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Functional Status and Quality of Life After Transcatheter Aortic Valve Replacement: A Systematic Review

Caroline A. Kim, MD, MS; Suraj P. Rasania, MD; Jonathan Afilalo, MD, MSc; Jeffrey J. Popma, MD; Lewis A. Lipsitz, MD; and Dae Hyun Kim, MD, MPH
[+] Article and Author Information

From Beth Israel Deaconess Medical Center, Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, and Harvard School of Public Health, Boston, Massachusetts; Jewish General Hospital and McGill University, Montreal, Quebec, Canada; and Geisinger Medical Center, Danville, Pennsylvania.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the Harvard Catalyst, Harvard University and its affiliated academic health care centers, or the National Institutes of Health.

Grant Support: Dr. Caroline A. Kim was supported by the Health Resources and Service, Administration (D01HP08794) and a John A. Hartford Foundation Center of Excellence Award. Dr. Rasania was supported by the Health Resources and Services Administration (D01HP08794). Dr. Lipsitz was supported by the National Institute on Aging (R37-AG025037). Dr. Dae Hyun Kim was supported by The Medical Foundation, a division of Health Resources in Action (Charles A. King Trust Postdoctoral Fellowship Award) and the Harvard Catalyst, the Harvard Clinical and Translational Science Center, which received funding from the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health (1KL2 TR001100-01) (KL2 Medical Research Investigator Training award).

Potential Conflicts of Interest: Dr. C.A. Kim: Grants (money to institution): Health Resources and Services Administration and John A. Hartford Foundation. Dr. Rasania: Grant (money to institution): Health Resources and Services Administration. Dr. Popma: Grants (money to institution): Medtronic, Boston Scientific, Cordis, Covidien, Abiomed, Cook, and Abbott Vascular; Personal fees: Boston Scientific, Cordis, Covidien, and Abbott Vascular. Dr. D.H. Kim: Grants (money to institution): National Institutes of Health and The Medical Foundation, a division of Health Resources in Action. All other authors have no disclosures. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-1316.

Requests for Single Reprints: Dae Hyun Kim, MD, MPH, Division of Gerontology, Beth Israel Deaconess Medical Center, 110 Francis Street, Suite 1B, Boston, MA 02215; e-mail, dkim2@bidmc.harvard.edu.

Current Author Addresses: Drs. C.A. Kim, Lipsitz, and D.H. Kim: Beth Israel Deaconess Medical Center, 110 Francis Street, Suite 1B, Boston, MA 02215.

Dr. Rasania: Geisinger Medical Center, 100 North Academy Avenue, Danville, PA 17822.

Dr. Afilalo: Jewish General Hospital, 3755 Cote Sainte Catherine Road, Montreal, QC, Canada H3T 1E2.

Dr. Popma: Beth Israel Deaconess Medical Center, 185 Pilgrim Road, Boston, MA 02215.

Author Contributions: Conception and design: C.A. Kim, J.J. Popma, D.H. Kim.

Analysis and interpretation of the data: C.A. Kim, S.P. Rasania, J. Afilalo, J.J. Popma, L.A. Lipsitz, D.H. Kim.

Drafting of the article: C.A. Kim, S.P. Rasania, L.A. Lipsitz, D.H. Kim.

Critical revision of the article for important intellectual content: C.A. Kim, S.P. Rasania, J. Afilalo, L.A. Lipsitz, D.H. Kim.

Final approval of the article: C.A. Kim, J. Afilalo, J.J. Popma, L.A. Lipsitz, D.H. Kim.

Statistical expertise: D.H. Kim.

Administrative, technical, or logistic support: L.A. Lipsitz.

Collection and assembly of data: C.A. Kim, S.P. Rasania, D.H. Kim.


Ann Intern Med. 2014;160(4):243-254. doi:10.7326/M13-1316
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Background: The functional and quality-of-life benefits of transcatheter aortic valve replacement (TAVR) have not been established.

Purpose: To evaluate the changes in functional status and quality of life after TAVR.

Data Sources: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from 1 January 2002 to 30 September 2013.

Study Selection: Studies of TAVR that reported the New York Heart Association (NYHA) class, Short Form-12/36 Health Survey physical and mental component summary (points), or other measures of functional status.

Data Extraction: Two reviewers independently extracted the mean change (follow-up minus baseline) in primary outcomes. Because of substantial heterogeneity, data were not pooled; the range of mean change was summarized.

Data Synthesis: We identified 60 observational studies (56 pre–post comparison and 4 head-to-head comparative studies) and 2 randomized, controlled trials (11 205 patients). Most studies showed a clinically important decrease in NYHA class at 6 to 11 months (range, −0.8 to −2.1 classes) and 12 to 23 months (range, −0.8 to −2.1 classes). The improvement in the Short Form-12/36 Health Survey physical component score was clinically important over 12 months (range, 4.9 to 26.9 points), and the change in mental component score was smaller (range, 1.0 to 8.9 points). Clinically important improvements were seen in other disease-specific measures but were less consistently seen in general health measures.

Limitations: Comparative evidence is limited by few head-to-head studies. Survivor bias may have overestimated the benefits.

Conclusion: Transcatheter aortic valve replacement provides clinically important benefits in physical function and disease-specific measures of quality of life but modest benefits in psychological and general health measures. More comparative studies on functional status and quality of life are needed for informed treatment decision making.

Primary Funding Source: Health Resources and Services Administration and Health Resources in Action.

Figures

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Appendix Figure 1.

Summary of evidence search and selection.

6MWT= 6-minute walk test; ADL = Activities of Daily Living; EQ-5D = EuroQol-5D; KCCQ = Kansas City Cardiomyopathy Questionnaire; MLHFQ = Minnesota Living With Heart Failure Questionnaire; NYHA = New York Heart Association; SF = Short Form; TAVR = transcatheter aortic valve replacement.

* In some cases, >1 study originated from the patient population.

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Appendix Figure 2.

Summary of quality assessment.

Study quality assessment was based on the following 6 criteria from the Newcastle-Ottawa Scale: representativeness of the transcatheter aortic valve replacement patients, selection of the comparison patients, adjustment for the difference in functional outcome of interest at baseline (for studies with comparison group), adjustment for the difference in LV systolic function at baseline (for studies with comparison group), assessment of functional outcomes, and adequacy of follow-up. Insufficient information to judge its adequacy was considered inadequate. LV = left ventricular.

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Figure 1.

Change in the NYHA functional class from baseline to 6–11 mo.

NYHA = New York Heart Association; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement.

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Figure 2.

Change in the NYHA functional class from baseline to 12–23 mo.

NYHA = New York Heart Association; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement.

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Appendix Figure 3.

Change in the NYHA functional class over 24 mo.

NYHA = New York Heart Association; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement.

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Figure 3.

Change in the SF-PCS score.

SAVR = surgical aortic valve replacement; SF-PCS = Short Form physical component summary; TAVR = transcatheter aortic valve replacement.

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Figure 4.

Change in the SF-MCS score.

SAVR = surgical aortic valve replacement; SF-MCS = Short Form mental component summary; TAVR = transcatheter aortic valve replacement.

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