Long-term outcomes for hybrid aortic arch repair.

OBJECTIVE: Since its inception in the early 2000s, hybrid arch repair (HAR) has evolved from novel approach to well-established treatment modality for aortic arch pathology in appropriately selected patients. Despite this nearly 20-year history of use, long-term results of HAR remain to be determined. As such, objectives of this study are to detail the long-term outcomes for HAR within an expanded classification scheme. METHODS: From August 2005 to August 2022, 163 consecutive patients underwent HAR at a single referral institution. Operative approach was selected according to an institutional algorithm and included zone 0/1 HAR in 25% (n = 40), type I HAR in 34% (n = 56), and type II/III HAR in 41% (n = 67). Specific zone 0/1 technique was zone 1 HAR in 31 (78%), zone 0 with innominate snorkel (zone 0S HAR) in 7 (18%), and zone 0 with single side-branch endograft (zone 0B HAR) in 2 (5%). The 30-day and long-term outcomes, including overall and aortic-specific survival, as well as freedom from reintervention, were assessed. RESULTS: The mean age was 63 ± 13 years and almost one-half of patients (47% [n = 77]) had prior sternotomy. Presenting pathology included degenerative aneurysm in 44% (n = 71), residual dissection after prior type A repair in 38% (n = 62), chronic type B dissection in 12% (n = 20), and other indications in 6% (n = 10). Operative outcomes included 9% mortality (n = 14) at 30 days, 5% mortality (n = 8) in hospital, 4% stroke (n = 7), 2% new dialysis (n = 3), and 2% permanent paraparesis/plegia (n = 3). The median follow-up was 44 month (interquartile range, 12-84 months). Overall survival was 59% and 47% at 5 and 10 years, respectively, whereas aorta-specific survival was 86% and 84% at the same time points. At 5 and 10 years, freedom from major reintervention was 92% and 91%, respectively. Institutional experience had a significant impact on both early and late outcomes: comparing the first (2005-2012) and second (2013-2022) halves of the series, 30-day mortality decreased from 14% to 1% (P = .01) and stroke from 6% to 3% (P = .62). Improved operative outcomes were accompanied by improved late survival, with 78% of patients in the later era vs 45% in the earlier era surviving to 5 years. CONCLUSIONS: HAR is associated with excellent operative outcomes, as well as sustained protection from adverse aortic events as evidenced by high long-term aorta-specific survival and freedom from reintervention. However, surgeon and institutional experience appear to play a major role in achieving these superior outcomes, with a five-fold decrease in operative mortality and a two-fold decrease in stroke rate in the latter half of the series. These long-term results expand on prior midterm data and continue to support use of HAR for properly selected patients with arch disease.

Defining the Value of Vascular Surgery Service at a Tertiary Academic Medical Center.

BACKGROUND: Vascular surgeons play a critical role in the functioning of a healthcare system. As a service line, vascular surgery not only performs its own complex operations but also provides support to other surgical specialties by assisting in the management of vascular-related complications. Previous reports have acknowledged the value of consulting vascular surgeons; however, these studies have primarily been limited to single-center series. In this study, we aim to contribute to the existing literature by sharing our experience and highlighting the financial value of consulting vascular surgeons at a large tertiary academic medical center. METHODS: Institutional electronic medical records were retrospectively queried for all operations performed by vascular surgeons from 2020 to 2022. Two separate procedural groups were identified. The first group comprised all surgeries where vascular surgery was listed as a co-surgeon for other surgical specialties. The second group comprised all surgeries where vascular surgery was the primary surgeon for service-level cases. Service-level cases were defined as operations resulting directly from (1) iatrogenic complications from other services, (2) consultations for traumatic injury, or (3) primary surgeon for nonvascular cases. The Centers for Medicare and Medicaid Services Physician Fee Schedule was used to calculate work relative value units (wRVUs) per primary procedure code. RESULTS: A total of 7,821 surgeries were performed with vascular involvement more than the study period. Of these, 726 operations (9.3%) were co-surgeon cases requiring intraoperative vascular assistance, from 109 surgeons across all 16 surgical specialties. There were no missing data. The most common specialties requesting vascular assistance included cardiac surgery (n = 247, 34.0%), orthopedic surgery (n = 152, 20.9%), and neurosurgery (n = 131, 18.0%). Total procedural wRVU for co-surgeon cases was 16,220, and total charges exceeded $77.5 million dollars. Vascular surgery served in a primary surgeon role in an additional 154 service-level cases (2.0%) resulting from 10 nonsurgical services. The most common service-level indication was iatrogenic vascular injury (n = 87, 56.4%), and most service-level cases required urgent or emergent surgery (n = 123, 79.9%). These procedures generated an additional 2,150 wRVUs and $1.1 million dollars in charges for the hospital system. Of all co-surgeon or service-level cases, 19.1% (n = 168) occurred after-hours and 10.3% (n = 91) occurred on a holiday or weekend. CONCLUSIONS: Vascular surgery is crucial to the operation of all surgical services and many nonsurgical service lines within an academic medical center. Apart from providing essential services for primary vascular diseases, the vascular surgery service line offers substantial financial benefits to the healthcare system through its consulting role. A considerable portion of operative consultations is performed under urgent or emergent circumstances, often necessitating surgical intervention outside regular working hours or on holidays/weekends. These findings have significant implications for assessing the value and compensation of vascular surgeons in today's healthcare landscape.

Surgical Specialty Impacts Quality of Operative Training in Carotid Endarterectomy.

BACKGROUND: Carotid endarterectomy (CEA) is currently performed by multiple surgical specialties. The impact of surgical specialty and operative volume on post-CEA outcomes has been well described. However, it is unclear whether trainees of different surgical specialties have similar quality of operative training. METHODS: Data from Accreditation Council for Graduate Medical Education annual reports were collected and compared between graduating vascular surgery (VS) residents, VS fellows, and neurological surgery (NS) residents. Only cases reported as chief/senior/lead resident, surgeon junior, or surgeon fellow were included in analysis. Linear regression analysis was utilized to evaluate trends in case-mix and volume. RESULTS: From 2013 to 2022, total CEA case volume was higher among VS residents and fellows, compared to NS residents (52.8 ± 0.8 vs. 44.3 ± 1.4 vs. 12.9 ± 0.6, P < 0.0001). Additionally, VS residents and fellows performed other carotid operations including transfemoral or transcarotid artery stenting (11.1 ± 0.9 vs. 11.2 ± 0.8 vs. 0), carotid body tumor resection (0.7 ± 0.1 vs. 0.7 ± 0.0 vs. 0), and extracranial cervical bypass (6.7 ± 0.3 vs. 6.3 ± 0.3 vs. 0) that were not reported by the NS resident cohort (P < 0.0001 each). On linear regression analysis, total CEA procedures did not change for VS residents (R2 = 0.03, P = 0.62), decreased for VS fellows (-1.29 cases/yr, R2 = 0.75, P < 0.0001), and decreased among NS residents (-0.41 cases/yr, R2 = 0.44, P = 0.01) over the study period. CONCLUSIONS: Although residents of multiple surgical specialties are trained in CEA, vascular training offers significantly greater numbers and diversity of extracranial carotid cases. It also appears that CEA volume is decreasing among neurosurgical trainees. In light of recent reports on the volume-outcome effect in carotid surgery, these data may have implications for future practice patterns in the domain of extracranial carotid artery disease.

Impact of Wound Closure Technique on Surgical Site Infection after Lower Extremity Bypass Surgery.

BACKGROUND: Surgical site infections (SSI) are among the most common complications after lower extremity bypass (LEB). Both patient and hospital-related factors have been associated with SSI after LEB, however, the impact of surgical closure technique on SSI incidence remains unclear. METHODS: Institutional electronic medical records were retrospectively queried for all LEB procedures performed from 2018 through 2022. Data were collected on patient demographics, medical comorbidities, operative details, wound closure techniques, and postoperative outcomes. Closure techniques included skin staples, absorbable monofilament (Monocryl), non-absorbable monofilament (Nylon), or left open to heal by secondary intention. Logistic regression analysis was utilized to identify risk factors and calculate adjusted odds ratios (OR) for postoperative SSI. RESULTS: A total of 517 patients underwent LEB surgery over the study period. SSI was diagnosed in 120 (23.2%) patients over a median follow-up period of 1.5 years. The most common SSI locations were groin incision (40.0%), saphenectomy (31.7%), and leg incision (19.2%). Median onset of SSI was 18.5 d (interquartile range [IQR] 11-28 d) post-LEB surgery. Patients with SSI had higher body mass index (BMI) (28.2 [IQR 24.2-33.5] vs 26.6 [23.1-31.5] kg/m2, p=0.03) compared with non-SSI patients. Patient age, sex, and medical comorbidities were otherwise similar between groups. There were no differences in closure technique (79.2% vs 78.1% staples, 18.3% vs 19.7% Monocryl, 0.8% vs 1.8% Nylon, 1.7% vs 0.5% open; p=0.53) in SSI versus non-SSI groups. On multivariate analysis, patient BMI (OR 1.04 per unit, 95% confidence interval [CI] 1.01-1.08, p=0.02), reoperative field (OR 1.81, 95% CI 1.00-3.25, p=0.03), and active smoking (OR 2.72, 95% CI 1.12-6.59, p=0.048) were independently associated with increased SSI incidence. Postoperative SSI resulted in prolonged hospital length of stay (7 vs 6 days, p=0.04), unplanned hospital readmission (49.2% vs 12.3%, p<0.001), and reoperation rates (64.7% vs 8.1%, p<0.001). Bypass graft infection rates were also higher among patients suffering postoperative SSI (9.2% vs 0.0%, p<0.001). On subset analysis of patients at increased risk of postoperative SSI, as found on multivariate modelling, there were no differences in closure technique between SSI and no SSI groups. CONCLUSIONS: This study provides insights on wound closure techniques and postoperative SSI made available through granular, operative data not found in large database analyses. Surgical wound closure technique was not associated with postoperative SSI after LEB surgery, even among patients at increased risk of infection. These data support individualization of wound closure techniques among patients undergoing LEB surgery.

Association Between Device Type and Type IIIb Endoleaks Following Thoracic Endovascular Aortic Repair.

OBJECTIVE: Endoleaks following thoracic endovascular aortic repair (TEVAR) can lead to the need for re-intervention and aortic rupture. Given the recent recall of a specific thoracic stent graft type due to concerns about type IIIb endoleak (T3bE), in which blood leaks through the stent graft fabric, the aim was to characterise patterns of T3bEs among available TEVAR devices. METHODS: Reports related to thoracic stent grafts in the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between 2010 and 2020 were reviewed. Proportional reporting ratios (PRRs) and chi squared tests were used to assess for the presence of a signal of association between device type and T3bE. A PRR > 2 and chi squared value > 4 with three or more reports overall constituted a signal of association. The institutional database of patients undergoing TEVAR for thoracic aneurysms since 2002 was also queried for T3bE. RESULTS: There were 7 328 MAUDE reports available for analysis. When analysing T3bEs in the MAUDE database, the lowest PRR was 0.36 (95% confidence interval [CI] 0 - 1.03 in Gore CTAG, nine T3bE among 1 328 reports) and the highest was 2.07 (95% CI 1.72 - 2.42 in Medtronic Valiant, 64 T3bE among 2 520 reports). The T3bE chi squared value for Medtronic Valiant was 17.3. The relationship between Medtronic Valiant and T3bE was ascertainable by MAUDE data as early as 2013. Among 542 TEVARs for an aneurysm indication at Duke University Hospital since 2002, there were eight T3bEs - all in devices with sutured on graft material. CONCLUSION: The Medtronic Valiant device met criteria for association with type IIIb endoleaks in the FDA's MAUDE database and met those criteria as early as 2013. A possible relationship between woven graft fabric and T3bEs is supported by the observation that all types of T3bE that occurred among a large number of TEVARs at the institution followed placement of grafts with sutured on woven fabric.

Outcomes among patients with peripheral artery disease in the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study.

BACKGROUND: We aimed to understand the effects of aspirin dose on outcomes in patients with peripheral artery disease (PAD) as well as their participation in a pragmatic randomized controlled trial. METHODS: In a subanalysis of the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study, we compared aspirin doses (81 vs 325 mg) among participants with PAD and study participation metrics in patients with and without PAD. The primary outcome composite was all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke. RESULTS: Among 14,662 participants enrolled in ADAPTABLE with PAD status available, 3493 (23.8%) had PAD. Participants with PAD were more likely to experience the primary composite (13.76% vs 5.31%, p < 0.001), all-cause mortality (7.55% vs 3.01%, p < 0.001), myocardial infarction (5.71% vs 2.09%, p < 0.001), stroke (2.45% vs 0.86%, p < 0.001), and major bleeding (1.19% vs 0.44%, p < 0.001). A higher aspirin dose did not reduce the primary outcome in patients with PAD (13.68% vs 13.84% in 81 mg and 325 mg groups; OR 1.05, 95% CI 0.88-1.25). Participants with PAD were less likely to enroll via email (33.0% vs 41.9%, p < 0.0001), less likely to choose internet follow-up (79.2% vs 89.5%, p < 0.0001), and were more likely to change their aspirin doses (39.7% vs 30.7%, p < 0.0001). CONCLUSIONS: ADAPTABLE participants with PAD did not benefit from a higher dose of aspirin and participated in the study differently from those without PAD. These results reinforce the need for additional PAD-specific research and suggest that different trial strategies may be needed for optimal engagement of patients with PAD. (ClinicalTrials.gov Identifier: NCT02697916).

A Systematic Review of Clopidogrel Resistance in Vascular Surgery: Current Perspectives and Future Directions.

BACKGROUND: Clopidogrel resistance is a well-described phenomenon that has been linked to adverse cardiovascular events in patients with coronary artery disease. The impact of clopidogrel resistance in patient outcomes after vascular and endovascular surgery is not well-established. METHODS: Using preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, a literature review with the medical subject headings (MeSH) terms "(clopidogrel resistance) and (vascular)", "(clopidogrel resistance) and (vascular surgery)", "(clopidogrel resistance) and (endovascular)", and "(clopidogrel resistance) and (endovascular surgery)" was performed in PubMed and Cochrane databases, to identify all peer-reviewed studies performed on clopidogrel resistance in vascular and endovascular surgery. Studies written in the English language from inception to 2022 were included. Case reports, studies with limited information, nonhuman studies, and studies not pertaining to vascular or endovascular surgery were excluded from analysis. Each study was independently reviewed by 2 qualified researchers to assess eligibility. RESULTS: Of the 691 studies identified through the MeSH strategy, 16 studies met the inclusion criteria and were reviewed and summarized. These studies focused on extracranial cerebrovascular disease (n = 5) and peripheral arterial disease (PAD, n = 11), encompassing a total of 1,716 patients. The prevalence of clopidogrel resistance ranged from 0% to 83.3%, depending on the diagnostic assay and cutoff values used. In cerebrovascular disease, clopidogrel resistance may be associated with cerebral embolization, ischemic neurologic events, and vascular-related mortality. In PAD, clopidogrel resistance has been linked to recurrent stent thrombosis, target lesion revascularization, amputation-free survival, and all-cause mortality. CONCLUSIONS: This systematic review provides an up-to-date summary of clopidogrel resistance in vascular and endovascular surgery. The impact of clopidogrel resistance remains incompletely investigated, and future studies are needed to clarify the role of resistance testing in patients with vascular disease.

Restoring Venous Patency with the ClotTriever Following Deep Vein Thrombosis.

BACKGROUND: Although randomized data remain inconclusive, invasive endovenous therapy is increasingly favored in patients with extensive iliocaval or iliofemoral deep vein thrombosis (DVT) to reduce the rates of postthrombotic syndrome. Previously, pharmacomechanical thrombectomy was the therapy of choice, but the Inari ClotTriever device is an appealing, purely mechanical, alternative. It may reduce bleeding risk, intensive care unit admission, and the need for multiple procedures when compared with traditional thrombolysis. We present a series of 18 patients treated with the ClotTriever for extensive iliocaval or iliofemoral DVT. METHODS: The Inari ClotTriever is a percutaneous mechanical thrombectomy system consisting of an expandable nitinol collection bag that is dragged along the vein wall, separating and capturing thrombus for collection into the retrieval sheath. We retrospectively reviewed all patients undergoing ClotTriever thrombectomy since the device became available at our quaternary referral center in June 2019. The review of these patients' records was determined to be exempt by our institutional review board. RESULTS: Eighteen patients underwent ClotTriever thrombectomy between June 2019 and November 2021. Most patients (N = 16, 89%) presented within 2 weeks of symptom onset, and identifiable provoking factors were present in all patients. The most common provoking factor was anatomy, with May-Thurner syndrome present in 8 patients. All patients had restoration of unimpeded venous flow in the treated segments, although 3 had some residual nonflow limiting thrombus. There were no bleeding events or repeat venous procedures. The median postprocedure length of stay of 2 days. Postoperative venous imaging was performed in 15 patients and showed patency of the treated segment in 14 patients. Revised Clinical Venous Severity Scores were available in 14 patients during the course of follow-up. Of these, 9 patients' highest scores were 0, 2 patients' highest scores were 2, 2 patients' highest scores were 4, and 1 patient had a high score of 8. CONCLUSIONS: Venous flow was re-established in all 18 patients treated with the ClotTriever in this series, with no bleeding complications, and median postprocedure length of stay of 2 days. All patients with available follow-up, except 1, retained patency of the treated venous segments, and most had mild postthrombotic syndrome or none at all. These findings suggest that the ClotTriever is a safe and effective way to treat extensive iliocaval/femoral DVT.

Preoperative Anemia is Associated with Poorer Postoperative Outcomes in Patients Undergoing Infrainguinal Bypass Surgery.

BACKGROUND: Preoperative anemia is an important, modifiable risk factor among surgical patients. However, data are scarce on the impact of preoperative anemia on postoperative outcomes after infrainguinal bypass. METHODS: In this multi-institutional analysis, data were retrospectively collected on all infrainguinal bypass procedures performed between 2010 and 2020. Patients were grouped by preoperative hemoglobin as per the National Cancer Institute anemia scale (mild, 10 g/dL-lower limit of normal; moderate, 8.0-9.9 g/dL; severe, 6.5-7.9 g/dL). Multivariable comparisons were performed using logistic regression analysis. RESULTS: A total of 492 patients underwent bypass for peripheral artery disease over the 10-year study period. Median preoperative hemoglobin was 11.0 g/dL (interquartile range 9.5-12.7) and median follow-up was 1.7 years. Preoperative anemia was prevalent among bypass patients (mild 52.4% [n = 258], moderate 26.4% [n = 130], and severe 5.1% [n = 25]). Women were more likely to have moderate (49.2% [women] vs. 50.8% [men]) or severe anemia (52.0% [women] vs. 48.0% [men]) compared with normal hemoglobin (17.7% [women] vs. 82.3% [men]) (P < 0.001). Patients with preoperative anemia were more likely to present with tissue loss (22.8% [normal] vs. 47.7% [moderate] vs. 52.0% [severe], P = 0.01). Bypass target and conduit types were similar between groups. Anemic patients had longer median hospital length of stay compared with nonanemic patients (4 days [normal] vs. 5 days [mild] vs. 6 days [moderate] vs. 7 days [severe], P < 0.001). Postoperative mortality at 30 days was similar across anemia groups (2.5% [normal] vs. 4.6% [moderate] vs. 8.0% [severe], P = 0.23). On multivariable analysis, however, postoperative mortality was independently associated with severe anemia (odds ratio 7.5 [1.2-48.8], P = 0.04) and male gender (odds ratio 7.5 [1.2-26.4], P = 0.03). CONCLUSIONS: Preoperative anemia is common among patients undergoing infrainguinal bypass surgery and is an independent risk factor for postoperative mortality. Future investigation is needed to determine whether correction of anemia improves postoperative outcomes in these high-risk patients.

Impact of risk factor control on peripheral artery disease outcomes and health disparities.

BACKGROUND: Peripheral artery disease (PAD) is associated with modifiable atherosclerotic risk factors like hypertension, diabetes, hyperlipidemia, and smoking. However, the effect of risk factor control on outcomes and disparities in achieving control is less well understood. METHODS: All patients in an integrated, regional health system with PAD-related encounters, fee-for-service Medicare, and clinical risk factor control data were identified. Component risk factors were dichotomized into controlled and uncontrolled categories (control defined as low-density lipoprotein < 100 mg/dL, hemoglobin A1c < 7.0%, SBP < 140 mmHg, and current nonsmoker) and composite categories (none, 1, ⩾ 2 uncontrolled RFs) created. The primary outcome was major adverse vascular events (MAVE, a composite of all-cause mortality, myocardial infarction, stroke, and lower-extremity revascularization and amputation). RESULTS: The cohort included 781 patients with PAD, average age 72.5 ± 9.8 years, of whom 30.1% were Black, and 19.1% were Medicaid dual-enrolled. In this cohort, 260 (33.3%) had no uncontrolled risk factors and 200 (25.6%) had two or more uncontrolled risk factors. Patients with the poorest risk factor control were more likely to be Black (p < 0.001), Medicaid dual-enrolled (p < 0.001), and have chronic limb-threatening ischemia (p = 0.009). Significant differences in MAVE by degree of risk factor control were observed at 30 days (none uncontrolled: 5.8%, 1 uncontrolled: 11.5%, ⩾ 2 uncontrolled: 13.6%; p = 0.01) but not at 1 year (p = 0.08). risk factor control was not associated with outcomes at 1 year after adjustment for patient and PAD-specific characteristics. CONCLUSIONS: risk factor control is poor among patients with PAD. Significant disparities in achieving optimal risk factor control represent a potential target for reducing inequities in outcomes.

Younger patients with chronic limb threatening ischemia face more frequent amputations.

INTRODUCTION: Amputations among younger patients with chronic limb threatening ischemia (CLTI) may carry higher personal and societal costs, but younger patients are often not included in CLTI research because of dataset limitations. We aimed to characterize and compare outcomes between younger (<65 years old) and older patients with CLTI. METHODS: This retrospective cohort study identified patients with CLTI between July 1, 2014 and December 31, 2017 in the MarketScan commercial claims database, a proprietary set of claims for over 50 million patients with private insurance in the United States. The primary outcome was major adverse limb events (MALE); secondary outcomes included amputations, major adverse cardiovascular events, and statin prescription fills. RESULTS: The study cohort included 64,663 people with CLTI, of whom 25,595 (39.6%) were <65 years old. Younger patients were more likely to have diabetes mellitus (54.1% versus 49.9%, P<.001) but less likely to have other comorbidities. A higher proportion of younger patients suffered MALE (31.7% versus 30.2%, P=.002), specifically amputation (11.5% versus 9.3%, P<.001). After adjustment, age <65 years old was associated with a 24% increased risk of amputation (HRadj 1.24, 95%CI 1.18-1.32, P<.001) and a 10% increased risk of MALE (HRadj 1.10, 95%CI 1.07-1.14, P<.001). CONCLUSIONS: A significant proportion of commercially insured patients with CLTI are under the age of 65, and younger patients have worse limb-related outcomes. These findings highlight the importance of aggressively treating risk factors for atherosclerosis and intentionally including younger patients with CLTI in future analyses to better understand their disease patterns and outcomes.

The association of healthcare disparities and patient-specific factors on clinical outcomes in peripheral artery disease.

BACKGROUND: PAD increases the risk of cardiovascular mortality and limb loss, and disparities in treatment and outcomes have been described. However, the association of patient-specific characteristics with variation in outcomes is less well known. METHODS: Patients with PAD from Duke University Health System (DUHS) between January 1, 2015 and March 31, 2016 were identified. PAD status was confirmed through ground truth adjudication and predictive modeling using diagnosis codes, procedure codes, and other administrative data. Symptom severity, lower extremity imaging, and ankle-brachial index (ABI) were manually abstracted from the electronic health record (EHR). Data was linked to Centers for Medicare and Medicaid Services data to provide longitudinal follow up. Primary outcome was major adverse vascular events (MAVE), a composite of all-cause mortality, myocardial infarction (MI), stroke, lower extremity revascularization and amputation. RESULTS: Of 1,768 patients with PAD, 31.6% were asymptomatic, 41.2% had intermittent claudication (IC), and 27.3% had chronic limb-threatening ischemia (CLTI). At 1 year, patients with CLTI had higher rates of MAVE compared with asymptomatic or IC patients. CLTI and Medicaid dual eligibility were independent predictors of mortality. CLTI and Black race were associated with amputation. CONCLUSIONS: Rates of MAVE were highest in patients with CLTI, but patients with IC or asymptomatic disease also had high rates of adverse events. Black and Medicaid dual-eligible patients were disproportionately present in the CLTI subgroup and were at higher risk of amputation and mortality, respectively. Future studies must focus on early identification of high-risk patient groups to improve outcomes in patients with PAD.

Predicting major adverse limb events in individuals with type 2 diabetes: Insights from the EXSCEL trial.

AIMS: Although models exist to predict amputation among people with type 2 diabetes with foot ulceration or infection, we aimed to develop a prediction model for a broader range of major adverse limb events (MALE)-including gangrene, revascularization and amputation-among individuals with type 2 diabetes. METHODS: In a post-hoc analysis of data from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial, we compared participants who experienced MALE with those who did not. A multivariable model was constructed and translated into a risk score. RESULTS: Among the 14,752 participants with type 2 diabetes in EXSCEL, 3.6% experienced MALE. Characteristics associated with increased risk of MALE were peripheral artery disease (PAD) (HRadj 4.83, 95% CI: 3.94-5.92), prior foot ulcer (HRadj 2.16, 95% CI: 1.63-2.87), prior amputation (HRadj 2.00, 95% CI: 1.53-2.64), current smoking (HRadj 2.00, 95% CI: 1.54-2.61), insulin use (HRadj 1.86, 95% CI: 1.52-2.27), coronary artery disease (HRadj 1.67, 95% CI: 1.38-2.03) and male sex (HRadj 1.64, 95% CI: 1.31-2.06). Cerebrovascular disease, former smoking, age, glycated haemoglobin, race and neuropathy were also associated significantly with MALE after adjustment. A risk score ranging from 6 to 96 points was constructed, with a C-statistic of 0.822 (95% CI: 0.803-0.841). CONCLUSIONS: The majority of MALE occurred among participants with PAD, but participants without a history of PAD also experienced MALE. A risk score with good performance was generated. Although it requires validation in an external dataset, this risk score may be valuable in identifying patients requiring more intensive care and closer follow-up.

Successful Peripheral Vascular Intervention in Patients with High-risk Comorbidities or Lesion Characteristics.

PURPOSE OF REVIEW: Certain comorbidities and lesion characteristics are associated with increased risk for procedural complications, limb events, and cardiovascular events following peripheral vascular intervention (PVI) in patients with peripheral arterial disease (PAD). The purpose of this review is to provide an overview of high-risk modifiable and unmodifiable patient characteristics and its relative impact on clinical outcomes such as amputation risk and mortality. Furthermore, general approaches to potentially mitigating these risks through pre-intervention planning and use of modern devices and techniques are discussed. RECENT FINDINGS: Diabetes, tobacco use, and older age remain strong risk factors for the development of peripheral arterial disease. Recent data highlight the significant risk of polyvascular disease on major limb and cardiac events in advanced PAD, and ongoing studies are assessing this risk specifically after PVI. Challenging lesion characteristics such as calcified disease and chronic total occlusions can be successfully treated with PVI by utilizing novel devices (e.g., intravascular lithotripsy, re-entry devices) and techniques (e.g., subintimal arterial "flossing" with antegrade-retrograde intervention). Understanding high-risk patient comorbidities and lesion characteristics will improve our ability to counsel and manage patients with advanced PAD. Continued device innovation and novel techniques will aid in procedural planning for successful interventions to improve clinical outcomes.

The Association of Accessory Auricular Tissue With Solid Organ Abnormalities and Its Effect on Auditory and Vestibular Function.

BACKGROUND: Accessory auricular tissue is a common congenital anomaly ranging from an accessory skin appendage to a separate pinna. The association between auditory or vestibular dysfunction and accessory auricular tissue is debated, and little is known about related solid organ abnormalities. We examine the prevalence of accessory auricular tissue, its association between solid organ abnormalities and auditory/vestibular dysfunction, and its management. METHODS: A retrospective cohort study was performed using the 2000 to 2012 HCUP kids' inpatient database. Live newborns with a diagnosis of accessory auricle were included. RESULTS: Of the 19,638,453 births recorded between 2000 and 2012, 0.13% had accessory auricular tissue (n = 25,802); 11.8% underwent excision or destruction of the tissue during birth admission. Newborns with this diagnosis were more likely to receive auditory and vestibular testing (5% vs 4.2%, P < 0.001; 5.5% vs 5%, P < 0.001) and to be diagnosed with abnormal auditory function (1.2% vs 0.5%, P < 0.001) and hearing loss (0.09% vs 0.02%, P < 0.001). Diagnosis of auditory impairment had a 3-fold higher odds of surgical management during birth stay (odds ratio, 3.12; 95% confidence interval, 1.826-5.339). Although none were diagnosed with vestibular dysfunction, patients with accessory auricular tissue were 1.5-fold to 3-fold more likely to have cardiac malformations and 4-fold more likely to have renal anomalies. CONCLUSIONS: Newborns with accessory auricular tissue more frequently undergo auditory and vestibular testing during birth stay. Auditory dysfunction, cardiac malformations, and renal anomalies are more frequently diagnosed in patients with accessory auricular tissue. However, none were diagnosed with vestibular impairment, bringing into question the necessity of vestibular testing.

Neonatal Micrognathia: National Trends in Early Mandibular Surgery.

BACKGROUND: Micrognathia is a congenital anomaly that may pose breathing and feeding limitations in newborns, sometimes necessitating invasive management. The present study aims to identify the complications associated with receiving mandibular surgery during the birth stay in order to better predict which patients may benefit from early surgical intervention. METHODS: A retrospective cohort study was performed using the 2000 to 2012 kids' inpatient databases. We included all live newborn infants born in the hospital through vaginal delivery or caesarean section. We used multivariate logistic regression to investigate the demographic and clinical factors associated with receiving mandibular surgery for micrognathia during the birth stay. RESULTS: Of 19,638,453 births, 999 were diagnosed with micrognathia (0.005%). Forty (4%) patients with micrognathia underwent mandibular surgery during the initial admission. On univariate analysis in newborns with micrognathia, mandibular surgery during birth stay was associated with cleft palate, apnea, intubation, tracheostomy, obstructive sleep apnea (OSA), and long mechanical ventilation. Multivariate analysis supported the association between mandibular surgery during the initial admission and long mechanical ventilation (odds ratio [OR], 24.6; 95% confidence interval [CI], 7.7-78.5), OSA (OR, 24.9; 95% CI, 2.5-261.8), apnea (OR, 4.2; 95% CI, 1.5-11.3), and cleft palate (OR, 4.6; 95% CI, 2.0-10.6). However, intubation and tracheostomy were not found to be associated with early mandibular surgery during the birth stay. CONCLUSIONS: The present study identified long mechanical ventilation, apnea, cleft palate, and OSA as factors indicating patients who may benefit from early mandibular surgery, such as mandibular distraction osteogenesis. These findings may bring the clinician closer to standardizing the indications for early mandibular distraction osteogenesis.

The Necessity of the Nipple: Redefining Completeness in Breast Reconstruction.

INTRODUCTION: Satisfaction with breast reconstruction is thought to be greatest among patients who complete nipple and areolar complex (NAC) reconstruction. Anecdotally, many patients are known to decline NAC reconstruction. The authors aimed to characterize the epidemiology of and factors associated with incomplete breast reconstruction. METHODS: Breast reconstruction patients with follow-up in a single institution's electronic medical record system were reviewed. Chi-squared and independent t-tests were used to identify variables associated with lack of NAC reconstruction; associated variables (P < 0.05) were used to build a binary logistic regression. RESULTS: Four hundred thirty-three patients were reviewed. Reconstructions consisted of an average of 4.0 ± 2.0 procedures over 503 (range, 2-3,652) days. One hundred twelve patients had NAC reconstruction or tattooing (25.9%) and 73 (17.6%) had both-226 women (54.6%) had neither. On multivariate analysis, a history of any implant removal was associated with a 93.4% decreased chance of NAC reconstruction (P = 0.002), whereas prophylactic or early-stage mastectomy was associated with 52.9% increased chances of NAC reconstruction (P = 0.009). CONCLUSIONS: Over half of the present cohort did not complete any NAC reconstruction. Patients with later-stage cancer and a history of implant removal were less likely to have NAC reconstruction. The high prevalence of incomplete reconstructions suggests that the classical definition of breast reconstruction completion as requiring NAC reconstruction may be outdated or not applicable to all populations. Instead, "completion" should be considered a subjective determination varying between patients.

Reconstructive Surgery in Times of Conflict.

BACKGROUND: Smile Train is a charitable organization that partners with and trains surgeons in developing countries to provide surgical care to patients with cleft lip/palate deformities. The organization supports surgeries in several countries that experience high levels of regional conflict and violence. Nigeria, a country where Smile Train is very active, has undergone numerous periods of extreme violence over the past 12 years. The purpose of the present study is to analyze how local violence and conflict have impacted the ability of surgeons partnered with Smile Train to provide care in Nigeria. METHODS: The authors retrospectively reviewed Smile Train Express, the organization's database, from 2003 to 2015 for cleft lip/palate repairs performed in Nigeria. The data was chronologically mapped against a detailed timeline of incidents of violence in Nigeria to compare how violence affected the work of Smile Train-affiliated surgeons. RESULTS: Smile Train-affiliates facilitated 11,499 surgeries in Nigeria from 2003 to 2015. During the same period, 46,370 people were killed in Nigeria in acts of terrorism and violence. Major drops in the frequency of cleft surgeries were preceded by spikes in violence. CONCLUSIONS: Violence in Nigeria has had a clear impact on the ability of Smile Train-affiliated surgeons to provide adequate cleft care. The international medical community needs to take steps in an attempt to continue to provide essential medical care in areas of conflict and instability.