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Study Questions Ability of TAVR to Improve Psychological, General Health

By L.A. McKeown

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Transcatheter aortic valve replacement (TAVR) results in clinically meaningful improvements in symptoms, physical function, and some disease-specific measures of quality of life (QoL) compared with surgery or medical therapy. However, any improvement in psychological or general health appears modest, according to a study published in the February 2014 issue of Annals of Internal Medicine.

Dae Hyun Kim, MD, MPH, of Beth Israel Deaconess Medical Center (Boston, MA), and colleagues examined functional status and QoL after TAVR in 62 studies (60 observational, 2 randomized) totaling 11,205 patients. The papers were published from January 2002 through September 2013.

Functional and Physical Gains Seen

Most studies found a clinically important mean decrease in New York Heart Association (NYHA) class with TAVR at 6 to 11 months (range, -0.8 to -2.1 classes), 12 to 23 months (range, -0.8 to -2.1 classes), 24 to 35 months (range, -1.2 to -2.6 classes), and 36 months or more (range, -1.2 to -1.6 classes). However, several studies showed a mean change of less than 1 NYHA class and a lower 95% confidence interval limit near 0, indicating that a large proportion of patients did not improve after TAVR.

NYHA class improvements also were seen with surgical aortic valve replacement (SAVR) at 6 to 11 months (range, -1.5 to -1.7 classes), 12 to 23 months (range, -0.9 to -1.7 classes), and 24 months (-1.7 classes). With conservative treatment, the mean change was less than 1 NYHA class.

Studies that looked at other disease-specific measures and physical function also reported clinically important changes with TAVR. The Short Form-12/36 Health Survey physical component summary, for example, improved at 6 to 11 months (range, 6.3 to 18.4 points) and 12 months (range, 4.9 to 26.9 points), with a smaller change in the mental component summary (range, 1.0 to 8.9 points).

Only the PARTNER trial assessed changes in Short Form-12/36 Health Survey scores for SAVR and conservative treatment. SAVR patients showed clinically important improvements in the physical and mental component summaries at 6 to 11 months (7.1 points and 3.9 points, respectively) and at 12 months (5.6 points and 4.4 points, respectively). Conservatively treated patients had little improvement in either of these scores.

NYHA Not the Full Picture

“On the basis of our review of current literature, we conclude that TAVR provides a clinically meaningful improvement in symptoms, physical function, and disease-specific measures of quality of life compared with conservative treatment,” the study authors write. “The psychological or general health benefits seem to be modest.”

They observe that the analysis calls into question whether a subjective measure such as NYHA class “is sensitive enough to capture the overall effect of severe [aortic stenosis] and treatment on patients’ quality of life and ability to perform routine daily activities.” They suggest that NYHA class be supplemented with other validated instruments of functional status and QoL.

However, Dr. Kim and colleagues say these results as a whole “suggest that TAVR alleviates symptoms and improves physical function and quality of life compared with conservative treatment.”

Of concern, they add, is the need to evaluate overall treatment effectiveness of TAVR in older patients. “Identifying patients who are most likely to have survival and functional benefits is critical to achieve optimum health outcomes and prevent avoidable harms,” they write. “More research is needed to develop a better classification algorithm that predicts procedural success as well as long-term survival and functional benefits.”

‘Apples to Oranges’

“One of the major limitations of this work is that the data are from such a wide time frame, spanning the evolution of TAVR,” said Philippe Généreux, MD, of Columbia University Medical Center (New York, NY), in a telephone interview with TCTMD. “In the early years we were not carefully collecting quality of life metrics the way we do today. That makes a study like this questionable. . . . [Y]ou can’t say TAVR didn’t have an impact on quality of life when you are looking at studies that didn’t even collect that type of data.”

He added that the comparison of first-generation TAVR devices, techniques, and patient selection with modern TAVR is another issue that adds an “apples and oranges” feel to the study. “You just can’t look at where we started with TAVR and compare that with where we are today because it’s just a world of difference,” Dr. Généreux stressed.

He agreed with the study authors’ assessment, however, that more precise tools and neuropsychological measures are needed to assess the effects of treatment on specific aspects of QoL.

“We definitely need head-to-head psychological testing of TAVR vs SAVR patients in the modern era before any absolute conclusion can be made,” Dr. Généreux said. “Those data will come from work being done now, not from compiling the history of all TAVR patients since the beginning, many of whom were so sick they had no other option.”

 

Source:

Kim CA, Rasania SP, Afilalo J, et al. Functional status and quality of life after transcatheter aortic valve replacement: a systematic review. Ann Intern Med. 2014;160:243-254.

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Disclosures
  • Dr. Kim reports having received grants to his institution from the National Institutes of Health and The Medical Foundation, a division of Health Resources in Action.
  • Dr. Généreux reports receiving speaker fees from Edwards Lifesciences.

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