Implementation of an enhanced recovery program for lower extremity bypass.

OBJECTIVE: Enhanced recovery programs (ERPs) have gained wide acceptance across multiple surgical disciplines to improve postoperative outcomes and to decrease hospital length of stay (LOS). However, there is limited information in the existing literature for vascular patients. We describe the implementation and early results of an ERP and barriers to its implementation for lower extremity bypass surgery. Our intention is to provide a framework to assist with implementation of similar ERPs. METHODS: Using the plan, do, check, adjust methodology, a multidisciplinary team was assembled. A database was used to collect information on patient-, procedure-, and ERP-specific metrics. We then retrospectively analyzed patients' demographics and outcomes. RESULTS: During 9 months, an ERP (n = 57) was successfully developed and implemented spanning preoperative, intraoperative, and postoperative phases. ERP and non-ERP patient demographics were statistically similar. Early successes include 97% use of fascia iliaca block and multimodal analgesia administration in 81%. Barriers included only 47% of patients achieving day of surgery mobilization and 19% receiving celecoxib preoperatively. ERP patients had decreased total and postoperative LOS compared with non-ERP patients (n = 190) with a mean (standard deviation) total LOS of 8.32 (8.4) days vs 11.14 (10.1) days (P = .056) and postoperative LOS of 6.12 (6.02) days vs 7.98 (7.52) days (P = .089). There was significant decrease in observed to expected postoperative LOS (1.28 [0.66] vs 1.82 [1.38]; P = .005). Variable and total costs for ERP patients were significantly reduced ($13,208 [$9930] vs $18,777 [$19,118; P < .01] and $29,865 [$22,110] vs $40,328 [$37,820; P = .01], respectively). CONCLUSIONS: Successful implementation of ERP for lower extremity bypass carries notable challenges but can have a significant impact on practice patterns. Further adjustment of our current protocol is anticipated, but early results are promising. Implementation of a vascular surgery ERP reduced variable and total costs and decreased total and postoperative LOS. We believe this protocol can easily be implemented at other institutions using the pathway outlined.

Effects of statin and antiplatelet therapy noncompliance and intolerance on patient outcomes following vascular surgery.

OBJECTIVE: Prior studies have evaluated the effects of statin and antiplatelet agent (APA) medications on patients with peripheral arterial disease. Although the benefits of statin and APA use are well-described, there is a paucity of research into the specific outcomes of patients who are not compliant or those who are unable to take the medication owing to intolerance. Here we examine the outcomes of patients intolerant to statin and APA and compare them with patients who are compliant or noncompliant with these therapies. METHODS: Patients treated from 2005 to 2018 in the Vascular Quality Initiative registry were included. Patients with missing data or deaths within 30 days of procedure were removed. Patients were considered noncompliant if they were previously prescribed a medication at discharge but were not taking it at 1-year follow-up or if the patient was reported to be noncompliant in the registry. Medication intolerance was defined if listed as "no, for medical reasons," and mortality data were ascertained using the Social Security Death Index, which is regularly cross-referenced to the Vascular Quality Initiative registry. RESULTS: We identified 105,628 patients who met our inclusion criteria. Statin intolerance was noted in 2.3% at discharge and 2.1% at the 1-year follow-up, with 0.7% listed as intolerant at all stages. Factors associated with increased risk of intolerance to statins included female gender (P = .001), discharge APA intolerance (P = .004), insurance status (non-U.S. insurance) (P < .001), discharge APA noncompliance (P = .019), and discharge angiotensin converting enzyme inhibitor noncompliance (P = .005). Patients who were compliant with statins showed a 91% survival at 5 years vs 87% survival in noncompliant patients and 87% in intolerant patients at 5 years (P < .001). Patients with statin intolerance have a similar survival curve as noncompliant patients across all registry cohorts. Noncompliance with statins was correlated with noncompliance with APA medications (R = 0.16, P < .001). Factors associated with increased risk of statin noncompliance included preoperative ambulatory status (requiring assistance) (P = .039), female sex (P < .001), peripheral vascular intervention (P < .001) or infrainguinal open bypass procedure surgery (P = .001), discharge status (to nursing home) (P = .006) and insurance (self-pay) (P < .001). CONCLUSIONS: Patients not taking statin and APA medications have a substantially decreased 5-year survival irrespective of the reason for not taking. Importantly, patients noted to be intolerant have a similar survival curve as noncompliant patients across all registry cohorts. Intolerant patients may benefit from attempts to alter statin dose, type (hydrophilic vs lipophilic), or from newer agents such as PCSK9 inhibitors.

Statin use improves limb salvage after intervention for peripheral arterial disease.

BACKGROUND: Statin use is recommended in all patients with peripheral arterial disease (PAD) owing to its morbidity and mortality benefits. However, the effect of statin use on limb salvage in patients with PAD after intervention is unclear. We examined the effect of statin use on limb salvage and survival among patients with PAD undergoing surgical or endovascular intervention. METHODS: A total of 488 patients with PAD were identified who underwent surgical (n = 297) or endovascular (n = 191) intervention between 2009 and 2010. Information was collected from electronic medical records and the Social Security Death Index. Predictors of ongoing statin use were identified first by univariate analysis and then via multivariable logistic regression. Survival and freedom from amputation were identified using Kaplan-Meier plots and adjusted hazard ratios by Cox regression. RESULTS: Of the 488 patients with PAD with intervention, 39% were non-whites, 44% were females, 41% received statins, 56% received antiplatelets, 26% received oral anticoagulants, 9% required a major amputation, and 11% died during follow-up of up to 88 months. Statin users were more often male (P = .03), white (P = .03), smokers (P < .01), and had higher comorbidities such as coronary artery disease (P < .01), hypertension (P < .01), and diabetes (P < .01). Antiplatelet use was not associated with limb salvage (P = .13), but did improve survival (P < .01). Dual antiplatelet therapy did not show any benefit over monotherapy for limb salvage (P = .4) or survival (P = .3). Statin use was associated with improved survival (P = .04), and improved limb salvage (hazard ratio, 0.3; 95% confidence interval, 0.1-0.7) after adjusting for severity of disease, traditional risk factors, and concurrent antiplatelet use. CONCLUSIONS: Statin use in patients with PAD with interventions was associated with improved limb salvage and survival. Despite existing guidelines, statin therapy was low in our PAD population, and efforts are ongoing to increase their use across the health care system.

Dual antiplatelet therapy (clopidogrel and aspirin) is associated with increased all-cause mortality after carotid revascularization for asymptomatic carotid disease.

OBJECTIVE: Despite the established guidelines, there is not a clear consensus about how to manage antiplatelet therapy after carotid surgery. It is a common practice in vascular surgery to use the combination of aspirin and clopidogrel in the treatment of such patients. In this work, we analyzed the impact on long-term survival of antiplatelet therapy in patients treated for carotid stenosis at a single institution over a 10-year period. METHODS: Outcomes of 471 patients who underwent carotid intervention (1999-2008) were analyzed. Discharge prescription summaries were retrieved, and patients were divided into two groups according to their antiplatelet regimen: aspirin-only group and aspirin plus clopidogrel group. Only patients with a minimum of 30 days of confirmed antiplatelet therapy were included. All-cause mortality during follow-up represented the primary outcome, whereas stroke and bleeding at 30 days and during follow-up represented secondary end points. When local records were sparse, the Social Security Death Index was queried to confirm mortality. The International Classification of Diseases, 9th Revision (ICD-9 codes), was reviewed for treatment related to a bleeding condition. RESULTS: When divided by indication, there was an increased mortality rate in patients with asymptomatic carotid disease receiving dual antiplatelet therapy as compared with aspirin alone (47% vs 40%; P = .05). Patients with symptomatic carotid disease had a nonsignificant decrease in all-cause mortality if they received dual antiplatelet therapy (38% vs 39%; P = .53). In a subgroup analysis, there was a significant increase in the rate of all-cause mortality among patients older than 75 years receiving dual antiplatelet therapy for asymptomatic carotid disease (82% vs 56%; P = .001), whereas there was a nonsignificant decrease in mortality in patients older than 75 years receiving dual antiplatelet therapy for symptomatic carotid disease (47% vs 63%; P = .50). There was no difference in secondary outcomes (stroke and bleeding) regardless of the indication or the antiplatelet therapy. CONCLUSIONS: In this retrospective, single-institution study, the use of dual antiplatelet therapy (aspirin plus clopidogrel) in patients intervened for asymptomatic carotid disease was related to increased all-cause mortality, whereas it did not significantly influence the outcome in patients with symptomatic carotid disease.

Risk scoring system to predict 3-year survival in patients treated for asymptomatic carotid stenosis.

OBJECTIVE: To identify risk factors and stratify their effect of compromising 3-year survival in patients treated for asymptomatic carotid disease based upon recently updated guidelines from the Society for Vascular Surgery. METHODS: Outcomes of 506 patients who underwent carotid intervention for asymptomatic carotid disease (1999-2008) were analyzed. Hospital computerized medical records were reviewed. When local records were sparse, Social Security Death Index was queried to confirm mortality. Following multivariable Cox regression analysis, a score was assigned based on the calculated hazard ratio (HR) in the following fashion: HR 1.5-1.9 = 1 point; HR 2.0-3.0 = 2 points; and HR >3 = 3 points. The sum of those points comprised the final score for each patient. Kaplan-Meier analyses were then performed to delineate survival differences. RESULTS: Seventy patients (13.83%) did not survive beyond 3 years after the procedure. Age >80 years (HR, 1.79; P = .05; score 1), diabetes mellitus (HR, 1.99; P < .05; score 1), coronary artery intervention (HR, 2.03; P < .01; score 2), severe chronic kidney disease defined as glomerular filtration rate <30 and not on dialysis (HR, 2.46; P = .03; score 2), dialysis patients (HR, 5.67; P = .001; score 3), and chronic obstructive pulmonary disease (HR, 3.53; P < .001; score 3) negatively influenced 3-year survival. Patients with score ≤2 experienced 3-year mortality of 6.0%, whereas score >2 was associated with 31.6% 3-year mortality (HR, 6.10; P < .001). The score value was not associated with the stroke rate at any time point. The resultant score was validated in a separate population of patients with symptomatic carotid disease. CONCLUSIONS: This easy predictive score underscores the association of medical risk factors with decreased 3-year survival. This finding may impact future clinical decisions for management of asymptomatic carotid disease.

Multicenter assessment of the repeatability and reproducibility of the revised Venous Clinical Severity Score (rVCSS).

BACKGROUND: The Venous Clinical Severity Score (VCSS) was designed and validated as an objective measure of disease severity in patients with chronic venous disease (CVD). Recently, a revision of the VCSS (rVCSS) was performed to resolve ambiguity in the clinical descriptors and improve clarity and ease of use. This new revised VCSS requires validation to determine its repeatability and reproducibility in clinical evaluation of patients with varying levels of CVD. METHODS: A prospective multicenter protocol was designed to enroll patients undergoing evaluation for CVD at venous practices with experience using the original VCSS. At the time of initial evaluation, two clinicians independently assessed both lower extremities to determine the rVCSS and the CEAP clinical score. Between 1 and 6 weeks, patients returned and received repeat assessment of the rVCSS by the same two clinicians independently. Patients were excluded if any venous intervention occurred between the two separate evaluation visits. Scores were compared to determine inter- and intra-observer variability overall and within each CEAP clinical class. RESULTS: Seven centers enrolled a total of 136 limbs yielding 248 paired evaluations for interobserver variability and 258 paired evaluations for intraobserver variability. The mean interobserver rVCSS difference was 1.4 ± 1.7 and the mean intraobserver variability was 1.3 ± 1.6. Statistical assessment with weighted kappa yielded good repeatability (κ = 0.68; P < .0001) and good reproducibility (κ = 0.72; P < .000001) for the rVCSS. The rVCSS correlated well with the CEAP clinical class with significant differences between rVCSS in increasing classes. (P < .0001). CONCLUSIONS: In this multicenter evaluation, the rVCSS was demonstrated to be a reliable and reproducible instrument for documentation of the severity of symptoms in patients with lower extremity venous insufficiency.

Validation of Venous Clinical Severity Score (VCSS) with other venous severity assessment tools from the American Venous Forum, National Venous Screening Program.

BACKGROUND: Several standard venous assessment tools have been used as independent determinants of venous disease severity, but correlation between these instruments as a global venous screening tool has not been tested. The scope of this study is to assess the validity of Venous Clinical Severity Scoring (VCSS) and its integration with other venous assessment tools as a global venous screening instrument. METHODS: The American Venous Forum (AVF), National Venous Screening Program (NVSP) data registry from 2007 to 2009 was queried for participants with complete datasets, including CEAP clinical staging, VCSS, modified Chronic Venous Insufficiency Quality of Life (CIVIQ) assessment, and venous ultrasound results. Statistical correlation trends were analyzed using Spearman's rank coefficient as related to VCSS. RESULTS: Five thousand eight hundred fourteen limbs in 2,907 participants were screened and included CEAP clinical stage C0: 26%; C1: 33%; C2: 24%; C3: 9%; C4: 7%; C5: 0.5%; C6: 0.2% (mean, 1.41 ± 1.22). VCSS mean score distribution (range, 0-3) for the entire cohort included: pain 1.01 ± 0.80, varicose veins 0.61 ± 0.84, edema 0.61 ± 0.81, pigmentation 0.15 ± 0.47, inflammation 0.07 ± 0.33, induration 0.04 ± 0.27, ulcer number 0.004 ± 0.081, ulcer size 0.007 ± 0.112, ulcer duration 0.007 ± 0.134, and compression 0.30 ± 0.81. Overall correlation between CEAP and VCSS was moderately strong (r(s) = 0.49; P < .0001), with highest correlation for attributes reflecting more advanced disease, including varicose vein (r(s) = 0.51; P < .0001), pigmentation (r(s) = 0.39; P < .0001), inflammation (r(s) = 0.28; P < .0001), induration (r(s) = 0.22; P < .0001), and edema (r(s) = 0.21; P < .0001). Based on the modified CIVIQ assessment, overall mean score for each general category included: Quality of Life (QoL)-Pain 6.04 ± 3.12 (range, 3-15), QoL-Functional 9.90 ± 5.32 (range, 5-25), and QoL-Social 5.41 ± 3.09 (range, 3-15). Overall correlation between CIVIQ and VCSS was moderately strong (r(s) = 0.43; P < .0001), with the highest correlation noted for pain (r(s) = 0.55; P < .0001) and edema (r(s) = 0.30; P < .0001). Based on screening venous ultrasound results, 38.1% of limbs had reflux and 1.5% obstruction in the femoral, saphenous, or popliteal vein segments. Correlation between overall venous ultrasound findings (reflux + obstruction) and VCSS was slightly positive (r(s) = 0.23; P < .0001) but was highest for varicose vein (r(s) = 0.32; P < .0001) and showed no correlation to swelling (r(s) = 0.06; P < .0001) and pain (r(s) = 0.003; P = .7947). CONCLUSIONS: While there is correlation between VCSS, CEAP, modified CIVIQ, and venous ultrasound findings, subgroup analysis indicates that this correlation is driven by different components of VCSS compared with the other venous assessment tools. This observation may reflect that VCSS has more global application in determining overall severity of venous disease, while at the same time highlighting the strengths of the other venous assessment tools.

Mandated quality measures and economic implications of venous thromboembolism prevention and management.

BACKGROUND: Although considerable evidence describes optimal prevention and treatment of venous thromboembolism (VTE), a gap still exists in the implementation of these measures. With increasing recognition from quality accreditation organizations, VTE prevention recently has become a mandated health care quality measure. A broad effort to implement quality care measures in the health care system is under way, but the economic implications of this effort have yet to be realized. This article reviews the current status and future trends of quality care measures for VTE prevention and treatment and the potential economic implications of wider implementation of evidence-based guidelines. DATA SOURCES: A MEDLINE literature search was performed to identify original studies. The National Guidelines Clearinghouse was searched to identify appropriate guidelines. CONCLUSIONS: Increased public awareness about risk factors and symptoms is needed, and patients must feel empowered to speak with health care providers about VTE. Health care practitioners require clearly understood and routinely applied evidence-based practices for the screening, prevention, diagnosis, and treatment of deep vein thrombosis and pulmonary embolism. Further research is required to determine the most efficient translation of these practices from bench to bedside.

Duplex scan-directed placement of inferior vena cava filters: a five-year institutional experience.

PURPOSE: The purpose of this study was the assessment of the safety, efficacy, and hospital charges of bedside duplex ultrasound-directed inferior vena cava (IVC) filter placement. METHODS: All duplex ultrasound-directed IVC filters that were placed from August 8, 1995, to December 31, 2000, are reviewed. Chart review combined with mailed questionnaires and telephone follow-up examinations were used to collect demographic and outcome data. RESULTS: Three hundred twenty-five patients underwent evaluation, and 284 underwent duplex ultrasound-directed IVC filter placement. Two hundred three (71%) were male patients, and 81 (29%) were female patients. Poor IVC visualization, IVC thrombosis, and unsuitable anatomy prevented duplex-directed filter placement in 41 patients (12%). Indication for filter placement included venous prophylaxis in the absence of thromboembolism in 235 patients (83%), contraindication to anticoagulation therapy in 34 patients (12%), prophylaxis with therapeutic anticoagulation therapy in the presence of thromboembolism in 7 patients (2%), and complication of anticoagulation therapy in 8 patients (3%). There were no procedure-related deaths or septic complications. Technical complications occurred in 12 patients (4%). Filter misplacement occurred in 6 patients (2%), access thrombosis in 1 (<1%), migration in 1 (<1%), bleeding in 1 (<1%), and IVC occlusion in 3 (1%). Pulmonary emboli after IVC filter placement occurred in one patient with a misplaced filter. Average hospital charges related to duplex ultrasound-directed filter placement were $2388 less than fluoroscopic placement charges in the year 2000. CONCLUSION: Our experience indicates that duplex ultrasound-directed IVC filter placement is safe, cost-effective, and convenient for patients who need IVC filter placement.