Initial experience with a new right ventricular support device for beating heart surgery.

Objective: Device supported beating heart surgery has been advocated to extend patient selection criteria for off-pump surgery. This article reports the initial experimental and clinical results with a novel paracardial right ventricular support device.

Methods: Preclinical experiments were performed in two pigs. Ten elective patients with triple vessel disease were subjected to beating heart coronary artery bypass grafting surgery during right ventricular support by the paracardial device. Measurements included intraoperative hemodynamics during cardiac tilting, perioperative left ventricular ejection fraction (LVEF), hemolysis parameters, mortality and major morbidity events.

Results: A mean of 3.2 +/- 0.2 distal anastomoses per patient were performed. Mean arterial pressure and central venous oxygen saturation remained stable during cardiac tilting. Perioperative LVEF did not vary significantly. Sixty-day mortality and postoperative infarction rate were 0%. Functional Canadian Cardiovascular Society class at 6 days after surgery was 1.2 +/- 0.1 vs. 3.3 +/- 0.2 pre-operatively.

Conclusion: In this initial clinical experience, application of the novel paracardial right ventricular support device proved to be safe and efficient.