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1.
Cardiovasc Intervent Radiol ; 46(8): 991-999, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-37430014

RESUMEN

PURPOSE: It is known that thermal liver ablation can induce liver hypertrophy. However, exact impact in liver volume remains unclear. The aim of this study is to assess the influence of radiofrequency or microwave ablation (RFA/MWA) on liver volume in patients with primary and secondary liver lesions. Findings can be relevant in assessing the potential extra benefit of thermal liver ablation in preoperatively performed liver hypertrophy inducing procedures, such as portal vein embolization (PVE). METHODS: Between January 2014-May 2022, 69 invasive treatment naïve patients with primary (n = 43) or secondary/metastatic (n = 26) liver lesions (in all segments, except in segments II/III) treated percutaneously by RFA/MWA were included. Total liver volume (TLV), segment II + III volume (serving as "distant liver volume"), ablation zone volume and absolute liver volume (ALV, calculated by subtracting the ablation zone volume from the TLV) were the study outcomes. RESULTS: ALV in patients with secondary liver lesions increased to a median percentage of 106.87% (IQR = 99.66-113.03%, p = 0.016), volume of segments II/III increased to a median percentage of 105.81% (IQR = 100.06-115.65%, p = 0.003). ALV and segments II/III in patients with primary liver tumours remained stable, with a median percentage of 98.72% (IQR = 92.99-108.35%, p = 0.856) and 100.43% (IQR = 92.85-109.41%, p = 0.699), respectively. CONCLUSION: In patients with secondary liver tumours, ALV and segments II/III increased after MWA/RFA by an average of approximately 6%, while ALV in patients with primary liver lesions remained unchanged. Besides the curative intent, these findings indicate the potential added benefit of thermal liver ablation on FLR hypertrophy inducing procedures in patients with secondary liver lesions. LEVEL OF EVIDENCE: Level 3, non-controlled retrospective cohort study.


Asunto(s)
Ablación por Catéter , Neoplasias Hepáticas , Ablación por Radiofrecuencia , Humanos , Estudios Retrospectivos , Microondas/uso terapéutico , Ablación por Radiofrecuencia/métodos , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/cirugía , Hipertrofia/etiología , Hipertrofia/cirugía , Ablación por Catéter/métodos , Resultado del Tratamiento
2.
Invest Radiol ; 58(11): 811-815, 2023 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-37289302

RESUMEN

MATERIALS AND METHODS: Phase I: Eleven radiological technologists were asked to fill a CM injector 3 times with 50% diluted CM (iopromide 300 mg I/mL). The dilution was injected (12 mL/s) through a Coriolis flowmeter, with CM concentration and total volume calculated. Interoperator, intraoperator, and intraprocedural variations were calculated as coefficients of variability. Contrast media dose reporting accuracy was determined. Phase II: The study was repeated after implementation of a standardized dilution protocol with 5 representative operators. RESULTS: Phase I: The average injected concentration among 11 operators was 68% ± 16% CM (n = 33; range, 43%-98%), as compared with the target of 50% CM. The interoperator variability was 16%, the intraoperator variability was 6% ± 3%, and the intraprocedural variability was 23% ± 19% (range, 5%-67%). This led to overdelivery of CM compared with intended patient dose by 36% on average. Phase II: After standardization, injections averaged 55% ± 4% CM (n = 15; range, 49%-62%), with interoperator variability of 8%, intraoperator variability of 5% ± 1%, and intraprocedural variability of 1.6% ± 0.5% (range, 0.4%-3.7%). CONCLUSIONS: Manual CM dilution can lead to substantial interoperator and intraoperator, as well as intraprocedural variability in injected concentration. This can result in underreporting of administered CM doses to patients. It is recommended that clinics assess their current standard of care regarding CM injections for endovascular interventions and evaluate potential corrective actions if appropriate.


Asunto(s)
Medios de Contraste , Yohexol , Humanos , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados
3.
Ann Med Surg (Lond) ; 80: 104146, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35846862

RESUMEN

Introduction: and importance: Upper gastrointestinal (GI) bleeding is common in the clinic. In combination with haemorrhagic shock, morbidity is high. Rapid diagnosis and treatment can save lives. With the introduction of precision imaging several treatment options are feasible. Up-to-date diagnosis and treatment requires expertise from interventional radiology, gastroenterology and surgery to form a dedicated intervention team. This is illustrated by a typical case. Case presentation: We report a 78-year-old otherwise healthy male with a severe diverticulum bleeding. He was initially diagnosed with acute pancreatitis. Approximately 60 minutes after CT scanning, he became haemodynamically instable. He also vomited coffee-like fluid but no clear blood or clots. A repeated CT scan showed active bleeding in the retroperitoneal space highly suspicious for a diverticular bleeding just outside the lumen of the duodenum. An acute multidisciplinary intervention team immediately decided not to perform endoscopy (according to the upper GI bleeding guidelines) but to extend the imaging procedure with digital subtraction angiography (DSA). By this time, active bleeding from a side branch of the gastroduodenal artery was noted and successfully coiled. Clinical discussion: Guidelines determine day-to-day management in clinical medicine. Still, there is an exception to every rule. The case presented here was typical of upper GI bleeding with haemodynamic instability and signs of shock, but without haematemesis. This combination indicated a bleeding from somewhere outside the lumen of the GI tract. Instead of endoscopy, the acute intervention team decided to perform CT angiography (CTa) with subsequent DSA. On imaging, the bleeding focus was immediately identified and treated by coiling. Conclusion: Performance of CTa immediately followed by DSA and no endoscopy was decided by an acute intervention team in a patient with upper GI bleeding and haemorrhagic shock. Swift coiling of the bleeding artery outside the GI tract lumen was successful. The team in charge relied on a hybrid multifunctional unit fully equipped to perform interventional radiologic as well as GI procedures.

4.
J Clin Med ; 10(16)2021 Aug 16.
Artículo en Inglés | MEDLINE | ID: mdl-34441909

RESUMEN

Tibio-peroneal trunk (TPT) lesions are usually categorized as 'complex' in anatomical classifications, which leads to the perception that endovascular therapy (EVT) will be challenging and the outcome most likely poor. This multicenter, retrospective cohort study investigates the efficacy of the EVT of TPT lesions in patients with chronic limb threatening ischemia (CLTI) or an infrapopliteal bypass at risk. The primary endpoint was limb-salvage. The secondary outcomes were technical success, freedom from clinically driven target lesion revascularization (CD-TLR), overall survival, and amputation-free survival. A total of 107 TPT lesions were treated in 101 patients. At 3 years, the limb-salvage rate was 76.4% (95% CI 66.0-86.8%). Technical success was achieved in 96.3% of cases. The freedom from CD-TLR, amputation-free survival, and overall survival at 3 years were 53.0% (95% CI 38.1-67.9%), 33.6% (95% CI 23.0-44.2%), and 47.7% (95% CI 36.1-59.3%), respectively. Reintervention significantly increased the hazard ratio for amputation by 7.65 (95% CI 2.50-23.44, p < 0.001). Our results show that the EVT of both isolated and complex TPT lesions is associated with high technical success and acceptable limb-salvage rates, with reintervention being a major risk factor for amputation. Moreover, mid-term mortality rate was relatively high. In future revisions of the anatomical grading scales, the classification of TPT lesions as highly complex should be reconsidered.

5.
Int J Surg Case Rep ; 79: 331-334, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33508613

RESUMEN

INTRODUCTION AND IMPORTANCE: Mycotic aneurysms are a severe and sometimes life-threatening complication of infections or sepsis. However, mycotic aneurysms of mesenteric arteries caused by a purulent peritonitis following perforated appendicitis are very rare and not previously reported. This case report contributes to the awareness and treatment of this rare complication. CASE PRESENTATION: We present a case of a middle aged patient with a purulent peritonitis after perforated appendicitis. Postoperatively, recovery was not as expected. One week after laparoscopic appendectomy, CRP increased and haemoglobin levels dropped. Abdominal CT imaging revealed several mesenteric mycotic aneurysms. Because of aneurysmatic rupture, coiling of several mesenteric arteries was performed, despite the risk of bowel ischemia. After long-term antibacterial and antifungal treatment, the patient recovered completely. CLINICAL DISCUSSION: Formation of mycotic aneurysms in mesenteric arteries is very rare and optimal treatment options are debatable. Given the high mortality of conservative therapy with antibiotics alone, treatment of mycotic aneurysms by surgery or endovascular treatment is strongly advised. In our case, it was decided to treat the aneurysms by endovascular coil embolization and to observe whether bowel ischemia would occur, because aneurysms were present in multiple mesenteric arteries. CONCLUSION: Mycotic aneurysms of several mesenteric arteries should be considered as a rare but potential complication of perforated appendicitis with purulent peritonitis. In case of rupture, successful treatment can be achieved by embolization followed by long-term antibiotics. A multidisciplinary approach including surgery, interventional radiology and microbiology is highly recommended and transfer to a tertiary referral centre should be considered.

6.
Expert Rev Cardiovasc Ther ; 18(7): 395-404, 2020 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-32544005

RESUMEN

INTRODUCTION: Endovascular revascularization has become the preferred treatment for most patients with iliac artery obstructions, with a high rate of clinical and technical success. AREAS COVERED: This review will describe novel developments in the diagnosis and treatment of iliac artery obstructions including the augmentation of preprocedural imaging with advanced flow models, image fusion techniques, and state-of-the-art device-tracking capabilities. EXPERT OPINION: The combination of these developments will change the endovascular field within the next 5 years, allowing targeted iliac treatment without the need for radiographic imaging or iodinated contrast media.


Asunto(s)
Arteriopatías Oclusivas/cirugía , Procedimientos Endovasculares/métodos , Arteria Ilíaca/cirugía , Medios de Contraste , Humanos , Resultado del Tratamiento
7.
J Cardiovasc Surg (Torino) ; 60(6): 679-685, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31603295

RESUMEN

BACKGROUND: Endovascular treatment of occlusive disease of the superficial femoral artery (SFA) has evolved from plain old balloon angioplasty (POBA) through primary stenting strategy to drug eluting technology-based approach. The RAPID Trial investigates the added value of drug coated balloons (DCB, Legflow) in a primary stenting strategy (Supera stent) for intermediate (5-15 cm) and long segment (>15 cm) SFA lesions. METHODS: In this multicenter, patient-blinded trial, 160 patients with intermittent claudication, ischemic rest pain, or tissue loss due to intermediate or long SFA lesions were randomized (1:1) between Supera + DCB and Supera. Primary endpoint was primary patency at 2 years, defined as freedom from restenosis on duplex ultrasound (peak systolic velocity ratio <2.4). RESULTS: At 2 years, primary patency was 55.1% (95% CI: 43.1-67.1%) in the Supera + DCB group versus 48.3% (95% CI: 35.6-61.0%) in the Supera group (P=0.957). Per protocol analysis showed a primary patency rate of 60.9% (95% CI: 48.6-73.2%) in the Supera + DCB group versus 49.8% (95% CI: 36.9-62.7%) in the Supera group (P=0.469). The overall mortality rate was 5% in both groups (P=0.975). Sustained functional improvement was similar in both groups. CONCLUSIONS: The 2-year results in the current trial of a primary Supera stenting strategy are consistent with other trials reporting on treatment of intermediate and long SFA lesions. A DCB supported Supera stent strategy did not improve patency rate compared to a Supera stent only strategy.


Asunto(s)
Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Arteria Femoral , Enfermedad Arterial Periférica/terapia , Stents , Dispositivos de Acceso Vascular , Angioplastia de Balón/efectos adversos , Fármacos Cardiovasculares/efectos adversos , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Estudios Prospectivos , Diseño de Prótesis , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción Vascular
8.
Cardiovasc Intervent Radiol ; 42(12): 1795-1799, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31267150

RESUMEN

AIMS AND BACKGROUND: We describe the initial results of the Syphontrack Super Distal Access (SDA) catheter (InNeuroco Inc., Sunrise, Fl, USA) used for endovascular treatment of patients with acute ischemic stroke of the anterior circulation. METHODS: A retrospective review of prospectively collected data from June 2017 to May 2018 in Maastricht University Medical Center plus (MUMC +) with direct distal aspiration or a combination of distal aspiration with stent retriever thrombectomy was performed. Primary outcome measurements were accessibility and reperfusion grade (eTICI). Secondary outcome measurements were early neurologic recovery (a decrease of four or more points on the NIHSS), symptomatic intracranial hemorrhage (sICH) within 24 h and mRS score at 3 months. RESULTS: The first 50 patients in whom the SDA catheter was used are included. Direct distal aspiration was performed in 33/50 (66%). In 29/33 (88%), distal position in contact with the clot was achieved of which 15 (52%) were successful (eTICI 2b or higher) after first attempt. Total successful reperfusion rate was 23/50 (46%) after first pass. Final successful reperfusion, after multiple attempts, was reached in 48/50 (96%). Early neurologic recovery was seen in 21/50 (42%), and functional independence (mRS score of 0-2) at 3 months was achieved in 17/50 (35%). sICH occurred in 4/50 (8%) within 24 h post-procedural. CONCLUSION: In our clinical practice, endovascular treatment of ischemic stroke with the SDA catheter had similar technical and clinical results as reported in the literature.


Asunto(s)
Isquemia Encefálica/terapia , Catéteres , Procedimientos Endovasculares/instrumentación , Accidente Cerebrovascular/terapia , Trombectomía/instrumentación , Anciano , Isquemia Encefálica/complicaciones , Procedimientos Endovasculares/métodos , Femenino , Humanos , Masculino , Estudios Prospectivos , Estudios Retrospectivos , Accidente Cerebrovascular/etiología , Trombectomía/métodos , Resultado del Tratamiento
9.
J Endovasc Ther ; 25(1): 140-149, 2018 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-29338645

RESUMEN

PURPOSE: To evaluate the long-term results of remote iliac artery endarterectomy (RIAE) in 2 vascular referral centers and review existing literature. METHODS: A retrospective analysis was conducted of 109 consecutive patients (mean age 64.2±10.7 years; 72 men) who underwent 113 RIAE procedures for lower limb ischemia from January 2004 to August 2015 at 2 vascular centers. The majority of limbs (82, 72.6%) had TASC II D lesions (31 TASC II C). Primary outcome measures were primary, assisted primary, and secondary patency. A comprehensive literature search was performed in the PubMed and EMBASE databases to identify all English-language studies published after 1990 reporting the results of RIAE. RESULTS: Technical success was achieved in 95 (84.1%) of the 113 procedures. The complication rate was 13.7%, and 30-day mortality was 0%. At 5 years, primary patency was 78.2%, assisted primary patency was 83.4%, and secondary patency was 86.7%. Hemodynamic success was obtained in 91.7% of patients, and clinical improvement was observed in 95.2%. Freedom from major amputation was 94.7% at 5 years. The systematic review comprised 6 studies including 419 RIAEs, and pooled data showed results similar to the current study. CONCLUSION: For external iliac artery occlusions extending into the common femoral artery, RIAE appears to be a valuable hybrid treatment option. It combines acceptable morbidity and low mortality with good long-term patency. It has some advantages over an open surgical iliofemoral bypass or complete endovascular revascularization and could be the best treatment option in selected cases.


Asunto(s)
Endarterectomía , Arteria Ilíaca/cirugía , Enfermedad Arterial Periférica/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Endarterectomía/efectos adversos , Femenino , Humanos , Arteria Ilíaca/fisiopatología , Masculino , Persona de Mediana Edad , Países Bajos , Enfermedad Arterial Periférica/fisiopatología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción Vascular
10.
J Cardiovasc Surg (Torino) ; 59(1): 37-44, 2018 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-28849900

RESUMEN

BACKGROUND: This study evaluated the accuracy of duplex ultrasonography (DUS)-based peak systolic velocity ratio (PSVR) and ipsilateral common femoral artery (CFA) velocity waveform analysis to identify a hemodynamically significant equivocal iliac artery stenosis (30-75% lumen diameter reduction). Intra-arterial pressure measurements were used as a reference. METHODS: In a previously performed prospective study (NTR5085), 30 patients with 35 iliac artery stenoses underwent intra-arterial angiography. To determine the hemodynamic significance of the iliac artery stenoses, intra-arterial translesional pressure measurements were performed under hyperemic conditions. Preprocedural DUS was obtained of the iliac and femoral arteries. PSVR over the iliac lesions was determined, and ipsilateral CFA velocity waveforms were retrospectively classified. The intraobserver and interobserver agreement for CFA velocity waveform classification were evaluated. Sensitivity, specificity, and overall accuracy were calculated by comparing PSVR, velocity waveform analysis, and a combination of these parameters to the intra-arterial translesional pressure gradient. A translesional pressure gradient ≥10 mmHg, PSVR ≥2.5, and a monophasic or biphasic CFA velocity waveform were considered to be indicative for a hemodynamically significant iliac artery stenosis. RESULTS: For classification of ipsilateral CFA velocity waveforms, intraobserver and interobserver agreement were 0.94 and 0.82, respectively. A PSVR ≥2.5 could identify a hemodynamically significant stenosis with 83% sensitivity, 67% specificity, and an overall accuracy of 77%. When both a monophasic and a biphasic velocity waveform were considered to indicate a hemodynamically significant iliac artery stenosis, sensitivity was 78%, specificity was 50%, and the overall accuracy was 69%. The combination of a PSVR ≥2.5 with either a monophasic or a biphasic CFA velocity waveform was found in 20 stenoses and resulted in 94% sensitivity, 75% specificity, and 90% accuracy. When the remainder of the stenoses (N.=15) was classified by means of the PSVR, the overall accuracy remained 77%. CONCLUSIONS: DUS is a very useful noninvasive imaging modality to determine the significance of an iliac artery stenosis. A combination of translesional PSVR ≥2.5 with either a monophasic or a biphasic ipsilateral CFA ultrasound waveforms has a good accuracy and helps to select patients that benefit most from follow-up examination by computed tomography angiography or magnetic resonance angiography.


Asunto(s)
Arteriopatías Oclusivas/diagnóstico por imagen , Arteriopatías Oclusivas/fisiopatología , Presión Arterial/fisiología , Arteria Femoral/diagnóstico por imagen , Arteria Ilíaca/diagnóstico por imagen , Arteria Ilíaca/fisiopatología , Ultrasonografía Doppler Dúplex , Adulto , Anciano , Angiografía , Índice Tobillo Braquial , Velocidad del Flujo Sanguíneo/fisiología , Femenino , Arteria Femoral/fisiopatología , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Sensibilidad y Especificidad
11.
J Am Heart Assoc ; 6(12)2017 12 23.
Artículo en Inglés | MEDLINE | ID: mdl-29275367

RESUMEN

BACKGROUND: Currently, the decision to treat iliac artery stenoses is mainly based on visual inspection of digital subtraction angiographies. Intra-arterial pressure measurements can provide clinicians with accurate hemodynamic information. However, pressure measurements are rarely performed because of their invasiveness and the time required. Therefore, the aim of the study was to test the feasibility of a computational model that can predict translesional pressure gradients across iliac artery stenoses on the basis of imaging data only. METHODS AND RESULTS: Patients (N=21) with symptomatic peripheral arterial disease and a peak systolic velocity ratio between 2.5 and 5.0 were included in the study. Patients underwent per-procedural 3-dimensional rotational angiography and hyperemic intra-arterial translesional pressure measurements. Vascular anatomical features were reconstructed from the 3-dimensional rotational angiography data into an axisymmetrical 2-dimensional computational mesh, and flow was estimated on the basis of the stenosis geometry. Computational fluid dynamics were performed to predict the pressure gradient and were compared with the measured pressure gradients. A good agreement by overlapping error bars of the predicted and measured pressure gradients was found in 21 of 25 lesions. Stratification of the stenosis on the basis of the predicted pressure gradient into hemodynamic not significant (<10 mm Hg) and hemodynamic significant (≥10 mm Hg) resulted in sensitivity, specificity, and overall predictive values of 95%, 60%, and 88%, respectively. CONCLUSIONS: The feasibility of the patient-specific computational model to predict the hyperemic translesional pressure gradient over iliac artery stenosis was successfully tested. Presented results suggest that, with further optimization and corroboration, the model can become a valuable aid to the diagnosis of equivocal iliac artery stenosis. CLINICAL TRIAL REGISTRATION: URL: http://www.trialregister.nl. Unique identifier: NTR5085.


Asunto(s)
Arteriopatías Oclusivas/fisiopatología , Velocidad del Flujo Sanguíneo/fisiología , Determinación de la Presión Sanguínea/métodos , Presión Sanguínea/fisiología , Arteria Ilíaca/fisiopatología , Adulto , Anciano , Angiografía de Substracción Digital , Arteriopatías Oclusivas/diagnóstico , Femenino , Estudios de Seguimiento , Humanos , Arteria Ilíaca/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Curva ROC , Índice de Severidad de la Enfermedad
12.
J Endovasc Ther ; 24(6): 783-792, 2017 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-28795638

RESUMEN

PURPOSE: To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions. METHODS: The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography. RESULTS: Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively. CONCLUSION: The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.


Asunto(s)
Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Arteria Femoral , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Stents Metálicos Autoexpandibles , Dispositivos de Acceso Vascular , Anciano , Aleaciones , Angiografía , Angioplastia de Balón/efectos adversos , Fármacos Cardiovasculares/efectos adversos , Diseño de Equipo , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Alemania , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Paclitaxel/efectos adversos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Estudios Prospectivos , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Doppler Dúplex , Grado de Desobstrucción Vascular
13.
Trials ; 14: 87, 2013 Mar 28.
Artículo en Inglés | MEDLINE | ID: mdl-23537403

RESUMEN

BACKGROUND: Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow(®) paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm. METHODS/DESIGN: A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera(®) stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention. DISCUSSION: The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting. TRIAL REGISTRATION: ISRCTN47846578.


Asunto(s)
Angioplastia de Balón/instrumentación , Arteriopatías Oclusivas/terapia , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Arteria Femoral , Paclitaxel/administración & dosificación , Proyectos de Investigación , Stents , Dispositivos de Acceso Vascular , Aleaciones , Amputación Quirúrgica , Angiografía de Substracción Digital , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Índice Tobillo Braquial , Arteriopatías Oclusivas/diagnóstico , Arteriopatías Oclusivas/mortalidad , Arteriopatías Oclusivas/fisiopatología , Protocolos Clínicos , Constricción Patológica , Diseño de Equipo , Falla de Equipo , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Hemodinámica , Humanos , Hiperplasia , Recuperación del Miembro , Neointima , Países Bajos , Valor Predictivo de las Pruebas , Diseño de Prótesis , Falla de Prótesis , Recurrencia , Resinas de Plantas , Método Simple Ciego , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Doppler Dúplex
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