Optimizing Health Outcomes in Patients With Symptomatic Aortic Valve Disease
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 10/15/2017 |
| Start Date: | May 2014 |
| End Date: | May 30, 2017 |
Disease of the aortic heart valve is both common and progressively disabling, with no
effective medical treatment. In November 2011, the United States Food and Drug Administration
(U.S. FDA) approved a new, less invasive transcatheter alternative to surgical aortic valve
replacement (AVR). This new technology has changed the treatment of patients with aortic
valve disease. In doing so, it has created a pressing clinical need for shared decision
making tools that will help patients understand the risks and benefits of each treatment
alternative in the setting of their individual characteristics.
The overarching goal of this study is to develop a new way to approach the treatment of
medical illness, by focusing on the expected treatment outcomes for individual patients using
information collected from large groups of patients. The corner-stone of this model is a
public website that is designed to engage patients and clinicians in a personalized
discussion of treatment alternatives. To achieve this goal for patients with aortic valve
disease, we will use existing clinical data from the Society of Thoracic Surgeons (STS) and
American College of Cardiology (ACC) national procedural registries that has been linked to
Medicare claims for patient follow-up to 1) evaluate important health outcomes with surgical
versus transcatheter AVR among patients who would be eligible for surgical AVR, and 2) create
and evaluate personalized decision assistance tools for all patients considering AVR. This
work will be accomplished in direct partnership with both patients and caregivers as well as
a diverse group of stakeholders who will help ensure its usefulness and dissemination.
effective medical treatment. In November 2011, the United States Food and Drug Administration
(U.S. FDA) approved a new, less invasive transcatheter alternative to surgical aortic valve
replacement (AVR). This new technology has changed the treatment of patients with aortic
valve disease. In doing so, it has created a pressing clinical need for shared decision
making tools that will help patients understand the risks and benefits of each treatment
alternative in the setting of their individual characteristics.
The overarching goal of this study is to develop a new way to approach the treatment of
medical illness, by focusing on the expected treatment outcomes for individual patients using
information collected from large groups of patients. The corner-stone of this model is a
public website that is designed to engage patients and clinicians in a personalized
discussion of treatment alternatives. To achieve this goal for patients with aortic valve
disease, we will use existing clinical data from the Society of Thoracic Surgeons (STS) and
American College of Cardiology (ACC) national procedural registries that has been linked to
Medicare claims for patient follow-up to 1) evaluate important health outcomes with surgical
versus transcatheter AVR among patients who would be eligible for surgical AVR, and 2) create
and evaluate personalized decision assistance tools for all patients considering AVR. This
work will be accomplished in direct partnership with both patients and caregivers as well as
a diverse group of stakeholders who will help ensure its usefulness and dissemination.
Aortic valve disease is a common, progressively debilitating condition with no effective
medical treatment. Surgical aortic valve replacement (AVR) has been the standard of care in
the presence of valve-associated symptoms which include heart failure, chest pain, and
syncope; however, in November 2011, long-standing treatment algorithms were disrupted with
the United States Food and Drug Administration (U.S. FDA) approval of a less invasive
transcatheter alternative to surgical aortic valve replacement (AVR) with a different profile
of associated risks and benefits. This new technology has created a pressing clinical need
for shared decision making tools to help translate the "average-patient" clinical trial
results to more relevant "patient-specific" information that will empower individuals facing
this important treatment decision.
The overarching goal of this study is to develop a broadly applicable patient-centered
paradigm for the treatment of medical illness. The corner-stone of this model is an
open-access, web-based resource to engage patients, their caregivers, and clinicians in a
personalized treatment discussion. To achieve this goal for patients with aortic valve
disease, we will use existing Medicare-linked clinical data from the Society of Thoracic
Surgeons (STS) and American College of Cardiology (ACC) national procedural registries. This
work will be accomplished in direct collaboration with patient and caregiver coinvestigators
and a diverse stakeholder panel to ensure wide utility and dissemination.
Specifically, we will achieve the following three research aims:
Specific Aim 1. Compare contemporary health outcomes with surgical versus transcatheter AVR
among operable patients in the United States; Specific Aim 2. Create and assess a
personalized decision assistance tool to evaluate expected health outcomes with surgical vs.
transcatheter AVR for operable patients with aortic valve disease; Specific Aim 3.Develop and
assess a personalized risk assessment tool to evaluate expected health outcomes with
transcatheter AVR for inoperable patients with aortic valve disease.
Additionally, we will achieve the general objective to create and evaluate web- and
print-based educational resources for targeted dissemination to patients with aortic
stenosis, their caregivers, and their healthcare providers.
The proposed research will facilitate a better match of patients with existing treatments and
empower patients to actively participate in their own healthcare decisions, thereby improving
the care of patients with aortic valve disease and reducing overall healthcare expenditures.
This study will serve as a model to promote personalized medicine among both cardiovascular
and non-cardiovascular disease states.
This study involves three primary comparisons. The first is a treatment comparison of
surgical vs. transcatheter AVR on short and intermediate-term outcomes (stratified across
important population subgroups)—important because the results will inform treatment
discussions and decisions in vulnerable patients. The second is a comparison of outcomes
across comorbidity sets using risk models—important because the resulting decision assistance
tools will provide personalized estimates of risk to patients, caregivers, and providers as
they select a treatment strategy. The third is an impact evaluation of an educational
resource, including comparison of the change in treatment selection patterns and clinical
outcomes across hospitals and geographic regions with high vs. low use of a web based
educational resource—important because the comparison will provide critical pilot information
to evaluate and tailor the resource impact.
medical treatment. Surgical aortic valve replacement (AVR) has been the standard of care in
the presence of valve-associated symptoms which include heart failure, chest pain, and
syncope; however, in November 2011, long-standing treatment algorithms were disrupted with
the United States Food and Drug Administration (U.S. FDA) approval of a less invasive
transcatheter alternative to surgical aortic valve replacement (AVR) with a different profile
of associated risks and benefits. This new technology has created a pressing clinical need
for shared decision making tools to help translate the "average-patient" clinical trial
results to more relevant "patient-specific" information that will empower individuals facing
this important treatment decision.
The overarching goal of this study is to develop a broadly applicable patient-centered
paradigm for the treatment of medical illness. The corner-stone of this model is an
open-access, web-based resource to engage patients, their caregivers, and clinicians in a
personalized treatment discussion. To achieve this goal for patients with aortic valve
disease, we will use existing Medicare-linked clinical data from the Society of Thoracic
Surgeons (STS) and American College of Cardiology (ACC) national procedural registries. This
work will be accomplished in direct collaboration with patient and caregiver coinvestigators
and a diverse stakeholder panel to ensure wide utility and dissemination.
Specifically, we will achieve the following three research aims:
Specific Aim 1. Compare contemporary health outcomes with surgical versus transcatheter AVR
among operable patients in the United States; Specific Aim 2. Create and assess a
personalized decision assistance tool to evaluate expected health outcomes with surgical vs.
transcatheter AVR for operable patients with aortic valve disease; Specific Aim 3.Develop and
assess a personalized risk assessment tool to evaluate expected health outcomes with
transcatheter AVR for inoperable patients with aortic valve disease.
Additionally, we will achieve the general objective to create and evaluate web- and
print-based educational resources for targeted dissemination to patients with aortic
stenosis, their caregivers, and their healthcare providers.
The proposed research will facilitate a better match of patients with existing treatments and
empower patients to actively participate in their own healthcare decisions, thereby improving
the care of patients with aortic valve disease and reducing overall healthcare expenditures.
This study will serve as a model to promote personalized medicine among both cardiovascular
and non-cardiovascular disease states.
This study involves three primary comparisons. The first is a treatment comparison of
surgical vs. transcatheter AVR on short and intermediate-term outcomes (stratified across
important population subgroups)—important because the results will inform treatment
discussions and decisions in vulnerable patients. The second is a comparison of outcomes
across comorbidity sets using risk models—important because the resulting decision assistance
tools will provide personalized estimates of risk to patients, caregivers, and providers as
they select a treatment strategy. The third is an impact evaluation of an educational
resource, including comparison of the change in treatment selection patterns and clinical
outcomes across hospitals and geographic regions with high vs. low use of a web based
educational resource—important because the comparison will provide critical pilot information
to evaluate and tailor the resource impact.
Inclusion Criteria:
- 'operable' transcatheter AVR patients enrolled in the TVT Registry (Nov 2011 -Dec
2013)
- surgical AVR patients with a STS perioperative risk of mortality (PROM) ≥4% whose
index procedure is included in the STS ACSD (Jan 2011 - Dec 2013)
Exclusion Criteria:
- We will exclude patients with endocarditis or emergency/salvage status because these
patients are rarely treated using transcatheter AVR in the United States (<0.2%
incidence of either condition during the first year of TVT Registry data).
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