Experimental Design and Study Population:
This study was a retrospective cohort investigation with a longitudinal
follow-up. We collected the study data by reviewing patients’ electronic
medical records who had undergone TAVR at the structural Heart unit of
Gates Vascular Institute in Buffalo, NY. This unit is one of the busiest
structural cardiology centers in the US and performs over 600 TAVR
procedures per year. The University of Buffalo Institutional Review
Board reviewed and approved this study. We took extreme caution to
minimize the risk of the privacy leak of the participants during data
collection and not to impact the rights and welfare of these patients
adversely.
We screened 677 patients who underwent TAVR from 2012 -to 2017. Based on
inclusion criteria, we included 272 patients for further analysis.
Patients were identified from the locally collected national database
registry and had if they did not meet the exclusion criteria. Follow-up
echocardiographic data (postoperative, six months, then annual
follow-ups) pertinent to ELI calculation and hemodynamic properties of
the prosthesis were collected. Patients were followed after the
procedure until the primary endpoint was met. The relevant clinical
information was collected along the way. ELI values were compared to
these post-procedural events to identify a trend and a cutoff ELI value
at which these events become more likely to occur. Inclusion criteria
were all patients who had undergone a successful TAVR procedure at the
Gates Vascular Institute from 2012 to 2017. Exclusion criteria applied
to patients who passed away due to vehicular accidents, homicide,
suicide, pre-procedural terminal illnesses, and patients who were lost
to follow-up.