Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane Oxygenation

Khalid, Nauman; Javed, Hasan; Ahmad, Sarah Aftab; Edelman, James; Shlofmitz, Evan; Chen, Yuefeng; Musallam, Anees; Rogers, Toby; Bernardo, Nelson L.; Waksman, Ron

doi:10.1016/j.carrev.2019.11.011

Cited by 14 publications

(4 citation statements)

References 17 publications

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“…As one of the core components of ECMO, a blood pump has a considerable impact on the therapeutic effect and development of ECMO. 3,4 Centrifugal pump delivers fluid through the centrifugal force generated by the high-speed rotation of the impeller with the ability to generate high flow at low pressure; patients can be conveniently transferred during extracorporeal life support (ECLS) owing to the small size of this pump. 5,6 Therefore, centrifugal pumps are conventionally used in recent years in clinics because of their simplicity and portability.…”

Section: Introductionmentioning

confidence: 99%

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Hemodynamic investigation of a novel rotary displacement blood pump for extracorporeal membrane oxygenation

Xue

Ren

Gao

et al. 2023

Numer Methods Biomed Eng

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Extracorporeal membrane oxygenation (ECMO) is a life support system used in the treatment of severe respiratory and circulatory failure. High shear stress caused by the high rotational speed of centrifugal blood pumps can cause hemolysis and platelet activation, which are among the major factors leading to the complications of the ECMO system. In this study, a novel blood pump named rotary displacement blood pump (RDBP), which can considerably reduce rotational speed and shear stress while ensuring the normal pressure flow relationship, was proposed. We employed computational fluid dynamics (CFD) analysis to investigate the performance of RDBP under adult ECMO support operating conditions (5 L/min with 350 mmHg). The efficiency and H‐Q curves of the RDBP were calculated to evaluate its hydraulic performance, and pressure, flow patterns, and shear stress distribution were analyzed to estimate the hemodynamic characteristics in the pump. In addition, the modified index of hemolysis (MIH) was calculated for the RDBP based on a Eulerian approach. The hydraulic efficiency of the RDBP was 47.28%. The velocity distribution of flow field in the pump was relatively uniform. Most of the liquid (more than 75%) in the pump was exposed to low scale shear stress (<1 Pa), which was close to normal physiological conditions. The gap area was the main distribution location of high scale shear stress. The high wall shear stress (>9 Pa) volume fraction of the RDBP was small and located in the boundary areas between the rotor's edge and the housing. The MIH value of the RDBP was 9.87 ± 0.93 (mean ± SD). The RDBP can achieve better hydraulic efficiency and hemodynamic performance at lower rotational speed. The design of this novel pump is expected to provide a new direction for developing a blood pump for ECMO.

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Section: Introductionmentioning

confidence: 99%

“…ECMO supports cardiac output and oxygenation through a blood pump to achieve circulating flow. As one of the core components of ECMO, a blood pump has a considerable impact on the therapeutic effect and development of ECMO 3,4 …”

Section: Introductionmentioning

confidence: 99%

Hemodynamic investigation of a novel rotary displacement blood pump for extracorporeal membrane oxygenation

Xue

Ren

Gao

et al. 2023

Numer Methods Biomed Eng

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“…Review of the FDA MAUDE database has also demonstrated the high rate of complications associated with ECMO (14). Reporting to the MAUDE database is mandatory for manufacturers, importers, and device user facilities but is voluntary for consumers, patients, and health care professionals.…”

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confidence: 99%

What to Do When Your Preferred Right Atrial Venovenous Cannula for Neonates Is Pulled From the Market: Choosing Between Scylla (Bicaval Venovenous) and Charybdis (Venoarterial)*

Gennaro

Brogan

2023

Pediatric Critical Care Medicine

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“…However, nosocomial infection remains one of the major complications associated with ECMO support. 2 Most patients who require ECMO often have infections initially and are more likely to develop nosocomial infections via indwelling cannulas, altered host immune function, urinary catheters, and endotracheal tubes. Microbial colonization of ECMO devices such as ECMO cannulas and oxygenators may cause bloodstream infections (BSIs).…”

mentioning

confidence: 99%

Microbial Colonization of Oxygenator and Clinical Outcomes in Extracorporeal Membrane Oxygenation

et al. 2021

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The importance of microbial colonization during extracorporeal membrane oxygenation (ECMO) is unclear. We prospectively cultured ECMO oxygenators and retrospectively reviewed the culture results, clinical outcomes, and associated factors in 112 ECMO patients (122 oxygenators, 1,196 ECMO days). Of the oxygenators, 11.6% (n = 13) had positive cultures. The most common pathogen was Klebsiella pneumoniae, followed by Acinetobacter baumannii and Staphylococcus epidermidis. Nine (69%) cases showed catheter colonization, and five (38%) bloodstream infection (BSI) with the same microorganism. Most of the microorganisms were multidrug resistant. BSI tended to be associated with oxygenator colonization (r = 0.172, p = 0.070). The patients were divided into oxygenator colonization (n = 13) and no colonization groups (n = 99). Successful weaning from ECMO and survival to discharge were significantly lower in the oxygenator colonization group (weaning 30.8% vs. 90.9%, p < 0.001, survival 23.1% vs. 76.8%; p < 0.001). In multivariate analyses, age (per decade) (odds ratio [OR] = 1.95, 95% CI = 1.28–2.95; p = 0.002), oxygenator colonization (OR = 15.49, 95% CI = 3.31–72.46; p < 0.001), and renal replacement therapy (OR = 4.61, 95% CI = 1.69–12.58; p = 0.003) were significantly associated with mortality. Oxygenator colonization was associated with poor outcomes in ECMO patients. These results support the early exchange and culture of oxygenators in patients with persisting bacteremia.

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Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane Oxygenation

Cited by 14 publications

References 17 publications

Hemodynamic investigation of a novel rotary displacement blood pump for extracorporeal membrane oxygenation

Hemodynamic investigation of a novel rotary displacement blood pump for extracorporeal membrane oxygenation

What to Do When Your Preferred Right Atrial Venovenous Cannula for Neonates Is Pulled From the Market: Choosing Between Scylla (Bicaval Venovenous) and Charybdis (Venoarterial)*

Microbial Colonization of Oxygenator and Clinical Outcomes in Extracorporeal Membrane Oxygenation

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