Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.

BACKGROUND: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited. METHODS: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%. RESULTS: A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433). CONCLUSION: The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496).

Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries.

PURPOSE: To report 24 month safety and efficacy of the Tack Endovascular System for treatment of post-percutaneous transluminal angioplasty (PTA) infrapopliteal dissections in patients with critical limb-threatening ischemia (CLTI). MATERIALS AND METHODS: The Tack-Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) study was a prospective, multicenter, single-arm evaluation of the Tack Endovascular system for post-PTA infrapopliteal dissection repair. Patients with Rutherford Clinical Category (RC) 3 to 5 and a post-PTA dissection(s) of the BTK arteries were enrolled. The 30 day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary effectiveness endpoint was a composite of MALE at 6 months and 30 day POD. Outcomes were assessed as observational endpoints at 24 months. RESULTS: Tack-Optimized Balloon Angioplasty II BTK enrolled 233 patients; all patients had a post-PTA dissection(s) and received ≥1 Tack implant (range, 1-16). Mean age was 74.4±10.0 years and 67.4% were men. Most patients had CLTI (RC 3: 16.3%; RC 4/5: 83.7%). Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions and total occlusions were present in 118 (47.6%) lesions. Kaplan-Meier freedom from MALE at 24 months + POD at 30 days was 92.2% and 24 month freedom from clinically-driven target lesions revascularization was 73.6%. Kaplan-Meier target limb salvage was 95.7% and amputation-free survival was 75.4%. Improvements in functional status and quality of life were observed through 24 months. CONCLUSION: The TOBA II BTK study demonstrated sustained safety and efficacy through 24 months in patients treated for post-PTA dissection(s) of BTK lesions. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02942966.

Objective Outcome Measures for Trials in Patients With Chronic Limb-Threatening Ischemia Across 2 Decades: Analysis and Recommendations.

Chronic limb-threatening ischemia (CLTI) is prevalent and associated with morbidity and mortality. The published research concerning CLTI therapeutics is evolving. The goals of this review are to: 1) summarize the endpoints that are being used in trials assessing interventions for patients with CLTI; and 2) review gaps and discrepancies in current outcome definitions. A search was conducted of the PubMed database and ClinicalTrials.gov to identify studies published between January 2000 and March 2020 that evaluated treatment options for patients with CLTI. Meta-analyses, case series, case reports, abstracts, and expert opinion were excluded. Forty-nine studies (n = 11,667) were identified that fulfilled the inclusion criteria. Most trials reported clinical outcomes (mortality, 69.4%; limb events, 87.8%; target lesion revascularization, 83.7%). Mean follow-up duration was 23.7 months. In investigational device exemption trials, total follow-up and follow-up to primary outcomes were discordant (12 months vs 6 months; P = 0.0018). Hemodynamic testing was reported in 71.4%, usually ankle-brachial index. Patency was assessed in 89.8% of trials; ultrasound was used in 65.3% and invasive angiography in 85.7%, at baseline and/or during follow-up. Wound assessment was performed in 49.0% of studies, qualitative in 28.6% and quantitative in 20.4%. Finally, quality of life assessment was performed in 55% of studies. Definitions for many outcomes varied across studies. Consensus regarding which outcomes to study, uniform definitions, and optimal methods to measure some of these outcomes are yet to be established. A comprehensive effort by all stakeholders is needed to move the field of CLTI forward.

A critical appraisal of registry-based objective performance goals in peripheral arterial disease.

The multidisciplinary Superficial Femoral Artery-Popliteal EvidencE Development (SPEED) Study Group, under the auspices of the Registry Assessment of Peripheral Interventional Devices (RAPID) partnership, recently published objective performance goals for peripheral vascular interventions in the femoropopliteal arteries. Retrospective outcomes from the Vascular Quality Initiative provided the sole study data source. Strengths and weaknesses of this landmark effort are examined. Critical concerns include the substantial risks of ascertainment bias, flawed end point selection, sparse and variable capture of midterm follow-up data, and lack of expected discrimination between treatment modalities. The current Vascular Quality Initiative registry data thus appear insufficiently robust for the generation of objective performance goals and practice benchmarks; suggestions for redesign are provided. The impact of the statutory framework of the US Food and Drug Administration on device approval pathways and the maturation of an evidence-based approach to peripheral vascular intervention is explored.

Six-month pivotal results of tack optimized balloon angioplasty using the Tack Endovascular System in below-the-knee arteries.

OBJECTIVE: No vascular implant is commercially available in the United States to treat post-angioplasty dissections in below-the-knee (BTK) arteries. The Tack Endovascular System (Intact Vascular, Wayne, Pa) is purpose-built to repair postpercutaneous transluminal angioplasty (PTA) BTK dissections. A trial was conducted to investigate the safety and efficacy of the first-of-a-kind implantable BTK device to treat post-PTA dissections in the setting of critical limb ischemia. METHODS: The present prospective, single-arm, multicenter study evaluated the Tack Endovascular System for treating post-PTA dissections in the mid/distal popliteal, tibial, and peroneal arteries. The primary safety endpoint was major adverse limb events (MALE) plus perioperative death (POD), assessed at 30 days after the index procedure. The primary efficacy endpoint was a composite of MALE at 6 months and POD. The unpowered secondary endpoint was primary patency at 6 months. With no available on-label comparator, the primary endpoints of the present trial were determined using objective performance goals from a systematic literature search. The secondary endpoints included Tacked segment patency and target limb salvage at 6 months. The 6-month results are reported. RESULTS: Of the 233 patients enrolled, 117 (50.2%) had Rutherford class 5 and 78 (33.5%) had Rutherford class 4. A total of 341 post-PTA dissections were treated. Each patient received at least one Tack implant, and 100% of the dissections resolved according to the angiographic core laboratory findings. The primary safety and efficacy endpoints were both met. The rate of MALE plus POD at 30 days was 1.3% (3 of 228) and freedom from MALE at 6 months plus POD at 30 days was 95.6% (196 of 205). The 6-month Tacked segment patency was 82.1% (247 of 301) and target limb salvage was 98.5% (202 of 205). The Kaplan-Meier freedom from clinically driven target lesion revascularization and amputation-free survival at 6 months was 92.0% and 95.7%, respectively. Rutherford improvement was reported in 79.4% (158 of 199). Most (90 of 122; 73.8%) preexisting wounds had healed or were improving. CONCLUSIONS: The Tack Endovascular System is safe and effective for treating post-PTA BTK dissections through 6 months, with favorable rates of MALE plus POD, patency, clinically driven target lesion revascularization, limb salvage, and wound healing.

Management of Seat Belt-type Blunt Abdominal Aortic Trauma and Associated Injuries in Pediatric Patients.

BACKGROUND: "Seat belt-type" pediatric abdominal aortic trauma is uncommon but potentially lethal. During high speed motor vehicle collisions (MVCs), seat or lap belt restraints may concentrate forces in a band-like pattern across the abdomen, resulting in the triad of hollow viscus perforation, spine fracture, and aortoiliac injury. We report 4 cases of pediatric seat belt-type aortic trauma and review management strategies for the aortic disruption and the associated constellation of injuries. METHODS: -approved, retrospective review of all pediatric patients requiring surgical intervention for seat belt-type constellation of abdominal aortic/iliac and associated injuries over a 5-year period. Blunt thoracic aortic injuries were excluded. RESULTS: We identified 4 patients, ranging from 2 to 17 years of age, who required surgical correction of seat belt-type aortoiliac trauma and associated injuries: 3 abdominal aortas and 1 left common iliac artery. The majority (3/4 patients) were hemodynamically unstable at emergency room presentation, and all underwent computed tomography angiography of the chest/abdomen/pelvis during initial resuscitation. Injuries of the suprarenal and proximal infrarenal aorta were accompanied by unilateral renal artery avulsion requiring nephrectomy. Presumed or proven spinal instability mandated supine positioning and midline laparotomy, with medial visceral rotation utilized for proximal injuries. Aortoiliac injuries requiring repair were accompanied by significant distal intraluminal prolapse of dissected intima, with varying degrees of obstruction. Conduit selection was dictated by the presence of enteric contamination and the rapid availability of an autologous conduit. The sole neurologic deficit was irreparable at presentation. CONCLUSIONS: Seat belt aortoiliac injuries in pediatric patients require prompt multidisciplinary evaluation. Evidence of contained aortoiliac transection, major branch vessel avulsion, and bowel perforation mandates immediate exploration, which generally precedes spinal interventions. Lesser degrees of aortoiliac injuries have been managed with surveillance, but long-term follow-up is needed to fully validate this approach.

Retroperitoneal Approach for Ilioinguinal, Iliohypogastric, and Genitofemoral Neurectomies in the Treatment of Refractory Groin Pain After Inguinal Hernia Repair.

Inguinal hernia repair is one of the most commonly performed surgical procedures. Postoperative neuropathic groin pain is a potentially disabling complication and can be due to a neuroma of the ilioinguinal, iliohypogastric, and/or genitofemoral nerves. In this article, we present our operative technique-a retroperitoneal approach to the ipsilateral ilioinguinal, iliohypogastric, and genitofemoral nerves with neurectomy and proximal transposition of these nerves-for management of neuropathic pain. A retrospective review was performed of 12 of the patients who underwent this surgery at our institution. Three of 12 patients underwent a selective neurectomy, whereas 9 of 12 underwent a triple neurectomy; 3 of the 9 patients who underwent triple neurectomy also had a retroperitoneal peripheral nerve stimulator placed at the time of neurectomy. Pain visual analog scores (VASs) demonstrated significant improvement after neurectomy (preoperative pain VAS of 85 ± 11 vs postoperative pain VAS of 47 ± 32, P = 0.0027). Eight of 12 patients experienced partial or complete pain relief, whereas 4 of 12 patients had no pain relief. There were no major complications, and the minor complication rate was low for all patients and primarily related to peripheral nerve stimulator placement. This retroperitoneal approach to triple neurectomy for treatment of refractory groin pain in postoperative inguinal hernia repair patients is safe and effective for an otherwise devastating problem.

Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK).

Purpose: To report the 12-month safety and efficacy outcomes of the investigational device exemption trial evaluating an implantable below-the-knee (BTK) dissection repair device. Materials and Methods: The prospective, multicenter, single-arm Tack-Optimized Balloon Angioplasty (TOBA) II BTK study (ClinicalTrials.gov identifier NCT02942966) evaluated the Tack Endovascular System in the BTK arteries vs objective performance goals derived from a systematic review of BTK angioplasty literature. Patients presenting with Rutherford category 3-5 ischemia were eligible and were enrolled during the procedure if angioplasty resulted in dissection(s) of the BTK arteries. Between February 2017 and December 2018, the study enrolled 233 patients (mean age 74.4±10.0 years; 157 men). Most lesions (93.8%) were de novo; almost half (118/248, 47.6%) were total occlusions. Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions. The 30-day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary efficacy endpoint was a composite of MALE at 6 months and 30-day POD. These safety and efficacy endpoints were assessed at 12 months as observational endpoints along with amputation-free survival (AFS), freedom from clinically-driven target lesion revascularization (CD-TLR), vessel patency, and changes from baseline in clinical and quality of life measures. Results: All patients had post-PTA dissection and received at least 1 Tack implant (range 1 to 16). The angiographic core laboratory noted successful resolution of 100% of the 341 treated dissections. At 12 months, 93.4% (170/182) of patients remained free of the composite endpoint of MALE + POD. Tacked segment patency was 81.3% and limb salvage was 96.8% at 12 months; freedom from CD-TLR and AFS were 83.1% and 89.3%, respectively. Sustained Rutherford category improvement was reported in 82.4% of evaluated patients, with 62.4% improving ≥3 categories (p<0.001). Ninety of 124 index wounds (72.5%) healed or improved. Conclusion: The Tack Endovascular System is safe and effective in the treatment of post-angioplasty BTK dissections. Twelve-month outcome data from the TOBA II BTK study demonstrate high rates of patency, limb salvage, and wound healing.

Drug-Coated vs Uncoated Percutaneous Transluminal Angioplasty in Infrapopliteal Arteries: Six-Month Results of the Lutonix BTK Trial.

OBJECTIVES: We hypothesized that a drug-coated balloon (DCB) could improve treatment efficacy while maintaining safety when compared with percutaneous transluminal angioplasty (PTA) for the treatment of atherosclerotic infrapopliteal arterial lesions. METHODS: A total of 442 patients with angiographically significant lesions were randomized (2:1) to DCB or PTA. The primary safety and efficacy endpoints were freedom from major adverse limb events and perioperative death (MALE-POD) at 30 days, and freedom from vessel occlusion, clinically driven target-lesion revascularization (CD-TLR), and above-ankle amputation measured at 6 months. Success was achieved if safety between groups was non-inferior (margin 12%), and efficacy was statistically significant either for the overall intention-to treat (ITT) or the proximal-segment DCB groups (ie, the proximal two-thirds of the below-knee arterial pathways). RESULTS: Freedom from MALE-POD for the DCB group (99.3%) was non-inferior to PTA (99.4%; non-inferiority P<.001). Proportional analysis of the primary efficacy endpoint was statistically significant for the proximal-segment DCB group (76%) vs PTA (62.9%; one-sided P<.01; Bayesian P-value for success of .0085) while not statistically significant for the overall ITT group (74.5% for DCB vs 63.5% for PTA; one-sided P=.02). Kaplan-Meier analyses demonstrated superior efficacy for DCB in both the overall ITT and proximal-segment groups at 6 months. Primary patency and CD-TLR, hypothesis-tested secondary endpoints, were also statistically better for the DCB group compared with PTA at 6 months (one-sided P<.025). CONCLUSIONS: DCB treatment for symptomatic infrapopliteal arterial lesions produced non-inferior safety at 30 days and a statistically significant difference in the primary efficacy endpoint when compared with PTA at 6 months.

Contemporary results of carotid endarterectomy in "normal-risk" patients from the Society for Vascular Surgery Vascular Registry.

OBJECTIVE: Acceptable complication rates after carotid endarterectomy (CEA) are drawn from decades-old data. The recent Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) demonstrated improved stroke and mortality outcomes after CEA compared with carotid artery stenting, with 30-day periprocedural CEA stroke rates of 3.2% and 1.4% for symptomatic (SX) and asymptomatic (ASX) patients, respectively. It is unclear whether these target rates can be attained in "normal-risk" (NR) patients experienced outside of the trial. This study was done to determine the contemporary results of CEA from a broader selection of NR patients. METHODS: The Society for Vascular Surgery (SVS) Vascular Registry was examined to determine in-hospital and 30-day event rates for NR, SX, and ASX patients undergoing CEA. NR was defined as patients without anatomic or physiologic risk factors as defined by SVS Carotid Practice Guidelines. Raw data and risk-adjusted rates of death, stroke, and myocardial infarction (MI) were compared between the ASX and SX cohorts. RESULTS: There were 3977 patients (1456 SX, 2521 ASX) available for comparison. The SX group consisted of more men (61.7% vs 57.0%; P = .0045) but reflected a lower proportion of white patients (91.3% vs 94.4%; P = .0002), with lower prevalence of coronary artery disease (P < .0001), prior MI (P < .0001), peripheral vascular disease (P = .0017), and hypertension (P = .029), although New York Heart Association grade >3 congestive heart failure was equally present in both groups (P = .30). Baseline stenosis >80% on duplex imaging was less prevalent among SX patients (54.2% vs 67.8%; P < .0001). Perioperative stroke rates were higher for SX patients in the hospital (2.8% vs 0.8%; P < .0001) and at 30 days (3.4% vs 1.0%; P < .0001), which contributed to the higher composite death, stroke, and MI rates in the hospital (3.6% vs 1.8; P = .0003) and at 30 days (4.5% vs 2.2%; P < .0001) observed in SX patients. After risk adjustment, the rate of stroke/death was greater among SX patients in the hospital (odds ratio, 2.05; 95% confidence interval, 1.18-3.58) although not at 30 days (odds ratio, 1.36; 95% confidence interval, 0.85-2.17). No in-hospital or 30-day differences were observed for death or MI by symptom status. CONCLUSIONS: The SVS Vascular Registry results for CEA in NR patients are similar by symptom status to those reported for CREST and may serve as a benchmark for comparing results of alternative therapies for treatment of carotid stenosis in NR patients outside of monitored clinical trials. The contemporary perioperative risk of stroke after CEA in NR patients continues to be higher for SX than for ASX patients.

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.

Preoperative symptom type influences the 30-day perioperative outcomes of carotid endarterectomy and carotid stenting in the Society for Vascular Surgery Vascular Registry.

OBJECTIVE: The objective of this study was to determine the effect of presenting symptom types on 30-day periprocedural outcomes of carotid endarterectomy (CEA) and carotid artery stenting (CAS) in contemporary vascular practice. METHODS: Retrospective review was undertaken of the Society for Vascular Surgery Vascular Registry database subjects who underwent CEA or CAS from 2004 to 2011. Patients were grouped by discrete 12-month preprocedural ipsilateral symptom type: stroke, transient ischemic attack (TIA), transient monocular blindness (TMB), or asymptomatic (ASX). Risk-adjusted odds ratios (ORs) were used to compare the likelihood of the 30-day outcomes of death, stroke, and myocardial infarction (MI) and the composite outcomes of death + stroke and death + stroke + MI. RESULTS: Symptom type significantly influences risk-adjusted 30-day outcomes for carotid intervention. Presentation with stroke predicted the poorest outcomes (death + stroke + MI composite: OR, 1.3; 95% confidence interval [CI], 0.83-2.03 vs TIA; OR, 2.56; 95% CI, 1.18-5.57 vs TMB; OR, 2.12; 95% CI, 1.46-3.08 vs ASX), followed by TIA (death + stroke + MI composite: OR, 1.97; 95% CI, 0.91-4.25 vs TMB; OR, 1.63; 95% CI, 1.14-2.33 vs ASX). For both CAS and CEA patients, presentation with stroke or TIA predicted a higher risk of periprocedural stroke than in ASX patients. Presentation with stroke predicted higher 30-day risk of death with CAS but not with CEA. MI rates were not affected by presenting symptom type. The 30-day outcomes for the TMB and ASX patient groups were equivalent in both treatment arms. CONCLUSIONS: Presenting symptom type significantly affects the 30-day outcomes of both CAS and CEA in contemporary vascular surgical practice. Presentation with stroke and TIA predicts higher rates of periprocedural complications, whereas TMB presentation predicts a periprocedural risk profile similar to that of ASX disease.

The effect of extremity vascular complications on the outcomes of cardiac support device recipients.

OBJECTIVE: To assess the effect of extremity vascular complications (EVCs, including ischemia or vessel trauma) on the outcomes of patients receiving cardiac support devices (CSDs, including ventricular assist device [VAD] and extracorporeal membrane oxygenation [ECMO]). METHODS: Institutional Review Board-approved, retrospective review of a prospectively maintained database of all temporary and permanent CSD recipients from 7/1/10 to 6/30/12. Patient demographics, procedural data, and outcomes were analyzed. The primary endpoint was all-cause mortality at 30-days post-CSD initiation. RESULTS: Of 208 patients who received CSDs, 31 (14.9%) experienced EVC: 13 (8.9%) of the 146 permanent VADs, 10 (26.3%) of the 38 temporary VADs, and 8 (33.3%) of the 24 ECMO patients. The 30-day mortality for CSD-EVC patients was not significantly higher than that of the CSD patients who did not experience EVC for permanent VAD (15.4% vs 4.5%; P = .15) and ECMO patients (50.0% vs 68.75%; P = 1.00), but was significantly higher for temporary VAD patients (80.0% vs 35.7%; P = .03). Within the CSD-EVC cohort, patients who received a temporary VAD had a significantly higher 30-day mortality and decision to withdraw care after EVC compared with those who received a permanent VAD (P = .01 and P < .01, respectively). Looking beyond the 30-day window, EVC was associated with higher mortality rates in the permanent VAD population (53.8% vs 25.6%; P = .025) but not the temporary VAD or ECMO groups. CONCLUSIONS: In temporary VAD recipients, EVCs result in higher 30-day mortality, more frequent withdrawal of care, and shortened survival time relative to the global temporary VAD group. EVC in permanent VAD recipients did not affect early (30-day) mortality rates, but strongly predicted a higher cumulative mortality risk for the 2-year study period. Overall ECMO mortality rates were high, and not significantly impacted by the occurrence of EVC. The nature of the EVC (cannulation site complication vs embolic injury) did not impact mortality. This data provides quality improvement targets for VAD programs.

Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease.

OBJECTIVE: The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation. METHODS: One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention. RESULTS: The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤ 2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. CONCLUSIONS: The long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endograft and bare nitinol stents are similar. Although primary patency rates are low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and quality-of-life measures. Patency rates diminish most rapidly in the first year after device implantation.

Use of Zenith TX2 endografts in endovascular abdominal aortic aneurysm repair for large-diameter aortic necks.

The purpose of this case report is to describe the use of thoracic endografts in endovascular repair of abdominal aortic aneurysms (AAAs) with large-diameter aortic necks. We present four patients who underwent elective repair of AAAs. Preoperative imaging demonstrated all to have large aortic necks (35-37 mm) precluding treatment with standard abdominal aortic devices. All underwent endovascular treatment, which included the use of a Zenith TX2 endograft (Cook Medical Incorporated, Bloomington, IN, USA) as a proximal aortic cuff. There was 100% technical success. One patient developed gastrointestinal bleeding and a myocardial infarction. All were subsequently discharged home. On follow-up, there was one aneurysm-related death at three months. The remaining three patients are alive at a mean of 25.7 months after their operation. In conclusion, large proximal aortic necks preclude endovascular treatment with standard abdominal endograft components. The use of a thoracic endograft as a proximal aortic cuff is a feasible technique for patients unable to tolerate open aortic reconstruction.

Outcomes of percutaneous endovascular intervention for type II endoleak with aneurysm expansion.

OBJECTIVE: Type II endoleak (T2EL) with aneurysm expansion is believed to place patients at risk for aneurysm-related mortality (ARM). Treatment with glue and/or coil embolization of the aneurysm sac, inferior mesenteric artery (IMA), and lumbar branches via translumbar or transarterial approaches has been utilized to ablate such endoleaks, and thus decrease ARM. We evaluated the midterm results of percutaneous endovascular treatment of T2EL with aneurysm expansion. METHODS: Single-institution, 5-year (January 2003 to August 2008) retrospective study of all endovascular interventions for T2EL with sac expansion. Blinded, independent review of all available pre- and post-T2EL intervention computed tomography (CT) scans was performed. Aneurysm sac maximal transverse diameters and aneurysm sac growth rates prior to and following T2EL intervention were analyzed. RESULTS: Forty-two patients (34 male, eight female; mean age, 75) underwent T2EL intervention at 26 ± 20 months after endovascular aneurysm repair (EVAR) and were subsequently followed for 23 ± 20 months. Seven out of 42 patients (17%) underwent repeat T2EL intervention. Interventions included 44 translumbar sac embolizations, and transcatheter embolizations of nine IMAs and seven lumbar/hypogastric arteries. Aneurysm diameter was 6.1 ± 1.6 cm at EVAR, 6.6 ± 1.5 cm at initial T2EL treatment, and 6.9 ± 1.7 cm at last follow-up. There were no significant differences in the rates of aneurysm sac growth pre- and post-T2EL treatment. At last follow-up imaging, recurrent or persistent T2EL was noted in 72% of patients. Of 42 patients, nine (21%) received operative endoluminal correction of occult type I or type III endoleaks that were diagnosed during the T2EL angiographic intervention. There were no aneurysm ruptures or ARMs during follow-up; overall mortality for the 5-year study period was 24%. CONCLUSIONS: In this series, percutaneous endovascular intervention for type II endoleak with aneurysm sac growth does not appear to alter the rate of aneurysm sac growth, and the majority of patients display persistent/recurrent endoleak. However, diagnostic angiographic evaluation may reveal unexpected type I and III endoleaks and is therefore recommended for all patients with T2EL and sac growth. While coil and glue embolization of aneurysm sac and selected branch vessels does not appear to yield benefit in our series, the diagnosis and subsequent definitive treatment of previously occult type I and III endoleaks may explain the absence of delayed rupture and ARM in our series.

Early protection and compression of residual limbs may improve and accelerate prosthetic fit: a preliminary study.

BACKGROUND: The goal of rehabilitation following lower extremity amputation is to restore the highest level of independent function. As much as possible, this includes the functional use of a prosthetic device fitted to the residual limb. Early prosthetic fit depends, in turn, on rapid healing of the amputation site. METHODS: We hypothesized that compliance with a novel custom-designed amputation protection and compression system (CAPCS) to the residual limb can accelerate and improve the likelihood of successful prosthesis use. We conducted a retrospective study of all patients who were offered CAPCS by certified prosthetists (Hanger Prosthetics and Orthotics, Bethesda, MD) during the period between April 2004 and November 2009. Variables included age, sex, indication for amputation, and compliance with CAPCS. Compliance was defined as consistent observed wearing of the CAPCS as directed. The primary end point was the fitting of a prosthetic device to the amputated limb, with time to prosthetic fit being the secondary outcome. RESULTS: Out of 100 patients who were offered CAPCS (n = 100) during the study period, 76% were considered compliant (n = 76). Sixty five patients (65%) were ultimately fitted with prosthetic limbs. In multivariate analysis, we found that patients who had compliant use of CAPCS were significantly more likely to be successfully fit with prosthesis (72 vs. 42%, p = 0.005). At 100 days post amputation, the cumulative incidence of prosthesis fitting was significantly higher in CAPCS compliant patients (69.7 vs. 22.2%, p = 0.012). CONCLUSIONS: Compliant use of a CAPCS following amputation is associated with earlier and more frequent use of a prosthetic. Based on this limited data set, a conclusion can be drawn that the potential exists to significantly improve functional outcomes after amputation, but well-designed prospective studies are needed to confirm this association.

Long-term outcomes of endovascular aneurysm repair for challenging aortic necks using the Talent endograft.

The aim of the present paper is to evaluate the long-term outcomes of endovascular aneurysm repair (EVAR) for challenging aortic necks. Subgroup analyses were performed on 156 patients from the prospective multicenter Talent eLPS (enhanced Low Profile Stent Graft System) trial. Patients with high-risk aortic necks (length < 15 mm or diameter ≥28 mm) were compared with the remaining patients. Patients with high-risk (n = 86) and low-risk necks (n = 70) had similar age and gender distribution. Despite similar prevalences of co-morbidities, the high-risk group had higher Society for Vascular Surgery scores. The high-risk group also had larger maximum aneurysm diameters (56.6 versus 53.0 mm, P < 0.02). There were lower freedoms from major adverse events (MAEs) for the high-risk group at 30 days (84.9 versus 95.7%; P < 0.04) and 365 days (73.4 versus 89.2%; P = 0.02). Effectiveness endpoints at 12 m showed no significant differences. Freedom from all-cause mortality at 30 days (96.5 versus 100%) and aneurysm-related mortality at 365 days (96.0 versus 100%) were similar. At five years, there were no differences in endoleaks or change in aneurysm diameter. All migrations occurred in the high-risk group. The five-year freedom from aneurysm-related mortality for the high- and low-risk groups was 93.2 and 100%, respectively. In conclusion, despite a higher rate of MAEs within the first year and higher migration rates at five years, EVAR in aneurysms with challenging aortic necks can be treated with acceptable long-term results.

Midterm outcomes of the Zenith Renu AAA Ancillary Graft.

OBJECTIVE: The Zenith Renu abdominal aortic aneurysm (AAA) Ancillary Graft (Cook Medical Inc, Bloomington, Ind) provides active proximal fixation for treatment of pre-existing endografts with failed or failing proximal fixation or seal. The purpose of this study was to evaluate the midterm outcomes of treatment with this device. METHODS: From September 2005 to November 2006, a prospective, nonrandomized, multicenter, postmarket registry was utilized to collect physician experiences from 151 cases (89 converters and 62 main body extensions) at 95 institutions. Preoperative indications and procedural and postimplantation outcomes were collected and analyzed. Technical success and clinical success were determined as defined by the Society of Vascular Surgery reporting standards. RESULTS: Patients were predominantly male (87%) with a mean age of 77 years. The interval between the original endograft implantation to Renu treatment was 43.4 ± 18.7 months. The indications for treatment were endoleak (n = 111), migration (n = 136), or both (n = 94). Technical success was 98.0% with two cases of intraoperative conversion and one case of persistent type IA endoleak. The median follow-up for the cohort was 45.0 months (range, 0-56 months; interquartile range, 25.0 months). Overall, 32 cases had treatment failures that included at least one of the following: death (n = 5), type I/III endoleak (n = 18), graft infection (n = 1), thrombosis (n = 1), aneurysm enlargement >5 mm (n = 9), rupture (n = 4), conversion (n = 9, with 7 after 30 days), and migration (n = 1). Overall, the clinical success for the entire cohort during the follow-up period was 78.8% (119/151). CONCLUSIONS: The postmarket registry data confirm that the Zenith Renu AAA Ancillary Graft can be used to treat endovascular repairs that failed due to proximal attachment failures. The salvage treatment with the Renu device had high technical success rate and resulted in clinical success in a majority of patients (78.8%). While failed endovascular repairs can be salvaged, a clinical failure in one of five patients still emphasizes the importance of patient and device selection during initial endovascular aneurysm repair to ensure durable success.

Outcome of endovascular repair of small and large abdominal aortic aneurysms.

BACKGROUND: To evaluate the outcomes of endovascular aneurysm repair (EVAR) in patients with small (≤5.4 cm) and large (≥5.5 cm) abdominal aortic aneurysms (AAAs). METHOD: Data for this study were obtained from the prospective, nonrandomized, multicenter Talent enhanced Low Profile Stent trial that enrolled patients between February 2002 and April 2003. A total of 156 patients with adequate preoperative imaging were identified for this study. Subgroup analyses were performed for patients with small (≤5.4 cm) and large (≥5.5 cm) AAAs. Demographics, aneurysm morphology, and perioperative endpoints were assessed. Safety and effectiveness endpoints were evaluated at 30 days, 1 year, and 5 years postprocedure. RESULTS: Patients with small AAAs (n = 85) had similar age, gender, and medical risk profile compared with those for larger AAAs (n = 71). The proximal aortic necks in small AAAs were longer (24.7 mm vs. 20.7 mm, p = 0.05), less angulated (27.2° vs. 34.2°, p = 0.01), and smaller (24.6 mm vs. 26.1 mm, p = 0.01). Patients with small AAAs spent less time in intensive care (8.1 hour vs. 26.3 hour, p = 0.03); however, other perioperative endpoints were similar. Although the group with small AAAs had a statistically significant higher rate of successful aneurysm treatment (96.8% vs. 84.9%, p = 0.04), no difference was observed in all other effectiveness endpoints at 12 months. No differences in freedom from major adverse events at 30 days and 365 days were reported. At 5 years, no differences in rates of migration, endoleaks, change in aneurysm diameter, or freedom from aneurysm-related mortality were found. Further subgroup analyses segregating patients with very small (≤5.0 cm, n = 55), small (5.1-5.4 cm, n = 30), and larger (≥5.5 cm) AAAs also showed no statistically significant differences in postoperative outcomes. CONCLUSIONS: In a prospective clinical trial setting with long-term follow-up, patients with small (≤5.4 cm) AAAs had aortic neck characteristics which were more favorable for EVAR. Despite these anatomic differences, clinical outcomes were similar to patients with large AAAs. Thus, we conclude that EVAR for small AAA should not be routinely recommended for patients on the basis of the assumption of improved outcomes.