A Global Vascular Guidelines-Based Bypass-Preferred Population and Their Surgical Risk Among CLTI Patients Treated With Endovascular Therapy in a Real-World Practice.

PURPOSE: To determine in a chronic limb-threatening ischemia (CLTI) population who underwent endovascular therapy (EVT) how many patients would have been categorized as preferred for bypass surgery according to the Global Vascular Guidelines (GVG) and ascertain their surgical risk. MATERIALS AND METHODS: The current study analyzed 1043 CLTI patients who presented WIfI (wound, ischemia, and foot infection) stage ≥2 and underwent EVT between April 2010 and December 2017. Of these, 176 were excluded for lack of angiographic or other data, leaving 867 CLTI patients (mean age 74±10 years; 523 men) for stratification according to the GVG into bypass-preferred, indeterminate, or EVT-preferred groups. The GVG recommend bypass as the first-line treatment when the wound is severe (WIfI stage ≥3) and lesions are complex (GLASS stage III). Surgical risk was estimated using the modified PREVENT III risk score. To further stratify the bypass-preferred population according to mortality risk, a survival decision tree was constructed using recursive partitioning. RESULTS: The bypass-preferred group accounted for 55% [95% confidence interval (CI) 51% to 58%] of the overall population. The decision tree analysis extracted a low-mortality risk subgroup with a survival rate of 99% (95% CI 98% to 100%) at 1 month and 80% (95% CI 73% to 87%) at 2 years. According to the PREVENT III score, 34% (95% CI 27% to 42%) of the low mortality risk subgroup were classified as high surgical risk. CONCLUSION: A high proportion of patients undergoing EVT were considered bypass preferred based on the GVG, and the survival of these patients was not significantly different whether they were high or low surgical risk.

Two-Year Outcomes of Early Cannulation Arteriovenous Grafts for End-Stage Renal Disease.

BACKGROUND: Almost 80% of patients with end-stage renal disease (ESRD) initiate dialysis via a central venous catheter (CVC). CVCs are associated with multiple complications and a high cost of care. The purpose of our project is to determine the impact of early cannulation arteriovenous grafts (ECAVGs) on quality of care and costs. METHODS: The dialysis access modality, complications, secondary interventions, hospital outcomes, and detailed costs were tracked for 397 sequential patients who underwent access creation between July 2014 and October 2018. Complications were grouped into deep vein thrombosis, line infections, sepsis, pneumothorax, and other. Secondary interventions included angioplasty, angioplasty and stent grafting, thrombectomy, surgical revision, and explantation. Hospital outcomes included length of stay, inpatient mortality, 30-day readmission, and discharge disposition. Costs included supplies, medications, laboratory tests, labor, and other direct costs. All variables were measured at the time of the index procedure, 30 days, 90 days, 180 days, 270 days, 1 year, 18 months, and 2 years. RESULTS: There were 131 patients who underwent arteriovenous fistula (AVF) and 266 who received ECAVG for dialysis access. The total cost of care per patient was $17,523 for AVF and $5,894 for ECAVG at 1 year (P < 0.01). Primary-assisted patency for AVF was 49.3% versus 81.4% for ECAVG (P = 0.027), and secondary-assisted patency for AVF was 63.8% versus 85.4% for ECAVG at 1 year (P = 0.011). There was a survival advantage for ECAVGs at 1 year (78.6% for AVF vs 85.0% for ECAVG, P = 0.034). Patients who received ECAVG had fewer CVC days (2.3% vs 19.1% for AVF, P < 0.001), fewer complications (1.6% vs. 21.5% for AVF, P < 0.001), and fewer secondary interventions (17.0% vs 52.5% for AVF, P < 0.001). CONCLUSIONS: This is the first study on patients with ESRD to report detailed outcomes and cost analysis as it relates to AVF versus ECAVG. ECAVGs have an advantage over AVFs due to lower overall cost and better clinical outcomes at 1 year. Implementation of an urgent start dialysis access program centered around ECAVGs may help achieve the national goal of better health care at a lower cost for patients with ESRD.

Objective Performance Goals for Surgical Treatment of Critical Limb Ischemia.

BACKGROUND: Based on prospective vein bypass trials for lower leg ischemia, objective performance goals (OPG) were established by the Society for Vascular Surgery (SVS) and are used as a benchmark tool for open and endovascular treatments. This study aims to analyze OPG of all patients with critical limb ischemia (CLI) treated by open revascularization techniques at a tertiary care facility in routine practice. METHODS: From January 2005 to March 2013, 315 patients (mean age 72 years) with CLI were retrospectively included in this study. Inclusion criteria were patients with Fontaine stage III and IV, realized revascularization with open surgical procedures (bypass grafting or endarterectomy), or hybrid method (open + endovascular). Exclusion criteria were primary major amputations, patients with revascularization treatments of the index leg within the last 3 months, and missing aftercare. Primary end point was "amputation-free survival" (AFS), and secondary end point was "freedom from major adverse limb event + perioperative death (30 days)" (MALE + POD) according to the SVS. The technical end point was primary patency. Mean follow-up was 34 months. The following variables were studied: clinical stage (Fontaine), previous interventions, bypass material used, and site of the distal anastomosis. The statistical evaluation and preparation was carried out using the Kaplan-Meier estimator and the log-rank test. A multivariate analysis was performed using the Cox proportional hazards model. A P value ≤0.05 was considered to be statistically significant. RESULTS: A total of 128 patients (31%) fulfilling the adjusted SVS OPG criteria showed significantly better results for AFS, MALE + POD, and primary patency (P = 0.013, P = 0.015, P = 0.002, respectively). Regarding the AFS (1 year: 74%), multivariate analysis displayed significant worse results for patients with end-stage renal disease (hazard ratio [HR] 2.90, 95% confidence interval [CI] 1.83-4.60, P < 0.001) and Fontaine stage IV (HR 1.69, 95% CI 1.11-2.57, P = 0.015). Regarding MALE + POD (1 year: 64%), male patients (HR 0.64, 95% CI 0.46-0.90, P = 0.011) showed a significantly better outcome and patients without previous interventions of the index leg (HR 1.51, 95% CI 1.09-2.09, P = 0.013) showed a significantly worse outcome. CONCLUSIONS: In this study, we were able to show that it is possible to reach the efficacy of OPGs set by SVS in a surgically treated all-comers cohort of CLI patients. Nevertheless, patients who did not fulfill the SVS OPG criteria showed significantly worse results for AFS and MALE + POD.

The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm.

BACKGROUND: Decision-making related to the care of patients with an abdominal aortic aneurysm (AAA) is complex. Aneurysms present with varying risks of rupture, and patient-specific factors influence anticipated life expectancy, operative risk, and need to intervene. Careful attention to the choice of operative strategy along with optimal treatment of medical comorbidities is critical to achieving excellent outcomes. Moreover, appropriate postoperative surveillance is necessary to minimize subsequent aneurysm-related death or morbidity. METHODS: The committee made specific practice recommendations using the Grading of Recommendations Assessment, Development, and Evaluation system. Three systematic reviews were conducted to support this guideline. Two focused on evaluating the best modalities and optimal frequency for surveillance after endovascular aneurysm repair (EVAR). A third focused on identifying the best available evidence on the diagnosis and management of AAA. Specific areas of focus included (1) general approach to the patient, (2) treatment of the patient with an AAA, (3) anesthetic considerations and perioperative management, (4) postoperative and long-term management, and (5) cost and economic considerations. RESULTS: Along with providing guidance regarding the management of patients throughout the continuum of care, we have revised a number of prior recommendations and addressed a number of new areas of significance. New guidelines are provided for the surveillance of patients with an AAA, including recommended surveillance imaging at 12-month intervals for patients with an AAA of 4.0 to 4.9 cm in diameter. We recommend endovascular repair as the preferred method of treatment for ruptured aneurysms. Incorporating knowledge gained through the Vascular Quality Initiative and other regional quality collaboratives, we suggest that the Vascular Quality Initiative mortality risk score be used for mutual decision-making with patients considering aneurysm repair. We also suggest that elective EVAR be limited to hospitals with a documented mortality and conversion rate to open surgical repair of 2% or less and that perform at least 10 EVAR cases each year. We also suggest that elective open aneurysm repair be limited to hospitals with a documented mortality of 5% or less and that perform at least 10 open aortic operations of any type each year. To encourage the development of effective systems of care that would lead to improved outcomes for those patients undergoing emergent repair, we suggest a door-to-intervention time of <90 minutes, based on a framework of 30-30-30 minutes, for the management of the patient with a ruptured aneurysm. We recommend treatment of type I and III endoleaks as well as of type II endoleaks with aneurysm expansion but recommend continued surveillance of type II endoleaks not associated with aneurysm expansion. Whereas antibiotic prophylaxis is recommended for patients with an aortic prosthesis before any dental procedure involving the manipulation of the gingival or periapical region of teeth or perforation of the oral mucosa, antibiotic prophylaxis is not recommended before respiratory tract procedures, gastrointestinal or genitourinary procedures, and dermatologic or musculoskeletal procedures unless the potential for infection exists or the patient is immunocompromised. Increased utilization of color duplex ultrasound is suggested for postoperative surveillance after EVAR in the absence of endoleak or aneurysm expansion. CONCLUSIONS: Important new recommendations are provided for the care of patients with an AAA, including suggestions to improve mutual decision-making between the treating physician and the patients and their families as well as a number of new strategies to enhance perioperative outcomes for patients undergoing elective and emergent repair. Areas of uncertainty are highlighted that would benefit from further investigation in addition to existing limitations in diagnostic tests, pharmacologic agents, intraoperative tools, and devices.

Editor's Choice - Late Open Surgical Conversion after Endovascular Abdominal Aortic Aneurysm Repair.

INTRODUCTION: Late open surgical conversion following endovascular aneurysm repair (EVAR) may occur more frequently after performing EVAR in anatomy outside the instructions for use (IFU). This study reviews predictors and outcomes of late open surgical conversion for failed EVAR. METHODS: This retrospective cohort study reviewed all EVARs performed at the Ottawa Hospital between January 1999 and May 2015. Open surgical conversions >1 month post EVAR were identified. Variables analysed included indication for conversion, pre-intervention AAA anatomy, endovascular device and configuration, operative technique, re-interventions, complications, and death. RESULTS: Of 1060 consecutive EVARs performed, 16 required late open surgical conversion. Endografts implanted were Medtronic Talent (n = 8, 50.0%), Medtronic Endurant (n = 3, 18.8%), Cook Zenith (n = 4, 25.0%), and Terumo Anaconda (n = 1, 6.2%). Eleven grafts were bifurcated (68.8%), five were aorto-uni-iliac (31.2%). The median time to open surgical conversion was 3.1 (IQR 1.0-5.2) years. There was no significant difference in pre-EVAR rupture status (1.4% elective, 2.1% ruptured, p = .54). Indications for conversion included: Type 1 endoleak with sac expansion (n = 4, 25.0%), Type 2 endoleak with expansion (n = 2, 12.5%), migration (n = 3, 18.8%), sac expansion without endoleak (n = 2, 12.5%), graft infection (n = 3, 18.8%), rupture (n = 2, 12.5%). Nine patients (56.2%) underwent stent graft explantation with in situ surgical graft reconstruction, seven had endograft preserving open surgical intervention. The 30 day mortality was 18.8% (n = 3, all of whom having had endograft preservation). Ten patients (62.5%) suffered major in hospital complications. One patient (6.5%) required post-conversion major surgical re-intervention. IFU adherence during initial EVAR was 43.8%, versus 79.0% (p < .01) among uncomplicated EVARs. CONCLUSIONS: Open surgical conversion following EVAR results in significant morbidity and mortality. IFU adherence of EVARs later requiring open surgical conversion is markedly low. More data are required to elucidate the impact of increasing liberalisation of EVAR outside of IFU.

Open and endovascular aneurysm repair in the Society for Vascular Surgery Vascular Quality Initiative.

The Society for Vascular Surgery Vascular Quality Initiative is a patient safety organization and a collection of procedure-based registries that can be utilized for quality improvement initiatives and clinical outcomes research. The Vascular Quality Initiative consists of voluntary participation by centers to collect data prospectively on all consecutive cases within specific registries which physicians and centers elect to participate. The data capture extends from preoperative demographics and risk factors (including indications for operation), through the perioperative period, to outcomes data at up to 1-year of follow-up. Additionally, longer-term follow-up can be achieved by matching with Medicare claims data, providing long-term longitudinal follow-up for a majority of patients within the Vascular Quality Initiative registries. We present the unique characteristics of the Vascular Quality Initiative registries and highlight important insights gained specific to open and endovascular abdominal aortic aneurysm repair.

Surgeon, not institution, case volume is associated with limb outcomes after lower extremity bypass for critical limb ischemia in the Vascular Quality Initiative.

OBJECTIVE: Studies from large administrative databases have demonstrated associations between institutional case volume and outcomes after lower extremity bypass (LEB). We hypothesized that increased institutional and surgeon volume would be associated with improved outcomes after LEB. Using a national, prospectively collected clinical database, the objective of this study was to determine the effects of both surgeon and institutional volume on outcomes after LEB. METHODS: The Vascular Quality Initiative (VQI) was queried to identify all LEBs for critical limb ischemia or claudication between 2004 and 2014. Average annual case volume was calculated by dividing an institution's or surgeon's total LEB volume by the number of years they reported to the VQI. Institutional and surgeon volumes were analyzed as continuous variables to determine the impact of volume on major adverse cardiac events (MACEs), major adverse limb events (MALEs), graft patency, and amputation-free survival. Hierarchical regression models were used with cases clustered by surgeon and center. Time-dependent outcomes were evaluated with multivariable shared frailty Cox proportional hazards models. RESULTS: From 2004 to 2014, there were 14,678 LEB operations performed at 114 institutions by 587 surgeons. Average annual institutional volume ranged from 1.0 to 137.5 LEBs per year, with a median of 26.9 (interquartile range, 14-45.3). Average annual surgeon volume ranged from 1 to 52 LEBs per year with a median of 5.7 (interquartile range, 2.5-9.3). Institutional LEB volume was not associated with MACEs or MALEs or with loss of patency. However, average annual surgeon volume was independently associated with reduced MALEs and improved primary patency. Institutional and surgeon volume did not predict MACEs. CONCLUSIONS: In contradistinction to previous studies, there was no relationship in this study between institutional LEB volume and outcomes after LEB. However, greater average annual surgeon volume was associated with improved primary patency and decreased risk of MALEs. Open LEB remains a safe and effective procedure for limb salvage. Limb-related outcomes in critical limb ischemia and claudication will be optimized if surgeons maintain adequate volume of LEB.

Increased risk of mortality after lower extremity bypass in individuals with acute kidney injury in the Vascular Quality Initiative.

OBJECTIVE: The development of acute kidney injury (AKI) and its effect on prognosis after lower extremity bypass (LEB) surgery have not been well described. We determined risk factors associated with AKI in patients undergoing infrainguinal LEB surgery and whether individuals with AKI are at increased risk for cardiovascular events and mortality. METHODS: Data for 12,907 operations entered in the Vascular Quality Initiative (VQI) registry from January 2012 through April 2015 were retrospectively reviewed. Procedures performed on patients not on dialysis before the surgery with perioperative assessments of renal function were eligible for the study. AKI was defined as a postoperative increase in serum creatinine ≥0.5 mg/dL or new dialysis requirement. Logistic regression was performed to determine the effect of AKI on the risk of in-hospital cardiovascular events, including myocardial infarction, stroke, congestive heart failure, or arrhythmias, and mortality. Cox proportional hazards regression was performed to determine the risk of long-term mortality (median follow-up of 11.5 months). RESULTS: AKI developed after 507 (4%) of the 12,907 operations performed in 11,859 patients. After adjustment for demographic, clinical, and perioperative variables, AKI was associated with an increased risk of in-hospital cardiovascular events (odds ratio, 2.50; 95% confidence interval [CI], 1.91-3.28) and in-hospital mortality (odds ratio, 6.96; 95% CI, 3.94-12.31). Risk of mortality persisted over the course of follow-up (hazard ratio, 1.98; 95% CI, 1.58-2.47). CONCLUSIONS: AKI after LEB is associated with an increased risk of cardiovascular events and all-cause mortality. Further study should evaluate whether preoperative interventions before LEB can be effectively applied for at-risk patients to reduce the incidence of AKI and its associated morbidity and mortality.

Evaluation of a Bovine Vascular Graft in Sheep.

The study objective was to determine safety and efficacy of a treated bovine vascular xenograft, in two Good Laboratory Practice compliant studies in sheep following carotid graft implantation. In one study, a 3- to 5-mm diameter xenograft was implanted into the right carotid artery of male sheep and compared to autologous jugular vein and a polymeric grafts similarly implanted. In a second study, a 9.5- to 14-mm diameter xenograft similarly implanted into the right carotid artery was compared to an autologous saphenous vein. Monthly Doppler ultrasound evaluation of implant patency and flow in implants and contralateral control carotid arteries was performed. The small vessel cohort 6 month xenograft patency was equivalent (or better) than animals with polymeric vascular graft or autologous vein implants; the aneurysm incidence was less than that of autologous vein grafts. In the large vessel cohort, all 15 xenografts and 12/15 saphenous vein implants were patent at 6 month follow-up. Tissue histology showed mild inflammatory responses in the xenografts that was slightly greater than suture material. In summary, treated bovine xenograft performance in this small study suggests it may be superior to polymeric autologous vein grafts, and may have a similar failure rate as autologous vein grafts after implantation.

A comparative evaluation of risk-adjustment models for benchmarking amputation-free survival after lower extremity bypass.

BACKGROUND: Providing patients and payers with publicly reported risk-adjusted quality metrics for the purpose of benchmarking physicians and institutions has become a national priority. Several prediction models have been developed to estimate outcomes after lower extremity revascularization for critical limb ischemia, but the optimal model to use in contemporary practice has not been defined. We sought to identify the highest-performing risk-adjustment model for amputation-free survival (AFS) at 1 year after lower extremity bypass (LEB). METHODS: We used the national Society for Vascular Surgery Vascular Quality Initiative (VQI) database (2003-2012) to assess the performance of three previously validated risk-adjustment models for AFS. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL), Finland National Vascular (FINNVASC) registry, and the modified Project of Ex-vivo vein graft Engineering via Transfection III (PREVENT III [mPIII]) risk scores were applied to the VQI cohort. A novel model for 1-year AFS was also derived using the VQI data set and externally validated using the PIII data set. The relative discrimination (Harrell c-index) and calibration (Hosmer-May goodness-of-fit test) of each model were compared. RESULTS: Among 7754 patients in the VQI who underwent LEB for critical limb ischemia, the AFS was 74% at 1 year. Each of the previously published models for AFS demonstrated similar discriminative performance: c-indices for BASIL, FINNVASC, mPIII were 0.66, 0.60, and 0.64, respectively. The novel VQI-derived model had improved discriminative ability with a c-index of 0.71 and appropriate generalizability on external validation with a c-index of 0.68. The model was well calibrated in both the VQI and PIII data sets (goodness of fit P = not significant). CONCLUSIONS: Currently available prediction models for AFS after LEB perform modestly when applied to national contemporary VQI data. Moreover, the performance of each model was inferior to that of the novel VQI-derived model. Because the importance of risk-adjusted outcome reporting continues to increase, national registries such as VQI should begin using this novel model for benchmarking quality of care.

A Retrospective Study to Evaluate Use of Negative Pressure Wound Therapy in Patients Undergoing Bilateral Internal Thoracic Artery Grafting.

Bilateral internal thoracic artery (BITA) grafting may be associated with a higher risk of postoperative deep sternal wound infection than monolateral internal thoracic artery grafting due to a limited blood supply to the thoracic chest wall. Because preliminary studies suggest negative pressure wound therapy (NPWT) may reduce the risk of infection, a retrospective chart review of 129 patients who underwent BITA between February 2003 and October 2014 was conducted. Of those, 21 patients received NPWT for 5 days immediately following surgery and the incisions of 108 patients were covered with a conventional gauze dressing. Patient demographic and history variables as well as surgical procedure and outcome variables were abstracted. Outcome variables assessed included infection, need for transfusion, and length of hospital stay. The NPWT group was significantly younger (average age 55.9 ± 7.6 versus 60 ± 10.5 years, P = 0.049), had fewer urgent/emergent surgeries (4 [19%] versus 36 [33.3%], P = 0.247), and had significantly lower surgical risk scores (2.0 ± 2.3 versus 3.8 ± 2.8, P = 0.010). The rate of deep sternal wound infections was lower in the NPWT than in the control group, but the difference was not statistically significant (0% versus 5.6%, P = 0.336). Sternal instability was noted in 4 control patients, requiring wound re-exploration versus 0 in the NPWT group (3.7% versus 0%, P = 0.487). One (1) patient in the NPWT group had postoperative bleeding that required removal of the device. The rates of re-thoracotomy due to bleeding were 9.3% in the control compared to 4.8% in the NPWT group (P = 0.435), which translated into a greater need for blood transfusions (1.77 ± 3.4 units versus 0.3 3± 0.7 units, P = 0.056) and larger chest drainage volume (997.8 ± 710 mL versus 591.2 ± 346 mL, P = 0.012) in the control group. Hospital stay was longer in the control group, but the difference was not statistically significant (12 ± 8.8 days versus 9.4 ± 4.2 days, P = 0.184). These preliminary results are encouraging, and prospective, randomized, controlled clinical studies to compare the efficacy, effectiveness, and costeffectiveness of NPWT to other wound management modalities following cardiac surgery are warranted.

Vascular heterogeneity between native rat pancreatic islets is responsible for differences in survival and revascularisation post transplantation.

AIMS/HYPOTHESIS: Highly blood-perfused islets have been observed to be the most functional islets in the native pancreas. We hypothesised that differences in vascular support of islets in donor pancreases influence their susceptibility to cellular stress and capacity for vascular engraftment after transplantation. METHODS: Highly blood-perfused islets in rats were identified by injection of microspheres into the ascending aorta before islet isolation. Cell death was evaluated after in vitro cytokine or hypoxia exposure, and 2 days post transplantation. One month post transplantation, islet engraftment, including vascular density, blood perfusion and oxygen tension (pO2) in the tissue, was evaluated. RESULTS: Microsphere-containing islets had a similar frequency of cell death during standard culture conditions but increased cell death after exposure to cytokines and hypoxia in comparison with other islets. Two days after transplantation the percentage of apoptotic or necrotic cells was also higher in grafts of such islets and 1 month post transplantation these grafts were composed of substantially more connective tissue. Grafts of highly blood-perfused islets in the native pancreas regained a higher vascular density, blood perfusion and pO2 in comparison with grafts of other islets. CONCLUSIONS/INTERPRETATION: Native islets that are highly blood-perfused regained this feature after transplantation, indicating a superior capacity for revascularisation and post-transplant function. However, the same group of islets was more vulnerable to different kinds of cellular stress, which limited their early survival post transplantation. Preferential death of these most active islets may contribute to the high number of islets needed to provide cure with islet transplantation.

ACCF/ACR/AIUM/ASE/IAC/SCAI/SCVS/SIR/SVM/SVS/SVU 2013 appropriate use criteria for peripheral vascular ultrasound and physiological testing. Part II: Testing for venous disease and evaluation of hemodialysis access.

The American College of Cardiology Foundation (ACCF), in partnership with key specialty and subspecialty societies, conducted a review of common clinical scenarios where noninvasive vascular testing (venous ultrasound and physiological testing) is frequently considered. The indications (clinical scenarios) were derived from common applications or anticipated uses, as well as from current clinical practice guidelines and results of studies examining the implementation of the original appropriate use criteria (AUC). The 116 indications in this document were developed by a diverse writing group and scored by a separate independent technical panel on a scale of 1 to 9, to designate appropriate use (A) (median 7 to 9), maybe appropriate use (M) (median 4 to 6), and rarely appropriate use (R) (median 1 to 3).

Composite measures for profiling hospitals on surgical morbidity.

CONTEXT: Although risk-adjusted morbidity is widely used as a surgical quality indicator, it may not always be a reliable indicator of hospital quality. In this study, we assess the value of a novel composite measure for improving the reliability of hospital morbidity rankings. DESIGN, SETTING, AND PATIENTS: Using data from the American College of Surgeons' National Surgical Quality Improvement Program (ACS-NSQIP), we studied all patients undergoing 4 surgical procedures (2008-2009): colectomy, ventral hernia repair, abdominal aortic aneurysm repair, and lower extremity bypass surgery. For these procedures, we created a composite measure by combining quality indicators from several distinct domains of quality: morbidity, reoperation, length of stay, and morbidity with other potentially related procedures. We empirically weighted each measure and adjusted for reliability using empirical Bayes techniques. To validate this approach, we assessed how well composite measures from 1 year (2008) predict morbidity in the next year (2009) compared with the standard ACS-NSQIP approach for assessing hospital rates of risk-adjusted morbidity. RESULTS: For all 4 operations, the composite measures explained a higher proportion of hospital-level variation in morbidity than the standard approach: ventral hernia repair (58% for the composite vs 8% for the standard approach), colon resection (33% vs 14%), abdominal aortic aneurysm repair (51% vs 38%), and lower extremity bypass surgery (32% vs 3%). When evaluating the ability to discriminate future performance, the composite approach performed best for ventral hernia repair. For this procedure, the bottom 20% of hospitals based on the composite approach had nearly threefold higher (odds ratio: 2.65; 95% confidence interval: 1.83-3.85) morbidity rates than the top 20% of hospitals. However, when using the standard approach, there was only a 1.3-fold difference (odds ratio: 1.30; 95% confidence interval: 0.87-1.96). Although the differences were smaller in magnitude, the composite measure also outperformed the standard approach for the other 3 procedures. CONCLUSIONS: Composite measures better reflect hospital quality than simple rates of risk-adjusted morbidity. In the context of ACS-NSQIP, composite measures would give hospitals a better sense of where they stand and help identify truly exemplary hospitals for benchmarking.

Hospital procedure volume should not be used as a measure of surgical quality.

INTRODUCTION: The Agency for Healthcare Research and Quality and the Leapfrog Group use hospital procedure volume as a quality measure for pancreatic resection (PR), abdominal aortic aneurysm (AAA) repair, esophageal resection (ER), and coronary artery bypass grafting (CABG). However, controversy exists regarding the strength and validity of the evidence for the volume-outcome association. The purpose of this study was to reevaluate the volume-outcome relationship for these procedures. METHODS: Discharge data for 261,412 patients were extracted from the 2008 Nationwide Inpatient Sample. The relationship between hospital procedure volume and mortality was rigorously assessed using hierarchical general linear modeling with restricted cubic splines, adjusted for patient demographics, comorbid disease, and elective procedure status. RESULTS: Unadjusted mortality rates were PR (4.7%), AAA (12.7%), ER (5.8%), and CABG (2.2%), and the majority of operations were elective. Hospital procedure volume was not a statistically significant predictor of in-hospital mortality for any of the 4 procedures. Strong predictors of mortality included age, elective procedure status, renal failure, and malnutrition (P < 0.001). Each of the models demonstrated excellent performance in estimating the probability of death. CONCLUSIONS: Hospital procedure volume is not a significant predictor of mortality for the performance of pancreatectomy, AAA repair, esophagectomy, or CABG. Procedure volume by itself should not be used as a proxy measure for surgical quality. Patient mortality risk is primarily attributable to patient-level characteristics such as age and comorbidity.

Validation of the Society for Vascular Surgery's objective performance goals for critical limb ischemia in everyday vascular surgery practice.

BACKGROUND: To develop standardized metrics for expected outcomes in lower extremity revascularization for critical limb ischemia (CLI), the Society for Vascular Surgery (SVS) has developed objective performance goals (OPGs) based on aggregate data from randomized trials of lower extremity bypass (LEB). It remains unknown, however, if these targets can be achieved in everyday vascular surgery practice. METHODS: We applied SVS OPG criteria to 1039 patients undergoing 1039 LEB operations for CLI with autogenous vein (excluding patients on dialysis) within the Vascular Study Group of New England (VSGNE). Each of the individual OPGs was calculated within the VSGNE dataset, along with its surrounding 95% confidence intervals (CIs) and compared to published SVS OPGs using χ(2) comparisons and survival analysis. RESULTS: Across most risk strata, patients in the VSGNE and SVS OPG cohorts were similar (clinical high-risk [age >80 years and tissue loss]: 15.3% VSGNE; 16.2% SVS OPG; P = .58; anatomic high risk [infrapopliteal target artery]: 57.8% VSGNE; 60.2% SVS OPG; P = .32). However, the proportion of VSGNE patients designated as conduit high-risk (lack of single-segment great saphenous vein) was lower (10.2% VSGNE; 26.9% SVS OPG;P < .001). The primary safety endpoint, major adverse limb events (MALE) at 30 days, was lower in the VSGNE cohort (3.2%; 95% CI, 2.3-4.6) than the SVS OPG cohort (6.2%; 95% CI, 4.2-8.1; P = .05). The primary efficacy OPG endpoint, freedom from any MALE or postoperative death within the first year (MALE + postoperative death [POD]), was similar between VSGNE and SVS OPG cohorts (77%; 95% CI, 74%-80%) SVS OPG, 74% (95% CI, 71%-77%) VSGNE, P = .58). In the remaining safety and efficacy OPGs, the VSGNE cohort met or exceeded the benchmarks established by the SVS OPG cohort. CONCLUSION: Community and academic centers in everyday vascular surgery practice can meet OPGs derived from centers of excellence in LEB. Quality improvement initiatives, as well as clinical trials, should incorporate OPGs in their outcome measures to facilitate communication and comparison of risk-adjusted outcomes in the treatment of CLI.