Current Transthoracic Supra-Aortic Trunk Surgical Reconstruction Has Similar 30-Day Cardiovascular Outcomes Compared to Extra-Anatomic Revascularization but With Higher Morbidity Burden.

BACKGROUND: Operative risk for supra-aortic trunk (SAT) surgical revascularization for occlusive disease, particularly transthoracic reconstruction (TR), remains ill-defined. This study sought to describe and compare 30-day outcomes of TR and extra-anatomic (ER) SAT surgical reconstruction for an occlusive indication across the United States over a contemporary 15-year period. METHODS: Using the National Surgical Quality Improvement Program, TR and ER performed during 2005-2019 were identified. Procedures performed for nonocclusive indications and those concomitant with coronary or valve operations were excluded. Rates of stroke, death, myocardial infarction (MI) and these as composite outcome (S/D/M) were compared. Logistic regression with stabilized inverse probability weighting (IPW) was used to compare groups via average treatment effect (ATE) while adjusting for covariate imbalances. RESULTS: Over the 15-year period, 166 TR and 1,900 ER patients were identified. The majority of ERs were carotid-subclavian bypass (n = 1,344; 70.7%) followed by carotid-carotid bypass (n = 261; 13.7%) and subclavian/carotid transpositions (n = 123; 6.5%). TR consisted of aorto-SAT bypass (n = 120; 72.3%) and endarterectomy (n = 46; 27.7%). The median age was 64 years for TR and 65 years in ER (P = 0.039). Those undergoing TR were more often women (69.0% vs. 56.9%; P = 0.001) and less likely to have undergone previous cardiac surgery (9.2% vs. 20.8%; P = 0.006). TR were also less frequently hypertensive (68.1% vs. 75.4%; P = 0.038) and had statistically lower preoperative creatinine levels (0.86 vs 0.91; P = 0.002). Unadjusted rates of MI (0.6% vs. 1.3%; P = 0.72) and stroke (3.6% vs. 1.9%; P = 0.15) were similar between groups with mortality (3.6% vs. 1.5%; P = 0.05) and S/D/M (6.6% vs. 3.9%; P = 0.10) trending higher with TR. IPWs could be calculated for 1,754 patients (148 TR; 1,606 ER). The estimated probability of S/D/M was 3.8% in the ER group and 6.2% in TR; no difference was seen in ATE (2.4%; 95% confidence interval [CI]: -1.5 to 6.2; P = 0.23). No differences were seen in individual component ATEs (stroke: 3.0% vs. 1.7%; ATE = 1.3%; 95% CI: -3.9 to 1.3; P = 0.32; mortality: 3.8% vs. 1.4%; ATE = 2.4%; 95% CI: -5.6 to 0.7; P = 0.13). Secondary outcomes showed TR patients were more likely to have non-home discharge (18.7% vs. 6.6%; ATE = 12.1%; 95% CI: 5.0-19.2; P < 0.001) and longer lengths of stay (6.1 vs. 4.0; ATE = 2.2 days; 95% CI: 0.9-3.4; P < 0.001). Moreover, TR patients were more likely to require transfusion (22.7% vs. 5.0%; ATE = 17.7%; 95% CI: 10.2-25.2; P < 0.001) and develop sepsis (2.7% vs. 0.2%; ATE = 2.5%; 95% CI: 0.1-5.0; P = 0.04). CONCLUSIONS: Transthoracic and extra-anatomic surgical reconstruction of the SATs for occlusive disease have similar operative cardiovascular risk. However, morbidity tends to be higher with TR due to higher transfusion requirements, sepsis risk, and need for facility stay. These results suggest ER as a first-line approach in those with proper disease anatomy is reasonable with lower morbidity, while TR remains justified in appropriate patients.

Impact of thoracic endovascular aortic repair timing on outcomes after uncomplicated type B aortic dissection in the Society for Vascular Surgery Vascular Quality Initiative postapproval project for dissection.

OBJECTIVE: The timing of thoracic endovascular aortic repair (TEVAR) after the onset of uncomplicated acute type B aortic dissection (uTBAD) remains controversial. The objective of this study was to evaluate the Society for Vascular Surgery Vascular Quality Initiative (VQI) postapproval study (VQI PAS) data for the impact of TEVAR timing for uTBAD on early and late outcomes, including mortality, procedural complications, and long-term reintervention. METHODS: The VQI PAS used for this analysis includes a total of 606 patients. Patients with uTBAD (defined as those without rupture or malperfusion) exclusive of cases categorized as emergent (N = 206) were divided into groups defined by the Society for Vascular Surgery/Society of Thoracic Surgeons reporting guidelines based on the timing of treatment after the onset of dissection: within 24 hours (N = 8), 1 to 14 days (N = 121), and 15 to 90 days (N = 77). Univariate and multivariable analysis were used to determine differences between timing groups for postoperative mortality, in-hospital complications, and reintervention. RESULTS: Demographics and comorbid conditions were very similar across the 3 TEVAR timing groups. Notable differences included a higher prevalence of baseline elevated creatinine (>1.8 mg/dL)/chronic end-stage renal disease and designation as "urgent" in the <24-hour group, as well as a higher rate of preoperative ß-blocker therapy in the 1- to 14-day group. Postoperative stroke, congestive heart failure, and renal ischemia were more common in the <24-hour group without an increase in mortality. Unadjusted 30-day mortality across groups was lowest in the early TEVAR group (0%, 3.3%, and 5.2%; P = .68), as was 1-year mortality (0%, 8.3%, and 18.2%; P = .06), although not statistically different at any time point. Reintervention out to 3 years was not different between the groups. Multivariable analysis demonstrated the need for a postoperative therapeutic lumbar drain to be the only a predictive risk factor for mortality (hazard ratio = 7.595, 95% confidence interval: 1.730-33.337, P = .007). When further subdivided into patients treated 1 to 7 days or 8 to 14 days after dissection, findings were similar. CONCLUSIONS: Patients with uTBAD treated within 24 hours were unusual (N = 8), too small for valid statistical comparison, and likely represent a high-risk subgroup, which is manifested in a higher risk of complications. Although there was a trend toward improved survival in the acute (1- to 14-day) phase, outcomes did not differ compared with the subacute (15- to 90-day) phase with relation to early mortality, postoperative complications, or 1-year survival. These data suggest that the proper selection of patients for early TEVAR can result in equivalent survival and early outcomes.

Retrograde type A dissection in the Vascular Quality Initiative thoracic endovascular aortic repair for dissection postapproval project.

BACKGROUND: Retrograde dissection (RD) can be a serious complication after thoracic endovascular aortic repair (TEVAR), with retrograde type A dissection (RTAD) particularly life-threatening. Prior studies have suggested that treatment timing, anatomic characteristics, device selection, and procedural conduct of TEVAR performed for type B aortic dissection could mitigate the occurrence of RD. The Vascular Quality Initiative TEVAR for Dissection Registry is an ongoing project meant to satisfy Food and Drug Administration requirements for postmarket approval surveillance of the Gore conformable TAG thoracic endoprosthesis (W.L. Gore & Associates, Flagstaff, Ariz), Medtronic Valiant thoracic stent graft (Medtronic, Santa Rosa, Calif), and Cook Medical dissection devices (Cook Medical, Bloomington, Ind) and provides a unique source of evaluation for RTAD in a prospectively collected real-world registry. METHODS: A total of 588 consecutive patients at 49 institutions had undergone TEVAR for acute (<30 days; n = 336) and chronic (≥30 days; n = 252) type B aortic dissection were included. The occurrence of RD as reported by the participating centers and de-identified source documents were reviewed and confirmed independently by two of us (A.W.B. and G.W.). The demographics, procedural and device data, and anatomic considerations were evaluated, and the devices were grouped in a de-identified manner as Gore, Medtronic, and other. RESULTS: The mean follow-up was 889 days (median, 658 days), and 408 patients had completed follow-up data available for >1 year. A total of 19 patients with RD (3.2%) were identified, 9 of whom had been treated for acute and 10 for chronic dissection, a 2.7% and 4.0% incidence, respectively (P = .48, acute vs chronic). Of the 19 RD cases, 15 were RTAD, 6 after treatment of acute and 9 after treatment of chronic dissection, a 1.8% and 3.6% incidence, respectively (P = .19, acute vs chronic). Five cases of RD had occurred intraoperatively (four of which were RTAD). The median time to RD and RTAD was 62 and 69 days, respectively (range, 0 to 1600 days). Of the 15 patients with RTAD, 12 had undergone surgical repair and 2 had not undergone repair; the treatment of one was unknown. The overall mortality was 33.3% (5 of 15). The factors associated with RTAD included more extensive dissection (mean, 5.6 zones without RTAD vs 8.5 zones with RTAD; P = .001), female sex (28.3% female without RTAD vs 53.3% with RTAD; P = .04), and non-White race (62.7% White without RTAD vs 33.3% White with RTAD; P = .05). Mean oversizing was not significantly different for those without RTAD compared with that for those with RTAD (14.0% vs 14.2%; P = .92). The device type was anonymized in this project; however, we found no significant differences between the Gore, Medtronic, and all other devices. CONCLUSIONS: The rate of RD in the present real-world postapproval project was consistent with that from previously reported studies, including highly controlled pivotal studies. Device type was not predictive of RD, and the newly identified risk factors for RTAD include more extensive dissection and a trend toward a greater risk for female sex and non-White race.

Patching an aortic tear using the side-arm and surrounding skirt of a physician-modified ascending aortic graft.

BACKGROUND AND AIM OF STUDY: Aortic complications during cannulation must be managed urgently and often require hypothermic circulatory arrest. We report a unique management strategy to repair an aortic tear without dissection by modifying a Dacron ascending aortic graft with side-arm. CASE PRESENTATION: A 32-year-old female patient undergoing reoperative cardiac surgery suffered an unexpected aortic tear during cannulation for cardiopulmonary bypass. The tear was repaired by utilizing a physician-modified ascending aortic graft with side-arm, in which the surrounding skirt of the side-arm was cut from the circumferential graft to patch the defect. The patient was rewarmed with the side-arm serving as arterial inflow for the bypass circuit, and the remainder of the operation proceeded without complication. CONCLUSION: This type of aortic repair for aortic tears without dissection can offer the patient the benefit of avoiding multiple aortotomies in a weakened aorta, reducing circulatory arrest time, and re-establishing a central cannulation strategy for cardiopulmonary bypass.

Aortic valve biologic protheses: A cohort comparison of premature valve failure.

BACKGROUND: Recent reports suggest an increased rate of early structural valve degeneration (SVD) in the Trifecta bioprosthesis (Abbott Cardiovascular). We sought to compare the intermediate-term outcomes of the Magna (Edwards Life Sciences) and Trifecta valves. METHODS: All surgical aortic valve replacements (SAVRs) with Trifecta or Magna/Magna Ease bioprostheses at an academic medical center were extracted from an institutional database. Patients who survived until after discharge (2011-2019) were included. The primary outcome was valve failure for any reason requiring reintervention or contributing to death, identified by reintervention or review of cause of death. Time to failure was estimated with Kaplan-Meier analysis and Cox Proportional Hazards Modeling. RESULTS: Out of 1444 patients, 521 (36%) underwent Trifecta and 923 (64%) underwent Magna implantation with a median follow-up of 27.6 months. Trifecta patients had larger median valve size (25 vs. 23 mm, p < .001) and lower median gradient (8.0 vs. 10.9 mmHg, p < .001). Trifecta patients had higher 48-month estimated failure rates (20.2 ± 7.6% vs. 2.6 ± 0.7%, p < .0001), with failure rates of 21.4 versus 9.2 failures per 1000 person-years (p < .001). After risk-adjustment, Trifecta patients had a 5.3 times hazard of failure (95% confidence interval: 2.78-12.34, p < .001) compared to Magna patients. Only Trifecta valves failed due to sudden aortic regurgitation, 8 out of 521 (1.5%). CONCLUSION: Despite lower postoperative mean gradients, the Trifecta bioprosthesis may have an increased risk of intermediate-term SVD. Further research is warranted to confirm the potential for sudden valve failure.

Meaningful Patient-centered Outcomes 1 Year Following Cardiac Surgery.

OBJECTIVE: To evaluate meaningful, patient-centered outcomes including alive-at-home status and patient-reported quality of life 1 year after cardiac surgery. BACKGROUND: Long-term patient-reported quality of life after cardiac surgery is not well understood. Current operative risk models and quality metrics focus on short-term outcomes. METHODS: In this combined retrospective/prospective study, cardiac surgery patients at an academic institution (2014-2015) were followed to obtain vital status, living location, and patient-reported outcomes (PROs) at 1 year using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS). We assessed the impact of cardiac surgery, discharge location, and Society of Thoracic Surgeons perioperative predicted risk of morbidity or mortality on 1-year outcomes. RESULTS: A total of 782 patients were enrolled; 84.1% (658/782) were alive-at-home at 1 year. One-year PROMIS scores were global physical health (GPH) = 48.8 ±â€Š10.2, global mental health (GMH) = 51.2 ±â€Š9.6, and physical functioning (PF) = 45.5 ±â€Š10.2 (general population reference = 50 ±â€Š10). All 3 PROMIS domains at 1 year were significantly higher compared with preoperative scores (GPH: 41.7 ±â€Š8.5, GMH: 46.9 ±â€Š7.9, PF: 39.6 ±â€Š9.0; all P < 0.001). Eighty-two percent of patients discharged to a facility were alive-at-home at 1 year. These patients, however, had significantly lower 1-year scores (difference: GPH = -5.1, GMH = -5.1, PF = -7.9; all P < 0.001). Higher Society of Thoracic Surgeons perioperative predicted risk was associated with significantly lower PRO at 1 year (P < 0.001). CONCLUSIONS: Cardiac surgery results in improved PROMIS scores at 1 year, whereas discharge to a facility and increasing perioperative risk correlate with worse long-term PRO. One-year alive-at-home status and 1-year PRO are meaningful, patient-centered metrics that help define long-term quality and the benefit of cardiac surgery.

Gastrointestinal Complications After Cardiac Surgery: Highly Morbid but Improving Over Time.

BACKGROUND: Gastrointestinal complications after cardiac surgery are associated with high morbidity and mortality. We sought to determine the granular impact of individual gastrointestinal complications after cardiac surgery and assess contemporary outcomes. MATERIALS AND METHODS: Patients undergoing cardiac surgery from 2010 to 2017 (6070 patients) were identified from an institutional Society of Thoracic Surgeons database. Records were paired with institutional data assessing gastrointestinal complications and cost. Patients were stratified by early (2010-2013) and current (2014-2017) eras. RESULTS: A total of 280 (4.6%) patients experienced gastrointestinal complications including Clostridiumdifficile infection (94, 33.6%), gastrointestinal bleed (86, 30.7%), hepatic failure (66, 23.6%), prolonged ileus (59, 21.1%), mesenteric ischemia (47, 16.8%), acute cholecystitis (17, 6.0%), and pancreatitis (14, 5.0%). Gastrointestinal complications were associated with higher rates of early postoperative major morbidity [206 (73.6%) versus 773 (13.4%), P < 0.0001], mortality [78 (27.9%) versus 161 (2.8%), P < 0.0001], length of stay (23 versus 6 d, P < 0.0001), and discharge to a facility [115 (41.1%) versus 1395 (24.1%), P < 0.0001]. Patients suffering gastrointestinal complications had worse risk-adjusted long-term survival (hazard ratio: 3.0, P < 0.0001) and higher adjusted cost ($9,173, P = 0.05). Between eras, there was no difference in incidence of gastrointestinal complications [139 (4.4%) versus 141 (4.8%), P = 0.51] or rate of specific complications (all P > 0.05). However, long-term survival increased in modern era (P < 0.0001). CONCLUSIONS: Although incidence of gastrointestinal complications after cardiac surgery has not changed over time, long-term survival has improved. Gastrointestinal complications remain associated with high resource utilization and major morbidity, but patients are now more likely to recover, highlighting the benefit of quality improvement efforts.

Bariatric surgery reduces long-term rates of cardiac events and need for coronary revascularization: a propensity-matched analysis.

BACKGROUND: Obesity and obesity-related comorbidities are associated with increased risk of coronary artery disease (CAD). Bariatric surgery results in durable weight loss and improvement in numerous CAD risk factors, yet limited data exist on CAD-related outcomes. We hypothesized that bariatric surgery would lead to decreased risk of CAD and reduced rates of coronary revascularization procedures. METHODS: All patients who underwent bariatric surgery at a single medical center from 1985 to 2015 were identified. A control population of morbidly obese patients who did not undergo bariatric surgery was identified using an institutional clinical data repository over the same study period, propensity score matched 1:1 on patient demographics and comorbidities including cardiac history. Univariate analyses were performed to compare outcomes in the surgery and non-surgery groups. RESULTS: A total of 3410 bariatric surgery patients and 45,750 non-surgical patients were identified. After 1:1 propensity-score matching, a total of 3242 patients in each group were found to be well balanced in baseline characteristics and risk factors. With a median follow-up of greater than 6 years, the surgery group had significantly lower rates of myocardial infarction (1.8% vs. 10.0%; RR 0.18), coronary catheterization (1.9% vs. 8.8%; RR 0.22), percutaneous coronary intervention (0.4% vs. 7.8%; RR 0.05), and coronary artery bypass grafting (0.6% vs. 2.3%; RR 0.26). Similar benefits were observed for subgroups of patients with and without diabetes. CONCLUSIONS: Bariatric surgery was associated with a significant reduction in the incidence of myocardial infarction as well as lower rates of coronary revascularization in a propensity-matched cohort of morbidly obese patients. Though the retrospective nature of this study may have introduced a degree of selection bias, these outcomes support increased utilization of bariatric surgery for the prevention of heart disease.

Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery.

BACKGROUND: Atrial fibrillation after cardiac surgery is associated with increased rates of death, complications, and hospitalizations. In patients with postoperative atrial fibrillation who are in stable condition, the best initial treatment strategy--heart-rate control or rhythm control--remains controversial. METHODS: Patients with new-onset postoperative atrial fibrillation were randomly assigned to undergo either rate control or rhythm control. The primary end point was the total number of days of hospitalization within 60 days after randomization, as assessed by the Wilcoxon rank-sum test. RESULTS: Postoperative atrial fibrillation occurred in 695 of the 2109 patients (33.0%) who were enrolled preoperatively; of these patients, 523 underwent randomization. The total numbers of hospital days in the rate-control group and the rhythm-control group were similar (median, 5.1 days and 5.0 days, respectively; P=0.76). There were no significant between-group differences in the rates of death (P=0.64) or overall serious adverse events (24.8 per 100 patient-months in the rate-control group and 26.4 per 100 patient-months in the rhythm-control group, P=0.61), including thromboembolic and bleeding events. About 25% of the patients in each group deviated from the assigned therapy, mainly because of drug ineffectiveness (in the rate-control group) or amiodarone side effects or adverse drug reactions (in the rhythm-control group). At 60 days, 93.8% of the patients in the rate-control group and 97.9% of those in the rhythm-control group had had a stable heart rhythm without atrial fibrillation for the previous 30 days (P=0.02), and 84.2% and 86.9%, respectively, had been free from atrial fibrillation from discharge to 60 days (P=0.41). CONCLUSIONS: Strategies for rate control and rhythm control to treat postoperative atrial fibrillation were associated with equal numbers of days of hospitalization, similar complication rates, and similarly low rates of persistent atrial fibrillation 60 days after onset. Neither treatment strategy showed a net clinical advantage over the other. (Funded by the National Institutes of Health and the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT02132767.).

Socioeconomically Distressed Communities Index independently predicts major adverse limb events after infrainguinal bypass in a national cohort.

BACKGROUND: Socioeconomic status is a major determinant of not only quality of life, but also mortality and health care-related outcomes. We hypothesized that patients coming from distressed communities would have worse short- and long-term limb related outcomes after infrainguinal bypass. METHODS: The infrainguinal bypass national Vascular Quality Initiative datasets for 2003 to 2018 were used. Clinical data were paired with the Distressed Communities Index (DCI) score before extraction. The DCI accounts for unemployment, education level, poverty rate, median income, business growth, and housing vacancies at the zip code level, with a range of 0 (no distress) to 100 (severe distress). Severely distressed communities were defined as DCI greater than 75 for univariate analysis. Hierarchical multivariable modeling adjusted for baseline and operative risk factors, and clustering at the hospital level. RESULTS: The 9711 patients who underwent infrainguinal bypass from severely distressed communities (out of 40,109 total) were younger, more likely to smoke, disproportionately African American, with more comorbid disease (all P < .05). Patients from less distressed communities had lower rates of critical limb ischemia (56% DCI ≤ 75 vs 60% DCI > 75; P < .0001) and prior amputation (4.7 vs 6.3%; P < .0001). There was no difference in in-hospital mortality (1.3% vs 1.3%; P = .906) or major adverse cardiovascular events (4.1% vs 3.7%; P = .097). However, patients from distressed communities had higher rates of major adverse limb events (MALE; 11.7% vs 14.4%; P < .0001), and the components amputation, thrombectomy, and revision. After risk adjustment, DCI remained an independent predictor of in-hospital MALE (odds ratio, 1.05 per 25 DCI points; 95% confidence interval [CI], 1.02-1.08; P = .001) and long-term MALE (hazard ration [HR] 1.02; 95% CI, 1.00-1.04; P = .045). DCI is predictive of long-term graft occlusion (HR, 1.04; 95% CI, 1.00-1.07; P = .028) and amputation (HR, 1.09; 95% CI, 1.06-1.12; P < .0001). CONCLUSIONS: The DCI is an independent predictor of MALE after infrainguinal bypass. Patients from distressed communities are at an increased risk of long-term graft occlusion, which is disproportionately treated with amputation instead of surgical limb-saving alternatives. Socioeconomic factors impact vascular disease and surgical outcomes with disparities that warrant further investigation.

Increased warm ischemia time during vessel harvest decreases the primary patency of cryopreserved conduits in patients undergoing lower extremity bypass.

OBJECTIVE: Autologous vein is the preferred conduit for lower extremity bypass. However, it is often unavailable because of prior harvest or inadequate for bypass owing to insufficient caliber. Cryopreserved cadaveric vessels can be used as conduits for lower extremity revascularization when autogenous vein is not available and the use of prosthetic grafts is not appropriate. Many studies have shown that donor characteristics influence clinical outcomes in solid organ transplantation, but little is known regarding their impact in vascular surgery. The purpose of this study was to examine the effects donor variables have on patients undergoing lower extremity bypass with cryopreserved vessels. METHODS: The tissue processing organization was queried for donor blood type, warm ischemia times (WITs), and serial numbers of cryopreserved vessels implanted at a single center from 2010 to 2016. The serial numbers were then matched with their respective patients using the institutional Clinical Data Repository and patient data were obtained from the Clinical Data Repository and chart review. Primary outcomes were primary patency of the bypass conduits and limb salvage. Time to loss of patency was evaluated using Kaplan-Meier methods and a Cox proportional hazards model determined risk-adjusted predictors of patency and limb salvage. RESULTS: Sixty patients underwent lower extremity bypass with 65 cryopreserved vessels (23 superficial femoral arteries, 41 saphenous veins, 1 femoral vein). Thirty-eight procedures were reoperations. There were 21 inflow, 44 outflow, and 44 infrainguinal procedures. Preexisting comorbidities did not differ significantly between those who lost patency and those who did not. The mean WIT among the entire cohort was 892.3 ± 389.1 minutes (range, 158.0-1434.0 minutes). The median follow-up was 394 days. Kaplan-Meier analysis demonstrated an overall 1-year primary patency rate of 51%. Primary patency at 1 year was 67% and 41% for inflow and outflow procedures, respectively, and did not differ significantly between the two groups (P = .15). Donor-to-recipient ABO incompatibility was not associated with loss of primary patency. The 1-year amputation-free survival was 74%. Primary patency significantly decreased with each hourly increase in WIT on risk-adjusted analysis (hazard ratio, 1.1; P = .02). CONCLUSIONS: Higher cryopreserved vessel WIT was associated with increased risk-adjusted loss of primary patency in this cohort. At 1 year, the overall primary patency was 51% and amputation-free survival was 74%. Vascular surgeons should be aware that WIT may affect outcomes for lower extremity bypass.

Socioeconomic Distressed Communities Index associated with worse limb-related outcomes after infrainguinal bypass.

OBJECTIVE: Several studies have demonstrated that socioeconomic factors may affect surgical outcomes. Analyses in vascular surgery have been limited by the availability of individual or community-level socioeconomic data. We sought to determine whether the Distressed Communities Index (DCI), a composite socioeconomic ranking by ZIP code, could predict short- and long-term outcomes for patients with peripheral artery disease. METHODS: All Virginia Quality Initiative patients (n = 2578) undergoing infrainguinal bypass (2011-2017) within a region of 17 centers were assigned a composite DCI score. The score was developed by the Economic Innovation Group and is normally distributed from 0 (no distress) to 100 (severe distress) based on measures of community unemployment, education level, poverty rate, median income, business growth, and housing vacancies. Severely distressed communities were defined as the top quartile DCI (>75). Hierarchical regression assessed short-term outcomes, and time-to-event analyses assessed long-term results. RESULTS: Infrainguinal bypass patients in this study came from disproportionately distressed communities, with 29% of patients living within the highest distress DCI quartile (P < .0001), with high variability by hospital (DCI range, 12-67). These patients from severely distressed areas were younger, more likely to smoke, and disproportionately African American and had higher rates of medical comorbidities (all P < .05). Whereas patients from severely distressed communities had an equivalent rate of 30-day major adverse cardiac and cerebrovascular events (5% vs 4%; P = .86), they had increased rates of major adverse limb events (MALEs) at 13% vs 10% (P = .03). This trend persisted in the long term, with higher 1-year estimates of MALEs (21% vs 17%; P = .01) as well as the components of amputation (17% vs 12%; P = .006) and thrombectomy (11% vs 6%; P = .002). Patients with high socioeconomic distress also had higher rates of occlusion (17% vs 11%; P = .003). CONCLUSIONS: In this study, patients from severely distressed communities were found to have increased rates of MALEs, an association that persisted long term. Mitigating risk associated with socioeconomic determinants of health has the potential to improve outcomes for patients with peripheral artery disease.

Cost-Effectiveness of Negative Pressure Incision Management System in Cardiac Surgery.

BACKGROUND: Sternal wound infections (SWIs) can be a devastating long-term complication with significant morbidity and health care cost. The purpose of this analysis was to evaluate the cost-effectiveness of negative pressure incision management systems (NPIMS) in cardiac surgery. MATERIALS AND METHODS: All cardiac surgery cases at an academic hospital with risk scores available (2009-2017) were extracted from an institutional database (n = 4455). Patients were stratified by utilization of NPIMS, and high risk was defined as above the median. Costs included infection-related readmissions and were adjusted for inflation. Multivariable regression models assessed the risk-adjusted cost of SWI and efficacy of NPIMS use. Cost-effectiveness was modeled using TreeAge Pro using institutional results. RESULTS: The rate of deep SWI was 0.9% with an estimated cost of $111,175 (P < 0.0001). The rate of superficial SWI was 0.8% at a cost of $7981 (P = 0.08). Risk-adjusted NPIMS use was not significantly associated with reduced SWI (OR 1.2, P = 0.62) and thus not cost-effective. However, in the high-risk cohort with an OR 0.84 (P = 0.72) and SWI rate of 2.3%, NPIMS use cost $205 per patient with an incremental cost-effectiveness ratio of $179,092. Therefore, NPIMS is estimated to be cost-effective with a deep SWI rate over 1.3% or improved efficacy (OR < 0.83). CONCLUSIONS: SWIs are extremely expensive complications with estimates of $111,175 for deep yet only $7981 for superficial. Although NPIMS was not cost-effective for SWI prevention as currently utilized, a protocol for use on patients with a higher risk of sternal infection could be cost-effective.

Impact of Venous Collaterals on Clinical Outcomes in Paget-Schroetter Syndrome.

PURPOSE: To characterize the degree of venous collateralization before and after endovascular therapy and determine the effect of collateralization on success of thrombolysis and rate of repeat intervention in patients with Paget-Schroetter syndrome. MATERIALS AND METHODS: A single-center retrospective study of 37 extremities in 36 patients (mean age, 32.64 y; range, 15-72 y; 24 men) with PSS treated with endovascular therapy from 2007 through 2017 was conducted. Venograms at presentation, after lysis, postoperatively, and at each repeat intervention were graded for venous stenosis, thrombus burden, and collateralization on a 5-point scale. Collateralization was classified as high-grade (9 extremities) or low-grade (28 extremities) based on grading of the venograms at presentation. RESULTS: Primary technical success rate for endovascular treatment was 100%. Eighty-six percent of patients (32 of 37) underwent thrombolysis, 91% (34 of 37) underwent mechanical thrombectomy, and 83% (30 of 37) underwent balloon angioplasty. Overall primary patency rate was 50% at 12 months. The repeat intervention rate within 12 months was significantly higher for extremities with high- vs low-grade collateralization (89% vs 43%; P = .016). There was a significant decrease in the median grade of collateral severity after initial intervention (2 vs 1; P = .044) and 1 day postoperatively (2 vs 1; P = .040) vs the venogram at presentation. CONCLUSIONS: Severity of venous collateralization on the venogram at presentation of patients with PSS does not appear to affect success of endovascular therapy but may predict long-term patency of affected extremities. Patients in this cohort with severe collateralization on presentation were more likely to need repeat intervention.

Pulmonary-Systemic Pressure Ratio Correlates with Morbidity in Cardiac Valve Surgery.

OBJECTIVES: Pulmonary hypertension portends worse outcomes in cardiac valve surgery; however, isolated pulmonary artery pressures may not reflect patients' global cardiac function accurately. To better account for the interventricular relationship, the authors hypothesized that patients with greater pulmonary-systemic ratios (mean pulmonary arterial pressure)/(mean systemic arterial pressure) would correlate with worse outcomes after valve surgery. DESIGN: Retrospective cohort study. SETTING: Single academic hospital. PARTICIPANTS: The study comprised 314 patients undergoing valve surgery with or without coronary artery bypass grafting (2004-2016) with Society of Thoracic Surgeons predicted risk scores and preoperative right heart catheterization. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The pulmonary-systemic ratio was calculated as follows: mean pulmonary arterial pressure/mean systemic arterial pressure. Patients were stratified by pulmonary-systemic ratio quartile. Logistic regression was used to assess the risk-adjusted association between pulmonary-systemic ratio or mean pulmonary arterial pressure. Median pulmonary-systemic ratio was 0.33 (Q1-Q3: 0.23-0.65); median pulmonary arterial pressure was 29 (21-30) mmHg. Patients with the highest pulmonary-systemic ratio had the highest rates of morbidity and mortality (p < 0.0001). A high pulmonary-systemic ratio was associated with longer duration in the intensive care unit (p < 0.0001) and hospital (p < 0.0001). After risk-adjustment, pulmonary-systemic ratio and pulmonary arterial pressure were independently associated with morbidity and mortality, but the pulmonary-systemic ratio (odds ratio 23.88, p = 0.008, Wald 7.1) was more strongly associated than the pulmonary arterial pressure (odds ratio 1.035, p = 0.011, Wald 6.5). CONCLUSIONS: The pulmonary-systemic ratio is more strongly associated with risk-adjusted morbidity and mortality in valve surgery than pulmonary arterial pressure. By integrating ventricular interactions, this metric may better characterize the risk of valve surgery.

Intramyocardial Injection of Mesenchymal Precursor Cells and Successful Temporary Weaning From Left Ventricular Assist Device Support in Patients With Advanced Heart Failure: A Randomized Clinical Trial.

Importance: Left ventricular assist device (LVAD) therapy improves myocardial function, but few patients recover sufficiently for explant, which has focused attention on stem cells to augment cardiac recovery. Objective: To assess efficacy and adverse effects of intramyocardial injections of mesenchymal precursor cells (MPCs) during LVAD implant. Design, Setting, and Participants: A randomized phase 2 clinical trial involving patients with advanced heart failure, undergoing LVAD implant, at 19 North American centers (July 2015-August 2017). The 1-year follow-up ended August 2018. Interventions: Intramyocardial injections of 150 million allogeneic MPCs or cryoprotective medium as a sham treatment in a 2:1 ratio (n = 106 vs n = 53). Main Outcomes and Measures: The primary efficacy end point was the proportion of successful temporary weans (of 3 planned assessments) from LVAD support within 6 months of randomization. This end point was assessed using a Bayesian analysis with a predefined threshold of a posterior probability of 80% to indicate success. The 1-year primary safety end point was the incidence of intervention-related adverse events (myocarditis, myocardial rupture, neoplasm, hypersensitivity reactions, and immune sensitization). Secondary end points included readmissions and adverse events at 6 months and 1-year survival. Results: Of 159 patients (mean age, 56 years; 11.3% women), 155 (97.5%) completed 1-year of follow-up. The posterior probability that MPCs increased the likelihood of successful weaning was 69%; below the predefined threshold for success. The mean proportion of successful temporary weaning from LVAD support over 6 months was 61% in the MPC group and 58% in the control group (rate ratio [RR], 1.08; 95% CI, 0.83-1.41; P = .55). No patient experienced a primary safety end point. Of 10 prespecified secondary end points reported, 9 did not reach statistical significance. One-year mortality was not significantly different between the MPC group and the control group (14.2% vs 15.1%; hazard ratio [HR], 0.89; 95%, CI, 0.38-2.11; P = .80). The rate of serious adverse events was not significantly different between groups (70.9 vs 78.7 per 100 patient-months; difference, -7.89; 95% CI, -39.95 to 24.17; P = .63) nor was the rate of readmissions (0.68 vs 0.75 per 100 patient-months; difference, -0.07; 95% CI, -0.41 to 0.27; P = .68). Conclusions and Relevance: Among patients with advanced heart failure, intramyocardial injections of mesenchymal precursor cells, compared with injections of a cryoprotective medium as sham treatment, did not improve successful temporary weaning from left ventricular assist device support at 6 months. The findings do not support the use of intramyocardial mesenchymal stem cells to promote cardiac recovery as measured by temporary weaning from device support. Trial Registration: clinicaltrials.gov Identifier: NCT02362646.

Estimating risk of adverse cardiac event after vascular surgery using currently available online calculators.

BACKGROUND: The decision to proceed with vascular surgical interventions requires evaluation of cardiac risk. Recently, several online risk calculators were created to predict outcomes and to lead to a more informed conversation between surgeons and patients. The objective of this study was to compare and further validate these online calculators with actual adverse cardiac outcomes at a single institution. METHODS: All patients from January 2011 through December 2015 undergoing carotid endarterectomy (CEA), infrainguinal lower extremity bypass, open abdominal aortic aneurysm (AAA) repair, and endovascular aneurysm repair (EVAR) on the vascular surgical service were included using the Society for Vascular Surgery Vascular Quality Initiative database at our health system. Additional information was collected through retrospective chart review. Each patient was entered through three online risk calculators: (1) the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) estimates the risk of cardiac arrest and myocardial infarction (MI); (2) the Revised Cardiac Risk Index (RCRI) estimates risk of MI, pulmonary edema, ventricular fibrillation, primary cardiac arrest, and complete heart block; and (3) the Vascular Study Group of New England (VSGNE) Cardiac Risk Index estimates risk of postoperative MI only. Observed adverse cardiac events (ACEs) were compared with expected values for each calculator using a χ2 goodness-of-fit test. Institutional Review Board exemption was obtained. RESULTS: A total of 856 cases were included: 350 CEAs, 210 infrainguinal bypasses, 77 open AAA repairs, and 219 EVARs. For CEA, no risk calculator showed statistically significant variation from the observed values (NSQIP, P = .45; RCRI, P = .17; VSGNE, P = .24). For infrainguinal bypass, NSQIP slightly underpredicted adverse events (P = .054), RCRI strongly underpredicted (P = .002), and VSGNE showed no difference (P = .42). For open AAA repair, NSQIP (P = .51) and VSGNE (P = .98) were adequate predictors, but RCRI strongly underpredicted the adverse events (P ≤ .0001). Finally, EVAR cardiac outcomes showed greater adverse events than predicted by all three calculators (NSQIP, P = .02; RCRI, P = .0002; and VSGNE, P = .025). Pooled data for the entire group documented that the VSGNE proved an accurate tool for prediction (P = .34), whereas ACEs were underpredicted by NSQIP (P = .0055) and RCRI (P ≤ .001). CONCLUSIONS: Although online cardiac risk calculators of adverse surgical events are easy to use and to reference in broad surgical decision-making, there is significant variability in their predictability at the procedure and institutional level. Our data suggest that ACEs often occur at a higher rate than expected on the basis of calculated risks profiles, thus creating a platform for future discussion about preoperative evaluation and postoperative care decision-making models.

Preoperative dementia is associated with increased cost and complications after vascular surgery.

OBJECTIVE: Dementia represents a major risk factor for medical complications and has been linked to higher rates of complication after surgery. Given the systemic nature of vascular disease, medical comorbidities significantly increase cost and complications after vascular surgery. We hypothesize that the presence of dementia is an independent predictor of increased postoperative complications and higher health care costs after vascular surgery. METHODS: The Vascular Quality Initiative database was queried for all patients undergoing vascular surgery at a single academic medical center from 2012 to 2017. All modules were included (open abdominal aortic aneurysm, suprainguinal bypass, lower extremity bypass, amputation, carotid endarterectomy, endovascular aortic aneurysm repair, thoracic endovascular aortic aneurysm repair, and peripheral endovascular intervention). An institutional clinical data repository was queried to identify patients with International Classification of Diseases, Ninth Revision diagnosis codes for dementia as well as total hospital cost and long-term survival using Social Security records from the Virginia Department of Health. Hierarchical logistic and linear regression models were fit to assess risk-adjusted predictors of any complication and inflation-adjusted cost. Kaplan-Meier and Cox proportional hazards models were used for survival analysis. RESULTS: A total of 2318 patients underwent vascular surgery and were captured by the Vascular Quality Initiative during the past 5 years, with 88 (3.8%) having a diagnosis of dementia. Patients with dementia were older and had higher rates of medical comorbidities, and the most common procedure was major amputation. In addition, dementia patients had a significantly higher rate of any complication (52% vs 16%; P < .0001) and increased 90-day mortality (14% vs 4.8%; P = .0002). Furthermore, dementia was associated with significant resource utilization, including preoperative length of stay (LOS), postoperative LOS, intensive care unit LOS, and inflation-adjusted total hospital cost (all P < .0001). Hierarchical modeling demonstrated that dementia was the strongest preoperative predictor for any complication (odds ratio, 8.64; P < .0001) and had the largest risk-adjusted impact on total hospital cost ($22,069; P < .0001). Finally, survival analysis demonstrated that dementia is independently associated with reduced survival after vascular surgery (hazard ratio, 1.37; P = .018). CONCLUSIONS: This study demonstrated that dementia is one of the strongest predictors of any complication and increased hospital cost after vascular surgery. Given the high risk of clinical and financial maladies, patients with dementia should be carefully considered and counseled before undergoing vascular surgery.

Improved outcomes and value in staged hybrid extent II thoracoabdominal aortic aneurysm repair.

OBJECTIVE: Complex Crawford extent II thoracoabdominal aortic aneurysms (TAAAs) can be treated in a hybrid manner with proximal thoracic endovascular aneurysm repair, followed by staged distal open thoracoabdominal repair. This study evaluated the outcomes and health care-associated value of this new method compared with traditional open repair over 10 years. METHODS: A prospectively collected database was used to identify all patients with an extent II TAAA undergoing repair at a single institution between 2005 and 2015. Patient characteristics, postoperative outcomes, and incidence of major adverse events (MAEs; renal failure, spinal cord ischemia, death) were compared. After adjusting for time since surgery, value was analyzed looking at quality (1/MAE) divided by cost (total health system cost). This was multiplied by a constant to set the value of open TAAA repair to 100. RESULTS: A total of 113 consecutive patients underwent extent II TAAA repairs, of whom 25 (22.1%) had a staged hybrid approach with a median of 129 days between procedures. No baseline differences in demographic or comorbidity variables existed between groups (P > .05). The hybrid group had shorter operative time (255 vs 306 minutes; P = .01), shorter postoperative length of stay (10.1 vs 13.3 days; P = .02), and reduced blood loss (1300 vs 2600 mL; P = .01) at the time of open operation. Despite higher rates of acute kidney injury in the hybrid group (76.0% vs 51.1%; P = .03), there was no difference in renal failure (8.0% vs 4.5%; P = .84). The incidence of MAEs was lower in the staged hybrid group (20.0% vs 48.9%; P = .01), without a difference in hospital mortality (4.0% vs 3.4%; P = .89). Median total cost was higher in the hybrid group ($112,920 vs $72,037; P = .003). Value was improved in the hybrid group by 56% using mean cost and 178% by median cost. CONCLUSIONS: The 20% MAE rate associated with staged hybrid repair of extent II TAAA was significantly decreased compared with open repair, with a relative reduction of >50%. Despite higher total hospital costs, staged hybrid repair had 56% to 178% higher health care-related value compared with standard open repair. In an era of increasing focus on costs and quality, staged hybrid repair of extensive TAAAs is associated with fewer complications than open TAAA repair, resulting in a good value investment from a resource utilization perspective.

Lower extremity bypass for critical limb ischemia decreases major adverse limb events with equivalent cardiac risk compared with endovascular intervention.

OBJECTIVE: Lower extremity bypass (LEB) has traditionally been the "gold standard" in the treatment of critical limb ischemia (CLI). Infrainguinal endovascular intervention (IEI) has become more commonly performed than LEB, but comparative outcomes are limited. We sought to compare rates of major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) after LEB and IEI in a propensity score-matched, national cohort of patients with CLI. METHODS: The National Surgical Quality Improvement Program (NSQIP) vascular targeted files (2011-2014) for LEB and IEI were merged. CLI patients were identified by ischemic rest pain or tissue loss. Patients were matched on a 1:1 basis for propensity to undergo LEB or IEI. Primary outcomes were 30-day MALEs and MACEs. Within the propensity-matched cohort, multivariate logistic regression was used to identify independent predictors of MALEs and MACEs. RESULTS: A total of 13,294 LEBs and IEIs were identified, with 8066 cases performed for CLI. Propensity matching identified 3848 cases (1924 per group). There were no differences in preoperative variables between the propensity-matched LEB and IEI groups (all P > .05). At 30 days, rates of MALEs were significantly lower in the LEB group (9.2% LEB vs IEI 12.2%; P = .003). On multivariate logistic regression, bypass with single-segment saphenous vein vs IEI (odds ratio [OR], 0.7; 95% confidence interval [CI], 0.54-0.92; P = .01), bypass with alternative conduit (prosthetic, spliced vein, or composite) vs IEI (OR, 0.7; 95% CI, 0.56-0.98; P = .04), antiplatelet therapy (OR, 0.8; 95% CI, 0.58-1.00; P = .049), and statin therapy (OR, 0.8; 95% CI, 0.62-0.99; P = .04) were protective against MALEs, whereas infrageniculate intervention (OR, 1.4; 95% CI, 1.09-1.72; P = .01) and a history of prior bypass of the same arterial segment (OR, 1.8; 95% CI, 1.41-2.41; P <. 0001) were predictive. Rates of 30-day MACEs were not significantly different (4.9% LEB vs 3.7% IEI; P = .07) between the groups. Independent predictors of MACEs included age (OR, 1.02; 95% CI, 1.01-1.04; P = .01), steroid use (OR, 1.8; 95% CI, 1.08-2.99; P = .03), congestive heart failure (OR, 1.7; 95% CI, 1.00-1.96; P = .02), beta blocker use (OR, 1.6; 95% CI, 1.09-1.43; P = .01), dialysis (OR, 2.3; 95% CI, 1.55-3.45; P < .0001), totally dependent functional status (OR, 3.1; 95% CI, 1.25-7.58; P = .02), and suboptimal conduit for LEB compared with IEI (OR, 1.6; 95% CI, 1.08-2.36; P = .02). CONCLUSIONS: Within this large, propensity-matched, national cohort, LEB predicted lower risk-adjusted 30-day MALE rate compared with IEI. Furthermore, there was no difference in 30-day MACE rate between the groups despite higher inherent risk with open surgical procedures. Therefore, this study supports the effectiveness and primacy of LEB for revascularization in CLI.