Prospective assessment of dynamic changes in frailty and its impact on early clinical outcomes following physician-modified fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

Frailty, a predictor of poor outcomes, has been widely studied as a screening tool in surgical decision-making. However, the impact of frailty on the outcomes after fenestrated-branched endovascular aortic repairs (FBEVARs) is less well established. In addition, the changes in frailty during recovery after FBEVAR are unknown. We aim to assess the impact of frailty on outcomes of high-risk patients undergoing physician-modified FBEVARs for complex abdominal and thoracoabdominal aortic aneurysms, as well as the changes in frailty during follow-up. Consecutive patients enrolled in a single-center prospective Physician-Sponsored Investigational Device Exemption protocol (FDA# G200159) were evaluated. In addition to the baseline characteristics, frailty was assessed using the Hopkins Frailty Score (HFS) and frailty index (FI) measured by the Frailty Meter. Sarcopenia was measured by L3 total psoas muscle area (PMA). These measurements were repeated during follow-up. The follow-up HFS and FI were compared with baseline scores using the Wilcoxon signed-rank test, whereas follow-up PMA measurements were compared with the baseline using the paired t test. The association between baseline frailty and morbidity was evaluated by the Wilcoxon rank-sum test. Seventy patients were analyzed in a prospective Physician-Sponsored Investigational Device Exemption study from February 9, 2021, to June 2, 2023. At baseline, HFS identified 54% of patients as not frail, 43% as intermediately frail, and 3% as frail. Technical success of FBEVAR was 94% with one in-hospital mortality. Early major adverse events were seen in 10 (14.3%) patients. No difference in baseline FI was seen between patients with early morbidity and those without. Patients who were not frail per HFS were less likely to experience early morbidity (P = .033), and there was a significantly lower baseline PMA in patients who experienced early morbidity (P = .016). At 1 month, patients experienced a significant increase in HFS and HFS category (P = .001 and P = .01) and a significant decrease in sarcopenia (mean PMA: -96 mm2, P = .005). At 6 months, HFS and HFS category as well as PMA returned toward baseline (P = .42, P = .38, and mean PMA: +4 mm2, P = .6). Preoperative frailty and sarcopenia were associated with early morbidity after physician-modified FBEVAR. During follow-up, patients became more frail and sarcopenic by 1 month. Recovery from this initial decline was seen by 6 months, suggesting that frailty and sarcopenia are reversible processes rather than a unidirectional phenomenon of continued decline.

Pyun AJ ，Ding L ，Hong YH ，Magee GA ，Tan TW ，Paige JK ，Weaver FA ，Han SM ... -  《-》

Comparative outcomes of physician-modified fenestrated-branched endovascular repair of post-dissection and degenerative complex abdominal or thoracoabdominal aortic aneurysms.

Fenestrated-branched endovascular repair has become a favorable treatment strategy for patients with complex abdominal aortic aneurysms (cAAAs) and thoracoabdominal aortic aneurysms (TAAAs) who are high risk for open repair. Compared with degenerative aneurysms, post-dissection aneurysms can pose additional challenges for endovascular repair. Literature on physician-modified fenestrated-branched endovascular aortic repair (PM-FBEVAR) for post-dissection aortic aneurysms is sparse. Therefore, the aim of this study is to compare the clinical outcomes of patients who underwent PM-FBEVAR for degenerative and post-dissection cAAAs or TAAAs. A single-center institutional database was retrospectively reviewed for patients that underwent PM-FBEVAR between 2015 and 2021. Infected aneurysms and pseudoaneurysms were excluded. Patient characteristics, intraoperative details, and clinical outcomes were compared between degenerative and post-dissection cAAAs or TAAAs. The primary outcome was 30-day mortality. The secondary outcomes included technical success, major complications, endoleak, target vessel instability, and reintervention. Of the 183 patients who underwent PM-FBEVAR in the study, 32 had aortic dissections, and 151 had degenerative aneurysms. There was one 30-day death (3.1%) in the post-dissection group and eight 30-day deaths (5.3%) in the degenerative aneurysm group (P = .99). Technical success, fluoroscopy time, and contrast usage were similar between the post-dissection and degenerative groups. Reintervention during follow-up (28% vs 35%; P = .54) and major complications were not statistically significantly different between the two groups. Endoleak was the most common reason for reintervention, with the post-dissection group having a higher rate of type IC, II, and IIIA endoleaks (31% vs 3%; P < .0001; 59% vs 26%; P = .0002; and 16% vs 4%; P = .03). During the mean follow-up of 14 months, all-cause mortality was similar between the groups (12.5% vs 21.9%; P = .23). PM-FBEVAR is a safe treatment for post-dissection cAAAs and TAAAs with high technical success. However, endoleaks requiring reintervention were more frequent in post-dissection patients. The impact of these reinterventions on long-term durability will be assessed with continued follow-up.

DiBartolomeo AD ，Pyun AJ ，Ding L ，O'Donnell K ，Paige JK ，Magee GA ，Weaver FA ，Han SM ... -  《-》

Outcomes of fenestrated and branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

More than 80% of infrarenal aortic aneurysms are treated by endovascular repair. However, adoption of fenestrated and branched endovascular repair for complex aortic aneurysms has been limited, despite high morbidity and mortality associated with open repair. There are few published reports of consecutive outcomes, inclusive of all fenestrated and branched endovascular repairs, starting from the inception of a complex aortic aneurysm program. Therefore, we examined a single center's consecutive experience of fenestrated and branched endovascular repair of complex aortic aneurysms. This is a single-center, prospective, observational cohort study evaluating 30-day and 1-year outcomes in all consecutive patients who underwent fenestrated and branched endovascular repair of complex aortic aneurysms (definition: requiring one or more fenestrations or branches). Data were collected prospectively through an Institutional Review Board-approved registry and a physician-sponsored investigational device exemption clinical trial (G130210). We performed 100 consecutive complex endovascular aortic aneurysm repairs (November 2010 to March 2016) using 58 (58%) commercially manufactured custom-made devices and 42 (42%) physician-modified devices to treat 4 (4%) common iliac, 42 (42%) juxtarenal, 18 (18%) pararenal, and 36 (36%) thoracoabdominal aneurysms (type I, n = 1; type II, n = 4; type III, n = 12; type IV, n = 18; arch, n = 1). The repairs included 309 fenestrations, branches, and scallops (average of 3.1 branch arteries/case). All patients had 30-day follow-up for 30-day event rates: three (3%) deaths; six (6%) target artery occlusions; five (5%) progressions to dialysis; eight (8%) access complications; one (1%) paraparesis; one (1%) bowel ischemia; and no instances of myocardial infarction, paralysis, or stroke. Of 10 type I or type III endoleaks, 8 resolved (7 with secondary intervention, 1 without intervention). Mean follow-up time was 563 days (interquartile range, 156-862), with three (3%) patients lost to follow-up. On 1-year Kaplan-Meier analysis, survival was 87%, freedom from type I or type III endoleak was 97%, target vessel patency was 92%, and freedom from aortic rupture was 100%. Average lengths of intensive care unit stay and inpatient stay were 1.4 days (standard deviation, 3.3) and 3.6 days (standard deviation, 3.6), respectively. These results show that complex aortic aneurysms can now be treated with minimally invasive fenestrated and branched endovascular repair. Endovascular technologies will likely continue to play an increasingly important role in the management of patients with complex aortic aneurysm disease.

Schanzer A ，Simons JP ，Flahive J ，Durgin J ，Aiello FA ，Doucet D ，Steppacher R ，Messina LM ... -  《-》

Sex-related outcomes after fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms in the U.S. Fenestrated and Branched Aortic Research Consortium.

Fenestrated-branched endovascular aneurysm repair (FBEVAR) has expanded the treatment of patients with thoracoabdominal aortic aneurysms (TAAAs). Previous studies have demonstrated that women are less likely to be treated with standard infrarenal endovascular aneurysm repair because of anatomic ineligibility and experience greater mortality after both infrarenal and thoracic aortic aneurysm repair. The purpose of the present study was to describe the sex-related outcomes after FBEVAR for treatment of TAAAs. The data from 886 patients with extent I to IV TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in eight prospective, physician-sponsored, investigational device exemption studies from 2013 to 2019, were analyzed. All data were collected prospectively, audited and adjudicated by clinical events committees and/or data safety monitoring boards, and subject to Food and Drug Administration oversight. All the patients had been treated with Cook-manufactured patient-specific FBEVAR devices or the Cook t-Branch off-the-shelf device (Cook Medical, Brisbane, Australia). Of the 886 patients who underwent FBEVAR, 288 (33%) were women. The women had more extensive aneurysms and a greater prevalence of diabetes (33% vs 26%; P = .043) but a lower prevalence of coronary artery disease (33% vs 52%; P < .0001) and previous infrarenal endovascular aneurysm repair (7.6% vs 16%; P < .001). The women had required a longer operative time from incision to surgery end (5.0 ± 1.8 hours vs 4.6 ± 1.7 hours; P < .001), experienced lower technical success (93% vs 98%; P = .002), and were less likely to be discharged to home (72% vs 83%; P = .009). Despite the smaller access vessels, the women did not have an increased incidence of access site complications. Also, the 30-day outcomes were broadly similar between the sexes. At 1 year, no differences were found between the women and men in freedom from type I or III endoleak (91.4% vs 92.0%; P = .64), freedom from reintervention (81.7% vs 85.3%; P = .10), target vessel instability (87.5% vs 89.2%; P = .31), and survival (89.6% vs 91.7%; P = .26). The women had a greater incidence of postoperative sac expansion (12% vs 6.5%; P = .006). Multivariable modeling adjusted for age, aneurysm extent, aneurysm size, urgent procedure, and renal function showed that patient sex was not an independent predictor of survival (hazard ratio, 0.83; 95% confidence interval, 0.50-1.37; P = .46). Women undergoing FBEVAR demonstrated metrics of increased complexity and had a lower level of technical success, especially those with extensive aneurysms. Compared with the men, the women had similar 30-day mortality and 1-year outcomes, with the exception of an increased incidence of sac expansion. These data have demonstrated that FBEVAR is safe and effective for women and men but that further efforts to improve outcome parity are indicated.

Edman NI ，Schanzer A ，Crawford A ，Oderich GS ，Farber MA ，Schneider DB ，Timaran CH ，Beck AW ，Eagleton M ，Sweet MP ，U.S. Fenestrated and Branched Aortic Research Consortium ... -  《-》

Psoas muscle area and attenuation are highly predictive of complications and mortality after complex endovascular aortic repair.

The present study evaluated the psoas muscle area and attenuation (radiodensity), quantified by computed tomography, together with clinical risk assessment, as predictors of outcomes after fenestrated and branched endovascular aortic repair (FBEVAR). The present single-center study included 504 patients who had undergone elective FBEVAR for pararenal or thoracoabdominal aortic aneurysms. The clinical risk assessment included age, sex, comorbidities, body mass index, glomerular filtration rate, aneurysm size and extent, cardiac stress test results, ejection fraction, and American Society of Anesthesiologists (ASA) score. Preoperative computed tomography was used to measure the psoas muscle area and attenuation at the L3 level. The lean psoas muscle area (LPMA; area in cm2 multiplied by attenuation in Hounsfield units [HU]) was calculated by multiplying the area by the attenuation. The risk factors for 90-day mortality, major adverse events (MAEs), and long-term mortality were determined using multivariable analysis. MAEs included 30-day or in-hospital death, acute kidney injury, myocardial infarction, respiratory failure, paraplegia, stroke, and bowel ischemia. A novel risk stratification method was proposed according to the strongest predictors of mortality and MAEs on multivariable analysis. The 30-day mortality, 90-day mortality, and MAE rates were 2.0%, 5.6%, and 20%, respectively. The independent predictors of 90-day mortality were chronic obstructive pulmonary disease, chronic kidney disease, ASA score, and LPMA. The independent predictors of MAEs were aneurysm diameter, glomerular filtration rate, and LPMA. For long-term mortality, the independent predictors were chronic kidney disease, congestive heart failure, extent I-III thoracoabdominal aortic aneurysms, ASA score, and LPMA. The patients were stratified into three groups according to the ASA score and LPMA: low risk, ASA score II or LPMA >350 cm2HU (n = 290); medium risk, ASA score III and LPMA ≤350 cm2HU (n = 181); and high risk, ASA score IV and LPMA ≤350 cm2HU (n = 33). The 90-day mortality and MAE rates were 1.7% and 16% in the low-, 7.2% and 24% in the medium-, and 30% and 33% in the high-risk patients, respectively (P < .001 and P = .02, respectively). Patients with ASA score IV and LPMA <200 cm2HU, indicating sarcopenia (n = 14) had a 43% risk of death within 90 days. The 3-year survival estimates were 80% ± 3% for the low-, 70% ± 4% for the medium-, and 35% ± 9% for the high-risk patients (P < .001). The mean follow-up time was 3.1 ± 2.3 years. LPMA was a strong predictor of outcomes and the only independent predictor of both mortality and MAEs after FBEVAR. A high muscle mass was protective against complications, regardless of the ASA score. Risk stratification based on the ASA score and LPMA can be used to identify patients at excessively high operative risk.

Kärkkäinen JM ，Oderich GS ，Tenorio ER ，Pather K ，Oksala N ，Macedo TA ，Vrtiska T ，Mees B ，Jacobs MJ ... -  《-》