# Biomechanical Approaches and Technologies for Enhancing TAVR Outcomes

> **NIH NIH U01** · STATE UNIVERSITY NEW YORK STONY BROOK · 2021 · $748,628

## Abstract

Project Summary
 Transcatheter Aortic Valve Replacement (TAVR) has emerged as a life-saving solution for inoperable
elderly patients with calcific aortic valve disease (CAVD) and severe Aortic Stenosis (AS). However, in recent
years certain limitations and serious adverse events emerged: failed delivery due to tortuous aortic geometry
and severe valvular calcification, valve migration, conduction abnormalities, and paravalvular leaks (PVL) leading
to embolization with increased stroke risk, increasing the overall morbidity and mortality post-TAVR. Current
TAVR technology is based on tissue valves adapted to, but not specifically designed for TAVR. Those may
sustain damage during crimping and deployment, resulting in limited durability and impaired functionality. In
latest-generation TAVR devices ad hoc solutions to reduce PVL have been associated with higher incidence of
cardiac conduction abnormalities (CCAs), often leading to the need for concurrent permanent pacemaker
implantation. This may limit TAVR utility and its anticipated expansion into younger, lower risk patients, including
a BAV (bicuspid aortic valve) patients, in which off-label use of TAVR is rapidly emerging. Given the aging U.S.
population segment at high risk for AS that is expected to double by mid-century, there is a critical need for
optimizing the procedure and developing long-term TAVR technology – optimized to reduce the complications
rates while achieving better clinical outcomes. Our translational project aims to develop next generation TAVR
technology. Combining imaging, computational, and in vitro tools in a refined biomechanical analysis methodology,
an optimization approach will guide the pre-planning and tailor TAVR procedures for achieving significantly better
patient outcomes and reduce ensuing complications. We also aim to offer a disruptive technology: next generation
valves specifically optimized for TAVR. The Polynova polymeric valve was developed using our design optimization
DTE methodology under a U01 Quantum project and a current STTR award. It incorporates a novel xSIBS
hemcompatible polymer with better tolerance to crimping and deployment stresses, improved hemodynamic
performance and thromboresistance, and extended durability. Its TAVR prototypes will be rigorously tested and
further optimized.
 These goals will be achieved by employing an innovative Reverse Calcification Technique (RCT) to predict
CAVD Progression. We will use patient specific reconstructed geometries from a large CAVD patient’s database
as input for refined numerical simulations. We will expand our existing large CT scans database of CAVD patients
(currently n=750), as well as utilize TAVR databases from two additional medical centers (n=293 and 94,
respectively), to catalog the disease progression to further serve to elucidate, plan and predict interventional
outcomes. Using RCT as a base for predictive models of prospective calcification growth – both in tricuspid
(TAV) and bicuspi...

## Key facts

- **NIH application ID:** 10201598
- **Project number:** 5U01EB026414-04
- **Recipient organization:** STATE UNIVERSITY NEW YORK STONY BROOK
- **Principal Investigator:** DANNY BLUESTEIN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $748,628
- **Award type:** 5
- **Project period:** 2018-09-15 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10201598

## Citation

> US National Institutes of Health, RePORTER application 10201598, Biomechanical Approaches and Technologies for Enhancing TAVR Outcomes (5U01EB026414-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10201598. Licensed CC0.

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