Data analysis of vascular surgery instrument trays yielded large cost and efficiency savings.

BACKGROUND: Surgical procedures account for 50% of hospital revenue and ∼60% of operating costs. On average, <20% of surgical instruments will be used during a case, and the expense for resterilization and assembly of instrument trays ranges from $0.51 to $3.01 per instrument. Given the complexity of the surgical service supply chain, physician preferences, and variation of procedures, a reduction of surgical cost has been extremely difficult and often ill-defined. A data-driven approach to instrument tray optimization has implications for efficiency and cost savings in sterile processing, including reductions in tray assembly time and instrument repurchase, repair, and avoidable depreciation. METHODS: During a 3-month period, vascular surgery cases were monitored using a cloud-based technology product (OpFlow, Operative Flow Technologies, Raleigh, NC) as a part of a hospital-wide project. Given the diversity of the cases evaluated, we focused on two main vascular surgery trays: vascular and aortic. An assessment was performed to evaluate the exact instruments used by the operating surgeons across a variety of cases. The vascular tray contained 131 instruments and was used for the vast majority of vascular cases, and the aortic tray contained 152 instruments. Actual instrument usage data were collected, a review and analysis performed, and the trays optimized. RESULTS: During the 3-month period, 168 vascular surgery cases were evaluated across six surgeons. On average, the instrument usage per tray was 30 of 131 instruments (22.9%) for the vascular tray and 19 of 152 (12.5%) for the aortic tray. After review, 45.8% of the instruments were removed from the vascular tray and 62.5% from the aortic tray, for 1255 instruments removed from the versions of both trays. An audit was performed after the removal of instruments, which showed that none of the removed instruments had required reinstatement. The instrument reduction from these two trays alone yielded an estimated costs savings of $97,781 for repurchase and $97,444 in annual resterilization savings. Annually, the removal of the instruments is projected to save 316.2 hours of personnel time. The time required for operating room table setup decreased from a mean of 7:44 to 5:02 minutes for the vascular tray (P < .0001) and from 8:53 to 4:56 minutes for the aortic tray (P < .0001). CONCLUSIONS: Given increasing cost constraints in healthcare, sterile processing remains an untapped resource for surgical expense reduction. A comprehensive data analytics solution provided the ability to make informed decisions in tray management that otherwise could not be reliably performed.

Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism.

PURPOSE: To report final 2-year outcomes with the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). MATERIALS AND METHODS: In a prospective multicenter trial, the Sentry filter was implanted in 129 patients with documented deep vein thrombosis (DVT) and/or PE (67.5%) or who were at temporary risk of developing DVT/PE (32.6%). Patients were monitored and bioconversion status ascertained by radiography, computed tomography (CT), and CT venography through 2 years. RESULTS: The composite primary 6-month endpoint of clinical success was achieved in 97.4% (111/114) of patients. The rate of new symptomatic PE was 0% (n = 126) through 1 year and 2.4% (n = 85) through the second year of follow-up, with 2 new nonfatal cases at 581 and 624 days that were adjudicated as not related to the procedure or device. Two patients (1.6%) developed symptomatic caval thrombosis during the first month and underwent successful interventions without recurrence. No other filter-related symptomatic complications occurred through 2 years. There was no filter tilting, migration, embolization, fracture, or caval perforation and no filter-related deaths through 2 years. Filter bioconversion was successful for 95.7% (110/115) of patients at 6 months, 96.4% (106/110) of patients at 12 months, and 96.5% (82/85) of patients at 24 months. Through 24 months of follow-up, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms. CONCLUSIONS: The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 2 years of follow-up.

The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism.

The Sentry inferior vena cava (IVC) filter is designed to provide temporary protection against pulmonary embolism (PE) during transient high-risk periods and then to bioconvert after 60 days after implantation. At the time of bioconversion, the device's nitinol arms retract from the filtering position into the caval wall. Subsequently, the stable stent-like nitinol frame is endothelialized. The Sentry bioconvertible IVC filter has been evaluated in a multicenter investigational-device-exemption pivotal trial (NCT01975090) of 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, and with contraindications to anticoagulation. Successful filter conversion was observed in 95.7% of patients at 6 months (110/115) and 96.4% at 12 months (106/110). Through 12 months, there were no cases of symptomatic PE. The rationale for development of the Sentry bioconvertible device includes the following considerations: (1) the period of highest risk of PE for the vast majority of patients occurs within the first 60 days after an index event, with most of the PEs occurring in the first 30 days; (2) the design of retrievable IVC filters to support their removal after a transitory high-PE-risk period has, in practice, been associated with insecure filter dynamics and time-dependent complications including tilting, fracture, embolization, migration, and IVC perforation; (3) most retrievable IVC filters are placed for temporary protection, but for a variety of reasons they are not removed in any more than half of implanted patients, and when removal is attempted, the procedure is not always successful even with advanced techniques; and (4) analysis of Medicare hospital data suggests that payment for the retrieval procedure does not routinely compensate for expense. The Sentry device is not intended for removal after bioconversion. In initial clinical use, complications have been limited. Long-term results for the Sentry bioconvertible IVC filter are anticipated soon.

Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study.

PURPOSE: This study sought to assess the performance of the LIFESTREAM balloon-expandable covered stent for the treatment of iliac artery atherosclerotic lesions. METHODS: A total of 155 patients were treated in a prospective, single-arm study at 17 centers in the United States, Europe, and New Zealand. The primary endpoint was a composite of device- or procedure-related death or myocardial infarction (MI) over the course of 30 days, or target lesion revascularization (TLR), major amputation of the target limb, or re-stenosis through 9-months. Secondary endpoints included primary patency, TLR, sustained clinical success, quality of life, and major adverse events (MAE). RESULTS: At 9 months, the primary composite endpoint rate was 16.2% (93.5% confidence interval [CI]: 10.6%-23.2%), primary patency was 89.1% (95% CI: 82.6%-93.7%), and freedom from TLR was 96%. There was a cumulative clinical improvement of at least one Rutherford category from baseline to 9 months of 90.5% (95% CI: 84.3%-94.9%). Quality of life, assessed by using the Walking Impairment Questionnaire (WIQ), demonstrated a mean change in total score from baseline through 9 months of 32.1 ± 26.84; overall, improvements were noted from baseline in each WIQ category. Seven of one-hundred fifty patients (4.7%; 95% CI: 1.9%-9.4%) experienced MAEs, but none were determined to be related to device or procedure. CONCLUSIONS: The LIFESTREAM balloon-expandable covered stent provided satisfactory 9-month clinical outcomes including a low rate of target lesion revascularization for the treatment of stenotic and occlusive lesions of the iliac arteries.

One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter.

PURPOSE: To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). MATERIALS AND METHODS: At 23 sites, 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, unable to use anticoagulation were enrolled. The primary end point was clinical success, including successful filter deployment, freedom from new symptomatic PE through 60 days before filter bioconversion, and 6-month freedom from filter-related complications. Patients were monitored by means of radiography, computerized tomography (CT), and CT venography to assess filtering configuration through 60 days, filter bioconversion, and incidence of PE and filter-related complications through 12 months. RESULTS: Clinical success was achieved in 111 of 114 evaluable patients (97.4%, 95% confidence interval [CI] 92.5%-99.1%). The rate of freedom from new symptomatic PE through 60 days was 100% (n = 129, 95% CI 97.1%-100.0%), and there were no cases of PE through 12 months for either therapeutic or prophylactic indications. Two patients (1.6%) developed symptomatic caval thrombosis during the first month; neither experienced recurrence after successful interventions. There was no filter tilting, migration, embolization, fracture, or caval perforation by the filter, and no filter-related death through 12 months. Filter bioconversion was successful for 95.7% (110/115) at 6 months and for 96.4% (106/110) at 12 months. CONCLUSIONS: The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 12 months of imaging-intense follow-up.

Warfarin Management and Outcomes in Patients with Nonvalvular Atrial Fibrillation Within an Integrated Health Care System.

BACKGROUND: Warfarin is a common treatment option to manage patients with nonvalvular atrial fibrillation (NVAF) in clinical practice. Understanding current pharmacist-led anticoagulation clinic management patterns and associated outcomes is important for quality improvement; however, currently little evidence associating outcomes with management patterns exists. OBJECTIVES: To (a) describe warfarin management patterns and (b) evaluate associations between warfarin treatment and clinical outcomes for patients with NVAF in an integrated health care system. METHODS: A retrospective cohort study was conducted among NVAF patients with warfarin therapy between January 1, 2006, and December 31, 2011, using Kaiser Permanente Southern California data, and followed until December 31, 2013. Management patterns related to international normalized ratio (INR) monitoring, anticoagulation clinic pharmacist intervention (consultation), and warfarin dose adjustments were investigated along with yearly attrition rates, time-in-therapeutic ranges (TTRs), and clinical outcomes (stroke or systemic embolism and major bleeding). Descriptive statistics and multivariable Cox proportional hazard models were used to determine associations between TTR and clinical outcomes. RESULTS: A total of 32,074 NVAF patients on warfarin treatment were identified and followed for a median of 3.8 years. About half (49%) of the patients were newly initiating warfarin therapy. INR monitoring and pharmacist interventions were conducted roughly every 3 weeks after 6 months of warfarin treatment. Sixty-three percent of the study population had ≥ 1 warfarin dose adjustments with a mean (SD) of 6.7 (6.3) annual dose adjustments. Warfarin dose adjustments occurred at a median of 1 day (interquartile ranges [IQR] 1-3) after the INR measurement. Yearly attrition rate was from 3.3% to 6.3% during the follow-up, and median (IQR) TTR was 61% (46%-73%). Patients who received frequent INR monitoring (≥ 27 times per year), pharmacist interventions (≥ 24 times per year), or frequently adjusted warfarin dose (≥ 11 times per year) consistently showed poor TTRs (mean TTR for the highest quartiles was 45.3%-48.3%). A higher TTR was associated with a lower risk of clinical outcomes regardless of frequency of INR monitoring, pharmacist interventions, or number of dose adjustments. Patients whose TTRs were < 65%, even with frequent pharmacist interventions, had similar stroke or systemic embolism event rates, as compared with patients with TTRs < 65% and less frequent interventions (1.88 vs. 1.54 stroke or systemic embolism rates per 100 person-years, respectively, P = 0.78). The lowest TTR quartile (< 46%) was associated with a 3 times higher risk of stroke or systemic embolism (hazard ratio [HR] = 3.19, 95% CI = 2.71-3.77) and a 2 times higher risk of major bleeding (HR = 2.10, 95% CI = 1.96-2.24) compared with the highest TTR quartile (≥ 73%). CONCLUSIONS: Despite close monitoring with timely warfarin dose adjustments, there were still a substantial number of challenging patients whose TTRs were suboptimal despite a higher number of pharmacist interventions. These patients eventually experienced more stroke or systemic embolism and bleeding events among NVAF patients managed by anticoagulation clinics. New individualized treatment or management strategies for patients who are not able to reach optimal therapeutic ranges are necessary to improve outcomes. DISCLOSURES: This research and manuscript were funded by Bristol-Myers Squibb Company and Pfizer. Authors from Bristol-Myers Squibb Company and Pfizer participated in the design of the study, interpretation of the data, review/revision of the manuscript, and approval of the final version of the manuscript. An received a grant for research support from Bristol-Myers Squibb/Pfizer. Niu, Rashid, and Zheng received a grant from Bristol-Myers Squibb/Pfizer to their institutions for salary reimbursement. Vo, Singh, and Aranda are employed by Bristol-Myers Squibb; Bruno was employed by Bristol-Myers Squibb at the time of this study. Mendes and Dills are employed by Pfizer, and Mendes was a member of the Pfizer Cardiovascular and Metabolic Field Medical Team during the time of this study. Lang, Jazdzewski, and Le have no known conflicts of interest to report. Study concept and design were contributed primarily by An and Rashid, along with the other authors. Niu took the lead in data collection, along with Zheng, and data interpretation was performed by An, along with Mendes and Dills, with assistance from the other authors. The manuscript was written by An and revised by Mendes, Dills, Vo, Singh, Bruno, and Aranda, along with Lang, Le, and Jazdezewski. Part of this study's findings was presented at the CHEST 2015 Annual Meeting in Montreal, Canada, on October 28, 2015.

Stroke and Bleeding Risk Associated With Antithrombotic Therapy for Patients With Nonvalvular Atrial Fibrillation in Clinical Practice.

BACKGROUND: The quality of antithrombotic therapy for patients with nonvalvular atrial fibrillation during routine medical care is often suboptimal. Evidence linking stroke and bleeding risk with antithrombotic treatment is limited. The purpose of this study was to evaluate the associations between antithrombotic treatment episodes and outcomes. METHODS AND RESULTS: A retrospective longitudinal observational cohort study was conducted using patients newly diagnosed with nonvalvular atrial fibrillation with 1 or more stroke risk factors (CHADS2 ≥1) in Kaiser Permanente Southern California between January 1, 2006 and December 31, 2011. A total of 1782 stroke and systemic embolism (SE) and 3528 major bleed events were identified from 23 297 patients during the 60 021 person-years of follow-up. The lowest stroke/SE rates and major bleed rates were observed in warfarin time in therapeutic range (TTR) ≥55% episodes (stroke/SE: 0.87 [0.71 to 1.04]; major bleed: 4.91 [4.53 to 5.28] per 100 person-years), which was similar to the bleed rate in aspirin episodes (4.95 [4.58 to 5.32] per 100 person-years). The warfarin TTR ≥55% episodes were associated with a 77% lower risk of stroke/SE (relative risk=0.23 [0.18 to 0.28]) compared to never on therapy; and the warfarin TTR <55% and on-aspirin episodes were associated with a 20% lower and with a 26% lower risk of stroke/SE compared to never on therapy, respectively. The warfarin TTR <55% episodes were associated with nearly double the risk of a major bleed compared to never on therapy (relative risk=1.93 [1.74 to 2.14]). CONCLUSIONS: Continuation of antithrombotic therapy as well as maintaining an adequate level of TTR is beneficial to prevent strokes while minimizing bleeding events.

The RETRIEVE trial: safety and effectiveness of the retrievable crux vena cava filter.

PURPOSE: To evaluate the safety and effectiveness of the Crux vena cava filter in patients at risk for pulmonary embolism (PE). MATERIALS AND METHODS: The Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System trial was an international prospective, multicenter, single-arm clinical trial in 125 patients implanted with the Crux filter between June 2010 and June 2011. Follow-up was 180 days after filter placement and 30 days after filter retrieval. The primary objective was to determine whether the clinical success rate was at least 80%. Clinical success was defined as technical success of deployment and freedom from definite PE, filter migration, and device-related adverse events requiring intervention. RESULTS: The clinical success rate was 96.0% (120 of 125), with a one-sided lower limit of the 95% confidence interval of 91.8%. The rate of technical success was 98.4% (123 of 125). There were three cases of definite PE (2.4%), two cases of deployment failure, and no cases of device migration, embolization, fracture, or tilting. Investigators observed nine cases of thrombus (all nonocclusive) in or near the filter (six during retrieval evaluation vena cavography, two during computed tomography [CT] scans for PE symptoms, and one during CT for cancer management) and 13 cases of deep vein thrombosis. Device retrieval was attempted at a mean of 84.6 days±57.6 (range, 6-190 d) after implantation and was successful for 98.1% of patients (53 of 54). All deaths (n = 14) were determined to be unrelated to the filter or PE. CONCLUSIONS: The Crux vena cava filter performed safely, with high rates of clinical, technical, and retrieval success.

Impact of high-dose atorvastatin in coronary heart disease patients age 65 to 78 years.

BACKGROUND: High-dose statin therapy may be underutilized in aged patients due to doubts about efficacy and safety. HYPOTHESIS: To investigate outcomes and safety in patients aged 65-78 years compared with patients aged < 65 years in the ALLIANCE study. METHODS: A total of 2,442 stable coronary heart disease (CHD) patients with dyslipidemia were randomized to either aggressive treatment (low-density lipoprotein cholesterol titration goal of < 80 mg/dL or maximum 80 mg/d of atorvastatin) or usual care (continuation of baseline lipid-lowering therapy, with changes and laboratory analyses directed by treating physicians). RESULTS: A total of 1,001 patients aged 65-78 years were followed for a median period of 53.9 mo. Older, aggressively treated atorvastatin patients experienced a 27% relative risk reduction for the primary composite endpoint of adverse cardiovascular outcomes (hazard ratio [HR]: 0.73; 95% confidence intervals [CI]: 0.57-0.94; p = 0.016). In addition, significant risk reductions were observed for nonfatal myocardial infarction (MI; HR: 0.43; 95% CI: 0.23-0.79; p = 0.006), cardiac revascularization (HR: 0.67; 95% CI: 0.48-0.93; p = 0.017), and the combined endpoint of cardiac death and nonfatal MI (HR: 0.48; 95% CI: 0.32-0.72; p = 0.001). The rate of significant liver transaminase elevations in atorvastatin patients was low and not age related. There were no cases of rhabdomyolysis. The rate of study discontinuations due to serious adverse events was higher in patients aged 65-78 years than in those younger than 65 years, but was similar between the treatment groups. CONCLUSIONS: Our data support the efficacy and safety of aggressive lipid management with atorvastatin in older CHD patients.

The importance of deep venous reflux velocity as a determinant of outcome in patients with combined superficial and deep venous reflux treated with endovenous saphenous ablation.

INTRODUCTION: Twenty to thirty percent of patients with symptomatic chronic venous insufficiency (CVI) are found to have combined superficial and deep venous reflux on duplex testing. It is currently unclear whether endovenous ablation (EVA) of the saphenous vein will result in correction of CVI without addressing the deep venous reflux. In this study, we examined deep venous reflux velocities to determine whether these would predict outcome after endovenous ablation. METHODS: Patients with symptomatic CVI and both saphenous and deep venous reflux were identified using duplex ultrasonography. Reflux times and maximal reflux velocity (MRV) in each examined vein segment were determined. In each limb, the venous filling index (VFI) and the venous clinical severity score (VCSS) were obtained both before and after laser ablation of the great and/or small saphenous veins. Preoperative venous reflux velocities were correlated with improvement in VFI and VCSS after ablation. RESULTS: 75 limbs with both deep and superficial venous reflux were identified. Seventy-five percent of limbs were CEAP clinical class 3 or 4 and the other 25% were class 5 or 6. Forty limbs demonstrated deep venous reflux in the femoral and/or popliteal vein. After EVA, significant improvements in VFI and VCSS were seen, but this depended on MRV in the deep vein. When MRV in the popliteal or femoral vein was <10 cm/sec, limbs had significantly better outcomes than limbs with MRV >10 cm/sec as measured by both VFI (P = .01) and VCSS (P = .03). In 35 limbs, deep venous reflux was identified only in the CFV. In this group, the average pre-procedure VFI (6.54 +/- 3.9 cc/sec) decreased significantly to 2.2 +/- 1.9 cc/sec (P < .001) and the VCSS improved markedly from 7.0 +/- 2.8 to 1.3 +/- 1.4 (P < .001). CONCLUSIONS: EVA of the saphenous veins can be performed in patients with concomitant deep venous insufficiency with hemodynamic and clinical improvement in most cases. Patients with popliteal or femoral reflux velocities lower than 10 cm/sec usually experience marked improvement in both the VFI and the VCSS. Patients with femoral or popliteal reflux velocities greater than 10 cm/sec have a high incidence of persistent symptoms after EVA.

Outcomes of surgical and endovascular treatment of acute traumatic thoracic aortic injury.

BACKGROUND: Acute thoracic aortic injury resulting from blunt trauma is a life-threatening condition. Endovascular therapy is a less invasive treatment modality that may potentially improve patient outcomes. We reviewed our experience with patients who sustained blunt thoracic aortic injuries distal to the left subclavian artery and presented for open surgical or endovascular repair. METHODS: Between August 1993 and August 2006, 62 patients sustained blunt thoracic aortic injuries distal to the origin of the left subclavian artery and proceeded to undergo open surgical (n = 48, 77%), or endovascular repair (n = 14, 23%). Revised trauma score (RTS), injury severity score (ISS), new injury severity score (NISS), individual associated traumatic injuries, as well as operative and postoperative outcomes were compared between open surgical and endovascular groups. RESULTS: Age, gender, race, and mechanism of injury did not differ between open surgical and endovascular groups. Additionally, RTS, ISS, and NISS values were not significantly different. The proportion of patients with sternal fractures (14% vs 0%), or unstable spinal fractures (36% vs 10%) was significantly greater in the endovascular group. Of the patients who received endografts, 93% (n = 13) were evaluated by a cardiothoracic surgeon and assessed to be prohibitive to operative intervention. Endografts utilized included commercially manufactured thoracic endografts (n = 6; 43%) and abdominal aortic endograft components (n = 8; 57%). Forty-one interposition grafts were placed in the open surgical group. Renal complications (32% vs 7%), and urinary tract infections (35% vs 7%) approached significance between surgical and endovascular groups (P = .082 and P = .077, respectively). Intraoperative mortality for the surgical and endovascular groups was 23% and 0%, respectively (P = .056). Endovascular repair was associated with significant reductions in operative time (118 vs 209 minutes), estimated blood loss (77 vs 3180 ml), and intraoperative blood transfusions (0.9 vs 6.1 units). No endoleaks were detected during a mean follow-up of 9.4 months in the endovascular group. CONCLUSION: Endovascular repair of blunt descending thoracic aortic injuries utilizing thoracic or abdominal endographs is a technically feasible modality that is at least equivalent to open therapy in the short term and associated with a lower intraoperative mortality (P = .056). Endovascular therapy has advantages in operative time, operative blood loss, and intraoperative blood transfusions.

Endovascular exclusion of an external carotid artery pseudoaneurysm using a covered stent.

Aneurysmal lesions of the external carotid artery are extremely rare. A case is presented of a 3.8 cm right external carotid artery pseudoaneurysm treated by transluminal exclusion using an endovascular stent-graft. Following stent-graft placement, complete occlusion of the aneurysmal sac and main vessel lumen patency was successfully demonstrated. This report demonstrates the technical feasibility of utilizing stent-grafts to treat aneurysmal lesions involving the external carotid artery.

Coverage of the left subclavian artery during thoracic endovascular aortic repair.

BACKGROUND: Thoracic aortic stent grafts require proximal and distal landing zones of adequate length to effectively exclude thoracic aortic lesions. The origins of the left subclavian artery and other aortic arch branch vessels often impose limitations on the proximal landing zone, thereby disallowing endovascular repair of more proximal thoracic lesions. METHODS: Between October 2000 and November 2005, 112 patients received stent grafts to treat lesions involving the thoracic aorta. The proximal aspect of the stent graft partially or totally occluded the origin of at least one great vessel in 28 patients (25%). The proximal attachment site was in zone 0 in one patient (3.6%), zone 1 in three patients (10.7%), and zone 2 in 24 patients (85.7%). Patients with proximal implantation in zones 0 or 1 underwent debranching procedures of the supra-aortic vessels before stent graft repair. In one patient who underwent zone 1 deployment, the left subclavian artery was revascularized before stent graft deployment. Among patients who underwent zone 2 deployment with partial or complete occlusion of the left subclavian artery, none underwent prior revascularization. Patients were assessed postoperatively and at follow-up for development of neurologic symptoms as well as symptoms of left upper extremity claudication or ischemia. RESULTS: Mean follow-up was 7.3 months. Among the 24 patients with zone 2 implantation, 10 (42%) had partial left subclavian artery coverage at the time of their primary procedure. A total of 19 patients experienced complete cessation of antegrade flow through the origin of the left subclavian artery without revascularization at the time of the initial endograft repair as a result of a secondary procedure or as a consequence of left subclavian artery thrombosis. Left upper extremity symptoms developed in three (15.8%) patients that did not warrant intervention, and rest pain developed in one (5.3%), which was treated with the deployment of a left subclavian artery stent. Two primary (type IA and type III) endoleaks (7.1%) and one secondary endoleak (type IA) (3.6%) were observed in patients who underwent zone 2 deployment. Three cerebrovascular accidents were observed. Thoracic aortic lesions were successfully excluded in all patients who underwent supra-aortic debranching procedures. CONCLUSION: Intentional coverage of the origin of the left subclavian artery to obtain an adequate proximal landing zone during endovascular repair of thoracic aortic lesions is well tolerated and may be managed expectantly, with some exceptions.

Effect of challenging neck anatomy on mid-term migration rates in AneuRx endografts.

OBJECTIVE: To establish the effect of challenging neck anatomy on the mid- and long-term incidence of migration with the AneuRx bifurcated device in patients treated after Food and Drug Administration approval and to identify the predictive factors for device migration. METHODS: Prospectively maintained databases at the University of North Carolina (UNC) and Washington University (WU) were used to identify 595 patients (UNC, n = 230; WU, n = 365) who underwent endovascular repair of an infrarenal abdominal aortic aneurysm with the AneuRx bifurcated stent graft. Those patients with at least 30 months of follow-up were identified and underwent further assessment of migration (UNC, n = 25; WU, n = 59) by use of multiplanar reconstructed computed tomographic scans. RESULTS: Eighty-four patients with a mean follow-up time of 40.3 months (range, 30-55 months) were studied. Seventy percent of the patients (n = 59) met all inclusion criteria for neck anatomy (length, angle, diameter, and quality) as defined by the revised instructions for use guidelines and are referred to as those with favorable neck anatomy (FNA). The remaining 25 patients retrospectively fell outside of the revised instructions for use guidelines and are referred to as those with unfavorable neck anatomy (UFNA). Life-table analysis for FNA patients at 2 and 4 years revealed a migration rate of 0% and 6.1%, respectively. For UFNA patients, it was 24.0% and 42.1% at 2 and 4 years, respectively (P < .0001). The overall (FNA and UFNA) migration rate was 7.1% and 17.1% at 2 and 4 years, respectively. Overall, late graft-related complications occurred in 38% of patients (FNA, 27%; UFNA, 64%; P = .003; relative risk, 1.7). There was no incidence of late rupture or open conversion. The relative risk of migration for UFNA patients was 2.5 compared with FNA patients (P = .0003). A larger neck angle and a longer initial graft to renal artery distance were predictors of migration, whereas shorter neck length approached but did not reach statistical significance. CONCLUSIONS: Patients who have unfavorable aneurysm neck anatomy experience significantly higher migration, device-related complication, and secondary intervention rates. However, there was no incidence of open conversion, rupture, or abdominal aortic aneurysm-related death, thereby supporting the AneuRx device as a feasible alternative to open repair even in patients with challenging neck characteristics. Enhanced surveillance should be used in these high-risk patients.

From vulnerable plaque to vulnerable patient--Part III: Executive summary of the Screening for Heart Attack Prevention and Education (SHAPE) Task Force report.

Screening for early-stage asymptomatic cancers (eg, cancers of breast and colon) to prevent late-stage malignancies has been widely accepted. However, although atherosclerotic cardiovascular disease (eg, heart attack and stroke) accounts for more death and disability than all cancers combined, there are no national screening guidelines for asymptomatic (subclinical) atherosclerosis, and there is no government- or healthcare-sponsored reimbursement for atherosclerosis screening. Part I and Part II of this consensus statement elaborated on new discoveries in the field of atherosclerosis that led to the concept of the "vulnerable patient." These landmark discoveries, along with new diagnostic and therapeutic options, have set the stage for the next step: translation of this knowledge into a new practice of preventive cardiology. The identification and treatment of the vulnerable patient are the focuses of this consensus statement. In this report, the Screening for Heart Attack Prevention and Education (SHAPE) Task Force presents a new practice guideline for cardiovascular screening in the asymptomatic at-risk population. In summary, the SHAPE Guideline calls for noninvasive screening of all asymptomatic men 45-75 years of age and asymptomatic women 55-75 years of age (except those defined as very low risk) to detect and treat those with subclinical atherosclerosis. A variety of screening tests are available, and the cost-effectiveness of their use in a comprehensive strategy must be validated. Some of these screening tests, such as measurement of coronary artery calcification by computed tomography scanning and carotid artery intima-media thickness and plaque by ultrasonography, have been available longer than others and are capable of providing direct evidence for the presence and extent of atherosclerosis. Both of these imaging methods provide prognostic information of proven value regarding the future risk of heart attack and stroke. Careful and responsible implementation of these tests as part of a comprehensive risk assessment and reduction approach is warranted and outlined by this report. Other tests for the detection of atherosclerosis and abnormal arterial structure and function, such as magnetic resonance imaging of the great arteries, studies of small and large artery stiffness, and assessment of systemic endothelial dysfunction, are emerging and must be further validated. The screening results (severity of subclinical arterial disease) combined with risk factor assessment are used for risk stratification to identify the vulnerable patient and initiate appropriate therapy. The higher the risk, the more vulnerable an individual is to a near-term adverse event. Because <10% of the population who test positive for atherosclerosis will experience a near-term event, additional risk stratification based on reliable markers of disease activity is needed and is expected to further focus the search for the vulnerable patient in the future. All individuals with asymptomatic atherosclerosis should be counseled and treated to prevent progression to overt clinical disease. The aggressiveness of the treatment should be proportional to the level of risk. Individuals with no evidence of subclinical disease may be reassured of the low risk of a future near-term event, yet encouraged to adhere to a healthy lifestyle and maintain appropriate risk factor levels. Early heart attack care education is urged for all individuals with a positive test for atherosclerosis. The SHAPE Task Force reinforces existing guidelines for the screening and treatment of risk factors in younger populations. Cardiovascular healthcare professionals and policymakers are urged to adopt the SHAPE proposal and its attendant cost-effectiveness as a new strategy to contain the epidemic of atherosclerotic cardiovascular disease and the rising cost of therapies associated with this epidemic.

Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization.

OBJECTIVES: The natural history of limbs affected by ischemic ulceration is poorly understood. In this report, we describe the outcome of limbs with stable chronic leg ulcers and arterial insufficiency that were treated with wound-healing techniques in patients who were not candidates for revascularization. METHODS: A prospectively maintained database of limb ulcers treated at a comprehensive wound center was used to identify patients with arterial insufficiency, defined as an ankle-brachial index (ABI) <0.7 or a toe pressure <50 mm Hg. Patients were treated without revascularization when medical comorbidity or anatomic considerations did not allow revascularization with acceptable risk. Ulcers were treated with a protocol emphasizing pressure relief, débridement, infection control, and moist wound healing. Risk factors analyzed for their affect on healing and amputation risk included age, gender, diabetes mellitus, chronic renal insufficiency (serum creatinine > 2.5 mg/dL), severity of ischemia measured by ABI or toe pressure, wound grade, wound size, and wound location. RESULTS: Between January 1999 and March 2005, 142 patients with 169 limbs having arterial insufficiency and full-thickness ulceration were treated without revascularization. Mean patient age was 70.8 +/- 4.5. Diabetes mellitus was present in 70.4% of limbs and chronic renal insufficiency in 27.8%. Toe amputations or other foot-sparing procedures were performed in 28% of limbs. Overall, limb loss occurred in 37 patients. By life-table analysis, 19% of limbs required amputation < or =6 months of initial treatment and 23% at 12 months. Complete wound closure was achieved in 25% by 6 months and in 52% by 12 months. Statistical analysis showed a correlation between ABI and the risk of limb loss. In patients with an ABI <0.5, 28% and 34% of limbs experienced limb loss at 6 and 12 months, respectively, compared with 10% and 15% of limbs in patients with an ABI >0.5 (P = .01). The only risk factor associated with wound closure was initial wound size (P < .005). CONCLUSIONS: Limb salvage can be achieved in most patients with arterial insufficiency and uncomplicated chronic nonhealing limb ulcers using a program of wound management without revascularization. Healing proceeds slowly, however, requiring more than a year in many cases. Patients with an ABI <0.5 are more likely to require amputation. Interventions designed to improve outcomes in critical limb ischemia should stratify outcomes based on hemodynamic data and should include a comparative control group given the natural history of ischemic ulcers treated in a dedicated wound program.

Endovenous saphenous ablation corrects the hemodynamic abnormality in patients with CEAP clinical class 3-6 CVI due to superficial reflux.

This investigation was designed to determine whether minimally invasive radiofrequency or laser ablation of the saphenous vein corrects the hemodynamic impact and clinical symptoms of chronic venous insufficiency (CVI) in CEAP clinical class 3-6 patients with superficial venous reflux. Patients with CEAP clinical class 3-6 CVI were evaluated with duplex ultrasound and air plethysmography (APG) to determine anatomic and hemodynamic venous abnormalities. Patients with an abnormal (>2 mL/second) venous filling index (VFI) and superficial venous reflux were included in this study. Saphenous ablation was performed utilizing radiofrequency (RF) or endovenous laser treatment (EVLT). Patients were reexamined within 3 months of ablation with duplex to determine anatomic success of the procedure, and with repeat APG to determine the degree of hemodynamic improvement. Venous clinical severity scores (VCSS) were determined before and after saphenous ablation. Eighty-nine limbs in 80 patients were treated with radiofrequency ablation (RFA) (n = 58), or EVLT (n = 31). The average age of patients was 55 years and 66% were women. There were no significant differences in preoperative characteristics between the groups treated with RFA or EVLT. Postoperatively, 86% of limbs demonstrated near total closure of the saphenous vein to within 5 cm of the saphenofemoral junction. Eight percent remained open for 5-10 cm from the junction, and 6% demonstrated minimal or no saphenous ablation. The VFI improved significantly after ablation in both the RF and EVLT groups. Postablation, 78% of the 89 limbs were normal, with a VFI <2 mL/second, and 17% were moderately abnormal, between 2 and 4 mL/second. VCSS scores (11.5 +/-4.5 preablation) decreased significantly after ablation to 4.4 +/-2.3. Minimally invasive saphenous ablation, using either RFA or EVLT, corrects or significantly improved the hemodynamic abnormality and clinical symptoms associated with superficial venous reflux in more than 90% of cases. These techniques are useful for treatment of patients with more severe clinical classes of superficial CVI.

Endovascular repair of lesions involving the descending thoracic aorta.

BACKGROUND: Vascular lesions involving the thoracic aorta are often life-threatening conditions that carry significant morbidity and mortality with traditional open surgical repair. Preliminary results suggest that endovascular therapy is an effective and possibly advantageous treatment for diseases of the descending thoracic aorta. METHODS: Between October 2000 and May 2004, 50 consecutive patients underwent endovascular stent-grafting of lesions involving the descending thoracic aorta. Attempted stent-graft deployment was performed electively in 39 patients and emergently in 11. The pathology of electively treated aortic lesions included degenerative/atherosclerotic aneurysms (n = 24), pseudoaneurysms (n = 11), aortic dissections (n = 2), and penetrating ulcers (n = 2). Emergently treated aortic lesions were for acute rupture due to infectious (mycotic) aneurysms (n = 4), atherosclerotic/degenerative aneurysms (n = 3), acute type B dissections (n = 2), and acute transections (n = 2). Devices used include Talent (n = 45), AneuRx aortic cuffs (n = 2), custom-fabricated Gianturco-Dacron grafts (n = 2), and a modified Cook-Zenith abdominal aortic graft (n = 1). Follow-up was performed at 1-month, 6-months, 1-year, and annually thereafter. RESULTS: Primary technical success, defined as successful deployment and exclusion of the lesion without evidence of type I or type III endoleak, was achieved in 48 (96%) of 50 patients. In one patient, the procedure was terminated due to inability to access the iliac vessels. In another patient, a type III endoleak was observed at the completion of the primary procedure that required deployment of an additional stent-graft component 2 months later. Of the 49 patients who received endografts, seven underwent secondary procedures to correct endoleaks, with five of these seven requiring the deployment of additional endovascular stent-graft components. Major complications included four in-hospital deaths, with three of these occurring in patients treated emergently. Additionally, respiratory failure (n = 6), multisystem organ failure (n = 2), cerebrovascular accident (n = 2), retroperitoneal hematoma (n = 2), acute renal insufficiency (n = 1), and pulmonary embolus (n = 1) were also observed. The overall endoleak rate was 20%, with five primary (< or = 30 days) and five secondary (> 30 days) endoleaks observed. Five of the endoleaks were treated with the deployment of one or more additional endovascular stent-graft components. Two of the endoleaks were treated with endovascular balloon remolding. Mean follow-up was 271 days. There were no aneurysm ruptures or aneurysm-related deaths. CONCLUSIONS: Endovascular treatment of vascular lesions involving the descending thoracic aorta can be safely performed with low morbidity in high-risk patients. Endovascular repair may become an attractive alternative for the treatment of a wide range of pathology along this vascular territory.