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Two cases of recurrent heart failure after receiving a CoreValve transcatheter aortic valve replacement (TAVR) device turned up within 1 to 5 years, a German group reported.
"The intraoperative findings in the two patients revealed thrombotic material on the frame, early structural degeneration of the aortic-valve prosthesis, and interference with motion of the anterior mitral leaflet," , of the University of Lubeck, Germany, and colleagues wrote in a letter in the March 12 issue of the New England Journal of Medicine.
Severe calcification was also seen in the first case, a 73-year-old woman who developed high-grade aortic stenosis and progressive coronary artery disease, causing repeated cardiac decompensation in the 5 years after TAVR.
The other case, an 80-year-old woman, showed "structural leaflet degeneration with dehiscence at two commissures ... leading to central aortic regurgitation" at 1 year after TAVR.
Both had thrombotic material on the frame of the CoreValve prosthesis, despite being on dual antiplatelet therapy the entire time after implantation.
Explantation wasn't easy because both devices were "firmly bonded to the aortic wall," but was accomplished by cutting down the long axis and then rolling it up.
"Whether early degeneration could be a problem of crimping (the procedure that is used to compress the prosthesis to enable transcatheter delivery), the implantation technique itself, or the use of a second balloon inflation during implantation (which occurred in Patient 2) cannot be determined in these two cases," Richardt's group concluded.
"Interference with mitral-valve leaflet motion was most likely due to implantation of the CoreValve too deeply in the aortic annulus with protrusion into the left ventricular outflow tract," they added.
A response from device-maker Medtronic noted that this isn't the first time early structural valve degeneration has been reported for CoreValve or Sapien TAVR devices.
In an accompanying response in NEJM, , of Medtronic in Minneapolis, agreed that interference of the prosthesis with normal movement of the anterior mitral valve leaflet was "evidence that the device was implanted too deeply within the left ventricular outflow tract" and "probably resulted in incomplete frame expansion."
Deep implant probably explains the problems seen, suggested Vassiliades, along with co-authors , of Mount Sinai Medical Center in New York City, and , of Beth Israel Deaconess Medical Center in Boston.
"Despite normal hydrodynamic function early after implantation, the long-term effects would be impaired leaflet mobility, increased leaflet stress, and accelerated wear, eventually manifested by premature calcification and thrombus formation," they wrote. "The positioning of a transcatheter aortic valve has a major influence on both short-term hydrodynamic performance and long-term durability."
From the American Heart Association
Disclosures
Richardt and co-authors disclosed no relevant relationships with industry.
Vassiliades is an employee of Medtronic.
Adams disclosed relevant relationships with Medtronic and Edwards Lifesciences.
Popma dislcosed relevant relationships with Medtronic, Boston Scientific, Abbott Vascular, and Covidien.
Primary Source
New England Journal of Medicine
Richardt D, et al "Two cases of heart failure after implantation of a corevalve prosthesis" N Engl J Med 2015; 372: 1079-1081.