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Clinical insights on the IntraClude intra-aortic occlusion device

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Explore clinical evidence comparing intra-aortic balloon occlusion and external aortic clamping methods.

Real-world evidence comparing hospitalization cost and clinical outcomes evaluation between the endo-aortic balloon and external aortic clamp in cardiac surgery1

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Objective

The objective of this study was to validate the results of the STS Database study and evaluate costs associated with external aortic clamping (EAC) versus endo-aortic balloon occlusion (EABO) using the Premier Healthcare Database.

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Methods

A 3:1 propensity score- and exact-matched cohort of 1,663 EABO-eligible cardiac surgery cases (10/2015 to 03/2020) was extracted from the Premier database. The researchers examined cost outcomes and clinical outcomes using multivariable generalized linear models to detect differences between groups.

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Results

There was no statistically significant difference in total hospitalization costs between EABO versus EAC patient stays. Length of stay was significantly shorter for the EABO group (median (IQR): 6 (5-8) days vs. 7 (5-10) days, P < 0.0001). Rates of myocardial infarction and postcardiotomy syndrome were significantly lower in patients with EABO versus EAC, with no significant differences in any other clinical outcomes.

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Conclusion

This real-world evidence suggests that EABO has similar costs and clinical outcomes as the EAC.

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Premier Healthcare datatable
Premier Healthcare datatable

Table 1: Comparison of the Premier database to the STS database analysis

Hospitalization costs and clinical outcomes comparison

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Hospitalization costs
Hospitalization costs
Hospitalization costs

Cost and clinical outcomes evaluation between the endoaortic balloon and external aortic clamp in cardiac surgery1

The authors compare outcomes and hospital costs of endo-aortic balloon occlusion (EABO) versus external aortic clamping (EAC) in patients undergoing minimally invasive cardiac surgery in a large administrative database.

Endo-aortic balloon occlusion vs. external aortic clamping2

Endo-aortic balloon occlusion is associated with shorter bypass and length-of-stay times in MIS mitral surgery with similar safety and effectiveness.

In an analysis of the STS Adult Cardiac Surgery Database, endo-aortic balloon occlusion was associated with:

  • significantly shorter CPB and LOS
  • similar clinical outcomes

IntraClude intra-aortic occlusion device

The IntraClude device is an integrated system to occlude, arrest, and vent the heart in addition to monitoring aortic root pressure.

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intra-aortic occlusion
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References

  1. Balkhy HH, Grossi EA, Kiaii B, et. al Cost and Clinical Outcomes Evaluation Between the Endoaortic Balloon and External Aortic Clamp in Cardiac Surgery. Innovations (Phila). 2023;15569845231185311. doi: 10.1177/15569845231185311.
  2. Balkhy HH, Grossi EA, Kiaii B, et. al A Retrospective Evaluation of Endo-Aortic Balloon Occlusion Compared to External Clamping in Minimally Invasive Mitral Valve Surgery. Semin Thorac Cardiovasc Surg. 2023:S1043-0679(23)00040-0. doi: 10.1053/j.semtcvs.2022.11.016.
Important safety information

Important safety information

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events.