Division of Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
JAMA Intern Med. 2019 Mar 1;179(3):383-391. doi: 10.1001/jamainternmed.2018.6738.
Functional status is a patient-centered outcome that is important for a meaningful gain in health-related quality of life after aortic valve replacement.
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.
Preoperative comprehensive geriatric assessment was performed and a deficit-accumulation frailty index (CGA-FI) (range, 0-1; higher values indicate greater frailty) was calculated.
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.
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%]).
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.
功能状态是一种以患者为中心的结果,对于主动脉瓣置换术后健康相关生活质量的显著改善非常重要。
确定经导管主动脉瓣置换术(TAVR)和外科主动脉瓣置换术(SAVR)后 1 年内的功能状态轨迹。
设计、地点和参与者:这是一项前瞻性队列研究,对 246 名因严重主动脉瓣狭窄接受 TAVR 或 SAVR 的患者进行了为期 12 个月的随访。研究于 2014 年 2 月 1 日至 2017 年 6 月 30 日进行;数据分析于 2017 年 12 月 27 日至 2018 年 5 月 7 日进行。
术前进行全面老年评估,并计算出缺陷累积衰弱指数(CGA-FI)(范围为 0-1;数值越高表示衰弱程度越严重)。
在手术后 1、3、6、9 和 12 个月,通过电话访谈评估自我报告的进行 22 项活动和身体任务的能力。
在这项研究中,共有 246 名患者入组,其中 143 名接受了 TAVR(74[51.7%]名女性;平均[标准差]年龄为 84.2[5.9]岁),103 名接受了 SAVR(46[44.7%]名女性;年龄为 78.1[5.3]岁)。基于基线和随访期间的功能状态,确定了 5 种轨迹:基线表现优秀,随访时改善(优秀基线-改善)、良好(高基线-完全恢复)、中等(中度基线-最小下降)、较差(低基线-中度下降)和非常差(低基线-大幅度下降)。TAVR 后,最常见的轨迹是中等(54[37.8%]),其次是良好(33[23.1%])、较差(21[14.7%])、优秀(20[14.0%])和非常差(12[8.4%])轨迹。SAVR 后,最常见的轨迹是良好(39[37.9%]),其次是优秀(38[36.9%])、中等(20[19.4%])、较差(3[2.9%])和非常差(1[1.0%])轨迹。术前衰弱程度与功能改善的可能性降低和功能下降的可能性增加相关。TAVR 后,CGA-FI 水平为 0.20 或更低的患者有优秀(3[50.0%])或良好(3[50.0%])轨迹,而 CGA-FI 水平为 0.51 或更高的大多数患者有较差(10[45.5%])或非常差(5[22.7%])轨迹。SAVR 后,CGA-FI 水平为 0.20 或更低的大多数患者有优秀(24[58.5%])或良好(15[36.6%])轨迹,而 CGA-FI 水平为 0.41 至 0.50 的患者有中等轨迹(5[71.4%])。TAVR 后术后谵妄和主要并发症与功能下降相关(谵妄存在与不存在:14[50.0%]与 11[13.4%])或 SAVR 后缺乏改善(谵妄存在与不存在:27[69.2%]与 31[81.6%])。
研究结果表明,严重衰弱的老年患者接受 TAVR 或 SAVR 后,功能下降或无改善较为常见。虽然这项非随机研究不允许比较 TAVR 和 SAVR 的有效性,但预期的功能轨迹可能有助于以患者为中心的决策和围手术期护理,以优化功能结果。