TCT 2015 Poster Finds Robotic PCI for Unprotected Left Main Stenosis is Feasible

October 14, 2015

A poster entitled “The Feasibility of Robotic Percutaneous Coronary Intervention for Unprotected Left Main Stenosis in the Presence and Absence of Left Ventricular Hemodynamic Support” by Drs. John Bahadorani, Arturo Dominguez, Mitul Patel, Ryan Reeves and Ehtisham Mahmud from the University of California at San Diego Sulpizio Cardiovascular Center, Division of Cardiovascular Medicine, San Diego, CA was presented at TCT on Tuesday, October 13.

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This study extended the results of the Percutaneous Robotically Enhanced Coronary Intervention Study (PRECISE) study that demonstrated the practicality of robotic PCI on simple coronary lesions. The current poster investigated the possibility of using the robotic CorPath system in percutaneous coronary interventions (PCI) performed on a more complicated situation, that of unprotected left main stenosis.

Study Design

  • The PRECISION Registry was queried to identify all patients with unprotected left main stenosis treated robotically at the University of California at San Diego.
    • The PRECISION Registry is a post-market prospective single-arm, multicenter registry that collects data on the use, safety and effectiveness of the CorPath 200 system for patients undergoing PCI.
  • Outcome definitions:
    • Clinical Success
      • A residual angiographic stenosis of <20% in the absence of major adverse cardiac events (MACE) within 48 hours of the procedure
    • MACE
      • Death, myocardial infarction or repeat revascularization
    • Technical Success
      • Successfully completed PCI performed entirely robotically

Key Points

  • A total of 102 patients in the PRECISION Registry underwent robotically assisted PCI.
  • Of these patients, 6 had unprotected left main stenosis.
  • The success rate of robotically assisted PCI for the 6 subjects was 100%.
    • 3 patients had robotically assisted PCI without hemodynamic support.
    • 2 patients received hemodynamic support from the Impella 2.5.
    • 1 patient was supported with an intra-aortic balloon pump.
  • Per the poster image below, Case #4 demonstrated use of the Impella 2.5 in a patient with a last remaining vessel. With the Impella in place, the left circumflex and LAD were wired and dilated. The Impella was removed at the end of the case.

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Conclusion

This study demonstrated the feasibility of robotically assisted PCI for left main stenosis with and without hemodynamic support in a small group of patients (n=6).


 


About Impella

The Impella 2.5 system is a temporary (<6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Protected PCI and use of the Impella 2.5 is not right for every patient. Patients may not be able to be treated with Impella if they have certain pre-existing conditions, which a cardiologist can determine, such as: severe narrowing of the heart valve, severe peripheral artery disease, clots in blood vessels, or a replacement heart valve or certain heart valve deficiencies.  Additionally, use of Impella has been associated with risks, including, but not limited to valvular and vascular injury, bleeding, and limb ischemia in certain patients. Learn more about the Impella devices’ approved indications for use, as well as important safety and risk information at www.protectedpci.com/hcp/information/isi

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