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Transcatheter aortic valve replacement (TAVR) represents a transformative technology that has revolutionized the treatment of patients with symptomatic aortic stenosis. Transcatheter aortic valve replacement provides a therapeutic option for patients who are not candidates for surgical aortic valve replacement because of prohibitive risk associated with age, severe comorbid conditions, or frailty, who previously had no options other than a predictably poor outcome from progressive aortic stenosis. Clinical trials also show that patients who are surgical candidates but have intermediate or high surgical risk have immediate and 2- to 3-year mortality rates with TAVR that are equivalent or even superior to those achieved with surgery. Clinical trials further demonstrate very promising improvement in symptoms and well-being after TAVR.1,2 As TAVR rolls out beyond the trial setting to expanded clinical use, critically important questions will arise regarding the appropriate selection of elderly symptomatic patients who are most likely to benefit in terms of quality of life (QOL).
The Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy (TVT) Registry was implemented in 2012 to aid in postmarket TAVR surveillance and to respond to the Centers for Medicare and Medicaid Services National Coverage Determination requirement for national registry participation for Medicare reimbursement. Thus, the TVT Registry captures data for the vast majority of US patients undergoing TAVR. This carefully orchestrated national strategy, with emphasis on team-based care at the local level, has delivered effective and technically proficient results, with 30-day mortality rates matching those in closely monitored clinical trials.3 However, it must be ascertained whether TAVR is providing meaningful improvement in symptoms and QOL in the community.
The report by Arnold et al4 is thus a welcome analysis of the QOL data existing in the TVT Registry. The QOL data at 1 year (available in 30% of more than 23 000 eligible patients, with a median age of 84 years) indicate significant symptom benefit in most patients. These findings are comforting, but as noted in the commentary by Alexander,5 the amount of missing data are a conundrum, as patients in whom QOL information was not captured at 1 year had more severe disability and lower QOL scores before TAVR than those with QOL data. And of course, QOL data are not captured in those who died before 1 year. This suggests that the current TVT data may overestimate the true symptomatic benefit of TAVR in this elderly population. The editors believe these data are insightful, but we urge the TVT Registry to intensify its efforts for more comprehensive QOL outcome data collection so that the cardiology community has a fuller comprehension of the benefits of this expensive and resource-intensive technology.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Bonow RO, O’Gara PT. Quality of Life After Transcatheter Aortic Valve Replacement . JAMA Cardiol. 2017;2(4):418. doi:10.1001/jamacardio.2016.6002