Clinical Research & Data, Safety & Efficacy, Protected PCI
No Increase in Mortality in Impella®-Supported Nonemergent High-Risk PCI
To address questions regarding whether there is a difference in mortality with Impella® heart pump use in nonemergent high-risk Protected PCI cases, Samin Sharma, MD, FSCAI, FACC, published a paper in Catheterization & Cardiovascular Interventions in April 2020. Dr. Sharma, of Mount Sinai Medical Center in New York, is the senior author of “Outcomes of Impella-supported high-risk nonemergent percutaneous coronary intervention in a large single-center registry.” The lead author is Lorenzo Azzalini, MD.
Dr. Sharma is a well-published national and international leader in interventional cardiology and a major contributor to the clinical evidence for Protected PCI. In addition to prominent roles in the PROTECT Series of FDA clinical studies, Dr. Sharma is also known for being one of the first people to publicly share his algorithm for selecting cases for Protected PCI. “Complex CAD and low EF are the ideal cases,” he explains, with Impella allowing interventional cardiologists time to “calmly” do their job.
The paper he coauthored describes growth in the use of Impella at Mount Sinai over a 9-year period from 2009 to 2018. While Impella was used in about 1% of high-risk PCI cases during the study period, he explains that today between 3% to 4% of the high-risk PCI cases at Mount Sinai use Impella.
In the single-center retrospective study documented in this paper, all patients undergoing high-risk nonemergent PCI supported with Impella 2.5® or Impella CP® were propensity matched with patients undergoing PCI with no MCS. The primary endpoint was major adverse cardiac events (MACE) at one-year follow-up. There were, however, significant procedural differences between the patient groups. For example, Dr. Sharma highlights that significantly more patients in the Impella group had 3 vessels treated (21% vs 6%), left main target vessel (26% vs 11%, p<0.001), and left main atherectomy (18% vs 8%, p = 0.001).
Dr. Sharma discusses how cases are treated more aggressively with more complete revascularization when Impella is used. If you do a good intervention, he explains, you may pay a short-term price with some CKMB elevation, but patients do well in the long-term. Most importantly, he concludes, as does the paper, “By using the Impella in these patients, there was no increase in mortality.”