Evaluation of Changes in Functional Status in the Year After Aortic Valve Replacement

Abstract

Importance: Functional status is a patient-centered outcome that is important for a meaningful gain in health-related quality of life after aortic valve replacement.

Objective: To determine functional status trajectories in the year after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).

Design, setting, and participants: A prospective cohort study with a 12-month follow-up was conducted at a single academic center in 246 patients undergoing TAVR or SAVR for severe aortic stenosis. The study was conducted between February 1, 2014, and June 30, 2017; data analysis was performed from December 27, 2017, to May 7, 2018.

Exposures: Preoperative comprehensive geriatric assessment was performed and a deficit-accumulation frailty index (CGA-FI) (range, 0-1; higher values indicate greater frailty) was calculated.

Main outcomes and measures: Telephone interviews were conducted to assess self-reported ability to perform 22 activities and physical tasks at 1, 3, 6, 9, and 12 months after the procedure.

Results: Of the 246 patients included in the study, 143 underwent TAVR (74 [51.7%] women; mean [SD] age, 84.2 [5.9] years), and 103 underwent SAVR (46 [44.7%] women; age, 78.1 [5.3] years). Five trajectories were identified based on functional status at baseline and during the follow-up: from excellent at baseline to improvement at follow-up (excellent baseline-improvement), good (high baseline-full recovery), fair (moderate baseline-minimal decline), poor (low baseline-moderate decline), and very poor (low baseline-large decline). After TAVR, the most common trajectory was fair (54 [37.8%]), followed by good (33 [23.1%]), poor (21 [14.7%]), excellent (20 [14.0%]), and very poor (12 [8.4%]) trajectories. After SAVR, the most common trajectory was good (39 [37.9%]), followed by excellent (38 [36.9%]), fair (20 [19.4%]), poor (3 [2.9%]), and very poor (1 [1.0%]) trajectories. Preoperative frailty level was associated with lower probability of functional improvement and greater probability of functional decline. After TAVR, patients with CGA-FI level of 0.20 or lower had excellent (3 [50.0%]) or good (3 [50.0%]) trajectories, whereas most patients with CGA-FI level of 0.51 or higher had poor (10 [45.5%]) or very poor (5 [22.7%]) trajectories. After SAVR, most patients with CGA-FI level of 0.20 or lower had excellent (24 [58.5%]) or good (15 [36.6%]) trajectories compared with a fair trajectory (5 [71.4%]) in those with CGA-FI levels of 0.41 to 0.50. Postoperative delirium and major complications were associated with functional decline after TAVR (delirium present vs absent: 14 [50.0%] vs 11 [13.4%]; complications present vs absent: 14 [51.9%] vs 19 [16.4%]) or lack of improvement after SAVR (delirium present vs absent: 27 [69.2%] vs 31 [81.6%]; complications present vs absent: 10 [62.5%] vs 69 [79.3%]).

Conclusions and relevance: The findings suggest that functional decline or lack of improvement is common in older adults with severe frailty undergoing TAVR or SAVR. Although this nonrandomized study does not allow comparison of the effectiveness between TAVR and SAVR, anticipated functional trajectories may inform patient-centered decision making and perioperative care to optimize functional outcomes.

Figure 1.. Functional Status Trajectories in the Year After Aortic Valve Replacement

The functional status composite score represents the number of daily activities and physical tasks that a patient could perform without assistance (range, 0-22). Functional status trajectories were identified using a group-based trajectory model based on functional status at baseline and during the follow-up: excellent (excellent baseline to improvement) (n = 58; mortality, 3.5%), good (high baseline to full recovery) (n = 72; mortality, 2.9%), fair (moderate baseline to minimal decline) (n = 74; mortality, 9.9%), poor (low baseline to moderate decline) (n = 24; mortality, 25.0%), and very poor (low baseline to large decline) (n = 13; mortality, 69.2%).

Figure 2.. Functional Status Trajectories by Procedure

Functional status trajectories of patients after transcatheter aortic valve replacement (TAVR) in 143 patients (A) and surgical aortic valve replacement (SAVR) in 103 patients (B). In the absence of randomization, these results cannot be used to compare the effectiveness of TAVR vs SAVR on functional status.

Figure 3.. Functional Status Trajectories by Postoperative Complications

A, Postoperative complications with transcatheter aortic valve replacement (TAVR) in patients with (n = 27) and without (n = 116) major complications and with (n = 28) and without (n = 82) delirium. B, Postoperative complications with surgical aortic valve replacement (SAVR) in patients with (n = 16) and without (n = 87) major complications and with (n = 39) and without (n = 38) delirium. In the absence of randomization, these results cannot be used to compare the effectiveness of TAVR vs SAVR on functional status. A composite end point of major complications was defined as any occurrence of the Society of Thoracic Surgeons major morbidity or mortality (operative mortality, stroke, acute kidney injury, prolonged ventilation, deep sternal wound infection, or reoperation) or the Valve Academic Research Consortium-2 early safety end point (mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, or valve-related dysfunction requiring repeat procedure). Because delirium assessment was added to the study protocol 8 months after the cohort began, delirium data were available in 110 TAVR and 77 SAVR patients.