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The 355 nm Auryon laser (AngioDynamics, Inc., Latham, New York) has been shown to be effective and safe in treating various morphology lesions in the femoropopliteal arteries. There are limited data on the Auryon laser in treating below-the-knee (BTK) arteries in patients with chronic limb-threatening ischemia. We present the 30-day efficacy and safety findings from the ongoing Auryon BTK study. Patients with chronic limb-threatening ischemia were prospectively enrolled in the Auryon BTK study between March 2022 and February 2023 in 4 US centers after obtaining written informed consent. The primary safety end point included major adverse limb events + postoperative death at 30 days, defined as a composite of all-cause death, major amputation, and target vessel revascularization. Demographic, procedural, angiographic, and outcome data were collected. A total of 60 patients (61 lesions) were treated. The mean age was 74.6 ± 10.3 years, with 65.0% men, 58.3% with diabetes, 43.3% Rutherford Becker (RB) IV, and 56.7% RB V. Of the 61 lesions, 59% had severe calcification, 31.1% were chronic total occlusions, and 90.2% were de novo disease. The baseline diameter stenosis was 80.2 ± 16.4%, after laser 57.4 ± 21.7%, and after final treatment 24.0 ± 23.1% (p <0.0050). The primary performance end point showed a procedure success rate of 37 of 68 (63.8%). Bailout stenting occurred in 1 of 61 lesions (1.6%). The RB category was 100% RB IV or higher at baseline versus 35.3% at 30 days. At 30 days, there was no target vessel revascularization and the patency was 88.9% (Peak Systolic Velocity Ratio (PSVR) ≤2.4). In conclusion, the Auryon laser is safe and relatively effective in treating BTK lesions with minimal complications.
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Isquemia Crônica Crítica de Membro , Humanos , Masculino , Feminino , Idoso , Estudos Prospectivos , Isquemia Crônica Crítica de Membro/cirurgia , Resultado do Tratamento , Terapia a Laser/métodos , Doença Arterial Periférica/cirurgia , Idoso de 80 Anos ou mais , Isquemia , Pessoa de Meia-Idade , Artéria Poplítea/cirurgia , Artéria Femoral , Salvamento de Membro/métodosRESUMO
PURPOSE: To assess the potential adjunctive role of a 3D electromagnetic (EM) navigational system for use in above-knee vessels afflicted with peripheral artery disease (PAD). Peripheral artery disease can be challenging to operators encountering significant vessel tortuosity, calcium, and stenoses, which may require prolonged procedure times and excessive use of nephrotoxic iodinated contrast when performed with conventional fluoroscopy. MATERIALS AND METHODS: Following appropriate ethical oversight, five 3D-printed bench phantoms modeling tortuous calcified PAD were created based on source CTA (computed tomography angiography) data sets from real patients. Investigational software was developed based on a commercially available aortic EM navigation platform (Intraoperative Positioning System [IOPS]; Centerline Biomedical, Inc., Cleveland, Ohio), with patient-specific structural maps of vessel lumens and calcification. Using a sensorized prototype 6 French (Fr) catheter and 0.035" guidewire, 15 interventionalists traversed each phantom using the EM platform as well as 2D simulated fluoroscopy-like image guidance and the times were recorded. Participants completed a 10-item standard system usability scale (SUS) questionnaire (score 1-5, 5=strongly agree) evaluating system usability and user satisfaction. Navigation times and SUS scores were compared with a 1-tailed statistical t test. RESULTS: Participants demonstrated a statistically significant reduction in navigation times using EM guidance, performing 0.7 minutes (42 seconds) faster on average (P < .001), corresponding to a 25% average relative reduction. Participants reported sufficiently high levels of usability satisfaction, with a mean SUS score of 4.29 (P < .001), exceeding the acceptance criterion (score ≥3.5). CONCLUSION: This preclinical phantom study highlights the future potential of Centerline Biomedical's EM navigation technology as a possible adjunct to fluoroscopy for highly precise visualization and navigation of PAD-afflicted vasculature. CLINICAL IMPACT: This preclinical proof-of-concept study highlights the feasibility of EM navigation not only for branch vessel cannulation, but also for inline navigation of peripheral vessels afflicted with calcified plaques via benchtop iliofemoral phantom simulations. The navigation platform studied addresses the need for improvements in EM technology through modelling algorithms that facilitate 3D visualization of calcified plaque in any projection in real time, in addition to sensorization of both catheter and guidewire in a compact 6Fr system.
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PURPOSE: To analyze the first 250 patients from the prospective, multicenter, industry-sponsored ClotTriever Outcomes (CLOUT) registry, assessing the safety and effectiveness of mechanical thrombectomy for acute, subacute, and chronic deep vein thrombosis (DVT). MATERIALS AND METHODS: Real-world patients with lower extremity DVT were treated with the ClotTriever System (Inari Medical, Irvine, California). Adjuvant venoplasty, stent placement, or both were performed at the physician's discretion. Thrombus chronicity was determined by visual inspection of removed thrombus, categorizing patients into acute, subacute, and chronic subgroups. Serious adverse events (SAEs) were assessed through 30 days. Clinical and quality-of-life (QoL) outcomes are reported through 6 months. RESULTS: Thrombus chronicity was designated for 244 of the 250 patients (acute, 32.8%; subacute, 34.8%; chronic, 32.4%) encompassing 254 treated limbs. Complete or near-complete (≥75%) thrombus removal was achieved in 90.8%, 81.9%, and 83.8% of the limbs with acute, subacute, and chronic thrombus, respectively. No fibrinolytics were administered, and 243 (99.6%) procedures were single sessions. One (0.4%) patient in the subacute group experienced a device-related SAE, a fatal pulmonary embolism. On comparing baseline and 6-month data, improvements were demonstrated in median Villalta scores (acute, from 10 to 1; subacute, from 9 to 1; chronic, from 10 to 3; for all, P < .0001) and mean EuroQol group 5-dimension (EQ-5D) self-report questionnaire scores (acute, 0.58 to 0.89; subacute, 0.65 to 0.87; chronic, 0.58 to 0.88; for all, P < .0001). There were no significant differences in outcomes across the subgroups. CONCLUSIONS: Mechanical thrombectomy using the ClotTriever System with adjunctive venoplasty and stent placement is safe and similarly effective for acute, subacute, and chronic DVT.
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Trombectomia , Trombose Venosa , Humanos , Trombectomia/efeitos adversos , Resultado do Tratamento , Estudos Prospectivos , Qualidade de Vida , Terapia Trombolítica , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/terapia , Trombose Venosa/etiologia , Sistema de Registros , Veia Ilíaca , Estudos RetrospectivosRESUMO
Background: We report in-hospital outcomes from the multicenter, prospective, single-arm ClotTriever Outcomes (CLOUT) registry, which enrolled up to 500 patients with proximal lower extremity deep vein thrombosis (DVT) treated with percutaneous mechanical thrombectomy using the ClotTriever System (Inari Medical). Methods: The CLOUT registry enrolled all-comer patients with DVT, irrespective of symptom duration, thrombus age, prior treatment of the current DVT, or bilateral thrombus. The primary effectiveness end point was defined as complete or near complete (≥75%) reduction in Marder score. Thrombus burden was assessed by an independent core laboratory. Mortality and serious adverse events, including device-relatedness, were adjudicated by an independent medical monitor. Here, safety and outcomes are evaluated through discharge. Results: The median age was 61.9 years (IQR, 48.0-70.8), 50.5% were women, 24.9% had a history of DVT, and 23.2% had previously failed treatment of the current DVT. Nearly all procedures (99.4%) were performed in a single session with negligible procedural blood loss (median 40.0 mL; IQR, 20.0-50.0), and most patients (97.8%) required no subsequent intensive care unit monitoring. The primary effectiveness end point was achieved in 91.2% of limbs. Through discharge, 1 device-related serious adverse event (0.2%) occurred. Health status, as assessed by self-reported pain and circumferential measurements of limb edema, were significantly improved at discharge. Conclusions: Thrombectomy with the ClotTriever System is a safe and effective treatment for proximal lower extremity DVT, while also avoiding the need of intensive care. Early patient improvements are demonstrated, and follow-up is ongoing to 2 years.
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OBJECTIVE: The all-comer ClotTriever Outcomes registry assessed indicators of thrombus chronicity in patients with acute, subacute, and chronic lower extremity deep vein thrombosis (DVT). The effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) by chronicity subgroup was also assessed and reported here in this subanalysis. METHODS: All-comer patients with lower extremity DVT were enrolled, with no limitation based on the patients' symptom duration. Chronicity was assessed three times and compared: before the procedure based on symptom duration, during the procedure based on available pre-thrombectomy imaging, and visual inspection of the extracted thrombus morphology after thrombectomy. Patients were grouped into acute, subacute, and chronic subgroups according to their post-thrombectomy thrombus chronicity based on thrombus morphology. Analyses on baseline and procedural characteristics along with thrombus removal were performed across subgroups. The effectiveness of thrombus removal was determined by Marder scores adjudicated by an independent core laboratory, with a prespecified primary effectiveness end point of complete or near-complete (≥75%) thrombus removal. RESULTS: Of the 260 treated limbs from 250 patients, using symptom duration alone, 70.7% were considered acute, 20.9% subacute, and 8.4% chronic. Upon visual inspection, the extracted thrombus chronicity was approximately one-third in each subgroup: 32.7% had acute thrombus, 35.4% subacute thrombus, and 31.9% chronic thrombus. Chronicity assessed using symptom duration alone mismatched the post-thrombectomy chronicity in 55.1% of limbs (P < .0001) with 49.0% being more chronic than suggested by the patients' duration of symptoms. Chronicity assessed using pre-thrombectomy imaging mismatched the post-thrombectomy chronicity in 17.5% of limbs (P < .0001). No patients received thrombolytics and 99.6% were treated in a single session. Complete or near-complete thrombus removal was achieved in a high percentage of limbs regardless of thrombus chronicity: 90.8%, 81.9%, and 83.8% in limbs with acute, subacute, and chronic thrombus, respectively. CONCLUSIONS: This subanalysis from the all-comer ClotTriever Outcomes registry demonstrates that extracted thrombus in DVT may be more chronic than suggested by the patients' duration of symptoms. The addition of imaging is helpful to determine the ability of thrombus to respond to therapy. Irrespective of thrombus chronicity, the ClotTriever system can be effective at removing acute, subacute, and chronic thrombus in a single-session procedure without the need for thrombolytics.
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Terapia Trombolítica , Trombose Venosa , Fibrinolíticos/uso terapêutico , Humanos , Veia Ilíaca , Sistema de Registros , Estudos Retrospectivos , Trombectomia/efeitos adversos , Trombectomia/métodos , Resultado do Tratamento , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/terapiaRESUMO
OBJECTIVES: The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi-center registry evaluating the safety and effectiveness of percutaneous mechanical thrombectomy for treatment of pulmonary embolism (PE) in a real-world patient population (NCT03761173). This interim analysis reports outcomes for the first 250 patients enrolled in FLASH. BACKGROUND: High- and intermediate-risk PEs are characterized by high mortality rates, frequent readmissions, and long-term sequelae. Mechanical thrombectomy is emerging as a front-line therapy for PE that enables immediate thrombus reduction while avoiding the bleeding risks inherent with thrombolytics. METHODS: The primary endpoint is a composite of major adverse events (MAE) including device-related death, major bleeding, and intraprocedural device- or procedure-related adverse events at 48 h. Secondary endpoints include on-table changes in hemodynamics and longer-term measures including dyspnea, heart rate, and cardiac function. RESULTS: Patients were predominantly intermediate-risk per ESC guidelines (6.8% high-risk, 93.2% intermediate-risk). There were three MAEs (1.2%), all of which were major bleeds that resolved without sequelae, with no device-related injuries, clinical deteriorations, or deaths at 48 h. All-cause mortality was 0.4% at 30 days, with a single death that was unrelated to PE. Significant on-table improvements in hemodynamics were noted, including an average reduction in mean pulmonary artery pressure of 7.1 mmHg (22.2%, p < 0.001). Patient symptoms and cardiac function improved through follow-up. CONCLUSIONS: These interim results provide preliminary evidence of excellent safety in a real-world PE population. Reported outcomes suggest that mechanical thrombectomy can result in immediate hemodynamic improvements, symptom reduction, and cardiac function recovery.
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Embolia Pulmonar , Trombectomia , Hemorragia/etiologia , Humanos , Estudos Prospectivos , Embolia Pulmonar/terapia , Sistema de Registros , Trombectomia/efeitos adversos , Trombectomia/métodos , Resultado do TratamentoAssuntos
Arteriopatias Oclusivas , Doença Arterial Periférica , Arteriopatias Oclusivas/diagnóstico por imagem , Arteriopatias Oclusivas/cirurgia , Doença Crônica , Artéria Femoral/diagnóstico por imagem , Humanos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Resultado do TratamentoRESUMO
OBJECTIVES: The multicenter, prospective, single arm CLOUT registry assesses the safety and effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) for the treatment of acute and nonacute lower extremity deep vein thrombosis (DVT) in all-comer patients. Reported here are the outcomes of the first 250 patients. METHODS: All-comer patients with lower extremity DVT were enrolled, including those with bilateral DVT, those with previously failed DVT treatment, and regardless of symptom duration. The primary effectiveness end point is complete or near-complete (≥75%) thrombus removal determined by independent core laboratory-adjudicated Marder scores. Safety outcomes include serious adverse events through 30 days and clinical outcomes include post-thrombotic syndrome severity, symptoms, pain, and quality of life through 6 months. RESULTS: The median age was 62 years and 40% of patients had contraindications to thrombolytics. A range of thrombus chronicity (33% acute, 35% subacute, 32% chronic) was observed. No patients received thrombolytics and 99.6% were treated in a single session. The median thrombectomy time was 28 minutes. The primary effectiveness end point was achieved in 86% of limbs. Through 30 days, one device-related serious adverse event occurred. At 6 months, 24% of patients had post-thrombotic syndrome. Significant and sustained improvements were observed in all clinical outcomes, including the Revised Venous Clinical Severity Score, the numeric pain rating scale, and the EuroQol Group 5-Dimension Self-Report Questionnaire. CONCLUSIONS: The 6-month outcomes from the all-comer CLOUT registry with a range of thrombus chronicities demonstrate favorable effectiveness, safety, and sustained clinical improvements.
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Síndrome Pós-Flebítica , Síndrome Pós-Trombótica , Trombose Venosa , Fibrinolíticos , Humanos , Veia Ilíaca , Pessoa de Meia-Idade , Dor/etiologia , Síndrome Pós-Flebítica/etiologia , Síndrome Pós-Trombótica/diagnóstico por imagem , Síndrome Pós-Trombótica/etiologia , Estudos Prospectivos , Qualidade de Vida , Sistema de Registros , Estudos Retrospectivos , Trombectomia/efeitos adversos , Trombectomia/métodos , Terapia Trombolítica , Resultado do Tratamento , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/cirurgiaRESUMO
Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study (ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.
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Angioplastia com Balão , Aterectomia , Artéria Femoral , Claudicação Intermitente/terapia , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Angioplastia com Balão/mortalidade , Aterectomia/efeitos adversos , Aterectomia/instrumentação , Aterectomia/mortalidade , Doença Crônica , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/mortalidade , Claudicação Intermitente/fisiopatologia , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Grau de Desobstrução VascularAssuntos
Diabetes Mellitus , Úlcera do Pé , Epoprostenol , Humanos , Iloprosta , Isquemia/cirurgia , Salvamento de MembroRESUMO
Background In 2015, there were 30.3 million patients with diabetes in the US, including 25.2% of people ages 65 or older and 108,000 hospitalizations for non-traumatic amputations. Severe diabetic limb disease includes critical limb ischemia (CLI ) due to an infrapopliteal disease with foot pain and ischemic ulcerations including gangrene. Environmentally acquired toxic metals, such as lead and cadmium, have been associated with cardiovascular disease. Thus, we designed the present unblinded pilot study to determine whether there was a signal of benefit for edetate disodium-based infusions in patients with critical limb ischemia. Methods This was an open-label pilot study in 10 patients with diabetes and critical limb ischemia. Each patient received up to 50 edetate disodium-based infusions and was assessed for safety, clinical efficacy, metal excretion, and quality of life. The primary endpoint was to assess the effect of edetate disodium-based therapy plus vitamins in patients with diabetes and infra-popliteal peripheral artery disease presenting with severe CLI and determine if there were improvements in vascular flow parameters. Results We enrolled 10 (60% male) predominantly Caucasian (90%) subjects. The mean age was 75.3 (8.0) years. Smoking was reported by 30%. There were 70% with coronary artery disease (30% had prior coronary artery bypass grafting) and 50% had a prior lower-extremity amputation, three having previous minor amputations and two major amputations. There were no major adverse cardiovascular events during the infusion phase through the one-year follow-up. Patients completing 40 infusions demonstrated complete wound healing and improvement in the quality of life. Conclusion Patients with diabetes and CLI treated with a regimen of edetate disodium-based infusions demonstrated a potential signal of benefit and preliminary evidence of safety. The Trial to Assess Chelation Therapy in Critical Limb Ischemia (TACT3a), a randomized double-blind, placebo-controlled clinical trial now in progress, will further test these findings.
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Clinical outcomes in patients with critical limb ischemia (CLI) depend not only on endovascular restoration of macrovascular blood flow but also on aggressive periprocedural wound care. Education about this area of CLI therapy is essential not only to maximize the benefits of endovascular therapy but also to facilitate participation in the multidisciplinary care crucial to attaining limb salvage. In this article, we review the advances in wound care products and therapies that have granted the wound care specialist the ability to heal previously nonhealing wounds. We provide a primer on the basic science behind wound healing and the pathogenesis of ischemic wounds, familiarize the reader with methods of tissue viability assessment, and provide an overview of wound debridement techniques, dressings, hyperbaric therapy, and tissue offloading devices. Lastly, we explore emerging technology on the horizons of wound care.
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BACKGROUND: Non-invasive limb hemodynamics may aid in diagnosis of critical limb ischemia (CLI), although the relationship with disease severity and response to endovascular therapy is unclear. METHODS AND RESULTS: This prospective, single-center study enrolled 100 CLI patients (Rutherford class 4-6) who underwent infrapopliteal endovascular revascularization (175 lesions) in the Peripheral RegIstry of Endovascular Clinical OutcoMEs (PRIME) registry. Hemodynamic measures included ankle-brachial index (ABI), toe-brachial index (TBI), and toe pressure (TP). Procedure success following revascularization was defined as stenosis ≤30%. Hemodynamic success was defined as an increase >0.15 in ABI or TBI relative to baseline. Freedom from amputation was defined as no major or minor amputation during follow-up. Clinical success was defined as a decrease of at least one Rutherford class during follow-up. Treatment success was defined as procedure success, freedom from amputation, and clinical improvement. Median baseline hemodynamic values were 0.90 for ABI, 0.39 for TBI, and 54 mm Hg for TP. Twenty-nine patients (29%) did not meet the common hemodynamic diagnostic criterion for eligibility in CLI trials (ABI ≤0.5, TBI ≤0.5, or TP <50 mm Hg). Main outcomes included 96% procedure success, 95% freedom from amputation, 64% clinical success, and 62% treatment success. There was no relationship between baseline (or with the pretreatment to posttreatment change) limb hemodynamic values and the response to infrapopliteal endovascular therapy. CONCLUSION: Non-invasive hemodynamic studies may have limited clinical usefulness in patients with CLI. The usefulness of these parameters to confirm eligibility and to assess response to therapy in interventional CLI clinical trials should be re-evaluated.
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Angioplastia com Balão/métodos , Hemodinâmica/fisiologia , Claudicação Intermitente/terapia , Artéria Poplítea , Grau de Desobstrução Vascular/fisiologia , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Angiografia/métodos , Angioplastia com Balão/efeitos adversos , Índice Tornozelo-Braço , Arteriopatias Oclusivas/diagnóstico por imagem , Arteriopatias Oclusivas/terapia , Estudos de Coortes , Estado Terminal , Procedimentos Endovasculares/métodos , Feminino , Seguimentos , Humanos , Claudicação Intermitente/diagnóstico por imagem , Salvamento de Membro/métodos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Prospectivos , Sistema de Registros , Medição de Risco , Resultado do TratamentoRESUMO
PURPOSE: To report a prospective, multicenter, observational study (ClinicalTrials.gov identifier NCT01609621) of the safety and effectiveness of tibiopedal access and retrograde crossing in the treatment of infrainguinal chronic total occlusions (CTOs). METHODS: Twelve sites around the world prospectively enrolled 197 patients (mean age 71±11 years, range 41-93; 129 men) from May 2012 to July 2013 who met the inclusion criterion of at least one CTO for which a retrograde crossing procedure was planned or became necessary. The population consisted of 64 (32.5%) claudicants (Rutherford categories 2/3) and 133 (67.5%) patients with critical limb ischemia (Rutherford category ≥4). A primary antegrade attempt to cross had been made prior to the tibiopedal attempt in 132 (67.0%) cases. Techniques used for access, retrograde lesion crossing, and treatment were at the operator's discretion. Follow-up data were obtained 30 days after the procedure. RESULTS: Technical tibiopedal access success was achieved in 184 (93.4%) of 197 patients and technical occlusion crossing success in 157 (85.3%) of the 184 successful tibial accesses. Failed access attempts were more common in women (9 of 13 failures). The rate of successful crossing was roughly equivalent between sexes [84.7% (50/59) women compared to 85.6% (107/125) men]. Technical success did not differ significantly based on a prior failed antegrade attempt: the access success rate was 92.4% (122/132) after a failed antegrade access vs 95.4% (62/65) in those with a primary tibiopedal attempt (p=0.55). Similarly, crossing success was achieved in 82.8% (101/122) after a failed antegrade access vs 90.3% (56/62) for patients with no prior antegrade attempt (p=0.19). Minor complications related to the access site occurred in 11 (5.6%) cases; no patient had access vessel thrombosis, compartment syndrome, or surgical revascularization. CONCLUSION: Tibiopedal access appears to be safe and can be used effectively for the crossing of infrainguinal lesions in patients with severe lower limb ischemia.
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Artérias/cirurgia , Isquemia/cirurgia , Salvamento de Membro , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Feminino , Humanos , Perna (Membro)/irrigação sanguínea , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: Arterial cannulation is a vital component of endovascular interventions and often unconventional access approaches are required due to disease complexity. Historically, varying maneuvers have been utilized to obtain arterial access. Lack of consensus exists regarding the safest and most effective method. This study examined the feasibility and immediate outcomes of ultrasound-guided access in traditional and advanced access approaches. METHODS: Data were analyzed from a cohort of 407 patients enrolled in the Peripheral RegIstry of Endovascular Clinical OutcoMEs (PRIME). The 407 patients underwent 649 procedures with 896 access sites utilized. Access success, immediate outcomes, complications, and length of hospital stay were analyzed. RESULTS: Mean age was 70 years, and 67% were male. The majority of patients had critical limb ischemia (58%), 39% were Rutherford classification III. Most commonly utilized access sites were common femoral retrograde, common femoral antegrade, posterior tibial, and anterior tibial arteries (34.6%, 33.0%, 12.1%, and 12.1%, respectively). Mean number of attempts was 1.2, 1.2, 1.5, and 1.4, respectively; median time to access was 39, 45, 41, and 59 seconds, respectively; and access success rate was 99.4%, 97.3%, 90.7%, and 92.6%; respectively. Access-site combinations utilized were femoral antegrade (n = 188), femoral retrograde (n = 185), dual femoral/ tibio-pedal (n = 130), dual femoral retrograde (n = 44), retrograde tibio-pedal (n = 73), and other (n = 29). Access-related complications were low overall: hematoma (1.2%), bleeding requiring transfusion/intervention (1.7%), pseudoaneurysm (1.7%), arteriovenous fistula (0.3%), aneurysm (0%), compartment syndrome (0%), and death (0%). CONCLUSION: Utilization of ultrasound-guided arterial access in this complex cohort was shown to be safe and effective regardless of arterial bed and approach.
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Cateterismo Periférico/métodos , Procedimentos Endovasculares/métodos , Artéria Femoral , Isquemia/cirurgia , Doença Arterial Periférica/cirurgia , Cirurgia Assistida por Computador/métodos , Ultrassonografia/métodos , Estudos de Viabilidade , Feminino , Humanos , Isquemia/diagnóstico , Perna (Membro)/irrigação sanguínea , Masculino , Doença Arterial Periférica/diagnóstico , Estudos Prospectivos , Sistema de RegistrosRESUMO
OBJECTIVES: This analysis compares the procedural and acute angiographic outcomes in patients with critical limb ischemia (CLI) treated with orbital atherectomy in above-the-knee (ATK)/popliteal (POP) lesions versus below-the-knee (BTK) lesions. BACKGROUND: Lesion location affects the procedural outcomes and the opportunity for limb salvage in patients with CLI suffering from peripheral artery disease (PAD). METHODS: The CONFIRM registry series was analyzed and includes 1109 real-world patients (1544 lesions) suffering from CLI treated with orbital atherectomy. The rates of dissection, perforation, slow flow, vessel closure, spasm, embolism, and thrombus formation were compared between CLI patients with ATK/POP lesions and BTK lesions. RESULTS: Patients with ATK/POP lesions had a higher final residual stenosis (10 vs. 9%; P = 0.004) and use of more adjunctive therapies (e.g. balloons and stents; 1.3 vs. 1.1%; P < 0.001) compared to patients with BTK lesions. Patients with BTK had higher incidence of perforation (1.5 vs. 0.2%; P = 0.005), slow flow (7.7 vs. 5.0%; P = 0.03) and spasm (10.3 vs. 4.2%; P < 0.001) but lower incidence of embolism (0.4 vs. 5.1%; P < 0.001). CONCLUSIONS: Plaque modification with orbital atherectomy was successful in CLI patients regardless of lesion location. BTK lesions were associated with increased rates of perforation, slow flow and spasm which may be explained by more challenging procedural characteristics in these patients such as smaller vessel size and tortuosity. The higher incidence of emboli in ATK/POP lesions is most likely attributed to the higher prevalence of severe calcium observed in this cohort.