Days at Home After Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients

Days at home, an emerging patient-centered outcome that quantifies time spent alive and out of health care facilities, has not been fully described in trials evaluating transcatheter aortic valve replacement (TAVR). We sought to compare the total number of days spent at home within the first year among intermediate-risk patients participating in a randomized clinical trial of TAVR with a self-expanding bioprosthesis vs surgical aortic valve replacement (SAVR).

In this comparative effectiveness research study, we performed a post hoc analysis between June 19, 2012, and June 30, 2018, of the Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients (SURTAVI) trial¹ linked to Medicare claims. The SURTAVI trial was a randomized clinical trial that occurred from June 19, 2012, to June 30, 2016, and involved data collected from 87 centers in the US, Europe, and Canada. Among 1660 participants in the present analysis, 355 (21.4%) were excluded (aged <65 years, index procedure at a Veterans Affairs or non-US hospital) and 702 (42.2%) were successfully linked to Medicare fee-for-service claims.^2,3 The cohorts available for analysis of days at home at 30 days, 90 days, and 1 year after the procedure and for the landmark analysis (patients who had fee-for-service coverage during the entire follow-up time or up to time of death) were 701, 700, 687, and 642 patients, respectively. This study was approved by the institutional review board at Beth Israel Deaconess Medical Center, Boston, Massachusetts, with a waiver of informed consent given the use of deidentified data.

The number of days at home at 1 year was calculated for each patient as follows: 365 − (mortality days + inpatient days + inpatient rehabilitation days + skilled nursing facility [SNF] days + long-term acute care hospital [LTAC] days + emergency department [ED] days + observation days).⁴ Inpatient, rehabilitation, SNF, and LTAC days were calculated using facility admission and discharge dates. Emergency department visits or observation days overlapping with a readmission were counted as inpatient days, and ED visits overlapping with observation claims were counted as observation days to count the most severe of the overlapping events; this method is used by the Centers for Medicare and Medicaid Services to count publicly reported condition-specific excess days in acute care.⁶ Each isolated ED visit was counted as 1 day.⁴ Observation stays are recorded in hours and were converted into whole days by rounding up. Mortality days represent the number of days lost to mortality and were calculated from the number of days remaining in the year after the date of death (eg, a patient who did not die during the year after the procedure would have 0 mortality days, whereas a patient who died 100 days after the procedure would have 265 mortality days. Days at home at 30 and 90 days after the procedure were also calculated. The rate of accumulation of days at home at 1 year was plotted. A landmark analysis from 1 year was performed. Analyses were conducted from July 13, 2020, to March 25, 2022, in SAS, version 9.4 (SAS Institute Inc) using a 2-tailed P < .05 to define significance.

The linked study population included 338 patients randomized to TAVR and 364 patients randomized to SAVR. This cohort of 702 patients included 404 men (57.5%) and 298 women (42.5%) and had a mean (SD) age of 80.3 (5.7) years. Baseline characteristics were similar between groups, including a mean (SD) age of 80.4 (5.6) years in the TAVR group and 80.2 (5.8) years in the SAVR group and also a mean (SD) Society of Thoracic Surgeons predicted risk of mortality score of 4.5 (1.5) in the TAVR group and 4.6 (1.6) in the SAVR group. In the 687 patients available for 1-year analysis (TAVR group, n = 333; SAVR group, n = 354), the mean (SD) number of days at home at 1 year was higher in the TAVR group vs the SAVR group (340.8 [57.1] vs 326.2 [70.4] days; difference, 14.7 days [95% CI, 5.1-24.2 days]; P = .003) (Table). Compared with the SAVR group, patients undergoing TAVR had a shorter index length of stay (mean [SD], 5.4 [2.7] vs 9.1 [4.8] days; P < .001) and fewer days in facilities after discharge from the index hospitalization (mean [SD], 9.2 [21.0] vs 16.0 [27.2] days; P < .001), including fewer days in an SNF (mean [SD], 4.6 [14.1] vs 9.9 [20.7] days; P < .001) and in rehabilitation (mean [SD], 0.1 [1.7] vs 0.5 [2.8] days; P = .02). Both groups had similar readmission days (mean [SD], 3.5 [7.8] vs 4.5 [9.5] days; P = .15), LTAC days (mean [SD], 0.3 [3.4] vs 0.5 [3.3] days; P = .59), ED days (mean [SD], 0.5 [0.9] vs 0.5 [1.2] days; P = .90), and observation days (mean [SD], 0.2 [0.6] vs 0.2 [0.6] days; P = .97).

The number of days at home 30 days after the procedure was higher in the TAVR group (n = 337) compared with the SAVR group (n = 364) (mean [SD], 21.8 [7.6] vs 14.3 [9.3] days; P < .001) as was the number 90 days after the procedure (TAVR group, n = 336; SAVR group, n = 364) (mean [SD], 78.7 [15.4] vs 68.7 [20.1] days; P < .001). The rate of accumulation of days at home at 1 year in the SAVR group diverged from that in the TAVR group early after the index procedure (Figure, B). Landmark analysis (TAVR group, n = 311; SAVR group, n = 331) showed more days at home in the SAVR group between years 1 and 2 (TAVR group vs SAVR group: mean [SD], 343.5 [65.8] vs 353.5 [43.2] days; difference, 10.0 days [95% CI, 1.3-18.6]; P = .03). After discharge from the index hospitalization, the proportion of patients who were alive at 1 year without additional facility days was higher in the TAVR group vs the SAVR group (134 of 333 patients [40.2%] vs 106 of 354 [29.9%]; P = .005).

The findings of this comparative effectiveness research study examining the SURTAVI trial linked to Medicare claims data suggest that intermediate-risk patients undergoing TAVR had approximately 15 more days at home 1 year after the procedure compared with those undergoing SAVR as a result of shorter index hospitalizations and fewer days in SNFs and rehabilitation. Much of the difference accrued by day 90, reflecting the expected early postprocedural course of TAVR vs SAVR, with attenuation between years 1 and 2.

In the SURTAVI trial, TAVR was noninferior to SAVR for the combined outcome of death or stroke at 24 months (12.6% vs 14.0%)¹; however, days at home at 1 year, an unconventional end point that captures the ability to live independently in the community, was higher among patients in the TAVR group, suggesting a net benefit not readily observed through the examination of traditional end points. Furthermore, days at home could be applied to other treatment comparisons, as the continuous nature of this end point increases the power to detect differences between trial arms compared with typical binary outcomes.

This study has limitations. It expands on prior work that assessed days at home in patients with similar risk who underwent TAVR or SAVR using only inpatient days,⁵ but its results may not be generalizable to higher- or lower-risk patients, patients younger than 65 years, or the real world. In summary, use of days at home at 1 year may complement traditional outcomes to inform decision-making for invasive procedures, including aortic valve replacement.

Accepted for Publication: August 18, 2021.

Published Online: October 20, 2021. doi:10.1001/jamacardio.2021.4036

Corresponding Author: Mabel Chung, MD, MPH, Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, 375 Longwood Ave, Fourth Floor, Boston, MA 02215 (mchung8@mgh.harvard.edu).

Correction: This article was corrected on June 29, 2022, after conducting a repeat analysis excluding Medicare Advantage patients.

Author Contributions: Drs Chung and Yeh had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Chung, Faridi, Kazi, Yeh.

Acquisition, analysis, or interpretation of data: Chung, Faridi, Kazi, Almarzooq, Song, Baron.

Drafting of the manuscript: Chung, Faridi.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Song.

Obtained funding: Yeh.

Administrative, technical, or material support: Almarzooq, Song.

Supervision: Kazi, Yeh.

Conflict of Interest Disclosures: Dr Faridi reported receiving a grant from the National Institutes of Health (NIH) Clinical and Translational Science Award outside the submitted work. Dr Baron reported receiving consulting fees from Abbott, Abiomed, Edwards LifeSciences, and MitraLabs outside the submitted work as well as speaker fees from and advisory board membership with Boston Scientific Corp. Dr Yeh reported receiving grants from AstraZeneca, BD Bard, Boston Scientific, Cook, Medtronic, and Philips and consulting fees from Abbott, Boston Scientific, Edwards, Medtronic, and Shockwave Medical outside the submitted work. No other disclosures were reported.

Funding/Support: The study was funded by T32 funding (T32-GM007592) from the NIH (Dr Chung) and an investigator-initiated grant from Medtronic.

Role of the Funder/Sponsor: The SURTAVI trial was sponsored by Medtronic. Medtronic had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation of the manuscript; and decision to submit the manuscript for publication. Medtronic reviewed and approved the manuscript.

Additional Contributions: We are grateful to Neel M. Butala, MD, MBA (Cardiology Division, Department of Medicine, Massachusetts General Hospital), for assistance with concept and design, interpretation of data, and critical revision of the manuscript; Laura Burke, MD, MPH (Department of Emergency Medicine, Beth Israel Deaconess Medical Center), for assistance with interpretation of data and critical revision of the manuscript; Rishi K. Wadhera, MD, MPP, MPhil(Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center), for assistance with interpretation of data and critical revision of the manuscript; Dingning Liu, MA(Baim Institute for Clinical Research), for assistance with statistical analysis; and Changyu Shen, PhD(Biogen), for assistance with concept and design, interpretation of data, and critical revision of the manuscript. None of these individuals were financially compensated for their contributions.