Results Summary

What was the research about?

The aortic valve controls the flow of blood from the heart to the rest of the body. With aortic valve disease, the aortic valve doesn’t work well to control blood flow. Patients can experience fatigue, chest pressure, and shortness of breath. Aortic valve disease can also cause heart failure and other life-threatening problems.

Two common treatments for aortic valve disease are

  • Transcatheter aortic valve replacement, or TAVR. In TAVR, doctors wedge a catheter, or replacement valve, into the aortic valve’s location. TAVR doesn’t involve major surgery.
  • Surgical aortic valve replacement, or SAVR. In SAVR, doctors remove the damaged aortic valve and replace it with a new valve, most often through open-heart surgery.

In this study, the research team compared patients with aortic valve disease who had either TAVR or SAVR. The team looked at health records to see where patients received care after treatment, the number of days patients spent at home without going back to the hospital, and the risk for stroke and death.

What were the results?

Compared with patients who received SAVR, patients who received TAVR were

  • More likely to go directly home. Of patients who received TAVR, 70 percent went directly home compared with 41 percent of patients who received SAVR.
  • Less likely to go somewhere else for care, like a rehab center. Of patients who received TAVR, 21 percent went somewhere else compared with 41 percent of patients who received SAVR.

Up to one year after their treatment, patients who received TAVR and patients who received SAVR didn’t differ in the number of days they spent at home without going back to the hospital. Patients also didn’t differ in the risk for stroke and death.

Who was in the study?

The study included health records for 9,464 patients who had either TAVR or SAVR to treat aortic valve disease. Patients were ages 77 to 85 and lived across the United States. Before treatment, patients were at medium or high risk of needing surgical valve replacement. The average age was 82, and 52 percent were men.

What did the research team do?

The research team compared health records of patients who had TAVR from 2014 to 2015 with health records of patients who had SAVR from 2011 to 2013. The team looked at how well the patients were doing one year after their treatment.

Patients who received TAVR or SAVR and their caregivers were involved in all parts of the study.

What were the limits of the study?

The study looked at data in patients’ health records for one year after treatment. Results may differ if the study looked at patients for a longer time period. Factors other than the type of treatment, such as support from family and friends, may affect study results. Also, the study included patients ages 77 to 85. Results may differ for younger patients.

Future research could look at patients’ health for longer than one year after treatment.

How can people use the results?

Doctors and patients with aortic valve disease can use these results when considering treatments.

Final Research Report

View this project's final research report.

More About This Research

PCORI Stories

A Less-Invasive Way to Replace a Heart Valve: Is Newer Better? (right)
A nonsurgical method to replace the aortic valve turned out as safe as surgery and allowed more patients to go home from the hospital, rather than to a nursing home or rehabilitation facility.

Videos

Aortic Valve Disease Study Focuses on Patients’ Quality of Life
Asking patients about what health outcomes mattered most to them helped guide the focus of this PCORI-funded study comparing two treatment options for replacing the aortic valve, one surgical and one less invasive.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers asked how blank clinical data fields might change results that users receive from the decision aid developed in this study. The researchers responded that generally there are three options in such cases: giving users an error message; generating an estimated value for the missing fields, in a way that requires a great deal of computing power; or assigning an average value for the missing data based on other data from the patient, which uses less computing power while allowing the user to personalize their risk estimate as much as possible. The researchers chose the third option but cautioned that their approach requires patients to use the tool’s results as only a starting point for discussions with their providers.
  • The reviewers noted that because transcatheter aortic valve replacement (TAVR) is a more recent technology than surgical aortic valve replacement (SAVR), data from the cohort that underwent TAVR were more recent than the data from the cohort that underwent SAVR. The researchers agreed that the different time frames over which they collected data for the two groups was a limitation but said it was necessary. The researchers also said they did not expect the difference to have altered results substantially because outcomes for the SAVR procedure had been relatively stable.
  • The reviewers asked why separate cohorts were not used to develop and test the decision model. The researchers agreed that this might lead to overestimating how well the models actually fit the data and added text to the limitations section explaining their reasoning. They explained that they did not have enough participants to allow for entirely independent cohorts when developing and testing the model.

Conflict of Interest Disclosures

View the COI disclosure form.

Stories and Videos

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers asked how blank clinical data fields might change results that users receive from the decision aid developed in this study. The researchers responded that generally there are three options in such cases: giving users an error message; generating an estimated value for the missing fields, in a way that requires a great deal of computing power; or assigning an average value for the missing data based on other data from the patient, which uses less computing power while allowing the user to personalize their risk estimate as much as possible. The researchers chose the third option but cautioned that their approach requires patients to use the tool’s results as only a starting point for discussions with their providers.
  • The reviewers noted that because transcatheter aortic valve replacement (TAVR) is a more recent technology than surgical aortic valve replacement (SAVR), data from the cohort that underwent TAVR were more recent than the data from the cohort that underwent SAVR. The researchers agreed that the different time frames over which they collected data for the two groups was a limitation but said it was necessary. The researchers also said they did not expect the difference to have altered results substantially because outcomes for the SAVR procedure had been relatively stable.
  • The reviewers asked why separate cohorts were not used to develop and test the decision model. The researchers agreed that this might lead to overestimating how well the models actually fit the data and added text to the limitations section explaining their reasoning. They explained that they did not have enough participants to allow for entirely independent cohorts when developing and testing the model.

Project Information

J. Matthew Brennan, MD, MPH
Duke University
$1,913,610
10.25302/08.2020.CER-1306-04350

Key Dates

43 months
December 2013
January 2020
2013
2019

Study Registration Information

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Last updated: October 20, 2021