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Literature Review

Quality-of-Life Outcomes After Transcatheter Aortic Valve Replacement in an Unselected Population: A Report From the STS/ACC Transcatheter Valve Therapy Registry

Arnold SV, Spertus JA, Vemulapalli S, et al. JAMA Cardiol. 2017;2(4):409-416.

Reviewer: Gautam Sreeram, MD1

  1. Assistant professor in anesthesiology, Emory University School of Medicine, Atlanta, GA
Background

Early clinical trials have demonstrated that transcatheter aortic valve replacement (TAVR) improves survival in carefully selected patient populations. Recently, indications for TAVR have expanded alongside the rapid growth in the number of centers performing this procedure. This study examines the effect of TAVR on symptoms, functional status, and quality of life (QOL) in an unselected patient population.

Methods

An observational cohort study of patients with severe aortic stenosis undergoing TAVR was performed using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry from November 1, 2011, to March 31, 2016. Health status was determined at baseline, 30 days, and 1 year after TAVR using the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score. Designed to describe and monitor symptoms, functional status, and QOL, the KCCQ is a patient-reported, disease specific health survey. The 12-item version included in the TVT Registry focuses on physical limitation, symptom frequency, QOL, and social limitations to produce an overall score from 0 to 100 points, with higher scores indicating reduced symptom burden and improved quality of life. KCCQ-OS scores were assessed as very poor (<25), poor (25–49), fair (50–74), and good (>75) QOL. A change in the KCCQ-OS score of more than 20 points was felt to reflect a large clinical improvement. First-year analyses were limited to sites with at least 50% completion rates for KCCQ data. Paired t-tests were used to evaluate changes in KCCQ-OS scores from baseline to 30 days and 1 year. Multivariable linear regression was used to assess factors associated with health status 1 year after TAVR with adjustment for baseline health status. 

Results

A total of 31 636 patients were included in the 30-day analytic sample, and the 1-year cohort included 7014 surviving patients (3454 women [49.2%] and 3560 men p50.8%]; median age 84 [78–88] years). Substantial impairment of health status was noted at baseline by a mean (SD) KCCQ-OS score of 42.3. Following TAVR, large improvements in health status were noted at 30 days, persisting until 1 year, with a mean improvement in the KCCQ-OS score of 27.6 (95% CI, 27.3-27.9) points at 30 days and 31.9 (95% CI, 31.3-32.6) points at 1 year. Older age, higher ejection fraction, lung disease, home oxygen use, lower mean aortic valve gradients, previous stroke, atrial fibrillation, diabetes, pacemaker use, slow gait speed, nonfemoral access, and worse baseline health status were all associated with worse health status at 1 year. Favorable outcomes at 1 year (alive with reasonable QOL [KKCCQ-OS score >60] and no significant decline [>10 points]) from baseline were present in 62.3% of patients, with lower rates seen in patients found to have severe lung disease (51.4%), dialysis dependence (47.4%), or poor baseline health status (49.2%). 

Discussion

Improvement in QOL is a key determinant for patients electing to undergo surgical procedures. TAVR trials began as a novel procedure in carefully controlled cohorts and hospital centers. This study examined the health status benefits in an expanding, increasingly elderly commercial patient population. 

Conclusion

The benefits of TAVR appear to extend beyond the original patient populations studied in carefully controlled clinical trials to the much larger U.S. population undergoing the procedure in a variety of hospital settings. Health status results were favorable for approximately 2 in 3 patients. Quality of life data at 1 year indicate significant symptom benefit in the majority of patients.

Comments

Landmark clinical trials such as the PARTNER (Placement of Aortic Transcatheter Valve) and CoreValve trials have demonstrated that patients at high risk have improvements in survival and major complications when undergoing TAVR versus open surgery.1,2 Since then, increased emphasis has been placed on examining the effects of TAVR on health status benefits such as symptomatology and QOL from a patient perspective. An increasingly elderly patient population undergoing this procedure makes examination of these outcomes critical.

The use of the TVT registry data collected from more than 450 clinical sites since 2102 provides a unique opportunity for a broader assessment of clinical patient outcomes. However, it is important to keep in mind several caveats to the use of the TVT registry in its current form. First, accurate assessment of symptomatology and QOL often is challenging. Recall of symptoms by both clinicians and patients may vary over time, and these symptoms often have more than one cause.3

Standardization and complete reporting also is critical. Unfortunately, there was a large amount of missing QOL data in the TVT registry. The rate of missing KCCQ data in the TVT registry was 18.3% at baseline, 30.6% at 30 days, and 55.7% at 1 year. This is problematic for several reasons. Patients with missing QOL data at 1 year may have had lower QOL data scores before TAVR than those with QOL data present. Furthermore, patients who die before 1 year do not have QOL data reported at all.

Second, as noted by the authors, the TVT registry did not include dementia and disability which would have been important factors to include as covariates in the multivariable model. As a result, the use of the TVT registry in this study may have overstated the true patient health status benefits of TAVR.4 Although overall outcomes were favorable, it is important to also keep in mind that 1 in 3 patients still had poor outcomes 1 year after TAVR. Along with more complete data collection, continued focus on periprocedural and postoperative care is essential to increase favorable outcomes after TAVR.

References
  1. Reynolds MR, Magnuson EA, Lei Y, et al. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011;124(18):1964-1972.
  2. Arnold SV, Reynolds MR, Wang K, et al. Health status after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis at increased surgical risk: results from the CoreValve US Pivotal Trial. JACC Cardiovasc Interv. 2015;8(9):1207-1217.
  3. Alexander KP. Assessing the utility of trancatheter aortic valve replacement. JAMA Cardiol. 2017;2(4):416-417.
  4. Bonow R, O’Gara P. Quality of life after transcathter aortic valve replacement. JAMA Cardiol. 2017;2(4):418.

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