RESUMEN
Purpose: Immunotherapy combined with chemotherapy have synergistic effects in multiple malignancies. We aimed to compare the efficacy and safety of toripalimab plus hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil, and leucovorin versus lenvatinib in advanced hepatocellular carcinoma (HCC). Materials and Methods: We conducted this retrospective study at 3 hospitals in China and eligible patients were 18 years or older and had a primary diagnosis of unresectable HCC with macroscopic vascular invasion and/or extrahepatic spread. These patients were treated with toripalimab plus HAIC or lenvatinib monotherapy. The primary endpoint was progression-free survival (PFS) and the secondary endpoints were overall survival (OS), disease control rate per response evaluation criteria in solid tumors (RECIST) 1.1, and objective response rate (ORR) per RECIST 1.1. The results were compared by Student's test or the chi-square test, and the survival curves were calculated by the Kaplan-Meier method, and propensity-score matching (PSM) was used to reduce bias. Results: A total of 118 patients were recruited for this study: 53 in the TorHAIC group and 65 in the lenvatinib group. We found that the TorHAIC group showed a longer PFS (9.3 [95% CI, 7.81-10.8] vs 4.8 months [95% CI, 3.31-6.29]; hazard ratio [HR] = 0.57, 95% CI, 0.38-0.85; p = .006), a longer OS (17.13 [95% CI, 13.99-20.27] vs 10.1 months [95% CI, 8.14-12.06]; HR = 0.5, 95% CI, 0.31 - 0.81; p = .005), a higher disease control rate (86.8% vs 69.2%, p = .002) and a higher ORR (47.2% vs 9.2%, p < .001) by RECIST criteria than the lenvatinib group. Both toripalimab plus HAIC and lenvatinib had acceptable safety profiles. No treatment-related deaths occurred in this study. In the propensity score-matched cohorts (47 pairs), the outcomes in the TorHAIC group were also better than those in the lenvatinib group (p < .05). Conclusion: Toripalimab plus HAIC was tolerable and effective in advanced HCC and the result needs to be confirmed in the phase III trial.
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Anticuerpos Monoclonales Humanizados/uso terapéutico , Carcinoma Hepatocelular/terapia , Quimioembolización Terapéutica/métodos , Inhibidores de Puntos de Control Inmunológico/uso terapéutico , Neoplasias Hepáticas/terapia , Compuestos de Fenilurea/uso terapéutico , Inhibidores de Proteínas Quinasas/uso terapéutico , Quinolinas/uso terapéutico , Adulto , Anciano , Anticuerpos Monoclonales Humanizados/administración & dosificación , Carcinoma Hepatocelular/diagnóstico , Carcinoma Hepatocelular/mortalidad , Toma de Decisiones Clínicas , Terapia Combinada , Manejo de la Enfermedad , Femenino , Humanos , Inhibidores de Puntos de Control Inmunológico/administración & dosificación , Infusiones Intraarteriales/instrumentación , Infusiones Intraarteriales/métodos , Estimación de Kaplan-Meier , Neoplasias Hepáticas/diagnóstico , Neoplasias Hepáticas/mortalidad , Masculino , Persona de Mediana Edad , Compuestos de Fenilurea/administración & dosificación , Pronóstico , Quinolinas/administración & dosificación , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
INTRODUCTION: Variant hepatic arterial anatomy (vHAA) is thought to occur in 20-30% of patients. Hepatic arterial infusion (HAI) pump placement for liver cancers requires thorough hepatic artery dissection; we sought to compare vHAA identified during pump placement with established dogma. METHODS: Between 2016 and 2020, n = 30 patients received a HAI pump. Intra-operatively identified vHAA was characterized and compared with published data. RESULTS: vHAA was identified in 60% (n = 18) of patients, significantly higher than 19% (3671 of 19013) in the largest published series (P < 0.001). The most common variations were accessory left (n = 12; 40%) and replaced right (n = 6; 20%) hepatic arteries; six (20%) had ≥2 variants. Pre-operative imaging correctly identified 67% of variant hepatic arteries. DISCUSSION: Meticulous operative dissection of the hepatic arterial tree reveals vHAA not captured by imaging or cadaveric dissection. vHAA likely has a higher prevalence than previously reported and should be addressed to optimize therapeutic efficacy of HAI pump therapy.
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Arteria Hepática/anomalías , Bombas de Infusión , Infusiones Intraarteriales/métodos , Adulto , Anciano , Femenino , Arteria Hepática/anatomía & histología , Arteria Hepática/diagnóstico por imagen , Arteria Hepática/cirugía , Humanos , Infusiones Intraarteriales/instrumentación , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Tomografía Computarizada por Tomografía Computarizada de Emisión de Fotón Único , Tomografía Computarizada por Rayos XAsunto(s)
Antineoplásicos/historia , Protocolos de Quimioterapia Combinada Antineoplásica/historia , Arteria Hepática , Infusiones Intraarteriales/historia , Neoplasias Hepáticas/historia , Antineoplásicos/administración & dosificación , Historia del Siglo XX , Historia del Siglo XXI , Humanos , Infusiones Intraarteriales/instrumentación , Infusiones Intraarteriales/métodos , Neoplasias Hepáticas/tratamiento farmacológico , Estados UnidosRESUMEN
To evaluate the benefits and risks of hepatic artery infusion (HAI) gemcitabine and floxuridine (FUDR) in patients with nasopharyngeal carcinoma liver metastases. HAI catheter systems were implanted under the guide of digital subtract angiography (DSA) in 16 patients with unresectable nasopharyngeal carcinoma liver metastases. HAI gemcitabine and FUDR in combination with radiotherapy and systemic chemotherapy were delivered. Disease control rate (DCR) of intrahepatic lesions is 100%, objective response rate (ORR) of intrahepatic lesions is 87.5%, including 4 patients (25%) with complete response (CR), 10 patients (62.5%) with partial response (PR) and 2 patients (12.5%) with stable disease (SD). The median overall survival (mOS) was 30 months. There was no significant difference between patients with < 9 intrahepatic lesions and patients with ≥ 9 intrahepatic lesions (31 months vs. 24 months, P = 0.562). Patients without extrahepatic metastases has longer survival than patients with extrahepatic metastases (31 months vs. 17 months, P = 0.005). In all 72 cycles of HAI, the main grade 3/4 toxicities related to HAI include: leukopenia occur in 8 cycles (11.1%), thrombocytopenia in 5 cycles (6.9%), AST/ALT elevation in 12 cycles (16.7). Catheter related complications occurred in 2 patients (12.5%). HAI gemcitabine and FUDR is effective to improve DCR of intrahepatic lesions and prolong mOS for patients with nasopharyngeal carcinoma liver metastases, and is associated with a relative low rate of toxicity.
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Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Neoplasias Hepáticas/tratamiento farmacológico , Carcinoma Nasofaríngeo/tratamiento farmacológico , Neoplasias Nasofaríngeas/tratamiento farmacológico , Adulto , Anciano , Angiografía de Substracción Digital , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Desoxicitidina/administración & dosificación , Desoxicitidina/análogos & derivados , Femenino , Floxuridina/administración & dosificación , Estudios de Seguimiento , Arteria Hepática/diagnóstico por imagen , Humanos , Bombas de Infusión , Infusiones Intraarteriales/efectos adversos , Infusiones Intraarteriales/instrumentación , Estimación de Kaplan-Meier , Hígado/irrigación sanguínea , Hígado/patología , Neoplasias Hepáticas/mortalidad , Neoplasias Hepáticas/secundario , Masculino , Persona de Mediana Edad , Carcinoma Nasofaríngeo/mortalidad , Carcinoma Nasofaríngeo/secundario , Neoplasias Nasofaríngeas/mortalidad , Neoplasias Nasofaríngeas/patología , Estudios Retrospectivos , Resultado del Tratamiento , Dispositivos de Acceso Vascular , GemcitabinaRESUMEN
BACKGROUND: Recurrences are reported in 70% of all patients after resection of colorectal liver metastases (CRLM), in which half are confined to the liver. Adjuvant hepatic arterial infusion pump (HAIP) chemotherapy aims to reduce the risk of intrahepatic recurrence. A large retrospective propensity score analysis demonstrated that HAIP chemotherapy is particularly effective in patients with low-risk oncological features. The aim of this randomized controlled trial (RCT) --the PUMP trial-- is to investigate the efficacy of adjuvant HAIP chemotherapy in low-risk patients with resectable CRLM. METHODS: This is an open label multicenter RCT. A total of 230 patients with resectable CRLM without extrahepatic disease will be included. Only patients with a clinical risk score (CRS) of 0 to 2 are eligible, meaning: patients are allowed to have no more than two out of five poor prognostic factors (disease-free interval less than 12 months, node-positive colorectal cancer, more than 1 CRLM, largest CRLM more than 5 cm in diameter, serum Carcinoembryonic Antigen above 200 µg/L). Patients randomized to arm A undergo complete resection of CRLM without any adjuvant treatment, which is the standard of care in the Netherlands. Patients in arm B receive an implantable pump at the time of CRLM resection and start adjuvant HAIP chemotherapy 4-12 weeks after surgery, with 6 cycles of floxuridine scheduled. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival, hepatic PFS, safety, quality of life, and cost-effectiveness. Pharmacokinetics of intra-arterial administration of floxuridine will be investigated as well as predictive biomarkers for the efficacy of HAIP chemotherapy. In a side study, the accuracy of CT angiography will be compared to radionuclide scintigraphy to detect extrahepatic perfusion. We hypothesize that adjuvant HAIP chemotherapy leads to improved survival, improved quality of life, and a reduction of costs, compared to resection alone. DISCUSSION: If this PUMP trial demonstrates that adjuvant HAIP chemotherapy improves survival in low-risk patients, this treatment approach may be implemented in the standard of care of patients with resected CRLM since adjuvant systemic chemotherapy alone has not improved survival. TRIAL REGISTRATION: The PUMP trial is registered in the Netherlands Trial Register (NTR), number: 7493 . Date of registration September 23, 2018.
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Antimetabolitos Antineoplásicos/administración & dosificación , Neoplasias Colorrectales/patología , Floxuridina/administración & dosificación , Hepatectomía , Neoplasias Hepáticas/terapia , Recurrencia Local de Neoplasia/prevención & control , Adulto , Quimioterapia Adyuvante/instrumentación , Quimioterapia Adyuvante/métodos , Ensayos Clínicos Fase III como Asunto , Neoplasias Colorrectales/mortalidad , Humanos , Bombas de Infusión Implantables , Infusiones Intraarteriales/instrumentación , Infusiones Intraarteriales/métodos , Neoplasias Hepáticas/mortalidad , Neoplasias Hepáticas/secundario , Estudios Multicéntricos como Asunto , Países Bajos , Supervivencia sin Progresión , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Adulto JovenAsunto(s)
Arteria Hepática , Bombas de Infusión Implantables/ética , Infusiones Intraarteriales/instrumentación , Medicina de Precisión/ética , Recall y Retirada del Producto/ética , Política de Salud , Humanos , Bombas de Infusión Implantables/economía , Infusiones Intraarteriales/economía , Infusiones Intraarteriales/ética , Medicina de Precisión/economía , Estados UnidosRESUMEN
PURPOSE: To develop an implantable port in which a microcatheter can be inserted for a combination therapy of repeated transarterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) for advanced liver cancer. MATERIALS AND METHODS: The design of a currently used implantable port was modified. A funnel part was constructed in the port. The septum was punctured by a 20-gauge indwelling needle, and 2.0-Fr non-tapered microcatheter was inserted into the port. In the in vitro studies, the advance of a microcatheter out of the funnel part was evaluated via seven different septum puncture sites. A 5-Fr indwelling catheter connected to the port was placed in a vascular model, and a microcatheter catheterization was evaluated. In an in vivo study, the port-catheter system was implanted in the hepatic artery in a pig. A microcatheter was percutaneously inserted through the port into the hepatic arterial branches, and embolization was performed. RESULTS: In the in vitro studies, the microcatheter was smoothly advanced out of the port and catheterizations into the hepatic arteries were successful via all septum puncture sites. In the in vivo study, repeated selective embolization through the port was successfully conducted on 7, 14 and 21 days after the implantation. CONCLUSION: The developed implantable port can be used for repeated catheter insertion into the hepatic artery. The combination of repeated TACE and HAIC could be possible using this device.
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Antineoplásicos/administración & dosificación , Catéteres de Permanencia , Quimioembolización Terapéutica/instrumentación , Arteria Hepática , Infusiones Intraarteriales/instrumentación , Neoplasias Hepáticas/tratamiento farmacológico , Animales , Modelos Animales de Enfermedad , Estudios de Factibilidad , PorcinosRESUMEN
PURPOSE: We developed an external carotid arterial sheath (ECAS) for performing intra-arterial chemotherapy (IACT) via the superficial temporal artery for head and neck cancer. This study aimed to assess the potential of a novel microcatheter with a steerable tip inserted through the ECAS in comparison to an existing hook-type microcatheter. MATERIALS AND METHODS: The same operator used two types of microcatheters alternately for each weekly IACT session with the same patient, and the fluoroscopy time required for catheterization and the arterial selectivity of each microcatheter were compared. RESULTS: Ten patients with advanced head and neck cancer were enrolled. The steerable microcatheter significantly shortened the fluoroscopy time required for catheterization in comparison to the hook-type microcatheter (45.9 ± 4.8 vs 70.2 ± 9.8 s, p < 0.02). The arterial selectivity was equivalent [97.1%, (34/35) vs 88.6%, (31/35), p = 0.36]. No serious adverse events were observed in association with the procedure. CONCLUSION: In combination with an ECAS, the steerable microcatheter might be more useful than the hook-type microcatheter.
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Arterias Carótidas , Cateterismo/instrumentación , Catéteres , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Adulto , Anciano , Femenino , Fluoroscopía , Neoplasias de Cabeza y Cuello/diagnóstico por imagen , Humanos , Infusiones Intraarteriales/instrumentación , Infusiones Intraarteriales/métodos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND: The treating aims of ST-segment elevation myocardial infarction (STEMI) are vessels recanalization and coronary flow restoration. Coronary slow flow phenomenon (CSFP) is one of the common complications in STEMI patients after percutaneous coronary intervention (PCI) and leads to a higher incidence of adverse clinical outcomes. Alprostadil is a kind of liposomal prostaglandin E1 with beneficial effects on vasodilation, platelet disaggregation and fibrinolysis. But it still remains unclear that whether alprostadil can improve the coronary perfusion in STEMI patients with CSFP after PCI. METHODS: In this study, a total of 57 STEMI cases with CSFP were included, 28 of which received 2⯵g alprostadil by intracoronary infusion with targeted perfusion microcatheter while the others received 200⯵g nitroglycerin. Coronary angiograms were analyzed by two experienced interventional cardiologists who were blinded to the medicine administration. RESULTS: We found that compared with nitroglycerin, alprostadil treatment was significantly more effective in increasing the incidence of TFG 3(78.6% vs. 48.3%, Pâ¯=â¯0.021), MBG 3(46.4% vs. 20.7%, Pâ¯=â¯0.039), TMPG 3(53.6% vs. 24.1%, Pâ¯=â¯0.022) and complete STR (42.8% vs. 17.2%, Pâ¯=â¯0.035) and reducing cTFC (28.71 frames vs. 46.03 frames, Pâ¯=â¯0.001). Furthermore, in this study, intracoronary infusion of alprostadil with targeted perfusion microcatheter hardly affected the blood pressure and heart rate of patients, and no threaten complication were observed. CONCLUSIONS: Alprostadil can effectively alleviate CSFP, which is at the same time secure even for STEMI patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT03296670.
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Alprostadil/administración & dosificación , Sistemas de Liberación de Medicamentos/métodos , Infusiones Intraarteriales/métodos , Nitroglicerina/administración & dosificación , Fenómeno de no Reflujo/tratamiento farmacológico , Infarto del Miocardio con Elevación del ST/tratamiento farmacológico , Anciano , Catéteres , Método Doble Ciego , Sistemas de Liberación de Medicamentos/instrumentación , Femenino , Humanos , Infusiones Intraarteriales/instrumentación , Masculino , Persona de Mediana Edad , Fenómeno de no Reflujo/diagnóstico por imagen , Inhibidores de Agregación Plaquetaria/administración & dosificación , Estudios Prospectivos , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Vasodilatadores/administración & dosificaciónRESUMEN
BACKGROUND: Intracranial access techniques in modern neurointerventions have shifted towards more robust access platforms. The long guide sheath is one of the building blocks of triaxial systems used in intracranial embolizations. Here we present our experience with the AXS Infinity LS long sheath in the triaxial platform for the implantation of the Pipeline embolization device (PED). METHODS: We retrospectively identified patients who underwent PED Flex treatment with the AXS Infinity LS at a single institution. Procedural data collected included parent artery tortuosity, patient demographics, vasodilator use, aneurysm characteristics, equipment utilized, and catheter-related complications. RESULTS: A total of 95 cases were completed using the AXS Infinity LS for the triaxial platform foundation in PED Flex treatment of cerebral aneurysms. Mean patient age was 56.2±12.2 years (range 21-86). Average aneurysm size was 6.9±6.2 mm (range 1-38). There were 89 anterior circulation cases (94%) and 6 posterior circulation cases (6%). Significant cervical ICA tortuosity was present in 11/89 (12%) and moderate to severe cavernous ICA tortuosity was present in 29/89 (33%). Mean fluoroscopy time was 40.0±19.8 min. In 14/95 cases (15%), vasospasm prophylaxis or treatment with intra-arterial verapamil infusion was performed. Catheter access-related complications included asymptomatic iatrogenic dissection in one case (1%) from the distal intracranial catheter and groin hematoma in one case (1%). No parent vessel wall abnormalities were visualized in the region of the Infinity long sheath on final control angiography in all 95 cases. CONCLUSION: The AXS Infinity LS is the newest long guide sheath available for modern neurointerventional procedures. We have shown its utility in augmenting the triaxial access platform in PED Flex cases by providing enhanced distal tip trackability with added support in the aortic arch and proximal great vessels.
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Embolización Terapéutica/instrumentación , Embolización Terapéutica/estadística & datos numéricos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Adulto , Anciano , Anciano de 80 o más Años , Angiografía/métodos , Cateterismo/métodos , Embolización Terapéutica/métodos , Femenino , Fluoroscopía/métodos , Humanos , Infusiones Intraarteriales/instrumentación , Infusiones Intraarteriales/métodos , Embolia Intracraneal/diagnóstico por imagen , Embolia Intracraneal/terapia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE: The purpose of this study was to describe a novel system for treating advanced head and neck cancer consisting of an external carotid arterial sheath (ECAS) and a microcatheter to inject drugs retrogradely into multiple feeding arteries through the superficial temporal artery (STA). MATERIALS AND METHODS: Four consecutive patients with head and neck cancer that had more than one feeding artery were enrolled in this study. The ECAS was made of polyurethane and surface-coated with heparin resin to prevent thrombus formation, allowing it to remain in place for a prolonged period of time. The ECAS was inserted through the STA, and its tip was placed between the maxillary artery and facial artery. The tumor-feeding arteries were selected using a hooked-shaped microcatheter through the ECAS. RESULTS: A total of 13 target arteries were selected in the four patients. The microcatheter inserted via the ECAS was used to catheterize ten arteries (five lingual arteries and five facial arteries). The remaining three lingual arteries were directly selected by the catheter without ECAS. All of the target arteries were able to be catheterized superselectively. The technical success rate was 100%. Vascular occlusion, which might have been caused by the ECAS, was observed in one patient. No neurologic toxicities occurred. CONCLUSION: This ECAS system is a new approach for retrograde superselective intra-arterial chemotherapy that covers the entire tumor with anticancer drugs. It has the potential to increase the effectiveness of therapy for advanced head and neck cancer. LEVEL OF EVIDENCE: Level 4, Case Series.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Arteria Carótida Externa , Catéteres de Permanencia , Cisplatino/administración & dosificación , Materiales Biocompatibles Revestidos , Heparina , Infusiones Intraarteriales/instrumentación , Neoplasias de Oído, Nariz y Garganta/irrigación sanguínea , Neoplasias de Oído, Nariz y Garganta/tratamiento farmacológico , Poliuretanos , Anciano , Diseño de Equipo , Femenino , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias de Oído, Nariz y Garganta/patología , Arterias TemporalesRESUMEN
A promising strategy for liver cancer treatment is to deliver chemotherapeutic agents with multifunctional carriers into the tumor tissue via intra-arterial (IA) transcatheter infusion. These carriers should release drugs within the target tissue for prolonged periods and permit intra-procedural multi-modal imaging of selective tumor delivery. This targeted transcatheter delivery approach is enabled via the arterial blood supply to liver tumors and utilized in current clinical practice which is called chemoembolization or radioembolization. During our study, we developed Doxorubicin (Dox) loaded porous magnetic nano-clusters (Dox-pMNCs). The porous structure and carboxylic groups on the MNCs achieved high-drug loading efficiency and sustained drug release, along with magnetic properties resulting in high MRI T2-weighted image contrast. Dox-pMNC within iodinated oil, Dox-pMNCs, and Dox within iodinated oil were infused via hepatic arteries to target liver tumors in a rabbit model. MRI and histological evaluations revealed that the long-term drug release and retention of Dox-pMNCs within iodinated oil induced significantly enhanced liver cancer cell death.
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Antibióticos Antineoplásicos/administración & dosificación , Preparaciones de Acción Retardada/química , Doxorrubicina/administración & dosificación , Sistemas de Liberación de Medicamentos/instrumentación , Infusiones Intraarteriales/instrumentación , Neoplasias Hepáticas/tratamiento farmacológico , Hígado/efectos de los fármacos , Animales , Antibióticos Antineoplásicos/uso terapéutico , Doxorrubicina/uso terapéutico , Halogenación , Hígado/irrigación sanguínea , Hígado/patología , Neoplasias Hepáticas/irrigación sanguínea , Neoplasias Hepáticas/patología , Nanopartículas de Magnetita/química , Aceites/química , Porosidad , ConejosRESUMEN
Hepatic artery infusion (HAI) therapy is a well-studied and viable regional therapy for patients with hepatic metastases. Implantable pump devices may be safely placed intraarterially with minimal morbidity and HAI treatments can be used as an adjunct to systemic therapy. Future trials may address sequencing of regional and systemic therapies. However, HAI is not without complications and requires close monitoring and attention to detail but can offer reasonable control of liver tumor burden when managed jointly between medical and surgical oncologists. Herein we describe the technical aspects of HAI pump placement and review pertinent studies in primary and secondary liver tumors.
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Antineoplásicos/administración & dosificación , Arteria Hepática , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Colorrectales/patología , Humanos , Infusiones Intraarteriales/instrumentación , Neoplasias Hepáticas/secundarioRESUMEN
BACKGROUND: The authors herein describe a novel method of repeatable hepatic isolation using an implantable access system allowing simultaneous control of hepatic arterial and portal flows by multiple endovascular catheters. PURPOSE: The aim of this study was to assess the feasibility and safety of the system and to compress standard intravenous chemotherapy into 4 weeks of targeted intra-arterial delivery. METHODS: An arterial access system was implanted to the axillary artery via an anastomosis. Infusions of oxaliplatin were performed biweekly for 4 weeks, using balloon catheters to achieve hepatic isolation and segmental selectivity for 20-25 min. Fifty-seven treatments under general anesthetic were performed in ten patients with inoperable chemotherapy-refractory metastatic colorectal cancer. Systemic, intrahepatic, and hepatic venous pressures were recorded to assess vascular isolation, and platinum levels were measured to assess chemotherapy distribution. RESULTS: Pressure verified, multiple day-only hepatic vascular isolation infusions were achieved in nine of ten patients, with a single patient receiving multiple hepatic arterial infusions. Positron emission tomography-computed tomography (PET-CT) imaging confirmed partial response in three of ten patients and stable disease in three of ten patients. Systemic toxicity was minimal as all treatment-related gastrointestinal and neuropathic symptoms reported throughout the 4 weeks were grades 1-2. CONCLUSIONS: Intra-arterial chemotherapy infusions with hepatic vascular isolation can be achieved repeatedly with targeted selectivity and minimal complications using an implantable multicatheter access system. Oxaliplatin infusions over a 4-week period may achieve tumor response in selected patients in the salvage setting. The technique should be further assessed in a phase Ib/II study.
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Antineoplásicos/administración & dosificación , Neoplasias Colorrectales/patología , Neoplasias Hepáticas/tratamiento farmacológico , Compuestos Organoplatinos/administración & dosificación , Dispositivos de Acceso Vascular , Anciano , Antineoplásicos/efectos adversos , Antineoplásicos/sangre , Arteria Axilar , Estudios de Factibilidad , Femenino , Humanos , Infusiones Intraarteriales/instrumentación , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/secundario , Masculino , Persona de Mediana Edad , Compuestos Organoplatinos/efectos adversos , Compuestos Organoplatinos/sangre , Oxaliplatino , Proyectos Piloto , Tomografía Computarizada por Tomografía de Emisión de Positrones , Retratamiento/efectos adversos , Dispositivos de Acceso Vascular/efectos adversos , Presión VenosaRESUMEN
PURPOSE: Previous reports have shown the effectiveness of adjuvant hepatic arterial infusion chemotherapy (HAIC) in pancreatic cancer. However, percutaneous catheter placement is technically difficult after pancreatic surgery. The purpose of this study was to evaluate the feasibility and outcome of HAIC using a coaxial technique compared with conventional technique for postoperative pancreatic cancer. MATERIALS AND METHODS: 93 consecutive patients who received percutaneous catheter-port system placement after pancreatectomy were enrolled. In 58 patients from March 2006 to August 2010 (Group A), a conventional technique with a 5-Fr indwelling catheter was used and in 35 patients from September 2010 to September 2012 (Group B), a coaxial technique with a 2.7-Fr coaxial catheter was used. RESULTS: The overall technical success rates were 97.1 % in Group B and 86.2 % in Group A. In cases with arterial tortuousness and stenosis, the success rate was significantly higher in Group B (91.7 vs. 53.8 %; P = 0.046). Fluoroscopic and total procedure times were significantly shorter in Group B: 14.7 versus 26.7 min (P = 0.001) and 64.8 versus 80.7 min (P = 0.0051), respectively. No differences were seen in the complication rate. The 1 year liver metastasis rates were 9.9 % using the conventional system and 9.1 % using the coaxial system (P = 0.678). The overall median survival time was 44 months. There was no difference in the survival period between two systems (P = 0.312). CONCLUSIONS: The coaxial technique is useful for catheter placement after pancreatectomy, achieving a high success rate and reducing fluoroscopic and procedure times, while maintaining the safety and efficacy for adjuvant HAIC in pancreatic cancer.
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Catéteres de Permanencia , Infusiones Intraarteriales/instrumentación , Infusiones Intraarteriales/métodos , Neoplasias Pancreáticas/tratamiento farmacológico , Neoplasias Pancreáticas/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Quimioterapia Adyuvante , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pancreatectomía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE: To assess the technical feasibility of transfemoral intra-arterial chemotherapy for head and neck cancer using a 3-French catheter system (3-Fr). MATERIALS AND METHODS: Sixty-two patients with head and neck cancer who underwent transfemoral intra-arterial chemotherapy were included in this study. Thirty-three patients underwent treatment using a 3-Fr (group 3-Fr). Twenty-nine patients underwent treatment using a 4-French catheter system (group 4-Fr). The technical success rate, duration of the procedure with fluoroscopy, and rate of procedure-related complications were compared between group 3-Fr and group 4-Fr. In addition, in group 3-Fr, bleeding at the puncture site after 1.5 h of bed rest was evaluated. RESULTS: The technical success rate was 100% in both groups. The duration of the procedure with fluoroscopy didn't differ between group 3-Fr (mean 28.0 min) and group 4-Fr (mean 30.2 min) (p = 0.524). There was no procedure-related complication in either group. In group 3-Fr, no hemorrhagic complication was observed. CONCLUSION: A 3-French catheter system can be used to perform transfemoral intra-arterial chemotherapy for head and neck cancer and is technically feasible with approximately the same duration of the procedure with fluoroscopy. Furthermore, this method may shorten the bed rest time without hemorrhagic complication, and may reduce the risk of pulmonary embolism.
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Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Infusiones Intraarteriales/instrumentación , Anciano , Anciano de 80 o más Años , Estudios de Factibilidad , Femenino , Arteria Femoral , Fluoroscopía , Neoplasias de Cabeza y Cuello/diagnóstico por imagen , Humanos , Masculino , Persona de Mediana Edad , Seguridad del Paciente , Punciones , Estudios RetrospectivosRESUMEN
PURPOSE: To evaluate the incidence, cause, and management of delivery system occlusions during yttrium-90 (90Y) microsphere infusions and to identify techniques to prevent occlusions. MATERIALS AND METHODS: A retrospective review was conducted of 885 consecutive radioembolization deliveries during 820 procedures (some with multiple deliveries) in 503 patients (mean age, 65 y; 293 male) performed between June 2001 and July 2013 at a single academic tertiary care hospital. Occlusions were reported prospectively, and procedural details were reviewed. Statistical analysis assessed associations between catheter occlusions and patient and procedural characteristics. RESULTS: Of 885 90Y microsphere deliveries, 11 resulted in occlusion (1.2%). Five occlusions were associated with contained leakage of radioactive material, and one was associated with a spill. Treatment was completed in the same day in 10 patients; repeat catheterization was required in five patients. One patient returned 1 week later to complete treatment. Occlusions were more frequent with deliveries of resin (11/492; 2.2%) versus glass (0/393; 0%) microspheres (P = .002). Occlusions were more likely to occur within the proximal portion of the delivery apparatus (P = .002). There was no significant relationship with any patient characteristics, and there was no improvement with operator experience. The most common cause of occlusion was resin microsphere delivery device failure. CONCLUSIONS: (90)Y microsphere delivery device occlusion is uncommon but does occur with resin microspheres. Understanding causes and how to troubleshoot can limit the incidence and detrimental effects.
Asunto(s)
Cateterismo Periférico/instrumentación , Falla de Equipo/estadística & datos numéricos , Neoplasias Hepáticas/epidemiología , Neoplasias Hepáticas/radioterapia , Radiofármacos/administración & dosificación , Radioisótopos de Itrio/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Arteriopatías Oclusivas , Cateterismo Periférico/estadística & datos numéricos , Causalidad , Comorbilidad , Femenino , Humanos , Incidencia , Infusiones Intraarteriales/instrumentación , Infusiones Intraarteriales/estadística & datos numéricos , Masculino , Michigan/epidemiología , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Insuficiencia del Tratamiento , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVE: Intravascular catheter procedures are often performed in patients undergoing antithrombotic therapy. However, methods for the management of antithrombotic agents in the perioperative period are currently unclear. Therefore, the safety and management of antithrombotic agents in these patients were investigated. METHODS: A prospective, multicenter, observational study [Management of Antithrombotic Agents During Surgery or Medical Procedures with Bleeding (MARK study)] at 58 National Hospital Organization institutions in Japan was performed. 1,040 patients were enrolled in the MARK study and underwent an intravascular catheter procedure. For all participants, the details of the procedure, method of perioperative management of antithrombotic agents, and occurrence of thrombosis, embolism, and bleeding complications during the study period were investigated. RESULTS: The use of antithrombotic agents was continued in 1,017 patients (98%, continuation group) and discontinued in the other 23 (2%, discontinuation group). Continuation of the antithrombotic agents did not have a significant effect on the overall occurrence of thromboembolism [hazard ratio (HR), 0.15; p=0.08] or bleeding events (HR, 0.19; p=0.12). However, the overall adverse event risk was significantly lower in the continuation group than in the discontinuation group (HR, 0.18; p=0.03). CONCLUSION: It is both safe and appropriate to perform intravascular catheter procedures in patients continuing with antithrombotic therapy.
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Cateterismo Periférico/métodos , Fibrinolíticos/administración & dosificación , Infusiones Intraarteriales/instrumentación , Trombosis/prevención & control , Anciano , Catéteres de Permanencia , Femenino , Humanos , Incidencia , Infusiones Intraarteriales/métodos , Japón/epidemiología , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Seguridad del Paciente , Periodo Perioperatorio , Inhibidores de Agregación Plaquetaria/administración & dosificación , Pautas de la Práctica en Medicina , Estudios Prospectivos , Trombosis/complicaciones , Trombosis/epidemiologíaRESUMEN
With the wide application of intra-arterial therapy for cerebrovascular disorders, preclinical intra-arterial drug-delivery studies based on middle cerebral artery occlusion (MCAO) models have become urgent. In the present study, a novel stroke model was developed for intra-arterial drug delivery: MCAO and drug delivery were accomplished using a microcatheter device. MCAO was induced in Sprague-Dawley rats using the microcatheter device (cMCAO group, n=10) or a nylon suture (sMCAO group, n=10). After 24-h occlusion, neurological deficit and infarct volume were compared between the groups. Drug-delivery models used in stroke studies were compared with the present model to verify the drug-delivery ability of the microcatheter device. MCAO was induced using the microcatheter device in 21 Sprague-Dawley rats. At 4h after occlusion, 2% Evans blue dye was infused using different methods, and 1h later, the dye was extracted from each hemisphere and spectrophotometrically quantified. All cMCAO group rats showed neurological deficits; none developed subarachnoid hemorrhage or died before sacrifice. Neurological deficits and infarct volumes were similar in the cMCAO and sMCAO groups. Significantly more dye leakage occurred in the ischemic hemispheres of the rats that received the dye via the microcatheter device. Compared to other intra-arterial drug-delivery models used in stroke studies, the present model was easily established, had a high success rate, caused minimal surgical injury, and enabled highly efficient drug delivery. Thus, the present model is an efficient tool for investigating the effect of intra-arterial drug delivery on ischemic cerebral tissue.
Asunto(s)
Modelos Animales de Enfermedad , Infarto de la Arteria Cerebral Media/complicaciones , Infusiones Intraarteriales/instrumentación , Accidente Cerebrovascular/etiología , Animales , Infarto Encefálico/etiología , Infarto Encefálico/patología , Catéteres , Infusiones Intraarteriales/métodos , Masculino , Ratas Sprague-Dawley , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular/patología , Accidente Cerebrovascular/fisiopatologíaRESUMEN
PURPOSE: We retrospectively assessed the feasibility of a side-hole catheter placement with fixation and embolization in the common hepatic artery (CHA) (modified CHA-coil method) for hepatic arterial infusion (HAI) chemotherapy. MATERIALS AND METHODS: HAI catheter placement was attempted with modified CHA-coil method in five patients with unresectable hepatic malignancies between 2000 and 2013. The reason for using this method, the mode of catheter placement, and the duration of HAI were investigated. RESULTS: All patients had either occlusion or stenosis of the celiac artery (CA) or CHA, and, as a result, CHA blood flow had either reversed or decreased and hepatopetal GDA flow was observed. In three patients, the proper hepatic artery was extremely short. The side-hole catheter was inserted through the left subclavian artery and was placed from CA to the right gastroepiploic artery in an anterograde manner (n = 4) and from the superior mesenteric artery to the splenic artery in a retrograde manner through GDA (n = 1). The side hole of the catheter was positioned at the proximal portion of GDA. Using a separate catheter inserted from the right femoral artery, coils were placed around the indwelling catheter of CHA to embolize CHA and to fix the catheter. Coil mislocation was not observed, and catheter placement was successful in all patients. HAI chemotherapy was administered for a median of 136 days. The catheter displacement was not observed during HAI. CONCLUSION: The modified CHA-coil method can be used as a stable method for catheter placement when CHA is narrow or there is retrograde CHA blood flow.