Johnson & Johnson announced results from three clinical analyses being presented during the Transcatheter Cardiovascular Therapeutics annual scientific symposium (TCT 2026) that report positive survival and patient outcomes data when Impella™ heart pumps are used to support a patient’s heart during and after high-risk percutaneous coronary intervention (HRPCI). Real-world and observational registry data from 1,379 HRPCI patients across hospitals in the U.S. and Europe show lower in-hospital cardiovascular mortality and lower 30- and 90-day mortality rates than those recently reported in CHIP-BCIS3. These contemporary findings from real-world U.S. and European experience with Impella-supported HRPCI provide important clinical context in contrast to the CHIP-BCIS3 study results.
“Data from these high-impact presentations add to more than two decades of evidence supporting Impella use in complex HRPCI patients,” said Navin Kapur, M.D., chief medical and scientific officer, Heart Recovery, MedTech, Johnson & Johnson. “They also reinforce that outcomes depend not only on the device but how and when it is used, from selecting the right patients and procedural approach to post-procedural management and critical care.”
The following data will be presented during TCT:
- TCT 197: Protected PCI with Microaxial-Flow Pump Support: Real-World Evidence from the TRI-GUARD-PCI Registry (Matthias Bossard, M.D., 11/1/26; 11 a.m. PST, station 4). This multicenter analysis of 279 patients undergoing elective protected PCI with Impella at hospitals in Germany, Switzerland and Austria showed lower 30-day (6.1%) and 180-day (7.9%) all-cause mortality rates than previously reported in the CHIP-BCIS3 trial Kaplan-Meier curve.
“These real-world results provide important insights into outcomes following Impella-supported high-risk PCI in contemporary clinical practice,” said Matthias Bossard, M.D.1, an interventional cardiologist and researcher now at Dalhousie University in Halifax, Nova Scotia, who conducted this research while at the Heart Center at Luzerner Kantonsspital in Lucerne, Switzerland, in collaboration with Mohamed Ayoub, MD, from Germany. “The findings may help inform patient selection and procedural planning for complex high-risk interventions.”
- TCT 888: Peri-procedural and Early Post-Procedural Cardiovascular Mortality Following HRPCI (Vasileios Panoulas, M.D., 11/2/26, 1 p.m. PST, station 2). Using a multicenter U.S. registry, this analysis of 522 patients who underwent Impella-supported HRPCI showed cardiovascular mortality of 3.4% at time of discharge compared with approximately 8% in the CHIP-BCIS3 study for patients treated with Impella on day 4 post-randomization. Kaplan-Meier curve estimates of cardiovascular mortality were 4.7% at 30 days and 6.5% at 90 days—both numerically lower than the corresponding rates reported in CHIP-BCIS3.
“This analysis provides real-world perspective on the use of Impella during HRPCI and highlights differences from the CHIP-BCIS3 study protocol,” said Vasileios Panoulas, M.D.,2 physician at Royal Brompton and Harefield Hospitals in London and the abstract’s lead author. In the CHIP-BCIS3 treatment arm, the device was removed before patients left the catheterization lab whereas in the LOQI study, one in six patients were supported by Impella for more than three hours. “These observations suggest a potential relationship between duration of support, post-procedural management and patient outcomes,” adds Panoulas.
- TCT 1228: Clinical Characteristics and Early Mortality in a High-Risk PCI Cohort Similar to CHIP-BCIS3 Undergoing Impella Support: Insights from PROTECT III (Vasileios Panoulas, M.D., 11/3/26, 8:50 a.m. PST, station 10). This analysis identified patients enrolled in the PROTECT III study who would meet the study entry criteria for the CHIP-BCIS3 trial. The in-hospital all-cause mortality for those 578 Impella-supported patients was 4.7%, which is lower than the estimated ~8% mortality reported in CHIP-BCIS3.
“In the high-risk PROTECT III cohort, Impella-supported HRPCI was performed in patients with severe left ventricular dysfunction and complex coronary anatomy, including frequent left main and multivessel treatment, with lower mortality rates than reported in CHIP-BCIS3,” said Panoulas3, who is presenting this data at TCT. “Understanding mortality after HRPCI requires looking at patient risk at baseline, procedural complexity and the importance of post-procedure patient management.”
Johnson & Johnson MedTech continues to study Impella across a range of coronary heart conditions, including the PROTECT IV randomized controlled trial, with results anticipated in 2027. This trial design builds on data demonstrating survival and patient outcomes and helps care teams further refine best practices for people with complex heart disease who need percutaneous coronary intervention. To learn more about PROTECT IV and our ongoing clinical research trials, visit https://www.heartrecovery.com/en-us/education/ongoing-studies/protect-iv.
About Impella Heart Pumps
Impella heart pumps are temporary mechanical circulatory support devices designed to unload the heart and provide hemodynamic support. Impella technology is used in appropriately selected patients with severe coronary artery disease or cardiogenic shock, consistent with applicable indications and labeling. Impella has been used to treat more than 450,000 patients globally.
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 and peripheral 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 information about heart recovery, visit https://www.heartrecovery.com/en-us.
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 surgery, orthopaedics, vision, and cardiovascular solutions at https://www.jnjmedtech.com/. Follow us at @jjmt_heartrecov and on LinkedIn.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to Impella heart pumps and the company’s research and innovation programs. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in research and development; uncertainty of clinical success and regulatory approvals; commercial success; manufacturing difficulties and delays; competition; intellectual property challenges; product efficacy or safety concerns; regulatory actions; changes in customer behavior and spending; changes in laws and regulations; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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1 Dr. Bossard is a paid consultant for J&J MedTech and was not compensated for his quote in this press release. |
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2 Dr. Panoulas is a paid consultant for J&J MedTech and was not compensated for his quote in this press release. |
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3 Dr. Panoulas is a paid consultant for J&J MedTech and was not compensated for his quote in this press release. |
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