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

Abstract

This comparative effectiveness research study uses Medicare claims data to examine the total number of days at home among intermediate-risk patients recovering from transcatheter aortic valve replacement (TAVR) vs patients recovering from surgical aortic valve replacement (SAVR).

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).

Methods

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 1005 (60.5%) were successfully linked to Medicare claims as previously described.^2,3 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 July 19, 2021, in SAS, version 9.4 (SAS Institute Inc) using a 2-tailed P < .05 to define significance.

Results

The final study population included 507 patients randomized to TAVR and 498 patients randomized to SAVR. The full cohort of 1005 patients included 579 men (57.6%) and 426 women (42.4%) and had a mean (SD) age of 80.4 (5.6) years. Baseline characteristics were similar between groups, including a mean (SD) age of 80.6 (5.6) years in the TAVR group and 80.2 (5.6) 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. The mean (SD) number of days at home at 1 year was higher in the TAVR group vs the SAVR group (339.3 [63.7] vs 330.5 [64.8] days; difference, 8.8 days [95% CI, 0.8-16.7 days]; P = .03) (Table). Compared with the SAVR group, patients undergoing TAVR had a shorter index length of stay (mean [SD], 5.4 [2.8] vs 9.1 [4.4] days; P < .001) and fewer days in facilities after discharge from the index hospitalization (mean [SD], 7.9 [18.7] vs 13.7 [24.5] days; P < .001), including fewer days in an SNF (mean [SD], 3.4 [12.1] vs 7.7 [18.5] days; P < .001) and in rehabilitation (mean [SD], 0.2 [1.9] vs 0.5 [2.7] days; P = .02). Both groups had similar readmission days (mean [SD], 3.6 [8.1] vs 4.5 [9.2] days; P = .11), LTAC days (mean [SD], 0.2 [2.7] vs 0.4 [3.4] days; P = .30), ED days (mean [SD], 0.3 [0.8] vs 0.4 [1.1] days; P = .26), and observation days (mean [SD], 0.1 [0.5] vs 0.1 [0.5] days; P = .79).

Table. Days at Home at 1 Year and Components in Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients (SURTAVI) Trial Participants Linked to Medicare Claims^a.

Days at home at 1 y and components	TAVR group (n = 507)	SAVR group (n = 498)	Difference (95% CI)	P value
Days at home at 1 y mean (SD)	339.3 (63.7)	330.5 (64.8)	8.8 (0.8 to 16.7)	.03
Median (IQR) [range]	358 (352-361) [0-363]	351 (336-357) [0-361]
Mortality days, mean (SD)	12.5 (59.1)	11.7 (56.5)	0.8 (−6.3 to 8.0)	.82
Median (IQR) [range]	0 (0-0) [0-361]	0 (0-0) [0-362]
Index LOS, mean (SD)	5.4 (2.8)	9.1 (4.4)	−3.7 (−4.2 to −3.3)	<.001
Median (IQR) [range]	5 (4-6) [2-27]	8 (6-10) [3-58]
Total facility days after discharge from the index hospitalization, mean (SD)	7.9 (18.7)	13.7 (24.5)	−5.9 (−8.6 to −3.2)	<.001
Median (IQR) [range]	1 (0-6) [0-197]	4 (0-17) [0-165]
Components of total facility days after discharge
Readmission days, mean (SD)	3.6 (8.1)	4.5 (9.2)	−0.9 (−2.0 to 0.2)	.11
Median (IQR) [range]	0 (0-4) [0-76]	0 (0-6) [0-79]
Rehabilitation days, mean (SD)	0.2 (1.9)	0.5 (2.7)	−0.3 (−0.6 to −0.1)	.02
Median (IQR) [range]	0 (0-0) [0-29]	0 (0-0) [0-22]
SNF days, mean (SD)	3.4 (12.1)	7.7 (18.5)	−4.4 (−6.3 to −2.4)	<.001
Median (IQR)	0.0 (0-0) [0-98]	0 (0-7) [0-134]
LTAC days, mean (SD)	0.2 (2.7)	0.4 (3.4)	−0.2 (−0.6 to 0.2)	.30
Median (IQR) [range]	0 (0-0) [0-41]	0 (0-0) [0-43]
ED days, mean (SD)	0.3 (0.8)	0.4 (1.1)	−0.1 (−0.2 to 0.0)	.26
Median (IQR) [range]	0 (0-0) [0-6]	0 (0-0) [0-12]
Observation days, mean (SD)	0.1 (0.5)	0.1 (0.5)	−0.0 (−0.1 to 0.1)	.79
Median (IQR) [range]	0 (0-0) [0-4]	0 (0-0) [0-3]

Abbreviations: ED, emergency department; LOS, length of stay; LTAC, long-term acute care hospital; SAVR, surgical aortic valve replacement; SNF, skilled nursing facility; TAVR, transcatheter aortic valve replacement.

^a Calculation of the different components is explained in the Methods section.

The number of days at home 30 days after the procedure was higher in the TAVR group compared with the SAVR group (mean [SD], 22.2 [7.1] vs 15.3 [8.9] days; P < .001) as was the number 90 days after the procedure (mean [SD], 79.0 [16.0] vs 70.5 [18.9] 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 showed no difference in days at home between groups between years 1 and 2 (TAVR group vs SAVR group: mean [SD], 347.9 [57.8] vs 353.2 [43.2] days; P = .11). 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 (232 of 507 patients [45.8%] vs 173 of 498 [34.7%]; P < .001).

Figure. Mean Days at Home Accrued Over 1 Year in Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients (SURTAVI) Trial Participants Linked to Medicare Claims.

A and B, Rate of accumulation of mean days at home after TAVR and SAVR. C and D, Landmark plots. Vertical lines indicate 95% CIs. SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.

Discussion

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 9 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. This difference accrued by day 90, reflecting the expected early postprocedural course of TAVR vs SAVR, but did not change thereafter.

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.