STS/ACC Transcatheter Valve Therapy Registry (TVT Registry)

Purpose of the Registry

The TVT Registry was designed to support a national surveillance system to assess the
characteristics, treatments, and outcomes of patients receiving transcutaneous valve
therapies. Patient-level data are submitted by participating hospitals to The Society of
Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT
Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized
data elements from participating hospitals, health care providers and others that measure and
assess the quality of care for patients receiving TVT; (ii) providing confidential periodic
reports to participating hospitals, health care providers and others, to evaluate and improve
the quality of care in these areas; and (iii) permitting and fostering appropriate research
based upon the data collected by means of the TVT Registry.

The secondary aim of the TVT Registry is to serve as a scalable data infrastructure for post
market studies.

Background and Significance

Transcatheter valve therapies are now emerging into clinical practice from the research phase
in the United States. The first of several approaches to replacing the aortic valve without
open-chest surgery has now become a reality. Other valve and delivery systems are expected to
be approved in the upcoming years. An Expert Consensus Document on Transcatheter Valve
Therapy has outlined the initial technology, targeted patient population, and the
multidisciplinary heart team and specialized facilities needed. The document also proposes
the establishment of a national registry of patients with valvular heart disease that can
collect and analyze data as these new valve treatment options become available. Surveillance
of device performance, monitoring of long-term outcomes, and performance of comparative
effectiveness research are some of the proposed uses of the registry.

Transcatheter valve therapies have emerged because of unmet patient needs. Furthermore, TVT
has developed at a time when degenerative heart valve diseases of both the mitral and aortic
valves are increasing in frequency as the population ages. With the introduction of the first
TAVR commercial product, the targeted patient group is the "inoperable" patient who cannot
receive the traditional therapy of surgical aortic valve replacement (SAVR). It is expected
that TAVR will subsequently be extended to patients who have high risk with SAVR. The marked
reduction of mortality by TAVR in the inoperable patients and the similar mortality of TAVR
versus SAVR in the high risk patients provide patients with a new therapy with benefits but
also with a different risk profile. Patients and their families will need to make informed
decisions regarding the likelihood of having a mortality benefit, of improving their
functional class and quality of life, of suffering a complication, and of choosing between
different care options and therapeutic approaches.

For these patients there are unique issues such as the prioritization of the health related
quality of life versus the quantity of life, the desire to preserve independence and avoid
becoming a burden to families, and the need to clearly understand what about their current
condition is reversible versus irreversible and linked to other conditions and aging. These
issues become further highlighted when considering the considerable costs and other treatment
burdens of the TVT technologies versus the disabling symptoms and recurrent hospitalizations
caused by untreated severe valvular heart disease.

Inclusion criteria:

- 18 years or older