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Intraclude Device: How to Predict the Balloon Volume Inflation from Previous Experience Analysis
Monica Contino1, Massimo Giovanni Lemma1, Claudia Romagnoni1, Andrea Mangini1, Antonietta Delle Fave1, Simone Colombo1, Carlo Antona2.
1Ospedale Luigi Sacco, Milan, Italy, 2Università degli Studi di Milano, Milan, Italy.
OBJECTIVE: The heart-port procedure is performed using the endo-balloon for aortic cross-clamping. The new IntraClude® Edwards is featured by a new design of both catheter and balloon, resulting in an easier clamping technique. A balloon filling strategy based on an initial volume of 10 ml of saline, followed by additional injections of 2 ml up to complete aortic occlusion, is suggested by the producer. We report a simpler and faster filling procedure based on a relationship between balloon pressure and volume and the size of ascending aorta.
METHODS: From August 2012 to November 2015, 33 patients (20 male) underwent minimally invasive valve surgery with the use of Intraclude (22 repair, 11 replacement, 2 redo); mean age was 58±9,2 years. All these patients have been selected basing on the analysis of a pre-operative thoracic and abdominal CT scan performed to analyze aortic course and diameters. During the first four surgeries we observed that the aortic occlusion was complete and stable when the balloon pressure was kept between 300 and 350 mmHg; an additional 2 ml volume was injected whenever this value get closed to 300 mmHg. We analysed the final balloon volume and the aortic diameter of each patient within a balloon pressure between 300 and 350 mmHg.
RESULTS: Mean ascending aorta diameter was 31,45±2,12 mm, mean cross-clamping time 120,73±41,01 minutes, mean saline volume inflated 27,73±4,24 ml, mean balloon pressures 340,94±53,74 mmHg.
There is a significant relationship between ascending aorta diameter and total balloon inflation volume calculated by linear regression:
Inflation volume=1,54*ascending aorta diameter-20,81.
The Pearson Product Moment Correlation showed an R=0.84 (p<0.001), R2=0.7 with an adjusted R2=0.69 and a Standard Error of Estimate=4.06
CONCLUSIONS: The presence of a relationship well correlating ascending aorta dimensions and the saline volume necessary to reach an effective aortic cross clamp is important to guarantee a stable occlusion throughout the operation. Additional saline volume can be required in order to keep the balloon pressure between the 300 and 350 mmHg. 
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