Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium.

OBJECTIVE: Spinal cord ischemia (SCI) is a well-known complication of thoracoabdominal aortic aneurysm repair and is associated with profound morbidity and mortality. The purpose of this study was to describe predictors for the development of SCI, as well as outcomes for patients who develop SCI, after branched/fenestrated endovascular aortic repair in a large cohort of centers with adjudicated physician-sponsored investigational device exemption studies. METHODS: We used a pooled dataset from nine US Aortic Research Consortium centers involved in investigational device exemption trials for treatment of suprarenal and thoracoabdominal aortic aneurysms. SCI was defined as new transient weakness (paraparesis) or permanent paraplegia after repair without other potential neurological etiologies. Multivariable analysis was performed to identify predictors of SCI, and life-table analysis and Kaplan-Meier methodologies were used to evaluate survival differences. RESULTS: A total of 1681 patients underwent branched/fenestrated endovascular aortic repair from 2005 to 2020. The overall rate of SCI was 7.1% (3.0% transient and 4.1% permanent). Predictors of SCI on multivariable analysis were Crawford Extent I, II, and III distribution of aortic disease (odds ratio [OR], 4.79; 95% confidence interval [CI], 4.77-4.81; P < .001), age ≥70 years (OR, 1.64; 95% CI, 1.63-1.64; P = .029), packed red blood cell transfusion (OR, 2.00; 95% CI, 1.99-2.00; P = .001), and a history of peripheral vascular disease (OR, 1.65; 95% CI, 1.64-1.65; P = .034). The median survival was significantly worse for patients with any degree of SCI compared with those without SCI (any SCI, 40.4 vs no SCI, 60.3 months; log-rank P < .001), and also worse in those with a permanent deficit (24.1 months) vs those with a transient deficit (62.4 months) (log-rank P < .001). The 1-year survival for patients who developed no SCI was 90.8%, compared with 73.9% in patients who developed any SCI. When stratified by degree of deficit, survival was 84.8% at 1 year for those who developed paraparesis and 66.2% for those who developed permanent deficits. CONCLUSIONS: The overall rates of any SCI at 7.1% and permanent deficit at 4.1% observed in this study compare favorably with those reported in contemporary literature. Our findings confirm that increased length of aortic disease is associated with SCI and those with Crawford Extent I to III thoracoabdominal aortic aneurysms are at highest risk. The long-term impact on patient mortality underscores the importance of preventive measures and rapid implementation of rescue protocols if and when deficits develop.

Surgical site infection after open lower extremity revascularization associated with doubled rate of major limb amputation.

OBJECTIVE: Surgical site infection (SSI) after open lower extremity revascularization is a relatively common complication associated with increased hospital stays, graft infection, and in severe cases, graft loss. Although the short-term effects of SSI can be significant, it has not been considered a complication that increases major limb amputation. The purpose of this study was to determine the association of SSI with outcomes in patients undergoing surgical revascularization for peripheral arterial disease. METHODS: We analyzed nationwide Vascular Quality Initiative (VQI) data from the infrainguinal bypass module from 2003 to 2017. The cohort included adults who underwent open lower extremity bypass for symptomatic peripheral arterial disease and had at least one follow-up record. Weighted Kaplan-Meier curves and Cox proportional hazards regression were used to assess the association between SSI and 1-year mortality and major limb amputation. Inverse-probability of treatment weights were used to account for differences in demographics and patient characteristics and allow for 'adjusted' Kaplan-Meier curves. RESULTS: The analysis included 21,639 patients, and 1155 (5%) had a reported SSI within 30 days of surgery. Patients with SSI were more likely be obese (41% vs 30%), but there were no other clinically relevant differences between demographics, comorbidities, and bypass details. After weighting, patients with SSI were almost twice as likely to undergo major amputation by 6 months (hazard ratio, 1.84; 95% confidence interval, 1.07-3.17). The association with SSI and increased amputation rates persisted at 1 year. The association of SSI on amputation was no different based on preoperative Rutherford class (P = .91). The association between SSI and 1-year mortality rate was not statistically significant (hazard ratio, 1.15; 95% confidence interval, 0.91-1.46). CONCLUSIONS: SSI is more common in obese patients, and patients who develop an SSI are observed to have a significantly increased rate of limb amputation after open lower extremity revascularization.

Clinical practice and volume trends of inferior vena cava filter usage at a single tertiary care center during a 19-year period.

BACKGROUND: We investigated the clinical practice and volume trends of inferior vena cava filter (IVCF) usage at a single institution for an extended period and identified the potential factors affecting the clinical decision for placement, follow-up, and retrieval. METHODS: An institutional database was queried for IVCFs placed from 2000 to 2018 using the Current Procedural Terminology codes. The medical records were reviewed to evaluate the demographics, economic status, placement indication, IVCF type, follow-up evaluation for retrieval, and retrieval success rates. Statistical analysis was performed using SPSS, and t tests for continuous and χ2 for categorical variables. RESULTS: A total of 3915 IVCFs were placed from 2000 to 2018. The placement of IVCFs had increased steadily from 2000 (127 IVCFs/y), peaking in 2010 at 371 IVCFs/y and representing a 292% increase in IVCF usage. Since 2010, the number of IVCFs placed has steadily declined until 2016 to 2018, with a 426% decrease from the peak. In a subgroup of IVCFs placed for prophylaxis, the total volume trends paralleled a shift in clinical indications, peaking in 2010 and accounting for 45% of all IVCFs placed and then decreasing from 2013 to 2018 to ≤10%. Overall, 989 permanent IVCFs (25.3%) and 2926 retrievable IVCFs (74.7%) were placed during the entire study period. Before dedicated efforts to implement retrieval follow-up visits, the successful retrieval rate was ∼1% from 2000 to 2006 and had increased to ∼10% to 15% from 2007 to 2015, 36.7% in 2016, 40.2% in 2017, and 40.3% in 2018 after implementation of more active retrieval follow-up protocols. The predictors for the lack of evaluation for IVCF retrieval included an extended length of stay (P = .004) and geographic distance (P < .001). CONCLUSIONS: The use of IVCFs during the past 19 years at our institution reflected increased usage from 2000 to 2010, corresponding to an increase in prophylactic placement, followed by a decreasing total volume from 2011 to 2018, largely attributable to decreased prophylactic IVCF placement. Improved retrieval rates were seen after implementation of an active IVCF retrieval program.

Trends in the use of cerebrospinal drains and outcomes related to spinal cord ischemia after thoracic endovascular aortic repair and complex endovascular aortic repair in the Vascular Quality Initiative database.

BACKGROUND: Spinal cord ischemia (SCI) is a dreaded complication of thoracic and complex endovascular aortic repair (TEVAR/cEVAR). Controversy exists surrounding cerebrospinal fluid drain (CSFD) use, especially preoperative prophylactic placement, owing to concerns regarding catheter-related complications. However, these risks are balanced by the widely accepted benefits of CSFDs during open repair to prevent and/or rescue patients with SCI. The importance of this issue is underscored by the paucity of data on CSFD practice patterns, limiting the development of practice guidelines. Therefore, the purpose of the present analysis was to evaluate the differences between patients who developed SCI despite preoperative CSFD placement and those treated with therapeutic postoperative CSFD placement. METHODS: All elective TEVAR/cEVAR procedures for degenerative aneurysm pathology in the Society for Vascular Surgery Vascular Quality Initiative from 2014 to 2019 were analyzed. CSFD use over time, the factors associated with preoperative prophylactic vs postoperative therapeutic CSFD placement in patients with SCI (transient or permanent), and outcomes were evaluated. Survival differences were estimated using the Kaplan-Meier method. RESULTS: A total of 3406 TEVAR/cEVAR procedures met the inclusion criteria, with an overall SCI rate of 2.3% (n = 88). The SCI rate decreased from 4.55% in 2014 to 1.43% in 2018. Prophylactic preoperative CSFD use was similar over time (2014, 30%; vs 2018, 27%; P = .8). After further exclusions to evaluate CSFD use in those who had developed SCI, 72 patients were available for analysis, 48 with SCI and prophylactic CSFD placement and 24 with SCI and therapeutic CSFD placement. Specific to SCI, the patient demographics and comorbidities were not significantly different between the prophylactic and therapeutic groups, with the exception of previous aortic surgery, which was more common in the prophylactic CSFD cohort (46% vs 23%; P < .001). The SCI outcome was significantly worse for the therapeutic group because 79% had documented permanent paraplegia at discharge compared with 54% of the prophylactic group (P = .04). SCI patients receiving a postoperative therapeutic CSFD had had worse survival than those with a preoperative prophylactic CSFD (50% ± 10% vs 71% ± 9%; log-rank P = .1; Wilcoxon P = .05). CONCLUSIONS: Prophylactic CSFD use with TEVAR/cEVAR remained stable during the study period. Of the SCI patients, postoperative therapeutic CSFD placement was associated with worse sustained neurologic outcomes and overall survival compared with preoperative prophylactic CSFD placement. These findings highlight the need for a randomized clinical trial to examine prophylactic vs therapeutic CSFD placement in association with TEVAR/cEVAR.

Spinal cord protection practices used during endovascular repair of complex aortic aneurysms by the U.S. Aortic Research Consortium.

BACKGROUND: Spinal cord ischemia/infarction (SCI) is a devastating complication of thoracoabdominal aortic aneurysm repair that can result in permanent paresis or paralysis. The reported incidence of SCI after aortic interventions has ranged from 2% to 10%. Methods to prevent SCI are a topic of ongoing research, and many current practices have been based on expert opinion. METHODS: In an effort to better delineate the best practice models for SCI prevention during endovascular thoracoabdominal aortic aneurysm repair, a 65-question survey was completed by the eight principal investigators of the U.S. Aortic Research Consortium to capture data related to current practices and management strategies related to the prevention and treatment of SCI. Specific categories of interest included considerations for the "high-risk" classification of SCI, current perioperative prevention practices, indications for and management of spinal drains, and SCI rescue maneuvers. RESULTS: The most common practices routinely included blood pressure elevation (7 of 8; 87.5%), with most having a mean arterial pressure goal of not less than 90 mm Hg in the perioperative period (5 of 7; 71%), a hemoglobin goal intra- and postoperatively of not less than 10 mg/dL (6 of 8; 75%), and the use of prophylactic spinal drains in high-risk patients (6 of 8; 75%). Significant variation was found among the group for the timing of the resumption of antihypertensive medications, duration of hemoglobin goals after the procedure, and management of spinal drains. Many methods described in reported studies were not routinely used by most of the group, including a perioperative steroid bolus (1 of 8; 12.5%), mannitol (2 of 8; 25%), and naloxone infusion (1 of 8; 12.5%). Rescue maneuvers included placement of a cerebrospinal fluid (CSF) drain if not already present (8 of 8; 100%), decreasing the target CSF drain pop-off pressure (6 of 8; 75%), increasing the CSF drainage volume (5 of 8; 62.5%), increasing the mean arterial pressure goal (8 of 8; 100%), increasing the hemoglobin goal (8 of 8; 100%), and imaging the spine using computed tomography or magnetic resonance imaging (7 of 8; 87.5). CONCLUSIONS: In general, consistent broad practices were used by most of the consortium; however, the details of specific parameters (ie, spinal drain management, therapy duration, and timing of resumption of antihypertensive medication) varied among the group. The U.S. Aortic Research Consortium group used the results of the survey for discussion and agreed on standardized SCI prevention recommendations in accordance with the group's collective expert opinion and experience. Variations in current practice were also identified to act as a foundation for future study, the most notable of which was the comparative effectiveness of therapeutic vs prophylactic use of CSF drains in the prevention of SCI.

Association between thoracoabdominal aneurysm extent and mortality after complex endovascular repair.

OBJECTIVE: Traditional open surgical repair of thoracoabdominal aortic aneurysms (TAAAs) has historically resulted in 30-day mortality rates ranging from 6% to 20%, depending on the Crawford anatomic extent. Although short-term survival is important, long-term survival is essential for patients to benefit from these often elective and potentially morbid procedures. The aneurysm extent affects the long-term survival after open repair; however, effect on endovascular repair is unknown and could influence the decision process for repair. We evaluated the association between aneurysm extent and survival and identified patient and perioperative factors associated with mortality after endovascular repair. METHODS: A retrospective cohort of patients treated for TAAAs recorded in the Society for Vascular Surgery Vascular Quality Initiative thoracic and complex endovascular aneurysm repair registry were evaluated. All patients treated for asymptomatic degenerative aneurysms from 2010 to 2019 were included. Crawford extent I to V was defined according to the proximal and distal landing zones documented in the registry. Patients without extension into the visceral aorta were used for comparison and categorized as having extent 0a or 0b, depending on the distal landing zone in the thoracic aorta. Kaplan-Meier plots were used to estimate survival, and Cox proportional hazard regression models were created to identify the predictors of mortality. RESULTS: From 2010 to 2019, 15,333 patients were entered into the registry, of whom 2062 met the inclusion criteria. The Crawford extent was 0a for 379, 0b for 848, I for 81, II for 98, III for 130, IV for 454, and V for 72. Three groups were created in accordance with the similar outcomes noted on a preliminary analysis: (1) extent 0a and 0b; (2) extent I, II, and III; and (3) extent IV and V. The mean survival time for the extent 0a and 0b group was 70.7 ± 1.43 months and was 48.6 ± 1.65 months for the extent I, II, and III group and 57.6 ± 1.24 months for the extent IV and V group. The corresponding 1-year mortality was 8.4%, 18.4%, and 7.8%. Cox regression analysis identified the following preoperative factors were associated with mortality: chronic obstructive pulmonary disease (odds ratio [OR], 1.70; P < .001), Crawford extent I to III (OR, 1.64; P = .015), preexisting chronic kidney disease (OR, 1.37; P = .024), and age per year (OR, 1.03; P < .001). A number of postoperative factors were also associated with mortality. CONCLUSIONS: Similar to open TAAA repair, patients with more extensive aortic disease treated with endovascular repair had worse 1-year and long-term survival. The extent of aortic disease and anticipated postoperative survival should factor prominently into the surgical decision-making process for elective endovascular TAAA repair.

Timing of thoracic endovascular aortic repair for uncomplicated acute type B aortic dissection and the association with complications.

OBJECTIVE: Previous publications have clearly established a correlation between timing of thoracic endovascular aortic repair (TEVAR) and complications after treatment of complicated acute type B aortic dissection (ATBAD). However, the temporal association of TEVAR with morbidity after uncomplicated presentations is poorly understood and has not previously been examined using real-world national data. Therefore, the objective of this analysis was to determine whether TEVAR timing of uncomplicated ATBAD (UATBAD) is associated with postoperative complications. METHODS: The Vascular Quality Initiative TEVAR and complex endovascular aneurysm repair registry was analyzed from 2010 to 2019. Procedures performed for non-dissection-related disease as well as for ATBAD with malperfusion or rupture were excluded. Because of inherent differences between timing cohorts, propensity score matching was performed to ensure like comparisons. Univariate and multivariable analysis after matching was used to determine differences between timing groups (symptom onset to TEVAR: acute, 1-14 days; subacute, 15-90 days) for postoperative mortality, in-hospital complications, and reintervention. RESULTS: A total of 688 cases meeting inclusion criteria were identified. After matching 187 patients in each of the 1- to 14-day and 15- to 90-day treatment groups, there were no statistically significant differences between groups. On univariate analysis, the 1- to 14-day treatment group had a higher proportion of cases requiring reintervention within 30 days (15.3%) compared with UATBAD patients undergoing TEVAR within 15 to 90 days (5.2%; P = .02). There was also a difference (P = .007) at 1 year, with 33.8% of the 1- to 14-day UATBAD patients undergoing reintervention compared with 14.5% for the 15- to 90-day group. There were no statistically significant differences on multivariable analysis for long-term survival, complications, or long-term reintervention. There was a trend toward significance (P = .08) with the 1- to 14-day group having 2.3 times the odds of requiring an in-hospital reintervention compared with the 15- to 90-day group. CONCLUSIONS: Timing of TEVAR for UATBAD does not appear to predict mortality or postoperative complications. However, there is a strong association between repair within 1 to 14 days and higher risk of reintervention. This may in part be related to the 1- to 14-day group's representing an inherently higher anatomic or physiologic risk population that cannot be entirely accounted for with propensity analysis. The role of optimal timing to intervention should be incorporated into future study design of TEVAR trials for UATBAD.

Collateral benefits of improving glycemic control on lipids in a diabetic population.

BACKGROUND: Diabetes is an illness with multiple quality indicators. This retrospective cohort study sought to determine if interventions directed at physicians to target improvements in hemoglobin A1c (HgA1c) quality indicators had collateral benefits on similarly measured low-density lipoprotein (LDL) indicators. METHODS: We initially analyzed the primary care diabetic patient electronic databases from 2008 (N â€Š=  16,503) and 2010 (N â€Š=  23,040). We then identified and selected for the study the cohort of patients who appeared in both databases (N â€Š=  11,288) and analyzed various measures of process and outcomes. RESULTS: Mean HgA1c decreased from 7.34% to 7.21% (P < .0001). Mean LDL level also improved from 100.2 mg/dL to 95.6 mg/dL (P < .0001). The proportion of patients with poor glycemic control and poor lipid control decreased from 10.3% to 8.42% (P < .0001) and from 38.2% to 32.1% (P < .0001), respectively. CONCLUSIONS: Sustained interventions directed at the glycemic control of a large population of diabetic patients were associated with significant improvement in their glycemic control and had collateral benefits for indicators of their lipid control. Targeted interventions to improve HgA1c levels may have further benefits in improving other quality measures of diabetic care.