Promising Data from US Pilot Study Shows Planned Impella 5.5 Use is Safe and Feasible in Non-Shock, High-Risk Cardiac Surgery Patients
Chicago, IL – Johnson & Johnson announced results from a novel U.S. pilot single-arm trial that evaluated the safety and feasibility of planned Impella 5.5™ support in adult patients undergoing cardiac surgery in the setting of severe left ventricular dysfunction. IMPACT (IMpella Protected cArdiaC surgery Trial) data demonstrated favorable post-operative outcomes and low device-related event rates with planned Impella 5.5 support initiated prior to weaning patients from cardiopulmonary bypass. These results represent a promising device-supported therapeutic strategy for a high-risk cardiac surgery population that suffer significant morbidity and mortality. The evaluated use is investigational and not currently cleared or approved by the FDA.
Patients undergoing high‑risk cardiac surgery, particularly those with left ventricular ejection fraction (LVEF) ≤35%, may face substantial perioperative risks, including mortality, renal failure, stroke and postcardiotomy cardiogenic shock.1,2,3,4,5,6,7,8 In this high‑risk surgical cohort (N=100), IMPACT demonstrated safety and feasibility of planned Impella 5.5 use in non-shock cardiac surgery patients with severely reduced ventricular function.
The U.S. pilot trial, presented during the American Academy of Thoracic Surgery (AATS) Annual Meeting in Chicago, reflects Johnson & Johnson’s commitment to advancing the science of heart recovery and improving outcomes for acute and chronic heart failure patients.
“IMPACT was designed to evaluate whether a planned strategy of prophylactic Impella 5.5 support – initiated prior to separation from cardiopulmonary bypass – could be implemented safely and feasibly in high-risk cardiac surgery patients with severe left ventricular dysfunction who are particularly vulnerable to post-cardiotomy heart failure,” said Edward Soltesz, MD, MPH9, surgical director of the Kaufman Center for Heart Failure and Recovery at Cleveland Clinic and principal investigator of IMPACT. “These early positive findings support the feasibility of this approach and provide an important foundation for future studies focused on improving outcomes in this challenging patient population.”
The Impella 5.5 microaxial flow pump is recognized as a primary therapy of choice for postcardiotomy shock and low cardiac output syndrome, as described in the 2025 guidelines released by the European Association for CardioThoracic Surgery (EACTS), the Society of Thoracic Surgeons (STS) and AATS. Early use of temporary mechanical circulatory support is a Class I recommendation for patients with cardiogenic shock to improve survival and prevent organ damage.
In addition to the IMPACT pilot study, there are several ongoing research trials investigating the role that Impella heart pumps play in heart failure therapy including:
- INTeGRATE – a prospective, single arm, post-market study evaluating if Impella 5.5 support allows for the initiation and optimization of guideline-directed medical therapy in heart failure reduced ejection fraction (HFrEF) patients with decompensated heart failure and cardiogenic shock.
- PROTECT IV – a prospective randomized controlled trial of Impella support versus no Impella support in high-risk percutaneous coronary intervention (PCI) patients with complex coronary disease and reduced left ventricular ejection fraction.
- OASIS – a prospective, multicenter study evaluating the safety outcomes of patients with acute myocardial infarction with cardiogenic shock who receive Impella CP™ support during PCI. The study incorporates the use of Impella best practices, identified by the National Cardiogenic Shock Initiative, including Impella placement pre-PCI, identifying shock early and minimizing the use of inotropes.
“IMPACT results set the stage for future study of planned Impella 5.5 use in this complex high-risk patient population,”10 said Navin Kapur, MD, chief medical and scientific officer, Heart Recovery, MedTech, Johnson & Johnson. “We remain committed to leading the science that advances cardiovascular disease therapies and improves patient outcomes.”
About Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit www.heartrecovery.com and follow us on LinkedIn and @jjmt_heartrecov.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopedics, surgery and vision solutions at https://www.jnjmedtech.com/en-US/. Follow us at @JNJMedTech and on LinkedIn.
Footnotes
1 Shahian DM, et al. Ann Thorac Surg. 2009.
2 Ahmed WA, et al. Ann Thorac Surg. 2009.
3 Koponen T, et al. British J Anaesthesia . 2019.
4 Samuels LE, et al. J Card Surg. 1999.
5 Reardon MJ, et al. JAMA Cardiol. 2016.
6 Ranucci M, et al. CCM. 2013.
7 Poirier Y, et al. Int J Cardiol. 2016.
8 Pilarczyk K, et al. Euro J Cardiothorac Surg. 2016.
9 Dr. Edward Soltesz is a paid consultant for Abiomed, Inc. and was not compensated for his quote in this press release.
10 Impella 5.5 is not indicated in this patient population in the United States and is not approved for this use by the FDA.
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