RESUMEN
BACKGROUND: Thrombus is highly prevalent in patients with recent symptoms (< 6 months) of claudication or limb ischemia due to an occluded culprit lower extremity vessels. Treatment of these thrombotic occlusions is challenging. In this feasibility study, the excimer laser (Spectranetics, Colorado Springs, CO) has been tested for its safety and ability to ablate thrombus in patients with recent arterial occlusions. METHODS: Angiographic operator assessment and volumetric core lab quantitation of the thrombus were performed at baseline and after excimer laser but prior to definitive treatment of the vessel to evaluate thrombus resolution. Consecutive patients were prospectively enrolled at a single site. Procedural success was defined as achieving a residual stenosis of <30% after final treatment with no intraprocedural complications requiring additional treatment. RESULTS: 20 consecutive patients were enrolled in this study (8 males, mean age 69.5±11.1 years). Based on patients symptom onset, 12 patients were subacute (> 24 h, < 30 days), and 8 chronic (between 1 to 6 months). 15/20 (75%) had restenotic occlusions. Due to the long, occlusive nature of these lesions, only 8 patients had complete intravascular ultrasound images at each time point which allowed volumetric analysis by the core lab. There was no statistical difference in plaque/thrombus volume between baseline (pretreatment) and excimer laser (P=.68). There was however a significant reduction in residual angiographic stenosis post laser alone (100% vs. 66.75%±23.9%, P=.001). Procedural success was 100%. There were no deaths or amputations. Bail out stenting was performed in 10/20 (50%) patients. Embolic filters were used in 15/20 (75%) of patients. Macrodebris>2 mm were seen in 85.7% of filters. There was no in-hospital or 30-day reocclusion of the treated vessel but one patient had a vascular access complication (small AV fistula) conservatively managed. No other serious adverse events were noted. CONCLUSION: Using the excimer laser appears safe in this small feasibility study of subacute and chronic thrombotic occlusions. Angiographically, there was a significant reduction in percent stenosis with the laser alone. The limited IVUS data did not show a reduction in plaque/thrombus volume but the number of interpretable ultrasounds was small. Further data are needed to address the effectiveness of the laser in treating these thrombotic occlusions and its advantages over balloon angioplasty.
Asunto(s)
Terapia por Láser/instrumentación , Láseres de Excímeros , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/cirugía , Trombosis/cirugía , Anciano , Anciano de 80 o más Años , Enfermedad Crónica , Constricción Patológica , Estudios de Factibilidad , Femenino , Humanos , Iowa , Terapia por Láser/efectos adversos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Complicaciones Posoperatorias/etiología , Estudios Prospectivos , Radiografía , Recurrencia , Sistema de Registros , Índice de Severidad de la Enfermedad , Trombosis/diagnóstico por imagen , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía IntervencionalRESUMEN
BACKGROUND: Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus cryoplasty (CRYO) in the treatment of de novo femoropopliteal disease has not been well defined in randomized trials. METHODS: In this prospective, 2-center randomized trial of PTA vs CRYO of femoropopliteal arteries, the primary endpoint of TLR was evaluated at 6 months. Secondary endpoints included the rate of bail out stenting because of suboptimal acute angiographic results (defined as a residual narrowing of ≥30% or type C or higher dissection) and target vessel revascularization (TVR). Major adverse events including death and amputations were recorded. A two sample t test was used to compare the two groups on the continuous variables. For categorical variables, cross tabular analysis was conducted with nonparametric tests (Chi Square and Fisher's Exact) used to test for significant differences. RESULTS: A total of 40 patients were included in the study. Of these 20 patients (24 vessels) were included in the PTA arm and 20 patients (26 vessels) in the CRYO arm. CRYO was performed at a predefined automated pressure of 8 atm. PTA was performed at a mean pressure of 9.57±1.34 atm (P=.001 compared to CRYO). TLR (10.5% vs. 15%, P=NS) and TVR (10% vs 25%, P=NS) were statistically similar between the PTA arm compared to the CRYO arm respectively. Bail out stenting was performed in 10/24 (41.7%) of vessels in the PTA arm and 10/26 (38.5%) of patients in the CRYO arm (P=NS). CONCLUSION: In this pilot randomized study of de novo femoropopliteal lesions, CRYO and PTA had the same TLR and TVR at 6 months in treating femoropopliteal de novo lesions. Also, bail out stenting was statistically similar between the 2 groups. Larger studies are needed to confirm these results.
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Angioplastia de Balón , Crioterapia , Arteria Femoral , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Anciano , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Índice Tobillo Braquial , Distribución de Chi-Cuadrado , Crioterapia/efectos adversos , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Iowa , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico , Proyectos Piloto , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Estudios Prospectivos , Radiografía , Retratamiento , Medición de Riesgo , Factores de Riesgo , Stents , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Thrombus is highly prevalent in patients with recent symptoms (<6 months) of claudication or limb ischemia with occluded culprit lower extremity arterial vessels. Treatment of these thrombotic occlusions is challenging. In this feasibility study, the Vascular ClearWay Irrigating PTFE Balloon Catheter (Atrium, Husdson, NH, USA) has been tested for its safety and ability to dissolve thrombus in patients with recent arterial occlusions. METHODS: Twenty consecutive patients with lower extremity occlusion were prospectively enrolled to test the feasibility of the ClearWay balloon irrigation system. Cohorts of five patients were tested with increasing doses of tPA (five control patients with saline, five patients with 0.25 mg/cm, five patients with 0.4 mg/cm and five patients with 0.6 mg/cm of lesion length). Volumetric intravascular ultrasound core laboratory assessment of the thrombus was performed at baseline and after ClearWay thrombolysis (but prior to definitive treatment of the vessel with other debulking or stenting) to evaluate the effectiveness of ClearWay to remove thrombus. RESULTS: Twenty consecutive patients were enrolled in this study (11 men; mean age, 68.54 ± 8.15 years), and 14 had volumetric intravascular ultrasound available both before and after Clearway. Based on patients' symptom onset, 1 patient was acute (< 24 h), 4 subacute (> 24 h, < 30 days) and 15 chronic (between 1 and 6 months). There were no safety events as predefined by the protocol including no major bleeding, death, distal embolization distal to the filter, acute renal failure or vascular complications. Acute procedural success was seen in 100% of cases. There were no statistical difference in plaque-thrombus volume between baseline (pretreatment) and control ClearWay treatment (saline infusion; P = .911, n = 4). Also, there was no statistical difference in plaque-thrombus volume between pretreatment baseline and ClearWay tPA treatment (P = .628, n = 14). Following Angiojet rheolytic thrombectomy (n = 8 patients) post-ClearWay lytic treatment, there was a statistical reduction of plaque-thrombus volume versus ClearWay lytic treatment alone (P = .030) or pretreatment baseline (P = .029). There were no deaths or amputations. Macrodebris > 2 mm were present in 50% of patients captured by embolic filter protection. In-hospital reocclusion of the treated vessel occurred in one patient (5%) and 30-day reocclusion occurred in two patients (10%) on follow-up. CONCLUSION: Using the ClearWay to deliver lytic therapy appears safe in this small feasibility study. Although lytic treatment with the ClearWay balloon alone did not demonstrate reduction in plaque-thrombus volume in this small population, the use of Angiojet rheolytic thrombectomy following ClearWay did reduce plaque volume. Further data are needed to address definitive effects of ClearWay balloon alone and utility to facilitate Angiojet thromboreduction.
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Arteriopatías Oclusivas/tratamiento farmacológico , Catéteres , Fibrinolíticos/administración & dosificación , Extremidad Inferior/irrigación sanguínea , Irrigación Terapéutica/instrumentación , Terapia Trombolítica/instrumentación , Trombosis/tratamiento farmacológico , Activador de Tejido Plasminógeno/administración & dosificación , Anciano , Análisis de Varianza , Arteriopatías Oclusivas/diagnóstico por imagen , Distribución de Chi-Cuadrado , Diseño de Equipo , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Politetrafluoroetileno , Estudios Prospectivos , Radiografía , Recurrencia , Sistema de Registros , Trombectomía , Trombosis/diagnóstico por imagen , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Intervencional , Estados UnidosRESUMEN
PURPOSE: Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus SilverHawk atherectomy and adjunctive PTA of de novo infrainguinal disease has not been well defined. This study was conducted to compare the two approaches. MATERIALS AND METHODS: In this prospective, two-center randomized trial of PTA versus atherectomy of infrainguinal vessels, the primary endpoint of TLR was evaluated at 1 year. Secondary endpoints included the rate of "bailout" stent placement for suboptimal acute angiographic results and the rate of target vessel revascularization (TVR). RESULTS: Fifty-eight patients were included in the study. Of these, 29 (36 vessels) were randomized to the atherectomy arm and 29 (48 vessels) to the PTA arm. Final acute angiographic success rates were 100% in the PTA arm and 97.2% in the atherectomy arm (P value not significant). There was no statistical difference in TLR (16.7% vs 11.1%) or TVR (21.4% vs 11.1%) between the PTA and atherectomy groups, respectively. Bailout stent placement was performed in 18 of 29 patients (62.1%) in the PTA arm and eight of 29 patients (27.6%) in the atherectomy arm (P = .017). Major adverse events were similar between the PTA and atherectomy arms. Finally, when embolic filter protection was used, distal macroembolization occurred in 11 of 17 patients (64.7%) treated with atherectomy versus none of 10 in the PTA group (P < .001). CONCLUSIONS: TLR and TVR at 1 year were statistically similar in atherectomy and primary PTA. Atherectomy reduced the need for bailout stent placement compared with primary PTA.
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Angioplastia de Balón , Aterectomía/instrumentación , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/terapia , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Angioplastia de Balón/mortalidad , Índice Tobillo Braquial , Aterectomía/efectos adversos , Aterectomía/mortalidad , Distribución de Chi-Cuadrado , Terapia Combinada , Dispositivos de Protección Embólica , Diseño de Equipo , Femenino , Humanos , Estimación de Kaplan-Meier , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Estudios Prospectivos , Radiografía , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Stents , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
Predictors of provisional stenting in patients undergoing lower extremity arterial interventions remain unclear. We performed an ad hoc analysis on the predictors of provisional stenting during infrainguinal arterial percutaneous interventions using data from the Percutaneous Lower Extremity Arterial Interventions Using Primary Balloon Angioplasty versus Silverhawk Atherectomy (SA) and Adjunctive Balloon Angioplasty trial. In the above trial, SA of infrainguinal de novo arterial lesions was shown to reduce significantly provisional stenting compared with primary percutaneous transluminal angioplasty (PTA). In this ad hoc analysis, patients were divided into two groups based on whether provisional stenting has occurred. Univariate analysis was conducted between the stent versus the no-stent group. Logistic regression (LR) analysis was performed to model for the predictors of provisional stenting. Variables included were diabetes, presence of moderate calcification (versus none to little), age, gender, hypercholesterolemia, Transatlantic Intersociety Consensus (TASC) D lesion (vs. TASC A to C), and treatment method (primary PTA vs. SA with adjunctive PTA). By LR analysis, predictors of stenting were as follows: moderate calcification (odds ratio [OR] 6.56, 95% confidence interval [CI] 1.21 to 35.56, p = 0.029), primary PTA (vs. SA) (OR 0.19, 95% CI 0.04 to 0.93, p = 0.04), and TASC D lesions (vs. A to C) (OR 0.10, 95% CI 0.01 to 0.87, p = 0.037). Provisional stenting in infrainguinal interventions is predicted by the use of primary PTA, presence of moderate calcification, and TASC D lesions after controlling for gender, age, hypercholesterolemia, and diabetes.
RESUMEN
PURPOSE: To report the results from a single-center prospective registry (DEEP EMBOLI) established to evaluate distal embolization during percutaneous lower extremity interventions using excimer laser ablative therapy. METHODS: Elective patients with infrainguinal occlusive disease were eligible for this registry if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. In all, 20 patients (15 women; mean age 70.9+/-10.8 years) with 28 lesions (de novo 13, restenotic 15) were enrolled and underwent treatment with laser atherectomy. SpiderFx filters were utilized before laser treatment in 18 of 20 patients and before final definitive treatment with angioplasty +/- stenting in all 20 patients. The primary angiographic outcome was a residual narrowing of <30% or 30% to 50% with <20 mmHg gradient across lesion after final treatment. The primary safety endpoint was the embolization rate produced by the laser based on the presence of clinically significant (>or=2 mm long) macrodebris in the filter. RESULTS: Adjunctive angioplasty and stenting were performed in 27 (96.4%) and 17 (60.7%) lesions, respectively. All filters were deployed and retrieved successfully, with no complications. The primary angiographic endpoint was met in 100% of patients. Macrodebris was found in 12 (66.7%) of 18 patients after treatment with the laser [4 (22.2%) filters with clinically significant emboli] and in 7 (35%) of 20 patients after adjunctive treatment [4 (20.0%) clinically significant emboli]. One (5.0%) distal embolization occurred after filter removal prior to completion of definitive treatment. CONCLUSION: Embolization does occur with laser photoablation in the lower extremity, but the rate of clinically significant macrodebris is low ( approximately 20%) and similar to that found after angioplasty and stenting. Embolic filter protection appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. Problems with filter retrieval were not encountered.
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Angioplastia de Balón/instrumentación , Arteriopatías Oclusivas/terapia , Aterectomía/métodos , Embolia/prevención & control , Filtración/instrumentación , Terapia por Láser , Extremidad Inferior/irrigación sanguínea , Stents , Anciano , Anciano de 80 o más Años , Angioplastia de Balón/efectos adversos , Arteriopatías Oclusivas/diagnóstico por imagen , Arteriopatías Oclusivas/cirugía , Aterectomía/efectos adversos , Constricción Patológica , Embolia/etiología , Diseño de Equipo , Femenino , Humanos , Terapia por Láser/efectos adversos , Masculino , Proyectos Piloto , Estudios Prospectivos , Radiografía , Sistema de Registros , Resultado del TratamientoRESUMEN
PURPOSE: To assess the presence of thrombus using intravascular ultrasound (IVUS) and evaluate the feasibility of combined thrombolysis [power-pulse spray (P-PS)] and rheolytic thrombectomy (RT) in patients with recent-onset limb ischemia (<6 months) due to total occlusion of at least 1 infrainguinal vessel. METHODS: Seventeen patients (12 women; mean age 68.3+/-10.7 years) enrolled in a prospective registry underwent IVUS imaging at baseline, after treatment with P-PS using tissue plasminogen activator and RT (AngioJet), and prior to definitive treatment of the vessel. The primary safety endpoints were major bleeding, distal embolization, vascular access complications, and renal failure. Effectiveness outcomes were (1) procedural success with a residual stenosis <30%, (2) IVUS-documented resolution of the thrombus, and (3) the combined clinical endpoint of procedure-related death, stroke, unplanned amputation, and unplanned urgent revascularization of the treated limb. RESULTS: At baseline, the majority of patients (16, 94.1%) had a definite thrombus identified by IVUS; in the remaining patient (6.3%), thrombus was likely to be present according to the IVUS scan. By angiography, 2 (11.8%) patients had a definite grade 3 thrombus and 5 (29.4%) patients had a grade 1 thrombus (modified TIMI scale) at baseline. IVUS data were available pre and post P-PS/RT in 16 (94.1%) patients. In 10 (62.5%), the thrombus was partially resolved; in 5 (31.25%), there was no apparent change. The thrombus appeared to have completely resolved in only 1 (6.3%) patient. Embolization occurred in 3 (17.6%) patients with no adverse clinical sequelae. The combined clinical endpoint was met in 1 (5.9%) of 17 patients. After final definitive treatment of the vessel, acute procedural success was 100%, with no angiographic filling defects seen. CONCLUSION: Thrombus is present in most if not all patients with a recent history of limb ischemia who are found to have an occluded culprit vessel. The application of the P-PS/RT led to partial or complete thrombus resolution in about two thirds of the patients treated. The overall safety outcome was favorable, but large studies are needed to test the effectiveness of the P-PS/RT technique prior to routine use.
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Pierna/irrigación sanguínea , Trombectomía , Terapia Trombolítica , Trombosis/terapia , Enfermedad Aguda , Anciano , Algoritmos , Enfermedad Crónica , Estudios de Factibilidad , Femenino , Humanos , Isquemia/etiología , Masculino , Estudios Prospectivos , Sistema de Registros , Terapia Trombolítica/métodos , Trombosis/complicaciones , Trombosis/diagnóstico por imagen , UltrasonografíaRESUMEN
PURPOSE: To report the results from a single-center prospective registry (PROTECT) established to evaluate the safety and effectiveness of embolic filter protection (EFP) in reducing distal embolization during percutaneous lower extremity interventions. METHODS: Patients undergoing angioplasty, stenting, or SilverHawk atherectomy and adjunctive balloon angioplasty for infrainguinal occlusive disease were eligible if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. The primary angiographic outcome was the ability of the filter to prevent angiographically visible distal embolization, slow flow, and loss of distal tibial runoff with or without capturing macrodebris. RESULTS: Forty patients (23 men; mean age 71.4+/-11.5 years) with 56 lesions (42 de novo and 14 restenotic) underwent treatment with angioplasty/stenting (group A, n = 29; 43 lesions) or SilverHawk atherectomy (group B, n = 11; 13 lesions). One filter was used per patient (25 SpiderFX and 15 EmboShield). Macroembolization occurred in 22 (55.0%) patients, 11 (37.9%) in group A and 11 (100%) in group B (p<0.001). Clinically significant (> or =2 mm in diameter) macrodebris was found in 18 (45.0%) patients: 8 (27.6%) in group A and 10 (90.9%) in group B (p<0.001). All filters were retrieved successfully with no complications. One side-branch embolization occurred proximal to the filter. In another case, the filter was overfilled, resulting in no distal flow; it was retrieved, with subsequent tibial embolization when the procedure was continued without protection. CONCLUSION: Macroembolization is very frequent in patients undergoing lower extremity interventions, particularly with SilverHawk atherectomy. EFP appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. The clinical significance of these findings needs to be determined in future studies.