Aortic Valve Stenosis Clinical Trial
Official title:
Edwards SAPIEN 3 PPI Registry - A Retrospective Survey and Prospective Identification of Procedure Related Variables Associated With Permanent Pacemaker Implantation in Patients Receiving an Edwards SAPIEN 3 Valve
There are patient related risk factors for PPI that can be identified and assessed in
retrospective pooling of 1000+ TAVI patient datasets.
Retrospective pooling of 6 datasets already available at participating centres (4 sites in
Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden).
Additional assessment of calcifications using a CT data core lab. Statistical analysis of the
obtained dataset with respect to the objectives of the registry.
Permanent pacemaker implantation is a widely recognized clinical event associated with TAVI
becoming evident within a few days after the procedure.
While a number of registries have documented the rates of PPI with different valves, much
less evidence has been provided for 1) patient based characteristics (e.g. RBBB etc.)
affecting the likelihood of PPI and for 2) procedural variables (e.g. implantation depth,
valve size etc.) that should be considered to perform an as safe and minimal invasive
procedure as possible.
Prior research To date there are 7 published reports on pacemaker rates and predictors
associated with the use of the Edwards SAPIEN 3 THV (see Table). These studies suggest that
the need for pacemaker implantation in single centers ranges between 14.4 and 20.4% derived
from patient numbers between 131 and 335. These analyses resulted in the identification of
pre-existing conduction disturbance / aortic valve calcification as patient related and
implantation depth /oversizing as procedure related variables associated with Edwards SAPIEN
3 THV TAVI. Furthermore a scoring algorithm for patient related factors has been proposed
from a dataset of 240 patients to predict the likelihood of PPI after THV .
Limitations of prior research Current evidence though is limited by patient numbers versus
event rates (with a max. of 62 PPI considered in any of the available datasets) resulting in
a limited power in multivariable analyses, the single center design of these ventures, the
lack of a consistent definition of variables potentially associated and the unexplained
differences in the number and type of variables identified.
Aims For this reason the investigators consider it necessary to 1) to retrospectively pool
data from all of these 7 datasets to arrive at a more comprehensive picture of patient
related variables (retrospective part I), to 2) assess procedural variables in a prospective
multicenter registry (prospective part II) and 3) to potentially validate the identified
variables in a future prospective cohort.
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