Brian G. DeRubertis

Simulation improves resident performance in catheter-based intervention: results of a randomized, controlled study.

Objectives:Surgical simulation has been shown to enhance the training of general surgery residents. Since catheter-based techniques have become an important part of the vascular surgeons armamentarium, we explored whether simulation might impact the acquisition of catheter skills by surgical residents. Methods:Twenty general surgery residents received didactic training in the techniques of catheter intervention. Residents were then randomized with 10 receiving additional training with the Procedicus, computer-based, haptic simulator. All 20 residents then participated in 2 consecutive mentored catheter-based interventions for lower extremity occlusive disease in an OR/angiography suite. Resident performance was graded by attending surgeons blinded to the residents training status, using 18 procedural steps as well as a global rating scale. Results:There were no differences between the 2 resident groups with regard to demographics or scores on a visuospatial test administered at study outset. Overall, residents exposed to simulation scored higher than controls during the first angio/OR intervention: procedural steps (simulation/control) (50 ± 6 vs. 33 ± 9, P = 0.0015); global rating scale (30 ± 7 vs. 19 ± 5, P = 0.0052). The advantage provided by simulator training persisted with the second intervention (53 ± 6 vs. 36 ± 7, P = 0.0006); global rating scale (33 ± 6 vs. 21 ± 6, P = 0.0015). Moreover, simulation training, particularly for the second intervention, led to enhancement in almost all of the individual measures of performance. Conclusion:Simulation is a valid tool for instructing surgical residents and fellows in basic endovascular techniques and should be incorporated into surgical training programs. Moreover, simulators may also benefit the large number of vascular surgeons who seek retraining in catheter-based intervention.

Shifting Paradigms in the Treatment of Lower Extremity Vascular Disease: A Report of 1000 Percutaneous Interventions

Objectives:Catheter-based revascularization has emerged as an alternative to surgical bypass for lower extremity vascular disease and is a frequently used tool in the armamentarium of the vascular surgeon. In this study we report contemporary outcomes of 1000 percutaneous infra-inguinal interventions performed by a single vascular surgery division. Methods:We evaluated a prospectively maintained database of 1000 consecutive percutaneous infra-inguinal interventions between 2001 and 2006 performed for claudication (46.3%) or limb-threatening ischemia (52.7%; rest pain in 27.7% and tissue loss in 72.3%). Treatments included angioplasty with or without stenting, laser angioplasty, and atherectomy of the femoral, popliteal, and tibial vessels. Results:Mean age was 71.4 years and 57.3% were male; comorbidities included hypertension (84%), coronary artery disease (51%), diabetes (58%), tobacco use (52%), and chronic renal insufficiency (39%). Overall 30-day mortality was 0.5%. Two-year primary and secondary patencies and rate of amputation were 62.4%, 79.3%, and 0.5%, respectively, for patients with claudication. Two-year primary and secondary patencies and limb salvage rates were 37.4%, 55.4%, and 79.3% for patients with limb-threatening ischemia. By multivariable Cox PH modeling, limb-threat as procedural indication (P < 0.0001), diabetes (P = 0.003), hypercholesterolemia (P = 0.001), coronary artery disease (P = 0.047), and Transatlantic Inter-Society Consensus D lesion complexity (P = 0.050) were independent predictors of recurrent disease. For patients that developed recurrent disease, 7.5% required no further intervention, 60.3% underwent successful percutaneous reintervention, 11.7% underwent bypass and 20.5% underwent amputation. Patency rates were identical for the initial procedure and subsequent reinterventions (P = 0.97). Conclusion:Percutaneous therapy for peripheral vascular disease is associated with minimal mortality and can achieve 2-year secondary patency rates of nearly 80% in patients with claudication. Although patency is diminished in patients with limb-threat, limb-salvage rates remain reasonable at close to 80% at 2 years. Percutaneous infra-inguinal revascularization carries a low risk of morbidity and mortality, and should be considered first-line therapy in patients with chronic lower extremity ischemia.

Reduced primary patency rate in diabetic patients after percutaneous intervention results from more frequent presentation with limb-threatening ischemia

OBJECTIVEnAlthough patients with diabetes are at increased risk of amputation from peripheral vascular disease, excellent limb-salvage rates have been achieved with aggressive surgical revascularization. It is less clear whether patients with diabetes will fare as well as nondiabetics after undergoing percutaneous lower extremity revascularization, a modality which is becoming increasingly utilized for this disease process. This study aimed to assess differential outcomes in between diabetics and nondiabetics in lower extremity percutaneous interventions.nnnMETHODSnWe retrospectively studied 291 patients with respect to patient variables, complications, and outcomes for percutaneous interventions performed for peripheral occlusive disease between 2002 and 2005. Tibial vessel run-off was assessed by angiography. Patency (assessed arterial duplex) was expressed by Kaplan-Meier method and log-rank analysis. Mean follow-up was 11.6 months (range 1 to 56 months).nnnRESULTSnA total of 385 interventions for peripheral occlusive disease with claudication (52.2%), rest pain (16.4%), or tissue loss (31.4%) were analyzed, including 336 primary interventions and 49 reinterventions (mean patient age 73.9 years, 50.8% male). Comorbidities included diabetes mellitus (57.2%), chronic renal insufficiency (18.4%), hemodialysis (3.8%), hypertension (81.9%), hypercholesterolemia (57%), coronary artery disease (58%), tobacco use (63.2%). Diabetics were significantly more likely to be female (55.3% vs 40.8%), and suffer from CRI (23.5% vs 12.0%), a history of myocardial infarction (36.5% vs 18.0%), and <three-vessel tibial outflow (83.5% vs 71.8%), compared with nondiabetics, although all other comorbidities and lesion characteristics were equivalent between these groups. Overall primary patency (+/- SE) at 6, 12, and 18 months was 85 +/- 2%, 63 +/- 3% and 56 +/- 4%, respectively. Patients with diabetes suffered reduced primary patency at 1 year compared with nondiabetics. For nondiabetics, primary patency was 88 +/- 2%, 71 +/- 4%, and 58 +/- 4% at 6, 12, and 18 months, while for diabetics it was 82 +/- 2%, 53 +/- 4%, and 49 +/- 4%, respectively (P = .05). Overall secondary patency at 6, 12, and 18 months was 88 +/- 2%, 76 +/- 3%, and 69 +/- 3%, and did not vary by diabetes status. One-year limb salvage rate was 88.3% for patients with limb-threatening ischemia, which was also similar between diabetics and nondiabetics. While univariate analysis revealed that female gender, <three-vessel tibial outflow, and a history of tobacco use were all predictive of reduced primary patency (P < .05), none of these factors significantly impacted secondary patency or limb-salvage rate. Furthermore, only limb-threatening ischemia remained a significant predictor of outcome on multivariate analysis, suggesting that the poorer primary patency in diabetics is related primarily to their propensity to present with limb-threatening disease compared with nondiabetics.nnnCONCLUSIONnPatients with diabetes demonstrate reduced primary patency rates after percutaneous treatment of lower extremity occlusive disease, most likely due to their advanced stage of disease at presentation. However, despite a higher reintervention rate, diabetics and others with risk factors predictive of reduced primary patency can attain equivalent short-term secondary patency and limb-salvage rates. Therefore, these patient characteristics should not be considered contraindications to endovascular therapy.

Percutaneous intervention for infrainguinal occlusive disease in women: Equivalent outcomes despite increased severity of disease compared with men

OBJECTIVESnExperience with open surgical bypass suggests similar overall outcomes in women compared with men, but significantly increased risk of wound complications. Percutaneous treatment of lower extremity occlusive disease is therefore an attractive alternative in women, although it is not clear whether there is a difference in outcomes between women and men treated with this technique. We sought to determine the results and predictors of failure in women treated by percutaneous intervention.nnnMETHODSnPercutaneous infrainguinal revascularization was performed on 309 women between 2001 and 2006. Procedures, complications, demographics, comorbidities, and follow-up data were entered into a prospective database for review. Patency was assessed primarily by duplex ultrasonography. Outcomes were expressed by Kaplan-Meier curves and compared by log-rank analysis.nnnRESULTSnA total of 447 percutaneous interventions performed in 309 women were analyzed and compared with 553 interventions in men. Mean age in women was 73.2 years; comorbidities included hypertension (HTN) (86%), diabetes melitus (DM) (58%), chronic renal insufficiency (CRI) (15%), hemodialysis (7%), hypercholesterolemia (52%), coronary artery disease (CAD) (42%), and tobacco use (47%). Indications in women included claudication (38.0%), rest pain (18.8%), and tissue loss (43.2%). Overall primary & secondary patency and limb-salvage rates for women were 38% +/- 4%, 66% +/- 3%, and 80% +/- 4% at 24 months. In this patient sample, women were significantly more likely than men to present with limb-threatening ischemia (61.6% vs 47.3%, P < 0.001) and have lesions of TASC C and D severity (71.4% vs 61.7%, P < .005). However, there were no significant differences in primary and secondary patency rates or limb-salvage rates between genders. Furthermore, while women with limb-threat, diabetes, and advanced TASC severity lesions were at increased risk of failure overall, there were no differences between women and men with these characteristics.nnnCONCLUSIONSnPercutaneous infrainguinal revascularization is a very effective modality in women with lower extremity occlusive disease. Although women in this sample were more likely to present with limb-threat than men, patency and limb-salvage rates were equivalent between genders, even in high-risk subsets such as diabetics or those with lesions of increased TASC severity.

Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal

OBJECTIVEnThis report presents the 30-day results of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial and evaluates the safety and efficacy of ENROUTE Transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcarotid neuroprotection system that provides direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting (CAS).nnnMETHODSnA prospective, single-arm, multicenter clinical trial was performed to evaluate the use of the ENROUTE Transcarotid NPS during CAS procedures performed in patients considered to be at high risk for complications from carotid endarterectomy. Symptomatic patients with ≥50% stenosis and asymptomatic patients with ≥70% stenosis were eligible to be treated with any U.S. Food and Drug Administration-approved carotid artery stent. The primary end point was the composite of all stroke, myocardial infarction (MI), and death at 30xa0days postprocedure as defined in the Food and Drug Administration-approved study protocol. Secondary end points included cranialxa0nerve injury; 30-day stroke, death, stroke/death, and MI; acute device, technical, and procedural success; and access site complications. All major adverse events were adjudicated by an independent clinical events committee.nnnRESULTSnBetween November 2012 and July 2014, 208 patients were enrolled at 18 sites. Sixty-seven patients were enrolled as lead-in cases, and 141 were enrolled in the pivotal phase. In the pivotal cohort, 26% were symptomatic and 75% were asymptomatic. Acute device and technical success were 99% (140 of 141). By hierarchical analysis, the all-stroke rate in the pivotal group was 1.4% (2 of 141), stroke and death was 2.8% (4 of 141), and stroke, death and MI was 3.5% (5 of 141). One patient (0.7%) experienced postoperative hoarseness from potential Xth cranial nerve injury, which completely resolved at the 6-month follow-up visit.nnnCONCLUSIONSnThe results of the ROADSTER trial demonstrate that the use of the ENROUTE Transcarotid NPS is safe and effective at preventing stroke during CAS. The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS.

Current Management of Extracranial Carotid Artery Disease

Stroke is the third most common cause of death in the United States. There are approximately 700,000 strokes/year; 80% are ischemic, and 20-30% of ischemic strokes are secondary to carotid disease. Carotid stenosis is traditionally treated by carotid endarterectomy (CEA). Multicenter, randomized, controlled trials have shown that surgery significantly reduces the risk of ipsilateral stroke in patients with severe symptomatic and asymptomatic carotid stenosis. Endovascular techniques for treating carotid stenosis have been developed over recent years. Carotid angioplasty and stenting (CAS) with cerebral protection has become an alternative to CEA for high-surgical-risk patients and the procedure of choice for stenoses inaccessible by surgery. In this review we summarize the existing data regarding the traditional state of management of extracranial carotid artery stenosis and compare these data to a critical analysis of the recent results of CAS.

Endovascular Treatment of Traumatic Carotid Pseudoaneurysm with Stenting and Coil Embolization

Posttraumatic internal carotid pseudoaneurysm is an infrequent but potentially life-threatening condition that complicates approximately one-third of blunt carotid injuries. Other types of injuries include dissection, thrombosis, and complete disruption. Historically, carotid pseudoaneurysms have been managed operatively with repair, ligation, and anticoagulation, with percutaneous angioplasty and stenting emerging over the past decade. We present the case of a 19-year-old patient with a posttraumatic internal carotid pseudoaneurysm that increased in size with conservative management and was treated with coil embolization and stenting.

Ischemic Preconditioning during the Use of the Percusurge Occlusion Balloon for Carotid Angioplasty and Stenting

Ischemic preconditioning (IP) uses transient ischemia to render tissues tolerant to subsequent, prolonged ischemia. This study sought to evaluate factors that contributed to the development of cerebral ischemia during PercuSurge balloon (Medtronic, Santa Rosa, CA) occlusion in patients undergoing carotid angioplasty and stenting (CAS). The PercuSurge occlusion balloon was used in 43 of 165 patients treated with CAS for high-grade stenosis; 20% were symptomatic. Symptoms of cerebral hypoperfusion during temporary occlusion of the internal carotid artery occurred in 10 of 43 patients and included dysarthria, agitation, decreased level of consciousness, and focal hemispheric deficit. The development of neurologic symptoms after initial PercuSurge balloon inflation and occluded internal carotid artery flow was associated with a decrease in the mean Glasgow Coma Scale (GCS) from 15 to 10 (range 9–14); the GCS returned to normal after occlusion balloon deflation. The mean time to spontaneous recovery of full neurologic function was 8 minutes (range 4–15 minutes). The mean subsequent procedure duration was 11.9 minutes (range 6–21 minutes). No recurrence of neurologic symptoms occurred when the occlusion balloon was reinflated. All 10 patients underwent successful CAS without occlusion, dissection, cerebrovascular accident, or death. Ischemic preconditioning can be used to enable CAS with embolic protection in patients who cannot tolerate initial interruption of antegrade cerebral perfusion by PercuSurge occlusion.

Models of abdominal aortic aneurysm: characterization and clinical applications.

Abdominal aortic aneurysms (AAAs) are responsible for considerable morbidity, mortality, and cost to society. The pathogenesis of AAA formation, however, remains poorly understood. Animal models have been used in a range of experiments designed to provide further objective scientific assessment of the pathogenesis as well as the treatment of AAA. The purpose of this manuscript is to review the current models of AAA and their potential clinical implications.

Periprocedural Complication Rates Are Equivalent between Symptomatic and Asymptomatic Patients Undergoing Carotid Angioplasty and Stenting

Patients with neurologic symptoms who undergo carotid endarterectomy (CEA) have a higher incidence of stroke and death in the perioperative period than those with asymptomatic carotid disease. This study examines the outcomes of symptomatic and asymptomatic patients undergoing carotid stenting (CAS). From 2002 to 2006, 201 CAS procedures were performed in 193 patients (117 men, mean age 73 +/- 10 years), of whom 142 were for asymptomatic (AS) and 59 for symptomatic (S) disease. Preoperative neurologic symptoms included recent ipsilateral cerebrovascular accident (CVA, 29%), transient ischemic attack (50%), and amaurosis fugax (22%). There were 201 carotid stents placed (107 Acculink, 43 Wallstent, 23 Precise, 21 NexStent, 3 Exponent, 3 Xact, 1 Herculink) and 198 protection devices used (79 Accunet, 53 EPI Filterwire, 43 PercuSurge, 20 Angiogard, 3 EmboShield). Mean follow-up was 41 weeks. The groups were matched in terms of demographics and comorbidities (carotid artery disease, hypertension, hyperlipidemia, diabetes mellitus, peripheral vascular disease, smoking, and chronic obstructive pulmonary disease; p = nonsignificant [NS]). There was no significant difference in anatomic risk factors (neck irradiation, S 3%, AS 6%; prior CEA, S 14%, AS 14%; bovine arch, S 22%, AS 16%; p = NS), and the types of embolic protection devices and stents used were similar between groups. The mean percentages of preintervention carotid stenosis were equal (S 88%, AS 88%), and the technical success rate was 99%. Incidence rates of CVA (S 3.4%, AS 1.4%), myocardial infarction (S 1.7%, AS 1.4%), and death (S 0, AS 0.7%) were equivalent between groups (p = NS). CAS with cerebral protection can be performed safely in both symptomatic and asymptomatic patients. The presence of preoperative neurologic symptoms does not significantly increase the risk of adverse events in the perioperative period in this study.