Neck radiation is not associated with increased risk of perioperative adverse events after transcarotid artery revascularization or transfemoral carotid artery stenting.

OBJECTIVE: It is unclear whether patients with prior neck radiation therapy (RT) are at high risk for carotid artery stenting (CAS). We aimed to delineate 30-day perioperative and 3-year long-term outcomes in patients treated for radiation-induced stenotic lesions by the transfemoral carotid artery stenting (TFCAS) or transcarotid artery revascularization (TCAR) approach to determine comparative risk and to ascertain the optimal intervention in this cohort. METHODS: Data were extracted from the Vascular Quality Initiative CAS registry for patients with prior neck radiation who had undergone either TCAR or TFCAS. The Student t-test and the χ2 test were used to compare baseline patient characteristics. Multivariable logistic regression and Cox Hazard Proportional analysis were used to compare perioperative and long-term differences between patients with and without prior neck radiation following TCAR and TFCAS. Kaplan-Meier estimator was used to determine the incidence of 3-year adverse events. RESULTS: A total of 72,656 patients (TCAR, 40,879; TFCAS, 31,777) were included in the analysis. Of these, 4151 patients had a history of neck radiation. Patients with a history of neck radiation were more likely to be younger, white, and have fewer comorbidities than patients with no neck radiation history. After adjustment for confounding factors, there was no difference in relative risk of 30-day perioperative stroke (P = .11), death (P = .36), or myocardial infarction (MI) (P = .61) between TCAR patients with or without a history of neck radiation. The odds of stroke/death (P = .10) and stroke/death/MI (P = .07) were also not statistically significant. In patients with prior neck radiation, TCAR had lower odds for in-hospital stroke/death/MI (odds ratio, 0.59; 95% confidence interval [CI], 0.35-0.99; P = .05) and access site complications than TFCAS. At year 3, patients with prior neck radiation had an increased hazard for mortality after TCAR (hazard ratio [HR], 1.24; 95% CI, 1.02-1.51; P = .04) and TFCAS (HR, 1.33; 95% CI, 1.12-1.58; P = .001). Patients with prior neck radiation also experienced an increased hazard for reintervention after TCAR (HR, 2.16; 95% CI, 1.45-3.20; P < .001) and TFCAS (HR, 1.67; 95% CI, 1.02-2.73; P<.001). CONCLUSIONS: Patients with prior neck radiation had a similar relative risk of 30-day perioperative adverse events as patients with no neck radiation after adjustment for baseline demographics and disease characteristics. In these patients, TCAR was associated with reduced odds of perioperative stroke/death/MI as compared with TFCAS. However, patients with prior neck radiation were at increased risk for 3-year mortality and reintervention.

Long-term costs to Medicare associated with endovascular and open repairs of infrarenal and complex abdominal aortic aneurysms.

OBJECTIVE: The vast majority of patients with abdominal aortic aneurysms (AAAs) undergoing repairs receive endovascular interventions (EVARs) instead of open operations (OARs). Although EVARs have better short-term outcomes, OARs have improved longer-term durability and require less radiographic follow-up and monitoring, which may have significant implications on health care economics surrounding provision of AAA care nationally. Herein, we compared costs associated with EVAR and OAR of both infrarenal and complex AAAs. METHODS: We examined patients undergoing index elective EVARs or OARs of infrarenal and complex AAAs in the 2014-2019 Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Network (VQI-VISION) dataset. We defined overall costs as the aggregated longitudinal costs associated with: (1) the index surgery; (2) reinterventions; and (3) imaging tests. We evaluated overall costs up to 5 years after infrarenal AAA repair and 3 years for complex AAA repair. Multivariable regressions adjusted for case-mix when evaluating cost differences between EVARs vs OARs. RESULTS: We identified 23,746 infrarenal AAA repairs (8.7% OAR, 91% EVAR) and 2279 complex AAA repairs (69% OAR, 31% EVAR). In both cohorts, patients undergoing EVARs were more likely to be older and have more comorbidities. The cost for the index procedure for EVARs relative to OARs was lower for infrarenal AAAs ($32,440 vs $37,488; P < .01) but higher among complex AAAs ($48,870 vs $44,530; P < .01). EVARs had higher annual imaging and reintervention costs during each of the 5 postoperative years for infrarenal aneurysms and the 3 postoperative years for complex aneurysms. Among patients undergoing infrarenal AAA repairs who survived 5 years, the total 5-year cost of EVARs was similar to that of OARs ($35,858 vs $34,212; -$223 [95% confidence interval (CI), -$3042 to $2596]). For complex AAA repairs, the total cost at 3 years of EVARs was greater than OARs ($64,492 vs $42,212; +$9860 [95% CI, $5835-$13,885]). For patients receiving EVARs for complex aneurysms, physician-modified endovascular grafts had higher index procedure costs ($55,835 vs $47,064; P < .01) although similar total costs on adjusted analyses (+$1856 [95% CI, -$7997 to $11,710]; P = .70) relative to Zenith fenestrated endovascular grafts among those that were alive at 3 years. CONCLUSIONS: Longer-term costs associated with EVARs are lower for infrarenal AAAs but higher for complex AAAs relative to OARs, driven by reintervention and imaging costs. Further analyses to characterize the financial viability of EVARs for both infrarenal and complex AAAs should evaluate hospital margins and anticipated changes in costs of devices.

One-year aneurysm-sac dynamics are associated with reinterventions and rupture following infrarenal endovascular aneurysm repair.

OBJECTIVE: One-year aneurysm sac changes have previously been found to be associated with mortality and may have the potential to guide personalized follow-up following endovascular aneurysm repair (EVAR). In this study, we examined the association of these early sac changes with long-term reintervention and rupture. METHODS: We identified all patients undergoing first-time EVAR for intact abdominal aortic aneurysm between 2003 and 2018 in the Vascular Quality Initiative with linkage to Medicare claims for long-term outcomes. We included patients with an imaging study at 1 year postoperatively. Aneurysm sac behavior was defined as per the Society for Vascular Surgery guidelines: stable sac (<5 mm change), sac regression (≥5 mm), and sac expansion (≥5 mm). Outcomes included mortality, reintervention, and rupture within 8 years, which were assessed with Kaplan-Meier methods and multivariable Cox regression analysis. Secondarily, we utilized polynomial spline interpolation to demonstrate the continuous relationship of diameter change to 8-year hazard of reintervention, rupture, or mortality as a composite outcome. RESULTS: Of 31,185 EVAR patients, 16,102 (52%) had an imaging study at 1 year and were included in this study. At 1 year, 44% of sacs remained stable, 49% regressed, and 6.2% displayed expansion. Following risk adjustment, compared with a stable sac at 1 year, sac regression was associated with lower 8-year mortality (49% vs 53%; hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.85-0.99; P = .036), reintervention rate (8.9% vs 15%; HR, 0.58; 95% CI, 0.50-0.68; P < .001), and rupture rate (2.0% vs 4.0%; HR, 0.45; 95%CI, 0.29-0.69; P < .001). Conversely, compared with a stable sac, sac expansion was associated with higher 8-year mortality (64% vs 53%; HR, 1.31; 95% CI, 1.14-1.51; P < .001) and reintervention rate (27% vs 15%; HR, 1.98; 95% CI, 1.57-2.51; P < .001), but similar risk of rupture (7.2% vs 4.0%; HR, 1.61; 95% CI, 0.88-2.96; P = .12). Polynomial spline interpolation demonstrated that, compared with no diameter change at 1 year, increased sac regression was associated with an incrementally lower risk of late outcomes, whereas increased sac expansion was associated with an incrementally higher risk of late outcomes. CONCLUSIONS: Following EVAR, compared with a stable sac at 1-year imaging, sac regression and expansion are associated with a lower and higher risk respectively of long-term mortality, reinterventions, and ruptures. Moreover, the amount of regression or expansion seems to be incrementally associated with these late outcomes, too. Future studies are needed to determine how to improve 1-year sac regression, and whether it is safe to extend follow-up intervals for patients with regressing sacs.

Systematic review and meta-analysis of outcomes after semi-conversion with graft preservation for failed endovascular aneurysm repair.

OBJECTIVE: The aim of this study was to evaluate the outcomes after semi-conversion (open conversion with graft preservation) after failed endovascular aneurysm repair (EVAR). The primary outcomes were 30-day mortality and semi-conversion failure. Secondary outcomes were 30-day major systemic complications, endoleak recurrence, reinterventions, and overall survival. METHODS: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol was prospectively registered on PROSPERO (CRD42023421153). All studies reporting the outcomes of semi-conversions for failed EVAR were eligible for inclusion. Quality assessment was performed using the Methodological Index for Non-Randomized Studies (MINORS) tool. A random effects meta-regression of proportions was conducted using the double arcsine-Tukey transformation, given the frequent zero event rate in the primary outcome. Heterogeneity was assessed with the I2 statistic. RESULTS: Eight studies were included in the review after full text screening. A total of 196 patients underwent semi-conversion at a mean time from EVAR of 47.4 months, 68.9% in an elective setting. Mean age at conversion was 78.1 years, and the main indication was isolated endoleak type II (70.1% of cases). Aortic clamping was not necessary in 92.3% of semi-conversions; the aortic sac was opened in 96.1% of cases; in 93.3% of cases, ligation/suture of one or more culprit arteries were performed; and aortic neck banding was executed in 29.2%. At 30 days from surgery, the pooled mortality and the major systemic complications rates were 5.3% (I2 = 24.9%) and 13.4% (I2 = 54.3%), respectively. At follow-up, endoleak recurred after 12.6% semi-conversions (I2 = 83.2%), and the rate of reinterventions was 7% (I2 = 50.1%); the semi-conversion failure rate was 5.5% (I2 = 54.1%), and the overall survival was 84.6% (I2 = 33.3%). CONCLUSIONS: Semi-conversions have acceptable 30-day mortality rates, but the early and mid-term risks of complications, reinterventions, ruptures, and infections are not negligible. This procedure might be an alternative to complete or partial graft explant in patients whom aortic cross-clamping is not ideal.

Pre-emptive False Lumen Embolization to Prevent Persistent Type II Endoleak in Fenestrated-Branched Endovascular Repair of Post-Dissection Thoracoabdominal Aortic Aneurysms.

PURPOSE: The purpose was to describe a technique to promote false lumen (FL) thrombosis in post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs) managed by fenestrated/branched endografting (F/B-EVAR). TECHNIQUE: A 5/6Fr-90 cm length sheath is advanced from the true lumen (TL) to FL through the most distal entry tear of the infrarenal aorta or iliac arteries. It is parked in the most cranial portion of the FL in the thoracic aorta. Aortic endografts are deployed in the TL excluding all the para-visceral/distal entry tears and target visceral vessels bridging stenting is performed. A selective FL angiography is performed through the 5/6Fr sheath to detect the origin of all segmentary arteries. Embolization of FL is performed from above to below by M-reye pushable coils, obtaining the packaging of FL. After completion angiography, the 5/6Fr sheath is retrieved in external iliac artery and molding ballooning of the distal segment of the aortic/iliac endograft is performed. Between 2019 and 2023, this technique was applied in 11cases with a median number of 73 (interquartile range [IQR=12) coils. Out of 8 (72%) patients with available radiological follow-up at 1 year, 7 exhibited complete FL thrombosis. CONCLUSIONS: The FL coiling in PD-TAAAs managed by F/B-EVAR is feasible, safe, and effective to promote the complete FL thrombosis. CLINICAL IMPACT: Preemptive false lumen embolization is a feasible, safe, and effective technique for preventing persistent type II endoleaks after fenestrated-branched endovascular repair of post-dissection thoracoabdominal aortic aneurysms. This technique may be routinely recommended to promote FL thrombosis and aortic remodeling after FB-EVAR in PD-TAAAs, thereby reducing the incidence of reinterventions during follow-up.

Outcomes and Patency of Endovascular Infrapopliteal Reinterventions in Patients With Chronic Limb-Threatening Ischemia.

PURPOSE: Endovascular revascularization is the preferred treatment to improve perfusion of the lower extremity in patients with chronic limb-threatening ischemia (CLTI). Patients with CLTI often present with stenotic-occlusive lesions involving the infrapopliteal arteries. Although the frequency of treating infrapopliteal lesions is increasing, the reintervention rates remain high. This study aimed to determine the outcomes and patency of infrapopliteal endovascular reinterventions. METHODS: This retrospective, multicenter cohort study of 3 Dutch hospitals included patients who underwent an endovascular infrapopliteal reintervention in 2015 up to 2021 after a primary infrapopliteal intervention for CLTI. The outcome measures after the reintervention procedures included technical success rate, the mortality rate and complication rate (any deviation from the normal postinterventional course) at 30 days, overall survival, amputation-free survival (AFS), freedom from major amputation, major adverse limb event (MALE), and recurrent reinterventions (a reintervention following the infrapopliteal reintervention). Cox proportional hazard models were used to determine risk factors for AFS and freedom from major amputation or recurrent reintervention. RESULTS: Eighty-one patients with CLTI were included. A total of 87 limbs underwent an infrapopliteal reintervention in which 122 lesions were treated. Technical success was achieved in 99 lesions (81%). The 30-day mortality rate was 1%, and the complication rate was 13%. Overall survival and AFS at 1 year were 69% (95% confidence interval [CI], 55%-79%) and 54% (95% CI, 37%-67%), respectively, and those at 2.5 years were 45% (95% CI, 33%-56%) and 21% (95% CI, 11%-33%), respectively. Freedom from major amputation, MALE, and recurrent reinterventions at 1 year and 2.5 years were 59% (95% CI, 46%-70%) and 41% (95% CI, 25%-56%); 54% (95% CI, 41%-65%) and 36% (95% CI, 21%-51%); and 68% (95% CI, 55%-78%) and 51% (95% CI, 33%-66%), respectively. A Global Limb Anatomic Staging System score of III showed an increased hazard ratio of 2.559 (95% CI, 1.078-6.072; p=0.033) for freedom of major amputation or recurrent reintervention. CONCLUSIONS: The results of this study indicate that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, outcomes and patency were moderate to poor, with low AFS, high rates of major amputations, and recurrent reinterventions. CLINICAL IMPACT: This multicenter retrospective study evaluating outcome and patency of endovascular infrapopliteal reinterventions for CLTI, shows that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, the short- and mid-term outcomes of the infrapopliteal reinterventions were moderate to poor, with low rates of AFS and a high need for recurrent reinterventions. While the frequency of performing infrapopliteal reinterventions is increasing with additional growing complexity of the disease, alternative treatment options such as venous bypass grafting or deep venous arterialization may be considered and should be studied in randomized controlled trials.

Does the use of postoperative brace help preventing mechanical complications following adult deformity surgery?

PURPOSE: There is scarce information regarding the effectiveness of postoperative braces in decreasing mechanical complications and reinterventions following adult deformity surgery. METHODS: Retrospective matched cohort study from a prospective adult deformity multicenter database. We selected operated patients, fused to the pelvis, > 6 instrumented levels, and minimum 2 year follow-up. Three hundred and eighty patients were separated into two groups (Brace-3 months TLSO-vs No Brace) and then matched controlling for age, gender and frailty. We studied demographic, intraoperative, and postoperative spinopelvic parameters. Both groups were compared regarding complications and reinterventions in the first 2 postoperative years, using univariate and multivariate logistic regression analysis. RESULTS: We finally analyzed 359 matched patients, mean age of 65.3 ± 8.9 years, frailty-index (0.43 ± 0.15), and mostly females (84%). 224 patients wore a postoperative brace (B) and 135 didn't (NoB). They showed no difference in intraoperative variables and postoperative spinopelvic alignment. They differed (P < 0.05) in: Pelvic incidence (B:58° ± 13 vs NoB:54.5° ± 13); BMI (B:25.8 ± 4 vs NoB:27.4 ± 5); upper instrumented vertebra (B:81.7% T8-L1 vs NoB:72.6% T8-L1), and the use of multiple rods (B:47.3% vs NoB:18.5%). Univariate analysis showed a higher rate of mechanical complications and reinterventions when not using a brace. As well as higher NRS-back and leg pain at 6 weeks. However, multivariate analysis selected the use of multiple rods as the only independent factor protecting against mechanical complications (OR: 0.38; CI 95% 0.22-0.64) and reinterventions (OR: 0.41; CI 95% 0.216-0.783). CONCLUSION: After controlling for potential confounders, our study could not identify the protective effect of postoperative braces preventing mechanical complications and reinterventions in the first two postoperative years.

The Rate of Postoperative Complications in Complicated Acute, and Subacute Type B Aortic Dissections after TEVAR vs. PETTICOAT Procedures: Systematic Review and Meta-Analysis.

Background and Objectives: Provisional extension to induce complete attachment (PETTICOAT) is suggested as being associated with a lower incidence of aorta-related events and fewer reinterventions compared to thoracic endovascular aortic repair (TEVAR) in patients with complicated acute, and subacute type B aortic dissections. Materials and Methods: This article is a systematic review and meta-analysis following the PRISMA guidelines. The Medline, PubMed, Embase, and Cochrane databases were searched, starting on 21 February 2022 and ending on 22 June 2022, to identify studies that investigated the rate of postoperative complications in patients treated with the PETTICOAT compared to the TEVAR. A random effects meta-analysis was performed. Of 2350 studies, 5 studies involving 360 patients were included: 143 patients after the PETTICOAT procedure and 217 after the TEVAR. Results: The meta-analysis of all studies showed that the rate of secondary endovascular reinterventions was smaller in patients treated with the PETTICOAT (n = 3 studies; OR, 0.30; 95% CI, 0.10 to 0.94; p = 0.04). The results of other postoperative complications (30-day mortality, mortality during follow-up, paraplegia, stroke, and occurrence of endoleak) were lower in the PETTICOAT group but were not statistically significant. The rate of postoperative renal failure was lower in patients treated with the TEVAR (n = 4; OR, 1.08; 95% CI, 0.46 to 2.51; p = 0.86). Conclusion: This meta-analysis suggests that the PETTICOAT procedure is related to the lower rate of secondary endovascular reinterventions for complicated acute, and subacute type B aortic dissections.

Reintervention does not affect long-term survival after fenestrated endovascular aneurysm repair.

OBJECTIVE: Fenestrated endovascular aneurysm repair (FEVAR) is increasingly used in the treatment of juxtarenal aortic aneurysms and short-neck infrarenal aneurysms. Reinterventions (REIs) occur frequently, contributing to patient morbidity and resource utilization. We sought to determine whether REI affects long-term survival after FEVAR. METHODS: A single-institution retrospective review of all Cook Zenith fenestrated (ZFEN; Cook Medical, Inc, Bloomington, IN) repairs was performed. Patients with ≥6 months of follow-up and without adjunctive branch modifications were included. REI was defined as any aneurysm, device, target branch, or access-related intervention after the index procedure. REIs were categorized as early (<30 days) or late (≥30 days), by indication (ie, branch, endoleak, limb related, access related, other), and by target branch or device components. Patients were stratified into REI vs no REI groups and branch REI vs non-branch REI groups. RESULTS: Of 219 consecutive ZFEN repairs from 2012 to 2021, 158 patients met the inclusion criteria. Of these 158 patients, 41 (26%) required a total of 51 REIs (10 early and 41 late) during a mean follow-up of 33.9 months. The most common indication for REI was branch-related (31 of 51; 61%), with the renal arteries the most frequently affected (26 of 51; 51%). The only differences found in baseline, aneurysm, and device characteristics were a higher mean Society for Vascular Surgery comorbidity score (9.6 vs 7.9; P = .04) and larger suprarenal neck angle (23.3° vs 17.1°; P = .04) in the no REI group. In contrast, the REI group had a larger mean proximal seal zone diameter (26.3 mm vs 25.1 mm; P = .03) and device diameter (31.9 mm vs 30.0 mm; P = .002) compared with the no REI group. Technical success and operative characteristics were similar between the groups, except for a longer mean fluoroscopy time (74.9 minutes vs 60.8 minutes; P = .01) and longer median length of stay (2 vs 2 days; P = .006) for the REI group. Although the rate of early (<30 days) major adverse events was greater for the REI group (24.4% vs 6.0%; P = .001), the difference in 30-day mortality was not statistically significant (4.9% vs 0.9%; P = .10). On Kaplan-Meier analysis, freedom from REI at 1 and 5 years was 85.7% and 62.6%, respectively, for the overall cohort. No difference was found in the estimated 5-year survival between the REI and no REI groups (62.8% vs 63.5%; log-rank, P = .87) and branch REI and non-branch REI groups (71.8% vs 49.9%; log-rank, P = .16). On multivariate analysis, REI was not an independent predictor for mortality. However, age, Society for Vascular Surgery comorbidity score, and preoperative maximum aneurysm diameter each increased the hazard of death (hazard ratio [HR], 1.07; 95% confidence interval [CI], 1.02-1.12 [P = .007]; HR, 1.10; 95% CI, 1.01-1.18 [P = .02]; HR, 1.05; 95% CI, 1.02-1.08 [P = .003], respectively). CONCLUSIONS: After ZFEN, 41 patients (26%) had required a total of 51 REIs, with most occurring ≥30 days after the index procedure, and 61% were branch related, with no influence on 5-year survival. Age, comorbidity, and baseline aneurysm diameter independently predicted mortality. The use of FEVAR mandates lifelong surveillance and protocols to maintain branch patency. Despite their relative frequency, REIs did not influence 5-year postprocedural survival.

Early and midterm outcomes following open surgical conversion after failed endovascular aneurysm repair from the "Italian North-easT RegIstry of surgical Conversion AfTer Evar" (INTRICATE).

OBJECTIVE: To report the early and mid-term outcomes following open surgical conversion (OSC) after failed endovascular aortic repair (EVAR) using data from a multicentric registry. METHODS: A retrospective study was carried out on consecutive patients undergoing OSC after failed EVAR at eight tertiary vascular units from the same geographic area in the North-East of Italy, from April 2005 to November 2019. Study endpoints included early and follow-up outcomes. RESULTS: A total of 144 consecutive patients were included in the study. Endoleaks were the most common indication for OSC (50.7%), with endograft infection (24.6%) and occlusion (21.9%) being the second most prevalent causes. The overall rate of 30-day all-cause mortality was 13.9% (n = 20); 32 patients (22.2%) experienced at least one major complication. Mean length of stay was 13 ± 12.7 days. On multivariate logistic regression, age (odds ratio [OR], 1.09; 95% confidence interval [CI], 1.01-1-19; P = .02), renal clamping time (OR, 1.07; 95% CI, 1.02-1.13; P = .01), and suprarenal/celiac clamping (OR, 6.66; 95% CI, 1.81-27.1; P = .005) were identified as independent predictors of perioperative major complications. Age was the only factor associated with perioperative mortality at 30 days. Renal clamping time >25 minutes had sensitivity of 65% and specificity of 70% in predicting the occurring of major adverse events (area under the curve, 0.72; 95% CI, 0.61-0.82). At 5 years, estimated survival was significantly lower for patients treated due to aortic rupture/dissection (28%; 95% CI, 13%-61%), compared with patients in whom the indication for treatment was endoleak (54%; 95% CI, 40%-73%), infection (53%; 95% CI, 30%-94%), or thrombosis (82%; 95% CI, 62%-100%; P = .0019). Five-year survival rates were significantly lower in patients who received emergent treatment (28%; 95% CI, 14%-55%) as compared with those who were treated in an urgent (67%; 95% CI, 48%-93%) or elective setting (57%; 95% CI, 43%-76%; P = .00026). Subjects who received suprarenal/celiac (54%; 95% CI, 36%-82%) or suprarenal (46%; 95% CI, 34%-62%) aortic cross-clamping had lower survival rates at 5 years than those whose aortic-cross clamp site was infrarenal (76%; 95% CI, 59%-97%; P = .041). Using multivariate Cox proportional hazard, older age and emergency setting were independently associated with higher risk for overall 5-year mortality. CONCLUSIONS: OSC after failed EVAR was associated with relatively high rates of early morbidity and mortality, particularly for emergency setting surgery. Endoleaks with secondary sac expansion were the main indication for OSC, and suprarenal aortic cross-clamping was frequently required. Endograft infection and emergent treatment remained associated with poorer short- and long-term survival.

Reinterventions in the modern era of thoracic endovascular aortic repair.

OBJECTIVE: Using a national data set, we sought to describe the population of patients and the nature and timing of reinterventions after thoracic endovascular aortic repair (TEVAR) by aortic disease as well as their impact on survival. METHODS: We evaluated the national data set for TEVAR in the Vascular Quality Initiative from 2010 to 2017. Student t-test and χ2 analysis were used to compare continuous and categorical variables in the reintervention and no reintervention groups, respectively. Freedom from reintervention and survival analysis was performed using Kaplan-Meier methods. RESULTS: A total of 7006 patients were evaluated: 51.2% thoracic aortic aneurysm, 33.5% type B dissection (TBD), 7.0% penetrating aortic ulcer, 6.7% trauma, and 1.6% intramural hematoma. Overall, 553 patients (7.9%) underwent at least one reintervention, with an in-hospital reintervention rate of 3.5%. Reinterventions were most commonly performed for TBD (11.5%), with reinterventions for other diseases occurring at lower rates: thoracic aortic aneurysm, 6.7%; intramural hematoma, 5.4%; penetrating aortic ulcer, 4.8%; and trauma, 1.8%. The most common cause of reintervention across all aortic diseases was type I endoleak. The most common long-term reinterventions were placement of endovascular stent graft (65%), other surgical treatments (15.9%), other endovascular treatment (13%), endovascular branch treatment (12.4%), surgical treatment with no device removal (11.0%), and surgical branch treatment (10.4%). Freedom from reintervention was decreased for TBD compared with other diseases (P < .001). There was no difference in survival comparing patients undergoing reinterventions and those without (P = .87). However, patients undergoing in-hospital reintervention trended toward increased mortality (P = .075). CONCLUSIONS: Whereas reinterventions were not rare after TEVAR, there was no difference in mortality between patients undergoing reintervention and those without. Patients undergoing TEVAR for TBD demonstrated the highest reintervention rate. This study highlights the importance of long-term follow-up to address disease-specific patterns of reintervention.

Little benefit of surgical anchor and suture removal and of antibiotic therapy beyond 6 weeks in infected rotator cuff repair.

BACKGROUND: The purpose of this study was to investigate the benefit of surgical anchor and/or suture removal and prolonged antibiotic therapy in acute and chronic infections of rotator cuff repair (RCIs). METHODS: A single-center cohort and case-control study (Cox regression) was performed. Outcome variables were remission of infection and postinfection reoperations due to failed tendon healing for mechanical causes. All analyses were performed with an emphasis on anchor and suture retention or removal. RESULTS: We identified 54 primary RCIs (44 men; median age 54 years) that were surgically revised (10 by open débridement and 44 by arthroscopy). Twenty-eight (52%) were not intact on revision surgery (débridement) - 10 were partially and 18 totally re-ruptured. The median number of surgical revisions was 1 (range, 1-3), and the median duration of postsurgical antibiotic therapy was 75 days. After a minimal follow-up of 2 years, 8 infections (8/54, 15%) recurred. Twenty patients needed a revision surgery; in all of those 20 patients, intraoperative samples were negative for infection. By multivariate analysis, anchor removal at the first revision influenced neither remission (hazard ratio [HR] 0.9, 95% confidence interval [CI] 0.4-2.0) nor the need for later revision surgery due to mechanical sequelae (HR 0.6, 95% CI 0.1-1.4). The corresponding HRs for suture removal were 0.9 (95% CI 0.4-1.7) and 0.4 (95% CI 0.1-1.2). Likewise, the numbers of revision surgery (HR 0.5, 95% CI 0.2-1.3) and antibiotics beyond 6 weeks failed to influence remission (HR 1.1, 95% CI 0.4-3.1). CONCLUSIONS: In our RCI cohort, the removal of anchors or sutures, repeated revision surgery, or an antibiotic therapy beyond 6 weeks failed to improve remission or to reduce sequelae.

Cost-effectiveness of repeated interventions on failing arteriovenous fistulas.

OBJECTIVE: Arteriovenous fistulas (AVFs) used for hemodialysis commonly undergo multiple percutaneous and open interventions to maintain functional patency, but it is unclear whether this strategy is cost-effective. The aim of this study was to evaluate the clinical effectiveness and cost-effectiveness of performing repeated interventions vs starting a new AVF. METHODS: We reviewed all patients with mature radiocephalic, brachiocephalic, and brachiobasilic AVFs at a single academic institution between 2007 and 2015 and assessed the clinical effectiveness of each open and percutaneous intervention to maintain functional patency after the fistula was created. These data were used to parameterize a Markov simulation model to determine the cost-effectiveness for performing an open or percutaneous intervention vs creating an AVF at a new anatomic location. This model compared strategies of creating a new AVF after the first to fourth reintervention within a 1-year time window, with the reference being creation of a new AVF on the fourth reintervention. Costs were measured from Medicare's perspective, and effectiveness was measured as quality-adjusted life-years (QALYs) and time in functional access. Incremental cost-effectiveness ratios (ICERs) were calculated by taking the ratio of the difference in cost and the difference in effectiveness between two strategies. RESULTS: A total of 720 AVFs that were created during the 8-year period reached maturity, and 407 (56%) underwent at least one intervention to maintain functional patency, with the median (interquartile range) time to first reintervention of 12.6 (10-17) months. For the strategies of creating a new AVF after the first versus the fourth reintervention, payer costs ranged from $3519 to $3922 for open procedures and $2134 to $3922 for percutaneous procedures. The ICERs for open interventions on failing AVFs were $357,143/QALY after the first reintervention and $95,876/QALY after the second reintervention. The ICERs for percutaneous interventions on failing AVFs ranged from $1,522,078/QALY after the first reintervention to $443,243/QALY after the third reintervention. CONCLUSIONS: Whereas the clinical effectiveness of performing percutaneous interventions on failing AVFs diminishes after each reintervention, they are nevertheless less costly than creating a new AVF. In comparison, our data show that creating a new AVF is cost-effective after the second open reintervention procedure.

Variability in aneurysm sac regression after endovascular aneurysm repair based on a comprehensive registry of patients in Eastern Ontario.

BACKGROUND: Although the absence of aneurysm-related mortality, postimplantation rupture, and reintervention after endovascular aneurysm repair (EVAR) is desirable, it may not necessarily reflect successful aneurysm sac exclusion. Sac regression may be a more sensitive marker for EVAR success and may be influenced by factors beyond the presence or absence of an endoleak. The objective of this study is to determine the rate of overall long-term sac regression after EVAR and the influence of nonanatomic factors, and endograft devices used at our center. METHODS: This retrospective cohort study included all EVARs performed for intact and ruptured abdominal aortic aneurysms (AAAs) at a university teaching hospital. Preoperative, operative, and follow-up data were collected using clinical and radiologic institutional databases. Preoperative and post-EVAR sac diameters were determined by a blinded observer in accordance with Society for Vascular Surgery guidelines. Absolute and relative sac regression was determined at the following intervals: 0 to 6 months, 6 to 12 months, 12 to 18 months, 18 months to 2 years, 2 to 5 years, 5 to 10 years, and more than 10 years. RESULTS: From 1999 to 2015, 1060 patients underwent EVAR for an AAA at the Ottawa Hospital. Procedures were performed using a total of nine unique endograft devices, with five devices (Cook Zenith, n = 398; Medtronic Endurant, n = 375; Medtronic Talent, n = 183; Cook Zenith LP, n = 52; and Terumo Anaconda, n = 23) used in 97% of the procedures. The mean preoperative AAA diameter was 61.2 mm, with no detectable differences between endograft devices with respect to age, preoperative AAA diameter, or rupture diagnosis. Overall mean sac regression increased from -1.3 mm at 6 months, to -14.9 mm beyond 10 years. The majority of sac regression was achieved within 2 years. Only 90 of the 1060 patients (8.5%) experienced sac expansion of greater than 5 mm at some point during their follow-up period. Kaplan-Meier analyses revealed statistically significant device-specific variability in sac regression rates, even in the absence of an endoleak. Cox proportional hazard modeling demonstrated that age less than 75 years (hazard ratio [HR], 1.4; P = .001), female sex (HR, 1.4; P = .003), absence of type I endoleak (HR, 4.6; P < .0001), AAA greater than 70 mm (HR, 1.6; P < .0001), and both the Zenith (HR, 2.0; P < .0001) and Endurant (HR, 1.7; P = .001) devices were associated with shorter time to more than 5 mm sac regression. CONCLUSIONS: This study demonstrated a pattern of sac diameter change after EVAR, with the majority of sac regression occurring within the first 2 years. Variability in sac regression was influenced by nonanatomic variables including age, sex, original AAA diameter, and specific endograft device, even after controlling for the presence or absence of an endoleak. The biophysical relationship between specific endograft design and materials, and sac regression is yet to be determined.

Implications of secondary aortic intervention after thoracic endovascular aortic repair for acute and chronic type B dissection.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) has become a mainstay of therapy for acute and chronic type B aortic dissection (TBAD). Dynamic aortic morphologic changes, untreated dissected aorta, and persistent false lumen perfusion have significant consequences for reintervention after TEVAR for TBAD. However, few reports contrast differences in secondary aortic intervention (SAI) after TEVAR for TBAD or describe their influence on mortality. This analysis examined incidence, timing, and types of SAI after TEVAR for acute and chronic TBAD and determined their impact on survival. METHODS: All TEVAR procedures for acute and chronic TBAD (2005-2016) were retrospectively reviewed. Patients with staged (<30 days) or concomitant ascending aortic arch repair or replacement were excluded. Acuity was defined by symptom onset (0-30 days, acute; >30 days, chronic). SAI procedures were grouped into open (intended treatment zone or remote aortic site), major endovascular (TEVAR extension or endograft implanted at noncontiguous site), and minor endovascular (side branch or false lumen embolization) categories. Kaplan-Meier methodology was used to estimate freedom from SAI and survival. Cox proportional hazards were used to identify SAI predictors. RESULTS: TEVAR for TBAD was performed in 258 patients (acute, 49% [n = 128]; chronic, 51% [n = 130]). Mean follow-up was 17 ± 22 months with an overall SAI rate of 27% (n = 70; acute, 22% [28]; chronic, 32% [42]; odds ratio, 1.7; 95% confidence interval, 0.9-2.9; P = .07]. Median time to SAI was significantly less after acute than after chronic dissection (0.7 [0-12] vs 7 [0-91] months; P < .001); however, freedom from SAI was not different (1-year: acute, 67% ± 4%, vs chronic, 68% ± 5%; 3-year: acute, 65% ± 7%, vs chronic, 52% ± 8%; P = .7). Types of SAI were similar (acute vs chronic: open, 61% vs 55% [P = .6]; major endovascular, 36% vs 38% [P = .8]; minor endovascular, 21% vs 21% [P = 1]). The open conversion rate (either partial or total endograft explantation: acute, 10% [13/128]; chronic, 15% [20/130]; P = .2) and incidence of retrograde dissection (acute, 6% [7/128]; chronic, 4% [5/130]; P = .5) were similar. There was no difference in survival for SAI patients (5-year: acute + SAI, 55% ± 9%, vs acute without SAI, 67% ± 8% [P = .3]; 5-year: chronic + SAI, 72% ± 6%, vs chronic without SAI, 72% ± 7% [P = .7]). Factors associated with SAI included younger age, acute dissection with larger maximal aortic diameter at presentation, Marfan syndrome, and use of arch vessel adjunctive procedures with the index TEVAR. Indication for the index TEVAR (aneurysm, malperfusion, rupture, and pain or hypertension) or remote preoperative history of proximal arch procedure was not predictive of SAI. CONCLUSIONS: SAI after TEVAR for TBAD is common. Acute TBAD has a higher proportion of early SAI; however, chronic TBAD appears to have ongoing risk of remediation after the first postoperative year. SAI types are similar between groups, and the occurrence of aorta-related reintervention does not affect survival. Patients' features and anatomy predict need for SAI. These data should be taken into consideration for selection of patients, device design, and surveillance strategies after TEVAR for TBAD.

Impact of secondary interventions on mortality after fenestrated branched endovascular aortic aneurysm repair.

BACKGROUND: Fenestrated and branched endovascular aortic repair (F/BEVAR) is increasingly used to manage pararenal and thoracoabdominal aortic disease (TAAA). Device-related reintervention after F/BEVAR is common, but little is known about its impact on postoperative mortality. The purpose of this analysis was to describe secondary intervention (SI) after F/BEVAR and determine the impact of these procedures on patient survival. METHODS: A single-center review was done on all consecutive F/BEVARs performed from 2010 to 2016. Primary end points were incidence of secondary aortic, branch, and/or access vessel‒related SI, and survival. SI was categorized as minor endovascular (branch restenting, access vessel treatment, or percutaneous coil embolization), major endovascular (new aortic graft placement), or open (bleeding, access vessel, and/or aortic). Kaplan-Meier methodology was used to estimate freedom from SI and survival. Multivariable analysis was used to identify predictors of SI. RESULTS: A total of 308 F/BEVAR procedures were performed (75% physician-modified, 18% custom, 7% Zfen), with 1022 vessels revascularized (celiac, 228; superior mesenteric artery [SMA], 263; renal, 525). There were 117 (39%) extent I-III TAAA, 132 (44%) extent IV TAAA/4-vessel pararenal, and 54 (18%) <4-vessel pararenal repairs performed. Any type of SI occurred in 24% (74) of patients during the mean follow-up of 20 ± 21 months. The majority of reinterventions were endovascular (minor, 53% [n = 39]; major, 32% [n = 24]), whereas 12% (n = 9) were open and 3% (n = 2) hybrid. Primary indication for SI included: 22 (29%) with branch-related endoleaks (1C or III); 15 (22%) with proximal or distal aortic degeneration; 8 (12%) with branch vessel thrombosis/stenosis; 10 (11%) with aortic device type III endoleak/loss of overlap; 4 (6%) with postoperative mesenteric or renal bleeding events; 5 (5%) with type II endoleak; 3 (5%) with access vessel complication; and 2 (3%) with graft infection. Most SIs were elective (65%; n = 48) with the remainder occurring emergently (24%; n = 18) or for symptoms/urgently (11%; n = 8). Compared with endovascular remediation, open SI was more likely to be emergent (89%, 8 of 9; P = .001). Freedom from SI was 80 ± 3% and 64 ± 4% at 1 and 3 years, respectively. One- and 5-year survival with or without SI was: 1 year, 88 ± 4% vs 81 ± 3%; 5 years, 76 ± 5% vs 59 ± 4% (log rank test, P = .06). There was no survival difference based on type of SI (log rank test, P = .3). Extent I-III TAAA (HR, 1.6; 95% CI, 0.98-3.3; P = .06) and history of cerebrovascular disease (HR, 1.8; 95% CI, 0.97-2.6; P = .07) were predictive of SI. CONCLUSIONS: SIs after F/BEVAR most frequently involve branch vessel or aortic device remediation procedures; however, they do not negatively impact out-of-hospital survival. These results further highlight the crucial role of imaging surveillance after F/BEVAR to maintain durability. Discussions with patients, periprocedural planning, and the next generation of device design must focus on issues surrounding the risk of device-related SI events.

[Long-term follow-up of continent cystostomy with the Mitrofanoff procedure: 5 years later]. / Évaluation à long terme des cystostomies continentes de type Mitrofanoff chez l'adulte : résultats à 5 ans.

INTRODUCTION: This study analyzed long-term functional outcome of continent catheterizable channels with the Mitrofanoff procedure, their continence, complications and the satisfaction of the patients. MATERIAL AND METHOD: Data from patients who underwent a Mitrofanoff procedure at our institution from June 1997 to March 2015 were retrospectively collected. All patients were contacted at the end of the study, a survey was submitted to them. RESULTS: Sixty-seven patients underwent a continent cystostomy with the Mirtrofanoff procedure. Forty-five patients had the inclusion criteria: 18 years old or older, no previous urinary diversion with a minimum of 6 months of follow-up. The cohort comprised mainly neurologic bladder (84 %) with spinal cord injuries (54 %) or spina-bifida patients (15 %). Median age was 35 years old [22-49]. Median follow-up was 64months [39-90]. The surgical procedure used an appendicular channel: 30 patients (67 %) or a continent ileal plasty: 15 patients (33 %). At the end of follow-up: 88 % patients have a full cystostomy continence, 89 % full uretral continence. Twenty-nine patients had one (41 %) or more reinterventions. Reasons for the 58 reinterventions were: stomal stenosis (31 %), uretral incontinence (29 %), cystostomy incontinence (15 %), lithiasis (9 %). Those reinterventions were done with a local surgery (31 %) or an endoscopic surgery (35 %). Overall early adverse events (<30days) or delayed (>30days) adverse events were similar (P=0.93) in appendicovesicostomy group or continent ileal plasty group. Ninety-four percent patients described a satisfactory urinary comfort. The cystostomy was considered esthetic by 71 %, its realization allowed an improvement of the quality of life for 89 % of them. CONCLUSION: Continent channels in adults demonstrate favorable long-term outcomes even if reinterventions could be necessary to maintain a continent and catheterizable channel. Despite reinterventions, patients remain satisfied by the Mitrofanoff procedure which facilitate the process of clean intermittent catheterization. LEVEL OF EVIDENCE: 4.

Status of Endovascular Aneurysm Sealing After 5 Years of Commercial Use.

Endovascular aneurysm sealing (EVAS) using the Nellix Endovascular Sealing System was introduced commercially in 2013 with the aim of reducing the incidences of reintervention and late complications observed after conventional endovascular aneurysm repair (EVAR). In the 5 years since its commercial launch, the Nellix system has evolved in terms of its structure, instructions for use, and delivery technique. Complications, including migration and proximal endoleak, have been recognized and treatment strategies developed, although durability remains to be demonstrated. Prospective multicenter trials have shown a low incidence of type I endoleak and reintervention at 1-year follow-up, comparable to conventional EVAR with modern devices. Since the aneurysm sac is "actively managed" with EVAS, similar to open surgical repair, type II endoleaks are rare with the Nellix system. Unexpected benefits of active sac management with EVAS include reduced incidences of postimplantation syndrome and cardiac complications, with low all-cause mortality at 1 year. Less neck dilatation compared to EVAR has also been observed. The Nellix device and procedure continue to evolve, and further prospective studies are indicated. This article analyzes the current EVAS evidence to update our knowledge of this technique in the management of abdominal aortic aneurysm.

A Multicenter Experience With a New Fenestrated-Branched Device for Endovascular Repair of Thoracoabdominal Aortic Aneurysms.

PURPOSE: To investigate the outcomes of patients who were treated for thoracoabdominal aortic aneurysms (TAAAs) using custom-made fenestrated-branched stent-grafts. METHODS: A consecutive series of 108 patients (mean age 73.5 years; 73 men) with TAAA were treated with E-xtra Design Engineering customized fenestrated-branched stent-grafts between November 2011 and January 2017. Data on baseline characteristics, procedures, and clinical follow-up were collected from 6 regional European surgical centers for retrospective analysis of endoleaks, reinterventions, and target vessel patency. The median aneurysm diameter was 6.75 cm (range 5.5-13). The distribution of the TAAA according to the modified Crawford classification of extent was 25 (24%) type I, 19 (17%) type II, 20 (18%) type III, 29 (27%) type IV, and 15 (14%) type V. RESULTS: Technical success was achieved in 95% (103/108) of cases. Major early perioperative complications occurred in 40 (37%) patients. The 30-day mortality was 9.2% (10/108), and perioperative spinal cord ischemia was observed in 6 (5.5%) patients [2 (1.8%) permanent]. During the mean follow-up of 17.6 months (range 3-52), 28 (26%) patients required late reintervention. Two patients died due to aneurysm- or procedure-related causes. The estimated survival rates at 1, 2, and 4 years were 87%, 84%, and 51%, respectively. The estimated target vessel patency rates at the same time points were 95%, 91%, and 90%, respectively. The freedom from reintervention estimates were 84% and 73% at 1 and 4 years, respectively. CONCLUSION: Endovascular repair of TAAA using Jotec customized fenestrated-branched stent-grafts appears to be safe and effective in the early to midterm. The considerable rate of secondary interventions indicates that further improvements, graft surveillance, and follow-up are required.

A 15-Year Single-Center Experience of Endovascular Repair for Elective and Ruptured Abdominal Aortic Aneurysms.

PURPOSE: To evaluate the differences in technical outcomes and secondary interventions between elective endovascular aneurysm repair (el-EVAR) procedures and those for ruptured aneurysms (r-EVAR). METHODS: Of the 906 patients treated with primary EVAR from September 1998 until July 2012, 43 cases were excluded owing to the use of first-generation stent-grafts. Among the remaining 863 patients, 773 (89.6%) patients (mean age 72 years; 697 men) with asymptomatic or symptomatic abdominal aortic aneurysms (AAAs) were assigned to the el-EVAR group; 90 (10.4%) patients (mean age 73 years; 73 men) were assigned to the r-EVAR group based on blood outside the aortic wall on preoperative imaging. The primary study outcome was technical success; secondary endpoints, including freedom from secondary interventions and late survival, were examined with Kaplan-Meier analyses. RESULTS: At baseline, r-EVAR patients had larger aneurysms on average (p<0.001) compared to el-EVAR patients. Technical success was comparable (p=0.052), but there were more type Ia endoleaks at completion angiography in the r-EVAR group (p=0.038). As anticipated, more patients died in the first month in the r-EVAR group (18.9% vs 2.2% el-EVAR, p<0.001). At 5 years, there was an overall survival of 65.1% for the el-EVAR patients vs 48.1% in the r-EVAR group (p<0.001). The freedom from AAA-related mortality was 95.7% for el-EVAR and 71.0% for r-EVAR (p<0.001). Five-year freedom from type I/III endoleaks was significantly lower in the r-EVAR group (78.7% vs 90.0%, p=0.003). Five-year freedom from secondary intervention estimates were not significantly different (el-EVAR 84.2% vs r-EVAR 78.2%, p=0.064). CONCLUSION: Within our cohort of primary EVAR patients, r-EVAR cases showed comparable stent-graft-related technical outcome. Although there was a higher incidence of type Ia endoleaks on completion angiography in the r-EVAR group, the overall secondary intervention rate was comparable to el-EVAR.