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Routine Use of the "Penumbra" Thrombectomy Device in Myocardial Infarction: A Real-World Experience-ROPUST Study
Nour Tashtish1, Tarek Chami1, Tony Dong2
1Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
Insights
The Penumbra Cat RX device safely and effectively removed thrombus in patients with acute myocardial infarction (MI), improving outcomes without increasing stroke risk. This thrombectomy approach is beneficial for high-risk patients undergoing percutaneous coronary intervention (PCI).
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Percutaneous coronary intervention (PCI) is standard for acute myocardial infarction (MI), but large thrombus burdens limit reperfusion success.
- Existing aspiration devices are linked to increased stroke incidence, posing a challenge in thrombectomy-assisted PCI.
- The Penumbra Cat RX device offers a potential solution for effective thrombus removal in acute MI patients.
Purpose of the Study:
- To evaluate the safety and efficacy of the Penumbra Cat RX device as an adjunct to PCI.
- To assess its performance in patients with ST-segment elevation MI (STEMI) and non-STEMI (NSTEMI) and large thrombus burden.
- To determine its impact on clinical outcomes, including thrombolysis in myocardial infarction (TIMI) flow and adverse cardiac events.
Main Methods:
- Retrospective chart review of patients undergoing PCI for MI with the Penumbra Cat RX device (May 2019 - February 2021).
- Primary outcome: final TIMI flow. Secondary outcomes: composite of adverse cardiac events at 6 months.
- Data collected on procedural approaches (radial/femoral) and guide catheter use.
Main Results:
- Successful TIMI flow 3 achieved in 90.2% of patients.
- A composite of adverse cardiac events occurred in 8.9% of patients (3 MI, 8 heart failure hospitalizations).
- No stroke events or device-related complications were reported; door-to-balloon time remained unaffected.
Conclusions:
- The Penumbra Cat RX device is safe and effective for thrombus removal in acute coronary syndrome patients.
- It leads to improved clinical outcomes, particularly in high-risk MI patients requiring thrombectomy.
- The device facilitates successful reperfusion without increasing procedural risks like stroke.
Objectives:
Evaluation of the safety and efficacy of the Penumbra device as an adjunct to percutaneous coronary intervention (PCI) in patients with myocardial infarction (MI) and a large thrombus burden that requires thrombectomy.
Background:
For patients with acute MI, PCI is the primary reperfusion method. Large thrombus burden has always been a limitation of successful reperfusion. However, the use of current aspiration devices has been associated with an increased incidence of stroke.
Methods:
We performed a retrospective chart review at the University Hospitals Medical Center in Cleveland. Our study included data from patients who underwent PCI for ST segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (NSTEMI) assisted by the Penumbra Cat RX device (a wide-lumen thrombus aspiration catheter) between May 2019 and February 2021. The primary outcome was the final thrombolysis in myocardial infarction (TIMI) flow. The secondary endpoints were a composite of adverse cardiac events at 6 months. About 50% of the patients did undergo transfemoral PCI as per preference of individual operators. The Penumbra thrombectomy device can be used both by radial and femoral approach and does not need any different guide catheter use.
Results:
TIMI flow 3 was achieved in 111 patients (90.2%). The secondary endpoint occurred in 11 patients (8.9%, 3 MI, 8 heart failure hospitalizations). There were no stroke events or device-related complications. The door-to-balloon time was not affected by usage of the Penumbra device. Failure in the restoration of TIMI 3 flow was associated with the use of balloon angioplasty prior to the application of the Penumbra device, leading to distal embolization.
Conclusions:
The Penumbra Cat RX provides safe and effective thrombus removal with better clinical outcomes, even in high-risk patients with acute coronary syndrome.
