_by":13,"name":"Shannon E. Hamrick","email":"","orcid":"","institution":"Emory University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Shannon","middleName":"E.","lastName":"Hamrick","suffix":""}],"badges":[],"createdAt":"2024-05-18 14:23:33","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4441381/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4441381/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00246-024-03629-z","type":"published","date":"2024-08-28T15:57:34+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":57721457,"identity":"4d4519d9-198d-4375-b214-cf090811dd2a","added_by":"auto","created_at":"2024-06-04 18:58:02","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":284932,"visible":true,"origin":"","legend":"\u003cp\u003e“Neonatal Patient Ductus Arteriosus (\u0026lt;2.5kg) – Transcatheter Device Closure Pathway, NICU Team”. Neonatal provider team checklist and pathway for peri-procedural care.\u003c/p\u003e\n\u003cp\u003eAbbreviations: NICU = neonatal intensive care unit; CHOA-Eg = Children’s Healthcare of Atlanta – Egleston; PDA = patent ductus arteriosus; CXR = chest x-ray; ETT = endotracheal tube; NPO = nil per os; VBG = venous blood gas; ABG = arterial blood gas; ECG = electrocardiogram; RT = respiratory therapist\u003c/p\u003e","description":"","filename":"Figure1NeoPDAPathwayforNICUTeam.png","url":"https://assets-eu.researchsquare.com/files/rs-4441381/v1/287e7e819e3da08a354733fe.png"},{"id":57721456,"identity":"a309fe73-3b90-484b-87be-7bfb4a7f0186","added_by":"auto","created_at":"2024-06-04 18:58:02","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":283236,"visible":true,"origin":"","legend":"\u003cp\u003e“Neonatal Patient Ductus Arteriosus (\u0026lt;2.5kg) – Transcatheter Device Closure Pathway, Cath Team”. Catheterization lab provider and personnel team checklist/pathway for peri-procedural care.\u003c/p\u003e\n\u003cp\u003eAbbreviations: RN = registered nurse; NICU = neonatal intensive care unit; RT = respiratory therapist; PDA = patent ductus arteriosus; LPA = left pulmonary artery; dAo = descending Aorta; FiO2 = fractionated of inspired oxygen; TR = tricuspid regurgitation; CXR = chest x-ray\u003c/p\u003e","description":"","filename":"Figure2NeoPDAPathwayforCATHTeam.png","url":"https://assets-eu.researchsquare.com/files/rs-4441381/v1/b71e3577fb5a13c35427bc45.png"},{"id":57721459,"identity":"b1482b87-e712-47af-bd2e-5ac6e51a4364","added_by":"auto","created_at":"2024-06-04 18:58:02","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":153100,"visible":true,"origin":"","legend":"\u003cp\u003eInstitutional trends in transcatheter device closure of patent ductus arteriosus for neonates/preemies. Encounters generated from neonatal intensive care unit-based referrals. PDA = patent ductus arteriosus; NICU = neonatal intensive care unit\u003c/p\u003e","description":"","filename":"Figure3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4441381/v1/9086103e97fb169fa24308a1.jpg"},{"id":57721458,"identity":"2967dc30-3c2a-464e-a6d4-f68e0ef61a19","added_by":"auto","created_at":"2024-06-04 18:58:02","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":131193,"visible":true,"origin":"","legend":"\u003cp\u003eInstitutional trends in transcatheter device closure of patent ductus arteriosus for neonates weighing 1.3 kg or less at the time of procedure. PDA = patent ductus arteriosus; kg = kilogram\u003c/p\u003e","description":"","filename":"Figure4.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4441381/v1/02b791a405b1043b0b196487.jpg"},{"id":63820971,"identity":"b4a4e015-cf19-4427-be86-c5801668dbb5","added_by":"auto","created_at":"2024-09-02 16:10:39","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1249834,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4441381/v1/a93c9512-6234-4d46-aea5-01d3657d33bc.pdf"}],"financialInterests":"Competing interest reported. Dr. Ligon is a proctor and education consultant for Abbott Vascular, Inc. ; Dr. Ligon is also a consultant for B. Braun Interventional Systems, Inc. No other authors have any financial relationships to disclose.","formattedTitle":"Impact of a Multidisciplinary Service Line and Program for Transcatheter Device Closure of the Neonatal Ductus Arteriosus","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe advent of new technologies and novel approaches to transcatheter device closure (TDC) has greatly altered the options for addressing the patent ductus arteriosus (PDA) in the preterm/neonatal population.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) These innovations allow for a less invasive, definitive PDA closure over surgical ligation with improvements in technique and short-term outcomes.(\u003cspan additionalcitationids=\"CR4 CR5\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) However, altering referral patterns away from surgical ligation and towards catheter-based closure are not immediate, and treatment approach to the PDA in the neonatal community remains controversial.(\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) The referring neonatologist might face challenges such as data review for patient candidacy, interfacility transfer to centers with a pediatric cardiac catheterization team, distance from the patient\u0026rsquo;s family, and facility revenues both from the procedure as well as neonatal intensive care unit stay.\u003c/p\u003e \u003cp\u003eAlthough a minority of programs nationally are transitioning to the bedside for TDC-PDA, most programs continue to perform neonatal TDC-PDA within the cardiac catheterization laboratory. All programs struggle with ensuring procedural efficacy as well as safety within this medically fragile population. At current state, there are limited publications outlining the practices for ensuring safety in this population to attain successful TDC-PDA.(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) Further, there is a paucity of literature speaking to a protocolized, systematic institutional approach with quality-driven metrics for rapid change.(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eIn September of 2021, we developed a comprehensive neonatal TDC-PDA closure program within our institution to address the multidisciplinary needs of these patients and sought to track its outcomes (designated as our Smart Aim). This study aimed to evaluate the impact of the quality initiative that established an institutional service line for neonatal TDC-PDA. The quality initiative spanned the period from referral via an interdisciplinary review team through generating checklist-pathways for all team members that encompass pre-, intra-, and post-procedural care and included tracking metrics for outcomes with institutional goals.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design, Setting, and Population-\u003c/h2\u003e \u003cp\u003eThis work represents a focused paper on a quality initiative; a retrospective descriptive observational study addressing the national trend of increasing referrals for TDC-PDA and establishment of a service line to meet increased demand. A quality-driven initiative was launched in September 2021 at Children\u0026rsquo;s Healthcare of Atlanta that serves the entirety of the population in the state of Georgia. At the time, we were the only hospital in the state with the resources and capabilities for TDC-PDA in patients less than 2kg. Therefore, the catchment population includes the entirety of the state\u0026rsquo;s extreme premature neonates with a hemodynamically significant ductus admitted to neonatal intensive care units. The state has two Level IV units (one being our own institutional 50 bed unit), 29 Level III units, and 15 Level II units. Study objectives include a summative programmatic and process (quality) measure outline of the approach to TDC-PDA in premature infants. This was to encompass a streamline of referral via an interdisciplinary review team and establishing institutional protocolized pathways for pre-, intra-, and post-procedural care.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eEthical Considerations-\u003c/h2\u003e \u003cp\u003e The Children\u0026rsquo;s Healthcare of Atlanta Institutional Review Board approved this quality initiative and waived the need for parental consent. The retrospective data pull was granted waiver from review board involvement and was approved for retrospective data analysis. The board also provided patient waiver of consent. This manuscript was prepared utilizing the published SQUIRE 2.0 guidelines.(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStepwise Practice Change Implementation-\u003c/h2\u003e \u003cp\u003e \u003cem\u003ePhase 1: Protocolization of Procedure\u003c/em\u003e. The multidisciplinary neonatal TDC-PDA team evaluated the institutional approach to TDC-PDA and outcomes for the year prior to team formation to better understand the scope. This year correlated with the advent of new transcatheter technology for neonatal TDC-PDA approval by the United States Food and Drug Administration. The institutional approach for TDC-PDA was then protocolized in its entirety to include the pre-, intra-, and post-procedural timelines \u003cb\u003e(\u003c/b\u003eFigs.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e and \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e. This effort included input from specialists within Neonatology (all provider levels), nursing, cardiology (imaging and interventional specialists), anesthesiology, respiratory therapy, and administration. All four congenital interventional cardiologists agreed to follow these protocols for the approach to any TDC-PDA if the patient was less than 2.5kg in weight.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003ePhase 2: Education and Criteria Outline for Referral Base.\u003c/em\u003e Clinical and echocardiographic criteria for neonatal TDC-PDA referral were generated and disseminated to neonatology providers and consulting cardiologists throughout the state of Georgia. The focus remained on outlining clinical and echocardiographic criteria that suggested a hemodynamically significant PDA. These criteria were disseminated throughout the cardiologists that cover the various neonatal intensive care units throughout the state. Numerous grand rounds lectures for neonatology teams around the state were performed by a team consisting of a neonatologist and interventional cardiologist.\u003c/p\u003e \u003cp\u003eFurther, the referral to the neonatal PDA program was centralized via an email listserv ([email protected]) which forwarded to the multidisciplinary neonatal PDA review team. This group consisted of two neonatologists, two interventional congenital cardiologists, an imaging congenital cardiology specialist, and a patient navigator (an administrative neonatal nurse). The multidisciplinary team reviewed patient information via direct phone call, meeting and/or video streaming platform(s) to ensure optimal candidacy for TDC-PDA. Once a consensus was reached regarding candidacy for the procedure, insurance/financial approval was sought by the parent institution to include transfer into and out of our center. Lastly, a \u0026ldquo;target date\u0026rdquo; for TDC-PDA was provided to the referring neonatal unit for expected transfer to allow preparation for the procedure. Repeat echocardiography to ensure candidacy was recommended within 48 hours before transfer.\u003c/p\u003e \u003cp\u003e\u003cem\u003ePhase 3: Plan-Do-Study-Act Rapid Cycling.\u003c/em\u003e Throughout Phase 1 and Phase 2, we performed numerous rounds of Plan-Do-Study-Act cycling to optimize procedural checklist-pathways, referral streamline, listserv adjustments, educational session content, and criteria for referral. This has continued to include a phase where we frequently adjust the program\u0026rsquo;s guidelines, based on staff feedback and experiences. Examples include transport equipment standardization, specific isolette utilization for any TDC-PDA patient, protocolization of patient preparation in the cath lab, and the like. Other steps of optimization include pathway-checklist implementation into the hospital electronic medical record and the dedication of staff (author S. Hash) to serving as patient navigator.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eOutcomes and Definitions-\u003c/h2\u003e \u003cp\u003eA retrospective chart review of patients undergoing transcatheter device closure of PDA from October 2020 to September 2023. This quality-driven initiative and multidisciplinary neonatal PDA review team was launched at the end of September of 2021. For statistical analyses, we performed a grouping time periods into three separate eras. Era 1 represented the year prior to program creation (October 2020 to September 2021); Era 2 being the first year after program formation (October 2021 to September 2022) and Era 3, the second year following program establishment (October 2022 to September 2023). Outcome measures included institutional referral rates for neonatal TDC-PDA, the number of procedures performed in patients weighing less than or equal to 1.3kg (institutional consensus to be the highest risk population), and finally, success rate of TDC-PDA encounter (leaving the lab with transcatheter device in place). Process measures included tracking \u0026ldquo;out of isolette\u0026rdquo; time for TDC-PDA patients. This was defined as the time in minutes the neonate is outside of a closed isolette while within the cardiac cath lab - the institutional goal less than 70 minutes total. The time includes any that the infant spends with the isolette bed-top opened \u0026ndash; spanning patient transfer to cath lab table, anesthesia induction, preparation/positioning, access, procedural time, hemostasis, and transfer back into the isolette. Other process measures encompassed protocolized checklist compliance rate by staff (goal of \u0026gt;\u0026thinsp;95% adherence rate, audited every 10 encounters) and the percent of patients with noted complications or clinical sequelae within the first 24 hours following TDC-PDA. Balancing measures included any documented post-procedure hypothermia rate (defined as less than 36 degrees Celsius) as well as staff satisfaction/care survey rating regarding the TDC-PDA procedural encounter. The latter was a survey created surrounding the TDC-PDA procedural experience, modified from the National Aeronautics and Space Administration (NASA) Task Load Index with scale of 1 (very low), 2 (low), 3 (moderate), 4 (high) to 5 (very high).(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) Lastly, we examined the institutional median intensive care stay measured in total days between transfer into our center and then back to referring center.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis -\u003c/h2\u003e \u003cp\u003eCenter referrals for neonatal TDC-PDA, patient demographics, and procedural characteristics/outcomes were collected retrospectively for data analysis. Outcomes of interventions, noted complications/clinical sequelae, and staff satisfaction scoring were outlined via descriptive analyses. Era time frames pre-program creation for the first two years following program generation were tracked as defined above. Statistical analyses were performed using SPSS version 23 (IBM, NY NY). Categorical variables presented as a number/percentage and continuous variables as a median with interquartile range. We compared categorical variables using Fisher\u0026rsquo;s exact test and continuous variables via Mann-Whitney tests; clinical significance set at p\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eDuring the study period, a total of 132 patients were referred to our institution for TDC-PDA with the breakdown into the defined eras as outlined in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. All outcome measure metrics demonstrated a significant increase following service line creation and practice implementation. The number of neonatal TDC-PDA referrals increased exponentially in the years since program inception (n\u0026thinsp;=\u0026thinsp;42 year 1, then n\u0026thinsp;=\u0026thinsp;74 year 2) relative to the comparative study period preceding (n\u0026thinsp;=\u0026thinsp;16) \u003cb\u003e(\u003c/b\u003eFig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e. Moreover, there was a significant increase in patients referred weighing less than or equal to 1.3 kilogram. The year prior to program inception, this cohort represented\u0026thinsp;\u0026lt;\u0026thinsp;13% of patient encounters, then subsequently transitioned into the primary patient subset in which the program served (55% in year 1; then 50% in year 2) \u003cb\u003e(\u003c/b\u003eFig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e. Procedural success of TDC-PDA increased following program creation with 81% success rate year prior to dedicated program, then 95% in year 1 and 99% in year 2. All patients with unsuccessful TDC-PDA underwent subsequent surgical ligation (3 patients in the year prior to program initiation, 2 patients in year 2, and 1 patient in year 2 of program).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eEra comparison of institutional program dedicated to neonatal transcatheter device closure of the patent ductus arteriosus.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEra 1, Pre-program (10/2020-09/2021)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eEra 2, Year 1 of Program (10/2021-09/2022)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eEra 3, Year 2 of Program (10/2022-09/2023)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCenter referrals for neonatal TDC-PDA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeonates \u0026lt;/= 1.3 kg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23 (55%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e37 (50%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePatient size, median (kg; IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.75 (1.6\u0026ndash;1.82)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.08 (0.9\u0026ndash;1.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.21 (0.93\u0026ndash;1.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.22\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTime \u0026ldquo;out of isolette\u0026rdquo;, median (mins)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e93\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuccessful TDC-PDA (n;%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (81%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e40 (95%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e73 (99%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStaff satisfaction \u0026amp; care rating survey score (scale to 5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5 (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNoted complications/sequelae within the first 24 hours:\u003c/p\u003e \u003cp\u003e-Tricuspid injury by echo (now all mild by echo with no intervention)\u003c/p\u003e \u003cp\u003e-Vascular injury\u003c/p\u003e \u003cp\u003e-Embolized device, snared \u0026amp; replaced\u003c/p\u003e \u003cp\u003e-Moderate LPA gradient (now all mild by echo with no intervention)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (19%)\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (12%)\u003c/p\u003e \u003cp\u003e2\u003c/p\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (4%)\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedian stay in TDC-PDA center (days; if referred into center for procedure)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (\u003cspan additionalcitationids=\"CR4 CR5\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.37\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e-Abbreviations: TDC-PDA\u0026thinsp;=\u0026thinsp;transcatheter device closure of patent ductus arteriosus; LPA\u0026thinsp;=\u0026thinsp;left pulmonary artery; dAo\u0026thinsp;=\u0026thinsp;descending Aorta\u003c/p\u003e \u003cp\u003eAfter implementation of the protocolized procedural checklists, we experienced a significant reduction in the \u0026ldquo;out of isolette\u0026rdquo; time process metric for TDC-PDA patients. The year prior to practice implementation, the median out of isolette time for any TDC-PDA neonate was 93 minutes which decreased to 59 minutes in year 1 then 52 minutes in year 2. The percentage of patients meeting the institutional goal (less than 70 minutes) improved significantly: 7.5% in year prior, 64.3% in year 1 then 70.3% in year 2. Checklist compliance rate (audited every 10 encounters) achieved a\u0026thinsp;\u0026gt;\u0026thinsp;95% attainment rate since inception of the institutional checklists at the time of program initiation.\u003c/p\u003e \u003cp\u003eThe final process measure included any appreciable complication or procedural sequalae within 24 hours of TDC-PDA, which decreased throughout practice implementation is also detailed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Tricuspid valve injury by echo has remained\u0026thinsp;~\u0026thinsp;5% or less throughout the center\u0026rsquo;s TDC-PDA experience, consistent with nationally published norms. No patient required any intervention for tricuspid injury; valve dysfunction continues to rate mild or less on echocardiographic follow up imaging and there have been no documented clinical sequelae. Vascular injury occurred in one patient pre-program creation to include hematoma formation and in another characterized by distal descending aortic clot (non-occlusive) formation after device embolization retrieval. The latter was treated with systemic anti-coagulation and had resolution following full treatment regimen. Both (n\u0026thinsp;=\u0026thinsp;2) embolized devices occurred in patients greater than 2 kg in size and were retrieved via transcatheter methodologies and subsequently replaced with successful TDC-PDA. Those patients with left pulmonary artery gradients, which was a tracked clinical sequela rather than a complication, rated up to the moderate range by echocardiographic evaluation post-device placement. These gradients have all improved following somatic growth and never warranted any subsequent intervention, just serial monitoring by outpatient cardiology.\u003c/p\u003e \u003cp\u003eBalancing measures included post-procedure hypothermia rate which did not demonstrate any significance throughout data collection. There were no neonates in the study cohort with documented hypothermia (less than 36 degrees Celsius) upon return to the intensive care unit from TDC-PDA. The creation of institutional procedural checklist-pathways did result in higher staff satisfaction and \u0026ldquo;care ratings\u0026rdquo; surrounding TDC-PDA encounters. Surveys were completed by 14 different individuals (n\u0026thinsp;=\u0026thinsp;10 cath lab nursing personnel and n\u0026thinsp;=\u0026thinsp;4 neonatal intensive care nurses) with the average care rating being 2 prior to checklist formation then a rating of 4 in year 1 and rating of 5 in year 2. The median inpatient stays in our referral-based TDC-PDA center for those patients transferred in (\u0026gt;\u0026thinsp;90% of patient cohort each year) remained 3 [3\u0026ndash;4] days throughout program creation and inception.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe premature neonate belongs to a medically fragile population with dedicated teams and protocols for implementation of new technology or procedures. A multidisciplinary approach to TDC-PDA has been linked to improved outcomes and the possibility of treating patients less than 1000 grams safely.(\u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e) With this quality initiative, we generated a multidisciplinary service line and program dedicated to neonatal TDC-PDA. This program has resulted in a significant referral increase as well as improved procedural efficacy, and safety. Our study adds to the literature by outlining the logistical hurdles (referral streamline, personnel comfort, minimizing procedural time in neonates, etc.) to TDC-PDA in the preterm neonate and provides some possible implementation strategies for overcoming these challenges. Although new devices and equipment are now available for TDC-PDA, the difficulty each institution now wrestles with is the safe and effective implementation within this population as well as altering referral patterns to capture suitable candidates for the procedure.\u003c/p\u003e \u003cp\u003eIt is increasingly evident that logistics surrounding the procedure may represent the most high-risk time frame for neonates undergoing TDC-PDA including transport and anesthesia considerations.(\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) The next horizon for our program lies within transition from procedures being performed in the cardiac catheterization laboratory to TDC-PDA at the bedside within the neonatal intensive care unit. Much akin to our institutional program establishment, the transition to bedside procedures warrants a multidisciplinary approach with new checklist-protocol generation and numerous safeguards in place. This study helps outline practice implementation methods for this population and will serve as a model for our next steps. Referral patterns for TDC-PDA remain difficult to predict, with unclear consensus from the medical literature on who represents the best candidate - there remain widely different patterns within the institutional and even provider levels. We continue to hold educational sessions throughout the nurseries in the state of Georgia outlining new TDC-PDA technology designed for preterm neonates as well as who we believe to be TDC-PDA candidates.\u003c/p\u003e \u003cp\u003eLimitations to this study include being a retrospective single-center data review with limited study population and no comparison cohort. We recognize that procedural success rate may be reflective of the program\u0026rsquo;s emphasis on referral screening for TDC-PDA candidacy. As TDC-PDA technology continues to advance and the experience of operators grows, the community has begun to learn the limitations of the currently available technologies. Admittedly, a question that the entirety of the neonatology (and consulted cardiologist) continues to wrestle with is distinguishing what represents a hemodynamically significant PDA and when it should be eliminated. Given that new technology enables the effective closure of the PDA in small neonates less than 1000 grams safely, this criteria and timing should be a focus of the literature moving forward. Our review team maintains its own clinical and imaging (i.e., echocardiographic) guidelines for consideration of referral to assist the neonatology providers outside our healthcare system and the consulting cardiologists. Lastly, the long term follow up for preterm neonates undergoing TDC-PDA remains quite limited within our network; this program serves numerous institutional networks throughout the entirety of the state of Georgia. Outside of those few infants that continue to follow up with our cardiac outpatient team (i.e., persistent pulmonary artery gradient, etc.) or the neonatal follow up clinic in the Atlanta area, we are not privy to the long-term clinical outcomes of TDC-PDA patients. Leveraging outpatient-based clinical encounters, both in-network and out-of-network, to evaluate longer-term outcomes continues to be a focus for our program.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eBuilding an institutional neonatal TDC-PDA service line that streamlines referrals and review can result in a significant increase in institutional referrals. A multidisciplinary team-based approach to these challenging patients is critical and can improve the success rate and safety of this procedure.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eTranscatheter device closure (TDC)\u003c/p\u003e\n\u003cp\u003ePatent ductus arteriosus (PDA)\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eConflicts of Interest:\u003c/h2\u003e\n\u003cp\u003eDr. Ligon is a proctor and education consultant for Abbott Vascular, Inc. ; Dr. Ligon is also a consultant for B. Braun Interventional Systems, Inc. No other authors have any financial relationships to disclose.\u003c/p\u003e\n\u003ch2\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003eDr. Ligon is a proctor and education consultant for Abbott Vascular, Inc. ; Dr. Ligon is also a consultant for B. Braun Interventional Systems, Inc. No other authors have any financial relationships to disclose.\u003c/p\u003e\n\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\n\u003cp\u003eRAL and SEG are the creators and generators of the project/manuscript. All authors have reviewed and edited the manuscript, are in agreement with its content. SBK, MA, SH, MM, and SM are major contributors to data collection and analysis. DWK, ASL, JL, KR, LT, CS, and AP are personnel with significant input on protocol generation and drivers of PDSA cycling.\u003c/p\u003e\n\u003ch2\u003eAcknowledgement\u003c/h2\u003e\n\u003cp\u003eDr. Timothy Watson, who without his advocacy and assistance this institutional program would have never been launched.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eSathanandam SK, Gutfinger D, O'Brien L, Forbes TJ, Gillespie MJ, Berman DP et al (2020) Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients \u0026gt;/=700 grams. Catheter Cardiovasc Interv 96(6):1266\u0026ndash;1276\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMorray BH, Sathanandam SK, Forbes T, Gillespie M, Berman D, Armstrong AK et al (2023) 3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo Occluder for transcatheter patent ductus arteriosus closure in children \u0026gt;/= 700 grams. J Perinatol 43(10):1238\u0026ndash;1244\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKuntz MT, Staffa SJ, Graham D, Faraoni D, Levy P, DiNardo J et al (2022) Trend and Outcomes for Surgical Versus Transcatheter Patent Ductus Arteriosus Closure in Neonates and Infants at US Children's Hospitals. J Am Heart Assoc 11(1):e022776\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBischoff AR, Kennedy KF, Backes CH, Sathanandam S, McNamara PJ (2023) Percutaneous Closure of the Patent Ductus Arteriosus in Infants =2 kg: IMPACT Registry Insights\u0026lt;/atz. Pediatrics. ;\u0026lt;vz\u0026gt;152\u0026lt;/vz\u0026gt;(\u0026lt;issz\u0026gt;3\u0026lt;/issz\u0026gt;).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBischoff AR, Jasani B, Sathanandam SK, Backes C, Weisz DE, McNamara PJ (2021) Percutaneous Closure of Patent Ductus Arteriosus in Infants 1.5 kg or Less: A Meta-Analysis. J Pediatr 230:84\u0026ndash;92e14\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBarry OM, Gudausky TM, Balzer DT, Bocks ML, Boe BA, Callahan R et al (2023) Safety and Short-Term Outcomes for Infants\u0026thinsp;\u0026lt;\u0026thinsp;2.5 kg Undergoing PDA Device Closure: A C3PO Registry Study. Pediatr Cardiol 44(6):1406\u0026ndash;1413\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eClyman RI, Liebowitz M, Kaempf J, Erdeve O, Bulbul A, Hakansson S et al (2019) PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age. J Pediatr. ;205:41\u0026thinsp;\u0026ndash;\u0026thinsp;8 e6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHundscheid T, Onland W, Kooi EMW, Vijlbrief DC, de Vries WB, Dijkman KP et al (2023) Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus. N Engl J Med 388(11):980\u0026ndash;990\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKaluarachchi DC, Rysavy MA, Carper BA, Chock VY, Laughon MM, Backes CH et al (2023) Secular Trends in Patent Ductus Arteriosus Management in Infants Born Preterm in the National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr 266:113877\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHubbard R, Edmonds K, Rydalch E, Pawelek O, Griffin E, Gautam N (2020) Anesthetic management of catheter-based patent ductus arteriosus closure in neonates weighing\u0026thinsp;\u0026lt;\u0026thinsp;3 kg: A Retrospective Observational Study. Paediatr Anaesth 30(4):506\u0026ndash;510\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSathanandam S, Gutfinger D, Morray B, Berman D, Gillespie M, Forbes T et al (2021) Consensus Guidelines for the Prevention and Management of Periprocedural Complications of Transcatheter Patent Ductus Arteriosus Closure with the Amplatzer Piccolo Occluder in Extremely Low Birth Weight Infants. Pediatr Cardiol 42(6):1258\u0026ndash;1274\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAlhalabi E, Zestos M, Kobayashi D, McKelvey GM, Taylor RA (2022) Interventions to prevent hypothermia in extremely preterm low-weight infants undergoing cardiac catheterisation. BMJ Open Qual. ;11(3)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOgrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D (2016) SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf 25(12):986\u0026ndash;992\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBell SW, Kong JCH, Clark DA, Carne P, Skinner S, Pillinger S et al (2022) The National Aeronautics and Space Administration-task load index: NASA-TLX: evaluation of its use in surgery. ANZ J Surg 92(11):3022\u0026ndash;3028\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKennedy-Metz LR, Wolfe HL, Dias RD, Yule SJ, Zenati MA (2020) Surgery Task Load Index in Cardiac Surgery: Measuring Cognitive Load Among Teams. Surg Innov 27(6):602\u0026ndash;607\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eApalodimas L, Waller Iii BR, Philip R, Crawford J, Cunningham J, Sathanandam S (2019) A comprehensive program for preterm infants with patent ductus arteriosus. Congenit Heart Dis 14(1):90\u0026ndash;94\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMcNamara PJ, Giesinger RE, Backes CH (2019) Cardiac catheterisation for closure of patent ductus arteriosus. Lancet Child Adolesc Health 3(5):290\u0026ndash;292\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSathanandam S, Agrawal H, Chilakala S, Johnson J, Allen K, Knott-Craig C et al (2019) Can transcatheter PDA closure be performed in neonates =1000 grams? The Memphis experience\u0026lt;/at. Congenit Heart Dis 14(1):79\u0026ndash;84\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAw TC, Chan B, Singh Y (2023) Transport and Anaesthesia Consideration for Transcatheter Patent Ductus Arteriosus Closure in Premature Infants. J Cardiovasc Dev Dis. ;10(9)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWillis A, Pereiras L, Head T, Dupuis G, Sessums J, Corder G et al (2019) Transport of extremely low birth weight neonates for persistent ductus arteriosus closure in the catheterization lab. Congenit Heart Dis 14(1):69\u0026ndash;73\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pediatric-cardiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pedc","sideBox":"Learn more about [Pediatric Cardiology](http://link.springer.com/journal/246)","snPcode":"246","submissionUrl":"https://submission.nature.com/new-submission/246/3","title":"Pediatric Cardiology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Quality improvement, Patent Ductus Arteriosus, Transcatheter therapy, prematurity, neonate","lastPublishedDoi":"10.21203/rs.3.rs-4441381/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4441381/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003eObjective\u003c/em\u003e–\u003c/p\u003e\n\u003cp\u003eOutline a quality initiative establishing an institutional service line for neonatal transcatheter device closure of the patent ductus arteriosus (TDC-PDA).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStudy Design \u003c/em\u003e–\u003c/p\u003e\n\u003cp\u003eA retrospective descriptive observational study surrounding programmatic approach to TDC-PDA in premature neonates with process measure spanning education, implementation, referral, and post-procedural care. Metrics tracked pre- and post-program creation with statistical analyses performed.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eResults\u003c/em\u003e –\u003c/p\u003e\n\u003cp\u003eNeonatal TDC-PDA referrals increased exponentially since program inception (n=13 in year prior; n=42 year 1; n=74 year 2), especially in patients weighing less than 1.3 kg (12.5%; 55%; 50%), and was associated with an increased procedural success rate (81%; 95%; 99%). Procedural checklist creation decreased procedural “out of isolette” time (median 93 minutes; 59; 52), and procedural-related complication or clinical sequelae (19%; 12%; 4%).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConclusion\u003c/em\u003e –\u003c/p\u003e\n\u003cp\u003eA multidisciplinary service line and program dedicated to neonatal TDC-PDA can result in a significant increase in referrals as well as procedural efficacy and safety for this medically fragile population.\u003c/p\u003e","manuscriptTitle":"Impact of a Multidisciplinary Service Line and Program for Transcatheter Device Closure of the Neonatal Ductus Arteriosus","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-06-04 18:57:53","doi":"10.21203/rs.3.rs-4441381/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-07-28T23:29:43+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-07-26T19:56:44+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"77383378375325059429403557686035669126","date":"2024-07-09T14:43:42+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"5654361543225507778468641816395776519","date":"2024-05-20T00:54:57+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-05-20T00:52:18+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-05-19T09:49:11+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-05-19T09:49:11+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pediatric Cardiology","date":"2024-05-18T14:22:15+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pediatric-cardiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pedc","sideBox":"Learn more about [Pediatric Cardiology](http://link.springer.com/journal/246)","snPcode":"246","submissionUrl":"https://submission.nature.com/new-submission/246/3","title":"Pediatric Cardiology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"560973be-fa88-4305-8991-37712a384292","owner":[],"postedDate":"June 4th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-09-02T16:01:45+00:00","versionOfRecord":{"articleIdentity":"rs-4441381","link":"https://doi.org/10.1007/s00246-024-03629-z","journal":{"identity":"pediatric-cardiology","isVorOnly":false,"title":"Pediatric Cardiology"},"publishedOn":"2024-08-28 15:57:34","publishedOnDateReadable":"August 28th, 2024"},"versionCreatedAt":"2024-06-04 18:57:53","video":"","vorDoi":"10.1007/s00246-024-03629-z","vorDoiUrl":"https://doi.org/10.1007/s00246-024-03629-z","workflowStages":[]},"version":"v1","identity":"rs-4441381","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4441381","identity":"rs-4441381","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}