A STEP for Patients Prior to Undergoing TAVR: A Pilot Study

TAVR is an approved alternative therapy for patients with severe aortic valve stenosis who
are deemed inoperable or high-risk for surgical aortic valve replacement (SAVR). Despite a
very high procedural success rate (>95%), mortality rates after TAVR at 1- and 2-year
follow-up remain ≥25% and ≥34%, respectively. It is becoming increasingly evident that
frailty, as a clinical syndrome, has a large impact on this long term mortality. In a study
by Green, et al. frailty status was independently associated with increased 1-year mortality
(OR=3.5) after TAVR. The investigators' own retrospective analysis showed that impaired
mobility and malnutrition were significantly associated with a longer hospital length of stay
(5 days vs. 3 days), and increased total cost (on average, an additional $10,000 per
patient). Given the phenotype of frailty is characterized by reductions in muscle mass,
strength, endurance and activity level, a STEP is ideally suited to counteract these
impairments. This pilot study aims to establish whether a STEP can safely improve the frailty
score in patients with symptomatic severe aortic valve stenosis prior to undergoing TAVR.

This single-center pilot study will be conducted in partnership between Heart Care Midwest
(HCMW), OSF St. Francis Medical Center (OSF SFMC), and University of Illinois College of
Medicine at Peoria (UICOMP). UICOMP Center of Outcomes Research will provide analytical
support. The study will be funded by an operational research grant from OSF SFMC.

Inclusion Criteria:

- All adult patients scheduled to undergo first-time elective TAVR

Exclusion Criteria:

- Vulnerable populations including prisoners, pregnant females and patients less than 18
years age.

- Patients with history of unstable angina, myocardial infarction, or decompensated
heart failure in the week prior to screening

- Patients with physical limitations (i.e. debilitating stroke, amputation, unable to
complete initial screening frailty profile)

- Patients with advanced dementia or cognitive deficits (i.e. unable to follow
instructions of initial screening frailty profile)

- Exercise-induced arrhythmias