We describe our experience of patients, from December 2005 through May 2007 who underwent percutaneous coronary intervention (PCI) with severely depressed left ventricle systolic function and complex coronary lesions. The complex coronary lesions included multiple vessel coronary artery disease, left main (LM) coronary artery disease, calcified coronary lesions and bypass graft disease. All patients were clinically assessed to be at too high of a risk for circulatory collapse without maximal hemodynamic support while they underwent high-risk PCI. The TandemHeart percutaneous ventricular assist device (THpVAD) may be able to provide the necessary circulatory support required to enhance procedural success and patient safety during high-risk PCI.
Methods and results: We implanted the THpVAD in 6 patients who underwent high-risk PCI. There was unanimity among several physicians in our institution that each patient was an exceptionally high risk for circulatory collapse due to the anticipated procedural complexity. The average ejection fraction was 33% (range 15-65%). Five of the patients were considered to be at an unacceptably high risk for coronary artery bypass surgery. All 6 patients underwent multivessel PCI. Five of the 6 underwent unprotected LM PCI. One patient of the 5 underwent vein-graft PCI as well as a debulking procedure with rotational atherectomy and PCI of the LM. We had a 100% success rate with implantation of the THpVAD. Five of the 6 patients were alive at 30 days post procedure. One patient died 3 days after the procedure due to multiorgan failure. A vascular surgeon performed the removal of the devices with no associated complications.
Conclusions: Our clinical experiences with the TandemHeart pVAD demonstrated that hemodynamic support could be achieved safely, efficiently and effectively by way of a percutaneous route in anticipation of high-risk PCI.