Publications by authors named "Kristina A Giles"

50 Publications

Editor's Choice - Protamine Reduces Serious Bleeding Complications Associated with Carotid Endarterectomy in Asymptomatic Patients without Increasing the Risk of Stroke, Myocardial Infarction, or Death in a Large National Analysis.

Eur J Vasc Endovasc Surg 2020 Dec 27;60(6):800-807. Epub 2020 Oct 27.

Division of Vascular Surgery & Endovascular Therapy, University of Florida, Gainesville, FL, USA.

Objective: Controversy persists regarding the use of protamine during carotid endarterectomy (CEA), despite real world evidence to support its use. The purpose of this study was to determine the impact of protamine reversal of heparin anticoagulation on the outcome of CEA in the USA.

Methods: A prospective national registry (Society for Vascular Surgery Vascular Quality Initiative) of 72 787 patients undergoing elective asymptomatic CEA by 1879 surgeons from 316 centres in the USA and Canada from 2012 to 2018 was reviewed. Protamine use varied by both surgeon (20% rare use [< 10%], 30% variable use [11%-79%], 50% routine use [> 80% cases]) and geographical region (44% vs. 96%). Temporal trends in protamine use were also determined. End points included post-operative re-operation for bleeding, as well as potential protamine related thrombotic complications, including stroke, death, and myocardial infarction (MI). Predictors of end points were determined by multivariable logistic regression. Propensity matching was additionally used to control for differences between groups.

Results: Of the 72 787 patients who underwent CEA, 69% received protamine, while 31% did not. Protamine use increased over time from 60% (2012) to 73% (2018). In total, 378 patients (0.7%) in the protamine treated group underwent re-operation for bleeding vs. 342 patients (1.4%) in the untreated cohort (p < .001). Protamine use did not affect the rate of MI (0.7% vs. 0.8%; p = .023), stroke (1.1% vs. 1.0%; p = .20), or in hospital death (0.2% vs. 0.2%; p = 0.70) between treated and untreated patients, respectively. On multivariable analysis, protamine use was independently associated with reduced risk of re-operation for bleeding (odds ratio 0.5, 95% confidence interval 0.39-0.55; p < .001). Independent of protamine exposure, the consequences of a return to the operating room (RTOR) for bleeding were statistically significant, with a sevenfold increase in MI (RTOR 4.9% vs. no RTOR 0.7%; p < .001), an eightfold increase in stroke (RTOR 7.2% vs. no RTOR 0.9%; p < .001), and a 13 fold increase in death (RTOR 2.4% vs. no RTOR 0.2%; p < .001).

Conclusion: Protamine reduces serious bleeding complications at the time of CEA without increasing the risk of MI, stroke, or death, in this large North American analysis. Based on this and previous regional work regarding protamine use in CEA, it is believed that there is now sufficient evidence to support its routine use, and it should be considered as a benchmark for quality during CEA.
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http://dx.doi.org/10.1016/j.ejvs.2020.08.047DOI Listing
December 2020

Remodeling, Reintervention, and Survival After Endovascular Repair of Chronic Type B Dissection.

Ann Thorac Surg 2020 Sep 20. Epub 2020 Sep 20.

Division of Vascular Surgery and Endovascular Therapy, University of Florida College of Medicine, Gainesville, Florida.

Background: The efficacy of thoracic endovascular aortic repair (TEVAR) of chronic type B aortic dissection (cTBAD) is controversial. Only limited evidence describes temporal anatomic changes after TEVAR for cTBAD and their relationship to outcomes. We sought to investigate early aortic remodeling events after TEVAR for cTBAD with thoracic aneurysm and determine the association with reintervention and survival.

Methods: Records from 95 cTBAD patients undergoing TEVAR from 2005 to 2017 were reviewed. Using 3-dimensional centerline analysis, anatomic phenotyping of the thoracoabdominal aorta was performed. Reverse aortic remodeling (RAR) was defined by a ≥5-mm reduction in maximal thoracic aortic diameter. Kaplan-Meier analysis estimated freedom from reintervention and survival.

Results: Visceral segment dissection involvement was present in 89% of patients (n = 85), and the mean preoperative thoracic diameter was 63 mm (SD, 10). Complete thoracic false lumen thrombosis occurred in 71% of patients (n = 67), whereas abdominal false lumen thrombosis was documented in 60% (n = 57) by 6 months. RAR occurred in 41%. Aortic reintervention rate was 39% (n = 37). The 1- and 3-year freedom from reintervention was significantly higher in subjects experiencing early RAR (log-rank P = .02), but reintervention did not impact overall survival (log-rank P = .9). Similarly, overall survival was similar between patients with or without RAR (log-rank P = .4).

Conclusions: Early RAR is associated with decreased rates of reintervention; however, overall survival is not impacted by these changes. TEVAR for cTBAD results in a high rate of reintervention, which mandates vigilant surveillance protocols.
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http://dx.doi.org/10.1016/j.athoracsur.2020.07.017DOI Listing
September 2020

Contemporary management and outcomes of complex vascular surgical groin wound infections.

J Vasc Surg 2021 Mar 21;73(3):1031-1040.e4. Epub 2020 Jul 21.

Division of Vascular Surgery and Endovascular Therapy, University of Florida, Gainesville, Fla.

Objective: Vascular surgical groin wound infection (VS-GWI) has multiple causes and frequently is manifested as a limb- or life-threatening problem, resulting in significant morbidity and mortality. For patients undergoing operative extirpation, in situ repair, extra-anatomic bypass, or ligation can be used; however, limited data exist describing comparative results of the different operative choices or conduit subtypes. Therefore, we sought to describe our experience with management of VS-GWI and to detail outcomes of the different strategies.

Methods: Patients (2003-2017) undergoing surgical treatment of VS-GWI (Szilagyi grade III) secondary to primary infectious arteritis or infected pseudoaneurysm after percutaneous intervention as well as previous prosthetic graft placement were reviewed. The primary end point was major adverse limb events (MALEs; major amputation, graft occlusion, or unplanned reintervention). Secondary end points included 30-day mortality, wound healing, amputation-free survival (AFS), and all-cause mortality. Cox proportional hazards modeling was used to determine relative risk of end points; Kaplan-Meier methodology was employed to estimate freedom from outcomes.

Results: There were 149 patients (age, 65 ± 11 years; body mass index, 27 ± 6 kg/m; 70% male; 32% diabetes) identified, of whom 120 (81%) had unilateral and 29 (19%) had bilateral VS-GWI. Indications included infected prosthetic bypass (88% [n = 131]; infrainguinal, 107; suprainguinal, 24) and primary infectious femoral artery complications (12% [n = 18]). A majority underwent single-stage operations (87% [n = 129]). In situ reconstruction occurred in 87% (n = 129); 9% (n = 13) underwent ligation, and 6% (n = 7) received extra-anatomic revascularization. Autogenous conduit was used most commonly (68% [n = 101/149]; 88% single stage), of which 81% (n = 80) were femoral vein. The remaining patients received cadaveric (15% [n = 23]; 87% single stage) or prosthetic (8% [n=12]; 67% single stage) grafts. Adjunctive myocutaneous flap was used in 37% (n = 54). Length of stay was 19 ± 15 days and 30-day mortality was 7% (n = 10), with no difference between conduit repair types. All femoral wounds healed (mean follow-up, 17 ± 11 months); however, 33% (n = 49) underwent reoperation (unplanned graft reintervention, 33%; graft occlusion, 16%; wound débridement, 15%; major amputation, 11%). Reinfection occurred in 17% (n = 27), with no difference between groups. MALE rate was 22% (n = 33; most were arterial reinterventions, 19%), with no difference in single-stage vs multistage, in situ vs extra-anatomic, or autogenous vs nonautogenous conduit strategies Predictors of MALE included younger age (hazard ratio [HR], 1.6 per decade; 95% confidence interval [CI], 1.1-2.5; P = .02) and lower body mass index (<25 kg/m; HR, 1.6 per BMI category; 95% CI, 1.1-2.5; P = .02). Overall, 1- and 3-year freedom from MALE, AFS, and survival were as follows: MALE, 74% ± 5% and 63% ± 6%; AFS, 68% ± 4% and 58% ± 5%; survival, 78% ± 3% and 70% ± 4%. Autogenous conduit use was associated with better survival (HR, 0.5; 95% CI, 0.3-0.8; 1-year: 83% ± 4% vs nonautogenous, 78% ± 4%; 3-year: 68% ± 8% vs 53% ± 9%; log-rank, P = .006).

Conclusions: An individualized approach to operative strategy and conduit choice leads to comparable outcomes in this challenging group of patients. VS-GWI can be safely managed with in situ, autogenous reconstruction in a majority of patients with acceptable mortality, excellent wound healing rates, and improved overall survival. However, a significant proportion of patients experience reinfection and MALEs, the preponderance of which are arterial reintervention, mandating need for close follow-up and graft surveillance.
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http://dx.doi.org/10.1016/j.jvs.2020.06.119DOI Listing
March 2021

Association between surgeon case volume and years of practice experience with open abdominal aortic aneurysm repair outcomes.

J Vasc Surg 2020 Jul 22. Epub 2020 Jul 22.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Background: Widespread adoption of endovascular aneurysm repair has led to a consequential decline in the use of open aneurysm repair (OAR). This evolution has had significant ramifications on vascular surgery training paradigms and contemporary practice patterns among established surgeons. Despite being the subject of previous analyses, the surgical volume-outcome relationship has remained a focus of controversy. At present, little is known about the complex interaction of case volume and surgeon experience with patient selection, procedural characteristics, and postoperative complications of OAR. The purpose of the present analysis was to examine the association between surgeon annual case volume and years of practice experience with OAR.

Methods: All infrarenal OARs (n = 11,900; elective, 70%; nonelective, 30%) included in the Society for Vascular Surgery Vascular Quality Initiative from 2003 to 2019 were examined. Surgeon experience was defined as years in practice after training. The experience level at repair was categorized chronologically (≤5 years, n = 1667; 6-10 years, n = 1887; 11-15 years, n = 1806; ≥16 years, n = 6540). The annual case volume was determined by the number of OARs performed by the surgeon annually (median, five cases). Logistic regression was used to perform risk adjustment of the outcomes across surgeon experience and volume (five or fewer vs more than five cases annually) strata for in-hospital major complications and 30-day and 1-year mortality.

Results: Practice experience had no association with unadjusted mortality (30-day death: elective, P = .2; nonelective, P = .3; 1-year death: elective, P = .2; nonelective, P = .2). However, more experienced surgeons had fewer complications after elective OAR (25% with ≥16 years vs 29% with ≤5 years; P = .004). A significant linear correlation was identified between increasing surgeon experience and performance of a greater proportion of elective OAR (P-trend < .0001). Risk adjustment (area under the curve, 0.776) revealed that low-volume (five or fewer cases annually) surgeons had inferior outcomes compared with high-volume surgeons across the experience strata for all presentations. In addition, high-volume, early career surgeons (≤5 years' experience) had outcomes similar to those of older, low-volume surgeons (P > .1 for all pairwise comparisons). Early career surgeons (≤5 years) had operated on a greater proportion of elective patients with American Society of Anesthesiologists class ≥4 (35% vs 30% [≥16 years' experience]; P = .0003) and larger abdominal aortic aneurysm diameters (mean, 62 vs 59 mm [≥16 years' experience]; P < .0001) compared with all other experience categories. Similarly, the use of a suprarenal cross-clamp occurred more frequently (26% vs 22% [≥16 years' experience]; P = .0009) but the total procedure time, estimated blood loss, and renal and/or visceral ischemia times were all greater for less experienced surgeons (P-trend < .0001).

Conclusions: Annual case volume appeared to be more significantly associated with OAR outcomes compared with the cumulative years of practice experience. To ensure optimal OAR outcomes, mentorship strategies for "on-boarding" early career, as well as established, low-volume, aortic aneurysm repair surgeons should be considered. These findings have potential implications for widespread initiatives surrounding regulatory oversight and credentialing paradigms.
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http://dx.doi.org/10.1016/j.jvs.2020.07.065DOI Listing
July 2020

A comparison of administrative data and quality improvement registries for abdominal aortic aneurysm repair.

J Vasc Surg 2021 Mar 16;73(3):874-888. Epub 2020 Jul 16.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass. Electronic address:

Objective: Databases are essential in evaluating surgical outcomes and gauging the implementation of new techniques. However, there are important differences in how data from administrative databases and surgical quality improvement (QI) registries are collected and interpreted. Therefore, we aimed to compare trends, demographics, and outcomes of open and endovascular abdominal aortic aneurysm (AAA) repair in an administrative database and two QI registries.

Methods: We identified patients undergoing open and endovascular repair of intact and ruptured AAAs between 2012 and 2015 within the National Inpatient Sample (NIS), the National Surgical Quality Improvement Program (NSQIP), and the Vascular Quality Initiative (VQI). We described the differences and trends in overall AAA repairs for each data set. Moreover, patient demographics, comorbidities, mortality, and complications were compared between the data sets using Pearson χ test.

Results: A total of 140,240 NIS patients, 10,898 NSQIP patients, and 26,794 VQI patients were included. Ruptured repairs composed 8.7% of NIS, 11% of NSQIP, and 7.9% of VQI. Endovascular aneurysm repair (EVAR) rates for intact repair (range, 83%-84%) and ruptured repair (range, 51%-59%) were similar in the three databases. In general, rates of comorbidities were lower in NIS than in the QI registries. After intact EVAR, in-hospital mortality rates were similar in all three databases (NIS 0.8%, NSQIP 1.0%, and VQI 0.8%; P = .06). However, after intact open repair and ruptured repair, in-hospital mortality was highest in NIS and lowest in VQI (intact open: NIS 5.4%, NSQIP 4.7%, and VQI 3.5% [P < .001]; ruptured EVAR: NIS 24%, NSQIP 20%, and VQI 16% [P < .001]; ruptured open: NIS 36%, NSQIP 31%, and VQI 26% [P < .001]). After stratification by intact and ruptured presentation and repair strategy, several discrepancies in morbidity rates remained between the databases. Overall, the number of cases in NSQIP represents 7% to 8% of the repairs in NIS, and the number of cases in VQI grew from 12% in 2012 to represent 23% of the national sample in 2015.

Conclusions: NIS had the largest number of patients as it represents the nationwide experience and is an essential tool to evaluate trends over time. The lower in-hospital mortality seen in NSQIP and VQI questions the generalizability of the studies that use these QI registries. However, with a growing number of hospitals engaging in granular QI initiatives, these QI registries provide a valuable resource to potentially improve the quality of care provided to all patients.
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http://dx.doi.org/10.1016/j.jvs.2020.06.105DOI Listing
March 2021

Association of hospital volume with patient selection, risk of complications, and mortality from failure to rescue after open abdominal aortic aneurysm repair.

J Vasc Surg 2020 11 12;72(5):1681-1690.e4. Epub 2020 Apr 12.

Division of Vascular Surgery and Endovascular Therapy, University of Florida, Gainesville, Fla. Electronic address:

Objective: The association of higher hospital volume with lower mortality after open abdominal aortic aneurysm (OAAA) repair is well known; however, the underlying mechanism for improved outcomes is poorly understood. Better patient selection, lower risk of complications, and improved ability to rescue patients after adverse events are assumed mechanisms, but few data exist to validate this hypothesis. The purpose of this analysis was to determine the association of hospital volume with patient selection, incidence of complications, and failure to rescue (FTR) after adverse events resulting from OAAA repair.

Methods: The Vizient (Irving, Tex) database (>95% of all academic hospitals) was reviewed for OAAA repairs (elective, n = 2827; nonelective, n = 1622) performed from 2012 to 2014. Presentation type (elective vs nonelective) was considered in all analyses. Elixhauser comorbidity index and van Walraven weighted scores were assigned to patients and volume-outcome relationships explored. By use of logistic regression, risk-adjusted complications (including preventable complications; Agency for Healthcare Research and Quality patient safety indicators [PSIs]) and FTR rates were determined. Predicted risk scores were assigned to delineate hospital volume association with these outcomes.

Results: Overall, no relationship between hospital volume and composite patient comorbidity severity score was identified (Elixhauser comorbidity index and van Walraven weighted scores: Pearson [ρ, 0.02], P = .2; [ρ, -0.01], P = .4; Spearman correlation coefficient [ρ, 0.02], P = .4; [ρ, -0.02], P = .2). The lack of correlation persisted in considering elective vs nonelective status. However, for elective cases, differences in specific comorbidities were noted because high-volume hospitals were more likely to repair patients with a history of peripheral vascular disease (P = .01), diabetes (P = .07), obesity (P = .004), and alcohol abuse (P = .05). Lower volume hospitals more frequently repaired patients with hypothyroidism (P = .05), fluid and electrolyte disorders (P = .007), and chronic blood loss anemia (P = .05). No specific individual comorbidity differences were detected for nonelective cases. In examining hospital volume effects on the likelihood for development of any complication (45%), PSIs (12%), and FTR (9%), a significant risk reduction was noted in high-volume institutions. Specifically, a nonlinear relationship between hospital volume and risk of any complication (P = .0004), PSI (P = .0004), and FTR (P =. 0003) was present. In exploring the risk of specific complications or PSI events, greater hospital volume was strongly correlated to a lower likelihood of multiple adverse outcomes.

Conclusions: Although high-volume institutions performing OAAA repair do not necessarily operate on patients with more comorbidities, there are important differences in the patients selected compared with lower volume hospitals. The risk for development of multiple specific postoperative complications as well as for preventable adverse events preceding FTR is significantly lower in high-volume centers. These findings provide benchmarks for multiple selected quality indicators and further support national initiatives to incentivize regionalization of OAAA care.
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http://dx.doi.org/10.1016/j.jvs.2019.12.044DOI Listing
November 2020

Surgeon experience association with patient selection and outcomes after open abdominal aortic aneurysm repair.

J Vasc Surg 2020 10 27;72(4):1325-1336.e2. Epub 2020 Feb 27.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Background: Growing calls for guidelines advocating minimum annual case volumes for surgeon credentialing remain controversial. Although most attention to date has focused on the impact of obligatory case volume, less attention has been devoted to the more complex association between surgeon years of independent practice experience and procedure outcomes after open abdominal aortic aneurysm repair (OAR). Therefore, the purpose of this study was to explore the association of surgeon experience with case selection and real-world outcomes after OAR.

Methods: All Society for Vascular Surgery-Vascular Quality Initiative infrarenal and juxtarenal OARs (n = 11,900; 71% elective; 29% nonelective) from 2003 to 2019 were examined. Surgeon experience was defined by years in practice after training completion. Experience level at time of repair was categorized (≤5 years, n = 1048; 6-10 years, n = 1309; 11-15 years, n = 1244; and ≥16 years, n = 4772) and intergroup univariate comparisons were made. Logistic regression identified independent predictors of complications, 30-day death, and 1-year mortality. Models were constructed with or without surgeon experience strata to determine association with outcomes.

Results: Increasing surgeon experience was associated with performing greater proportions of elective procedures, whereas less experienced surgeons had disproportionate exposure to nonelective operations (elective, 73% ≥16 years vs 62% ≤5 years [P < .0001]; nonelective, ≤5 years, 38% vs 27%, ≥16-years [P < .0001]). Among surgeons who perform five or fewer cases per year, the risk of any aggregate major complication after elective OAR decreased significantly as experience increased (P = .0004), although no differences were detected in nonelective cases or among higher volume surgeons. Similarly, the risk of in-hospital death decreased with increasing experience (P = .004), but only among low-volume surgeons performing elective procedures. Comorbidities were similar across all experience strata for both elective and nonelective presentations; however, more experienced surgeons operated on higher proportions of nonelective patients with coronary disease (P = .04). Early career surgeons more frequently operated on patients with American Society of Anesthesiologists IV designation, larger abdominal aortic aneurysm diameters and used suprarenal/celiac cross-clamps more frequently than later career surgeons. The 1-year survival after elective and nonelective OAR was not impacted by surgeon experience (P > .15 for all comparisons).

Conclusions: Increasing surgeon years of practice experience correlated significantly with a reduced risk of developing multiple postoperative complications, including postoperative death in the elective setting. Surgeons within their first 5 years of practice are exposed to greater proportions of nonelective cases but seem to have similar outcomes after these repairs compared with surgeons with more experience. Notably, surgeons in their first 5 years of practice operate on more complex elective patients as underscored by higher aggregate comorbidity scores, larger aneurysm diameters, and need for suprarenal aortic cross-clamping. These data have important implications on training paradigms, faculty recruitment, and the organization of mentorship when on boarding new surgeons.
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http://dx.doi.org/10.1016/j.jvs.2019.12.031DOI Listing
October 2020

Five-year survival following endovascular repair of ruptured abdominal aortic aneurysms is improving.

J Vasc Surg 2020 07 21;72(1):105-113.e4. Epub 2020 Feb 21.

Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address:

Objective: Increasing experience and improving technology have led to the expansion of endovascular aneurysm repair (EVAR) for ruptured abdominal aortic aneurysms (AAA). We investigated whether the 5-year survival after both EVAR and open repair for ruptured AAA changed over the last 14 years.

Methods: We identified repairs for ruptured infrarenal AAA within the Vascular Quality Initiative registry between 2004 and 2018. We compared the 5-year survival of both EVAR and open repair between the early (2004-2012) and late (2013-2018) cohorts. In addition, we compared EVAR with open repair in the early and late cohorts. We used propensity score modeling to create matching cohorts for each analysis. Kaplan-Meier analysis was used to estimate survival proportions and univariate Cox proportional hazards analysis was used to compare differences in hazard of mortality in the matched cohorts.

Results: We identified 4638 ruptured AAA repairs. This included 409 EVARs in the early cohort and 2250 in the late cohort, as well as 558 open repairs in the early cohort and 1421 in the late cohort. Propensity matching resulted in 366 matched pairs of late vs early EVAR and 391 matched-pairs of late vs early open repair. When comparing EVAR with open repair, propensity matching resulted in 277 matched pairs of early EVAR versus open, and 1177 matched pairs of late EVAR versus open. In matched EVAR patients, 5-year survival was higher in the late cohort (63% vs 49%; hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.61-0.97; P = .027), whereas there was no difference between matched late vs early for open repair patients (52% vs 59%; HR, 1.04; 95% CI, 0.85-1.28; P = .69). In the early cohort, there was no survival difference between EVAR and open repair (51% vs 46%; HR, 0.88; 95% CI, 0.69-1.11; P = .28). However, in the late cohort EVAR was associated with higher survival compared with open repair (63% vs 54%; HR, 0.69; 95% CI, 0.60-0.79; P < .001).

Conclusions: The 5-year survival after EVAR for ruptured AAA has improved over time, whereas survival after open repair remained constant. Consequently, the relative survival benefit of EVAR over open repair has increased over time, which should encourage further adoption of EVAR for ruptured AAA.
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http://dx.doi.org/10.1016/j.jvs.2019.10.074DOI Listing
July 2020

National incidence, mortality outcomes, and predictors of spinal cord ischemia after thoracic endovascular aortic repair.

J Vasc Surg 2020 07 21;72(1):92-104. Epub 2020 Jan 21.

Division of Vascular Surgery, University of Alabama at Birmingham, Birmingham, Ala.

Objective: Spinal cord ischemia (SCI) is a dreaded complication of thoracic endovascular aortic repair (TEVAR). There are limited national data describing the incidence and influence of in-hospital SCI recovery on survival. Moreover, no robust preoperative SCI risk assessment models currently exist. The purpose of this analysis was to analyze the Vascular Quality Initiative to determine the national incidence, survival association, and preoperative predictors of SCI after TEVAR.

Methods: All Vascular Quality Initiative TEVAR procedures (June 2014-June 2019) were reviewed. The primary end point was development of in-hospital SCI, defined as any new neurologic deficit or paralysis not attributable to intracranial disease. Secondary end points were disease-specific SCI rates and long-term out-of-hospital survival. Functional outcomes (transient vs permanent SCI) were independently determined by treating physicians. Kaplan-Meier analysis and Cox proportional hazards methodology were used to assess the association of SCI with survival. A logistic regression model of candidate preoperative SCI predictors was created, and bootstrapped backward elimination (retaining predictors with ≥50% selection frequency) was used for model reduction. Model fit and performance statistics were validated by adjustment for Efron's optimism.

Results: The overall rate of SCI was 3.7% (n = 422/11,473; transient, 1.6% [n = 179]; permanent, 2.1% [n = 243]). Patients who developed any SCI had significantly lower Kaplan-Meier survival estimate compared with those without SCI (1-year survival: SCI, 65%; no SCI, 87%; P < .0001), and patients with permanent SCI had notably worse survival than patients with transient SCI (1-year survival: permanent SCI, 54%; transient SCI, 80%; P < .0001). Disease-specific incidence of any SCI was as follows: aneurysm, 3.4%; dissection, 5.3%; aneurysm from dissection, 4.1%; trauma, 1.1%; penetrating ulceration, 2.4%; intramural hematoma, 5.7%; penetrating ulceration and intramural hematoma, 4.3%; and aortic thrombus, 4.8%. Several factors were selected on multivariable analysis as the most robust preoperative predictors of any SCI, including distal landing zone 5 to zone 10, nonelective case, creatinine concentration >1.38 mg/dL, smoking history, American Society of Anesthesiologists class, adjunctive procedure, nonwhite race, and preoperative hypertension (area under the curve = 0.72; Nagelkerke R = 0.06).

Conclusions: SCI is a devastating complication after TEVAR that is associated with worse overall survival, particularly when no functional recovery occurs by hospital discharge. Disease-specific, real-world benchmarks for SCI rates are provided that may inform quality initiatives focused on reducing this complication. Importantly, this analysis is the first description of a preoperative prediction model derived from national data for determining SCI risk after TEVAR. These predictors should be used to identify high-risk patients to balance the risk of SCI and its associated increased short-term mortality with the risk of the underlying disease. Furthermore, all available adjunctive measures should be implemented in these high-risk patients to reduce risk of SCI.
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http://dx.doi.org/10.1016/j.jvs.2019.09.049DOI Listing
July 2020

Impact of Secondary Aortic Interventions After Thoracic Endovascular Aortic Repair on Long-Term Survival.

Ann Thorac Surg 2020 07 27;110(1):27-38. Epub 2019 Nov 27.

Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Florida, Gainesville, Florida. Electronic address:

Background: The indications for and technology surrounding thoracic endovascular aortic repair (TEVAR) have undergone significant evolution with increasing adoption. The purpose of this report is to evaluate pathology-specific incidence, timing, and types of secondary aortic intervention (SAI) after TEVAR and their impact on survival.

Methods: A single-center retrospective review was made of all TEVAR and SAI performed from 2004 to 2018. Kaplan-Meier and multivariable logistic regression were used to estimate freedom from SAI and survival, and to identify SAI predictors.

Results: Of 1037 patients (mean age 65.4 ± 15.1 years), 155 (14.9%) underwent 212 SAIs (median 5 months; interquartile range, 1.5 to 18) with 37 (3.6%) requiring more than one SAI. The primary aortic pathology at index TEVAR significantly (P = .0001) affected the incidence of SAI: chronic dissection, 26.5%; postsurgical anastomotic pseudoaneurysm, 19.4%; degenerative aneurysm, 15.3%; and acute dissection, 11.2%. The most common indications for SAI were endoleaks (44.8%), disease progression or remote aortic procedure (23.1%), and persistent false lumen flow (9.9%). After exclusion of 30-day mortality events, patients who did not undergo a SAI had better survival compared with patients having SAI: no SAI 1 year 88.8% ± 1.1%, 5 years 75.2% ± 1.7%, and 10 years, 66.5% ± 2.3%; SAI 1 year 91.7% ± 2.4%, 5 years 61.9% ± 4.9%, and 10 years 33.5% ± 8.4% (log rank P = .004).

Conclusions: Secondary aortic intervention after TEVAR is not uncommon, particularly among patients with chronic dissection pathology. Patients surviving their index hospitalization who undergo SAI have worse long-term survival. The varying incidence of SAI by indication identifies the need for pathology-specified patient selection, surveillance strategies after TEVAR, and better device design that addresses the limitations of TEVAR, particularly in dealing with dissection-related indications.
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http://dx.doi.org/10.1016/j.athoracsur.2019.10.015DOI Listing
July 2020

Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms.

J Vasc Surg 2020 05 11;71(5):1503-1514. Epub 2019 Nov 11.

Division of Vascular Surgery and Endovascular Therapy, University of Florida College of Medicine, Gainesville, Fla.

Objective: Open repair of extent II and III thoracoabdominal aortic aneurysms (TAAA) is associated with substantial morbidity. Alternative strategies, such as hybrid operations combining proximal thoracic endovascular aortic repair with either staged open distal TAAA repair or visceral debranching (hybrid), as well as fenestrated/branched endografts (FEVAR), have been increasingly reported; however, benefits of these approaches compared with direct open surgery remain unclear. The purpose of this study was to compare outcomes of these three different strategies in the management of extent II/III TAAA.

Methods: All extent II/III TAAA repairs (2002-2018) for nonmycotic, degenerative aneurysm or chronic dissection at a single institution were reviewed. The primary end point was 30-day mortality. Secondary end points included incidence of spinal cord ischemia (SCI), complications, unplanned re-operation, 90-day readmission, and out-of-hospital survival. To mitigate impact of covariate imbalance and selection bias, intergroup comparisons were made using inverse probability weighted-propensity analysis. Cox regression was used to estimate survival while cumulative incidence was used to determine reoperation risk.

Results: One hundred ninety-eight patients (FEVAR, 92; hybrid, 40; open, 66) underwent repair. In unadjusted analysis, compared with hybrid/open patients, FEVAR patients were significantly older with more cardiovascular risk factors, but less likely to have a connective tissue disorder or dissection-related indication. Unadjusted 30-day mortality and complication rates were: 30-day mortality, FEVAR 4%, hybrid 13%, open 12% (P = .01); and complications, FEVAR 36%, hybrid 33%, open 50% (P = .11). Permanent SCI was not different among groups (FEVAR 3%, hybrid 3%, open 6%; P = .64). In adjusted analysis, 30-day mortality risk was greater for open vs FEVAR (hazard ratio, 3.6; 95% confidence interval, 1.4-9.2; P = .01) with no difference for hybrid vs open/FEVAR. There was significantly lower risk of any SCI for open vs FEVAR (hazard ratio, 0.3; 95% confidence interval, 0.09-0.96; P = .04); however, no difference in risk of permanent SCI was detected among the three groups. There was no difference in complications or unplanned reoperation, but open patients had the greatest risk of unplanned 90-day readmission. There was a time-varying effect on survival probability, with open repair having a significant survival disadvantage in the first 1 to 6 months after the procedure compared with hybrid/FEVAR patients (Cox model P = .03), but no difference in survival at 1 and 5 years (1- and 5-year survival: FEVAR, 86 ± 3%, 55 ± 8%; hybrid, 86 ± 5%, 60 ± 11%; open 69 ± 7%, 59 ± 8%; Cox-model P = .10).

Conclusions: Extent II/III TAAA repair, regardless of operative strategy, is associated with significant morbidity risk. FEVAR is associated with the lowest 30-day mortality risk compared with hybrid and open repair when estimates are adjusted for preoperative risk factors. These data support greater adoption of FEVAR as first-line therapy to treat complex TAAA disease in anatomically suitable patients who present electively.
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http://dx.doi.org/10.1016/j.jvs.2019.08.236DOI Listing
May 2020

Impact of hospital volume on patient safety indicators and failure to rescue following open aortic aneurysm repair.

J Vasc Surg 2020 04 9;71(4):1135-1146.e4. Epub 2019 Sep 9.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Objective: Failure to rescue (FTR), a patient safety indicator (PSI) defined, codified, and adjudicated by the Agency for Healthcare Research and Quality, is classified as a preventable inpatient death following major complications. FTR has been reported to be a significant driver of postoperative mortality after open abdominal aortic aneurysm (OAAA) repair. The association between hospital volume (HV) and mortality is well known; however, the mechanisms responsible for these improved outcomes and relative contribution to observed interhospital variation is poorly understood. Similarly, HV influence on specific complications predictive of FTR is unknown; therefore, we sought to determine how HV influences risk and contributes to interhospital variation in PSI events leading to FTR and/or in-hospital mortality after OAAA repair.

Methods: The Vizient database (174 academic/nonacademic hospitals) was queried for all OAAA repairs (elective, n = 2827; nonelective, n = 1622) completed from 2012 to 2014. The primary endpoint was combined FTR and/or in-hospital 30-day mortality. Risk-adjusted rates of complications, Agency for Healthcare Research and Quality-designated PSIs, and FTR were determined. Additional modeling identified PSIs associated with FTR, whereas HV effects on PSIs and FTR were evaluated using mixed-effect models accounting for interhospital variation. Proportion of variation attributable to HV was estimated by contrasting hospital random effect variances in the presence/absence of volume effects.

Results: The combined overall FTR/in-hospital 30-day mortality rate was 9.3% (n = 414). For elective and nonelective cases, the overall FTR and 30-day mortality rates were: FTR, 1.6%, 4.9%; and 30-day in-hospital mortality, 3.4%, 17.5%, respectively. HV significantly influenced FTR/30-day in-hospital mortality (P < .0001). FTR/30-day mortality odds for hospitals with 3-year volumes of 50, 100, 150, and 200 cases were 1.4, 2.0, 2.7, and 3.0 times lower, respectively, than hospitals performing ≤25 cases/3 years. The proportion of interhospital variation attributed to HV was greatest for FTR/30-day mortality (62%). Procedural volume accounted for 41% and 38% of interhospital variation in postoperative bleeding and myocardial infarction, respectively. Preoperative predictors of FTR included coagulopathy, arrhythmia (nonelective cases); congestive heart failure, obesity (elective cases); and age, neurological disease, hypertension, and valvular disease (all cases).

Conclusions: OAAA FTR/30-day in-hospital mortality strongly correlated with annual case volume with higher volume centers having the lowest risk. Notably, HV accounted for a significant proportion of the observed variation in FTR and specific complications providing direct evidence for how the volume-outcome relationship may influence perioperative mortality. These findings can inform stakeholders to strategically enable them to implement processes of care directed at the most vulnerable patients that are designed to reduce the likelihood of preventable adverse events and death after OAAA repair. Furthermore, these results underscore the need to regionalize OAAA repair and potentially other complex operations, to HV centers because of their improved ability to rescue patients experiencing complications associated with postoperative mortality.
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http://dx.doi.org/10.1016/j.jvs.2019.06.194DOI Listing
April 2020

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

J Vasc Surg 2019 12 13;70(6):1737-1746.e1. Epub 2019 Aug 13.

Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, Ala.

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.
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http://dx.doi.org/10.1016/j.jvs.2019.02.029DOI Listing
December 2019

Interaction between frailty and sex on mortality after elective abdominal aortic aneurysm repair.

J Vasc Surg 2019 12 27;70(6):1831-1843. Epub 2019 May 27.

Department of Epidemiology, University of Florida, Gainesville, Fla.

Background: Controversy exists surrounding gender outcome disparity and abdominal aortic aneurysm (AAA) repair. Previous reports have demonstrated worse outcomes for women undergoing open aneurysm repair (OAR); however, these differences are less evident with endovascular aneurysm repair (EVAR). Epidemiologic studies have documented that women score higher on most frailty assessment scales but paradoxically have longer life expectancy compared to men. The interaction of gender/frailty and the influence on outcomes and practice patterns surrounding EVAR and OAR is poorly described. This analysis characterizes the association of frailty/sex interactions on mortality as well as patient selection surrounding elective AAA repair in the Society for Vascular Surgery Vascular Quality Initiative.

Methods: All elective infrarenal AAA (EVAR + OAR; 2003-2017) cases were queried from the Vascular Quality Initiative database. Each patient was assigned a previously published modified frailty index (mFI) score derived from comorbidity and preoperative functional status data. Cox proportional hazard models, adjusted for statistically significant covariates, including procedural complexity, determined associations within full models and sex-stratified models.

Results: A total of 20,750 elective AAA cases were analyzed (EVAR 15,893 [77%]; OAR 4857 [23%]). Thirty-day mortality for EVAR and OAR was 0.7% (n = 115) and 3.5% (n = 169), respectively. Patients who died were significantly more likely to be older (EVAR, 78 vs 73 years; OAR, 74 vs 69 years; P < .0001), have larger AAA diameters (EVAR, 59 vs 56 mm; P = .005; OAR, 62 vs 59 mm; P = .001), higher mFI scores (EVAR, 3.2 vs 2.4; OAR, 3.1 vs 2.2; P < .0001), and be of female sex (EVAR hazard ratio = 1.66 [95% confidence interval, 1.10-2.52]; P = .007; OAR-1.43 [1.02-1.99]; P = .003). Significant differences in the gender distribution of frailty scores among EVAR patients were evident (mean mFI: male 2.42 vs female 2.34; P = .02), but no difference was detected for OAR (male 2.17 vs female 2.22; P = .38). The mFI was a strong independent predictor of mortality (30 days: EVAR hazard ratio = 1.36 [1.22-1.53] and OAR 1.46 [1.32-1.60]; 1 year: EVAR 1.32 [1.25-1.39] and OAR-1.38 [1.28-1.48]). There was no interaction between mFI and gender on the association with mortality. Across frailty strata, male patients were nearly twofold more likely to undergo either elective EVAR or OAR for an AAA below recommended minimum diameter thresholds (male, <5.5 cm; female, <5.0 cm). Greater mFI score did not alter OAR selection but was associated with less frequent EVAR of small AAA.

Conclusions: Given the strong association between frailty and postoperative mortality, mFI can be used as a predictive tool to aid in surgical planning of patients undergoing elective AAA repair. While mFI can predict postoperative mortality for both men and women, it does not account for the survival disparity between sexes, and further research is warranted to explain this difference. There appear to be significant gender differences in patient selection based on current Society for Vascular Surgery-endorsed treatment thresholds that may have important implications on the appropriateness of AAA care delivery nationally.
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http://dx.doi.org/10.1016/j.jvs.2019.01.086DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6878148PMC
December 2019

The Weekend Effect in AAA Repair.

Ann Surg 2019 06;269(6):1170-1175

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, MA.

Background: Conflicting reports exist regarding whether patients undergoing surgery on the weekend or later in the week experience worse outcomes.

Methods: We identified patients undergoing abdominal aortic aneurysm (AAA) repair in the Vascular Quality Initiative between 2009 and 2017 [n = 38,498; 30,537 endovascular aneurysm repair (EVAR) and 7961 open repair]. We utilized mixed effects logistic regression to compare adjusted rates of perioperative mortality based on the day of repair.

Results: Tuesday was the most common day for elective repair (22%), Friday for symptomatic repairs (20%), and ruptured aneurysms were evenly distributed. Patients with ruptured aneurysms experienced similar adjusted mortality whether they underwent repair during the week or on weekends. Transfers of ruptured AAA were more common over the weekend. However, patients transferred on the weekend experienced higher adjusted mortality than those transferred during the week (28% vs 21%, P = 0.02), despite the fact that during the week, transferred patients actually experienced lower adjusted mortality than patients treated at the index hospital (21% vs 31%, P < 0.01). Among symptomatic patients, adjusted mortality was higher for those undergoing repair over the weekend than those whose surgeries were delayed until a weekday (7.9% vs 3.1%, P = 0.02). Adjusted mortality in elective cases did not vary across the days of the week. Results were consistent between open and EVAR patients.

Conclusion: We found no evidence of a weekend effect for ruptured or symptomatic AAA repair. However, patients with ruptured AAA transferred on the weekend experienced higher mortality than those transferred during the week, suggesting a need for improvement in weekend transfer processes.
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http://dx.doi.org/10.1097/SLA.0000000000002773DOI Listing
June 2019

Validation of a preoperative prediction model for mortality within 1 year after endovascular aortic aneurysm repair of intact aneurysms.

J Vasc Surg 2019 08 25;70(2):449-461.e3. Epub 2019 Mar 25.

Division of Vascular Surgery and Endovascular Therapy, University of Florida, Gainesville, Fla. Electronic address:

Objective: Most would agree that at least 1-year survival is necessary after intact abdominal aortic aneurysm (AAA) repair to appropriately justify the cost and risk of the procedure. No validated clinical decision instruments exist to predict survival after endovascular aneurysm repair (EVAR) beyond the perioperative period. The purpose of this analysis was to create a preoperative prediction model for 1-year mortality after EVAR for intact AAA in the Society for Vascular Surgery Vascular Quality Initiative.

Methods: All intact EVARs in the Society for Vascular Surgery Vascular Quality Initiative from 2011 to 2015 were randomly divided into training (n = 17,836) and validation (n = 2500) data sets, and 31 preoperative candidate predictors were identified. A logistic regression model for 1-year mortality was created, and bootstrapped stepwise variable elimination was used to reduce this model to a best subset of predictors. Penalized maximum likelihood estimation was used to correct for potential overfitting. The final model was internally validated by bootstrapping the area under the curve (AUC) and the calibration slope and intercept, and its performance when applied to the training and validation data sets was compared.

Results: After elective and nonelective (symptomatic, intact) EVAR, 1-year mortality was 5.5% (n = 900/16,411) and 11.4% (n = 162/1425), respectively. The mean probability of 1-year mortality was 6.0% (n = 1062) in the training set and 5.7% (n = 143) in the validation cohort (P = .12). Significant preoperative predictors of 1-year mortality included chronic obstructive pulmonary disease, age, preoperative renal insufficiency (creatinine concentration ≥1.8 mg/dL or on hemodialysis), ejection fraction <50%, transfer status, body mass index <24 kg/m, preoperative beta-blocker exposure, larger AAA diameter, and lower admission hemoglobin level. Preoperative statin use was found to be protective. The bias-corrected AUC was 0.759 (Hosmer-Lemeshow goodness-of-fit P value of 0.36; calibration intercept, -0.003; slope, 0.999). When applied to the validation data set, the model had AUC of 0.724 (95% confidence interval, 0.676-0.768; calibration intercept, 0.0009; slope, 0.970), which was in excellent agreement with the original data set bias-corrected AUC. Notably, ∼27.5% (n = 4902) had four or more risk factors with a predicted 1-year post-EVAR mortality risk of 10% to 22% despite that 33.2% of these patients had AAA diameters below recommended treatment guideline minimum thresholds.

Conclusions: This validated preoperative prediction model for 1-year mortality identifies patients less likely to benefit from EVAR. Appropriateness of intact AAA EVAR care delivery can be improved by use of this clinical decision aid to determine which high-risk patients have lower probability of mortality within the first postoperative year relative to their predicted annualized rupture risk.
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http://dx.doi.org/10.1016/j.jvs.2018.10.122DOI Listing
August 2019

Management of patch infections after carotid endarterectomy and utility of femoral vein interposition bypass graft.

J Vasc Surg 2019 Jun 24;69(6):1815-1823.e1. Epub 2018 Dec 24.

Division of Vascular Surgery and Endovascular Therapy, University of Florid, Gainesville, Fla.

Objective: Patch infection after carotid endarterectomy (CEA) is a rare but devastating complication. A variety of different treatment options are reported; however, there is currently no consensus on how to manage this highly morbid problem. The purpose of this study was to review our experience with management of infectious patch complications after CEA and to highlight utility of femoral vein interposition bypass grafting.

Methods: All CEA patch infection operations at the University of Florida from 2002 to 2017 were reviewed retrospectively. Preoperative history, intraoperative details, and postoperative complications were recorded. Bypass patency was verified with duplex ultrasound imaging (1 month, 6 months, annually). The primary end point was 30-day stroke or death; secondary end points included cranial nerve injury, reintervention, reinfection, and survival. Life tables were used to estimate end points.

Results: Twenty-nine patients (mean age, 70 ± 9 years; male, 76%) were identified. The index CEA occurred at a median of 15 months (interquartile range, 1-55 months) preoperatively (39% <2 months after the index procedure). A variety of patch materials were implicated (Dacron, n = 9; unknown/undocumented, n = 8; bovine pericardium, n = 5; expanded polytetrafluoroethylene, n = 3; unidentified nonbiologic prosthetic, n = 3; saphenous vein, n = 1). Carotid reintervention antecedent to the infected patch presentation occurred in 41% (incision and drainage, n = 10; carotid stent, n = 2; vein patch, n = 1). The most common infecting organisms were Staphylococcus and Streptococcus species (52%; n = 15). The most frequent presentation (46%; n = 13) was pericarotid abscess or phlegmon (pulsatile neck mass or pseudoaneurysm, 28% [n = 8]; carotid-cutaneous fistula, 28% [n = 8]). Reconstruction strategy included femoral vein interposition bypass in 24 patients (83%; nonreversed configuration, 16/24 [67%]), saphenous vein patch in 4 patients (14%), and femoral vein patch in 1 patient (3%). Median postoperative length of stay was 5 days (interquartile range, 4-8 days). Twelve patients (41%) experienced a complication, and the 30-day stroke/death rate was 7% (death, n = 1; stroke, n = 1). The single postoperative death occurred in a patient with history of congestive heart failure who developed a pulseless electrical activity arrest on postoperative day 11 that resulted in multiorgan system failure. Cranial nerve injury occurred in 28% (n = 8; cranial nerves X [3], VII [2], XII [2], and IX [1]), all of which resolved by last follow-up. In follow-up (mean clinical follow-up, 17 ± 14 months; mean survival time, 108 months [95% confidence interval, 81-135 months]), two (7%) complained of limb edema with femoral cutaneous nerve palsy that resolved by 3 months. One interposition bypass occluded at 3 months (asymptomatic); the remaining grafts remained patent with no restenosis, reinfection, or reintervention events. The 1- and 5-year survival was 87% ± 6% and 82% ± 8%, respectively.

Conclusions: CEA patch infection can be successfully managed with femoral vein interposition bypass with acceptable postoperative outcomes. Excellent patency can be anticipated with good long-term survival. This strategy can be considered especially in cases with carotid size mismatch or if there is limited availability of alternative biologic conduits.
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http://dx.doi.org/10.1016/j.jvs.2018.09.036DOI Listing
June 2019

Outcomes of antegrade and retrograde open mesenteric bypass for acute mesenteric ischemia.

J Vasc Surg 2019 01 29;69(1):129-140. Epub 2018 Jun 29.

Division of Vascular Surgery & Endovascular Therapy, University of Florida, Gainesville, Fla.

Background: Acute mesenteric ischemia (AMI) is a challenging clinical problem associated with significant morbidity and mortality. Few contemporary reports focus specifically on patients undergoing open mesenteric bypass (OMB) or delineate outcome differences based on bypass configuration. This is notable, because there is a subset of patients who are poor candidates for endovascular intervention including those with flush mesenteric vessel occlusion, long segment occlusive disease, and a thrombosed mesenteric stent and/or bypass. This analysis reviewed our experience with OMB in the treatment of AMI and compared outcomes between patients undergoing either antegrade or retrograde bypass.

Methods: A single-center, retrospective review was performed to identify all patients who underwent OMB for AMI from 2002 to 2016. A preoperative history of mesenteric revascularization, demographics, comorbidities, operative details, and outcomes were abstracted. The primary end point was in-hospital mortality. Secondary end points included complications, reintervention, and overall survival. Kaplan-Meier estimation and Cox proportional hazards regression were used to analyze all end points.

Results: Eighty-two patients (female 54%; age 63 ± 12 years) underwent aortomesenteric bypass (aortoceliac/superior mesenteric, n = 44; aortomesenteric, n = 38) for AMI. A history of prior stent/bypass was present in 20% (n = 16). A majority (76%; n = 62) underwent antegrade bypass and the remainder received retrograde infrarenal aortoiliac inflow. Patients receiving antegrade OMB were more likely to be male (53% vs 25%; P = .02), have coronary artery disease (48% vs 25%; P = .06), chronic obstructive pulmonary disease (52% vs 25%; P = .03), and peripheral arterial disease (60% vs 35%; P = .05). Concurrent bowel resection was evenly distributed (antegrade, 45%; retrograde, 45%; P = .9) and 37% (n = 30) underwent subsequent resection during second look operations. The median duration of stay was 16 days (interquartile range, 9-35 days) and 78% (n = 64) experienced at least one major complication with no difference in rates between antegrade/retrograde configurations. In-hospital mortality was 37% (n = 30; multiple organ dysfunction, 22; bowel infarction, 4; hemorrhage/anemia, 2; arrhythmia, 1; stroke, 1; 30-day mortality, 26%). The median follow-up was 8 months (interquartile range, 1-26 months). The 1- and 3-year primary patency rates were both 82% ± 6% (95% confidence interval, 71%-95%), with 10 patients requiring reintervention. Estimated survival at 1 and 5 years was 57% ± 6% and 50% ± 6%, respectively. Bypass configuration was not associated with complication rates (P > .10), in-hospital mortality (log-rank, P = .3), or overall survival (log-rank, P = .9). However, a higher risk of reintervention was observed in patients undergoing retrograde bypass (hazard ratio, 3.0; 95% confidence interval, 0.9-11.0; P = .08).

Conclusions: OMB for AMI results in significant morbidity and mortality, irrespective of bypass configuration. Antegrade OMB is associated with comparable outcomes as retrograde OMB. The bypass configuration choice should be predicated on patient presentation, anatomy, physiology, and surgeon preference; however, an antegrade configuration may provide a lower risk of reintervention.
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http://dx.doi.org/10.1016/j.jvs.2018.04.063DOI Listing
January 2019

Weekend Effect in Carotid Endarterectomy.

Stroke 2018 12;49(12):2945-2952

From the Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, MA (T.F.X.O., M.L.S., P.L., C.L., N.J.S., M.C.W.).

Background and Purpose- Patients undergoing surgery on the weekend may experience worse outcomes, but this weekend effect has not been studied in carotid endarterectomy (CEA). Methods- We identified patients undergoing isolated CEA in the Vascular Quality Initiative between 2003 and 2018. Our primary outcome was in-hospital stroke or perioperative death (stroke/death), stratified by symptom status. For asymptomatic patients, we also compared rates of the Centers for Medicare and Medicaid Services quality metric prolonged length of stay (>2 days or failed discharge home). We calculated propensity scores and used multilevel, inverse probability weighted logistic regression clustering at the hospital level. Results- There were 86 123 repairs during the study period, 53% asymptomatic lesions and 47% symptomatic. Only 0.7% of asymptomatic patients underwent CEA on the weekend, compared with 3.1% of symptomatic patients. Patients undergoing weekend repairs were more often white, with lower rates of most comorbidities. In asymptomatic patients, weekend operations were associated significantly higher odds of stroke/death (odds ratio [OR], 2.3 [1.1-4.8]; P=0.02), and prolonged length of stay (OR, 3.6 [2.7-4.7]; P<0.001). In symptomatic patients, weekend operations were associated with significantly higher adjusted odds of stroke/death (OR, 1.7 [1.2-2.4]; P=0.007) and longer postoperative length of stay (3.3 days versus 2.0 days, P=0.002). However, the difference in stroke/death was driven by patients presenting with stroke (OR, 2.2 [1.5-2.3]; P<0.001), rather than those presenting with transient ischemic attack (OR, 1.2 [0.6-2.1]; P=0.56). Conclusions- We found evidence of a significant weekend effect in CEA, as weekend operations in asymptomatic patients and patients who presented with stroke were associated with higher rates of stroke/death and prolonged length of stay. However, there was no evidence of such an effect in patients with transient ischemic attack. These data suggest that weekend CEA should be avoided except in the case of expedited revascularization after transient ischemic attack.
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http://dx.doi.org/10.1161/STROKEAHA.118.022305DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6309973PMC
December 2018

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

J Vasc Surg 2019 05 13;69(5):1367-1378. Epub 2018 Dec 13.

Division of Vascular Surgery and Endovascular Therapy, University of Florida, Gainesville, Fla.

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.
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http://dx.doi.org/10.1016/j.jvs.2018.07.080DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478524PMC
May 2019

Contemporary outcomes of thoracofemoral bypass.

J Vasc Surg 2019 04 3;69(4):1150-1159.e1. Epub 2018 Oct 3.

Division of Vascular Surgery & Endovascular Therapy, University of Florida, Gainesville, Fla.

Objective: Thoracofemoral bypass (TFB) is an alternative to aortofemoral bypass (AFB) or extra-anatomic bypass for severe aortoiliac occlusive disease (AIOD). TFB may be particularly useful in select patients with concurrent visceral aortic branch vessel disease, infrarenal aortic occlusions, or after failed AFB. However, there are few contemporary series describing the indications and outcomes for TFB. Therefore, the purpose of this analysis was to review our experience with TFB.

Methods: All patients undergoing TFB for occlusive disease from 2002 to 2017 were reviewed. All patients underwent left thoracoretroperitoneal exposure of the supraceliac aorta with division of the diaphragmatic crus and supraceliac cross-clamping. An end-to-side aortic anastomosis was created and each graft limb was tunneled in the retroperitoneum to the femoral bifurcation. Adjunctive visceral/infrainguinal revascularization was performed selectively based on symptoms, end-organ function, and/or preoperative imaging. The primary end points were major complications and 30-day mortality. Secondary end points included limb patency, freedom from major adverse limb events, and survival. Kaplan-Meier methodology was used to characterize the end points.

Results: Forty-one patients (age 61 ± 9 years; 54% female; 7% in a hypercoaguable state) underwent TFB. The mean preoperative ankle-brachial index was 0.4 bilaterally. Indications included critical limb ischemia (56%), claudication (30%), acute limb ischemia (7%), and combined AIOD and mesenteric ischemia (7%). Seven patients (17%) had previously undergone AFB and 15 (38%) had previously undergone any prior aortic operation. Adjunctive visceral bypass occurred in 8 patients (20%; N = 14 grafts, n = 6 renal, n = 5 superior mesenteric artery, and n = 3 celiac). The postoperative duration of stay was 11 days (interquartile range [IQR], 7-16 days) and the 30-day mortality was 5% (n = 2). Major complications occurred in 34% of patients (N = 14; pulmonary, 15%; cardiac, 12%; bleeding, 7%; accidental splenectomy, 5%; renal, 5%; wound, 2%). The mean postoperative ankle-brachial index was 0.9 bilaterally. At a median follow-up of 7 months (IQR, 1-17 months), 5 patients (12%) underwent some form of reintervention (graft/limb related, n = 4 [n = 2 graft thrombosis, n = 2 graft infection], n = 1 mesenteric bypass revision). The estimated 3-year primary limb patency and freedom from major adverse limb events were 80 ± 10%, and 70 ± 10%, respectively. The estimated 5-year survival was 93 ± 5% (median, 27.3; IQR, 14.5-35.2; 95% confidence interval, 17.9-32.8).

Conclusions: This experience represents one of the largest and most current series of retroperitoneal TFB. We demonstrate that TFB can be performed with good outcomes for patients with severe AIOD, especially if concomitant visceral/infrainguinal reconstruction is warranted. These results support a continued role for TFB in select patients.
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http://dx.doi.org/10.1016/j.jvs.2018.07.053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6433534PMC
April 2019

Financial implications of coding inaccuracies in patients undergoing elective endovascular abdominal aortic aneurysm repair.

J Vasc Surg 2019 01 21;69(1):210-218. Epub 2018 Jun 21.

Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Florida, Gainesville, Fla. Electronic address:

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.
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http://dx.doi.org/10.1016/j.jvs.2018.04.027DOI Listing
January 2019

Regional variation in racial disparities among patients with peripheral artery disease.

J Vasc Surg 2018 08 16;68(2):519-526. Epub 2018 Feb 16.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass. Electronic address:

Objective: Prior studies identified significant racial disparities as well as regional variation in outcomes of patients with peripheral artery disease (PAD). We aimed to determine whether regional variation contributes to these racial disparities.

Methods: We identified all white or black patients who underwent infrainguinal revascularization or amputation in 15 deidentified regions of the Vascular Quality Initiative between 2003 and 2017. We excluded three regions with <100 procedures. We used multivariable linear regression, allowing clustering at the hospital level to calculate the marginal effects of race and region on adjusted 30-day mortality, major adverse limb events (MALEs), and amputation. We compared long-term outcomes between black and white patients within each region and within patients of each race treated in different regions using multivariable Cox regression.

Results: We identified 90,418 patients, 15,527 (17%) of whom were black. Patients underwent 31,263 bypasses, 52,462 endovascular interventions, and 6693 amputations. Black patients were younger and less likely to smoke, to have coronary artery disease, or to have chronic obstructive pulmonary disease, but they were more likely to have diabetes, limb-threatening ischemia, dialysis dependence, and hypertension and to be self-insured or on Medicaid (all P < .05). Adjusted 30-day mortality ranged from 1.2% to 2.1% across regions for white patients and 0% to 3.0% for black patients; adjusted 30-day MALE varied from 4.0% to 8.3% for white patients and 2.4% to 8.1% for black patients; and adjusted 30-day amputation rates varied from 0.3% to 1.2% for white patients and 0% to 2.1% for black patients. Black patients experienced significantly different (both higher and lower) adjusted rates of 30-day mortality and amputation than white patients did in several regions (P < .05) but not MALEs. In addition, within each racial group, we found significant variation in the adjusted rates of all outcomes between regions (all P < .01). In adjusted analyses, compared with white patients, black patients experienced consistently lower long-term mortality (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.73-0.88; P < .001) and higher rates of MALEs (HR, 1.15; 95% CI, 1.06-1.25; P < .001) and amputation (HR, 1.33; 95% CI, 1.18-1.51; P < .001), with no statistically significant variation across the regions. However, rates of all long-term outcomes varied within both racial groups across regions.

Conclusions: Significant racial disparities exist in outcomes after lower extremity procedures in patients with PAD, with regional variation contributing to perioperative but not long-term outcome disparities. Underperforming regions should use these data to generate quality improvement projects, as understanding the etiology of these disparities is critical to improving the care of all patients with PAD.
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http://dx.doi.org/10.1016/j.jvs.2017.10.090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057812PMC
August 2018

Implementation of a bundled protocol significantly reduces risk of spinal cord ischemia after branched or fenestrated endovascular aortic repair.

J Vasc Surg 2018 02 7;67(2):409-423.e4. Epub 2017 Oct 7.

Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, Ala.

Objective: Spinal cord ischemia (SCI) is a devastating complication after branched or fenestrated endovascular aortic repair (B/FEVAR) for thoracoabdominal aortic disease. The purpose of this analysis was to describe the impact of a bundled clinical care protocol designed to reduce the risk of SCI in this population of patients.

Methods: A bundled SCI prevention protocol including cerebrospinal fluid drainage, blood pressure parameters, transfusion goals, and pharmacologic adjuncts (steroids, naloxone) was initiated in May 2015. Before that date, portions of the protocol (cerebrospinal fluid drainage in particular) were used in an informal fashion in patients perceived to be at high risk. B/FEVAR cases completed from January 2012 to May 2016 were reviewed, and outcomes before (n = 223) and after (n = 70) SCI bundle application were compared. The primary end point was the incidence of SCI events. Secondary end points included length of stay, complications, and survival. High-risk patients for SCI were defined as those undergoing B/FEVAR resulting in aortic coverage equivalent to open Crawford extent I to III thoracoabdominal aortic aneurysm (TAAA) repair. Survival was estimated using Kaplan-Meier life-table analysis.

Results: Postprotocol patients were more likely to be older (75 ± 7 vs 72 ± 8 years; P = .03), to have an American Society of Anesthesiologists class 4 designation (94% vs 81%; P = .04), and to be treated for TAAA (67% vs 56%; P = .004). Postprotocol pre-emptive spinal drain use was greater in high-risk patients (100% vs 87%; P = .04) but significantly decreased in lower risk patients (suprarenal aneurysm or extent IV TAAA: 5% after protocol implementation vs 21% before protocol implementation; P = .04). Rates of any SCI before and after implementation of the bundled protocol were 13% (n = 29 of 223) and 3% (n = 2 of 70; P = .007), respectively. In comparing high-risk patients, protocol use resulted in an even more significant reduction in SCI rate (19% [28 of 144] vs 4% [2 of 50]; P = .004). Postoperative morbidity (41% vs 33%; P = .2) and 30-day mortality (5% vs 1%; P = .3) were not different between groups. However, patients treated on protocol had significantly improved 1-year survival (99% ± 1% after protocol implementation vs 90% ± 2% before protocol implementation; log-rank, P = .05).

Conclusions: Implementation of a bundled multimodal protocol may significantly reduce risk of SCI after B/FEVAR, with the greatest risk reduction occurring in the most vulnerable patients. Interestingly, reduction in SCI risk was associated with improvement in 1-year survival.
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http://dx.doi.org/10.1016/j.jvs.2017.05.136DOI Listing
February 2018

Outcomes of thoracic endovascular aortic repair in adult coarctation patients.

J Vasc Surg 2018 02 22;67(2):369-381.e2. Epub 2017 Sep 22.

Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, Ala.

Background: Aortic coarctation (AC) is most commonly identified in pediatric patients; however, adults can present with late sequelae of untreated coarctation or complications of prior open repair. To date, there are limited data about the role of thoracic endovascular aortic repair (TEVAR) in this group of patients. The purpose of this analysis was to describe our experience with management of adult coarctation patients using TEVAR.

Methods: All TEVAR patients treated for primary coarctation or late sequelae of previous open repair (eg, pseudoaneurysm, recurrent coarctation or anastomotic stenosis related to index open coarctation repair) were reviewed. Demographics, comorbidities, procedure-related variables, postoperative outcomes, and reintervention were recorded. Computed tomography centerline assessments of endograft morphology were completed to delineate stent anatomy at the coarctation site. Survival and reintervention were estimated using life-table analysis.

Results: A total of 21 patients were identified (median age, 46 years [range, 33-71 years]; 67% male [n = 14]). Nine patients (43%) were treated for symptomatic primary (n = 6) or recurrent (n = 3) coarctation. Other indications included degenerative thoracic aneurysm (n = 6), pseudoaneurysm (n = 4), and dissection (n = 2). Technical success was 100% (95% confidence interval [CI], 84%-100%). No 30-day mortality or paraplegia events occurred; however, two patients (10%) experienced postoperative nondisabling stroke. In primary or recurrent coarctation patients with available computed tomography imaging (n = 8 of 9), nominal stent graft diameters were achieved proximal and distal to the coarctation (range, -0.4 to -1.2 mm of desired final stent diameter). Specific to the coarctation site, there was a significant increase in aortic diameter after TEVAR (before stenting, 11.5 [95% CI, 6.8-12.3] mm; after stenting, 15 [95% CI, 13.7-15.7] mm; P = .004). Concurrently, systolic arterial blood pressure at time of discharge was significantly lower (before stenting: 147 mm Hg; 95% CI, 137-157 mm Hg; after stenting: 124 mm Hg; 95% CI, 118-134 mm Hg; P = .02). For all patients, median clinical follow-up time was 8 months (interquartile range, 3-13 months; range, 1-106 months). Three endoleaks were detected, all of which were type II related to left (n = 2) or aberrant (n = 1) subclavian arteries. Four patients (19%) underwent reintervention (median time, 7 months; range, 2-12 months), with three of four being subclavian artery embolization; one was an aortic root replacement for ascending aneurysm with bicuspid aortic valve. One-year freedom from reintervention was 78% ± 9% (95% CI, 42%-92%). The 1- and 3-year survival was 95% ± 5% (95% CI, 71%-99%). One late death was related to complications from pre-existing congenital heart disease.

Conclusions: Adult AC patients can be treated safely with TEVAR, and the annular constriction of an AC can be successfully dilated by the stent graft. Given these findings, a greater number of patients with longer term follow-up is warranted to further define the role of TEVAR in the management of adult AC patients.
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http://dx.doi.org/10.1016/j.jvs.2017.06.103DOI Listing
February 2018

Female sex independently predicts mortality after thoracic endovascular aortic repair for intact descending thoracic aortic aneurysms.

J Vasc Surg 2017 07 1;66(1):2-8. Epub 2017 Mar 1.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass. Electronic address:

Objective: Whereas sex differences in the pathogenesis, presentation, and outcomes of repair for abdominal aortic aneurysms are well studied, less is known about sex differences after thoracic endovascular aortic repair (TEVAR). The goal of this study was to evaluate the association between sex and morbidity and mortality after TEVAR.

Methods: A retrospective review of all TEVARs in the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry from 2011 to 2015 was conducted, excluding those with dissection, trauma, and rupture. Statistical analysis was performed using the Fisher exact test and the Mann-Whitney U test for categorical and continuous variables. Multivariable logistic regression and Cox hazards modeling were used to account for differences in demographics, comorbidities, and aneurysm characteristics in 30-day mortality and long-term survival.

Results: We identified 2574 patients (40% women) who underwent TEVAR. Women were older, were less likely to be white, and had smaller aortic diameters but larger aortic size indices (aortic diameter/body surface area). Women also had more chronic obstructive pulmonary disease but less coronary artery disease and fewer coronary interventions. Women were more likely to be symptomatic at presentation and subsequently to have a nonelective procedure. Women had higher estimated blood loss >500 mL (20% vs 17%; P = .04), were more likely to be transfused (29% vs 21%; P < .001), and more frequently underwent iliac access procedures (4.3% vs 2.1%; P < .01). Operative time and left subclavian intervention were similar. Postoperatively, women had increased median hospital (5 vs 4 days; P < .001) and intensive care unit (2.5 vs 2 days; P < .001) lengths of stay and were less likely to be discharged home (75% vs 86%; P < .001). Mortality was higher for women at 30 days (5.4% vs 3.3%; P < .01) and 1 year (9.8% vs 6.3%; P < .01). After adjusting for age, aortic size index, symptoms, and comorbidities, female sex remained independently predictive of 30-day mortality (odds ratio, 1.5; 95% confidence interval, 1.1-2.1, P < .01) and long-term mortality (hazard ratio, 1.3; 95% confidence interval, 1.03-1.6; P = .02).

Conclusions: Even after adjusting for differences in age and comorbidities, female patients have higher perioperative mortality and lower long-term survival after TEVAR. These findings, along with the rupture risk by sex, should be considered by clinicians in determining the timing of intervention.
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http://dx.doi.org/10.1016/j.jvs.2016.12.103DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5483382PMC
July 2017

Outcomes of thoracic endovascular aortic repair using aortic arch chimney stents in high-risk patients.

J Vasc Surg 2017 07;66(1):9-20.e3

Division of Vascular Surgery and Endovascular Therapy, University of Florida College of Medicine, Gainesville, Fla.

Background: Aortic arch disease is a challenging clinical problem, especially in high-risk patients, in whom open repair can have morbidity and mortality rates of 30% to 40% and 2% to 20%, respectively. Aortic arch chimney (AAC) stents used during thoracic endovascular aortic repair (TEVAR) are a less invasive treatment strategy than open repair, but the current literature is inconclusive about the role of this technology. The focus of this analysis is on our experience with TEVAR and AAC stents.

Methods: All TEVAR procedures performed from 2002 to 2015 were reviewed to identify those with AAC stents. Primary end points were technical success and 30-day and 1-year mortality. Secondary end points included complications, reintervention, and endoleak. Technical success was defined as a patient's surviving the index operation with deployment of the AAC stent at the intended treatment zone with no evidence of type I or type III endoleak on initial postoperative imaging. The Kaplan-Meier method was used to estimate survival.

Results: Twenty-seven patients (age, 69 ± 12 years; male, 70%) were identified, and all were described as being at prohibitive risk for open repair by the treating team. Relevant comorbidity rates were as follows: coronary artery disease/myocardial infarction, 59%; oxygen-dependent emphysema, 30%; preoperative creatinine concentration >1.8 mg/dL, 19%; and congestive heart failure, 15%. Presentations included elective (67%; n = 18), symptomatic (26%; n = 7), and ruptured (7%; n = 2). Eleven patients (41%) had prior endovascular or open arch/descending thoracic repair. Indications were degenerative aneurysm (49%), chronic residual type A dissection with aneurysm (15%), type Ia endoleak after TEVAR (11%), postsurgical pseudoaneurysm (11%), penetrating ulcer (7%), and acute type B dissection (7%). Thirty-two brachiocephalic vessels were treated: innominate (n = 7), left common carotid artery (LCCA; n = 24), and left subclavian artery (n = 1). Five patients (19%) had simultaneous innominate-LCCA chimneys. Brachiocephalic chimney stents were planned in 75% (n = 24), with the remainder placed for either LCCA or innominate artery encroachment (n = 8). Overall technical success was 89% (one intraoperative death, two persistent type Ia endoleaks in follow-up). The 30-day mortality was 4% (n = 1; intraoperative death of a patient with a ruptured arch aneurysm), and median length of stay was 6 (interquartile range, 4-9) days. Seven (26%) patients experienced a major complication (stroke, three [all with unplanned brachiocephalic chimney]; respiratory failure, three; and death, one). Nine (33%) patients underwent aorta-related reintervention, and no chimney occlusion events occurred during follow-up (median follow-up, 9 [interquartile range, 1-23] months). The 1-year and 3-year survival is estimated to be 88% ± 6% and 69% ± 9%, respectively.

Conclusions: TEVAR with AAC can be performed with high technical success and acceptable morbidity and mortality in high-risk patients. Unplanned AAC placement during TEVAR results in an elevated stroke risk, which may be related to the branch vessel coverage necessitating AAC placement. Acceptable midterm survival can be anticipated, but aorta-related reintervention is not uncommon, and diligent follow-up is needed.
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http://dx.doi.org/10.1016/j.jvs.2016.11.063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5483394PMC
July 2017

Outcomes after endovascular aneurysm repair conversion and primary aortic repair for urgent and emergency indications in the Society for Vascular Surgery Vascular Quality Initiative.

J Vasc Surg 2016 Aug 7;64(2):338-347. Epub 2016 Jun 7.

Division of Vascular Surgery and Endovascular Therapy, University of Florida College of Medicine, Gainesville, Fla.

Objective: Open conversion after endovascular aortic aneurysm repair (EVAR-c) is performed nonelectively in up to 60% of cases. EVAR-c has been reported to have significantly greater risk of postoperative morbidity and mortality than primary aortic repair, but few data exist on outcomes for symptomatic or ruptured presentations. This study determined outcomes and identified predictors of postoperative major adverse cardiac events (MACEs) and mortality for patients undergoing nonelective EVAR-c compared with nonelective primary aortic repair (PAR) in the Vascular Quality Initiative (VQI).

Methods: All VQI patients undergoing urgent/emergency EVAR-c or urgent/emergency PAR from 2002 to 2014 were reviewed. Urgent presentation was defined by repair ≤24 hours of a nonelective admission, and emergency operations had clinical or radiographic evidence, or both, of rupture. End points included in-hospital MACE (myocardial infarction, dysrhythmia, congestive heart failure) and 30-day mortality. Possible covariates identified on univariate analysis (P < .2) were entered into a multivariable model, and stepwise elimination identified the best subset of predictors. Generalized estimating equations logistic regression analysis was used to determine the relative effect of EVAR-c compared with PAR on outcomes.

Results: During the study interval, we identified 277 EVAR-c, and 118 (43%) underwent urgent/emergency repair. nonelective PAR was performed in 1388 of 6152 total (23%). EVAR-c patients were older (75 ± 9 vs 71 ± 10 years; P < .0001), more likely to be male (84% vs 74%; P = .02), and had a higher prevalence of hypertension (88% vs 79%; P = .02) and coronary artery disease (38% vs 27%; P = .01). No differences in MACE (EVAR-c, 31% [n = 34] vs PAR, 30% [n = 398]) or any major postoperative complication (EVAR-c, 57% [n = 63] vs PAR, 55% [n = 740]; P = .8) were found; however, 30-day mortality was significantly greater in EVAR-c (37% [n = 41]) than in (PAR, 24% [n = 291]; P = .003), with an odds ratio (OR) of 2.2 (95% confidence interval [CI], 1.04-4.77; P = .04) for EVAR-c. Predictors of any MACE included age (OR, × 1.03 for each additional year; 95% CI, 1.01-1.03; P = .0002), male gender (OR, 1.3; 95% CI, 1.03-1.67; P = .03), body mass index ≤20 kg/m (OR, 1.8; 95% CI, 1.13-2.87; P = .01), chronic obstructive pulmonary disease (OR, 1.2; 95% CI, 0.86-1.80; P = .25), congestive heart failure (OR, 1.5; 95% CI, 0.98-2.34; P = .06), preoperative chronic β-blocker use (OR, 1.3; 95% CI, 0.97-1.63; P = .09), and emergency presentation (OR, 2.3; 95% CI, 1.8-3.01; area under the curve, 0.70; P < .0001). Significant predictors for 30-day mortality were age (OR × 1.07 for each additional year; 95% CI, 1.05-1.09; P < .0001), female gender (OR, 1.6; 95% CI, 1.01-2.46; P = .04), preoperative creatinine >1.8 mg/dL (OR, 1.6; 95% CI, 1.04-2.35; P = .03), an emergency presentation (OR, 4.8; 95% CI, 2.93-7.93; P < .0001), and renal/visceral ischemia (OR, × 1.1 for each unit increase log (time-minutes); 95% CI, 1.02-1.22; area under the curve, 0.84; P = .01).

Conclusions: Nonelective EVAR-c patients are older and have higher prevalence of cardiovascular risk factors than PAR patients. Similar rates of postoperative complications occur; however, urgent/emergency EVAR-c has a significantly higher risk of 30-day mortality than nonelective PAR. Several variables are identified that predict outcomes after these repairs and may help risk stratify patients to further inform clinical decision making when patients present nonelectively with EVAR failure.
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http://dx.doi.org/10.1016/j.jvs.2016.02.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5545799PMC
August 2016

Fate of Aneurysmal Common Iliac Artery Landing Zones Used for Endovascular Aneurysm Repair.

J Endovasc Ther 2015 Oct 19;22(5):748-59. Epub 2015 Aug 19.

Division of Vascular Surgery and Endovascular Therapy, University of Florida, Gainesville, FL, USA.

Purpose: To determine outcomes of aneurysmal common iliac arteries (aCIA) used for landing zones (LZs) during endovascular aneurysm repair (EVAR).

Methods: This single-center study retrospectively compared 57 EVAR patients (mean age 72±8 years; 56 men) with 70 aCIAs (diameter ≥20 mm) to 25 control EVAR subjects (mean age 73±7 years; 20 men) with 50 normal (≤15-mm) CIA LZs treated consecutively during the same time interval. The CIA LZ measurements were analyzed using random effects linear mixed models to determine diameter change over time. Life tables were used to estimate freedom from endoleak, reintervention, and all-cause mortality.

Results: The mean maximum preoperative CIA diameter in the aCIA LZ group was 24.8±4.5 mm (range 20.0-47.3, median 23.9) vs 13.6±1.5 mm (range 9.2-15.0, median 13.9; p<0.001) in the controls. Nineteen aCIA LZs were treated outside the instructions for use of the device. Median follow-up in the aCIAs LZ cohort was 39.2 months [interquartile range (IQR) 15, 61] vs 49.3 months (IQR 36, 61) in the controls (p=0.06). The rate of aCIA LZ change (0.09 mm/mo, 95% CI 0.07 to 0.1) was significantly greater than controls (0.03 mm/mo, 95% CI -0.009 to 0.07; p<0.0001). No type Ib endoleaks developed in either group; however, aCIA LZ patients had 6 (11%) iliac limb-related reinterventions. There were significantly more endograft-related reinterventions in the aCIA LZ patients (n=10, 14%) compared with controls (n=2, 4%; p=0.06). There was no difference in mortality or freedom from any post-hospital discharge endoleak.

Conclusion: Aneurysmal CIA LZs used during EVAR experience greater dilatation compared with normal LZs, but no significant difference in outcome was noted in midterm follow-up. However, an increased incidence of graft limb complications or endograft-related reintervention may be encountered. Use of aCIA LZs appears to be safe; however, greater patient numbers and longer follow-up are needed to understand the clinical implications of morphologic changes in these vessels when used during EVAR.
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http://dx.doi.org/10.1177/1526602815602121DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5624232PMC
October 2015

Results of transcaval embolization for sac expansion from type II endoleaks after endovascular aneurysm repair.

J Vasc Surg 2015 May;61(5):1129-36

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Objective: Management of type II endoleaks after endovascular aneurysm repair can be problematic. This study reports our experience with a relatively novel strategy to treat this complication, transcaval coil embolization (TCCE) of the aneurysm sac.

Methods: We reviewed 29 consecutive patients undergoing TCCE from 2010 to 2013. Demographics, operative details, and outcomes were assessed.

Results: Since 2006, 29 TCCEs have been performed at our institution in 26 patients for sac expansion from type II endoleaks. Patients were male (83%) and former or current smokers (88%), with an average age of 78 ± 7.1 years. TCCE was performed a mean of 4.2 ± 4 years after initial endovascular aneurysm repair. Endoleaks resulted in a mean sac growth of 1.2 ± 1 cm in diameter and 37% ± 32% by volume. Forty-six percent had prior procedures (5 translumbar, 3 transarterial, 3 transcaval, 1 aortic cuff, and 1 iliac limb extension). Two patients had no flow identified in the aneurysm sac after puncture was successful, and one was found to have a hygroma rather than arterial flow. An additional two patients had ultimate embolization from sac access between the endograft iliac limb and arterial wall after transcaval puncture failed, for a 90% procedural success (83% for transcaval technical success). Mean fluoroscopy time was 27 ± 13 minutes with 29 ± 21 mL of contrast material used and a median of 10 coils per case. Additional adjuncts included thrombin injection (17%), intravascular ultrasound (14%), sac pressure measurements (28%), and on-table integrated computed tomography (17%). Median length of stay was 1 day (range, 0-5 days). There were no procedural adverse events. Reintervention was required in five cases (three repeated TCCEs, two graft relinings). One-year freedom from reintervention was 95%. At a mean 16.5 months of follow-up, 70% experienced no further endoleak and had stable or decreasing sac diameters. There have been no ruptures during follow-up.

Conclusions: In this series, TCCE for treatment of aneurysm enlargement due to type II endoleaks was safe and relatively effective despite prior failed interventions in nearly half of the cases. TCCE is a useful alternative in cases in which the anatomy makes other approaches difficult or impossible.
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http://dx.doi.org/10.1016/j.jvs.2014.12.002DOI Listing
May 2015