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The NCSI Study is a single-arm, prospective study assessing outcomes associated with early mechanical circulatory support (MCS) in AMICS patients treated with PCI. The goal of the NCSI Study is to increase cardiogenic shock survival, which has historically been approximately 50%, by providing early unloading therapy and allowing the heart to rest prior to PCI, promoting native heart recovery. The NCSI Study prospectively validated the previously identified best practices of identifying shock early, placing Impella support pre-PCI within 90 minutes of arriving at the hospital, using a pulmonary artery catheter to guide decision-making, and reducing the use of inotropes and vasopressors.
The study investigators categorized patients according to SCAI Shock classification stages. For SCAI stages C/D, they found higher survival to discharge (79%), 30-days (77%) and 1-year (62%) compared to historical data in similar patients during the last 30 years. SCAI stage E patients, who are on the brink of cardiovascular collapse, also had improved survival to discharge (54%), 30-days (49%), and 1-year (31%) compared to recent studies of patients who were not treated with the NCSI protocol that published in
“The NCSI Study demonstrates the benefit of following a protocolized approach to AMICS, which includes early implantation of Impella. We are impressed with the improved survival rates seen with the use of best practices compared to the stagnant historical survival rate,” said
“NCSI is the largest prospective study of therapy for AMICS done in the
Other investigator-led research demonstrates results similar to the NCSI Study results, including the 2019 Inova Study and the 2020 J-PVAD Study. These studies found an 82% and 77% survival at 30 days, respectively, when best practices were followed including the early identification of cardiogenic shock and the early use of Impella. (see figure 1)
“The NCSI Study has shown that, through rapid identification and treatment of patients who will benefit from mechanical circulatory support, higher cardiogenic shock survival rates can be achieved,” said
The authors concluded early use of mechanical circulatory support and hemodynamics is associated with improved outcomes. Additional clinical research in the treatment of cardiogenic shock includes the RECOVER IV RCT, which is being developed and will be a prospective, two-arm trial to assess whether Impella pre-PCI is superior to PCI without Impella in AMICS patients. In addition, the DanGer Shock RCT is an ongoing trial in
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