In the 3.6% of patients undergoing the
valve-in-valve procedure to fix a leak, the most common type of device
malposition was deployment that was too low inside the left ventricular
outflow tract (75% of cases). The only statistically significant
baseline difference between the patients needing a second valve and
those who did not is that the former group had a slightly larger average
annulus diameter (23.6 mm vs 22.1, p=0.010).

In most cases, balloon dilation was necessary
to optimize the expansion of the second device, but this did not damage
the leaflets or aortic root structures. There were no major adverse
cerebrovascular and cardiac events within 30 days for the patients
undergoing the a second safety valve implant, and the procedural, 30-day, and
12-month outcomes of the valve-in-valve group, including survival and
major adverse events, were statistically equivalent to the outcomes of
those who did not require a second intervention (95.5% for the
valve-in-valve patients and 86.3% for the patients who did not need a
second procedure). Procedural success was obtained in 100% of the
valve-in-valve patients, with no periprocedural death. There were no
cases of valve deterioration or new onset of central or perivalvular
regurgitation observed or any reports of thrombotic or embolic events in
the valve-in-valve group, "which reflects well on the design features
and the endothelialization of the [CoreValve] device," according to the
authors.

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