Data Show Positive Survival and Patient Outcomes with Best-Practice Impella Support in HRPCI, in Contrast to CHIP-BCIS3 Study Results
Analyses presented at TCT highlight how patient selection, timely Impella support and consistent care protocols may help improve outcomes during and after complex heart procedures
SAN DIEGO, November 01, 2026--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.