Getinge Announces Results of Study of Contemporary Practice Showing Larger Volume Intra-Aortic Balloon Effective as First-Line Therapy in Patients with Cardiogenic Shock
Data Shows Counterpulsation Therapy with 50cc Balloon Represents Safe, Clinically Effective, Cost-Conservative Strategy in Managing Critically Ill Cardiac Patients
WAYNE, N.J., May 3, 2017 /PRNewswire/ -- Getinge, a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences, today announced results from a study of contemporary practice demonstrating that intra-aortic balloon counterpulsation (IABC) appears effective as a first-line therapy for critically ill patients. The single-center, retrospective, observational study showed that use of the Company's newer large volume MEGA® 50cc intra-aortic balloon (IAB) in contemporary practice resulted in improved hemodynamic profiles, and was associated with a very low overall complication rate. The findings were published online in Catheterization and Cardiovascular Interventions, a publication of the Society for Cardiovascular Angiography and Interventions (SCAI). IAB catheters are circulatory assist devices that are inserted into the aorta and counterpulsate to help the heart pump blood in patients in need of cardiac support.
"Our results showed that counterpulsation therapy with a MEGA 50cc IAB improved hemodynamics with low complications in critically ill patients. These findings are notable because the patients we evaluated were sicker and had worse cardiac function than patients evaluated in prior studies, including the Benchmark registry and the IABP SHOCK II triali,ii,iii," said Marc Cohen, M.D., co-author of the published study and Chief of the Division of Cardiology at Newark Beth Israel Medical Center in Newark, N.J. "Additionally, the positive hemodynamic changes we observed with this larger volume balloon exceeded those seen in a separate study by Dr. Navin K. Kapur and colleagues at Tufts University School of Medicine, which compared a 50cc IAB with a 40cc IABiv."
Study Design and Results
Dr. Cohen, together with Dr. Gautam Visveswaran, Dr. David Baran and colleagues at Newark Beth Israel Medical Center, retrospectively analyzed demographic, clinical, laboratory and hemodynamic variables, adverse events and survival to discharge in 150 consecutive patients who received IABC with a 50cc IAB between 2011 and 2015. The majority of patients (100) needed IABC for management of cardiogenic shock; in this group, the average ejection fraction was 20 percent. The primary objective was to study the clinical outcomes and adverse events associated with the 50cc IAB in contemporary practice.
The results showed that 72.5 percent of patients survived to discharge. In the group with cardiogenic shock, the rate of survival to hospital discharge was 66 percent. Among the full study cohort, in-hospital mortality was 27.3 percent, and 94.7 percent of patients were free of any IAB device-related complications. Five patients (3.3 percent) experienced bleeding requiring blood transfusion, one patient (0.7 percent) experienced a major vascular complication, and three patients (2 percent) experienced a minor vascular complication. Laboratory and hemodynamic results showed that serum creatinine significantly improved (p<0.01), and diastolic augmented pressure increased (median +42 mmHg). Significant systolic unloading and diastolic unloading was observed, as were reductions in right atrial and pulmonary filling pressures, which occurred in parallel with significant increases in cardiac output, cardiac index and cardiac power output.
"The findings from this study add to the body of literature on improved hemodynamic benefits with the use of larger-volume IABs," said Pierluca Lombardi, M.D., Corporate Medical Officer, Getinge. "IABC is a safe, effective and more cost-effective option than newer-generation circulatory support devices. The effects of IABC with larger volume IABs result in more blood volume displacement in the aorta during the cardiac cycle. Customizing the size of the IAB to the specific anatomy of the patient maximizes the effects of IABC. The results of this study demonstrated a significant increase in diastolic augmentation, which increases coronary perfusion, and a decrease in end-diastolic and systolic pressures, which reduce the workload of the heart, in a very high-risk patient population."
About IABC Therapy
Based on extensive literature supporting the hemodynamic effects and safety and effectiveness of IABC, the U.S. Food and Drug Administration (FDA) has cleared balloon pumps for use in patients with acute coronary syndrome, patients undergoing cardiac and non-cardiac surgery, and patients experiencing complications of heart failure of both ischemic and non-ischemic etiologies.v The FDA clearance for these indications was based on results from a comprehensive literature review of IABC devices, which demonstrated low overall rates of complications despite the fact that patients in whom an IAB was implanted had more severe comorbidities and underlying illnesses than patients without a device. Additionally, the literature shows a trend toward fewer device-related complications over time, as balloon catheter sizes have decreased and procedural techniques have improved in recent years.
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i Ferguson JJ, Cohen M, Freedman RJ, et al. The current practice of intra-aortic balloon counterpulsation: Results from the benchmark registry. J Am Coll Cardiol. 2001;38:1456-1462.
ii Thiele H, Zeymer U, Neumann FJ, et al. Intra-aortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012;367:1287-1296.
iii Thiele H, Zeymer U, Neumann FJ, et al. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): Final 12 month results of a randomized, open-label trial. Lancet. 2013;382:1638-1645.
iv Kapur NK, Paruchuri V, Majithia A, et al. Hemodynamic effects of standard versus larger-capacity intra-aortic balloon counterpulsation pumps. J Invasive Cardiol. 2015;27:182-188.
v FDA Executive Summary https://www.federalregister.gov/documents/2013/12/30/2013-31218/cardiovascular-devices-reclassification-of-intra-aortic-balloon-and-control-systems-for-acute