Clinical Research & Data, Cardiomyopathy, Surgical Applications
EACTS 2023 Alexander Bernhardt: Perioperative Use of Impella® Heart Pump in Cardiac Surgery
Alexander Bernhardt, M.D., discusses the use of Impella® pumps in cardiac surgery, primarily mitral and aortic valve surgery and coronary procedures. He explains that Impella devices can be used preoperatively to optimize patients before an intervention, and it can be used intraoperatively as well as postoperatively if a patient experiences difficulties during the weaning process from cardiopulmonary bypass. Dr. Bernhardt is a cardiac surgeon at the University Heart and Vascular Center in Hamburg, Germany.
“The system allows us to optimize patients prior to cardiac procedures,” Dr. Bernhardt emphasizes, as he presents a case to illustrate preoperative Impella use. In this case Impella 5.5® was used for 10 days to bridge a patient to a MitraClipTM* procedure. The patient was able to undergo the procedure with improved pulmonary and end-organ function.
“We can also treat postcardiotomy failure,” he states, as he presents a patient with deteriorated aortic valve function and an ejection fraction (EF) of 25%. The patient couldn't be weaned from cardiopulmonary bypass, so the surgeons inserted an Impella 5.5. The patient has been extubated after 4 hours, fully mobilized on POD 1, and Impella was removed on POD 8.
Dr. Bernhardt presents data supporting the use of early, rather than delayed, Impella insertion. This data shows that survival after CABG is much better in patients with simulataneous Impella insertion in the OR compared to patients in the delayed Impella insertion group.
After a brief discussion of Impella protected off-pump coronary artery bypass (OPCAB) surgery—in which he reports 100% complete revascularization and 100% in-hospital and mid-term survival in 9 patients—Dr. Bernhardt turns his focus to the IMPACT trial (Impella Protected Cardiac Surgery Trial). The IMPACT trial, being conducted in the EU as well as US, is a single-arm, postmarket clinical follow-up study in which eligible patients are treated with the Impella 5.5® with SmartAssist® pump before going off bypass. The objective of the study is to collect data on the safety and effectiveness of Impella 5.5 in improving functional status and quality of life in high-risk cardiac surgery patients with severe LV dysfunction.
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