Conflict of interest: No authors have relevant conflicts of interest to declare with the exception of Dr. Virmani who receives research support from Abbott Vascular, BioSensors International, Biotronik, Boston Scientific, Medtronic, MicroPort Medical, OrbusNeich Medical, SINO Medical Technology, and Terumo Corporation; has speaking engagements with Merck; receives honoraria from Abbott Vascular, Boston Scientific, Lutonix, Medtronic, and Terumo Corporation; and is a consultant for 480 Biomedical, Abbott Vascular, Medtronic, and W.L. Gore.
Valvular and Structural Heart Diseases
A pathologic study of explanted parachute devices from seven heart failure patients following percutaneous ventricular restoration
Article first published online: 9 NOV 2013
Copyright © 2013 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions
Volume 83, Issue 4, pages 619–630, 1 March 2014
How to Cite
Ladich, E., Otsuka, F. and Virmani, R. (2014), A pathologic study of explanted parachute devices from seven heart failure patients following percutaneous ventricular restoration. Cathet. Cardiovasc. Intervent., 83: 619–630. doi: 10.1002/ccd.25010
- Issue published online: 15 FEB 2014
- Article first published online: 9 NOV 2013
- Accepted manuscript online: 22 MAY 2013 10:30AM EST
- Manuscript Accepted: 12 MAY 2013
- Manuscript Revised: 30 APR 2013
- Manuscript Received: 29 JAN 2013
- CardioKinetix, Inc., Menlo Park, CA
- heart failure;
- percutaneous ventricular restoration
We sought to evaluate the pathologic findings of the percutaneous Parachute device implanted in patients with severe heart failure (HF).
Currently, most treatments of HF rest on optimal medical therapy with adjunctive interventional or surgical palliative treatments. One such treatment is the Parachute device, which partitions the left ventricle excluding the scarred myocardium from functioning myocardium, and has shown promise in clinical studies.
We have examined histopathologically seven cases [six males (age range 43–74 years; mean 56 years) and one female (55 years)] of Parachute device that were either retrieved at autopsy (n = 4) or during transplantation (n = 3); implant duration, 15–1,533 days.
Three patients died of cardiac causes and none died from complications. Histologic early changes (<30 days, n = 1) included adherent thrombus, with focal neutrophil infiltration and degenerating inflammatory cells. Over time (31–300 days, n = 4), there was organized thrombus and development of neoendocardial thickening especially at the free-edge of the device and its contact with the adjacent endocardium while the base of the device showed varying degrees of fibrin thrombus. The greatest organization of thrombus was observed in devices removed at >300 days (680 and 1533 days); both had fractures of the foot along with strut fracture and one had tearing of the expanded polytetrafluoroethylene.
The percutaneous Parachute device appears as a promising adjunctive treatment for patients suffering from severe HF. The pathologic changes are those of organizing thrombus with and without inflammation with minor complications of foot and strut fracture. © 2013 Wiley Periodicals, Inc.