The transseptal puncture experience: Safety insights from FDA MAUDE database

Morcos, Ramez; Megaly, Michael; Desai, Anand; Alkouli, Mohamed; Saad, Marwan; Luna, Michael; García, Santiago; Khalili, Houman; Maini, Brijeshwar

doi:10.1002/ccd.29746

Cited by 2 publications

(2 citation statements)

References 11 publications

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“…Cardiac tamponade is the most common life-threatening complication of transseptal puncture. In the meta-analysis published in 2021, pericardial tamponade was found to have a frequency of 23.4% 11 . In studies on atrial septal Interventions with HLHS patients, life-threatening complication rates were reported as 10% and 8.9%, which parallels our patient population and results 2,12 .…”

Section: Discussionmentioning

confidence: 99%

Transseptal Puncture in Children Weighing Less Than 20 kg in Invasive Cardiac Catheterization and Electrophysiology

Maze,

Bekir,

Candas

et al. 2024

Preprint

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Introduction: Transseptal puncture (TSP) is a widely utilized technique for left-sided electrophysiological studies (EPS), interventions in left heart lesions, or creating interatrial shunts in congenital heart diseases (CHD). This study aims to evaluate the outcome of TSP in children under 20 kg. Methods: This retrospective study analyzed TSP procedures in infants and children <20 kg between December 2015 and December 2021. TSPs were performed with a biplane angiography system in the catheter angiography laboratory. A Brockenbrough needle (BRK Transseptal Needle; Abbott/St.Jude Medical, Inc) was used for TSP. In patients whose Brockenbrough needles could not achieve sufficient patency, TSP was performed by applying cautery energy over the Brockenbrough needle. Results: Twenty-one patients were studied (8 females, median age 2.6 years, median weight 12 kg), and 66% required TSP for CHD, including HLHS and pulmonary hypertension. The CHD group had younger patients (median age: 6.6 months) with smaller weights (median: 5.7 kg) compared to the catheter ablation group. TSP success rate was lower in patients with CHD, especially those with complex anatomy. Radiofrequency energy was used without complications in three cases when traditional methods failed. In four patients, the septum couldn't be traversed. The median weight of the patients who failed TSP was 3,4 kg. The only major complication was pericardial tamponade developed in two patients diagnosed with hypoplastic left heart syndrome. Conclusion: TSP is a safe option when carefully selected but carries higher risks in complex CHD with abnormal cardiac anatomy compared to patients with normal anatomy used for electrophysiology procedures.

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Section: Discussionmentioning

confidence: 99%

Transseptal Puncture in Children Weighing Less Than 20 kg in Invasive Cardiac Catheterization and Electrophysiology

Maze,

Bekir,

Candas

et al. 2024

Preprint

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“…From 336 articles, 21 that downloaded MAUDE data files were set aside for further analysis 11–31 . Upon manual review, 135 articles with unclear queries 32–164 and 120 with incomplete queries 165–284 were excluded. Ultimately, 60 executable queries were found 5,10,285–342 .…”

Section: Methodsmentioning

confidence: 99%

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Li,

Feng,

Gong

et al. 2024

J Patient Saf

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Objective This article aims to assess the reproducibility of Manufacturer and User Facility Device Experience (MAUDE) data-driven studies by analyzing the data queries used in their research processes. Methods Studies using MAUDE data were sourced from PubMed by searching for “MAUDE” or “Manufacturer and User Facility Device Experience” in titles or abstracts. We manually chose articles with executable queries. The reproducibility of each query was assessed by replicating it in the MAUDE Application Programming Interface. The reproducibility of a query is determined by a reproducibility coefficient that ranges from 0.95 to 1.05. This coefficient is calculated by comparing the number of medical device reports (MDRs) returned by the reproduced queries to the number of reported MDRs in the original studies. We also computed the reproducibility ratio, which is the fraction of reproducible queries in subgroups divided by the query complexity, the device category, and the presence of a data processing flow. Results As of August 8, 2022, we identified 523 articles from which 336 contained queries, and 60 of these were executable. Among these, 14 queries were reproducible. Queries using a single field like product code, product class, or brand name showed higher reproducibility (50%, 33.3%, 31.3%) compared with other fields (8.3%, P = 0.037). Single-category device queries exhibited a higher reproducibility ratio than multicategory ones, but without statistical significance (27.1% versus 8.3%, P = 0.321). Studies including a data processing flow had a higher reproducibility ratio than those without, although this difference was not statistically significant (42.9% versus 17.4%, P = 0.107). Conclusions Our findings indicate that the reproducibility of queries in MAUDE data-driven studies is limited. Enhancing this requires the development of more effective MAUDE data query strategies and improved application programming interfaces.

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The transseptal puncture experience: Safety insights from FDA MAUDE database

Cited by 2 publications

References 11 publications

Transseptal Puncture in Children Weighing Less Than 20 kg in Invasive Cardiac Catheterization and Electrophysiology

Transseptal Puncture in Children Weighing Less Than 20 kg in Invasive Cardiac Catheterization and Electrophysiology

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

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