Transcatheter Patent Ductus Arteriosus Research Articles

Cardiorespiratory Instability after Percutaneous Patent Ductus Arteriosus Closure: A Multicenter Cohort Study

ObjectiveTo evaluate post-procedural clinical characteristics of preterm infants undergoing transcatheter patent ductus arteriosus (PDA) closure, including oxygenation/ventilation failure and cardiovascular compromise Study designMulticenter retrospective cohort study of preterm infants who were ≤2 kg at the time of percutaneous PDA closure between August 2018 and July 2021. Indices of cardiorespiratory stability were collected pre-closure, immediately post-closure, and subsequently averaged every 4 hours for the first 24 hours post-procedure. The primary outcome was incidence of post-transcatheter cardiorespiratory syndrome: composite of: (i) hemodynamic instability (defined by systemic hypotension, systemic hypertension, or use of new inotropes/vasopressors in the first 24 hours after catheterization and at least one of the following: (i)ventilation failure or (ii) oxygenation failure. ResultsA total of 197 patients were included with a median [IQR] age and weight at catheterization of 34 [25, 43] days and 1090 [900, 1367] grams, respectively. The primary composite outcome was reported in 46 (23.3%) patients and subcomponents of oxygenation and/or ventilation failure, systolic hypotension or systolic hypertension were noted in 81 (41.1%), 3 (1.5%) and 86 (43.6%) respectively. Logistic regression models showed weight at catheterization and respiratory severity score pre-closure to be significantly associated with post-transcatheter cardiorespiratory syndrome. ConclusionPost-transcatheter cardiorespiratory syndrome is characterized primarily by systemic hypertension and oxygenation failure, with a very low incidence of hypotension and need for inotropes.

Transcatheter patent ductus arteriosus closure in premature infants requiring high-frequency ventilation.

Transcatheter closure has become a common treatment method for patent ductus arteriosus in premature infants at many centres; however, many remain uncertain about the ability to perform the procedure in the catheterisation laboratory for infants requiring high-frequency ventilation. This study presents our centre's experience following the implementation of neonatal ventilatory guidelines, which resulted in 100% procedural success without any procedural or respiratory adverse events.

Post-ligation cardiac syndrome after surgical versus transcatheter closure of patent ductus arteriosus in low body weight premature infants: a multicenter retrospective cohort study.

Transcatheter patent ductus arteriosus (PDA) closure is a safe and effective alternative to surgical ligation in low-body-weight infants. Post-ligation cardiac syndrome (PLCS) is defined as severe hemodynamic and respiratory collapse within 24h of PDA closure, requiring initiation or an increase of an inotropic agent by > 20% of preligation dosing and an absolute increase of at least 20% in ventilation parameters compared with the preoperative value. Whilst PLCS is routinely observed after surgery, its incidence remains poorly described following transcatheter closure. This study aimed to compare the incidence of PLCS after surgical versus transcatheter closure of PDA in low-body-weight premature infants. Propensity scores were used to compare surgical (N = 78) and transcatheter (N = 76) groups of preterm infants who underwent PDA closure at a procedural weight less than 2000g in two tertiary institutions between 2009 and 2021. The primary outcome was the incidence of PLCS. Secondary outcomes included overall mortality before discharge, risk factors for PLCS, and post-procedural complications. Procedural success was 100% in both groups. After matching, transcatheter group experienced no PLCS vs 15% in the surgical group (p = 0.012). Furthermore, overall mortality (2% vs 17%; p = 0.03) and major complications (2% vs 23%; p = 0.002) were higher in the surgical group. Surgery (100% vs 47%; p < 0.01), gestation age (25 ± 1 vs 26 ± 2weeks, p < 0.05) and inotropic support before closure (90% vs 29%; p < 0.001) were associated with PLCS occurrence. Conclusion: Transcatheter PDA closure may be equally effective but safer than surgical PDA closure in low-body-weight premature infants. What is Known: • Post-ligation cardiac syndrome is a serious and common complication of surgical closure of the ductus arteriosus in preterm infants. • Transcatheter closure of preterm ductus arteriosus is a safe and effective technique that is becoming more and more common worldwide. What is New: • Device closure is safer than surgical ligation for patent ductus arteriosus closure in preterm infants and may be the first-line non-pharmacological therapeutic option in this indication in experienced teams. • Our findings should encourage neonatologists and pediatric cardiologists to start and/or strengthen a durable interventional program for transcatheter PDA closure in premature infants.

Percutaneous closure of patent ductus arteriosus versus surgical treatment in low-birth-weight preterms: a systematic review and meta-analysis.

The optimal management of a patent ductus arteriosus in a population of preterm infants is controversial. Traditionally, when the patent ductus arteriosus does not close either with conservative treatment or in response to pharmacological therapy, the only option is surgical closure. However, transcatheter occlusion might provide a therapeutic alternative. We searched PubMed, Embase, and Cochrane databases for non-randomised and randomised controlled trials that compared transcatheter percutaneous closure of patent ductus arteriosus with surgical ligation in low-birth-weight preterm infants (<2,500 g). A random-effects model was used for outcomes with high heterogeneity. We included twelve studies comprising 4,668 low-birth-weight preterm infants, of whom 966 (20.7%) were in the transcatheter percutaneous closure group, and 3,702 (79.3%) patients were included in the surgical group. All-cause mortality (OR0.28; 95% confidence interval 0.18-0.423; p < 0.00001; I2 = 0%) and haemodynamic instability (OR 0.10; 95% confidence interval 0.05-0.21; p < 0.001; I2 = 14%) were significantly lower in the transcatheter percutaneous closure group. There was no significant difference between transcatheter and surgical patent ductus arteriosus closure for the outcomes of bronchopulmonary dysplasia (0.93; 95% confidence interval 0.46-1.87; p = 0.83; I2 = 0%) and major complications (OR 0.76; 95% confidence interval 0.34-1.69; p = 0.51; I2 = 43%). These findings suggest that transcatheter patent ductus arteriosus closure in preterm infants under 2,500 g is a safe and effective alternative to surgical treatment. There was a substantial reduction in all-cause mortality and haemodynamic instability with transcatheter intervention compared to surgical closure.

The Transcatheter Closure of Patent Ductus Arteriosus in Extremely Low-Birth-Weight Infants: Technique and Results.

Persistent patent ductus arteriosus is a very common condition in preterm infants. Although there is no management agreed by consensus, despite numerous randomized controlled trials, hemodynamically significant patent ductus arteriosus increases morbidity and mortality in these vulnerable patients. Medical treatment is usually offered as first-line therapy, although it carries a limited success rate and potential severe adverse events. In recent years, transcatheter patent ductus arteriosus closure has fast developed and become widely accepted as a safe and efficient alternative to surgical ductal ligation in extremely low birth weight infants >700 g, using most often the dedicated Amplatzer Piccolo Occluder device. This article aims to provide an appraisal of the patients' selection process, and a step-by-step description of the procedure as well as a comprehensive review of its outcomes.

Transcatheter Patent Ductus Arteriosus Closure in Children With Different Devices and Long-Term Results.

With the development of transcatheter interventional techniques and the introduction of next-generation duct occluder devices, transcatheter closure has become the first treatment option for patent ductus arteriosus (PDA) in pediatric patients. In this study, we compared the effectiveness and safety of different devices for transcatheter PDA closure in pediatric patients, focusing on long-term outcomes. A total of 235 patients aged 0-18 years who underwent transcatheter PDA closure at a tertiary care center between January 2005 and February 2020 were included. The medical records of the cases were retrospectively evaluated. The median age of the patients was 2.3 years (range: 3.5 months to 17 years), with a mean weight of 12.8 kg (range: 5.7-43.2 kg). The mean PDA diameter at its narrowest point was 2.9 mm (range: 2.2-5.1 mm). Ductal anatomy was as follows: Type A in 98 (41.7%) patients, Type E in 36 (15.6%) patients, Type C in 32 (13.5%) patients, Type F in 27 (11.4%) patients, Type D in 23 (9.7%) patients, and Type B in 19 (8.1%) patients. Arterial access was used in 138 (57.1%) patients, venous + arterial access in 58 (24.6%) patients, and venous access only in 39 (16.5%) patients. Closure was performed with Amplatzer Duct Occluder (ADO; AGA Medical Corp., Golden Valley, MN, USA) II in 151 (64.2%) cases, ADO I in 43 (18.2%) cases, and coils in 41 (17.4%) cases. The mean fluoroscopy time and mean procedural time were 10.3 ± 4.2 minutes and 41 ± 7.2 minutes, respectively. The mean radiation dose was 1364 ± 497 cGy/min. The early closure rate after the procedure was 92%, while residual shunting on the first day post-procedure was observed in 1.8% of cases, decreasing to 0.1% at the one-month follow-up. The overall procedural success rate for all cases was 96.0%. The mean follow-up duration was 9.7 years (range: 2.9-13.8 years). For percutaneous PDA closure, ADO I devices are preferred for larger defects, whereas ADO II devices are prioritized for small- to medium-sized defects instead of coils.

Transport and Anaesthesia Consideration for Transcatheter Patent Ductus Arteriosus Closure in Premature Infants.

Transcatheter device closure of patent ductus arteriosus (PDA) in preterm infants has been proven to be a feasible and safe technique with promising results when compared to surgical ligation. However, managing transport and anaesthesia in extremely premature infants with haemodynamically significant PDA and limited reserves presents unique challenges. This review article focuses on the key considerations throughout the clinical pathway for the PDA device closure, including referral hospital consultation, patient selection, intra- and inter-hospital transport, and anaesthesia management. The key elements encompass comprehensive patient assessment, meticulous airway management, optimised ventilation strategies, precise thermoregulation, patient-tailored sedation protocols, vigilant haemodynamic monitoring, and safe transport measures throughout the pre-operative, intra-operative, and post-operative phases. A multidisciplinary approach enhances the chances of procedure success, improves patient outcomes, and minimises the risk of complications.

3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams

ObjectiveThis study describes 3-year follow-up of 200 infants weighing ≥ 700 grams who underwent transcatheter patent ductus arteriosus (PDA) closure with the Amplatzer Piccolo™ Occluder.Study DesignBetween June 2017 and February 2019, 200 children were enrolled in this U.S. study (NCT03055858). PDA closure, survival, and device- or procedure-related events were evaluated. A total of 156 of the available 182 patients (86%) completed the study.ResultsThe implant success rate was 95.5% (191/200). At 3 years, PDA closure was observed in 100% (33/33) of patients. Survival was >95% with 9 reported deaths. No deaths were adjudicated as device- or procedure-related. Notable events included aortic obstruction (2) requiring stent placement and tricuspid regurgitation (5), for which no interventions were required.ConclusionsThis follow-up study demonstrates high rates of PDA closure, low serious complication rates, and survival > 95% at 3 years. The Amplatzer Piccolo™ Occluder is a safe and effective therapy for PDA treatment in premature infants. ClinicalTrials.gov identifier: NCT0305585.

A Global Perspective on PDA Management in the Extremely Premature: Shifting Trend Toward Transcatheter Closure

Patent ductus arteriosus (PDA) is a frequently encountered defect in infants born extremely premature (≤26 weeks’ gestation). Historically, closure of the PDA was performed using cyclooxygenase inhibitor medications or by surgical ligations. However, the benefits of PDA closure using these therapies have never been demonstrated, albeit studies have previously not focused on the extremely premature infants. Therefore, there was a worldwide trend toward conservative management of the PDA. With improved survival of extremely premature infants, comorbidities associated with the PDA has increased, resulting in finding alternate treatments such as transcatheter patent ductus arteriosus closure (TCPC) for this population. Currently, there is a renewed interest toward selective treatment of the PDA in this high-risk cohort of small infants. This Comprehensive Review article inspects the globally changing trends in the management of the PDA in premature infants, with a special focus on the rising adoption of TCPC. Moreover, this article compiles data from several neonatal networks worldwide to help understand the problem at hand. Understanding the current management of premature infants and their outcomes is fundamentally essential if pediatric cardiologists are to offer TCPC as a viable therapeutic option for this population. This article aims to serve as a guide for pediatric cardiologists on this topic by compiling the results on landmark clinical trials on PDA management and the controversies that arise from these trials. Comparative outcomes from several countries are presented, including interpretations and opinions of the data from experts globally. This is a step toward coming to a global consensus in PDA management in premature infants.

Perioperative anesthetic management of premature neonates weighing less than 1500 grams undergoing transcatheter PDA (TC-PDA) closure: An institutional anesthetic experience

ObjectivesThe aim of our study is to describe the various anesthetic techniques and intraoperative management used during transcatheter closure of hemodynamically significant PDAs in VLBW premature infants weighing less than 1.5 kg and their potential impact on postoperative outcomes using a retrospective chart review. DesignA retrospective electronic medical chart review was performed in infants who underwent Transcatheter Patent Ductus Arteriosus (TC-PDA) closure at an academic institution between January 1, 2008 and October 4th 2019. Only premature patients with isolated PDA weighing less than 1500 g at the time of the procedure were included in the study. SettingSingle Institutional Hospital. ParticipantsPremature patients with isolated PDA weighing less than 1500 g at the time of the procedure. InterventionsNone. Measurements and main resultsInterprocedurally, there was no evidence of device embolization or clinically significant vascular obstruction on follow-up echocardiography, and inotropic or vasoactive infusions were not required. All patients survived and were discharged from the hospital after a mean of 86.4 ± 48.49 days (median 74, range 40–180) following initial admission to the NICU. At 7 post-operative days, freedom from ventilatory support reached 70% in all patients. Incidences of device embolization or clinically significant vascular obstruction were not noted on follow-up echocardiography. ConclusionsThough our preliminary findings show promising outcomes following TC-PDA closure relative to traditional surgical approaches, further investigations with higher patient volume are needed to validate these promising observations.

The Amplatzer duct occluder (ADOII) and Piccolo devices for patent ductus arteriosus closure: a large single institution series.

Evaluate Piccolo and ADOII devices for transcatheter patent ductus arteriosus (PDA) closure. Piccolo has smaller retention discs reducing risk of flow disturbance but residual leak and embolization risk may increase. Retrospective review of all patients undergoing PDA closure with an Amplatzer device between January 2008 and April 2022 in our institution. Data from the procedure and 6 months follow-up were collected. 762 patients, median age 2.6 years (range 0-46.7) years and median weight 13 kg (range 3.5-92) were referred for PDA closure. Overall, 758 (99.5%) had successful implantation: 296 (38.8%) with ADOII, 418 (54.8%) with Piccolo, and 44 (5.8%) with AVPII. The ADOII patients were smaller than the Piccolo patients (15.8 vs. 20.5 kg, p < 0.001) and with larger PDA diameters (2.3 vs. 1.9 mm, p < 0.001). Mean device diameter was similar for both groups. Closure rate at follow-up was similar for all devices ADOII 295/296 (99.6%), Piccolo 417/418 (99.7%), and AVPII 44/44 (100%). Four intraprocedural embolizations occurred during the study time period: two ADOII and two Piccolo. Following retrieval the PDA was closed with an AVPII in two cases, ADOI in one case and with surgery in the fourth case. Mild stenosis of the left pulmonary artery (LPA) occurred in three patients with ADOII devices (1%) and one patient with Piccolo device (0.2%). Severe LPA stenosis occurred in one patient with ADOII (0.3%) and one with AVPII device (2.2%). ADOII and Piccolo are safe and effective for PDA closure with a tendency to less LPA stenosis with Piccolo. There were no cases of aortic coarctation related to a PDA device in this study.

Late aortic obstruction due to ductal vasoconstriction on pulmonic end after transcatheter patent ductus arteriosus closure in an extremely low-birth-weight infant.

Device-induced aortic obstruction is a known rare complication following transcatheter closure of patent ductus arteriosus in extremely low-birth-weight infants. Various mechanisms have been proposed. We report the first description of late aortic obstruction due to ductal vasoconstriction on pulmonic end causing device to be gradually pushed out of aortic end in a 980-gram premature infant.

Transcatheter Closure of Patent Ductus Arteriosus in infants between 2-10 kg

Objective: The aim of this study was to present our experiences on transcatheter patent ductus arteriosus (PDA) closure with different devices, mostly the Amplatzer Piccolo Occluder, in infants weighing between 2-10 kg. Material and Methods: In this study, the files of 31 patients who underwent transcatheter PDA closure between December 2019 and August 2022 were reviewed retrospectively. Results: Transcatheter PDA closure was performed on 31(14 female) infants weighing between 2-10 kg. The mean age of patients was 10.7±6.7 months (2-28), and the mean weight was 6.6±2 kg (3-9.9). The median narrowest diameter of the ductus was 2.2 mm (IQR 2-3) and the median ductus length was 6 mm (IQR 4.75-8). The procedural success rate of all interventional procedures was 88% (30 of 34). Complications occurred in a total of four patients including failure of device implantation in one patient, post-procedural device embolization in 2 patients, and the significant residual shunt in one patient. None of the patients required surgery. In 34 interventional procedures, 3 of which were reintervention, 34 devices were used. Twenty-seven (79%) of them were Amplatzer Piccolo Occluder. The median fluoroscopy and procedural times were 10.5 minutes (IQR 7.25-18.5) and 40 minutes (IQR 35-57.5) respectively. The mean duration of follow-up was 10.3±8.8 months (1-32 months). Conclusion: In our experience, transcatheter treatment of PDA with the Amplatzer Piccolo Occluder device which was our first choice for appropriate duct anatomy and size in infants weighing between 2-10 kg, is safe and effective.

Changes in left ventricular systolic function after transcatheter patent ductus arteriosus closure in premature infants.

Changes in left ventricular (LV) systolic function have not been well described in premature neonates after transcatheter patent ductus arteriosus (PDA) closure. We retrospectively identified all premature neonates < 3 kg who underwent a transcatheter PDA closure at our center between January 1 2015 and January 31, 2021. LV indices before and after closure were extracted and an analysis was performed. Overall, 23 neonates were included with a mean procedural weight of 1894 ± 622 g. At 24 h after closure, the median left ventricular ejection fraction (LVEF) (66% interquartile range [IQR] 12% vs. 61% IQR 12, P< 0.001) and median LV end-diastolic dimension z-score (3.3 IQR 1.8 vs. 1.4 IQR 2.6, P < 0.001) both decreased and 5 (22%) neonates had an LVEF <55%. Patients who had an LVEF <55% at 24 h had a higher preprocedure LV end-diastolic dimension z-score (4.2 IQR 1.2 vs. 2.8 IQR 1.6, P = 0.01), a higher preprocedure LV end-diastolic volume (19 mL IQR 4 mL vs. 11 mL IQR 11, P = 0.03), a higher birth weight (940 g IQR 100 g vs. 760 g IQR 140, P = 0.04), and were more likely to receive intravenous calcium during the procedure (60% vs. 11%, P = 0.04) compared to those with an LVEF ≥55% at 24 h after closure. Of those with LVEF <55% at 24 h, all normalized before discharge. In preterm neonates who underwent successful transcatheter PDA closure, 23% developed abnormal LVEF after closure and those with significant LV dilation before the procedure were at increased risk for the development of LVEF <55% after closure.

Off-label use of KONAR-MF™ occluder for transcatheter closure of patent ductus arteriosus in unusual circumstances.

Transcatheter patent ductus arteriosus (PDA) closure with unusual morphology associated with multiple constrictions or unusual circumstances such as interruption of inferior vena cava (IVC) is still challenging. This study evaluates the use of KONAR-MF™ (Lifetech Scientific Co Ltd., Shenzhen) for transcatheter closure of PDA in such situations. Between January 2021 and October 2021, 24 patients from three different tertiary care centers underwent PDA device closure using the KONAR-MF™ device and are included in the study. Patient demographics, echocardiographic assessment, procedural details including the approach, device details, complications, and follow-up data were recorded. The median age and weight of the cohort were 2 years (0.5-41) and 10 kg (5-98), respectively. The indications for using KONAR-MF™ were (a) unusual morphology of PDA in 14, long tubular PDA in 8, and long tubular with multiple constrictions in 6 patients and (b) unusual circumstances such as interrupted IVC in 6 and inability to cross PDA antegradely in 4 due to dilated main pulmonary artery. The procedure was successful in all the patients and no procedure-related complications were noted in this cohort. Median follow-up of 9 months (range: 5-18) showed no residual shunt and only one patient had flow acceleration across the left pulmonary artery (peak Doppler gradient 16 mmHg). KONAR-MF™ device can be used safely and effectively for transcatheter closure of PDA with unusual anatomy or in unusual circumstances.

Echocardiography Versus Angiography for Guiding Device Selection for Transcatheter Patent Ductus Arteriosus Closure Among children

Echocardiography Versus Angiography for Guiding Device Selection for Transcatheter Patent Ductus Arteriosus Closure Among children

An infant with congenital heart defects and proteinuria: a case report

BackgroundBranchio-Oto-Renal (BOR) Syndrome is a rare autosomal disorder with a wide variety of clinical manifestations and a high degree of heterogeneity. Typical clinical manifestations of BOR syndrome include deafness, preauricular fistula, abnormal gill slits, and renal malformations. However, atypical phenotypes such as congenital hip dysplasia, congenital heart anomaly or facial nerve paresis are rare in BOR syndrome, and this might be easily misdiagnosed with other congenital disorders.Case presentationWe report a 5-month-old boy of BOR syndrome with "congenital heart defects and proteinuria" as clinical features. Initially, as this case mainly presented with symptoms of recurrent respiratory infections and was found to be with congenital heart disease and proteinuria at the local hospital, but he only was diagnosed with congenital heart disease combined with pulmonary infection and anti-infective and supportive treatment was given. Subsequently, during the physical examination at our hospital, left side preauricular pit and branchial fistulae on the right neck were found. Subsequent evaluation of auditory brainstem response and distortion product otoacoustic emission were revealed sensorineural hearing impairment. Results of renal ultrasonography showed small kidneys. Genetic analysis revealed a microdeletion at chromosome 8q13.2-q13.3 encompassing EYA1 gene, this patient was finally diagnosed with BOR syndrome. Then, this patient received transcatheter patent ductus arteriosus closure and hearing aid treatment. Proteinuria, renal function and hearing ability are monitoring by nephrologist and otologist. The patient is currently being followed up until 3 months after discharge and his condition is stable.ConclusionCareful physical examination, detailed history and the implementation of diagnostic laboratory tests can reduce the incidence of misdiagnosis. Genetic sequencing analysis of patients is a key guide to the differential diagnosis of BOR syndrome.

Radiation Dose Exposure to Patients During Transcatheter Patent Ductus Arteriosus Closure via the Arterial Route

Objective This study aims to evaluate the radiation dose for transcatheter patent ductus arteriosus (PDA) viathe arterial route and compare it with previously published benchmarks. Background Exposure to radiation in the catheterization lab can cause skin injury and cancer in the long run, especially in pediatric patients with complex heart conditions, which necessitate serial catheterizations. Therefore, measuring the patient radiation dose and establishing a benchmark for each cardiac interventional procedure is essential. Material and methods In this prospective study, 34 patients with transcatheter patent ductus arteriosus closure via an arterial route were included. Patients who had silent PDAs, no left heart dilatation and PDA size of less than 2mm had PDA closed via an arterial route. All the study group patients received an Amplatzer duct occluder II-additional size device (St. Jude Medical Corp, St. Paul, MN) using biplane flat-panel fluoroscopy equipment adjusted in accordance with the pediatric parameters. Patients' dose area product, air kerma and fluoroscopytime were recorded in the catheterization lab and finally compared with internationally published reference data. Results Of 73 patients who had transcatheter patent ductus arteriosus closure between April 2021 to December 2021, 34patients who had a PDA closure via an arterial route were enrolled. The median age and weight were 11.5 (4-168) months and 10.5 (6-31) kg. Twenty-one (61.8%) were males, and 13 (38.2%) were males. The median radiation dose parameters were as follows: air kerma 11 (3-42) milliGray, dose area product 131 (33-443) microGray per m2, median dose area product indexed to weight 12 (1-48) microGray m2 per kg, fluoroscopy time 2 (2-4) min and frame rate 15 (7.5-15) frames per second. Due to many factors, our radiation dose parameters were less than internationally published reference values for transcatheter PDA closure. Conclusion Patient selection, detailed pre-catheterization echocardiography and procedure planning are essential for accomplishing device closure of PDA with a significant reduction in radiation dose. Hemodynamic assessment in the catheterization lab is unnecessary for most PDA patients. Additionally, a next-generation imaging platform equipped with flat-panel detectors and adjusted for pediatric settings and a fluoro recording option can be used to reduce radiation exposure.

Two stenoses for a shunt: A rare complication after transcatheter patent ductus arteriosus closure

Two stenoses for a shunt: A rare complication after transcatheter patent ductus arteriosus closure

Transcatheter closure of persistent ductus arteriosus in 2 to 6 kg infants: Preliminary results from an international, retrospective study

Transcatheter patent ductus arteriosus (PDA) closure has proved to be safe in < 2 kg preterm infants, but major safety concerns remain when applied to the 2 to 6 kg body weight range. The aim of the present work is to assess efficacy and safety of transcatheter PDA occlusion in low-body-weight infants. Patients weighing 2 to 6 kg who underwent attempted transcatheter closure of an isolated PDA in 10 tertiary pediatric cardiology units (5 countries, 2000 to 2022) were retrospectively analyzed to review the outcome. A total of 339 infants (m/f sex ratio: 0.53; 56% ex-preterm, median age: 5.3 months [9 days–41 months], median weight: 4.7 kg [2 kg–6 kg]) were analyzed. Patients were all symptomatic (respiratory support: 33.2%, hospitalization for heart failure: 49.6%, nutrition care: 45.7%) with a hemodynamically significant PDA. Ductus was large (minimal ductal diameter: 4.2 ± 1.6 mm) and mainly conical (Krichenko type A: 57%) or tubular (Krichenko type C: 23%). Procedure was performed under both fluoroscopy (fluoro time: 10.7 ± 7.3 min) and transthoracic echocardiography guidance in all patients, with both arterial and venous femoral access (90%). Successful device implantation and complete PDA occlusion was achieved in 320 (94.4%) patients using devices in 91% (mainly ADO-I: 43.1%, ADO-IIAS: 20.0%, AVP-II: 8.0%, ODO: 5.3%, ADO-II: 3.5%, MFO: 2.1%, AVP-IV: 0.9%) vs. coils in 9%. Moderate to major complications occurred in 27 (8.0%) patients, including one death (0.3%) after delayed device embolization to descending aorta, device embolization (5.3%) and device-related obstruction of the left pulmonary artery (1.5%) or of the aorta (0.3%). These are preliminary data from a wider international study. We plan to collect both surgical and transcatheter cases in a wider series (40 tertiary centers, 20 countries), i.e. the largest cohort to date. This will allow better delineation of risk stratification, to keep refining indications for device closure in low-body-weight infants and achieve ever-safer results.