Viola clampless anastomosis device, First Clinical Study

Objective

This study evaluates a novel device for clampless proximal anastomosis in coronary artery bypass grafting to reduce air emboli , minimize bleeding m and lower the risk of neurological events, therapy enhancing patient safety and surgical outcomes.

Methods

Fifteen adult male patients (mean age 61.1 years) without prior neurological events underwent on-pump CABG, following ethical approval and informed consent. The radial artery and saphenous vein were used as conduits. Epi-aortic ultrasound assessed the ascending aorta.

For proximal anastomosis, a 14-18 gauge needle created an initial hole for Viola sheath insertion. The Viola device`s 4 mm punch then made a circular hole for conventional anastomosis. Flow was measured with a flow meter. Follow-ups were at two weeks, six weeks, and six months post-surgery.

Results

The Viola device demonstrated good results in 15 patients. It was used 23 times for proximal anastomosis. Radial arteries were utilized in 8 cases, while saphenous vein were used in all 15 cases. Intraoperative outcomes showed minimal bleeding. The blower was used in three (out of 15) during venous anastomosis and only once (out of 8) during arterial anastomosis. The mean anastomosis time was 10.7 ± 3.1 minutes, with no significant trauma to the aorta and no thrombus formation. Flow measurements were 50.07 ± 30.52 ml/min in veins and 46.88 ± 14.0 ml/min in arteries.

Postoperatively ,All patients discharged in good condition, without MACCE during their hospital stay .Follow-ups were performed on all patients at 2 ,6 weeks and six months after surgery, and all were feels well, without any cardiovascular or neurological complications

Conclusion

In this small post marketing clinical study, the Viola device was found to be effective and safe. The minimal use of blower and the minimal bleeding suggest a potential clinical advantages as compared to other available clamp-less proximal devices