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1.

Objective

As our collective experience with complex endovascular aneurysm repair (EVAR) has grown, an increasing number of older patients are being offered endovascular repair of juxtarenal aneurysms. Outcomes after complex EVAR in this older subpopulation are not well-described. We sought to specifically evaluate clinical outcomes after complex EVAR compared with infrarenal EVAR in a cohort of octogenarians.

Methods

A single-center retrospective review was conducted using a database of consecutive patients treated with elective EVAR for abdominal aortic aneurysms (AAAs) between 2009 and 2015. Only patients 80 years of age or older were included. Patients in the complex EVAR group were treated with either snorkel/chimney or fenestrated techniques, whereas infrarenal EVAR consisted of aneurysm repair without renal or visceral involvement. Relevant demographic, anatomic, and device variables, and clinical outcomes were collected.

Results

There were 103 patients (68 infrarenal, 35 complex) treated within the study period with a mean follow-up of 21 months. A total of 75 branch grafts were placed (59 renal, 11 celiac, 5 superior mesenteric artery) in the complex group, with a target vessel patency of 98.2% at latest follow-up. Patients undergoing complex EVAR were more likely to be male (82.8% vs 60.2%; P = .02) and have a higher prevalence of renal insufficiency (71.4% vs 44.2%; P = .008). The 30-day mortality was significantly greater in patients treated with complex EVAR (8.6% vs 0%; P = .03). There were no differences in major adverse events (P = .795) or late reintervention (P = .232) between groups. Interestingly, sac growth of more than 10 mm was noted to be more frequent with infrarenal EVAR (17.6% vs 2.8%; P = .039). However, both type IA (5.7% infrarenal; 4.9% complex) and type II endoleaks (32.3% infrarenal; 25.7% complex) were found to be equally common in both groups. Complex EVAR was not associated with increased all-cause mortality at latest follow-up (P = .322). Multivariable Cox modeling demonstrated that AAAs greater than 75 mm in diameter (hazard ratio; 4.9; 95% confidence interval, 4.6-48.2) and renal insufficiency (hazard ratio, 3.71; 95% confidence interval, 1.17-11.6) were the only independent risk factors of late death.

Conclusions

Complex EVAR is associated with greater perioperative mortality compared with infrarenal EVAR among octogenarians. However, late outcomes, including the need for reintervention and all-cause mortality, are not significantly different. Larger aneurysms and chronic kidney disease portends greater risk of late death after EVAR, regardless of AAA complexity. These patient-related factors should be considered when offering endovascular treatment to older patients.  相似文献   

2.

Objective

Effective strategies to reduce costs associated with endovascular aneurysm repair (EVAR) remain elusive for many medical centers. In this study, targeted interventions to reduce inpatient EVAR costs were identified and implemented.

Methods

From June 2015 to February 2016, we analyzed the EVAR practice at a high-volume academic medical center to identify, to rank, and ultimately to reduce procedure-related costs. In this analysis, per-patient direct costs to the hospital were compared before (September 2013-May 2015) and after (March 2016-January 2017) interventions were implemented. Improvement efforts concentrated on three categories that accounted for a majority of costs: implants, rooming costs, and computed tomography scans performed during the index hospitalization.

Results

Costs were compared between 141 EVAR procedures before implementation (PRE period) and 47 EVAR procedures after implementation (POST period). Based on data obtained through the Society for Vascular Surgery EVAR Cost Demonstration Project, it was determined that implantable device costs were higher than those at peer institutions. New purchasing strategies were implemented, resulting in a 30.8% decrease in per-case device costs between the PRE and POST periods. Care pathways were modified to reduce use of and costs for computed tomography scans obtained during the index hospitalization. Compared with baseline, per-case imaging costs decreased by 92.9% (P < .001), including a 99.0% (P = .001) reduction in postprocessing costs. Care pathways were also implemented to reduce preprocedural rooming for patients traveling long distances the day before surgery, resulting in a 50% decrease in utilization rate (35.4% PRE to 17.0% POST; P = .021), without having a significant impact on median postprocedural length of stay (PRE, 2 days [interquartile range, 1-11 days]; POST, 2 days [1-7 days]; P = .185). Medication costs also decreased by 38.2% (P < .001) as a hospital-wide effort.

Conclusions

Excessive costs associated with EVAR threaten the sustainability of these procedures in health care organizations. Targeted cost reduction efforts can effectively reduce expenses without compromising quality or limiting patients' access.  相似文献   

3.

Objective

Although lifelong surveillance is recommended by the Society for Vascular Surgery for patients undergoing endovascular aneurysm repair (EVAR) reported that compliance with long-term follow-up has been poor. We sought to identify factors that predict compliance with EVAR surveillance through analysis of patient variables and post-EVAR questionnaire results.

Methods

We analyzed 28 patient variables gathered from our computerized registry, patient charts, and phone questionnaires of patients who underwent EVAR between January 1, 2010, and December 31, 2014. These factors included patient demographics, education, postoperative complications, satisfaction with vascular surgery care, transportation mode, distance to our medical center, and living situation. Compliance was defined as a patient who underwent the most recent recommended follow-up surveillance study within the prescribed timeframe. Post-EVAR surveillance protocol consisted of office evaluation and duplex ultrasound examination performed in our accredited noninvasive vascular laboratory at 1 week, 6 months, then annually. Computed tomography angiography was obtained only if duplex ultrasound examination suggested endoleak, sac enlargement of more than 5 mm, or a failing limb.

Results

Of 144 patients who underwent EVAR during this time period, 89 patients (62%) were compliant with the most recent recommended follow-up study. One hundred two patients completed the questionnaire or their families did if patients died or were incapacitated. Of those, 80 were compliant with follow-up and 22 were not. Based on the questionnaires of these 102 patients, estimated compliance at 3 years after EVAR was 69.6 ± 6.0% based on Kaplan-Meier analysis. In the compliant vs noncompliant groups, the estimated 3-year survival rate was 93.2 ± 3.4% vs 52.4 ± 12.7%, respectively (P < .001), and the estimated 5-year survival rate was 83.1 ± 6.4% vs 34.4 ± 13.4%, respectively (P < .001), respectively. However, none of the mortalities observed in the noncompliant group were aneurysm related. Adverse neurologic events after EVAR demonstrated a trend predicting noncompliance after 5 years based on multivariate Cox regression analysis (hazard ratio [HR], 2.57; 95% confidence interval [CI], 0.95-6.90; P = .062). Patient dissatisfaction with their vascular surgeon and hospital care predicted noncompliance with recommended postoperative surveillance (HR, 5.0; 95% CI, 1.52-16.7; P = .008). College education or higher was associated with compliance (HR, 0.28; 95% CI, 0.06-1.23; P = .092). No other variables, including postoperative complications or distance from the hospital, predicted follow-up noncompliance.

Conclusions

Patient satisfaction with their vascular surgeon and hospital experience predicted compliance with post-EVAR surveillance regardless of postoperative complications. Noncompliant patients had decreased survival, but mortality and surveillance noncompliance were likely due to disabling chronic disease.  相似文献   

4.

Objective

The accurate measurement of reintervention after endovascular aneurysm repair (EVAR) is critical during postoperative surveillance. The purpose of this study was to compare reintervention rates after EVAR from three different data sources: the Vascular Quality Initiative (VQI) alone, VQI linked to Medicare claims (VQI-Medicare), and a “gold standard” of clinical chart review supplemented with telephone interviews.

Methods

We reviewed the medical records of 729 patients who underwent EVAR at our institution between 2003 and 2013. We excluded patients without follow-up reported to the VQI (n = 68 [9%]) or without Medicare claims information (n = 114 [16%]). All patients in the final analytic cohort (n = 547) had follow-up information available from all three data sources (VQI alone, VQI linked to Medicare, and chart review). We then compared reintervention rates between the three data sources. Our primary end points were the agreement between the three data sources and the Kaplan-Meier estimated rate of reintervention at 1 year, 2 years, and 3 years after EVAR. For gold standard assessment, we supplemented chart review with telephone interview as necessary to assess reintervention.

Results

VQI data alone identified 12 reintervention events in the first year after EVAR. Chart review confirmed all 12 events and identified 18 additional events not captured by the VQI. VQI-Medicare data successfully identified all 30 of these events within the first year. VQI-Medicare also documented four reinterventions in this time period that did not occur on the basis of patient interview (4/547 [0.7%]). The agreement between chart review and VQI-Medicare data at 1 year was excellent (κ = 0.93). At 3 years, there were 81 (18%) reinterventions detected by VQI-Medicare and 70 (16%) detected by chart review for a sensitivity of 92%, specificity of 96%, and κ of 0.80. Kaplan-Meier survival analysis demonstrated similar reintervention rates after 3 years between VQI-Medicare and chart review (log-rank, P = .59).

Conclusions

Chart review after EVAR demonstrated a 6% 1-year and 16% 3-year reintervention rate, and almost all (92%) of these events were accurately captured using VQI-Medicare data. Linking VQI data with Medicare claims allows an accurate assessment of reintervention rates after EVAR without labor-intensive physician chart review.  相似文献   

5.

Objective

Long-term outcomes after endovascular aneurysm repair (EVAR) are threatened by aortic neck dilation (AND), graft migration, and subsequent endoleak development. The aim of this study was to determine the rate of AND and the occurrence of endoleaks after fenestrated EVAR of juxtarenal aneurysms with physician-modified endovascular grafts (PMEGs).

Methods

The study included 77 patients presenting with asymptomatic and ruptured juxtarenal abdominal aortic aneurysms treated with PMEGs who received radiologic follow-up. Analysis of computed tomography images took place on a three-dimensional workstation (TeraRecon, San Mateo, Calif). Aortic neck diameter was measured before and after EVAR at the lowest patent renal artery outer wall to outer wall. Significant AND was defined as >3-mm increase between baseline and follow-up, and sac regression >5 mm was considered significant. The patient's 1-month initial postoperative computed tomography measurement was considered baseline. The rate of AND was measured by comparing the baseline measurement with measurements at 6 months, 12 months, and annually thereafter up to 4 years.

Results

In this cohort of patients, 75% were men with a mean age of 74 ± 7.9 years. Median preoperative aneurysm size was 62 (57-73) mm, and median follow-up was 12 (3.5-30) months. Mean endograft oversizing was 17% ± 12.5%, and mean seal zone length was 41 ± 11 mm. At 1-year follow-up, the median aortic neck increase was 1.7 (0-3) mm. Maximum aneurysm size decreased dramatically during the first postoperative year, with significant sac regression in 65% of the patients. Aortic neck diameter at 1 year did correlate positively with the percentage of device oversizing. No other correlations were found. During the 4-year follow-up, there were no cases of type IA endoleaks.

Conclusions

AND does not influence outcome after endovascular repair of juxtarenal aneurysms using PMEGs. These midterm results support the applicability of PMEGs in juxtarenal aneurysm repair.  相似文献   

6.

Background

Failure of endovascular aneurysm repairs (EVARs) requiring open conversion remains a major challenge. We analyzed indications for repair, operative strategies, and outcomes with a focus on iliac artery degeneration after endograft removal.

Methods

A prospective, institutional database was reviewed to identify patients who underwent explantation of a failed EVAR device. Demographics, reason for failure, operative details including extent of endograft removal, and complications/survival were examined. Postexplantation computed tomography imaging was evaluated for iliac artery degeneration.

Results

There were 32 patients who underwent explantation from 2002 to 2017. Six patients were treated emergently for rupture. The majority were elderly (average age, 76 ± 8.5 years), white (100%) men (91%) who had their EVAR graft inserted 45.5 months (range, 0.3-86 months) before open conversion, usually at an outside institution (75%). Explanted endografts included nine AneuRx (Medtronic, Minneapolis, Minn), nine Excluder (W. L. Gore & Associates, Flagstaff, Ariz), four Endurant (Medtronic), three Zenith (Cook Medical, Bloomington, Ind), three Powerlink/AFX (Endologix, Irvine, Calif), one Aorfix (Lombard Medical, Oxfordshire, United Kingdom), one Talent (Medtronic), and two unknown. Failure was due to endoleak in 91% (type I, 38%; type II, 28%; type III, 13%; type V, 13%), infection in 6%, and occlusion/kinking in 3%. A previous attempt at endovascular salvage of EVAR occurred in 12 (37.5%) patients. Operative approach was transabdominal in 69% and retroperitoneal in 31%. Initial aortic clamp position was supraceliac in 31%, suprarenal in 31%, and infrarenal in 38%. Most patients had complete removal of their endograft (n = 19 [59%]), with 22 (69%) having at least the iliac limbs removed. Grafts with suprarenal fixation were more likely to have the upper main body left in situ (67% vs 17%; P = .029). The 30-day mortality was 6.3% (3.8% elective, 16.7% ruptured), and 31% had a major complication. Of the 23 patients who had follow-up imaging, there was a trend for more iliac degeneration (>5 mm in growth) in those who had the iliac limbs removed (29.4% vs 0%; P = .184). Three patients with iliac limb removal required subsequent iliac endovascular intervention (two for rupture). Patients who presented with a rupture had a decreased 5-year overall survival (33%) compared with those who were converted electively (59%).

Conclusions

Both complete and partial endograft explantation, although morbid procedures, can be performed safely. Postoperative imaging surveillance is important, especially if the endograft has been removed from the iliac arteries, as degeneration can occur.  相似文献   

7.

Objective

During endovascular aneurysm repair (EVAR), severely tortuous aortoiliac anatomy can alter the deployment and conformability of the endograft. The accuracy of treatment length measurements is commonly recognized to be affected by severe tortuosity. However, the exact mechanism of the postintervention length discrepancy is poorly understood. The objective of this study was to determine the mechanism of how severe aortoiliac tortuosity influences the endograft and native aorta during EVAR and its impact on the distal sealing zone.

Methods

A prospectively collected vascular surgery database was retrospectively reviewed at a university-affiliated medical center to identify the study patients. Patients who underwent EVAR with the main body device deployed on the side of the severely tortuous iliac artery were selected. Severe aortoiliac tortuosity was defined as having either aortoiliac or common iliac angulation <90 degrees.

Results

A total of 469 patients between 2008 and 2014 underwent EVAR using the Endurant endograft (Medtronic Cardiovascular, Santa Rosa, Calif). Severe aortoiliac tortuosity was observed in 36% of patients; 17 patients were found to have the main body placed on the side of severe tortuosity without an extension limb. There was a significant shortening of the main body endograft length from 169 mm before EVAR to 147 mm after EVAR (P < .001). The treatment length of the main body, measured from the lowest renal artery to hypogastric artery, also significantly shortened from 179 mm to 170 mm (P < .001). There was a decrease in tortuosity at the most angulated portion of the aneurysm after EVAR, in which angulation changed from 86 degrees to 114 degrees (P < .001). There was no significant change in treatment length (P = .859) and angulation (P = .195) on the nontortuous side of the aneurysm.

Conclusions

The study observed significant shortening of endografts and native aorta and iliac arteries in patients with severe aortoiliac tortuosity during EVAR. This shortening effect can have a negative impact on the distal sealing zone during EVAR. A longer main body or an extension limb should be considered when one is faced with severely tortuous aneurysms.  相似文献   

8.

Objective

Significant research efforts have been made to improve the safety and efficacy of endovascular aneurysm repair (EVAR) in treating abdominal aortic aneurysm. This study aimed to examine the trends of perioperative outcomes of EVAR in the recent decade using a national validated database.

Methods

Patients who underwent EVAR for intact abdominal aortic aneurysm between 2006 and 2015 were identified from the National Surgical Quality Improvement Program and divided into early (2006-2010) and late (2011-2015) periods. The primary outcome of the study was 30-day mortality. Secondary outcomes included operative time, length of hospital stay, and 30-day major complications (renal, cardiopulmonary, and wound infection).

Results

A total of 30,076 patients were identified, with 11,539 in the early period and 18,537 in the late period. The 30-day mortality was kept at a low level in both periods (1.2% vs 1.2%; P = .98), whereas both the mean operation time (155.5 ± 72.6 minutes vs 141.9 ± 73.7 minutes; P < .001) and length of hospital stay (3.24 ± 5.32 days vs 2.81 ± 4.30 days; P < .001) were decreased in the late period. The 30-day major complication rate was reduced by 19.6% (5.1% vs 4.1%; P < .0001), with decreased renal failure (1.4% vs 1.0%; P = .003), cardiopulmonary complications (2.2% vs 1.7%; P = .006), and wound complications (2.5% vs 1.8%; P < .001). All the decreasing trends of mortality, any 30-day complication, and each type of major complication were statistically significant. Being treated in the late period was independently associated with decreased 30-day major complications (odds ratio, 0.75; 95% confidence interval, 0.65-0.87; P < .001), and this effect was confirmed in the propensity score-matched cohort (odds ratio, 0.76; 95% confidence interval, 0.66-0.90; P < .001).

Conclusions

Although the 30-day mortality remains similar, postoperative complications in EVAR have decreased significantly during the recent decade. The continuous improvement in endograft technology and surgical skills has resulted in decreased operative time, marked reduction in surgical complications, and shorter hospital length of stay after endovascular repair.  相似文献   

9.

Objective

Endovascular aneurysm repair (EVAR) is widely used with excellent results, but its infectious complications can be devastating. In this paper, we report a multicenter experience with infected EVAR, symptoms, and options for explantation and their outcome.

Methods

We have reviewed all consecutive endograft explants for infection at 11 French university centers following EVAR, defined as index EVAR, from 1998 to 2015. Diagnosis of infected aortic endograft was made on the basis of clinical findings, cultures, imaging studies, and intraoperative findings.

Results

Thirty-three patients with an infected aortic endograft were identified. In this group, at index EVAR, six patients (18%) presented with a groin or psoas infection and six patients (18%) presented with a general infection, including catheter-related infection (n = 3), prostatitis (n = 1), cholecystitis (n = 1), and pneumonia (n = 1). After index EVAR, eight patients underwent successful inferior mesenteric artery embolization for a type II endoleak within 6 months of index EVAR and one patient received an additional stent for a type Ib endoleak 1 week after index EVAR. Median time between the first clinical signs of infection and endograft explantation was 30 days (range, 1 day to 2.2 years). The most common presenting characteristics were pain and fever in 21 patients (64%) and fever alone in 8 patients (24%). Suprarenal fixation was present in 20 of 33 endografts (60%). All patients underwent endograft explantation, with bowel resection in 12 patients (36%) presenting with an endograft-enteric fistula. Methods of reconstruction were graft placement in situ in 30 patients and extra-anatomic bypass in 3 patients. In situ conduits were aortic cryopreserved allografts in 23, polyester silver graft in 5, and autogenous femoral vein in 2. Microbiology specimens obtained from the endograft and the aneurysm were positive in 24 patients (74%). Gram-positive organisms were the most commonly found in 18 patients (55%). Early mortality (30 days or in the hospital) was 39% (n = 13) in relation to graft blowout (n = 3), multiple organ failure (n = 6), colon necrosis (n = 3), and peripheral embolism (n = 1). At 1 year, the rates of patient survival, graft-related complications, and reinfection were 44%, 10%, and 5%, respectively.

Conclusions

Abdominal aortic endograft explantation for infection is high risk and associated with graft-enteric fistula in one-third of the cases. Larger multicenter studies are needed to better understand the risk factors and to improve preventive measures at index EVAR and during follow-up.  相似文献   

10.

Background

The early survival advantage of endovascular aneurysm repair (EVAR) compared with open repair reverses over time, possibly because of higher rates of reintervention related to endoleaks and aneurysm sac expansion. Therefore, we sought to examine the association between sac behavior, endoleaks, reintervention, and long-term survival.

Methods

We reviewed all patients undergoing EVAR in the Vascular Quality Initiative between 2003 and 2017 with an imaging study at 1 year postoperatively (±6 months). We defined aneurysm sac changes by Society for Vascular Surgery guidelines (change ≥5 mm) and determined independent predictors of sac behavior, new endoleak, and reintervention using hierarchical logistic regression. We employed Cox regression to examine the association between sac behavior and long-term survival. We performed propensity matching between patients with sac regression and those with failure to regress as a secondary analysis.

Results

Of 30,074 EVAR patients, 14,817 (49%) had a 1-year imaging study and were included in this study. At 1 year, 40% of sacs regressed, 35% remained stable, and 25% expanded. Factors independently associated with sac expansion were age (by decade: odds ratio [OR], 1.07; 95% confidence interval [CI], 1.01-1.13; P = .02), appearance of new endoleak (OR, 1.23; 95% CI, 1.10-1.37; P = .001), smaller aortic diameter (diameter <5 cm: OR, 1.37; 95% CI, 1.21-1.55; P < .001), anemia (OR, 1.47; 95% CI, 1.20-1.80; P < .001), rupture (OR, 1.33; 95% CI, 1.07-1.65; P = .01), and chronic kidney disease (OR, 1.15; 95% CI, 1.05-1.25; P < .01), whereas former smoking (OR, 0.86; 95% CI, 0.76- 0.96; P < .01), cerebrovascular disease (OR, 0.82; 95% CI, 0.67-0.99; P = .04), and statin therapy at discharge (OR, 0.83; 95% CI, 0.75-0.91; P < .001) were associated with lower risk of expansion. Both sac expansion (OR, 2.3; 95% CI, 2.0-2.7; P < .001) and a stable sac (OR, 3.1; 95% CI, 2.7-3.5; P < .001) were associated with the development of new endoleaks. Any failure of the aneurysm sac to regress was associated with long-term mortality compared with sac regression (stable sac size: hazard ratio, 1.2; 95% CI, 1.03-1.4; P = .02; sac expansion: hazard ratio, 1.6; 95% CI, 1.3-2.1; P < .001). This association persisted in patients without documented endoleaks and remained robust after accounting for reinterventions and endoleaks seen in follow-up or on completion angiography. In the propensity-matched cohort, patients with failure to regress experienced lower long-term survival (77% at 10 years compared with 82% for patients with sac regression; P = .01).

Conclusions

After EVAR, aneurysm sac behavior is associated with the development of new endoleaks, reintervention, and long-term mortality. Not only sac expansion but any failure of the sac to regress is associated with higher long-term mortality, independent of reinterventions or endoleaks, and may be modified by statin therapy. Further study is needed to establish whether patients with stable sacs could benefit from selective reintervention.  相似文献   

11.

Objective

Acute kidney injury (AKI) is a common postoperative complication after abdominal aortic aneurysm (AAA) repair and is associated with significant morbidity and mortality. However, limited studies have investigated this complication in elderly patients. This study aims to evaluate AKI in octogenarians after open endovascular AAA repair (OAR) and endovascular AAA repair (EVAR).

Methods

Data were obtained from the Vascular Quality Initiative database on all patients who underwent elective infrarenal AAA repair between January 2003 and April 2017. Univariate analysis was used to compare AKI rates as well as failure to rescue after AKI between octogenarians and nonoctogenarians in OAR and EVAR. Stepwise multivariable logistic regression analysis was implemented to identify independent predictors and develop a risk calculator of AKI in octogenarians undergoing AAA repair.

Results

A total of 27,993 patients (12% OAR and 88% EVAR) were included, of which 6708 (24%) were octogenarians (OAR, 332; EVAR, 6376). Postoperative AKI was more common in octogenarians as compared with nonoctogenarians in OAR (15.1% vs 10.1%; P = .01) and EVAR (4.2% vs 2.7%; P < .001). Similarly, failure to rescue, defined as 30-day mortality after postoperative AKI, was higher in octogenarians whether undergoing OAR (28.0% vs 8.8%; P < .001) or EVAR (14.1% vs 7.5%; P < .01). On multivariable analysis, octogenarians undergoing OAR had a 3.5 times higher odds of AKI compared with those undergoing EVAR (odds ratio [OR], 3.52; 95% confidence interval [CI], 2.36-5.23; P < .001). Other independent risk factors for postoperative AKI in octogenarians included chronic obstructive pulmonary disease (OR, 1.48; 95% CI, 1.14-1.93), chronic kidney disease stage III (OR, 2.17; 95% CI, 1.26-3.76) and chronic kidney disease stage IV-V (OR, 5.7; 95% CI, 3.0-10.9), peripheral artery disease (OR, 1.99; 95% CI, 1.34-2.94), preoperative β-blocker use (OR, 1.85; 95% CI, 1.45-2.38), and aneurysm diameter (OR, 1.25; 95% CI, 1.11-1.41). These predictors were incorporated in an interactive risk calculator of AKI after AAA repair in octogenarians (C-statistic = 0.728).

Conclusions

AKI is a serious complication after AAA repair, especially in octogenarians, and is associated with high failure to rescue rates. A careful assessment of risk factors for AKI in elderly patients should be performed to inform clinical decision making.  相似文献   

12.

Background

We report midterm outcomes with the GORE Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) in the U.S. investigational device exemption (IDE) trial and comparatively assess outcomes in the IDE trial with outcomes in a real-world population of patients treated in the Gore Global Registry for Endovascular Aortic Treatment (GREAT).

Methods

From 2013 to 2016, the IDE trial enrolled 99 patients treated with the IBE for common iliac artery (CIA) aneurysms or aortoiliac aneurysms. Bilateral IBE treatment was allowed only in the continued access phase. From 2013 to 2016, there were 92 patients treated with the IBE in the GREAT registry. Baseline characteristics, procedural variables, and reinterventions through 6 months were compared in the IDE trial and GREAT registry. Clinical and core laboratory-assessed imaging outcomes were assessed in the IDE trial through 2 years.

Results

GREAT patients were significantly older (P = .01) and of shorter height (P < .001) and lower weight (P < .001). There were also significantly more women treated in GREAT vs the IDE trial (8% vs 1%; P = .02). Thirteen GREAT patients (14%) and 4 of 35 continued access IDE patients (11%) had bilateral IBE placement (P = .70). IDE patients were more likely to be treated with percutaneous access methods (55% vs 40%; P = .04). Three IDE patients and three GREAT patients underwent 1-month reintervention, with two IDE reinterventions (2.1%) and one GREAT reintervention (1.6%) for thrombotic events. Five additional patients in each study underwent reintervention through 6 months (5% vs 5%; P = .92), all for nonthrombotic events. Internal iliac limb patency was 93.6% (95% confidence interval, 86.4%-97.1%) at 12 and 24 months in the IDE study. Subset analyses of the 10 IDE and GREAT patients with ≤6-month reintervention vs 181 intervention-free patients found that acute myocardial infarction (P = .01), nonpercutaneous access (P = .01), and surgical conduit use (P < .001) were associated with reintervention through 6 months. In the IDE trial, 3.4% and 4.1% of patients underwent reintervention at 12 months and 24 months, respectively, all for treatment of type II endoleaks. At 24 months, 8.7% of IDE patients exhibited abdominal aortic aneurysm sac expansion; 21.7% exhibited abdominal aortic aneurysm sac regression. No patients exhibited CIA aneurysm sac expansion; 45% exhibited CIA aneurysm sac regression.

Conclusions

Midterm IDE outcomes and 6-month outcomes in the worldwide GREAT registry suggest that endovascular aortic aneurysm repair with concomitant CIA aneurysm repair with the IBE device is safe and effective. Thrombotic events are uncommon and are concentrated in the first month after the index procedure, and they typically can be resolved with endovascular reintervention.  相似文献   

13.

Objective

Previous cost analyses have found small to negative margins between hospitalization cost and reimbursement for endovascular aneurysm repair (EVAR). Hospitals obtain reimbursement on the basis of Medicare Severity Diagnosis Related Group (MS-DRG) coding to distinguish patient encounters with or without major comorbidity or complication (MCC). This study's objective was to evaluate coding accuracy and its effect on hospital cost for patients undergoing EVAR.

Methods

A retrospective, single university hospital review of all elective, infrarenal EVARs performed from 2010 to 2015 was completed. Index procedure hospitalizations were reviewed for MS-DRG classification, comorbidities, complications, length of stay (LOS), and hospitalization cost. Patients' comorbidities and postoperative complications were tabulated to verify accuracy of MS-DRG classification. Misclassified patients were audited and reclassified as “standard” or “complex” on the basis of a corrected MS-DRG: standard for 238 (major cardiovascular procedure without MCC) and complex for 237 (major cardiovascular procedure with MCC).

Results

There were 104 EVARs identified, including 91 standard (original MS-DRG 238, n = 85; MS-DRG 254, n = 6) and 13 complex hospitalizations (original MS-DRG 237, n = 9; MS-DRG 238, n = 3; MS-DRG 253, n = 1). On review, 3% (n = 3) of the originally assigned MS-DRG 238 patients were undercoded while actually meeting MCC criteria for a 237 designation. Hospitalizations coded with MS-DRG 253 and 254 were considered billing errors because MS-DRG 237 and 238 are more appropriate and specific classifications as major cardiovascular procedures. Overall, there was a 9.6% miscoding rate (n = 10), representing a total lost billing opportunity of $587,799. Mean LOS for standard and complex hospitalizations was 3.0 ± 1.5 days vs 7.8 ± 6.0 days (P < .001), with respective intensive care unit LOS of 0.4 ± 0.7 day vs 2.6 ± 3.1 days (P < .001). Postoperative complications occurred in 23% of patients; however, not all met the Centers for Medicare and Medicaid Services criteria as MCC. Miscoded complexity was found to be due to postoperative events in all patients rather than to missed comorbidities. Mean hospitalization cost for standard and complex patients was $28,833 ± $5597 vs $41,543 ± $12,943 (P < .001). Based on institutional reimbursement data, this translates to a mean loss of $5407 per correctly coded patient. Miscoded patients represent an additional overall reimbursement loss of $140,102.

Conclusions

Our study reveals a large lost billing opportunity with miscoding of elective EVARs from 2010 to 2015, with errors in categorization of the procedure as well as miscoding of complexity. The revenue impact is potentially significant in this population, and additional reviews of coding practices should be considered.  相似文献   

14.

Objective

The purpose of this systematic review and meta-analysis was to investigate the diagnostic accuracy of contrast-enhanced ultrasound (CEUS) for detection of endoleak after endovascular aneurysm repair (EVAR).

Methods

We searched electronic bibliographic databases for original articles comparing concurrent CEUS and computed tomography angiography for detection of endoleak after EVAR. We assessed the methodologic quality of the studies with the Quality Assessment of Diagnostic Accuracy Studies-2 tool. We constructed 2 × 2 contingency tables for all selected studies including true-positive, false-positive, false-negative, and true-negative results for all endoleaks and for type I and type III endoleaks. We used a mixed-effects logistic regression model to estimate summary sensitivity and specificity. We developed hierarchical summary receiver operating characteristic curves and calculated the area under the curve (AUC).

Results

We identified 26 studies reporting a total of 2638 paired scans in 2217 patients. The major risk of bias of the selected studies pertained to blinding for the index test and the reference standard. The pooled sensitivity and specificity of CEUS for all endoleaks were 0.94 (95% confidence interval [CI], 0.89-0.97) and 0.93 (95% CI, 0.89-0.96), respectively. The AUC was 0.98 (95% CI, 0.93-0.99). The summary estimate of sensitivity and specificity for type I and type III endoleaks was 0.97 (95% CI, 0.8-1.00) and 1.00 (95% CI, 0.99-1.00), respectively. The AUC was 1.00 (95% CI, 0.99-1.00).

Conclusions

CEUS has a high sensitivity and specificity in the detection of endoleaks after EVAR. CEUS is a useful tool in EVAR surveillance.  相似文献   

15.

Background

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).

Methods

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.

Results

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).

Conclusions

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.  相似文献   

16.

Objective

Because of advances in technology and experience of the operator, endovascular aneurysm repair (EVAR) has supplanted open repair to treat abdominal aortic aneurysm (AAA). The low 30-day mortality and morbidity of EVAR make the endovascular approach particularly suitable for patients at high surgical risk. However, endoleak or endograft migration requiring secondary intervention or open surgical conversion is a limitation of EVAR. The Nellix system (Endologix, Inc, Irvine, Calif) has been designed to seal the entire AAA to overcome these limitations with EVAR. We report the results of a retrospective, multicenter study with endovascular aneurysm sealing (EVAS) aimed to assess technical success, procedure-related mortality, complications, and reinterventions.

Methods

This study included patients selected for elective treatment with the Nellix device per the endovascular repair protocol at 16 Italian vascular centers. All patients were enrolled in a postoperative surveillance imaging program including duplex ultrasound investigations, computed tomography, and magnetic resonance controls following local standards of care.

Results

From 2013 to 2015, there were 335 patients (age, 75.5 ± 7.4 years; 316 men) who underwent elective EVAS. In 295 cases (88.0%), EVAS was performed under standard instructions for use of the Nellix system. Preoperative aneurysm diameter was 55.5 ± 9.4 mm (range, 46-65 mm). The inferior mesenteric artery and lumbar arteries emerging from the AAA were patent in 61.8% and 81.3% of cases, respectively. Chimney grafts were electively carried out in eight cases (2.4%). One (0.3%) intraprocedural type IB endoleak was observed and promptly corrected. Device deployment was successful in all patients, with no perioperative mortality. Early (≤30 days) complications included 1 (0.3%) type IA endoleak, 2 (0.6%) type II endoleaks (0.6%), 2 (0.6%) stent occlusions (0.6%), 3 (0.9%) distal embolizations, and 2 (0.2%) femoral artery dissections. Six (2.9%) patients underwent reinterventions. At 1-year follow-up, complications included 3 (1.1%) type II endoleaks, 4 (1.4%) type IA endoleaks, 1 (0.3%) type IB endoleak, 2 (0.7%) distal stent migrations, 5 (1.8%) distal embolizations, and 1 (0.3%) stent occlusion. Twelve patients (3.7%) underwent reinterventions, including four (1.4%) surgical conversions due to aortoduodenal fistula (1), endograft infection (1), and type IA endoleak that was unsuccessfully treated percutaneously (2). Two AAA-related deaths occurred. Freedom from aneurysm-related reintervention was 98.3% at 1-month and 94.7% at 12-month follow-up.

Conclusions

The preliminary results of this real-world multicenter study showed that EVAS with Nellix for the management of AAAs appears feasible. This device platform is associated with acceptable procedure-related mortality and low overall complication and reintervention rates. Definitive conclusions on the value of this novel device await long-term follow-up data.  相似文献   

17.

Background

Several vascular surgical procedures, including repair of abdominal aortic aneurysms (AAAs), show poorer outcomes for women than for men. We evaluated the impact of sex-based demographic differences on survival after endovascular aneurysm repair (EVAR).

Methods

We reviewed EVARs performed at our institution between 2003 and 2009 and assessed aortic neck variables (length, diameter, angulation, and calcification), iliac artery variables (length, tortuosity, angulation, and calcification), and AAA diameter. Cox proportional hazards models were used to examine the association between sex and 5-year mortality while adjusting for patients' demographics, comorbidities, anatomic variables, and AAA parameters. The final model adjusted for sex, age, body mass index, hypertension, iliac artery length, and aortic neck length.

Results

Of 336 patients, 278 were male (mean age, 73 years) and 58 were female (mean age, 77 years; P = .0005). Men had more coronary artery bypass grafts (79 vs 8; P = .02) and percutaneous coronary interventions (52 vs 4; P = .03) than women did. Significant differences between the sexes was seen for aortic neck angle, diameter, and length and for iliac artery diameter and length. Men (44%) were more likely than women (22%; P = .0002) to have EVAR performed within the device guidelines. Five-year survival was 73% in men and 49% in women. Multivariable analysis showed that female sex, increase in age, low body mass index (<25 kg/m2), and aortic neck length were significantly associated with risk of 5-year mortality.

Conclusions

Women presented at an older age and with a more hostile anatomy. They had reduced survival compared with men after EVAR. After controlling for comorbidities and aortic neck and iliac artery anatomy, sex remained an independent predictor for survival.  相似文献   

18.

Objective

Long-term results of abdominal aortic aneurysm (AAA) endovascular repair are affected by graft design renewals that tend to improve the performance of older generation prostheses but usually reset the follow-up times to zero. The present study investigated the long-term outcomes of endovascular AAA repair (EVAR) using the Zenith graft, still in use without major modification, in a single center experience.

Methods

Between 2000 and 2011, 610 patients underwent elective EVAR using the Zenith endograft (Cook Inc, Bloomington, Ind) and represent the study group. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes included freedom from late (>30 days) reintervention, freedom from late (>30 days) conversion to open repair, freedom from aneurysm sac enlargement >5.0 mm and freedom from EVAR failure, defined as a composite of AAA-related death, AAA rupture, AAA growth >5 mm, and any reintervention.

Results

Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. There were five perioperative deaths (0.8%) and three intraoperative conversions. At a mean follow-up of 99.2 (range, 0-175) months, seven AAA ruptures occurred, all fatal except one. Overall survival was 92.8% ± 1.1% at 1 year, 70.1% ± 1.9% at 5 years, 37.8% ± 2.9% at 10 years, and 24 ± 4% at 14 years. Freedom from AAA-rupture was 99.8% ± 0.02 at 1 year (one case), 99.4% ± 0.04 at 5 years (three cases), and 98.1% ± 0.07 at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6 at 1 year, 87.7% ± 1.5 at 5 years, 75.7% ± 3.2 at 10 years, and 69.9% ± 5.2 at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 96.6% ± 0.7 at 5 years, 81.0% ± 3.4 at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 (21.6%) patients at 14 years. At multivariate analysis, independent predictors of EVAR failure resulted type I and III endoleak (hazard ratio [HR], 6.7; 95% confidence interval [CI], 4.6- 9.7; P < .001], type II endoleak (HR, 2.3; 95% CI, 1.6-3.4; P < .001), and American Society of Anesthesiologists grade 4 (HR, 1.6; 95% CI, 1.0-2.6; P = .034).

Conclusions

EVAR with Zenith graft represents a safe and durable repair. Risk of rupture and aneurysm-related death is low, whereas overall long-term survival remains poor. Novel endograft models should be tested and evaluated considering that one-fourth of the operated patients will still be alive after 14 years.  相似文献   

19.

Objective

Although endovascular repair of abdominal aortic aneurysms (AAAs) has been demonstrated to have favorable outcomes, not all cohorts of patients with AAA fare equally well. Our goal was to investigate perioperative and 1-year outcomes in patients with end-stage renal disease (ESRD) on dialysis, who have traditionally fared worse after vascular interventions, to assess how ESRD affects outcomes in a large modern cohort of endovascular aneurysm repair (EVAR) patients.

Methods

The Vascular Quality Initiative database was queried for all patients undergoing EVAR from 2010 to 2017. ESRD patients were compared with patients not on dialysis. Propensity-matched scoring and multivariable analysis were used to isolate the effects of ESRD.

Results

Of 28,683 EVARs identified, there were 321 (1.12%) patients with ESRD on dialysis. Patients with ESRD had no difference in presenting AAA size (57.5 ± 12.7 mm vs 56.7 ± 17.2 mm; P = .44); however, they had more urgent/emergent repairs (20.6% vs 13.6%; P = .002) than those without ESRD. ESRD patients were more often younger, nonwhite, and nonobese and less likely to have commercial insurance (P < .05). ESRD patients more often had hypertension, coronary artery disease, congestive heart failure, previous lower extremity bypass, aneurysm repair, and carotid interventions (P < .05). There was no difference in the rate of concomitant procedures. Matching based on demographics, comorbidities, and operative details showed that ESRD patients had longer hospital length of stay (4.8 ± 9.4 days vs 4.1 ± 12.6 days; P = .026) and higher 30-day mortality (7% vs 2.4%; P < .001). There was no difference in cardiac, pulmonary, lower extremity, bowel, and stroke complications or return to the operating room. On multivariable analysis, ESRD was associated with 30-day mortality (odds ratio, 4.1; 95% confidence interval, 2.6-6.7; P < .001). Of the 24,750 elective EVARs, 1.04% had ESRD on dialysis. Matched data for elective EVAR show increased postoperative length of stay, hospital mortality, and 30-day mortality for ESRD patients on dialysis compared with those who are not. There was no association with postoperative myocardial infarction or pulmonary complications. At 1 year, patients with ESRD on dialysis had worse survival (78% vs 94%; P < .001), and ESRD was associated with higher mortality (hazard ratio, 3.3; 95% confidence interval, 2.5-4.2; P < .001).

Conclusions

Among patients undergoing EVAR, ESRD is independently associated with higher perioperative and 1-year mortality despite not being associated with higher postoperative complications. This should be taken into account during informed consent for EVAR and risk-benefit considerations in this high-risk population, particularly for elective repair.  相似文献   

20.

Objective

Many studies have found that preoperative aneurysm anatomy can determine the postoperative complication rates for endovascular aneurysm repair (EVAR). With continual improvement in endograft technology, patients with challenging anatomy are increasingly able to undergo successful treatment with EVAR. This study aimed to quantify the influence of proximal neck anatomy on contemporary outcomes in a cohort of abdominal aortic aneurysm patients with highly angulated aneurysm necks.

Methods

The study included 205 patients originally enrolled in the Prospective Aneurysm Trial: High Angle Aorfix Bifurcated Stent Graft (PYTHAGORAS) trial, the largest study to date to enroll patients with aortic aneurysm neck angles >60 degrees. Anatomic parameters included measurements of the proximal aneurysm neck as well as seal zones modeled in preoperative computed tomography scans. Follow-up up to 5 years postoperatively was available, for which stent-related complications (defined as sac expansion, stent migration, and type Ia endoleak) were assessed. Predictive anatomic parameters were assessed by Cox regression models, and a final multivariate model was created to predict complications. The cohort was also stratified by neck diameter for further comparison of complication rates.

Results

Of 205 patients enrolled in the trial, 67 stent-related complications occurred in 36 patients (17.6%) at 5 years after EVAR. Median follow-up was 48 months. Demographic and medical comorbidities did not predict risk of complications, nor did proximal neck length or neck angle. Independent predictors of post-EVAR complications included increasing proximal neck diameter (hazard ratio, 1.14; 95% confidence interval, 1.03-1.27; P < .05) and decreasing seal zone inner curve length (hazard ratio, 1.03; 95% confidence interval, 1.01-1.06; P < .05), which yielded a fair discriminatory utility (concordance, 0.67). Stratification by median neck diameter of 22.5 mm yielded two groups; patients with larger aortic necks (mean diameter, 24.8 ± 2.1 mm) had a 21.8% complication rate vs 12.6% in patients with smaller necks (mean diameter, 20.1 ± 1.6 mm; P < .05).

Conclusions

Proximal aortic neck diameter and the seal zone inner curve length were found to be the best predictors of complications related to Aorfix (Lombard Medical, Oxfordshire, United Kingdom) in this population with highly angulated neck anatomy. Modeled seal zones are better able than traditional measurements to capture the limitations of a short, angled neck. These findings may inform preoperative risk stratification and planning in patients with hostile aortic neck anatomy undergoing EVAR.  相似文献   

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