Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease.

BACKGROUND: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).

Assessing Veterinary Practice and Practitioner Preparedness for Natural and Man-Made Disasters, Including COVID-19.

Natural and man-made disasters lead to hundreds of millions of dollars in economic losses annually worldwide. Veterinarians are most qualified to support local, state, national, and international efforts in emergency management. However, they may lack the knowledge and advanced training to most effectively plan, prepare, and respond. Currently, only two colleges offer training embedded in their core veterinary curriculum. In this study, a survey was conducted to gain an understanding of veterinary practice and practitioner preparedness for natural and man-made disasters in the United States and Canada, with questions assessing pandemic preparedness. The participants graduated from 28 American Veterinary Medical Association (AVMA)-accredited veterinary colleges globally and 2 non-accredited veterinary colleges, represent a diverse set of veterinary practice types, and have an average of 26 years' practice experience. Overall, 63.5% of veterinary respondents had experienced a natural disaster, while only 9.6% had experienced a man-made disaster. Approximately 66% reported having a practice disaster preparedness plan, while less than 20% of those actively maintained and updated the plan. Furthermore, less than 50% of the practices and practitioners were ready to face the challenges of a global pandemic. Approximately 68% reported using some form of communication to educate clients about family and pet disaster readiness. Many felt that some advanced disaster readiness training would have been helpful in their veterinary curriculum. Our findings indicate that additional training in the veterinary curriculum, as well as continuing education, would help veterinarians and practices be better prepared for natural and man-made disasters.

Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study.

BACKGROUND: Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation. OBJECTIVES: Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD. METHODS: REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events. RESULTS: A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported. CONCLUSIONS: Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.

Efficacy and safety of intravascular lithotripsy for the treatment of peripheral arterial disease: An individual patient-level pooled data analysis.

BACKGROUND: Peripheral arterial disease (PAD) is one of the most common manifestations of atherosclerotic disease worldwide. Peripheral arterial calcification reduces acute success and long-term patency of endovascular therapy for PAD. Several calcium modification devices are available for use in peripheral interventions. Outcomes after peripheral intravascular lithotripsy (IVL), a novel approach using pulsatile sonic waves to treat luminal and medial calcium in patients with PAD, have not been extensively characterized. Therefore, we sought to perform an individual patient-level data (IPD) pooled analysis of available studies to evaluate the efficacy and safety of IVL in the treatment of PAD. METHODS AND RESULTS: We pooled IPD, including baseline and procedural variables, from five prospective studies which assessed IVL in the treatment of patients with extensive peripheral artery calcification. Final postprocedural percent diameter stenosis (%DS) and procedural angiographic complications were assessed by independent core laboratory. Efficacy endpoints were analyzed using linear mixed effects models and safety endpoints were tabulated overall and by vascular bed. Among 336 patients who underwent endovascular revascularization with use of IVL, there was a significant reduction between pre-procedural and final %DS of 55.1% (95% confidence interval 53.3-57.0%, p < .0001). Core-laboratory assessed lesion-level complications, including flow-limiting dissections (Types D-F), vessel perforation, distal embolization, thrombus, abrupt closure, and no reflow, occurred in 4/328 (1.22%) of treated lesions. CONCLUSIONS: The present IPD of five prospective studies, marking the largest analysis to date evaluating the use of IVL in significantly calcified PAD lesions, demonstrates this treatment strategy to be both effective and safe.

Management of common femoral artery occlusive disease: A review of endovascular treatment strategies and outcomes.

Isolated atherosclerotic lesions of the common femoral artery (CFA) are rare but can produce significant claudication and critical limb ischemia. To date, the "gold standard" treatment for this entity has been common femoral endarterectomy (CFE) with or without patch angioplasty. However, surgery does have significant early postoperative complications, with a 15% combined mortality/morbidity. This manuscript sought to perform a comprehensive review of all studies and available data on endovascular treatment of isolated CFA disease and compare its utility to the traditional gold standard treatment. Twenty-one studies from 1987 to 2018 were included exploring the various CFA endovascular therapies (percutaneous transluminal angioplasty, intravascular stenting, drug-coated balloons, and directional atherectomy employed to treat CFA disease, in terms of efficacy, safety, and complications). As a conclusion, endovascular interventions provide acceptable short-term technical outcomes for CFA disease while limiting procedural complications. While only two randomized controlled trials compare short and long-term outcomes of surgical versus endovascular treatment, further studies are required to clarify the role of endovascular therapy.

Stent graft treatment for infra-inguinal arterial disease for either instent-restenosis and denovo lesions associated with very high rates of failure.

BACKGROUND: FDA approved the Gore Viabahn (WL Gore, Flagstaff, AZ, USA) stent for both femoro-popliteal arterial denovo and instent restenosis (ISRS) lesions. To date there is little data on Viabahn stent graft outcomes in ISRS arterial disease. METHODS: Between 2007 and 2014 we identified 734 patients who underwent 1573 endovascular interventions in our institution for infra-inguinal revascularization. Among these, 48 patients had 143 Viabahn stents placed. Of these, 26 patients had 94 stents placed for ISRS and 22 patients had 49 stents placed for denovo lesions. RESULTS: The patients in the ISRS group were younger and more likely to have hypertension, hyperlipidemia, coronary artery disease, compared to the patients in the denovo group. Stents were placed principally for femoro-popliteal lesions, with mean length of 21 ± 12.5 cm (19.2 ± 14, ISRS vs. 22.1 ± 11, denovo; P = 0.2). Both groups had low primary patency rates during one year follow up (54% vs. 33%, OR = 2.3 (0.9-2.2). Target lesion revascularization (TLR) (57% vs. 27%, P < 0.0001, OR = 3.7, CI = 1.8-8) and surgical revascularization (21% vs. 4%, OR = 6.3, CI = 1.4-28) occurred more frequently in the ISRS group than in the denovo group. Amputation rate (17% vs. 31%, OR 0.7, CI = 0.2-1), cumulative blockage (defined as ISRS and thrombosis) (62% vs. 47%, P = 0.09, OR = 1.8, CI = 0.9-3.6), and Restenosis (40% vs. 31%, OR 1.5, CI = 0.7-3.2) were not statistically different between the two groups. Mean duration of follow-up was 12.8 ± 13 months. CONCLUSION: Stent graft treatment using the Gore Viabahn for denovo and ISRS in femoro-popliteal arterial obstructive disease have high restenosis and failure rates, of both stent patency and limb outcomes, which is consistent with existed literature.

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.

SUPERB final 3-year outcomes using interwoven nitinol biomimetic supera stent.

IMPORTANCE: Long-term outcomes of an interwoven nitinol stent design represent the best in class for treatment of lower limb arterial obstructive disease METHODS: The subjects were enrolled in an open single arm study comparing the outcomes to an FDA mandated objective performance goal (OPG). RESULTS: About 325 patients (264 intention-to-treat and 64 roll-in subjects) were enrolled. Mean follow-up period was 887+/- 352 days. Treated lesion lengths were 7.8 cm ± 4.3 cm in the trial with chronic total occlusions comprising 24.6% (65/264) of subjects. Freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months was 89%, at 24 and 36 months it was 84% and 82% respectively. The difference in the 12 month CD-TLR was 7% at 36 months. The difference of clinically driven-TLR at 36 months in those subjects who received their stents deployed nominally in length, compressed or elongated (between -10% and +10% nominal length) had an impact on the CD-TLR. At 2 and 3 years, freedom from CD-TLR in minimal compression was 86.7%, and was 90.0% for moderate compression. In those stents deployed with minimal, moderate, or severe elongation (10-20%, 20-40%, or >40%, respectively) freedom from CD-TLR of 84.1%, 87.4%, and 77.0% respectively at 12 months. At 2 and 3 years, freedom from CD-TLR for moderate elongation was 81.8% and 78.2%, and for severe elongation was 63.4% and 42.3%, respectively. Fractures were distinctly uncommon with this stent with a single facture event in the 36 month follow-up period. DISCUSSION: The interwoven nitinol design stent is a stent that achieves an excellent primary patency but further maintains the durability of the stent through 36 months. Optimal stent deployment remains critical to the performance of this stent device and requires optimal vessel preparation. © 2017 Wiley Periodicals, Inc.

Angiographic classification of patterns of restenosis following femoropopliteal artery intervention: A proposed scoring system.

OBJECTIVES: To propose a classification system for characterizing angiographic femoropopliteal artery restenosis patterns associated with common endovascular modalities. BACKGROUND: Peripheral artery disease is a worldwide issue affecting millions of people. Despite a myriad of endovascular technologies available to treat peripheral artery disease of the femoropopliteal arteries, restenosis remains a common failure mode. Characterizing common patterns of restenosis is important to discern the potential impact of baseline patient, lesion, and procedural characteristics, as well as treatment modalities on either the primary success or the failure patterns associated with restenosis. METHODS: Studies included in the analysis were from previous core laboratory-adjudicated femoropopliteal artery disease trials and registries reflecting a wide array of treatment modalities. RESULTS: From the subjects enrolled and analyzed, there were 403 total angiograms for analysis and adjudication. Target lesion revascularization images of the 32 validation cases were evaluated for index treated length, diameter stenosis, and lesion morphology characteristics. The following lesion types are proposed: Type 1 "Focal" pattern, which may be "Edge Proximal" or "Edge Distal" depending on location; a Type 2 "Multifocal" pattern which may also exhibit edge restenosis, but may also be "Edge Bilateral"; a Type 3 "Moderate" pattern and a Type 4 "Diffuse" pattern; and finally, a Type 5 "Occlusion". CONCLUSIONS: A classification system that enables healthcare professionals to anticipate and describe failures following the index procedure, thereby impacting the choice of options for retreatment, may facilitate consistency and standardization within the heterogeneous field of endovascular device treatments for the femoropopliteal artery.

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.

Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial.

BACKGROUND AND PURPOSE: Evidence indicates that center volume of cases affects outcomes for both carotid endarterectomy and stenting. We evaluated the effect of enrollment volume by site on complication rates in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). METHODS: The primary composite end point was any stroke, myocardial infarction, or death within 30 days or ipsilateral stroke in follow-up. The 477 approved surgeons performed >12 procedures per year with complication rates <3% for asymptomatic patients and <5% for symptomatic patients; 224 interventionists were certified after a rigorous 2 step credentialing process. CREST centers were divided into tertiles based on the number of patients enrolled into the study, with Group 1 sites enrolling <25 patients, Group 2 sites enrolling 25 to 51 patients, and Group 3 sites enrolling >51 patients. Differences in periprocedural event rates for the primary composite end point and its components were compared using logistic regression adjusting for age, sex, and symptomatic status within site-volume level. RESULTS: The safety of carotid angioplasty and stenting and carotid endarterectomy did not vary by site-volume during the periprocedural period as indicated by occurrence of the primary end point (P=0.54) or by stroke and death (P=0.87). A trend toward an inverse relationship between center enrollment volume and complications was mitigated by adjustment for known risk factors. CONCLUSIONS: Complication rates were low in CREST and were not associated with center enrollment volume. The data are consistent with the value of rigorous training and credentialing in trials evaluating endovascular devices and surgical procedures. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Evaluating Socioeconomic, Racial, and Ethnic Disparities in Survival Among Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplants.

This study was undertaken to monitor potential disparities in survival after allogeneic hematopoietic stem cell transplantation (HSCT) with the aim of optimizing access and outcomes for minority and low-income patients. We analyzed 463 patients transplanted over a 72-month study period with a median 19-month follow-up, focused on differences by individual patient race/ethnicity and patients' household income derived from geocoded addresses at the census block group level. Patient sociodemographic and clinical characteristics were abstracted from electronic health records and our HSCT registry, including disease category and status, donor age, transplant type, and conditioning. Approximately, 15% of HSCT patients were non-Hispanic Black or Hispanic with a similar proportion from block groups below the median metropolitan Index of Concentration at the Extremes income score. The overall survival probability was 61.8% at 36 months. Non-Hispanic white (63.6%) and especially Hispanic patients (49.2%) had lower survival probabilities at 36 months than non-Hispanic Black patients (75.6%, p = 0.04). There were no other patient characteristics significantly associated with survival at the p < 0.01 level. The lack of significant differences likely reflects the careful selection of patients for transplants. However, the proportion of minority and low-income patients relative to expected disease prevalence in our area population raises important considerations about which patients successfully make it to transplant. We conclude with recommendations to increase the diversity of patients who receive HSCT by reviewing potential barriers in the transplant referral and selection process and advocating for needed psychosocial and community resources.

Call for Formalized Pathways in Vascular Medicine Training: JACC Review Topic of the Week.

The burden of vascular diseases and complexity of their management have been growing. Vascular medicine specialists may help to bridge gaps in care, especially as part of multidisciplinary teams. However, there is a limited number of vascular medicine specialists because of constraints in training. Despite established pathways for training in vascular medicine, there are obstacles that restrict completion of training in dedicated programs. A key factor is lack of funding as a result of inadequate recognition by key national accrediting and credentialing organizations. A concerted effort is required to overcome the obstacles to expand vascular medicine training programs and ultimately the pool of vascular medicine specialists. Well-trained vascular medicine specialists will be well positioned to ease the burden of vascular disease and optimize patient outcomes.

Acute Kidney Injury Following In-Patient Lower Extremity Vascular Intervention: From the National Cardiovascular Data Registry.

OBJECTIVES: The authors analyzed data from the NCDR (National Cardiovascular Data Registry) PVI Registry and defined acute kidney injury (AKI) as increased creatinine of ≥0.3 mg/dl or 50%, or a new requirement for dialysis after PVI. BACKGROUND: AKI is an important and potentially modifiable complication of peripheral vascular intervention (PVI). The incidence, predictors, and outcomes of AKI after PVI are incompletely characterized. METHODS: A hierarchical logistic regression risk model using pre-procedural characteristics associated with AKI was developed, followed by bootstrap validation. The model was validated with data submitted after model creation. An integer scoring system was developed to predict AKI after PVI. RESULTS: Among 10,006 procedures, the average age of patients was 69 years, 58% were male, and 52% had diabetes. AKI occurred in 737 (7.4%) and was associated with increased in-hospital mortality (7.1% vs. 0.7%). Reduced glomerular filtration rate, hypertension, diabetes, prior heart failure, critical or acute limb ischemia, and pre-procedural hemoglobin were independently associated with AKI. The model to predict AKI showed good discrimination (optimism corrected c-statistic = 0.68) and calibration (corrected slope = 0.97, intercept of -0.07). The integer point system could be incorporated into a useful clinical tool because it discriminates risk for AKI with scores ≤4 and ≥12 corresponding to the lower and upper 20% of risk, respectively. CONCLUSIONS: AKI is not rare after PVI and is associated with in-hospital mortality. The NCDR PVI AKI risk model, including the integer scoring system, may prospectively estimate AKI risk and aid in deployment of strategies designed to reduce risk of AKI after PVI.

Isolated Renal Artery Dissection: A Systematic Review of Case Reports.

Isolated renal artery dissection (IRAD) is a rare and often unrecognized clinical entity, with a paucity of data on its epidemiology and management. We extracted 129 cases of IRAD from the medical literature between 1972 and 2016. IRAD as a result of an extended dissection from the aorta and splanchnic or mesenteric arteries was excluded. The mean age of presentation was 42.7±12.9 years, with a male predominance (79%). Abdominal pain (75.9%) was the most common presenting symptom. Etiology was more likely to be spontaneous (76%) than traumatic (12%), iatrogenic (9%), or drug-induced (1.5%). The most common risk factors were hypertension (28.7%), fibromuscular dysplasia (8.5%), and Ehlers-Danlos syndrome (5.4%). Unilateral renal artery dissection (right 45.5%, left 40.5%) was more frequent than bilateral (14%). More than half (56.6%) of the cohort were managed medically (blood pressure control and /or anticoagulation). Of those who underwent intervention, endovascular stenting or embolization (35%) was utilized more frequently than nephrectomy or bypass (21%). Computed tomography (CT) and magnetic resonance angiography (MRA) have the highest diagnostic sensitivity (91% and 93%, respectively) as compared to ultrasonography (27%). A high degree of clinical suspicion is required to diagnose IRAD. CT and MRI have a higher diagnostic sensitivity. As compared to invasive management, conservative management has comparable outcomes.

Endovascular carotid artery stenting and early coronary artery bypass grafting for asymptomatic carotid artery stenosis: long-term outcomes and neurologic events.

BACKGROUND: Optimal management of patients with asymptomatic critical carotid artery stenoses prior to coronary artery bypass grafting (CABG) has no clear consensus. Further, optimal timing for surgical coronary revascularization has not been defined after or with any carotid revascularization. METHODS: We reviewed the data from 2002 to 2007, of all patients in our institution who underwent carotid artery stenting (CAS) for critical carotid artery stenoses, prior to CABG. Twenty patients with critical carotid disease were referred for preoperative carotid intervention prior to CABG. Carotid duplex demonstrated evidence of critical stenoses in all patients. Patients were serially assessed by a stroke neurologist before and after the procedure (immediately, at 24 hr, at 48 hr, immediately following CABG, and at 30 days). We evaluated initial procedural success as well as freedom from periprocedure stroke. RESULTS: Prior to undergoing CABG, 20 patients had stents placed in a single carotid artery for unilateral asymptomatic critical carotid artery stenoses. All the procedures, except one, were performed with distal embolic protection. Patients received aspirin and clopidogrel. There were no strokes or deaths up to a mean follow up of 486 days. The mean time from CAS to CABG performed in the same hospital admission was 6.4 days. Transfusion rates were not excessive despite dual antiplatelet therapy. CONCLUSION: In a real-world setting, endovascular extracranial CAS for asymptomatic carotid artery stenosis by experienced operators, prior to CABG was safe and permitted early coronary revascularization without increased risk of strokes or death in this high-risk cardiovascular patient population.

Jetstream Atherectomy System treatment of femoropopliteal arteries: Results of the post-market JET Registry.

OBJECTIVES: To report on procedural, safety, and effectiveness outcomes of real-world practice with the Jetstream rotational atherectomy system for treatment of femoropopliteal artery lesions. BACKGROUND: Safety and effectiveness of treatment with the Jetstream device has been demonstrated in clinical trials, but outcomes during real-world clinical practice have yet to be examined. METHODS: 241 patients (66% male, mean age 67years, 41% diabetes; Rutherford 1-3) with de novo or restenotic (non-stent) femoropopliteal lesions ≥4cm in length were recruited. Major adverse events (MAE), defined as amputation, death, target lesion/vessel revascularization (TLR/TVR), myocardial infarction, or angiographic distal embolization that required a separate intervention; and binary restenosis were assessed at 30days and 12months. RESULTS: The mean (±SD) lesion length was 16.4±13.6cm; 35% of patients received adjunctive stents. Procedural success was achieved for 98.3% of lesions. The 30-day MAE rate was 2% (5/219; 2 TLR/TVR and 3 distal embolization); there were no deaths, index limb amputations, or myocardial infarctions. At 12months, the overall estimated freedom from TLR/TVR was 81.7% and 77.2% (44/57) of patients were free from duplex ultrasound-assessed restenosis. Efficacy and patency in a diabetic subset were similar to those of the overall cohort, while maintaining a similar safety profile. CONCLUSION: In a cohort reflecting real-world practice, the Jetstream Atherectomy System demonstrated a high procedural success rate with a low rate of complications and reinterventions, especially given the relatively long lesions studied.