Implications of the Centers for Medicare and Medicaid Services (CMS) decision to expand indications for carotid artery stenting.

OBJECTIVE: On October 11, 2023, the Centers for Medicare and Medicaid Services (CMS) expanded the indications for carotid artery stenting (CAS) to include patients with ≥50% symptomatic or ≥70% asymptomatic carotid stenosis. The aim of this article was to investigate the implications of this decision. METHODS: The reasons behind the increased coverage for CAS are analyzed and discussed, as well as the various Societies supporting or opposing the expansion of indications for CAS. RESULTS: The benefits associated with expanding CAS indications include providing an additional therapeutic option to patients and enabling individualization of treatment according to patient-specific characteristics. The drawbacks of expanding CAS indications include a possible bias in decision-making and an increase in inappropriate CAS procedures. CONCLUSIONS: The purpose of the CMS recommendation to expand indications for CAS is to improve the available therapeutic options for patients. Hopefully this decision will not be misinterpreted and will be used to improve patient options and patient outcomes.

Comparison of Patient Outcomes Among Integrated Residency Versus Fellowship-trained Vascular Surgeons.

OBJECTIVE: This study aims to evaluate whether graduates of integrated vascular surgery residency (IVSR) programs achieve similar surgical outcomes in clinical practice as compared to graduates of vascular surgery fellowships (VSF). SUMMARY OF BACKGROUND DATA: Early sub-specialization through IVSR programs decreases the total years of surgical training. However, it is unclear whether IVSR graduates achieve comparable outcomes to fellowship-trained surgeons once in clinical practice. METHODS: We identified all vascular surgeons who finished IVSR and VSF programs between 2013-2017 using American Board of Surgery data, which was linked to the Vascular Quality Initiative registry (2013-2019) to evaluate provider-specific clinical outcomes following carotid, lower extremity, and aortic aneurysm repair procedures. The association between training models and the composite outcome of 1-year mortality, major adverse cardiac events and/or other major complications were analyzed using mixed-effects logistic regression models. RESULTS: A total of 338 surgeons (31% IVSR, 69% VSF) submitted cases into the Vascular Quality Initiative registry, including 8155 carotid, 21,428 lower extremity, and 5800 aortic aneurysm repair procedures. Composite 1-year outcome rates were comparable between IVSR and VSF-trained surgeons following carotid endarterectomy (8%-IVSR vs 7%-VSF), lower extremity revascularization (19%-IVSR vs 16%-VSF), and aortic aneurysm repair (13%-IVSR vs 13%-VSF) procedures. These findings among IVSR-trained surgeons persisted following risk adjustment for severity of patient disease and indications for undertaking carotid [aOR: 1.04 (0.84-1.28)], lower extremity [aOR: 1.03 (0.84-1.26)], and aortic [aOR: 0.96 (0.76-1.21)] procedures when compared to VSF-trained surgeons. CONCLUSIONS: Despite fewer total years of training, graduates of IVSR programs achieve equivalent surgical outcomes as fellowship-trained vascular surgeons once in practice. These results suggest that concerns about differential competence among integrated residency graduates are not warranted.

Implementation of the Vascular Surgery Board virtual certifying examination.

OBJECTIVE: The onset of the COVID-19 (coronavirus disease 2019) pandemic mandated postponement of the in-person Vascular Surgery Board 2020 certifying examination (CE). Vascular surgery virtual CEs (VVCEs) were developed for the scheduled 2020 CEs (rescheduled to January 2021) and 2021 CEs (rescheduled to July 2021) to avoid postponing the certification testing. In the present study, we have reported the development, implementation, and outcomes of the first two VVCEs. METHODS: The VVCE was similar to the in-person format (three 30-minutes sessions, two examiners, four questions) but required a proctor and a host. In contrast to the general surgery VCEs, the VVCE also incorporated images. The candidates and examiners were instructed on the format, and technology checks were performed before the VVCE. The candidates were given the opportunity to invalidate their examination for technology-related reasons immediately after the examination. Postexamination surveys were administered to all the participants. RESULTS: The VVCEs were completed by 356 of 357 candidates (99.7%). The pass rates for the January 2021 and July 2021 examinations were 97.6% (first time, 99.4%; retake, 70%) and 94.7% (first time, 94.6%; retake, 100%), respectively. The pass rates were not significantly different from the 2019 in-person CE (χ2 = 2.30; P = .13; and χ2 = 0.01; P = .91, for the January 2021 and July 2021 examinations, respectively). None of the candidates had invalidated their examination. The candidates (162 of 356; 46%), examiners (64 of 118; 54%), proctors (25 of 27; 93%), and hosts (8 of 9; 89%) completing the survey were very satisfied with the examination (Likert score 4 or 5: candidates, 92.6%; noncandidates, 96.9%) and found the technology domains (Zoom, audio, video, viewing images) to be very good (Likert score 4 or 5), with candidate and other responder scores of 73% to 84% and >94%, respectively. Significantly more of the candidates had favored a future VVCE compared with the examiners (87% vs 32%; χ2 = 67.1; P < .001). The free text responses from all responders had commented favorably on the organization and implementation of the examination. However, some candidates had expressed concerns about image sizes, and some examiners had expressed concern about the time constraints for the question format. The candidates appreciated the convenience of an at-home examination, especially the avoidance of travel costs. CONCLUSIONS: The two Vascular Surgery Board VCEs were shown to be psychometrically sound and were overwhelmingly successful, demonstrating that image-based virtual examinations are feasible and could become the standard for the future.

Index atherectomy peripheral vascular interventions performed for claudication are associated with more reinterventions than nonatherectomy interventions.

OBJECTIVE: Despite limited evidence supporting atherectomy alone over stenting/angioplasty as the index peripheral vascular intervention (PVI), the use of atherectomy has rapidly increased in recent years. We previously identified a wide distribution of atherectomy practice patterns among US physicians. The aim of this study was to investigate the association of index atherectomy with reintervention. METHODS: We used 100% Medicare fee-for-service claims to identify all beneficiaries who underwent elective first-time femoropopliteal PVI for claudication between January 1, 2019, and December 31, 2019. Subsequent PVI reinterventions were examined through June 30, 2021. Kaplan-Meier curves were used to compare rates of PVI reinterventions for patients who received index atherectomy versus nonatherectomy procedures. Reintervention rates were also described for physicians by their overall atherectomy use (by quartile). A hierarchical Cox proportional hazard model was used to evaluate patient and physician-level characteristics associated with reinterventions. RESULTS: A total of 15,246 patients underwent an index PVI for claudication in 2019, of which 59.7% were atherectomy. After a median of 603 days (interquartile range, 77-784 days) of follow-up, 41.2% of patients underwent a PVI reintervention, including 48.9% of patients who underwent index atherectomy versus 29.8% of patients who underwent index nonatherectomy (P < .001). Patients treated by high physician users of atherectomy (quartile 4) received more reinterventions than patients treated by standard physician users (quartiles 1-3) (56.8% vs 39.6%; P < .001). After adjustment, patient factors association with PVI reintervention included receipt of index atherectomy (adjusted hazard ratio [aHR], 1.33; 95% confidence interval [CI], 1.21-1.46), Black race (vs White; aHR; 1.18; 95% CI, 1.03-1.34), diabetes (aHR, 1.13; 95% CI, 1.07-1.21), and urban residence (aHR, 1.11; 95% CI, 1.01-1.22). Physician factors associated with reintervention included male sex (aHR, 1.52; 95% CI, 1.12-2.04), high-volume PVI practices (aHR, 1.23; 95% CI, 1.10-1.37), and physicians with a high use of index atherectomy (aHR, 1.49; 95% CI, 1.27-1.74). Vascular surgeons had a lower risk of PVI reintervention than cardiologists (vs vascular; aHR, 1.22; 95% CI, 1.09-1.38), radiologists (aHR, 1.55; 95% CI, 1.31-1.83), and other specialties (aHR, 1.59; 95% CI, 1.20-2.11). The location of services delivered was not associated with reintervention (P > .05). CONCLUSIONS: The use of atherectomy as an index PVI for claudication is associated with higher PVI reintervention rates compared with nonatherectomy procedures. Similarly, high physician users of atherectomy perform more PVI reinterventions than their peers. The appropriateness of using atherectomy for initial treatment of claudication needs critical reevaluation.

The vascular surgery in-training examination predicts performance on qualifying examination.

OBJECTIVE: Vascular surgery trainees participate in the vascular surgery in-training examination (VSITE) during each year of their training. Although the VSITE was developed as a low-stakes, formative examination, performance on that examination might correlate with the pass rates for the Vascular Surgery Board written qualifying examination (VQE) and oral certifying examination (VCE) and might, therefore, guide both trainees and program directors. The present study was designed to examine the ability of the VSITE to predict trainees' performance on the VQE and VCE. METHODS: All first-time candidates of the Vascular Surgery Board VQE and VCE were analyzed from 2016 to 2020, including those from both the integrated and independent training pathways. VSITE scores from the final year of training were associated with the VQE scores and the probability of passing the VQE and VCE both. Linear and logistic regression models were used to determine the ability of VSITE results to predict the VQE scores and the probability of passing each board examination. RESULTS: VSITE scores available for the 559 candidates (69.3% male; 30.7% female) who had completed the VQE and 369 candidates (66.7% male; 33.3% female) who had completed both the VQE and the VCE. The linear regression model results for the final year of training showed that the VSITE scores explained 34% of the variance in the VQE scores (29% for the integrated and 37% for the independent trainees). Logistic regression demonstrated that the final year VSITE scores were a significant predictor of passing the VQE for both integrated and independent trainees (P < .001). A VSITE score of 500 during the final year of training predicted a VQE passing probability of >90% for each group of candidates. The probability of passing the VQE decreased to 73% for candidates from integrated programs, 61% for candidates from independent programs, and 64% for the whole cohort when the score was 400. The VSITE scores were a significant predictor of passing the VCE only for the candidates from independent programs (odds ratio, 1.01; 95% confidence interval, 1.00-1.02; P < .01), for whom a VSITE score of 400 correlated with an 82% probability of passing the VCE. CONCLUSIONS: VSITE performance is predictive of passing the VQE for trainees from both integrated and independent training paradigms. Vascular surgery trainees and training programs should optimize their preparation and educational efforts to maximize performance on the VSITE during their final year of training to improve the likelihood of passing the VQE. Further analysis of the predictive value of VSITE scores during the earlier years of training might allow the board certification examinations to be administered earlier in the final year of training.

Society for Vascular Surgery clinical practice guidelines for management of extracranial cerebrovascular disease.

Management of carotid bifurcation stenosis in stroke prevention has been the subject of extensive investigations, including multiple randomized controlled trials. The proper treatment of patients with carotid bifurcation disease is of major interest to vascular surgeons and other vascular specialists. In 2011, the Society for Vascular Surgery published guidelines for the treatment of carotid artery disease. At the time, several randomized trials, comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS), were reported. Since the 2011 guidelines, several studies and a few systematic reviews comparing CEA and CAS have been reported, and the role of medical management has been reemphasized. In the present publication, we have updated and expanded on the 2011 guidelines with specific emphasis on five areas: (1) is CEA recommended over maximal medical therapy for low-risk patients; (2) is CEA recommended over transfemoral CAS for low surgical risk patients with symptomatic carotid artery stenosis of >50%; (3) the timing of carotid intervention for patients presenting with acute stroke; (4) screening for carotid artery stenosis in asymptomatic patients; and (5) the optimal sequence of intervention for patients with combined carotid and coronary artery disease. A separate implementation document will address other important clinical issues in extracranial cerebrovascular disease. Recommendations are made using the GRADE (grades of recommendation assessment, development, and evaluation) approach, as was used for other Society for Vascular Surgery guidelines. The committee recommends CEA as the first-line treatment for symptomatic low-risk surgical patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 70% to 99%. The perioperative risk of stroke and death in asymptomatic patients must be <3% to ensure benefit for the patient. In patients with recent stable stroke (modified Rankin scale score, 0-2), carotid revascularization is considered appropriate for symptomatic patients with >50% stenosis and should be performed as soon as the patient is neurologically stable after 48 hours but definitely <14 days after symptom onset. In the general population, screening for clinically asymptomatic carotid artery stenosis in patients without cerebrovascular symptoms or significant risk factors for carotid artery disease is not recommended. In selected asymptomatic patients with an increased risk of carotid stenosis, we suggest screening for clinically asymptomatic carotid artery stenosis as long as the patients would potentially be fit for and willing to consider carotid intervention if significant stenosis is discovered. For patients with symptomatic carotid stenosis of 50% to 99%, who require both CEA and coronary artery bypass grafting, we suggest CEA before, or concomitant with, coronary artery bypass grafting to potentially reduce the risk of stroke and stroke/death. The sequencing of the intervention depends on the clinical presentation and institutional experience.

Drug-Eluting Stents are Associated with Superior Mid-Term Outcomes for the Treatment of Infrainguinal Bypass Graft Stenoses.

BACKGROUND: We previously demonstrated that everolimus drug-eluting stents (eDES) have reasonable short-term patency for the treatment of infrainguinal bypass stenoses. The aim of this study is to compare mid-term outcomes of eDES, plain balloon angioplasty (PTA), percutaneous cutting balloon (PCB), and drug-coated balloon (DCB) interventions for failing infrainguinal bypasses. METHODS: We conducted a retrospective review of patients with infrainguinal bypass stenoses treated by endovascular intervention (August 2010-August 2021). The primary outcome was primary patency (PP). Secondary outcomes were primary-assisted patency (PAP), secondary patency (SP), limb salvage (LS), and mortality. Outcomes were compared by treatment using Kaplan-Meier curves with log-rank tests and Cox proportional hazards models adjusting for baseline differences between groups. RESULTS: Seventy-two consecutive patients with 152 discrete infrainguinal bypass graft stenoses were identified. Mean age was 65.1 ± 10.6 years, 55.6% were male, and 48.6% were Black. In total, 81.9% of patients were originally treated for chronic limb-threatening ischemia, and 57.2% of distal anastomoses were to tibial or pedal targets. Of 152 lesions, 44.1% (n = 67) were treated with PTA, 17.8% (n = 27) with PCB, 20.4% (n = 31) with DCB, and 17.8% (n = 27) with eDES. Median follow-up was 28.5 months (interquartile range 11.5-51.9). There was no difference in bypass configuration, conduit choice, or stenosis location (proximal anastomosis, mid-bypass, distal anastomosis) between groups. At 24 months postintervention, PP was significantly better for eDES (72.9%, 95% confidence interval [CI] 49.8-85.6), followed by PCB (55.9%, 95% CI 34.2-72.9), PTA (34.4%, 95% CI 21.7-47.4), and DCB (33.6%, 95% CI 14.5-53.9) (P = 0.03). PAP, LS, and mortality did not significantly differ between modalities (P > 0.05). After risk adjustment, eDES was associated with the lowest risk of PP loss (hazard ratio versus PTA 0.15, 95% CI 0.05-0.47). CONCLUSIONS: eDES is associated with superior 24-month patency rates compared to other endovascular technologies, and should be considered a primary therapy modality for the treatment of infrainguinal bypass graft stenoses.

Race and socioeconomic differences associated with endovascular peripheral vascular interventions for newly diagnosed claudication.

BACKGROUND: Despite guidelines cautioning against the use of endovascular peripheral vascular interventions (PVI) for claudication, more than 1.3 million PVI procedures are performed annually in the United States. We aimed to describe national rates of PVI for claudication, and identify patient and county-level risk factors associated with a high rate of PVI. METHODS: We used the Medicare claims database to identify all Medicare beneficiaries with a new diagnosis of claudication between January 2015 and June 2017. A hierarchical logistic regression model accounting for patient age, sex, comorbidities; county region and setting; and a patient race-county median income interaction was used to assess the associations of race and income with a high PVI rate. RESULTS: We identified 1,201,234 patients with a new diagnosis of claudication for analysis. Of these, 15,227 (1.27%) underwent a PVI. Based on hierarchical logistic regression accounting for patient and county-level factors, black patients residing in low-income counties had a significantly higher odds of undergoing PVI than their white counterparts (odds ratio [OR], 1.30; 95% confidence interval [CI], 1.20-1.40), whereas the odds of PVI for black versus white patients was similar in high-income counties (OR, 1.06; 95% CI, 0.99-1.14). PVI rates were higher for low versus high-income counties in both the black (OR, 1.46; 95% CI, 1.31-1.64) and white (OR, 1.19; 95% CI, 1.12-1.27) groups. There were no significant associations of Hispanic, Asian, North American native, or other races with PVI in either low- or high-income counties after risk adjustment (all P ≥ .09). CONCLUSIONS: In the Medicare population, the mean rate of PVI of 12.7 per 1000 claudication patients varies significantly based on race and income. Our data suggest there are racial and socioeconomic differences in the treatment of claudication across the United States.

Drug-eluting stents are associated with improved outcomes for the treatment of infrainguinal bypass graft stenoses.

BACKGROUND: Existing endovascular therapies for failing infrainguinal bypass grafts are associated with modest patency rates. The use of everolimus drug-eluting stents (eDESs) for endovascular bypass graft revision has not yet been reported. The objective of this study was to describe and to compare clinical outcomes of eDESs vs percutaneous cutting balloons (PCBs) vs percutaneous transluminal angioplasty (PTA) for the treatment of infrainguinal bypass graft stenoses. METHODS: A multicenter, single-institution retrospective analysis of patients with infrainguinal bypass graft stenoses treated by endovascular intervention (August 2010-December 2017) was conducted. The primary study outcome was primary patency of the treated lesion. The secondary outcome was limb salvage. Outcomes are described overall and stratified by endovascular treatment modality using Kaplan-Meier curves and log-rank tests. RESULTS: During the 7-year study period, 43 patients with 78 infrainguinal bypass stenoses were treated by endovascular intervention (eDES, 15; PCB, 23; PTA, 40). Mean age was 63.3 ± 1.7 years, 53.5% were male, and 55.8% were black. The majority of patients were diabetic (60.5%) with a history of smoking (74.4%), and nearly all (83.7%) had two or more comorbidities. Half (48.7%) of bypasses treated were femoral-popliteal bypasses, followed by popliteal-distal (25.6%) and femoral-tibial (25.6%) configurations. The location of revision was the proximal anastomosis in 37.2%, midbypass in 25.6%, and distal anastomosis in 37.2%. There were no significant differences in baseline characteristics, bypass configuration, or revision location between treatment groups (P ≥ .19). Technical success for endovascular bypass intervention was 100%. At 2 years after intervention, primary patency was significantly better for patients treated with eDES (81.8%) compared with PCB (54.7%) or PTA (33.2%; log-rank, P = .03). Limb salvage was achieved in 93.6% of patients, including 86.7%, 91.3%, and 97.5% for eDES, PCB, and PTA, respectively (P = .30). CONCLUSIONS: This is the first study reporting the results of eDESs for the treatment of infrainguinal bypass graft stenoses. Use of eDESs for endovascular bypass graft revision not only is feasible but may have better primary patency than other endovascular therapies. These data suggest that eDESs may be considered a safe and efficacious endovascular technique in the armamentarium for treatment of infrainguinal bypass graft stenoses.

The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system predicts wound healing but not major amputation in patients with diabetic foot ulcers treated in a multidisciplinary setting.

OBJECTIVE: The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) threatened limb classification has been shown to correlate well with risk of major amputation and time to wound healing in heterogeneous diabetic and nondiabetic populations. Major amputation continues to plague the most severe stage 4 WIfI patients, with 1-year amputation rates of 20% to 64%. Our aim was to determine the association between WIfI stage and wound healing and major amputation among patients with diabetic foot ulcers (DFUs) treated in a multidisciplinary setting. METHODS: All patients presenting to our multidisciplinary DFU clinic from July 2012 to December 2015 were enrolled in a prospective database. Wound healing and major amputation were compared for patients stratified by WIfI classification. RESULTS: There were 217 DFU patients with 439 wounds (mean age, 58.3 ± 0.8 years; 58% male, 63% black) enrolled, including 28% WIfI stage 1, 11% stage 2, 33% stage 3, and 28% stage 4. Peripheral arterial disease and dialysis were more common in patients with advanced (stage 3 or 4) wounds (P ≤ .05). Demographics of the patients, socioeconomic status, and comorbidities were otherwise similar between groups. There was a significant increase in the number of active wounds per limb at presentation with increasing WIfI stage (stage 1, 1.1 ± 0.1; stage 4, 1.4 ± 0.1; P = .03). Mean wound area (stage 1, 2.6 ± 0.6 cm2; stage 4, 15.3 ± 2.8 cm2) and depth (stage 1, 0.2 ± 0.0 cm; stage 4, 0.8 ± 0.1 cm) also increased progressively with increasing wound stage (P < .001). Minor amputations (stage 1, 18%; stage 4, 56%) and revascularizations (stage 1, 6%; stage 4, 55%) were more common with increasing WIfI stage (P < .001). On Kaplan-Meier analysis, WIfI classification was predictive of wound healing (P < .001) but not of major amputation (P = .99). For stage 4 wounds, the mean wound healing time was 190 ± 17 days, and risk of major amputation at 1 year was 5.7% ± 3.2%. CONCLUSIONS: Among patients with DFU, the WIfI classification system correlated well with wound healing but was not associated with risk of major amputation at 1 year. Although further prospective research is warranted, our results suggest that use of a multidisciplinary approach for DFUs may augment healing time and reduce amputation risk compared with previously published historical controls of standard wound care among patients with advanced stage 4 disease.

Management of infected vascular grafts.

Infections of vascular grafts are associated with significant mortality and morbidity risk and cost an estimated $640 million annually in the United States. Clinical presentation varies by time elapsed from implantation and by surgical site. A thorough history and physical examination in conjunction with a variety of imaging modalities is often essential to diagnosis. For infected aortic grafts, there are several options for treatment, including graft excision with extra-anatomic bypass, in situ reconstruction, or reconstruction with the neo-aortoiliac system. The management of infected endovascular aortic grafts is similar. For infected peripheral bypasses, graft preservation techniques can be utilized, but in cases where it is not possible, graft removal and revascularization through uninfected tissue planes is necessary. Infected dialysis access can be surgically treated by complete or subtotal graft excision. Diagnosis, general management, and surgical approaches to infected vascular grafts are discussed in this review.

Poststent ballooning is associated with increased periprocedural stroke and death rate in carotid artery stenting.

BACKGROUND: Whereas carotid endarterectomy (CEA) remains the "gold standard" treatment, given its low complication rate, carotid artery stenting (CAS) has emerged as a valid alternative in patients with prohibitive surgical risks. However, the application of CAS has been scrutinized, given its increased perioperative risk in comparison to CEA. Operators follow general guidelines in intraoperative techniques in CAS. However, few of those are evidence based. We believe that a specific outcome-driven examination of the effect of pre- and poststent deployment ballooning is warranted. The objective of this study was to analyze the effect of prestent ballooning (pre-SB) and poststent ballooning (post-SB) on hemodynamic depression (HD) and perioperative stroke or death. METHODS: We performed a retrospective analysis of all patients who had CAS between 2005 and 2014 in the Vascular Quality Initiative database. Logistic regression analyses of the effect of different pre-SB and post-SB combinations on HD and the 30-day stroke and death rate were performed. We excluded patients who had no protection device, those with isolated common carotid artery lesions, and those who had no ballooning at all. The models controlled for patient age, gender, comorbidities, smoking status, symptomatic status, history of previous ipsilateral CEA, preoperative medications, and ipsilateral degree of stenosis. RESULTS: A total of 3772 patients who underwent CAS were included for analysis. Average age of patients was 69.8 ± 9.6 years, with 63% being male. The overall perioperative stroke and death rate was 3.0%. Compared with pre-SB only technique, the combined pre-SB and post-SB technique had a 2.1-fold increase in HD (odds ratio, 2.13; 95% confidence interval, 1.51-3.01; P < .001) and 2.4-fold increase in perioperative stroke and death rate (odds ratio, 2.37; 95% confidence interval, 1.01-5.62; P < .050). CONCLUSIONS: Compared with pre-SB alone, the use of post-SB increases the chances of perioperative HD and stroke and death rate in patients undergoing CAS. Post-SB should be used only in those cases with severe residual stenosis.

Rates and predictors of readmission after minor lower extremity amputations.

OBJECTIVE: One goal of the Patient Protection and Affordable Care Act is to reduce hospital readmissions, with financial penalties applied for excessive rates of unplanned readmissions within 30 days among Medicare beneficiaries. Recent data indicate that as many as 24% of Medicare patients require readmission after vascular surgery, although the rate of readmission after limited digital amputations has not been specifically examined. The present study was therefore undertaken to define the rate of unplanned readmission among patients after digital amputations and to identify the factors associated with these readmissions to allow the clinician to implement strategies to reduce readmission rates in the future. METHODS: The electronic medical and billing records of all patients undergoing minor amputations (defined as toe or transmetatarsal amputations using International Classification of Diseases, Ninth Revision, codes) from January 2000 through July 2012 were retrospectively reviewed. Data were collected for procedure- and hospital-related variables, level of amputation, length of stay, time to readmission, and level of reamputation. Patient demographics included hypertension, diabetes, hyperlipidemia, smoking history, and history of myocardial infarction, congestive heart failure, peripheral arterial disease, chronic obstructive pulmonary disease, and cerebrovascular accident. RESULTS: Minor amputations were performed in 717 patients (62.2% male), including toe amputations in 565 (72.8%) and transmetatarsal amputations in 152 (19.5%). Readmission occurred in 100 patients (13.9%), including 28 (3.9%) within 30 days, 28 (3.9%) between 30 and 60 days, and 44 (6.1%) >60 days after the index amputation. Multivariable analysis revealed that elective admission (P < .001), peripheral arterial disease (P < .001), and chronic renal insufficiency (P = .001) were associated with readmission. The reasons for readmission were infection (49%), ischemia (29%), nonhealing wound (19%), and indeterminate (4%). Reamputation occurred in 95 (95%) of the readmitted patients, including limb amputation in 64 (64%) of the patients (below knee in 58, through knee in 2, and above knee in 4). CONCLUSIONS: Readmission after minor amputation was associated with limb amputation in the majority of cases. This study identified a number of nonmodifiable patient factors that are associated with an increased risk of readmission. Whereas efforts to reduce unplanned hospital readmissions are laudable, payers and regulators should consider these observations in defining unacceptable rates of readmission. Further, although beyond the scope of this study, it is not unreasonable to assume that pressure to reduce readmission rates in the population of patients with extensive comorbidity may induce practitioners to undertake amputation at a higher level initially to minimize the risk of readmission for reamputation and associated financial penalties and thus deprive the patient the chance for limb salvage.

Mortality variability after endovascular versus open abdominal aortic aneurysm repair in a large tertiary vascular center using a Medicare-derived risk prediction model.

OBJECTIVE: Previous reports have documented better outcomes after open abdominal aortic aneurysm (AAA) repair in tertiary centers compared with lower-volume hospitals, but outcome variability for endovascular AAA repair (EVAR) vs open AAA repairs in a large tertiary center using a Medicare-derived mortality risk prediction model has not been previously reported. In the current study, we compared the observed vs predicted mortality after EVAR and open AAA repair in a single large tertiary vascular center. METHODS: We retrospectively analyzed all patients who underwent repair of a nonruptured infrarenal AAA in our center from 2003 to 2012. Univariable and multivariable logistic regression were used to evaluate 30-day mortality. Patients were stratified into low-risk, medium-risk, and high-risk groups, and mortality was predicted for each patient based on demographics and comorbidities according to the Medicare risk prediction model. RESULTS: We analyzed 297 patients (EVAR, 72%; open AAA repair, 28%; symptomatic, 25%). Most of our patients were of high and moderate risk (48% and 28%, respectively). The observed 30-day mortality was 1.9% after EVAR vs 2.4% after open repair (odds ratio [OR], 0.77; 95% confidence interval [CI], 0.14-4.29; P = .67). There was no difference in mortality with EVAR vs open repair after adjusting for predefined patient characteristics (OR, 0.92; 95% CI, 0.16-7.43; P = .93); only preoperative renal disease was predictive of 30-day mortality after AAA repair in our cohort (OR, 8.39; 95% CI, 1.41-67.0). The observed mortality within our study was significantly lower than the Medicare-derived expected mortality for each treatment group within patients stratified as high risk or medium risk (P ≤ .0002 for all). CONCLUSIONS: Despite treating patients with high preoperative risk status, we report a 10-fold decrease in operative mortality for EVAR and open AAA repair in a tertiary vascular center compared with national Medicare-derived predictions. High-risk patients should be considered for aneurysm management in dedicated aortic centers, regardless of approach.

Fenestrated endovascular repair of abdominal aortic aneurysms is associated with increased morbidity but comparable mortality with infrarenal endovascular aneurysm repair.

OBJECTIVE: A recent prospective study found that fenestrated endovascular abdominal aortic aneurysm (AAA) repair (FEVAR) was safe and effective in appropriately selected patients at experienced centers. As this new technology is disseminated to the community, it will be important to understand how this technology compares with standard endovascular AAA repair (EVAR). The goal of this study was to compare the outcomes of FEVAR vs EVAR of AAAs. METHODS: The American College of Surgeons-National Surgical Quality Improvement Program database from 2005 to 2012 was queried for AAAs (International Classification of Diseases, Ninth Revision code 441.4). Patients were stratified according to procedure (FEVAR vs EVAR). A bivariate analysis was done to assess preoperative and intraoperative risk factors for postoperative outcomes. Thirty-day postoperative mortality and complication rates were described for each procedure type. Multivariable logistic regression was performed to assess the association between the type of procedure and the risk of postoperative complications. RESULTS: A total of 458 patients underwent FEVAR and 19,060 patients underwent EVAR for AAA. Patients undergoing FEVAR were older (P = .02) and less likely to have a bleeding disorder (P = .046). Otherwise, the incidence of comorbidities in both groups was similar. FEVAR was associated with increased median operative time (156 vs 137 minutes; P < .001), and average postoperative length of stay (3.3 vs 2.8 days; P = .03). There was a statistically significant increase in overall complications (23.6% vs 14.3%; P < .001) and postoperative transfusions (15.3% vs 6.1%, P < .001) and trends toward increased cardiac complications (2.2% vs 1.3%; P = .09) and the need for dialysis (1.5% vs 0.8%; P = .08) in the FEVAR group. Mortality (2.4% vs 1.5%; P = .12) was not statistically different. On multivariable analysis, FEVAR remained independently associated with the need for postoperative transfusions when operative time was <75th percentile (adjusted odds ratio, 1.72; 95% confidence interval, 1.09-2.72; P = .02) as well as when operative time was >75th percentile for respective procedures (adjusted odds ratio, 5.33; 95% confidence interval, 3.55-8.00; P < .001). CONCLUSIONS: Patients undergoing FEVAR are more likely than patients undergoing EVAR to receive blood transfusions postoperatively and are more likely to sustain postoperative complications. Although mortality was similar, trends toward increased cardiac and renal complications may suggest the need for judicious dissemination of this new technology. Future research with larger number of FEVAR cases will be necessary to determine if these associations remain.

The age effect in increasing operative mortality following delay in elective abdominal aortic aneurysm repair.

BACKGROUND: Elective repair of large abdominal aortic aneurysms (AAAs) is associated with the risk of significant perioperative mortality. When abdominal aneurysm repair is delayed, patients with asymptomatic large AAAs face the risk of death from rupture. In addition to the risk of rupture, the advancing age of the patients adds a future operative risk. This risk has been historically documented in age groups. However, a more accurate representation of the increasing operative risk with age is needed. METHODS: We analyzed all patients in the American College of Surgeons National Surgical Quality Improvement Program database who underwent endovascular or open repair for asymptomatic infrarenal AAA between 2005 and 2012. Multivariable logistic regression was used to evaluate the effect of increasing age and operative delay on 30-day postoperative mortality. RESULTS: There were 27,576 patients who underwent AAA repair during the study period (mean age 73.5 years, standard deviation 8.6, 80% male, 24% open repair). There was a linear relative increase of 5% (odds ratio [OR] 1.05, 95% confidence interval [CI] 1.04-1.06, P < 0.001) in the odds of operative death after AAA repair with each year of operative delay irrespective of treatment approach. There was a linear relative increase of 4% for endovascular aneurysm repair (OR 1.04, 95% CI 1.02-1.05, P < 0.001) and 6% for open repair (OR 1.06, 95% CI 1.04-1.08, P < 0.001) with each year of delay in repair. CONCLUSIONS: Because of increasing age, delay in surgery is associated with uniform increase in the risk of perioperative mortality in asymptomatic patients who meet criteria for AAA repair. It is important for surgeons to incorporate this more accurate estimation of operative risk into discussions with patients who qualify for treatment yet decide to forgo surgery for the repair of their AAA.

Risk of disease progression in patients with moderate asymptomatic carotid artery stenosis: implications of tobacco use and dual antiplatelet therapy.

BACKGROUND: Because of improved medical therapy in contemporary practice, some have advocated that, most if not, all patients with asymptomatic carotid disease should be managed medically without intervention. Disease progression in this patient population is not well established, and data describing risk factors for disease progression in patients with moderate asymptomatic carotid artery stenosis (ASCAS) are lacking. The aim of our study was to determine the incidence of and risk factors for disease progression in this patient population. METHODS: All patients presenting to a tertiary center between January 2005 and May 2012 with moderate (50-69%) ASCAS as determined by carotid artery duplex were included. Outcomes including disease progression to severe stenosis (≥70%), incidence of symptoms, need for operative intervention, and all-cause mortality were recorded. Cox proportional hazard regression models were used to identify risk factors for disease progression. RESULTS: A total of 282 carotid arteries in 258 patients with moderate ASCAS were identified from 1555 carotid duplex scans over the 7.5-year study period (mean age: 70.6 ± 0.55 years, 52% male). Mean follow-up time was 2.6 ± 0.10 years. Overall, disease progression to severe stenosis occurred in 25.2% (n = 71) and followed a linear trend. The incidence of symptoms including ipsilateral stroke (2.13%, n = 6) and transient ischemic attack (0.71%; n = 2) was low. Carotid endarterectomy was performed in 15.3% (n = 43) of patients, all with severe disease. Carotid stenting was performed in 3.90% (n = 11) patients. Risk of progression was higher in patients receiving dual antiplatelet therapy (Hazard Ratio [HR] 1.85, 95% confidence interval [CI] 1.09-3.15; P = 0.02) and smokers (HR 1.85, 95% CI 0.96-3.55; P = 0.05). Age, gender (women), hypertension, statin use, and aspirin use were not significant predictors of progression to severe stenosis. There was a nonsignificant trend toward increased mortality in patients who progressed compared with those who did not (HR 3.39, 95% CI 0.91-12.6; P = 0.07). CONCLUSIONS: In our study, one-quarter of patients with moderate ASCAS progressed to severe disease, although the majority remained asymptomatic. Smoking and dual antiplatelet therapy are independent risk factors for disease progression. Patients with identifiable risk factors may warrant more careful follow-up.