Registry Data Reported for Best-Practice Impella Heart Pump Support in High-Risk PCI 

November 4, 2026—Johnson & Johnson MedTech announced results from three clinical analyses that report survival and patient outcomes data when the company’s Impella heart pumps are used to support a patient’s heart during and after high-risk percutaneous coronary intervention (HRPCI). The findings were presented at TCT 2026.

According to the company, real-world and observational registry data from 1,379 HRPCI patients across hospitals in the United States and Europe showed lower in-hospital cardiovascular mortality and lower 30- and 90-day mortality rates than those recently reported in the CHIP-BCIS3 trial by Perera et al (NEJM; 2026;394:1779-1789).

As summarized in Johnson & Johnson’s press release, the following three presentations were delivered during TCT:

1. “Protected PCI with Microaxial-Flow Pump Support: Real-World Evidence From the TRI-GUARD-PCI Registry” was presented by Matthias Bossard, MD.

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’s Kaplan-Meier curve estimates.

“These real-world results provide important insights into outcomes following Impella-supported high-risk PCI in contemporary clinical practice,” commented Dr. Bossard in the press release. “The findings may help inform patient selection and procedural planning for complex high-risk interventions.”

2. “Periprocedural and Early Post-Procedural Cardiovascular Mortality Following HRPCI” was presented by Vasileios Panoulas, MD.

Using a multicenter United States registry, this analysis of 522 patients who underwent Impella-supported HRPCI showed cardiovascular mortality of 3.4% at the 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,” commented Dr. Panoulas in the press release.

Furthermore, in the CHIP-BCIS3 treatment arm, the device was removed before patients left the catheterization lab whereas in the LOQI—Long-term Outcome and Quality Indicator—Impella registry study, one in six patients were supported by Impella for > 3 hours. “These observations suggest a potential relationship between duration of support, post-procedural management and patient outcomes,” added Dr. Panoulas.

3. “Clinical Characteristics and Early Mortality in a High-Risk PCI Cohort Similar to CHIP-BCIS3 Undergoing Impella Support: Insights From PROTECT III” was presented by Dr. Panoulas.

According to J&J, 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 approximately 8% mortality estimated 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,” stated Dr. Panoulas. “Understanding mortality after HRPCI requires looking at patient risk at baseline, procedural complexity, and the importance of post-procedure patient management.”