Comment On - Piccolo Device for Treating Patent Ductus Arteriosus Beyond Premature Newborn Patients - A Novel Experience in South America: A Retrospective Study

Q: What study design limitations are discussed regarding the Piccolo device paper?

The letter highlights that the research is retrospective and conducted at a single center, which limits external validity and may introduce selection bias. It also notes a small sample size that restricts statistical power.

Q: How does the letter compare follow-up and statistical robustness with other studies?

The letter argues that limited and variable follow-up (about 8 months) may underestimate late complications. It contrasts this with prospective, multicenter trials and longer structured follow-up approaches.

Q: What improvements does the letter recommend for future research?

Future work should use prospective multicenter designs with larger cohorts and uniform follow-up protocols. The letter also calls for subgroup analyses (e.g., weight-based groups) and discussion of the operator’s learning curve.

Sep 29, 2026

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Letter to the editor comments on a retrospective research paper evaluating the Piccolo device for treating Patent Ductus Arteriosus beyond the neonatal period. The authors support the reported efficacy and safety, but highlight methodological limitations affecting generalizability, including single-center retrospective design, selection bias, small sample size, limited or variable follow-up, and absence of subgroup analyses. They also note that the operator’s learning curve may influence outcomes and recommend future prospective multicenter studies with larger cohorts and uniform follow-up protocols.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages2

Reading Time5 min

AccessFree to download

Letter to the Editor

Comment On

Received and Accepted Dates

Methodological Limitations and Comparisons

Future Study Recommendations

Author Contributions

Ethics and Consent

Conflicts of Interest and AI Declaration

Data Availability and Transparency Statement

References

Health Science Reports LETTER TO THE EDITOR Comment On: Piccolo Device for Treating Patent Ductus Arteriosus Beyond Premature Newborn Patients, a Novel Experience in South America: A Retrospective Study Asad Ali | Rayyan Ahmad Zaka Department of Medicine, Sheikh Khalifa Bin Zayed Al Nayhan Medical and Dental College, Lahore, Punjab, Pakistan Correspondence: Asad Ali ([asadaali5324@gmail.com](asadaali5324@gmail.com); [fayyazras799@gmail.com](fayyazras799@gmail.com)) Received: 7 July 2025 | Accepted: 25 November 2025 To the editor, We read with great interest the research paper by Aristizabalet al. [1] on the treatment of Patent Ductus Arteriosus (PDA) using the Piccolo Device, which is a retrospective study. We would like to applaud Aristizabal et al for their efforts in highlighting this novel experience. This piece beautifully discusses the utility of the Piccolo device for treating PDA in patients beyond the neonatal phase, precisely demonstrating its efficacy and safety in older geriatric patients, without a significant increase in complications or mortality rates. While these findings provide valuable insights, several limitations, some of which are mentioned by the author, as well as others not mentioned, warrant discussion. We would like to highlight some key methodological limitations that may influence the generalizability of the results. The study employs a retrospective design in a single center, which limits its external validity and introduces potential selection bias. In contrast, Sathanadam et al. [2] conducted a prospective, multicenter trial enrolling 200 patients across nine centers, ensuring broader applicability. The small sample size (n = 29) in the study under discussion restricts statistical power, particularly in detecting rare follow‐ up complications. In contrast, Morray et al. [3] addressed this by enrolling 200 patients across three centers, thereby improving both statistical validity and representativeness. Moreover, limited and variable follow‐up (mean, 8 months) may underestimate the incidence of late complications. In comparison, Morray et al. [3] conducted a structured 3‐year follow‐up to assess residual shuntsand adverse events carefully. The discussion compares the results to those of extensive multicentre studies and concludes that they are comparable or equally effective. Future studies should aim for prospective multi‐center designs with larger cohorts and uniform follow‐up protocols, as seen in Baspinar et al. [4] . Outcomes were discussed as a whole. Still, no subgroup analysis was conducted (i.e., > 2 kg vs. < 2 kg), as in Sathanandam et al. [2], because the two groups may vary in terms of complications and results. Sub‐group comparisons should be encouraged in future studies. The discussion overlooks the operator's learning curve, which may significantly impact the outcome, particularly in a single‐center study. An operator's skill and device familiarity can influence the results, as evidenced in past studies [5]; thus, a brief note should have discussed this. We appreciate the author's effort and hope our comments added value to the discussion. Author Contributions Asad Ali: conceptualization, methodology, writing – review and editing, writing – original draft, project administration, supervision. Rayyan Ahmad Zaka: writing – review and editing, validation, writing – original draft. Acknowledgments The authors have nothing to report. Funding The authors received no specific funding for this work. | Author of “Piccolo Device for Treating Patent Ductus Arteriosus Beyond Premature Newborn Patients, a Novel Experience in South America: A Retrospective Study”offered no comments. | | --- | | This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
© 2026 The Author(s) . Health Science Reports published by W

FAQs

What study design limitations are discussed regarding the Piccolo device paper?

The letter highlights that the research is retrospective and conducted at a single center, which limits external validity and may introduce selection bias. It also notes a small sample size that restricts statistical power.

How does the letter compare follow-up and statistical robustness with other studies?

The letter argues that limited and variable follow-up (about 8 months) may underestimate late complications. It contrasts this with prospective, multicenter trials and longer structured follow-up approaches.

What improvements does the letter recommend for future research?

Future work should use prospective multicenter designs with larger cohorts and uniform follow-up protocols. The letter also calls for subgroup analyses (e.g., weight-based groups) and discussion of the operator’s learning curve.

Sep 29, 2026

Uploaded by Aran