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
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 – 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 Panoulas[3], 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.
[1] Dr. Bossard is a paid consultant for J&J MedTech and was not compensated for his quote in this press release.
[2] Dr. Panoulas is a paid consultant for J&J MedTech and was not compensated for his quote in this press release.
[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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