<scp>S</scp>ingle‐center experience in percutaneous closure of arterial duct with <scp>A</scp>mplatzer duct Occluder II additional sizes

Mahmoud, Heba Talat; Santoro, Giuseppe; Gaio, Gianpiero; D'Aiello, F A; Capogrosso, Cristina; Palladino, Maria Teresa; Russo, Maria Giovanna

doi:10.1002/ccd.26860

Cited by 10 publications

(15 citation statements)

References 23 publications

(45 reference statements)

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“…Four patients experienced events adjudicated by the CEC as a major complication. The implant success rate and closure rate observed in this study are similar to those derived from a literature review (Table 5) involving patient‐level data from 277 patients reported in ten peer reviewed manuscripts 26‐35 from medical centers in Italy, Ireland, United Kingdom, Turkey, Spain, France and Israel, receiving the ADO II AS (95.3% for patients ≤2 kg, 93.2% for patients 2–6 kg, and 100% for patients >2 kg). FDA approval of the Amplatzer Piccolo Occluder was obtained on January 11, 2019.…”

Section: Discussionsupporting

confidence: 81%

“…The relatively small sample size of 50 patients for the IDE was justified on the basis that ADO II AS was a line extension to the first and second generations of Amplatzer Duct Occluders and that the device has been used extensively outside the United States since 2011. Additionally, a body of published clinical experience with the device from outside the United States 26‐35 . provided reasonable assurance that the device had acceptable procedural safety and effectiveness in a real‐world setting, including in infants <2 kg.…”

Section: Discussionmentioning

confidence: 99%

“…Only the sizes used are reported, the 03-06 size was not used. Patient-level data from 277 patients receiving ADO II AS in 10 European medical centers[26][27][28][29][30][31][32][33][34][35] Data presented as mean ± SD, range [minimum, maximum] for continuous variables or number of patients (percentage) for binary variables.…”

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confidence: 99%

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Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams

Sathanandam

Gutfinger

O’Brien

et al. 2020

Cathet Cardio Intervent

111

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Objectives: Characterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure. Background: The presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature. Methods: This was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ≥700 g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ≤2 kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6 months' follow-up. Results: The implant success rate was 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ≤2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ≥700 g. Conclusions: This study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier:

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 99%

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Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams

Sathanandam

Gutfinger

O’Brien

et al. 2020

Cathet Cardio Intervent

111

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“…Now, 50 years and countless innovations after Porstmann's pioneering work, transcatheter PDA closure remains at the frontier of our field, as illustrated by the concentration of studies related to this topic in the current and recent issues of Catheterization and Cardiovascular Interventions , as well as elsewhere . In this issue, there are four articles focused on transcatheter PDA closure with recently approved, unapproved but dedicated, or off‐label devices, which shine a spotlight on one of the most promising and challenging frontiers in congenital interventional cardiology, percutaneous anatomical intervention in small and preterm infants .…”

mentioning

confidence: 99%

“…Another article in this issue describes a relatively large single‐center experience with PDA closure using the Amplatzer Duct Occluder II Additional Sizes device (ADOII‐AS) , which was developed with an eye toward PDA occlusion in neonates and small infants . Although only a handful of patients in the Mahmoud series could be considered “small,” and none were <3 kg, prior studies with this device have demonstrated successful PDA closure in a number of preterm infants under 2 kg using the ADOII‐AS .…”

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confidence: 99%

Small and preterm infants: The shrinking frontier of transcatheter patent ductus arteriosus closure

McElhinney

2017

Cathet Cardio Intervent

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Transcatheter Closure of Arterial Duct in Infants < 6 kg: Amplatzer Duct Occluder Type I vs Amplatzer Duct Occluder II Additional Sizes

Santoro¹,

Giordano²,

Gaio³

et al. 2018

Pediatr Cardiol

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Transcatheter closure of arterial duct (AD) remains challenging in low-weight patients and using Amplatzer Duct Occluder devices is still considered off-label in infants < 6 kg. This study aimed to report a large, single-center experience of percutaneous AD closure in infants < 6 kg as well as to compare the most frequently used devices, Amplatzer Duct Occluder type I (ADO I) and Amplatzer Duct Occluder type II Additional Sizes devices (ADO II-AS) (St. Jude Medical Corp, St. Paul, MN, USA). From March 2000 to March 2017, among the 762 patients submitted to percutaneous closure of AD at our Institution, 33 were infants < 6 kg (age 4.8 ± 2.1 months; weight 5.0 ± 0.9 kg). Fourteen patients (45%) underwent ADO I (Group I) and 19 patients ADO II-AS (Group II) device implantation. AD diameter was 2.6 ± 0.8 (range 1.5-4.0) mm resulting in QP/QS of 2.6 ± 0.0.9 (range 1.1-4.5). Successful device deployment was achieved in all patients without procedural morbidity or mortality. Procedural and fluoroscopy times were not significantly different between the groups. However, total X-ray absorbed dose was significantly higher in Group I (121 ± 69 vs 29 ± 16 mGy/cm, p < 0.01). Immediate, 24 h, and mid-term (46 ± 37 months, median 39) complete occlusion were recorded in 72.7, 90.9, and 97% of patients, respectively without significant difference between the groups. In conclusion, transcatheter closure of AD with Amplatzer Duct Occluder devices is feasible, safe, and effective also in infants less than 6 kg, without significant difference between the most commonly used devices, namely, ADO I and ADO II-AS.

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Single‐center experience in percutaneous closure of arterial duct with Amplatzer duct Occluder II additional sizes

Abstract: In our experience, trans-catheter closure of AD of different sizes and morphologies using ADO II-AS is highly feasible, safe and effective also in challenging anatomic/clinical settings. © 2016 Wiley Periodicals, Inc.

Cited by 10 publications

References 23 publications

Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams

Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams

Small and preterm infants: The shrinking frontier of transcatheter patent ductus arteriosus closure

Transcatheter Closure of Arterial Duct in Infants < 6 kg: Amplatzer Duct Occluder Type I vs Amplatzer Duct Occluder II Additional Sizes

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