The Operating Room Black Box: Understanding Adherence to Surgical Checklists.

OBJECTIVE: We report for the first time the use of the Operating Room Black Box (ORBB) to track checklist compliance, engagement, and quality. BACKGROUND: Implementation of operative checklists is associated with improved outcomes. Compliance is difficult to monitor. Most studies report either no assessment of checklist compliance or deployed in-person short-term assessment. The ORBB a novel artificially intelligence-driven data analytic platform affords the opportunity to assess checklist compliance without disrupting surgical workflow. METHODS: This was a retrospective review of prospectively collected ORBB data. Operative cases included elective surgery at a quaternary referral center. Cases were analyzed as prepolicy change (first 9 months) or as a postpolicy change (last 9 months). Measures of checklist compliance, engagement, and quality were assessed. RESULTS: There were 3879 cases that were performed and monitored for checklist compliance between August 15, 2020, and February 20, 2022. The overall scores for compliance, engagement, and quality were 81%, 84%, and 67% respectively. When broken down by phase, the scores for time-out were compliance 100%, engagement 98%, and quality 61%. Scores for the debrief phase were 81% for compliance, 98% for engagement, and 66% for quality. After a hospital policy change, the debrief scores improved significantly (85%; P <0.001 for compliance, 88%; P <0.001 for engagement and 71%; P <0.001 for quality). CONCLUSIONS: ORBB provides the unprecedented ability to assess not only compliance with surgical safety checklists but also engagement and quality. Utilization of this technology allows the assessment of compliance in near real time and to accurately address safety threats that may arise from noncompliance.

An inverse planned oil release validation method for estimating oil slick thickness from thermal contrast remote sensing by in-scene calibration.

This study demonstrates a method to estimate floating oil slick thickness based on remote sensing of thermal infrared contrast. The approach was demonstrated for thick oil slicks from natural seeps in the Coal Oil Point seep field, offshore southern California. Airborne thermal infrared and visible spectrum remote sensing imagery were acquired along with position and orientation data by the SeaSpires™ science package. Remote sensing data were acquired in the cross-slick direction of oil slick segments that were targeted for collection, termed "collects." A collect consisted of booming, skimming, and offloading the oil slick segment into buckets for analysis at the laboratory. Each collect provided an in-scene calibration point of oil thickness versus brightness temperature contrast, ΔTB , where TB is the sensor-reported temperature based on the emitted thermal radiation and differs from the true temperature due to the oil's emissivity. ΔTB is the TB difference between the oil and oil-free sea surface. Thus, this study is a reverse planned oil-release experiment that demonstrates the value of natural seeps for oil spill science. • Novel approach to quantify floating oil thickness • Custom modified weir skimmer used with added floor and structural strengthening.

Ovarian Cancer Ascites Inhibits Transcriptional Activation of NK Cells Partly through CA125.

Malignant ascites is a common clinical problem in ovarian cancer. NK cells are present in the ascites, but their antitumor activity is inhibited. The underlying mechanisms of the inhibition have yet to be fully elucidated. Using an Fcγ receptor-mediated NK cell activation assay, we show that ascites from ovarian cancer patients potently inhibits NK cell activation. Part of the inhibitory activity is mediated by CA125, a mucin 16 fragment shed from ovarian cancer tumors. Moreover, transcriptional analyses by RNA sequencing reveal upregulation of genes involved in multiple metabolic pathways but downregulation of genes involved in cytotoxicity and signaling pathways in NK cells purified from ovarian cancer patient ascites. Transcription of genes involved in cytotoxicity pathways are also downregulated in NK cells from healthy donors after in vitro treatment with ascites or with a CA125-enriched protein fraction. These results show that ascites and CA125 inhibit antitumor activity of NK cells at transcriptional levels by suppressing expression of genes involved in NK cell activation and cytotoxicity. Our findings shed light on the molecular mechanisms by which ascites inhibits the activity of NK cells and suggest possible approaches to reactivate NK cells for ovarian cancer immunotherapy.

Near Complete Pathologic Response to PD-1 Inhibitor and Radiotherapy in a Patient with Locally Advanced Pancreatic Ductal Adenocarcinoma.

Pancreatic ductal adenocarcinoma (PDAC) remains deadly despite advances in systemic therapies and surgical techniques. While there is increasing utilization of immune therapies across diverse cancer types, PDAC remains generally resistant to these treatments. We report a case of locally advanced PDAC treated with preoperative radiation and anti-PD-1 immunotherapy guided by preoperative PD-L1 tumor analysis. After 4 months of preoperative therapy, the patient was submitted to resection, demonstrating a near-complete pathologic response on final tumor analysis. We will discuss the relevant literature and current state of immunotherapeutics for PDAC.

Chemo- and Regioselective Functionalization of Isotactic Polypropylene: A Mechanistic and Structure-Property Study.

Polyolefins represent a high-volume class of polymers prized for their attractive thermomechanical properties, but the lack of chemical functionality on polyolefins makes them inadequate for many high-performance engineering applications. We report a metal-free postpolymerization modification approach to impart functionality onto branched polyolefins without the deleterious chain-coupling or chain-scission side reactions inherent to previous methods. The identification of conditions for thermally initiated polyolefin C-H functionalization combined with the development of new reagents enabled the addition of xanthates, trithiocarbonates, and dithiocarbamates to a variety of commercially available branched polyolefins. Systematic experimental and kinetic studies led to a mechanistic hypothesis that facilitated the rational design of reagents and reaction conditions for the thermally initiated C-H xanthylation of isotactic polypropylene (iPP) within a twin-screw extruder. A structure-property study showed that the functionalized iPP adheres to polar surfaces twice as strongly as commercial iPP while demonstrating similar tensile properties. The fundamental understanding of the elementary steps in amidyl radical-mediated polyolefin functionalization provided herein reveals key structure-reactivity relationships for the design of improved reagents, while the demonstration of chemoselective and scalable iPP functionalization to realize a material with improved adhesion properties indicates the translational potential of this method.

[Analysis of uterus cervical cancer screening campaign results in Conakry, Guinea]. / Analyse des résultats des campagnes de dépistage du cancer du col de l'utérus à Conakry, Guinée.

OBJECTIVE: Reduce morbidity and death rates of women with cervical cancer in Guinea. METHODOLOGY: This was a five-day cross-sectional study carried out in two successive years (2012 and 2013) at the CERFFO-PCG in Conakry. The target population was women aged 25-49. Approximately 500 women for 2012 and 900 women were expected in these cervical screening campaigns by visual methods (IVA and IVL) with immediate treatment of precancerous lesions. After histologic confirmation of the cancer lesions, the management was carried out according to the protocols in force in the country. We performed a simple descriptive analysis and the results expressed as a percentage and on average. RESULTS: The target population represented 60.4% in 2012 and 76.2% in 2013, of the total number of women received. The incidence rate of high-grade intraepithelial lesions and cancers increased from 2.6% in 2012 to 0.9% in 2013. In 2012, the 57 precancerous lesions were treated with immediate treatment and 10 cases of cancers out of the 16 had a surgical treatment. Also in 2013, all precancerous lesions were treated immediately and 2 cancers out of the 4 benefited from surgery. CONCLUSION: Our research shows that, with creativity, flexibility, good organization and efficient use of resources, morbidity and death rates of women with cervical cancer in a very resources can be significantly reduced.

The impact of clopidogrel therapy on postoperative bleeding after robotic-assisted coronary artery bypass surgery.

OBJECTIVES: The purpose of this study was to determine whether patients undergoing robotic-assisted coronary artery bypass graft surgery (CABG) on clopidogrel had an increased risk of bleeding complications compared with those not on clopidogrel. METHODS: From 2008 to 2011, 322 patients underwent robotic-assisted CABG either as an isolated procedure or as part of a hybrid coronary revascularization procedure (HCR). Patients were classified according to whether they received clopidogrel within 5 days of surgery or intraoperatively (n = 64) compared with those who never received or who had discontinued clopidogrel therapy >5 days before surgery (n = 258). A propensity analysis using 31 preoperative variables was used to control for confounding variables. In a subgroup analysis, patients undergoing one-stage HCR (clopidogrel load 600 mg in odds ratio (OR) prior to stenting) were compared with patients in the clopidogrel group who underwent two-stage HCR. RESULTS: In the Clopidogrel group, the mean interval between surgery and last dose of clopidogrel was 2.1 ± 1.5 days. Compared with the No Clopidogrel group, the Clopidogrel group had greater 24-h chest tube drainage (1003 ± 572 vs 782 ± 530 ml, P = 0.004) and more blood transfusions (35.9%, 23 of 64 patients vs 20.9%, 54 of 258 patients, P = 0.01). On logistic regression analysis, there was greater 24-h chest tube drainage in the Clopidogrel group (+198 ml, P = 0.02) and a significantly higher incidence of blood transfusion (OR = 2.30, P = 0.01). In the subgroup analysis, patients undergoing one-stage HCR (n = 17) had greater 24-h chest tube drainage compared with patients undergoing two-stage HCR (1262 vs 909 ml, P = 0.03). CONCLUSIONS: Patients undergoing robotic-assisted CABG on clopidogrel had more postoperative bleeding and a higher incidence of blood transfusion. Therefore, despite a less invasive approach, surgery should be delayed in these patients when possible.

Is the liberal use of preoperative 3-dimensional imaging and presternotomy femoral cutdown beneficial in reoperative adult congenital heart surgery?

OBJECTIVE: Patients with congenital heart disease frequently survive into adulthood, and many of them will require repeat surgery. Often, the unique anatomy can make reoperative sternotomy and the conduct of cardiopulmonary bypass challenging. We evaluated the utility of preoperative 3-dimensional imaging and presternotomy femoral cutdown in reoperative adult congenital heart disease surgery. METHODS: We retrospectively studied 205 adult patients, who had undergone reoperative cardiac surgery for congenital heart disease from 2006 to 2011. Using the operative history and 3-dimensional preoperative imaging findings, an algorithm was created to determine whether femoral cutdown or cannulation should be performed before sternal reentry. Analyses were performed to determine the benefits of this strategy. In addition, analyses were performed to identify adverse outcomes related to this strategy. RESULTS: Presternotomy femoral intervention was performed in 112 of 205 patients (55%)-femoral cutdown alone in 69 (34%) and femoral cutdown, cannulation, and institution of cardiopulmonary bypass in 43 (21%). Of the 19 patients (9%) with a cardiac injury, femoral cutdown had already been performed in 17, of whom 10 had also undergone cannulation. Only 2 patients required urgent femoral cutdown or cannulation. A strong correlation was found between the site of injury predicted by the preoperative algorithm and the actual site of cardiac injury (88%). In both univariate and multivariate models, the risk factors for cardiac injury included a history of cardiac injury during sternal reentry (18% vs 1%, P = .0001), proximity of the right ventricular outflow tract to the posterior chest wall (35% vs 14%, P = .04), and increased reoperative sternotomy incidence (P = .01). In 31 patients, despite safe reentry, the femoral vessels were used as a preferential site of venous (n = 6), arterial (n = 9), or venous and arterial cannulation (n = 16) because of anatomic constraints within the chest cavity. Three patients experienced groin complications (pseudoaneurysm, abscess, ischemia) requiring surgery. CONCLUSIONS: Cardiac injury during reoperative surgery in adults with congenital heart disease is not uncommon. The preoperative history and imaging findings could be predictive of certain cardiac injury patterns. Using the preoperative history and 3-dimensional imaging findings, a more selective algorithm for presternotomy femoral intervention might be warranted.

Trends in aortic clamp use during coronary artery bypass surgery: effect of aortic clamping strategies on neurologic outcomes.

OBJECTIVE: The purpose of the present study was to determine the effect of different clamping strategies during coronary artery bypass grafting on the incidence of postoperative stroke. METHODS: In the present case-control study, all patients at Emory hospitals from 2002 to 2009 with postoperative stroke after isolated coronary artery bypass grafting (n = 141) were matched 1:4 to a contemporaneous cohort of patients without postoperative stroke (n = 565). The patients were matched according to the Society of Thoracic Surgeons' predicted risk of postoperative stroke score, which is based on 26 variables. The patients who received on-pump and off-pump coronary artery bypass grafting were matched separately. Multiple logistic regression analysis with adjusted odds ratios was performed to identify the operative variables associated with postoperative stroke. RESULTS: Among the on-pump cohort, the single crossclamp technique was associated with a decreased risk of stroke compared with the double clamp (crossclamp plus partial clamp) technique (odds ratio, 0.385; P = .044). Within the on-pump cohort, no significant difference was seen in the incidence of stroke according to clamp use. Epiaortic ultrasound of the ascending aorta increased from 45.3% in 2002 to 89.4% in 2009. From 2002 to 2009, clamp use decreased from 97.7% of cases to 72.7%. CONCLUSIONS: During on-pump coronary artery bypass grafting, the use of a single crossclamp compared with the double clamp technique decreased the risk of postoperative stroke. The use of any aortic clamp decreased and epiaortic ultrasound use increased from 2002 to 2009, indicating a change in the operative technique and surgeon awareness of the potential complications associated with manipulation of the aorta.

The accuracy of transit time flow measurement in predicting graft patency after coronary artery bypass grafting.

OBJECTIVE: Transit time flow measurement (TTFM) is a method used to assess intraoperative blood flow after vascular anastomoses. Angiography represents the criterion standard for the assessment of graft patency after coronary artery bypass grafting (CABG). The purpose of this study was to compare flow measurements from TTFM to diagnostic angiography. METHODS: From October 9, 2009, to April 30, 2012, a total of 259 patients underwent robotic-assisted CABG procedures at a single institution. Of these, 160 patients had both TTFM and either intraoperative or postoperative angiography of the left internal mammary artery to the left anterior descending coronary artery graft. Transit time flow measurements were obtained after completion of the anastomosis and after administration of protamine before chest closure. Transit time flow measurement assessment included pulsatility index, diastolic fraction, and flow (milliliters per minute). Angiograms were graded according to the Fitzgibbon criteria. The patients were grouped according to angiographic findings, with perfect grafts defined as FitzGibbon A and problematic grafts defined as either Fitzgibbon B or O. RESULTS: Overall, there were 152 (95%) of 160 angiographically perfect grafts (FitzGibbon A). Of the eight problematic grafts, five were occluded (Fitzgibbon O) and three had significant flow-limiting lesions (FitzGibbon B). Two patients had intraoperative graft revision after completion angiography, one had redo CABG during the same hospitalization, and five were treated with percutaneous coronary intervention. A significant difference was seen in mean ± SD flow (34.3 ± 16.8 mL/min vs 23.9 ± 12.5 mL/min, P = 0.033) between patent and nonpatent grafts but not in pulsatility index (1.98 ± 0.76 vs 1.65 ± 0.48, P = 0.16) or diastolic fraction (73.5% ± 8.45% vs 70.9% ± 6.15%, P = 0.13). CONCLUSIONS: Although TTFM can be a useful tool for graft assessment after CABG, false negatives can occur. Angiography remains the criterion standard to assess graft patency and quality of the anastomosis after CABG.

Prospective analysis of coronary calcium in patients on dialysis undergoing a near-total parathyroidectomy.

BACKGROUND: Patients with secondary hyperparathyroidism and on dialysis are more likely to die of cardiovascular disease than the general population; and we have reported that near-total parathyroidectomy (NTPTX) reduces that mortality rate. Patients on dialysis experience an average of a 15% increase in coronary calcification yearly, contributing to cardiovascular death. Cardiac computed tomography (CT) enables objective measuring of coronary calcium. The purpose of our study was to determine the impact of NTPTX on coronary artery calcium score (CACS). METHODS: CACS measurement was performed in patients with stage 5 chronic kidney disease before and after NTPTX from 2001 to 2008. Demographics, morbidities, CACS, outcomes, intact parathyroid hormone (PTH) measurements in follow-up (mean, 5.1 years) were maintained in an institutional review board-approved prospective database. Of 31 patients, 19 (61%) returned for a follow-up coronary CT. RESULTS: Preoperative mean PTH level and CACS were 1,794 ± 943 pg/mL and 979 ± 079, respectively; postoperatively, PTH and CACS were 321 ± 244 pg/mL (P < .001) and 1,285 ± 1,577 (P = .044), respectively. CACS was stable or reduced (<10% per year) in 6 of 19 patients (32%), and 42% of patients (n = 8) had nearly undetectable (<1% per year) change in CACS after NTPTX. In patients with stable CACS, mean postoperative PTH was 251 versus 516 pg/mL in patients with increasing CACS (P = .02). In patients with recurrent hyperparathyroidism (PTH > 400) compared with patients with stable postoperative PTH, CACS increased by 804 ± 1082 versus 16 ± 84 (P = .02). CONCLUSION: Successful NTPTX with stable postoperative PTH levels is associated with stabilization of CACS in patients with severe secondary hyperparathyroidism undergoing hemodialysis, which could contribute to the improved survival seen after NTPTX.

Evaluation of the risk of noncontiguous fractures of the spine in blunt trauma.

BACKGROUND: There is significant debate over the risk of additional noncontiguous (NC) fractures among blunt trauma patients with an identified spinal column injury, often prompting routine full-spine imaging. We sought to determine the incidence of NC spinal fractures and the relationship between injury pattern and mechanism. METHODS: A review of all adult blunt trauma patients from the 2010 National Trauma Data Bank with a spine fracture. Patient demographics, mechanism of injury, and frequencies of all combinations of spinal fractures were analyzed. RESULTS: Among 654,052 blunt trauma patients, 83,338 (13%) had a diagnosed spine fracture. The mean (SD) Injury Severity Score (ISS) was 15 (11). Of these, 7% (5,496) sustained spinal cord injury, and 17% (14,413) underwent spinal surgery during their index hospitalization. Among those with spinal column fractures, the overall incidence of NC fractures was 19% and was associated with severe truncal injuries, primarily involving the chest. The relative incidences of cervical, thoracic, and lumbar fractures were 41% (34,480), 37% (30,383), and 43% (35,778), respectively. Rates of NC fractures of the spine included 9% cervicothoracic (7,406), 4% cervicolumbar (3,415), and 10% thoracolumbar (7,929). The slight majority (57%) of patients with spinal fractures sustained high-velocity trauma compared with 43% associated with low-velocity trauma. However, NC fractures of the spine were strongly associated with high-velocity trauma. CONCLUSION: Spine fractures are relatively common with blunt trauma, and approximately 20% of patients with a spinal column fracture will have an NC fracture. NC fractures were associated with other severe injuries and should be mainly suspected and investigated in high-velocity mechanisms.

Specific adverse events predict survival benefit in patients treated with tamoxifen or aromatase inhibitors: an international tamoxifen exemestane adjuvant multinational trial analysis.

PURPOSE: Specific adverse events (AEs) associated with endocrine therapy and related to depletion or blocking of circulating estrogens may be related to treatment efficacy. We investigated the relationship between survival outcomes and specific AEs including vasomotor symptoms (VMSs), musculoskeletal adverse events (MSAEs), and vulvovaginal symptoms (VVSs) in postmenopausal patients with breast cancer participating in the international Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial. PATIENTS AND METHODS: Primary efficacy end points were disease-free survival (DFS), overall survival (OS), and distant metastases (DM). VMSs, MSAEs, and VVSs arising in the first year of endocrine treatment were considered. Patients who did not start or who discontinued their allocated therapy and/or had an event (recurrence/death) within 1 year after randomization were excluded. Landmark analyses and time-dependent multivariate Cox proportional hazards models assessed survival differences up to 5 years from the start of treatment. RESULTS: A total of 9,325 patients were included. Patients with specific AEs (v nonspecific or no AEs) had better DFS and OS (multivariate hazard ratio [HR] for DFS: VMSs, 0.731 [95% CI, 0.618 to 0.866]; MSAEs, 0.826 [95% CI, 0.694 to 0.982]; VVSs, 0.769 [95% CI, 0.585 to 1.01]; multivariate HR for OS: VMSs, 0.583 [95% CI, 0.424 to 0.803]; MSAEs, 0.811 [95% CI, 0.654 to 1.005]; VVSs, 0.570 [95% CI, 0.391 to 0.831]) and fewer DM (VMSs, 0.813 [95% CI, 0.664 to 0.996]; MSAEs, 0.749 [95% CI, 0.601 to 0.934]; VVSs, 0.687 [95% CI, 0.436 to 1.085]) than patients not reporting these symptoms. Increasing numbers of specific AEs were also associated with better survival outcomes. Outcomes were unrelated to treatment allocation. CONCLUSION: Certain specific AEs are associated with superior survival outcomes and may therefore be useful in predicting treatment responses in patients with breast cancer treated with endocrine therapy.

Lessons learned from robotic-assisted coronary artery bypass surgery: risk factors for conversion to median sternotomy.

OBJECTIVE: Robotic-assisted coronary artery bypass is a minimally invasive alternative to traditional coronary artery bypass surgery via median sternotomy with an associated learning curve. The purpose of this study was to investigate the reasons for conversion to sternotomy. METHODS: From October 2009 to June 2012, two surgeons at one US academic institution performed 271 consecutive robotic-assisted coronary artery bypass procedures. For all cases, isolated, off-pump left internal mammary artery (LIMA) to left anterior descending coronary artery grafting was planned via a 3- to 4-cm sternal-sparing thoracotomy after robotic internal mammary artery harvest and pericardiotomy. RESULTS: Conversion to sternotomy occurred in 15 of 271 (5.5%) patients. The most common reason was technical difficulty with the anastomosis, which occurred in 6 (40.0%) patients. Others included LIMA dissection, 2 (13.3%); wrong vessel grafted, 2 (13.3%); ventricular fibrillation and cardiac arrest, 1 (6.7%); equipment malfunction, 1 (6.7%); adhesions, 1 (6.7%); and other. Two underwent emergent conversion. Six underwent multivessel bypass after conversion instead of hybrid coronary revascularization. No mortality occurred among converted patients. Two patients had postoperative myocardial infarction and one had a superficial sternal wound infection. Conversion rate was relatively stable among the four different time quartiles (range, 3.0%-7.4%), although the reasons for conversion were different. CONCLUSIONS: Conversion to sternotomy is an infrequent complication of robotic-assisted coronary artery bypass, most commonly because of technical difficulties during the LIMA harvest and the LIMA to left anterior descending anastomosis. Anatomic and patient variables as well as inherent technical problems with minimally invasive procedures make conversion unavoidable in some patients.

Long-term frontal sinus patency after endoscopic frontal sinusotomy.

BACKGROUND: The frontal recess is the drainage pathway that connects the frontal sinus to the anterior ethmoid sinus. Mechanical obstruction is the primary cause of chronic frontal sinusitis with or without a secondary inflammatory process. Eosinophilic inflammation is one of the underlying causes for chronic rhinosinusitis. OBJECTIVES/HYPHOTHESIS: To evaluate long-term frontal sinus patency after endoscopic frontal sinusotomy in chronic rhinosinusitis patients and to assess the effect of eosinophilic inflammation on frontal sinus patency. STUDY DESIGN: Retrospective chart review. Symptom assessment and archived endoscopic photographs were prospectively collected on patients who underwent frontal sinusotomy between 7-1-1999 and 12-31-2000. Subjective symptom improvements were evaluated using the SNOT-20 = 20-item Sino-Nasal Outcome Test. Objective findings of endoscopic frontal sinus patency were documented by archived digital photography. RESULTS: A total of 161 patients with 294 frontal sinuses who underwent endoscopic frontal sinus surgery in the 18 months had an average follow-up of 45.9 months. The patient population was divided into two groups: 58 patients had eosinophilic CRS (ECRS), and 103 patients had CRS without eosinophils (non-ECRS). The mean follow-up for patients with ECRS is 61.6 months and 37.0 months for non-ECRS patients. The non-ECRS patients had a documented endoscopic frontal sinus patency of 90%, and the ECRS patients had an endoscopic frontal sinus patency of 85%. The overall frontal ostium patency rate for all patients was 88.0%. CONCLUSIONS: Long-term endoscopic confirmation of frontal ostium patency demonstrates that endoscopic frontal sinusotomy can yield high quality, durable results. There was no significant difference in patency results between ECRS and non-ECRS patients. Laryngoscope, 2009.

Quantifying improvement in symptoms, functioning, and quality of life after peripheral endovascular revascularization.

BACKGROUND: Patients with peripheral arterial disease often undergo peripheral endovascular revascularization (PER) to alleviate symptoms. Despite the growth of PER, little information exists quantifying the health status benefits after the procedure. METHODS AND RESULTS: From February 2001 to August 2004, 477 consecutive patients underwent PER for symptomatic peripheral arterial disease. Of these, 300 consented to participate in a longitudinal follow-up study of their health status. Health status was quantified with the disease-specific Peripheral Artery Questionnaire and the generic Short Form-12 and the EuroQol 5 Dimensions (EQ5D)questionnaire. Scores range from 0 to 100; higher scores represent fewer symptoms and better health status. The average age of the cohort was 68+/-11 years (mean+/-SD); 186 (62%) were male, 288 (96%) were white, and 118 (39%) were diabetic. Clinical follow-up was attained in 99% of patients; health status assessments were made in 86%. Mean Peripheral Artery Questionnaire summary scores improved significantly after revascularization from 31+/-19 to 62+/-27 at 1 year (P<0.0001). Generic health status scores also improved significantly (P<0.001 for all). Despite a technically successful procedure in 98% of patients, 21% of patients did not achieve the minimal clinically important improvement of an 8-point change in Peripheral Artery Questionnaire Summary score after PER (35+/-19 at baseline versus 31+/-16 at 1 year; P=0.09). CONCLUSIONS: For most patients, significant and sustained improvements in symptoms, functioning, and quality of life occur after PER. Identifying and counseling patients less likely to benefit from PER is an important future research direction.