Percutaneous axillary artery access for endovascular interventions.

BACKGROUND: As endovascular therapy becomes increasingly complex, adjunct techniques such as upper extremity arterial access facilitate visceral branch interventions. The purpose of this study was to assess the viability of axillary artery percutaneous access in endovascular repair. METHODS: Records of all patients undergoing axillary artery percutaneous access as part of an endovascular intervention from December 2015 to December 2016 were examined. Demographics of the patients (age, sex, medical comorbidities, smoking status, and anticoagulation) were documented. Each case was examined for technical success and perioperative complications, including hematoma, brachial plexus injury, and return to the operating room. Early functional outcomes were assessed using clinic follow-up documentation. RESULTS: During the study interval, 25 axillary artery punctures in a total of 19 patients were performed for endovascular intervention. The mean age was 72 years; most patients were male (68%), and the cohort had a typical vascular comorbidity profile (hypertension in 84%, hyperlipidemia in 90%, diabetes in 21%, coronary artery disease in 58%, and chronic obstructive pulmonary disease in 47%; 90% were active or former smokers). Axillary access was obtained as part of complex endovascular aneurysm repair in 13 patients, mesenteric vessel intervention in 3 patients, and iliac intervention in 3 patients. Sheath size was most frequently 6F (6 punctures) or 7F (15 punctures). Closure devices included Perclose (Abbott Vascular, Santa Clara, Calif) in 36% and Angio-Seal (Terumo Interventional Systems, Somerset, NJ) in 64%. There were two perioperative deaths and one instance of return to the operating room for hematoma. There was no perioperative stroke, axillary occlusion, or severe brachial plexus injury. One patient had transient ipsilateral postoperative thumb numbness, and one patient had residual bleeding after closure requiring manual pressure. CONCLUSIONS: Percutaneous axillary artery access is a viable strategy to facilitate complex endovascular interventions. This technique avoids the need for brachial or axillary artery exposure and allows larger sheath sizes because of the caliber of the axillary artery. There were no major neurologic or ischemic complications. This technique is a relatively safe and practical alternative to approaches involving exclusively femoral and brachial access.

Regionalization of Emergent Vascular Surgery for Patients With Ruptured AAA Improves Outcomes.

OBJECTIVE: Safe and efficient endovascular aneurysm repair (EVAR) for ruptured abdominal aortic aneurysm (r-AAA) requires advanced infrastructure and surgical expertise not available at all US hospitals. The objective was to assess the impact of regionalizing r-AAA care to centers equipped for both open surgical repair (r-OSR) and EVAR (r-EVAR) by vascular surgeons. METHODS: A retrospective review of all patients with r-AAA undergoing open or endovascular repair in a 12-hospital region. Patient demographics, transfer status, type of repair, and intraoperative variables were recorded. Outcomes included perioperative morbidity and mortality. RESULTS: Four hundred fifty-one patients with r-AAA were treated from 2002 to 2015. Three hundred twenty-one patients (71%) presented initially to community hospitals (CHs) and 130 (29%) presented to the tertiary medical center (MC). Of the 321 patients presenting to CH, 133 (41%) were treated locally (131 OSR; 2 EVAR) and 188 (59%) were transferred to the MC. In total, 318 patients were treated at the MC (122 OSR; 196 EVAR). At the MC, r-EVAR was associated with a lower mortality rate than r-OSR (20% vs 37%, P = 0.001). Transfer did not influence r-EVAR mortality (20% in r-EVAR presenting to MC vs 20% in r-EVAR transferred, P > 0.2). Overall, r-AAA mortality at the MC was 20% lower than CH (27% vs 46%, P < 0.001). CONCLUSIONS: Regionalization of r-AAA repair to centers equipped for both r-EVAR and r-OSR decreased mortality by approximately 20%. Transfer did not impact the mortality of r-EVAR at the tertiary center. Care of r-AAA in the US should be centralized to centers equipped with available technology and vascular surgeons.

Anatomic characteristics of abdominal aortic aneurysms presenting with delayed rupture after endovascular aneurysm repair.

OBJECTIVE: Endovascular aneurysm repair (EVAR) has become the mainstay of treatment for abdominal aortic aneurysms (AAAs) requiring repair. Delayed rupture after EVAR represents a rare but potentially fatal complication. The purpose of this study was to review the frequency and characteristics of patients presenting with secondary rupture and to define the relationship between rupture after EVAR and initial compliance with instructions for use (IFU). METHODS: This is a retrospective study of a prospectively maintained database. Patients presenting with delayed rupture after EVAR were identified from January 2002 to December 2014. Medical records and imaging were reviewed to define anatomic characteristics and compliance with IFU criteria. Demographics, comorbidities, preoperative imaging, and long-term outcomes were analyzed. Patients were divided into two groups according to compliance with IFU criteria. Outcomes included type of repair (open vs secondary endovascular) as well as perioperative morbidity and mortality. RESULTS: A total of 3081 patients underwent EVAR for AAA from 2002 to 2014. Of the 3081 patients, 45 experienced delayed rupture after EVAR. The mean time interval between initial repair and rupture was 38 months. All patients with delayed ruptures had a type Ia endoleak. Mean follow-up after secondary repair was 44.1 months, and overall mortality was 6.7% (n = 3). Patients were divided in two groups according to compliance with IFU criteria: within the IFU and outside the IFU. There was no significant difference in comorbidities between the two groups except smoking, which was more frequent in the outside the IFU group (25% vs 21%; P = .03). Patients repaired outside the IFU had a higher incidence of type Ia endoleak before presenting with a rupture (44% vs 6%; P = .001), more frequently required open repair (44% vs 12%; P = .002), and had higher perioperative mortality (10.3% vs 0%; P = .01). On review of preoperative computed tomography scans, the outside the IFU group had larger aneurysm sac diameters (7.2 vs 5.6 cm; P = .04), larger proximal neck diameters (28 vs 24 mm; P = .01), shorter proximal necks (12 vs 21 mm; P = .007), and a higher degree of neck angulation >40 degrees (56 vs 11%; P < .001). CONCLUSIONS: Delayed rupture after EVAR is a rare but potentially fatal complication. In patients presenting with secondary rupture, EVAR performed outside the IFU was associated with higher perioperative mortality and need for open repair. Careful selection of patients based on AAA anatomy and adherence to the IFU criteria may reduce the incidence of delayed rupture.

Endovascular aneurysm repair delivery redesign leads to quality improvement and cost reduction.

OBJECTIVE: Endovascular aneurysm repair (EVAR) is now a mainstay of therapy for abdominal aortic aneurysm, although it remains associated with significant expense. We performed a comprehensive analysis of EVAR delivery at an academic medical center to identify targets for quality improvement and cost reduction in light of impending health care reform. METHODS: All infrarenal EVARs performed from April 2011 to March 2012 were identified (N = 127). Procedures were included if they met standard commercial instructions for use guidelines, used a single manufacturer, and were billed to Medicare diagnosis-related group 238 (n = 49). By use of DMAIC (define, measure, analyze, improve, and control) quality improvement methodology (define, measure, analyze, improve, control), targets for EVAR quality improvement were identified and high-yield changes were implemented. Procedure technical costs were calculated before and after process redesign. RESULTS: Perioperative services and clinic visits were identified as targets for quality improvement efforts and cost reduction. Mean technical costs before the intervention were $31,672, with endograft implants accounting for 52%. Pricing redesign in collaboration with hospital purchasing reduced mean EVAR technical costs to $28,607, a 10% reduction in overall cost, with endograft implants now accounting for 46%. Perioperative implementation of instrument tray redesign reduced instrument use by 32% (184 vs 132 instruments), saving $50,000 annually. Unnecessary clinic visits were reduced by 39% (1.6 vs 1.1 clinic visits per patient) through implementation of a preclinic imaging protocol. There was no difference in mean length of stay after the intervention. CONCLUSIONS: Comprehensive EVAR delivery redesign leads to cost reduction and waste elimination while preserving quality. Future efforts to achieve more competitive and transparent device pricing will make EVAR more cost neutral and enhance its financial sustainability for health care systems.

Inferior vena cava filter retrieval provides no advantage in the average patient.

BACKGROUND: Inferior vena cava (IVC) filter placement is performed to mitigate the risk of pulmonary embolism (PE) when anticoagulation is contraindicated or ineffective. Technical advances now allow catheter-based filter retrieval. Many believe the benefits of retrieval are self-evident, yet retrieval carries an inherent complication risk and cost. The purpose of this study was to quantitatively weigh the risks and benefits of IVC filter retrieval using formal decision analysis. METHODS: A Markov state-transition model was used to simulate two clinical scenarios: to leave a previously placed IVC filter or to retrieve it. Analysis was performed during the lifetime of the individual, and outcomes were expressed in quality-adjusted life-years (QALYs). The base case is a 60-year-old man with a filter placed within 3 months who no longer requires mechanical thromboprophylaxis. Potential events included PE, filter complications, and death from all other causes during each cycle. Tolls were used to incorporate the disutility of short-term treatment for PE and filter complications. For the base case and sensitivity analyses, we used utilities and probabilities derived from the literature. RESULTS: In the base case scenario, leaving the filter in place was preferred to filter retrieval, yielding 22.3 vs 21.9 QALYs. One-way sensitivity analysis demonstrated that filter retrieval may be preferable if the utility of living with a filter is <0.98. For all probabilities of retrieval and PE mortality, leaving the filter in place is preferred. CONCLUSIONS: Leaving a previously placed IVC filter provides a 0.4 QALY benefit over retrieving the filter for the average patient. This decision is sensitive to the utility of living with the IVC filter.

Cilostazol is associated with improved outcomes after peripheral endovascular interventions.

OBJECTIVE: Although cilostazol is commonly used as an adjunct after peripheral vascular interventions, its efficacy remains uncertain. We assessed the effect of cilostazol on outcomes after peripheral vascular interventions using meta-analytic techniques. METHODS: We searched MEDLINE (1946-2012), Cochrane CENTRAL (1996-2012), and trial registries for studies comparing cilostazol in combination with antiplatelet therapy to antiplatelet therapy alone after peripheral vascular interventions. Treatment effects were reported as pooled risk/hazard ratio (HR) with random-effects models. RESULTS: Two randomized trials and four retrospective cohorts involving 1522 patients met inclusion criteria. Across studies, mean age ranged from 65 to 76 years, and the majority of patients were male (64%-83%); mean follow-up ranged from 18 to 37 months. Most interventions were in the femoropopliteal segment, and overall, 68% of patients had stents placed. Pooled estimates demonstrated that the addition of cilostazol was associated with decreased restenosis (relative risk [RR], 0.71; 95% confidence interval [CI], 0.60-0.84; P < .001), improved amputation-free survival (HR, 0.63; 95% CI, 0.47-0.85; P = .002), improved limb salvage (HR, 0.42; 95% CI, 0.27-0.66; P < .001), and improved freedom from target lesion revascularization (RR, 1.36; 95% CI, 1.14-1.61; P < .001). There was no significant reduction in mortality among those receiving cilostazol (RR, 0.73; 95% CI, 0.45-1.19; P = .21). CONCLUSIONS: The addition of cilostazol to antiplatelet therapy after peripheral vascular interventions is associated with a reduced risk of restenosis, amputation, and target lesion revascularization in our meta-analysis of six studies. Consideration of cilostazol as a medical adjunct after peripheral vascular interventions is warranted, presuming these findings are broadly generalizable.

Functional outcomes following catheter-based iliac vein stent placement.

OBJECTIVES: Although previous reports have demonstrated the efficacy of catheter-directed thrombolytic therapy and iliac vein stent placement for the management of iliofemoral deep vein thrombosis (DVT), functional outcomes remain undefined. The purpose of this study was to determine midterm outcomes and functional quality of life among patients treated with iliac vein stenting. METHODS: Records of all the patients treated with iliac vein stent placement between March 2004 and March 2011 were examined for primary patency, assisted primary patency, and secondary patency. Midterm functional outcomes were measured quantitatively, including ongoing symptoms and return to work status. RESULTS: Over the study interval, 32 patients (33 limbs) underwent iliac vein stent placement. In all, 72% (n = 23) of these patients were female, with an average age of 43 years. In all, 78% (n = 25) of the patients were diagnosed with acute DVT, 89% of which occurred in the left leg. Catheter-directed thrombolysis was utilized in 92% (23 of 25) of the patients with acute DVT. All patients treated with thrombolysis and stent placement presented with pain and edema in the affected limb. One-year primary, assisted primary, and secondary patencies were 75%, 96%, and 96%, respectively. Freedom from reintervention at 1 year was 83%. Treatment was associated with a sustained significant reduction in pain (91% vs 6%, P < .001) and edema (97% vs 12%, P < .001) at a mean follow-up of 29 months (range 5-83 months), at which time 89% of the patients reported to be at their pre-DVT functional status. CONCLUSIONS: Aggressive therapy of symptomatic iliac vein stenosis or occlusion with venography, catheter-directed thrombolysis, and iliac vein stent placement provides durable patency and freedom from reintervention. Most patients can anticipate good functional recovery with decreased pain, decreased edema, and high likelihood of returning to work.

Lean principles optimize on-time vascular surgery operating room starts and decrease resident work hours.

OBJECTIVE: Lean process improvement techniques are used in industry to improve efficiency and quality while controlling costs. These techniques are less commonly applied in health care. This study assessed the effectiveness of Lean principles on first case on-time operating room starts and quantified effects on resident work hours. METHODS: Standard process improvement techniques (DMAIC methodology: define, measure, analyze, improve, control) were used to identify causes of delayed vascular surgery first case starts. Value stream maps and process flow diagrams were created. Process data were analyzed with Pareto and control charts. High-yield changes were identified and simulated in computer and live settings prior to implementation. The primary outcome measure was the proportion of on-time first case starts; secondary outcomes included hospital costs, resident rounding time, and work hours. Data were compared with existing benchmarks. RESULTS: Prior to implementation, 39% of first cases started on time. Process mapping identified late resident arrival in preoperative holding as a cause of delayed first case starts. Resident rounding process inefficiencies were identified and changed through the use of checklists, standardization, and elimination of nonvalue-added activity. Following implementation of process improvements, first case on-time starts improved to 71% at 6 weeks (P = .002). Improvement was sustained with an 86% on-time rate at 1 year (P < .001). Resident rounding time was reduced by 33% (from 70 to 47 minutes). At 9 weeks following implementation, these changes generated an opportunity cost potential of $12,582. CONCLUSIONS: Use of Lean principles allowed rapid identification and implementation of perioperative process changes that improved efficiency and resulted in significant cost savings. This improvement was sustained at 1 year. Downstream effects included improved resident efficiency with decreased work hours.