Outcomes and cost of fenestrated versus standard endovascular repair of intact abdominal aortic aneurysm in the United States.

Fenestrated endovascular aneurysm repair (FEVAR) has expanded the indications of this minimally invasive procedure to include patients with pararenal aneurysms. The actual cost of this relatively newer technology compared with standard endovascular aneurysm repair (EVAR) has not been studied before. Thus, the aim of this study was to analyze in-hospital costs and adverse outcomes in patients undergoing FEVAR vs EVAR for intact abdominal aortic aneurysms (AAAs). Using the Premier Healthcare Database (2012-2015), we identified all patients who underwent elective EVAR and FEVAR. Univariable (χ2 test, Student t-test, median test) and multivariable (logistic regression and generalized linear modeling) analyses were implemented to examine in-hospital cost and adverse outcomes adjusting for patients' demographics, comorbidities, and regional characteristics. A total of 17,689 elective endovascular AAA repairs were performed; 1641 patients underwent FEVAR (9%), and the remaining 16,048 patients underwent standard EVAR (91%). Patients undergoing FEVAR were more likely to be white (86.3% vs 84.3%; P = .03). Both groups had similar comorbidities except for cerebrovascular disease, which was higher among patients undergoing FEVAR (8.4% vs 6.7%; P = .01). The total length of hospital stay was slightly higher in patients undergoing FEVAR compared with EVAR (mean [standard deviation], 2.40 [3.39] days vs 2.23 [3.10] days; P = .03). The rates of any complication (11.3% vs 9.6%), renal injury (5.8% vs 4.3%), and neurologic injury (0.7% vs 0.4%) were significantly higher in the FEVAR group (all P < .05). No differences were seen in mortality (0.8% vs 0.5%) or cardiac (4.9% vs 4.4%), pulmonary (2.4% vs 2.2%), and bowel (1.5% vs 1.2%) complications between the two groups (all P > .05). In multivariable logistic regression analysis, FEVAR was associated with 40% increased odds of renal failure (odds ratio, 1.40; 95% confidence interval [CI], 1.11-1.76; P = .004) and 91% increased odds of neurologic injury (odds ratio, 1.91; 95% CI, 1.02-3.57; P = .04). The median total cost of the treatment was also significantly higher among patients undergoing FEVAR ($28,227 vs $26,781; P < .001). After adjustment, generalized linear modeling analysis showed that the cost of FEVAR was on average $1612 higher than the cost of EVAR (adjusted cost, $1612; 95% CI, $1123-$2101; P < .001). In this large cohort of elective endovascular AAA repairs, compared with standard EVAR, FEVAR is associated with significantly increased odds of renal and neurologic injury. In addition, despite adjusting for patients' demographics, comorbidities, and major complications, total cost of FEVAR was significantly higher compared with standard EVAR. This is likely driven by the additional cost of fenestrated endografts and by the increased rate of complications related to FEVAR.

Locham S ，Faateh M ，Dhaliwal J ，Nejim B ，Dakour-Aridi H ，Malas MB ... -  《-》

Fenestrated endovascular repair of abdominal aortic aneurysms is associated with increased morbidity but comparable mortality with infrarenal endovascular aneurysm repair.

A recent prospective study found that fenestrated endovascular abdominal aortic aneurysm (AAA) repair (FEVAR) was safe and effective in appropriately selected patients at experienced centers. As this new technology is disseminated to the community, it will be important to understand how this technology compares with standard endovascular AAA repair (EVAR). The goal of this study was to compare the outcomes of FEVAR vs EVAR of AAAs. The American College of Surgeons-National Surgical Quality Improvement Program database from 2005 to 2012 was queried for AAAs (International Classification of Diseases, Ninth Revision code 441.4). Patients were stratified according to procedure (FEVAR vs EVAR). A bivariate analysis was done to assess preoperative and intraoperative risk factors for postoperative outcomes. Thirty-day postoperative mortality and complication rates were described for each procedure type. Multivariable logistic regression was performed to assess the association between the type of procedure and the risk of postoperative complications. A total of 458 patients underwent FEVAR and 19,060 patients underwent EVAR for AAA. Patients undergoing FEVAR were older (P = .02) and less likely to have a bleeding disorder (P = .046). Otherwise, the incidence of comorbidities in both groups was similar. FEVAR was associated with increased median operative time (156 vs 137 minutes; P < .001), and average postoperative length of stay (3.3 vs 2.8 days; P = .03). There was a statistically significant increase in overall complications (23.6% vs 14.3%; P < .001) and postoperative transfusions (15.3% vs 6.1%, P < .001) and trends toward increased cardiac complications (2.2% vs 1.3%; P = .09) and the need for dialysis (1.5% vs 0.8%; P = .08) in the FEVAR group. Mortality (2.4% vs 1.5%; P = .12) was not statistically different. On multivariable analysis, FEVAR remained independently associated with the need for postoperative transfusions when operative time was <75th percentile (adjusted odds ratio, 1.72; 95% confidence interval, 1.09-2.72; P = .02) as well as when operative time was >75th percentile for respective procedures (adjusted odds ratio, 5.33; 95% confidence interval, 3.55-8.00; P < .001). Patients undergoing FEVAR are more likely than patients undergoing EVAR to receive blood transfusions postoperatively and are more likely to sustain postoperative complications. Although mortality was similar, trends toward increased cardiac and renal complications may suggest the need for judicious dissemination of this new technology. Future research with larger number of FEVAR cases will be necessary to determine if these associations remain.

Glebova NO ，Selvarajah S ，Orion KC ，Black JH 3rd ，Malas MB ，Perler BA ，Abularrage CJ ... -  《-》

Fenestrated endovascular aneurysm repair is associated with lower perioperative morbidity and mortality compared with open repair for complex abdominal aortic aneurysms.

The Zenith Fenestrated Endovascular Graft (ZFEN; Cook Medical, Bloomington, Ind) has expanded the anatomic eligibility of endovascular aneurysm repair (EVAR) for complex abdominal aortic aneurysms (AAAs). Current data on ZFEN mainly consist of single-institution experiences and show conflicting results. Therefore, we compared perioperative outcomes after repair using ZFEN with open complex AAA repair and infrarenal EVAR in a nationwide multicenter registry. We identified all patients undergoing elective AAA repair using ZFEN, open complex AAA repair, and standard infrarenal EVAR between 2012 and 2016 within the American College of Surgeons National Surgical Quality Improvement Program targeted vascular module. Open complex AAA repairs were defined as those with a juxtarenal or suprarenal proximal AAA extent in combination with an aortic cross-clamping position that was above at least one renal artery. The primary outcome was perioperative mortality, defined as death within 30 days or within the index hospitalization. Secondary outcomes included postoperative renal dysfunction (creatinine concentration increase of >2 mg/dL from preoperative value or new dialysis), occurrence of any complication, procedure times, blood transfusion rates, and length of stay. To account for baseline differences, we calculated propensity scores and employed inverse probability-weighted logistic regression. We identified 6825 AAA repairs-220 ZFENs, 181 open complex AAA repairs, and 6424 infrarenal EVARs. Univariate analysis of ZFEN compared with open complex AAA repair demonstrated lower rates of perioperative mortality (1.8% vs 8.8%; P = .001), postoperative renal dysfunction (1.4% vs 7.7%; P = .002), and overall complications (11% vs 33%; P < .001). In addition, fewer patients undergoing ZFEN received blood transfusions (22% vs 73%; P < .001), and median length of stay was shorter (2 vs 7 days; P < .001). After adjustment, open complex AAA repair was associated with higher odds of perioperative mortality (odds ratio [OR], 4.9; 95% confidence interval [CI], 1.4-18), postoperative renal dysfunction (OR, 13; 95% CI, 3.6-49), and overall complication rates (OR, 4.2; 95% CI, 2.3-7.5) compared with ZFEN. Compared with infrarenal EVAR, ZFEN presented comparable rates of perioperative mortality (1.8% vs 0.8%; P = .084), renal dysfunction (1.4% vs 0.7%; P = .19), and any complication (11% vs 7.7%; P = .09). Furthermore, after adjustment, there was no significant difference between the odds of perioperative mortality, postoperative renal dysfunction, or any complication between infrarenal EVAR and ZFEN. ZFEN is associated with lower perioperative morbidity and mortality compared with open complex AAA repair, and outcomes are comparable to those of infrarenal EVAR. Long-term durability of ZFEN compared with open complex AAA repair warrants future research.

Varkevisser RRB ，O'Donnell TFX ，Swerdlow NJ ，Liang P ，Li C ，Ultee KHJ ，Pothof AB ，De Guerre LEVM ，Verhagen HJM ，Schermerhorn ML ... -  《-》

Outcomes and cost of open versus endovascular repair of intact thoracoabdominal aortic aneurysm.

Many previous studies have evaluated the outcomes of open and endovascular repair of thoracoabdominal aortic aneurysms (TAAAs). However, little is known about the differences in cost of these procedures and the potential factors driving these differences. The aim of this study was to evaluate the outcomes and cost of open aortic repair (OAR) vs endovascular repair of intact TAAA. All patients undergoing repair for intact TAAA were identified in the Premier Healthcare Database (July 2009-March 2015). Categorical and continuous variables were analyzed using the χ2 test, Student t-test, and median test as appropriate. A multivariable generalized linear model was used to examine total in-hospital cost. A total of 879 TAAA repairs were identified (481 [55%) endovascular repairs vs 398 [45%] OARs). Patients undergoing endovascular repair were on average 5 years older (71.2 [±10.0] years vs 66.5 [±10.9] years; P < .001) and more likely to be female (48% vs 42%; P = .05) and hypertensive (87% vs 80%; P = .009). Otherwise, there were no significant differences in comorbidities between the two groups. Patients undergoing OAR were more likely to stay longer in the hospital (median [interquartile range], 11 [7-20] days vs 5 [2-9] days; P < .001). In-hospital mortality (15% vs 5%; P < .001) and all major complications were two to three times higher after OAR. The median total cost of OAR was significantly higher compared with endovascular repair (cost [interquartile range], $44,355 [$32,177-$54,824] vs $36,612 [$24,395-$53,554]; P = .004). The majority of the cost attributed to TAAA repair was also higher in patients undergoing open repair: room and board ($11,561 vs $4720), operating room ($9230 vs $4929), pharmacy ($2309 vs $900), blood bank ($1189 vs $195), rehabilitation/physical therapy ($378 vs $236), and respiratory therapy ($875 vs $168; all P < .001). Only the cost of central supplies, which includes endovascular grafts and stents, was the highest among patients undergoing endovascular repair ($17,472 vs $5501; P < .001). The cost of diagnostic imaging ($625 vs $595) and anesthesia ($479 vs $478) was similar in both approaches. In a multivariable analysis, the adjusted total hospitalization cost for OAR was $5974 (95% confidence interval, $1828-$10,120; P = .005) higher compared with endovascular repair. However, after adjusting for in-hospital complications, no difference was seen between the two approaches (-$460; 95% confidence interval, -$4390 to $3470; P = .82). In this large cohort of intact TAAAs, we showed a significantly higher adjusted total hospitalization cost of open compared with endovascular repair despite the additional cost of endografts. This is likely driven by longer length of stay and higher morbidity after OAR.

Locham S ，Dakour-Aridi H ，Nejim B ，Dhaliwal J ，Alshwaily W ，Malas M ... -  《-》

Two-year evaluation of fenestrated and parallel branch endografts for the treatment of juxtarenal, suprarenal, and thoracoabdominal aneurysms at a single institution.

Despite numerous recent pivotal and small-scale trials, real-world endovascular management of juxtarenal aneurysms (JRA), suprarenal aneurysms (SRA), and thoracoabdominal aortic aneurysms (TAAA) remains challenging without consensus best practices. This study evaluated the mortality, graft patency, renal function, complication, and reintervention rates for fenestrated and parallel endografts in complex aortic aneurysms repairs. This retrospective review of consecutive included patients with JRA, SRA, or TAAA who underwent complex endovascular repair from August 2014 to March 2017 at one high-volume institution. Treatment modality was a single surgeon decision based on patients anatomy and the urgency of the repair. Patient demographics, hospital course, and follow-up visits inclusive of imaging were analyzed. Ruptured aneurysms were excluded. Survival rates and outcomes were determined using the Kaplan-Meier method with log-rank tests. Seventy complex endovascular aortic repairs were performed; 38 patients with TAAA were treated with snorkel/sandwich parallel endografts (21 celiac, 28 superior mesenteric arteries, 58 renal arteries) and 32 patients with JRA/SRA were treated by fenestrated endovascular aneurysm repair (FEVAR) with 94 total fenestrations (2 celiac, 30 SMA, 62 renal). The mean patient age was 74.8 ± 10.0 years. Sixty percent were male, and the mean aortic aneurysm diameter was 6.0 ± 1.4 cm. Perioperative mortality was 3.1% (1/32) for FEVAR compared with 2.6% (1/38) for parallel endografts (P = .9). All-cause reintervention rates were 15.6% in FEVAR (5/32) vs 23.6% with parallel endografts (9/38; P = .4). Branch reintervention rates per each branch endograft were 4.3% for FEVAR (4/94; 2 renal stent occlusions, 1 colonic ischemia without technical issue found on reintervention, 1 perinephric hematoma) vs 3.7% for parallel endografts (4/107; 2 renal and 1 celiac stent thromboses, and 1 renal stent kink; P = .41). The endograft branch thrombosis rate was 2.1% in FEVAR (2/94) vs 2.7% in parallel endografts (3/109; P = .77). Reinterventions owing to endoleaks were performed in five patients (2 type I, 2 type III, and 1 gutter endoleak; 13.1%) with parallel grafts vs no endoleak reinterventions in FEVAR. The overall survival and freedom from aneurysm-related mortality at 24 months was 78% and 96.9% in FEVAR vs 73% and 93.4% for parallel endografts (P = .8 and P = .6). The median follow-up was 12 months (range, 1-32 months). Parallel and fenestrated endografts have acceptable and comparable mortality and patency rates in endovascular treatment of JRA, SRA, and TAAA. This study reaffirms that parallel endografts are a safe and viable alternative to fenestrated devices for complex aortic aneurysmal disease despite often treating more urgent patients and more complicated anatomy unable to be treated with FEVAR.

Bannazadeh M ，Beckerman WE ，Korayem AH ，McKinsey JF ... -  《-》