Study on Cardiogenic Shock during Acute MI Wins Top 50 Abstract and Posters Award at TCT 2015

October 14, 2015

At TCT on Tuesday, October 13, Drs. Navin Kapur, Anuradha Lala, Yu Gho, Noam Josephy, Richard Karas, and Daniel Burkhoff were awarded the Top 50 Abstract and Poster Awards for their poster entitled “The Recover Right Trial Criteria for Right Ventricular Failure: An Analysis of the Should we emergently revascularize Occluded coronaries for Cardiogenic shock (SHOCK) Trial and Registry.”

The number of deaths associated with cardiogenic shock during acute myocardial infarction is high, even with the use of the intra-aortic balloon pump and revascularization. These authors hypothesized that right ventricular dysfunction may contribute to poor clinical outcomes in patients with cardiogenic shock during acute myocardial infarction.

With the availability of a right ventricular support device called the Impella RP, it may be possible to provide support for the right ventricle if patients with right ventricular dysfunction could be identified. This study was conducted to determine the prevalence of right ventricular dysfunction among patients with cardiogenic shock during acute myocardial infarction.

Study Design

  • Hemodynamic data from the SHOCK Trial and Registry were analyzed. Specifically:
    • Central venous pressure (CVP)
    • CVP/pulmonary capillary wedge pressure (CVP/PCWP) ratio
    • Pulmonary artery pulsatility index (PAPi)
    • Right ventricular stroke work index (RVSWI)
    • Cardiac index (CI)
    • Use of ionotropes or vasopressors
  • Right ventricular dysfunction was defined as: CVP >10 mmHg, CVP/PCWP >0.63, PAPi <2.0 and RVSWI <450.
  • Right ventricular failure was defined as: CVP >15 mmHg, CVP/PCWP >0.8, PAPi <1.5 and RVSWI <300.
  • Recover Right Trial Criteria: CVP >15 mmHg, CVP/PCWP >0.63, CI <2.2 L/min/mm2 and ionotropes/pressor ≥1

Key Points

  • Hemodynamic data for all indices of right ventricular function were available for a total of 140 patients in the SHOCK trial.
  • The patient characteristics of patients who had died (n=65) and those who were alive (n=75) were similar with the following exception:
    • the right coronary artery was the culprit artery more often (44%) in the alive group compared to those who died (13%).
  • Right ventricular dysfunction was common among all participants (n=140) in the SHOCK trial with the following distribution:
    • 37% of patients had right ventricular dysfunction
    • 15% of patients right ventricular failure
    • 45% of patients met the criterial for the Recover Right Trial
    • Similar hemodynamic results were observed in patients enrolled in the SHOCK Registry for whom all of these hemodynamic indices were available (n=260).
  • Patients meeting the Recover Right Trial criteria were at significantly (p=0.03) greater risk of death in 30 days.

Conclusion

Right ventricular dysfunction was common in patients with cardiogenic shock during acute myocardial infarction. The Recover Right Trial inclusion criteria may be used to determine which patients are at risk of mortality. If these patients experience cardiogenic shock during acute myocardial infarction, they may be potential candidates for right ventricular support with the Impella RP.

 


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