Midterm outcomes in patients undergoing endovascular repair of thoracic aortic aneurysms and penetrating atherosclerotic ulcers using the RelayPlus stent graft.

BACKGROUND: The Relay Thoracic Stent-Graft with Plus Delivery System (RelayPlus; Terumo Aortic, Sunrise, Fla) was designed to handle the curvature and tortuosity of the thoracic aorta. It was approved by the Food and Drug Administration in 2012; the postapproval study was stopped early because of adequate safety and efficacy data, and no difference was identified in experienced vs first-time users of RelayPlus. The purpose of this study was to report real-world outcomes of patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers (PAUs) undergoing thoracic endovascular aortic repair (TEVAR) with RelayPlus. METHODS: This is a prospective, multicenter, nonrandomized postapproval study that required the use of novice implanters in the United States. Primary and secondary end points included device-related adverse events (deployment failure, conversion to open repair, endoleaks, migration, rupture, and mortality) and major adverse events (stroke, paraplegia/paraparesis, renal failure, respiratory failure, and myocardial infarction), respectively. Continuous and categorical covariates were reported in means or medians and percentages, respectively. Kaplan-Meier survival estimates were used to report long-term TEVAR-related mortality, all-cause mortality, and reinterventions at 3 years. RESULTS: A total of 45 patients with mean age (standard deviation [SD]) of 73.5 (±7.20) years were treated for descending thoracic fusiform aneurysm (56%) or saccular aneurysm/PAU (44%). The patients were predominantly white (80.0%) and male (68.9%). Mean (SD) proximal neck, distal neck, and lesion lengths were 38.2 (±37) mm, 42.1 (±28) mm, and 103.8 (±74) mm, respectively. Mean (SD) aneurysm, proximal neck, and distal neck diameters were 53.9 (±13) mm, 31.3 (±4) mm, and 31.7 (±6) mm, respectively. Technical success was 100%. TEVAR-related mortality at 30 days was 4.4%; two patients died postoperatively, one of shock and the second of bilateral hemispheric stroke. No patient in the study had any conversion to open repair or post-TEVAR rupture. Two patients experienced three major adverse events, which included stroke (2.2%), paraplegia (2.2%), and respiratory failure (2.2%) at 30 days. Three-year freedom from TEVAR-related mortality, all-cause mortality, and reinterventions was 95.6%, 84.0%, and 97.2%, respectively. There were two type I endoleaks at 3 years: one type IB associated with no migration or aneurysm sac increase and one type IA associated with caudal migration of proximal neck and expansion of the proximal aorta. CONCLUSIONS: The RelayPlus postapproval study reported low operative mortality and morbidity and supported use of the device as a safe and effective thoracic aortic aneurysm and PAU endovascular treatment. Early midterm follow-up showed sustained freedom from TEVAR-related mortality in real-world practice. Follow-up continues to evaluate the durability of this endograft.

Two-year evaluation of fenestrated and parallel branch endografts for the treatment of juxtarenal, suprarenal, and thoracoabdominal aneurysms at a single institution.

OBJECTIVE: Despite numerous recent pivotal and small-scale trials, real-world endovascular management of juxtarenal aneurysms (JRA), suprarenal aneurysms (SRA), and thoracoabdominal aortic aneurysms (TAAA) remains challenging without consensus best practices. This study evaluated the mortality, graft patency, renal function, complication, and reintervention rates for fenestrated and parallel endografts in complex aortic aneurysms repairs. METHODS: This retrospective review of consecutive included patients with JRA, SRA, or TAAA who underwent complex endovascular repair from August 2014 to March 2017 at one high-volume institution. Treatment modality was a single surgeon decision based on patients anatomy and the urgency of the repair. Patient demographics, hospital course, and follow-up visits inclusive of imaging were analyzed. Ruptured aneurysms were excluded. Survival rates and outcomes were determined using the Kaplan-Meier method with log-rank tests. RESULTS: Seventy complex endovascular aortic repairs were performed; 38 patients with TAAA were treated with snorkel/sandwich parallel endografts (21 celiac, 28 superior mesenteric arteries, 58 renal arteries) and 32 patients with JRA/SRA were treated by fenestrated endovascular aneurysm repair (FEVAR) with 94 total fenestrations (2 celiac, 30 SMA, 62 renal). The mean patient age was 74.8 ± 10.0 years. Sixty percent were male, and the mean aortic aneurysm diameter was 6.0 ± 1.4 cm. Perioperative mortality was 3.1% (1/32) for FEVAR compared with 2.6% (1/38) for parallel endografts (P = .9). All-cause reintervention rates were 15.6% in FEVAR (5/32) vs 23.6% with parallel endografts (9/38; P = .4). Branch reintervention rates per each branch endograft were 4.3% for FEVAR (4/94; 2 renal stent occlusions, 1 colonic ischemia without technical issue found on reintervention, 1 perinephric hematoma) vs 3.7% for parallel endografts (4/107; 2 renal and 1 celiac stent thromboses, and 1 renal stent kink; P = .41). The endograft branch thrombosis rate was 2.1% in FEVAR (2/94) vs 2.7% in parallel endografts (3/109; P = .77). Reinterventions owing to endoleaks were performed in five patients (2 type I, 2 type III, and 1 gutter endoleak; 13.1%) with parallel grafts vs no endoleak reinterventions in FEVAR. The overall survival and freedom from aneurysm-related mortality at 24 months was 78% and 96.9% in FEVAR vs 73% and 93.4% for parallel endografts (P = .8 and P = .6). The median follow-up was 12 months (range, 1-32 months). CONCLUSIONS: Parallel and fenestrated endografts have acceptable and comparable mortality and patency rates in endovascular treatment of JRA, SRA, and TAAA. This study reaffirms that parallel endografts are a safe and viable alternative to fenestrated devices for complex aortic aneurysmal disease despite often treating more urgent patients and more complicated anatomy unable to be treated with FEVAR.

The Epidemiology, Pathophysiology, and Novel Treatment of Calcific Arterial Disease.

Endovascular treatment of arterial diseases has become first-line in most cases due to improved technology. However, until recently, excessive atherosclerotic calcification has been a major limiting factor in the endovascular management of peripheral arterial disease, as well as vascular access for endovascular aneurysm repair (EVAR) and transcatheter aortic valve replacement (TAVR). The Peripheral Intravascular Lithotripsy (IVL) System (Shockwave Medical, Inc., Fremont California) applies pulsatile mechanical energy under fluoroscopic guidance to disrupt calcified lesions. The purpose of this paper is to introduce IVL in the treatment of calcific access vessels in preparation for EVAR and TAVR, as well as peripheral arterial disease applications to enhance luminal gain. Using the IVL System, angioplasty can be performed with lower pressures, which may minimize arterial dissection. Further, the lithotripsy effect on calcium will enhance vessel compliance. We describe several cases where IVL was applied successfully and present additional cases that may have benefitted from the use of this technology.

One-Year Outcomes Following Directional Atherectomy of Popliteal Artery Lesions: Subgroup Analysis of the Prospective, Multicenter DEFINITIVE LE Trial.

PURPOSE: To report the effectiveness of directional atherectomy for the treatment of popliteal artery occlusive disease. METHODS: This subset of the prospective, multicenter, single-arm DEFINITIVE LE trial included 158 patients (mean age 72.0±10.9 years; 82 men) who underwent directional atherectomy in 162 popliteal artery lesions between 2009 and 2011. Forty-eight (30.4%) patients were suffering from critical limb ischemia (CLI). The mean lesion length was 5.8±3.9 cm; 38 (23.5%) arteries were occluded. The primary outcome measure for patients with intermittent claudication (IC) was duplex ultrasound-defined primary patency at 1 year; the outcome for subjects with CLI was freedom from major amputation of the target limb at 1 year. Outcomes and adverse events were independently assessed. RESULTS: Procedure success (≤30% residual stenosis) was achieved in 84.4% of treated lesions; adjunctive stenting was required in 6 (3.7%) of the 162 lesions. The 1-year primary patency rate was 75.0% (IC patients 78.2% and CLI patients 67.5%, p=0.118). The freedom from major amputation in both cohorts was 100%. In both IC and CLI patients, significant improvements were demonstrated at 1 year in the Rutherford category, walking distance, and quality of life in comparison to baseline. CONCLUSION: This study indicates that directional atherectomy in popliteal arteries leads to favorable technical and clinical results at 1 year for claudicant as well as CLI patients.

Femoral Access for Iliac Branched Endoprosthesis Deployment in Patients with a Prior Bifurcated Aortic Stent Graft.

This series describes an innovative technique to deploy iliac branched endoprostheses (IBEs) in patients with preexisting endovascular aneurysm repair (EVAR). It demonstrates an alternative approach that may be preferred when brachial access is anatomically challenging or when access site complications are of concern. We detail a technique that uses transfemoral access to bring IBE device components up and over an infrarenal endograft bifurcation and into proper position. This series suggests that endovascular specialists should consider the advantages and disadvantages of a transfemoral approach when selecting the best method of repairing a patient's iliac artery aneurysm after prior EVAR.

Results from multiple prospective single-center clinical trials of the off-the-shelf p-Branch fenestrated stent graft.

OBJECTIVE: The purpose of this study was to report prospective data of an off-the-shelf fenestrated endograft (Zenith p-Branch; Cook Medical, Bloomington, Ind) from four centers for the treatment of patients with pararenal abdominal aortic aneurysms. METHODS: Data were combined from four single-center investigational studies conducted in the United States and Europe. The p-Branch endograft consists of a proximal off-the-shelf component incorporating a scallop for the celiac artery, a superior mesenteric artery fenestration, and two conical pivot fenestrations to preserve flow to the renal vessels. The device is available in two configurations, a left renal fenestration at the same (configuration A) or lower (configuration B) longitudinal position than the right to accommodate varied anatomy of the patients. RESULTS: Between August 2011 and September 2015, 76 patients (82% male; mean age, 72 years; 65 elective and 11 emergent) were enrolled, with 55% implanted with option A and 45% with B. The device was deployed successfully in all patients, and stents were placed in all target vessels except in three cases (one elective, two emergent): a left kidney was sacrificed in one patient, and a right renal artery was left unstented in two patients during the index procedure. There was no 30-day mortality. During follow-up (mean, 25 ± 13 months), 10 late deaths occurred (6 elective, 4 emergent; none related to device or procedure), and there were no ruptures or conversions to open repair. Two patients experienced bowel ischemia; one case resolved with nonoperative treatment and one required superior mesenteric artery and celiac artery angioplasty and stent placement. Renal artery occlusion occurred in eight patients (11%) and was deemed procedure related in 63% (5/8) of these patients. Four of these were successfully intervened on with preservation of renal function. The overall renal insufficiency incidence was 7% (5/76). One patient developed renal failure requiring dialysis. CONCLUSIONS: Early results incorporating learning curves for physicians with a new device and delivery system indicate that the use of the Zenith p-Branch device is feasible and safe. Long-term follow-up is needed to assess the effectiveness and durability of this treatment strategy and to refine the indications for use.

Hybrid Repair Techniques for Complex Aneurysms and Dissections Involving the Aortic Arch and Thoracic Aorta.

Aortic aneurysms involving the ascending aorta, aortic arch, and descending thoracic aorta have been a challenging entity to surgically treat for over 60 years. Despite the mortality of the disease, early open surgical procedures also had significant morbidity and mortality. The inherent risk in treating multiple anatomic segments simultaneously led to the innovation of the staged elephant trunk (ET) approach by Borst in 1983. To avoid the thoracotomy and associated complications related to the second stage of the procedure, an endovascular completion paradigm was begun by Volodos in 1991. This theoretical hybrid technique combinined shorter and less elaborate open supra-aortic trunk debranching with less invasive endovascular exclusion and has grown since then in terms of different approaches and case volume. The rise of thoracic endovascular aortic repair (TEVAR) combined with debranching bypass has allowed certain lesions to be treated without a large scale intrathoracic open surgical procedure. The complexity and extensiveness of certain lesions, however, has necessitated a hybrid approach such as the frozen elephant trunk (FET) and the standard ET with second stage TEVAR. The former has been used to treat multifocal degenerative aneurysms, chronic dissections with aneurysm, and acute extensive dissections. After conventional proximal aortic replacement, a stent-graft (SG) is delivered antegrade through the transected arch where it is sutured proximally and then "frozen" distally via endovascular means. The FET has the advantage of avoiding a second stage, but potentially introduces a greater rate of spinal cord ischemia compared to the standard elephant trunk. Improvements on the FET procedure have included the development of more advanced hybrid SG such as the Vascutek® Thoraflex™ Hybrid graft (Vascutek Ltd, Scotland, UK), which consists of a distal en,dograft sealed to a proximal four-branched Vascutek Gelweave™ Vascutek Ltd, Scotland, UK) and incorporated sewing collar. While open surgery continues to be a component of complex aortic arch aneurysms, the development of hybrid devices that can bridge the gap between open and endovascular surgery will continue to flourish.

Contemporary Management of Type B Aortic Dissection in the Endovascular Era.

Aortic dissection (AD) is one of the most common catastrophic pathologies affecting the aorta. Anatomic classification is based on the origin of entry tear and its extension. Type A dissections originate in the ascending aorta, whereas the entry tear in Type B dissections starts distal to the left subclavian artery. The patients with aortic dissection who manifest complications such as rupture, malperfusion, aneurysmal degeneration, and intractable pain are classified as complicated AD. Risk factors for developing aortic dissection include age, male gender, and aortic wall structural abnormalities. The most common presenting symptom of acute aortic dissection is pain. Malperfusion occurs as a result of end-organ ischemia due to involvement of aortic branches from the dissecting process. This can happen in various locations causing mesenteric ischemia (mesenteric vessels), stroke (aortic arch vessels), renal failure (renal arteries), spinal ischemia, and limb ischemia (iliac or subclavian arteries). Aneurysmal degeneration is the most common complication of patients with chronic Type B dissection who are managed with medical therapy. Management of Type B aortic dissection (TBAD) remains controversial. Many groups recommend conservative therapy for newly diagnosed TBAD and reserve surgical management for patients who develop complications such as rupture, malperfusion, aneurysmal dilatation, and refractory pain. The mainstay of medical therapy includes antihypertensive medication to reduced ΔP/ ΔT by lowering blood pressure and heart rate. With the continued success of thoracic endovascular aortic repair (TEVAR), this procedure has been extended to treat TBAD in selected patients. The outcomes of TEVAR are promising, with early mortality rates from 10% to 20%. With promising results from these series, some groups recommend early TEVAR in uncomplicated TBAD to prevent future adverse events. The goals of endovascular treatment of TBAD are to cover the entry tear, treat or prevent impending rupture, reestablish organ perfusion, restore flow in the true lumen, and induce the false lumen thrombosis. Patients with TBAD need long-term follow-up.

Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication.

Peripheral arterial disease (PAD) continues to grow in global prevalence and consumes an increasing amount of resources in the United States health care system. Overall rates of intervention for PAD have been rising steadily in recent years. Changing demographics, evolution of technologies, and an expanding database of outcomes studies are primary forces influencing clinical decision making in PAD. The management of PAD is multidisciplinary, involving primary care physicians and vascular specialists with varying expertise in diagnostic and treatment modalities. PAD represents a broad spectrum of disease from asymptomatic through severe limb ischemia. The Society for Vascular Surgery Lower Extremity Practice Guidelines committee reviewed the evidence supporting clinical care in the treatment of asymptomatic PAD and intermittent claudication (IC). The committee made specific practice recommendations using the GRADE (Grades of Recommendation Assessment, Development and Evaluation) system. There are limited Level I data available for many of the critical questions in the field, demonstrating the urgent need for comparative effectiveness research in PAD. Emphasis is placed on risk factor modification, medical therapies, and broader use of exercise programs to improve cardiovascular health and functional performance. Screening for PAD appears of unproven benefit at present. Revascularization for IC is an appropriate therapy for selected patients with disabling symptoms, after a careful risk-benefit analysis. Treatment should be individualized based on comorbid conditions, degree of functional impairment, and anatomic factors. Invasive treatments for IC should provide predictable functional improvements with reasonable durability. A minimum threshold of a >50% likelihood of sustained efficacy for at least 2 years is suggested as a benchmark. Anatomic patency (freedom from restenosis) is considered a prerequisite for sustained efficacy of revascularization in IC. Endovascular approaches are favored for most candidates with aortoiliac disease and for selected patients with femoropopliteal disease in whom anatomic durability is expected to meet this minimum threshold. Conversely, caution is warranted in the use of interventions for IC in anatomic settings where durability is limited (extensive calcification, small-caliber arteries, diffuse infrainguinal disease, poor runoff). Surgical bypass may be a preferred strategy in good-risk patients with these disease patterns or in those with prior endovascular failures. Common femoral artery disease should be treated surgically, and saphenous vein is the preferred conduit for infrainguinal bypass grafting. Patients who undergo invasive treatments for IC should be monitored regularly in a surveillance program to record subjective improvements, assess risk factors, optimize compliance with cardioprotective medications, and monitor hemodynamic and patency status.

One-Year Outcomes Following Directional Atherectomy of Infrapopliteal Artery Lesions: Subgroup Results of the Prospective, Multicenter DEFINITIVE LE Trial.

PURPOSE: To report a subgroup analysis of the prospective, multicenter, single-arm DEFINITIVE LE trial to assess the effectiveness of directional atherectomy for the treatment of infrapopliteal artery lesions at 1 year. METHODS: In the DEFINITIVE LE trial, follow-up assessments occurred up to 1 year postprocedure. Of the 800 patients enrolled, 145 subjects with 189 infrapopliteal lesions met the criteria for this analysis. Seventy (48.3%) and 75 (51.7%) patients were suffering critical limb ischemia (CLI) and intermittent claudication, respectively; 68.3% (99/145) had diabetes. The mean lesion length was 58±44 mm (all lesions); 20.2% were occluded. The primary endpoint for patients with claudication was duplex ultrasound-derived primary patency, while for subjects with CLI it was freedom from major amputation of the target limb at 1 year. Endpoints and adverse events were independently assessed. RESULTS: Procedure success (≤30% residual stenosis) was achieved in 84% of treated lesions. The 1-year primary patency rate was 84% (claudicants 89.6% and CLI patients 78%, p=0.11), and the freedom from major amputation rate was 97.1% (claudicants 100% and CLI 93.8%, p=0.03). In both claudication and CLI patients, significant improvements in Rutherford category and objective measures of walking distance and quality of life were seen at 1 year in comparison to baseline. CONCLUSION: This study demonstrates that directional atherectomy in infrapopliteal arteries results in promising technical and clinical results at 1 year for claudicant as well as CLI patients.

A Comparison of Clinical Outcomes for Diabetic and Nondiabetic Patients Following Directional Atherectomy in the DEFINITIVE LE Claudicant Cohort.

PURPOSE: To report a subset analysis that evaluated the hypothesis that directional atherectomy for peripheral artery disease in diabetic claudicants has noninferior primary patency at 12 months compared with nondiabetic claudicants. METHODS: DEFINITIVE LE, a US/European multicenter study, assessed the effectiveness of directional atherectomy using SilverHawk/TurboHawk systems for treatment of peripheral artery disease in the superficial femoral, popliteal, and infrapopliteal arteries. Of the 800 patients enrolled in the study, only the 598 claudicant patients (mean age 69.5±10.4 years; 336 men) who were classified at baseline as Rutherford category 1-3 were eligible for this subset analysis. Of these, 46.8% (280/598) had diabetes. Follow-up to 12 months included duplex ultrasound examination, functional assessments, and adverse event evaluations. Independent angiographic and duplex ultrasound core laboratories assessed primary patency and secondary endpoints; a clinical events committee adjudicated adverse events. RESULTS: Although diabetics had significantly more baseline comorbidities, 12-month primary patency (77.0%) was no different than for nondiabetics (77.9%; superiority p=0.98; noninferiority p<0.001) across all anatomic territories treated. Freedom from clinically driven target lesion revascularization was no different between diabetics (83.8%) and nondiabetics (87.5%) overall (p=0.19) or by lesion locations. Secondary clinical outcomes (Rutherford category, ankle-brachial index, and walking impairment) improved at 12 months for both diabetics and nondiabetics. CONCLUSION: Noninferior 12-month patency rates demonstrate that directional atherectomy is an effective treatment in diabetic as well as nondiabetic claudicants. Directional atherectomy remains an attractive treatment option, improving luminal diameters without stents, which preserves future treatment options for both diabetic and nondiabetic patients with progressive, diffuse vascular disease.

Trend, Risk Factors, and Costs of Clostridium difficile Infections in Vascular Surgery.

BACKGROUND: Starting in December 2013, the Hospital Inpatient Quality Reporting Program included Clostridium difficile infection (CDI) rates as a new publically reported quality measure. Our goal was to review the trend, hospital variability in CDI rates, and associated risk factors and costs in vascular surgery. METHODS: The rates of CDI after major vascular procedures including aortic abdominal aneurysm (AAA) repair, carotid endarterectomy or stenting, lower extremity revascularization (LER), and LE amputation were identified using Nationwide Inpatient Sample database for 2000-2011. Risk factors associated with CDI were analyzed with hierarchical multivariate logistic regression. Extra costs, length of stay (LOS), and mortality were assessed for propensity-matched hospitalizations with and without CDI. RESULTS: During the study period, the rates of CDI after vascular procedures had increased by 74% from 0.6 in 2000 to 1.05% in 2011, whereas the case fatality rate was stable at 9-11%. In 2011, the highest rates were after ruptured aortic abdominal aneurysm (rAAA) repair (3.3%), followed by lower extremity amputations (2.3%) and elective open AAA (1.3%). The rates of CDI increased after all vascular procedures during the 12 years. The highest increase was after endovascular LER (151.8%) and open rAAA repair (135.7%). In 2011, patients who had experienced CDI had median LOS of 15 days (interquartile range, 9-25 days) compared with 8.3 days for matched patients without CDI, in-hospital mortality 9.1% (compared with 5.0%), and $13,471 extra cost per hospitalization. The estimated cost associated with CDI in vascular surgery in the United States was ∼$98 million in 2011. Hospital rates of CDI varied from 0 to 50% with 3.5% of hospitals having infection rates ≥5%. Factors associated with CDI included multiple chronic conditions, female gender, surgery type, emergent and weekend hospitalizations, hospital transfers, and urban locations. CONCLUSIONS: Despite potential reduction of infection rates as evidenced by the experience of hospitals with effective interventions, CDI is increasing among vascular surgery patients. It is associated with prolonged LOS, increased mortality, and higher costs.

Failure to rescue trends in elective abdominal aortic aneurysm repair between 1995 and 2011.

OBJECTIVE: Factors affecting mortality after abdominal aortic aneurysm (AAA) repair have been extensively studied, but little is known about the effects of the shift to endovascular aneurysm repair (EVAR) vs open repair on failure to rescue (FTR). This study examines the impact of treatment modalities on FTR for elective AAA surgery during the years 1995 to 2011. METHODS: Data for 491,779 patients undergoing elective AAA surgery were collected from Medicare files. Patient demographics, comorbidities, hospital volume, and repair type were collected. Primary outcome was FTR: the percentage of deaths in patients who had a complication within 30 days of surgery. Data were analyzed by univariate and multivariate analysis. RESULTS: Patients undergoing AAA surgery have become progressively more complex, with 84.96%, 89.33%, 93.76%, and 95.72% presenting with one or more comorbidities in 1995, 2000, 2005, and 2011, respectively. Despite this, overall FTR after AAA surgery was stable from 1995 to 2000 (P = .38) and decreased from 2.68% to 1.58% between 2000 and 2011 (P < .001). In addition, FTR in EVAR decreased from 1.70% to 0.58% from 2000 to 2006 (P = .03) and then stabilized at 0.88% ± 0.9% after 2007 (P = .45). Unlike for EVAR, FTR for open repair remained stable at 3.06% ± 0.17% to 2.74% ± 0.16% from 1995 to 2000 (P = .38) but increased to 4.51% ± 0.21% in 2011 (P < .001). Mortality was highest after transfusion (20.86%), prolonged ventilation (17.37%), and respiratory complications (29.78%) for all AAA surgeries. Of note, high-volume hospitals had lower FTR rates than low-volume hospitals for both open (2.73% vs 5.66%; P < .001) and endovascular (0.7% vs 1.69%; P < .001) repair. Multivariate analysis showed that high annual volume hospital status (odds ratio, 0.6; confidence interval, 0.58-0.63) and endovascular repair (odds ratio, 0.3; confidence interval, 0.28-0.31) were associated with decreased FTR. CONCLUSIONS: The success in AAA surgery of rescuing patients from 30-day mortality after a complication is associated with increased volume of EVAR. This increased success can also be attributed to the improved FTR outcomes and complication rates when surgeries are performed at high-volume hospital centers.

Endovascular treatment of lesions in the below-knee popliteal artery.

BACKGROUND: Endovascular interventions are increasing; however, there are little data regarding outcomes of complex interventions involving the below-knee popliteal/P3 artery. This study evaluated the short-term and long-term results and predictors of success of below-knee popliteal artery endovascular interventions. METHODS: This was a retrospective review of a prospectively maintained endovascular lower extremity database of all patients with below-knee popliteal interventions from 2004 to 2012. Patient demographics, angiographic findings, interventions, primary and secondary patency, limb loss, and mortality were recorded. Analysis was performed using Kaplan-Meier life-table and multivariate analysis, with P < .05 indicating significance. RESULTS: There were 221 patients (56% male) with below-knee popliteal/P3 artery lesions. Mean age was 73 ± 11.2 years. Claudication was present in 22% and critical limb ischemia (CLI) in 78%. Mean lesion length was 10 ± 8.5 cm, with 45% having total occlusions. Treatment included percutaneous transluminal angioplasty (PTA) with or without a stent (47%), atherectomy (ATH) with or without PTA/stent (52%), and stenting with PTA and ATH (3%). Complications included embolization (0.4%), hematoma (2.7%), pseudoaneurysm (1.3%), and dissection (7%). Freedom from restenosis (peak systolic velocity ratio >2.4) was 65% at 1 year. Independent predictors of restenosis were CLI (hazard risk [HR], 4.4; 95% confidence interval [CI], 1.9-9.9) and stenting combined with PTA and ATH (HR, 2.7; 95% CI, 1.01-7.4). Primary assisted and secondary patencies were 95% and 85% at 1 year. ATH with PTA had lower short-term restenosis in diabetic patients compared with nondiabetic patients (95% vs 78% at 4 months). Limb loss was 18% at 4 years. Mortality was 24% at 4 years. Statin use was protective against primary restenosis (HR, 0.39; 95% CI, 0.23-0.67) and death (HR, 0.5; 95% CI, 0.28-1.0). CONCLUSIONS: Endovascular intervention for lesions involving the below-knee popliteal artery is a safe and effective therapy for claudication and CLI. Diabetic patients benefit most from ATH with PTA. Statin use is protective against restenosis and mortality and should be the standard of care in patients undergoing peripheral endovascular interventions.

Statins reduce neurologic injury in asymptomatic carotid endarterectomy patients.

BACKGROUND AND PURPOSE: Statins are neuroprotective in a variety of experimental models of cerebral injury. We sought to determine whether patients taking statins before asymptomatic carotid endarterectomy exhibit a lower incidence of neurological injury (clinical stroke and cognitive dysfunction). METHODS: A total of 328 patients with asymptomatic carotid stenosis scheduled for elective carotid endarterectomy consented to participate in this observational study of perioperative neurological injury. RESULTS: Patients taking statins had a lower incidence of clinical stroke (0.0% vs 3.1%; P=0.02) and cognitive dysfunction (11.0% vs 20.2%; P=0.03). In a multivariate regression model, statin use was significantly associated with decreased odds of cognitive dysfunction (odds ratio, 0.51 [95% CI, 0.27-0.96]; P=0.04). CONCLUSIONS: Preoperative statin use was associated with less neurological injury after asymptomatic carotid endarterectomy. These observations suggest that it may be possible to further reduce the perioperative morbidity of carotid endarterectomy. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00597883.

Final results of the Chronic Total Occlusion Crossing With the Ocelot System II (CONNECT II) study.

PURPOSE: To evaluate the safety and effectiveness of the optical coherence tomography-guided Ocelot catheter to cross femoropopliteal chronic total occlusions (CTOs). METHODS: The CONNECT II study was a prospective, multicenter, non-randomized single-arm study of the safety and effectiveness of the Ocelot catheter in CTO crossing. Key inclusion criteria were a 99% to 100% stenosed femoropopliteal segment, lesion length between 1 and 30 cm, and resistance to guidewire crossing. The main exclusion criterion was a severely calcified target vessel. The primary safety endpoint was 30-day major adverse events (MAE), while the primary effectiveness endpoint was successful CTO crossing (i.e., guidewire placement in the distal true lumen) with the Ocelot catheter. Endpoint analysis was based on pre-specified objective performance criteria. Between February and June 2012, 100 patients (55 men; mean age 69 years) were enrolled. Most of the CTOs (94%) were in the superficial femoral artery (SFA); mean lesion length was 16.6±9.3 cm. RESULTS: Through 30 days, 2 patients experienced MAE (significant perforations) related to the Ocelot catheter. The Ocelot catheter successfully crossed 97% of target CTOs either alone (72%), in conjunction with an assist device (18%), or in conjunction with a re-entry device (7%). Both primary safety and effectiveness endpoints were met. CONCLUSION: The Ocelot catheter with optical coherence tomography guidance offers physicians a reliable option for crossing femoral and popliteal chronic total occlusions with low MAE rates.

Statin therapy is associated with superior clinical outcomes after endovascular treatment of critical limb ischemia.

OBJECTIVE: The aim of this study was to determine if statin therapy improves clinical outcomes after endovascular intervention in patients with critical limb ischemia (CLI). METHODS: A retrospective review of all patients undergoing endovascular treatment for CLI was performed. Two groups were created according to whether they were receiving statin therapy at the time of intervention. Demographics, lesion morphology, overall mortality, primary and secondary patency, and limb salvage were compared between these groups. Analysis was performed using multivariate regression and Kaplan-Meier analysis. RESULTS: Between 2004 and 2009, 646 patients, 319 receiving statin therapy and 327 without, underwent an endovascular intervention for CLI. The statin group had significantly higher rates of diabetes mellitus, coronary artery disease, congestive heart failure, previous myocardial infarction, and coronary artery bypass grafting (P < .05). The two groups had similar lesion length, location, lesion type, TransAtlantic Inter-Society Consensus (TASC) classification, and primary procedure. At 24 months, the statin-treated group had higher rates of primary patency (43% vs 33%; P = .007), secondary patency (66% vs 51%; P = .001), limb salvage (83% vs 62%; P = .001), and overall survival (77% vs 62%; P = .038). Statin therapy was also independently associated with improved limb salvage by multivariate regression analysis (hazard ratio, 2.55; P < .001). CONCLUSIONS: Patients who were receiving statin therapy when they underwent interventions to treat CLI had significantly improved overall survival, primary and secondary patency, and limb salvage rates. Our findings suggest that statins should be part of the periprocedural treatment regimen and support further investigation into the beneficial effects of statins in patients undergoing endovascular treatment of CLI.

Heart failure is associated with reduced patency after endovascular intervention for symptomatic peripheral arterial disease.

OBJECTIVE: Congestive heart failure (CHF) is a highly prevalent comorbidity among patients with symptomatic peripheral arterial disease. The effect of CHF on the procedural success of endovascular treatment, however, remains unknown. Theoretically, poor inflow secondary to systolic dysfunction and peripheral vascular alterations may predispose endovascular interventions to failure. METHODS: A retrospective review of a prospectively maintained database was performed to identify CHF patients undergoing endovascular peripheral arterial intervention from 2004 to 2009. Demographics, comorbidities, procedural details, and outcomes were analyzed. Patients underwent duplex ultrasound imaging and clinical follow-up at scheduled intervals. Kaplan-Meier and Cox proportional hazards models were used to evaluate risk factors for loss of primary patency, secondary patency, and limb salvage. RESULTS: Of 1220 patients undergoing intervention, 271 (22%) with documented congestive heart failure (CHF) underwent an intervention for claudication (22.5%) or critical limb ischemia (77.5%). Primary patency at 1 year was 51.9% ± 2.5% among those with CHF vs 64.6% ± 1.3% in those without CHF (P < .001); this disparity continued throughout follow-up (P < .001). Patients with CHF also had reduced secondary patency throughout follow-up. Multivariate analysis showed CHF was an independent predictor of reduced primary patency (hazard ratio [HR], 1.2; 95% confidence interval [CI] 1.0-1.4; P = .038) and secondary patency (HR, 1.5; 95% CI, 1.2-1.8; P < .001). In the setting of CHF, 1-year patency was 56.6% ± 4.1% if the ejection fraction (EF) was >40% (n = 147) vs 43.2% ± 3.5% if the EF was <40% (n = 124; P < .001). Secondary patency was also significantly reduced in patients with EF <40% throughout follow-up compared with patients without CHF (n = 949) as well as those with CHF and EF >40% (P < .001). CHF with EF <40% was an independent predictor of reduced primary patency (HR, 1.4; 95% CI, 1.2-1.8; P < .01) and secondary patency (HR, 1.8; 95% CI, 1.3-2.3; P < .001). Limb salvage was also worse in patients with EF <40% (P = .038). CONCLUSIONS: CHF is associated with reduced patency after peripheral endovascular intervention and is an independent risk factor for patency loss. Specifically, CHF and reduced EF (<40%) is a strong independent risk factor for patency loss.

Utility of duplex ultrasound in detecting and grading de novo femoropopliteal lesions.

BACKGROUND: Digital subtraction angiography (DSA) is the gold standard for diagnosing lower extremity (LE) arterial lesions. However, duplex ultrasound (DUS) is a widely used, safe, and noninvasive method of detecting LE lesions. The purpose of this study was to establish DUS criteria for detecting and grading de novo stenotic lesions in the femoropopliteal arterial segment. METHODS: A prospective database was established including all patients who underwent LE endovascular interventions between 2004 and 2009. Patients with de novo stenotic lesions in the femoropopliteal segment were selected. DUS and DSA data pairs ≤30 days apart were analyzed. Peak systolic velocity (PSV; cm/s), velocity ratio (Vr), and DSA stenosis were noted. Linear regression and receiver operator characteristic (ROC) curves were used. RESULTS: Two hundred seventy-five lesions in 200 patients were analyzed. Indications were claudication (50.5%), rest pain (12.5%), and tissue loss (37.0%). Mean time interval between DUS and DSA was 24 days. Both PSV (R = .80, R(2) = .641; P < .001) and Vr (R = .73, R(2) = .546; P < .001) showed strong correlation with the degree of angiographic stenosis. ROC analysis showed that to detect ≥70% stenosis, a PSV of 200 cm/s had 89.2% sensitivity and 89.7% specificity, and a Vr of 2.0 had 88.7% sensitivity and 90.2% specificity. Similarly, to differentiate between <50% and ≥50% stenosis, PSV of 150 cm/s and Vr of 1.5 were highly specific and predictive. Combining PSV 200 cm/s and Vr 2.0 for ≥70% stenosis gave 79.0% sensitivity, 99.0% specificity, 99.0% positive predictive value, and 85.0% negative predictive value. CONCLUSION: DUS shows a strong agreement with angiography and has good accuracy in detecting femoropopliteal lesions. We propose DUS criteria of PSV 200 cm/s and Vr 2.0 to differentiate between <70% and ≥70% de novo stenosis in the femoropopliteal arterial segment.

Lesion types and device characteristics that predict distal embolization during percutaneous lower extremity interventions.

OBJECTIVE: Distal embolization (DE) during percutaneous lower extremity revascularization (LER) may cause severe clinical sequelae. To better define DE, we investigated which lesion types and treatment modalities increase the risk for embolization. METHODS: A prospective registry of LER from 2004 to 2009 was reviewed. All cases with runoff evaluated before and after intervention were included. Angiograms and operative reports were reviewed for evidence of DE. Interventions included percutaneous transluminal angioplasty (PTA), with or without stent placement, and atherectomy with four different devices. Chi-square analysis and Fisher's exact test were used to assess significance. Patency rates were calculated using Kaplan-Meier analysis and compared using log-rank analysis. RESULTS: There were 2137 lesions treated in 1029 patients. The embolization rate was 1.6% (34 events). Jetstream (Pathway, Kirkland, Wash) and DiamondBack 360 (Cardiovascular Systems Inc, St Paul Minn) devices had a combined embolization rate of 22% (8 of 36), 4 of 18 (22%) in each group, which was significantly higher than with PTA alone (5 of 570, 0.9%), PTA and stent (5 of 740, 0.7%), SilverHawk (ev3, Plymouth, Minn) atherectomy (14 of 736, 1.9%), and laser atherectomy (2 of 55, 3.6%; P < .001). There was a significantly higher rate of embolization for in-stent restenosis (6 of 188, 3.2%) and chronic total occlusions (15 of 615, 2.4%) compared with stenotic lesions (13 of 1334, 0.9%; P = .01). The embolization rate was significantly higher in Transatlantic Inter-Society Consensus (TASC) II C and D lesions compared with TASC A and B lesions (P = .018). DE rates were not affected by preoperative runoff status (P = .152). Patency was restored at the completion of the procedure in 32 of 34 cases of DE. The 24-month primary patency, assisted primary patency, and secondary patency in the DE group was 54.0% ± 11.9%, 70.0% ± 10.3%, and 73.2% ± 10.3%, respectively, and was 44.4% ± 1.7%, 61.5% ± 1.7%, and 68.2% ± 1.6%, respectively, when embolization did not occur (P > .05). Limb salvage was 72.6% ± 3.1% in lesions in which no DE occurred vs 83.3% ± 15.2% in lesions in which DE occurred (P = .699). CONCLUSIONS: DE is a rare event that occurs more often with the Jetstream and DiamondBack 360 devices. In-stent and complex native lesions are at higher risk for DE. DE is typically reversible with endovascular techniques and has no effect on patency rates and limb salvage.