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Use of a Percutaneous Ventricular Assist Device/Left Atrium to Femoral Artery Bypass System for Cardiogenic Shock
Published on: August 16, 2021
Percutaneous left ventricular assist device: "TandemHeart" for high-risk coronary intervention
Joseph Aragon1, Michael S Lee, Saibal Kar
1Cardiovascular Intervention Center, Division of Cardiology, Cedars-Sinai Medical Center, University of California, Los Angeles School of Medicine, CA 90048, USA.
Insights
The TandemHeart device offers circulatory support during high-risk percutaneous coronary intervention (PCI) for patients with severe left ventricular dysfunction. This approach achieved 100% procedural success in complex cases, improving patient outcomes.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Patients with severely compromised left ventricular systolic function undergoing percutaneous coronary intervention (PCI) face high risks, including hemodynamic collapse.
- Complex coronary lesions such as multivessel, left main, or bypass graft disease exacerbate these risks.
Observation:
- The TandemHeart percutaneous ventricular assist device was implanted in eight high-risk PCI patients with a mean ejection fraction of 30% +/- 9%.
- Five patients were unsuitable for surgical revascularization; seven underwent multivessel PCI, including three with unprotected left main coronary artery PCI.
Findings:
- The TandemHeart device demonstrated 100% procedural success in this high-risk cohort.
- The device was removed post-PCI without complications. Six patients remained event- and symptom-free at a mean follow-up of 189 days.
- One patient died post-PCI following unrelated surgery, and another developed acute renal failure requiring hemodialysis.
Implications:
- Percutaneous hemodynamic support with the TandemHeart device is feasible and effective during high-risk PCI.
- This technology offers a viable option for critically ill patients with complex coronary artery disease and impaired left ventricular function.
- Further research is warranted to assess long-term outcomes and expand the application of ventricular assist devices in interventional cardiology.
Abstract:
Patients undergoing percutaneous coronary intervention (PCI) with severely compromised left ventricular systolic function and complex coronary lesions, including multivessel disease, left main disease, or bypass graft disease, are at higher risk of adverse outcomes from hemodynamic collapse. The TandemHeart percutaneous ventricular assist device may provide circulatory support during high-risk PCI. We implanted the TandemHeart device in eight patients who underwent high-risk PCI. The patients were considered to be at exceptionally high risk for decompensation due to procedural complexity combined with underlying LV dysfunction. The mean ejection fraction was 30% +/- 9% and five patients were turned down for surgical revascularization. Seven patients underwent multivessel PCI, including three patients who underwent unprotected left main coronary artery PCI. There was 100% procedural success. The TandemHeart was removed immediately post-PCI with no groin complications. Six patients are event- and symptom-free at 189 +/- 130 days; one patient died 10 days post-PCI after lower extremity bypass surgery and another developed acute renal failure postprocedure, requiring hemodialysis. Our initial clinical experience with the TandemHeart ventricular assist device demonstrates that hemodynamic support can be rapidly achieved percutaneously during high-risk PCI, with excellent procedural success in highly complex and critically ill patients.
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