3 percent, as well as low rates of stroke and paravalvular
Additionally, valve leakage (known as paravalvular
leak or PVL) rates were low and decreased over time as the self-expanding valve conformed to the shape of a patient's annulus--an improvement that has not been reported in other major TAVR studies.
CardiAQ's second generation TMVI products are built upon the company's proprietary method for anchoring the implant through leaflet engagement, chordal preservation, and annular attachment, while offering greater durability, improved flow properties, and a novel feature for the prevention of paravalvular
leaks, said Arshad Quadri, MD, Cardiac Surgeon, Founder, and CMO.
The positive outcomes in the CoreValve ADVANCE Direct Aortic (DA) Study of 100 patients demonstrated low rates of mortality, stroke and paravalvular
leak (PVL) at 30 days.
Occlutech, a leading innovator of products to treat structural heart disease today announced that it has obtained a European CE Mark approval for its dedicated Paravalvular
Leak Closure Device, (PLD).
172) Following a randomized clinical trial called AVERT, which had "revealed a small, but statistically significant increase in expiants due to a medical complication known as paravalvular
leak (PVL) in patients who had received a Silzone implant," the defendants in Andersen issued a worldwide recall of all Silzone-coated products in early 2000.
On July 31, 2010, the aortic valve (bioprosthesis) and proximal portion of the ascending aorta were replaced (the latter was a homograft), the paravalvular
abscess was debrided, and the coronary ostial sites were implanted into the homograft.
AR is more common after TAVR than after surgery (52, 53).
Results from the multi-center trial, which were presented during the late-breaking trial sessions at the recent European Association for Cardio-Thoracic Surgery and the Society of Thoracic Surgeons annual meetings, revealed high rates of procedural success, minimal paravalvular
leak (PVL) and continuing benefits over time.
Four months later, paravalvular
insufficiency of the bioprosthesis developed in the patient, requiring a second valve replacement.
In addition, the only case of paravalvular
leak in our patient group occurred in this patient with infective endocarditis, consistent with the theory that paravalvular
leak often occurs as a complication of endocarditis.
A recent echocardiogram revealed a high-velocity, jetting paravalvular
leak of the mitral valve replacement.