Objective
The objective of this study was to compare safety and efficacy outcomes between external aortic clamping (EAC) and endo-aortic balloon occlusion (EABO) techniques in a large patient population using the STS Adult Cardiac Surgery Database.
Explore clinical evidence comparing intra-aortic balloon occlusion and external aortic clamping methods.
Results comparing IntraClude device vs. clamp in a retrospective propensity-matched analysis of a large, multicenter cohort of patients undergoing cardiac surgery1
Methods
A cohort was extracted from the STS database consisting of 7,978 patients who underwent isolated MIMVS (repair or replacement) with EAC or EABO after exclusion criteria (7/2017 to 12/2018); a total of 2,326 patients were 1:1 propensity score matched. Intra- and post-operative outcomes were compared using generalized linear modeling and negative binomial or logistic regression.
Results
Compared to the EAC group, the EABO group demonstrated significantly shorter cardiopulmonary bypass times (mean ± std. deviation: 125 ± 53 minutes vs. 134 ± 67 minutes, P = 0.0009) and postoperative length of stay (median (IQR): 4.00(3.00) days vs. 5.00(2.00) days, P < 0.0001). Effectiveness was similar between EABO and EAC, as measured by intraoperative outcomes and postoperative moderate/severe mitral regurgitation.
Conclusion
These results suggest that the endo-aortic balloon was similar to the external aortic clamp in most major outcomes and has potential for greater efficiencies in the operating room and improvements in patient recovery time.
EABO and EAC were associated with similar safety and effectiveness
Table 1: EABO and EAC were associated with similar safety and effectiveness
Endo-aortic balloon occlusion vs. external aortic clamping
A retrospective evaluation of endo-aortic balloon occlusion compared to external clamping in minimally invasive mitral valve surgery1
The authors compare outcomes of endo-aortic balloon occlusion (EABO) versus external aortic clamping (EAC) in patients undergoing minimally invasive mitral valve surgery (MIMVS) in the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database.
How do the costs and clinical outcomes of aortic occlusion methods compare?2
Real-world evidence shows similar hospitalization costs between endo-aortic balloon occlusion and external aortic clamping.
In an analysis of real-world hospital claims from the Premier Healthcare Database, endo-aortic balloon occlusion was associated with:
- similar hospitalization costs
- 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.
