(PC012) Long-Term Trends in Quality of Life in Patients Who Undergo Branched Endovascular Repair of Pararenal and Extent IV Thoracoabdominal Aortic Aneurysms

Objectives: The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis(TAMBE) is the first FDA-approved device for treatment of thoracoabdominal(TAAA) and pararenal(PAA) aortic aneurysms. Branched/fenestrated endovascular repair has become the mainstay treatment for TAAA/PAA, yet little is known about its impact on patient quality of life(QoL). Our objective was to analyze patient long-term QoL trends in the TAMBE pivotal clinical trial.

Methods: The multicenter, prospective TAMBE pivotal trial enrolled patients with extent IV TAAA and PAA. Health-related QoL was assessed using the RAND 36-Item Health Survey(SF36) at baseline and at 1-, 3-, 6-, and 12- months post-operatively. QoL composite scores were compared across these domains: physical functioning, role limitations due to physical health, role limitations due to emotional health, energy/fatigue, emotional well-being, social functioning, pain, and general health. Patient characteristics were summarized using descriptive statistics and mean QoL scores were compared across study timepoints using paired t-tests.

Results: 121 patients underwent repair with TAMBE: mean age 73 years (range 57-89 years), male 109(84.5%), White race 116(92.1%), median Body Mass Index 27.5 kg/m2 (range 17.0–46.5 kg/m2). 70(58.7%) patients had an extent IV TAAA and 50(41.3%) had a PAA. Of all patients, 113(87.6%) completed the SF36 through one year of follow-up. 94(77.7%) patients were considered low versus high frailty risk, 21(17.4%) patients experienced a branch vessel/graft occlusion, and 29(24%) patients underwent a reintervention. Following TAMBE, QoL domain scores noted a drop at 1 month post-operatively, most pronounced in limitations due to physical health. QoL in all domains recovered towards baseline by 3 months post-operatively (Figure 1). Interestingly, QoL in all domains gradually declined in the long term over one year, but did not reach statistical significance (Table 1). Mean SF36 domain scores at baseline for the TAMBE cohort were similar to those of the general population (Table 1). For each domain, there were no differences in mean scores at any time point between patients who a) had a PAAA vs. Type IV TAAA (p=NS), b) had a branch occlusion versus not (p=NS), or c) underwent reintervention or not (p=NS).

Conclusions: In the TAMBE pivotal trial, patients had similar pre-screening QoL compared to the general population. They sustained an immediate drop in all QoL domains, especially physical health, but recovered by 3 months post-operatively. Aneurysm extent, branch occlusion or reinterventions did not impact this postoperative QoL trends. Patients who undergo TAMBE exhibit a gradual decline in health-related QoL over the long term.